29.6.

202 E Official Journal of the European L 165/1

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I
(Legislative acts)

REGULaTIONS

REGULATION (EU) 2023/1230 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 14 June 2023
on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council
and Council Directive 73/361/EEC
(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article

114 thereof, Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the ordinary legislative procedure

(2), Whereas:

(1) Directive2006/42/EC of the European Parliament and of the Council (3) was adopted in the
context of estab lishing the internal market, in order to harmonise health and safety
requirements for machinery in all Member States and to remove obstacles to trade in
machinery between Member States.

(2) The machinery sector is an important part of the engineering industry and is one of the
industrial mainstays of the Union economy. The social cost of the large number of accidents
caused directly by the use of machinery can be reduced by inherently safe design and
construction of machinery and by proper installation and maintenance.

(3) Experience with the application of Directive 2006/42/EC has shown inadequacies and
inconsistencies in the
product coverage and conformity assessment procedures. It is therefore necessary to improve,
simplify and adapt the provisions set out in that Directive to the needs of the market and
provide clear rules in relation to the framework within which products within the scope of
this Regulation may be made available on the market.

(4) Since the rules setting out the requirements for products within the scope of this Regulation,
in particular the essential health and safety requirements and the conformity assessment
procedures, need to be of uniform application for all operators across the Union, and not give
room for divergent implementation by Member States, Directive 2006/42/EC should be
replaced by a regulation.

(5) Member States are responsible for protecting, on their territory, the health and safety of
persons, in particular workers and consumers, and, where appropriate, domestic animals and
property, and, where applicable, for protecting the environment, notably in relation to the
risks arising out of the intended use or any reasonably foreseeable misuse of machinery or
related products. For the avoidance of doubt, domestic animals should be considered to
include farm animals.

(1) OJ C 517, 22.12.2021, p. 67.

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(2) Position of the European Parliament of 18 April 2023 (not yet published in the Official Journal) and
decision of the Council of 22 May 2023.
(3) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and
amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24).
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(6) Regulation (EC) No 765/2008 of the European Parliament and of the Council (4) lays down
rules on the accreditation of conformity assessment bodies, and the general principles of the
CE marking. That Regulation should be applicable to products within the scope of this
Regulation in order to ensure that those products, which are benefiting from the free
movement of goods within the Union, fulfil requirements providing for a high level of protection
of public interests such as the protection of the health and safety of persons and, where
appropriate, domestic animals and property, and, where applicable, of the environment.

(7) Regulation (EU) 2019/1020 of the European Parliament and of the Council (5) sets out rules on
market surveillance and control of products entering the Union market. As Directive
2006/42/EC is listed in Annex I of Regulation (EU) 2019/1020, that Regulation already applies
to products within the scope of this Regulation. However, Regulation (EU) 2019/1020 applies to
products within the scope of this Regulation insofar as there are no specific provisions with the
same objective, which regulate in a more specific manner particular aspects of market
surveillance and enforcement.

(8) Regulation (EU) 2019/1020 lays down the tasks of economic operators regarding products
subject to certain Union harmonisation legislation. It also provides that such products are to
be placed on the market only if there is an economic operator established in the Union who is
responsible for those tasks. That Union harmonisation legislation includes Directive
2006/42/EC. As a result, products within the scope of this Regulation are to be placed on
the market only if there is an economic operator established in the Union who is responsible
for the tasks set out in Regulation (EU) 2019/1020 in respect of those products.

(9) Decision No 768/2008/EC of the European Parliament and of the Council (6) lays down common
principles and reference provisions intended to apply across sectoral legislation. In order to
ensure consistency with other sectoral product legislation, it is appropriate to align certain
provisions of this Regulation to that Decision, insofar as sectoral specificities do not require a
different solution. Therefore, certain definitions, the general obligations of economic
operators, the rules on presumption of conformity, the rules on EU declaration of conformity,
the rules on CE marking, the requirements for conformity assessment bodies, the rules on
notifi cation procedures and conformity assessment procedures and the rules on procedures to
deal with machinery or related products, and, where applicable, with partly completed machinery,
presenting a risk should be adapted to the reference provisions laid down in that Decision.

(10) This Regulation should cover products which are new to the Union market when placed on the
market, and are either new products made by a manufacturer established in the Union or
products, whether new or second-hand, imported from a third country.

(11) Where there is a possibility that machinery or related products will be used by a consumer,
that is to say, a non- professional user, the manufacturer should take account of the fact that
the consumer does not have the same knowledge of and experience in handling machinery or
related products in the design and construction of the products. The same applies where the
machinery or related product is normally used to provide a service to a consumer.

(12) Recently, more advanced machinery, which is less dependent on human operators, has been
introduced on the market. Such machinery is working on defined tasks and in structured
environments, yet it can learn to perform new actions in this context and become more
autonomous. Further refinements to machinery, already in place or to be expected, include real-
time processing of information, problem solving, mobility, sensor systems, learning, adaptability,
and capability of operating in unstructured environments (for example construction sites). The
Commission Report on the safety and liability implications of Artificial Intelligence, the
Internet of Things and Robotics of 19 February 2020, states that the emergence of new digital
technologies, like artificial intelligence, the Internet of things and robotics, raises new
challenges in terms of product safety. The report concludes that the current product safety
legislation, including Directive 2006/42/EC, contains a number of gaps in this respect that need to
be addressed. Thus, this Regulation should cover the safety risks stemming from new digital
technologies.

(4) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out
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the requirements for accreditation and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30). 3
Union
(5) Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market
surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008
and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1.)
(6) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common
framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008,
p. 82).
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(13) In order to ensure protection of the health and safety of persons, and, where appropriate,
domestic animals and property, and, where applicable, of the environment, this Regulation
should apply to all forms of supply of products within the scope of this Regulation,
including distance selling as referred to in Regulation (EU) 2019/1020.

(14) In order to ensure legal certainty, the scope of this Regulation should be set out in a clear
manner and the concepts relating to its application should be defined as precisely as
possible.

(15) In order to ensure that the scope of this Regulation is sufficiently clear, a distinction should be
made between machinery, related products and partly completed machinery. Moreover, related
products should be understood as comprising interchangeable equipment, safety components,
lifting accessories, chains, ropes and webbing, and removable mechanical transmission devices,
which are all products within the scope of this Regulation.

(16) In order to avoid legislating twice on the same product, it is appropriate to exclude from the
scope of this Regulation weapons, including firearms, that are subject to Directive (EU) 2021/555
of the European Parliament and of the Council (7).

(17) The purpose of this Regulation is to address the risks stemming from machinery function
and not from the transport of goods, persons or animals. Consequently, this Regulation should not
apply to means of transport by air, on water and on rail networks although it should still apply
to the machinery mounted on those means of transport. Means of transport by road that are
not yet covered by a specific Union legal act should be regulated by this Regulation except in
respect of risks that might arise from circulation on public roads. This means that vehicles,
including e-bikes, e-scooters and other personal mobility devices that are not subject to
EU type approval under Regulation (EU) No 167/2013 of the European Parliament and of the
Council (8) or Regulation (EU) No 168/2013 of the European Parliament and of the Council
(9) or approval under Regulation (EU) 2018/858 of the European Parliament and of the
Council (10) are covered by this Regulation.

(18) Household appliances intended for domestic use which are not electrically operated furniture,
audio and video equipment, information technology equipment, office machinery, low-voltage
switchgear and control gear and electric motors fall within the scope of Directive 2014/35/EU
of the European Parliament and of the Council (11) and should therefore be excluded from
the scope of this Regulation. Some of those products, for example
washing machines, are progressively incorporating Wi-Fi functions and are therefore covered
by Directive
2014/53/EU of the European Parliament and of the Council (12) as radio equipment. Those
products should also be excluded from the scope of this Regulation.

(19) The evolution of the machinery sector has resulted in the growing use of digital means and
software plays a more and more important role in machinery design. Consequently, the
definition of machinery should be adapted. In this respect, machinery missing only the upload
of software intended for the specific application foreseen by the manufacturer, and which is the
subject of the conformity assessment procedure of the machinery, should fall under the
definition of machinery and not under the definitions of related products or partly completed
machinery. Furthermore, the definition of safety components should cover not only physical
devices but also digital devices. In order to take into account the increasing use of software as
a safety component, software that performs a safety function and which is placed
independently on the market should be considered a safety component.

(7) Directive (EU) 2021/555 of the European Parliament and of the Council of 24 March 2021 on control
of the acquisition and possession of weapons (OJ L 115, 6.4.2021, p. 1).
(8) Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the
approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1).
(9) Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the
approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p.
52).
(10) Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the
approval and market surveillance of motor vehicles and their trailers, and of systems, components and
separate technical units intended for such
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vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive
2007/46/EC (OJ L 151, 14.6.2018, p. 1).
(11) Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the
harmonisation of the laws of the Member States relating to the making available on the market of electrical
equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 357).
(12) Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the
harmonisation of the laws of the Member States relating to the making available on the market of radio
equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62).
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(20) Considering their critical protective function, certain components included in the indicative
list of safety components in Annex II should also be subject to specific conformity assessment
procedures and included in Annex I.

(21) Partly completed machinery is a product within the scope of this Regulation which needs to
undergo further construction in order to be able to perform its specific application, namely the
well-defined operations for which the product is designed. It is not necessary that all
requirements of this Regulation apply to partly completed machinery but, in order to ensure
the safety of the product as a whole, it is nevertheless important that the free movement of
such partly completed machinery be guaranteed by means of a specific procedure.

(22) Where products within the scope of this Regulation present risks that are addressed by the
essential health and safety requirements set out in this Regulation but which are also wholly or
partly covered by more specific Union harmonisation legislation than this Regulation, this
Regulation should not apply to the extent that those risks are covered by that other Union
legislation. In other cases, products within the scope of this Regulation might present risks
that are not covered by the essential health and safety requirements set out in this Regulation.
For example, products incorporating a Wi-Fi function might present risks not addressed by the
essential health and safety requirements set out in this Regulation, as this Regulation does not
deal with risks specific to such Wi-Fi function.

(23) For trade fairs, exhibitions and demonstrations or similar events, it should be possible to display
products within the scope of this Regulation which do not meet the requirements of this
Regulation, since this would not present any safety risk. However, for the sake of transparency,
interested parties should be properly informed that the products within the scope of this
Regulation are not compliant and cannot be purchased.

(24) The evolution of the state of the art in the machinery sector has an impact on the classification
of categories of machinery or related products listed in Annex I. With a view to properly
reflecting any categories of machinery or related products presenting a higher risk factor,
criteria should be established for the assessment of categories of products which should be
included in the list of categories of machinery or related products subject to a stricter
conformity assessment procedure.

(25) Other risks related to new digital technologies are those provoked by malicious third parties
that have an impact on the safety of products within the scope of this Regulation. In this respect,
manufacturers should be required to adopt proportionate measures which are limited to the
protection of the safety of the product within the scope of this Regulation. This does not preclude
the application to products within the scope of this Regulation of other Union legal acts
specifically addressing cybersecurity aspects.

(26) In order to ensure that machinery or related products, when placed on the market or put
into service, do not entail health and safety risks for persons or domestic animals and do not
cause harm to property, and, where applicable, to the environment, essential health and
safety requirements should be set out which have to be met in order for the machinery or
related products to be allowed on the market. Machinery or related products should comply with
the essential health and safety requirements when placed on the market or put into service.
Where such products are subsequently modified, by physical or digital means, in a way that
is not foreseen or planned by the manufacturer and which affects the safety of such
products by creating a new hazard or increasing an existing risk, the modification should be
considered as substantial when new significant protective measures are required. However,
repair and maintenance operations which do not affect the machinery or related product’s
compliance with the relevant essential health and safety requirements should not be considered to
be substantial modifications. In order to ensure the compliance of such a product with the
relevant essential health and safety requirements, the person that carries out the
substantial modification should be required to perform a new conformity assessment before
placing the modified product on the market or putting it into service. In order to avoid an
unnecessary and disproportionate burden, the person carrying out the substantial
modification should not be required to repeat tests and produce new documentation in relation to
machinery or related products that are part of an assembly of machinery, and that are not
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affected by the modification.

(27) In the machinery sector, approximately 98 % of companies are small or medium sized
enterprises (SMEs). In order to reduce the regulatory burden on SMEs, it is important that
notified bodies consider adapting the fees for conformity assessment and reducing them
proportionately to the specific interests and needs of SMEs.
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(28) Economic operators should be responsible for the compliance of products within the scope of
this Regulation with the requirements of this Regulation in relation to their respective roles in
the supply chain so as to ensure a high level of protection of public interests, such as the
protection of the health and safety of persons, in particular consumers and professional users, and,
where appropriate, domestic animals, property, and, where applicable, of the environment, as
well as fair competition on the Union market.

(29) All economic operators intervening in the supply and distribution chain should take
appropriate measures to ensure that they make available on the market only products
within the scope of this Regulation, which are in conformity with this Regulation. This
Regulation should provide a clear and proportionate distribution of obligations, which
correspond to the role of each economic operator in the supply and distribution chain.

(30) In order to facilitate communication between economic operators, market surveillance

authorities and users, manufacturers and importers should indicate a website, email address
or other digital contact in addition to the postal address.

(31) The manufacturer, having detailed knowledge of the design and production process, is best
placed to carry out the conformity assessment procedure. Conformity assessment should therefore
remain solely the obligation of the manufacturer.

(32) The manufacturer should also ensure that a risk assessment is carried out for the product within
the scope of this Regulation, which the manufacturer wishes to place on the market or put into
service. In this context, the manufacturer should determine which essential health and safety
requirements are applicable to the product within the scope of this Regulation and which
measures need to be taken to address the risks that the product might present. The risk
assessment should also address future updates or developments of software installed in the
machinery or related product, which are foreseen when the machinery or related product is
placed on the market or put into service. The risks identified during the risk assessment
should include those risks that might arise during the product’s lifecycle due to an intended
evolution of its behaviour to operate with varying levels of autonomy.

(33) The safety of the entire machinery or related product relies on the dependencies and
interactions between its components, including partly completed machinery, and, if relevant,
with other machinery or related products that participate in a coordinated assembly of a
machinery system, which can also result in an assembly of machinery. Therefore,
manufacturers should be required to assess all those interactions in the risk assessment.

(34) It is essential that, before drawing up the EU declaration of conformity or the EU declaration
of incorporation, the manufacturer prepare technical documentation. The manufacturer should be
required to make that technical documentation available to national authorities on request or
to notified bodies in the context of the relevant conformity assessment procedure. Detailed plans
of subassemblies used for the manufacture of the product within the scope of this Regulation
should only be required as part of the technical documentation where knowledge of such
plans is essential for assessing conformity with the essential health and safety requirements
set out in this Regulation.

(35) A person who manufactures machinery or related products for his or her own use is
considered as to be a manufacturer and should be required to fulfil all the related obligations.
In that case, the machinery or related product is not placed on the market, since it is not made
available by the manufacturer to another person but is used by the manufacturer itself.
However, such machinery needs to comply with this Regulation before it is put into service.

(36) It is necessary to ensure that products within the scope of this Regulation from third
countries entering the Union market comply with the requirements of this Regulation and do not
present a risk to the health and safety of persons, in particular consumers and professional
users, and, where appropriate, to domestic animals and property, and, where applicable, to
the environment, and in particular that appropriate conformity assessment procedures have
been carried out by manufacturers with regard to such products. Provision should therefore
be made for importers to ensure that products within the scope of this Regulation that they
place on the market comply with the requirements of this Regulation and do not present a
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risk to the health and safety of persons, and, where appropriate, domestic animals and property,
and, where applicable, to the environment. For the same reason, provision should also be made
for importers to ensure that the conformity assessment procedures have been carried out and
that the CE marking, in the case of machinery and related products, is affixed and technical
documentation drawn up by manufacturers is available for inspection by the competent
national authorities.
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(37) When placing products within the scope of this Regulation on the market, importers should
indicate on those products their respective names, registered trade names or registered trade
marks, postal addresses, websites, email addresses or other digital contacts at which they can
be contacted. Exceptions should be provided for in cases where the size or nature of the
product does not allow it. This includes cases where the importers would have to open the
packaging to put their names and addresses on the product.

(38) As the distributor makes products within the scope of this Regulation available on the market
after they have been placed on the market by the manufacturer or the importer, the
distributor should act with due care to ensure that its handling of the product within the scope
of this Regulation does not adversely affect its compliance with the requirements set out in
this Regulation.

(39) With a view to ensuring the health and safety of the users of products within the scope of this
Regulation, economic operators should ensure that all relevant documentation, such as the
instructions for use, while containing precise and comprehensible information, is easily
understandable and available in a language which can be easily understood by users, as
determined by the Member State concerned, takes into account tech nological developments
and changes to user behaviour, and is as up to date as possible. When products within the
scope of this Regulation are made available on the market in packages containing multiple
units, the instructions and information should accompany the smallest commercially available
unit.

(40) Instructions and other relevant documentation may be provided in a digital printable format.
However, the manufacturer should ensure that distributors can provide, at the request of the
user at the time of the purchase, the instructions for use in a paper format free of charge. The
manufacturer should also consider providing the contact details where the user can request
the instructions to be dispatched by mail.

(41)
Distributo and importers, being close to the market place, should be involved in market
rs surveillance tasks
carried out by the competent national authorities, and should be prepared to participate actively,
providing those authorities with all necessary information relating to the product within the scope
of this Regulation concerned.

(42) Any economic operator who either places a product within the scope of this Regulation on the
market under its own name or trademark or modifies a product within the scope of this
Regulation in such a way that compliance with the requirements of this Regulation might be
affected should be considered to be the manufacturer and should assume the obligations of
the manufacturer.

(43) Ensuring traceability of products within the scope of this Regulation throughout the whole supply
chain enables a simpler and more efficient market surveillance. The economic operators should
therefore be required to keep the information on their transactions of products within the
scope of this Regulation for a certain period of time. However, that obligation should be
proportionate to the role of each economic operator in the supply chain and the economic
operators should not be required to update information that they have not produced.

(44) This Regulation should be limited to setting out the essential health and safety requirements,
supplemented by a number of more specific requirements for certain categories of products
within the scope of this Regulation. In order to facilitate the assessment of conformity with
those health and safety requirements, it is necessary to provide for a presumption of
conformity for products within the scope of this Regulation which are in conformity with
harmonised standards that are developed and in respect of which the references are published
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in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 of the
13
European Parliament and of the Council ( ) for the purpose of expressing the detailed technical
specifications of those requirements.

(13) Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on
European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC,
94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the
European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No
1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
29.6.202 E Official Journal of the European L 165/13
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(45) The current EU standardisation framework which is based on the New Approach principles set
out in Council Resolution of 7 May 1985 on a new approach to technical harmonization and
standards (14) and on Regulation (EU) No 1025/2012 represents the framework by default to
elaborate standards that provide for a presumption of conformity with the relevant essential
health and safety requirements of this Regulation. European standards should be market-
driven, take into account the public interest, as well as the policy objectives clearly stated in the
Commission’s request to one or more European standardisation organisations to draft
harmonised standards, within a set deadline and be based on consensus. However, in the
absence of relevant references to harmonised standards, the Commission should be able to adopt
implementing acts establishing common specifications for the essential health and safety
requirements of this Regulation, provided that in doing so it duly respects the role and functions of
standardisation organisations, as an exceptional fall back solution to facilitate the
manufacturer’s obligation to comply with those health and safety requirements, when the
standardisation process is blocked or when there are delays in the establishment of
appropriate harmonised standards. If such delay is due to the technical complexity of the
standard in question, this should be considered by the Commission before contem plating the
establishment of common specifications.

(46) With a view to establishing, in the most efficient way, common specifications that cover the
essential health and safety requirements of this Regulation, the Commission should involve
relevant stakeholders in the process.

(47) Reasonable period should mean, in relation to the publication of reference to harmonised standards
in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012, a
period during which the publication in the Official Journal of the European Union of the reference
to the standard, its corrigendum or its amendment is expected and which should not exceed one
year after the deadline for drafting a European standard set in accordance with Regulation
(EU) No 1025/2012.

(48) Compliance with harmonised standards and with common specifications established by the
Commission should be voluntary. Alternative technical solutions should therefore be
acceptable where compliance of the products within the scope of this Regulation with the
relevant essential health and safety requirements is demonstrated in the technical file.

(49) The essential health and safety requirements should be satisfied in order to ensure that the
product within the scope of this Regulation is safe. Those requirements should be applied with
discernment to take account of the state of the art at the time of construction and of
technical and economic requirements.

(50) Regulation (EU) No 1025/2012 provides for a procedure for objections to harmonised
standards where those standards do not satisfy or entirely satisfy the requirements of this
Regulation.

(51) With a view to addressing the risks stemming from malicious third party actions that have an
impact on the safety of products within the scope of this Regulation, this Regulation should
include essential health and safety requirements in respect of which conformity to the
appropriate extent can be presumed as the result of a certificate or statement of conformity
issued under a relevant cybersecurity certification scheme adopted in accordance with
Regulation (EU) 2019/881 of the European Parliament and of the Council (15).

(52) Manufacturers should draw up an EU declaration of conformity to provide information on the

conformity of machinery or related products with this Regulation. Manufacturers may also be
required by other Union legal acts to draw up an EU declaration of conformity. To ensure
effective access to information for market surveillance purposes, a single EU declaration of
conformity should be drawn up in respect of all Union legal acts. In order to reduce the
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administrative burden on economic operators, it should be possible for that single EU
declaration of conformity to be a dossier made up of relevant individual declarations of
conformity.

(14) OJ C 136, 4.6.1985, p. 1.

(15) Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA
(the European Union Agency for Cybersecurity) and on information and communications technology
cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (OJ L 151,
7.6.2019, p. 15).
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(53) The harmonised standards relevant to this Regulation should take into account the requirements of
Directive(EU) 2019/882 of the European Parliament and of the Council (16) and the United
Nations Convention on the Rights of Persons with Disabilities (17).

(54) The list of products in Annex IV of Directive 2006/42/EC has until now been based on the risk
emanating from the intended use or any reasonably foreseeable misuse of those products or
their critical protective function. Nevertheless, the machinery field embraces new ways of
designing and constructing machinery or related products that might present higher risk
factors, regardless of such intended use or any reasonably foreseeable misuse. For example,
systems with self-evolving behaviour ensuring safety functions should be included in
Annex I due to their characteristics such as data dependency, opacity, autonomy and
connectivity, which
might considerably increase the probability and severity of harm and seriously affect the
safety of the machinery or related product. Therefore, the conformity assessment of a safety
component or a system with self-evolving behaviour ensuring safety functions should be carried
out by a third party, whether or not the safety component has been placed independently on the
market or is part of a system embedded in machinery that is placed on the market. However,
where machinery embeds a system of which the safety component has already been subject to
third party conformity assessment when it was placed independently on the market, that
machinery should not have to be re-certified by a third party solely on the basis of the embedding
of that system.

(55) Provisions related to the third-party conformity assessment of software ensuring safety
functions set out in this Regulation should only apply to systems with a fully or partially self-
evolving behaviour using machine learning approaches ensuring safety functions. On the
contrary, those provisions should not apply to software incapable of learning or evolving, and
programmed only to execute certain automated functions of machinery or related products.

(56) The CE marking, indicating the conformity of a product, is the visible consequence of a whole
process comprising conformity assessment in a broad sense. The general principles governing
the CE marking are set out in Regulation (EC) No 765/2008. Rules governing the affixing of
the CE marking on machinery or related products should be laid down in this Regulation.

(57) The CE marking should be the only marking which guarantees that machinery or related
products comply with the requirements of this Regulation. Member States should therefore
take appropriate action as regards other markings which are likely to mislead third parties as
to the meaning or the form of the CE marking.

(58) In order to enable economic operators to demonstrate and the competent authorities to ensure that
machinery or related products made available on the market are in conformity with the
essential health and safety require ments, it is necessary to provide for conformity assessment
procedures. Decision No 768/2008/EC establishes modules for conformity assessment
procedures, which include procedures from the least to the most stringent, in proportion to the
level of risk involved and the level of safety required. In order to ensure inter-sectoral
coherence and to avoid ad hoc variants, conformity assessment procedures should be chosen
from among those modules.

(59) Manufacturers should be responsible for ensuring that a conformity assessment is carried out in
respect of their machinery or related products in accordance with this Regulation.
Nevertheless, for certain categories of machinery or related products that have a higher risk
factor, a stricter conformity assessment procedure requiring the participation of a notified
body should be required.

(60) It is essential that all notified bodies perform their functions to the same level and under
conditions of fair competition. That requires the setting of obligatory requirements for conformity
assessment bodies wishing to be notified in order to provide conformity assessment services.

(61) If a conformity assessment body demonstrates conformity with the criteria laid down in harmonised
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standards, it should be presumed to comply with the corresponding requirements set out in
this Regulation.

(16) Directive (EU) 2019/882 of the European Parliament and of the Council of 17 April 2019 on the
accessibility requirements for products and services (OJ L 151, 7.6.2019, p. 70).
(17) OJ L 23, 27.1.2010, p. 35.
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(62) In order to ensure a consistent level of quality in the performance of conformity assessment of
machinery or related products, it is also necessary to set requirements for notifying authorities
and other bodies involved in the assessment, notification and monitoring of notified bodies.

(63) The system set out in this Regulation should be complemented by the accreditation system
provided for in Regulation (EC) No 765/2008. Since accreditation is an essential means of
verifying the competence of conformity assessment bodies, it should also be used for the
purposes of notification.

(64) Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring the
necessary level of confidence in certificates of conformity, should be considered by the
national public authorities throughout the Union as the preferred means of demonstrating the
technical competence of conformity assessment bodies. However, national authorities may
consider that they possess the appropriate means of carrying out that evaluation themselves.
In such cases, in order to ensure the appropriate level of credibility of evaluations carried out
by other national authorities, they should provide the Commission and the other Member States
with the necessary documentary evidence demonstrating the compliance of the conformity
assessment bodies evaluated with the relevant regulatory requirements.

(65) Conformity assessment bodies frequently subcontract parts of their activities linked to
the assessment of conformity or have recourse to a subsidiary. In order to safeguard the
level of protection required for the machinery or related products to be placed on the
market, it is essential that conformity assessment subcon tractors and subsidiaries fulfil the
same requirements as notified bodies in relation to the performance of conformity
assessment tasks. Therefore, it is important that the assessment of the competence and
the performance of bodies to be notified, and the monitoring of bodies already notified,
cover also activities carried out by subcontractors and subsidiaries.

(66) Since notified bodies may offer their services throughout the Union, it is appropriate to give
the other Member States and the Commission the opportunity to raise objections concerning a
notified body. It is therefore important to provide for a period during which any doubts or
concerns as to the competence of conformity assessment bodies can be clarified before they
start operating as notified bodies.

(67) In the interests of competitiveness, it is crucial that notified bodies apply the conformity
assessment procedures without creating unnecessary burdens for economic operators. For the
same reason, and to ensure equal treatment of economic operators, consistency in the
technical application of the conformity assessment procedures needs to be ensured. That can
best be achieved through appropriate coordination and cooperation between notified bodies.

(68) Market surveillance is an essential instrument to ensure the proper and uniform application of
Union law. It is therefore appropriate to put in place a legal framework within which market
surveillance can be carried out in an appropriate manner with regard to products within the
scope of this Regulation.

(69) Member States should take all appropriate measures to ensure that machinery and related
products may be placed on the market or put into service only if, where properly installed and
maintained and used for its intended purpose, or under conditions of use which can be
reasonably foreseen, they do not endanger the health or safety of persons, in particular
consumers and professional users, and, where appropriate, of domestic animals and property,
and, where applicable, the environment. In particular, the proper installation of lifting
machinery is essential to ensure the compliance with applicable essential health and safety
requirements. Machinery and related products should be considered as non-compliant with the
essential health and safety requirements laid down in this Regulation only under conditions of
use, which could result from lawful and readily predictable human behaviour.

(70) In the context of market surveillance, a clear distinction should be established between the
disputing of a harmonised standard or of common specifications conferring a presumption of
conformity on products within the scope of this Regulation and the safeguard clause relating
to products within the scope of this Regulation.
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(71) Directive 2006/42/EC already provides for a safeguard procedure, which is necessary to allow for
the possibility of contesting the conformity of products within the scope of this Regulation. In
order to increase transparency and to reduce processing time, it is necessary to improve the
existing safeguard procedure, with a view to making it more efficient and drawing on the
expertise available in Member States.
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(72) The existing safeguard procedure should be supplemented by a procedure under which
interested parties are informed of measures intended to be taken with regard to products
within the scope of this Regulation presenting a risk to the health or safety of persons and,
where appropriate, domestic animals and property, and, where applicable, to the environment.
It should allow market surveillance authorities, in cooperation with the relevant economic
operators, to act at an earlier stage in respect of such products.

(73) Where the Member States and the Commission agree as to the justification of a measure taken
by a Member State, no further involvement of the Commission should be required, except
where non-compliance can be attributed to shortcomings in a harmonised standard or in
common specifications.

(74) In order to take into account technical progress and knowledge or new scientific evidence and
to ensure a sufficient level of data availability, the power to adopt acts in accordance with
Article 290 of the Treaty on the Functioning of the European Union should be delegated to the
Commission in respect of amending the list of categories of machinery and related products in
Annex I and the indicative list of safety components in Annex II, and if necessary of
supplementing the obligations of Member States to provide data and information on the
categories of machinery and related products which are subject to a specific conformity
assessment procedure through the establishment of a common methodology. Where a new
category of machinery or related products is added to the list in Annex I, the Commission should
ensure that economic operators are provided with sufficient time to comply with their
obligations under this Regulation. It is of particular importance that the Commission carry out
appropriate consultations during its preparatory work, including with the stakeholders
concerned and that those consultations be conducted in accordance with the principles laid
down in the Interinstitutional
Agreement of 13 April 2016 on Better Law-Making (18). In particular, to ensure equal
participation in the
preparation of delegated acts, the European Parliament and the Council receive all documents
at the same time as Member States’ experts, and their experts systematically have access to
meetings of Commission expert groups dealing with the preparation of delegated acts.

(75) In order to ensure uniform conditions for the implementation of this Regulation, implementing
powers should be conferred on the Commission for the establishment of a uniform template
for the collection of data and information for the purpose of adding a category of machinery
or related products to Annex I or withdrawing a category of machinery or related products
from Annex I, for the establishment of common specifications for the essential health and
safety requirements set out in Annex III, for requesting the notifying Member State to take
the necessary corrective measures in respect of a notified body that does not meet the
requirements for its notification, and for establishing whether a national measure in respect of
compliant products within the scope of this Regulation which are found by a Member State to
present a risk to the health and safety of persons, in particular consumers and professional
users, or, where appropriate, to domestic animals or property, or, where applicable, to the
environment, is justified. Those powers should be exercised in accordance with Regulation (EU) No
182/2011 of the European Parliament and of the Council (19).

(76) In order to facilitate the proper implementation of this Regulation, when adopting the
implementing acts setting out and updating a template concerning the collection of the data
and the information by the Member States on accidents or damage to health caused by
machinery or related products, the Commission should issue guidance regarding the collection
and transmission of comparable, high-quality data and information.

(77) The Commission should adopt immediately applicable implementing acts determining
whether a national measure taken in respect of compliant products within the scope of
this Regulation that present a risk is justified or not where, in duly justified cases relating
to the protection of the health or safety of persons, imperative grounds of urgency so
require.
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(78) In line with established practice, the committee set up by this Regulation can play a useful
role in examining matters concerning the application of this Regulation raised either by its chair
or by a representative of a Member State in accordance with its rules of procedure.

(18) OJ L 123, 12.5.2016, p. 1.

(19) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying
down the rules and general principles concerning mechanisms for control by Member States of the
Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
29.6.202 E Official Journal of the European L 165/21
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(79) When matters relating to this Regulation, other than its implementation or infringements, are
being examined in a Commission expert group, the European Parliament should, in line with
existing practice, receive full information and documentation and, where appropriate, an
invitation to attend such meetings.

(80) The Commission should, by means of implementing acts and, given their special nature,
acting without the application of Regulation (EU) No 182/2011, determine whether measures
taken by Member States in respect of non-compliant products within the scope of this
Regulation are justified or not.

(81) The traceability of machinery data required for the technical file and for market surveillance
purposes should comply with confidentiality rules to protect manufacturers.

(82) Member States should lay down rules on penalties applicable to infringements of this Regulation
and ensure that those rules are implemented. The penalties provided for should be effective,
proportionate and dissuasive.

(83) Since the objective of this Regulation, namely to ensure that the products within the scope of
this Regulation placed on the market fulfil the requirements providing for a high level of
protection of the health and safety of persons, and, where appropriate, domestic animals
and property, and, where applicable, of the environment, while guaranteeing the functioning of
the internal market, cannot be sufficiently achieved by the Member States, but can rather, by
reason of the need for harmonisation, be better achieved at Union level, the Union may adopt
measures, in accordance with the principle of subsidiarity set out in Article 5 of the Treaty on
European Union. In accordance with the principle of proportionality, as set out in that Article,
this Regulation does not go beyond what is necessary in order to achieve that objective.

(84) By including machinery and lifting accessories and chains and ropes in its scope, Directive
2006/42/EC has
completely superseded Council Directive 73/361/EEC (20). Directive 73/361/EEC should therefore
be repealed.

(85) Directive 2006/42/EC has been amended several times. Since further substantial amendments are
needed, and in order to ensure a uniform implementation of the rules on products within the
scope of this Regulation throughout the Union, Directive 2006/42/EC should be repealed.

(86) It is necessary to provide for sufficient time for economic operators to comply with their
obligations under this Regulation, and for Member States to set up the administrative
infrastructure necessary for its application. The application of this Regulation should
therefore be deferred,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1
Subject matter
This Regulation lays down health and safety requirements for the design and construction of
machinery, related products and partly completed machinery to allow them to be made
available on the market or put into service while ensuring a high level of protection of the health
and safety of persons, in particular consumers and professional users, and, where appropriate, of
domestic animals and property, and, where applicable, of the environment. It also establishes
rules on the free movement of products within the scope of this Regulation in the Union.

Article 2
Scope
1. This Regulation applies to machinery and the following related products:
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(a) interchangeable equipment;

(20) Council Directive 73/361/EEC of 19 November 1973 on the approximation of the laws, regulations and
administrative provisions of the Member States relating to the certification and marking of wire-ropes,
chains and hooks (OJ L 335, 5.12.1973, p. 51).
29.6.202 E Official Journal of the European L 165/23
3 N Union

(b) safety components;

(c) lifting accessories;

(d) chains, ropes and webbing;

(e) removable mechanical transmission devices.

This Regulation also applies to partly completed machinery.

For the purposes of this Regulation, machinery, the related products listed in the first
subparagraph and partly completed machinery shall together be referred to as ‘products within the
scope of this Regulation’.

2. This Regulation does not apply to:

(a) safety components that are intended to be used as spare parts to replace identical components
and are supplied by the manufacturer of the original machinery, related product or partly
completed machinery;

(b) specific equipment for use in fairgrounds or amusement parks;

(c) machinery and related products specially designed for use within or used in a nuclear
installation and whose conformity with this Regulation may undermine the nuclear safety of
that installation;

(d) weapons, including firearms;

(e) means of transport by air, on water and on rail networks except for machinery mounted on
those means of transport;

(f) aeronautical products, parts and equipment that fall within the scope of Regulation (EU)
2018/1139 of the European Parliament and of the Council (21) and the definition of machinery
under this Regulation, insofar as Regulation (EU) 2018/1139 covers the relevant essential health
and safety requirements set out in this Regulation;

(g) motor vehicles and their trailers, as well as systems, components, separate technical units, parts
and equipment designed and constructed for such vehicles, which fall within the scope of
Regulation (EU) 2018/858, except for machinery mounted on those vehicles;

(h) two- or three-wheel vehicles and quadricycles, as well as systems, components, separate technical
units, parts and equipment designed and constructed for such vehicles, that fall within the scope
of Regulation (EU) No 168/2013, except for machinery mounted on those vehicles;

(i) agricultural and forestry tractors, as well as systems, components, separate technical units,
parts and equipment designed and constructed for such tractors, that fall within the scope of
Regulation (EU) No 167/2013, except for machinery mounted on those tractors;

(j) motor vehicles exclusively intended for competition;

(k) seagoing vessels and mobile offshore units and machinery installed on board such vessels or units;

(l) machinery or related products specially designed and constructed for military or police purposes;

(m)machinery or related products specially designed and constructed for research purposes for
temporary use in laboratories;

(n) mine winding gear;

(o) machinery or related products intended to move performers during artistic performances;

(21) Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules
in the field of civil
L 165/24 E Official Journal of the European 29.6.202
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aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No3
Union
2111/2005, (EC)
No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European
Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the
European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p.
1).
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(p) the following electrical and electronic products, insofar as they fall within the scope of Directive
2014/35/EU or of Directive 2014/53/EU:

(i) household appliances intended for domestic use which are not electrically operated furniture;

(ii) audio and video equipment;

(iii) information technology equipment;

(iv)ordinary office machinery, except additive printing machinery for producing three-dimensional
products;

(v) low-voltage switchgear and control gear;

(vi)electric motors;

(q) the following high-voltage electrical products:

(i) switchgear and control gear;

(ii)transformers.

Article 3
Definitions
For the purposes of this Regulation, the following definitions apply:

(1) ‘machinery’ means:

(a) an assembly, fitted with or intended to be fitted with a drive system other than directly
applied human or animal effort, consisting of linked parts or components, at least one of
which moves, and which are joined together for a specific application;

(b) an assembly referred to in point (a), missing only the components to connect it on site or to
sources of energy and motion;

(c) an assembly referred to points (a) and (b), ready to be installed and able to function as it
stands only if mounted on a means of transport, or installed in a building or a structure;

(d) assemblies of machinery referred to in points (a), (b) and (c), or of partly completed machinery,
which, in order to achieve the same end, are arranged and controlled so that they function
as an integral whole;

(e) an assembly of linked parts or components, at least one of which moves, and which are
joined together, intended for lifting loads and whose only power source is directly
applied human effort;

(f) an assembly as referred to in points (a) to (e) missing only the uploading of the software
intended for the specific application foreseen by the manufacturer;

(2) ‘interchangeable equipment’ means a device which, after the putting into service of machinery or an
agricultural or forestry tractor, is assembled with that machinery or agricultural or forestry
tractor by the operator in order to change its function or to attribute a new function to it,
provided that the device is not a tool;

(3) ‘safety component’ means a physical or digital component, including software, of a product
within the scope of this Regulation, which is designed or intended to fulfil a safety function and
which is independently placed on the market, the failure or malfunction of which endanger the
safety of persons, but which is not necessary in order for that product to function or for which
normal components may be substituted in order for that product to function;

(4) ‘safety function’ means a function that serves to fulfil a protective measure designed to
eliminate, or, if that is not possible, to reduce, a risk, which, if it fails, could result in an
increase of that risk;
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(5) ‘lifting accessory’ means a component or equipment, not attached to the lifting machinery, which
enables the load to be held, which is placed between the machinery and the load or on the load
itself, or which is intended to constitute an integral part of the load and which is independently
placed on the market, including slings and their components;
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(6) ‘chains’ means chains designed and constructed for lifting purposes as part of lifting machinery
or lifting acces sories;

(7) ‘ropes’ means ropes designed and constructed for lifting purposes as part of lifting machinery or
lifting accessories;

(8) ‘webbing’ means webbing designed and constructed for lifting purposes as part of lifting
machinery or lifting accessories;

(9) ‘removable mechanical transmission device’ means a removable component for transmitting
power between self- propelled machinery or a tractor and other machinery or related products
by joining them at the first fixed bearing; when it is placed on the market with a guard, the
device and the guard are to be regarded as one item;

(10)‘partly completed machinery’ means an assembly which is not yet machinery as it cannot in
itself perform a specific application and which is only intended to be incorporated into or
assembled with machinery or other partly completed machinery or equipment, thereby forming
machinery;

(11)‘making available on the market’ means any supply of a product within the scope of this
Regulation for distribution or use on the Union market in the course of a commercial activity,
whether in return for payment or free of charge;

(12)‘placing on the market’ means the first making available of a product within the scope of this
Regulation on the Union market;

(13)‘putting into service’ means the first use, for its intended purpose, in the Union, of machinery or
related products;

(14)‘essential health and safety requirements’ means the mandatory provisions, set out in Annex III,
relating to the design and construction of products within the scope of this Regulation to
ensure a high level of protection of the health and safety of persons, and, where appropriate,
domestic animals and property, and, where applicable, of the environment;

(15)‘Union harmonisation legislation’ means any Union legislation harmonising the conditions for
the marketing of products;

(16)‘substantial modification’ means a modification of machinery or a related product, by physical

or digital means after that machinery or related product has been placed on the market or put into
service, which is not foreseen or planned by the manufacturer, and which affects the safety of that
machinery or related product, by creating a new hazard, or by increasing an existing risk, which
requires:

(a) the addition of guards or protective devices to that machinery or related product the
processing of which necessitates the modification of the existing safety control system; or

(b) the adoption of additional protective measures to ensure the stability or mechanical strength of
that machinery or related product;

(17)‘instructions for use’ means the information, provided by the manufacturer when the machinery or
related product is placed on the market or put into service, to inform the user of the machinery
or related product, of the intended and proper use of that machinery or related product, as well
as information on any precautions to be taken when using or installing the machinery or related
product, including information on the safety aspects, and on how to keep that machinery or
related product safe, and to ensure that it remains fit for purpose during its entire lifetime;

(18)‘manufacturer’ means any natural or legal person who:

(a) manufactures products within the scope of this Regulation or who has those products
designed or manu factured, and markets those products under its name or trademark; or

(b) manufactures products within the scope of this Regulation, and puts those products into
service for its own use;
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(19)‘authorised representative’ means any natural or legal person established within the Union who
has received a written mandate from a manufacturer to act on its behalf in relation to
specified tasks;
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(20)‘importer’ means any natural or legal person established within the Union who places a product
within the scope of this Regulation from a third country on the Union market;

(21)‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer
or the importer, who makes a product within the scope of this Regulation available on the
market;

(22)‘economic operator’ means the manufacturer, the authorised representative, the importer or the
distributor;

(23)‘technical specifications’ means a document that prescribes technical requirements to be fulfilled by

products within the scope of this Regulation;

(24)‘harmonised standard’ means a harmonised standard as defined in Article 2, point 1, point (c), of
Regulation (EU) No 1025/2012;

(25)‘CE marking’ means a marking by which the manufacturer indicates that machinery or a
related product is in conformity with the applicable requirements set out in Union harmonisation
legislation providing for its affixing;

(26)‘accreditation’ means accreditation as defined in Article 2, point (10), of Regulation (EC) No

765/2008;

(27)‘national accreditation body’ means a national accreditation body as defined in Article 2, point
(11), of Regulation (EC) No 765/2008;

(28)‘conformity assessment’ means the process for demonstrating whether the applicable essential
health and safety requirements in this Regulation relating to machinery or related products
have been fulfilled;

(29)‘conformity assessment body’ means a body that performs conformity assessment activities,
including calibration, testing, certification and inspection;

(30)‘notified body’ means a conformity assessment body notified in accordance with this Regulation;

(31)‘market surveillance authority’ means a ‘market surveillance authority’ as defined in Article 3,

point (4), of Regu lation (EU) 2019/1020;

(32)‘recall’ means any measure aimed at achieving the return of a product within the scope of this
Regulation that has already been made available to a user;

(33)‘withdrawal’ means, for a product, any measure aimed at preventing a product within the scope of
this Regulation that is in the supply chain from being made available on the market;

(34)‘lifetime’ means the period from the moment that machinery or a related product is placed on
the market or put into service until the moment that it is discarded, including the effective time
when the machinery or related product is capable of being used and the phases of transport,
assembly, dismantling, disabling, scrapping or other physical or digital modifications foreseen by
the manufacturer;

(35)‘source code’ means the currently installed version of the software of a product within the scope of
this Regulation, written in a programming language so that it is unambiguous and
understandable to humans;

(36)‘professional user’ means a natural person who uses or operates machinery or a related product in
the course of his or her professional activity or work.

Article 4
Free movement
1. Member States shall not impede, for reasons relating to the aspects covered by this
Regulation, the making available on the market of products within the scope of this Regulation
or the putting into service of machinery or related products which comply with this Regulation.
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2. At trade fairs, exhibitions and demonstrations or similar events, Member States shall not prevent
the display of a
product within the scope of this Regulation which does not comply with this Regulation, provided
that a visible sign clearly indicates that it does not comply with this Regulation and will not be made
available on the market until it has been brought into conformity.

During demonstrations, adequate measures shall be taken to ensure the protection of persons.
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Article 5
Protection of persons during installation or use of machinery or related products
Member States may lay down requirements to ensure that persons, including workers, are protected
when installing or using machinery or related products, provided that such rules do not allow for the
modification of machinery or a related product in a way that is not compatible with this
Regulation.

Article 6
Categories of machinery and related products listed in Annex I subject to relevant conformity assessment
procedures
1. Machinery and related products that fall within the categories listed in Annex I, Part A, shall be
subject to the specific conformity assessment procedures referred to in Article 25(2), and machinery
and related products that fall within the categories listed in Annex I, Part B shall be subject to the
specific conformity assessment procedures referred to in Article 25(3).

2. The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend
Annex I, after consulting the stakeholders concerned, in the light of technical progress, advances
in knowledge or new scientific
evidence by adding to the list of categories of machinery and related Anne I a new category
products in x of
machinery or related products, withdrawing an existing category of machinery or related products
from that list or moving a category of machinery or related products from one Part of Annex I to
another Part of that Annex, in accordance with the criteria and the procedures laid down in
paragraphs 4, 5 and 7 of this Article.

3. Before adopting a delegated act, the Commission shall seek the views of experts in the
relevant expert group in accordance with Article 47(4).

4. The Commission shall assess the seriousness of the inherent potential risk presented by a category
of machinery or related product for the purpose of determining whether to add that category of
machinery or related product to Annex I or to withdraw that category of machinery or related product
from Annex I. That assessment shall be established based on the combination of the probability of
occurrence of harm and the severity of that harm.

In determining the probability and severity of harm, the following criteria shall, where relevant, be
taken into account:

(a) the nature of the hazard inherent to the function of the category of machinery or related
product, taking into account the intended use and any reasonably foreseeable misuse;

(b) the severity of harm which a person would suffer, including the degree of reversibility of that
harm;

(c) the number of persons potentially affected by the harm;

(d) the frequency and the duration of the exposure to the hazard that a person would be exposed to in
the course of the intended use or any reasonably foreseeable misuse of the category of
machinery or related product;

(e) the possibilities of avoiding or limiting harm;

(f) in the case of safety components, the likelihood of serious consequences for the safety of the
persons exposed to harm in the event of their failure.

5. When conducting the assessment referred in paragraph 4, the Commission shall consider the
following elements:
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(a) indications of harm that have been caused in the past by machinery or related products which
have been used for their intended use or following any reasonably foreseeable misuse;

(b) information about safety defects detected in the course of market surveillance, and material possibly
available in the information systems administered by the Commission;
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(c) information about known accidents and serious ‘close calls’, including the characteristics of those
accidents or ‘close calls’;

(d) data on accidents or damage to health caused by the machinery or related product for at least
the preceding four years. In particular, information obtained, inter alia, from the Information
and Communication System on Market Surveillance (ICSMS), safeguard clauses, Safety Gate
Rapid Alert System, the European Injury Database (EU-IDB), Eurostat’s European Statistics on
Accidents at Work (ESAW) and the Machinery Administrative Cooperation Group (AdCo).

In addition to points (a) to (d) of this paragraph, the Commission shall take into account any other
information available that is relevant to the assessment referred to in paragraph 4.

6. The data and information referred to in paragraph 5, points (a) to (d), shall be provided by
Member States in accordance with paragraph 9.

7. A category of machinery or related product shall be included in Annex I, Part A, if, according
to the assessment referred to in paragraph 4, and taking into account the available
information, including the data referred to in paragraph 5, it presents a serious inherent
potential risk, and one or more of the following conditions is fulfilled:

(a) there is a lack of harmonised standards or common specifications covering the relevant essential
health and safety requirements;

(b) residual risks exist, including those which, according to the manufacturer, could be reduced by
particular training or personal protective equipment, and the data and information referred to in
paragraph 5, demonstrate the recurrence of similar serious or fatal accidents or damage to health
in connection with those residual risks;

(c) data and information exist which according to the Commission demonstrate recurring wrongful
application of the relevant harmonised standards or common specifications and for which the market
surveillance activities that were carried out have not led to major improvements of the market
situation, in a reasonable period;

(d) there is a degree of uncertainty in the existing risk assessment methods related to new
categories of machinery or technologies.

Any other category of machinery or related product that, according to that assessment, presents a
serious inherent potential risk but does not fulfil one or more of the conditions in points (a) to (d) shall
be included in Annex I, Part B.

8. A Member State which has concerns about a category of machinery or related product being
listed or not in Annex I shall immediately inform the Commission of those concerns and provide
reasons in support thereof.

The Commission shall conduct the assessment referred to in paragraph 4 immediately after being
informed by a Member State.

After making that assessment, the Commission may initiate the procedure laid down in paragraph 2.

9. By 14 July 2025, and every five years thereafter, Member States shall provide the data and
information referred to in paragraph 5, including information to the effect that none of the events
referred to in paragraph 5 has occurred, for every category of machinery or related products
which is included in Annex I or which is not included in Annex I where that non-inclusion is a
cause of concern for the Member State.

10. The Commission shall adopt implementing acts setting out and, where necessary in the light of
technological and market development, updating a template concerning the collection by Member
States of the data and the information referred to in paragraph 5, points (a) to (d).

When adopting those implementing acts, the Commission shall issue guidance to Member States on the
collection and transmission of comparable, high-quality data and information.
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Those implementing acts shall be adopted in accordance with the examination procedure referred to

in Article 48(3). The first such implementing act shall be adopted not later than 14 July 2024.
29.6.202 E Official Journal of the European L 165/35
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11. If necessary after the Commission report referred to in Article 53(3), the Commission shall
adopt delegated acts in accordance with Article 47 to supplement paragraph 5 of this Article by
specifying the obligations of Member States to provide data and information required pursuant to this
Article through the establishment of a common methodology concerning the data and information to be
collected, including the methods for their collection and compilation, and the procedures for their
transmission, as well as the relevant definitions, in order to ensure that sufficient and comparable
data is available for the Commission to carry out the assessment referred to in paragraph 4.

Article 7
Safety components
1. An indicative list of safety components is set out in Annex II.

2. The Commission is empowered to adopt delegated acts in accordance with Article 47 to

amend Annex II in the light of technical progress and knowledge or new scientific evidence by
including a new safety component in the indicative list of safety components or withdrawing an
existing safety component from that list.

3. A Member State which has concerns about a safety component being listed or not
II shall
listed in Annex immediately inform the Commission of its concerns and provide reasons in
support thereof.

Article 8
Essential health and safety requirements for products within the scope of this Regulation
Machinery or related products shall only be made available on the market or put into service if, where
properly installed and maintained and used for their intended use or under conditions which can
reasonably be foreseen, they meet the essential health and safety requirements set out in Annex III.

Partly completed machinery shall only be made available on the market if it meets the relevant
essential health and safety requirements set out in Annex III.

Article 9
Specific Union harmonisation legislation
Where, for a certain product within the scope of this Regulation, the risks addressed by the
essential health and safety requirements set out in Annex III are wholly or partly covered by Union
harmonisation legislation that is more specific than this Regulation, this Regulation shall not apply
to that product to the extent that that specific Union legislation covers such risks.

CHAPTER II

OBLIGATIONS OF ECONOMIC OPERATORS

Article 10
Obligations of manufacturers of machinery and related products
1. When placing machinery or a related product on the market or putting it into service,
manufacturers shall ensure that it has been designed and constructed in accordance with the
essential health and safety requirements set out in Annex III.

2. Before placing machinery or a related product on the market or putting it into service,
manufacturers shall draw up the technical documentation set out in Annex IV, Part A and carry out the
relevant conformity assessment procedure referred to in Article 25 or have it carried out.

Where compliance of machinery or a related product with the essential health and safety requirements
laid down in
Annex III has been demonstrated by that conformity assessment procedure, manufacturers shall
draw up the EU
declaration of conformity in accordance with Article 21 and affix the CE marking in accordance with
Article 24.

3. Manufacturers shall keep the technical documentation and the EU declaration of conformity at the
disposal of the market surveillance authorities for at least 10 years after the machinery or the
related product has been placed on the market or put into service. Where relevant, the source
L 165/36 E Official Journal of the European 29.6.202
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code or the programming logic included in the technical documentation shall, upon a reasoned
request, be made available to the competent national authorities, if that source code or
programming logic is necessary in order for them to be able to check compliance with the
essential health and safety requirements set out in Annex III.
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4. Manufacturers shall ensure that procedures are in place in order that machinery or related products
that are part of a series production remain in conformity with this Regulation. Adequate account
shall be taken of changes in the production process or in the design or characteristics of the
machinery or related product, and changes in the harmonised standards, in other technical
specifications, or in the common specifications referred to in Article 20 by reference to which the
conformity of the machinery or related product is declared.

When deemed appropriate with regard to the risks presented by machinery or related products,
manufacturers shall, in order to protect the health and safety of users, carry out sample testing of
machinery or related products made available on the market and investigate their results. If
necessary, manufacturers shall keep a register of complaints, of non- conforming machinery or
related products and machinery or related product recalls, and shall keep distributors informed of
any such monitoring.

5. Manufacturers shall ensure that the machinery or related product which they place on the
market or put into service bears at least a designation of the machinery or related product model,
series or type, the year of construction, namely the year in which the manufacturing process was
completed, and any batch or serial number or other element allowing its identification that exists,
or, where the size or nature of the machinery or related product does not allow this, that the
required information is provided on the packaging or in a document accompanying the machinery
or related product.

6. Manufacturers shall indicate their name, registered trade name or registered trade mark, and the
postal address and website, e-mail address or other digital contact at which they can be contacted, on
the machinery or related product or, where that is not possible, on its packaging or in a document
accompanying the machinery or related product. The address shall indicate a single point at which
the manufacturer can be contacted. The contact details shall be in a language easily understood by
users and market surveillance authorities.

7. Manufacturers shall ensure that the machinery or related products are accompanied by the
instructions for use and the information set out in Annex III. The instructions may be provided in a
digital format. Such instructions and information shall clearly describe the product model to which
they correspond.

When the instructions for use are provided in digital format, the manufacturer shall:

(a) mark on the machinery or related product, or, where that is not possible, on its packaging or in
an accompanying document, how to access the digital instructions;

(b) present them in a format that makes it possible for the user to print and download the instructions
for use and save them on an electronic device so that he or she can access them at all times, in
particular during a breakdown of the machinery or related product; this requirement also
applies where the instructions for use are embedded in the software of the machinery or related
product;

(c) make them accessible online during the expected lifetime of the machinery or related product
and for at least 10 years after the placing on the market of the machinery or related product.

However, at the request of the user at the time of the purchase, the manufacturer shall provide the
instructions for use in paper format free of charge within one month.

In the case of machinery or a related product intended for non-professional users or that can, under
reasonably foreseeable conditions, be used by non-professional users, even if not intended for them,
the manufacturer shall provide, in paper format, the safety information that is essential for putting
the machinery or related product into service and for using it in a safe way.

The instructions for use, the safety information and the information set out in Annex III shall be in a
language which can be easily understood by users, as determined by the Member State concerned, and
shall be clear, understandable and legible.

8. Manufacturers shall ensure that the machinery or related product is accompanied by the EU
declaration of
conformity set out Anne V, Part A or, alternatively, manufacturers shall provide the internet
in x address or
L 165/38 E Official Journal of the European 29.6.202
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machine-readable code where that EU declaration of conformity can be accessed in the instructions
for use and the information set out in Annex III.

Digital EU declarations of conformity shall be made accessible online for the expected lifetime of the
machinery or related product and in any event for at least 10 years after the placing on the market
or the putting into service of the machinery or related product.
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9. Manufacturers who consider or have reason to believe that machinery or a related product, which
they have placed on the market or put into service is not in conformity with this Regulation shall
immediately take the corrective actions necessary to bring that machinery or related product into
conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the machinery or
related product presents a risk to the health or safety of persons, and, where appropriate, domestic
animals or to property, and, where applicable, to the environment, manufacturers shall immediately
inform the competent national authorities of the Member States in which they made the machinery
or related product available on the market, or in which they put it into service, to that effect, giving
details, in particular, of the non-conformity and of any corrective actions taken.

10. Manufacturers shall, further to a reasoned request from a competent national authority,
provide that authority with all the information and documentation, in paper or digital format, necessary
to demonstrate the conformity of the machinery or related products with this Regulation, in a
language which can be easily understood by that authority. They shall cooperate with that
authority, at its request, on any actions taken to eliminate the risks presented by the machinery or
related products, which they have placed on the market or put into service.

Article 11
Obligations of manufacturers of partly completed machinery
1. When placing partly completed machinery on the market, manufacturers shall ensure that it
has been designed and constructed in accordance with the relevant essential health and safety
requirements set out in Annex III.

2. Before placing partly completed machinery on the market, manufacturers shall draw up the
technical documen tation set out in Annex IV, Part B.

Where compliance of partly completed machinery with the relevant essential health and safety
requirements set out in Annex III has been demonstrated in the technical documentation set out in
Annex IV, Part B, manufacturers shall draw up the EU declaration of incorporation in accordance
with Article 22.

3. Manufacturers shall keep the technical documentation and the EU declaration of incorporation
at the disposal of the market surveillance authorities for at least 10 years after the partly
completed machinery has been placed on the market. Where relevant, the source code or the
programming logic included in the technical documentation shall, upon a reasoned request, be made
available to the competent national authorities, if that source code or programming logic is necessary in
order for them to be able to check compliance with the relevant essential health and safety requirements
set out in Annex III.

4. Manufacturers shall ensure that procedures are in place for partly completed machinery that is
part of a series production to remain in conformity with this Regulation. Adequate account shall be taken
of changes in the production process, or in the design or characteristics of the partly completed
machinery, and changes in the harmonised standards or other technical specifications, or in the
common specifications referred to in Article 20, by reference to which the conformity of the partly
completed machinery is declared or verified.

5. Manufacturers shall ensure that the partly completed machinery which they place on the market
bears at least the designation of the partly completed machinery, the year of construction, namely
the year in which the manufacturing process was completed, model and series or type and any
batch or serial number or other element allowing its identification that exists, or, where the size or
nature of the partly completed machinery does not allow this, that the required information is
provided on the packaging or in a document accompanying the partly completed machinery.

6. Manufacturers shall indicate their name, registered trade name or registered trade mark, and the
postal address and website, email address or other digital contact at which they can be contacted, on
the partly completed machinery or, where that is not possible, on its packaging or in a document
accompanying the partly completed machinery. The address shall indicate a single point at which
the manufacturer can be contacted. The contact details shall be in a language easily understood by
the person who incorporates the partly completed machinery into machinery and by market
surveillance authorities.

7. Manufacturers shall ensure that the partly completed machinery is accompanied by the assembly
instructions set out in Annex XI.

The assembly instructions may be provided by the manufacturer in digital

L 165/40 E Official Journal of the European 29.6.202
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format. When the assembly instructions are provided in digital format, the

manufacturer shall:

(a) mark on the partly completed machinery, or, where that is not possible, on its packaging or in
an accompanying document, how to access the digital assembly instructions;
29.6.202 E Official Journal of the European L 165/41
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(b) present them in a format that makes it possible for the person who incorporates the partly
completed machinery to print and download the assembly instructions and save them on an
electronic device so that he or she can access them at all times, in particular during a breakdown of
the partly completed machinery; this requirement also applies where the assembly instructions are
embedded in the software of the partly completed machinery;

(c) make them accessible online for at least 10 years after the placing on the market of the partly
completed machinery.

However, at the request of the person who incorporates the partly completed machinery at the time
of purchase, the manufacturer shall provide the assembly instructions in paper format free of
charge within one month.

The assembly instructions shall be in a language which can be easily understood by the person who
incorporates the partly completed machinery, as determined by the Member State concerned, and
shall be clear, understandable, and legible.

8. Manufacturers shall ensure that the partly completed machinery is accompanied by the EU
declaration of incor poration set out in Annex V, Part B or, alternatively, manufacturers shall
provide the internet address or machine readable code where that EU declaration of incorporation
can be accessed in the assembly instructions set out in Annex XI.

Digital EU declarations of incorporation shall be made accessible online for at least 10 years after the
placing on the market of the partly completed machinery.

9. Manufacturers who consider or have reason to believe that partly completed machinery which they
have placed on the market is not in conformity with this Regulation shall immediately take the
corrective actions necessary to bring that partly completed machinery into conformity, to withdraw it
or to recall it, as appropriate. Furthermore, where the partly completed machinery presents a risk as
regards the relevant essential health and safety requirements, manu facturers shall immediately
inform the competent national authorities of the Member States in which they made the partly
completed machinery available on the market to that effect, giving details, in particular, of the non-
conformity and of any corrective actions taken.

10. Manufacturers shall, further to a reasoned request from a competent national authority,
provide that authority with all the information and documentation, in paper or digital format, necessary
to demonstrate the conformity of the partly completed machinery with this Regulation, in a language
which can be easily understood by that authority. They shall cooperate with that authority, at its
request, on any actions taken to eliminate the risks as regards the relevant essential health and
safety requirements presented by the partly completed machinery, which they have placed on the
market.

Article 12
Authorised representatives
1. A manufacturer of a product within the scope of this Regulation may, by a written mandate,
appoint an auth orised representative.

The obligations laid down in Article 10(1) and Article 11(1) and the obligation to draw up the
technical documentation set out in Annex IV shall not form part of the authorised representative’s
mandate.

2. An
authorised representative shall perform the tasks specified in the mandate received from the
manufacturer. The
mandate shall allow the authorised representative to do at least the following:

(a) keep the technical documentation and the EU declaration of conformity of machinery and
related products or the EU declaration of incorporation of partly completed machinery at the
disposal of the national market surveillance authorities for at least 10 years after the product
has been placed on the market;

(b) further to a reasoned request from a competent national authority, provide that authority with
all the information and documentation necessary to demonstrate the conformity of the product
within the scope of this Regulation, either in paper or digital format;

(c) cooperate with the competent national authorities, at their request, on any actions taken to
eliminate the risks presented by a product within the scope of this Regulation covered by the
L 165/42 E Official Journal of the European 29.6.202
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authorised representative’s mandate.

Article 13
Obligations of importers of machinery and related products
1. Importers shall place only compliant machinery or related products on the market.
29.6.202 E Official Journal of the European L 165/43
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2. Before placing machinery or a related product on the market, importers shall ensure that
the appropriate conformity assessment procedures referred to in Article 25 have been carried
out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical
documentation set out in Annex IV, Part A, that the machinery or related product bears the CE
marking referred to in Article 23 and is accompanied by the required documents, and that the
manufacturer has complied with the requirements set out in Article 10(5), (6) and (8).

Where an importer considers or has reason to believe that machinery or a related product is not in
conformity with this Regulation, the importer shall not place it on the market until it has been brought
into conformity. Furthermore, where the machinery or related product presents a risk to the health
and safety of persons and, where appropriate, domestic animals and property, and, where
applicable, to the environment, the importer shall inform the manufacturer and the market
surveillance authorities to that effect.

3. Importers shall indicate their name, registered trade name or registered trade mark, and the
postal address and website, email address or other digital contact at which they can be contacted,
on the machinery or related product or, where that is not possible, on its packaging or in a
document accompanying the machinery or related product. The contact details shall be in a
language easily understood by users and market surveillance authorities.

4. Importers shall ensure that the machinery or related product is accompanied by the
instructions for use and the information referred to in Article 10(7).

5. Importers shall ensure that, while the machinery or related product is under their
responsibility, the storage or transport conditions do not jeopardise conformity with the essential
health and safety requirements set out in Annex III.

6. When deemed appropriate with regard to the risks presented by machinery or a related product,
importers shall, in order to protect the health and safety of persons, and where appropriate,
domestic animals and property, and, where applicable, the environment carry out sample testing of
machinery or related products made available on the market, investigate, and, if necessary, keep a
register of complaints, of non-conforming machinery or related products and machinery or related
product recalls, and shall keep distributors informed of any such monitoring.

7. Importers who consider or have reason to believe that machinery or a related product, which
they have placed on the market, is not in conformity with this Regulation shall immediately take
the corrective actions necessary to bring that machinery or related product into conformity, to
withdraw it or recall it, as appropriate. Furthermore, where the machinery or related product
presents a risk to the health and safety of persons and, where appropriate, domestic animals
and property, and, where applicable, to the environment, importers shall immediately inform the
competent national authorities of the Member States in which they made the machinery or related
product available on the market to that effect, giving details, in particular, of the non-conformity
and of any corrective actions taken.

8. Importers shall, for at least 10 years after the machinery or related product has been placed on
the market, keep a copy of the EU declaration of conformity at the disposal of the market
surveillance authorities and ensure that the technical documentation set out in Annex IV, Part A,
can be made available to those authorities upon request.

Where relevant, the source code or the programming logic included in the technical
documentation shall, upon a reasoned request, be made available to the competent national
authorities, if that source code or programming logic is necessary in order for them to be able to
check compliance with the essential health and safety requirements set out in Annex III.

9. Importers shall, further to a reasoned request from a competent national authority, provide that
authority with all the information and documentation, in paper or digital format, necessary to
demonstrate conformity of the machinery or related products with this Regulation in a language that
can be easily understood by that authority. Importers shall cooperate with that authority, at its
request, on any action taken to eliminate the risks to the health and safety of persons and, where
appropriate, domestic animals and property, and, where applicable, to the environment presented by
machinery or related products which they have placed on the market.

Article 14
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Obligations of importers of partly completed machinery
1. Importers shall place only compliant partly completed machinery on the market.

2. Before placing partly completed machinery on the market, importers shall ensure that the
manufacturer has drawn up the technical documentation set out in Annex IV, Part B, that the partly
completed machinery is accompanied by the required documents and that the manufacturer has
complied with the requirements set out in Article 11(5), (6) and (8).
29.6.202 E Official Journal of the European L 165/45
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Where an importer considers or has reason to believe that partly completed machinery is not in
conformity with this Regulation, the importer shall not place it on the market until it has been brought
into conformity. Furthermore, where the partly completed machinery presents a risk as regards the
relevant essential health and safety requirements, the importer shall inform the manufacturer and
the market surveillance authorities to that effect.

3. Importers shall indicate their name, registered trade name or registered trade mark, and the
postal address and website, email address or other digital contact at which they can be contacted,
on the partly completed machinery or, where that is not possible, on its packaging or in a document
accompanying the partly completed machinery. The contact details shall be in a language easily
understood by the person who incorporates the partly completed machinery and by the market
surveillance authorities.

4. Importers shall ensure that the partly completed machinery is accompanied by the assembly
instructions referred to in Article 11(7).

5. Importers shall ensure that, while the partly completed machinery is under their responsibility,
the storage or transport conditions do not jeopardise the conformity with the relevant essential health
and safety requirements set out in Annex III.

6. Importers who consider or have reason to believe that partly completed machinery which they have
placed on the market is not in conformity with this Regulation shall immediately take the corrective
actions necessary to bring that partly completed machinery into conformity, to withdraw it or recall
it, as appropriate. Furthermore, where the partly completed machinery presents a risk as regards
relevant essential health and safety requirements, importers shall immediately inform the
competent national authorities of the Member States in which they made the partly completed
machinery available on the market to that effect, giving details, in particular, of the non-conformity
and of any corrective actions taken.

7. Importers shall, for at least 10 years after the partly completed machinery has been placed on
the market, keep a copy of the EU declaration of incorporation at the disposal of the market
surveillance authorities and ensure that the technical documentation set out in Annex IV, Part B
can be made available to those authorities upon request.

8. Importers shall, further to a reasoned request from a competent national authority, provide that
authority with all the information and documentation, in paper or digital format, necessary to
demonstrate the conformity of the partly completed machinery with this Regulation in a language that
can be easily understood by that authority. Importers shall cooperate with that authority, at its request,
on any action taken to eliminate the risks as regards the relevant essential health and safety
requirements presented by a partly completed machinery, which they have placed on the market.

Article 15
Obligations of distributors of machinery and related products
1. When making machinery or a related product available on the market, distributors shall act
with due care in relation to the requirements of this Regulation.

2. Before making machinery or a related product available on the market, distributors shall verify
that:

(a) the machinery or related product bears the CE marking;

(b) the machinery or related product is accompanied by the EU declaration of conformity referred to in
Article 10(8);

(c) the machinery or related product is accompanied by the instructions for use and the information
referred to in Article 10(7), and that they are in a language which can be easily understood by users,
as determined by the Member State in which the machinery or related product is to be made
available on the market;

(d) the manufacturer and the importer have complied with the requirements referred to in Article
10(5) and (6) and Article 13(3) respectively.

3. Where a distributor considers or has reason to believe that machinery or a related product is
not in conformity with this Regulation, the distributor shall not make the machinery or related product
L 165/46 E Official Journal of the European 29.6.202
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available on the market until it has been brought into conformity. Furthermore, where the machinery
or related product presents a risk to the health and safety of persons and, where appropriate,
domestic animals and property, and, where applicable, to the environment, the distributor shall inform
the manufacturer or the importer as well as the market surveillance authorities to that effect.

4. Distributors
shall ensure that, while machinery or a related product is under their responsibility,
the storage or
transport conditions do not jeopardise conformity with the essential health and safety requirements set
out in Annex III.
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5. Distributors
who consider or have reason to believe that machinery or a related product which
they have made
available on the market is not in conformity with this Regulation shall make sure that the corrective
actions necessary to bring that machinery or related product into conformity, to withdraw it or recall
it, as appropriate, are taken. Furthermore, where the machinery or related product presents a risk
to the health and safety of persons and, where appropriate, domestic animals and property, and, where
applicable, to the environment, distributors shall immediately inform the competent national
authorities of the Member States in which they have made the machinery or related product
available on the market to that effect, giving details, in particular, of the non-conformity and of any
corrective actions taken.

6. Distributors
shall, further to a reasoned request from a competent national authority, provide that
authority with
all the information and documentation, in paper or digital format, necessary to demonstrate the
conformity of the machinery or related product with this Regulation in a language that can be easily
understood by that authority. They shall cooperate with that authority, at its request, on any action
taken to eliminate the risks to the health and safety of persons and, where appropriate, domestic
animals and property, and, where applicable, to the environment presented by machinery or a related
product which they have made available on the market.

Article 16
Obligations of distributors of partly completed machinery
1. When making partly completed machinery available on the market, distributors shall act with due
care in relation to the requirements of this Regulation.

2. Before making partly completed machinery available on the market, distributors shall verify that:

(a) the partly completed machinery is accompanied by the EU declaration of incorporation referred to in
Article 11(8);

(b) the partly completed machinery is accompanied by the assembly instructions referred to in
Article 11(7), and that they are in a language which can be easily understood by the person who
incorporates the partly completed machinery as determined by the Member State in which the
partly completed machinery is to be made available on the market;

(c) the manufacturer and the importer have complied with the requirements referred to in Article
11(5) and (6) and Article 14(3) respectively.

3. Where a distributor considers or has reason to believe that partly completed machinery is not in
conformity with this Regulation, the distributor shall not make the partly completed machinery available
on the market until it has been brought into conformity. Furthermore, where the partly completed
machinery presents a risk as regards relevant essential health and safety requirements, the
distributor shall inform the manufacturer or the importer as well as the market surveillance
authorities to that effect.

4. Distributorsshall ensure that, while a partly completed machinery is under their responsibility,
the storage or
transport conditions do not jeopardise conformity with the relevant essential health and safety
requirements set out in Annex III.

5. Distributorswho consider or have reason to believe that partly completed machinery which
they have made
available on the market is not in conformity with this Regulation shall make sure that the corrective
actions necessary to bring that partly completed machinery into conformity, to withdraw it or recall
it, as appropriate, are taken. Furthermore, where the partly completed machinery presents a risk as
regards the relevant essential health and safety requirements distributors shall immediately inform
the competent national authorities of the Member States in which they have made the partly
completed machinery available on the market to that effect, giving details, in particular, of the non-
conformity and of any corrective actions taken.

6. Distributors shall, further to a reasoned request from a competent national authority, provide that
authority with
all the information and documentation, in paper or digital format, necessary to demonstrate the
conformity of the partly completed machinery with this Regulation. They shall cooperate with that
authority, at its request, on any action taken to eliminate the risks as regards the essential health and
safety requirements presented by partly completed machinery which they have made available on the
market.
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Article 17
Cases in which obligations of manufacturers apply to importers and distributors
An importer or distributor shall be considered to be a manufacturer for the purposes of this
Regulation, and shall be subject to the obligations of the manufacturer set out in Articles 10 and
11, where that importer or distributor places a product within the scope of this Regulation on the
market under its name or trademark or modifies a product already placed on the market in such a
way that compliance with the applicable requirements might be affected.
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Article 18
Other cases in which obligations of manufacturers apply
A natural or legal person that carries out a substantial modification of machinery or a related
product shall be considered to be a manufacturer for the purposes of this Regulation and shall be
subject to the obligations of the manufacturer set out in Article 10 for that machinery or related
product or, if the substantial modification has an impact on the safety of only machinery or a related
product that is part of an assembly of machinery, for that affected machinery or related product, as
demonstrated in the risk assessment.

The person who carries out the substantial modification shall in particular, but without prejudice to other
obligations set out in Article 10, ensure and declare on its sole responsibility that the machinery or
related product concerned is in conformity with the applicable requirements of this Regulation and
shall apply the relevant conformity assessment procedure as provided in Article 25 (2), (3) and (4)
of this Regulation.

A non-professional user who carries out a substantial modification to his or her machinery or related
product, for his or her own use, shall not be considered to be a manufacturer for the purposes of this
Regulation and shall not be subject to the obligations on the manufacturer set out in Article 10.

Article 19
Identification of economic operators
1. Economic operators shall, on request, identify the following to the market surveillance authorities:

(a) any economic operator who has supplied them with a product within the scope of this Regulation;

(b) any economic operator to whom they have supplied a product within the scope of this Regulation.

2. In order to be able to comply with the obligation in paragraph 1, economic operators shall
retain the information referred to in that paragraph for at least 10 years after they supplied or
were supplied with the products within the scope of this Regulation.

CHAPTER III

CONFORMITY OF PRODUCTS WITHIN THE SCOPE OF THIS REGULATION

Article 20
Presumption of conformity of products within the scope of this Regulation
1. A product within the scope of this Regulation which is in conformity with harmonised standards
or parts thereof the references of which have been published in the Official Journal of the European Union
shall be presumed to be in conformity with the essential health and safety requirements set out in
Annex III covered by those standards or parts thereof.

2. The Commission shall, as provided in Article 10(1) of Regulation (EU) No 1025/2012, request
one or more European standardisation organisations to draft harmonised standards for the essential
health and safety requirements set out in Annex III.

3. The Commission may adopt implementing acts establishing common specifications covering
technical requirements that provide a means to comply with the essential health and safety
requirements set out in Annex III for products within the scope of this Regulation.

Those implementing acts shall only be adopted where the following conditions are fulfilled:

(a) the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or
more European standardisation organisations to draft a harmonised standard for the essential health
and safety requirements set out in Annex III and:

(i) the request has not been accepted; or

(ii) the harmonised standards addressing that request are not delivered within the deadline set in
accordance with Article 10(1) of Regulation (EU) No 1025/2012; or

(iii)the harmonised standards do not comply with the request; and

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(b) no reference to harmonised standards covering the relevant essential health and safety
requirements set out in
Annex III has been published in the Official Journal of the European Union in accordance with
Regulation (EU)
No 1025/2012 and no such reference is expected to be published within a reasonable period.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in
Article 48(3).

4. Before preparing the draft implementing act referred to in paragraph 3, the Commission shall
inform the
committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the
conditions in
paragraph 3 have been fulfilled.

5. When preparing the draft implementing act referred to in paragraph 3, the Commission shall take
into account the views of relevant bodies or the expert group and shall duly consult all relevant
stakeholders.

6. A product within the scope of this Regulation which is in conformity with the common
specifications established by implementing acts referred to in paragraph 3, or parts thereof, shall
be presumed to be in conformity with the essential health and safety requirements set out in Annex
III covered by those common specifications or parts thereof.

7. Where a harmonised standard is adopted by a European standardisation organisation and

proposed to the Commission for the purpose of publishing its reference in the Official Journal of the
European Union, the Commission shall assess the harmonised standard in accordance with Regulation
(EU) No 1025/2012. When reference of a harmonised standard is published in the Official Journal of the
European Union, the Commission shall repeal the imple menting acts referred to in paragraph 3, or parts
thereof which cover the same essential health and safety requirements as those covered by that
harmonised standard.

8. When a Member State considers that a common specification does not entirely satisfy the
essential health and safety requirements set out in Annex III, it shall inform the Commission thereof
by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if
appropriate, amend the implementing act establishing the common specification in question.

9. Machinery and related products that have been certified or for which a statement of conformity
has been issued under a cybersecurity certification scheme adopted in accordance with Regulation
(EU) 2019/881 the references of which have been published in the Official Journal of the European Union
shall be presumed to be in conformity with the essential health and safety requirements set out in
Annex III, sections 1.1.9 and 1.2.1, as regards protection against corruption and safety and
reliability of control systems insofar as those requirements are covered by the cybersecurity
certificate or statement of conformity or parts thereof.

Article 21
EU declaration of conformity of machinery and related products
1. The EU declaration of conformity shall state that the fulfilment of the applicable essential
health and safety requirements set out in Annex III has been demonstrated.

2. The EU declaration of conformity shall have the model structure set out in Annex V, Part A,
and shall contain the elements specified in the relevant modules set out in Annexes VI, VIII, IX, and
X. It shall be continuously updated and shall be translated into the language or languages
required by the Member State in which the machinery or related product is placed on the
market, is made available on the market or put into service.

3. Where machinery or a related product is subject to more than one Union legal act that requires an
EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all
such acts. That declaration shall contain the identification of the Union legal acts concerned,
including their publication references.
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4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for
the compliance of the machinery or related product with the requirements laid down in this
Regulation.

Article 22
EU declaration of incorporation of partly completed machinery
1. The EU declaration of incorporation shall state that the fulfilment of the relevant essential
health and safety requirements set out in Annex III has been demonstrated.
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2. The EU declaration of incorporation shall have the model structure set out in Annex V, Part
B. It shall be
continually updated and shall be translated into the language or languages required by the Member
State in which the partly completed machinery is placed on the market or is made available on the
market.

3. Where partly completed machinery is subject to more than one Union legal act requiring an EU
declaration of conformity, the EU declaration of incorporation shall include a sentence declaring the
conformity with such acts. That declaration shall contain the identification of the Union legal acts
concerned, including their publication references.

4. By drawing up the EU declaration of incorporation, the manufacturer shall assume

responsibility for the compliance of the partly completed machinery with the requirements laid
down in this Regulation.

Article 23
General principles of the CE marking
The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No
765/2008.

Article 24
Rules for affixing the CE marking to machinery and related products
1. The CE marking shall be affixed visibly, legibly and indelibly to the machinery or related
product. Where that is not possible or not warranted on account of the nature of the machinery or
related product, it shall be affixed to the packaging and to the documents accompanying the
machinery or related product.

2. The CE marking shall be affixed before the machinery or related product is placed on the
market or put into service.

3. Where the conformity of machinery or a related product is assessed in accordance with the
conformity assessment procedure referred to in Article 25(2), points (a), (b) and (c) and in Article
25(3), points (b), (c) and (d), the CE marking shall be followed by the identification number of the
notified body involved in that procedure.

The identification number of that notified body shall be affixed by the body itself or, under its
instructions, by the manufacturer or the manufacturer’s authorised representative.

4. The CE marking and, where applicable, the identification number of the notified body may be
followed by a pictogram or any other marking indicating a special risk or use.

5. Member States shall build upon existing mechanisms to ensure correct application of the regime
governing the CE marking and shall take appropriate action in the event of improper use of that
marking.

CHAPTER IV

CONFORMITY ASSESSMENT

Article 25
Conformity assessment procedures for machinery and related products
1. The manufacturer or the natural or legal person referred to in Article 18 shall apply one of
the conformity assessment procedures referred to in paragraphs 2, 3 and 4.

2. Where the category of machinery or related product is listed in Annex I, Part A, the manufacturer or
the natural or legal person referred to in Article 18 shall apply one of the following procedures:

(a) EU type-examination (module B) set out in Annex VII, followed by conformity to type based on
internal production control (module C) set out in Annex VIII;

(b) conformity based on full quality assurance (module H) set out in Annex IX;

(c) conformity based on unit verification (module G) set out in Annex X.

3. Where the category of machinery or related product is listed in Annex I, Part B, the manufacturer or
the natural or legal person referred to in Article 18 shall apply one of the following procedures:
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(a) internal production control (module A) set out in Annex VI;

(b) EU type-examination (module B) set out in Annex VII, followed by conformity to type based on
internal production control (module C) set out in Annex VIII;
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(c) conformity based on full quality assurance (module H) set out in Annex IX;

(d) conformity based on unit verification (module G) set out in Annex X.

If a manufacturer applies the internal production control procedure referred to in point (a), it shall
design and construct the machinery or related product in accordance with the harmonised standards
or common specifications specific to that category of machinery or related product covering all the
relevant essential health and safety requirements.

Where the category of machinery or related product is listed in Annex I, Part B, and the machinery
or related product was not designed and constructed in accordance with the harmonised standards
or common specifications specific to that category of machinery or related product covering all the
relevant essential health and safety requirements for that category of machinery or related product, the
manufacturer, including a natural or legal person referred to in Article 18, shall apply one of the
procedures referred to in points (b), (c) or (d) of this paragraph.

4. Where the category of machinery or related product is not listed in Annex I, the manufacturer,
including a natural or legal person referred to in Article 18, shall apply the internal production
control procedure (module A) set out in Annex VI.

5. Notified bodies shall take into account the specific interests and needs of small and medium sized
enterprises when setting the fees for conformity assessment.

CHAPTER V

NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

Article 26
Notification
Member States shall notify the Commission and the other Member States of bodies authorised to carry
out third-party conformity assessment tasks in accordance with this Regulation.

Article 27
Notifying authorities
1. Member States shall designate a notifying authority that shall be responsible for setting up
and carrying out the necessary procedures for the assessment and notification of conformity
assessment bodies and the monitoring of notified bodies, including compliance with Article 32.

2. Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be
carried out by a national accreditation body, as defined in Regulation (EC) No 765/2008 in accordance
with that Regulation.

3. Where the notifying authority delegates or otherwise entrusts the assessment, notification or
monitoring referred to in paragraph 1 to a body, which is not a governmental entity, that body
shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in Article
28. In addition, that body shall have arrangements in place to cover liabilities arising out of its
activities.

4. The notifying authority shall take full responsibility for the tasks performed by the body
referred to in paragraph 3.

Article 28
Requirements relating to notifying authorities
1. A notifying authority shall be established in such a way that no conflict of interest with
conformity assessment bodies occurs.

2. A notifying authority shall be organised and operated so as to safeguard the objectivity and
impartiality of its activities.
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3. A notifying authority shall be organised in such a way that each decision relating to
notification of a conformity assessment body is taken by competent persons different from those
who carried out the assessment.
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4. A notifying authority shall not offer or provide any activities that conformity assessment bodies
perform, nor shall it offer or provide consultancy services on a commercial or competitive basis.

5. A notifying authority shall safeguard the confidentiality of the information it obtains.

6. A notifying authority shall have a sufficient number of competent personnel at its disposal
for the proper performance of its tasks.

Article 29
Information obligation of notifying authorities
Member States shall inform the Commission of their procedures for the assessment and notification
of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto.

The Commission shall make that information publicly available.

Article 30
Requirements relating to notified bodies
1. For the purposes of notification, a conformity assessment body shall meet the
requirements laid down in paragraphs 2 to 11.

2. A conformity assessment body shall be established under the national law of a Member State and
shall have legal personality.

3. A conformity assessment body shall be a third-party body that is independent of the

organisation or of the machinery or related product that it assesses.

A body belonging to a business association or professional federation representing undertakings involved

in the design, manufacture, provision, assembly, use or maintenance of machinery or related
products which it assesses, may, on condition that its independence and the absence of any conflict
of interest are demonstrated, be considered such a conformity assessment body.

4. A conformity assessment body, its top-level management and the personnel responsible for
carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier,
importer, distributor, installer, purchaser, owner, user or maintainer of machinery or related products
that they assess, nor shall it fulfil any of those roles in relation to partly completed machinery that has
been incorporated into the assessed product or be the representative of any of those parties. This shall
not preclude the use of assessed machinery or related products that are necessary for the operations of
the conformity assessment body or the use of machinery or related products for personal
purposes.

A conformity assessment body, its top-level management and the personnel responsible for carrying out
the conformity assessment tasks shall not be directly involved in the design, import, distribution,
manufacture, marketing, installation, use or maintenance of the machinery or related products, or
represent the parties engaged in those activities. They shall not engage in any activity that may conflict
with their independence of judgement or integrity in relation to conformity assessment activities for
which they are notified. This shall in particular apply to consultancy services.

A conformity assessment body shall ensure that the activities of its subsidiaries or subcontractors
do not affect the confidentiality, objectivity or impartiality of its conformity assessment activities.

5. A conformity assessment body and its personnel shall carry out the conformity assessment
activities with the highest degree of professional integrity and the requisite technical competence in the
specific field and shall be free from all pressures and inducements, particularly financial, which might
influence its judgement or the results of its conformity assessment activities, especially as regards
persons or groups of persons with an interest in the results of those activities.
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6. A conformity assessment body shall be capable of carrying out all the conformity assessment
tasks assigned to it by Annexes VII, IX and X and in relation to which it has been notified, regardless
of whether those tasks are carried out by the conformity assessment body itself or on its behalf and
under its responsibility.
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At all times, and for each conformity assessment procedure and each kind of machinery or related
products for which it has been notified, a conformity assessment body shall have at its disposal the
necessary:

(a) personnel with technical knowledge and sufficient and appropriate experience to perform the
conformity assessment tasks;

(b) descriptions of procedures in accordance with which conformity assessment is carried out, ensuring
the transparency and the ability of reproduction of those procedures;

(c) appropriate policies and procedures to distinguish between tasks that it carries out as a notified
body and other activities;

(d) procedures for the performance of conformity assessment activities which take due account of
the size of an undertaking, the sector in which it operates, its structure, the degree of complexity
of the machinery or related product technology in question and the mass or serial nature of the
production process.

A conformity assessment body shall have the means necessary to perform the technical and
administrative tasks connected with the conformity assessment activities in an appropriate manner
and shall have access to all necessary equipment or facilities.

7. The personnel responsible for carrying out conformity assessment tasks shall have the following:

(a) sound technical and vocational training covering all the conformity assessment activities in
relation to which the conformity assessment body has been notified;

(b) satisfactory knowledge of the requirements of the assessments they carry out and adequate
authority to carry out those assessments;

(c) appropriate knowledge and understanding of the essential health and safety requirements set out in
Annex III, of the applicable harmonised standards and common specifications referred to in Article 20,
and of the relevant provisions of Union harmonisation legislation and of national legislation;

(d) the ability to draw up certificates, records and reports demonstrating that conformity assessments
have been carried out.

8. The impartiality of a conformity assessment body, its top-level management and the personnel
responsible for carrying out the conformity assessment tasks shall be guaranteed.

The remuneration of the top-level management and the personnel responsible for carrying out the
conformity assessment tasks shall not depend on the number of conformity assessments carried out
or on the results of those assessments.

9. A conformity assessment body shall take out liability insurance unless liability is assumed by the
Member State in accordance with national law, or the Member State itself is directly responsible for
the conformity assessment.

10. The personnel of a conformity assessment body shall observe professional secrecy with regard to
all information obtained in carrying out the conformity assessment tasks in accordance with Annexes
VII, IX and X, except in relation to the competent authorities of the Member State in which its tasks
are carried out. Proprietary rights, intellectual property rights and trade secrets shall be protected.

11. A conformity assessment body shall participate in, or ensure that its personnel responsible for
carrying out the conformity assessment tasks are informed of, the relevant standardisation activities and
the activities of the notified body coordination group established under Article 42 and shall apply as
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general guidance the administrative decisions and documents produced as a result of the work of
that group.
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Article 31
Presumption of conformity of notified bodies
Where a conformity assessment body demonstrates its conformity with the criteria laid down in the
relevant harmonised standards or parts thereof the references of which have been published in the
Official Journal of the European Union, it shall be presumed to comply with the requirements set out in
Article 30 insofar as the applicable harmonised standards cover those requirements.

Article 32
Use of subcontractors and subsidiaries by notified bodies
1. Where a notified body subcontracts specific tasks connected with conformity assessment or has
recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements
set out in Article 30 and shall inform the notifying authority accordingly.

2. A notified body shall take full responsibility for the tasks performed by subcontractors or
subsidiaries wherever those are established.

3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the
client.

4. A notified body shall keep at the disposal of the notifying authority the relevant documents
concerning the assessment of the qualifications of the subcontractor or the subsidiary and the
work carried out by them under Annexes VII, IX and X.

Article 33
Application for notification
1. A conformity assessment body shall submit an application for notification to the notifying
authority of the Member State in which it is established.

2. The application for notification shall be accompanied by a description of the conformity

assessment activities, of the conformity assessment procedures set out in Annexes VII, IX and X and
of the kinds or categories of machinery or related products for which the conformity assessment
body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a
national accreditation body attesting that the conformity assessment body fulfils the requirements laid
down in Article 30.

3. Where the conformity assessment body concerned cannot provide an accreditation certificate
as referred to in paragraph 2, it shall provide the notifying authority with all the documentary
evidence necessary for the verification, recognition and regular monitoring of its compliance with
the requirements laid down in Article 30.

Article 34
Notification procedure
1. A notifying authority shall notify only conformity assessment bodies which have satisfied the
requirements laid down in Article 30.

2. The notifying authority shall send a notification to the Commission and the other Member
States, using the electronic notification tool developed and managed by the Commission.

3. The notification referred to in paragraph 2 shall include the following:

(a) full details of the conformity assessment activities to be performed;

(b) an indication of the conformity assessment module or modules and the kinds or categories of
machinery or related products concerned;

(c) the relevant attestation of competence.

4. Where a notification is not based on an accreditation certificate referred to in Article 33(2), the
notifying authority shall provide the Commission and the other Member States with documentary
evidence which attests to the conformity assessment body’s competence and the arrangements in place
29.6.202 E Official Journal of the European L 165/61
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to ensure that that body will be monitored regularly and will continue to satisfy the requirements
laid down in Article 30.
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5. The conformity assessment body concerned may perform the activities of a notified body
only where no objections are raised by the Commission or the other Member States within two
weeks of the validation of the notification where it includes an accreditation certificate
referred to in Article 33(2), or within two months of the notification where it includes
documentary evidence referred to in paragraph 4 of this Article.

Only such a body shall be considered a notified body for the purposes of this Regulation.

6. The notifying authority shall notify the Commission and the other Member States of any
subsequent relevant changes to the notification referred to in paragraph 2.

Article 35
Identification numbers and lists of notified bodies
1. The Commission shall assign an identification number to a notified body.

It shall assign a single such number even where the body is notified under several Union acts.

2. The Commission shall make publicly available the list of bodies notified under this Regulation
including the identification numbers that have been assigned to them and the conformity
assessment activities for which they have been notified.

The Commission shall ensure that the list is kept up to date.

Article 36
Changes to notifications
1. Where a notifying authority has ascertained or has been informed that a notified body no
longer meets the requirements laid down in Article 30, or that it is failing to fulfil its obligations as
set out in Article 38 the notifying authority shall restrict, suspend or withdraw the notification, as
appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those
obligations. It shall immediately inform the Commission and the other Member States accordingly.

2. In the event of restriction, suspension or withdrawal of notification, or where the notified body
has ceased its activity, the notifying authority shall take appropriate steps to ensure that the files of
that body are either processed by another notified body or kept available for the responsible notifying
and market surveillance authorities at their request.

Article 37
Challenge of the competence of notified bodies
1. The Commission shall investigate all cases where it doubts, or doubt is brought to its attention
regarding, the competence of a notified body or the continued fulfilment by a notified body of the
requirements and responsibilities to which it is subject.

2. The notifying Member State shall provide the Commission, on request, with all information
relating to the basis for the notification or the maintenance of the competence of the notified
body concerned.

3. The Commission shall ensure that all sensitive information obtained in the course of its
investigations is treated confidentially.

4. Where the Commission ascertains that a notified body does not meet or no longer meets the
requirements for its notification, it shall adopt an implementing act requesting the notifying Member
State to take the necessary corrective measures, including the withdrawal of the notification if
necessary.

That implementing act shall be adopted in accordance with the advisory procedure referred to in
Article 48(2).

Article 38
Operational obligations of notified bodies
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1. A notified body shall carry out conformity assessments in accordance with the conformity
assessment procedures set out in Annexes VII, IX and X.
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2. A notified body shall perform its activities in a proportionate manner, avoiding unnecessary burdens
for economic operators, and taking due account of the size of an undertaking, the sector in which
the undertaking operates, the structure of the undertaking, the degree of complexity of the technology
in question and the mass or serial nature of the production process.

In so doing, the notified body shall nevertheless respect the degree of rigour and the level of protection
required for the compliance of the machinery or related product with the requirements of this
Regulation.

3. Where a notified body finds that the essential health and safety requirements
Anne
III, or
set out in
x
corresponding harmonised standards or common specifications referred to in Article 20 have not
been met by a
manufacturer, it shall require the manufacturer to take appropriate corrective actions and shall not
issue an EU-type examination certificate, adopt a quality system approval decision or issue a unit
verification certificate.

4. Where, in the course of the monitoring of conformity, following the adoption of an approval
decision, in accordance with Annex IX, a notified body finds that machinery or a related product no
longer complies, it shall require the manufacturer to take appropriate corrective actions and shall
suspend or withdraw the approval decision, if necessary.

Where corrective actions are not taken or do not have the required effect, the notified body shall
restrict, suspend or withdraw any approval decisions, as appropriate.

Article 39
Appeals against decisions of notified bodies
A notified body shall ensure that a transparent and accessible appeals procedure against its
decisions is available.

Article 40
Information obligation of notified bodies
1. A notified body shall inform the notifying authority of the following:

(a) any refusal, restriction, suspension or withdrawal of an EU type-examination certificate, quality

system approval decision or unit verification certificate;

(b) any circumstances affecting the scope of, or the conditions for, its notification;

(c) any request for information which it has received from market surveillance authorities regarding
its conformity assessment activities;

(d) on request, any conformity assessment activities performed within the scope of its notification and
any other activity performed, including cross-border activities and subcontracting.

2. A notified body shall provide the other bodies notified under this Regulation carrying out
similar conformity assessment activities covering the same kinds of machinery or related products
with relevant information on issues relating to negative and, on request, positive conformity
assessment results.

Article 41
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Exchange of experience
The Commission shall provide for the organisation of exchange of experience between the Member
States’ national authorities responsible for notification policy.
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Article 42
Coordination of notified bodies
The Commission shall ensure the establishment and good functioning of appropriate coordination
and cooperation between bodies notified under this Regulation in the form of a sectoral group of
notified bodies.

Notified bodies shall participate in the work of that group, directly or by means of designated
representatives.

CHAPTER VI

UNION MARKET SURVEILLANCE AND UNION SAFEGUARD PROCEDURES

Article 43
Procedure at national level for dealing with products within the scope of this Regulation presenting a risk
1. Where the market surveillance authorities of one Member State have sufficient reason to
believe that a product within the scope of this Regulation presents a risk to the health or safety of
persons, and, where appropriate, domestic animals or property, and, where applicable, to the
environment, they shall carry out an evaluation in relation to the product concerned covering all
relevant requirements laid down in this Regulation. The relevant economic operators shall
cooperate as necessary with the market surveillance authorities for that purpose.

Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance
authorities find that the product within the scope of this Regulation does not comply with the
requirements laid down in this Regulation, they shall without delay require the relevant economic
operator to take appropriate and proportionate corrective action, as provided for in Article 16(3) of
Regulation (EU) 2019/1020, to bring the non-compliance to an end or to eliminate hazards or, if that
is not possible, minimise the risk specified by the market surveillance authorities within a reasonable
period which is commensurate with the nature of the risk referred to in the first subparagraph.

The market surveillance authorities shall inform the relevant notified body accordingly.

2. Where the market surveillance authorities consider that non-compliance is not restricted to their
national territory, they shall inform the Commission and the other Member States of the results of the
evaluation and of the actions which they have required the economic operator to take.

3. The economic operator shall ensure that all appropriate corrective action is taken in respect of the
products within the scope of this Regulation concerned that the economic operator has made
available on the market, throughout the Union.

4. Where the relevant economic operator does not take the corrective action referred to in
paragraph 1, second subparagraph, within the specified period or where the non-compliance,
referred to in paragraph 1, second subpara graph, or the risk referred to in paragraph 1, first
subparagraph, persists, the market surveillance authorities shall ensure that the product concerned is
withdrawn or recalled, or that making it available on the market is prohibited or restricted. In such
cases, the market surveillance authorities shall ensure that the public, the Commission and the
other Member States are informed accordingly, without delay.

5. The information referred to in paragraph 4 shall include all available details, in particular the
data necessary for the identification of the non-compliant product within the scope of this
Regulation, the origin of that product, the nature of the non-compliance alleged and the risk involved,
the nature and duration of the national measures taken and the arguments put forward by the relevant
economic operator. In particular, the market surveillance authorities shall indicate whether the
non-compliance is due to any of the following:

(a) the failure of the product to meet the requirements relating to the essential health and safety
requirements set out in Annex III;

(b) shortcomings in the harmonised standards referred to in Article 20(1);

(c) shortcomings in the common specifications referred to in Article 20(6).

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6. Member States other than the Member State initiating the procedure under this Article shall
without delay inform the Commission and the other Member States of any measures adopted and of
any additional information at their disposal relating to the non-compliance of the product within the
scope of this Regulation concerned, and, in the event of disagreement with the adopted national
measure, of their objections.
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7. Where, within three months of receipt of the information referred to in paragraph 4, no objection
has been raised by either a Member State or the Commission in respect of a provisional measure taken
by a Member State, that measure shall be deemed to be justified.

8. Member States shall ensure that appropriate restrictive measures, such as withdrawal of the
product, are taken in respect of the product within the scope of this Regulation concerned without
delay.

Article 44
Union safeguard procedure
1. Where, on completion of the procedure set out in Article 43(4), (6) and (7) objections are raised
against a measure taken by a Member State, or where the Commission considers a national measure to
be contrary to Union legal acts, the Commission shall without delay enter into consultation with the
Member States and the relevant economic operator or operators and shall evaluate the national
measure.

On the basis of the results of that evaluation, the Commission shall adopt an implementing act in the
form of a decision determining whether the national measure is justified or not.

The Commission shall address its decision to all Member States and shall without delay communicate
it to them and to the relevant economic operator or operators.

2. If the national measure is considered to be justified, all Member States shall ensure that
appropriate restrictive measures, such as withdrawal, are taken in respect of the non-compliant
product within the scope of this Regulation, and shall inform the Commission accordingly.

If the national measure is considered to be unjustified, the Member State concerned shall withdraw
that measure.

3. Where the national measure is considered to be justified and the non-compliance of the product
within the scope of this Regulation is attributed to shortcomings in the harmonised standards
referred to in Article 43(5), point (b), of this Regulation or common specifications referred to in Article
43(5), point (c), of this Regulation, the Commission shall apply the procedure provided for in Article 11
of Regulation (EU) No 1025/2012 or in Article 20(8) of this Regulation respectively.

Article 45
Compliant products within the scope of this Regulation which present a risk
1. Where, having carried out an evaluation under Article 43(1), a Member State finds that
although a product within the scope of this Regulation is in compliance with the essential health
and safety requirements set out in Annex III, it presents a risk to the health and safety of persons and,
where appropriate, domestic animals or to property, and, where applicable, to the environment, it
shall require the relevant economic operator to take all appropriate measures to ensure that the
product concerned, when placed on the market, no longer presents that risk, to withdraw that
product or to recall it within a reasonable period, commensurate with the nature of the risk.

2. The economic operator shall ensure that all appropriate corrective action is taken in respect of
all the products within the scope of this Regulation concerned that the economic operator has made
available on the market, throughout the Union.

3. The Member State shall immediately inform the Commission and the other Member States
about the product which presents a risk, as referred to in paragraph 1. That information shall include all
available details, in particular the data necessary for the identification of the product concerned, the
origin and the supply chain of that product, the nature of the risk involved and the nature and
duration of the national measures taken.

4. The Commission shall without delay enter into consultation with the Member States and the
relevant economic operator or operators and shall evaluate the national measures taken.

On the basis of the results of that evaluation, the Commission shall adopt an implementing act in the
form of a decision determining whether the national measure is justified or not and, where necessary,
order appropriate measures.

That implementing act shall be adopted in accordance with the examination procedure referred to in
Article 48(3).
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On duly justified imperative grounds of urgency relating to the protection of the health and
safety of persons, the Commission shall adopt an immediately applicable implementing act in
accordance with the procedure referred to in Article 48(4).
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5. The Commission shall address its decision to all Member States and shall immediately communicate
it to them and to the relevant economic operator or operators.

Article 46
Formal non-compliance
1. Without prejudice to Article 43, where a Member State makes one of the following
findings with regard to machinery or a related product, it shall require the relevant economic
operator to put an end to the non-compliance concerned:

(a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of
Article 24 of this Regulation;

(b) the CE marking has not been affixed;

(c) the identification number of the notified body involved in the production control phase has been
affixed in violation of Article 24(3) or has not been affixed;

(d) the EU declaration of conformity has not been drawn up or has not been drawn up correctly;

(e) the technical documentation is either not available or not complete;

(f) the information referred to in Article 10(6) or Article 13(3) is absent, false or incomplete;

(g) any other administrative requirement provided for in Article 10 or Article 13 is not fulfilled.

2. Without prejudice to Article 43, where a Member State makes one of the following findings with
regard to partly completed machinery, it shall require the relevant economic operator to put an end to
the non-compliance concerned:

(a) the EU declaration of incorporation has not been drawn up or has not been drawn up correctly;

(b) the technical documentation is either not available or not complete;

(c) the information referred to in Article 11(5) or Article 14(3) is absent, false or incomplete;

(d) any other administrative requirement provided for in Article 11 or Article 14 is not fulfilled.

3. Where the non-compliance referred to in paragraphs 1 and 2 persists, the Member State
concerned shall take all appropriate measures to restrict or prohibit the product within the scope of
this Regulation concerned being made available on the market or ensure that it is recalled or
withdrawn from the market.

CHAPTER VII

DELEGATED POWERS AND COMMITTEE PROCEDURE

Article 47
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions
laid down in this Article.

2. The power to adopt delegated acts

Article
6(2), 6(11) and 7(2) shall be conferred
referred to in
s on the
Commission for a period of five years from 13 July 2023. The Commission shall draw up a report
in respect of the delegation of power not later than nine months before the end of the five-year
period. The delegation of power shall be tacitly extended for periods of an identical duration,
unless the European Parliament or the Council opposes such extension not later than three
months before the end of each period.

3. The delegation of power referred to in Articles 6(2), 6(11) and 7(2) may be revoked at any
time by the European Parliament or by the Council. A decision to revoke shall put an end to the
delegation of the power specified in that decision. It shall take effect the day following the
publication of the decision in the Official Journal of the European Union or at a later date specified therein.
It shall not affect the validity of any delegated acts already in force.
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4. Before adopting a delegated act, the Commission shall consult experts designated by each
Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13
April 2016 on Better Law-Making.
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5. As
soon as it adopts a delegated act, the Commission shall notify it simultaneously to the
European Parliament
and to the Council.

6. A delegated act adopted pursuant to Articles 6(2), 6(11) or 7(2) shall enter into force only if no
objection has been expressed either by the European Parliament or by the Council within a period
of two months of notification of that act to the European Parliament and the Council or if, before
the expiry of that period, the European Parliament and the Council have both informed the
Commission that they will not object. That period shall be extended by two months at the initiative
of the European Parliament or of the Council.

Article 48
Committee procedure
1. The Commission shall be assisted by a committee. That committee shall be a committee within
the meaning of Regulation (EU) No 182/2011.

2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Where the committee delivers no opinion regarding the draft implementing act referred to in Article
20(3), Article 5(4), third subparagraph, of Regulation (EU) No 182/2011 shall apply.

4. Where reference is made to this

Article
8 of Regulation (EU) No 182/2011, in
paragraph, Article 5 thereof, shall apply.
conjunction with

5. The committee shall be consulted by the Commission on any matter for which consultation of
sectoral experts is required by Regulation (EU) No 1025/2012 or by any other Union legal act.

The committee may furthermore examine any other matter concerning the application of this
Regulation raised either by its chair or by a representative of a Member State in accordance with its
rules of procedure.

CHAPTER VIII

CONFIDENTIALITY AND PENALTIES

Article 49
Confidentiality
1. All
parties shall respect the confidentiality of the following information and data obtained in
carrying out their
tasks in accordance with this Regulation:

(a) personal data;

(b) commercially confidential information and trade secrets of a natural or legal person, including
intellectual property rights, unless disclosure is in the public interest.

2. Without prejudice to paragraph 1, information exchanged on a confidential basis between the

competent national authorities and between competent national authorities and the Commission
shall not be disclosed without the prior agreement of the competent national authority that
originally provided the information.

3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member
States and notified bodies with regard to the exchange of information and the dissemination of
warnings, nor shall it affect the obligations of the persons concerned to provide information under
criminal law.
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4. The Commission and Member States may exchange confidential information with regulatory
authorities of third countries with which they have bilateral or multilateral confidentiality
agreements and arrangements when those agreements and arrangements ensure that any exchange
of information is in accordance with applicable Union law.
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Article 50
Penalties
1. Member States shall lay down the rules on penalties applicable to infringements by economic
operators of this Regulation and shall take all measures necessary to ensure that they are
implemented. The penalties provided for shall be effective, proportionate and dissuasive and may
include criminal penalties for serious infringements.

2. Member States shall, by 14 October 2026, notify the Commission of those rules and of those
measures and shall notify it, without delay, of any subsequent amendment affecting them.

CHAPTER IX

TRANSITIONAL AND FINAL PROVISIONS

Article 51
Repeals
1. Directive 73/361/EEC is
repealed.

References to the repealed Directive 73/361/EEC shall be construed as references to this Regulation.

2. Directive 2006/42/EC is repealed with effect from 14 January 2027.

References to the repealed Directive 2006/42/EC shall be construed as references to this Regulation and
shall be read in accordance with the correlation table in Annex XII.

Article 52
Transitional provisions
1. Member States shall not impede the making available on the market of products which were placed
on the market in conformity with Directive 2006/42/EC before 14 January 2027. However, Chapter
VI of this Regulation shall apply, from 13 July 2023, mutatis mutandis to such products instead of
Article 11 of that Directive, including products for which a procedure has already been initiated
under Article 11 of Directive 2006/42/EC.

2. EC type-examination certificates and approval decisions issued in

Article 12 Directiv
accordance with 2006/42/EC shall remain valid until they expire.
of e

Article 53
Evaluation and review
1. By 14 July 2028 and every four years thereafter, the Commission shall submit a report on
the evaluation and review of this Regulation to the European Parliament and to the Council. The
reports shall be made public.

2. Taking account of technical progress and practical experience gained in Member States as
indicated in Article 6, the Commission shall in its report include an evaluation on the following
aspects of this Regulation:

(a) the essential health and safety requirements set out in Annex III;

(b) the conformity assessment procedure applicable to machinery or related products listed in Annex I.

Where appropriate, the report shall be accompanied by a legislative proposal for amendment of the
relevant provisions of this Regulation.

3. By 14 July 2026 and every five years thereafter, the Commission shall submit a specific report
on the assessment of Article 6(4) and (5) of this Regulation to the European Parliament and to
the Council. The reports shall be made public.

The Commission shall include in its reports the following:

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(a) a summary of data and information provided by Member States in accordance with Article 6(5)
during the reporting period;
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(b) an assessment of the list of categories of machinery or related products in Annex I in view of the
criteria set out in Article 6(4).

In the reports, the Commission shall assess the appropriateness and availability of data and
information provided by Member States, including its sufficiency and suitability for the purposes of
making comparisons, identifying any short comings, necessary to ensure effective functioning and
enforcement of Article 6.

Article 54
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the
Official Journal of the European Union.

It shall apply from 14 January 2027.

However, the following Articles shall apply from the following dates:

(a) Articles 26 to 42 from 14 January 2024;

(b) Article 50(1) from 14 October 2023;

(c) Article 6(7) and Articles 48 and 52 from 13 July 2023;

(d) Article 6(2) to (6), (8) and (11) and Articles 47 and 53(3) from 14 July 2024.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Strasbourg, 14 June 2023.

For the European Parliament

For the Council
The President
The President
R. METSOLA
J. ROSWALL
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ANNEX I

CATEGORIES OF MACHINERY OR RELATED PRODUCTS TO WHICH ONE OF THE PROCEDURES

REFERRED TO IN ARTICLE 25(2) AND (3) SHALL BE APPLIED

PART A

Categories of machinery or related products to which a procedure referred to in Article 25(2) shall be
applied:

1. Removable mechanical transmission devices including their guards.

2. Guards for removable mechanical transmission devices.

3. Vehicle servicing lifts.

4. Portable cartridge-operated fixing and other impact machinery.

5. Safety components with fully or partially self-evolving behaviour using machine learning approaches
ensuring safety functions.

6. Machinery that has embedded systems with fully or partially self-evolving behaviour using
machine learning approaches ensuring safety functions that have not been placed independently
on the market, in respect only of those systems.

PART B

Categories of machinery or related products to which one of the procedures referred to in Article 25(3)
shall be applied:

1. Circular saws (single- or multi-blade) for working with wood and material with similar physical
characteristics or for working with meat and material with similar physical characteristics, of
the following types:

[Link] machinery with fixed blade(s) during cutting, having a fixed bed or support with
manual feed of the workpiece or with a demountable power feed;

[Link] machinery with fixed blade(s) during cutting, having a manually operated
reciprocating saw-bench or carriage;

[Link] machinery with fixed blade(s) during cutting, having a built-in mechanical feed device
for the work pieces, with manual loading and/or unloading;

[Link] machinery with movable blade(s) during cutting, having mechanical movement of
the blade, with manual loading and/or unloading.

2. Hand-fed surface planing machinery for woodworking.

3. Thicknessers for one-side dressing having a built-in mechanical feed device, with manual loading
and/or unloading for woodworking.

4. Band-saws with manual loading and/or unloading for working with wood and material with
similar physical characteristics or for working with meat and material with similar physical
characteristics, of the following types:

[Link] machinery with fixed blade(s) during cutting, having a fixed or reciprocating-movement
bed or support for the workpiece;
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[Link] machinery with blade(s) assembled on a carriage with reciprocating motion.
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5. Combined machinery of the types referred to in points 1 to 4 and in point 7 for working with
wood and material with similar physical characteristics.

6. Hand-fed tenoning machinery with several tool holders for woodworking.

7. Hand-fed vertical spindle moulding machinery for working with wood and material with similar
physical char acteristics.

8. Portable chainsaws for woodworking.

9. Presses, including press-brakes, for the cold working of metals, with manual loading and/or
unloading, whose movable working parts may have a travel exceeding 6 mm and a speed
exceeding 30 mm/s.

10. Injection or compression plastics-moulding machinery with manual loading or unloading.

11. Injection or compression rubber-moulding machinery with manual loading or unloading.

12. Machinery for underground working of the following types:

12.1. locomotives and brake-vans;

12.2. hydraulic-powered roof supports.

13. Manually loaded trucks for the collection of household refuse incorporating a compression
mechanism.

14. Devices for the lifting of persons or of persons and goods involving a hazard of falling from a
vertical height of more than 3 m.

15. Protective devices designed to detect the presence of persons.

16. Power-operated interlocking movable guards designed to be used as safeguards in machinery

referred to in points 9, 10 and 11 of this Part.

17. Logic units to ensure safety functions.

18. Roll-over protective structures (ROPS).

19. Falling-object protective structures (FOPS).

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ANNEX II

INDICATIVE LIST OF SAFETY COMPONENTS

1. Guards for removable mechanical transmission devices.

2. Protective devices designed to detect the presence of persons.

3. Power-operated interlocking movable guards designed to be used as safeguards in machinery

referred to in points 9, 10 and 11 of Annex I, Part B.

4. Logic units to ensure safety functions.

5. Valves with additional means for failure detection intended for the control of dangerous movements
of machinery.

6. Extraction systems for machinery emissions.

7. Guards and protective devices designed to protect persons against moving parts involved in the
process of the machinery.

8. Monitoring devices for loading and movement control in lifting machinery.

9. Restraint systems to keep persons in their seats.

10. Emergency stop devices.

11. Discharging systems to prevent the build-up of potentially dangerous electrostatic charges.

12. Energy limiters and relief devices referred to in sections 1.5.7, 3.4.7 and [Link] of Annex III.

13. Systems and devices to reduce the emission of noise and vibrations.

14. Roll-over protective structures (ROPS).

15. Falling-object protective structures (FOPS).

16. Two-hand control devices.

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17. The following components for machinery designed for lifting and/or lowering persons between
different landings:

(a) devices for locking landing doors;

(b) devices to prevent the load-carrying unit from falling or unchecked upwards movement;

(c) overspeed limitation devices;

(d) energy-accumulating shock absorbers, non-linear or with damping of the return movement;

(e) energy-dissipating shock absorbers;

(f) safety devices fitted to jacks of hydraulic power circuits and used to prevent falls;

(g) safety switches containing electronic components.

18. Software ensuring safety functions.

19. Safety components with fully or partially self-evolving behaviour using machine learning approaches
ensuring safety functions.

20. Filtration systems intended to be integrated into machinery cabins in order to protect operators
or other persons against hazardous materials and substances, includingplant protection
products, and filters for such filtration systems.
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ANNEX III

ESSENTIAL HEALTH AND SAFETY REQUIREMENTS RELATING TO THE DESIGN AND CONSTRUCTION
OF MACHINERY OR RELATED PRODUCTS

PART A

Definitions
For the purposes of this Annex, the following definitions apply:

(a) ‘hazard’ means a potential source of injury or damage to health;

(b) ‘danger zone’ means any zone within and/or around machinery or a related product in which a
person is subject to a risk to his or her health or safety;

(c) ‘exposed person’ means any person wholly or partially in a danger zone;

(d) ‘operator’ means the person or persons installing, operating, adjusting, maintaining, cleaning,
repairing or moving machinery or a related product;

(e) ‘risk’ means a combination of the probability and the degree of an injury or damage to health
that can arise in a hazardous situation;

(f) ‘guard’ means a part of machinery or a related product used specifically to provide protection
by means of a physical barrier;

(g) ‘protective device’ means a device (other than a guard) which reduces the risk, either alone or in
conjunction with a guard;

(h) ‘intended use’ means the use of machinery or a related product in accordance with the information
provided in the instructions for use;

(i) ‘reasonably foreseeable misuse’ means the use of machinery or a related product in a way not
intended in the instructions for use, but which may result from readily predictable human
behaviour.

PART B

General principles
1. The manufacturer of machinery or a related product shall ensure that a risk assessment is
carried out in order to determine the essential health and safety requirements which apply
to the machinery or related product. The machinery or related product shall then be
designed and constructed to eliminate hazards or, if that is not possible, to minimise all
relevant risks, taking into account the results of the risk assessment.

By the iterative process of risk assessment and risk reduction referred to in the first
subparagraph, the manufacturer shall:

(a) determine the limits of the machinery or related product, which include the intended
use and any reasonably foreseeable misuse thereof;

(b) identify the hazards that may be generated by the machinery or related product and
the associated hazardous situations;

(c) estimate the risks, taking into account the severity of the possible injury or damage to
health and the probability of its occurrence;

(d) evaluate the risks, with a view to determining whether risk reduction is required, in
accordance with the objective of this Regulation;

(e) eliminate the hazards or reduce the risks associated with these hazards by
application of protective measures, in the order of priority established in section
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1.1.2(b).
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The risk assessment and risk reduction shall include hazards that might arise during the
lifecycle of the machinery or related product that are foreseeable at the time of placing the
machinery or related product on the market as an intended evolution of its fully or partially
self-evolving behaviour or logic as a result of the machinery or related product designed to
operate with varying levels of autonomy. The risk assessment and risk reduction shall include
risks resulting from interactions between machinery in order to achieve the same end that are
arranged and controlled so that they function as an integral whole, thus forming machinery
as defined in Article 3, point 1, point (d).

2. The obligations laid down by the essential health and safety requirements only apply when the
corresponding hazard exists for the machinery or related product in question when it is
used under the conditions foreseen by the manufacturer or in foreseeable abnormal
situations. However, the principles of safety integration established in section 1.1.2 and
the obligations concerning marking of machinery or related products referred to in
section 1.7.3, and instructions for use referred to in section 1.7.4 apply in all cases.

3. The essential health and safety requirements laid down in this Annex are mandatory;
however, taking into account the state of the art, it may not be possible to meet the
objectives set by them. In that event, the machinery or related product shall, as far as
possible, be designed and constructed with the purpose of approaching those objectives.

4. Thi
Anne is organised into six chapters. The first chapter is of general scope and
s
x applicable to all
machinery or related products. The other chapters refer to certain sorts of more specific
hazards. Never theless, it is essential to examine the whole of this Annex in order to be
sure of meeting all the relevant essential health and safety requirements. When machinery
or a related product is being designed, the requirements of the first chapter and the
requirements of one or more of the other chapters shall be taken into account, depending
on the results of the risk assessment carried out in accordance with point 1 of these
General Principles. Essential health and safety requirements for the protection of the
environment are applicable only to the machinery or related products referred to in
section 2.4.

5. These general principles shall apply to the risk assessment carried out by the
manufacturer of partly completed machinery.

1. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS

1.1. General remarks

1.1.1. Applicability
The obligations laid down by the essential health and safety requirements are applicable to
partly completed machinery insofar as those requirements are relevant.

The relevant requirements in relation to partly completed machinery do not cover the
requirements that can only be fulfilled at the time of the incorporation of the partly
completed machinery. However, the principles of safety integration established in section
1.1.2 are applicable in all cases.

1.1.2. Principles of safety integration

(a) Machinery or related products shall be designed and constructed so that they are fit for
their function, and can be operated, adjusted and maintained without putting persons at
risk when these operations are carried out under the conditions foreseen but also taking into
account any reasonably foreseeable misuse thereof. The aim of protective measures shall be
to eliminate any risk throughout the foreseeable lifetime of the machinery or related
product including the phases of transport, assembly, dismantling, disabling and
scrapping.

(b) In selecting the most appropriate methods, the manufacturer shall apply the following
principles, in the order given:
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(i) eliminate hazards or, if that is not possible, minimise risks (inherently safe
machinery or related product design and construction);

(ii) take the necessary protective measures in relation to risks that cannot be eliminated;
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(iii)inform users of the residual risks due to any shortcomings of the protective
measures adopted, indicate whether any particular training is required and specify
any need to provide personal protective equipment.

(c) When designing and constructing machinery or a related product and when drafting the
instructions for use, the manufacturer shall envisage not only the intended use of the
machinery or related product but also any reasonably foreseeable misuse thereof. The
machinery or related product shall be designed and constructed in such a way as to
prevent abnormal use if such use would engender a risk. Where appropriate, the
instructions for use shall draw the user’s attention to ways – which experience has
shown might occur – in which the machinery or related product should not be used.

(d) Machinery or related products shall be designed and constructed to take account of the
constraints to which the operator is subject as a result of the necessary or foreseeable
use of personal protective equipment.

(e) Machinery or related products shall be designed and constructed in such a way that it is
possible for the user, where applicable, to test the safety functions. The machinery or
related product shall be supplied with all the special equipment and accessories, and
where appropriate, with the description of specific functional test procedures, essential
to enable it to be tested, adjusted, maintained and used safely.

1.1.3. Materials and products

The materials used to construct machinery or related products, or products used or
created during its use, shall not endanger the health and safety of persons. In particular,
where fluids are used, machinery or related products shall be designed and constructed to
prevent risks due to filling, use, recovery or draining.

1.1.4. Lighting
Machinery or related products shall be supplied with integral lighting suitable for the
operations concerned, where the absence thereof is likely to cause a risk despite ambient
lighting of normal intensity.

Machinery or related products shall be designed and constructed so that there is no area of
shadow likely to cause nuisance, that there is no irritating dazzle and that there are no
dangerous stroboscopic effects on moving parts due to the lighting.

Internal parts requiring frequent inspection and adjustment, and maintenance areas shall be
provided with appropriate lighting.

1.1.5. Design of machinery or a related product to facilitate its handling

Machinery or a related product or each component part thereof, shall:

(a) be capable of being handled and transported safely;

(b) be packaged or designed so that it can be stored safely and without damage.

During the transportation of the machinery or related product or its component parts,
there shall be no possibility of sudden movements or of hazards due to instability as long as
the machinery or related product or its component parts are handled in accordance with
the instructions.

Where the weight, size or shape of machinery or a related product or its various
component parts prevents it or them from being moved by hand, the machinery or
related product or each component part shall:

(a) either be fitted with attachments for lifting gear; or

(b) be designed so that it can be fitted with such attachments; or

(c) be shaped in such a way that standard lifting gear can easily be attached.

Where machinery or a related product or one of its component parts is to be moved by hand,
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it shall either:

(a) be easily moveable; or

(b) be equipped for picking up and moving safely.

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Special arrangements shall be made for the handling of tools and/or machinery or related
product parts, which, even if lightweight, could be hazardous.

1.1.6. Ergonomics
Under the intended conditions of use, the discomfort, fatigue and physical and
psychological stress faced by the operator shall be eliminated or reduced to the
minimum possible, taking into account at least, the following ergonomic principles:

(a) allowing for the variability of the operator’s physical dimensions, strength and stamina;

(b) avoiding the need for demanding work postures or movements and manual force
exertions that exceed the operator’s capacity;

(c) providing enough space for movements of the parts of the operator’s body;

(d) avoiding a machine-determined work rate;

(e) avoiding monitoring that requires lengthy concentration;

(f) adapting the human-machine interface to the foreseeable characteristics of the operators,
including with respect to machinery or a related product with intended fully or partially
self-evolving behaviour or logic that is designed to operate with varying levels of
autonomy;

(g) where relevant, adapting machinery or a related product with intended fully or
partially self-evolving behaviour or logic that is designed to operate with varying
levels of autonomy to respond to people adequately and appropriately (such as
verbally through words and non-verbally through gestures, facial expressions or body
movement) and to communicate its planned actions (such as what it is going to do and
why) to operators in a comprehensible manner.

1.1.7. Operating positions

The operating position shall be designed and constructed in such a way as to avoid any risk
due to exhaust gases or lack of oxygen.

If the machinery or related product is intended to be used in a hazardous environment

presenting risks to the health and safety of the operator or if the machinery or related
product itself gives rise to a hazardous environment, adequate means shall be provided to
ensure that the operator has good working conditions and is protected against any
foreseeable hazards.

Where appropriate, the operating position shall be fitted with an adequate cabin designed,
constructed or equipped to fulfil the above requirements. The exit shall allow rapid evacuation.
Moreover, when applicable, an emergency exit shall be provided in a direction which is
different from the usual exit.

1.1.8. Seating
Where appropriate and where the working conditions so permit, work stations constituting
an integral part of the machinery or related product shall be designed for the
installation of seats.

If the operator is intended to sit during operation and the operating position is an integral
part of the machinery or related product, the seat shall be provided with the machinery or
related product.

The operator’s seat shall enable him or her to maintain a stable position. Furthermore, the
seat and its distance from the control devices shall be capable of being adapted to the
operator.

If the machinery or related product is subject to vibrations, the seat shall be designed and
constructed in such a way as to reduce the vibrations transmitted to the operator to the
lowest level that is reasonably possible. The seat mountings shall withstand all stresses to
which they can be subjected. Where there is no floor beneath the feet of the operator,
footrests covered with a slip-resistant material shall be provided.
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1.1.9. Protection against corruption
The machinery or related product shall be designed and constructed so that the
connection to it of another device, via any feature of the connected device itself or via any
remote device that communicates with the machinery or related product does not lead
to a hazardous situation.
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A hardware component transmitting signal or data, relevant for connection or access to

software that is critical for the compliance of the machinery or related product with the
relevant essential health and safety requirements shall be designed so that it is adequately
protected against accidental or intentional corruption. The machinery or related product shall
collect evidence of a legitimate or illegitimate intervention in that hardware component,
when relevant for connection or access to software that is critical for the compliance of the
machinery or related product.

Software and data that are critical for the compliance of the machinery or related product
with the relevant essential health and safety requirements shall be identified as such and shall
be adequately protected against accidental or intentional corruption.

The machinery or related product shall identify the software installed on it that is
necessary for it to operate safely, and shall be able to provide that information at all times
in an easily accessible form.

The machinery or related product shall collect evidence of a legitimate or illegitimate

intervention in the software or a modification of the software installed on the machinery or
related product or its configuration.

1.2. Control systems

1.2.1. Safety and reliability of control systems

Control systems shall be designed and constructed in such a way as to prevent hazardous
situations from arising.

Control systems shall be designed and constructed in such a way that:

(a) they can withstand, where appropriate to the circumstances and the risks, the intended
operating stresses and intended and unintended external influences, including
reasonably foreseeable malicious attempts from third parties leading to a hazardous
situation;

(b) a fault in the hardware or the logic of the control system shall not lead to hazardous
situations;

(c) errors in the control system logic shall not lead to hazardous situations;

(d) the limits of the safety functions are to be established as part of the risk assessment
performed by the manufacturer and no modifications are allowed to the settings or
rules generated by the machinery or related product or by operators, including during the
machinery or related product learning phase, where such modifications could lead to
hazardous situations;

(e) reasonably foreseeable human errors during operation shall not lead to hazardous
situations;

(f) the tracing log of the data generated in relation to an intervention and of the versions of
safety software uploaded after the machinery or related product has been placed on the
market or put into service is enabled for five years after such upload, exclusively to
demonstrate the conformity of the machinery or
related product with this Annex further to a reasoned request from a competent
national authority.

Control systems of machinery or related products with fully or partially self-evolving

behaviour or logic that are designed to operate with varying levels of autonomy shall be
designed and constructed in such a way that:

(a) they shall not cause the machinery or related product to perform actions beyond its
defined task and movement space;

(b) recording of data on the safety related decision-making process for software based safety
29.6.202 E Official Journal of the European L 165/91
3 N Union
systems ensuring safety function including safety components, after the machinery or
related product has been placed on the market or put into service, is enabled and that
such data is retained for one year after its collection, exclusively to demonstrate the
conformity of the machinery or related product with this Annex further to a reasoned
request from a competent national authority;

(c) it shall be possible at all times to correct the machinery or related product in order to
maintain its inherent safety.
L 165/92 E Official Journal of the European 29.6.202
N Union 3

Particular attention shall be given to the following points:

(a) the machinery or related product shall not start unexpectedly;

(b) the parameters of the machinery or related product shall not change in an uncontrolled
way, where such change could lead to hazardous situations;

(c) modifications to the settings or rules, generated by the machinery or related product or
by operators, including during the machinery or related product learning phase, shall
be prevented, where such modifications could lead to hazardous situations;

(d) the machinery or related product shall not be prevented from stopping if the stop
command has already been given;

(e) no moving part of the machinery or related product or piece held by the machinery or
related product shall fall or be ejected;

(f) automatic or manual stopping of the moving parts, whatever they may be, shall be
unimpeded;

(g) the protective devices shall remain fully effective or give a stop command;

(h) the safety-related parts of the control system shall apply in a coherent way to the whole
of an assembly of machinery or related products or partly completed machinery, or a
combination thereof.

For wireless control, a failure of the communication or connection or a faulty connection

shall not lead to a hazardous situation.

1.2.2. Control devices

Control devices shall be:

(a) clearly visible and identifiable, using pictograms where appropriate;

(b) positioned in such a way as to be safely operated without hesitation or loss of time
and without ambiguity;

(c) designed in such a way that the movement of the control device is consistent with its
effect;

(d) located outside the danger zones, except where necessary for certain control devices
such as an emergency stop or a teach pendant;

(e) positioned in such a way that their operation cannot cause additional risk;

(f) designed or protected in such a way that the desired effect, where a hazard is involved,
can only be achieved by a deliberate action;

(g) made in such a way as to withstand foreseeable forces, paying particular attention to
emergency stop devices liable to be subjected to considerable forces.

Where a control device is designed and constructed to perform several different actions,
namely, where there is no one-to-one correspondence, the action to be performed shall be
clearly displayed and subject to confirmation, where necessary.

Control devices shall be so arranged that their layout, travel and resistance to operation are
compatible with the action to be performed, taking account of ergonomic principles.

Machinery or related products shall be fitted with indicators as required for safe operation. The
operator shall be able to read them from the control position.

From each control position, the operator shall be able to ensure that no one is in the
danger zones, or the control system shall be designed and constructed in such a way that
starting is prevented while someone is in the danger zone.

If neither of these possibilities is applicable, before the machinery or related product starts, an
acoustic and/or visual warning signal shall be given. The exposed persons shall have time to
29.6.202 E Official Journal of the European L 165/93
3 N Union
leave the danger zone or prevent the machinery starting up.
L 165/94 E Official Journal of the European 29.6.202
N Union 3

If necessary, means shall be provided to ensure that the machinery or related product can
be controlled only from control positions located in one or more predetermined zones or
locations.

Where there is more than one control position, the control system shall be designed in
such a way that the use of one of them precludes the use of the others, except for stop
controls and emergency stops.

When the machinery or related product has two or more operating positions, each position shall
be provided with all the required control devices without the operators hindering or putting
each other into a hazardous situation.

1.2.3. Starting
It shall be possible to start the machinery or related product only by voluntary actuation
of a control device provided for the purpose.

The same requirement applies:

(a) when restarting the machinery or related product after a stoppage, whatever the cause;

(b) when effecting a significant change in the operating conditions.

However, the restarting of the machinery or related product or a change in operating

conditions may be effected by voluntary actuation of a device other than the control
device provided for the purpose, on condition that this does not lead to a hazardous
situation.

For the machinery or related product functioning in automatic mode, the starting of the
machinery or related product, restarting after a stoppage, or a change in operating
conditions may be possible without inter vention, provided this does not lead to a
hazardous situation.

Where the machinery or related product has several starting control devices and the
operators can therefore put each other in danger, additional devices shall be fitted to rule out
such risks. If safety requires that starting and/or stopping shall be performed in a specific
sequence, there shall be devices that ensure that these operations are performed in the
correct order.

1.2.4. Stopping

[Link]. N o r m a l s t o p
The machinery or related product shall be fitted with a control device whereby the machinery
can be brought safely to a complete stop.

Each workstation shall be fitted with a control device to stop some or all of the functions of
the machinery or related product, depending on the existing hazards, so that the
machinery or related product is rendered safe.

The machinery or related product’s stop control shall have priority over the start controls.

Once the machinery or related product or its hazardous functions have stopped, the
energy supply to the actuators concerned shall be cut off.

[Link]. O p e r a t i o n a l s t o p
Where, for operational reasons, a stop control that does not cut off the energy supply to
the actuators is required, the stop condition shall be monitored and maintained.

[Link]. E m e r g e n c y s t o p
The machinery or related product shall be fitted with one or more emergency stop devices to
enable actual or impending danger to be averted.

The following exceptions apply:

29.6.202 E Official Journal of the European L 165/95
3 N Union
(a) the machinery or related product in which an emergency stop device would not lessen
the risk, either because it would not reduce the stopping time or because it would not
enable the special measures required to deal with the risk to be taken;
L 165/96 E Official Journal of the European 29.6.202
N Union 3

(b) portable hand-held or hand-guided machinery or related products.

The device shall:

(a) have clearly identifiable, clearly visible and quickly accessible control devices;

(b) stop the hazardous process as quickly as possible, without creating additional risks;

(c) where necessary, trigger or permit the triggering of certain safeguard movements.

Once active operation of the emergency stop device has ceased following a stop command,
that command shall be sustained by engagement of the emergency stop device until that
engagement is specifically over ridden; it shall not be possible to engage the device without
triggering a stop command; it shall be possible to disengage the device only by an
appropriate operation, and disengaging the device shall not restart the machinery or
related product but only permit restarting.

The emergency stop function shall be available and operational at all times, regardless of the

operating mode. Emergency stop devices shall be a backup to other safeguarding measures

and not a substitute for them.

[Link]. A ssembly of machinery or related products

In the case of machinery or a related product or parts of machinery or a related product
designed to work together, the machinery or a related product shall be designed and
constructed in such a way that the stop controls, including the emergency stop devices, can
stop not only the machinery or related product itself but also all related equipment, if its
continued operation may be dangerous.

1.2.5. Selection of control or operating modes

The control or operating mode selected shall override all other control or operating
modes, with the exception of the emergency stop.

If the machinery or related product has been designed and constructed to allow its use in
several control or operating modes requiring different protective measures and/or work
procedures, it shall be fitted with a mode selector, which can be locked in each position. Each
position of the selector shall be clearly identifiable and shall correspond to a single
operating or control mode.

The selector may be replaced by another selection method, which restricts the use of
certain functions of the machinery or related product to certain categories of operator.

If, for certain operations, the machinery or related product shall be able to operate with a
guard displaced or removed and/or a protective device disabled, the control or operating
mode selector shall simultaneously:

(a) disable all other control or operating modes;

(b) permit operation of hazardous functions only by control devices requiring sustained action;

(c) permit the operation of hazardous functions only in reduced risk conditions while
preventing hazards from linked sequences;

(d) prevent any operation of hazardous functions by voluntary or involuntary action on the
machinery’s or related product’s sensors.

If these four conditions cannot be fulfilled simultaneously, the control or operating mode
29.6.202 E Official Journal of the European L 165/97
3 N Union
selector shall activate other protective measures designed and constructed to ensure a safe
intervention zone.

In addition, the operator shall be able to control the operation of the parts he or she is
working on from the adjustment point.
L 165/98 E Official Journal of the European 29.6.202
N Union 3

1.2.6. Failure of the power supply or communication network connection

The interruption, the re-establishment after an interruption or the fluctuation in
whatever manner of the power supply or communication network connection to the
machinery or related product shall not lead to hazardous situations.

Particular attention shall be given to the following:

(a) the machinery or related product shall not start unexpectedly;

(b) the parameters of the machinery shall not change in an uncontrolled way when such
change can lead to hazardous situations;

(c) the machinery or related product shall not be prevented from stopping if the stop
command has already been given;

(d) no moving part of the machinery or related product or piece held by the machinery or
related product shall fall or be ejected;

(e) automatic or manual stopping of the moving parts, whatever they may be, shall be
unimpeded;

(f) the protective devices shall remain fully effective or give a stop command.

1.3. Protection against mechanical risks

1.3.1. Risk of loss of stability

The machinery or related product and its components and fittings shall be stable enough to
avoid over turning, falling or uncontrolled movements during transportation, assembly,
dismantling and any other action involving the machinery or related product.

If the shape of the machinery or related product itself or its intended installation does not
offer sufficient stability, appropriate means of anchorage shall be incorporated and
indicated in the instructions for use.

1.3.2. Risk of break-up during operation

The various parts of machinery or related products and their linkages shall be able to
withstand the stresses to which they are subject when used.

The durability of the materials used shall be adequate for the nature of the working
environment foreseen by the manufacturer, in particular as regards the phenomena of
fatigue, ageing, corrosion and abrasion.

The instructions for use shall indicate the type and frequency of inspections and
maintenance required for safety reasons. They shall, where appropriate, indicate the parts
subject to wear and the criteria for replacement.

Where a risk of rupture or disintegration remains despite the measures taken, the parts
concerned shall be mounted, positioned or guarded in such a way that any fragments will
be contained, preventing hazardous situations.

Both rigid and flexible pipes carrying fluids, particularly those under high pressure, shall be
able to withstand the foreseen internal and external stresses and shall be firmly attached or
protected to ensure that no risk is presented by a rupture.

Where the material to be processed is fed to the tool automatically, the following conditions
shall be fulfilled to avoid risks to persons:

(a) when the work piece comes into contact with the tool, the latter shall have attained its
normal working condition;

(b) when the tool starts and/or stops (intentionally or accidentally), the feed movement
29.6.202 E Official Journal of the European L 165/99
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and the tool movement shall be coordinated.
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1.3.3. Risks due to falling or ejected objects

Precautions shall be taken to prevent risks from falling or ejected objects.

1.3.4. Risks due to surfaces, edges or angles

Insofar as their purpose allows, accessible parts of the machinery or a related product
shall have no sharp edges, no sharp angles and no rough surfaces likely to cause injury.

1.3.5. Risks related to a combined machinery or related product

Where the machinery or related product is intended to carry out several different
operations with manual removal of the piece between each operation (combined machinery
or related product), it shall be designed and constructed in such a way as to enable each
element to be used separately without the other elements constituting a risk for exposed
persons.

For this purpose, it shall be possible to start and stop separately any elements that are not
protected.

1.3.6. Risks related to variations in operating conditions

Where the machinery or related product performs operations under different conditions of
use, it shall be designed and constructed in such a way that selection and adjustment of
these conditions can be carried out safely and reliably.

1.3.7. Risks related to moving parts

The moving parts of the machinery or related product shall be designed and constructed in
such a way as to prevent risks of contact which could lead to accidents or shall, where
risks persist, be fitted with guards or protective devices.

All necessary steps shall be taken to prevent accidental blockage of moving parts. In cases
where, despite the precautions taken, a blockage is likely to occur, the necessary specific
protective devices and tools shall, when appropriate, be provided to enable the equipment
to be safely unblocked.

The instructions for use and, where possible, a sign on the machinery or related product
shall identify these specific protective devices and how they are to be used.

The prevention of risks of contact leading to hazardous situations and the psychological
stress that may be caused by the interaction with the machinery shall be adapted to:

(a) human-machine coexistence in a shared space without direct collaboration;

(b) human-machine interaction.

1.3.8. Choice of protection against risks arising from moving parts

Guards or protective devices designed to protect against risks arising from moving parts
shall be selected on the basis of the type of risk. The following guidelines shall be used
to help to make the choice.

[Link]. M o v i n g t r a n s m i s s i o n p a r t s
Guards designed to protect persons against the hazards generated by moving transmission
parts shall be:

(a) either fixed guards as referred to in section [Link]; or

(b) interlocking movable guards as referred to in section [Link].

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3 N Union 165/101
Interlocking movable guards shall be used where frequent access is envisaged.
L E Official Journal of the European 29.6.202
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[Link]. M o v i n g p a r t s i n v o l v e d i n t h e p r o c e s s
Guards or protective devices designed to protect persons against the hazards generated by
moving parts involved in the process shall be:

(a) either fixed guards as referred to in section [Link]; or

(b) interlocking movable guards as referred to in section [Link]; or

(c) protective devices as referred to in section 1.4.3; or

(d) a combination of the above.

However, when certain moving parts directly involved in the process cannot be made
completely inaccessible during operation owing to operations requiring operator
intervention, such parts shall be fitted with:

(a) fixed guards or interlocking movable guards preventing access to those sections of the
parts that are not used in the work; and

(b) adjustable guards as referred to in section [Link] restricting access to those sections of
the moving parts where access is necessary.

1.3.9. Risks of uncontrolled movements

When a part of the machinery or related product has been stopped, any drift away from the
stopping position, for whatever reason other than action on the control devices, shall be
prevented or shall be such that it does not present a risk.

1.4. Required characteristics of guards and protective devices

1.4.1. General requirements

Guards and protective devices shall:

(a) be of robust construction;

(b) be securely held in place;

(c) not give rise to any additional hazard;

(d) not be easy to by-pass or render non-operational;

(e) be located at an adequate distance from the danger zone;

(f) cause minimum obstruction to the view of the production process, and;

(g) enable essential work to be carried out on the installation and/or replacement of tools
and for main tenance purposes by restricting access exclusively to the area where the
work has to be done, if possible without the guard having to be removed or the
protective device having to be disabled.

In addition, guards shall, where possible, protect against the ejection or falling of materials
or objects and against emissions generated by the machinery or related product.

1.4.2. Special requirements for guards

[Link]. F i x e d g u a r d s
Fixed guards shall be fixed by systems that can be opened or removed only with tools.

Their fixing systems shall remain attached to the guards or to the machinery or related
product when the guards are removed.

Where possible, guards shall be incapable of remaining in place without their fixings.
29.6.202 E Official Journal of the European L
3 N Union 165/103

[Link]. I n t e r l o c k i n g m o v a b l e
g u a r d s Interlocking movable
guards shall:

(a) as far as possible remain attached to the machinery or related product when open;

(b) be designed and constructed in such a way that they can be adjusted only by means of
an intentional action.

Interlocking movable guards shall be associated with an interlocking device that:

(a) prevents the start of hazardous machinery or related product functions until those guards
are closed; and

(b) gives a stop command whenever those guards are no longer closed.

Where it is possible for an operator to reach the danger zone before the risk due to the
hazardous machinery or related product functions has ceased, movable guards shall be
associated with a guard locking device in addition to an interlocking device that:

(a) prevents the start of hazardous machinery or related product functions until the guard
is closed and locked; and

(b) keeps the guard closed and locked until the risk of injury from the hazardous
machinery or related product functions has ceased.

Interlocking movable guards shall be designed in such a way that the absence or failure of
one of their components prevents starting or stops the hazardous machinery or related
product functions.

[Link]. A djustable guards restricting access

Adjustable guards restricting access to those areas of the moving parts strictly necessary for the
work shall be:

(a) adjustable manually or automatically, depending on the type of work involved; and

(b) readily adjustable without the use of tools.

1.4.3. Special requirements for protective devices

Protective devices shall be designed and incorporated into the control system in such a way
that:

(a) moving parts cannot start up while they are within the operator’s reach;

(b) persons cannot reach moving parts while the parts are moving, and

(c) the absence or failure of one of their components prevents starting or stops the moving
parts.

Protective devices shall be adjustable only by means of an intentional action.

1.5. Risks due to other causes

1.5.1. Electricity supply

Where machinery or related products have an electricity supply, they shall be designed,
constructed and equipped in such a way that all hazards of an electrical nature are or can
L E Official Journal of the European 29.6.202
165/104 N Union 3
be prevented.

The safety objectives set out in Directive 2014/35/EU shall apply to machinery or related
products. However, the obligations concerning conformity assessment and the placing on
the market or putting into service of machinery or related products with regard to
electrical risks are governed solely by this Regulation.
29.6.202 E Official Journal of the European L
3 N Union 165/105

1.5.2. Static electricity

Machinery or related products shall be designed and constructed to prevent or limit the
build-up of poten tially dangerous electrostatic charges and/or be fitted with a discharging
system.

1.5.3. Energy supply other than electricity

Where machinery or related products are powered by source of energy other than electricity,
they shall be so designed, constructed and equipped as to avoid all potential risks
associated with such sources of energy.

1.5.4. Errors of fitting

Errors likely to be made when fitting or refitting certain parts, which could be a source of
risk, shall be made impossible by the design and construction of such parts or, failing this,
by information given on the parts themselves or their housings. The same information
shall be given on moving parts or their housings where the direction of movement needs
to be known in order to avoid a risk.

Where necessary, the instructions for use shall give further information on these risks.

Where a faulty connection can be the source of risk, incorrect connections shall be made
impossible by design or, failing this, by information given on the elements to be connected
and, where appropriate, on the means of connection.

1.5.5. Extreme temperatures

Steps shall be taken to eliminate any risk of injury arising from contact with or proximity to
machinery or related product parts or materials at high or very low temperatures.

The necessary steps shall also be taken to avoid or protect against the risk of hot or very
cold material being ejected.

1.5.6. Fire
Machinery or related products shall be designed and constructed in such a way as to avoid
any risk of fire or overheating presented by the machinery or related product itself or by
gases, liquids, dust, vapours or other substances produced or used by the machinery or
related product.

1.5.7. Explosion
Machinery or related products shall be designed and constructed in such a way as to avoid
any risk of explosion presented by the machinery or related product itself or by gases,
liquids, dust, vapours or other substances produced or used by the machinery or related
product.

Machinery or related products shall comply, as far as the risk of explosion due to its use in
a potentially explosive atmosphere is concerned, with the provisions of the specific Union
harmonisation legislation.

1.5.8. Noise
Machinery or related products shall be designed and constructed in such a way that risks
resulting from the emission of airborne noise are reduced to the lowest level, taking
account of technical progress and the availability of means of reducing noise, in particular
at source.

The level of noise emission may be assessed with reference to comparative emission
data for similar machinery or related products.

1.5.9. Vibrations
Machinery or related products shall be designed and constructed in such a way that risks
resulting from vibrations produced by the machinery or related product are reduced to the
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lowest level, taking account of technical progress and the availability of means of reducing
vibration, in particular at source.

The level of vibration emission may be assessed with reference to comparative emission
data for similar machinery or related products.
29.6.202 E Official Journal of the European L
3 N Union 165/107

1.5.10. Radiation
Undesirable radiation emissions from machinery or related products shall be eliminated or
be reduced to levels that do not have adverse effects on persons.

Any functional ionising radiation emissions shall be limited to the lowest level, which is
sufficient for the proper functioning of the machinery or related product during setting,
operation and cleaning. Where a risk exists, the necessary protective measures shall be
taken.

Any functional non-ionising radiation emissions during setting, operation and cleaning
shall be limited to levels that do not have adverse effects on persons.

1.5.11. External radiation

Machinery or related products shall be designed and constructed in such a way that
external radiation does not interfere with its operation.

1.5.12. Laser radiation

Where laser equipment is used, the following shall be taken into account:

(a) laser equipment on machinery or related products shall be designed and constructed in
such a way as to prevent any accidental radiation;

(b) laser equipment on machinery or related products shall be protected in such a way that
effective radi ation, radiation produced by reflection or diffusion and secondary
radiation do not damage health;

(c) optical equipment for the observation or adjustment of laser equipment on machinery or
related products shall be such that no health risk is created by laser radiation.

1.5.13. Emissions of hazardous materials and substances

Machinery or related products shall be designed and constructed in such a way that risks
of inhalation, ingestion, contact with the skin, eyes and mucous membranes and penetration
through the skin of hazardous materials and substances which it produces can be avoided.

Where a hazard cannot be eliminated, the machinery or related product shall be so equipped
that hazardous materials and substances can be contained, captured, evacuated,
precipitated by water spraying, filtered or treated by another equally effective method.

Where the process is not totally enclosed during normal operation of the machinery or
related product, the devices for containment or capture, filtration or separation and
evacuation shall be situated in such a way as to have the maximum effect.

1.5.14. Risk of being trapped in a machine

Machinery or related products shall be designed, constructed or fitted with a means of
preventing a person from being enclosed within it or, if that is impossible, with a means
of summoning help.

1.5.15. Risk of slipping, tripping or falling

Parts of the machinery or related product where persons are liable to move about or stand
shall be designed and constructed in such a way as to prevent persons slipping, tripping
or falling on or off these parts.

Where appropriate, these parts shall be fitted with handholds that are fixed relative to the
user and that enable them to maintain their stability.

1.5.16. Lightning
Machinery or related products in need of protection against the effects of lightning while
being used shall be fitted with a system for conducting the resultant electrical charge to
earth.

1.6. Maintenance

1.6.1. Machinery or related product maintenance

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Adjustment and maintenance points shall be located outside danger zones. It shall be
possible to carry out adjustment, maintenance, repair, cleaning and servicing operations while
the machinery or related product is at a standstill.
29.6.202 E Official Journal of the European L
3 N Union 165/109

If one or more of the above conditions cannot be satisfied for technical reasons, measures
shall be taken to ensure that these operations can be carried out safely (see section
1.2.5).

In the case of automated machinery and, where necessary, other machinery or related
products, a connecting device for mounting diagnostic fault-finding equipment shall be
provided.

Automated machinery or related product components, which have to be changed frequently,

shall be capable of being removed and replaced easily and safely. Access to the
components shall enable these tasks to be carried out with the necessary technical
means in accordance with a specified operating method.

1.6.2. Access to operating positions and servicing points

Machinery or related products shall be designed and constructed in such a way as to allow
access in safety to all areas where intervention is necessary during operation, adjustment,
maintenance and cleaning of the machinery or related product.

In the case of machinery or related products into which persons shall enter for operation,
adjustment, maintenance or cleaning, the machinery accesses shall be dimensioned and
adapted for the use of rescue equipment in such a way that an emergency rescue of the
persons is possible.

1.6.3. Isolation of energy sources

Machinery or related products shall be fitted with means to isolate it from all energy
sources. Such isolators shall be clearly identified. They shall be capable of being locked if
reconnection could endanger persons. Isolators shall also be capable of being locked where
an operator is unable, from any of the points to which he or she has access, to check that
the energy is still cut off.

In the case of machinery or related products capable of being plugged into an electricity
supply, removal of the plug is sufficient, if the operator can check from any of the points
to which he or she has access that the plug remains removed.

After the energy is cut off, it shall be possible to dissipate normally any energy remaining
or stored in the circuits of the machinery or related product without risk to persons.

As an exception to the requirement laid down in the previous paragraphs, certain circuits
may remain
connected to their energy sources in order, for example, to hold parts, to protect
information, to light interiors, etc. In this case, special steps shall be taken to ensure
operator safety.

1.6.4. Operator intervention

The machinery or related product shall be so designed, constructed and equipped that the
need for operator intervention is limited. If operator intervention cannot be avoided, it shall
be possible to carry it out easily and safely.

1.6.5. Cleaning of internal parts

The machinery or related product shall be designed and constructed in such a way that it is
possible to clean internal parts, which have contained dangerous substances or mixtures
without entering them; any necessary unblocking shall also be possible from the outside. If it
is impossible to avoid entering the machinery or related product, it shall be designed and
constructed in such a way as to allow cleaning to take place safely.

1.7. Information

1.7.1. Information and warnings on the machinery or related product

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Information and warnings on the machinery or related product shall preferably be provided
in the form of readily understandable symbols or pictograms.

Any written or verbal information and warnings must be expressed in a language which
can be easily
understood by users, as determined by the Member State concerned.
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[Link]. I n f o r m a t i o n a n d i n f o r m a t i o n d e v i c e s
The information needed to control machinery or a related product shall be provided in
a form that is unambiguous and easily understood. It shall not be excessive to the
extent of overloading the operator.

Visual display units or any other interactive means of communication between the
operator and the machinery or related product shall be easily understood and easy to
use.

[Link]. W a r n i n g d e v i c e s
Where the health and safety of persons may be endangered by a fault in the operation of
unsupervised machinery or a related product, the machinery or related product shall be
equipped in such a way as to give an appropriate acoustic or light signal as a warning.

Where machinery or a related product is equipped with warning devices, these shall be
unambiguous and easily perceived. The operator shall have facilities to check the operation of
such warning devices at all times.

The requirements of the specific Union legal acts concerning colours and safety signals
shall be complied with.

1.7.2. Warning of residual risks

Where risks remain despite the inherent safe design measures, safeguarding and
complementary protective measures adopted, the necessary warnings, including warning
devices, shall be provided.

1.7.3. Marking of machinery or related products

In addition to the marking requirements in Article 10 and 24, machinery or related products
shall be marked visibly, legibly and indelibly.

Machinery or related products covered by chapters 2 to 6 of this Annex shall also be

marked according to the additional requirements set out in those chapters.

Furthermore, machinery, or a related product, designed and constructed for use in a

potentially explosive atmosphere shall be marked accordingly.

Machinery or related products shall also bear full information relevant to their type and
essential for safe use. Such information is subject to the requirements set out in section
1.7.1.

Where machinery or a related product part is handled during use with lifting equipment,
its mass shall be indicated legibly, indelibly and unambiguously.

1.7.4. Instructions for use

In addition to the obligations set out in Article 10(7), instructions for use shall be drawn up as
set out below.

By way of exception to Article 10(7), the maintenance instructions intended for use by
specialised personnel mandated by the manufacturer or its authorised representative may be
supplied in only one official language of the Union which the specialised personnel
understand.

[Link]. G e n e r a l p r i n c i p l e s f o r t h e d r a f t i n g o f i n s t r u c t i o n s f o r u s e
(a) The contents of the instructions for use shall cover not only the intended use of the
machinery or related product but also take into account any reasonably foreseeable
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misuse thereof;

(b) In the case of machinery or related products intended for use by non-professional operators,
the wording and layout of the instructions for use shall take into account the level of
general education and acumen that can reasonably be expected from such operators.
29.6.202 E Official Journal of the European L
3 N Union 165/113

[Link]. C o n t e n t s o f t h e i n s t r u c t i o n s f o r u s e
1. Instructions for use shall contain, where applicable, at least the following information:

(a) the business name and full address of the manufacturer and, where applicable, of
its authorised representative;

(b) the designation of the machinery or related product as marked on the machinery or
related product itself, except for the serial number (see section 1.7.3);

(c) the EU declaration of conformity, or the internet address or machine readable code,
where the EU declaration of conformity can be accessed, in accordance with
Article 10(8);

(d) a general description of the machinery or related product;

(e) the drawings, diagrams, descriptions and explanations necessary for the use,
maintenance and repair of the machinery or related product and for checking its
correct functioning;

(f) a description of the workstation(s) likely to be occupied by operators;

(g) a description of the intended use of the machinery or related product;

(h) warnings concerning the ways in which the machinery or related product must not
be used that experience has shown might occur;

(i) assembly, installation and connection instructions, including drawings, diagrams and
the means of attachment and the designation of the chassis or installation on which
the machinery or related product is to be mounted;

(j) instructions relating to installation and assembly for reducing noise or vibration;

(k) instructions for the putting into service and use of the machinery or related product and,
if necessary, instructions for the training of operators;

(l) information about the residual risks that remain despite the inherent safe design
measures, safe guarding and complementary protective measures adopted;

(m)instructions on the protective measures to be taken by the user, including, where

appropriate, the personal protective equipment to be provided;

(n) the essential characteristics of tools, which may be fitted to the machinery or related
product;

(o) the conditions in which the machinery or related product meets the requirement of
stability during use, transportation, assembly, dismantling when out of service,
testing or foreseeable breakdowns;

(p) instructions with a view to ensuring that transport, handling and storage operations
can be made safely, giving the mass of the machinery or related product and of its
various parts where these are regularly to be transported separately;

(q) the operating method to be followed in the event of accident or breakdown; if a

blockage is likely to occur, the operating method to be followed so as to enable
the equipment to be safely unblocked;

(r) the description of the adjustment and maintenance operations that should be carried out
by the user and the preventive maintenance measures that should be observed taking
account of the design and the use of the machinery or related product;

(s) instructions designed to enable adjustment and maintenance to be carried out

safely, including the protective measures that should be taken during these
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operations;

(t) the specifications of the spare parts to be used, when these affect the health and safety
of operators;
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(u) the following information on airborne noise emissions:

(i) the A-weighted emission sound pressure level at workstations, where this
exceeds 70 dB (A); where this level does not exceed 70 dB (A), this fact shall
be indicated;

(ii) the peak C-weighted instantaneous sound pressure value at workstations, where
this exceeds 63 Pa (130 dB in relation to 20 μPa);

(iii)the A-weighted sound power level emitted by the machinery or related product,
where the
A-weighted emission sound pressure level at workstations exceeds 80 dB (A).

These values shall be either those actually measured for the machinery or related
product in question or those established on the basis of measurements taken for
technically comparable machinery or for a technically comparable related product,
which is representative of the machinery or related product to be produced.

In the case of very large machinery or a related product, instead of the A-

weighted sound power level, the A-weighted emission sound pressure levels at
specified positions around the machinery or related product may be indicated.

Where the harmonised standards or common specifications adopted by the

Commission in accordance with Article 20(3) cannot be applied, sound levels shall
be measured using the most appropriate method for the machinery or related
product.

Whenever sound emission values are indicated, the uncertainties surrounding these
values shall be specified. The operating conditions of the machinery or related product
during measurement and the measuring methods used shall be described.

Where the workstation(s) are undefined or cannot be defined, A-weighted sound

pressure levels shall be measured at a distance of 1 m from the surface of the
machinery or related product and at a height of 1,6 m from the floor or access
platform. The position and value of the maximum sound pressure shall be
indicated.

With respect to noise reduction machinery or related products, the instructions for use
shall specify, where appropriate, how to correctly assemble and install that equipment
(see also section [Link](1), point (j)).

Where specific Union legal acts lay down other requirements for the measurement of
sound pressure levels or sound power levels, those legal acts shall be applied and
the corresponding provisions of this section shall not apply;

(v) information on the necessary precautions, devices and means for the immediate and
gentle rescue of persons;

(w) where machinery or related products are likely to emit non-ionising radiation, which
may cause harm to persons, in particular persons with active or non-active implantable
medical devices, information concerning the radiation emitted for the operator and
exposed persons;

(x) where the design of machinery or related products allows emissions of hazardous
substances from the machinery or related product, the characteristics of the capturing,
filtration or discharge device if such device is not provided with the machinery or
related product, and any of the following:

(i) the flow rate for the emission of hazardous materials and substances from the
machinery or related product;

(ii) the concentration of hazardous materials or substances around the machinery or

related product coming from the machinery or related product or from
materials or substances used with the machinery or related product;

(iii)the effectiveness of the capturing or filtration device and the conditions to be

observed to maintain its effectiveness over time.
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The values referred to in the first subparagraph shall either be actually measured
for the machinery or related product in question or established based on
measurements in respect of technically comparable machinery or a technically
comparable related product, which is representative of the state of the art.
29.6.202 E Official Journal of the European L
3 N Union 165/117

1.7.5. Sales literature

Sales literature describing the machinery or related product shall not contradict the
instructions for use as regards health and safety aspects. Sales literature describing the
performance characteristics of the machinery or related product shall contain the same
information on emissions as is contained in the instructions for use.

2. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR CERTAIN CATEGORIES OF

MACHINERY AND RELATED PRODUCTS

Machinery and related products for foodstuffs, machinery and related products for
cosmetics or phar maceutical products, portable hand-held or hand-guided machinery and
related products, portable fixing and other impact machinery and related products,
machinery and related products for working wood and material with similar physical
characteristics and machinery and related products for plant protection products
application shall meet all the essential health and safety requirements set out in this
chapter (see General Principles, point 4).

2.1. Machinery and related products for foodstuffs and machinery and related products for cosmetics or
pharmaceutical products

2.1.1. General
Machinery or related products intended for use with foodstuffs or with cosmetics or
pharmaceutical products shall be designed and constructed in such a way as to avoid any
risk of infection, sickness or contagion.

The following requirements shall be observed:

(a) materials in contact with, or intended to come into contact with, foodstuffs or water
intended for human consumption or cosmetics or pharmaceutical products shall satisfy
the conditions laid down in the relevant Union legal acts; the machinery or related
product shall be designed and constructed in such a way that these materials can be
cleaned before each use and where this is not possible, disposable parts shall be used;

(b) all surfaces in contact with foodstuffs or water intended for human consumption or
cosmetics or phar maceutical products, other than surfaces of disposable parts, shall:

(i) be smooth and have neither ridges nor crevices, which could harbour organic materials,
and the same applies to their joinings;

(ii) be designed and constructed in such a way as to reduce the projections, edges
and recesses of assemblies to a minimum;

(iii)be easily cleaned and disinfected, where necessary after removing easily dismantled
parts; the inside surfaces shall have curves with a radius sufficient to allow
thorough cleaning;

(c) it shall be possible for liquids, gases and aerosols deriving from foodstuffs, cosmetics or
pharmaceutical products as well as from cleaning, disinfecting and rinsing fluids to be
completely discharged from the machinery or related product (if possible, in a
‘cleaning’ position);

(d) machinery or related products shall be designed and constructed in such a way as to
prevent any substances or living creatures, in particular insects, from entering, or any
organic matter from accumu lating in, areas that cannot be cleaned;

(e) machinery or related products shall be designed and constructed in such a way that no
ancillary substances hazardous to health, including the lubricants used, can come into
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contact with foodstuffs or water intended for human consumption, cosmetics or
pharmaceutical products; where necessary, machinery or related products shall be
designed and constructed in such a way that continuing compliance with this
requirement can be checked.
29.6.202 E Official Journal of the European L
3 N Union 165/119

2.1.2. Instructions for use

The instructions for use for machinery or related products for foodstuffs and machinery or
related products for cosmetics or pharmaceutical products shall indicate recommended
products and methods for cleaning, disinfecting and rinsing, not only for easily accessible
areas but also for areas to which access is impossible or inadvisable.

2.2. Portable hand-held or hand-guided machinery or related products

2.2.1. General
Portable hand-held or hand-guided machinery or related products shall:

(a) depending on the type of machinery or related product, have a supporting surface of
sufficient size and have a sufficient number of handles and supports of an appropriate
size, arranged in such a way as to ensure the stability of the machinery or related
product under the intended operating conditions;

(b) except where technically impossible, or where there is an independent control device,
in the case of handles which cannot be released in complete safety, be fitted with manual
start and stop control devices arranged in such a way that the operator can operate
them without releasing the handles;

(c) present no risks of accidental starting or continued operation after the operator has
released the handles; equivalent steps shall be taken if this requirement is not
technically feasible;

(d) permit, where necessary, visual observation of the danger zone and of the action of
the tool with the material being processed;

(e) have a device or a connected exhaust system, with an extraction connection outlet or
equivalent system to capture or reduce emissions of hazardous substances; this
requirement does not apply if it leads to a new hazard or where the main function of
the machinery or related product is the application of hazardous substances and to
emissions of internal combustion engines;

(f) be designed and constructed in such a way that the handles of portable machinery or
related products make starting and stopping straightforward.

[Link]. I n s t r u c t i o n s f o r u s e
The instructions for use shall give the following information concerning vibrations, expressed as
acceleration (m/s2), and transmitted by portable handheld or hand-guided machinery or
related products:

(a) the vibration total value from continuous vibrations to which the hand-arm system is
subjected;

(b) the mean value of the peak amplitude of the acceleration from repeated shock
vibrations, to which the hand-arm system is subjected;

(c) the uncertainty of both measurements.

The values referred to in the first subparagraph shall either be those actually measured for
the machinery or related product in question or those established on the basis of
measurements in respect of a technically comparable machinery or related product, which
is representative of the state of the art.

If harmonised standards or common specifications adopted by the Commission in

accordance with Article 20(3) cannot be applied, the vibration data shall be measured
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using the most appropriate measurement code for the machinery or related product.

The operating conditions during measurement and the methods used for measurement, or
the reference of the harmonised standard applied, shall be specified.
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3 N Union 165/121

2.2.2. Portable fixing and other impact machinery or related products

[Link]. G e n e r a l
Portable fixing and other impact machinery or related products shall be designed and
constructed in such a way that:

(a) energy is transmitted to the impacted element by the intermediary component that does
not leave the device;

(b) an enabling device prevents impact unless the machinery or related product is
positioned correctly with adequate pressure on the base material;

(c) involuntary triggering is prevented; where necessary, an appropriate sequence of actions on

the enabling device and the control device shall be required to trigger an impact;

(d) accidental triggering is prevented during handling or in case of shock;

(e) loading and unloading operations can be carried out easily and safely.

Where necessary, it shall be possible to fit the device with splinter guard(s) and the appropriate
guard(s) shall be provided by the manufacturer of the machinery or related product.

[Link]. I n s t r u c t i o n s f o r u s e
The instructions for use shall give the necessary information regarding:

(a) the accessories and interchangeable equipment that can be used with the machinery or
related product;

(b) the suitable fixing or other impacted elements to be used with the machinery or related
product;

(c) where appropriate, the suitable cartridges to be used.

2.3. Machinery or related products for working wood and material with similar physical characteristics
Machinery or related products for working wood and materials with similar physical
characteristics shall comply with the following requirements:

(a) the machinery or related product shall be designed, constructed or equipped in such a
way that the piece being machined can be placed and guided in safety; where the piece
is hand-held on a work-bench, the latter shall be sufficiently stable during the work
and shall not impede the movement of the piece;

(b) where the machinery or related product is likely to be used in conditions involving the
risk of ejection of work pieces or parts of them, it shall be designed, constructed, or
equipped in such a way as to prevent such ejection, or, if this is not possible, so that the
ejection does not engender risks for the operator and/or exposed persons;

(c) the machinery or related product shall be equipped with an automatic brake that stops
the tool in a sufficiently short time if there is a risk of contact with the tool whilst it
runs down;

(d) where the tool is incorporated into non-fully automated machinery or a related product,
that machinery or related product shall be designed and constructed in such a way as to
eliminate or reduce the risk of accidental injury.

2.4. Machinery or related products for plant protection products application

2.4.1. For the purposes of section 2.4., the following definition applies:

‘Machinery or related products for plant protection products application’ means machinery
or related products specifically intended for the application of plant protection products
within the meaning of Article 2(1), of Regulation (EC) No 1107/2009 of the European
Parliament and of the Council (1).
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(1) Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning
the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and
91/414/EEC (OJ L 309, 24.11.2009, p. 1).
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3 N Union 165/123

2.4.2. General
The manufacturer of machinery or related products for plant protection products application
shall ensure that an assessment is carried out of the risks of unintended exposure of the
environment to plant protection products, in accordance with the process of risk
assessment and risk reduction referred to in the General Principles, point 1.

Machinery or related products for plant protection products application shall be designed
and constructed taking into account the results of the risk assessment referred to in the
first subparagraph so that the machinery or related products can be operated, adjusted
and maintained without unintended exposure of the environment to plant protection
products.

Leakage shall be prevented at all times.

2.4.3. Controls and monitoring

It shall be possible to easily and accurately control, monitor and immediately stop the plant
protection products application from the operating positions.

2.4.4. Filling and emptying

The machinery or related product shall be designed and constructed to facilitate
precise filling with the necessary quantity of plant protection products and to ensure easy and
complete emptying, while preventing spillage of plant protection products and avoiding
the contamination of the water source during such operations.

2.4.5. Application of plant protection products

[Link]. A pplication rate

The machinery or related product shall be fitted with means of adjusting the application rate
easily, accurately and reliably.

[Link]. Distribution, deposition and drift of plant protection produ

cts
The machinery or related product shall be designed and constructed to ensure that the
plant protection product is deposited on target areas, to minimise losses to other areas and to
prevent drift of plant protection products to the environment. Where appropriate, an even
distribution and homogeneous deposition shall be ensured.

[Link]. T e s t s
In order to verify that the relevant parts of the machinery or related product comply with
the requirements set out in sections [Link] and [Link], the manufacturer shall, for each
type of machinery or related product concerned, perform appropriate tests, or have such
tests performed.

[Link]. L o s s e s d u r i n g s t o p p a g e
The machinery or related product shall be designed and constructed to prevent losses
while the plant protection products application function is stopped.

2.4.6. Maintenance

[Link]. C l e a n i n g
The machinery or related product shall be designed and constructed to allow its easy and
thorough cleaning without contamination of the environment.

[Link]. S e r v i c i n g
The machinery or related product shall be designed and constructed to facilitate the
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changing of worn parts without contamination of the environment.
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3 N Union 165/125

2.4.7. Inspections
It shall be possible to easily connect the necessary measuring instruments to the machinery or
related product to check the correct functioning of the machinery or related product.

2.4.8. Marking of nozzles, strainers and filters

Nozzles, strainers and filters shall be marked so that their type and size can be clearly
identified.

2.4.9. Indication of the plant protection product in use

Where appropriate, the machinery or related product shall be fitted with a specific mounting
on which the operator can place the name of the plant protection product in use.

2.4.10. Instructions for use

The instructions for use shall provide the following information:

(a) precautions to be taken during mixing, loading, application, emptying, cleaning, servicing
and transport operations in order to avoid contamination of the environment;

(b) detailed conditions of use for the different operating environments envisaged, including the
corresponding preparation and adjustments required to ensure the deposition of the
plant protection product on target areas while minimising losses to other areas, to prevent
drift to the environment and, where appropriate, to ensure an even distribution and
homogeneous deposition of the plant protection product;

(c) the range of types and sizes of nozzles, strainers and filters that can be used with the
machinery or related product;

(d) the frequency of checks and the criteria and method for the replacement of parts
subject to wear that affect the correct functioning of the machinery or related product,
such as nozzles, strainers and filters;

(e) specification of calibration, daily maintenance, winter preparation and other checks
necessary to ensure the correct functioning of the machinery or related product;

(f) types of plant protection products that may cause incorrect functioning of the
machinery or related product;

(g) an indication that the operator should keep updated the name of the plant protection
product in use on the specific mounting referred to in section 2.4.9;

(h) the connexion and use of any special equipment or accessories, and the necessary
precautions to be taken;

(i) an indication that the machinery or related product may be subject to national
requirements for regular inspection by designated bodies, as provided for in Directive
2009/128/EC of the European Parliament and of the Council (2);

(j) the features of the machinery or related product, which shall be inspected to ensure its
correct func tioning;

(k) instructions for connecting the necessary measuring instruments.

3. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS TO OFFSET RISKS DUE TO THE
MOBILITY OF MACHINERY OR RELATED PRODUCTS

Machinery or related products presenting risks due to their mobility shall meet all the
essential health and safety requirements set out in this chapter (see General Principles,
point 4).
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(2) Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing
a framework for
Community action to achieve the sustainable use of pesticides (OJ L 309, 24.11.2009, p. 71).
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3.1. General
3.1.1. For the purposes of this section, the following definitions apply:

(a) ‘Machinery or related products presenting risks due to their mobility’ means:

(i) machinery or related products, the operation of which requires either mobility while
working, or continuous or semi continuous movement between a succession of
fixed working locations; or

(ii)machinery or related products which are operatedwithout being moved, but which may
be equipped in such a way as to enable it to be moved more easily from one place
to another;

(b) ‘Driver’ means an operator responsible for the movement of machinery or a related
product, who may be transported by the machinery or may be on foot,
accompanying the machinery, or may guide the machinery by remote control;

(c) ‘Autonomous mobile machinery’ means mobile machinery which has an autonomous
mode, in which all the essential safety functions of the mobile machinery are ensured in
its travel and working operations area without permanent interaction of an operator;

(d) ‘Supervisor’ means a person responsible for the supervision of autonomous mobile
machinery;

(e) ‘Supervisory function’ means remote non permanent surveillance of autonomous mobile
machinery by a device allowing to receive information or alerts and to give limited
orders to this machinery.

3.2. Work positions

3.2.1. Driving position

Visibility from the driving position shall be such that the driver can, in complete safety for
himself or herself and the exposed persons operate the machinery or related product and
its tools in their reasonably fore seeable conditions of use. Where necessary, appropriate
devices shall be provided to remedy risks due to inadequate direct vision.

Machinery or a related product on which the driver is transported shall be designed and
constructed in such a way that, from the driving positions, there is no risk to the driver from
inadvertent contact with the wheels and tracks.

The driving position of ride-on drivers shall be designed and constructed in such a way that
a driver’s cab may be fitted, provided this does not increase the risk and there is room for
it. The cab shall incorporate a place for the instructions for use needed for the driver.

3.2.2. Seating
Where there is a risk that operators or other persons transported by the machinery may be
crushed between parts of the machinery and the surroundings should the machinery roll or
tip over, in particular for machinery equipped with a protective structure referred to in
section 3.4.3 or 3.4.4:

(a) the machinery shall be designed or equipped with a restraint system so as to keep the
persons in their seats or in the protective structure, without restricting movements
necessary for operations or movements relative to the structure caused by the
suspension of the seats;

where there is a significant risk of roll or tip over and its restraint system is not used it
shall not be possible for the machinery to move;

such restraint systems or provision shall take ergonomic principles into account and shall
not be fitted if they increase the risk;
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(b) a visual and audible signal shall be provided at the driving position alerting the driver
when the driver is in the driving position and not using the restraint system.
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3.2.3. Positions for other persons

If the conditions of use provide that persons other than the driver may occasionally or
regularly be trans ported by the machinery or work on it, appropriate positions shall be
provided which enable them to be transported or to work on it without risk.

The second and third subparagraphs of section 3.2.1 also apply to the places provided for
persons other than the driver.

3.2.4. Supervisory function

Where relevant, autonomous mobile machinery or related products shall have a supervisory
function specific to the autonomous mode. This function shall allow the supervisor to
remotely receive information from the machinery. The supervisory function shall only allow
actions to stop and to start remotely the machinery or related product or move it to a safe
position and a safe state to avoid causing other risks. It shall be designed and constructed
to allow those actions only when the supervisor can see directly or indirectly the machine’s
movement and working area and the protective devices are operational.

The information the supervisor receives from the machinery when the supervisory function
is active shall enable the supervisor to have a complete and accurate view of the operation,
movement and safe positioning of the machinery in its travel and working area.

This information shall alert the supervisor of the occurrence of unforeseen or dangerous
situations present or impending, which require the intervention of the supervisor.

If the supervisory function is not active, the machinery shall not be able to operate.

3.3. Control systems

If necessary, steps shall be taken to prevent unauthorised use of controls.

In the case of remote controls, each control unit shall clearly identify the machinery or
related product to be controlled from that unit.

The remote control system shall be designed and constructed in such a way as to affect only:

(a) the machinery or related product in question;

(b) the functions in question.

Remote-controlled machinery or related products shall be designed and constructed in such a

way that it will respond only to signals from the intended control units.

For autonomous mobile machinery or related product, the control system shall be designed
to perform the safety functions by itself as set out in this section, even when actions are
ordered by using a remote supervisory function.

3.3.1. Control devices

The driver shall be able to actuate all control devices required to operate the machinery or
related product from the driving position, except for functions, which can be safely
actuated only by using control devices located elsewhere. These functions include, in
particular, those for which operators other than the driver are responsible or for which the
driver has to leave the driving position in order to control them safely.

Where there are pedals, they shall be so designed, constructed and fitted as to allow safe
operation by the driver with the minimum risk of incorrect operation. They shall have a
slip-resistant surface and be easy to clean.

Where their operation can lead to hazards, notably dangerous movements, the control
devices, except for those with pre-set positions, shall return to the neutral position as soon as
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they are released by the operator.
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In the case of wheeled machinery, the steering system shall be designed and constructed
in such a way as to reduce the force of sudden movements of the steering wheel or the
steering lever caused by shocks to the guide wheels.

Any control that locks the differential shall be so designed and arranged that it allows the
differential to be unlocked when the machinery is moving.

The sixth paragraph of section 1.2.2, concerning acoustic and/or visual warning signals,
applies only in the case of reversing.

3.3.2. Starting/moving
All travel movements of self-propelled machinery with a ride-on driver shall be possible
only if the driver is at the controls.

Where, for operating purposes, machinery is fitted with devices which exceed its normal
clearance zone (e.g. stabilisers, jib, etc.), the driver shall be provided with the means of
checking easily, before moving the machinery, that such devices are in a particular
position which allows safe movement.

This also applies to all other parts which; to allow safe movement, have to be in particular
positions, locked if necessary.

Where it does not give rise to other risks, movement of the machinery shall depend on safe
positioning of the aforementioned parts.

It shall not be possible for unintentional movement of the machinery to occur while the
engine is being started.

The movement of autonomous mobile machinery shall take into account the risks related to the
area where it is intended to move and work.

3.3.3. Travelling function

Without prejudice to road traffic regulations, self-propelled machinery and its trailers shall
meet the requirements for slowing down, stopping, braking and immobilisation so as to
ensure safety under all the operating, load, speed, ground and gradient conditions allowed
for.

The driver shall be able to slow down and stop self-propelled machinery by means of a
main device. Where safety so requires, in the event of a failure of the main device, or in the
absence of the energy supply needed to actuate the main device, an emergency device with a
fully independent and easily accessible control device shall be provided for slowing down
and stopping.

Where safety so requires, a parking device shall be provided to render stationary

machinery immobile. This device may be combined with one of the devices referred to in
the second paragraph, if it is purely mechanical.

Remote-controlled machinery shall be equipped with devices for stopping operation

automatically and immediately and for preventing potentially dangerous operation in the
following situations:

(a) if the driver loses control;

(b) if it receives a stop signal;

(c) if a fault is detected in a safety-related part of the system;

(d) if no validation signal is detected within a specified time.

Section 1.2.4 does not apply to the travelling function.

Autonomous mobile machinery or related products shall comply, with one or both
where necessary
according to the risk assessment, of the following conditions:
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(i) it shall move and operate in an enclosed zone fitted with a peripheral protection
system comprising guards or protective devices;
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(ii)it shall be equipped with devices intended to detect any human, domestic animal or any
other obstacle in its vicinity, where those obstacles could give rise to a risk to the
health and safety of persons or domestic animals or to the safe operation of the
machinery or related product.

The movements of mobile machinery or a related product connected with one or more
trailers or towed equipment, including autonomous mobile machinery or a related
product connected with one or more trailers or towed equipment, shall not give rise to
risks for persons, domestic animals or to any other obstacle in the danger zone of such
machinery or related product and trailers or towed equipment.

3.3.4. Movement of pedestrian-controlled machinery

Movement of pedestrian-controlled self-propelled machinery shall be possible only through
sustained action on the relevant control device by the driver. In particular, it shall not be
possible for movement to occur while the engine is being started. The control systems for
pedestrian-controlled machinery shall be designed in such a way as to minimise the risks
arising from inadvertent movement of the machinery towards the driver, in particular:

(a) crushing;

(b)injury from rotating tools.

The speed of travel of the machinery shall be compatible with the pace of a driver on foot.

In the case of machinery on which a rotary tool may be fitted, it shall not be possible
to actuate the tool when the reverse control is engaged, except where the movement of the
machinery results from movement of the tool. In the latter case, the reversing speed shall
be such that it does not endanger the driver.

3.3.5. Control circuit failure

A failure in the power supply to the power-assisted steering, where fitted, shall not
prevent machinery from being steered during the time required to stop it.

For autonomous mobile machinery, a failure in the steering system shall not have an impact
on the safety of the machinery.

3.4. Protection against mechanical risks

3.4.1. Uncontrolled movements

Machinery or related products shall be designed, constructed, and where appropriate
placed on a mobile support, in such a way as to ensure that, when moved, uncontrolled
oscillations of its centre of gravity do not affect its stability or exert excessive strain on its
structure.

3.4.2. Moving transmission parts

By way of exception to section [Link], in the case of engines, moveable guards preventing
access to the moving parts in the engine compartment do not need to have interlocking
devices if they have to be opened either by the use of a tool or key or by a control located
in the driving position, providing the latter is in a fully enclosed cab with a lock to prevent
unauthorised access.

3.4.3. Roll-over and tip-over

Where, in the case of self-propelled machinery with a ride-on driver, operator(s) or other
person(s), there is a risk of rolling or tipping over, the machinery shall be fitted with an
appropriate protective structure, unless this increases the risk.

This structure shall be such that in the event of rolling or tipping over it affords the ride-on
person(s) an adequate deflection-limiting volume.
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In order to verify that the structure complies with the requirement laid down in the second
paragraph, the manufacturer shall, for each type of structure concerned, perform
appropriate tests or have such tests performed.
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3.4.4. Falling objects

Where, in the case of self-propelled machinery with a ride-on driver, operator(s) or other
person(s), there is a risk due to falling objects or material, the machinery shall be designed
and constructed in such a way as to take account of this risk and fitted, if its size allows,
with an appropriate protective structure.

This structure shall be such that, in the event of falling objects or material, it guarantees the
ride-on person(s) an adequate deflection-limiting volume.

In order to verify that the structure complies with the requirement laid down in the second
paragraph, the manufacturer shall, for each type of structure concerned, perform
appropriate tests or have such tests performed.

3.4.5. Means of access

Handholds and steps shall be designed, constructed and arranged in such a way that the
operators use them instinctively and do not use the control devices to assist access.

3.4.6. Towing devices

All machinery used to tow or to be towed shall be fitted with towing or coupling
devices designed,
constructed and arranged in such a way as to ensure easy and secure connection and
disconnection and to prevent accidental disconnection during use.

Insofar as the tow bar load so requires, such machinery shall be equipped with a support
with a bearing surface suited to the load and the ground.

3.4.7. Transmission of power between self-propelled machinery (or a tractor) and recipient machinery
Removable mechanical transmission devices linking self-propelled machinery (or a tractor)
to the first fixed bearing of recipient machinery shall be designed and constructed in such
a way that any part that moves during operation is protected over its whole length.

On the side of the self-propelled machinery (or the tractor), the power take-off to which the
removable mechanical transmission device is attached shall be protected either by a guard
fixed and linked to the self- propelled machinery (or the tractor) or by any other device
offering equivalent protection.

It shall be possible to open this guard for access to the removable transmission device.
Once it is in place, there shall be enough room to prevent the drive shaft damaging the
guard when the machinery (or the tractor) is moving.

On the recipient machinery side, the input shaft shall be enclosed in a protective casing
fixed to the machinery.

Torque limiters or freewheels may be fitted to universal joint transmissions only on the
side adjoining the driven machinery. The removable mechanical transmission device shall
be marked accordingly.

All recipient machinery the operation of which requires a removable mechanical

transmission device to connect it to self-propelled machinery (or a tractor) shall have a
system for attaching the removable mech anical transmission device so that, when the
machinery is uncoupled, the removable mechanical transmission device and its guard are not
damaged by contact with the ground or part of the machinery.

The outside parts of the guard shall be so designed, constructed and arranged that they
cannot turn with the removable mechanical transmission device. The guard shall cover the
transmission to the ends of the inner jaws in the case of simple universal joints and at least
to the centre of the outer joint or joints in the case of wide-angle universal joints.
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If means of access to working positions are provided near to the removable mechanical
transmission device, they shall be designed and constructed in such a way that the shaft
guards cannot be used as steps, unless designed and constructed for that purpose.
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3.5. Protection against other risks

3.5.1. Batteries
The battery housing shall be designed and constructed in such a way as to prevent the
electrolyte being ejected on to the operator in the event of rollover or tip over and to
avoid the accumulation of vapours in places occupied by operators.

Machinery or related products shall be designed and constructed in such a way that the
battery can be disconnected with the aid of an easily accessible device provided for that
purpose.

The batteries with automatic charging for mobile machinery or related products,
including autonomous mobile machinery or related products, shall be designed to
prevent hazards referred to in sections [Link] and 1.5.1, including the risks of contact
or collision of the machinery or related product with a person or other machinery or
related products when the machinery or related product moves autonomously to the
charging station.

3.5.2. Fire
Depending on the hazards anticipated by the manufacturer, machinery shall, where its size
permits:

(a) either allow easily accessible fire extinguishers to be fitted; or

(b)be provided with built-in extinguisher systems.

3.5.3. Emissions of hazardous substances

The second and third paragraphs of section 1.5.13 do not apply where the main function of
the machinery is the application of hazardous substances. However, the operator shall be
protected against the risk of exposure to such hazardous emissions.

Ride-on mobile machinery having application of hazardous substances as the main function
shall be equipped with filtration cabs or equivalent safety measures.

3.5.4. Risk of contact with live overhead power lines

Depending on their height, mobile machinery or related products shall, where relevant,
be designed,
constructed and equipped, so as to prevent the risk of contact with an energised overhead
power line or the risk of creating an electric arc between any part of the machinery or an
operator driving the machinery and an energised overhead power line.

When the risk to the persons operating machinery incurred by the contact with an energised
overhead power line cannot be fully avoided, mobile machinery or related products shall be
designed, constructed and equipped so as to prevent any electrical hazards.

3.6. Information and indications

3.6.1. Signs, signals and warnings

All machinery or related products shall have signs and/or instruction plates concerning use,
adjustment and maintenance, wherever necessary, so as to ensure the health and safety of
persons. They shall be chosen, designed and constructed in such a way as to be clearly
visible and indelible.

Without prejudice to the provisions of road traffic regulations, machinery or related products
with a ride-on driver shall have the following equipment:

(a) an acoustic warning device to alert persons;

(b)a system of light signals relevant to the intended conditions of use; the latter requirement
does not apply to machinery or related products intended solely for underground
working and having no electrical power;
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(c) where necessary, there shall be an appropriate connection between a trailer and the
machinery or a related product for the operation of signals.
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Remote-controlled machinery or related products which, under normal conditions of use,

exposes persons to the risk of impact or crushing shall be fitted with appropriate means to
signal its movements or with means to protect persons against such risks. The same shall
apply to machinery or related products, which involves, when in use, the constant repetition of
a forward and backward movement on a single axis where the area to the rear of the
machinery is not directly visible to the driver.

Machinery or related products shall be constructed in such a way that the warning and
signalling devices cannot be disabled unintentionally. Where it is essential for safety, such
devices shall be provided with the means to check that they are in good working order and
their failure shall be made apparent to the operator.

Where the movement of machinery or its tools is particularly hazardous, signs on the
machinery shall be provided to warn against approaching the machinery while it is
working; the signs shall be legible at a sufficient distance to ensure the safety of persons
who have to be in the vicinity.

3.6.2. Marking
(1) The following shall be shown legibly and indelibly on all machinery or related products:

(a) nominal power expressed in kilowatts (kW);

(b) mass of the most usual configuration, in kilograms (kg).

(2) In addition, where appropriate, the following shall be shown legibly and indelibly on all
machinery or related products:

(a) maximum drawbar pull provided for at the coupling hook, in Newtons (N);

(b) maximum vertical load provided for on the coupling hook, in Newtons (N).

3.6.3. Instructions for use

[Link]. V i b r a t i o n s
The instructions for use shall give the following information concerning vibrations, expressed as
acceleration (m/s2), transmitted by the machinery or related products to the hand-arm
system or to the whole body:

(a) the vibration total value from continuous vibrations to which the hand-arm system is
subjected;

(b) the mean value of the peak amplitude of the acceleration from repeated shock
vibrations, to which the hand-arm system is subjected;

(c) the highest root mean square value of weighted acceleration to which the whole body is
subjected, if it exceeds 0,5 m/s2; where this value does not exceed 0,5 m/s2, this shall
be mentioned;

(d) the uncertainty of measurements.

These values shall be either those actually measured for the machinery or related product in
question or those established on the basis of measurements taken in respect of technically
comparable machinery or related products which are representative of the machinery or
related products to be produced.

Where harmonised standards or common specifications adopted by the Commission in

accordance with Article 20(3) cannot be applied, the vibration shall be measured using the
most appropriate measurement code for the machinery or related products concerned.

The operating conditions during measurement and the measurement codes used shall be
described.
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[Link]. M u l t i p l e u s e s
The instructions for use for machinery or a related product allowing several uses depending on
the equipment used and the instructions for use for the interchangeable equipment shall
contain the information necessary for safe assembly and use of the basic machinery or
related product and the interchangeable equipment that can be fitted.
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[Link]. A utonomous mobile machinery or related products

The instructions for use of autonomous mobile machinery or related products shall specify the
characteristics of its intended travel, working areas and danger zones.

4. SUPPLEMENTA
ESSENTIA HEALT AN SAFET REQUIREMENTS TO OFFSET DU TO
RY
L H D Y RISKS E LIFTING
OPERATIONS
Machinery or related products presenting risks due to lifting operations shall meet all the
relevant essential health and safety requirements set out in this chapter (see General
Principles, point 4).

4.1. General
4.1.1. For the purposes of section 4.1., the following definitions apply:

(a) ‘Lifting operation’ means a movement of unit loads consisting of goods and/or persons
necessitating, at a given moment, a change of level;

(b) ‘Guided load’ means a load where the total movement is made along rigid or flexible
guides whose position is determined by fixed points;

(c) ‘Working coefficient’ means the arithmetic ratio between the load guaranteed by the
manufacturer up to which a component is able to hold it and the maximum working
load marked on the component;

(d) ‘Test coefficient’ means the arithmetic ratio between the load used to carry out the static or
dynamic tests on the machinery or related product or lifting accessory and the maximum
working load marked on the machinery or related product or lifting accessory;

(e) ‘Static test’ means the test during which the machinery or related product or lifting
accessory is first inspected and subjected to a force corresponding to the maximum
working load multiplied by the appropriate static test coefficient and then re-inspected
once the said load has been released to ensure that no damage has occurred;

(f) ‘Dynamic test’ means the test during which the machinery or related product is operated in
all its possible configurations at the maximum working load multiplied by the appropriate
dynamic test coefficient with account being taken of the dynamic behaviour of the lifting
machinery in order to check that it functions properly;

(g) ‘Carrier’ means a part of the machinery or related product on or in which persons
and/or goods are supported in order to be lifted.

4.1.2. Protection against mechanical risks

[Link]. R i s k s d u e t o l a c k o f s t a b i l i t y
Machinery or related products shall be designed and constructed in such a way that the
stability required by section 1.3.1 is maintained both in service and out of service, including
all stages of transportation, assembly and dismantling, during foreseeable component
failures and also during the tests carried out in accordance with the instructions for use. To
that end, the manufacturer shall use the appropriate verification methods.

[Link]. M a c h i n e r y o r r e l a t e d p r o d u c t s r u n n i n g o n g u i d e r a i l s a n d r a i l
tracks
Machinery or related products shall be provided with devices, which act on the guide rails
or tracks to prevent derailment.
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If, despite such devices, there remains a risk of derailment or of failure of a rail or of a
running component, devices shall be provided which prevent the equipment, component or
load from falling or the machinery from overturning.
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[Link]. M e c h a n i c a l s t r e n g t h
Machinery or related products, including lifting accessories and their components, shall be
capable of with standing the stresses to which they are subjected during their lifetime, both
in and, where applicable, out of use, under the installation and operating conditions provided
for and in all relevant configurations, with due regard, where appropriate, to the effects of
atmospheric factors and forces exerted by persons. This requirement shall also be satisfied
during transport, assembly and dismantling.

Machinery or related products, including lifting accessories, shall be designed and constructed
in such a way as to prevent failure from fatigue and wear, taking due account of their
intended use and any reasonably foreseeable misuse.

The materials used shall be chosen on the basis of the intended working environments, with
particular regard to corrosion, abrasion, impacts, extreme temperatures, fatigue, brittleness,
radiation and ageing.

Machinery or related products, including lifting accessories, shall be designed and constructed
in such a way as to withstand the overload in the static tests without permanent
deformation or patent defect. Strength calculations shall take account of the value of the
static test coefficient chosen to guarantee an adequate level of safety. That coefficient has,
as a general rule, the following values:

(a) manually-operated machinery or related products, including lifting accessories: 1,5;

(b) other machinery or related products: 1,25.

Machinery or related products shall be designed and constructed in such a way as to undergo,
without failure, the dynamic tests carried out using the maximum working load multiplied
by the dynamic test coefficient. This dynamic test coefficient is chosen so as to guarantee
an adequate level of safety: the coefficient is, as a general rule, equal to 1,1. As a general
rule, the tests will be performed at the nominal speeds provided for. Should the control
circuit of the machinery or related product allow for a number of simultaneous move
ments, the tests shall be carried out under the least favourable conditions, as a general rule by
combining the movements concerned.

[Link]. P u l l e y s , d r u m s , w h e e l s , r o p e s a n d c h a i n s
Pulleys, drums and wheels shall have a diameter commensurate with the size of the ropes
or chains with which they can be fitted.

Drums and wheels shall be designed, constructed and installed in such a way that the ropes
or chains with which they are equipped can be wound without coming off.

Ropes used directly for lifting or supporting the load shall not include any splicing other
than at their ends. Splicings are, however, tolerated in installations, which are intended by
design to be modified regularly according to needs of use.

Complete ropes and their endings shall have a working coefficient chosen in such a way
as to guarantee an adequate level of safety. As a general rule, this coefficient is equal
to 5.

Lifting chains shall have a working coefficient chosen in such a way as to guarantee an
adequate level of safety. As a general rule, this coefficient is equal to 4.

In order to verify that an adequate working coefficient has been attained, the manufacturer
shall, for each type of chain and rope used directly for lifting the load and for the rope
ends, perform the appropriate tests or have such tests performed.

[Link]. L i f t i n g a c c e s s o r i e s a n d t h e i r c o m p o n e n t s
Lifting accessories and their components shall be sized with due regard to fatigue and
ageing processes for a number of operating cycles consistent with their expected life-span
as specified in the operating conditions for a given application.

Moreover:
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(a) the working coefficient of wire-rope/rope-end combinations shall be chosen in such a way as
to guarantee an adequate level of safety; this coefficient is, as a general rule, equal to 5.
Ropes shall not comprise any splices or loops other than at their ends;
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(b) where chains with welded links are used, they shall be of the short-link type. The
working coefficient of chains shall be chosen in such a way as to guarantee an adequate
level of safety; this coefficient is, as a general rule, equal to 4;

(c) the working coefficient for textile ropes, slings or webbing is dependent on the material,
method of manufacture, dimensions and use. This coefficient shall be chosen in such a
way as to guarantee an adequate level of safety; it is, as a general rule, equal to 7,
provided the materials used are shown to be of very good quality and the method of
manufacture is appropriate to the intended use. Should this not be the case, the
coefficient is, as a general rule, set at a higher level in order to secure an equivalent
level of safety. Textile ropes, slings or webbings shall not include any knots, connections or
splicing other than at the ends of the sling, except in the case of an endless sling;

(d) all metallic components making up, or used with, a sling shall have a working
coefficient chosen in such a way as to guarantee an adequate level of safety; this
coefficient is, as a general rule, equal to 4;

(e) the maximum working load of a multilegged sling is determined on the basis of the
working coefficient of the weakest leg, the number of legs and a reduction factor which
depends on the slinging configur ation;

(f) in order to verify that an adequate working coefficient has been attained, the manufacturer
shall, for each type of component referred to in points (a) to (d), perform the appropriate
tests or have such tests performed.

[Link]. C o n t r o l o f m o v e m e n t s
Devices for controlling movements shall act in such a way that the machinery or related
product on which they are installed is kept safe.

(a) Machinery or related products shall be designed and constructed or fitted with devices in
such a way that the amplitude of movement of its components is kept within the
specified limits. The operation of such devices shall, where appropriate, be preceded
by a warning;

(b) Where several fixed or rail-mounted machinery or related products can be manoeuvred
simultaneously in the same place, with risks of collision, such machinery shall be designed
and constructed in such a way as to make it possible to fit systems enabling these risks
to be avoided;

(c) Machinery or related products shall be designed and constructed in such a way that the
loads cannot creep dangerously or fall freely and unexpectedly, even in the event of partial
or total failure of the power supply or when the operator stops operating the machinery;

(d) It shall not be possible, under normal operating conditions, to lower the load solely
by friction brake, except in the case of machinery or related products whose function
requires it to operate in that way;

(e) Holding devices shall be designed and constructed in such a way that inadvertent dropping
of the loads is avoided.

[Link]. M o v e m e n t s o f l o a d s d u r i n g h a n d l i n g
The operating position of machinery shall be located in such a way as to ensure the widest
possible view of trajectories of the moving parts, in order to avoid possible collisions with
persons, equipment or other machinery, which might be manoeuvring at the same time
and liable to constitute a hazard.

Machinery with guided loads shall be designed and constructed in such a way as to prevent
persons from being injured by movement of the load, the carrier or the counterweights, if
any.

[Link]. M a c h i n e r y s e r v i n g f i x e d l a n d i n g s
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[Link].1. Movements of the carrier
The movement of the carrier of machinery serving fixed landings shall be rigidly guided to
and at the landings. Scissor systems are also regarded as rigid guidance.
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[Link].2. Access to the carrier

Where persons have access to the carrier, the machinery shall be designed and constructed in
such a way as to ensure that the carrier remains stationary during access, in particular while
it is being loaded or unloaded.

The machinery shall be designed and constructed in such a way as to ensure that the
difference in level between the carrier and the landing being served does not create a risk
of tripping.

[Link].3. Risks due to contact with the moving carrier

Where necessary in order to fulfil the requirement expressed in the second paragraph of
section [Link], the travel zone shall be rendered inaccessible during normal operation.

When, during inspection or maintenance, there is a risk that persons situated under or above
the carrier may be crushed between the carrier and any fixed parts, sufficient free space
shall be provided either by means of physical refuges or by means of mechanical devices
blocking the movement of the carrier.

[Link].4. Risk due to the load falling off the carrier

Where there is a risk due to the load falling off the carrier, the machinery shall be
designed and constructed in such a way as to prevent this risk.

[Link].5. Landings
Risks due to contact of persons at landings with the moving carrier or other moving parts shall
be prevented.

Where there is a risk due to persons falling into the travel zone when the carrier is not
present at the landings, guards shall be fitted in order to prevent this risk. Such guards shall
not open in the direction of the travel zone. They shall be fitted with an interlocking device
with guard locking controlled by the position of the carrier that prevents:

(a) hazardous movements of the carrier until the guards are closed and locked;

(b) hazardous opening of a guard until the carrier has stopped at the corresponding landing.

4.1.3. Fitness for purpose

When lifting machinery or related products, including lifting accessories, are placed on the
market or are first put into service, the manufacturer shall ensure, by taking appropriate
measures or having them taken, that the machinery or related products, including lifting
accessories, which are ready for use – whether manually or power-operated – can fulfil their
specified functions safely.

The static and dynamic tests referred to in section [Link] shall be performed on all lifting
machinery or related products ready to be put into service.

Where the machinery or related products cannot be assembled in the manufacturer’s

premises, the appro priate measures shall be taken at the place of use by the manufacturer.
Otherwise, the measures may be taken either in the manufacturer’s premises or at the place
of use.

4.2. Requirements for machinery or related products whose power source is other than manual effort

4.2.1. Control of movements

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Hold-to-run control devices shall be used to control the movements of the machinery or
related products or their equipment. However, for partial or complete movements in which
there is no risk of the load or the machinery or related product colliding, the said devices
may be replaced by control devices authorising automatic stops at pre-selected positions
without the operator holding a hold-to-run control device.
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4.2.2. Loading control

Machinery or related products with a maximum working load of not less than 1 000 kg or
an overturning moment of not less than 40 000 Nm shall be fitted with devices to warn
the driver and prevent dangerous movements in the event:

(a) of overloading, either as a result of the maximum working load or the maximum working
moment due to the load being exceeded; or

(b) of the overturning moment being exceeded.

4.2.3. Installations guided by ropes

Rope carriers, tractors or tractor carriers shall be held by counterweights or by a device
allowing permanent control of the tension.

4.3. Information and markings

4.3.1. Chains, ropes and webbing

Each length of lifting chain, rope or webbing not forming part of an assembly shall bear a
mark or, where this is not possible, a plate or irremovable ring bearing the name and
address of the manufacturer and the identifying reference of the relevant certificate.

The certificate mentioned above shall show at least the following information:

(a) the name and address of the manufacturer;

(b) a description of the chain or rope, which includes:

(i) its nominal size;

(ii) its construction;

(iii)the material from which it is made; and

(iv)any special metallurgical treatment applied to the material;

(c) the test method used;

(d) the maximum load to which the chain or rope should be subjected in service. A range of
values may be given on the basis of the intended applications.

4.3.2. Lifting accessories

Lifting accessories shall show the following particulars:

(a) identification of the material where this information is needed for safe use;

(b) the maximum working load.

In the case of lifting accessories on which marking is physically impossible, the particulars
referred to in the first paragraph shall be displayed on a plate or other equivalent means and
securely affixed to the accessory.

The particulars shall be legible and located in a place where they are not liable to
disappear as a result of wear or jeopardise the strength of the accessory.

4.3.3. Lifting machinery or related products

The maximum working load shall be prominently marked on the lifting machinery or
related product. This marking shall be legible, indelible and in an un-coded form.

Where the maximum working load depends on the configuration of the lifting machinery or
related product, each operating position shall be provided with a load plate indicating,
preferably in diagrammatic form or by means of tables, the working load permitted for
each configuration.
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Machinery or related products intended for lifting goods only, equipped with a carrier, which
allows access to persons, shall bear a clear and indelible warning prohibiting the lifting of
persons. This warning shall be visible at each place where access is possible.

4.4. Instructions for use

4.4.1. Lifting accessories

Each lifting accessory or each commercially indivisible batch of lifting accessories shall be
accompanied by instructions setting out at least the following particulars:

(a) the intended use;

(b) the limits of use (particularly for lifting accessories such as magnetic or vacuum pads
which do not fully comply with section [Link](e));

(c) instructions for assembly, use and maintenance;

(d) the static test coefficient used.

4.4.2. Lifting machinery or related products

Lifting machinery or related products shall be accompanied by instructions for use
containing information on:

(a) the technical characteristics of the lifting machinery or related product, and in particular:

(i) the maximum working load and, where appropriate, a copy of the load plate or load
table described in the second paragraph of section 4.3.3;

(ii) the reactions at the supports or anchors and, where appropriate, characteristics of the
tracks;

(iii)where appropriate, the definition and the means of installation of the ballast;

(b) the contents of the logbook, if the latter is not supplied with the lifting machinery;

(c) advice for use, particularly to offset the lack of direct vision of the load by the operator;

(d) where appropriate, a test report detailing the static and dynamic tests carried out by or
for the manu facturer;

(e) for lifting machinery or related products, which are not assembled on the premises of the
manufacturer in the form in which they are to be used, the necessary instructions for
performing the measures referred to in section 4.1.3 before they are first put into
service.

5. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR MACHINERY OR RELATED

PRODUCTS INTENDED FOR UNDERGROUND WORK

Machinery or related products intended for underground work shall meet all the essential
health and safety requirements set out in this chapter (see General Principles, point 4).

5.1. Risks due to lack of stability

Powered roof supports shall be designed and constructed in such a way as to maintain a given
direction when moving and not slip before and while they come under load and after the
load has been removed. They shall be equipped with anchorages for the top plates of the
individual hydraulic props.

5.2. Movement
Powered roof supports shall allow for unhindered movement of persons.

5.3. Control devices

The accelerator and brake controls for movement of machinery running on rails shall be
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hand-operated. However, enabling devices may be foot-operated.
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The control devices of powered roof supports shall be designed and positioned in such a
way that, during displacement operations, operators are sheltered by a support in place. The
control devices shall be protected against any accidental release.

5.4. Stopping
Self-propelled machinery running on rails for use in underground work shall be equipped
with an enabling device acting on the circuit controlling the movement of the machinery
such that movement is stopped if the driver is no longer in control of the movement.

5.5. Fire
Section 3.5.2 (b) is mandatory in respect of machinery or related products, which
comprises highly flammable parts.

The braking system of machinery or related products intended for use in underground
workings shall be designed and constructed in such a way that it does not produce sparks
or cause fires.

Machinery or related products with internal combustion engines for use in underground
workings shall be fitted only with engines using fuel with a low vaporising pressure and
which exclude any spark of electrical origin.

5.6. Exhaust emissions

Exhaust emissions from internal combustion engines shall not be discharged upwards.

6. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR MACHINERY OR RELATED

PRODUCTS PRESENTING PARTICULAR RISKS DUE TO THE LIFTING OF PERSONS

Machinery or related products presenting particular risks due to the lifting of persons shall
meet all the relevant essential health and safety requirements set out in this chapter (see
General Principles, point 4).

6.1. General

6.1.1. Mechanical strength

The carrier, including any trapdoors, shall be designed and constructed in such a way as to
offer the space and strength corresponding to the maximum number of persons permitted
on the carrier and the maximum working load.

The working coefficients for components set out in sections [Link] and [Link] are
inadequate for machinery or related products intended for the lifting of persons and shall,
as a general rule, be doubled. Machinery or related products intended for lifting persons or
persons and goods shall be fitted with a suspension or supporting system for the carrier
designed and constructed in such a way as to ensure an adequate overall level of safety
and to prevent the risk of the carrier falling.

If ropes or chains are used to suspend the carrier, as a general rule, at least two
independent ropes or chains are required, each with its own anchorage.

6.1.2. Loading control for machinery or related products moved by power other than human strength
The requirements of section 4.2.2 apply regardless of the maximum working load and
overturning moment, unless the manufacturer can demonstrate that there is no risk of
overloading or overturning.

6.2. Control devices

Where safety requirements do not impose other solutions, the carrier shall, as a general rule, be
designed and constructed in such a way that persons in the carrier have means of
controlling upward and downward movements and, if appropriate, other movements of the
carrier.
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In operation, those control devices shall override any other devices controlling the same
movement with the exception of emergency stop devices.
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The control devices for the movements referred to in the first paragraph shall be of the
hold-to-run type except where the carrier is completely enclosed. If there is no risk of
persons or objects on the carrier colliding or falling and no other risks due to the upward
and downward movements of the carrier, control devices authorising automatic stops at
preselected positions may be used instead of hold-to-run type control devices.

6.3. Risks to persons in or on the carrier

6.3.1. Risks due to movements of the carrier

Machinery or related products for lifting persons shall be designed, constructed or
equipped in such a way that the acceleration or deceleration of the carrier does not
engender risks for persons.

6.3.2. Risk of persons falling from the carrier

The carrier shall not tilt to an extent, which creates a risk of the occupants falling,
including when the machinery or related product and carrier are moving.

Where the carrier is designed as a workstation, provision shall be made to ensure stability
and to prevent hazardous movements.

If the measures referred to in section 1.5.15 are not adequate, carriers shall be fitted with a
sufficient number of suitable anchorage points for the number of persons permitted on the
carrier. The anchorage points shall be strong enough for the use of personal protective
equipment against falls from a height.

Any trapdoor in floors or ceilings or side doors shall be designed and constructed in such a
way as to prevent inadvertent opening and shall open in a direction that obviates any risk
of falling, should they open unexpectedly.

6.3.3. Risk due to objects falling on the carrier

Where there is a risk of objects falling on the carrier and endangering persons, the carrier
shall be equipped with a protective roof.

6.4. Machinery or related products serving fixed landings

6.4.1. Risks to persons in or on the carrier

The carrier shall be designed and constructed in such a way as to prevent risks due to
contact between persons and/or objects in or on the carrier with any fixed or moving
elements. Where necessary in order to fulfil this requirement, the carrier itself shall be
completely enclosed with doors fitted with an interlocking device that prevents hazardous
movements of the carrier unless the doors are closed. The doors shall remain closed if the
carrier stops between landings where there is a risk of falling from the carrier.

Machinery or related products shall be designed, constructed and, where necessary, equipped
with devices in such a way as to prevent uncontrolled upward or downward movement of the
carrier. These devices shall be able to stop the carrier at its maximum working load and at
the foreseeable maximum speed.

The stopping action shall not cause deceleration harmful to the occupants, whatever the
load conditions.

6.4.2. Controls at landings

Controls, other than those for emergency use, at landings shall not initiate movements of the
carrier when:
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(a) the control devices in the carrier are being operated;

(b) the carrier is not at a landing.

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6.4.3. Access to the carrier

The guards at the landings and on the carrier shall be designed and constructed in such a
way as to ensure safe transfer to and from the carrier, taking into consideration the
foreseeable range of goods and persons to be lifted.

6.5. Markings
The carrier shall bear the information necessary to ensure safety including:

(a) the number of persons permitted on the carrier;

(b) the maximum working load.

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ANNEX IV

Technical documentation

PART A

Technical documentation for machinery and related products

The technical documentation shall specify the means used by the manufacturer to ensure the
conformity of the machinery or related product with the applicable essential health and safety
requirements set out in Annex III.

The technical documentation shall include at least the following elements:

(a) a complete description of the machinery or related product and of its intended use;

(b) the documentation on risk assessment demonstrating the procedure carried out, including:

(i) a list of the essential health and safety requirements that are applicable to the machinery or
related product;

(ii)the description of the protective measures implemented to meet each applicable essential
health and safety requirement and, when appropriate, the indication of the residual risks
associated with the machinery or related product;

(c) design and manufacturing drawings and schemes of the machinery or related product and of its
components, sub- assemblies and circuits;

(d) the descriptions and explanations necessary for the understanding of the drawings and schemes
referred to in point (c) and of the operation of the machinery or related product;

(e) the references of the harmonised standards referred to in Article 20(1) or common specifications
adopted by the
Commission in accordance with Article 20(3) that have been applied for the design and
manufacture of the
machinery or related product. In the event of partial application of harmonised standards or
common specifi cations, the documentation shall specify the parts, which have been applied;

(f) where harmonised standards or common specifications have not been applied or have been only
partially applied, descriptions of the other technical specifications that have been applied in order
to meet each applicable essential health and safety requirement;

(g) reports and/or results of the design calculations, tests, inspections and examinations carried out
to verify the conformity of the machinery or related product with the applicable essential health
and safety requirements;

(h) a description of the means used by the manufacturer during the production of the machinery or
related product to ensure the conformity of the machinery or related product produced with the
design specifications;

(i) a copy of the instructions for use and the information set out in section 1.7.4 of Annex III;
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(j) where appropriate, the EU declaration of incorporation for partly completed machinery set out in
Annex V, Part B, and the assembly instructions set out in Annex XI;
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(k) where appropriate, copies of the EU declarations of conformity of machinery or related

products as well as any product covered by other Union harmonisation legislation incorporated
into the machinery or related product;

(l) for machinery or related products produced in series, the internal measures that will be implemented
to ensure that the machinery or related product remains in conformity with this Regulation;

(m)the source code or programming logic of the safety related software to demonstrate the
conformity of the machinery or related product with this Regulation further to a reasoned
request from a competent national authority provided that is necessary in order for those
authorities to be able to check compliance with the essential health and safety requirements set
out in Annex III;

(n) for sensor-fed, remotely-driven, or autonomous machinery or related products, if the safety related
operations are controlled by sensor data, a description, where appropriate, of the general
characteristics, capabilities and limitations of the system, data, development, testing and
validation processes used;

(o) the results of research and tests on components, fittings or the machinery or related product
carried out by the manufacturer to determine whether by its design or construction it is capable
of being assembled and put into service safely.

PART B

Technical documentation for partly completed machinery

The technical documentation shall specify the means used by the manufacturer to ensure the
conformity of the partly completed machinery with the relevant essential health and safety
requirements set out in Annex III.

The technical documentation shall include at least the following elements:

(a) a complete description of the partly completed machinery and of its intended function when
incorporated into or assembled with machinery or other partly completed machinery or
equipment;

(b) the risk assessment documentation showing the procedure carried out, including:

(i) a list of the essential health and safety requirements which apply to the partly completed
machinery;

(ii)the description of the protective measures implemented to eliminate identified hazards or to

reduce risks and, where appropriate, the indication of the residual risks;

(c) design and manufacturing drawings and schemes of the partly completed machinery and of its
components, sub- assemblies and circuits;
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(d) the descriptions and explanations necessary for the understanding of the drawings and schemes
referred to in point (c) and of the operation of the partly completed machinery;
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(e) the references of the harmonised standards referred to in Article 20(1) or common specifications
adopted by the Commission in accordance with Article 20(3) that have been applied for the
design and manufacture of the partly completed machinery. In the event of partial application of
harmonised standards or common specifications, the documentation shall specify the parts,
which have been applied;

(f) where harmonised standards or common specifications have not been applied or have been only
partially applied, descriptions of the other technical specifications that have been applied in order
to meet each applicable essential health and safety requirement;

(g) reports and/or results of the design calculations, tests, inspections and examinations carried out
to verify the conformity of the partly completed machinery with the applicable essential health
and safety requirements;

(h) a description of the means used by the manufacturer during the production of the partly
completed machinery to ensure the conformity of the partly completed machinery produced
with the design specifications;

(i) a copy of the assembly instructions for the partly completed machinery set out in Annex XI;

(j) for partly completed machinery produced in series, the internal measures that will be
implemented to ensure that the partly completed machinery remains in conformity with the
essential health and safety requirements applied;

(k) the source code or programming logic of the safety related software upon a reasoned request
from a competent national authority, provided that is necessary in order for those authorities to be
able to check compliance with the essential health and safety requirements set out in Annex III;

(l) for sensor-fed, remotely-driven, or autonomous partly completed machinery, if the safety related
operations are controlled by sensor data, a description, where appropriate, of the general
characteristics, capabilities and limitations of the system, data, development, testing and
validation processes used;

(m)the results of research and tests on components, fittings or the partly completed machinery
carried out by the manufacturer to determine whether by its design or construction it is capable of
being assembled and incorporated safely.
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ANNEX V

EU DECLARATION OF CONFORMITY AND EU DECLARATION OF INCORPORATION

PART A

EU declaration of conformity of machinery and related products No … (1)

The EU declaration of conformity shall contain the following particulars:

1. The machinery or related product (product, type, model, batch or serial number) or
substantially modified machinery or related product.

2. Name and address of the manufacturer and, where applicable, its authorised representative.

3. For lifting machinery which is intended to be permanently installed in a building or a structure

and which cannot be assembled in the manufacturer’s premises but can only be assembled at
the place of use, the address of that place.

4. This declaration of conformity is issued under the sole responsibility of the manufacturer.

5. Object of the declaration (identification of the machinery or related product allowing traceability;
where necessary for the identification of the machinery or related product, a colour image of
sufficient clarity may be included).

6. The object of the declaration referred to in point 5 is in conformity with the following
Union harmonisation legislation.

7. References to the harmonised standards referred to in Article 20(1) or common specifications

adopted by the
Commission in accordance with Article 20(3) that were applied, including the date of the
publication of the
reference to harmonised standards in the Official Journal of the European Union or of the common
specification, or references to the other technical specifications, including their date, in relation to
which conformity is declared. In the event of partial application of harmonised standards or
common specifications, the EU declaration of conformity shall specify the parts which were
applied.

8. Where applicable, the notified body … (name, number) … performed the EU type-examination
(Module B) and issued the EU type-examination certificate … (reference to that certificate), followed
by conformity to type based on internal production control (module C) or the conformity based
on unit verification (module G) or full quality assurance (module H).

9. Where applicable, the machinery or related product is subject to the conformity assessment
procedure based on internal production control (Module A).

10. Additional information:

Signed for and on behalf of: …

(place and date of issue):

(name, function) (signature):

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(1) It is optional for the manufacturer to assign a number to the declaration of conformity.
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PART B

EU declaration of incorporation of partly completed machinery No … (2)

The declaration of incorporation shall contain the following particulars:

1. The partly completed machinery (product, type, model batch or serial number).

2. Name and address of the manufacturer and, where applicable, its authorised representative.

3. This declaration of incorporation is issued under the sole responsibility of the manufacturer.

4. Object of the declaration (identification of partly completed machinery allowing traceability; where
necessary for the identification of the partly completed machinery, a colour image of sufficient
clarity may be included).

5. A sentence declaring which essential health and safety requirements

Anne
III of Regulation
set out in
x (EU)
2023/1230 of the European Parliament and of the Council (3) are applied and fulfilled and
that the relevant technical documentation was drawn-up in accordance with Annex IV, Part B,
and, where appropriate, a sentence declaring the conformity of the partly completed machinery
with other relevant Union harmonisation legislation.

6. References to the harmonised standards referred to in Article 20(1) or common specifications

adopted by the
Commission in accordance with Article 20(3) that were applied, including the date of the
standard or of the
common specification, or references to the other technical specifications, including their date, in
relation to which conformity is declared. In the event of partial application of harmonised standards
or common specifications, the EU declaration of incorporation shall specify the parts which were
applied.

7. An undertaking to transmit, in response to a reasoned request by the national authorities,

relevant information on the partly completed machinery. This shall include the method of
transmission and shall be without prejudice to the intellectual property rights of the manufacturer
of the partly completed machinery.

8. A statement that the partly completed machinery shall not be put into service until the final
machinery into which it is to be incorporated has been declared in conformity with this
Regulation.

9. Additional information:

Signed for and on behalf of: …

(place and date of issue):

(name, function) (signature):

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(2) It is optional to assign a number to the declaration of conformity.

(3) Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery
and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive
73/361/EEC (OJ L 165, 29.6.2023, p. 1).
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ANNEX VI

INTERNAL PRODUCTION CONTROL

(Module A)

1. Internal production control is the conformity assessment procedure whereby the manufacturer
fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on its sole
responsibility that the machinery or related product concerned satisfies the applicable
requirements of this Regulation.

2. Technical documentation
The manufacturer shall draw up the technical documentation described in Annex IV, Part A.

3. Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its
monitoring ensure compliance of the manufactured machinery or related products with the
technical documentation referred to in point 2 and with the applicable requirements of this
Regulation.

4. CE marking and EU declaration of conformity

[Link] manufacturer shall affix the CE marking to machinery or related products, individually, that
satisfies the applicable requirements of this Regulation.

[Link] manufacturer shall draw up an EU declaration of conformity for each machinery or related
product model in accordance with Article 21 and keep it, together with the technical
documentation, at the disposal of the national authorities for at least 10 years after the
machinery or related product has been placed on the market or put into service. The EU
declaration of conformity shall identify the machinery or related product model for which it
has been drawn up.

A copy of the EU declaration of conformity shall be made available to the relevant authorities
upon request.

5. Authorised representative
The manufacturer’s obligations set out in point 4 may be fulfilled by its authorised representative, on
its behalf and under its responsibility, provided that they are specified in the mandate.
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ANNEX VII

EU TYPE-EXAMINATION

(Module B)

1. EU type-examination is the part of a conformity assessment procedure in which a notified body

examines the technical design of machinery or a related product and verifies and attests that
the technical design of the machinery or related product meets the applicable requirements of
this Regulation.

2. EU type-examination shall be carried out by assessment of the adequacy of the technical design of
the machinery or related product through examination of the technical documentation, plus
examination of a specimen of the machinery or related product that is representative of the
production envisaged (production type).

3. Application for EU type-examination

The manufacturer shall lodge an application for EU type-examination with a single notified body
of its choice.

The application shall include:

(a) the name and address of the manufacturer and, if the application is lodged by an authorised
representative, the name and address of that authorised representative;

(b) a written declaration that the same application has not been lodged with any other notified
body;

(c) the technical documentation described in Annex IV, Part A;

(d) the access to the specimen(s) of the machinery or related product representative of the
production envisaged. The notified body may request further specimens if needed for carrying
out the test programme. For machinery or related products produced in series where each item
is adapted to fit an individual user, specimens shall be provided that are representative of the
range of different users, while for machinery or related products produced as a single unit to
accommodate the special needs of an individual user, a basic model shall be provided.

4. EU type-

examination The

notified body shall:

(a) examine the technical documentation to assess the adequacy of the technical design of the
machinery or related product. In conducting such an examination, Annex IV, Part A, second
subparagraph, points (h) and (l), need not be taken into account;

(b) for machinery or related products produced in series where each item is adapted to fit an
individual user, examine the description of the measures to assess their adequacy;
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(c) verify that the specimen(s) have been manufactured in conformity with the technical
documentation, and identify the elements that have been designed in accordance with the
applicable provisions of the relevant harmonised standards or common specifications adopted
by the Commission in accordance with Article 20(3), as well as the elements that have been
designed in accordance with other technical specifications;
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(d) carry out appropriate examinations and tests, or have them carried out, to check whether,
where the manu facturer has chosen to apply the solutions in the relevant harmonised
standards, or common specifications adopted by the Commission in accordance with Article
20(3), those have been applied correctly;

(e) carry out appropriate examinations and tests, or have them carried out, to check whether,
where the solutions in the relevant harmonised standards or common specifications adopted by
the Commission in accordance with Article 20(3) have not been applied, the solutions adopted
by the manufacturer, including those in other technical specifications applied, meet the
corresponding essential health and safety requirements and have been applied correctly.

5. Evaluation report

The notified body shall draw up an evaluation report that records the activities undertaken in
accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à-vis the
notifying authorities, the notified body shall release the content of that report, in full or in
part, only with the agreement of the manufacturer.

6. EU type-examination certificate

[Link] the type meets the applicable essential health and safety requirements, the notified body
shall issue an EU type-examination certificate to the manufacturer.

The period of validity of a newly issued certificate and, where appropriate, of a renewed certificate
shall not exceed five years.

[Link] EU type-examination certificate shall contain at least the following information:

(a) the name and identification number of the notified body;

(b) the name and address of the manufacturer and, if the application is lodged by an authorised
representative, the name and address of that authorised representative;

(c) an identification of the machinery or related product covered by the certificate (type number);

(d) a statement that the machinery or related product type complies with the applicable essential
health and safety requirements;

(e) where harmonised standards or common specifications adopted by the Commission in

accordance with Article 20(3) have been fully or partially applied, the references of those
standards or common specifications or parts thereof;

(f) where other technical specifications have been applied, the references of those technical
specifications;

(g) the date of issue, the date of expiry and, where appropriate, the date(s) of renewal;
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(h) any conditions attached to the issuing of the certificate.
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[Link] EU type-examination certificate may have one or more annexes attached.

[Link] the type does not satisfy the applicable essential health and safety requirements, the
notified body shall refuse to issue an EU type-examination certificate and shall inform the
applicant accordingly, giving detailed reasons for its refusal.

7. Review of the EU type-examination certificate

[Link] notified body shall keep itself apprised of any changes in the generally acknowledged state
of the art, which indicate that the approved type may no longer comply with the applicable essential
health and safety requirements, and shall determine whether such changes require further
investigation. If so, the notified body shall inform the manufacturer accordingly.

[Link] manufacturer shall inform the notified body that holds the technical documentation
relating to the EU type- examination certificate of all modifications to the approved type and
of all modifications to the technical docu mentation that may affect the conformity of the
machinery or related product with the applicable essential health and safety requirements or the
conditions for validity of that certificate. Such modifications shall require additional approval in the
form of an addition to the original EU type-examination certificate.

[Link] manufacturer shall ensure that the machinery or related product continues to fulfil the
applicable essential health and safety requirements in light of the state of the art.

[Link] manufacturer shall ask the notified body to review the EU type-examination certificate either:

(a) in the case of a modification to the approved type referred to in point 7.2;

(b) in the case of a change in the state of the art referred to in point 7.3;

(c) at the latest, before the date of expiry of the certificate.

In the case referred to in point (c), the review may lead to a renewal of the EU type-examination
certificate only when the application is submitted by the manufacturer at the earliest 12 months
and at the latest 6 months prior to the expiry date of the EU type-examination certificate.
Where the manufacturer fails to comply with the deadlines mentioned above, the review may
lead only to an approval in the form of an addition to the original EU type-examination certificate
and the expiry date of the certificate shall be that of the original certificate.

[Link] notified body shall examine the machinery or related product type and, where necessary in
the light of the changes made, carry out the relevant tests to ensure that the approved type
continues to fulfil the applicable essential health and safety requirements. If the notified body is
satisfied that the approved type continues to fulfil the applicable essential health and safety
requirements, it shall renew the EU type-examination certificate or issue an addition to the
original EU type-examination certificate. The notified body shall ensure that the review
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procedure is finalised before the expiry date of the EU type-examination certificate.
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[Link] the conditions referred to in points (a) and (b) of point 7.4 are not met, a simplified review
procedure shall apply. The manufacturer shall supply the notified body with the following:

(a) its name and address and data identifying the EU type-examination certificate concerned;

(b) confirmation that there has been no modification to the approved type as referred to in point
7.2, including materials, sub-components or sub-assemblies, nor to the relevant harmonised
standards or common specifi cations adopted by the Commission in accordance with Article
20(3) or other technical specifications applied;

(c) confirmation that there has been no change in the state of the art as referred to in point 7.3;
and

(d) where not already supplied, copies of current product drawings and photographs,
product marking and information;

Where the notified body has confirmed that no modification to the approved type referred to in
point 7.2 and no change in the state of the art referred to in point 7.3 has occurred, the
simplified review procedure shall be applied and the examinations and tests referred to in point
7.5 shall not be carried out. In that case, the notified body shall renew the EU type-examination
certificate.

The costs associated with that renewal shall be proportionate to the administrative burden of
the simplified procedure.

If the notified body finds that a change in the state of the art referred to in point 7.3 has
occurred, the procedure set out in point 7.5 shall apply.

[Link], following the review, the notified body concludes that the EU type-examination certificate is no
longer valid, the body shall withdraw it and the manufacturer shall cease the placing on the
market of the machinery or related product concerned.

8. Each notified body shall inform its notifying authority concerning the EU type-examination
certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically
or upon request, make available to its notifying authority the list of such certificates and/or any
additions thereto refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies concerning the EU type-examination
certificates and/or any additions thereto, which it has refused, withdrawn, suspended or
otherwise restricted, and, upon request, concerning the EU type-examination certificates and/or
additions thereto which it has issued.

The Commission, the Member States and the other notified bodies may, on request, obtain a
copy of the EU type- examination certificates and/or additions thereto. On request, the Commission
and the Member States may obtain a copy of the technical documentation and the results of the
examinations carried out by the notified body.

The notified body shall keep a copy of the EU type-examination certificate, its annexes and additions,
as well as the technical file including the documentation submitted by the manufacturer, for a period
of five years after the expiry of the validity of that certificate.

9. The manufacturer shall keep a copy of the EU type-examination certificate, its annexes and
additions, together with the technical documentation at the disposal of the national authorities,
for at least 10 years after the machinery or related product has been placed on the market or
put into service.

10. The manufacturer’s authorised representative may lodge the application referred to in point 3
and fulfil the obligations set out in points 7.2, 7.4 and 9, provided that they are specified in
the mandate.
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ANNEX VIII

CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL

(Module C)

1. Conformity to type based on internal production control is the part of a conformity assessment
procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 3, and
ensures and declares under its sole responsibility that the machinery or related product
concerned is in conformity with the type described in the EU type-examination certificate and
satisfies the applicable requirements of this Regulation.

2. Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its
monitoring ensure conformity of the manufactured machinery or related products with the type
described in the EU type-examination certificate and with the applicable requirements of this
Regulation.

3. CE marking and EU declaration of conformity

[Link] manufacturer shall affix the CE marking to all machinery or related products that are in
conformity with the type described in the EU type-examination certificate and satisfy the
applicable requirements of this Regulation.

[Link] manufacturer shall draw up an EU declaration of conformity for a machinery or related

product model and keep it at the disposal of the national authorities for at least 10 years after
the machinery or related product has been placed on the market or put into service. The EU
declaration of conformity shall identify the machinery or related product for which it has been
drawn up.

A copy of the EU declaration of conformity shall be made available to the relevant authorities
upon request.

4. Authorised representative
The manufacturer’s obligations set out in point 3 may be fulfilled by its authorised representative, on
its behalf and under its responsibility, provided that they are specified in the mandate.
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ANNEX IX

CONFORMITY BASED ON FULL QUALITY ASSURANCE

(Module H)

1. Conformity based on full quality assurance is the conformity assessment procedure whereby
the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares
on its sole responsibility that the machinery or related product concerned satisfies the
requirements of this Regulation that apply to it.

2. Manufacturing

The manufacturer shall operate an approved quality system for design, manufacture and final
product inspection and testing of the machinery or related products concerned as specified in
point 3 and shall be subject to surveillance as specified in point 4.

3. Quality system

3.1. The manufacturer shall lodge an application for assessment of its quality system with the
notified body of its choice, for the machinery or related products concerned.

The application shall include:

(a) the name and address of the manufacturer and, if the application is lodged by an authorised
representative, the name and address of that authorised representative;

(b) the technical documentation described in Annex IV, Part A, points (a) to (g), (i) to (k) and (m)
to (o) for one model of each category of machinery or related products intended to be
manufactured.

(c) the documentation concerning the quality system; and

(d) a written declaration that the same application has not been lodged with any other notified
body.

3.2. The quality system shall ensure compliance of the machinery or related products with the
requirements of this Regulation that apply to them.

All the elements, requirements and provisions adopted by the manufacturer shall be
documented in a systematic and orderly manner in the form of written policies, procedures and
instructions. That quality system documen tation shall permit a consistent interpretation of the
quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of:

(a) the quality objectives and the organisational structure, responsibilities and powers of the
management with regard to design and product quality;

(b) the technical design specifications, including standards, that will be applied and, where the
relevant harmonised standards or common specifications adopted by the Commission in
accordance with Article 20(3) will not be applied in full, the means, including other technical
specifications, that will be used to ensure that the essential health and safety requirements of
this Regulation that apply to the machinery or related product will be met;

(c) the design control and design verification techniques, processes and systematic actions that will
be used when designing the machinery or related product;

(d) the corresponding manufacturing, quality control and quality assurance techniques, processes
and systematic actions that will be used;
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(e) the examinations and tests that will be carried out before, during and after manufacture and the
frequency with which they will be carried out;
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(f) the quality records, such as inspection reports and test data, calibration data, qualification
reports on the personnel concerned, etc.;

(g) the means of monitoring the achievement of the required design and product quality
and the effective operation of the quality system.

3.3. The notified body shall assess the quality system to determine whether it satisfies the
requirements referred to in point 3.2.

It shall presume conformity with those requirements in respect of the elements of the quality
system that comply with the corresponding specifications of the relevant harmonised standard.

In addition to experience in quality management systems, the auditing team shall have at least
one member experienced as an assessor in the relevant machinery or related product field and
technology concerned, and with knowledge of the applicable essential health and safety
requirements set out in Annex III. The audit shall include an assessment visit to the
manufacturer’s premises. The auditing team shall review the technical documentation referred
to in point 3.1(b), to verify the manufacturer’s ability to identify the applicable essential health and
safety requirements set out in Annex III and to carry out the necessary examinations with a view to
ensuring compliance of the machinery or related product with those requirements.

The manufacturer or its authorised representative shall be notified of the decision.

The notification shall contain the conclusions of the audit and the reasoned assessment decision.

3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as
approved and to maintain it so that it remains adequate and efficient.

3.5. The manufacturer shall keep the notified body that has approved the quality system informed
of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether the modified quality
system will continue to satisfy the requirements referred to in point 3.2 or whether a
reassessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of
the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body

4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations
arising out of the approved quality system.

4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the design,
manufacture, inspection, testing and storage sites, and shall provide that body with all
necessary information, in particular:

(a) the quality system documentation;

(b) the quality records as provided for by the design part of the quality system, such as
results of analyses, calculations, tests, etc.;

(c) the quality records as provided for by the manufacturing part of the quality system, such as
inspection reports and test data, calibration data, qualification reports on the personnel
concerned, etc.

4.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains
and applies the quality system and shall provide the manufacturer with an audit report.

4.4. In addition, the notified body may pay unexpected visits to the manufacturer. During such visits, the
notified body may, if necessary, carry out product tests, or have them carried out, in order to
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check the proper functioning of the quality system. It shall provide the manufacturer with a
visit report and, if tests have been carried out, with a test report.
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5. CE marking and EU declaration of conformity

5.1. The manufacturer shall affix the required CE marking set out in this Regulation, and, under the
responsibility of the notified body referred to in point 3.1, the latter’s identification number to each
individual product that satisfies the applicable requirements of this Regulation.

5.2. The manufacturer shall draw up a written EU declaration of conformity for each machinery or
related product model and keep it at the disposal of the national authorities for at least 10
years after the machinery or related product has been placed on the market or put into service.
The EU declaration of conformity shall identify the machinery or related product model for
which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the relevant

authorities upon request.

6. The manufacturer shall, for at least 10 years after the machinery or related product has been placed
on the market or put into service, keep at the disposal of the national authorities:

(a) the technical documentation referred to in point 3.1(b);

(b) the documentation concerning the quality system referred to in point 3.1(c);

(c) the information relating to the change referred to in point 3.5, as approved;

(d) the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.

7. Each notified body shall inform its notifying authority of quality system approval decisions issued
or withdrawn, and shall, periodically or upon request, make available to its notifying authority the
list of quality system approval decisions refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approval decisions,
which it has refused, suspended or withdrawn, and, upon request, of quality system approval
decisions, which it has issued.

8. Authorised representative

The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by its authorised
representative, on its behalf and under its responsibility, provided that they are specified in
the mandate.
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ANNEX X

CONFORMITY BASED ON UNIT VERIFICATION

(Module G)

1. Conformity based on unit verification is the conformity assessment procedure whereby the
manufacturer fulfils the obligations laid down in points 2, 3 and 5, and ensures and declares on
its sole responsibility that the machinery or related product, which is subject to point 4, is in
conformity with the essential health and safety requirements set out in Annex III.

2. Technical documentation
The manufacturer shall establish the technical documentation and make it available to the notified
body referred to in point 4. The documentation shall make it possible to assess the machinery or
related product’s conformity with the relevant essential health and safety requirements set out in
Annex III, and shall include an adequate analysis and assessment of the risk(s). The technical
documentation shall specify the applicable essential health and safety requirements and
cover, as far as relevant for the assessment, the design, manufacture and operation of the
machinery or related product.

The technical documentation shall, wherever applicable, contain at least the following elements:

(a)the name and address of the manufacturer and, if the application is lodged by an authorised
representative, the name and address of that authorised representative;

(b)the technical documentation for the unit of machinery or related products intended to be
manufactured.

In addition, the technical documentation shall, wherever applicable, contain at least:

(i) the elements set out in points (a) to (g) of Annex IV, Part A;

(ii) the documentation concerning the quality system; and

(iii)a written declaration that the same application has not been lodged with any other notified
body.

2.1. The manufacturer shall keep the technical documentation at the disposal of the relevant national
authorities for at least 10 years after the machinery or related product has been placed on
the market.

3. Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its
monitoring ensure conformity of the manufactured machinery or related product with the
applicable essential health and safety requirements set out in Annex III.

4. Verification
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests,
set out in the relevant harmonised standards and/or common specifications, or equivalent tests,
to check the conformity of the machinery or related product with the applicable essential health
and safety requirements set out in Annex III, or have them carried out. In the absence of such a
harmonised standard and/or common specification the notified body concerned shall decide on
the appropriate tests to be carried out.

The notified body shall issue a certificate in respect of the examinations and tests carried out
and shall affix its identification number to the approved machinery or related product, or have
it affixed under its responsibility.
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The manufacturer shall keep the certificates at the disposal of the national authorities for at least 10
years after the machinery or related product has been placed on the market.
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5. CE marking and EU declaration of conformity

5.1. The manufacturer shall affix the required CE marking set out in Article 10(2) and, under the
responsibility of the notified body referred to in point 4, that body’s identification number, to
the machinery or related product that satisfies the applicable essential health and safety
requirements set out in Annex III.

5.2. The manufacturer shall draw up a written EU declaration of conformity and keep it at the
disposal of the national authorities for at least 10 years after the machinery or related product
has been placed on the market or put into service. The EU declaration of conformity shall
identify the machinery or related product for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the relevant authorities
upon request.

6. Authorised representative
The manufacturer’s obligations set out in points 2.1 and 5 may be fulfilled by its authorised
representative, acting on its behalf and under its responsibility, provided that those obligations
are specified in the mandate.
L E Official Journal of the European 29.6.202
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ANNEX XI

ASSEMBLY INSTRUCTIONS FOR PARTLY COMPLETED MACHINERY

1. The assembly instructions for partly completed machinery shall contain a description of the
conditions, which are to be met to ensure that the partly completed machinery is correctly
incorporated in the machinery or other partly completed machinery or equipment, and that the
machinery or other partly completed machinery or equipment with the incorporated partly
completed machinery does not compromise the health and safety of persons and, where
appropriate, domestic animals and property, and, where applicable, of the environment.

2. The assembly instructions shall contain relevant information to be used in the instructions of
the machinery or other partly completed machinery or equipment, in which the partly completed
machinery is to be assembled. Each assembly instruction shall contain, where applicable, at least
the following information:

(a) a general description of the partly completed machinery;

(b) the drawings, diagrams, descriptions and explanations necessary for the incorporation into the
final machinery, maintenance and repair of the partly completed machinery and for
checking its correct functioning;

(c) warnings concerning the ways in which the partly completed machinery must not be used
that experience has shown might occur;

(d) assembly, installation and connection instructions, including drawings, diagrams and the means
of attachment and the designation of the chassis or installation on which the partly completed
machinery is to be mounted;

(e) information regarding noise or vibration which is likely to be reduced by the incorporation;

(f) information about the essential health and safety requirements set out in Annex III which are
applicable to the partly completed machinery;

(g) the essential characteristics of tools which may be fitted to the partly completed machinery;

(h) the conditions in which the partly completed machinery meets the requirement of stability,
transportation, assembly, dismantling when out of service, testing or foreseeable
breakdowns;

(i) instructions with a view to ensuring that transport, handling and storage operations can be made
safely, giving the mass of the partly completed machinery and of its various parts where these
are regularly to be transported separately;

(j) the operating method to be followed in the event of accident or breakdown; if a blockage is
likely to occur, the operating method to be followed so as to enable the equipment to be
safely unblocked;

(k) the description of the adjustment and maintenance operations that should be carried out by
the user and the preventive maintenance measures that should be observed taking account
of the design;
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(l) instructions designed to enable adjustment and maintenance to be carried out safely,
including the protective measures that should be taken during these operations;
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(m)the specifications of the spare parts to be used, when these affect the health and safety of
operators;

(n) a clear description of the version of the assembly instructions which corresponds to the
partly completed machinery model.

If the partly completed machinery is intended to be used in machinery covered by Annex III,
chapters 2 to 6, the assembly instructions must also contain relevant information to be used in
the instructions for use for these machinery.

3. The assembly instructions for partly completed machinery shall contain the EU declaration of
incorporation, or the internet address or machine readable code where the EU declaration of
incorporation can be accessed.
29.6.202 E Official Journal of the European L
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ANNEX XII

CORRELATION TABLE

Directive 2006/42/EC This Regulation

Articl 1 Articl 2
e e
Articl 2 Articl 3
e e
Articl 3 Articl 9
e e
Articl 4 (1) and (2) Articl 8
e e
Articl 4 (3) and (4) —
e
Articl 5 Article 10 and 11
e s
Articl 6 Articl 4
e e
Articl 7 Articl 20 (1)
e e
Articl 8 (1) Article 6 (1) and 7 (1)
e s
Articl 8 (2) —
e
Articl 9 —
e
Articl 10 Articl 44 (3)
e e
Articl 11 Article 43, 44 and 45
e s
Articl 12 Articl 25
e e
Articl 13 Articl 11
e e
Articl 14 (and Annex XI) Articl 26 to Article 42
e e
Articl 15 Articl 5
e e
Articl 16 Article 23 and 24
e s
Articl 17 Articl 46
e e
Articl 18 Articl 49
e e
Articl 19 —
e
Articl 20 —
e
Articl 21 Articl 53
e e
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Articl 21 a Articl 47
e e
Articl 22 Articl 48
e e
Articl 23 Articl 50
e e
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Directive 2006/42/EC This Regulation

Article 24 —

Article 25 Article 51

Article 26 —

Article 27 —

Article 28 Article 54 (first paragraph)

Article 29 Article 54 (second and third paragraphs)

Annex I - General principles and Section 1.1.1 Annex III – Part A (Definitions) and Part B
(Defini (General prin
tions) ciples)

Annex I, Sections 1.1.2 - 1.1.8. Annex III, Chapter 1

Annex I, Section 2 Annex III, Chapter 2

Annex I, Section 3 Annex III, Chapter 3

Annex I, Section 4 Annex III, Chapter 4

Annex I, Section 5 Annex III, Chapter 5

Annex I, Section 6 Annex III, Chapter 6

Annex II, Parts A and B Annex V, Parts A and B

Annex III —

Annex IV Annex I

Annex V Annex II

Annex VI Annex XI

Annex VII, Parts A and B Annex IV, Parts A and B

Annex VIII, when read in conjunction Annex VI

with Article 12 (3) (a)

Annex VIII (Point 3), when read in conjunction Annex VIII

with Article 12 (3) (b)

Annex IX Annex VII

Annex X Annex IX

Annex XI Article 30