Mars Petcare Safety Standard Book 6.7 CE-Marking & Doc. V1 - 0
Mars Petcare Safety Standard Book 6.7 CE-Marking & Doc. V1 - 0
Book 6
6.7 CE MARKING AND DOCUMENTATION
Version 1.0
Machine Safety Standard - Book 6.7
TABLE OF CONTENT
NOTE:
This part is one of a series of documents belonging to the Mars Machinery Safety Standard which includes altogether the following
parts:
6.1 OVERVIEW
6.2 RISK ASSESSMENT
6.3 MACHINE GUARDING REQUIREMENTS
6.4 SAFETY FUNCTIONS
6.5 CONTROL OF HAZARDOUS ENERGY
6.6 VALIDATION
6.7 CE-MARKING & DOCUMENTATION
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REVISIONS
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6.7.1. Scope
This section explains the main requirements of the health and safety laws which you need to know when you are buying new
machinery (for second-hand machinery, see question 9) to be put into service in the European Union (EU).
Therefore, a machine made outside of the EU but placed on the EU market shall comply with the EU rules regarding CE
marking.
The EU countries are: Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden and the UK.
By virtue of the Agreement on the European Economic Area (EEA) machinery that complies with the CE marking rules also
benefits from free movement in Iceland, Liechtenstein and Norway. The same is true in Switzerland by virtue of the mutual
recognition agreement with the EU and in Turkey in virtue of the EU-Turkey Customs Union.
Outside of the EU market, different countries could have different requirements (NEC, OSHA…) for machinery put into service
in such countries but the process given in this document remains valid.
6.7.2. Attendance
This section of the current Mars standard is intended for personnel responsible to purchase compliant new machinery in term of
safety in accordance with European directives.
6.7.3.1. General
Most new machinery should have CE marking when you buy it. However, CE marking is only a claim by the manufacturer
that the machinery is safe and that they have met relevant supply law. You, the user, also have to check that it is, in fact,
safe. To understand what this means when you are buying new machinery, it helps if you understand what the manufacturer
(or supplier) has to do.
(References: 2006/42/EC - Machinery Directive and 2009/104/EC - Use of Work Equipment by Workers at Work Use Directive)
A "European Harmonised Standard" is a standard that is in support of one or more European Directives as a practical method
of guaranteeing the high level of protection to workers that is intended by essential requirements (EHSR’s) of the Directives.
The use of standards is not mandatory although some European Directives make direct reference to them and therefore their
application becomes obligatory. There is always a presumption of conformity with the directives if a machine is built to the
appropriate Harmonised Standards.
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European Standards (or Euro Norms) are identified by the letters “EN”.
The communalisation of standards is taking place throughout the world and the European Union is working with international
standard authorities, such as ISO (the International Organization for Standardization) and the IEC, (the International
Electrotechnical Commission), to adopt a global approach to this policy. As such standard references such as EN ISO 12100
are entering the family of European Standards.
Standards for the safety of machinery in Europe fall into 3 basic categories:
Type A standards:
Fundamental safety standards, giving basic principles for design and general aspects for all machinery.
Type B standards:
Grouping more specific safety standards that may be applied across a range of machines and industries. B standards are further
subdivided:
• B1 standards detail the overriding safety aspects.
• B2 standards cover the actual safety devices.
Type C standards:
Machinery safety standards for specific types of machines or industry applications.
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The CEN has produced a number of type C standards which set out safety requirements for certain types or groups of food
industry machinery.
If there is a published standard relevant to a machine you are purchasing, this should be specified in the purchase contract.
See Appendix B where a list of type C standards for food and packaging process is reported.
The full updated list of applicable harmonized standards is published in the Official Journal of the European Union and is
available at the following website address:
https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en
Reminder: A 'CE' mark on a machine is a claim by the manufacturer that the machine complies with the Essential Health
and Safety Requirements (EHSRs) of the Machinery Directive (supply law), for example by complying with the relevant
harmonized standards that give the presumption of conformity.
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When you combine a series of complete machines and / or partly completed machines so they operate as a single
assembly line (i.e. under a single control system), you have to:
apply the CE mark
issue a Declaration of Conformity
produce / keep a technical file
This must be done for the complete assembly line as a whole, even if each individual machine has its own CE mark.
The technical file only needs to contain the design details and drawings of any control systems and other parts you've
had to supply or modify, and the Declarations of Conformity / Incorporation for each of the items in the line.
This can help you to decide which machine may be suitable, particularly if you are buying a standard machine 'off the shelf'.
If you are buying a more complex or custom-built machine you should discuss your requirements with potential suppliers. They
can often advise you on the options available.
For a custom-built machine, you can use the opportunity to work with the supplier to design out the causes of injury and ill
health. Some of the items you can cover are in checklist A. Time spent now on agreeing the necessary safeguards, to control
health and safety risks, could save time and money later and prevent safety related incidents due to a risk misidentification.
Requirements specified at Question 2 still apply here. Therefore, Question 2 and 3 are closely related.
Safety specifications should be written together with the supplier(s) on the basis of a Risk Assessment previously executed
with the same supplier(s)
Sometimes machinery is supplied via another organization, e.g. an importer, rather than direct from the manufacturer, so this
organization is referred to as the supplier.
When you place the order, specify in writing that the machine should be compliant to Machine Directive (and other if
any), to relevant standards and Mars internal standard as well.
However, if possible, the approach described in 6.7.3.5. should be preferred.
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Question 7: Do importers and suppliers have to follow these requirements if the machinery is made outside Europe?
All suppliers have to make sure the machinery they supply in the European Economic Area (EEA) is safe no matter where it
is made. The EEA includes the European Union member countries and also Iceland, Norway and Liechtenstein, but excludes
Switzerland even though that country is implementing the European Directive.
WARNING: If you are importing or constructing the machine yourself, you take on the responsibilities of the supplier.
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If a second-hand machine has been totally refurbished (for example, adding CNC control to a machine, together with other
work) it may have CE marking. This is because the way it operates is different after the refurbishment and as a result it has
been treated as if it was a new machine.
These all requirements apply also in the case of a Mars business unit outside the EEA is to transfer a machine to a Mars business
unit inside.
Question 10: What about machinery that will be part of an assembly line?
If a machine is designed to be incorporated into other machinery, it might not have CE marking fixed to it. It should be
manufactured to be as safe as possible and be provided with a Declaration of Incorporation Instructions on safe installation and
use should also be provided (see Appendix D).
When the machine is fitted into the assembly line, particular attention must be given to any hazards which may have been
caused by the machine being fitted into the line. For instance, additional guarding or other controls may be required (see also
note in Question 2)
Once the machine has been fitted and the whole line is safe, the technical file should be completed and either the machine or
the whole line should have CE marking. This can be done by a project manager (e.g. the installer, assembler or the manufacturer)
but in many cases you can do it according to article 12 of Machinery Directive (see
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These machines have specific regulations and/or European directives and/or harmonised standard.
For instance: Steam Boiler, tanks and pressure vessel must comply with 2014/68/EU - Pressure Equipment Directive and
relevant harmonized standards published in the Official Journal of European Union as e.g. EN ISO 4126-1:2013 Safety devices
for protection against excessive pressure - Part 1: Safety valves
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6.7.3.4. Checklists
Tell the supplier where the machine will be used, what you want to use it for and who will be using it, relevant corporate
standards, particularly if it is a complex or custom-built machine. Ask the supplier the following:
□ What health and safety risks might there be when using the machine?
□ Are there any dangerous parts and what guards will be provided?
□ Will it need emergency stop controls and how will it be isolated?
□ How do the controls and control systems work?
□ Will dust or fumes, etc. be produced by the machine? If these are likely to be in significant quantities, can an existing
extraction system be adapted to cope with the new machine or will you have to buy a new system?
□ Has the machinery been designed to minimize the noise and vibration levels produced?
□ Are there any extremely hot or very cold parts of the machine, and can they be insulated or protected?
□ Are there any lasers or thickness gauges, and can any exposure to radiation be eliminated? If not, what
precautions are there to stop any exposure to radiation?
□ What has been done to eliminate the risk of electric shock particularly during maintenance work, when
covers or control panel doors may be open?
□ Will the supplier conform to relevant Company standards (or parts of), such as the Asset Conservation Manual,
Machinery Safeguarding and Control of Hazardous Energy, etc.?
□ Are there possible risks from other sources of energy such as hydraulic or pneumatic?
□ Is there clear information about installation, maintenance, and breakdown procedures?
□ Will you inform me if problems arise with similar machines bought by other users?
In addition it is good practice for the supplier or manufacturer to have a service back-up or help line, so that you can get further
information as you need it. You could check what is in place before buying.
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□ Check that it has CE marking (where necessary) and ask for a copy of the EC Declaration of Conformity if you have
not been given one.
□ Check that the supplier has explained what the machinery is designed to be used for and what it cannot be used for
(unless this is off-the-shelf machinery).
□ Make sure a manual has been supplied which includes instructions for safe use, assembly, installation,
commissioning, safe handling, adjustment and maintenance.
□ Make sure the instruction manual is written in your language. (The maintenance instructions may however be written
in another language if specialized staff from the manufacturer or supplier will carry out maintenance.)
□ Make sure information has been provided about any remaining risks from the machine, and the precautions you need
to take to deal with them. These may include electrical, hydraulic, pneumatic, stored energy, thermal, radiation, dust,
fumes or health hazards.
□ Check that data about noise and vibration levels have been provided and, where necessary, explained to you.
□ Ensure that any warning signs are visible and easy to understand.
□ For a complex or custom-built machine arrange for a trial run so you can be shown the safety features and how they
work.
Remember:
By affixing the CE mark, the manufacturer is claiming that the machinery complies with the law but this should be
dubious sometimes. CE marking in itself does not guarantee safety. You still need to check the machine is safe for
use on your site, before it is used.
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By European legislation, the manufacturer is not obligated to deliver elements of the technical file related to the machinery to
you.
It is mandatory for the machine builder to give you the instruction manual, the declaration of conformity and to place a CE mark
on the machine. In case of partly completed machinery, the assembly instructions and the declaration of incorporation.
However, in order to be help you in checking the conformity of the machinery and check if the relevant directive(s) and related
standards (which shall be mentioned on the declaration of conformity) are properly applied, it is recommended, you request
expressly during negotiations the following additional documentation:
- a), b), c), should be delivered immediately after design and before construction.
-When construction is ended, d) should be delivered to you by the manufacturer before equipment shipment.
Another best practice, if possible, should be to check this documentation directly on manufacturer’s site during specific visits
after each step or at least before shipment to be sure to introduce a safe and compliant machinery in Mars production site.
These checks should be done and documented by Mars personnel or safety specialist third part charged by Mars.
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EU Legislation References
REFERENCE TITLE
2006/42/EC Machinery Directive
2009/104/EC Use of Work Equipment by Workers at Work Directive
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EN 415-3:1999+A1:2009 Safety of packaging machines - Part 3: Form, fill and seal machines
EN 415-4:1998 Safety of packaging machines - Part 4: Palletizers and depalletizers
EN 415-5:2006+A1:2009 Safety of packaging machines - Part 5: Wrapping machines
EN 415-6:2013 Safety of packaging machines - Part 6: Pallet wrapping machines
EN 415-7:2006+A1:2009 Safety of packaging machines - Part 7: Group and secondary packaging machines
EN 415-8:2008 Safety of packaging machines - Part 8: Strapping machines
EN 415-10:2014 Safety of packaging machines - Part 10: General Requirements
EN 15166:2008 Food processing machinery - Automatic back splitting machines of butchery carcasses - Safety and hygiene
requirements
EN 453:2000+A1:2009 Food processing machinery - Dough mixers - Safety and hygiene requirements
EN 454:2000+A1:2009 Food processing machinery - Planetary mixers - Safety and hygiene requirements
EN 1672-2:2005+A1:2009 Food processing machinery - Basic concepts - Part 2: Hygiene requirements
EN 1673:2000+A1:2009 Food processing machinery - Rotary rack ovens - Safety and hygiene requirements
EN 1974:1998+A1:2009 Food processing machinery - Slicing machines - Safety and hygiene requirements
EN 12041:2000+A1:2009 Food processing machinery - Moulders - Safety and hygiene requirements
EN 12042:2005+A1:2010 Food processing machinery - Automatic dividers - Safety and hygiene requirements
EN 12043:2000+A1:2010 Food processing machinery - Intermediate provers - Safety and hygiene requirements
EN 12267:2003+A1:2010 Food processing machinery - Circular saw machines - Safety and hygiene requirements
EN 12268:2003+A1:2010 Food processing machinery - Band saw machines - Safety and hygiene requirements
EN 12331:2003+A2:2010 Food processing machinery - Mincing machines - Safety and hygiene requirements
EN 12463:2004+A1:2011 Food processing machinery - Filling machines and auxiliary machines - Safety and hygiene requirements
EN 12505:2000+A1:2009 Food processing machinery - Centrifugal machines for processing edible oils and fats - Safety and hygiene
requirements
EN 12852:2001+A1:2010 Food processing machinery - Food processors and blenders - Safety and hygiene requirements
EN 12854:2003+A1:2010 Food processing machinery - Beam mixers - Safety and hygiene requirements
EN 12855:2003+A1:2010 Food processing machinery - Rotating bowl cutters - Safety and hygiene requirements
EN 13570:2005+A1:2010 Food processing machinery - Mixing machines - Safety and hygiene requirements
EN 13870:2005+A1:2010 Food processing machinery - Chop cutting machines - Safety and hygiene requirements
EN 13871:2005+A1:2010 Food processing machinery - Cubes cutting machinery - Safety and hygiene requirements
EN 13885:2005+A1:2010 Food processing machinery - Clipping machines - Safety and hygiene requirements
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Declaration of Conformity
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Article 12
1. The manufacturer or his authorized representative shall, in order to certify the conformity of machinery with the
provisions of this Directive, apply one of the procedures for assessment of conformity described in paragraphs 2, 3 and 4.
2. Where the machinery is not referred to in Annex IV, the manufacturer or his authorized representative shall apply the
procedure for assessment of conformity with internal checks on the manufacture of machinery provided for in Annex VIII.
3. Where the machinery is referred to in Annex IV and manufactured in accordance with the harmonized standards referred
to in Article 7(2), and provided that those standards cover all of the relevant essential health and safety requirements, the
manufacturer or his authorized representative shall apply one of the following procedures:
(a) the procedure for assessment of conformity with internal checks on the manufacture of machinery, provided
for in Annex VIII;
(b) the EC type-examination procedure provided for in Annex IX, plus the internal checks on the manufacture of
machinery provided for in Annex VIII, point 3;
4. Where the machinery is referred to in Annex IV and has not been manufactured in accordance with the harmonized
standards referred to in Article 7(2), or only partly in accordance with such standards, or if the harmonized standards do
not cover all the relevant essential health and safety requirements or if no harmonized standards exist for the machinery in
question, the manufacturer or his authorized representative shall apply one of the following procedures:
(a) the EC type-examination procedure provided for in Annex IX, plus the internal checks on the manufacture of
machinery provided for in Annex VIII, point 3;
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ANNEX IV
Categories of machinery to which one of the procedures referred to in Article 12(3) and (4) must 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:
1.1. sawing 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;
1.2. sawing machinery with fixed blade(s) during cutting, having a manually operated reciprocating saw-bench or carriage;
1.3 sawing machinery with fixed blade(s) during cutting, having a built-in mechanical feed device for the workpieces, with
manual loading and/or unloading;
1.4. sawing machinery with movable blade(s) during cutting, having mechanical movement of the blade, with manual
loading and/or unloading.
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:
4.1. sawing machinery with fixed blade(s) during cutting, having a fixed or reciprocating-movement bed or support for the
workpiece;
4.2. sawing machinery with blade(s) assembled on a carriage with reciprocating motion.
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.
7. Hand-fed vertical spindle moulding machinery for working with wood and material with similar physical characteristics.
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.
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13. Manually loaded trucks for the collection of household refuse incorporating a compression mechanism.
17. Devices for the lifting of persons or of persons and goods involving a hazard of falling from a vertical height of more
than three metres.
20. Power-operated interlocking movable guards designed to be used as safeguards in machinery referred to in points 9,
10 and 11.
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