Strategija Za Harmonizovanu Oblast ENG Draft 19102016 SDJ NM
Strategija Za Harmonizovanu Oblast ENG Draft 19102016 SDJ NM
INTRODUCTION
1.1. The integration of the Serbian economy into the single market of the European Union
1.2. The realization of the positive effects of harmonization
1.3. The framework for the adoption of the Strategy and Action Plan for harmonized area
1.4. ethodology
1.5. Extract from the Report of the European Commission on measures that Serbia needs to
fulfill in order to open negotiations for Chapter 1
1.6.Areas to be included in the Strategy and Action Plan
2. LEGAL AND INSTITUTIONAL FRAMEWORK OF QUALITY INFRASTRUCTURE
IN THE REPUBLIC OF SERBIA
2.1.Horizontal legal framework of quality infrastructure
2.2.Horizontal institutional framework of quality infrastructure
2.2.1.Ministry of Economy - Sector for Quality Infrastructure
2.2.2.Directorate of Measures and Precious Metals
2.2.3.Institute for Standardization of Serbia
2.2.4.Accreditation Body of Serbia
2.2.5.Ministry of Trade, Tourism and Telecommunications - Sector for Market Inspection
3. STATUS AND DEVELOPMENT PLAN IN HORIZONTAL AREAS OF QUALITY
INFRASTRUCTURE
3.1. Metrology
3.2. Standardization
3.3. ccreditation
3.4. Harmonization evaluation
3.5. Notification
3.6. Market surveillance
4. NEW APPROACH
5. OLD APPROACH
6. PROCEDURAL MEASURES
7. ACTION PLAN FOR HARMONIZED AREA*
*(GIVEN AS A SEPARATE DOCUMENT DUE TO ITS VOLUME)
LIST OF ACRONYMS
BS
Accreditation Body of Serbia
CEFTA
Central European Free Trade Agreement
CEN
European Committee for Standardization
CENELEC European Committee for Electrotechnical Standardization
CCIS
Chamber of Commerce and Industry of Serbia
DMDM
Directorate of Measures and Precious Metals
European Commission
U
European Union
ETSI
European Telecommunications Standards Institute
EURAMET European Association of National Metrology Institutes
IEC
International Electrotechnical Commission
ILACMLA International Laboratory Accreditation Cooperation Multilateral Agreement
ISS
Institute for Standardization of Serbia
ISO
International Organization for Standardization
ITU
International Telecommunication Union
E
Ministry of Economy
INTRODUCTION
1.1. THE INTEGRATION OF THE SERBIAN ECONOMY INTO THE SINGLE MARKET OF
THE EUROPEAN UNION
The full integration of the Serbian economy in the single market of the European Union (hereinafter: EU),
which now consists of markets of 28 member states, is one of the strategic goals of the Republic of Serbia.
Being part of the single market means having open access to the market of over 500 million consumers and
the full integration of the Serbian economy in the international production flows.
Serbia's path to EU accession will facilitate the possibility of full membership in the World Trade
Organization, which includes, among many other reforms, preparation for full compliance with the
requirements of a competitive single market.
During the EU and WTO accession process, candidate countries must adopt measures to ensure the free
flow of goods, i.e. trade without unnecessary technical barriers, taking into account that marketed highquality and safe products are placed on the market.
This process requires great commitment, not only in relation to the safety and quality of products, but also
in relation to the implementation of one of the basic principles of EU legislation and the Agreement on
Technical Barriers to Trade (WTO/TBT), so that regulations, standards and conformity assessment
procedures for products do not create unnecessary barriers to international trade.
In the process of improving and modernizing the system of quality infrastructure in the Republic of Serbia,
the ministry responsible for economic affairs (ME), as an authority of the state administration responsible
for policy development in the field of metrology, standardization, accreditation and conformity assessment,
undertakes actions to create a normative and institutional base for the development of these authorities in
accordance with European legislation and practice.
This process involves the active participation of the competent state authorities and regulatory bodies within
their jurisdiction, to successfully complete the process of full integration of Serbia into the European Union
single market.
1.2. THE REALIZATION OF THE POSITIVE EFFECTS OF HARMONIZATION
Through implementation and completion of the process of harmonization, i.e. completion of an improved
quality infrastructure system, the Republic of Serbia will be a few important steps closer to Europe in the
Euro-integration process and its values.
The fulfillment of the planned objectives in this process will have a positive impact on: Serbian economic
operators who will produce, import and export products by the rules that are accepted in the international
context, ie. in the EU and beyond, especially bearing in mind that a large number of countries which are
not EU members, particularly countries in the region, are striving towards harmonization with EU
legislation in this area;
consumers and users of products to whom high-quality and safe products will be available;
bodies of state administration which will exercise supervision over the implementation of technical
regulations in a simpler and more efficient way;
removing trade barriers.
By achieving these objectives, the Republic of Serbia will be in a position to become an active participant
in the European and world market.
In order to fully integrate the Serbian economy in the single market of the European Union, in accordance
with the Screening Report of the European Commission, i.e. the standards that the Republic of Serbia
needs to fulfill in order to open negotiations for Chapter 1 (explanatory screening held 17-20 June 2014,
bilateral screening held 9-12 September 2014), the Republic of Serbia prepared a Strategy and Action
plan for harmonized area.
Strategy and Action Plan for harmonized area covers activities relating to the requirements for the products
concerned by the New approach, Old approach and the so-called procedural measures as well as horizontal
legislation and relevant institutions in the field of quality infrastructure (standardization, accreditation,
metrology and market surveillance) and the plan to remove the existing unnecessary trade barriers.
1.3. FRAMEWORK FOR STRATEGY AND ACTION PLAN FOR HARMONIZED AREA
The EC submitted the Report on measures that the Republic of Serbia needs to fulfill in order to
open negotiations for Chapter 1
Preparation of the Draft Strategy and Action Plan for harmonized area
Draft Strategy and Action Plan is translated and sent to the EC for comments
When the draft is harmonized with the suggestions of the European Commission and the European
Commission confirms this, it is considered that the document is finalized.
Draft Strategy and Action Plan was submitted to the National Convention as a representative of
civil society organizations and to professional associations to provide comments (comments are not
binding)
The Government of the Republic of Serbia adopted the Strategy and Action Plan
1.4. METHODOLOGY
1. Commitment to European values
The Republic of Serbia is fully committed to the process of European integration and accepts that this process
requires substantial changes at the normative and implementation level. In that sense, the process of
implementing reform measures under Chapter 1 in Serbia is primarily guided by the EU legislation. The main
task of the Strategy and Action Plan is a completely objective approach to the current situation in the field of
the so-called New and Old Approach products, as well as setting realistic goals, with an estimated optimal and
sustainable balance between the needs arising from the harmonization of the laws and standards of the
European Union (which provides mainly short deadlines) and institutional and administrative capacity and
limited financial resources in the Republic of Serbia.
2. Development and implementation of the Strategy and Action Plan
The institutions responsible for supervising the development and implementation of the Action Plan
Implementation of the activities envisaged by the Strategy and Action Plan is entrusted to the Negotiating
Group for Chapter 1, the Coordinating Body for the process of accession of Serbia to the European Union
(hereinafter: the Coordination Body) and the Council of the Coordination Body, as well as the relevant
ministries and institutions in the field of quality infrastructure, according to this Strategy and Action Plan. All
competent institutions are represented at the appropriate levels of planning, decision making and
implementation of activities envisaged by the Strategy and Action Plan, with the possibility of involvement of
civil society and professional associations in terms of their advisory roles.
The system for early warning in case of delays in the implementation of the Action Plan
In case of delays, slowdowns or other problems in the implementation of the Action Plan, as a supplement to
regular reports, the Chairman of the Negotiating Group for Chapter 1 may issue a warning, which is submitted
to the Council and the Coordination Body. Depending on the nature of the problem and the responsibility for
solving them, the bodies may take further measures within the scope of their competence in the direction of
competent institutions with the proposal for solving the problems in the implementation.
In the event of a significant delay or problems related to the implementation of the Action Plan, President of
the Negotiating Group 1 and the Coordinating Council may inform the Government of the Republic of Serbia
and propose to the Government to take further steps within its jurisdiction towards entities listed as competent
institutions in the Action Plan, with the aim of competing the activities whose implementation is overdue, or
where there are other problems in implementation.
1.5. AREAS TO BE ENCOMPASSED BY THE STRATEGY AND ACTION PLAN FOR
HARMONIZED AREA
In accordance with the report of the European Commission on the criteria that the Republic of Serbia needs to
fulfill in order to open negotiations for Chapter 1, Strategy and Action plan for Harmonized area encompasses
the following areas (the relevant ministries/institutions in the Republic of Serbia for each specific area are also
listed):
Horizontal areas:
1) Metrology [Ministry of Economy, Directorate of Measures and Precious Metals]
1.6. EXCERPT FROM THE EC REPORT ON CRITERIA WHICH SERBIA SHOULD MEET TO
OPEN NEGOTIATIONS FOR CHAPTER 1
III. ASSESSMENT OF THE DEGREE OF ALIGNMENT AND IMPLEMENTING CAPACITY
Serbia's legislation is partially aligned with the acquis in Chapter 1, Free Movement of Goods. Implementing
structures have been established or identified in several sectors. Serbia has also produced plans for alignment
in many areas. In some sectors, such as with regard to Toys, Serbia needs to reinforce administrative capacity
to ensure the effective implementation of the acquis.
Specific gaps remain to be addressed in relation to the amendments of the legal framework, including the coordination and planning of steps towards full alignment and ensuring sufficient administrative capacity. Serbia
also needs to amend its legislation in several cases in order to remove additional customs or other controls
prior to marketing imported goods, where importers currently have to provide a certificate of conformity at the
border before importing the goods in question.
Serbia has not yet aligned its legislation with Articles 34-36 TFEU. Its current legislation is also only partly
aligned with the acquis on metrology and market surveillance. It has established the Accreditation Body of
Serbia (ATS), as the sole accreditation body in Serbia, and Serbia's standardisation body (ISS) has aligned
Serbian standards to a large percentage of EU standards, though it is not yet a full member of CEN and
CENELEC and its competences are not yet fully aligned with EU standardisation bodies.
Specific sectoral implementing legislation is sometimes being developed in parallel with the basic framework
legislation, such as for weapons and ammunition and for testing, marking and labelling of firearms, devices
and ammunition. However, in some sectors Serbia's current basic framework legislation needs to be adapted
to the acquis, such as in the area of toys and of cableway installations, before specific sectoral implementing
legislation can be drafted.
Serbia should adopt a strategy and an action plan in order to align with the acquis covered by the Chapter,
including ensuring the necessary administrative capacity and the removal of the above-mentioned barriers to
trade.
III.a. General Principles
Serbia needs to fully align its legislation with Articles 34-36 TFEU. To support this objective, Serbia should
adopt a strategy and an action plan to analyse national legislation in order to align with Articles 34-36 TFEU,
and to identify outdated technical and other requirements for products which are not in line with the acquis
and the need for mutual recognition clauses in individual regulations. In doing this Serbia will firstly need to
perform an initial review of its legislation and administrative practices during the drafting of this action plan
in order to identify areas that will potentially need further action. The build-up of institutions and their role in
this system will also have to be defined.
III.b. Horizontal Measures
Serbia has reached a good level of alignment with the acquis on standardisation and accreditation, but it is not
fully aligned. As regards metrology and market surveillance in particular Serbia's legislation is partly in line
with the acquis. A standardisation body (ISS) is well established and it is issuing Serbian standards. However,
ISS does not cover all of the sectors covered by standards bodies in the EU (including electro-magnetic
standardisation), and it is not yet a full member of CEN and CENELEC.
Serbian legislation is not fully aligned with the acquis with regard to conformity marking. Under Serbia's
current legislation the entity responsible for affixing the conformity mark is determined by the relevant
technical legislation, which, depending on the cases, stipulates that it is to be done by the manufacturer, by an
authorised representative, but also by the importer, which is not in line with the acquis.
In many cases Serbian legislation stipulates that the Serbian conformity mark is in force, and that, as a transition
measure, the CE mark will be applied on date of accession or if Serbia signs an Agreement on Conformity
Assessment and Acceptance of Industrial Products (ACAA) with the EU. However, Serbia has not yet
envisaged transitional provisions for products that will be placed on the market before an ACAA comes into
force/before accession and it will now have to foresee transitional provisions in this regard.
Serbia needs to further align its legislation in the area of market surveillance, which is currently partly aligned
with the acquis.
III.c. New and Global Approach Product Legislation
Serbia has reached a reasonable level of legislative alignment in the areas of Personal protective equipment
(PPE), Pressure equipment, and Simple Pressure Vessels (SPVD).
Serbian legislation is partially aligned with the acquis with regard to Equipment and protective systems
intended for use in potentially explosive atmospheres (ATEX), Eco-design requirements for energy-related
products (ErP) and Energy Labelling of products. Serbian legislation is also partially aligned with the acquis
with regard to Low Voltage equipment (LVD), Electromagnetic compatibility (EMC), Radio
Telecommunications terminal equipment (RTTE) and machinery. However, items imported in these last four
sectors are subjected to additional customs or other controls prior to marketing in that importers have to provide
the certificate of conformity at the border, before importing the goods in question. Serbia needs to remove such
barriers to trade.
Serbian legislation is not in line with the acquis on Toy Safety, Medical devices, Gas appliances, Aerosol
dispensers, Cableways, Construction products, Recreational craft, and Explosives for civil uses and
Pyrotechnic articles. In some cases work on alignment is on-going, but in other cases (such as toys) only some
initial work has been undertaken, and Serbia's administrative capacity also needs reinforcing in areas including
toys.
III.d. Old Approach Product Legislation
Serbia has reached a reasonable level of legislative alignment in the area of Fertilizers.
Serbian legislation is partially aligned with the acquis in the areas of Chemicals Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH), Chemicals (Classification, Labelling and Packaging,
CLP), Detergents, Drug precursors, and Good laboratory practice (GLP), although Serbia has not yet adopted
a REACH Implementing Act or a CLP Implementing Act, a competent authority for REACH and CLP remains
to be designated, and mutual recognition of GLP monitoring programmes remains to be implemented.
Serbian legislation is not in line with the acquis on motor vehicles, and on Emissions of pollutants from nonroad mobile machinery engines.
III.e. Procedural Measures
Serbian legislation is partly aligned with the acquis on Transparency in relation to Pricing and reimbursement
of Medicinal Products, Defence products, and Firearms.
Serbian legislation is not aligned with the acquis with regard to Textiles and to Footwear, but Serbia intends
to fully align by mid-2015 with regard to footwear, and to partly align (with the exception of one article) by
the same time with regard to textiles. Serbian legislation is also not aligned with the acquis with regard to
Crystal Glass or to Cultural Objects.
and horizontal legislation and the relevant horizontal organisations (standardisation, accreditation, metrology,
and market surveillance). They should also set out how and by when Serbia will remove barriers to trade with
regard to products covered by this chapter, notably additional border or other controls. They should define
clear responsibilities for introducing and effectively implementing legislative measures and for ensuring the
necessary administrative capacity.
1. LEGAL AND INSTITUTIONAL QUALITY INFRASTRUCTURE FRAMEWORK IN THE
REPUBLIC OF SERBIA
2.1. Horizontal legal framework of quality infrastructure in Serbia
Horizontal legal framework of quality infrastructure in the Republic of Serbia was set up through the
adoption of four systemic laws in the area of technical requirements for products and conformity assessment,
standardization, metrology and accreditation, as well as the adoption of bylaws for their implementation.
Law on Technical Requirements for Products and Conformity Assessment created the legal preconditions
for harmonization with EU technical legislation, if prescribing technical requirements for products is not
regulated by special laws. At the same time, this Law allows prescribing technical requirements for products
in areas where there are no harmonized regulations at EU level.
For the purposes of implementation of this Law, several bylaws were adopted, which lay down more closely
the conformity assessment procedures for implementation; ways of naming and authorizing CABs; methods
of recognition of foreign documents and marks of conformity; application procedures and information relating
to technical regulations, standards and conformity assessment; ways of marking of products as well as the use
of marks of conformity; content and method of maintaining registers relating to technical regulations and the
content of the form on which a list of Serbian standards referred to in a technical regulation is published.
Law on Standardization ("Official Gazette of RS", no. 36/09, 46/15) promotes the adoption of Serbian
standards that are the basis of European and international standards and the voluntarity of standards. The Law
regulates the general standardization which includes the widest range of users, but not the branch standards
that apply in specific areas (rail, air and river transport, defense, etc.). This Law provided the conditions for
faster and more efficient adoption of European standards, and meeting the requirements for full membership
of the European standardization organizations.
On the basis of this Law, the Decision on Amending the Founding Act of the Institute for Standardization of
Serbia ("Official Gazette of RS", no. 88/09) was adopted, which closely regulates the establishment,
organization and the work of the Institute.
Law on Metrology ("Official Gazette of RS", No. 15/16) is the basic legal framework for the organization of
a metrology system in the Republic of Serbia, which includes the organization of activities of metrology, the
legal units of measurement, measurements standards of the Republic of Serbia, distribution, use and legal
control of the measuring instruments. In drafting this Law, the documents of the International Organization of
Legal Metrology (OIML D1 and OIML D9) and EU regulations relating to metrology were taken into
consideration.
A number of bylaws was also passed which, inter alia, more closely determine: measuring instruments that are
subject to legal control, the terms and conditions of designation or authorization of CABs, i.e. certification of
measuring instruments, implementation of metrological control, recognition of foreign certificates, marks and
signs of compliance and other issues of importance for the functioning of the metrology system. In addition,
this Law provided legal basis for compliance with the essential requirements and principles of European
directives in the field of metrology on the basis of which all three European directives in this area are taken
(MID-which regulates 10 types of measuring instruments, NAWI - non-automatic weighing instruments, as
well as and directives on pre-packaged products and units of measurement). Also, the regulation of metrology
requirements for measuring instruments of nonharmonized areas is also based on this Law (source national
legislations regulations).
Law on Accreditation ("Official Gazette of RS", no. 73/10) regulates the accreditation system in a
comprehensive manner, which includes, in addition to the national accreditation body, accredited CABs, as
well as rules and procedures for accreditation, which determine the competence of CABs (testing, calibration,
inspection, certification of: products, management systems and persons). On the basis of this Law, the Decision
on Amending the Founding Act of the Accreditation Body of Serbia was passed ("Official Gazette of RS", no.
14/2011), which closer regulates the establishment, organization and operation of this body.
These laws also included taking over the solutions from the so-called European "New package of measures for
improving goods trade", i.e."new good's package" (New Legislative Framework - NLF).
The laws that complement the horizontal legal framework of quality infrastructure. Laws that are essential to
the completion of the horizontal legal framework of quality infrastructure in the Republic of Serbia, and Law
on General Product Safety ("Official Gazette of RS", no. 41/09) and the Law on Market Surveillance ("Official
Gazette of RS", no. 92/11 ).
Law on General Product Safety created the legal framework for guaranteeing the overall safety of all products
not covered by specific technical regulations. This Law has taken the principles and the essential requirements
of the European Directive on General Product Safety (2001/95/EC) and the Directive on Misleading Products
(87/357/EEC), and it promotes the basic principle that all products placed on the market or in use of must be
safe.
Law on General Product Safety, in addition to the general safety requirement, determines the criteria on the
basis of which compliance with the general safety requirement for all products is assessed, as well as the
conditions and manner of information regarding the risks which the product may present in terms of health
and safety of people. This Law introduced a system of rapid exchange of information on dangerous products
found on the market in the legal system of the Republic of Serbia for the first time, i.e. products posing a
serious risk to the health and safety of consumers and professional users of these products. The System of
Rapid Exchange of Information (information on dangerous products - NEPRO base - http://www.nepro.gov.rs)
aims to create a unified system approach of all competent market surveillance authorities in collecting and
forwarding information on dangerous products, and to further develop regional, and international cooperation
in this area, including the accession of the Republic of Serbia to the RAPEX system and informing the
European Commission of Serbia's accession to the EU.
Law on Market Surveillance systematically regulates: general market surveillance rules, market surveillance
authorities and their scope, cooperation, exchange of information and communication between market
surveillance authorities and customs authorities, as well as the coordination of market surveillance authorities
and monitoring of market surveillance activities. According to this law, market surveillance, as a set of
measures and activities carried out by the market surveillance authorities, ensures compliance of products with
the safety, technical and other requirements prescribed by technical regulations. This is to ensure that products
placed on the market in the Republic of Serbia do not endanger the health and safety of people and the
protection of other public interests. Market surveillance over the implementation of technical regulations is an
essential link in the QI system.
The adoption of the Law on Market Surveillance ensures that the area of market surveillance is compliant with
Regulation 765/2008/EC.
2.2 Horizontal institutional framework of quality infrastructure
2.2.1. Ministry of Economy
In accordance with the Law on Ministries ("Official Gazette", no. 44/14), the Ministry of Economy, among
other tasks, performs state administration tasks relating to standardization; technical regulations, accreditation;
measures and precious metals. Other ministries, within their scope, perform public administration tasks related
to the preparation, adoption, and proposal of technical regulations.
The Ministry of Economy is responsible for monitoring the application of horizontal legislation in this field.
In accordance with the systematization of affairs within the Ministry of Economy and within the jurisdiction
of the ME, Sector for Quality Infrastructure performs tasks related to: technical regulations, the process of
harmonization of laws with the EU acquis in the area of free movement of goods, as well as the adoption of
bylaws; transposition and implementation of the transposed EU technical legislation - internal market; strategy
and policy of standardization, accreditation and metrology; coordination with competent ministries;
development of programs for the adoption of technical regulations; development of technical regulations for
industrial non-food products; authorization and designation of bodies for assessing conformity of products
with the prescribed requirements; the designation of bodies for assessing conformity of criteria; authorization
of bodies for performing verification of measuring instruments; authorization of bodies for testing and marking
of precious metal or testing valuable metals and their alloys; notification of authorized and designated bodies
to the European Commission (notification of conformity assessment bodies); supervision of the work
authorized and designated conformity assessment bodies; recognition of the validity of foreign documents and
marks of conformity and giving opinion on the decision on the recognition of foreign documents and marks of
conformity issued by other ministries; management and issuance of registry excerpts of technical regulations
in preparation, registers of valid technical regulations and designated conformity assessment bodies - CABs,
register of foreign documents and marks of conformity valid in the Republic of Serbia, register of authorized
bodies for verification criteria and designated conformity assessment bodies criteria, register of authorized
bodies for testing and marking of precious metal or precious testing metals and their alloys; providing
information on technical regulations and their application to companies and other stakeholders; as an
information center under the rules of the WTO and CEFTA (including the work of the focal point according
to the EU rules); notification of the preparation of technical regulations and related conformity assessment
procedures (notification of EU and WTO legislation) in order to eliminate technical barriers to trade within the
CEFTA, the WTO and the EU; conducting second instance administrative procedure in the field of metrology;
setting priorities, preparing, proposing and monitoring the implementation of approved projects in the field of
free movement of goods and coordination of development projects with institutions in this area for signing the
Agreement on Conformity Assessment and Acceptance of Industrial Products (hereinafter the ACAA
hereinafter); planning, implementation and coordination of activities relating to the process of accession the
EU within the scope of the Sector; preparation and organization of meetings of the Negotiating Group on the
movement of goods (Negotiating Group 1 of the Coordination Body for the process of accession of Serbia to
the European Union) and entering data into the NPAA electronic database; cooperation with other state
administration bodies and institutions in the area of free movement of goods in connection with the
harmonization of the legal framework and the application of technical and other regulations in the area of free
movement of goods; and other activities in this field.
In the Sector for Quality Infrastructure, the following internal units were formed:
1. Department for Technical Regulations in Harmonized Area, the Removal of Barriers to trade and
projects
2. Department for Technical Regulations in Nonharmonized area, Notification and Registers
3. Group for the Development of Standardization, Accreditation and Metrology.
2.2.2. Directorate of Measures and Precious Metals (DMDM)
Directorate of Measures and Precious Metals (DMDM) as the national Metrology Institute and Metrology
Council as an expert advisory body established by the Government of the Republic of Serbia. In addition to
these entities, the following also play an important role in the metrology system: public authorities and other
business entities who keep, maintain and improve certain national measurement standards, authorized bodies
for verification of measuring instruments, accredited laboratories for calibration and designated CABs.
Directorate of Measures and Precious Metals is a state administration body, which is the backbone of the entire
metrology system in the Republic of Serbia. According to the Law on Metrology, DMDM is responsible for
fundamental, industrial and legal metrology. In addition, DMDM is responsible for the implementation of the
Law on Control of Precious Metals Articles and the Law on Daylight Saving Time and performing professional
and related administrative activities in the field of metrology that are listed in these laws.
DMDM is the national metrology institute (NMI) of the Republic of Serbia and it conducts research in the field
of metrology, applies units of the international system of units (SI system) through the national measurement
standards of the Republic of Serbia, provides traceability for all interested parties to the national and
international levels, develops and improves the methods of calibration, performs calibration of measuring
equipment and provides the necessary expert assistance to accredited laboratories for calibration and other
users.
DMDM as the NMI of the Republic of Serbia is a signatory of the CIPM MRA from 2002 for the specific
possibilities of calibration and measurement capabilities (CMC) published in the database of BIPM (KCDB)
and, in this regard, it participates in appropriate key and supplementary comparisons in certain areas of
metrology. To date, DMDM published CMC in KCDB in the following areas, in the fields of electricity and
magnetism, dimensional measurement, photometry, temperature, time and frequency, mass and volume. In
these areas, in accordance with the CIPM MRA, the national measurement standards of the Republic of Serbia
and the certificates of calibration issued by DMDM are internationally recognized.
DMDM is also in charge of legal metrology, which includes in particular: the conformity assessment of
measuring instruments with the prescribed requirements, such as, for example, the requirements prescribed in
the Rulebook on Measuring Instruments and Rulebook on Non-automatic Weighing Instruments (which
transposed European Directive MID and NAWI to the legal system of the Republic of Serbia), testing and type
approval of the measuring instruments, testing of pre-packaged products, metrological control (supervision
over measuring instruments and pre-packaged products), supervision over the use of legal units of
measurement, verification of the measuring instruments for which there are no authorized bodies, participation
in drafting regulations in metrology, metrological expertise, etc.
The Directorate represents Serbia in international and regional metrological organizations and establishes
cooperation in the field of metrology with other countries. DMDM actively participates in the work of these
organizations. The Republic of Serbia is a member state of the Metre Convention and the International Bureau
of Weights and Measures (BIPM) since 1879 and a member state of the International Organization of Legal
Metrology (OIML) since 1955. DMDM is also a member of the International Association of Assay Offices
(IAAO) since 2002. At the European level, DMDM is a member of the European metrology organizations
EURAMET and WELMEC. DMDM became a member of EURACHEM in 2013 and contact organization
through which other organizations in the Republic of Serbia can be involved in the work of EURACHEM.
2.2.3. Institute for Standardization of Serbia (ISS)
The first form of institutionalized activities on the adoption of standards was established in 19341. Today, ISS
is the only standardization body in the Republic of Serbia.
Today, the standardization of the Republic of Serbia is based on the recognized principles of the Agreement
on Technical Barriers to Trade of the World Trade Organization (WTO/TBT), Annex 3: Code of Good Practice
for the Preparation, Adoption and Application of Standards, which include the involvement of all stakeholders,
consensus, transparency, coherence, voluntarism, non-discrimination and efficiency.
The authorities of the ISS are General Assembly, Managing, Board, Director and Supervisory Board.
Moreover, expert councils and national technical committees operate in the context of ISS as professional
bodies, which were formed to guide professional work in certain areas of standardization and for the
development and adoption of standards and related documents, and other activities in the field of
standardization.
The position and operation of ISS and other issues of importance for standardization are regulated by the Law
on Standardization ("Official Gazette of RS", no. 36/09, 46/15), the Decision amending the Decision on
Establishing the Institute for Standardization of Serbia ("Offial Gazette of RS ", no. 93/15) and the Statute of
the Institute for Standardization of Serbia ("Official Gazette of RS", no. 6/11).
1
The founding session of the Yugoslav National Committee for Normalization was held on 16 September 1934 at the 15th session of the Yugoslav Association of Engineers
and Architects, which is considered the first form of activities on the adoption of standards in this area.
The main activities of ISS are adoption of standards, ensuring compliance of Serbian standards with
international and European standards, interpretation of standards, official notification of the standards in
accordance with the requirements laid down in the relevant international treaties and obligations arising from
membership in international and European standardization organizations, as well as sales of standards and the
provision of services in connection with standardization.
In preparing ISS annual work programs and annual plans of adoption of Serbian standards and related
documents, the priorities arising from the process of accession of Serbia to the WTO, above all, as well as
from the SAA are taken into account, which establishes obligations that RS must fulfill before accession the
EU.
ISS is a full member of ISO - International Organization for Standardization since 1950 and IEC - International
Electrotechnical Commission since 1953, and an affiliate member of CEN - the European Committee for
Standardization since 2008 and CENELEC - European Committee for Electrotechnical Standardization since
2005.
Full membership ISS in CEN and CENELEC is one of the conditions that the Republic of Serbia has to
fulfill to join the EU. One of the conditions for obtaining the status of a full member in the above mentioned
organizations is the transposition of at least 80% of European standards and harmonization documents2
into Serbian standardization, which the ISS fulfilled so that by the end of 2014, about 95% of all European
standards, or about 97% of European harmonized standards was transposed. The dynamics of European
standardsadoption is presented in the following graph.
ISS applied for full membership in these European organizations in May 2016. ISS also acts as an information
center for standards by providing information on standards in accordance with the requirements of the
WTO/TBT, laying down the procedure for the provision of information in the field of standards and technical
regulations.
2.2.4. Accreditation Body of Serbia (ABS)
The first form of institutionalized activities in the field of accreditation was established in 1998 with the
establishment of the Yugoslav Accreditation Body within the system of state administration. Since 2007, the
only national accreditation body in the Republic of Serbia is the Accreditation Body of Serbia (ABS), which
became a public institution in 2010 which the Law on Accreditation ("Official Gazette of RS", no. 73/10)
entrusted with performing accreditation tasks.
The position and operation of ABS and other issues of importance for accreditation are regulated by the Law
on Accreditation, the Decision on amending the founding act of the Accreditation Body of Serbia ("Official
Gazette of RS", no. 14/11) and the Statute of the Accreditation Body of Serbia ("Official Gazette of RS", no.
97/11).
In addition to accreditation tasks, ABS also performs the following tasks: develops and publishes the rules of
accreditation that are based on the relevant Serbian, international and European standards and documents of
international and European accreditation organizations; maintains a public register of accredited CABs;
participates in the work of international and European organizations for accreditation; performs other duties in
accordance with law, the founding act and the statute.
The Law on Accreditation was adopted as a result of the need to harmonize the system of accreditation in the
Republic of Serbia with European legislation and standardized requirements, namely:a) Regulation (EC)
765/2008 of the European Parliament and of the Council laying down the requirements for accreditation and
market surveillance relating to the marketing of products on the market andb) Standard ISO IEC 17011
Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment
bodies.
The main activity of the ABS is to determine the CAB competence for performing the following tasks: testing,
calibration, inspection and certification of products, management systems and persons, as well as PT providers
and verification operations, i.e. EMAS and ETS.
These documents are published by CENELEC and they have the same status as European standards.
In May 2012, ABS became a full member of the European Organization for Accreditation (EA) when the
Multilateral agreement (EA MLA) with EA on the recognition of national accreditation was also concluded
for the following: testing laboratories, medical laboratories, calibration laboratories, inspection bodies and
certification bodies for certification of products. In the first half of 2014, the scope of the signed EA MLA
expanded to certification bodies for management systems and certification of persons. This agreement was
signed on the basis of the results of a thorough peer evaluation by the EA, in accordance with Regulation
765/2008/EC. The signing of this agreement confirms the equivalence of the national system of accreditation
with the accreditation systems in the member states of the EU and an important prerequisite was created for
the acceptance of certificates of conformity issued by the CABs accredited by ABS.
In addition, ABS signed a number of agreements as a member of the International Laboratory Accreditation
Cooperation (ILAC), such as: ILAC MRA multilateral agreement (Mutual Recognition Agreement) for field
testing, calibration, inspection and other. ABS is also a member of the International Accreditation Forum (IAF)
and it also signed the IAF MLA multilateral agreement in the field of certification of products and management
systems.
ABS bodies are the management board, the CEO and the supervisory board. Advisory bodies of the ABS are
the Accreditation Council and permanent and/or temporary technical committees.
The Accreditation Council is an expert advisory body of the ABS which provides opinions regarding the
development of an accreditation system; initiates the expansion of the area of operation of the ABS; provides
opinions regarding the application of the standards required for accreditation in specific areas; proposes the
establishment of permanent and temporary technical committees as working bodies for certain areas of
accreditation. The Council consists of 11 members as representatives of interested parties.
Technical committees are established as expert bodies for certain areas of accreditation. They give the
interpretation of the requirements and documents of international organizations in certain types and areas of
accreditation, consider proposals of EA, ILAC/IAF documents, assist the ABS in its expansion activities,
establish criteria for competency assessors in certain areas of conformity assessment, identify potential
assessors and assist ABS in the recognition of schemes of interlaboratory comparisons (PT schemes).
Supervision over the work of ABS is exercised by the ministry in charge of accreditation and ABS supervises
the work of accredited CABs.
2.2.5. Ministry of Trade, Tourism and Telecommunications - Sector for Market Inspection
This Department carries out activities related to: administrative support to the Product Safety Council in
coordination of monitoring activities and improving inter-agency cooperation in the field of market
surveillance, development and harmonization of operational interpectoral plans, market surveillance and
consolidating reports of coordinated market surveillance for the government of the RS, coordination of NEPRO
system on information exchange between Market Surveillance Authorities and Customs Authority and
informing the public about unsafe products on the market; inspection supervision over the implementation of
laws and other regulations relating to: trade; electronic commerce; conditions and provision of certan services;
compliance and safety of non-food products (monitoringMarket Surveillance: Electrical equipment intended
for use in certain voltage limits, Simple pressure vessels, Construction products, Electromagnetic
compatibility, Personal protective equipment, Home appliances to gas, Hot water boilers for liquid or gaseous
fuels, Oil and oil products, biofuels and compressed natural gas, Machines, Lifts, Radio-communication and
telecommunication terminal equipment, Motor vehicles, equipment and parts for these vehicles, Textiles,
textile products and footwear, Crystal glass in accordance with special regulations); prevention of unfair
commercial practices and aggressive practices and other issues in the field; consumer protectionenforcement
including general product safety; advertising; enforcement of Intellectual Property Rights in production and
marketing of goods which violate intellectual property rights, i.e. production and marketing of goods protected
by copyright and related rights; prevention of money laundering and financing of terrorismthe prevention of
gray economy; jobs that are directly related to the inspection supervision: creating procedures for performing
the inspection; internal training of market inspectors for the implementation of new regulations and procedures
for the inspectionas well as all logistical jobs aiming the support of operational work in the scope of Market
Inspection Sector.
3. CURRENT SITUATION AND DEVELOPMENT PLAN IN HORIZONTAL AREAS OF
QUALITY INFRASTRUCTURE
3.1 etrology
) Current level of compliance of national legislation with key EU acquis
A new Law on Metrology was adopted in February 2016. The law was published in the "Official Gazette of
RS", no. 15/2016 of 25/02/2016 and entered into force on 4 March 2016. Adopting a new Law on Metrology
was done, inter alia, to comply with the revised recommendations of the International Organization of Legal
Metrology (OIML - D1 Considerations for a Law on Metrology Edition 2012).
In the field of metrology, full harmonization with the EU acquis has been achieved with the adoption of the
following bylaws: - Regulation on Certain Legal Units of Measurement and the Ways of Use Thereof ("Official
Gazette of RS", no. 43/11), which transposed the Directive on Units of Measurement 80/181/EEC;
Rulebook on Measuring Instruments ("Official Gazette of RS", no. 63/13), which transposed Directive
2004/22/EC on Measuring Instruments (Measuring Instruments Directive - MID) and Directive
2009/137/EC;
Rulebook on Non-automatic Weighing Instruments ("Official Gazette of RS", no. 17/13), which
transposed Directive 2009/23/EC relating to non-automatic weighing instruments (Non-Automatic
Weighing Instruments - NAWI), and
Rulebook on Pre-packaged Products ("Official Gazette of RS", no. 43/13 and 16/16), which transposed
the directives that apply to pre-packed products, 76/211/EEC, 78/891/EEC, 2007/45/EC and directive
75/107/EEC relating to bottles used as measuring containers .
A list of Serbian standards in the field of non-automatic weighing instruments was also published ("Official
Gazette of RS", no. 10/16) - EN 45501: 2015 Metrological aspect of non-automatic weighing instruments, the
application of which provides a presumption of conformity with the Rules on Non-automatic Weighing
Instruments, as well as a list of Serbian standards in relation to measuring instruments ("Official Gazette of
RS", no. 39/14) and a list of Serbian standards (normative documents OIML recommendation) in the field
of measuring instruments ("Official Gazette of RS", no. 39/2014), the application of which provides a
presumption of conformity with the Rulebook on Measuring Instruments.
Full implementation of Rulebook on Measuring Instruments begins on 1 January 2017.
These rulebooks are completely harmonized with all principles and essential requirements of mentioned
directives.
b) Institutional structure and administrative capacity
The Directorate of Measures and Precious Metals (hereinafter DMDM) has a total of 102 employees with 103
wrkplaces that underwent job classification. DMDM conducts its operations in several locations, in Belgrade
where the headquarters of DMDM is located, and in Subotica, Novi Sad, Zrenjanin, Ni and Kruevac where
the immediate organizational units DMDM are located.
c) Description of the measures taken and activities in order to achieve full harmonization with the EU
acquis
The metrology system in the Republic of Serbia is modeled in accordance with international and European
trends and it consists of the following entities: the Ministry responsible for metrology - ME; Directorate of
Measures and Precious Metals (hereinafter DMDM); Metrology Council; designated conformity assessment
bodies, authorized bodies for verification of measuring instruments, accredited calibration laboratories and
designated holders of national measurement standards.
ME is responsible for creating strategies and policies in the field of metrology, and DMDM, as a body within
the MP, performs professional affairs and state administration in the field of science, fundamental, industrial
and legal metrology in the Republic of Serbia. DMDM operates in accordance with the Law on Metrology, the
Law on Control of Precious Metals Articles and the Law on Daylight Saving Time. In the field of scientific
and industrial metrology, DMDM develops, implements, maintains and improves national measurement
standards of the Republic of Serbia and provides traceability to SI units for all users, while in legal metrology
it primarily performs tasks related to conformity assessment of measuring instruments with the metrological
requirements, such as requirements laid down in the directive MID and NAWI, type approval, verification of
the measuring instruments for which there are no authorized bodies, testing of pre-packaged products,
metrological supervision and others.
The Republic of Serbia is a member of the Metre Convention, the International Organization of Legal
Metrology (OIML) and DMDM , as the National Metrology Institute of the Republic of Serbia, is a member
of the European Association of National Metrology Institutes (EURAMET) and an associate member of the
European Cooperation in Legal Metrology (WELMEC) and a member of the European organizations network
with the aim of establishing a system for international traceability in the field of chemical measurements
(EURACHEM).
From the date of entry into force of the new rulebooks, DMDM undertakes activities for the implementation
of conformity assessment, as well as for improving supervision in accordance with the requirements of the
new rulebooks (training, procurement of equipment, DMDM laboratory accreditation, etc.) in order to prepare
for the full implementation of these rulebooks.
d) Plans for full harmonization with the EU acquis
) Plans in respect of the remaining necessary harmonization of the national legislative framework
with the EU acquis
The Ministry of Economy, in cooperation with DMDM and other stakeholders, will work on harmonization of
bylaws necessary for implementing the new law regulating metrology. In context of the adoption of the new
Law on Metrology and bylaws that result from it, especially the Rulebook on Verification of Measuring
Instruments and the Rulebook of Type Approval of Measuring Instruments, Directive of the European
Communities 2009/34/EC on the common provisions for measuring instruments and methods of metrological
control will be transposed.
After the release of the new directives in the Official Journal of the European Union (29 March 2014)
concerning the non-automatic weighing instruments (NAWI) and measuring instruments (MID), transposition
of these directives is planned by adopting new rulebooks.
The following directives shall be transposed:
1) 2014/31/EU on the harmonization of the laws of the member states relating to making available on the
market of non-automatic weighing instruments;
2) 2014/32/EU on the harmonization of the laws of the member states relating to making availbale on the
market of weighing instruments.
The adoption of the following legislation is also planned in 2017:
1) Rulebook on amending the Rulebook on Pre-packaged Products ("Official Gazette of RS", no. 43/13 and
16/16), which transposed the directive relating to pre-packaged products, 76/211/EEC, 78/891/EEC,
2007/45/EC and directive 75/107/EEC relating to bottles used as measuring containers;
2) Rulebook on Aerosols, which will transpose the EU Directives 75/324/EEC and 2008/47/EC.
After the completion of harmonizaton of regulations with European directives, work on the national metrology
regulations is planned, which shall, in accordance with OIML recommendation, regulate requirements for the
criteria that are used in legal metrology, but are not covered by European directives (currently there are 26
types of measuring instruments in legal metrology of the Republic of Serbia that are not covered by European
directives).
b) Review of measures and activities that will be implemented to strengthen the institutional structure
and administrative capacity
Strengthening the capacity of DMDM is planned in preparation for performing the function of a notified body
for measuring instruments for which there are domestic producers, i.e. non-automatic Weighing Instruments,
electricity meters, water meters, and taxi meters. In relation to this, it is necessary to increase the number of
employees (high degree of technical, physical and related sciences). Along with strengthening the capacity to
implement DMDM conformity assessment in accordance with the principles and requirements of European
legislation, it is necessary to take measures and activities to improve the capacity of metrological supervision
in preparation for the full implementation of harmonized European legislation in the field of metrology.
Also, DMDM will be in charge of the implementation of the Rulebook on Aerosols and jobs will be carried
out within the area of pre-packaged products, which the number of employees should also be increased, and
existing employees should be trained in the field of aerosols. The right equipment for the application of this
Rulebook should also be purchased. Training and equipment can be supported through appropriate technical
assistance projects (IPA, PTB, etc.).
Appendix A) Plan of harmonization of legislation of the RS with the EU acquis
Planned
Regulation
Competent
No
regulation
Deadline
name
institution
code
1. 2014-132
Rulebook on
ME-DMDM
II quarter
Verification of
2017
Measuring
Instruments
2. 2014-156
Rulebook on
ME-DMDM
II quarter
Type Approval of
2017
Measuring
Instruments
3.
2016-409
Rulebook on
ME-DMDM
II quarter
Non-automatic
2017
Weighing
Instruments
4.
2016-410
Rulebook on
ME-DMDM
II quarter
Measuring
2017
Instruments
5.
2016-413
Rulebook on PreME-DMDM
II quarter
packaged
2017
Products and
Measuring
Bottles
6.
2016-415
Rulebook on
Aerosols
ME-DMDM
II quarter
2017
elex
Regulation
translated
32009L0034
no
32009L0034
no
32014L0031
32014L0032
31976L0211
31975L0107
32007L0045
32009L0034
1975L0324
32008L0047
32009L0034
3.2. Standardization
) The level of harmonization of national legislation with key EU acquis
Legislation of the RS in the field of standardization is partially3 harmonized with the EU acquis. Harmonization
of national legislation with the said EU legal act (Regulation 1025/2012) is provided by adjusting the following
acts, namely:
Law on Amendments to the Law on Standardization ("Off. Gazette of RS", no. 46/15)
Decision amending the Decision on Establishing the Institute for Standardization of Serbia ("Off. Gazette
of RS", no. 93/15)
Regulation on amending the Regulation on the Application Procedure and Manner of Information relating
to Technical Regulations, Conformity Assessment Procedures and Standards ("Off. Gazette of RS", No.
114/15).
Tabulation of national legislations issued pursuant to Regulation EU 1025/2012
3. 3.1.1.1. Standardization
Number
Regulation name
Competent ministry or
special organization
1.
2.
Deadline for
stipulation
/adoption by the
government
/ministries
2015/ II
2015/III
Law on Standardization ("Off. Gazette of RS", no. 36/09 and 46/15) and all bylaws are consistent with Regulation (EU) no 1025/2012 of the European Parliament and
the Council, which regulates the area of standardization in RS and obligations of the ISS as a national body for standardization in the RS.
Reasons for partial harmonization of national legislation with Regulation 1025 are primarily of legal nature. Certain provisions of that EU regulations are transposed into
national legal documents because they detail the specific rights, financing, as well as the obligations of the European Commission, Member States and the European
standardization organizations, and as such they cannot be transposed into national legislation.
The degree of full harmonization of legislation will be achieved on the day of accession of the Republic of Serbia to the EU.
c) Description of the measures and activities taken in order to achieve full harmonization with the EU
acquis
The legal basis for the adoption of Serbian standards and related documents is contained in Article 6 of the
Law on Standardization ("Off. Gazette of RS", 36/09 and 46/15). In preparing the ISS annual work programs
and annual plans of Serbian standards and related documents, above all, the priorities arising from the
accession of the Republic of Serbia (RS) to the World Trade Organization (WTO), as well as from the
Stabilisation and Association Agreement (SAA), which defines obligations that RS must fulfill before
accession the European Union (EU), are taken into account.
ISS is a full member of the International Organization for Standardization (ISO) and International
Electrotechnical Commission (IEC) and is an affiliate member of the European standardization organizations
such as the European Committee for Standardization (CEN) and the European Committee for Electrotechnical
Standardization (CENELEC). ISS has the status of a National Standards Organization in the European
Telecommunicaitons Standard Institute (ETSI). Full membership of ISS in CEN and CENELEC is one of the
conditions that RS must fulfill to join the EU.
Until 31 December 2015, ISS took over about 96% of European standards and harmonization documents as
Serbian standards, for which the deadline for publication at the national level expired to date. ISS plans to finish
taking over almost all other European standards in 2016, with the exception of a small number of standards that
will be taken immediately before entering or after entering the Republic of Serbia in the EU and to undertake
further activities on the adoption of European standards in synchronization with the activities of the European
standardization organizations. In other words, each newly released European standard will be adopted as Serbian,
within a time limit that applies to all countries that are full members of CEN and CENELEC, i.e. the EU.
Given the fact that in 2012 the ISS fulfilled the basic requirement for membership in the European
standardization organizations CEN and CENELEC relating to taking over the European standards and
harmonization documents into national standardization, in the second half of 2015 intensive work on preparing,
updating and translating documents necessary for the submission of ISS for full membership in these
organizations began, which will continue into the first half of 2016. These activities are aimed at meeting the
criteria contained in the new edition of the CEN-CENELEC Guide 20 (4th edition, 2015-02), which have been
established for all full members of the European standardization organizations, in order to create an adequate
basis for equal participation of ISS in European standardization. In addition, special attention will be paid to
the harmonization of the existing ISS internal rules of standardization with new editions of the rules of
international and European standardization organizations. ISS plans to submit its application for full
membership in CEN and CENELEC in 2016, when ISS fulfills the prescribed conditions.
In addition, ISS plans to work more intensively on promoting the importance of standardization and application
of standards, as well as education of all interested parties in the RS participating in the process of adoption of
standards, both at national and at European and international level.
In the first half of 2016 the harmonization of the Statute of the ISS as the highest general act of ISS with the
Decision amending the Decision on Establishing the Institute for Standardization of Serbia is planned.
Strategy for Improving the System of Quality Infrastructure in the RS for the period 2015-2020 was drafted
and adopted ("Off. Gazette of RS", no. 93/15). In order to achieve the general objectives of the system of
quality infrastructure in the field of standardization, specific objectives have been set up and one of the basic
ones is maintenance of full membership of ISS in international organizations for standardization and gaining
full membership in relevant European standardization organizations (CEN and CENELEC) as well as active
participation in their work and creation of standardization policy. The framework for the implementation of
this defined goal is specified by the action plan for 2016. This plan foresees the adoption of a new Statute of
ISS in the first half of 2016.
In addition to the above objective, in the period from 2016 to 2020 the ISS strategy will focus on achievement
of the following strategic objectives:
raising awareness of all stakeholders and the public on the importance of standardization and the
benefits of implementing the standards in practice;
active involvement of the largest possible number of stakeholders, especially SMEs in the work of the
national technical committees;
ensuring the translation of European standards into the Serbian language;
introduction of new services and increasing efficiency in the provision of all ISS services.
Some of the specific requirements from provisions of EU Regulation 1025/2015, which are transferred in the
above mentioned legal acts of the RS, were implemented through:
facilitating effective access to standards and enhancing the participation of SMEs in the preparation of
standards;
ensuring more effective cooperation between the European standardization organizations, national
standardization bodies and the European Commission;
ensuring more direct participation of all stakeholders in European standardization;
improving and accelerating the process of preparation of standards at European level through increased
transparency of the procedure and consultations with stakeholders, etc.
During the explanatory screening held on 18 June 2014 in the field of standardization, the European
Commission presented the Regulation on European standardization no. 1025/2012 ((Regulation (EU) No
1025/2012 of the European Parliament and of the Council). The Screening Report from the bilateral meeting
held on 10 September 2014 for the area of standardization indicated the complete harmonization of national
legal acts with the EU Regulation 1025/2012 as one of the planned activities, through amendments to the Law
on Standardization and amendments to the Regulation on the application procedure and manner of information
relating to technical regulations, conformity assessment procedures and standards, as well as the submission
of an application by ISS for full membership in CEN and CENELEC and becoming a full member of these
organizations in 2016.
In the Annual report of the European Commission for 2015, as part of the overall assessment for the free
movement of goods, it is stated that the RS has made some progress, especially in the area of adoption of
European standards and that better application of technical requirements and standards should be ensured in
the coming year.
Plans for full harmonization with the EU acquis
) Plans in respect of the remaining required legal harmonization of the national framework with the
EU acquis
ISS will adopt a Statute as its general act in the second quarter of 2016, or within six months of the entry into
force of the Decision amending the Decision on Establishing the Institute for Standardization of Serbia and
this will be to harmonize national legal acts with the EU (as well as the general acts of ISS), which regulate
the area of standardization in RS and obligations of ISS as a national standardization body in the RS.
b) Review of measures and activities to be undertaken in order to establish or strengthen institutional
structures and administrative capacity
ISS as a relevant institution involved in the transposition, implementation and enforcement of Regulation
1025/2012 plans to increase its number of employees to 61 in 2016, but the ultimate goal is to increase this
number to 10, i.e. 71 employees by the end of 2018. The number of employees is in accordance with the
objectives stated in the bilateral screening held on 10 September 2014, in the field of standardization.
In addition, ISS plans to submit an application for full membership in European organizations CEN and
CENELEC in 2016, meet the criteria for membership in these organizations on the basis of the document
CEN/CENELEC Guide 20: 2015-02 (fourth edition) and be admitted to these organizations as a full member.
ISS intends to maintain the status of a full member of CEN and CENELEC before RS becomes a member of
the European Union at the beginning of the next EU budget period, i.e. 1 January 2021.
criteria for competency assessors in certain areas of conformity assessment, identify potential assessors and
assist the ABS regarding the recognition of interlaboratory comparison schemes.
For performing tasks from its scope, ABS has the appropriate necessary resources at its disposal, in terms of
financial and material and human resources. When it comes to human resources, ABS has competent staff
(permanent employees of the ABS, assessors and technical experts from the Register of assessors and technical
experts and other persons engaged externally) so that accreditation procedures are carried out in a competent
and orderly manner and within the set and satisfying time limits.
In late August 2016, ABS had a total of 40 full-time employees, 22 of whom are leading assessors and/or
managers of the subject of accreditation. In the Register of assessors and technical experts used in the CAB
evaluation process, the ABS has 301 (19 foreign) leading assessors, technical assessors and technical experts
on 31 August 2016. In the Register of decision experts, ABS has 81 experts - members of 13 different sectoral
committees. Those human capacities are used as relevant to the transfer, implementation and enforcement of
the EU acquis in the field of accreditation of CABs.
c) Description of other measures and activities taken so far in order to achieve full harmonization with
the EU acquis
With the implementation of the Law on Accreditation, which is aligned with the EU acquis, by 31 August
2016 the ABS has, through the realization of annual plans and programs adopted by the management board, in
response to the needs of business entities in the Republic of Serbia, accredited a total of 531 CABs as follows:
123 inspection bodies, 21 certification body for certification of products, 14 certification bodies for
certification of management systems, 5 certification bodies for certification of persons, 55 calibration
laboratories, 11 medical laboratories and 302 testing laboratories. Among the accredited CABs are also CABs
which are, based on accreditation with the ABS, appointed/authorized for conformity assessment activities of
the technical regulations of the Republic of Serbia which transposed the Directives of the New Approach, or
regulations for EU harmonization as follows: Rulebook on Safety of Machinery (5), Rulebook on
Electromagnetic Compatibility (5), Rulebook on Safety of Elevators (11), Rulebook on Personal Protective
Equipment (4), Rulebook on Electrical Equipment designed for Use Within Certain Voltage Limits (4),
Rulebook on Transportable Pressurized Equipment (10), Rulebook on Equipment and Protective Systems
intended for Use in Potentially Explosive Atmospheres (2), Rulebook on Radio Equipment and
Telecommunications Terminal Equipment (1), Rulebook on Technical Requirements for the Design,
Manufacture and Conformity Assessment of Pressurized Equipment (12), Rulebook on the Labeling and
Marking of Textile Products (1), Rulebook on Measuring Instruments (-), Rulebook on Non-automatic
Weighing Instruments (1) and the Rulebook on the Labeling of Footwear (1).
On 24 May 2012, the ABS became a full member of the European Organization for Accreditation (EA), when
the decision on the signing of multilateral agreements within EA (EA MLA) on the recognition of equivalence
of the accreditation system in the Republic of Serbia with accreditation systems in the member states and the
EU was adopted for the following types of accreditation: testing laboratories, medical laboratories, calibration
laboratories, inspection bodies and certification bodies for certification of products. On 27 May 2014, the ABS
signed a new EA MLA agreement which expanded the area of the recognition of equivalence of accreditation
systems in the Republic of Serbia with accreditation systems in the member states of the EU, the certification
of management systems and certification of persons.
EA MLA was signed based on the results of a detailed and complex peer evaluation of ABS by the EA, when
it was confirmed that the EU acquis in the field of accreditation is applied in the Republic of Serbia. The
aforementioned assessment, pursuant to Regulation (EC) no. 765/2008, was carried out using reliable and
transparent criteria laid down in the international standard ISO/IEC 17011 and Regulation (EC) no. 765/2008,
as well as the evaluation procedure prescribed by the EA. By signing the EA MLA agreement, in addition to
confirming the equivalency of the accreditation system which is being implemented in the Republic of Serbia
with accreditation systems in the member states of the EU, the assumption was created that the competent
national authorities accept the accreditation certificates of accreditation bodies of signatories and documents
of conformity issued by the CAB accredited by the accreditation bodies which are signatories to the EA MLA.
Also, on 24 May 2012 the ABS became a full member of the International Laboratory Accreditation
Cooperation - ILAC and signatory of the ILAC MRA agreement (Mutual Recognition Agreement) for testing
and calibration. On 24 October 2012, the ABS also signed an ILAC MRA agreement for the area of control.
In addition, on 29 December 2011 ABS became a member of the International Accreditation Forum - IAF,
after the signing of the Memorandum of Understanding between the ABS and the IAF, i.e. on 25 October 2012
the ABS signed the IAF MLA (Multilateral Agreement) agreement in the field of product certification. Based
on the aforementioned multilateral agreement signed with the EA, which expanded the area of equivalency
recognition system of accreditation in the Republic of Serbia with accreditation systems in EU member states,
from 6 October 2014 the ABS is a signatory to the IAF MLA agreement in the field of certification of
management systems.
ATS maintains signed agreements by regularly participating in the work of EA, ILAC and IAF bodies,
exchanging information and documentation necessary to maintain the EA MLA, ILAC MRA and IAF MLA
and accredited certificates of conformity issued by accredited CABs with the ABS are accepted by
accreditation bodies from the framework of these multilateral agreements. In particular, by participating in the
work of the EA expert bodies, based on the signed EA MLA agreement, ABS takes part in the development
of concrete plans of implementation of EU legislation in the field of accreditation and conformity assessment,
including the development of sectoral schemes of conformity assessment and other legal acts, as well as in
their implementation, to the extent applicable to the candidate country for accession to the EU.
Plans for full harmonization with the EU acquis
) Review of measures and activities to be undertaken in order to establish or strengthen institutional
structure and administrative capacity
In accordance with the Law on Budget System, it was planned that by the end of 2018, ABS extends its
administrative capacity to 8 employees, i.e. to have a total of 45 employees.
According to the Government's decision on the maximum number of permanent employees in the system of
state bodies, public service system, the system of the Autonomous Province of Vojvodina and local selfgovernment system in 2015, the maximum number of permanent employees in the ABS in 2015 is 39.
ABS has 301 assessors and technical experts, of which 72 are leading assessors, 266 are technical assessors
for all types of accreditation.
b) Planned measures for achieving full harmonization with the EU acquis
In the area of accreditation, strategic orientation of the Republic of Serbia considers ABS as an internationally
recognized and leading accreditation body in the region that provides all the necessary accreditation services,
in accordance with the needs of the economy, CABs and the authorities of the Republic of Serbia. Accordingly,
the strategic role of the ABS is to ensure confidence in the reliability of the results of conformity assessment
of CABs from the Republic of Serbia through the accreditation system.
In order to achieve the general objectives of the system of quality infrastructure of the Republic of Serbia in
the field of accreditation, the following objectives have been established:
1) improving the accreditation system in the Republic of Serbia, with the expansion of the area of operation
of the ABS, in accordance with the needs of the economy, CAB and public administration bodies;
2) maintaining the status of the signatory of the agreement on the recognition of equivalence of the system
of accreditation (EA MLA, ILAS MRA and IAF MLA);
3) raising awareness of all stakeholders and the public about the importance of accreditation.
In order to achieve objective 1), the following measures and activities will be implemented:
- strengthening the competence of employees in the ABS by increasing the number of employees who
have the appropriate expertise and experience that is necessary for the performance of accreditation tasks in
accordance with the requirements of the relevant standards and international documents, as well as through
additional training of employees from ABS for specific types and fields of accreditation;
- enhancing knowledge and providing continuous training, externally hired evaluators and technical
experts, as well as employees within the ABS for new types and areas of accreditation, to meet the needs of
the CAB, the economy and state administration bodies;
- improvement and renewal of knowledge and competence of assessors for existing types and areas
of accreditation through informative seminars and workshops, including annual meetings/training refreshing
the assessors' knowledge;
- continuous review and improvement of the management system of the ABS in accordance with the
requirements of applicable standards, regulations and documents of international accreditation organizations;
- promoting cooperation of the ABS with stakeholders for accreditation and conformity assessment,
especially with the state administration bodies;
- signing of appropriate protocols on cooperation with technical regulations authorities regarding the
use of the function of accreditation for the implementation of such regulations;
- improving the information and communication capacities and optimizing their use.
In order to achieve objective 2), it is necessary for ABS to take the following measures and activities:
- provision of accreditation services in accordance with the best international practice and continuous
improvement of its own processes and procedures and aligning its management system with the EA, IAF and
ILAS recommendations and procedures;
- active participation in the work of relevant international and European accreditation organizations
and the contribution to the harmonization of practice between accreditation bodies and policy-making in the
field of accreditation;
- contributing to the implementation of European cross-border rules by enhancing cooperation with
other accreditation bodies;
- taking all necessary actions to ensure international recognition of the equivalence of Serbian
accreditation in new areas;
- providing conditions for ABS to achieve a stable independent source of funding, which is one of the
conditions for full membership in the European and international accreditation organizations (Regulation
765/2008/EC).
In order to achieve objective 3), it is necessary to implement the following measures and activities:
- continuous implementation of promotional activities about the importance and role of accreditation
in the print and electronic media;
- organizing and holding seminars about the requirements and benefits of accreditation in specific
areas of conformity assessment;
- organizing presentations for state administration bodies which adopt technical regulations on the
role and importance of accreditation as the best and most efficient ways of determining the competence of
CABs.
3.4 Conformity assessment
) The level of compliance of national legislation with key EU acquis
In accordance with the Law on Technical Requirements for Products and Conformity Assessment ("Official
Gazette of RS, no. 36/09), technical requirements and procedures for assessing the conformity of products with
the requirements are prescribed by the competent ministry, in accordance with its scope. At the end of 2009,
bylaws were adopted to regulate in detail the assessment of conformity, when the designation of conformity
assessment bodies started, in accordance with the law, i.e. the new technical regulations.
The manner of application of conformity assessment, the manner of determining and paying the cost of
conformity assessment, the content of the document of conformity, as well as the shape, appearance and
content of the mark of conformity are determined by the Regulation on Manner of Performing Conformity
Assessment, Content of the Document of Conformity, and Shape, Appearance and Content of Mark of
Conformity ("Official Gazette of RS", no. 98/09) and harmonized with the modules defined in the Decision
on a Common Framework for the Marketing of Products no. 768/2008/EC.
The method of designation of conformity assessment bodies (CABs), determining the fulfillment of the
requirements for the designation of CABs, their registration and revocation of licenses for carrying out
conformity assessment is determined by the Regulation on the Manner of Designation and Authorization of
Conformity Assessment Bodies ("Official Gazette of RS", no. 98/09).
The manner of recognition the validity in the Republic of Serbia of the documents of conformity issued by
foreign conformity assessment bodies and marks of conformity is determined by the Regulation on the Manner
of Recognition of Foreign Documents and Marks of Conformity ("Official Gazette of RS", no. 98/09).
Conformity assessment procedures for specific products/product groups in harmonized area are regulated in
detail by the technical regulations of the Republic of Serbia which transpose the relevant EU directives. Lists
of Serbian standards transposed from European harmonized standards which follow Serbian technical
regulations transposed from the EU New Approach directives are regularly updated (and published in the
Official Gazette of the Republic of Serbia).
The procedure of notification of technical regulations, standards and conformity assessment procedures in
accordance with ratified international agreements signed by the Republic of Serbia and European Union rules
is regulated by the Regulation on the Manner of Providing information and Notification of Technical
Regulations, Conformity Assessment and Standards ("Official Gazette RS", no. 45/10, 114/15).
The manner of placing conformity marks on products that comply with the requirements of technical
regulations, prior to the placement on the market and use thereof, as well as the use of marks of conformity
are regulated by the Rulebook on the manner of placing marks of conformity on products as well as the use of
marks of conformity ("Official Gazette RS", no. 25/10).
Serbian legislation is partially harmonized with EU legislation relating to the conformity marking. According
to the applicable legislation in Serbia, the persons responsible for placing the mark of conformity shall be
determined by the relevant technical regulations, where it is stipulated, depending on the case, that a conformity
mark may be placed by the manufacturer, the authorized representative (but also importer), so it is necessary
to further harmonize these provisions with EU legislation.
Technical regulations based on the Law on Technical Requirementsfor Products and Conformity Assessment
regulate, as a rule, placing of the Serbian mark of conformity, and transitional provision in a number of
technical regulations stipulates that the CE mark will be applied as a mark of conformity from the date of
accession of Serbia to the EU or if Serbia signs an Agreement on Conformity Assessment and Acceptance of
industrial products (ACAA) with the EU. However, the transitional provisions are not intended for products
marked by the Serbian conformity mark which will be in the market of Serbia on the day of EU accession, i.e.
entry into force of ACAA agreement, so this area also needs further harmonization, i.e. regulation of the
transitional provisions.
b) Institutional structure and state of administrative capacity
In the Ministry of Economy, Sector for Quality Infrastructure, Department of Technical Regulations in
Harmonized Area, the removal of Barriers to Trade and Projects is in charge of conformity assessment in the
field of legislation harmonized with the EU within the scope of the ministry. Two employees in the Department
are in charge of the activities related to conformity assessment. The Ministry also established the committees
for the designation of conformity assessment bodies under its jurisdiction, in accordance with the technical
regulations transposed from the European New Approach directives. In the period since 2010, the Ministry of
Economy has issued a total of 12 technical regulations transposing the EU New Approach directives and
Committees for the designation of conformity assessment bodies in the following areas were formed:
machinery, lifts, personal protective equipment, electrical equipment/electromagnetic compatibility, noise
emitted by outdoor equipment, ATEX, measuring instruments and non-automatic weighing instruments. The
work of these committees is coordinated by the aforementioned organizational unit. In addition to employees
of the Ministry of Economy, ABS and ISS experts also participate in the committees, as well as other experts
outside the Ministry if necessary.
The current number of employees engaged in conformity assessment at the Department of Technical
Regulations in Harmonized Area, the removal of Barriers to Trade and Projects, the Sector for Quality
Infrastructure, the Ministry of Economy is not enough to support all activities necessary for full harmonization
with EU legislation in this area, as well as the implementation and enforcement thereof.
In addition to the Ministry of Economy, other competent ministries carry out procedures for the designation of
conformity assessment bodies for products conformity assessment under their jurisdiction.
Further education and improvement of human resource capacity is necessary within all ministries that enact
and implement technical regulations, especially in the part relating to the designation/authorization of CABs
and recognition of foreign certificates of conformity issued by foreign conformity assessment bodies.
So far, a total of 39 bodies for the implementation of conformity assessment according to the regulations that
are harmonized with EU directives have been appointed, in the field of machinery, low-voltage electrical
equipment, electromagnetic compatibility, lifts, vessels and pressure equipment, simple pressure vessels,
personal protective equipment, devices and systems intended for use in potentially explosive atmospheres and
radio and telecommunications terminal equipment.
Further directions of development in this area are defined by the Strategy for Improving the System of Quality
Infrastructure for the period 2015-2020 ("Official Gazette of RS", no. 93/15).
c) Description of other measures and activities taken so far in order to achieve full harmonization with
the EU acquis
Activities in this field have been and will continue to be focused on establishing and maintaining a constant
mutual cooperation between competent ministries which adopt regulations, ministries which apply these
regulations, the quality infrastructure institution (ABS ISS), conformity assessment bodies, as well as market
operators and consumers to which these regulations apply, all in order to implement activities to improve the
infrastructure for conformity assessment, i.e. monitoring of the implementation of the new framework for
placing these products on the market or in use.
Also, monitoring and harmonization of national legislation with EU legislation relating to conformity
assessment will continue, i.e. directives and regulations in harmonized area (in the case of changes in EU
legislation).
In order to improve the capacity of conformity assessment bodies, in terms of staff training and provision of
equipment, a project financed from the funds of IPA 2013 Support to Industry Development through
Strengthening Capacities of Authorities in charge of NQI and Providers of Conformity Assessment (CA)
Services is underway within the Program for Strengthening the Business Environment, Infrastructure and
Innovation. As part of these measures, two operations are foreseen: purchase of equipment for conformity
assessment bodies and technical support to institutions of quality infrastructure.
Twinning project - Strengthening Capacities of National Quality Infrastructure (NQI) and Conformity
Assessment (CA) Services in the Republic of Serbia - SR 13 IB EC 01, with the aim of strengthening the
capacity of the quality infrastructure and full implementation of technical regulations harmonized with EU
regulations began in October 2015 and it is carried out by a consortium of institutions from the fields of quality
infrastructure in the Czech Republic (CMI, CAI, UNMZ) in cooperation with the Ministry of Economy of the
Republic of Serbia.
Project of the Swedish International Development Cooperation Agency (SIDA), EFTA and of the European
Committee for Standardization (CEN) "Quality Infrastructure in the Western Balkans" is focused on easier
integration of the Serbian economy into the European market, including the establishment of a regional forum
for the conformity assessment, increasing the level of awareness about the importance of conformity
assessment, as well as activities aimed at strengthening capacities and increasing confidence in product testing
and validity of reports and certificates.
After the realization of the projects mentioned in the program which will be financed from IPA II funds, project
proposals planned from 2017 will further strengthen the capacities of conformity assessment systems in Serbia.
2) Plans for full harmonization with the EU acquis
) Plans in respect of the remaining necessary harmonization of the national legislative framework
with the EU acquis
Amendments to the Law on Technical Requirements for Products and Conformity Assessment, as well as
preparation for the amendment of bylaws that more closely regulate the area of conformity assessment is
planned to be completed by the end of 2017, in order to effect complete harmonization with the Decision on a
Common Framework for the Marketing of Products no. 768/2008/EC.
b) Review of measures and activities to be undertaken in order to establish or strengthen institutional
structure and administrative capacity
Promotional meetings and training on the use of technical regulations are also planned which, with the
technical requirements for products, also prescribe conformity assessment procedures (for manufacturers,
importers, distributors of products that are covered by the requirements for the implementation of conformity
assessment procedures, conformity assessment bodies and other interested parties).
c) The measures planned to achieve full harmonization with the EU acquis
In the period until 31 December 2018, and after that date, training of business entities in connection with the
implementation of the Law on Technical Requirements for Products and Conformity Assessment will be
carried out as a regular activity, as well as the bylaws issued pursuant to this law.Appendix A) Plan of
harmonization of legislation of RS with the EU acquis
Planned
Regulation
Regulation
Competent
No
regulation
Deadline
elex
translated
name
institution
code
7.
2016-405
Law on
E
IV quarter
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Technical
2017
Requirements
for Products and
Conformity
Assessment
8.
2016-552
Regulation on
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Manner of
2018
Recognition of
Foreign
Documents of
Conformity and
Marks of
Conformity
9.
2016-553
Regulation on
E
IV quarter
32008D0768
no
Manner of
2018
Designation and
Authorization of
Conformity
Assessment
Bodies
10.
2016-554
Regulation on
Manner of
Conformity
Assessment,
Content of
Document of
Conformity, and
Shape,
Appearance and
Content of Mark
of Conformity
IV quarter
2018
32008D0768
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3.5. Notification
) The level of harmonization of national legislation with the key EU acquis
Activities on the harmonization of the laws of the Republic of Serbia in this area was conducted by the Ministry
of Economy, Sector for Quality Infrastructure. Regulation on amending the Regulation on the Manner of
Providing information and Notification of Technical Regulations, Conformity Assessment and Standards was
adopted by the Government on 30 December 2015 and published in the "Official Gazette of RS", no. 114/15
of 31 December 2015. Regulation transposed Directive (EU 2015) 1535 of the European Parliament and of the
Council of 9 September 2015, which refers to the procedure for notifying technical regulations and rules on
information society services.
The European Commission issued a recommendation in terms of adoption of technical regulations under urgent
procedure to allow giving remarks to such technical regulations under preparation by the European
Commission and member states.
The suggestion of the European Commission was adopted and the text was improved in the revised Regulation,
and giving remarks to technical regulations was allowed in the preparatory phase when decisions are under
urgent procedure.
b) Institutional structure and state of administrative capacity
The Ministry of Economy, Sector for Quality Infrastructure, the Group for the Removal of Barriers to Trade
in Non-harmonized Area, Registers and Info-center with 3 employees are in charge of transposing this
regulation, which, in addition to other tasks, perform tasks related to the transposition and implementation of
this regulation.
Plans for full harmonization with the EU acquis
b) Review of measures and activities to be undertaken in order to establish or strengthen institutional
structure and administrative capacity
Through the Twinning project funded by the IPA 2013 - Strengthening Capacities of National Quality
Infrastructure and Conformity Assessment Services in the Republic of Serbia is intended to strengthen the
capacity of the Ministry of Economy as the contact point for notifying technical regulations.
c) The measures planned to achieve full harmonization with the EU acquis
The preparation of the campaign is underway relating to the application of the adopted Regulation, taking into
account the partial application of the Regulation pursuant to Article 13 of CEFTA Agreement and obligations
of the CEFTA parties to apply technical regulations in the preparation stage. The campaign will be primarily
directed towards all the bodies and organizations of the state administration adopting technical regulations, but
also towards business entities as potential actors in giving objections to domestic and foreign technical
regulations at the stage of their preparation. The campaign will be conducted in 2016 and 2017.
3.6. Market surveillance product safety
) The level of harmonization of national legislation with key EU acquis
Strategy of Market Surveillance ("Off. Gazette of RS", no. 68/10) identified the main directions of
development in the field of market surveillance. That Strategy of Market Surveillance was implemented in the
period 2010-2015 and it required a New Approach in the implementation of market surveillance activities in
the Republic of Serbia. The obligation of the authorities was established to take responsibility for the
implementation of the principles that make market surveillance effective in the period of implementation of
this strategy so as to contribute to fair competition in the market, consumer protection and other aspects of
public interest. Among other things, this Strategy bound the market surveillance authorities to apply risk
assessment methods focused on dangerous products, services and practices with serious and intentional
irregularities using a coordinated approach. The market surveillance authorities are expected to take measures
in cooperation with other enforcement measures and directing of operational programs and measures. This is
aimed towards adopting a unified approach in the application of the same measures for the same violation of
regulations to all who make the violation. The tendency is towards reducing the number of controls and
increasing the results. In this sense, cooperation has been established between the Market Inspection, Sanitary
Inspection, Inspection for Environmental Protection, as well as between the Market Inspection, Customs
Administration and the Sector for quality infrastructure ME, which is based on a protocol on cooperation and
which is further developed through established mechanisms of communication.
One of the key tasks based on the Strategy of Market Surveillance is achieved through the adoption of the Law
on Market Surveillance with the aim of fully implementing the EU principles in the field of market surveillance
and fuller compliance with Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9
July 2008, prescribing the requirements for accreditation and market surveillance relating to trade products
and repealing Regulation (EEC) No 339/93.
On 6 December 2011, the Assembly of the Republic of Serbia adopted the Law on Market Surveillance ("Off.
Gazette of RS", no. 92/11). The law regulates the implementation of activities and undertaking measures of
market surveillance within the scope of the competent market surveillance authorities, governing cooperation
between market surveillance authorities and customs authorities, exchange of information and communication
with stakeholders, planning and monitoring of market surveillance activities and in this regard, it is harmonized
with Regulation (EC) 765/2008 of the European Parliament and of the Council of 9 July 2008, laying down
the requirements for accreditation and market surveillance relating to trade products and repealing Regulation
(EEC) No 339/93. This law is the basis for the constitution of the Product Safety Council which aims to
improve the coordination of market surveillance.
The Product Safety Council was constituted in order to improve coordination and cooperation in the field of
market surveillance. The composition, role and tasks of this Council are defined by the Law on Market
Surveillance ("Off. Gazette of RS", no. 92/11) and the Decision of the Government O5 number 02-93/2013 of
24 January 2013, as amended in August 2015.
The composition of the Council includes representatives from the market surveillance authorities and other
bodies and organizations in the field of quality infrastructure, as well as representatives of the Customs
Administration and the ministry responsible for science and technological development. The representatives
of the Chamber of Commerce and consumer organizations also participate in the work of the Council.
Bearing in mind the legal and institutional framework for market surveillance, it was found that the Council
performs the following tasks:
monitors and analyzes the implementation of the activities and takes measures of market surveillance and
the effects of these actions and measures;
gives opinions and recommendations relating to the implementation of regulations in the area of market
surveillance;
monitors the functioning of mechanisms for communication and cooperation between market surveillance
authorities and customs authorities and market surveillance authorities and other stakeholders;
makes recommendations for the effective implementation of these mechanisms;
considers and gives opinion on the reports relating to the handling of complaints in relation to the risks
arising from non-food products as well as accidents and damage to health which are suspected to have
been caused by those products, taking corrective measures and other issues related the obligations of
market surveillance authorities;
coordinates the activities and measures of market surveillance.
Coordination in the field of market surveillance, carried out by this council with professional, administrative
and technical support to the Ministry of Trade, Tourism and Telecommunications, includes the following tasks:
performing administrative tasks and management of the Product Safety Council (preparation of meetings,
action plans, managing the work of the working groups, preparation and consolidation of reports for the
Government);
supporting the market surveillance authorities in the implementation of their obligations in accordance
with the Law on Market Surveillance and other regulations in this area;
consolidation of the administration system of rapid exchange of information on hazardous (non food)
products.
The Product Safety Council directs the affairs of products in the field of market surveillance to the activities
that are based on effective consultation with all stakeholders and that contribute to the protection of consumers
and other users of products and support the business sector and fair competition, in accordance with the
strategic and legal framework in this area and by applying best practices in market surveillance.
The Council discussed the issues from the scope of market surveillance authorities, including the reports on
activities of market surveillance authorities in certain sectors, in accordance with the approved work plan.
Status information regarding the transposition of relevant EU legislation in certain sectors (construction
products, toys) were required and considered. The issues of cooperation between authorities responsible for
the implementation of the Rulebook on the Safety of Lifts, regulations from the scope of the Market Inspection,
Sanitary Inspection, Inspection for Protection against Ionizing Radiation, Labour Inspection were discussed,
as well as specific cases from the direct cooperation of the Customs Administration with inspection authorities.
The information-documentation basis was made for the preparation of a general market surveillance program,
and three workshops for members of the Council were organized where particular attention was paid to the
forms of cooperation and coordination from practice of the EU Member States.
Within the project IPA 2010 Strengthening of market surveillance in Serbia for non-food and food products,
which was implemented as of 16 July 2012 to December 2014, the Plan of continuous professional education
and training of inspectors (485 participants) was implemented, which covers the area of application of
regulations on safety of electrical products (LVD), machines (MD), electromagnetic compatibility (EMC), risk
assessment, and includes educating trainers for further training of market inspectors in the field of application
of these regulations. Within the same project, software for information management in the area of market
surveillance (MIS MI) was developed, aimed at improving the database for more efficient performance of
market surveillance and a System for the Rapid Exchange of Information on Dangerous Products (NEPRO
Plus).
Quality manual was designed with procedures for key work processes, which include the procedure of direct
inspection supervision and the procedure of sampling products for laboratory tests. A detailed analysis of the
conformity of the Law on General Product Safety was done and a high level of compliance with the Directive
on General Product Safety (2001/95/EC) was established. Recommendations regarding the further
harmonization of this law with the Directive on General Product Safety (2001/95/EC) were given.
During 2015, the market inspectors conducted 5,199 inspections in the field of compliance and product safety.
In connection with these controls, they have filed 688 requests to judicial authorities and adopted 763 decisions
ordering the elimination of established irregularities. In accordance with the Annual plan of market
surveillance and complaints received, inspections included the following groups of products: electrical
appliances, insulation material, textile products, concrete steel and welded tubes, cordless phones, power
detectors, portable chain saws, tires for passenger cars, brake linings, water filtration apparatuses, furniture,
leather goods, cotton, petroleum products and other products. Withdrawal from the market and other measures
of trade restrictions are taken for non-compliant or hazardous products from mentioned product groups in the
amount of 612,147,721.00 dinars. Measures of market surveillance measures were in proportion to the
irregularities. For products in the System of Rapid Exchange of Information on Hazardous Products (electrical
appliances, motor vehicles, products for children, etc.), restrictive measures were taken by informing the public
that these are hazardous products.
In the context of regional cooperation in the field of market surveillance, a network of contact points for the
exhange of information on hazardous products was set up. Regular cooperation through the network of contact
points and through the development of a plan of joint actions for the selected product groups was established.
Joint activities are organized by PROSAFE methodology, project planning and implementation of the
supervision of such surveillance, which included sampling of products for analysis and risk assessment and
taking appropriate measures of market surveillance. Joint inspections in the region related to the safety checks
of electrical products, toys and products for children and were implemented in the framework of the regional
Project- Open Regional Fund for the Promotion of Trade implemented by GIZ (Deutsche Gesellschaft fuer
Internationale Zusammenarbeit) and funded within the funds approved by the German Federal Ministry for
Economic Cooperation and Development. This Project devoted attention to the cooperation of market
surveillance authorities with the relevant customs authorities, as well as communication and cooperation of
market surveillance authorities with business entities and consumer organizations and training was organized
in these subjects. The Project was completed in May 2015.
Further directions of development of market surveillance are determined by the Strategy for Improving the
System of Quality Infrastructure for the Period 2015-2020 ("Official Gazette of RS", no. 93/15).
Also, it is important to bear in mind that the National Assembly adopted the Law on Inspection Control
("Official Gazette of RS", no. 36/15) in April 2015, which entered into force on 29 April 2015 with determined
application of 30 April 2016, except for the prevention of illegal work, which is applicable from 30 July 2015.
The professional developer of this law is the Ministry of Public Administration and Local Self-Government.
The Law regulates the contents, types and forms of inspection, the authorizations and obligations of
participants in inspection and other issues of importance for inspection, thus regulating the general rules for
inspections regardless of the area of the inspection without prejudice to the application of procedural measures
harmonized with the EU acquis, and therefore does not preclude the application of the Law on Market
Surveillance relating to the obligations, activities and measures of market surveillance authorities in the field
of market surveillance in the meaning of Regulation 2008/756/EC relating to market surveillance.
The existing Law on Market Surveillance ("Official Gazette of RS", no. 92/2011) is substantially in compliance
with Regulation 2008/765/EC in the part relating to market surveillance. In terms of the provisions of
Regulation 2008/765/EC governing the CE marking, Law on Market Surveillance refers to special regulation
from the scope of Ministry of Economy, i.e. other specific regulations which are also in the process of further
harmonization (e.g. Law on Health Safety of Items of General Use, under the competence of the Ministry of
Health).
Institutional structure and state of administrative capacity
The Ministry of Trade, Tourism and Telecommunications Sector for Market Inspection
There are 434 employees in the Sector for Market Inspection, with 100 market inspectors performing control
of compliance and product safety. The administrative capacity of the Sector for Market Inspection is shown in
the following table:
Total
Number of employees working on
Enforcement
Organizational unit
number of
the transposition/implementation
of regulations
and enforcement of EU acquis
employees
entrusted to
other
institutions
Sector for Market
Inspection (SMI)Assistant MinisterChief market
inspector
Senior Advisers for
coordination in the
field of work of the
Sector-SMI
headquarters
Contact point in the
System of Rapid
Exchange of
Information on
Hazardous Products
(NEPRO)-SMI
headquarters
Department for
General Supervision
of the seat-SMI
headquarters (illegal
trade, unfair
competition,
advertising,
implementation of
IPRs, prevention of
money laundering,
electronic commerce)-coordination
Department for
Technical
Supervision-SMI
headquarters
(monitoring for
compliance and
product safety)coordination
Department for
Training and
Reporting-SMI
headquarterscoordination
Department for
Control of Promptness
of work-SMI
Transposition,
implementation and
enforcement of regulations
Transposition,
implementation and
enforcement of regulations
Implementation and
application of law
Implementation and
application of law
15
15
Implementation and
application of law
24
24
Implementation and
application of law in the
area of conformity and
product safety
Implementation and
application of law
Implementation and
application of law
headquarterscoordination
75
75
289
289
Departments outside
SMI headquarters
Administrative tasks
in SMI-departments in
the headquarters and
departments outside
the headquarters
Implementation and
application of law in the
area of confiormity and
product safety
Implementation and
application of the law for
the prevention of gray
economy, unfair
competition, violation of
IPRs, prevention of money
laundering, protection of
economic interests of
consumers, etc.
Filing tasks
The current number of employees in the Sector for Market Inspection in charge of coordination and
implementation of market surveillance activities, including activities that support market surveillance (regional
and intersectoral cooperation, operations regarding work improvement, exchange of information on hazardous
products, coordination in the field of technical control, education and reporting and other tasks in SMI)
represent the minimum number required for the performance of market surveillance within the scope of this
sector.
c) Description of the measures and activities taken in order to achieve full harmonization with the EU
acquis
The destruction of hazardous products seized during inspection and stored in warehouses under the control of
market inspection began in 2015. The destruction was carried out using machines that were purchased and
installed in the warehouses where the goods seized during an inspection in Belgrade and Irig is stored.
In relation to the use of authorizations of market inspectors for the destruction of hazardous goods, a guide for
dealing with hazardous goods was made, workshops were held for waste management and implementation of
instructions and guidelines for the handling of hazardous goods.
2) Plans for full harmonization with the EU acquis
) Plans in respect of the remaining necessary harmonization of the national legislative framework with
the EU acquis
Expert processing of the law in the process of further harmonization of the horizontal framework for market
surveillance with the relevant EU acquis is the competence of the Ministry of Trade, Tourism and
Telecommunications and is closely associated with the activites of the Ministry of Economy in the field of
editing the technical requirements for products and conformity assessment, the Ministry of Health, the Ministry
of Construction, Transport and Infrastructure and other government bodies responsible for the expert
development of special regulations governing technical requirements for specific categories of products and
conformity assessment.
Therefore, the further harmonization of regulations in the field of market surveillance is closely linked and
coordinated with the planned activities and the dynamics of harmonization of regulations in the field of
conformity assessment, as well as the planned activities and dynamics of adoption of technical regulations
transposing the New Approach directives relating to the CE marking.
b) Review of measures and activities to be undertaken in order to establish or strengthen institutional
structure and administrative capacity
Bearing in mind the results achieved in the 2010 project - "Strengthening the Serbian market surveillance
system, which refers to the introduction of quality systems in the field of market surveillance, the Ministry of
Trade, Tourism and Telecommunications Sector for Market Inspection will continue to work on the analysis
and further development of quality control procedures included in the Quality Manual. Development of
procedures and the list of verification of products to support the operational work of the inspectors in the field
include the purchase of standards which are relevant for the implementation of market surveillance activities
and the application of sector regulations in this area. The purchase of standards for certain groups of products
which transpose New Approach directives and Old Approach directives is planned during 2017. Annual
updating the database of required standards is also planned.
Regional cooperation in the field of market surveillance will be continued.
In order to strengthen administrative capacity for the implementation of market surveillance, the initiated
activities regarding the implementation of the Plan of continuous professional education of market inspectors
will be continued, which includes training in the application of sectoral regulations, practical training in the
field, in laboratories, application of good practice, cooperation with the authorities responsible for customs
control, with other market surveillance authorities and functioning of market surveillance system in general.
Key activities in the period from 2016 to the end of 2018
In 2018 it is necessary to do a detailed analysis in terms of fulfillment of information, technical and human
resources for access to RAPEX and ICSMS and, according to the results of this analysis, submit a formal
request for access to these systems.
In connection with the accession to RAPEX and ICSMS, it is necessary to keep the number of employees in
the Sector for market inspection in charge of coordinating activites of this sector at the headquarters of the
Sector, in charge of exchange of information on hazardous products, in charge of market surveillance, and
primarily in relation to the conformity assessment and product safety, in education and reporting and other
activities related to market surveillance, as shown in the previous table below 1) a) Institutional structure and
state of administrative capacity.
Accession to RAPEX and ICSMS systems requires an appropriate level of development of other market
surveillance authorities participating in the system (Sanitary Inspection, Environmental Protection Inspection,
Labour Inspection, Building Inspection and other inspections, i.e. competent authorities of market surveillance
and Customs Administration).
c) The measures planned to achieve full harmonization with the EU acquis
2016
Draft Law on Amendments to the Law on General Product Safety, after the opinion of the European
Commission and the cross-sectoral harmonization has been obtained, will be submitted to the Government for
laying down the Proposal for the law for consideration and adoption in parliamentary procedure in the IV
quarter of 2016. Law will be passed pursuant to the activities planned in more detail in Chapter 28 "Consumer
Protection and Public Health".
2017-2019
Given the upcoming changes to the Regulation relating to accreditation and market surveillance 765/2008/EC,
depending on how EU regulations in the field of market surveillance change, regulations in the field of market
surveillance shall be subject to amendments.
Also, the harmonization of the Law on Market Surveillance will be done according to organizational changes
in the ministries, depending on the amendments to the Law on Ministries in the period 2017-2019.
Appendix A) Plan of harmonization of legislation of RS with the EU acquis
No
1.
2.
Planned
regulation
code
2016-121
2016-120
Regulation
name
Competent
institution
Deadline
elex
Regulation
translated
Law on
Amendments to
the Law on
General Product
Safety
Law on
Amendments to
the Law on
Market
Surveillance
IV quarter
32001L0095
yes
32008R0765
yes
2016
IV quarter
2017
NEW APPROACH
Low-voltage electrical equipment
1) Outline of status of harmonization
) The level of harmonization of national legislation with key EU acquis
Technical requirements, conformity assessment, as well as other requirements and conditions for the placing
on the market and/or in use of low-voltage electrical equipment are governed by the Rulebook on Electrical
Equipment Intended for Use Within Certain Voltage Limits ("Official Gazette of RS", no. 13/10). This
rulebook was adopted on the basis of the Law on Technical Requirements for Products and Conformity
Assessment ("Official Gazette of RS", no. 36/09), and its implementation started on 20 March 2010. In
accordance with the Screening Report for Chapter 1, this Regulation is partially harmonized with the Directive
2006/95/EC, given that it contains certain national provisions which shall apply until the entry into force of
the ACAA Agreement for low-voltage electrical equipment or unitl the accession of the Republic of Serbia to
the EU (full harmonization is provided by the transitional provisions of this Rulebook). New Rulebook, which
is made to comply with the new Directive 2014/35/EU, is published in the "Official Gazette of RS", no.
25/2016 of 03/09/2016.
b) Institutional structure and state of administrative capacity
The Ministry of Economy is the authority responsible for the adoption and implementation of technical
regulations in the field of low-voltage electrical equipment. At this point, two employed civil servants in the
Sector for Quality Infrastructure perform tasks within the scope of the Sector pertaining to the adoption and
implementation of technical regulations transposing the EU directives of the new and the Old Approach in the
following areas: low-voltage electrical equipment, electromagnetic compatibility, machinery, lifts, personal
protective equipment, equipment and protective systems intended for use in potentially explosive atmospheres,
equipment that emits noise outdoors, textiles, footwear, crystal glass.
Market surveillance of low-voltage electrical equipment is the jurisdiction of the Ministry of Trade, Tourism
and Telecommunications. At this point, in the Sector for Market Inspection about 100 inspectors perform tasks
related to the market surveillance of products from the scope of the sector, including the monitoring of lowvoltage electrical equipment. For more information, see "Market Surveillance product safety".
c) Description of other measures and activities taken so far in order to achieve full harmonization with
the EU acquis
In the period from 2010 to 2016 various projects supporting the development of quality infrastructure (QI)
have been implemented in the Republic of Serbia (IPA 2008, IPA 2010, IPA 2011, GIZ ACCESS 1), including
QI in the field of low-voltage electrical equipment. Users of these projects were relevant ministries and other
QI institutions in this area, as well as the conformity assessment bodies of low-voltage electrical equipment.
In accordance with the obligation under Article 77, item 2a of the SAA, numerous seminars and trainings were
organized on the application of national technical legislations which transposed Directive 2006/95/EC;
seminars also include education on the importance of harmonized standards and promotion of their application;
a guide and a manual for the implementation of this technical regulation was prepared and published.
In accordance with the recommendation of the European Commission and the Screening Report for Chapter
1, in April 2015 the regulation governing the import of low-voltage electrical equipment was amended, which
required certificates of conformity at customs, ie. the measure that the EC recognized as a trade barrier was
revoked.
2) Plans for full harmonization with the EU acquis
) Plans in respect of the remaining necessary harmonization of the national legislative framework
with the EU acquis
Implementation of the new Rulebook on Electrical Equipment Intended for Use Within Certain Voltage Limits
("Official Gazette of RS", no. 25/2016), which provides for compliance with Directive 2014/35/EU, starts 1
July 2017.
b) Review of measures and activities to be undertaken in order to establish or strengthen institutional
structure and administrative capacity
It is necessary to employ at least one civil servant in the competent unit in 2016/2017 for effective performance
of all tasks within the scope of the Ministry of Economy.
For plans in the field of market surveillance, see section "Market surveillance - product safety".
The competent authorities will continue to provide training of civil servants employed in these bodies regarding
the application of national legislation harmonized with the EU directive, in accordance with EC guidelines and
good practice in EU member states.
c) The measures planned to achieve full harmonization with the EU acquis
Within the Project of Support to the Development of Quality Infrastructure (IPA 2013), purchase of equipment
is planned for conformity assessment bodies of low-voltage electrical equipment in the course of 2016.
In the period from 2016 to 2018, the implementation of the project "Quality Infrastructure in the Western
Balkans" is planned, funded jointly by the Swedish International Development Cooperation Agency (SIDA)
and the European Free Trade Association (EFTA). In the framework of this project, activities relating to QI in
the field of low-voltage electrical equipment are also planned.
In the period to 31 December 2018, and as a regular activity after that date, training of business entities in
connection with the implementation of national technical regulations harmonized with Directive 2014/35/EU
and promotion of the implementation of the harmonized standards in the field of safety of low-voltage electrical
equipment will be carried out.
Gas appliance
1) Outline of status of harmonization
) The level of harmonization of national legislation with key EU acquis
Ministry of Mining and Energy issued the Rulebook on the Requirements for the Design, Manufacture and
Conformity Assessment of Gas Appliances ("Official Gazette of RS, no. 41/15), which entered into force on
16 May 2015, and is applied from 1 January 2016. This rulebook was adopted on the basis of the Law on
Technical Requirements for Products and Conformity Assessment ("Official Gazette of RS, no. 36/09). List of
Serbian standards in the field of gas appliances ("Official Gazette of RS, No. 65/15) was published, which is
in effect from 7 July 2015.
b) Institutional structure and state of administrative capacity
Ministry of Mining and Energy is the body responsible for the adoption and implementation of technical
regulations in the field of gas appliances.
Appendix A) Plan of harmonization of legislation of RS with the EU acquis
No
Planned
regulati
on code
1.
Regulation
name
Rulebook on the
Requirements for
the Design,
Manufacture and
Conformity
assessment of gas
appliances
Competen
t
institution
ME
Deadline
Regulation
entered into
force on 16
May 2015
and shall
apply from 1
January 2016
elex
32009L0142
Regula
tion
transla
ted
No
Safety of machinery
1) Outline of status of harmonization
) The level of harmonization of national legislation with key EU acquis
Technical requirements, conformity assessment, as well as other requirements and conditions for the placement
on the market and putting into service of machinery are governed by the Rulebook on the Safety of Machinery
("Official Gazette of RS", no. 13/10). This rulebook was adopted on the basis of the Law on Technical
Requirements for Products and Conformity Assessment ("Official Gazette of RS, no. 36/09) and its
implementation started on 20 March 2010. In accordance with the Screening Report for Chapter 1, this
rulebook is partially harmonized with the Directive 2006/42/EC, given that it contains certain national
provisions that shall apply until the entry into force of the ACAA agreement for machines or until the accession
of the Republic of Serbia to the EU. A new Rulebook on the Safety of Machines was adopted ("Official Gazette
of RS", no. 58/16), which provides additional harmonization with Directive 2006/42/EC, in accordance with
its amendments of Directive 2009/127/EC relating to machinery for applying pesticides.
The competent authorities will continue to provide training of employees in these bodies regarding the
application of national legislation harmonized with the EU directive, in accordance with EC guidelines and
good practice in EU member states.
c) The measures planned to achieve full harmonization with the EU acquis
In the period to 31 December 2018, and after that date, training of business entities in connection with the
implementation of national technical legislations harmonized with Directive 2006/42/EC will be carried out as
a regular activity and the use of harmonized standards in the field of machine safety will be promoted.
Explosives for civilian use and pyrotechnical products
1) Outline of status of harmonization
) The level of harmonization of national legislation with key EU acquis
Adoption of regulations in the field of explosives for civil use and pyrotechnical products is the responsibility
of the Ministry of Interior (MI) - Sector for Emergency Management Preventive Protection Directorate.
This area is currently regulated by the Law on Trade of Explosive Substances ("Off. Gazette of the SFRY",
no. 30/85) and the Law on Explosive Substances, Flammable Liquids and Gases ("Off. Gazette of SRS, no.
44/77, 45/85 and 18/89 ("Official Gazette of RS", no. 53/93, 67/93, 48/94 and 101/2005 state law) and
secondary legislation adopted thereunder.
These laws and bylaws are not harmonized with European directives.
b) Institutional structure and state of administrative capacity
Preventive Protection Directorate is the competent authority in the field of explosives for civil use and
pyrotechnical products.
In the scope of Preventive Protection Directive, Department for Control of Traffic and Transport of Hazardous
Substances performs legislative, administrative and coordination activities relating to explosives for civilian
use and pyrotechnical products.
The institutional framework and the existing capacities relevant to the transposition, implementation and
enforcement of the EU acquis are also presented in the following table:
Organizational
unit
Department for
Control of
Traffic and
Transport of
Hazardous
Substances
Total
number of
employees
Enforcement of
regulations entrusted to
other institutions
Transposition
Not entrusted to other
institutions.
7
7
Implementation and
enforcement
The current number of employees and their educational profile in the Preventive Protection Directorate in this
area is not sufficient to support the further transposition of EU legislation into national legislation, as well as
their implementation and enforcement.
The Department for Control of Traffic and Transport of Hazardous Substances, in addition to implementation
and enforcement of the Law on Trade of Explosive Substances, also implements authorization of legal entities
for transport and control over the work of these legal entities.
c) Description of other measures and activities taken so far in order to achieve full harmonization with
the EU acquis
Members of the subcommittee for explosives for civil use and pyrotechnical products participate in the
activities carried out by NG 1.
2) Plans for full harmonization with the EU acquis
) Plans in respect of the remaining necessary harmonization of the national legislative framework
with the EU acquis
Given the fact that the area of explosives for civilian use and pyrotechnical products is not harmonized with
the European legislation, adoption of the Law on Explosive Substances and relevant bylaws - Rulebook on
Explosives for Civilian Use and the Rulebook of Pyrotechnical Products is planned, which will transpose EU
legal acts.
b) Review of measures and activities to be undertaken in order to establish or strengthen institutional
structure and administrative capacity
In addition to the harmonization of legislation of the Republic of Serbia as a state in the process of accession
to the EU, one of the main priorities is also to ensure that the competent authorities in this field have a sufficient
number of suitably qualified and experienced staff so that obligations laid down in EU regulations are carried
out efficiently and effectively, including the relevant inspection bodies and testing laboratories. In addition, it
is necessary to determine the national reference laboratories.
In the period until 2018 it is necessary to perform recruitment of new staff for inspection activities, bearing in
mind the obligations arising from the Law on Inspection Control ("Off. Gazette of RS", no. 36/15). In the
context of the implementation of the Law, in addition to employment of new staff for inspection tasks, activities
will be conducted on the development of information system, as well as the establishment of a system of
training and evaluation of skills of inspectors.
c) The measures planned to achieve full harmonization with the EU acquis
2016 and 2017
In accordance with the relevant EU regulations, a draft Law on Explosive Materials will be drawn up. Key
activities to be undertaken during the period by the end of 2016 relate to the drafting of the draft of the new
Law on Explosive Substances, adoption thereof, and adoption of bylaws by the end of 2017 and organization
of workshops for informing stakeholders of the new legal regulations in the period thereafter by the end of
2018.
Appendix A) Plan of harmonization of legislation of RS with the EU acquis
Planned
Regulation
Regulation
Competent
No
regulation
Deadline
elex
translated
name
institution
code
1.
2013-245
Law on
Explosive
Substances
MI
III quarter
2017
no
IV quarter
2017
31993L0015
32004L0057
32007L0023
32014L0028
32014L0028
31993L0015
2.
Rulebook on
Explosives for
Civilian Use
MI
3.
Rulebook on
Pyrotechnical
Products
MI
IV quarter
2017
32004L0057
32007L0023
no
no
Equipment and protective systems intended for use in potentially explosive atmospheres
1) Outline of status of harmonization
) The level of harmonization of national legislation with key EU acquis
Technical requirements, conformity assessment, as well as other requirements and conditions for the placing
on the market and/or putting into service of products intended for use in potentially explosive atmospheres are
regulated by the Rulebook on Equipment and Protective Systems Intended for Use in Potentially Explosive
Atmospheres ("Official Gazette of RS", no. 1/13). This Rulebook was adopted on the basis of the Law on
Technical Requirements for Products and Conformity Assessment ("Official Gazette of RS", no. 36/09), and
its implementation stared on 1 January 2015. In accordance with the Screening Report for Chapter 1, this
Rulebook is partially harmonized with the Directive 94/9/EC, given that it contains certain national provisions
which shall apply until the entry into force of the ACAA Agreement for products intended for use in potentially
explosive atmospheres or until the accession of the Republic of Serbia to the EU (full compliance is ensured
by transitional provisions of this Rulebook).
b) Institutional structure and state of administrative capacity
The Ministry of Economy is the authority responsible for the adoption and implementation of technical
regulations in the field of products intended for use in potentially explosive atmospheres. At this point in the
Sector for Quality Infrastructure employs two employees performing tasks related to the adoption and
implementation of technical regulations transposing the EU directives of the new and the Old Approach in the
following areas: low-voltage electrical equipment, electromagnetic compatibility, machinery, lifts, personal
protective equipment, equipment and protective systems intended for use in potentially explosive atmospheres,
equipment that emits noise outdoors, textiles, footwear and crystal glass.
The inspectors of the Ministry of Interior (MI) - Sector for Emergency Situations and the Ministry of Mining
and Energy (MME) - Department of Geology and Mining are responsible for market surveillance of products
intended for use in potentially explosive atmospheres. At this point, at the Sector for emergency situations at
the Ministry of Interior, at the headquarters and regional organizational units, a total of about 220 inspectors
perform inspection tasks in the field of preventive protection, including protection from explosions in overhead
industry facilities. In the Department of Geology and Mining of MME, at this point, three inspectors exercise,
inter alia, supervision in connection with potentially explosive atmospheres in places of underground and
aboveground mining of mineral raw materials. Inspection supervision over the implementation of the
Regulation on Preventive Measures for Safe and Healthy Work Due to the Risk of Explosive Atmospheres
("Official Gazette of RS", no. 101/12 and 12/13-corr.) transposing Directive 1999/92/EC is also exercised by
labour inspectors in the Ministry of Labour, Employment and Veteran and Social Affairs - Labour Inspectorate.
For more information, see section "Market surveillance product safety".
c) Description of other measures and activities taken so far in order to achieve full harmonization with
the EU acquis
Within the project "Support of the Quality Infrastructure in Serbia", with the support of the German conformity
assessment bodies PTB (Physikalisch-Technische Bundesanstalt), for the needs of the relevant institutions and
bodies for conformity assessment, a seminar was held on the application of Directive 94/9/EC and innovations
brought by the new Directive 2014/34/EU in May 2014 in Belgrade. Also, within this project a study visit of
representatives of ABS and conformity assessment bodies to RTV was realized in December 2014.
In accordance with the obligation under Article 77, item 2a of SAA, a number of seminars was organized on
the implementation of national technical legislations which transposed Directive 94/9 EC; seminars and
training also included education on the importance of harmonized standards and promotion of their application;
a short guide for the application of this technical regulation was developed and published.
2)Plans for full harmonization with the EU acquis
) Plans in respect of the remaining necessary harmonization of the national legislative framework
with the EU acquis
When drafting the Rulebook on equipment and protective systems intended for use in potentially explosive
atmospheres, proposal of the new EU directive was taken into account, so this technical regulation already
significantly complies with Directive 2014/34/EU, which will start to apply April 20, 2016 in the EU. Further
harmonization of this Rulebook with the new directive is planned by the end of 2016.
b) Review of measures and activities to be undertaken in order to establish or strengthen institutional
structure and administrative capacity
To effectively perform these tasks within the scope of the Ministry of Economy, it is essential for this
department to hire at least one employee in 2016/2017.
For plans in the field of market surveillance, see section "Market surveillance product safety".
In the period from 2016 to the end of 2018, training of employees are necessary of competent authorities in
charge of market surveillance activities related to the implementation of technical regulations which transposed
EU Directive on Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres,
and further training of employees in relevant institutions is planned regarding the implementation of Directive
2014/34/EU and the authorization and designation of conformity assessment bodies.
c) The measures planned to achieve full harmonization with the EU acquis
Within the Project of Support for the Development of Quality Infrastructure (IPA 2013), the purchase of testing
equipment for conformity assessment bodies of products intended for use in potentially explosive atmospheres
is planned during 2016.
In the period from 2016 to 2018, the implementation of the Twinning project "Strengthening capacities of
national quality infrastructure and conformity assessment services in the Republic of Serbia" is planned, funded
by the IPA 2013, under which activities relating to QI in this area are planned.
In the period to 31 December 2018, and after that date as a regular activity, training of business entities will
be carried out in connection with the implementation of national technical legislations which transposed EU
directives.
Appendix A) Plan of harmonization of legislation of RS with the EU acquis
Planned
Regulation
Competent
No
regulation
Deadline
name
institution
code
CELEX
Regulation
translated
2016-417
Rulebook on
Equipment and
Protective
Systems
Intended for Use
in Potentially
Explosive
Atmospheres
IV
quarter
2016
32014L0034
No
Lifts
1) Outline of status of harmonization
) The level of harmonization of national legislation with key EU acquis
Technical requirements, conformity assessment, as well as other requirements and conditions for the placing
on the market and putting into service of lifts and safety components of lifts are regulated by the Rulebook on
the Safety of Lifts ("Official Gazette of RS", no. 101/10). This rulebook was adopted on the basis of the Law
on Technical Requirements for Products and Conformity Assessment ("Official Gazette of RS", no. 36/09),
and its implementation started on January 6, 2011, except for the provisions of Art. 27 and 28 of this Rulebook
which were applied from 1 January 2014. In accordance with the Screening Report for Chapter 1, this rulebook
is partly aligned with Directive 95/16/EC, given that it contains certain national provisions shall apply until
the entry into force of the ACAA Agreement for lifts and safety components of lifts or to accession the Republic
of Serbia to the EU.
b) Institutional structure and state of administrative capacity
The Ministry of Economy is the authority responsible for the adoption and implementation of technical
regulations in the field of safety of lifts. At this point the Sector for Quality Infrastructure employs two
employees performing tasks related to the adoption and implementation of technical regulations transposing
the EU directives of the New and the Old Approach in the following areas: low-voltage electrical equipment,
electromagnetic compatibility, machinery, lifts, personal protective equipment, equipment and protective
systems intended for use in potentially explosive atmospheres, equipment that emits noise outdoors, textiles,
footwear and crystal glass.
The market surveillance of lifts and safety components for lifts is the jurisdiction of the Ministry of Trade,
Tourism and Telecommunications. The control of lifts in use is the jurisdiction of the Ministry of Construction,
Transport and Infrastructure, i.e. the Ministry of Labour, Employment and Social Affairs, depending on
whether the lift which is subject to supervision is located in residential or business premises.
c) Description of the measures and activities taken in order to achieve full harmonization with the EU
acquis
In the period from 2011 to 2016 various projects supporting the development of quality infrastructure (QI)
have been implemented in the Republic of Serbia (IPA 2008, IPA 2010, IPA 2011, GIZ ACCESS 1), including
QI in the field of safety of lifts. Users of these projects were relevant ministries and other QI institutions and
conformity assessment bodies in this area.
In accordance with the obligation under Article 77, item 2a of the SAA, a number of seminars, round tables
and training on the application of national technical legislations were organized, which transposed Directive
95/16/EC. The seminars also included education on the importance of harmonized standards and promotion of
their application. A guide and a manual for the implementation of this technical regulation was also prepared
and published.
In accordance with the recommendation of the European Commission and the Screening Report for Chapter
1, publication of a new Rulebook on the Safety of Lifts is planned by the end of 2016, transposing the revised
Directive 2014/33/EU on lifts, as well as the separation from the existing Rulebook and the publication of a
special technical regulation which shall apply to both regular and irregular inspections of lifts during their
service life.
2) Plans for full harmonization with the EU acquis
) Plans in respect of the remaining necessary harmonization of the national legislative framework with
the EU acquis
Adoption of the new Rulebook on the Safety of Lifts, which will transpose Directive 2014/33/EU, and the
application of which will start on 20 April 2016 in the EU, is planned for the fourth quarter of 2016. Also,
within the same period, the Rulebook on Regular and Extraordinary Inspections of Elevators in Use will also
be passed.
b) Review of measures and activities to be undertaken to establish or strengthen the institutional
structure and administrative capacity
For effective performance of these tasks within the scope of the competent Sector in the Ministry of economy,
it is necessary to employ at least one civil servant in 2016/2017.
For plans in the field of market surveillance, see subsection 3.1.1.5.
The competent authorities will continue to provide training of employees in these bodies regarding the
application of national legislation harmonized with the EU Directive, in accordance with EC guidelines and
good practice in EU member states.
c) Review of measures and activities to be undertaken in order to establish or strengthen institutional
structure and administrative capacity
In the period from 2016 to 2018, the implementation of the Twinning project "Strengthening capacities of
national quality infrastructure and conformity assessment services in the Republic of Serbia" is planned, funded
by the IPA 2013, under which activities relating to QI in the field of security of lifts are also planned.
In the period to 31 December 2018, and after that date as a regular activity, training of business entities will
be carried out in connection with the implementation of national technical legislations harmonized with
Directive 2014/33/EU and promotion of the implementation of the harmonized standards in the field of safety
of lifts.
Appendix A) Plan of harmonization of legislation of RS with the EU acquis
Planned
Regulation
Competent
No
regulation
Deadline
elex
name
institution
code
1.
2016-400
Rulebook on
E
IV quarter 32014L0033
Safety of Lifts
2016
2.
2016-550
Rulebook on
ME
IV quarter
Regular and
2016
Extraordinary
Inspections of
Lifts in Use
Pressurized equipment and simple pressure vessels
Regulation
translated
elex
Regulation
translated
32014L0068
no
32014L0029
no
on the preparation and in the process of adopting regulations in the field of radio equipment as well as control
of the implementation of this regulation.
c) Description of the measures and activities taken in order to achieve full harmonization with the EU
acquis
In the framework of the implementation of the Rulebook on R&TT equipment and pursuant to Article 192,
Paragraph 1 of the Law on Administrative Procedure ("Official Gazette of FRY", no. 338/97 and 31/01 and
"Official Gazette of RS", no. 30/10), Article 13 of the Law on Technical Requirements and Article 7, paragraph
4 of the Regulation on the Manner of Designation and Authorization of Conformity Assessment Bodies
("Official Gazette of RS", no. 98/09), the Ministry designated RATEL on 29 May 2012, joint stock company
for quality testing "Quality" on 22 October 2013 and the Company for testing, inspection and certification
"Idvorski laboratories" on 12 June 2015 as the conformity assessment bodies of R&TT equipment.
In July 2014, the Ministry adopted a List of Serbian standards in the field of radio equipment and
telecommunications terminal equipment ("Official Gazette of RS", no. 76/14). The preparation and publication
of the List of Serbian standards in the field of radio equipment and telecommunications terminal equipment is
an obligation stemming from the Law on Technical Requirements and is linked to the implementation of the
Rulebook on R&TT equipment. This act adopted list of standards published by the European Commission, in
connection with the implementation of EU Directive 1999/5.
2) Plans for full harmonization with the EU acquis
) Plans in respect of the remaining necessary harmonization of the national legislative framework with
the EU acquis
Special emphasis is placed on the adoption of the new Rulebook on Radio Equipment, given that the new
Directive on radio equipment 2014/53/EC (Directive 2014/53/EU of the European Parliament and of the
Council of 16 April 2014 on the harmonization of the laws of the Member States relating to the making
available on the market of radio equipment and repealing Directive 1999/5/EC) enters into force in June 2016,
and that the Republic of Serbia assumed the obligation to harmonize its legislation with the EU arising from
Article 77 of the Stabilisation and Association Agreement, as well as from NPAA regarding the transposition
of EU directives into national legislation. The transposition of the Directive on Radio Equipment 2014/53/EC
is anticipated in the period from 2017 - 2018. It also includes work on the harmonization of national legislation
in the field of electronic communication with the regulatory framework of the European Union (hereinafter:
EU).
b) Review of measures and activities to be undertaken in order to establish or strengthen institutional
structure and administrative capacity
The establishment of permanent mutual cooperation between the Ministry, RATEL, the Institute for
Standardization, Accreditation Body of Serbia, designated bodies, participants in the R&TT market and users
of R&TT equipment, in order to create an infrastructure that enables free placement of R&TT equipment on
the market, but at the same time the protection of users, the improvement of inspection activities carried out in
the field, after the R&TT equipment is already placed on the market, promotion of the importance of
standardization, further training of R&TT equipment manufacturers and notified bodies to prepare for the full
implementation of EU legislation.
Given that the market of R&TT equipment is a big one and the inspection should be implemented in the
territory of the whole of the Republic of Serbia, it is necessary to hire and train new inspectors in the Ministry
of Trade, Tourism and Telecommunications Sector for Market Inspection, who will be able to carry out
market surveillance of R&TT equipment market in accordance with the strategic activities and on the
application of harmful interferences identified during the control of the radio-frequency spectrum by RATEL,
operator report or end users of R&TT equipment.
Planned
regulation
code
Regulation
name
Comptent
institution
Rulebook on
Radio
Equipment
MTT
Deadline
elex
Regulation
translated
IV quarter
2017
32014L0053
no
Electromagnetic compatibility
1) Outline of status of harmonization
) The level of harmonization of national legislation with key EU acquis
Technical requirements, conformity assessment, as well as other requirements and conditions for the supply
on the market and putting into service of equipment in terms of electromagnetic compatibility are governed by
the Rulebook on Electromagnetic Compatibility ("Official Gazette of RS", no. 13/10). This rulebook was
adopted on the basis of the Law on Technical Requirements for Products and Conformity Assessment
("Official Gazette of RS", no. 36/09), and its implementation started on 20 March 2010. In accordance with
the Screening Report for Chapter 1, this rulebook is partially harmonized with the Directive 2004/108/EC,
given that it contains certain national provisions shall apply until the entry into force of the ACAA agreement
for electronic and electrical equipment or to the accession of the Republic Serbia to the EU (full compliance is
ensured by transitional provisions of this rulebook).
The new Rulebook, made to comply with the new Directive 2014/30/EU, is published in the "Official Gazette
of RS", no. 25/2016 of 03/09/2016, entered into force on 17 March 2016 and is applied as of 1 July 2017.
b) Institutional structure and state of administrative capacity
The Ministry of Economy is the authority responsible for the adoption and implementation of technical
regulations in the field of electromagnetic compatibility. At this point the Sector for Quality Infrastructure
employs two employees performing tasks related to the adoption and implementation of technical regulations
transposing the EU directives of the New and the Old Approach in the following areas: low-voltage electrical
equipment, electromagnetic compatibility, machinery, lifts, personal protective equipment, equipment and
protective systems intended for use in potentially explosive atmospheres, equipment that emits noise outdoors,
textiles, footwear and crystal glass.
Market surveillance of equipment in connection with the requirements for electromagnetic compatibility is the
jurisdiction of the Ministry of Trade, Tourism and Telecommunications. At this point, about 100 inspectors in
the Sector for Market Inspection perform tasks related to the market surveillance of products from the scope
of this section, including the monitoring of low-voltage electrical equipment. For more information, see section
"Market surveillance - product safety".
c) Description of other measures and activities taken so far in order to achieve full harmonization with
the EU acquis
In the period from 2010 to 2016 various projects supporting the development of quality infrastructure (QI)
have been implemented in the Republic of Serbia (IPA 2008, IPA 2010, IPA 2011, GIZ ACCESS 1), including
QI in the field of electomagnetic compatibility. Users of these projects were relevant ministries and other QI
institutions in this area, as well as the conformity assessment bodies of low-voltage electrical equipment.
In accordance with the obligation under Article 77, item 2a of the SAA, numerous seminars and training were
organized on the application of national technical legislations which transposed Directive 2004/108/EC;
seminars and training included education on the importance of harmonized standards and promotion of their
application; a guide and a manual for the implementation of this technical regulation was prepared and
published.
In accordance with the recommendation of the European Commission and the Screening Report for Chapter
1, in April 2015 the regulation on imported equipment which required certificates of conformity at customs
was amended, and the measures that the EC recognized as a trade barrier were revoked.
2) Plans for full harmonization with the EU acquis
) Plans in respect of the remaining necessary harmonization of the national legislative framework
with the EU acquis
The implementation of the new Rulebook on Electromagnetic Compatibility ("Official Gazette of RS", no.
25/2016), made to comply with the Directive 2014/30/EU, starts on 1 July 2017.
b) Review of measures and activities to be undertaken in order to establish or strengthen institutional
structure and administrative capacity
To effectively perform these tasks within the scope of the competent Sector, it is necessary for the Ministry of
Economy to employ another civil servant in 2016/2017.
For plans in the field of market surveillance, see section "Market surveillance product safety".
The competent authorities will continue to provide training of employees in these bodies regarding the
application of national legislation harmonized with the EU Directive, in accordance with EC guidelines and
good practice in EU member states.
c) The measures planned to achieve full harmonization with the EU acquis
Within the project of support to the development of quality infrastructure (IPA 2013), the purchase of
equipment for conformity assessment bodies of electromagnetic compatibility of equipment is planned during
2016.
In the period from 2016 to 2018, the implementation of the Project- Quality Infrastructure in the Western
Balkans is planned, which is funded jointly by the Swedish International Development Cooperation Agency
(SIDA) and the European Free Trade Association (EFTA). In the framework of this project, activities relating
to the QI in the field of electromagnetic compatibility are also planned.
In the period to 31 December 2018, and after that date as a regular activity, training of business entities in
connection with the implementation of national technical legislations harmonized with Directive 2014/30/EU
will be carried out and the implementation of the harmonized standards in the field of electromagnetic
compatibility equipment will be promoted.
Recreational crafts
1) Outline of status of harmonization
) The level of harmonization of national legislation with key EU acquis
In accordance with the National Programme for the Adoption of the EU acquis (NPAA), on the basis of Article
6 Paragraph 1 of the Law on Technical Requirements for Products and Conformity Assessment ("Official
Gazette of RS", No. 36/09), the Minister of Construction, Transport and Infrastructure issued The Rulebook
on the Safety Requirements for Recreational crafts and Watercraft ("Official Gazette of RS", No. 140/14). The
Rulebook came into force on 30 December 2014, and shall apply from 1 January 2018.
The Rulebook fully implements Directive 2013/53/EU, which repealed Directive 94/25/EC and lays down
requirements in terms of safety to be met by recreational craft to be put on the market. The application of
Directive 2013/53/EC will raise the level of environmental requirements in relation to the emissions from the
vessels, but also in relation to the materials used for the construction the recreational crafts.
b) Institutional structure and state of administrative capacity
The transposition of Directive 2013/53/EC and implementation of The Rulebook on the Safety Requirements
for Recreational crafts and Watercraft is under the responsibility of the Ministry of Construction, Transport
and Infrastructure. The organisational structure of the Ministry includes the Inspection Department, which
employs 8 navigation safety inspectors, in the Division of the safety navigation inspection. The job description
of inspection of the safety of navigation understands both, the control products in the domestic market and
taking the restrictive measures if it is necessary.
Until the establishment of the Department of inspections, the navigation safety inspectors were deployed on
inspectors positions within the organisation in the Harbor Master Offices - the regional unit of the Ministry
of Construction, Transport and Infrastructure, Department of Water Transport and Safety of Navigation.
c) Description of the measures and activities taken in order to achieve full compliance with the EU
acquis
The Rulebook on the Safety Requirements for Recreational crafts and Watercraft complies with all principles
and essential requirements of Directive 2013/53/EU of the European Parliament and of the Council of 20
November 2013 on the harmonisation of laws, regulations and other regulations relating to the recreational
crafts. The Rulebook was entered into force on 30 December 2014, and shall apply from 1 January 2018.
2) Plans for full harmonization with the EU acquis
) Plans in respect of the remaining necessary harmonization of the national legislative framework with
the EU acquis
The Rulebook on the Safety Requirements for Recreational crafts and Watercraft fully implements Directive
2013/53 / EU and prescribe conditions in terms of safety to be met by recreational craft to be put on the market.
Pursuant to the Article 7 paragraphs 3 and 4 of the Law on Technical Requirements for Products and
Conformity Assessment ("Official Gazette of RS", No. 36/09) in line with the Article 8 of The Rulebook on
the Safety Requirements for Recreational crafts and Watercraft ("Official Gazette of RS "No. 140/14), the
Minister of construction, transport and infrastructure will publish the list of Serbian standards in the field of
recreational craft, by the end of 2016
b) Review of measures and activities to be implemented in order to establish or strengthen institutional
structure and administrative capacity
Capacity building through training and raising employee skills by the introduction an advanced training for
inspectors of safety of navigation.
c) The measures planned to achieve full harmonization with the EU acquis
The Rulebook on the Safety Requirements for Recreational crafts and Watercraft complies with all principles
and essential requirements of Directive 2013/53 / EU of the European Parliament and the Council.
It is necessary to form a conformity assessment body that will perform activities of conformity assessment of
products.
Cableways for the transport of persons
1) Outline of status of harmonization
) The level of harmonization of national legislation with key EU acquis
The field of cableways in Serbia has not been regulated by a special law. In accordance with the obligations
deriving from the National Programme for the Adoption of the EU acquis (NPAA) in the first quarter of 2015,
29 April 2015, the Law on Cableways for the Transport of Persons was adopted ("Official Gazette of RS", no.
38/2015) and entered into force on 7 May 2015. This Law is partially harmonized with the Directive
2000/9/EC. Decision of the Minister of Construction, Transport and Infrastructure established a working group
for preparation of secondary legislation to be adopted pursuant to the law on cableways for the transport of
persons. The Law stipulates the adoption of 34 bylaws, which are grouped into 17 bylaws according to the
matter they deal with, due to efficiency. The number of bylaws is a variable category and the exact number
will not be known until their adoption because they can be grouped in another way, in accordance with a
subsequent reassessment of the matters which they cover.
In 2015, a bylaw was passedand in 2016 two bylaws passed, but only one of totally 3 contains subject matter
which is subject to harmonization with Directive 2000/9/EC. Others bylaws are in the process of adoption or
preparation.
Institutions responsible for the adoption of bylaws on the basis of the Law on Cableways for the Transport of
Persons are the Ministry of Construction, Transport and Infrastructure and the Directorate of Railways.
b) Institutional structure and state of administrative capacity
So far, there has not been any institutional framework in the field of cableways in Serbia. With the adoption
of the Law on Cableways for the Transport of Persons ("Official Gazette of RS", no. 38/2015), the Ministry of
Construction, Transport and Infrastructure and Directorate for Railways will have new responsibilities on the
basis of which they will become the key institution for the implementation of the said law.
Ministry of Construction, Transport and Infrastructure is responsible for supervising the implementation of the
Law on cableways for the transport of persons, inspection and market surveillance.
As a separate organization with legal personality, the Directorate for Railways received new responsibilities
listed below:
Issuance of Approval for the operation of the cableway for a period of one year,
Issuance of Approval for the operation to specific traction installations for a period of one year, and
Keeping records of cableways and all entities defined by this law that affect the safety of the cableways.
Institutional frame in field of cableways is formed in way that in Ministry of Construction, Transport and
Infrastructure there is one systematized post for cableways and two posts who has other competencies but
include cableways and in Directorate for Railways there is one systematized post for cableways.
This instutional frame has not sufficient number of employess competent for cableways
c) Description of the measures and activities taken in order to achieve full compliance with the EU acquis
In order to train employees in the institutions that implement and to which the Law on Cableways for the
Transport of Persons applies, with the aim of better drafting of secondary legislation to be adopted on the basis
of the said law, and the preparation for its implementation, four workshops related to the field of cableways
were held in 2015 and 2016, in the framework of the TWINNING project and one study visit in 2016. in the
framework of the TAIEX.
2) Plans for full harmonization with the EU acquis
) Plans in respect of the remaining necessary harmonization of the national legislative framework with
the EU acquis
Plans for full harmonization with the EU acquis by 31 December 2018 consist in the adoption and
implementation of bylaws whose adoption is required by Law on Cableways for the Transport of Persons.
Bylaws refer to 17 different subject matters related to cableways and those related to the following are to be
harmonized with the Directive 2000/9/EC:
The requirements for the installation of the cableway, stops, columns, foundations, other infrastructure,
the width and height of the security zone, the requirements for the route of the cableway;
Types, safety requirements and the manner of maintaining the drive of the cableway, cableway accessory
drive and brakes;
Conditions for ropes, vehicles and towing devices;
Conditions for cableway subsystems and safety components;
The content, method of preparation and form of safety analysis and safety report;
Requirements for the type of equipment, stops, the method and procedure of the implementation of
technical conditions for the functioning of the device and the safety of persons and property;
Documents of conformity and marking of conformity;
Manner, procedures, types and terms of maintenance and safety checks of the cableway, contents and
manner of keeping records of regular maintenance and records of interventions to eliminate irregularities
and the manner, the procedures and types of cableway maintenance, and
Conditions for temporary cableways (ski lifts).
The deadline for adoption of bylaws is the fourth quarter of 2016, and after their adoption, in the period from
2016 to 31 December 2018, the Law on Cableways for the Transport of Persons and the bylaws issued
thereunder will be implemented.
For the period from 31 December 2018 until 2021, the implementation of the Law on Cableways for the
Transport of Persons and the bylaws issued thereunder is expected to continue, as well as the monitoring any
changes of relevant EU regulations and harmonization with them.
Although the designation of the body for conformity assessment of safety components and subsystems of
cableways is not provided for by this law, this possibility is provided for by the Law on Technical
Requirements for Products and Conformity Assessment and regulations made thereunder.
b) Review of measures and activities to be undertaken in order to establish or strengthen institutional
structure and administrative capacity
For the period to 31 December 2018 with a view to the effective implementation of the said law, there is a
need to establish adequate administrative capacity, which creates the need for employees to engage in activities
related to the cableway, but taking into account the limiting factor expressed in the Decision of the Government
on the maximum number of employees with permanent placement in the system of state bodies, public service
system, the system of the Autonomous province of Vojvodina and local self-government system for 2015
("Off. Gazette of RS", no. 101/15), it is planned to expand the number of employees in the Directorate of
Railways by 1 civil servant in 2016 and by 1 civil servant in 2017.
c) The measures planned to achieve full harmonization with the EU acquis
For the period to 31 December 2018, ongoing mutual cooperation is planned between the institutions
responsible for the implementation of the cableways for the transport of persons and entities to which these
regulations will be applied, as well as with representatives of the state authorities of EU member states who
are responsible for field of cableways and have implemented Directive 2000/9/EC in its legislation, with a
view to better application of these regulations.
Also, monitoring and harmonization of national legislation with EU legislation in the field of cableways is
planned in order to take timely action in the event of changes of EU legislation, which is the competence of
the Ministry of Construction, Transport and Infrastructure, which also refers to the period from 31 December
2018 until 2021.
In order to prepare for the execution of the legal obligation of establishing the tasks related to the cableways
for the first time, one study visit was approved for the Directorate for railways under the TAIEX program
which was held in 2016., and the organization of additional workshops is planned to train employees of the
institutions that will implement the law in the framework of TWINNING project in 2016 and in 2017.
1.
Planned
regulation
code
2016-517
2.
2016-518
No
3.
2016-519
4.
2016-519
5.
2016-521
6.
2016-522
7.
2016-523
8.
2016-524
Regulation name
Competent
institution
Deadline
elex
Rulebook on
Requirements for
Cableway
Installations, Stops,
Columns,
Foundations and
other Infrastructure
Rulebook on the
Conditions for
Ropes
MCTI
IV quarter
2016
32000L0009
MCTI
IV quarter
2016
32000L0009
Rulebook on the
Type, Safety
Requirements and
Methods of
Maintaining the
Cableway Drive
Rulebook on the
Type, Safety
Requirements and
Methods of
Maintaining the
Auxiliary Drive of
the Cableway
Rulebook on the
Type, Safety
Requirements and
Methods of
Maintaining Brakes
Rulebook on
Conditions for
Vehicles and
Towing Devices
Rulebook on the
Requirements for
the Type of
Equipment of
Stations
Rulebook on the
Manner and
Procedure of
Implementation of
the Defined
Technical
Requirements
(requirements and
conditions for the
MCTI
IV quarter
2016
32000L0009
MCTI
IV quarter
2016
32000L0009
MCTI
IV quarter
2016
32000L0009
MCTI
IV quarter
2016
32000L0009
MCTI
IV quarter
2016
32000L0009
MCTI
IV quarter
2016
32000L0009
Regulation
translated
9.
2016-525
10.
2016-526
11.
2016-527
12.
2016-528
13.
2016-529
14.
2016-530
15.
2016-531
functioning of
devices)
Rulebook on the
Procedure for
Implementation of
Technical
Requirements and
Measures (technical
requirements for the
safety of persons)
Rulebook on the
Width and Height
of the Safety Belt
with Respect to the
Technical
Specifications of
the Device and
Other Requirements
Rulebook on the
Requirements for
the Cableway Route
Rulebook on the
Content, Method of
Preparation and
Form of Saftey
Analysis
MCTI
IV quarter
2016
32000L0009
MCTI
IV quarter
2016
32000L0009
MCTI
IV quarter
2016
32000L0009
MCTI
Adopted in
2016
32000L0009
Rulebook on the
Content, Method of
Preparation and
Form of Safety
Report
MCTI
Rules on the
Conditions to be
met by Cableway
Subsystems and
Safety Components
Rulebook on
Compliance and
Conformity
Marking, in
accordance with the
Law on Technical
Requirements for
Products and
Conformity
Assessment
MCTI
MCTI
("Official
Gazette of
RS", no.
22/2016)
Adopted in
2016
("Official
Gazette of
RS", no.
22/2016)
IV quarter
2016
IV quarter
2016
32000L0009
32000L0009
32000L0009
16.
2016-532
17.
2016-533
18.
2016-543
19.
2016-544
Rulebook on the
Methods,
Procedures, Types
and Terms of
Maintenance and
Safety Checks of
the Cableway
Rulebook on the
Conditions for
Temporary
Tableways,
Reduced Volume of
Work and
Maintenance
Requirements
Rules on the
Content and
Manner of Keeping
Records of Regular
Maintenance and
Records of
Interventions to
Eliminate
Irregularities
Rulebook on the
Method, Procedures
and Types of
Cableway
Maintenance
MCTI
IV quarter
2016
32000L0009
MCTI
IV quarter
2016
32000L0009
MCTI and
Directorate
for Railways
IV quarter
2016
32000L0009
MCTI and
Directorate
for Railways
IV quarter
2016
32000L0009
Construction products
1) Outline of status of harmonization
) The level of harmonization of national legislation with key EU acquis
In the field of construction products legislation of the Republic of Serbia is not harmonized with the Regulation
(EC) No 305/2011 of the European Parliament and of the Council of 9 March 2011 on laying down harmonised
conditions for the marketing of construction products and repealing Council Directive 89/106/EEC which
refers to establishing the conditions for placing on the market or making available on the market of construction
products by establishing harmonised rules on the method of expressing the performance of construction
products relating to their essential characteristics and on the use of CE marking on those products.
Amendments to the Law on Planning and Construction ("Official Gazette of RS", no. 72/09, 81/10 - CC, 24/11,
121/12, 42/13 - CC, 50/13 - CC, 98/13 - CC, 132/14 and 145/14) were adopted, which enabled partial alignment
and adoption of only some technical regulations, as follows: Rulebook on the Quality of Cement ("Off. Gazette
of RS", no. 34/13 and 44/14), Rulebook on Technical and Other Requirements for Cold-formed Welded
Structural Hollow Sections of Non-alloy and Fine Grain Steels ("Off. Gazette of RS", no. 93/15) and the
Regulation on Technical and Other Requirements for Ash as a Construction Material Intended for Use in the
Construction, Reconstruction, Rehabilitation and Maintenance of Infrastructure Construction Works of Public
Use ("Off. Gazette of RS", no. 56/15).
Technical regulations which were adopted earlier are still in force: Order on mandatory attestation of concrete
sewage pipes over a meter long ("Off. Journal of SFRY", no. 34/85), Order on mandatory attestation of
admixtures for concrete ("Off. Journal of SFRY", no. 34/85), Order on mandatory attestation of prefabricated
elements of aerated concrete ("Off. Journal of SFRY", no. 34/85), Rulebook on Technical Norms for Steel
Wires, Rods and Ropes for Prestressing of Structures ("Off. Journal of SFRY", no. 41/85 and 21/88), Rulebook
on Technical Norms for load-bearing Steel Structures ("Off. Journal of SFRY", no. 61/86), Rulebook on
Technical Norms for Concrete and Reinforced Concrete ("Off. Journal of SFRY", no. 11/87), Order on
mandatory attestation of fractioned rock aggregates for concrete and asphalt ("Off. Journal of SFRY", no.
41/87), Rulebook on Technical Norms for Concrete and Reinforced Concrete Made with Natural and Artificial
Lightweight Aggregate Filler ("Off. Journal of SFRY", no. 15/90), Rulebook on Mandatory Attestation of
Elements of Standard Constructions for Resistance to Fire and the Conditions to be met by Authorized
Attestation Bodies ("Off. Journal of SFRY", no. 24/90), Rulebook on Technical Norms for Masonry Walls
("Off. Journal of SFRY", no. 87/91), Rulebook on Technical and Other Requirements for Ceramic Sanitary
Appliances ("Official Gazette of SCG", no. 62/04), Rulebook on Technical and Other Requirements for Brick
Products Made of Clay and Sandlime Bricks and Blocks, Rulebook on Technical and Other Requirements for
Clay Roofing Tiles for Discontinuos Laying, Concrete Tiles and Glazed Ceramic Slabs for Roofing and the
Rulebook on Technical and Other Requirements for Facing Solid Clay Brick, Facing Hollow Brick and Clay
Blocks and Facing Sandlime Solid and Hollow Bricks and Blocks ("Off. Journal of SCG", no. 53/05),
Rulebook on Technical and Other Requirements for Thermal Insulation Materials ("Off. Journal of SCG", no.
54/05), Rulebook on Technical and Other Requirements for Waterproofing Materials and the Rulebook on
Technical and Other Requirements for Ceramic Tiles ("Off. Journal of SCG", no. 1/06).
b) Institutional structure and state of administrative capacity
The Division for Energy Efficiency and Construction Products in Buildings of the Ministry of Construction,
Transport and Infrastructure is the competent authority in the field of construction products.
The Division for Energy Efficiency in Buildings and Construction Products performs legislative,
administrative and coordination activities relating to construction products, the Market Inspectorate of the
Ministry of Trade, Tourism and Telecommunications carries out inspection activities of construction products
supplied to the market, and the Customs Administration of the Ministry of Finance performs control tasks on
imports.
The institutional framework and the existing capacities relevant to the transposition, implementation and
enforcement of the EU acquis are presented in the following table:
Organizational
unit
Total
number of
employees
Division for
Energy
Efficiency in
Buildings and
Construction
Products
4
with the
head of the
Division
Number of employees
working on the
transposition/implementation
and enforcement of EU
acquis
Transposition,
implementation and
application
Enforcement of
regulations entrusted to
other institutions
The current number of employees and their educational profile of the Division for Energy Efficiency in
Buildings and Construction Products, in the field of construction products, is not sufficient to support the
further transposition of EU legislation into national legislation, as well as implementation and enforcement
thereof.
The Division for Energy Efficiency in Buildings and Construction Products, in addition to transpositin of
Regulation (EC) No 305/2011 of the European Parliament and of the Council on establishing harmonized
conditions for the marketing of construction products and implementation and enformcement of the existing
legislation related to marketing and use of construction products , shall implement and apply the regulations
in the field of energy efficiency of buildings.
c) Description of other measures taken so far and activities in order to achieve full harmonization with
the EU acquis
Since the entry into force of the Law on Planning and Construction ("Official Gazette of RS", no. 72/09, 81/10
- CC, 24/11, 121/12, 42/13 - CC, 50/13 CC, 98/13 - CC, 132/14 and 145/14), the Project "Analysis of the
market of construction materials and products: aggregates for construction, concrete, reinforced and
prestressed concrete, concrete products and materials for the finishing of roads" within the IPA project was
funded by the Project Fund for Institutional Development (PROFID), whose budget amounted to 25,600.00.
The said project included employees of the Division for Energy Efficiency in Buildings and Construction
Products of the Ministry of Construction, Transport and Infrastructure.
The employees of the Division for energy efficiency in buildings and construction products are taking part in
the following activities aiming to support the establisment of quality infrustructure of construction products in
the Republic of Serbia:
Quality infrastructure in the Western Balkans (funded jointly by SIDA and EFTA, nd implemented by CEN);
Bilateral project Assistance in transposition and implementation of technical legislation, organized by the
Mission of the Czech Republic;
Project Strengthening capacities of the national system of quality infrastructure and service providers for
product conformity assessment in the Republic of Serbia organised by the Consortium from the Czech
Republic.
Ministry of Construction, Transport and Infrastructure applied to the TAIEX programme for an expert visit
that will take place by the end of 2016.
2) Plans for full harmonization with the EU acquis
) Plans of complete harmonization of national legislative framework with the EU acquis
Given the fact that the field of construction products is not harmonized with the European legislation, in the
forthcoming period the adoption of the Regulation on Construction Products is planned, transposing
Regulation 305/2011.
b) Review of measures and activities aimed at establishing or strengthening institutional structure and
administrative capacity
In addition to the harmonization of legislation of the Republic of Serbia as a state in the process of accession
to the EU, one of the main priorities is also to ensure that the competent authorities in the field of construction
products have a sufficient number of suitably qualified and experienced staff so that the obligations laid down
in EU regulations would be carried out efficiently and effectively, including appropriate inspection bodies and
conformity assessment bodies.
Key activities to be completed in the period from 2016 to the end of 2018
Until 2018, it is necessary to increase the administrative capacity for implementation of the new regulation, by
the formation of the Division for Construction Products.
Strengthening the institutional framework and the existing capacity relevant for the transposition,
implementation and enforcement of the EU acquis are presented in the following table:
Organizational
unit
Total
number of
employees
Division for
Construction
Products
within the
Department for
Energy
Efficiency in
Buildings and
Construction
Products
7
with the
head of
Division
Number of employees
required for the work on
transposition/implementation
and enforcement of EU
acquis
Transposition,
implementation and
enforcement
Enforcement of
regulations entrusted to
other institutions
In addition to increasing administrative capacity, in the period from 2016 to 2020, activities will be
implemented to promote continuous cooperation between the competent ministry which issues regulations, the
ministry which applies these regulations partially, ISS, ABS, conformity assessment bodies, as well as the
responsible designers and responsible contracting engineers, businessmen and consumers to which these
regulations apply, all in order to implement activities for the improvement of quality infrastructure construction
products, i.e. monitoring of the implementation of the new framework for placing construction products on the
market.
Key activities to be completed in the period from 2019 to the end of 2020
Key activities to be undertaken during the period from 2019 to the end of 2020 relate to full implementation
of the Regulation.
Apart from the domestic Regulation which will allow formal and legal transposition of Regulation 305/2011
into national legislation, its application in practice requires responsible and professional staff of the competent
authorities, as well as the future "contact point for construction products" for providing information, primarily
to interested businesses, on the conditions and requirements for the placement of construction products on the
market of the Republic of Serbia.
Very important activities in this period are organizing educational seminars for representatives MCTI,
inspection, customs, manufacturers of construction products, conformity assessment bodies and all interested
parties, as well as participation in the work of the Standing Committee for Construction.
c) The measures planned to achieve full compliance with the EU acquis
2016
In accordance with the amendments to EU regulations, the following will be adopted:
Regulation on Construction Products.
2017-2018
Given the fact that the European Commission informed us at the bilateral screening that, in addition to
Regulation 305/2011, a large number of decisions made on the basis of Regulation 305/2011 is in effect,
depending on the pace of implementation of the domestic Regulation, and depending on the changes of EU
regulations in the field of construction products, their transposition and adoption of technical regulations for
certain families of construction products will be planned.
Appendix A) Plan of harmonization of legislation of RS with the EU acquis
Planned
Regulation
Competent
regulation
Deadline
name
institution
No
code
1.
2013-243
Construction
Products
Regulation
CTI
IV quarter
2016
elex
1:32011R0305
Regulation
translated
yes
In the period from 2011 to 2016 various projects have been implemented supporting the development of quality
infrastructure (QI) in the Republic of Serbia (IPA 2008, IPA 2010, IPA 2011, GIZ ACCESS 1), including QI
in the field of PPE. Users of these projects are relevant ministries and other QI institutions and conformity
assessment bodies in this area.
In accordance with the obligation under Article 77, item 2a of the SAA, a number of seminars, round tables
and trainings were organized on the application of national technical legislations which transposed Directive
89/686 EEC. The seminars also include education on the importance of harmonized standards and promotion
of their application. A guide and a manual for the implementation of this technical regulation are also prepared
and published.
2) Plans for full harmonization with the EU acquis
) Plans in respect of the remaining necessary harmonization of the national legislative framework
with the EU acquis
Bearing in mind that, in accordance with the Screening Report for Chapter 1, this Regulation partially complies
with Directive 89/686 EEC, full alignment will be achieved by the Republic of Serbia accession the EU or the
entry into force of the ACAA agreement for PPE, in accordance with the provisions of applicable regulations,
and harmonization with the EU Regulation 425-2016.
b) Review of measures and activities to be undertaken in order to establish or strengthen institutional
structure and administrative capacity
For the effective performance of these tasks from the scope of the relevant units of the Ministry of Economy,
it is necessary to employ at least one employee in 2016/2017.
For plans in the field of market surveillance, see subsection 3.1.1.5.
The competent authorities will continue to provide training of employees in these bodies regarding the
application of national legislation harmonized with the EU Directive, in accordance with EC guidelines and
good practice in EU member states.
c) The measures planned to achieve full harmonization with the EU acquis
In the period to 31 December 2018, and after that date as a regular activity, training of business entities will
be carried out in connection with the implementation of national technical legislations harmonized with
Directive 89/686 EEC, and the implementation of the harmonized standards in the field of PPE will be
promoted.
Appendix A) Plan of harmonization of legislation of RS with the EU acquis
Planned
Regulation
Competent
regulation
Deadline
name
institution
No
code
Regulation on
Personal
IV quarter
1.
E
Protective
2018
Equipment
Noise emitted by outdoor equipment
1) Outline of status of harmonization
) The level of harmonization of national legislation with key EU acquis
elex
Regulation
translated
32016R0425
no
Technical requirements, conformity assessment, as well as other requirements and conditions for the supply
on the market and/or putting into service of equipment emitting noise outdoors are governed by the Rulebook
on Noise Emitted by Equipment Used Outdoors ("Official Gazette of RS", 1/13). This Rulebook was adopted
on the basis of the Law on Technical Requirements for Products and Conformity Assessment ("Official Gazette
of RS", no. 36/09), and its implementation began on 1 July 2015. The Rulebook is completely harmonized
with the essential requirements and principles set out in Directive 2000/14/EC, including its amendments of
Directive 2005/88/EC, except for the provisions relating to the collection of data on noise by the member states
of the EU and the EC.
b) Institutional structure and state of administrative capacity
The Ministry of Economy is the authority responsible for the adoption and implementation of technical
regulations in the field of noise emitted by equipment used outdoors. At this point the Sectorfor Quality
Infrastructure employs two employees who are performing tasks related to the adoption and implementation
of technical regulations transposing the EU directives of the New and the Old Approach in the following areas:
low-voltage electrical equipment, electromagnetic compatibility, machinery, lifts, personal protective
equipment, equipment and protective systems intended for use in potentially explosive atmospheres,
equipment that emits noise outdoors, textiles, footwear and crystal glass.
Market surveillance of equipment in relation to the requirements in terms of noise emissions is the jurisdiction
of the Ministry of Agriculture and Environmental Protection. At this point, in the Sector of Inspection for
Environmental Protection, the Department of Prevention and Control of Environmental Pollution, 21 republic
inspector exercises supervision over the implementation of regulations in the field of environmental protection
against pollution, including noise protection. Inspection in the area of protection of the environment from
pollution, including noise protection is also carried out by about 220 local and provincial inspectors. Market
surveillance of machinery, including machinery emitting noise outdoors, is the jurisdiction of the Ministry of
Trade, Tourism and Telecommunications. For more information, see section "Market surveillance product
safety".
c) Description of other measures and activities taken so far in order to achieve full harmonization with
the EU acquis
The adoption of the Law on amendments to the Law on Standardization ("Official Gazette of RS", no. 46/15)
enabled the full implementation of all standards that the technical regulation which transposed Directive
2000/14/EC refers to, including those international and European standards that the Institute for
Standardization has not issued and published as Serbian standards, in accordance with the Screening Report
for Chapter 1.
Consultations were carried out between the Ministry of Economy (ME), the Accreditation Body of Serbia
(ABS) and interested conformity assessment bodies (CABs) in connection with the authorization and
designation of CABs in accordance with the requirements of technical regulations in the field of noise emitted
by equipment used outdoors. Based on these consultations, the ME has published information on authorization
and designation of CABs on its official website, along with other information on the implementation of the
technical regulations (internet portal TEHNIS).
2) Plans for full harmonization with the EU acquis
) Plans in respect of the remaining necessary harmonization of the national legislative framework with
the EU acquis
Bearing in mind that the Rulebook of Noise Emitted by Equipment Used Outdoors is fully compliant with the
EU Directive, except with regard to the obligations arising from EU membership, amendments to this rulebook
are planned for 2018.
elex
Regulation
translated
32000L0014
no
Aerosol dispensers
This area is covered within the point 'Metrology'.
Eco-design requirements for energy-related products and energy labeling
1) Outline of status of harmonization
) The level of harmonization of national legislation with key EU acquis
Directive 2010/30/EU of the European Parliament and of the Council of 19 May 2010 on the indication by
labelling and standard product information of the consumption of energy and other resources by energy-related
products and related delegated regulation. Activities on the harmonization of legislation of the Republic of
Serbia in this field is conducted by the Ministry of Mining and Energy, Sector for Energy Efficiency. The most
important law relevant for the application of this regulation is the Law on the Efficient Use of Energy ("Official
Gazette of RS", no. 25/2013).
The Law on the Efficient Use of Energy and the Regulation on the Types of Products that Affect Energy
Consumption for which Labeling of the consumption of energy and other resources is required ("Official
Gazette of RS", no. 92/2013) (hereinafter: Regulation) transposed Directive 2010/30/EU of the European
Parliament and of the Council of 19 May 2010 on the indication by labelling and standard product information
of the consumption of energy and other resources by energy-related products. The Law regulates obligations
of manufacturers, suppliers and retailers in terms of products that are labeled, content frames and appearance
of the energy efficiency label, while the Regulation stipulates that, on the basis of special regulations to be
issued by the minister responsible for energy affairs, the following will be labeled: consumption of energy or
energy efficiency of certain products, energy efficiency class, obligations with regard to data sheets and
technical documentation accompanying the product, methodology for determining the energy efficiency class,
obligations when selling products remotely and inspection.
The Law on the Efficient Use of Energy and the Regulation on Labeling are Fully aligned with Directive
2010/30/EU.
In accordance with the Regulation on Labeling, the following rulebooks on energy labeling were adopted:
Rulebook on Energy Labeling of Household Refrigeration Equipment ("Official Gazette of RS", no.
17/14), which is aligned with the delegated regulation of the European Commission No 1060/2010 of 28
September 2010 amending Directive of the European Parliament and the Council No 2010/30/EU in
relation to energy labeling of household refrigeration appliances,
Rulebook on the Labeling of Energy Efficiency of Household Washing Machines ("Official Gazette of
RS", no. 24/14), which is aligned with the delegated regulation of the European Commission No
1061/2010 of 28 September 2010 amending Directive of the European Parliament and the Council No
2010/30/EU in relation to energy labeling of household washing machines,
Rulebook on Labeling of Energy Efficiency of Household Dishwashers ("Official Gazette of RS", No.
24/14), which is aligned with the delegated regulation of European Commission Regulation No 1059/2010
of 28 September 2010 amending Directive of the European Parliament and the Council No 2010/30/EU
in relation to the energy labeling of household dishwashers,
Regulation on Labeling of Energy Efficiency of Televisions ("Official Gazette of RS", no. 24/14), which
is aligned with the delegated regulation of the European Commission No 1062/2010 of 28 September 2010
amending Directive of the European Parliament and the Council No 2010/30/EU in relation to energy
labeling of televisions,
Rulebook on the Labeling of Energy Efficiency of Electric Ovens ("Official Gazette of RS", no. 24/14),
which is aligned with the EC Directive 2002/40/EC of 8 May 2002 applying European Council Directive
No 92/75/EEC in relation to energy labeling of electrical ovens,
Rules on the Labeling of Energy Efficiency of Electric Light Bulbs and Luminaires ("Official Gazette of
RS", no. 24/14), which is aligned with the delegated regulation of the European Commission No 874/2012
of 12 July 2012 amending Directive of the European Parliament and the Council No 2010/30 / EU in
relation to the energy labeling of electrical lamps and luminaires,
Rulebook on the Labeling of Energy Efficiency of Air Conditioning ("Official Gazette of RS", no. 24/14),
which is aligned with the delegated regulation of the European Commission No. 626/2011 of 4 May 2011
amending the Directive of the European Parliament and the Council No 2010/30/EU in relation to the
energy labeling of air conditioning.
Rulebooks on the Labeling of Energy Efficiency came into force on 1 March 2014.
In the future it is necessary to work on the transposition of delegated regulations in relation to energy labeling
of new products, considering that these regulations are constantly updated by the EU.
Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a
general framework for establishing requirements for the eco-design of energy related products.
Directive 2009/125/EC has not yet been transposed into the legal system of the Republic of Serbia. The legal
acts which are relevant to this directive and which are the basis for its implementation in the Republic of Serbia
are:
Law on the Efficient Use of Energy Requires that products be placed on the market and in use only if they
fulfill eco-design requirements specified in a technical regulation, if their compliance was determined in
a prescribed procedure and if they are labeled in accordance with the regulation that applies to this group
of products. Up to the current Law Minister shall prescribe the requirements of eco-design, the process of
establishing the conformity of products with the requirements of eco-design, the manner of labeling
products, the content of the declaration of conformity and other conditions ensuring the implementation
of eco-product design requirements, and shall adopt technical regulations which prescribe technical
requirements for individual types or groups of products. However, in the framework of implementation of
PLAC project during 2014/2015, the need for the corrections of the Law on the Efficient Use of Energy
was perceived in so that transpositionof the Directive by a Regulation would be provided for instead of a
transposition by a Rulebook, as the rulebooks would transpose only implementing measures.
Law on Technical Requirements for Products and Conformity Assessment ("Official Gazette of RS", no.
36/2009)
Regulation on Manner of Conformity Assessment, Content of Document of Conformity, and Shape,
Appearance and Content of Mark of Conformity ("Official Gazette of RS", no. 98/2009)
Law on Environmental Protection ("Official Gazette of RS", no. 135/04, 36/09, 36/09-state law, 72/09state law and 43/11-CC) - prescribes the Ecological sign
After the change of the Law on the Efficient Use of Energy, preparation of a Regulation is expected which will
transpose Directive 2009/125/EC, after which the development of rulebooks will begin that will apply
individual implementating measures of this Directive.
b) Institutional structure and state of administrative capacity
The Department for Energy Efficiency at the Ministry of Mining and Energy is in charge of the transposition
of legislation in the field of energy efficiency.
The Department at the Ministry of Mining and Energy at present has four permanent employees, one person
engaged under a temporary service contract and three people engaged through projects financed by donors.
The Department does not employ a lawyer, and the person who is in charge of legal affairs outside the
Department at the moment is engaged through a JICA project contract until March 2017, with an uncertain
possibility of extending the contract for another couple of months. According to job classification, nine
workplaces in the Department were classified. According to the educational structure of permanent staff, the
Department has three mechanical engineers and one electrical engineer. The Ministry does not have sufficient
administrative capacity to draft bylaws and to monitor the implementation and enforcement of the EU acquis.
A particularly big problem is that the lawyer vacancy at the Department. The Ministry of Trade, Tourism and
Telecommunications through the market inspection is in charge of monitoring and control of the
implementation of Directive 2009/125/EC and 2010/30/EU. Market inspection has a limited budget which
represents a difficulty in controlling the situation in the market. At the moment, there are a number of
laboratories on the market, but at this point it is not known to which extent they are able and accredited to carry
out the assessment of compliance with the directives on energy labeling and eco-design.
c) Description of other measures and activities taken so far in order to achieve full harmonization with
the EU acquis
Directive 2009/125/EC
In late 2014 and early 2015 the legal, institutional and financial framework for the transposition of Directive
2009/152/EC was analyzed under the PLAC Project, when, based on the results of the project, it was concluded
that it was necessary to make amendments in the existing Law on the Efficient Use of Energy. Also, a result
of this Project are the recommendations on the method of transposition of individual articles, Guide for
companies for the implementation of the directive, the analysis of existing companies in the RS that will
include directives and recommendations on the timetable of transposition of individual delegated regulations
- implementing measures. The new PLAC Project (for period January - April 2016) resulted in the Draft of
amendment of Article 42 of the Law on the Efficient Use of Energy that is related to eco-design, Draft of the
Regulation that will transpose the Directive and Draft version of 7 rulebooks that will transpose 7 delegated
regulations.
Directive 2010/30/EU
The regulation has already been transposed. In the course of 2016, 5 more delegated regulation are expected
to be adopted: 65/2014, 392/2012, 665/2013, 811/2013 and 812/2013, and their Draft version are obtained
through the PLAC Project which lasted from January to April 2016.
2) Plans for full harmonization with the EU acquis
) Plans in respect of the remaining necessary harmonization of the national legislative framework with
the EU acquis
Directive 2009/125/EC
For the eco-design Directive 2009/125/EC, the planned deadline for amending the Law on the Efficient Use
of Energy which would allow the Directive to be introduced as Regulation is I quarter of 2017. After that,
during the II quarter of 2017 Regulation on eco-design will be issued, which will transpose Directive
2009/125/EC. For the implementation of individual delegated regulations adopted by the EU - as recommended
by the PLAC Project, a period of 5 years from the adoption of the Directive 2009/125/EC should be provided
for.
Directive 2010/30/EU
In the course of 2016 adoption of 5 more delegated regulations are expected: 65/2014, 392/2012, 665/2013,
811/2013 and 812/2013. Their adoption is expected in the fourth quarter of 2016.
b) Review of measures and activities to be undertaken in order to establish or strengthen institutional
structure and administrative capacity
As already stated in paragraph 2, the Department for Energy Efficiency, according to the current job
classification, has 9 workplaces, of which 5 are vacancies. Of four permanent employees with permanent
placement, only one person is partially engaged in transposing regulations related to energy labeling and ecodesign, since the Department covers the whole area of energy efficiency in terms of: legislative activities, the
establishment of energy management and implementation of numerous projects. Given the announced further
rationalization in the state administration, at this moment it is not known whether some positions that are
currently classified will be abolished. It is estimated that it is necessary to employ 1-2 persons with full-time
jobs only for transposition of all acts (directives and delegated regulations) and monitoring of their
implementation.
c) The measures planned to achieve full harmonization with the EU acquis
The realization of a project from IPA 2014 funds is planned aimed at transposing Directive 2012/27/EU of the
European Parliament and of the Council of 25 October 2012 on energy efficiency, amending Directive
2009/125/EC and 2010/30/EU and repealing Directive 2004/8/EC and 2006/32/EC, but also MRE capacity
building for implementation of the Law on the Efficient Use of Energy. The project entered into a financial
agreement and the preparation of the terms of reference is underway.
IPA funds 2016 provide for the financial support of 1,500,000.00 euros to strengthen the system of monitoring
and checking the quality of the products in accordance with the requirements of Directive 2009/125/EC and
2010/30/EU.
Appendix A - Plan of harmonization of legislation of RS with the EU acquis
Regulatio
Regulation
Competent
Place in
Adoption
n code
name
institution
the NPAA
deadline
in charge
structure
(quartet/yea
of
r)
CELEX
marks of EU
regulations
with which
preparatio
n
2016-128
2016-92
2016-97
2016-105
Amendment
s to the Law
on
the
Efficient
Use
of
Energy
Regulation
on
the
Procedure
for
Determining
Product
Compliance
with
the
Requirement
s of Ecodesign, the
Method of
Labeling
Products, the
Content of
the
Declaration
of
Conformity
and Other
Conditions
which
Ensure the
Application
of
Requirement
s of Ecodesign
of
Products
Rules
on
Eco-design
Requirement
s
for
Refrigeratio
n Appliances
Rules
on
Eco-design
Requirement
s
for
Standby and
ME
(number
of
subchapte
r)
MRE 1 and
15
(free
movement
of
goods
and energy)
I quarter 2017
the
harmonizatio
n is carried
out
32009L0125
MRE 1 and
15
(free
movement
of
goods
and energy)
II quarter 2017
32009L0125
MME
3.15.2.
Energy
efficiency
and
renewable
energy
3.15.2.
Energy
efficiency
and
III quarter
2017
32009R0643
IV quarter
2017
32008R1275
and
32013R0801
MME
2016-104
Off
mode
Power
Consumptio
n
of
Electrical
and
Electronic
Home
Appliances
and Office
Equipment
Rulebook on
Eco-design
Requirement
s
for
Televisions
renewable
energy
MME
2016-91
Rulebook on
Eco-design
Requirement
s for Set-top
Boxes
MME
2016-101
Rulebook on
Eco-design
Requirement
s
for
Household
Dishwashers
Rules
on
Eco-design
Requirement
s
for
Washing
Machines
Rules
on
Eco-design
Requirement
s for Airconditioning
MME
Rulebook
Energy
Labeling
Electrical
Ovens
Rulebook
Energy
Labeling
2016-103
2016-98
2016-118
2016-114
on
MME
MME
of
on
of
3.15.2.
Energy
efficiency
and
renewable
energy
3.15.2.
Energy
efficiency
and
renewable
energy
3.15.2.
Energy
efficiency
and
renewable
energy
3.15.2.
Energy
efficiency
and
renewable
energy
3.15.2.
Energy
efficiency
and
renewable
energy
1 and 15
(free
movement
of
goods
and energy)
1 and 15
(free
movement
IV quarter
2017
32009R0642
and
32013R0801
III quarter
2017
32009R0107
IV quarter
2017
32010R1016
IV quarter
2017
32010R1015
IV quarter
2017
32012R0206
IV quarter
2016
32014R0065
IV 2016
32012R0392
2016-111
2016-112
2016-117
2016-137
2016-132
Tumble
Dryers
Rulebook on
Energy
Labeling of
Space
Heaters
Rulebook on
Energy
Labeling of
Water
Heaters
Rulebook on
Energy
Labeling of
Vacuum
Cleaners
Amendment
to
the
Regulation
on the Types
of Products
that Affect
Energy
Consumptio
n for Which
Labeling of
Energy and
Other
Resources is
Required
Amendment
s to the Law
on
the
Efficient
Use
of
Energy
of
goods
and energy)
1 and 15
(free
movement
of
goods
and energy)
1 and 15
(free
movement
of
goods
and energy)
1 and 15
(free
movement
of
goods
and energy)
1 and 15
(free
movement
of
goods
and energy)
1 and 15
(free
movement
of
goods
and energy)
IV
2016
quarter
32013R0811
IV
2016
quarter
32013R0812
IV
2016
quarter
32013R0665
IV
2016
quarter
32010L0030
I quarter 2018
32012L0027
Safety of toys
1) Outline of status of harmonization
) The level of harmonization of national legislation with key EU acquis
National legislations in the field of safety of toys (Law on Health Safety of Products of General Use "Official
Gazette of the Republic of Serbia", no. 92/2011) were partially harmonized with the relevant EU legislation in
the said area.
In the National Programme for Integration of the Republic of Serbia in the EU for the period 2008-2012, the
adoption of the Law on the Health Safety of Products of General Use was planned. The Law was adopted and
published in the "Official Gazette of the Republic of Serbia" no. 92/2011. Pursuant to Article 6, paragraph 2
of this Law, the adoption of the following rulebooks is provided for: Rulebook on Health Safety and the
Method, Content and Detailed Conditions of Labeling and Marking of Children's Toys and Items for Children
and Infants (Directive 2009/48/EC). Rulebook on Health Safety and the Method, Content and Detailed
Conditions of Labeling and Marking of Children's Toys and Items for Children and Infants is in preparation.
In cooperation with the project Policy and Legal Advice Centre - PLAC, at the end of 2014/fourth quarter of
2014, we transposed all transferable provisions of the Directive on the Safety of Toys (2009/48/EC) into a
bylaw (Rulebook on Health Safety and the Method, Content and Detailed Conditions of Labeling and Marking
of Children's Toys and Items for Children and Infants), with the idea of the Law on amendments to the Law
on Health Safety of Products of General Use (drafting process underway) providing legal basis to the
mentioned bylaw.
In September 2015, Working Group of the Ministry of Health was established, with the task of drafting a new
Law on Products of General Use, which will sufficiently transpose the provisions of the relevant EU legislation,
and at the same time provide a legal basis that is now missing for bylaws in the following areas: toys,
cosmetics, materials and articles in contact with food, the work on some of them having been completed, and
on some coming to an end. The new Law on Products of General Use will be the best way to regulate this area
of great importance for human health.
b) Institutional structure and state of administrative capacity
The institutional framework and the existing capacities relevant to the transposition, implementation and
enforcement of the EU acquis are also presented in the following table:
Organizational
unit
Ministry of Health
Inspection
Operations Sector Department of
Sanitary Inspection
Total number
of employees4
146 classified
workplaces
sanitary
inspectors
(8 in the
headquarters,
109 internal
control +29
control at the
border and
customs
clearance
locations)
Filled:
147 republic
sanitary
inspectors (120
internal
control
Enforcement of
regulations
entrusted to
other
institutions
The network of
institutes for
public health and
other accredited
and authorized
laboratories
(laboratory
analyses)
4
The present administrative capacities perform the duties of alignment, implementation, supervision over the implementation of regulations in the area under sanitary
supervision (protection of the population from infectious diseases, safety of food and health safety of articles for general use in all stages of production, transport and
import and areas of public supply of the population with drinking water) distribution of work has not been carried out in terms of defined groups of inspectors who
perform tasks in just one area under sanitary supervision, but all inspectors carry out surveillance in all areas under sanitary supervision
29 control at
the border and
customs
clearance
locations)
Provincial
Secretariat for
Health Care, Social
Policy and
Demography AP
Vojvodina
Department for
Sanitary Control and
Public Health
entrusted affairs
Classified and
filled:
54 provincial
sanitary
inspectors
(internal
control).
U
Regulation
which is
transposed
Expected
degree of
harmonization
Directive
Partial
2009/48/EC of
harmonization
the European
Parliament and Full harmonization
of the Council
of 18 June 2009
on the safety of
toys
Deadline
for the
adoption of
regulations
(quartet)
II quarter
2017
IV quarter
2018
Short description of
regulations that will be
achieved by these
regulations
Establish rules on the
safety of toys (products or
materials designed and
intended for playing of
children up to 14 years of
age): general safety
requirements and specific
safety requirements
(physical and mechanical
properties, flammability,
chemical properties,
electrical properties,
hygiene and radioactivity),
with the aim of high level
of protection of health and
safety of children and their
Directive
2009/48/EC of
the European
Parliament and
of the Council
of 18 June 2009
on the safety of
toys
Partial
harmonization
Full
harmonization
III quarter
2017
IV quarter
2018
b) Review of measures and activities that will be carried out works and the establishment or
strengthening of institutional structure and administrative capacity
Considering that it is necessary to strengthen the administrative capacity of the Ministry of Health (toy safety),
the Ministry of Health is working on preparing a plan to "strengthen" its administrative capacity in this area
(harmonization and implementation of regulations in this area). The plan is the realization of continuous
training of employees in the Inspection Operations Sector of the Ministry of Health, with the support of
available programs of international development assistance.
c) The measures planned to achieve full harmonization with the EU acquis
In 2016 cooperation initiated during 2015 with the Twinning project "Strengthening Capacities of National
Infrastructure Quality and Conformity Assessment Services in the Republic of Serbia" continues, which is
funded by the IPA 2013 funds. So far the cooperation has been implemented in terms of analysis of harmonized
national legislation on toy safety and cosmetic products by the experts of the Project, as well as the organization
of a series of workshops to support the negotiation process and the opening of negotiation chapters.
OLD APPROACH
Motor vehicles and emissions of gaseous and particulate pollutants from the engines for non-road
mobile machinery
1. Outline of status of harmonization
) The level of harmonization of national legislation with key EU acquis
So far, partial harmonization with EU acquis has been achieved in the field of motor vehicles on the basis of
long-term application of UNECE Regulations in the Republic of Serbia (57 Orders issued). UNECE
Regulations are implemented into EU legislation through regulations on the whole vehicle type-approval.
Achieving full compliance with Directives 97/68/EC, 2007/46/EC and the EU Regulations 167/2013 and
168/2013, establishing a framework for the whole vehicle type-approval, is conditioned by adopting the
amendments to the Law on Road Traffic Safety, which is planned for adoption in 2016/2017, and the adoption
of appropriate bylaws which will enable the achievement of full harmonization of legislation in the field of
motor vehicles, and the emission of pollutants from diesel engines of off-road vehicles.
b) Institutional structure and state of administrative capacity
Transposition of legal acts of the European Union in the field of type approval with all its amendments is the
competence of the respective Ministry of Construction, Transport and Infrastructure of the Republic of Serbia
(in terms of adoption). Road Traffic Safety Agency (hereinafter referred to as RTSA), Vehicle Sector,
Department for Type Approval of Vehicles, Equipment and Parts is responsible for the preparation of
transposition and subsequent implementation and enforcement.
Organizational
unit
Total
number of
employees
Department for
Type Approval of
Vehicles,
Equipment and
Parts
3
+
head of the
Department
Preparation of transmission,
implementation and
enforcement
Enforcement of
regulations
entrusted to
other
institutions
Not entrusted to
other institutions
Implementation of the regulations on the type approval relating to road vehicles, motor vehicles and trailers is
carried out by the RTSA where approval tasks constitute the essence of the mentioned legal acts of the EU.
The Department for Type Approval of Vehicles, Equipment and Parts has a total of 4 employees. In addition
to the monitoring of EU regulations within the Department for Type Approval, RTSA is responsible for
monitoring 137 UNECE Regulations under the Law on the Recognition of the International 1958 Agreement
(Geneva) and perform tasks of issuing documents under the customs procedure.
The long-standing use of UNECE Regulations, as well as the control of conformity of vehicles and type
approval documentation on various grounds, has contributed to the education of domestic vehicle
manufacturers and the development of the profession in terms of the whole vehicle type approval. Parallel to
these processes, technical services (laboratories) for the implementation of the type approval tests have also
developed in the Republic of Serbia.
c) Description of other measures and activities taken in order to achieve full harmonization with the EU
acquis
In accordance with the above, RTSA has a constant tendency towards training and raising employee skills
through constant monitoring of these regulations in the European Union and the World Forum for
Harmonization of Vehicles Regulations (UNECE/WP29). This measure impliesattendance as observers at the
Technical Committees and the Working Groups for the vehicle type M, N, O, L and T at the European
Commission - Directorate General for Internal Market, Industry, Entrepreneurship and SMEs as a
representative of the candidate country, as well as participation in the work of UNECE/WP.29 as a permanent
member.
RTSA is actively involved in preparing the Serbian version of the EU acquis, where a significant number of
EU regulations in the area of vehicle type approval has been nominated, professionally translated and edited.
Accordingly, the consolidated versions of the EU regulations in the Serbian language are ubeing prepared,
which will be transposed into national legislation.
Harmonization with Framework Directive 2007/46/EC in the field of type approval of vehicles with
wheels type M, N and O is planned through transposition of the legal instrument of the European Union,
together with all amendments, in the fourth quarter of 2018 through the adoption of "Rulebook on
Establishing the Framework for the Type Approval of Motor Vehicles and Their Trailers and Systems,
Components and Separate Technical Units Intended for Such Vehicles", where the planned basis for
harmonization will be contained in the relevant amendments to the Law on Road Traffic Safety in
2016/2017.
Adoption of the basis for harmonization with EU Regulation 168/2013 in the area of vehicle type-approval
with wheels of type L is planned through appropriate amendments to the Law on Road Traffic Safety in
2016/2017. Transposition of the legal act of the European Union with all the amendments with the aim of
complete hamonization is planned in the fourth quarter of 2018 through the adoption of " Rulebook on the
Approval and Market Surveillance of Two- or Three-Wheel Vehicles and Quadricycles".
Adoption of the basis for compliance with Directive 97/68/EC with all the amendments in the field relating
to measures against the emission of gaseous pollutants and particulate particles of pollutants from internal
combustion engines to be installed in non-road mobile machinery is planned through appropriate
amendments to the Law on Road Traffic Safety in 2016/2017. Transposition of the legal act of the
European Community, with the aim of complete harmonization, is planned for the fourth quarter of 2017
through the adoption of "Rulebook on Action to be Taken Against the Emission of Gaseous and
Particulate Pollutants from Internal Combustion Engines to be Installed in Non-road Mobile Machinery".
Adoption of the basis for harmonization with EU Regulation 167/2013 in the area of vehicle type-approval
with wheels of type T is planned through appropriate amendments to the Law on Road Traffic Safety in
2016/2017. Transposition of the legal act of the European Union with all the amendments, with the aim
of compete harmonization is planned in the fourth quarter of 2018 through the adoption of "Rulebook on
the Approval and Market Surveillance of Agricultural and Forestry Vehicles".
Adoption of the basis for compliance with specified EU regulations concerning the UNECE Regulations,
which are an integral part of these regulations, is related to the already planned the expected amendments
to the Law on Road Traffic Safety in 2016/2017, where the necessary non-transposed UNECE Regulations
will be transposed in accordance with the relevant orders in accordance with the Agreement on the
adoption of uniform technical prescriptions for wheeled vehicles, equipment and parts which can be fitted
and/or used on wheeled vehicles and the conditions for mutual recognition of type approvals allocated on
the basis of these regulations ("Off. Gazette of RS", no. 11/2011 - International Treaties).
b) Review of measures and activities aimed at establishing or strengthening institutional structure and
administrative capacity for the period to 31 December 2018
The continuation of the implementation of fully harmonized Rulebooks with monitoring of amendments to the
relevant regulations of the European Union is planned and the harmonization of the Rulebook with the
amendments, in accordance with the aforementioned. Serious strengthening of the administrative capacity is
necessary, both in terms of number and in terms of educational profile of employees who will work on the
implementation and enforcement of regulations in the field of motor vehicles.
c) The measures planned to achieve full harmonization with the EU acquis
Further implementation and enforcement of harmonized legislation, in order to achieve greater and more
effective active and passive safety in traffic, as well as defining the place and role of RTSA in terms of market
surveillance.
elex
Regulation
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32007L0046
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32013L0168
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2016
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32013R0167
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subsector. National legislation aligned with the EU regulations was adopted in order to ensure protection of
human health and the environment, but also to prepare both, administrative structures and the private sector
for the full implementation of the regulations after the accession and entry into the common market. In
accordance with the principle of direct applicability of the EU regulations, alignment with regulations
requirements is considered to be a temporary measure.
Plan of harmonization:
In the period 2016 end 2018 the following activities are planned:
In terms of further legislative actions in order to ensure the legal framework which is necessary from the date
of accession, the plan comprises the following:
Repealing of national legislation that transposes EU Regulations; since alignment with Regulations is a
temporary measure; repealing of national legislation is a part of implementation strategy and will be
prepared thoroughly. Furthermore, any national requirement which goes beyond the Acquis will be reconsidered for its compliance with the Acquis and in particular with regard to the articles 34-36 of the
Treaty establishing the EU as well as for its cost effectiveness. Provisions/ measures that are not compliant
will be addressed/ amended or repealed accordingly.
Draft/Proposal of the Law on the Implementation of the REACH Regulation, the Law on the
implementation of the CLP Regulation and the Law on implementation of the Regulation on Detergents.
These laws will regulate the issues which should be arranged by the member states for each peace of
regulation (e.g. designation of competent authority, establishment of help desk, enforcement arrangements
etc.) These laws should be adopted and enter into force before accession, but would be applicalble from
the date of accession.
Classification, labeling and packaging of substances and mixtures (CLP) (Regulation 1272/2008)
National legislation is partly aligned with the CLP Regulation, provisions that require EU membership status
to be implemented have not been incorporated into the national legislation. Legal base for harmonization of
national legislation with Regulation 1272/2008 has been provided in the Law on chemicals ("Off. Gazette of
RS", no. 36/09, 88/10, 92/11, 93/12 and 25/15), while the detailed provisions (i.e. criteria for classification,
labeling elements, harmonized classification and labeling of substances etc) have been laid down in the
rulebooks.
Most of the provisions of the CLP Regulation and all of its annexes were incorporated into the national
legislation. However, there are certain differences e.g. in terms of designation of bodies responsible for
receiving information relating to emergency health response (Article 45 of the CLP Regulation). In accordance
with the Law on chemicals, the ministry responsible for the environment shall submit the relevant and available
information on chemicals and their properties to the National Poison Control Center. Importers and
downstream users placing mixtures on the market are not obliged to submit information to the Poison Control
Center and the Center is not officially designated as the authority responsible for receiving such information.
Serbia actively follows developments with regard to harmonization of format and the data set which should be
sent to the Poison Centres (i.e. adding a new Annex to the CLP).
Plan of harmonization:
In the period 2016 2018 the following activities are planned:
758/2013 correcting Annex VI to CLP and Regulation (EU) No 1297/2014 amending CLP are underway
and should be published by the I quarter of 2017;
Drafting of the Law on implementation of the CLP Regulation. This Law will appoint competent authority/
authorities responsible for proposals for harmonised classification and labelling and authority/authorities
responsible for the enforcement of the obligations set out in CLP, body responsible for receiving
information relating to emergency health response, establish Help desk under CLP and define enforcement
arrangements, as required in CLP, Title VI.
organizational units with total of 14 employees out of which 5 are engaged with the tasks arising from
legislation aligned with REACH, CLP and Regulation on Detergents.
Having in mind all the tasks to be performed by the competent authority for REACH, CLP and Regulation on
detergents that the Serbian CA will have to perform after the accession, strengthening of administrative
capacity will continue during the pre-accession period. This is in particularly important in terms of further
employment and introducing additional work posts requiring the relevant soft skills, especially in the field of
risk assessment, as it is concluded in the Serbia Progress Report for 2014.
Enforcment capacities
Inspection and control over the implementation of national legislation on chemicals is under the responsibility
of Department for large chemical accidents, chemicals and biocidal products, an organizational unit within the
Sector for environmental protection inspection is responsible for inspection and control. Organizational unit
has 6 inspectors. In some cases, these inspectors are supported by the inspectors competent for enforcement of
the majors accidents hazards who usually supervise and control Seveso facilities but who are also trained to
control chemicals. In the past, in order to strengthen the capacity of the inspection, trainings and workshops
and several pilot inspections were organized with the participation of inspectors from the EU MSs.
In order to re-assign clear responsibilities for chemicals inspection Law on amendments to the Law on
chemicals has been adopted and entered into force on 14th of March 2015. According to these amendments
chemicals compliance control is conducted by the Ministry in charge of environmental protection through the
environmental inspectors, Ministry in charge of health through sanitary inspectors. Sanitary inspectors control
bans and restrictions of chemicals (Annex XVII of REACH) in products/chemicals intended to general public,
while all other provisions and corresponding control of implementation is under the compterence of the
environmental inspectors.
Inspectors are working in accordance with the work plans which are developed upon the assessment of
quantities of imported and/or produced chemicals. Usually, work plan contains two major campaigns such as
detergents, paint, certain restriction etc. Also, annual plan contains certain controls conducted during the whole
year, such as classification and labeling or Safety data sheets. Finally, inspection control is conducted upon
notifications on actions contrary to the provisions of Law submitted by legal or physical persons weather these
notification are anonymous or not.
Since the inspection control of chemicals in Serbia is still young, quantities of import and manufacturing of
chemicals are main input for inspection. Adequate classification and labelling is priority at this moment, which
is the first step that provides information necessary for safe use of chemicals. Also, one of factors for choosing
companies for inspection is if chemicals placed on the market by that company are intended for general public
i.e. there is significant risk of exposure during use of chemicals.
Classification, labeling and packaging of substances and mixtures (Regulation 1272/2008)
The institutional framework for the transposition, implementation and enforcement is established within
MAEP, Department for Chemicals, Group for classification, risk assessment and communication of risks of
chemicals and biocidal products. Two employees are in charge of transferring and implementing requirements
harmonized with this Regulation; three more people need to be hired for the full implementation of this
regulation.
Control and inspection of the implementation of the provisions governing the classification, packaging and
labeling of chemicals is done by Ministry through organizational units within the Sector for Inspection of
Environmental Protection, the Department for large chemical accidents, chemicals and biocidal products. In
MAEP, Sector for Inspection of Environmental Protection, Department for chemicals and biocidal products,
six inspectors are in charge of all matters related to inspection under the Law on Chemicals and Law on
Biocidal products, which are in some cases supported by the employees of the Department for large chemical
accidents which employs nine inspectors.
The CLP methodology of hazard assessment and communication is introduced under the Law on chemicals
making manufacturers, importers and downstream users placing chemicals on the Serbian market obliged to
implement it. CLP aligned rulebook is in force since 2010. Harmonized classification and labelling in line with
the CLP Annex VI has been implemented also. Roles and responsabilities of the economic operators placing
chemicals on the market as given in the CLP have been established, criteria for hazard assessment as well as
the labeling elements have been prescribed in line with CLP.
Serbian rulebooks and guidelines repeat the detailed content of individual CLP-provisions. Central staffs have
acquired knowledge and practical experience on classification and labelling during several years. Capacities
of staffs in the Department of Chemicals and inspectors have been further underpinned by the cooperation with
Austria/Slovenia and Sweden; central staff received also support from the European Chemicals Agency
(ECHA) through the workshop on CLP Regulation and CLP related activities as well as through the workshop
on IUCLID organized within the ECHAs IPA project supporting the candidate and potential candidate
countries. However, lack of capacity for development and submission of proposals for harmonized
classification and labeling of substances has been identified. Central administration has not executed these or
similar tasks so far.
Some of the most relevant measures for implementation of CLP that are already in place are the following:
Data on intrinsic properties of substances and mixtures to be used for the aim of classification may stem from
different sources and labs from anywhere in the world supported by the OECD-systems for data generation
(OECD guidelines, GLP), built on mutual acceptance of such test data between countries. These requirements
are implemented in Serbia under chemicals legislation to the same extent as they are implemented in the EU
as envisaged by chemicals legislation (CLP, REACH etc); Qualified and/or certified (ISO 17025) laboratories
for determining physico-chemical properties of chemicals exist in Serbia. Laboratory capacities are prescribed
by the Rulebook on methods for testing of chemicals which is aligned with the Regulation No 440/2008 laying
down test methods pursuant to REACH.
Classification and labelling inventory that is built up according to CLP Regulation by the notifications to
ECHA serves already under the current Serbian chemicals management system as a source of information
to industry. Serbian manufacturers and importers are encouraged to consult this inventory when deciding
on classification of chemicals they place on the market..
Arrangements have been implemented to ensure implementation of national legislation as well as the CLP
Regulation after the accession. A number of seminars with industry participation were organized during
the recent years to ensure that chemicals industry in Serbia is well informed about its roles and obligations
regarding the classification and labelling of chemicals. A system of certified chemicals advisors ensures
that industry has access to knowledge for the purpose of classification and labelling of chemicals..
Guidance for industry on classification, labelling and packaging in Serbian is provided by the competent
authority in terms of guidelines and instructions prepared and made available via the Internet and by means
of leaflets, posters etc. ..
National helpdesk has been established since 2010 to ensure assistance to enterprises, especially to SMEs,
with regard to the requirements of the national legislation as well as with the REACH and CLP (e.g. for
exporters). This helpdesk is foreseen to become the member of the ECHA helpdesk network once Serbia
is the EU member. Its staffs already take part in Help Net activities with the capacity of an observer.
Representatives of the Department for Chemicals participate with a capacity of observers at CARACAL
meetings of competent authorities for REACH and CLP. This is recognized as important capacity bilding
activitiy
REACH (Regulation 1907/2006)
The institutional framework for the transposition, implementation and enforcement has been established within
MAEP, Department of Chemicals, as the Group for chemicals management. Two employees are in charge of
harmonization and implementation of REACH harmonized provisions. For the implementation of the REACH
Regulation, it is necessary to hire four additional civil servants.
Control and inspection of the implementation of the national REACH provisions is done by the
Ministry,competent for the environment and the Ministry competent for health. Within the ministry competent
for the environemnt, Sector for Inspection of Environmental Protection, Department of chemicals and biocidal
products, a total of six inspectors are engaged in inspections under the Law on Chemicals and Law on Biocidal
products. In certain occasions, they are supported by the employees of the Department of major chemical
accidents which has nine inspectors.
National legislation harmonized with REACH is in force since 2010, and/or since 2011. The Serbian legislation
reiterate the detailed content of the provisions of REACH Regulation (with the exception of the provisions that
are not transposed). In the period of several years, the employees in the central administration have gained
knowledge and practical experience regarding the rules that are harmonized with the REACH Regulation. The
capacities of employees of the Department for Chemicals and the inspectors were further strengthened through
cooperation with Austria/Slovenia and Sweden; The European Chemicals Agency (ECHA) has also provided
support to employees in the central administration through workshops organized within the IPA project which
provides support to candidate countries and potential candidate countries.
Representatives of the Department of Chemicals participate as observers at CARACAL meetings of competent
authorities for REACH and CLP.
Some of the most relevant measures for the implementation of the REACH Regulation that are already in place
are the following:
In line with its importance, communication within the supply chain has been implemented. Legal entities
placing chemicals on the market provide SDS together with the chemical and the form and content are in
line with REACH, Annex II. Duty to communicate information on substances in articles (REACH, Art.
33) is implemented also.
The Guidelines on implementation of REACH were prepared for the exporters, such as Guidelines on the
identification of substances and brochures on exports of products that contain SVHC. Help Desk function
has also prepared Guidelines on the safety data sheet, Guidelines on the implementation of bans and
restrictions on asbestos, a national list of frequently asked questions (FAQ) etc;
The provisions of Annex XVII of the REACH Regulation have been implemented since 2010 and
harmonization of national legislation with the amendments to this Annex is carried out continuously
(Regulation EC No: 552/2009; 276/2010; 207/2011; 366/2011; 494/2011; 109/2012 ; 412/2012; 835/2012;
836/2012; 848/2012; 847/2012, 126/2013 and 474/2014);
Operators are well aware of the List of substances of very high concern (SVHC). From 1 January 2016,
they have the obligation to provide information for the Register of chemicals about the SVHC that they
put on the market on their own or in the mixtures;
National helpdesk has been established since 2010 to ensure assistance to enterprises, especially to SMEs,
with regard to the requirements of the national legislation as well as with the REACH and CLP (e.g. for
exporters). This helpdesk is foreseen to become the member of the ECHA helpdesk network once Serbia
is the EU member. Its staffs already take part in Help Net activities with the capacity of an observer.;
Official website of the Ministry contains information about household chemicals (detergents, biocidal
products, etc.), hazardous chemicals in products (phthalates, BPA, SVHC, asbestos, etc.) Active
cooperation with the Cnsumers organizations has been establised.
Plans for full harmonization
In order to achieve full readiness to implement the EU acquis in the field of chemicals management, further
activities are necessary. The following briefly outlines the strategy that should provide this.
Institutional/administrative structure for the performance of all the tasks of the member states in compliance
with regulations on chemicals was established before accession.
In the period 2016 2018, the following activities are planned:
Evaluation of existing administrative capacity, redistribution of work and increasing the number of
employees in order to reach the level necessary for the implementation of EU legislation in the field of
chemicals.
Drafting a Development Plan of the competent authority, which will cover issues such as the current
administrative capacities and responsibilities (e.g. a list of expertise, knowledge and skills, etc.), available
staff and their workload, required capacity at the date of accession in terms of its obligations of the
competent authority of the member state, as well as a timetable for hiring new staff. The plan will be based
on existing capacity and allow maximum utilization of the existing number of employees due to financial
constraints. Special attention will be paid to ensuring a sufficient number of trained staff in order to fulfill
all the tasks delegated to the competent authority of the member state, including the obligation to cooperate
with the Commission and the European Chemicals Agency.
The resources required for further employment will be provided from the state budget.
Disadvantages in connection with the expertise and skills of staff in the competent authority will be overcome
in the pre-accession period. Some of the drawbacks be eliminated through activities related to further
strengthening the capacity of the competent authority provided under the IPA twinning project SR13 Iben 03
"Further development of the management of chemicals and biocidal products".
Employees of the Department of Chemicals will continue to participate as observers in the meetings of the
competent authorities of the member states, which will contribute to further strengthening the capacity and the
acquisition of knowledge and skills that are essential for full participation in the work after the accession.
In order to ensure effective monitoring of the implementation of EU legislation, further training of inspectors
will also be carried out.
their chemicals portfolio. This will be achieved by enhanced communication and different means of
information and knowledge dissemination (informative seminars, workshops etc). Standing dialogue and
practice of organizing Stakeholder Days will be continued. Beside the chemicals industriy i.e, companies,
additional target groups such as industry associations as well as consulting sector have been identified having
in mind their role and importance in terms of supporting the industry.
In the period after 2021 the following activities are planned:
By 2020 (indicative date for the accession of Serbia to the EU), transitional periods for registration of
substances established by REACH will expire. In addition, in accordance with Article 29 (3) of REACH, each
SIEF will be operational until 1 June 2018. On the other hand, Serbian industry has to implement REACH
provisions and register substances to comply with the principle no data no market. However, registration and/or
authorization procedures envisaged by REACH require certain time and cannot be performed in a single day.
Furhtermore, there has been no country with experience of becoming the EU member in sauch curcamstances
with respect to REACH. Therefor adaptation arrangements are needed for Serbian industry to fulfill the
REACH requirements and join the level playing field of the single market.
Serbia is going to ensure that administrative capacity necessary for implementation of REACH are in place on
the day of accession, however for full implementation of REACH provisions on registration and authorization
Serbia will carefully consider transitional arrangements in the form of Negotiation position
Crystal glass
1) Outline of status of harmonization
) The level of harmonization of national legislation with key EU acquis
The Rulebook on Labeling of Products from Crystal Glass ("Official Gazette of RS", No. 143/14), which was
adopted on the basis of the Law on Technical Requirements for Products and Conformity Assessment
("Official Gazette of RS", No. 36/09) entered into force on 3 January 2015 and its implementation starts from
1 January 2018. This Rulebook prescribes the requirements for labeling of products from crystal glass, as well
as the overview of crystal glass products after their placement on the market.
The Rulebook is in compliance with all the principles and essential requirements of Directive 69/493/EEC of
15 December 1969 on the approximation of the laws of the member states relating to crystal glass.
In accordance with the Screening Report for Chapter 1, this regulation is in compliance with the mentioned
EU Directive.
b) Institutional structure and state of administrative capacity
The Ministry of Economy is the authority responsible for the adoption and implementation of technical
regulations in the field of crystal glass. At this point, the Sector for Quality Infrastructure employs two
employees performing tasks related to the adoption and implementation of technical regulations transposing
the EU directives of the New and the Old Approach in the following areas: low-voltage electrical equipment,
electromagnetic compatibility, machinery, lifts, personal protective equipment, equipment and protective
systems intended for use in potentially explosive atmospheres, equipment that emits noise outdoors, textiles,
footwear and crystal glass.
Supervision over the implementation of regulations in the field of crystal glass products is carried out by the
Ministry of Trade, Tourism and Telecommunications Sector for Market Inspection.
c) Description of the measures and activities taken in order to achieve full compliance with the EU acquis
In the period from 2011 to 2016 various projects have been implemented supporting the development of quality
infrastructure (QI) in the Republic of Serbia (IPA 2008, IPA 2010, IPA 2011, IPA 2013, GIZ ACCESS 1),
including QI in the field of crystal glass. Users of these projects were relevant ministries and other QI
institutions.
In accordance with the obligation under Article 77, item 2a of the SAA, a number of seminars, round tables
and trainings were organized on the application of national technical legislation which transposed Directive
69/493/EEC. Also, a guide for the application of this technical regulation was developed and published.
2) Plans for full harmonization with the EU acquis
b) Review of measures and activities that will be conducted in order to establish or strengthen
institutional structure and administrative capacity
For the effective performance of these tasks within the scope of the competent Department in the Ministry of
Economy, it is necessary to employ at least one employee in this section in 2016/2017.
The competent authorities will continue to provide training of employees in these bodies regarding the
application of national legislation harmonized with the EU Directive, in accordance with EC guidelines and
good practice in EU member states.
c) The measures planned to achieve full harmonization with the EU acquis
In the period to 31 December 2018, and as a regular activity after that date, training of business entities will
be carried out in connection with the implementation of national technical legislation harmonized with
Directive 69/4.
Textile
1) Outline of status of harmonization
) The level of harmonization of national legislation with key EU acquis
The Rulebook on the Labeling and Marking of Textile Products ("Official Gazette of RS, no. 1/14) was adopted
on the basis of the Law on Technical Requirements for Products and Conformity Assessment ("Official Gazette
of RS", no. 36/09), entered into force on 14 January 2014, and is applied from 1 July 2015.
This Rulebook specifies the requirements for marking and labeling information on the fiber composition of
textile products, the requirements for the use of the names of textile fibers in the said marking and labeling,
marking and labeling data on textile products containing non-textile parts of animal origin and determination
of the fiber composition of textile products which are marked or labeled in accordance with this rulebook, as
well as requirements for additional marking and labeling information on the procedure and method of
maintaining clothing textile products, data collection for the maintenance of clothing textile products, as well
as data on the size of clothing textile products.
The Rulebook complies with all the principles and substantive requirements of Regulation No 1007/11 of the
European Parliament and of the Council on textile fiber names and the labeling and marking of the fiber
composition of textile products, as well as the requirements of Commission Regulation No 286/2012 amending
Regulation No 1007/11 of the European Parliament and of the Council.
In accordance with the Screening Report for Chapter 1, this Regulation is partially harmonized with the
mentioned EU Regulation, given that it contains certain national provisions shall apply until the entry into
force of ACAA agreement or accession of the Republic of Serbia to the EU.
b) Institutional structure and state of administrative capacity
The Ministry of Economy is the authority responsible for the adoption and implementation of technical
regulations in the field of textile products. At this point, the Sector for Quality Infrastructure employs two
employees performing tasks related to the adoption and implementation of technical regulations transposing
the EU directives of the New and the Old Approach in the following areas: low-voltage electrical equipment,
electromagnetic compatibility, machinery, lifts, personal protective equipment, equipment and protective
systems intended for use in potentially explosive atmospheres, equipment that emits noise outdoors, textiles,
footwear and crystal glass.
Supervision over the implementation of regulations in the field of textile products is carried out by the Ministry
of Trade, Tourism and Telecommunications Sector for Market Inspection.
c) Description of the measures and activities taken in order to achieve full harmonization with the EU
acquis
In the period from 2011 to 2016 various projects have been implemented supporting the development of quality
infrastructure (QI) in the Republic of Serbia (IPA 2008, IPA 2010, IPA 2011, GIZ ACCESS 1), including QI
in textile products. Users of these projects were relevant ministries and other QI institutions.
In accordance with the obligation under Article 77, item 2a of the SAA, a number of seminars, round tables
and trainings were orgnaized on the application of national technical legislation transposing Regulation No
1007/11. Also, a guide to the application of this technical regulation was developed and published.
2) Plans for full harmonization with the EU acquis
) Plans in respect of the remaining necessary harmonization of the national legislative framework with
the EU acquis
Bearing in mind that, in accordance with the Screening Report for Chapter 1, this rulebook was partially
harmonized with Regulation No 1007/11, complete harmonization is expected upon the accession of the
Republic of Serbia to the EU, in accordance with the provisions of this Rulebook.
b) Review of measures and activities that will be conducted in order to establish or strengthen
institutional structure and administrative capacity
For the effective performance of all the tasks within the scope of the competent Department of the Ministry of
Economy, it is necessary to employ at least one civil servant in 2016/2017.
The competent authorities will continue to provide training of employees in these bodies regarding the
application of national legislation harmonized with EU regulation, in accordance with EC guidelines and good
practice in EU member states.
c) The measures planned to achieve full compliance with the EU acquis
In the period to 31 December 2018, and as a regular activity after that date, training of business entities will
be carried out in connection with the implementation of national technical legislation harmonized with
Regulation No 1007/11.
Footwear
Outline of status of harmonization
) The level of harmonization of national legislation with key EU acquis
The Rulebook on the Labeling of Footwear ("Official Gazette of RS", no. 1/14) which was adopted on the
basis of the Law on Technical Requirements for Products and Conformity Assessment ("Official Gazette of
RS", no. 36/09), entered into force on 14 January 2014 and is applied from 1 July 2015. This Rulebook
prescribes the requirements for labeling of main components of footwear and materials of the main components
of footwear for sale to consumers, as well as requests for additional written information accompanying the
footwear.
The Rulebook is in compliance with all the principles and essential requirements of Directive 94/11/EC of the
European Parliament and of the Council of 23 March 1994 on the labeling of the materials of main components
of footwear.
In accordance with the Screening Report for Chapter 1, this rulebook is partially harmonized with the
mentioned EU directive, since it contains certain national provisions that will apply until the accession of the
Republic of Serbia to the EU.
b) Institutional structure and state of administrative capacity
The Ministry of Economy is the authority responsible for the adoption and implementation of technical
regulations in the field of footwear. At this point, the competent Department of the Sector for Quality
Infrastructure employs two employees who perform tasks within the scope of this unit relating to the adoption
and implementation of technical regulations transposing the EU directives of the New and the Old Approach
in the following areas: low-voltage electrical equipment, electromagnetic compatibility, machinery, lifts,
personal protective equipment, equipment and protective systems intended for use in potentially explosive
atmospheres, equipment that emits noise outdoors, textiles, footwear and crystal glass.
Control over the implementation of regulations in the field of footwear is carried out by the Ministry of Trade,
Tourism and Telecommunications Sector for Market Inspection.
c) Description of the measures and activities taken in order to achieve full compliance with the EU acquis
In the period from 2011 to 2016 various projects have been implemented supporting the development of quality
infrastructure (QI) in the Republic of Serbia (IPA 2008, IPA 2010, IPA 2011, GIZ ACCESS 1), including in
the field of QI footwear. Users of these projects were relevant ministries and other QI institutions.
In accordance with the obligation under Article 77, item 2a of the SAA, a number of seminars, round tables
and trainings were organized on the application of national technical legislation which transposed Directive
94/11/EC. Also, a guide to the application of this technical regulation was developed and published.
Plans for full harmonization with the EU acquis
) Plans in respect of the remaining necessary harmonization of the national legislative framework with
the EU acquis
Bearing in mind that, in accordance with the Screening Report for Chapter 1, this rulebook is partially
harmonized with Directive 94/11/EC, complete harmonization is expected by the accession of the Republic of
Serbia to the EU, in accordance with the provisions of this Rulebook.
b) Review of measures and activities that will be conducted in order to establish or strengthen
institutional structure and administrative capacity
For the effective performace of these tasks within the scope of the competent Department in the Ministry of
Economy, it is necessary to recruit at least one civil servant in this unit in 2016/2017.
The competent authorities will continue to provide training of civil servants employed in these bodies regarding
the application of national legislation harmonized with EU regulation, in accordance with EC guidelines and
good practice in EU member states.
c) The measures planned to achieve full harmonization with the EU acquis
In the period to 31 December 2018, and as a regular activity after that date, training of business entities will
be carried out in connection with the implementation of national technical legislations harmonized with
Directive 94/11/EC.
Fertilizers
1) Outline of status of harmonization
) The level of harmonization of national legislation with key EU acquis
The field of fertilizers is regulated by the Law on Fertilizers and Soil Enhancers ("Off. Gazette of RS", no.
41/09), which, in part related to inorganic (mineral) fertilizers, fully complies with the Regulation (EC) of the
European Parliament and of the Council No 2003/2003/EC of 13 October 2003 relating to fertilizers, except
for the provisions of the Regulation which cannot be transposed into national legislation (Articles of the
Regulation relating to the procedures of the European Commission, including the notification of the European
Commission by the member states relating to national provisions, as well as transitional and final provisions
of this Regulation).
Most Articles of the Regulation 2003/2003/EC (Art. 6, 9, 16-23), as well as most of the Annexes (I, II, III and
IV) were transposed into appropriate bylaws that, also in the part related to inorganic (mineral) fertilizers, fully
comply with the said Regulation, namely:
Rulebook on Requirements for Classification and Determination of Quality of Plant Nutrients, Deviations
in Respect of Content of Nutritives and Minimum and Maximum Values of Permitted Deviations in
Respect of Content of Nutritives, and on the Content of Declaration and Method of Marking of Plant
Nutrients ("Off. Gazette of RS", no. 78/09);
Rulebook on Characteristics of Ammonium Nitrate High-nitrogen Fertilizer, Limit Contents of Nitrogen
in Ammonium Nitrate High-nitrogen Fertilizer and Methods of Explosion Resistance Testing the
Ammonium Nitrate High-nitrogen Fertilizer must meet ("Off. Gazette of RS", no. 70/10), and
Rulebook on Testing Methods for Plant Nutrients and Soil Conditioners ("Off. Gazette of RS", no. 71/10).
The Screening Report of the European Commission on screenings held with representatives of the Republic of
Serbia - Negotiating Group for Chapter 1 also noted that the field of fertilizers has been fully harmonized with
European legislation.
In addition to inorganic (mineral) fertilizers, the Law on Fertilizers and Soil Enhancers regulates the plant
nutrition products (fertilizers and substrates) and soil enhancers of organic, organic-inorganic and
microbiological origin, as well as plant nutrition products containing plant extracts.
The compliance with Regulation 1069/2009 related to organic and inorganic organic fertilizers and soil
enhancers containing byproducts of animal origin not intended for human consumption is achieved by a bylaw
which contains a link to the relevant national legislation in the veterinary field, which was adopted in
accordance with the said Regulation.
b) Institutional structure and state of administrative capacity
Plant Protection Directorate of the Ministry of Agriculture and Environmental Protection is the competent
authority in the field of plant nutrition products and soil enhancers.
Within the framework of the Plant Protection Directorate, the Department of Plant Protection and Plant
Nutrition performs legislative, administrative and coordination tasks related to plant nutrition products and soil
enhancers (registration and placing on the market), and the departments of phytosanitary inspection (border
and internal) control duties on imports, transport and application.
In addition to departments of phytosanitary inspection, the control activities are also carried out by authorized
official laboratories that perform testing of samples of plant nutrition products and soil enhaners taken to
control the import, manufacture, transport and application.
The institutional framework and the existing capacities relevant to the transposition, implementation and
enforcement of the EU acquis are also presented in the following table:
The number of employees
Enforcement of
Total
Organizational
working on the
regulations
number of
unit
transposition/implementation
entrusted to other
employees
and enforcement of EU acquis
institutions
Department of
3
Transposition,
Plant Protection
with
the
Not entrusted to other
4
implementation
and
and Plant
head of the
institutions.
enforcement
Nutrition
Department
Department of
Border
Phytosanitary
Inspection
Department
of
Phytosanitary
Inspection
Transposition
33
Implementation
enforcement
Transposition
53
Implementation
enforcement
34
54
and
7 authorized
laboratories for
testing samples of
plant nutrition
products and soil
enhancers taken to
control the import,
manufacture,
transport and
application.
and
The current number of employees and their educational profile in the Department of Plant Protection, in the
field of plant nutrition products and soil enhancers, is not sufficient to support the further transposition of EU
regulations into national legislation, as well as their implementation and enforcement.
Departments of Phytosanitary Inspection, in addition to implementation and enforcement of the Law on
fertilizers and soil enhancers and regulations made thereunder, implement and enforce regulations in other
areas which include the phytosanitary system, such as legislation in the field of plant health, seeds and planting
material of agricultural plants, recognizing varieties of agricultural plants, plant protection and residue
products, protection of rights of plant variety enhancers and genetically modified organisms.
c) Description of the measures and activities taken in order to achieve full harmonization with the EU
acquis
Since the entry into force of the plant nutrition and soil enhancers, several workshops, study visits and expert
missions have been organized by TAIEX, as well as BTSF (Better Training for Safer Food) trainings in the
organization of the European Commission, which were related to certain issues in the field of plant nutrition
products and soil enhancers.
These training courses were attended by the employees of the Ministry of Agriculture and Environmental
Protection, as well as the representatives of laboratories involved in official controls and manufacturers of
plant nutrition products and soil enhancers. During these events, advice was given that is also incorporated
into this Law and the bylaws. For example, in the period from 2010 to 2014 the following BTSF and TAIEX
training sessions were held:
1. Registration, quality control and testing of plant nutrition products - expert mission (Directorate of Plant
Protection, laboratories, manufacturers);
2. Classification, quality control, labeling and marking of plant nutrition products - study visit (Directorate
for Plant Protection);
3. Organic fertilizers, quality control and application in conventional and organic production - study visit
(Directorate for Plant Protection);
4. Organic fertilizers and soil conditioners manufactured from byproducts of animal origin (Directorate for
Plant Protection).
2) Plans for full harmonization with the EU acquis
) Plans in respect of the remaining necessary harmonization of the national legislative framework with
the EU acquis
Given the fact that the field of fertilizers fully harmonized with European legislation, in the coming period
amendments are planned to the bylaws in accordance with the amendments to Regulation 2003/2003/EC from
2009 to 2014.
b) Review of measures and activities aimed at establishing or strengthening institutional structure and
administrative capacity
In addition to the harmonization of legislation of the Republic of Serbia, as a state in the process of accession
to the EU, one of the main priorities is also to ensure that the competent authorities in the field of plant nutrition
products and soil enhancers have a sufficient number of suitably qualified and experienced staff so that the
obligations laid down in EU legislation are carried out efficiently and effectively, including appropriate
inspection bodies and testing laboratories. In addition, it is necessary to determine the national reference
laboratories.
Activities to be completed in the period from 2016 to the end of 2018
In 2018 it is necessary to employ new staff for inspection tasks, namely 35 employees in the Department of
Phytosanitary Inspection, who will perform other tasks within the phytosanitary system, in addition to activities
in the field of plant nutrition products and soil enhancers.
Strengthening the institutional framework and the existing capacities relevant to the transposition,
implementation and enforcement of the EU acquis are presented in the following table:
Organizational
unit
Department of
Plant Protection
and Plant
Nutrition
Department of
Border
Phytosanitary
Inspection
Total
number of
employees
3
with the
head of the
Department
34
Transposition,
implementation
enforcement
Transposition
and
Enforcement
of
regulations
entrusted to other
institutions
Will not be entrusted
to other institutions.
... official laboratories
for testing samples of
plant
nutrition
products and soil
Department of
Phytosanitary
Inspection
33
Transposition
enforcement
Transposition
87
Transposition
enforcement
54 + 35
enhancers taken to
control the import,
and
manufacture,
transport
and
application.
...
reference
laboratories for testing
samples of plant
nutrition products and
and
soil
enhancers,
depending on the type.
In addition to employing new staff for inspection tasks, activities on the development of phytosanitary
information system will be conducted, as well as the establishment of a system of training and evaluation of
knowledge of phytosanitary inspectors in the field of plant nutrition products and soil enhancers, which will
be supported by the application of twinning projects which are being implemented (IPA 2012) or will be
implemented in the period from 2016 to 2020.
Activities to be completed in the period from 2019 to the end of 2020
Key activities to be undertaken during the period from 2019 to the end of 2020 relate to the identification and
equipping of border crossings to third countries, in cooperation with the customs authority and the definition
of other places that are not entry points for the review of plant nutrition products and soil enhancers. In this
respect, it is necessary to implement the reorganization of the Department of Border Phytosanitary Inspection
by deployment of a number of phytosanitary inspectors in the Department of Phytosanitary Inspection.
c) The measures planned to achieve full harmonization with the EU acquis
2016
In accordance with the changes of EU acquis, the following bylaws will change:
Rulebook on Requirements for Classification and Determination of Quality of Plant Nutrients, Deviations in
Respect of Content of Nutritives and Minimum and Maximum Values of Permitted Deviations in Respect of
Content of Nutritives, and on the Content of Declaration and Method of Marking of Plant Nutrients and
1) Rulebook on Testing Methods for Plant Nutrients and Soil Enhancers.
2017-2018
Given the fact that the European Commission informed us at the explanatory screening that Regulation
2003/2003/EC is currently in the process of revision concerning the extension of its scope to other fertilizers
such as organic, inorganic-organic fertilizers, soil enhancers, substrates, herbal stimulants and others, which
should be completed by the end of 2016 which was confirmed setting on the website of the European
Commission's proposal for a new Regulation on fertilizers, which should begin to be implemented from
January 1, 2018 changes and additions bylaws will be planned for the first quarter 2018.
Appendix A) Plan of harmonization of legislation of RS with the EU acquis
Planned
Regulation
Competent
No
regulation
Deadline
name
institution
code
elex
Regulation
translated
1.
2016-478
Law on the
amendments to the
Law on Fertilizers
and Soil Enhancers
MAEP
IV quarter
2016
02003R2003
no
2.
2016-476
MAEP
IV quarter
2016
02003R2003
no
3.
2016-475
Rulebook on the
amendments to the
Rulebook on
Requirements for
Classification and
Determination of
Quality of Plant
Nutrients,
Deviations in
Respect of Content
of Nutritives and
Minimum and
Maximum Values
of Permitted
Deviations in
Respect of Content
of Nutritives, and
on the Content of
Declaration and
Method of Marking
of Plant Putrients
Rulebook on the
amendments to the
Rulebook on
Testing Methods
for Plant Nutrients
and Soil Enhancers
MAEP
IV quarter
2016
02003R2003
no
PROCEDURAL ISSUES
Notification
1) Outline of status of harmonization
) The level of harmonization of national legislation with key EU acquis
Activities on the harmonization of the laws of the Republic of Serbia in this area were conducted by the Ministry
of Economy, Sector for Quality Infrastructure. Regulation on the Manner of Providing information and
Notification of Technical Regulations, Conformity Assessment and Standards was adopted by the Government on
30 December 2015 and published in the "Official Gazette of RS", no. 114/15 of 31 December 2015. Regulation
transposed Directive (EU 2015) 1535 of the European Parliament and of the Council of 9 September 2015, which
refers to the procedure for notifying technical regulations and rules on information society services.
The European Commission issued a recommendation in terms of adoption of technical regulations under urgent
procedure to allow giving remarks by the European Commission and member states to such technical regulations
under preparation.
The suggestion of the European Commission was adopted, so the text was improved in the revised Regulation and
giving remarks to technical regulations was allowed in the preparatory phase when they are adopted under urgent
procedure.
b) Institutional structure and state of administrative capacity
The transposition of this regulation is the competence of the Ministry of Economy, Sector for Quality
Infrastructure, the Group for the Removal of Barriers to Trade in Non-harmonized area, Registers and Infocenter with 3 employees, who, in addition to other tasks, also perform tasks related to the transposition and
implementation of this regulation.
2) Plans for full harmonization with the EU acquis
b) Review of measures and activities to be undertaken in order to establish or strengthen institutional
structure and administrative capacity
Through the Twinning project funded by the IPA 2013 - "Strengthening the capacity of the national system of
quality infrastructure and service providers of conformity assessment", strengthening the capacity of the
Ministry of Economy as the contact point for notifying technical regulation is planned.
c) The measures planned to achieve full harmonizaton with the EU acquis
The preparation of a campaign relating to the application of the adopted Regulation is underway, taking into
account the partial application of the Regulation pursuant to Article 13 of the CEFTA Agreement and
obligations of the parties to apply technical regulations in the stage of their preparation. The campaign will be
primarily directed towards all the bodies, i.e. organizations of the state administration adopting technical
regulations, but also towards business entities as potential actors in giving objections to domestic and foreign
technical regulations at the stage of their preparation. The campaign will be conducted in 2016 and 2017.
Firearms
1) Outline of status of harmonization
) The level of compliance of national legislation with key EU acquis
The Republic of Serbia adopted a new Law on Arms and Ammunition ("Official Gazette of RS", no. 20),
which entered into force on 4 March 2015, and its implementation started on 5 March 2015. Law enforcement
is the responsibility of the Ministry of Interior.
The new Law on Arms and Ammunition is in compliance with the EU Directive 477/91 on the control of
acquisition and possession of weapons and Directive 51/2008.
Work is underway on the finalization of drafted bylaws from the jurisdiction of this Ministry, i.e. the adoption
of the rulebook.
The strategic framework is regulated by Strategy on Small Arms and Light Weapons Control of the Republic
of Serbia (2010-2015) and the Action Plan.
b) Institutional structure and state of administrative capacity
Tasks relating to the enforcement of the Law on Arms and Ammunition at the Ministry of Interior were
organized in the Police Directorate, Department for Administrative Affairs, as well as in police administrations
and police stations with a total of 331 police officers.
c) Description of other measures and activities taken so far in order to achieve full harmonization with
the EU acquis
Police officers actively participate in training sessions that are conducted during the implementation of
activities under the Action Plan for Chapter 24, referring to the team of experts for weapons that is formed on
the basis of the recommendations of the European Commission for Chapter 24.
Realized activities planned by the Action Plan related to organizing a study visit to the Ministry of Internal
Affairs of Italy enabled a quick introduction to the legal framework of the deactivation of firearms in the
European Union, which is implemented through the Rulebook on disabling weapons.
Measures planned for the period 2016-2018
The Republic of Serbia is preparing a new strategy on small arms and light weapons control of the Republic
of Serbia for the period 2016-2021, which will also be aimed at reducing the quantity and the fight against
illegal production, possession and trafficking in small arms and light weapons in all aspects. Department for
Administrative Affairs began work in the coming period and will draw up a new draft of the Strategy and
Action Plan for the implementation of the Strategy.
Arms trade and defense products
1) Outline of status of harmonization
) The level of harmonization of national legislation with key EU acquis
The field of exports and imports of arms and military equipment is regulated by the Law on Exports and
Imports of Arms and Military Equipment ("Off. Gazette of RS", no. 107/14) and the Law on Production and
Trade of Arms and Military Equipment ("Off. Gazette of FRY", no. 41/96, "Off. Gazette of SCG", no. 7/05state law and 8/05 - state law).
The Law on Exports and Imports of Arms and Military Equipment for the most part complies with EU
Directive 43/2009. The part remaining for harmonization is the one which concerns the legal possibility of
issuing global and general licenses stipulated by the said Directive.
Draft Law on Production and Trade of Arms and Military Equipment is in the process of adoption. The current
law was passed in 1996 ( "Official Gazette of RS", no. 41/96, "Official Gazette of SCG", no 7/2005 - state law
and "Off. Gazette of RS", no. 85/2005 state law) and it regulates the production, trade and transport of
weapons and military equipment as well as activities of general interest, the planning of the security measures,
planning of production and trade of arms and military equipment, quality control of arms and military
equipment production and other issues of importance for the production, trade and transport of weapons and
military equipment.
The main reasons for the adoption of new legislation in this area, among other things, are the creation of
conditions for improving the production and trade of NGOs, as well as the complete definition of the terms
that belong to the category of weapons and military equipment and their harmonization with EU regulations.
The proposed Draft law will improve the legislative framework for the fulfillment of the main objective control of the production and trade of arms and military equipment for the exercise and protection of defense,
security, economic and foreign policy interests of the Republic of Serbia, its international credibility and
integrity. The adoption of the new law will contribute to strengthening the control mechanisms in the area of
planning security measures, security and protection in the production of arms and military equipment, rights
and obligations of the manufacturer, compliance with standards and technical regulations, issuing licenses for
the production of arms and military equipment, providing a wider range of powers of the competent authority
and creating the environment for foreign investment.
After the public hearing, further harmonization and implementation of remarks and proposals obtained during
the public hearings was carried out. In this process, the full cooperation with the Office of the Commissioner
for Information of Public Importance, the National Convention on the EU and the Centre for Public Policy
Research was realized, and the process was considered transparent and affirmative.
The harmonization procedure was completed and the submission of the Draft law to the Government and
referral to parliamentary procedure is expected.
b) Institutional structure and state of administrative capacity
Licenses for export and import of arms and military equipment, the provision of brokering services and
technical assistance are issued by the Ministry of Trade, Tourism and Telecommunications. These tasks are
the responsibility of the Sector for Trade Policy, Multilateral and Regional Economic and Trade Cooperation,
Department for international contracts, concessions and public-private partnerships and foreign trade in
controlled goods.
The process of issuing said licenses includes the Ministry of Foreign Affairs, Ministry of Interior, Ministry of
Defense and the Security Information Agency. The license is issued on the basis of the consent of all of those
bodies. In the event that one of them does not give their consent, the Government decides on the issuance of
licenses, and if two or more bodies do not give their consent, the license cannot be issued.
The institutional framework and the existing capacities are presented in the following table:
Enforcement of
Total
Number of employees working on
regulations
Organizational unit
number of
the transposition/implementation
entrusted to
and enforcement of EU acquis
employees
other
institutions
Department of
International
Agreements,
8, with the
Transposition,
Concessions and
Head of
4
implementation and
/
Public-private
Department
enforcement
Partnerships and
Foreign Trade in
Controlled Goods
c) Description of other measures taken so far and activities in order to achieve full harmonization with
the EU acquis
Regular updating of the National control list is done in the Department, not only of weapons and military
equipment, but also of dual-use goods, with the EU lists. National Control List of Arms and Military Equipment
("Off. Gazette of RS", no. 66/2015) complies fully with the EU Military List of 2015 which is in force in the
member states. National Control List of Dual-Use Goods ("Off. Gazette of RS", no. 44/2015) is harmonized
with the EU list of December 2014. In December 2015, the EU adopted a new List of Dual-Use Goods. The
process of harmonization of our list with the latest EU List of Dual-Use Goods is in progress.
2) Plans for full harmonization with the EU acquis
) Plans in respect of the remaining necessary harmonization of the national legislative framework with
the EU acquis
In the field of export and import of arms and military equipment, full harmonization with EU legislation is
anticipated until the moment of full membership in the EU.
In this area, it is necessary to amend the Law and to provide for the possibility of issuing global and general
licenses.
In 2016 and 2017, in accordance with the amendments to the EU regulations, the following bylaws will change:
1. The National Control List of weapons and military equipment;
2. The National Control List of Dual-Use Goods.
Cultural goods
1) Outline of status of harmonization
) The level of harmonization of national legislation with key EU acquis
In accordance with the National Programme for the Adoption of the EU acquis (NPAA), the report of the EC
from the bilateral screening and the scope of the Ministry of Culture and Information, at the moment the
adoption of the new Law on Cultural Heritage is underway, and the aim of this organic law is to achieve full
compliance for all types of cultural heritage with the Directive 2014/60/EU of the European Parliament and of
the Council of 15 May 2014 on the return of cultural objects unlawfully removed from the territory of a member
state and on amending Regulation (EU) No 1024/2012 (amendment) (CELEX 32014L0060).
b) Institutional structure and state of administrative capacity
The Ministry of Culture and Information is in charge of the implementation of the new Law on Cultural
Heritage which is fully harmonized with the Directive 2014/60/EU of the European Parliament and of the
Council of 15 May 2014 on the return of cultural objects unlawfully removed from the territory of a member
state and on amending Regulation (EU) No 1024/2012 (amendment).
The Ministry of Culture and Information does not have the appropriate administrative capacities for the
transposition and implementation of Directive 2014/60/EU of the European Parliament and of the Council of
15 May 2014 on the return of cultural objects unlawfully removed from the territory of the Member States and
on amending Regulation (EU) No 1024/2012 (amendment). Given that these are new competences of the
Ministry (establishment of a central body for the return of cultural goods), which include continuously carrying
out a series of tasks and activities, it is necessary to create at least one new workplace, which means increasing
the number of workplaces in the Ministry of Culture and Information.
c) Description of other measures and activities taken so far in order to achieve full harmonization with
the EU acquis
Despite the current lack of administrative capacity, the Ministry of Culture and Information has a constant
tendency towards training and raising employee skills through constant monitoring of regulations of all
relevant institutions in this area in the European Union as well as those organizations with which the EU is
harmonizing its regulations.
2) Plans for full harmonization with the EU acquis
) Plans in respect of the remaining necessary harmonization of the national legislative framework with
the EU acquis
Plans in respect of the remaining harmonization until 31 December 2017 consist of the implementation of the
new Law on Cultural Heritage, fully compliant with Directive 2014/60/EU of the European Parliament and of
the Council of 15 May 2014 on the return of cultural objects unlawfully removed from the territory of a member
state and on amending Regulation (EU) No 1024/2012 (amendment).
It should be noted that the beginning of the enforcement of certain transitional provisions of the Law was set
for the date of entry of Serbia into the European Union. The reason for this measure is that the Directive, with
which the new Law on Cultural Heritage is harmonized, foresees a central body whose task, among others, is
communication with the central bodies of other member states as well as sending periodic reports to the
European Commission.
For the period from 31 December 2018 until 2021, the continuation of the implementation of the fully
harmonized Law on Cultural Heritage is planned, as well as monitoring any changes of the relevant regulations
of the European Union (Directive 2014/60/EU of the European Parliament and of the Council of 15 May 2014
on on the return of cultural objects unlawfully removed from the territory of a member state and on amending
Regulation (EU) No 1024/2012 (amendment) and, in accordance with the aforementioned, harmonization of
the Law with changes that may occur until 2021 or the full membership of the Republic of Serbia in the
European Union.
b) Review of measures and activities to be undertaken in order to establish or strengthen institutional
structure and administrative capacity
Institutional framework for the return of cultural goods for the said period is represented by the Ministry of
Culture and Information in collaboration with the Ministry of Foreign Affairs, Ministry of Interior, the Ministry
of Finance-Customs Administration, and cultural institutions.
No
1.
Planned
regulation
code
2016-2
Regulation
name
Competent
institution
Law on
Cultural
Heritage
CI
Deadline
Celex
Regulation
translated
IV quarter
2017
32014L0060
No