list of acronyms bc bpr cards cfcu clp - esteri e montenegro/sr_13_ib_en... · list of acronyms bc...
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List of Acronyms
BC Beneficiary Country
BPR Biocidal Products Regulation
CARDS Community Assistance for Reconstruction, Development and Stabilisation
Programme
CARACAL Competent Authorities for REACH and CLP
CFCU Contracting and Financing of EU Funded Projects
CLP Regulation on Classification, Labelling and Packaging of substances and
mixtures
COMPETENT
AUTHORITY Department for Chemicals
EAS Environmental Approximation Strategy
EC European Commission
ECHA European Chemicals Agency
EU European Union
ICR Integrated Chemicals Registry
ICMS Integrated chemicals management system
IPA Instrument for Pre-Accession Assistance
IUCLID International Uniform Chemical Information Database
GHS Globally Harmonized System for Classification and Labelling of Chemicals
KemI Swedish Chemicals Agency
MESP Ministry of the Environment and Spatial Planning
MAEP Ministry of Agriculture and Environmental Protection
MEDEP Ministry of Energy, Development and Environmental Protection
MS Member State
MSCAs Member States Competent Authority
NPAA National Program for Adoption of the Acquis
NPEP National Programme for Environmental Protection
NPI National Programme for Integration with the European Union
NSDS National Sustainable Development Strategy
PIC Prior Informed Consent Procedure for Certain Hazardous Chemicals
PL Project Leader
PSC Project Steering Committee
REACH Regulation (EC) No 1907/2006 concerning the Registration, Evaluation,
Authorization and Restriction of Chemicals
RTA Resident Twinning Adviser
R4BP Register for Biocidal Products
SAICM Strategic Approach for International Chemicals Management
SEIO Serbian European Integration Office
SEPA Serbian Environment Protection Agency
SIDA Swedish International Development Cooperation Agency
SVHC Substances of Very High Concern
SPO Senior Programme Officer
STE Short-term Expert
TNA Training Needs Analysis
UN United Nations
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UNITAR United Nations Institute for Training and Research
STANDARD TWINNING PROJECT FICHE
STANDARD TWINNING PROJECT FICHE
1. Basic Information
1.1 Publication reference: EuropeAid/ 136-368/IH/ACT/RS
1.2 Programme: IPA 2013 National Programme part A (Decentralized management)
1.3 Twinning Number: SR 13 IB EN 03
1.3 Title: Further development of chemicals and biocides products management in the
Republic of Serbia
1.4 Sector: Environment, Climate change and Energy Sector
1.5 Beneficiary country: The Republic of Serbia
2. Objectives
2.1 Overall Objective:
To assist Serbia to meet environmental and climate Acquis through institutional building and
improvement of environmental infrastructure.
2.2 Project purpose:
Ensured further alignment with the EU Environment Acquis, with the specific focus on
further development of institutional capacities and enforcement of national legislation and
strategic planning, including strengthening capacities of the Department for chemical
management in the Ministry of Agriculture and Environmental Protection, and other
stakeholders for effective implementation of relevant national legislation aligned with EU
legislation as well as for implementation of the EU acquis after the EU accession.
2.3 Contribution to National Development Plan/Cooperation
agreement/Association Agreement/Action Plan
The European Partnership 2008 defines a number of priorities for the environmental
sector. Among other things, the priorities are to strengthen further the administrative capacity
of environmental institutions at national and local level and ensure full implementation and
enforcement of legislation approximated to the EU legislation.
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Based on the Stabilization and Association Agreement (Article 111, Environment) the
Parties shall develop and strengthen their cooperation in the environmental field with the
vital task of halting further degradation and start improving the environmental situation with
the aim of sustainable development. The Parties shall, in particular, establish cooperation
with an aim of strengthening administrative structures and procedures to ensure strategic
planning of environmental issues and coordination between relevant actors and shall focus
on alignment of Serbia’s legislation with the Community acquis.
It addresses the need to strengthen administrative and professional capacities of the staff in
governmental bodies. Strengthening of professional capacities is not only based on an
increased number of staff, but also on training employees to enable them to implement
regulations.
The National Plan for Adoption of the Acquis (NPAA) (2014-2018) states that the
improvement of administrative and technical capacities has been planned in the field of risk
assessment and risk management of chemicals and biocidal products, as well as for the
effective implementation of the legislation harmonized with the EU legislation through the
implementation of project activities.
In the National Sustainable Development Strategy (NSDS) is also stated that: “In order to
achieve a more efficient implementation of new legislation in the field of management of
chemicals it is necessary to strengthen administrative and professional capacities of staff.”
In the National Programme for Environmental Protection 2010-2019 (NPEP) a set of
objectives for Government policy over 2010-2019 is defined, among others “Established and
improved system for chemicals and biocidal products management on the territory of the
Republic of Serbia on the basis of developed regulations, procedures and standards
harmonized with the EU Acquis Communautaire”.
The National Environmental Approximation Strategy 2011-2019 (EAS) aims to address
the challenges that approximation will pose to legislation (including the response to
deficiencies in the current legislative process in Serbia), the extent of change that will be
required in organizing and operating institutions responsible for environmental protection,
and the approach to closing the economic gap between 'business as usual' and full
compliance with the acquis. One of the challenges, as stated in the EAS, relates to
preparation of industry for their future obligation.
According to the EAS Strategy, overcoming this challenge requires sustained progress in
three particular areas: full transposition of the EU’s environmental legislation into national
legislation; putting in place the administrative capacity to implement, monitor and enforce
that legislation; and establishing the infrastructure required to be able to comply with the
legislation.
The Serbia 2013 Progress Report states: “As regards chemicals management, the closure of
the Chemicals Agency in September and the transfer of its mandate to the Ministry of
Energy, Development and Environmental Protection have removed the legal basis for
carrying out statutory duties related to issuing permits and decisions. Serbia needs to re-
instate a sound legal basis for chemicals management. Joint inspections under the Law on
Chemicals have been discontinued. The advanced level of competence in this domain should
be preserved in the new structure and the legislation applied again”.
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National Profile for Chemicals Management (developed in 2007 and updated in 2008 )
addresses the need to strengthen administrative and professional capacities of the staff in
governmental bodies.
This twinning project will contribute to achievement of objectives defined under these entire
national and sector strategies as it will assure strengthening capacities of institutions and
other stakeholders for implementing of chemicals and biocidal products related legislation.
3. Description
3.1 Background and justification:
Since several years Serbia has been developing and implementing contemporary chemicals
management system having in mind all features of the sound chemicals management as
emphasised at the Earth Summit on Environment, Rio de Janeiro 1992 (Chapter 19 of
Agenda 21). Sound chemicals management was one of the objectives of the Implementation
Plan of the Earth Summit held in Johannesburg in 2002. A global policy framework to
coordinate and support the achievement of the set objective of the 2002 Earth Summit -
Strategic Approach for International Chemicals Management (SAICM) was adopted at the
International Conference on Chemicals Management in 2006. Therefore the former Ministry
of the Environment and Spatial Planning (MESP) introduced SAICM to different
stakeholders back in 2008 aiming to catch up with the set trends.
During previous years and in line with our commitment to the EU integration all efforts were
targeted to streamline national legislative framework with the EClegislation on chemicals
developed in accordance to the European Commission White Paper (2001), Strategy for a
future Chemicals Policy that sets goals and procedures for improving chemical safety in the
EU internal market.
This Strategy seeks to ensure high level of protection of human health and the environment,
while ensuring the efficient functioning of the internal market and stimulating innovation and
competitiveness in the chemicals industry. Corresponding alignment of national legislation
with the EC legal framework is significant for the EU integration process but also contributes
to the protection of human health and the environment as well as to the competitiveness of
Serbian chemicals industry. Part of this Strategy is the Registration, Evaluation and
Authorisation of Chemicals (REACH) and Classification, Labelling and Packaging (CLP)
regulatory regime and Serbian first goal was to cope with the general principles of this
regulatory regime at national level.
Furthermore, recent developments in the EC- legislative framework on chemicals resulted in
regulations which are directly applicable in its totality in all the EU member states. The
consequence is that transposition of those acts into the national legislation is not required but
the candidate country shall ensure the capacity for full implementation and enforcement after
the accession.
The system as a whole cannot become fully implemented in a country outside the EEA
context. The reasons are as follows: supply chains are more complete in the EU; risk
communication could engage, exposure scenarios could cover and risk management
measures could address the numerous users of chemical substances and mixtures at the
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whole EEA-market; chemical safety assessment costs could effectively be distributed and
shared by industry within the whole EEA; safety data and test data could be shared among
the high number of EEA-manufacturers, importers and downstream users; the fulfilment of
central administrative tasks and enforcement tasks within the system requires that the
country is already the EU-member.
This does however not exclude the possibility for the EU-accession country to have a pro-
active approach to general principles but also to the fully EC-based elements which are
outside the limits to be incorporated into law.
This Twining Project should contribute to:
- Alignment of the national legal framework with the BPR;
- Improved administrative capacity for implementation of legislation on biocidal products
(i.e. improved Organizational structure for biocidal products management, establishment
of Operational scheme for biocidal product dossier assessment etc);
- Establishment of sustainable system for financing of administrative procedures in line
with the BPR;
- Improved professional capacities (i.e. competences) of the central administration on
chemicals (e.g.. competences for further implementation of REACH, biocidal products
risk assessment and dossier evaluation etc);
- Development of guidance/handbooks for further implementation of REACH;
- Increased competences of the staff of the organizational unit in charge for chemicals and
biocidal products management (foreseen to become Competent Authority under REACH,
CLP and BPR) and their capability to participate in the work of different committees and
bodies of the ECHA and the EC meetings on chemicals and biocidal products1;
3.1.1. Institutional issues
According to the Law on Ministries, currently the Ministry of Agriculture and Environmental
Protection (MAEP) (established on 26th
April 2014 after elections in March 2014) is
competent for the environment including chemicals and biocidal products management.
Within the MAEP, the tasks of chemicals and biocidal products management are
responsibility of the Department for Chemicals. Furthermore, the Ministry competent for the
environment is foreseen to become competent authority under EC-chemicals legislation after
the accession. With regard to chemicals and biocidal products, among other MAEP is
responsible for the following:
Enacting of implementing acts for implementation of the Law on Chemicals and the
Law on Biocidal Products;
Keeping the Integrated Chemicals Registry;
Issuing of decision on inclusion of biocidal product in the Temporary list for
submission of technical dossier;
Issuing of the authorisation for placing the biocidal product on the market;
1Competent Authorities meetings for REACH and CLP (CARACAL), Competent Authority meetings for BPR,
Committee for Risk Assessment, Committee for Socio-economic Analysis, Biocidal Products Committee,
Coordination Group, HelpNet.
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Cooperation with the ECHA, other national’ agencies and Secretariats of
International Conventions which regulate chemicals and other international
organisations dealing with different aspects of chemicals management;
Carrying out activities of awareness rising about the effects of chemicals on human
health and environment, risk reduction measures and sound use of chemicals.
Since the EC-legislation on chemicals consists of regulations that are directly applicable in
the all EU member states, transposition of those regulations is not required. However,
candidate countries have to demonstrate that they are fully capable to implement each of the
regulations after accession. The pull of capacities within the core administration and other
stakeholders on the day of accession is compulsory.
Therefore and in order to facilitate implementation of those regulations in the future, general
principles and provisions which are not too membership dependent are transposed into the
national legislation. However capacity needed for full implementation of the EU acquis on
chemicals has to be built further. Additionally, it has to be taken into account that the
chemicals and biocidal products are under different legislative regime. Some of the
capacities necessary for implementation of legislation on both chemicals and biocidal
products can be “shared” while other has to be built separately.
According to the national legislation, chemicals risk assessment at national level is not
envisaged but relies on the EC decisions coming out of centralized procedures managed at
the EU level by ECHA (e.g. decisions on bans and restrictions as well as on Substances of
Very High Concern (SVHC) are directly taken over into national legislation). However,
national authority foreseen to become competent authority under the legislation on chemicals
(i.e. REACH, CLP, PIC) have to build capacity and competences for the tasks it shall
perform under the legislation after the accession.
In order to successfully implement national legislation already harmonized with the parts of
REACH Regulation and build capacity for performing of all the CA’s tasks under REACH in
future, central staff for chemicals management needs extensive and comprehensive trainings
especially with regard to obligations which relate to procedures that are not transposed into
national legislation, such as: substances evaluation, authorization, preparation of dossiers for
identification of SHVC, preparation of proposals for restrictions etc. With the aim to achieve
this goal it would be beneficial for the Competent Authority staff to attend trainings on use
of REACH IT tools, IUCLID 5, CHESAR etc.
Furthermore, the Law on Chemicals has introduced obligation for legal entities placing
chemicals i.e. SVHC on their own, in mixtures or in articles on the market to submit data on
the SVHC. The competent authority for chemicals management is required to assess the
submitted data as well as to issue an approval of the proposed risk reduction measures.
Threfore, staff of the competent authority has to upgrade professional capacities and
knowledge in order to fulfill commitments stipulated in the Law at national level.
Finally, trainings on socio-economic analysis would be beneficial in order to increase the
understanding of the role that this analysis have in chemicals risk management. Socio-
economic expertise is relevant for deciding on national deadlines for mandatory application
of bans and restrictions while also will be needed for work in the ECHA Socio-Economic
Committee (SEAC), once Republic of Serbia becomes an EU member state.
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Contrary to the national legislative framework on chemicals, according to the national
legislation on biocidal products, risk assessment of biocidal products shall be done by
Serbian competent authority (i.e. Department for chemicals within MAEP). In that respect,
biocidal products risk management, particularly risk assessment is the field where the
capacity building has to be done more urgently. A wider cluster of scientific expertise is
available and shall be engaged to support the core administration in specific technical-
scientific tasks. Even though central staffs could be supported by (eco)toxicologists staying
back in the scientific field they have to have competences for carrying out complex
administrative procedures and have to provide for some in-house competence that will make
them able to engage and control the results of the external expert support.
Currently the staffs of the Department of Chemicals, Division for Biocidal Products Risk
Management does not have background in toxicology, ecotoxicology, exposure or risk
assessment area since education on risk assessment (purely scientific field) is not included in
the education programs in the Republic of Serbia and risk assessment was not prescribed in
previous legislation framework. Additionally, regulatory risk assessment differs from
academic scientific research grounds. In the regulatory context risk assessors do not work as
traditional (eco)toxicologists but have to acquire very specific skills. Their competences are
unique to their risk assessment schemes and skills are mostly earned through practice.
Therefore and upon the role of risk assessment (i.e. (eco)toxicology and exposure
assessment) in chemicals legislation, identified need for further institution building has to be
seriously taken into consideration together with sustainable investments in administrative
capacity.
Thorough evaluation of current administrative and professional capacities and capacities
needed for formation of future competent authority under the all EC-legislation on chemicals
is necessary in order to identify capacity building needs as well as modes of trainings that
will provide the optimum cluster of competence and capacity.
3.1.2. Legislative issues
Chemicals management is regulated by the Law on Chemicals and the Law on Biocidal
Products in order to establish sound management of chemicals and biocidal products at
national level as well as to carry out preferential activities in the framework of the globally
set aims (see Annex II).
The both laws have been harmonized with relevant provisions of the EU legislation listed in
the Annex II to the extent that was feasible and justified. Listed EU legislation have been
transposed by the Law on Chemicals, the Law on Biocidal Products and its implementing
legislation adopted on the basis of the provisions of the national laws (see Annex II). The
national implementing legislation shall be updated accordingly to the amendments of the
relevant EU legislation (REACH, CLP, BPR).
MAEP shall assure further harmonization of legislation and full implementation and
enforcement of the legislation concerned.
The Law on Chemicals presents a legal ground for EC harmonized chemicals management
system. The law is harmonized with the Regulation 1907/2006/EC (REACH) and Regulation
1272/2008/EC (CLP) to the most possible extent for the candidate country.
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General principles and procedures of REACH and CLP Regulation that are not too
membership dependent (e.g. rules on Safety Data Sheet (SDS), bans and restriction of
substances) have been transposed into the national legislation; provisions on procedures that
shall be done on the EU level (EU centralized procedures) (e.g. provisions on substance
evaluation, on authorization etc.) have not been transposed. The fact is that even if they have
been transposed as such under every circumstance the outcomes would not be recognized by
the EU and will be regarded as the EC- competitive. Even though transposition is not
possible Serbia shall ensure capacities necessary to perform all related tasks envisaged by
this procedures and delegated to the MS CAs. Therefore this twining shall contribute to
capacity building for fulfillment of those competent authorities’ capacity related
requirements.
Furthermore, the Law on chemicals enabled establishment of national helpdesk as envisaged
by the REACH and CLP Regulation aiming to support enterprises and other stakeholders to
navigate through the national legislation on chemicals.
Finally, the Law on chemicals establishes legal base for keeping of comprehensive data on
chemicals placed on the Serbian market via the Integrated Chemicals Registry data base.
Chemicals Registry is important tool for identification and adequate preparation of our
industry for the obligation under the REACH when Serbia becomes an EU Member State.
The procedure of reporting of the data on chemicals into the Chemicals Registry allows
mapping of manufacturers, importers and downstream users that will have obligation to
register substances under REACH after the accession of Republic of Serbia to EU. Besides,
establishment of the Registry contributes to identification of those manufacturers, importers
and downstream users that will have to obtain the authorization from ECHA for use of
SVHC. In addition, in order to ensure risk control and replacement of certain substance with
suitable safer alternative substance, from 2016 SVHC, i.e. mixture containing SVHC shall be
reported into the Chemicals Registry.
In order to adequately prepare for implementation of REACH after Serbia’s accession to the
EU, it is necessary to build knowledge within the future competent authority for REACH,
especially related to those obligations in REACH that are related to centralized procedures
which are not part of the national legislation.
The Law on Biocidal Products enables establishment, maintaining and development of
unique system for placing on the market and use of biocidal products in Serbia. The main
objective of this law is to assure that biocidal products placed on the Serbian market are
efficient enough to destroy or control harmful organisms and do not present unacceptable
risk for humans, target organisms, other organisms and/or environment. The Law is
harmonized with Directive 98/8/EC concerning the placing of biocidal products on the
market to the extent that was feasible and justified; general principles and rules have been
transposed into the national Law, while with regard to the procedures centralized at the EU
level final decisions of the Commission are directly taken over into the national legislation.
Biocidal products have to be authorized for placing on the market, and the active substances
contained in them must be approved. As given in the previous paragraph, procedure for
assessing whether an active substance may be added to the “positive” list of active
substances (Directive 98/8/EC, Annex I, IA or IB) which may be used in biocidal products
has not been laid down by the Law on Biocidal Products. Active substances listed in those
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annexes are taken over into national legislation by publishing of the List of the approved
active substances in Official Gazette of the Republic of Serbia.
But, since the authorization of biocidal products shall be conducted on the national level
provisions of the Directive 98/8/EC with this regard are transposed in the Law on Biocidal
Products. In accordance to the Law on Biocidal Products shall be placed on the market if
authorization has been granted following the requirements set out by the Law and relevant
implementing legislation.
MAEP shall carry out risk assessment on the basis of data provided in the biocidal product
dossier and authorize biocidal product if the conditions laid down in the Law are met.
Currently, MAEP carries out national “transitional” procedure (inclusion of biocidal product
into the Temporary List for the delivery of dossier) based on which biocidal products
containing not only active substances listed in Annex I or IA, but also active substances
which are being examined under the Review Programme (Regulation 1451/2007/EC) may be
placed on the Serbian market. Temporary List contains, among others, deadline for
submission of dossier for the biocidal product for the purpose of granting the authorisation.
In addition to already stated problems, the EU legal framework regulating placing of biocidal
products on the market has been changed recently. The Biocidal Products Regulation (BPR)
(528/2012/EU) repealing the Directive 98/8/EC entered into application on 1st September
2013. The regulation introduces new provisions on authorization of biocidal products.
Similarly with the provisions of other EC regulations on chemicals (e.g. REACH) the
provisions of the BPR that are general and not too member-ship related should be transposed
into the national legislation in order to facilitate its implementation and enforcement after the
accession. Therefore support for identification of the provisions to be transposed is required
and recommendations for transposition of BPR should be developed through this twining.
Furthermore current national system prescribes obligation to duty holder to pay fees for
administrative procedures prescribed by the Law on Biocidal Products; those fees are the
revenue of the state budget and are not “reserved” for financing the biocidal products
management related administrative costs. It will be necessary to develop national rules on
fees in line with the EU guidance concerning the harmonized structure of the fees under BPR
to ensure sustainable financing of biocidal products management in future. Therefore
proposal of fees for services that Competent Authority provides with respect to procedures
under BPR taking into consideration the EU guidance concerning the harmonized structure
of fees shall be developed and submitted within the project. A document containing
recommendations for sustainable financing of biocidal products management administration
shall also be one of the outputs of this twining.
3.1.3. Training needs
There are identified problems:
Further alignment of the national legislation with the EU acquis on the biocidal products
is needed;
Administrative and professional capacities to effectively implement national legislation
on biocidal products are not fully in place and have to be improved;
System for sustainable financing of biocidal products management administration is not
in place;
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Professional capacities to effectively perform further implementation and enforcement of
the REACH regulation have to be improved.
Professional capacities to effectively perform risk management and risk assessment of
biocidal products have to be improved.
Competences of the central staffers to participate in the work of ECHA’s Committees
and bodies and the EC meetings on chemicals and biocidal products are low.
Consequently, there is a need for further support in the form of advisory missions and
trainings particularly on the following issues:
transposition of BPR and its future implementation;
risk management and risk assessment of biocidal products (e.g. dossier completeness
check, classification of mixtures (e.g. biocidal products) in compliance with the CLP
Regulation);
risk reduction measures for intended use of SVHC on their own, in preparations or in
articles and the proposal for the systematic monitoring of their usage;
performing of socio-economic analysis related to the banning of chemicals;
competences and skills required to fully serve (i.e. participate in the work of different
committees and bodies of the ECHA) within the context of the EU Competent
Authorities for chemicals and biocidal products management prior and after accession;
The above are indicative of requirements. The MS Twinning partner will conduct a training
needs analysis, develop a corresponding training programme and deliver the required
training.
Some introductory trainings was organized within the scope of previous projects. . However
further support is needed to improve the capacity in order to be fully prepared to perform all
tasks envisaged by the relevant EU acquis on chemicals. As the final remark it should be
noticed that some of the recipients of the previous training are not employed within the
organizational unit in charge for chemicals and biocidal products management anymore.
3.1.4. International cooperation
Platform for cooperation with ECHA was developed within the framework of the IPA 2008
Twinning project “Assistance in the Implementation of a Chemicals Management System in
Serbia. Serbia has been granted the status of an observer in the EU Competenet Authorities
for biocidal products meetings as well as in the ECHA HelpNet meetings. In addition,
Serbian representative have been granted status of an observers in the CARACAL meetings
in July 2014.
Having in mind that the EC-legislation on chemicals puts demands on the competent
authority to take direct part in ECHA work and since the representatives of the competent
authority shall actively participate in the work of meetings of competent authorities under the
each piece of the legislation, competence of the Serbian representatives have to be built
further. In that term cooperation with ECHA and the EC shall be enhanced in order to
facilitate Serbian participation in the work of ECHA bodies and in the competent authority
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meetings in the future. Thorough insight into the structure, organization and procedures of
those meetings will enhance Serbian representatives’ preparedness for future tasks.
Therefore, documents on common principles and tips for participation in the work of various
ECHA committees and bodies and the EC meetings should be prepared through this twining
to support Serbian Competent Authority for chemicals and biocidal products management to
fully serve within the context of the EU MS Competent Authorities prior and after accession.
3.2 Linked activities (other international and national initiatives):
To facilitate harmonisation with the Acquis and institution building, a CARDS project
provided assistance in drafting of the Law on Chemicals during 2004 and 2005. The Swedish
Chemicals Agency (KemI) assisted in development of legislation on chemicals and biocidal
products; subsequently the Law on Chemicals and the Law on Biocidal Products were
adopted by the National Assembly in May 2009.
To develop sound chemicals management within the framework of SAICM’s Overarching
Policy Strategy, the former Ministry of Environment and Spatial Planning (MESP) with the
United Nations Institute for Training and Research (UNITAR) implemented during 2007 -
2009 the project: “Updating National Chemicals Management Profile, Development of a
National SAICM Capacity Assessment, and Holding of a National SAICM Priority Setting
Workshop” (SAICM Project). This project introduced SAICM to different stakeholders; it
gave systematic overview of national chemicals management problems/gaps, strengths and
actions (actors) proposals, raised awareness and information exchange on different issues
related to broader chemicals management and strengthened national coordination through
ongoing dialogue on chemicals safety/management among all concerned parties and sectors.
“Chemicals Risk Management in Serbia” project has being implemented with the Swedish
Chemicals Agency (KemI) and financed by the Swedish International Development
Cooperation Agency (SIDA) in two phases from May 2007 to December 2014. The main
objective of this project was to contribute to the establishment of adequate institutional
capacities for chemicals management and development of administrative measures for
chemicals control. Some of the main activities on this project were:
development of the Integrated Chemicals Registry;
preparation of technical guidelines for implementation of the relevant legislation;
training of the core administration and stakeholders in industry and local self-
government;
development of methods and tools for inspection;
support in establishment of the GLP system in Serbia.
Also some introductory training on hazard assessment and one study visit in relation with the
risk assessment of biocidal products to Swedish Chemicals Agency (KemI) was organized
within the framework of this project in 2012.
IPA 2008 Twinning project “Assistance in the Implementation of a Chemicals Management
System in Serbia” was implemented together with the Austrian Environmental Agency and in
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cooperation with the Chemicals Office of the Republic of Slovenia, German Federal Ministry
for the Environment, Nature Conservation and Nuclear Safety and experts from Hungary,
form August 2010 to March 2013. The main objective of this project was strengthening of
the institutional framework in the Republic Serbia for the effective implementation of the EU
harmonized legislation on chemicals management. It contributed, among others, to:
improved knowledge on chemicals safety issues;
development of training policy and plan for sustainable education and trainings in
chemicals management;
development of manuals for implementation of legislation for different stakeholder
groups;
development of cooperation platform with ECHA;
development of the communication strategy for the Serbian Chemicals Agency;
organization of the awareness raising campaign targeted at the general public in order to
improve knowledge on chemicals safety issues.
Some introductory training e.g. on risk assessment was organized within the scope of this
project.
ECHA has supported Serbian authorities in capacity building in relation to REACH, CLP,
BPR and PIC under ECHA’s IPA project “Preparatory measures for the participation of
candidate countries and potential candidates in and their cooperation with the European
Chemicals Agency (ECHA)”. During the period from June 2013 to June 2014 representatives
of the Department for Chemicals took part in the “Workshop on CLP and CLP related
activities“, “Workshop on ECHA’s IT tools and IUCLID“, “ECHA’s workshop on the
Biocidal Product Regulation, roles and necessary institutional capacities of the members of
the Biocidal Products Committee and tasks related to the Committee work“, and also in the
study visit to the Polish PIC/Rotterdam Convention designated national authority. Within the
framework of this project representatives of Serbia were supported to participate in Biocides’
Stakeholder Day and ECHA’s Ninth Stakeholder Day.
Finally, further support for candidate and potential candidate countries within the future
ECHA’s IPA project is foreseen with Serbia as one of the beneficiaries. No further
information with regard to scope of this support is available at present.
The MS Twinning partner shall ensure full complementarities between ongoing projects and
this twinning through the twining work plan. The work plan will also take on board and
consider the principal conclusions and recommendations of the above mentioned projects as
far as possible. The work plan will make certain that work already undertaken will not be
repeated under this twinning.
3.3 Results:
The results of this project should contribute to the achievement of the higher level objectives:
At sector objective indicator is:
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Percentage of adopted legislation in accordance with EU environment and energy
Аcquis comparing to Report on Implementation of the National Plan for Adoption of
the Acquis (NPAA)
At sector support objective indicator is:
Recommendations for transposition of the Biocidal Products Regulation adopted by
Competent Authority.
Guidance/handbooks for further implementation of REACH adopted by Competent
Authority.
Result 1: l National legal framework pertaining to transposition of the Biocidal Products
Regulation (EU) No 528/2012 improved.
The expected result indicators are:
Recommendations for transposition of Biocidal Products Regulation (i.e. alignment
of national legal framework with the EU acquis) developed and relevant document
submitted to Competent Authority.
Proposal of fees for services that Competent Authority provides with respect to
procedures under BPR taking into consideration the EU guidance concerning the
harmonized structure of fees developed and submitted to Competent Authority.
Result 2: Administrative capacities for biocidal products management enhanced The
expected result indicators are:
Document on assessment of institutional organization of biocidal products
management system in Serbia prepared, with recommendations for improvement of
organizational structure and development of operational capacity;
Proposal for Operational scheme for evaluation of biocidal product dossier prepared;
Recommendations for sustainable financing of biocidal products management
administration prepared and relevant document submitted to Competent Authority.
Result 3: Professional capacities (i.e. competences) of the Competent Authority responsible
for chemicals and biocidal products management (i.e. Chemicals Department) improved.
The expected result indicators are:
TNA report and corresponding training plan and materials prepared to cover capacity
building of the Competent Authority staff related to placing of chemicals on the
market (particularly REACH with special emphasis on SVHC);
TNA report and corresponding training plan and materials prepared to cover capacity
building of the Competent Authority staff for the risk assessment and risk
management of biocidal products (e.g. IT tools, dossier completeness check, risk
assessment);
14
At least 4 of staff from the Competent Authority are trained on at least one two days
training/workshop on SVHC with relevant case studies to be fully conversant with
SVHC related issues and to perform future tasks effectively;
At least 4 of staff from the Competent Authority are trained on at least one two days
workshop to be conversant with socio-economic analysis in the field of regulating
chemicals;
At least one guidance/handbook for further implementation of REACH prepared;
At least 7 of staff from the Competent Authority are trained on at least four two days
trainings to be fully conversant with the REACH IT system, IUCLID 5, R4BP,
CHESAR etc. and to perform future tasks effectively;
At least 2 of staff from Competent Authority are trained on at least five two days
trainings/workshops with relevant case studies on biocidal product risk assessment to
be fully conversant with future tasks and to perform them effectively.
Result 4: Competences and skills of the Competent Authority staff regarding participation in
the work of ECHA’s Committees and bodies and EC meetings for chemicals and biocidal
products management improved.
The expected result indicators are:
Documents on common principles and tips for participation in the work of the
different committees and bodies of the ECHA and EC meetings prepared;
At least 5 of staff from Competent Authority are trained to participate in the work of
ECHA’s Committees and bodies and the EC meetings for chemicals and biocidal
products management to be fully conversant to perform future tasks effectively;
Reports from study visits and delivered trainings.
3.4 Activities:
The Member State(s) shall in its offer develop the methodology and corresponding
activities it finds are best suited to achieve the results above described. The below
activities are thus indicative of requirements and based on experience with similar projects
carried out previously. The numbers provided are equally indicative and result of a first
assessment notably of the number of primary recipients of capacity building measures. The
information serves to guide the Member State as to the anticipated geographic distribution
and scale of the operation notably as regards training activities.
Activities related to result 1:
1.1. To prepare advisory mission plan and to organize and conduct at least 2 advisory
missions/workshops to support Competent Authority staff for transposition of Biocidal
Products Regulation (EU) No 528/2012; special care shall be taken of transposition of
provisions that are applicable on national level as well as of the new concepts and
administrative procedures prescribed by this Regulation;
15
1.2. To prepare document containing recommendations for transposition of BPR and
alignment of national legal framework with the EU acquis;
1.3. To prepare advisory mission plan and to organize and conduct at least 2 advisory
missions/workshops to support Competent Authority staff for developing of national fees for
the services that Competent Authority provides with respect to procedures under BPRthaking
into account EU guidance concerning the harmonized structure of fees 1.4. To prepare
document containing proposal of fees for services that Competent Authority provides with
respect to procedures under BPR.
Activities related to result 2:
2.1. To prepare advisory mission plans and to organize and conduct at least 2 advisory
missions in order to perform analyses of current in-house organization of biocidal products
management and prepare a document containing recommendations for improvements of
organizational structure and operational capacity;
2.2. To develop a document with proposal for operational scheme for evaluation of biocidal
product dossier;
2.3. To organize and conduct at least one advisory mission in order to review and assess
current model for financing of biocidal products management administration and to prepare
assessment report on current model for financing of biocidal products management
administration;
2.4. To organize and conduct at least two advisory missions for staff from Competent
Authority and other stakeholders (e.g. Ministry of Finance) in order to share the findings of
the above mentioned assessment report;
2.5. To prepare document containing recommendations for sustainable financing of biocidal
products management administration.
Activities related to result 3:
3.1. To conduct TNA and prepare training programme and corresponding training materials
to cover capacity building of the Competent Authority staff relating to further
implementation of legislation regarding placing of chemicals on the market (particularly
REACH, with special emphasis on SVHC);
3.2. To conduct TNA and prepare training programme and corresponding training materials
to cover capacity building of the Competent Authority staff in the field of risk assessment
and risk management of biocidal products;
3.3. To organize and conduct training for at least 4 of staff from Competent Authority on at
least one two days trainings/workshops in the field of risk management and risk assessment
of chemicals with special emphasis on SVHC with relevant case studies according to the
training programme;
3.4. To organize and conduct at least two days workshop on socio-economic analysis in the
field of regulating chemicals for at least 4 of staff from the Competent Authority;
16
3.5. To prepare at least one guidance/handbook on further implementation of REACH for
stakeholders;
3.6. To organize and conduct training for at least 7 of staff from Competent Authority on at
least four two days trainings/workshops in order to prepare for use of REACH IT system,
IUCLID 5, R4BP, CHESAR etc.; it should be noticed that 1 day basic training on IUCLID
was provided by ECHA and further trainings shall be of advanced level;
3.7. To organize and conduct at least five two days trainings/workshops with relevant case
studies for at least 2 Competent Authority staff per training/workshop to gain knowledge in
the field of risk assessment and risk management of biocidal products, with particular
attention on dossier completeness check and risk assessment.
Activities related to result 4:
4.1. To prepare advisory mission plan and to organize and conduct at least three advisory
missions for at least 5 staff from Competent Authority with experts which have experience in
participating in ECHA bodies and EC Competent Authority meetings relevant for chemicals
and biocidal products management, in order to improve competences and skills of Competent
Authority staff for participation in the work of ECHA bodies and EC meetings;
4.2. To identify opportunities for additional participation in the work of ECHA bodies and
EC meetings for chemicals and biocidal products management as observers;
4.3. To organize and conduct at least two up to five days study visits in the twinning EU
Member State for at least 5 Competent Authority representatives, and prepare report on the
findings of the study visit;
4.4. To prepare documents containing common principles and tips for participation in the
work of different committees and bodies of the ECHA.
At least two major visibility events with not less than 30 participants will be organized in the
course of the implementation of the project; Kick-off meeting at the start of the
implementation and the Final meeting at the end of the implementation of the project
activities.
The MS will propose additional visibility actions as stand alone or associated with training
workshops etc. – and as may be deemed appropriate.
3.5 Means/ Input from the MS Partner Administration:
The Project Leader (PL) and the Resident Twinning Adviser (RTA) shall provide support to
the responsible Serbian authorities in strengthening their capacities as well as in
implementation of this project.
During the implementation of this project RTA will be positioned in Ministry of Agriculture
and Environmental Protection.
3.5.1 Profile and tasks of the Project Leader
17
The MS Project Leader will manage the project team of selected member state(s) supervise
and and co-ordinate the implementation of activities.
PL tasks:
Overall management and coordination of the project with MS, MAEP, key
institutions, other partners and stakeholders;
Project reporting;
Ensuring backstopping and financial management of the project in the MS;
Ensuring timely, effective and efficient implementation of the project and
achievement of results, through proposed activities;
Coordination of deployment of short-term experts;
Coordination with RTA, from the MS side, the PSC meetings, which will be held in
Serbia every three months;
Participation at the PSC meetings (every three months);
Assuring compatibility with the EU requirements.
The PL profile:
Requirements:
The Project Leader will have the following profile:
University degree
High-ranking official with ability to call on short term experts in support of the
efficient project implementation;
At least 7 years of professional experience in the area relevant to the project.
Experience in the project management in EU funded twinning projects;
Fluency in English language;
Computer literacy.
Assets:
Experience in projects in the area of chemicals and/or biocidal products management
An advanced degree is preferable
3.5.2 Profile and tasks of the RTA (24 months full time)
The RTA works on a daily basis with the BC staff to implement project, support and
coordinate activities in the beneficiary country.
RTA must have a broad knowledge in the chemicals management area, which will enable
her/him to organise an interdisciplinary team for successful implementation and monitoring
of the project. He/she should be an employee of the MS administration or mandated body
responsible for implementation/enforcement of legislation related to placing of chemicals on
the market (REACH, CLP, BPR etc.) and is expected to ensure, together with the BC
administration, the achievement of the general and specific objectives. . He/she should
accordingly have a broad knowledge of the EU legislation in the area relevant to the project.
RTA tasks:
18
Responsible for monitoring project implementation and proposing corrective
management actions if required;
Support and coordination of all project activities in BC in line with the agreed work
program to enable timely completion of project results and delivery of the outputs;
Advise on related EU policies and best practices, legislation and regulation;
Establish and maintain cooperation with all beneficiaries involved in the
implementation of the project and other related projects (ensuring the avoidance of
overlapping), in close co-ordination with the PL;
Nomination, mobilization and supervision of the STE, together with the PL;
Facilitation of the contacts with peer institutions in EU MS in order to stimulate a
proper exchange of information and data;
Organization of visibility events (kick-off and final event);
Responsible for organisation of the PSC meetings and reporting on the project
progress in cooperation with PL;
Identifying and reporting to the Contracting authority, at early stage, all difficulties
that may jeopardize the implementation of the project and the achievement of its
results;
RTA profile:
Requirements:
Relevant university degree (e.g. MSc in Chemistry, Chemical engineering,
Toxicology or similar discipline relevant to the project);
At least 7 years of general professional experience;
At least 3 years of experience in activities related to the implementation of the EU
acquis in the area covered by the Twinning project ficheExperience in implementing
of relevant EU legislation and best practices in project related fields;
Proven contractual relation to public administration or mandated body, as defined
under twinning manual 5.4.5;
Fluency in English language;
Computer literacy.
Assets:
Experience of working with EU funded projects, preferably twinning i.e. as STE,
RTA or PL;
Experience in organizing and conducting trainings;
An advanced degree is preferable
.
3.5.3 Profile and tasks of the short-term experts
The twinning partners will decide on the profile, number and involvement of short term
experts during the drafting of the project work plan. There should be a pool of short term
experts to ensure smooth implementation of the project during the overall implementation
period. STEs should be identified by the Project Leader/RTA and have to be agreed with the
19
beneficiary administration in the course of designing and delivery of the project. Team of
short-term experts should be mobilized according to the agreed work plan.
Short- term experts’ tasks:
STEs will provide specialized know-how for the individual tasks in this project; therefore,
the raft of experts should have a relevant professional experience in administration and
minimum qualifications required, as well as specific skills needed for individual task. As a
general approach, the STEs will take the responsibility for the implementation of the Project
and the achievement of the results, each for his/her individual mission tasks. They will also
prepare the required reports and the output described. They shall have long-standing
experience in all relevant fields.
Detailed profiles and tasks of short-term experts including the duration of their assignments
will be provided in the Twinning Work Plan. The indicative requirements are the following:
Chemicals management expert:
Minimum qualifications required:
At least 3 years professional experience in planning and management, harmonisation
and implementation of chemicals related legislation (REACH and CLP);
University degree or equivalent professional experience in relevant areas (e.g. MSc in
Chemistry, Chemical engineering, Toxicology (PhD preferred));
Training experience;
Good communication skills;
Fluency in English language.
Biocidal products management expert:
Minimum qualifications required:
At least 3 years professional experience in planning and management, harmonisation
and implementation of biocidal products related legislation (BPD/BPR);
University degree or equivalent professional experience in relevant areas (e.g. MSc in
Chemistry, Chemical engineering and similar (PhD preferred));
Training experience;
Good communication skills;
Fluency in English language.
Risk assessment expert:
Minimum qualifications required:
At least 3 years professional experience in risk assessment of chemicals or biocidal
products (regulatory risk assessment, (eco)toxicology, humans and environment
exposure);
University degree or equivalent professional experience in relevant areas (e.g. MSc in
Chemistry, Chemical engineering, Toxicology, Ecotoxicology (PhD preferred));
Training experience;
Good communication skills;
Fluency in English language.
20
Expert involved in the work of ECHA and/or other EU committees and bodies
Minimum qualifications required:
At least 3 years professional experience in planning and management, harmonisation
and implementation of chemicals and biocidal products related legislation (REACH,
CLP, BPD/BPR) and participation in the work of ECHA and/or other EU committees
and bodies;
University degree or equivalent professional experience in relevant areas;
Training experience;
Good communication skills;
Fluency in English language.
Legal expert(s):
Minimum qualifications required:
At least 3 years of experience in the field of chemicals/biocidal products legislation
and/or regulatory affairs;
University degree in Law;
Good communication skills;
Fluency in English language.
Economy expert(s):
Minimum qualifications required:
At least 3years of experience in the field of socio-economic analysis;
University degree in economy, finance or other field relevant to the project, an
advanced degree is preferable;
Fluency in English language.
IT tools expert(s):
Minimum qualifications required:
At least 3 years of work experience with IT tools used for implementation of
legislation regulating chemicals and biocidal products (IUCLID, REACH IT, R4BP,
etc.);
University degree and professional experience in relevant area;
Fluency in English language.
The specific assignments will be subject to the preparation of the twinning Contract and the
recommendations of the twinning partner(s).
4. Institutional Framework
Based on the provisions of the Law on Chemicals, Serbian Chemicals Agency was
established on September 17th
2009 by the Government Decision, as the regulatory body for
integrated chemicals management. The main goals of the Chemicals Agency were to
establish, develop and improve chemicals management system in the Republic of Serbia, to
21
ensure high level of protection of human health and environment, as well as to improve free
trade of chemicals with the EU countries and other countries, while assuring competitiveness
of Serbian enterprises and promotion of safer alternatives. Additionally, one of the Agency’s
main tasks was to assure administrative conditions for efficient and safe chemicals and
biocidal products management.
The Agency was abolished by the Law on Amendments to the Law on Chemicals which
came into force on September 29th
2012. Rights and obligations of the Serbian Chemicals
Agency as well as employees, items (cases), equipment, assets, archive material and
registration material for which the validity period has not expired yet, were taken over by the
former Ministry of Energy, Development and Environmental Protection (MEDEP). Since the
above stated date MEDEP become Competent Authority for chemicals and biocidal products
management. After elections in March 2014, Government has been formed on 26th
April
2014 and the Ministry of Agriculture and Environmental Protection (MAEP) taken above
mentioned responsibility.
Former Chemicals Agency consisted of four departments, as follows: Department for
Chemicals Management, Department for Integrated Chemicals Registry, Department for
Biocidal Products Management and Department for Risk Assessment.
According to the MAEP Systematization of work posts, which came into force in September
2014, the tasks of chemicals and biocidal products management are responsibility of the
Department for Chemicals, divided into the Division for Chemicals Management, Division
for Integrated Chemicals Registry, Division for Biocidal Products Risk Management and
Group for chemicals’ and biocidal products’ hazard classification and communication.
The Department for Risk Assessment from the former Chemicals Agency was abolished, but
staff within the Department of chemicals should share the responsibility for the risk
assessment tasks envisaged. Currently 14 employees work in the Department for Chemicals.
The MAEP’s Department for Chemicals is responsible for performing the task in relation
with:
Enforcement of the Law on Chemicals and Law on Biocidal Products;
Harmonisation with the EU legislation;
Preparing strategic documents on chemicals management;
Implementing of international agreements such as the Stockholm convention, Rotterdam
convention, as well as implementation of ratified international agreements such as the
Convention on the Prohibition of the Development, Production, Stockpiling and Use of
Chemical Weapons and on their Destruction;
Projects for the training of governmental bodies, industry and scientific-research sectors
for modern chemicals management; and
Other activities necessary for sustainable chemicals management.
Division for Chemicals Management is in charge for tasks which correspond to the national
legilation harmonized with the REACH system for placing of chemicals on the market, such
as bans and restrictions; for import and export of certain hazardous chemicals (i.e. PIC
procedures) and placing of detergents on the market as well as for non-harmonized area
(solely national provisons) of chemicals management such as issuing of permits for placing
22
on the market and permits for use of particularly hazardous chemicals, systematic monitoring
of chemicals and National help-desk;
Division for Integrated Chemicals Register is in charge for development and management of
Integrated Chemicals Register, consisting of Chemicals, Biocidal Products and Plant
Protection Products Register;
Division for Biocidal Products Risk Management is in charge for tasks corresponding to the
national legislation on biocidal products and placing of biocidal products on the market;
Group for chemicals’ and biocidal products’ hazard classification and communication is
responsible for the tasks which correspond to the national legislation aligned with the CLP
regulation (i.e. classification, labeling and packaging of chemicals) and hazard
communication including Safety Data Sheets (i.e. national legislation aligned with the
REACH Annex II, national legislation on test methods for chemicals hazardous properties
etc.
Key Stakeholders
Ministry of Finance: responsible for the system and policy of taxes and
implementation of the law regulating budget system;
Ministry of Health: among others, responsible for verification whether laboratories
implement the good laboratory practice (GLP), implementation of the law regulating health
safety of items for general use as well as for compliance control within the context of the
Law on Chemicals and Law on Biocidal Products Laws
Ministry of Trade, Tourism and Telecommunications: among others, responsible for
the functioning of the market, consumer protection as well as compliance control within the
context of the Law on Chemicals and Law on Biocidal Products Laws.
Interested partners
The Chamber of Commerce of Serbia (Committee on Environmental Protection and
Sustainable Development);
National Centre for Poison Control;
National Universities and Institutes.
Department for project management within the MAEP as IPA unit will be a body within the
Operating Structure which have tasks mainly related to technical implementation and
monitoring of Twinning, while the CFCU will be the implementing agency and will be
responsible for all procedural aspects of the tendering process, contracting matters and
financial management including payment of project activities.
A Project Steering Committee (PSC) will be established. The role and main functions of the
PSC will be: to have an advisory role, which includes: to assess project progress and monitor
all activities of the project; to guide the implementing team on all technical matters and
review and make comments on and approve the Inception, interim/progress and Final
reports; to jointly discuss any critical points, risks or bottlenecks of project implementation
and to propose and discuss remedies in case of problems; to ensure close co-operation among
the relevant ministries and institutions and closely coordinate with other EU projects related
to this field and with other relevant donors’ projects to promote synergies and integration
23
The exact composition of the PSC will be defined in the Twinning Contract. However, the
following persons should at least be a member: MS Project Leader, BC Project Leader, RTA,
BC Counterpart to the RTA, Ministry in charge for environmental protection (Department
for Chemicals), Ministry in charge for finance, Ministry in charge for health, Ministry in
charge for trade, representatives of CFCU, representatives of SEIO. The EC Delegation will
be invited as an observer. The PSC will be chaired by the BC Project Leader. The PSC will
meet on quarterly basis.
5. Budget
The total budget for this Twinning is EUR 1,000,000.
Title: “Further development of chemicals and
biocidal products management in RS”
IPA
Community
Contribution
National
Co-
financing
TOTAL
Twinning Contract (EUR) 950.000 50.000 1.000.000
The co-financing requirement foreseen under IPA will be considered fulfilled according to
the provision of the relevant Financing Agreement.
The beneficiary will provide the MS twinning partner with adequate office space for RTA
and experts, meeting rooms and equipment necessary for relevant everyday activities and
training foreseen in twinning fiche.
Translation of the project documents (e.g. recommendations/reports/etc.) will be provided
only in cases where parties involved find it necessary. It is recommended that the costs for
the translation will not cover more than 6% of the budget of the project, which should be
calculated in the twining working plan budget.
Additionally, the expenses in relation with the study visit shall be covered with the project
funds in accordance with the Twinning Manual 5.7.2.
6. Implementation Arrangements
6.1 Implementing Agency responsible for tendering, contracting and accounting
Ministry of Finance
Department for Contracting and Financing of EU Funded Programmes
Sremska Street, No 3-5
SRB - 11000, Belgrade
Mrs. Natasa Šimšić, Programme Authorising Officer (PAO)/Head of CFCU
Phone: +381 11 20 21 -389
24
Mr. Darko Vasić, Quality Control Officer, NCP
Phone: +381 11 2021 412
E-mail : [email protected]
6.2 Main Counterpart in the BC:
Senior Programme Officer (SPO) / BC Project Leader:
The BC Project Leader will manage a project team at the Serbian side and will assure that the
decision makers at the national level will be informed properly on the implementation of the
project. He/she will ensure close co-operation and overall steering and coordination of the
project. He/she will be also responsible for drafting reports and other documents, related to
project management at the Serbian side and will chair PSC meetings.
Ms. Stana Božović, State Secretary
Ministry of Agriculture and Environmental Protection
Address: 1, Omladinskih Brigada str., 11070 New Belgrade
Tel.: +381 11 2600 433
Fax: +381 11 2601 034
E-mail: [email protected]
RTA counterpart:
Ms. Bojana Djordjević, Advisor
Ministry of Agriculture and Environmental Protection
Department for chemicals
Address: 27a, Ruze Jovanovića str., 11000 Belgrade
Tel.: +381 11 7155 223
Fax: +381 11 2860 204
E-mail: [email protected]
6.3 Contracts
One Twinning contract.
7. Implementation Schedule (indicative)
7.1 Launching of the call for proposals: October 2014
7.2 Start of project activities: 2nd
quarter 2015
7.3 Project completion: 2nd
quarter 2017
7.4 Duration of the execution period: (24 months + 3 months)
8. Sustainability
25
The project will result in further development of biocidal products and chemicals
management in Serbia which will make a contribution to achievement of the EU
environmental standards and broader objectives of sustainable development. Thus in medium
and long-term scale the project will improve the quality of life for citizens. Another is that
rising environmental standards can help to stimulate innovation, improve efficiency and
contribute to the new markets so that economy related benefits are expected too.
In particular, the project will provide support for transposition of the Biocidal Products
Regulation which allows for a more sophisticated level of scientific and administrative effort
in biocidal products management. Assistance provided with the aim of the Biocidal Products
Regulation transposition will be further exploited through its implementation within the
years to come.
Recommendations developed through the project activities will ensure further improvements
of both, organizational structure of the Competent Authority and operational schemes for
biocidal products management. Furthermore, recommendations for financial arrangements
for financing of biocidal products administration (e.g. issuing of authorization for BP) will
provide for stable and sustainable BP management while in line with the relevant EU
legislation. This is important precondition for legal framework to be fully implemented in a
sustainable manner.
One of the main principles of the project is utilizing mentorship and gaining experience by
“learning by doing” approach. This will improve foundation to draw on the necessary
expertise in daily work whenever relevant but also will serve as the new base-line indicator
for development of further projects with regard to building of professional capacities for
regulatory risk assessment so that training becomes a permanent activity for strengthening of
administrative capacity.
By integrating the project results and the work effort at least central staff of core
administration will acquire competences and skills necessary to participate with a capacity of
an observer in different meetings of ECHA and other EC institutions and bodies. This will be
further developed and fully acquired after Serbia becomes an EU member. User-friendly
guidance documents provided by the project will assure transfer of knowledge obtained
through the project. Developed and printed guidance with regard to REACH procedures will
be also used continuously as a valuable tool for new staff envisaged to be hired in a future.
9. Crosscutting issues
Equal Opportunity
Based on the fundamental principles of promoting equality and combating discrimination,
participation in the project will be guaranteed on the basis of equal access regardless of sex,
racial or ethnic origin, religion or belief, disability, age or sexual orientation. All contractors
shall be requested to provide monitoring data recording the participation of men and women
in terms of expert inputs (in days) and of trainees benefiting under the project (in days) as an
integral component of all project progress reports. Equal participation of man and woman
during the implementation of the project will be assured.
26
Environment
This project directly relates to environment issues and will not have any negative effects on
the environment. The project will implement a part of the European environmental policy,
hence it will provide positive effects on the environment through improvement of chemicals
and biocidal products management.
For this project environmental impact assessment is not obligatory.
Minorities
Considering this project will deal with environmental issues targeting a general improvement
of chemicals management, its outcomes will be beneficial to all citizens’ especially national
minority and underprivileged social groups, having in mind that these groups frequently live
in areas where solving environmental problems is one of the top priorities.
10. Conditionality and sequencing
Successful implementation of the Twinning project requires full commitment and
participation of the senior decision-makers in the Ministry responsible for chemicals
management (i.e. MAEP).
A sufficient number of employees in the MAEP (i.e. Department for Chemicals) should be in
place in accordance with time schedule of the National Program for Adoption of the Acquis
Communautaire to fulfil obligation to meet the project objectives.
Ministry competent for the environment (i.e. MAEP) is responsible for chemicals
management personnel having the necessary resources to carry out their duties based on the
outputs of this project.
The Result 1 shall be given the highest priority. All other activities have the equal priority
level and their sequencing shall be arranged through the twining work plan, subject to
availability of the required STE. In addition, some of the envisaged activities may be
performed in parallel.
List of Annexes
ANNEX I Logical framework matrix in standard format
ANNEX II List of laws and regulations
ANNEX III: Reference to relevant Government Strategic plans and studies
ANNEX IV: Ministry of Agriculture and Environmental Protection – organogram
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ANNEX I: Logical framework matrix in standard format
LOGFRAME PLANNING MATRIX FOR Twinning Fiche Programme name and number
Further development of chemicals management and biocidal products
management
Contracting period expires 5
years after the signature of the
Financing Agreement
Disbursement period: expires
6 years after the signature of
the Financing Agreement
Total budget: 1.0million € IPA budget: 0.95 million €
Overall objective Sector objective indicators Sources of Verification
To assist Serbia to meet environmental and
climate Acquis through institutional building
and improvement of environmental
infrastructure.
Percentage of adopted legislation
in accordance with EU
environment and energy Аcquis
comparing to Report on
Implementation of the National
Plan for Adoption of the Acquis
(NPAA)
Report on state of the
environment; reports of
environmental inspection;
national health statistics
Project purpose Sector support objective
indicators
Sources of Verification Assumptions
Ensured further alignment with the EU
Environment Acquis, with the specific focus
on further development of institutional
capacities and enforcement of national
legislation and strategic planning, including
strengthening capacities of the Department
for chemical management and other
stakeholders for effective implementation of
relevant national legislation aligned with EU
legislation as well as for implementation of
the EU acquis after the EU accession.
Recommendations for
transposition of the Biocidal
Products Regulation adopted.
Guidance/handbooks for
further implementation of
REACH adopted.
Official reports on project
implementation progress
(quarterly and annual reports,
signed minutes, etc.)
- Political stability of the
country
- Continuation of reform-
oriented policy in the
Ministry’ Sector in charge
for biocidal products and
chemicals management
- Government officials and
other relevant stakeholders
available and interested in
improving knowledge
Results Objectively verifiable indicators Sources of Verification Assumptions
28
Result 1: National legal framework for
transposition of the Biocidal Products
Regulation (EU) No 528/2012
improved.
- Recommendations for transposition of Biocidal
Products Regulation (i.e. alignment of national
legal framework with the EU acquis) developed
and relevant document submitted to Competent
Authority;
- Proposal of fees for services that Competent
Authority provides with respect to procedures
under BPR taking into consideration the EU
guidance concerning the harmonized structure
of fees developed and submitted to Competent
Authority.
Text of the document
Project progress reports
Project monitoring and
evaluation reports
- Consultant provides
appropriate level of
expertise, skills and
resources
Result 2: Administrative capacities for
biocidal products management
enhanced
- Document on assessment of institutional
organization of biocidal products management
system in Serbia prepared, with
recommendations for improvement of
organizational structure and development of
operational capacity;
- Proposal for Operational scheme for evaluation
of biocidal product dossier prepared;
- Recommendations for sustainable financing of
biocidal products management administration
prepared and relevant document submitted to
Competent Authority.
Text of the document
Project progress reports
Project monitoring and
evaluation reports
- Improved administrative
capacities of Competent
Authority responsible
for biocidal products
management
- Consultant provides
appropriate level of
expertise, skills and
resources
Result 3: Professional capacities (i.e.
competences) of the Competent
Authority responsible for chemicals
and biocidal products management
(i.e. Chemicals Department)
improved.
- TNA report and corresponding training plan and
materials prepared to cover capacity building of
the Competent Authority staff related to placing
of chemicals on the market (particularly
REACH with special emphasis on SVHC);
- TNA report and corresponding training plan and materials prepared to cover capacity building of
the Competent Authority staff for the risk
assessment and risk management of biocidal
products (e.g. IT tools, dossier completeness
check, risk assessment);
- At least 4 of staff from the Competent Authority
are trained on at least one two days
Document on training policy
and training plan
Project progress reports
Project monitoring and
evaluation reports
- Sufficient number of
pre-qualified and
motivated participants in
the training exercises
- Availability of twinning
experts
- Consultant provides
appropriate level of
expertise, skills and
resources
29
training/workshop on SVHC with relevant case
studies to be fully conversant with SVHC
related issues and to perform future tasks
effectively;
- At least 4 of staff from the Competent Authority
are trained on at least one two days workshop to
be conversant with socio-economic analysis in
the field of regulating chemicals;
- At least one guidance/handbook for further
implementation of REACH prepared;
- At least 7 of staff from the Competent Authority
are trained on at least four two days trainings to
be fully conversant with the REACH IT system,
IUCLID 5, R4BP, CHESAR etc. and to perform
future tasks effectively;
- At least 2 of staff from Competent Authority are
trained on at least five two days
trainings/workshops with relevant case studies
on biocidal product risk assessment to be fully
conversant with future tasks and to perform
them effectively.
Result 4: Competences and skills of
the Competent Authority staff
regarding participation in the work of
ECHA’s Committees and bodies and
EC meetings for chemicals and
biocidal products management
improved.
- Documents on common principles and tips for
participation in the work of the different
committees and bodies of the ECHA and EC
meetings prepared;
- At least 5 of staff from Competent Authority are
trained to participate in the work of ECHA’s
Committees and bodies and the EC meetings for
chemicals and biocidal products management to
be fully conversant to perform future tasks
effectively;
- Reports from study visits and delivered
trainings.
Meeting reports
Project progress reports
Project monitoring and
evaluation reports
Reports of the MSs short
term experts
- Government interest in
continues cooperation
- Coordination of efforts
and readiness for
cooperation of all
stakeholders
Activities Means & Costs Assumptions
30
Activities Means & Costs Assumptions
Activities related to the Result 1:
1.1. To prepare advisory mission plan and to organize and conduct at least 2 advisory
missions/workshops to support Competent Authority staff for transposition of Biocidal
Products Regulation (EU) No 528/2012; special care shall be taken of transposition of
provisions that are applicable on national level as well as of the new concepts and
administrative procedures prescribed by this Regulation;
1.2. To prepare document containing recommendations for transposition of BPR and
alignment of national legal framework with the EU acquis.
1.3. To prepare advisory mission plan and to organize and conduct at least 2 advisory
missions/workshops to support Competent Authority staff for developing of national fees
for the services that Competent Authority provides with respect to procedures under BPR
taking into account the EU guidance concerning the harmonized structure of 1.4. To
prepare document containing proposal of fees for services that Competent Authority
provides with respect to procedures under BPR.
Twinning contract:
€ 1,000,000
Provision by the national
authorities of sufficient
staff and financial
resources in the national
budget.
Relevant Serbian
documents bound to the
project implementation
(e.g. input information on
chemicals and biocidal
products management,
relevant information on
previous projects/ studies
stakeholders etc.) made
available to Consultant in
due-time.
Commitment of BC and
MS
Activities related to the Result 2:
2.1. To prepare advisory mission plans and to organize and conduct at least 2 advisory
missions in order to perform analyses of current in-house organization of biocidal products
management and prepare a document containing recommendations for improvements of
organizational structure and operational capacity;
2.2. To develop a document with proposal for operational scheme for evaluation of
biocidal product dossier;
2.3. To organize and conduct at least one advisory mission in order to review and assess
current model for financing of biocidal products management administration and to
prepare assessment report on current model for financing of biocidal products management
administration;
2.4. To organize and conduct at least two advisory missions for staff from Competent
Authority and other stakeholders (e.g. Ministry of Finance) in order to share the findings of
the above mentioned assessment report;
31
Activities Means & Costs Assumptions
2.5. To prepare document containing recommendations for sustainable financing of
biocidal products management administration.
Activities related to result 3:
3.1. To conduct TNAand prepare training programme and corresponding training materials
to cover capacity building of the Competent Authority staff relating to further
implementation of legislation regarding placing of chemicals on the market (particularly
REACH, with special emphasis on SVHC);
3.2. To conduct TNA and prepare training programme and corresponding training
materials to cover capacity building of the Competent Authority staff in the field of risk
assessment and risk management of biocidal products;
3.3. To organize and conduct training for at least 4 of staff from Competent Authority on
at least one two days trainings/workshops in the field of risk management and risk
assessment of chemicals with special emphasis on SVHC with relevant case studies
according to the training programme;
3.4. To organize and conduct at least two days workshop on socio-economic analysis in the
field of regulating chemicals for at least 4 of staff from the Competent Authority;
3.5. To prepare at least one guidance/handbook on further implementation of REACH for
stakeholders;
3.6. To organize and conduct training for at least 7 of staff from Competent Authority on at
least four two days trainings/workshops in order to prepare for use of REACH IT system,
IUCLID 5, R4BP, CHESAR etc.; it should be noticed that 1 day basic training on IUCLID
was provided by ECHA and further trainings shall be of advanced level;
3.7. To organize and conduct at least five two days trainings/workshops with relevant case
studies for at least 2 Competent Authority staff per training/workshop to gain knowledge in
the field of risk assessment and risk management of biocidal products, with particular
attention on dossier completeness check and risk assessment.
Activities related to result 4:
32
Activities Means & Costs Assumptions
4.1. To prepare advisory mission plan and to organize and conduct at least three advisory
missions for at least 5 staff from Competent Authority with experts which have experience
in participating in ECHA bodies and EC Competent Authority meetings relevant for
chemicals and biocidal products management, in order to improve competences and skills
of Competent Authority staff for participation in the work of ECHA bodies and EC
meetings;
4.2. To identify opportunities for additional participation in the work of ECHA bodies and
EC meetings for chemicals and biocidal products management as observers;
4.3. To organize and conduct at least two up to five days study visits in the twinning EU
Member State for at least 5 Competent Authority representatives, and prepare report on the
findings of the study visit;
4.4. To prepare documents containing common principles and tips for participation in the
work of different committees and bodies of the ECHA.
33
ANNEX II: List of relevant Laws and Rulebooks
The Law on Ministries forms ministries and special organizations and defines their
responsibilities (“Official Gazette of RS“, No. 44/14). The Law on Ministries prescribes that the
Ministry of Agriculture and Environmental Protection is responsible for chemicals management.
The Law on Chemicals regulates: integrated chemicals management, classification, packaging
and labelling of chemicals, integrated chemicals registry and registry of chemicals placed on the
market, bans and restrictions of manufacturing, placing on the market and use of chemicals,
import and export of certain hazardous chemicals, permits for placing on the market and permits
for use of particularly hazardous chemicals, placing of the detergent on the market, systematic
monitoring of chemicals, data availability, supervision and other issues of importance for
chemicals management.
The Law on Chemicals presents a foundation for preparation of implementation of Regulation
1907/2006/EC on the Registration, Evaluation, Authorisation and Restriction of Chemicals
(REACH) and Regulation 1272/2008 on Classification, Labelling and Packaging of Chemicals
(CLP), as this law is harmonised with REACH and CLP to the extent that was possible to
transpose into the national legislation.
The Law on Biocidal Products regulates: list of active substances, procedures for issuing of the
acts on the basis of which the biocidal products are placed on the market, bans and restrictions for
placing on the market and use of the biocidal products; research and development of the biocidal
products; classification, packaging, labelling, advertising and safety data sheet of the biocidal
product; Registry of biocidal products; safe use of the biocidal products; supervision and other
important issues related to sound placing on the market and use of biocidal products.
Reference list of relevant laws:
1. Law on Chemicals (”Official Gazette of the RS”, number. 36/09, 88/10, 92/11 and 93/12),
2. Law on Biocidal Product (”Official Gazette of the RS”, number. 36/09, 88/10 and 92/11).
Reference list of relevant regulations:
1. Rulebook on criteria for identification of substances such as PBT and vPvB (“Official
Gazette of the RS”, number 23/10);
2. Rulebook on Chemicals Registry (“Official Gazette of the RS”, number 100/11, 16/12,
47/12,15/13 and 115/13);
3. Decision on Fees Rates According to the Law on Biocidal Products (“Official Gazette of
the RS”, number 23/10 and 39/11);
4. Rulebook on biocidal products types (“Official Gazette of the RS”, number 23/10);
5. Rulebook on Content of the Basic Information on Biocidal Products (“Official Gazette of
the RS”, number 23/10 and 28/11);
3. Rulebook on detergents (“Official Gazette of the RS”, number 40/10 and 5/12);
4. Rulebook on specific requirements for packaging, labelling and advertising of biocidal
product (“Official Gazette of the RS”, number 59/10 and 26/11);
5. Rulebook on classification, packaging, labelling and advertising of chemical and certain
product (“Official Gazette of the RS”, number 59/10, 25/11, 5/12 and 105/13);
6. Rulebook on content of Safety Data Sheet (“Official Gazette of the RS”, number 81/10);
7. Rulebook on content of Safety Data Sheet (“Official Gazette of the RS”, number 100/11);
34
8. Rulebook on permits for placing on the market and permits for use of particularly
hazardous chemicals (“Official Gazette of the RS”, number 94/10, 55/11 and 15/13);
9. List of surfactants for which the authorisation is issued or act which allows use of
surfactants in detergent in the EU is enacted and list of surfactants for which the authorisation is
rejected and surfactants which are forbidden in the EU (“Official Gazette of the RS”, number
94/10);
10. Rulebook on scope and content of technical dossier for biocidal products, i.e. low-risk
biocidal products (“Official Gazette of the RS”, number 97/10);
11. Rulebook on Chemicals Adviser as well as on conditions which must be fulfilled by legal
or natural persons conducting the training and examination for the Chemicals Adviser (“Official
Gazette of the RS”, number 13/11, 28/11 and 47/12);
12. Common principles for the evaluation of the Biocidal Product on the basis of Technical
Dossier, (“Official Gazette of the RS”, number 28/11);
13. Rulebook on the Manner of Keeping of the Records on Biocidal Products (“Official
Gazette of the RS”, number 28/11);
14. Rulebook on the Manner of Keeping of the Records on Chemicals (“Official Gazette of
the RS”, number 31/11);
15. Rulebook on closer conditions for keeping of hazardous chemical in retail facilities and
manner of labelling of these facilities (“Official Gazette of the RS”, number 31/11 and 16/12);
16. Rulebook on certain hazardous biocidal products which cannot be placed on the market
for general use (“Official Gazette of the RS”, number 37/11);
17. Rulebook on manner of conduction of chemicals safety assessment and content of
chemicals safety report (“Official Gazette of the RS”, number 37/11);
18. List of biocidal products included in the Register of biocidal products (“Official Gazette
of the RS”, number 28/12).
According to the Law on Chemicals, the Law on Biocidal Products, the National Strategy of
Sustainable Development (Official Gazette of RS, 57/08) and the National Programme for
Environmental Protection (Official Gazette of RS, 88/10,), during 2013-2014, the following
pieces of subsidiary legislation were harmonised with up-to-date amendments of the relevant EU
provisions and subsequently adopted:
Rulebook on Classification, Packaging, Labelling and Advertising of Chemical and Certain
Article According to Globally Harmonised System for Classification and Labelling of the UN
(“Official Gazette of the RS”, number 105/2013) transposing Regulation 1272/2008/EC,
Regulation 790/2009/EC and Regulation 286/2011/ЕU;
Rulebook on Changes and Amendments to the Rulebook on Import and Export of Certain
Hazardous (“Official Gazette of the RS“ number 15/13), which is partially harmonized with
Regulation 649/2012/ЕU, Regulation 71/2012/ЕU, Regulation 834/2011/ЕU, Regulation
214/2011/ЕU, Regulation 186/2011;
Rulebook on Bans and Restrictions of Production, Placing on the Market and Use of
Chemicals (“Official Gazette of the RS“ number 90/13) transposing Regulation 109/2012/EU,
Regulation 848/2012/EU, Regulation 836/2012/EU and Regulation 835/2012/EU);
Rulebook on Methods for Testing of Chemicals’ Hazardous Properties (“Official Gazette of
the RS”, number 117/13) transposing Regulation 440/2008/EC, Regulation 761/2009/ЕC and
Commission Regulation 1152/2010/EU;
35
List of Substances of Very High Concern (“Official Gazette of the RS”, number 94/13)
transposing Regulation 143/2011/EU, Regulation 125/2012/EU and Regulation
348/2013/EU);
Rulebook on the List of Classified Substances (“Official Gazette of the RS”, number
48/2014) transposing: Regulation 1272/2008/EU, Regulation 790/2009/ЕU, Regulation
286/2011/ЕU and Regulation 618/2012/ЕU;
Lists of Active Substances in Biocidal Products (“Official Gazette of the RS”, number
72/2014) transposing: Commission Directives: 2012/20/ЕU, 2012/22/ЕU, 2012/38/ЕU,
2012/40/ЕU, 2012/41/ЕU; 2012/42/ЕU, 2013/3/EU, 2013/4/EU, 2013/5/EU, 2013/6/EU,
2013/7/EU, 2013/27/ЕU, 2013/41/ЕU and 2013/44/ЕU; Commission Implementing
Regulations (EU) No: 945/2013, 955/2013, 1032/2013, 1033/2013, 1034/2013, 1035/2013,
1036/2013, 1037/2013, 1038/2013, 1039/2013, 89/2014, 90/2014, 91/2014, 92/2014,
93/2014, 94/2014, 405/2014, 406/2014, 407/2014, 408/2014, 437/2014 and 438/2014 as well
as Commission Implementing Decisions: 2012/728/ЕU, 2013/85/EU, 2013/204/ЕU and
2014/227/EU
The Law on Chemicals is in compliance with the following EU legislation:
1. Regulation 1907/2006/EC concerning the Registration, Evaluation, Authorization and
Restriction of Chemicals (REACH) – this is a partial harmonisation with the REACH Regulation;
2. Regulation 1272/2008/EC on classification, labelling and packaging of substances and
mixtures;
3. Directive 67/548/EEC on the approximation of laws, regulations and administrative
provisions relating to the classification, packaging and labelling of dangerous substances;
4. Council Directive 99/45/EC concerning the approximation of the laws, regulations and
administrative provisions of the Member States relating to the classification, packaging and
labelling of dangerous preparations;
5. Council Directive 2004/42/EC on the limitation of emissions of volatile organic
compounds due to the use of organic solvents in certain paints and vehicle refinishing products
and amending Directive 1999/13/EC;
6. Regulation 689/2008/EC and 649/2012/EU concerning the export and import of
dangerous chemicals;
7. Regulation 648/2004/EC on detergents;
8. Commission Regulation 440/2008/EC laying down test methods pursuant to the
Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the
Registration, Evaluation, Authorization and Restriction of Chemicals (REACH).
36
ANNEX III: Reference to relevant Government Strategic plans and studies
The European Partnership 2008 defines a number of priorities for the environmental sector.
Among other things, the priorities are to strengthen further the administrative capacity of
environmental institutions at national and local level and ensure full implementation and
enforcement of legislation approximated to the EU legislation.
Based on the Stabilization and Association Agreement (Article 111, Environment) the Parties
shall develop and strengthen their cooperation in the environmental field with the vital task of
halting further degradation and start improving the environmental situation with the aim of
sustainable development. The Parties shall, in particular, establish cooperation with an aim of
strengthening administrative structures and procedures to ensure strategic planning of
environmental issues and coordination between relevant actors and shall focus on alignment of
Serbia’s legislation with the Community acquis.
The National Plan for Adoption of the Acquis (NPAA) (2014-2018) states that the
improvement of administrative and technical capacities has been planned in the field of risk
assessment and risk management of chemicals and biocidal products, as well as for the effective
implementation of the legislation harmonized with the EU legislation through the implementation
of project activities.
According to NPAA (activities planned for the period 2014-2017) updating of the existing
implementing legislation has been planned with the aim of its harmonization with the relevant
amendments to the Regulation 1907/2006/ЕC, Regulation 1272/2008/ЕC, Regulation
440/2008/ЕC, Regulation 649/2012/ЕU as well as adoption of the new Law on Biocidal Products
harmonised with the Regulation 528/2012/ЕU.
Trainings for the participation in the activities of ECHA and other EU institutions competent in
the field of chemicals management have been planned.
In the National Sustainable Development Strategy (NSDS) is stated that: “In order to achieve a
more efficient implementation of new legislation in the field of management of chemicals it is
necessary to strengthen administrative and professional capacities of staff. It is necessary to
develop a program for monitoring of chemicals including risk reduction measures, to establish a
system of authorization (use permits issuance) for certain hazardous chemicals for the purpose of
their replacement with less hazardous ones, and to undertake socio-economic studies including
the calculation of costs associated with replacement of hazardous chemicals with less hazardous
ones. In order to establish and develop an information system for management of chemicals, it is
necessary to establish and update data bases of chemicals on the market, their properties and
impact on human health and the environment. It is also necessary to strengthen capacities of
NGOs, including consumer protection organizations for the purpose of informing the public of
risks associated with chemicals”.
The broad framework for implementing environmental policy is set by the National Programme
for Environmental Protection 2010-2019 (NPEP) (Official Gazette of the Republic of Serbia,
no. 12/10), which covers all aspects of environmental policy including chemicals management. It
lays down a set of objectives for Government policy over 2010-2019, among them are the
following short-term (2010-2014) objectives:
37
Established and improved system for chemicals and biocidal products management on the
territory of the Republic of Serbia on the basis of developed regulations, procedures and
standards harmonized with the EU Acquis Communautaire;
Developed professional and administrative capacities in the Chemicals Agency with a high
level of professional knowledge, established communication with stake holders and
cooperation with other competent authorities;
Established Integrated Chemicals Registry that will enable development and continuous
updating of the database on chemicals, biocidal products and plant protection products placed
on the market of the Republic of Serbia;
Established adequate communication with and education of users of chemicals and biocidal
products about their hazardous properties and risk reduction measures.
The National Environmental Approximation Strategy 2011-2019 (EAS) was adopted in
October 2011. EAS includes legislative, institutional and financial components and addresses the
complexity of the challenge of applying EU environmental legislation in Serbia and provides a
sound basis for the accession negotiations on Chapter 27. It aims to address the challenges that
approximation will pose to legislation (including the response to deficiencies in the current
legislative process in Serbia), the extent of change that will be required in organizing and
operating institutions responsible for environmental protection, and the approach to closing the
economic gap between 'business as usual' and full compliance with the acquis. One of the
challenges, as stated in the EAS, relates to preparation of industry for their future obligation
“Whilst a lot is done to prepare local operators for the entry into the common market, joining that
level playing field will require undoing the part of the regulatory framework that was
provisionally adopted to harmonise with EU Regulations, the bulk of Acquis in this sector. That
will require careful preparation”.
Republic of Serbia gained the status of “Candidate Country” for membership in the EU in March
2012. In a view of the candidate status of the Republic of Serbia for the EU Membership, and
forthcoming process of opening the negotiations, the EAS Strategy is one of the most important
documents in terms of European integrations in the field of environment. It will be the basis for
accession negotiations in connection with the Chapter 27 (Environment). Bearing in mind the
experience of other countries, this chapter is considered one of the most difficult and complex in
negotiations, therefore it is of great importance to join this process prepared in the best possible
way. According to the EAS Strategy, overcoming this challenge requires sustained progress in
three particular areas: full transposition of the EU’s environmental legislation into national
legislation; putting in place the administrative capacity to implement, monitor and enforce that
legislation; and establishing the infrastructure required to be able to comply with the legislation.
The Serbia 2013 Progress Report states: “As regards chemicals management, the closure of the
Chemicals Agency in September and the transfer of its mandate to the Ministry of Energy,
Development and Environmental Protection have removed the legal basis for carrying out
statutory duties related to issuing permits and decisions. Serbia needs to re-instate a sound legal
basis for chemicals management. Joint inspections under the Law on Chemicals have been
discontinued. The advanced level of competence in this domain should be preserved in the new
structure and the legislation applied again.”
National Profile for Chemicals Management was developed in 2007 within the scope of the
project “Enabling activities for development of a national plan for implementation of the
Stockholm convention on persistent organic pollutants (POPs Project)” and was updated in 2008
38
within the project “Updating a National Chemicals Management Profile, Development of a
National SAICM Capacity Assessment and Holding of a National SAICM Priority Setting
Workshop in Serbia”. The National Profile provides a comprehensive overview and assessment
of the existing national legal, institutional, administrative and technical infrastructure related to
the sound management of chemicals. It addresses the need to strengthen administrative and
professional capacities of the staff in governmental bodies. Strengthening of professional
capacities is not only based on an increased number of staff, but also on training employees to
enable them to implement new regulations, for example, assessment of risks from chemicals to
health and the environment, classification and labelling of chemicals, regulatory toxicology,
development of socio-economic assessment regarding decision making, etc. Besides employees
in the state administration, improvement of professional capacities is also needed in educational
and scientific-research institutes regarding chemicals management, building of professional
capacities in the chemical industry and industries using chemicals, as well as informing chemical
exporters and importers on new administrative procedures in the international chemicals trade.
39
ANNEX IV: Ministry of Agriculture and Environmental Protection – organogram
Agricultural
Policy Sector
Legal and Regulatory
Affairs Sector
MINISTER
Serbian Environmental Protection
Agency
Agricultural Inspection Sector
Rural Development
Sector
Internal unit outside the Sector and
Secretariat:
Sector for Planning and Management in
Environment
Sector for Environmental
Protection
Group for strategic, program and
planning documents
Group for standards and clean
production
Department of Planning and
Standards
Department for Integrated
Permits
Group for strategic environment
impact assesment
Department for environment impact
assesment
Division for the protection of
large chemical accident
Department for Waste
Management
Division for crossborder
movement of waste
Division for issuing permits of
waste management
Department for protected
areas and ecological network
Division for protected areas
MINISTRY OF AGRICULTURE AND ENVIRONMENTAL PROTECTION
Division for ecological networks
and assessment of eligibility
Group for the implementation of
CITES Covention
Department for Licensing in the
Field of Biodiversity Protection
Cabinet of
Minister
Environmental Protection Inspection
Sector
Department for Prevention and control
of Environmental Pollution
Division for chemicals and biocidal
products
Division for large chemical
accidents
Department for protection from
ionizing and non-ionizing radiations
Division for integrated prevention
and control of Environmental
Pollution
Division for Environmental
Protection from Pollution
Department for protection of soil,
groundwater and surface water from
pollution
Division for protection of soil, and
groundwater from pollution
Division for protection of surface
water from pollution
Department for large chemical
accidents, chemicals and biocidal
products
Department for Control of Waste
Treatment
Department for Environmental
Protection in the field of protection and
use of natural resources
Department for Environmental
Protection in the field of protection of
fish fund
State
Secretaries
INDEPENDENT OFFICIERS OUT OF THE ORGANIZATION UNITS:
REPRESENTATIVE OF THE MINISTRY WITHIN THE PERMANENT
MISSION OF THE REPUBLIC OF SERBIA TO THE EU IN BRUSSELS
Division for protection of noise,
vibration and non- ionizonig radiation
Department for Natural Resources
Protection
Division for Water Protection
Group for Land Protection and
Monitoring, Rehabilitation and
Remediation of the Environment
from the Effects of Erosion and
Torrents
Division for Protection of Air
and Ozone Layer
Department for Chemicals
Division for Integrated
Chemicals Registry
Gropu for
Internal Audit
Division for Chemicals
Management
Division for development of
system of waste management
Department for European
Integration, Multilateral
and Bilateral Cooperation
in the Area of Agriculture
Sector for International
Cooperation
Department for European
Integration and
International Cooperation in
the Environmental Field
Department for Project
Magamenta in the
Agriculture Field
Department for Project
Magamenta in the
Environmental Field
Division for Climate Changes
SectorforFinacial
Management
Division forthe protection and
sustainable use of fish resources
Group for licensing for the
collection, use and trade of
protected species of wild flora
and fauna
Group for Sustainable Use of
Natural Resources
Division for environment impact
assesment of projects and
activities
Division for Biocidal Products
Risk Management
Group for Classification, Risk
Assessment, and Communication
of Hazards from Chemicals and
Biocidal Products
Division for preparation
of Project funded byEU
and international
assistance in teh area of
environment
Division for
implementation and
monitoring of projects
funded by the EU and
international assistance
in the Environment field
Group for preparation of
Project funded byEU and
international assistance
in the agriculture field
Group for
implementation and
monitoring of projects
funded by the EU and
international assistance
in the agriculture field
Division for European
Integration the
Environmental Field
Division for International
Cooperation and
Sustainable Development
the Environmental Field