List of Acronyms BC BPR CARDS CFCU CLP - Esteri e montenegro/sr_13_ib_en... · List of Acronyms BC Beneficiary Country BPR ... No 1907/2006 concerning the Registration, Evaluation,

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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.


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.


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;


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.


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.


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;


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.


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:



and implementation of biocidal products related legislation (BPD/BPR);


Chemistry, Chemical engineering and similar (PhD preferred));




Risk assessment expert:


At least 3 years professional experience in risk assessment of chemicals or biocidal

products (regulatory risk assessment, (eco)toxicology, humans and environment

exposure);


Chemistry, Chemical engineering, Toxicology, Ecotoxicology (PhD preferred));




20

Expert involved in the work of ECHA and/or other EU committees and bodies



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;




Legal expert(s):


At least 3 years of experience in the field of chemicals/biocidal products legislation

and/or regulatory affairs;

University degree in Law;



Economy expert(s):


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;


IT tools expert(s):


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;


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

27

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



evaluation reports

- Improved administrative

capacities of Competent

Authority responsible

for biocidal products

management




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



evaluation reports

- Sufficient number of

pre-qualified and

motivated participants in

the training exercises

- Availability of twinning

experts




resources

29

training/workshop on SVHC with relevant case

studies to be fully conversant with SVHC

related issues and to perform future tasks

effectively;


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;


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



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 related to the Result 1:


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.


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


2.5. To prepare document containing recommendations for sustainable financing of

biocidal products management administration.


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;


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.


32


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


in the agriculture field

Group for

implementation and

monitoring of projects

funded by the EU and


in the agriculture field

Division for European

Integration the

Environmental Field

Division for International

Cooperation and

Sustainable Development

the Environmental Field

40