List of Acronyms Beneficiary Country BPR Biocidal Products Regulation CARDS Community Assistance for Reconstruction, Development and Stabilisation

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1 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 1

2 UNITAR United Nations Institute for Training and Research STANDARD TWINNING PROJECT FICHE STANDARD TWINNING PROJECT FICHE 1. Basic Information 1.1 Publication reference: EuropeAid/ /IH/ACT/RS 1.2 Programme: IPA 2013 National Programme part A (Decentralized management) 1.3 Twinning Number: SR 13 IB EN 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. 2

3 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) ( ) 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 (NPEP) a set of objectives for Government policy over 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 (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 reinstate 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. 3

4 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 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 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 4

5 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 proactive 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 products 1 ; Institutional issues According to the Law on Ministries, currently the Ministry of Agriculture and Environmental Protection (MAEP) (established on 26 th 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; 1 Competent 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. 5

6 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. Socioeconomic 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. 6

7 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 technicalscientific 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 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. 7

8 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 8

9 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 1 st September 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 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; 9

10 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 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 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 10

11 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 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 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 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 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 selfgovernment; 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 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 11

12 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 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: 12

13 Percentage of adopted legislation in accordance with EU environment and energy Аcquis comparing to Report on Implementation of the National Plan for Adoption of the Acquis (NPAA) At sector support objective indicator is: Recommendations for transposition of the Biocidal Products Regulation adopted by Competent Authority. Guidance/handbooks for further implementation of REACH adopted by Competent Authority. Result 1: l National legal framework pertaining to transposition of the Biocidal Products Regulation (EU) No 528/2012 improved. The expected result indicators are: Recommendations for transposition of Biocidal Products Regulation (i.e. alignment of national legal framework with the EU acquis) developed and relevant document submitted to Competent Authority. Proposal of fees for services that Competent Authority provides with respect to procedures under BPR taking into consideration the EU guidance concerning the harmonized structure of fees developed and submitted to Competent Authority. Result 2: Administrative capacities for biocidal products management enhanced The expected result indicators are: Document on assessment of institutional organization of biocidal products management system in Serbia prepared, with recommendations for improvement of organizational structure and development of operational capacity; Proposal for Operational scheme for evaluation of biocidal product dossier prepared; Recommendations for sustainable financing of biocidal products management administration prepared and relevant document submitted to Competent Authority. Result 3: Professional capacities (i.e. competences) of the Competent Authority responsible for chemicals and biocidal products management (i.e. Chemicals Department) improved. The expected result indicators are: TNA report and corresponding training plan and materials prepared to cover capacity building of the Competent Authority staff related to placing of chemicals on the market (particularly REACH with special emphasis on SVHC); TNA report and corresponding training plan and materials prepared to cover capacity building of the Competent Authority staff for the risk assessment and risk management of biocidal products (e.g. IT tools, dossier completeness check, risk assessment); 13

14 At least 4 of staff from the Competent Authority are trained on at least one two days training/workshop on SVHC with relevant case studies to be fully conversant with SVHC related issues and to perform future tasks effectively; At least 4 of staff from the Competent Authority are trained on at least one two days workshop to be conversant with socio-economic analysis in the field of regulating chemicals; At least one guidance/handbook for further implementation of REACH prepared; At least 7 of staff from the Competent Authority are trained on at least four two days trainings to be fully conversant with the REACH IT system, IUCLID 5, R4BP, CHESAR etc. and to perform future tasks effectively; At least 2 of staff from Competent Authority are trained on at least five two days trainings/workshops with relevant case studies on biocidal product risk assessment to be fully conversant with future tasks and to perform them effectively. Result 4: Competences and skills of the Competent Authority staff regarding participation in the work of ECHA s Committees and bodies and EC meetings for chemicals and biocidal products management improved. The expected result indicators are: Documents on common principles and tips for participation in the work of the different committees and bodies of the ECHA and EC meetings prepared; At least 5 of staff from Competent Authority are trained to participate in the work of ECHA s Committees and bodies and the EC meetings for chemicals and biocidal products management to be fully conversant to perform future tasks effectively; Reports from study visits and delivered trainings. 3.4 Activities: The Member State(s) shall in its offer develop the methodology and corresponding activities it finds are best suited to achieve the results above described. The below activities are thus indicative of requirements and based on experience with similar projects carried out previously. The numbers provided are equally indicative and result of a first assessment notably of the number of primary recipients of capacity building measures. The information serves to guide the Member State as to the anticipated geographic distribution and scale of the operation notably as regards training activities. Activities related to result 1: 1.1. To prepare advisory mission plan and to organize and conduct at least 2 advisory missions/workshops to support Competent Authority staff for transposition of Biocidal Products Regulation (EU) No 528/2012; special care shall be taken of transposition of provisions that are applicable on national level as well as of the new concepts and administrative procedures prescribed by this Regulation; 14

15 1.2. To prepare document containing recommendations for transposition of BPR and alignment of national legal framework with the EU acquis; 1.3. To prepare advisory mission plan and to organize and conduct at least 2 advisory missions/workshops to support Competent Authority staff for developing of national fees for the services that Competent Authority provides with respect to procedures under BPRthaking into account EU guidance concerning the harmonized structure of fees 1.4. To prepare document containing proposal of fees for services that Competent Authority provides with respect to procedures under BPR. Activities related to result 2: 2.1. To prepare advisory mission plans and to organize and conduct at least 2 advisory missions in order to perform analyses of current in-house organization of biocidal products management and prepare a document containing recommendations for improvements of organizational structure and operational capacity; 2.2. To develop a document with proposal for operational scheme for evaluation of biocidal product dossier; 2.3. To organize and conduct at least one advisory mission in order to review and assess current model for financing of biocidal products management administration and to prepare assessment report on current model for financing of biocidal products management administration; 2.4. To organize and conduct at least two advisory missions for staff from Competent Authority and other stakeholders (e.g. Ministry of Finance) in order to share the findings of the above mentioned assessment report; 2.5. To prepare document containing recommendations for sustainable financing of biocidal products management administration. Activities related to result 3: 3.1. To conduct TNA and prepare training programme and corresponding training materials to cover capacity building of the Competent Authority staff relating to further implementation of legislation regarding placing of chemicals on the market (particularly REACH, with special emphasis on SVHC); 3.2. To conduct TNA and prepare training programme and corresponding training materials to cover capacity building of the Competent Authority staff in the field of risk assessment and risk management of biocidal products; 3.3. To organize and conduct training for at least 4 of staff from Competent Authority on at least one two days trainings/workshops in the field of risk management and risk assessment of chemicals with special emphasis on SVHC with relevant case studies according to the training programme; 3.4. To organize and conduct at least two days workshop on socio-economic analysis in the field of regulating chemicals for at least 4 of staff from the Competent Authority; 15

16 3.5. To prepare at least one guidance/handbook on further implementation of REACH for stakeholders; 3.6. To organize and conduct training for at least 7 of staff from Competent Authority on at least four two days trainings/workshops in order to prepare for use of REACH IT system, IUCLID 5, R4BP, CHESAR etc.; it should be noticed that 1 day basic training on IUCLID was provided by ECHA and further trainings shall be of advanced level; 3.7. To organize and conduct at least five two days trainings/workshops with relevant case studies for at least 2 Competent Authority staff per training/workshop to gain knowledge in the field of risk assessment and risk management of biocidal products, with particular attention on dossier completeness check and risk assessment. Activities related to result 4: 4.1. To prepare advisory mission plan and to organize and conduct at least three advisory missions for at least 5 staff from Competent Authority with experts which have experience in participating in ECHA bodies and EC Competent Authority meetings relevant for chemicals and biocidal products management, in order to improve competences and skills of Competent Authority staff for participation in the work of ECHA bodies and EC meetings; 4.2. To identify opportunities for additional participation in the work of ECHA bodies and EC meetings for chemicals and biocidal products management as observers; 4.3. To organize and conduct at least two up to five days study visits in the twinning EU Member State for at least 5 Competent Authority representatives, and prepare report on the findings of the study visit; 4.4. To prepare documents containing common principles and tips for participation in the work of different committees and bodies of the ECHA. At least two major visibility events with not less than 30 participants will be organized in the course of the implementation of the project; Kick-off meeting at the start of the implementation and the Final meeting at the end of the implementation of the project activities. The MS will propose additional visibility actions as stand alone or associated with training workshops etc. and as may be deemed appropriate. 3.5 Means/ Input from the MS Partner Administration: The Project Leader (PL) and the Resident Twinning Adviser (RTA) shall provide support to the responsible Serbian authorities in strengthening their capacities as well as in implementation of this project. During the implementation of this project RTA will be positioned in Ministry of Agriculture and Environmental Protection Profile and tasks of the Project Leader 16

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 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: 17

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 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 18