REPUBLIC OF SERBIA Negotiating Group for the Chapter 27 Environment and Climate Change Bilateral screening: Chapter 27 PRESENTATION OF THE REPUBLIC OF SERBIA Biocidal Products Regulation (BPR) Department for Chemicals Ministry of Agriculture and Environmental Protection Brussels, November 2014
Overview INTRODUCTION LEGISLATIVE FRAMEWORK IMPLEMENTING CAPACITY Competent Authority Administrative capacities Enforcement arrangements Communication and support Implementing capacity needs Further capacity building IMPLEMENTATION IN PRACTICE ENFORCEMENT IN PRACTICE SUMMARY HIGHLIGHTS
Introduction Grounds for the BPR have been prepared for several years through the implementation of the national BPD-harmonised legislation on biocidal products: Law on Biocidal Products has been in force since 2009; The Law has been almost fully harmonised with the BPD; Rulebooks repeat the material content of individual BPDprovisions; Core administration and enforcement authorities have been building up their competence for several years; Industry placing biocidal products on the market has acquired knowledge on the BPD-harmonised rules.
BPD - harmonised legislation Law on Biocidal Products ( Official Gazette of the RS, No 36/09, 88/10 and 92/11) lays down rules for: national transitional procedure for placing BPs on the market; authorisation of BPs, i.e. law-risk BPs (national authorisation, recognition of EU authorisation); authorisation the use of unauthorised BPs; classification, packaging, labelling and SDS for BPs; import of BPs; monitoring of the compliance and enforcement; penalties applicable for infringement of the provisions...
BPD - harmonised legislation National transitional procedure Inclusion of a biocidal product into the Temporary List for delivery of technical dossier... biocidal products containing not only active substances listed in Annex I or IA of the BPD, but also active substances which are being examined under the Review Programme (Regulation (EC) No 1451/2007) may be placed on the market. Ref: Rulebook on content of the basic information on biocidal product ( Official Gazette of the RS, No 23/10 and 28/11) Temporary List contains, among others, deadline for submission of dossier for a biocidal product for the purpose of granting the authorisation.
BPD - harmonised legislation Active substances (ASs) listed in Annex I, IA or IB of the BPD have been taken over into national legislation by publishing of the Lists of active substances in biocidal products in the Official Gazette of the Republic of Serbia. The Lists have been regularly updated to align with the amendments in the EU legislation. Existing ASs for which a decision on non-inclusion into Annex I or IA was adopted have been also published in the Official Gazette of the Republic of Serbia. Rulebooks promulgated thereof
BPD - harmonised legislation EC legislation (BPD) ASs included in Annex I/IA as well as existing ASs for which a decision on noninclusion into Annex I/IA was adopted Annex II, III and IV Annex V Annex VI National legislative act Lists of active substances in biocidal products ( Official Gazette of the RS, No 72/2014) Last amended by Commission Implementing Regulation (EU) No 438/2014 as well as Commission Implementing Decisions 2014/227/EU Rulebook on scope and content of technical dossier for biocidal product, i.e. low-risk biocidal product ( Official Gazette of the RS, No 97/10) Rulebook on biocidal products types ( Official Gazette of the RS, No 23/10) Common principles for the evaluation of the biocidal product on the basis of technical dossier ( Official Gazette of the RS, No 28/11)
BPD - harmonised legislation EC legislation (BPD) Article 20 Article 5(2) Article 18(3) Article 25 National legislative act Rulebook on specific requirements for packaging, labelling and advertising of biocidal product ( Official Gazette of the RS, No 59/10 and 26/11) Rulebook on certain hazardous biocidal products which cannot be placed on the market for general use ( Official Gazette of the RS, No 37/11) List of biocidal products included in the Register of Biocidal Products ( Official Gazette of the RS, No 28/12) Decision on fees rates according to the Law on Biocidal Products ( Official Gazette of the RS, No 23/10 and 39/11)
Additional applicable legislation Rulebook on classification, packaging, labelling and advertising of the chemical and certain article in accordance with Globally Harmonised System for Classification and Labelling of the UN ( Official Gazette of the RS, No 64/10, 26/11 and 105/13); In parallel to the alignment to the CLP, rules for the harmonisation to the former EC-system for classification and labelling based on the Directives 67/548/EEC and 1999/45/EC have been introduced. Rulebook on methods for testing of chemicals hazardous properties ( Official Gazette of the RS, No 117/13); Rulebook on content of safety data sheet ( Official Gazette of the RS, No 100/11). Ref: Law on Chemicals ( Official Gazette of the RS, No 36/09, 88/10, 92/11 and 93/12)
Further legislative alignment New Law on Biocidal Products shall be drafted To facilitate implementation and enforcement of the BPR rules upon accession; To get industry acquainted with their respective responsibilities and obligations under the BPR. Adoption is envisaged by the end of 2016. Ref. Draft National Plan for Adoption of the Acquis (2014-2018)
Legal ground for the BPR BPR is directly applicable in all MSs. BPR Implementing Law will be adopted in due time before accession and shall: Designate the CA responsible for the application of the BPR; Establish arrangements for monitoring, enforcement and reporting; Provide for penalties applicable to infringement of the provisions of the BPR; Set fees structure with respect to the procedures in the BPR; Appoint a body responsible for receiving information relating to emergency health response; Officially establish Helpdesk under the BPR. First draft will be developed by the 2 nd half of 2016. Ref. Draft National Plan for Adoption of the Acquis (2014-2018)
Ministry competent for the environment, organisational unit for chemicals, is foreseen to become the MS CA under the BPR. Competent Authority (CA) Ministry of Agriculture and Environmental Protection (hereafter: Ministry competent for the environment) is responsible for the biocidal products management, i.e. implementation of the Law on Biocidal Products (April 2014) Ref: Law on Ministries ( Official Gazette of the RS, No 44/14) and Law on Chemicals...Ministry of Energy, Development and Environmental Protection (2012)...Serbian Chemicals Agency (2009)
Administrative capacities Ministry competent for the environment, Department for Chemicals: Currently: 13 employees + Head of Department; 2 full time employees are engaged on tasks related to the biocidal products management. Envisaged: 21 working posts; 5 emplyees will work on BPs related tasks. Ref: Rulebook on internal organisation and sistematisation of the work posts (September 2014)
Core administration has built up its competence and gained practical experience implementing the BPD-harmonised legislation for 5 years. Core administration has benefit of the documents and guidance provided on the DG environment, CIRCABC and ECHA s website. Core administration has been further underpinned by the cooperation with some MSs and ECHA: Administrative capacities contd. Bilateral cooperation with Sweden Chemicals Risk Management... 2007-2014; IPA 2008 Twinning with Austria and Slovenia Strengthening Administrative Capacities for... Chemicals Management... 2010-2012; ECHA s IPA project Preparatory measures for the participation of candidate countries... in and their cooperation with the ECHA.
Administrative capacities contd. Core administration competences have been enhanced by the participation in the: CA meetings; Former PA&MRFG meetings (possible participation in the Coordination Group has been communicated with the chair of the Group); Mid-European Group on Biocides meetings; ECHA HelpNet activities; Biocides Stakeholders Day.
Enforcement arrangements Ministry competent for the environment is responsible for administrative supervision of the Law on Biocidal Products and legislation promulgated thereof. Inspection and control of compliance with the Law on Chemicals and Law on Biocidal Products have been carried out by: 6 environmental inspectors; 10 trade inspectors (Ministry competent for trade); 17 sanitary inspectors (Ministry competent for health). Inspections authorities shall cooperate, inform each other about the undertaken measures, exchange information and undertake joint activities relevant for enforcement of the Law. Ref: Law on Biocidal Products
Enforcement arrangements Inspectors have the powers and mandate to issue injunctions given by the Law on Biocidal Products. List of offences and penalties for non-compliance has been laid down by the Law on Biocidal Products. Enforcement authorities have been built up their competences within the capacity building projects (2010-2012). Inspectors received trainings, participated in workshops where case studies were discussed and established contacts with some MSs enforcement authorities. Necessary arrangements for the monitoring and enforcement under the BPR as well as penalties for non-compliance shall be set out in the BPR Implementing Law.
Communication and support Website to navigate applicants, in particular SMEs and other stakeholders in the national BPD-harmonised legislation has been developed. National helpdesk to provide advice to companies to comply with the requirements of the chemicals and biocidal products legislation has been established. Ref: Law on Chemicals Helpdesk is foreseen to become Helpdesk under the BPR.
Implementing capacity needs Needs for further strengthening of the administrative capacities with regard to qualification and experience: Evaluation of AS dossier; Evaluation of application for Union authorisation; Authorisation and mutual recognition of BP; Monitoring of compliance; Participation in the CA meetings and work of Coordination Group, Biocidal Products Committee and its Working Groups as well as Standing Committee on Biocidal Products.
Further capacity building Further capacity building support will be provided: Serbian-Swedish cooperation project; (possible extension is under consideration) IPA 2013 Twinning Project Further development of chemicals and biocidal products management in the RS (2015-2017); (circulation of Twinning fiche to select a Twinning partner) ECHA International Activities; Participation in the meetings (e.g. CA, Mid-European Group on Biocides, HelpNet).
Further capacity building contd. Short-term plans (2015-2016): Review of the in-house capacity and competences of the Department for Chemicals; Review of the requirements set out in the BPR, including other EC-chemicals regulations which place obligations on a MS CA to optimise work processes and use of resources; Make an inventory of available competence within the wider cluster of expertise to support the core administration in specific technical-scientific tasks; Prepare 4-5 years capacity development plan for the establishment of the MS CA in this broad meaning, including further strengthening of competences.
Implementation in practice Only BPs complying with the requirements of the BPDharmonised legislation are placed on the market. 1,023 BPs are included into the Temporary List. No application for national authorisation has been submitted so far. The first applications should have been submitted in 2015. No application for recognition of the EU authorisation has been submitted so far. Several phone and email enquires about the procedure received. The first applications should have been submitted in 2015. Representative of Serbia takes part as an observer in the CA meetings.
Implementation in practice National helpdesk provides support to companies and any other stakeholders to comply with the requirements of the BPD-harmonised legislation. Helpdesk staffs take part as an observer in ECHA Helpdesk network activities. Cooperation and permanent dialog with Serbian Chamber of Commerce have been established. A number of seminars were organised in 2010-2012 aimed to ensure that the companies are aware of their responsibilities and obligations under the BPD-harmonised legislation. Manual of Decision in Serbian and Guidelines for industry to support national transitional procedure were developed.
Implementation in practice BPs industry plays an important role in national economy: 238 legal entities (LEs) placing 1,023 BPs on the market will have to comply with the requirements of the BPR: cca. 172 LEs importing 696 BPs; cca. 76 LEs manufacturing 327 BPs; Ref: Register for Biocidal Products (September 2014) cca. 11,700t of BPs were placed on the market in 2013. Ref: Records on the Biocidal Products (2013) (118 duty holders )
Implementation in practice Importers vs. Serbian producers of BPs 31% 69% Importers of BPs Serbian producers of BPs Ref: Register for Biocidal Products (September 2014)
Implementation in practice BPs placed on the Serbian market 18% 6% 8% 12% 56% Disinfectants Preservatives Rodenticides Insecticides Repellents Ref: Register for Biocidal Products (September 2014)
Implementation in practice BPs subject to national authorisation vs. BPs subject to authorisation under mutual recognition 32% 5% 63% EU manufactured BPs Non-EU manufactured BPs Serbian BPs Ref: Register for Biocidal Products (September 2014)
Implementation in practice BPs with regard to Article 95 List 21% 11% 26% 42% NA (Article 95) NA cond. MR (Article 95) MR cond. 42% of the BPs subject to authorisation under the mutual recognition contain AS(s) included in the Article 95 List; 11% of the BPs subject to national authorisation contain AS(s) included in the Article 95 List. Ref: Register for Biocidal Products (September 2014)
Implementation in practice LEs subject to national authorisation 19% 5% 43% 33% Micro Small Medium Not SMEs Companies having an obligation to apply for national authorisation are SMEs. Ref: Serbian Business Registers Agency
Enforcement in practice Control of compliance with the Law on Biocidal Products is regularly carried out in accordance with annual work-plans. Nearly 25% of all companies placing BPs on the market were subject of controls carried out to verify the compliance with the Law on Biocidal Products (2013-2014). Enforcement activities were mainly preventive. Environmental and trade inspectors
Summary highlights Serbian legislation regulating biocidal products has been almost fully harmonised with the BPD. Grounds for the BPR have been prepared for several years through the implementation of the national BPD-harmonised legislation. Core administration and enforcement authorities have been building up their competence for several years. Industry is acquainted with the BPD-harmonised rules. Only BPs complying with the requirements of the BPDharmonised legislation are placed on the market. There is Register of Biocidal Products placed on the market.
Summary highlights Actions toward the BPR: To develop and adopt the BPR Implementing Law; To develop and adopt new Law on Biocidal Products aligned with the provisions of the BPR; To prepare 4-5 years capacity development plan for the establishment of the MS CA in a broad meaning, including further strengthening of competences; To support industry to integrate into the BPR system and comply with the BPR requirements; To make thorough assessment in order to decide whether to raise the issue of possible adaptation periods for certain BPR provisions.
Thank you for your attention