REPUBLIC OF SERBIA Negotiating Group for the Chapter 27 Environment and Climate Change Bilateral screening: Chapter 27 PRESENTATION OF THE REPUBLIC OF SERBIA Classification, labelling and packaging of substances and mixtures - CLP Department for Chemicals Ministry of Agriculture and Environmental Protection Brussels, November 2014
C O N T E N T Introductory notes National legislative framework Legal ground for implementation of CLP Regulation Competent authority (CA) Enforcement authority Administrative capacity Enforcement capacity Economic operators Experience in implementation Enforcement in practice Summary highlights
INTRODUCTORY NOTES Grounds for CLP have being prepared for several years through Serbian chemicals management system aligned with the REACH & CLP to the extent applicable for a candidate country; Legislation aligned with the CLP has been in force since 2010; Present system for chemicals classification and labelling is substantially aligned with the EC-system; Through the work as the core administration, central staffs have been building on their formal education, gaining practical experience and training during several years.
NATIONAL LEGISLATIVE FRAMEWORK (1) Law on Chemicals, (Official Gazette No 36/09, 88/10, 92/11 and 93/12); Legislation promulgated there of o 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 Republic of Serbia, No 64/10, 26/11 and 105/13); Date of mandatory application: 1 st October 2011 for substances, 1 st June 2015 for mixtures.
NATIONAL LEGISLATIVE FRAMEWORK (2) o Rulebook on the List of classified substances ( Official Gazette of Republic of Serbia, No 82/10 and 48/14); o Rulebook on Methods for Testing of Chemicals Hazardous Properties ( Official Gazette of the RS, No 117/13). National rules are continuously aligned with the amendments to the CLP Regulation alignment with 4 th ATP and 5 th ATP is planned for 2015 (National Program for Adoption of the Acquis (NPAA)).
NATIONAL LEGISLATIVE FRAMEWORK (3) In parallel to the alignment with the CLP, rules which have cared for the harmonisation with the former EC-system for classification and labelling based on the directives 67/548/EEC and 1999/45/EC have been introduced; Important for Serbian chemicals management system and still important with regard to classification of mixtures, since the CLP Regulation is not mandatory until 1 st June 2015; Rulebook aligned with the CLP may be applied on mixtures prior the above stated date.
NATIONAL LEGISLATIVE FRAMEWORK (4) CLP CLP Regulation, Annex I, II, III, IV, V, VII; Аnnex VI Harmonised classification and labelling for certain hazardous substances; National legislative act 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; Rulebook on the List of classified substances; *Currently, national rules are aligned with the 3 rd ATP to the CLP.
NATIONAL LEGISLATIVE FRAMEWORK (5) Main differences from our legislation in comparison with the CLP Regulation: no obligation for manufacturers and importers to notify classification and labeling of substances into the C&L inventory; no procedure for harmonization of C&L of substances; decision upon a request for use of an alternative chemical name shall be given by the Serbian authority and not ECHA; Date of entry into application of the rules for substances (1 st October 2011). No obligation is put on importers and downstream users placing mixtures on the market to provide data to the Poison Control Centre.
LEGAL GROUND FOR CLP (1) CLP Regulation is directly applicable in all the EU MSs Serbia needs national provisions complementary to the CLP Regulation which shall enable implementation and enforcement of the CLP on the day of accession (i.e. CLP implementing Law); CLP Implementing Law (deadline for 1 st Draft 1 st half of next year).
LEGAL GROUND FOR CLP (2) CLP Implementing Law will: Appoint Competent Authority under the CLP Regulation and its responsibilities (i.e. duty to submit to the ECHA a proposal for a harmonized classification and labeling) and authority responsible for the enforcement; Officially establish Helpdesk under CLP; Appoint National Poison Control Center as the body responsible for receiving information relating to emergency health response; Provide enforcement arrangements, list of offences and penalties for non-compliance.
COMPETENT AUTHORITY (CA) Ministry Competent for the Environment, Organizational Unit for Chemicals, is foreseen to become the MS CA responsible for proposals for harmonised classification and labelling under the CLP Regulation (Art. 43); Law on chemicals, Law on Ministries ( Official Gazette of Republic of Serbia, No 44/14)...Ministry of Agriculture and Environmental Protection Ministry of Energy, Development and Environment Serbian Chemicals Agency CA under CLP Regulation will be officially appointed by the CLP Implementing Law.
ENFORCEMENT AUTHORITIES (1) Ministry competent for the Environment is authority responsible for the enforcement of the Law on chemicals and legislation promulgated thereof and for inspection and control of compliance with the Law, via the environmental inspectors (Law on chemicals, Art. 86); Two additional ministries are responsible for inspection and control of compliance with the Law on chemicals, the Ministry competent for trade via trade inspectors and the Ministry competent for health via sanitary inspectors (Law on chemicals, Art. 86); Inspectors have the powers given by the Law (a range of tools at their disposal to secure compliance);
ENFORCEMENT AUTHORITIES (2) Inspections authorities shall cooperate, inform each other about the undertaken measures, exchange information and undertake joint activities relevant for enforcement of the Law (Law on chemicals, Art. 86). Clear and non-overlapping responsibilities for chemicals inspection remain to be assigned (Serbia Progress Report 2014). Enforcement arrangements under the CLP Regulation, authority responsible for the enforcement, duties and the powers of inspectors, as well as the list of offences and penalties for non-compliance will be part of CLP implementing Law.
ADMINISTRATIVE CAPACITIES (1) MAEP, Organizational Unit for Chemicals 21 posts are envisaged Currently: 13 employees + Head of Department 1/2 full time staff engaged on tasks related to alignment with the CLP; up to 1/2 full time Helpdesk staff. A rough estimate is that Serbia would need a minimum of 2-3 full-time staffers at its CA for CLP related tasks; The need for further employment has been identified; it is a process of continuous considerations underway also dependent on recruitment possibilities (i.e. budgetary limitations).
ADMINISTRATIVE CAPACITIES (2) Central staffs have acquired knowledge and practical experience on rules aligned with the CLP during several years; Capacities of central staffs and inspectors have been further underpinned by the cooperation with Austria/Slovenia and Sweden and also the European Chemicals Agency (ECHA); Serbian-Swedish cooperation project Chemicals Risk Management in Serbia 2007-2014; IPA 2008 Strengthening Administrative Capacities for the Implementation of a Chemicals Management System 2010-2012; 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).
ADMINISTRATIVE CAPACITIES (3) technical posts have been reduced by 30 %. Further strengthening of administrative capacity is therefore necessary, especially in the field of risk assessment (Serbia Progress Report 2014). Needs for capacity building (in terms of technical job skills): Competence for preparation of proposal for harmonised classification and labelling of substances; Competences and skills required for active participation in the work of ECHA s Committees and EC bodies and meetings for chemicals; Capability to participate in technical work (e.g. technical subgroups to the meeting of the CARACAL).
ADMINISTRATIVE CAPACITIES (4) Actions toward further capacity building: IPA 2013 Twinning Project Further development of chemicals and biocidal products management in RS (Twinning Fiche is circulated); Participation in the meetings (e.g. CARACAL, HelpNet) ECHA International Activities. National cluster of relevant scientific expertise is available as an external support.
ADMINISTRATIVE CAPACITIES (5) Future steps 2015 Review of in house capacity and competence of the Organizational Unit for Chemicals; Review of requirements of the EC legislation on chemicals which impose obligations on the MS CAs 2015/2016 Develop a 4-5 years plan for formation of the MS CA in a broad meaning, including further development of competence; further employment time line.
ENFORCEMENT CAPACITY MAEP, unit for enforcement of chemicals legislation 6 environmental inspectors, background in Chem. or Chem. Eng. Lot of efforts were put in enforcement capacity building activities (2010-2012): inspectors received trainings, took part in workshops where case studies were discussed within the international cooperation projects; Several Pilot inspections were performed with participation of inspectors from the EU MSs. 11 inspectors competent for trade and 13 sanitary inspectors also took part at the capacity building trainings.
ECONOMIC OPERATORS Chemicals Industry holds important share in national economy; Serbia has significant number of producers and downstream users of chemicals subject to CLP Regulation c.a.1.700 Legal Entities (duty-holders) placing industrial chemicals on the market; c.a. 250 Legal Entities placing BP on the market; c.a. 100 Legal Entities placing PPP on the market. 30 000 40 000 chemicals (i.e. substances and mixtures) placed on the market.
EXPERIENCE IN IMPLEMENTATION (1) Knowledge on chemicals and assessment of intrinsic hazardous properties is available and will be continuously improved; The core administration staffs benefit from the guidance, FAQs and other information on CLP provided on the ECHA s website; Representatives of Serbia take part as observers in CARACAL meetings since July 2014. National helpdesk is established and provides help to duty holders to navigate in the CLP-aligned legislation. Helpdesk staffs take part in ECHA Helpdesk network activities with the capacity of an observer.
EXPERIENCE IN IMPLEMENTATION (2) Guidance in Serbian was developed by the competent authority and with other information provided through the Internet and by means of leaflets, bookmarks, posters etc. A number of seminars with industry participation were organized during the 2010-2012 to ensure that chemicals industry is informed about its roles and obligations; Classification inventory built up according to the CLP Regulation serves already under the CLP-aligned legislation as a source of information to Serbian industry. Serbian manufacturers and importers are encouraged to consult the inventory when deciding on C&L of chemicals they place on the market; Awareness raising campaign on classification and new CLP labelling elements has been performed in 2012.
ENFORCEMENT IN PRACTICE Control of compliance with CLP-harmonized rules is regularly performed in accordance with annual work-plans; Around 200 inspection controls of compliance with the C&L legislation (2011 2013). Enforcement activities were predominantly preventive while also successive in order to follow up if the inspected legal entity has improved its performance.
SUMMARY HIGHLIGHTS National legislation is substantially aligned with the CLP Reg; Institutional and enforcement arrangements for national legislative framework are in place; central staff, enforcement authorities and industry have been gaining experience on a daily basis; Industry is acquainted with the CLP aligned rules; CLP Implementing Law will be developed and adopted in due time before accession; Administrative capacities need to be strengthen further; 4-5 years Plan for formation of the member state CA in a broad meaning will be developed (2015/2016); Enforcement responsibilities need to be reassessed and clearly assigned.
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