REPUBLIC OF SERBIA Bilateral screening: C L P Classification, Labeling and Packaging of substances and mixtures
C O N T E N T STATE OF PLAY LEGISLATIVE FRAMEWORK COMPETENT AUTHORITY (CA) ADMINISTRATIVE CAPACITY EXPERIENCE IN IMPLEMENTATION ENFORCMENT ECONOMIC OPERATORS SUMARY HIGHLIGHTS
STATE OF PLAY Grounds for CLP have being prepared for several years through Serbian REACH & CLP harmonised chemicals management system; CLP-harmonised legislation has been in force since 2010; Present system for chemicals classification and labelling is almost fully harmonised to the EC-system; Through the work as the core administration, central staffs got education, training and practical experience during several years.
LEGISLATIVE FRAMEWORK Law on Chemicals, (Official Gazette No 36/09, 88/10, 92/11 and 93/12); Legislation promulgated there of CLP Implementing Act (deadline for 1 st Draft 1 st half of next year)
LEGISLATIVE FRAMEWORK contd. 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 entry into application: 1 st October 2011 for substances, 1 st June 2015 for mixtures. Rulebook on the List of classified substances ( Official Gazette of Republic of Serbia, No 82/10 and 48/14); Rulebook on Methods for Testing of Chemicals Hazardous Properties ( Official Gazette of the RS, No 117/13).
LEGISLATIVE FRAMEWORK contd. In parallel to the harmonisation to the CLP, rules which have cared 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; Important for Serbian chemicals management system and with regard to classification of mixtures for which the CLP Regulation becomes mandatory from 1 st June 2015; CLP harmonized Rulebook may be applied on mixtures prior the above stated date.
LEGISLATIVE FRAMEWORK contd. 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 CLP CLP Regulation, Annex I, II, III, IV, V, VII Аnnex VI Harmonised classification and labelling for certain hazardous substances
LEGISLATIVE FRAMEWORK contd. Main differences from our legislation: Origin from the fact that Serbia is not an EU member state: 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.
COMPETENT AUTHORITY (CA) Ministry Competent for the Environment, Organizational Unit for Chemicals is foreseen to become the MS CA under CLP Regulation; 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 designated in CLP Implementing Law.
ADMINISTRATIVE CAPACITIES MAEP, Organizational Unit for Chemicals 13 employees + Head of Department 1/2 full time staff engaged on CLP harmonized tasks; 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 contd. Central staffs have acquired knowledge and practical experience on CLP harmonized rules 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); IPA 2008 Strengthening Administrative Capacities for the Implementation of a Chemicals Management System 2010-2012; Serbian-Swedish cooperation project Chemicals Risk Management in Serbia 2007-2014. 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 contd. Needs for further capacity building: for proposal for harmonised classification and labelling of substances; to participate in technical work such as the Partner Experts Groups, technical subgroups to the meeting of the CARACAL, etc.
ADMINISTRATIVE CAPACITIES contd. The capacity of central staff will be built striving to optimize the use of resources taking into account all requirements placed on the MS CA under all EC legislation on chemicals; National cluster of relevant expertise will be engaged as an external support; Further capacity building support IPA 2013 Twinning Project Further development of chemicals and biocidal products management in RS (Project Fiche has been drafted and in final phase to be submitted to the European Commission); ECHA International Activities; Participation in the meetings (e.g. CARACAL) will be important step further in competence building.
ADMINISTRATIVE CAPACITIES contd. Capacity building 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 the formation of the member state CA in a broad meaning, including: Further development of competence, Further employment time line.
EXPERINCE IN IMPLEMENTATION Present system for chemicals classification and labelling is almost fully harmonised to the EC-system; Adequate 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.
EXPERINCE IN IMPLEMENTATION contd. A national helpdesk is established and provides help to duty holders to navigate in the CLP-harmonised legislation. Helpdesk staffs take part in ECHA Helpdesk network activities with the capacity of an observer. Helpdesk is foreseen to become Helpdesk under CLP Regulation (to be legally established under the future CLP implementing Law); Guidance on classification, labelling and packaging in Serbian was developed by the competent authority and provided through the Internet and by means of leaflets, bookmarks, posters etc.
EXPERINCE IN IMPLEMENTATION contd. 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 regarding the classification and labelling of chemicals; The EC-classification inventory built up according to the CLP Regulation by the notifications sent to ECHA serves already under the CLP-harmonised 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.
ENFORCMENT Ministry responsible for the Environment is the Competent Authority for enforcement of the Law on chemicals and legislation promulgated thereof and also competent for supervision and control of placing chemicals on the market; Two additional ministries are responsible for inspection and control of chemicals on the market, the Ministry competent for trade via trade inspectors and the Ministry competent for health via sanitary inspectors; Inspections authorities shall cooperate, inform each other about the undertaken measures, exchange information and undertake joint activities relevant for enforcement of the law.
ENFORCMENT contd. Inspectors have the powers given by the Law (a range of tools at their disposal to secure compliance); Control of compliance with CLP-harmonized rules is regularly performed in accordance with annual work-plans; Around 200 official 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; A list of penalties including fines and protective measure of prohibition of certain economic activity up to 10 years is envisaged.
ENFORCMENT contd. Enforcement arrangements under the CLP Regulation, duties and the powers of inspectors, as well as the list of offences and penalties for non-compliance to the regulation will be part of CLP implementing law.
ENFORCMENT contd. 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 have received trainings, took part in workshops where case studies were discussed within the international cooperation projects; a few Pilot inspections were performed with participation of inspectors from the EU MSs (mainly Austria, Slovenia and Sweden). 11 inspectors competent for trade and 13 sanitary inspectors also took part at the capacity building trainings.
ECONOMIC OPERATORS Chemicals Industry holds significant 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.
SUMARY HIGHLIGHTS National CLP legislation is almost fully harmonized with the CLP Regulation; Chemicals Industry is significant for national economy; NO barriers to trade on the grounds of C&L; Central staff, enforcement authorities and industry will benefit from experience gained during pre-accession period; Capacities will be improved further; 4-5 years Plan for the formation of the member state CA in a broad meaning will be developed (2015/2016); A broader cluster of expertise is available and will be engaged to support national CA.
SUMARY HIGHLIGHTS Proposals for domestic CLP supplementing provisions have still to be prepared; CLP Implementing Act will be developed and adopted in due time before accession; Deadline for developing 1 st Draft is first half of 2015. Act will establish: CA and its responsibilities, including duty to submit to the ECHA a proposal for a harmonized classification and labeling, and official Help-desk function; National Poison Control Center as the body responsible for receiving information relating to emergency health response; Enforcement arrangements as well as list of offences and penalties for non-compliance.
Thank you for your attention