CLP-REACH main obligations on industry
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1 CLP-REACH main obligations on industry TA workshop Zagreb 15 June 2011 Torbjörn Lindh Swedish Chemicals Agency Twinning Adviser to Croatia Ref EC-Regulation (1272/2008) on CLP; EC-Regulation (1907/2006) on REACH
2 EU provides the almost complete Member State chemical management system CLP and REACH plus a few other pieces of EC-legislation, provide the system for chemicals management in the Member states Chemicals legislation is supposed to be fully harmonised Domestic national provisions may not be competening or contradicting
3 Chemicals legislation addresses chemicals when placed on the market EC-chemicals legislation places the emphasis on the first steps of the supply chain, the manufacturers and importers placing chemicals on the market. Downstream use is subject to special legislation (for example legislation on environmental protection; consumer safety; health and safety at work; prevention of major chemicals accidents)
4 EC-manufacturers & importers are supposed to eliminate adverse risks from the chemicals they manufacture, import and place on the market (REACH Article 1.3). They shall: - Make knowledge on hazards and risks available; - Communicate hazards, uses, exposure and risks with the industrial / professional users of the chemicals; and -Inform users and the general public on hazards and risks Ref EC-Regulation (1272/2008) on CLP; EC-Regulation (1907/2006) on REACH
5 REACH-limitations to the free access to chemicals Access to substances of very high concern because of their hazards will be limited it through h permits to individual id manufacturers, importers or users (Article 56) Certain particularly dangerous chemicals are generally banned or generally severely restricted (Article 67) The use in consumer chemicals is banned when it comes to about 1,100 substances considered to be carcinogenic, mutagenic or repro-toxic to humans Ref Titles VII and VIII, Annexes XIV and XVII of EC-Regulation (1907/2006) on REACH
6 CLP-REACH main obligations on industry A manufacturer or importer of a chemical product shall provide the downstream user with a safety data sheet according to REACH-rules (article 31) A manufacturer or importer of a chemical product shall provide classification and labelling according to CLP-rules (CLP Chapter 1) Substances on their own, in mixtures or in articles shall not be manufactured or placed on the market unless they have been registered according to REACH provisions (REACH Chapter 1) Ref Regulation on CLP Title 1 articles 3-8; REACH Titles II, III and IV,: Annex II
7 CLP-REACH main obligations on industry A manufacturer and importer placing 10 tonnes or more per year of a chemical substance on the market shall perform a Chemical safety assessment and shall apply and recommend risk reduction measures, based on an exposure scenario, according to REACH-rules In certain cases also the downstream user has to perform a chemical safety assessment Ref REACH Title II, Chapter 1, Articles 13-14; Annex I; Title V, Article 37.4, Annex XII
8 CLP-REACH main obligations on the Member State Establish the sufficiently strong competent authorities; Give the necessary powers to inspections; Introduce the necessary ypenalties in order to enforce CLP- REACH; Co-operate operate with ECHA, the EC Commission and competent authorities in other MS; and Organise CLP-REACH helpdesks Ref Accession Advice from MS-experts on Member States Competent authorities tasks in the EU
9 EC-chemicals management system Manufacturer and importers Placing chemicals on the market Risk communication Enforcement Risk management instructions Supervision/ Inspection Hazards & risk information Penalty provisions SDS/CLP CLP-REACH helpdesks Downstream users
10 Member State domestic chemicals regulation Purely domestic regulation in the area of chemicals management has to comply with EC-chemicals legislation domestic provisions being either EC-supplementary or ECsupportive The area of chemicals management is a good example of how all EU-members can benefit from EC legislation
11 Recommendation Consider whether pieces of purely domestic EC-supplementary or EC-supportive legislation really are effective in terms of chemicals management and / or enforcement Even though regarded as being EC-compatible a provision better should be repealed if not effective
12 Present Croatian system Manufacturer and importers SDS checked Placing chemicals on the market & published by CITA Risk communication (not yet) Enforcement? Risk management instructions (not yet) Inspection SDS/C&L (not yet CLP) Penalties Helpdesk Downstream users
13 Judging effectiveness What are provisions meant to contribute to? Do they enhance chemicals management? Do they improve enforcement? Are they possible to uphold? What are the costs for administration to enforce them? What are the costs for industry to comply with them?
14 Examples of possible supplementary provisions - Chemical safety provisions in areas of special legislation, not fully EC-harmonised, like work environment or the prevention and control of major chemicals accidents; - Rules on keeping registries i i.e. for the needs of supervision i and enforcement; - Rules to ensure that t particularly l hazardous chemicals do not fall into unsafe hands / the hands of unreliable persons; in so far this is deemed necessary
15 Recommendation Consider to concentrate on a National domestic chemicals registry of manufacturers and importers, in order to monitor the volumes, the spread and the hazards of the chemicals on the domestic market and to support chemicals inspection Note that hazard assessment / classification are necessary leads to chemicals risk management: A national registry would preferably include all chemicals on the market. Such registry would also better monitor true trends and patterns
16 Division of tasks TA-Twinning Technical assistance What you would like to achieve, your plans, prospects and wishes. How this could be achieved: Professional solutions Twinning institutional co-operation What you are supposed to achieve, in support and as supplement to EC-legislation. How you could achieve it: Domestic provisions; institutional solutions
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