FINAL DRAFT REACH: STATUS, CHALLENGES AND CURRENT WORK. ETRMA CRIA meeting Tyre Industry Regulatory Dialogue

Transcription

1 FINAL DRAFT REACH: STATUS, CHALLENGES AND CURRENT WORK ETRMA CRIA meeting Tyre Industry Regulatory Dialogue Brussels HOTEL BRISTOL STEPHANIE, Avenue Louise BRUSSELS 1 October 26, 2010

2 1907/2006/EC - REACH REGISTRATION, EVALUATION, AUTORISATION, RESTRICTION of CHEMICALS: December 2006: REACH entered into force in EU The industry is now responsible to evaluate environment and human health risk associated to use of chemicals placed on the EU market and covering their entire life cycle. This is done by mean of the so called registration (registration dossier to be submitted to the European Chemical Agency - ECHA). The evaluation of the risk might also generate specific requirement in terms of risk management measure and operative conditions associated to the use of the chemicals (reflected in the Safety Data Sheet). In certain cases, specific uses might be restricted. The complexity and level of details required in the registration dossier (see next slide) requires deep information exchange along the entire supply chain (manufacturers, importers, distributors and downstream users). The supply chain communication include information on certain dangerous substances (SVHC) that need to reach final consumers Substances of Very High Concern (SVHC) will be constantly identified. These substances might require in the future a special authorization (objective: replacement in the long term) 2

3 REACH Registration requirements if more than 1 ton/year + If dangerous, persistent, bioaccumulative or toxic + if more than 10 ton/year Technical dossier Identification of the substances and description of its physical and chemical properties Chemical Safety Assessment/Report Evaluation of the hazardousness of the substance: human and environment Exposure Assessment and Risk Characterization Assessment of risk associated to human and environmental exposure during the entire life cycle. Safety data sheet 3

4 ETRMA: input to chemical manufactures In 2008 ETRMA created a specific Task Force composed members from ETRMA and European Rubber Chemicals Association. The TF is still operative! * European Rubber Chemicals Association 4

5 DANGEROUS SUBSTANCES (SVHC) IN ARTICLES SUBSTANCES OF VERY HIGH CONCERN Substances considered to be extremely dangerous are included in a list of, so called Substances of Very High Concern (SVHC) The list is constantly updated and the number of SVHC is expected to increase significanlty in the coming years IMPLICATION FOR SVHC SVHC are potential candidate substances that will be subject to authorization. A substance subject to authorization is expected to be replaced in the medium long term. In the while a 5-years renewable authorization is required in order to manufacture or import it in EU. Long and costly authorization procedure IMPLICATION FOR ARTICLES CONTAINING SVHC Presence of SVHC in article need to be communicated along the supply chain down to the final consumer (REACH Art. 33) SVHC contained in imported articles need to be declared to the European Chemical Agency 5

6 EUROPEAN ENFORCEMENT ACTIVITIES A dedicated forum (EU Forum Enforcement Project) has been created for allowing Member States and EU authorities to discuss on common enforcement strategies. Inspections are/will be intended to ensure that: - Only registered chemicals are manufactured or imported in EU - Appropriate safety data sheet is provided when dangerous substances/preparations are placed on the market - Chemicals will be handled only according to the specific uses for which have been registered and according to the conditions described in the safety data sheets (for instance compliance with specific risk management measures such as, for instance, protective equipments) - Manufactured and imported articles complies with the restrictions set in Annex XVII of REACH (such as high aromatic oils in tyre). - Information on identified dangerous substances (according to the official list of Substance of Very High Concern SVHC) present in articles are properly communicated along the supply chain. - Presence of SVHC in articles imported in EU is notified to the European Chemical Agency 6

7 ONGOING EUROPEAN INSPECTIONS: HIGH AROMATIC OILS IN TYRE (REACH RESTRICTION) REACH RESTRICTION ON OILS IN TYRE Starting from 1st January 2010 only oils containing a limited amount of PAHs can be used for manufacturing tyre (REACH Annex XVII, 50) The restriction applies to ALL tyres manufactured from 1 st Jan 2010, or imported in EU ONGOING EU INSPECTIONS ON TYRES Checking compliance with the restriction on HA Oils in tyres has been included in the scope of the EU Enforcement Project UK is coordinating the activities at EU level European Member States are currently performing tests on tyres available on EU market for checking their compliance with the oil restriction The UK Environmental Agency has recently published a dedicated guidance document: Complying with REACH Annex XVII Restrictions: PAHs 7

8 FUTURE ETRMA REACH-CHALLENGES REGISTRATION PROCESS Close monitoring of registration process. Deadlines: 2010, 2013, 2018 SAFETY DATA SHEET Monitor and support chemical manufacturers to develop the new Safety Data Sheets, which will include: identified uses, operative conditions and risk management measures RUBBER CHEMICAL MONITORING PROGRAM Authorization/restrictions: support authorities when performing risk assessments and socio-economic analysis associated to the introduction of new chemicals to be subject to authorization or restriction REACH ENFORCEMENT ACTIVITIES When needed due to direct impact on the tyre and rubber sector, promotion of proper implementation of EU enforcement activities. 8

9 ETRMA Published Documents REACH Manual REACH Frequently Asked Questions Guidelines for recovered rubber Guidance document for natural rubber within REACH 2009/ Position Paper on Natural Rubber Latex Identified uses for substances used in tyre and rubber manufacturing Generic Exposure Scenarios for chemicals used in the tyre and rubber industry (Including supporting document covering tyre service life and end-of-life) Emission factor guidance for formulation and industrial use, updated with new emission factors for the rubber industry 2010 (update) PAH Restriction: REPLACEMENT OF HIGHLY AROMATIC OILS IN TYRES 9