The role of the authorities, SVHC substances, data issues

Transcription

1 The role of the authorities, SVHC substances, data issues T E O D O R A K R I S T O F T E O D O R A _ K R I S T O U M L. E D U V I S I T I N G S C H O L A R E N V I R O N M E N T A L S C I E N T I S T 2 0 J A N U A R Y

2 Overview Brief overview on REACH The implementing authorities under REACH: European Chemicals Agency (ECHA) REACH Competent Authorities (CAs) of Member States (National Helpdesks) European Commission

3 Overview of REACH I. REACH is the Regulation for Registration, Evaluation, Authorization and Restriction of Chemicals Entered into force on 1 st June 2007 REACH applies to all chemicals: not only chemicals used in industrial processes but also chemicals used, for example in cleaning products, paints as well as in articles such as clothes, furniture (however it has a substance based approach) Industry has to deal with all the obligations

4 Overview of REACH II. Exempted from the scope of REACH: radioactive substances, substances under customs supervision, the transport of substances and nonisolated intermediates are not covered under REACH, and waste is also specifically exempted Exempted from specific parts of REACH: polymers, isolated intermediates, substances listed in Annex IV and V, substances used for research and development, re-imported substances

5 Overview of REACH III. Registration deadlines November 2010: phase-in substances manufactured in the Community or imported at least in quantities of 1000 tons to the Community; or substances classified as carcinogenic, mutagenic or toxic to reproduction at least in quantity of 1 ton per year, or classified as R50/53 at least in quantities of 100 tons per manufacturer or per importer May 2013: phase-in substances manufactured or imported at least in quantities of 100 tons May 2018: phase-in substances manufactured in the Community or imported in quantities of 1 tons

6 Organizational chart of implementing authorities ECHA Commission Member States Management Board, RAC, SEAC, MSC, Forum MSCA Helpdesk Report on implementation of REACH Support MSCAs Decision making processes Appoint members for MB Report to ECHA and Commission Delegate members

7 The European Chemicals Agency MSC, RAC, SEAC Administration and coordination Assistance (technical guidance documents) Managing accounts (inventory on classification and labeling, database for public data) Information exchange Preparation of decisions (authorization, restriction, evaluation) Report to the Commission about the implementation and evaluation of REACH

8 The European Commission Review of the regulation Information exchange (information campaign, conferences, trainings) tm Participation in the decision making process of ECHA (authorization and restriction) Appoint members for the Management Board of ECHA

9 Competent Authorities of MS I. Cooperation with other authorities (ECHA, European Commission, CAs) Caracal (CAs expert group for REACH and CLP) Information of the public on the hazards of chemicals Participation in the preparation of decision making processes (Annex XV dossiers for authorization and restriction) Evaluation of substances

10 Competent Authorities of MS II. Set up the Helpdesk (close connection) Implementation (harmonization, system of penalties, training the enforcement authorities) Report to ECHA Report to the Commission every 5 year about the implementation process (first report was due by June 2010)

11 Helpdesk I. Inform interested parties on their roles and responsibilities under REACH not obliged to help the companies in the registration process etc. (website, phone, , personal meeting) Cooperation (with helpdesks of other MSCAs, ECHA, other nongovernmental helpdesks) Provide information for the public (direct contact, indirect contact)

12 Helpdesk II. HELPEX (REACH and CLP Helpdesk Correspondent Network) Trainings (conference, leaflet, brochure) The Helpdesk does not assume any responsibility for the information provided on inquires

13 Overview II. REACH and American companies Public data Confidential data Database on website of ECHA SVHC substances, authorization process Fees Data sharing, SVHC substances, authorization process

14 How REACH affects American companies US companies -> exporters: NO obligations! Importers, manufacturers, downstream users, distributors -> duties Helping their business partners: Only Representative (in the EU) one per substance Sharing duties and costs Collecting relevant information/data Facilitating communication Keep database and SDS updated Be informed about authorization and restriction _eu_location_en.asp

15 Public data Article 119 ECHA website ( Information on: name in IUPAC or EINECS list, classification and labeling, physical-chemical properties, results of toxicological and ecotoxicological studies, hazard properties, how to use the chemicals safely If there is no CBI, the following details can be published: impurities, additives, range of amount registered, results of robust study summaries, commercial names of the substance

16 Confidential data Article 118 Chemical characteristics, usage or function of substance/mixture, exact amount of substance manufactured or placed on the market Article 119 Information on registration - fee! Commission Regulation No. 340/2008 ECHA and MSCAs access to confidential information SIEF (competition laws) Regulation (EC) No 45/2001

17 Database on ECHA website Pre-registered substances Registered substances in 2010 Identified substances for registration in 2010 Search engine: chemical name, EC number or CAS number; or list all the substances in the database About 30,000 substances are expected to be available in the database after expiry of the last registration deadline in 2018

18 Data sources for interested parties For information about chemical substances from databases outside of ECHA, please visit the OECD echemportal. Substances previously notified under Directive 67/548/EEC (about dangerous substances placed on the market in the EU) can also be found in ESIS. SIEF Industrial Associations

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22 Fees Registration fees (Euro) Tonnage Individual submission Joint submission 1-10 tons/year tons/year tons/year tons/year The registration fees set out above are further subject to a reduction of 30% for medium sized enterprises, 60% for small enterprises and 90% for micro-sized enterprises Authorization fee: Euro per application, Euros per additional substance or use applied for and Euros for each additional applicant More information on fees: please consult ECHA website or guidance documents

23 Agreement between ECHA and EPA Enhance collaboration on chemicals signed in December 2010 in Washington D.C Exchange of data and information, such as nonconfidential information on hazards, uses, and substance identification between ECHA and EPA, including data collected under REACH Share criteria for managing confidential business information with the goal to increase the availability of chemical information to the public Share information on approaches to more efficiently address chemicals of concern

24 Authorization I. SVHC - Article 57, 58, 59 obligations: SDS, information (Article 33), notification (Article 7) In the framework of the authorization process, MSCAs or ECHA may submit Annex XV dossiers for the identification of Substances of Very High Concern in accordance with REACH REACH regulation requires ECHA to publish such proposals thereby inviting all interested parties to submit comments

25 Authorization II. The proposals and the comments are forwarded to the MSC with a view to reaching agreement on the identification as SVHC and inclusion of these substances in the Candidate List (38 substances) No agreement: Member State Committee or later on the Commission prepares a draft amendment Prioritization process - 7 substances, (the criteria system is under development) ECHA submits to the Commission a draft proposal to include the substance in Annex XIV Substances will be included in Annex XIV

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