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R egistration E valuation A uthorisation of CH emicals

REACH New requirements for introduction of chemicals on EU market Jana Kovačičová Centre for Chemical Substances and Preparations Bratislava, Slovakia. R egistration E valuation A uthorisation of CH emicals . reach.

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R egistration E valuation A uthorisation of CH emicals

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  1. REACHNew requirements for introductionof chemicals on EU marketJana KovačičováCentre for Chemical Substances and PreparationsBratislava, Slovakia

  2. RegistrationEvaluation Authorisation ofCH emicals reach

  3. What is REACH ?- REGULATION of European Parliament and Council (EC) no. 197/2006 of 18 December 2006 - In force in EU member states as of 1 June 2007 (no approval by the National Parliaments needed)- In case of non-compliance with current national legislation , that national legislation should be changed- Act No. 163/2001 is currently being amended

  4. Why REACH ? 1.To improve protection of human health and environmentCurrent system is not sufficiently effective for „existing“ substances and does not consider the specific uses. Risk assessment for „existing substances“ is not mandatory.2.To improve the competitivness of European chemical industry Present system for „new substances“ presents obstacles to reseacrh an innovation, thus leading to European industry lagging behind the US an JP

  5. Principle changes introduced by REACH1. Responsibility for risk assessment is transferred from the state(s) to industry 2. No differentiation between „new“ and „existing“ substances. The legislation applies for all substances, the different requirements are imposed depending on the tonnage and properties 3. Articles and downstream users are also covered

  6. LIMITATIONS ON ANIMAL TESTING • Information shall be generated whenever possible by means other than vertebrate animal tests • Duplication of animal testing should be avoided. Registrants must share/make available test results under specified conditions. • Substance Information Exchange Fora (SIEF) established by ECHA • Use of alternative (in vitro) methods is encouraged • Utilisation of (Q)SAR methods (estimate of endpoint value based on mathematical modelling) • Endpoint estimates based on structural similarity (read-across)

  7. REACH is a stepwise process: • REGISTRATION: obligation of manufacturer/importer A substance is deemed registered after the technical dossier had been submitted and no information on incompleteness was received • EVALUATION : - dossier evaluation: Agency (completeness check and control of testing proposals) - substance evaluation: Agency and Member States May result in - decision on authorisation - restrictions • AUTHORISATION : permit to put on market substances of high concern (CMR cat. 1 a 2, PBT, vPvB, others). List of substances for authorisation : Agency,(Annex XIV). Authorisation relates to specific manufacturer/importer and specific use

  8. Main characteristics of REACH • All substances >1 t/year/manufacturer or importer must be registered . Non-registered substances shall not be manufactured or placed on EU market • Registration is submitted to European Chemicals Agency (ECHA) • „No data – no market“ Registration implies ensuring appropriate information • Downstream users are involved in the system

  9. Registration applies for • substances on their own • substances in preparations • substances in articles providing the substance is intended to be released under normal or reasonably foreseeable conditions of use

  10. Registration is submitted by each manufacturer/importer Registration includes (1) Technical dossier : - identity of manufacturer/importer, - identity of substance - information on the substance (manufacture, identified use, classification, safe use, data on properties, testing proposals etc.) - level of detail depends on tonnage (2) Chemical safety reportfor substances > 10 t/yr, incl. exposure scenarios for substances classified as hazardous, PBT, vPvB.

  11. Substances exempted from registration • Substances included in Annex IV as sufficient information is known about them indicating that they cause minimum risk because of their intrinsic properties(e.g.water, cellulose, fatty acids, sugars,...) • Substances covered by Annex Vas registration is deemed inappropriate, such asby-products, substances resulting from incidental reactions, specified substances occuring in nature ...) • Substances resulting from recovery processesunder specified conditions • Reimported substancesunder specified conditions

  12. Non-Community manufacturers • A natural or legal person established outside the Community who manufactures a substance on its own, in preparations or in articles, formulates a preparation or produces an article that is imported into the Community may by mutual agreement appoint a natural or legal person established in the Community to fulfil, as his only representative, the obligations on importers. • The non-Community manufacturer shall inform the importer(s) within the same supply chain of the appointment. These importers shall be regarded as downstream users for the purposes of this Regulation. (Article 8, REACH) • Option : If no only representative is appointed, each individual customer will be regarded as importer i.e. must register the subtance imported (on its own, in preparations and in articles)

  13. DEFINITIONS Substance :chemical elements and compounds (incl. impurities and/or necessary additives) Preparation :mixture or solution of substances Article :object produced to have a special shape/design determining its function more than its chemical composition Downstream user: Person who uses a substance, either on its own or in a preparation, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user.

  14. Identified use: use of a substance on its own or in a preparation, intended by an actor in the supply chain, or that is made known to him in writing by an immediate downstream user • Exposure scenario: set of conditions, including operational conditions and risk management measures, that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment.

  15. PHASE-IN SUBSTANCE1. Substance listed in EINECS 2. Manufactured in the Community, or in the new MS, but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of REACH 3. Placed on the market in the Community, or in the new MS, before entry into force of REACH, and considered as having been notified in accordance with  Directive 67/548/EEC

  16. TRANSITIONAL PROVISIONS Article 23 : Specific provisions for phase-in substances Enables transferring registration to a later term Article 28 : pre-registration of phase-in substances Benefits provided for in Art. 23 can be applied only for pre-registered substance Pre-registration: - name of the substance - identification of the potential registrant - envisaged deadline for the registration Time period : 1 June – 1 December 2008 By 1 January 2009 the Agency shall publish a list of pre-registered substances

  17. Pre-registration - important deadlines 1.6.2007 - REACH in force - ECHA established - provisions on SDS, classification & labelling effective 1.6.2008 - pre-registration of phase-in substances started - registration ofnon phase-in substances started 1.12.2008 – end of pre-registration 1.1.2009 – list of pre-registered substances published by ECHA

  18. REACH – key deadlines 1.6.2007- REACH entering into force 1.6.2008 -start of pre-registration of phase-in substancesstart of registration of non phase-in substances 1.12.2008-endof pre-registration of phase-in substances (1.1.2009 - pre-registered substances published by ECHA) 1.12.2010 -last registration of phase-in substances> 1000 t/yr (CMR 1. a 2.> 1 t/yr ; T+ for water organismsand R50/53 >100 t/yr) 1.12.2011 - start of notification of phase-in substances in articles for substances identified for inclusion into Annex XIV REACH (authorisation) 1.6.2013 - last registrationof phase-in substances >100 t/yr 1.6.2018 -last registrationof phase-in substances>1t/yr

  19. HELP DESKS • REACH envisages establishment of help desk(s) in each Member State to assist the businesses in implementation of REACH • Central help desk is being established with EChA • MS help desks act as a network • Main role of help desks is to provide consultancy in particular for small and medium entreprises. • Helps desks do not provide legally binding opinions

  20. USEFUL LINKS • http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm • http://ecb.jrc.it/reach-it_informatics

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