REACHOteven otzky ve 2. tenKarel BlhaOdbor environmentlnch rizikMinisterstvo ivotnho prosted
Kouty n. Desnou, 18. 5. 2006
RegistraceHlavn zmny v tchto oblastechRozsahPreregistrace, existujc ltky Poadavky na registracipedevm v psmu 1-10 t/rokLtky ve vrobcchSdlen dat, spolen pedloen
Rozsah registraceHlava Ilnek 2
Plohy II a III
Scope of RegistrationClarification of exemptions for foods and feedingstuffs and recycled materialsLittle change to Annex II; cellulose pulpAnnex IIIMinerals, ores and ore concentratesCement clinkerOther substances occurring in nature if not dangerous
Pre-registration and phase-in Titles II and IIIArticle 21 Article 26
Pre-registration and phase-in A single pre-registration phase 12 18 months after entry into forceInformation on possible groups to be submitted for read acrossThose entering market after entry into force may use phase-in periodEarly registration of PBTs/vPvBs over 100 tonnes
Pre-registration and phase-in EIF12 monthsPre-registration3 years6 years11 years 1000+ tonnes CMRs 1+ tonne PBTs/vPvBs (R50-53) 100+ tonnesAgency start up100-1000 tonnes1-100 tonnes [6 months]18 monthsNotification of SVHCs in SIANon-phase-in substances
Registration requirements Title IIArticles 9, 11, 12
Annexes Ic, IV IX
Registration requirements1 10 tonnes, targeted approach:Maintains industry responsibilityFor phase-in substances onlyMinimum physchem alwaysFull Annex V (+3) if one of two criteria met10 100 tonnes:One reproductive toxicity test onlyPossibility of exposure-based waiving
Data sharing and joint submission Title IIArticles 10 and 17
Title III
Data sharing and joint submission
Key elements of OSOR includedSharing of animal data mandatorySharing of non-animal data mandatory if requestedJoint submission of key parts of the dossier with possibility of opt-out;Disproportionate costDisclosure of confidential informationDisagreement on data
Substances in articles Title IIArticle 6Title IVArticle 30Title VIIArticle 55
Substances in articles
Provisions closer to those for substancesRegistration substances intentionally released above 1 tonneNotification SVHCs contained in articlesAgency power to request registrationDuty for suppliers to provide information on SVHCs in articlesRestrictions possible for SVHCs
AuthorisationChanges made to:
Identification of substances
Granting of authorisations
Conditions of authorisation
Identification of substances Title VIIArticles 54 and 56
Identification of substancesScope of authorisation as in Commission proposal butSubstances of equivalent concern clarified in Article 54(f) irreversible removedAgency to develop and publish a candidate list
Granting of authorisations Title VIIArticles 57 and 59
Granting of authorisationsAuthorisation clarified and strengthenedAdequate control NOT applicable:To CMRs and equivalent concern where a safe threshold cannot be determinedPBTs and vPvBsAll applications to include an analysis of alternatives
Conditions of authorisation Title VIIArticles 57 and 58
Conditions of authorisationAll authorisation to be subject to a time-limited reviewSet on a case-by-case basis; no specific maximum time-limitAuthorisations shall normally subject to monitoring
Issues subject to changes in the EPKey changes made to:Information and downstream usersEvaluationFees and the AgencyAccess to informationScope of the Regulation
Scope of the Regulation Title IArticles 1 to 3a
Scope of the Regulation Exemption for wastesConsolidation of all exemptions under Article 2Important definitions eg: alloys, phase-in substances, use and exposure categoriesNew provision for appointment of third party representative
Supply chain and downstream users Titles IV and VArticles 29, 34, 35
Supply chain and downstream usersSafety data sheets for PBTs/vPvBs and preparations containing themDownstream user CSR threshold of 1 tonne of substance or preparationMust assess risks and report to AgencyDeletion of Annex Ib
Evaluation Title VI
EvaluationAgency responsible for dossier evaluationMinimum 5% with prioritiesOne EU-wide rolling plan for substance evaluationAgency responsible for co-ordinating, relying on Competent Authorities
Fees and the AgencyNew Title VIIIa
Title IXArticles 75, 101a
Fees and the AgencyNew Title on fees, which are to be established in a Commission RegulationHelp for SMEs lower feesIncentives on OSOR, 1 10 tonnesManagement board one member per MSLanguage regime of the Agency
Access to informationTitle XI
Access to informationRules for access to information to be agreed by Management BoardSome information always to be made public on websiteSubject to Agency decision and payment of fee, possibility for industry to justify not publishing some information
ConclusionPolitical agreement good balance between health, environment and competitivenessImpact on industry in particular SMEs minimisedBenefits maximised
Zdroj: Summary of Councils political agreement
Gian Marco CurradoChemicals & GM Policy DivisionDefra, UK
Vienna, March 29, 2006
Dkuji za [email protected]
