REACHREACHOtevřené otázky ve 2. čteníOtevřené otázky ve 2. čtení
Karel BláhaKarel BláhaOdbor environmentálních rizikOdbor environmentálních rizik
Ministerstvo životního Ministerstvo životního prostředíprostředí
Kouty n. Desnou, 18. 5. 2006Kouty n. Desnou, 18. 5. 2006
RegistraRegistracece
Hlavní změny v těchto oblastechHlavní změny v těchto oblastechRozsahRozsahPreregistraPreregistrace, existující látkyce, existující látky Požadavky na registraciPožadavky na registraci
především v pásmupředevším v pásmu 1-10 t 1-10 t/rok/rokLátky ve výrobcíchLátky ve výrobcíchSdílení dat, společné předloženíSdílení dat, společné předložení
Rozsah rRozsah registraegistracece
HlavaHlava I IČlánekČlánek 2 2
PřílohyPřílohy II a III II a III
Scope of RegistrationScope of Registration
Clarification of exemptions for foods Clarification of exemptions for foods and feedingstuffs and recycled materialsand feedingstuffs and recycled materials
Little change to Annex II; cellulose pulpLittle change to Annex II; cellulose pulp Annex IIIAnnex III
Minerals, ores and ore concentratesMinerals, ores and ore concentratesCement clinkerCement clinkerOther substances occurring in nature Other substances occurring in nature
if not dangerousif not dangerous
Pre-registration and phase-inPre-registration and phase-in
Titles II and IIITitles II and IIIArticle 21 Article 21 Article 26 Article 26
A single pre-registration phase A single pre-registration phase 12 – 18 months after entry into 12 – 18 months after entry into forceforce
Information on possible groups Information on possible groups to be submitted for read acrossto be submitted for read across
Those entering market after Those entering market after entry into force may use phase-entry into force may use phase-in periodin period
Early registration of PBTs/vPvBs Early registration of PBTs/vPvBs over 100 tonnesover 100 tonnes
Pre-registration and phase-inPre-registration and phase-in
Pre-registration and phase-inPre-registration and phase-in
EIF
12 months
Pre
-reg
istra
tion
3 years 6 years 11 years
• 1000+ tonnes• CMRs 1+ tonne• PBTs/vPvBs (R50-53) 100+ tonnes
Ag
en
cy sta
rt up
100-1000 tonnes
1-100 tonnes
[6 months]
18 months
Notification of SVHCs in SIA
Non-phase-in substances
Registration requirementsRegistration requirements
Title IITitle IIArticles 9, 11, 12Articles 9, 11, 12
Annexes Ic, IV – IX Annexes Ic, IV – IX
Registration requirementsRegistration requirements
1 – 10 tonnes, targeted approach:1 – 10 tonnes, targeted approach: Maintains industry responsibilityMaintains industry responsibility For phase-in substances onlyFor phase-in substances only Minimum physchem alwaysMinimum physchem always Full Annex V (+3) if Full Annex V (+3) if oneone of two criteria of two criteria
metmet 10 – 100 tonnes:10 – 100 tonnes:
One reproductive toxicity test onlyOne reproductive toxicity test only Possibility of exposure-based waiving Possibility of exposure-based waiving
Data sharing and joint Data sharing and joint submissionsubmission
Title IITitle IIArticles 10 and 17Articles 10 and 17
Title IIITitle III
Data sharing and joint Data sharing and joint submissionsubmission
Key elements of OSOR includedKey elements of OSOR included Sharing of animal data mandatorySharing of animal data mandatory Sharing of non-animal data Sharing of non-animal data
mandatory if requestedmandatory if requested Joint submission of key parts of the Joint submission of key parts of the
dossier with possibility of “opt-out”;dossier with possibility of “opt-out”; Disproportionate costDisproportionate cost Disclosure of confidential informationDisclosure of confidential information Disagreement on data Disagreement on data
Substances in articlesSubstances in articles
Title IITitle IIArticle 6Article 6
Title IVTitle IVArticle 30Article 30
Title VIITitle VIIArticle 55Article 55
Substances in articlesSubstances in articles
Provisions closer to those for Provisions closer to those for substancessubstances
Registration – substances intentionally Registration – substances intentionally released above 1 tonnereleased above 1 tonne
Notification – SVHCs contained in Notification – SVHCs contained in articlesarticles
Agency power to request registrationAgency power to request registration Duty for suppliers to provide Duty for suppliers to provide
information on SVHCs in articlesinformation on SVHCs in articles Restrictions possible for SVHCsRestrictions possible for SVHCs
AuthorisationAuthorisation
Changes made to:Changes made to:
Identification of substancesIdentification of substances
Granting of authorisationsGranting of authorisations
Conditions of authorisationConditions of authorisation
Identification of substancesIdentification of substances
Title VIITitle VIIArticles 54 and Articles 54 and
5656
Identification of substancesIdentification of substances
Scope of authorisation as in Scope of authorisation as in Commission proposal but…Commission proposal but…
Substances of equivalent Substances of equivalent concern clarified in Article 54(f) – concern clarified in Article 54(f) – “irreversible” removed“irreversible” removed
Agency to develop and publish a Agency to develop and publish a candidate listcandidate list
Granting of authorisationsGranting of authorisations
Title VIITitle VIIArticles 57 and Articles 57 and
5959
Granting of authorisationsGranting of authorisations Authorisation clarified and Authorisation clarified and
strengthenedstrengthened Adequate control NOT Adequate control NOT
applicable:applicable:To CMRs and equivalent concern To CMRs and equivalent concern
where a safe threshold cannot be where a safe threshold cannot be determineddetermined
PBTs and vPvBsPBTs and vPvBs All applications to include an All applications to include an
analysis of alternativesanalysis of alternatives
Conditions of authorisationConditions of authorisation
Title VIITitle VIIArticles 57 and Articles 57 and
5858
Conditions of authorisationConditions of authorisation
All authorisation to be subject to All authorisation to be subject to a time-limited reviewa time-limited review
Set on a case-by-case basis; no Set on a case-by-case basis; no specific maximum time-limitspecific maximum time-limit
Authorisations shall normally Authorisations shall normally subject to monitoringsubject to monitoring
IssuesIssues subject to changes in the subject to changes in the EPEP
Key changes made to:Key changes made to:Information and downstream usersInformation and downstream usersEvaluationEvaluationFees and the AgencyFees and the AgencyAccess to informationAccess to informationScope of the RegulationScope of the Regulation
Scope of the RegulationScope of the Regulation
Title ITitle IArticles 1 to 3aArticles 1 to 3a
Scope of the RegulationScope of the Regulation
Exemption for wastesExemption for wastes Consolidation of all exemptions Consolidation of all exemptions
under Article 2under Article 2 Important definitions egImportant definitions eg:: alloys, alloys,
phase-in substances, use and phase-in substances, use and exposure categoriesexposure categories
New provision for appointment New provision for appointment of third party representative of third party representative
Supply chain and Supply chain and downstream usersdownstream users
Titles IV and VTitles IV and VArticles 29, 34, Articles 29, 34,
3535
Supply chain and Supply chain and downstream usersdownstream users
Safety data sheets for Safety data sheets for PBTs/vPvBs and preparations PBTs/vPvBs and preparations containing themcontaining them
Downstream user CSR threshold Downstream user CSR threshold of 1 tonne of substance or of 1 tonne of substance or preparationpreparation
Must assess risks and report to Must assess risks and report to AgencyAgency
Deletion of Annex Ib Deletion of Annex Ib
EvaluationEvaluation
Title VITitle VI
EvaluationEvaluation
Agency responsible for dossier Agency responsible for dossier evaluationevaluation
Minimum 5% with prioritiesMinimum 5% with priorities One EU-wide rolling plan for One EU-wide rolling plan for
substance evaluationsubstance evaluation Agency responsible for co-Agency responsible for co-
ordinating, relying on Competent ordinating, relying on Competent AuthoritiesAuthorities
Fees and the AgencyFees and the Agency
New Title VIIIaNew Title VIIIa
Title IXTitle IXArticles 75, 101aArticles 75, 101a
Fees and the AgencyFees and the Agency New Title on fees, which are to New Title on fees, which are to be be
established in a Commission established in a Commission RegulationRegulation
Help for SMEs – lower feesHelp for SMEs – lower fees Incentives on OSOR, 1 – 10 tonnesIncentives on OSOR, 1 – 10 tonnes Management board – one member Management board – one member
per MSper MS Language regime of the AgencyLanguage regime of the Agency
Access to informationAccess to information
Title XITitle XI
Access to informationAccess to information Rules for access to information Rules for access to information
to be agreed by to be agreed by MManagement anagement BBoardoard
Some information always to be Some information always to be made public on websitemade public on website
Subject to Agency decision and Subject to Agency decision and payment of fee, possibility for payment of fee, possibility for industry to justify not publishing industry to justify not publishing some informationsome information
ConclusionConclusion
Political agreement – good Political agreement – good balance between health, balance between health, environment and environment and competitivenesscompetitiveness
Impact on industry in particular Impact on industry in particular SMEs minimisedSMEs minimised
Benefits maximisedBenefits maximised
Zdroj:Zdroj: Summary of Council’s political Summary of Council’s political
agreementagreement
Gian Marco CurradoGian Marco CurradoChemicals & GM Policy DivisionChemicals & GM Policy Division
Defra, UKDefra, UK
Vienna, March 29, 2006Vienna, March 29, 2006
Děkuji za pozornostDěkuji za pozornostkarel_blahakarel_blaha@@env.czenv.cz