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