NOVÁ STRATEGIE EU V OBLASTI CHEMICKÝCH LÁTEK REACH Karel Bláha Odbor environmentálních rizik

NOVÁ STRATEGIE EUNOVÁ STRATEGIE EUV OBLASTI CHEMICKÝCH LÁTEKV OBLASTI CHEMICKÝCH LÁTEK

REACHREACH

Karel BláhaKarel BláhaOdbor environmentálních rizikOdbor environmentálních rizik

Ministerstvo životního prostředíMinisterstvo životního prostředí

REACH – a little historyREACH – a little history

Feb 2001Feb 2001 White Paper publishedWhite Paper published May 2003May 2003 Internet consultation Internet consultation

launched: 6000+ launched: 6000+ comments receivedcomments received

Aug/Sep 2003Aug/Sep 2003 Proposals substantially Proposals substantially amended as result of amended as result of comments comments

29 Oct 200329 Oct 2003 Draft REACH regulation Draft REACH regulation adopted by Commissionadopted by Commission

20 Nov 200320 Nov 2003 Ad-hoc Working Group Ad-hoc Working Group established established

Ad-hoc WG calendar, 2004Ad-hoc WG calendar, 2004 JanJan 12/1312/13 Scope, registrationScope, registration Feb 2/3Feb 2/3 Data Sharing, Info in the Data Sharing, Info in the

Supply Supply Chain, Downstream usersChain, Downstream users Feb 23/24Feb 23/24 Authorization, Restrictions, Authorization, Restrictions,

ClassificationClassification March 15/16March 15/16 Restrictions, Classification, Restrictions, Classification,

AgencyAgency April 5/6April 5/6 Information, Competent Information, Competent

Authorities, EnforcementAuthorities, Enforcement April 29/30April 29/30 2nd reading – Titles I and II2nd reading – Titles I and II May 24/25May 24/25 June 14/15June 14/15

REACH: main featuresREACH: main features

Registration Registration of substances above 1 of substances above 1

tonnetonne

Evaluation Evaluation by the Member Statesby the Member States

Authorisation Authorisation for substances of very for substances of very

high concernhigh concern

Restrictions Restrictions - the safety net- the safety net

Agency Agency to manage the systemto manage the system

ScopeScope

REACH coversREACH covers Manufacture, import, placing on market and use of Manufacture, import, placing on market and use of

substancessubstances Substances “on their own”, in preparations or in articlesSubstances “on their own”, in preparations or in articles

General exemptions from scope of REACH listed in General exemptions from scope of REACH listed in Article 2Article 2

Specific exemptions from parts of REACH set out Specific exemptions from parts of REACH set out in those Titles in those Titles

Generally, the authorisation and restrictions titles Generally, the authorisation and restrictions titles have a wider scope than the registration titlehave a wider scope than the registration title

RegistrationRegistration

…….. obliges manufacturers and importers to obtain .. obliges manufacturers and importers to obtain

information on their substances and to use this information on their substances and to use this

knowledge to ensure responsible and well-knowledge to ensure responsible and well-

informed management of the risks the substances informed management of the risks the substances

may presentmay present

OverviewOverview

General :

Full Dossier

Deemed to be Registered

Special :

Reduced Dossier

Obligation to Register

Manufacturer Importer EU Representative of

non-EU manufacturer

1 t/yr per M/I Monomers Substances in articles

(conditions apply)

Exemptions Uses covered by other

legislation

Annex II (well known) Annex III (by-products etc)

PPORD (time limited) Re-importation

Isolated intermediates on-site Transported

Exemptions Polymers

(subject to review)

Biocide Pesticide

Notified substances

(67/548/EEC)

PPORDPPORD

Wide definitionWide definition 5-year exemption – notification required5-year exemption – notification required 4 weeks delay before manufacture or import4 weeks delay before manufacture or import Agency may impose conditionsAgency may impose conditions Extension by up to 5 yearsExtension by up to 5 years Extension by up to 10 years for medicinesExtension by up to 10 years for medicines

Decisions by AgencyDecisions by Agency Draft decisions to MS Competent AuthoritiesDraft decisions to MS Competent Authorities All information treated as confidentialAll information treated as confidential

Substances in ArticlesSubstances in Articles

Meet the criteria for classification as dangerousMeet the criteria for classification as dangerous

> 1 t/yr per article type per M/I> 1 t/yr per article type per M/I

Not registered further up the supply chainNot registered further up the supply chain

Intended to be releasedIntended to be released

General obligation to registerGeneral obligation to register

Known to be released andKnown to be released and

Quantity released may Quantity released may

adversely affect human adversely affect human

health or the environmenthealth or the environment

Obligation to notify the AgencyObligation to notify the Agency

Agency may require registrationAgency may require registrationAgency may require registrationAgency may require registration

RequirementsRequirements

apply 11 yearsapply 11 years

after entry intoafter entry into

forceforce

RequirementsRequirements

apply 11 yearsapply 11 years

after entry intoafter entry into

forceforce

TimetableTimetable

Non phase-in (‘new’) substances Non phase-in (‘new’) substances ‘immediately’ (60 days after entry into force)‘immediately’ (60 days after entry into force)

Phase-in (‘existing’ substances)Phase-in (‘existing’ substances)

1000 t per year per M/I1000 t per year per M/I 3 years3 years CMR cat. 1 & 2 CMR cat. 1 & 2 3 years3 years 100 t per year per M/I100 t per year per M/I 6 years6 years 1 t per year per M/I1 t per year per M/I 11 years11 years Substances in articlesSubstances in articles 11 years11 years

ConsortiaConsortia

EncouragedEncouraged Share dataShare data

Share costsShare costs

Avoids animal/repeat testingAvoids animal/repeat testing

1/3 registration fee1/3 registration fee

Some data submitted on behalf of the Some data submitted on behalf of the

consortiumconsortium

Some data submitted per registrantSome data submitted per registrant

Information RequirementsInformation Requirements

TECHNICAL DOSSIERTECHNICAL DOSSIER

Common information for all registrationsCommon information for all registrations Annex IVAnnex IV

Depending on tonnage thresholdDepending on tonnage threshold > 1 t/yr> 1 t/yr Annex VAnnex V

> 10 t/yr> 10 t/yr As above + Annex VIAs above + Annex VI

> 100 t/yr> 100 t/yr As above + proposals for Annex VIIAs above + proposals for Annex VII

> 1000 t/yr> 1000 t/yr As above + proposals for Annexes As above + proposals for Annexes

VII and VIIIVII and VIII

Chemical Safety Report (CSR) if > 10 t/yrChemical Safety Report (CSR) if > 10 t/yr

Registration AnnexesRegistration Annexes

Annex VAnnex V Physicochemical propertiesPhysicochemical properties

Basic human health data (4 end-points)Basic human health data (4 end-points)

Short term aquatic toxicityShort term aquatic toxicity

Annex VIAnnex VI Human health data (including Human health data (including in vivoin vivo))

Ecotoxicological dataEcotoxicological data

Annex VII and Annex VIIIAnnex VII and Annex VIII Long term, repeat dose, chronic, fate etcLong term, repeat dose, chronic, fate etc

Exemptions built into Annexes V to VIIIExemptions built into Annexes V to VIII

Generation of InformationGeneration of Information

(Q)SARs(Q)SARs Use of category approachesUse of category approaches Analogs, read acrossAnalogs, read across Available data (non-EU, GLP, non-GLP)Available data (non-EU, GLP, non-GLP) Exposure based waiving (Annexes VII and Exposure based waiving (Annexes VII and

VIII)VIII) Historical human dataHistorical human data Data sharing (existing and new)Data sharing (existing and new)

Testing (Testing (in vitroin vitro, , in vivoin vivo) as a last resort) as a last resort

See Annex IX = See Annex IX = F L E X I B I L I T Y F L E X I B I L I T Y !!

Chemical Safety Assessments Chemical Safety Assessments

Per substance or per group of substancesPer substance or per group of substances

Concentration limits apply (substances and Concentration limits apply (substances and

preparations)preparations)

0.1 % for PBTs and vPvBs0.1 % for PBTs and vPvBs

Exposure scenarios Exposure scenarios

Summarised in CSRs and information Summarised in CSRs and information

passed downstream in Safety Data Sheets passed downstream in Safety Data Sheets

(SDS)(SDS)

Chemical Safety AssessmentsChemical Safety Assessments

6 steps6 steps

Human health hazard assessmentHuman health hazard assessment

Human health hazard assessment of Human health hazard assessment of

physicochemical propertiesphysicochemical properties

Environmental hazard assessmentEnvironmental hazard assessment

PBT and vPvB assessmentPBT and vPvB assessment

----------- if dangerous or a PBT or vPvB -------------------- if dangerous or a PBT or vPvB ---------

Exposure assessment incl exposure scenariosExposure assessment incl exposure scenarios

Risk characterisationRisk characterisation

Role of the AgencyRole of the Agency

Completeness check Completeness check 3 weeks3 weeks

within 3 months of registration deadline for ‘late’ within 3 months of registration deadline for ‘late’

registration of ‘phase-in’ substancesregistration of ‘phase-in’ substances

Further information to Agency by deadlineFurther information to Agency by deadline

Deadline missed = no registrationDeadline missed = no registration

Appeal possibleAppeal possible

Information to relevant MS CAInformation to relevant MS CA

Downstream Users (1)Downstream Users (1)

Registration by manufacturers or importers must Registration by manufacturers or importers must

cover all “identified uses”, i.e.:cover all “identified uses”, i.e.:

Uses that he intends to market the substance for, or to Uses that he intends to market the substance for, or to

use the substance for himself;use the substance for himself;

Uses that are identified to him by DUs.Uses that are identified to him by DUs.

Downstream users have a right to identify a use; or Downstream users have a right to identify a use; or

may choose to keep a use confidential.may choose to keep a use confidential.

In the latter case, the DU has to notify his use to In the latter case, the DU has to notify his use to

the Agency.the Agency.


In practiceIn practice

Manufacturer develops exposure scenario(s) to Manufacturer develops exposure scenario(s) to

cover all identified uses;cover all identified uses;

DU role in this will vary from case to case;DU role in this will vary from case to case;

Exposure scenarios can be narrow or wide;Exposure scenarios can be narrow or wide;

Exposure scenarios communicated to DUs via Exposure scenarios communicated to DUs via

safety data sheets (SDSs);safety data sheets (SDSs);

SDSs and exposure scenarios are the trigger for SDSs and exposure scenarios are the trigger for

deciding if the DU has to take further action.deciding if the DU has to take further action.


DU takes no further action in the following DU takes no further action in the following

cases:cases:

He is operating inside an exposure scenario He is operating inside an exposure scenario

communicated to him in a SDS;communicated to him in a SDS;

A SDS is not required for the substance (e.g. it A SDS is not required for the substance (e.g. it

is not hazardous);is not hazardous);

A CSR is not required to be completed by his A CSR is not required to be completed by his

supplier (e.g. he produces the substance below supplier (e.g. he produces the substance below

10 tonnes)10 tonnes)


The DU must complete a CSR and report to the The DU must complete a CSR and report to the

Agency in the following cases :Agency in the following cases :

He is operating outside an exposure scenario He is operating outside an exposure scenario

communicated to him in a SDS;communicated to him in a SDS;

He has chosen to keep his use secret.He has chosen to keep his use secret.


DU report is not a registrationDU report is not a registration

He simply informs the Agency of his and He simply informs the Agency of his and

his supplier’s identity, the identity of the his supplier’s identity, the identity of the

substance and a generic use descriptionsubstance and a generic use description

In a small number of cases, he may propose In a small number of cases, he may propose

testingtesting

Reporting not required for small quantities Reporting not required for small quantities

(below 1 tonne)(below 1 tonne)


SDS is main tool for communicating SDS is main tool for communicating information downstreaminformation downstream

Dir 91/155 incorporated in REACHDir 91/155 incorporated in REACH SDSs have same scope as before; but have SDSs have same scope as before; but have

additional role as communicator of additional role as communicator of exposure scenarios and trigger for DU exposure scenarios and trigger for DU actionaction

Also duties to pass other relevant Also duties to pass other relevant information down the supply chain when information down the supply chain when SDSs not required; and up the supply chain SDSs not required; and up the supply chain when relevant new HSE information arises.when relevant new HSE information arises.

DATA SHARING – GENERAL RULESDATA SHARING – GENERAL RULES

Information Information

on intrinsic properties of substanceson intrinsic properties of substances

> 10 years freely available> 10 years freely available

< 10 years:< 10 years: Sharing of data and costSharing of data and cost

Different rules for non-phase-in and phase-in Different rules for non-phase-in and phase-in

substancessubstances

No obligation to share tests not involving No obligation to share tests not involving

vertebrate animals (declaration in registration)vertebrate animals (declaration in registration)

NON-PHASE-IN SUBSTANCESNON-PHASE-IN SUBSTANCES

Potential registrants consult database and Agency: Is same Potential registrants consult database and Agency: Is same

substance registered?substance registered? Agency enables contact with previous or other potential Agency enables contact with previous or other potential

registrantsregistrants Studies involving vertebrate animals shall not be repeatedStudies involving vertebrate animals shall not be repeated

Registrants shall take all reasonable steps to Registrants shall take all reasonable steps to reachreach an an agreementagreement

If not: Agency shall make studies available to potential If not: Agency shall make studies available to potential registrant, previous registrant gets 50% of the cost registrant, previous registrant gets 50% of the cost and may request that waiting period is extendedand may request that waiting period is extended

Other studies: potential registrants may ask for information Other studies: potential registrants may ask for information that previous registrants are willing to sharethat previous registrants are willing to share

PHASE-IN SUBSTANCESPHASE-IN SUBSTANCES

Pre-registration Pre-registration database database Potential registrants submit info on available studies at the Potential registrants submit info on available studies at the

latest after 1,5 (> 1000t) or 4,5 yrs (> 1t)latest after 1,5 (> 1000t) or 4,5 yrs (> 1t) Contributions by DU and M/I < 1t possibleContributions by DU and M/I < 1t possible

SIEF = Substance Info Exchange ForumSIEF = Substance Info Exchange Forum Potential registrants of same substancePotential registrants of same substance Access to database for that substanceAccess to database for that substance

Within SIEFWithin SIEF Aim: exchange info to minimise duplication of testsAim: exchange info to minimise duplication of tests Study not available: participants agree who performs itStudy not available: participants agree who performs it Study available: participants agree on sharing cost, otherwise Study available: participants agree on sharing cost, otherwise

equal sharesequal shares Sharing of tests involving vertebrate animals mandatorySharing of tests involving vertebrate animals mandatory

if participant refuses to share => sanctionsif participant refuses to share => sanctions testing allowed by rest of SIEFtesting allowed by rest of SIEF

CONSORTIACONSORTIA

S E P A R A T E L Y C H O I C E O N E F O R A L L

Identification of manufacturer or importer

Identification of substance

Information on manufacture and use

Statement whether information has been generated by testing on vertebrate animals

Guidance on safe use

Chemical Safety Report

Classification and labelling

Summaries and robust study summaries of information derived from application of Annexes V to IX

Proposals for testing where required for the application of Annexes V to IX

Article 40Compliance check, esp.

waiving statements require information needed for compliance

Article 40Compliance check, esp.

waiving statements require information needed for compliance

EVALUATIONEVALUATION

prevent animal tests + ensure high quality of tests

ensure high quality of dossiers submitted

clarify the suspicion of risks to human health or the

environment of a substance

D O S S I E R E V A L U A T I O N S U B S T A N C E E V A L U A T I O N

Article 39Examination of testing

proposals

request to carry out the tests

Article 39Examination of testing

proposals

request to carry out the tests

Article 44Request for further

information

Article 44Request for further

information

Registrants submit information requiredRegistrants submit

information requiredRegistrants submit




information required

Check of information submitted

conclusion


conclusion


conclusion


conclusion


conclusion


conclusion

COMPETENT AUTHORITYCOMPETENT AUTHORITY

DOSSIER EVALUATIONDOSSIER EVALUATION SUBSTANCE EVALUATIONSUBSTANCE EVALUATION

CA of Member State CA of Member State where manufacture takes place where manufacture takes place or or importer is establishedimporter is established

Consortia: CA of Member States Consortia: CA of Member States of the manufacturer or importer of the manufacturer or importer who submits who submits information on behalf of othersinformation on behalf of others

CA of a Member State CA of a Member State that has included the that has included the substance in its substance in its definitive Rolling Plan (RP)definitive Rolling Plan (RP)

Draft RP shall take account Draft RP shall take account of prioritisation criteria by of prioritisation criteria by AgencyAgency

If only one MS: CA of that If only one MS: CA of that MSMS

If two or more MS have If two or more MS have included the substance or included the substance or expressed an interest:expressed an interest:

MS-Committee: agreementMS-Committee: agreement(GDP+dossier evaluation)(GDP+dossier evaluation)

Commission decisionCommission decision

Adoption of definitive RPAdoption of definitive RP

ONDERBR

EVALUATION PROCEDUREEVALUATION PROCEDURE

Comments

Commission

Draft

Decision

Draft

Decision

Agency M e m b e r S t a t e s CA Registrants / DU

Amended

Draft

Decision

Amended

Draft

Decision

Amended

Draft

Decision

Amended

Draft

Decision

Amended

Draft

Decision

Amended

Draft

Decision

Decision

130 (2)

Decision

130 (2)

AmendmentsAmendments

Modified DDModified DD Comments

AgreementAgreement

OpinionOpinion

M S C O M M I T T E E M S C O M M I T T E E

DecisionDecision

DecisionDecision

Authorisation (1)Authorisation (1)

Criteria for substances subject to authorisation:Criteria for substances subject to authorisation:

((a)a) carcinogenic substances, cat. 1 and 2carcinogenic substances, cat. 1 and 2

(b)(b) mutagenic substances, cat. 1 and 2mutagenic substances, cat. 1 and 2

(c)(c) reprotoxic substances, cat. 1 and 2reprotoxic substances, cat. 1 and 2

(d)(d) PBTs (Annex XII criteria)PBTs (Annex XII criteria)

(e)(e) vPvBs (Annex XII criteria)vPvBs (Annex XII criteria)

(f )(f ) causing serious, irreversible effects to humanscausing serious, irreversible effects to humans

or the environment which are equivalent toor the environment which are equivalent to

those listed under (a) to (e); case-by-casethose listed under (a) to (e); case-by-case

decision, Art. 56 proceduredecision, Art. 56 procedure

AuthorisationAuthorisation (2) (2)

Applies to a M, I, DU who places a substance on Applies to a M, I, DU who places a substance on the market for a use or uses it himselfthe market for a use or uses it himself

No volume threshold, registration not requiredNo volume threshold, registration not required Series of exemptionsSeries of exemptions

Granting of an authorisationGranting of an authorisation:: COMCOM shall shall grant an authorisation if the risks are grant an authorisation if the risks are

adequately controlled as documented in the adequately controlled as documented in the CSRCSR

If not, it If not, it may may be granted if the socio-economic be granted if the socio-economic benefits outweigh the risk and if there are no benefits outweigh the risk and if there are no suitable alternative substances or technologiessuitable alternative substances or technologies


Inclusion of a substance in Annex XIII:Inclusion of a substance in Annex XIII: Agency recommendation of priority Agency recommendation of priority

substances, subject to public commentssubstances, subject to public comments regulatory committee procedureregulatory committee procedure specification ofspecification of

identity + intrinsic propertyidentity + intrinsic property sunset date and application datesunset date and application date exemptions exemptions review periodsreview periods


Application for an authorisationApplication for an authorisation Submitted to the Agency Submitted to the Agency Grouping of substances or usesGrouping of substances or uses Required information:Required information:

Identity of substance + applicantIdentity of substance + applicant If not registered: CSA covering the risks If not registered: CSA covering the risks

triggering inclusion in Annex XIIItriggering inclusion in Annex XIII Optional information:Optional information:

Socio-economic analysisSocio-economic analysis Analysis of the alternativesAnalysis of the alternatives


Procedure for authorisation decisionsProcedure for authorisation decisions Agency’s RA Comm. and SEA Comm. provide Agency’s RA Comm. and SEA Comm. provide

draft opinions, based ondraft opinions, based on Information contained in the applicationInformation contained in the application Information from third parties on alternative substances Information from third parties on alternative substances

or technologies possibility to comment on the draft or technologies possibility to comment on the draft opinions by the applicantopinions by the applicant

Committees consider these comments when Committees consider these comments when adopting their final opinionsadopting their final opinions

Agency forwarding them to COM, MS and Agency forwarding them to COM, MS and applicant,applicant,non-confidential parts to be publishednon-confidential parts to be published

COM to prepare a draft decision:COM to prepare a draft decision: advisory committee procedureadvisory committee procedure

Restrictions Restrictions

Any substance on its own, in a preparation Any substance on its own, in a preparation or in an articleor in an article

POPsPOPs Current restrictions under 76/769/EC Current restrictions under 76/769/EC

continue (recast: Annex XVI)continue (recast: Annex XVI) CMRs for consumer use – current CMRs for consumer use – current

restrictions will continue to apply – ‘fast restrictions will continue to apply – ‘fast track’track’

R&D below 1 t/yrR&D below 1 t/yr exempted exempted Waste being treatedWaste being treated exempted exempted Use in cosmeticsUse in cosmetics exempted exempted

Process (1)Process (1)

Member State Dossier (Annex XIV)Member State Dossier (Annex XIV) Proposal Proposal

Technical and scientific basis (risk Technical and scientific basis (risk

assessment)assessment)

Justification for action at Community levelJustification for action at Community level

Socio-economic assessmentSocio-economic assessment

Other information (consultation)Other information (consultation)


MS Dossiers submitted to AgencyMS Dossiers submitted to Agency Decision by Committees within 30 daysDecision by Committees within 30 days

Reasons for negative decision within 45 daysReasons for negative decision within 45 days

Further 30 days to make Dossier conformFurther 30 days to make Dossier conform

Conforming MS Dossiers published on Agency Conforming MS Dossiers published on Agency

websitewebsite

Interested parties given 3 months toInterested parties given 3 months to Comment on Dossier (e.g. risk assessment)Comment on Dossier (e.g. risk assessment)

Contribute to socio-economic impactContribute to socio-economic impact


Risk Assessment Risk Assessment CommitteeCommittee 9 months to 9 months to

formulate an opinionformulate an opinion Opinion takes Opinion takes

account ofaccount of DossierDossier Comments on DossierComments on Dossier

Socio-economic Socio-economic Analysis CommitteeAnalysis Committee 12 months to 12 months to

formulate an opinionformulate an opinion Draft opinion Draft opinion

published on Agency published on Agency website and website and comments invitedcomments invited

Opinion takes Opinion takes account ofaccount of

DossierDossier Comments on DossierComments on Dossier Comments received Comments received

on draft opinion on draft opinion


Agency submits opinions to CommissionAgency submits opinions to Commission

Agency publishes opinions on websiteAgency publishes opinions on website

Commission proposal within 3 monthsCommission proposal within 3 months

Divergence from opinions to be justifiedDivergence from opinions to be justified

Final decision by Regulatory ProcedureFinal decision by Regulatory Procedure

Restriction(s) added to Annex XVIRestriction(s) added to Annex XVI

Agency (1)Agency (1)

Composed of:Composed of: Executive Director Executive Director Management Board (6 nominated by Council; 6 nominated by Management Board (6 nominated by Council; 6 nominated by

Commission; 3 non-voting members from stakeholders)Commission; 3 non-voting members from stakeholders) Committee for risk assessment (authorisations and restrictions)Committee for risk assessment (authorisations and restrictions) Committee for socio-economic analysis (authorisations and Committee for socio-economic analysis (authorisations and

restrictions)restrictions) Member State Committee (evaluation, C&L and identification of Member State Committee (evaluation, C&L and identification of

SVHC)SVHC) Forum (enforcement)Forum (enforcement) Technical and scientific Secretariat (registration, C&L, Agency Technical and scientific Secretariat (registration, C&L, Agency

decisions, management of committees)decisions, management of committees) Board of AppealBoard of Appeal

Classification and Labelling Classification and Labelling

Changes to C&L Directives to implement GHS - not in current Changes to C&L Directives to implement GHS - not in current REACH proposal but planned for next phaseREACH proposal but planned for next phase

Current legislation: C&L all substances placed on market; some Current legislation: C&L all substances placed on market; some substances harmonised in Annex I of 67/548substances harmonised in Annex I of 67/548

REACH: in addition - industry to notify Agency of all substances REACH: in addition - industry to notify Agency of all substances C&Ld, applies 3 years after entry into forceC&Ld, applies 3 years after entry into force

Agency to maintain an inventoryAgency to maintain an inventory

Industry to make all efforts to harmonise the C&L of substances, Industry to make all efforts to harmonise the C&L of substances, where there are differenceswhere there are differences

Harmonisation by authorities required only for CMRs (cats 1,2 Harmonisation by authorities required only for CMRs (cats 1,2 and 3) and respiratory sensitisersand 3) and respiratory sensitisers

ConfidentialityConfidentiality

Normal Community rules apply regarding Normal Community rules apply regarding access to information held by the Agencyaccess to information held by the Agency the Agency will consult the party who submitted the Agency will consult the party who submitted

the information before deciding if it can be the information before deciding if it can be releasedreleased

Agency decisions to release, or not release, info Agency decisions to release, or not release, info can be appealed againstcan be appealed against

Some information always considered as Some information always considered as confidentialconfidential

Some information always considered as non-Some information always considered as non-confidentialconfidential

All other information may be released on All other information may be released on request, following the rules aboverequest, following the rules above

Reviews and reportsReviews and reports

MSs and Agency report to Commission on MSs and Agency report to Commission on operation of REACH after 5 years, and then every operation of REACH after 5 years, and then every 10 years10 years

Commission publishes general report after 6 years Commission publishes general report after 6 years and then every 10 years, based on aboveand then every 10 years, based on above

Specifically:Specifically: The first Commission report will review the handling of The first Commission report will review the handling of

substances between 1 and 10 tonnessubstances between 1 and 10 tonnes After 12 years, the Commission will review CSA/CSR After 12 years, the Commission will review CSA/CSR

requirementsrequirements When it is possible to accurately identify dangerous When it is possible to accurately identify dangerous

polymers, the Commission will review the handling of polymers, the Commission will review the handling of polymers under REACHpolymers under REACH

Cost savingsCost savings

Measure Saving

Major reduction in requirements for Chemical SafetyReports

- € 6,450 million

Exclude Polymers, pending selection criteria - € 1,900 million

Increased use of QSARs - € 950 million

Reduced requirements for 1 to 10 tonnes - € 500 million

Lighter requirements for transported intermediates - € 600 million

Other factors - € 200 million

Cost savings € 10,600 million

Impact Assessment (1)Impact Assessment (1)

Direct costs to chemicals sectorDirect costs to chemicals sector • Estimated testing and registration costs: € 2.3 bnEstimated testing and registration costs: € 2.3 bn

• use of validated computer-based methods (QSARs) use of validated computer-based methods (QSARs) should allow significant reduction in costsshould allow significant reduction in costs

Alternative QSAR ScenariosAlternative QSAR Scenarios Slower progress in validating QSARs Slower progress in validating QSARs + € 0.9 bn+ € 0.9 bn Faster development of QSARsFaster development of QSARs - € 0.4 - € 0.4

bnbn

Impact Assessment (2)Impact Assessment (2)

Cost to downstream users (price increases Cost to downstream users (price increases and substitution costs)and substitution costs)

Based on € 2.3 bn direct costs:Based on € 2.3 bn direct costs: Normal expectation scenario: Normal expectation scenario: € 2.8 - 3.6 billion€ 2.8 - 3.6 billion Higher substitution cost scenario:Higher substitution cost scenario: € 4.0 - 5.2 billion € 4.0 - 5.2 billion

Benefits: Illustration - 10% effectiveness in Benefits: Illustration - 10% effectiveness in reducing chemical diseases worth 4,500 reducing chemical diseases worth 4,500 lives per year, valued at € 50 billionlives per year, valued at € 50 billion

CONCLUSIONSCONCLUSIONS

Expenses for registration - manufacturersExpenses for registration - manufacturers1,8 – 5,6 mld CzK1,8 – 5,6 mld CzK

Expenses for registration - manufacturersExpenses for registration - manufacturers0,2 – 0,6 mld CzK0,2 – 0,6 mld CzK

Expenses for authorization (one substance)Expenses for authorization (one substance)1,6 mil. CzK (+application)1,6 mil. CzK (+application)

Expenses for registration of preparationsExpenses for registration of preparations

Up to 10 mil of CzKUp to 10 mil of CzK

Thank you for your Thank you for your attentionattention

[email protected]@env.cz

Documents

NOVÁ STRATEGIE EU V OBLASTI CHEMICKÝCH LÁTEK REACH Karel Bláha Odbor environmentálních rizik