European Commission, DG Environment Unit C.3: Chemicals REACH Key issues for the paper industry CEPI Open Seminar – European Paper Week 1 December 2005

European Commission, DG Environment

Unit C.3: Chemicals

REACH Key issues for the paper industry

CEPI Open Seminar – European Paper Week

1 December 2005

Cristina de AvilaDG Environment, European Commission


Unit C.3: Chemicals

Contents

Why REACH?Goals of REACHWhat is REACH?Elements of REACHKey issues for the paper industryAdopting REACH


Unit C.3: Chemicals

Why REACH?

Difficult to identify risks – difficult to address risks:Lack of information about most substances on the

marketBurden of proof on public authoritiesNo efficient instrument to deal with problematic

substances

Lack of incentives for innovationLow consumer confidence.

Inefficient chemicals management system


Unit C.3: Chemicals

Goals of REACH

Improving health and safety of workers and the general public

Environmental protection – avoiding chemical contamination of air, water, soil and damage to biodiversity

Maintaining a competitive/innovative chemicals industry.


Unit C.3: Chemicals

What is REACH?

Proposal for a Regulation on the Registration, Evaluation and the Authorisation of CHemicals

Scope:manufacture, import, placing on market and use of substances (on their own, in preparations or in articles)

Prioritises:high volumes (early deadline)greatest concern (CMRs early).


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Elements of REACH

Registration of all substances M/I ≥ 1 tonne/yr Evaluation of some substances by Member StatesAuthorisation only for substances of very high

concernRestrictions - the safety netAgency to manage system.


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Key issues for the paper industry

WasteExempted from REACHRecycled products = those from virgin raw material

Cellulose pulp: exempted from registrationSubstances in articlesPaper industry as downstream user.


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Adopting REACH

Oct.2003: Proposal made by Commission17 Nov 2005: EP adopts 1st reading opinion 13 Dec 2005: Council adopts political agreementMay.2006 ?: Council Common PositionEP 2nd reading (3+1 months) (May-June 2006?)

Council looks at EP 2nd reading (3+1 months) (Oct.-Nov. 2006?)

Conciliation (6+2 weeks) (Mar.-Apr. 2007?)

Entry into force (Mid-2007?).


Unit C.3: Chemicals

Information

http://europa.eu.int/comm/enterprise/chemicals/index.htm

http://europa.eu.int/comm/environment/chemicals/index.htm


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AIM: Ensure industry adequately manages risks from substances

Registration

Method:M/I obtains/generates adequate informationElectronic dossier submitted to AgencyCertain non-confidential information to central (largely public)

database.Scope

Substances M/I 1 tonne/yearExemptions: other law, Annex II/III; polymers (review); PPORDAs registered: biocides, pesticides, notified substances.

Consortia encouraged

Industry’s responsibility


Unit C.3: Chemicals

Chemicals Safety Assessment

In registration of all substances above 10 tonnesDocumented in a Chemical Safety Report

Part of the registration dossierExemptions

Substances in preparations below certain concentration limits

Defined in Annex IIncludes

Human health hazard assessmentEnvironmental hazard assessmentPBT and vPvB assessment.


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Meet the criteria for classification as dangerous

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

Not registered further up the supply chain

Intended to be released

General obligation to register

Known to be released and Quantity released may adversely

affect human health or the environment

Obligation to notify the Agency

Agency may require registration

11 years and

3 months after entry into force

Registration: Substances in articles


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EvaluationDossier evaluation

CA from MS where registrant is basedExamination of testing proposalsCompliance check

Substance evaluationMS prepare rolling plansMechanism to select one CA if several MS want to evaluateFollow-up suspicion of risk: request more info

AgencySets prioritiesTakes decisions if all MS agree (else comitology).

Member States’ responsibility


Unit C.3: Chemicals

AIM: Provide confidence that industry is meeting obligations

Prevent unnecessary testing

Evaluation

Dossier evaluation Substance evaluation

Check test proposals Compliance

Output:

• Further information decisions

• Info to other parts of REACH/other legislation

Examine any information on a substance


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Authorisation

SVHC (CMR, PBT, vPvB, ‘serious and irreversible effects’)Prioritised (progressively authorised as resources allow)

each substance given individual deadline and use allowed until decision taken.

Applicant to show: adequate control of risks, or social and economic benefits

outweigh the risksSocio-economic authorisation - normally time-limited

substitution plan consideredDU can use suppliers authorisation

AIM: Ensure risks from substances of very high concern (SVHC) are properly controlled or that they are substituted.


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Authorisation: Granting

If the risks are adequately controlled

(as documented in the CSR) If the socio-economic benefits outweigh the risks and

if there are no suitable alternative substances or technologies.

European Commission’s responsibility


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AIM: act as safety net

Restrictions

Community wide concernMS/COM initiated

Fast track possible e.g. CMR substances for consumers Agency Committees examine:

the risk, and the socio-economic aspects involved

Commission - final decision through comitologyCarry-over of existing restrictions (76/769/EEC)POPs.

European Commission’s responsibility


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European Chemicals Agency

Day to day management of REACHTechnical, scientific and administrative aspects

Responsibilities:

Registration - reject or require completion of registrationEvaluation - ensure a harmonised approach; take decisionsSubstances in articles - require registrationAuthorisation/restrictions - facilitate process; suggest

prioritiesSecretariat for Forum and CommitteesDeal with appeals - registration, R&D, evaluation,

confidentiality.


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Downstream Users (DU)

Manufacturer/importer CSR to cover all uses identified by DU

DU benefit from choice of: supplier carrying out assessment, or for confidentiality reasons doing own assessment.

If using suppliers CSR just have to: implement supplier’s RRM for identified uses

If carrying own CSR will have to:perform assessments only for ‘unidentified uses’ (using

supplier hazard information) inform Agency of ‘unidentified uses’ ≥ 1 tonne.


Unit C.3: Chemicals

Information through the supply chain

What?Expanded SDSs – info from Chemical Safety ReportsExposure scenarios (risk management measures) as AnnexInformation on authorisations, restrictions, registration

number etc.Information up the supply chain on new hazards and if

received info is challenged.Result?

More information on risksDownstream users brought into the systemDialogue up/down the supply chain:encouraged/stimulated.

Encourage communication Improve risk management


Unit C.3: Chemicals

Information

http://europa.eu.int/comm/enterprise/chemicals/index.htm

http://europa.eu.int/comm/environment/chemicals/index.htm


Unit C.3: Chemicals

Substances in Articles

Art. 6.1: as in COM Proposal, but without reference to article type

Exempts ingredients of tobacco products from Article 6.1.

Art. 6.1: as in COM Proposal, but:no need to meet criteria for classification as dangerous without reference to article type.


Unit C.3: Chemicals


Art. 6.2: notification of substances in new Annex XIIIa: It is present above a concentration limit of 0,1% substances which are

PBT, vPvB or 54(f) It is present above the concentration limits specified in Directive

1999/45/EC all other substances the producer/importer cannot exclude any exposure of the public or the

environment during the full life cycle of the article.

Art. 6.2: notification of substances meeting criteria Art.54: It is present above 1 tonne It is present above the concentration of 0.1% Does not apply if producer/importer can exclude any exposure to humans

or the environment during normal and foreseeable conditions of use including disposal.


Unit C.3: Chemicals


Agency can request registration of any substance contained in articles and notified, when: Substance presents risk to human health or the environment Substance has not been registered for that use.

Authorisation procedure shall apply to producers and importers of articles

Agency can request registration any substance contained in articles, when: Substance is present over 1t; AND Suspects that the substance is released and that release presents a risk to

human health or the environment; AND Substance is not subject to Art. 6.1.

Documents

European Commission, DG Environment Unit C.3: Chemicals REACH Key issues for the paper industry CEPI Open Seminar – European Paper Week 1 December 2005