European Commission, DG Environment Unit C.3: Chemicals REACH Key issues for the paper industry CEPI...
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Transcript of European Commission, DG Environment Unit C.3: Chemicals REACH Key issues for the paper industry CEPI...
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
European Commission, DG Environment
Unit C.3: Chemicals
Contents
Why REACH?Goals of REACHWhat is REACH?Elements of REACHKey issues for the paper industryAdopting REACH
European Commission, DG Environment
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
European Commission, DG Environment
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.
European Commission, DG Environment
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).
European Commission, DG Environment
Unit C.3: Chemicals
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.
European Commission, DG Environment
Unit C.3: Chemicals
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.
European Commission, DG Environment
Unit C.3: Chemicals
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?).
European Commission, DG Environment
Unit C.3: Chemicals
Information
http://europa.eu.int/comm/enterprise/chemicals/index.htm
http://europa.eu.int/comm/environment/chemicals/index.htm
European Commission, DG Environment
Unit C.3: Chemicals
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
European Commission, DG Environment
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.
European Commission, DG Environment
Unit C.3: Chemicals
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
European Commission, DG Environment
Unit C.3: Chemicals
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
European Commission, DG Environment
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
European Commission, DG Environment
Unit C.3: Chemicals
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.
European Commission, DG Environment
Unit C.3: Chemicals
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
European Commission, DG Environment
Unit C.3: Chemicals
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
European Commission, DG Environment
Unit C.3: Chemicals
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.
European Commission, DG Environment
Unit C.3: Chemicals
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.
European Commission, DG Environment
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
European Commission, DG Environment
Unit C.3: Chemicals
Information
http://europa.eu.int/comm/enterprise/chemicals/index.htm
http://europa.eu.int/comm/environment/chemicals/index.htm
European Commission, DG Environment
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.
European Commission, DG Environment
Unit C.3: Chemicals
Substances in Articles
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.
European Commission, DG Environment
Unit C.3: Chemicals
Substances in Articles
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.