Aufgaben des ECB in Vorbereitung der Agentur

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Aufgaben des ECB in Vorbereitung der
Agentur
JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION
REACH Entwurf Mai 2003

• Aufgaben der Agentur

Dr. Gerald Vollmer Wien, 2. Juli 2003
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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION
Tasks of the ECB in the interim Period (
2003 - .)
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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION
Current Activities/Obligations
Directive 67/548/EEC Class Label,
Notification, Testing Methods Directive
93/67/EEC Risk Assessment New
Substances Directive 98/8/EC Biocides
Regulation 793/93 Existing
Substances Regulation 1488/94 Risk
Assessment Existing Substances Regulation 2455/92
Export/Import
Directive 76/769/EEC Restrictions on Marketing
and Use Directive 91/414/EEC Plant Protection
Products
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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION
Current Activities, high Priorities

• Alternative Testing methods in Annex V
• CL, substances of very high concern (e.g. CMR)
• New chemicals, risk assessment and RRM
• New chemicals, notification scheme
• Existing chemicals, risk assessment and RRM
• (finalisation of the 4 priority lists)

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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION
Current Activities, low priorities

• other testing methods in Annex V
• CL, other substances in Annex I
• Notification scheme, conformity check
• ELINCS in other languages
• existing substances, additional priority lists

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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION
Interim Activities
RI-1 REACH Process Description   RI-2
Informatics systems development (REACH-IT)
  RI-3 Horizontal activities TGDs and
training for industry   RI-4 Horizontal
activities Guidance and capacity building
for
Authorities   RI-5 Meeting structure
development RI-6 Administrative
procedures   RI Reach Implementation
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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION
RI-1 REACH Process Description   A detailed
process description of the practical functioning
of the REACH system Will be finalised in 2003
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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION
RI-2 REACH-IT Establishment of the central IT
system
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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION
One Central database, details
Use Exposure Languages (gt 25) Class
Label. Effects (Bioc.) RAR, Authorisation other
legislation
Identity phys-chem toxicol. Ecotox. (RAR)
List of producers, down stream users, ...
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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION
Pillar 1 Registrations Pillar 2 Entries
(Substances etc) Pillar 3 Legal status
Reach-IT Database
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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION
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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION

• RI-3 Horizontal activities TGDs and training
  for industry
• To assist industry and other stake holders in
  their preparation for REACH by
• drafting guidance documents and making available
  training material
•  
•   TGD on testing strategies and derogations from
  testing (COM MSs)
• TGD on (Q)SAR and grouping of chemicals (OECD)
• TGD on classification labelling under GHS
  (Annex VI, ready prepared by ECB)
• CL inventory (IND)
• TGD on preparation of registration dossiers
  (COM)
• TGD on Manufacturer/Importer (M/I) and
• Downstream Users (DU)
  risk assessment (COM MSs)
• Additional Emission Scenario Documents (OECD)
• M/I and DU risk assessment report formats (COM
  MSs)
• TGD on Socio-Economic analysis (COM MSs)
• TGD on preparation of authorisation requests
  (COM MSs)
• Training courses for M/I, DU, etc. 
• Most of the guidance documents should be
  contracted out, co-ordination by ECB

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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION

• RI-4 Horizontal activities
• Guidance and capacity building for
  Authorities
• To assist Competent Authorities in their
  preparation for REACH by drafting
• guidance and procedures on technical and
  administrative issues
• Procedures for evaluation of Registration
  Dossiers
• TGD on Community risk assessment (incl.
  targeting and metals/inorganics)
• Procedures for priority setting
• (incl. substances of potential concern, for
  risk management and for authorisation)
• Procedures for or TGD on risk management
• Procedures for authorisation
• Capacity building in Member States (including
  new Member States)
• Most of the guidance documents should be
  contracted out, co-ordination by ECB
• Co-operation with Competent Authorities

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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION

• RI-5 Meeting structure development / strategic
  partnership
• To test and validate the REACH system by
  transforming the current
• meeting structures into those needed for the
  future legislation
• Industry voluntary submits REACH compatible
  dossiers on new and
• existing substances
• REACH compatible dossiers are evaluated by
  Rapporteur MSs
• new meeting structure is established and its
  functionality is tested
• Evaluate and report on the trial exercise on
  the REACH system

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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION

• RI-6 Administrative procedures
• To develop administrative routines and
  organisational structures for the Agency
• Standard operational procedures (SOPs) for data
  handling and database management
• SOPs for work processes pertaining to the REACH
  system
• SOPs for administrative routines
• Identify staff needs and qualifications
  (prepare job descriptions)
• Define needs for physical facilities
  (buildings, meeting rooms,
• computers and network, etc.)
• Design of the fee system
• Discussion item Development of administrative
  procedures ECB task
• or should it be left to Agency?

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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION
New Chemicals Policy, Council Conclusions
Council Conclusions 25 June 1999 24. to
undertake a review of the present structures and
instruments of the work assigned to the Community
and to ensure that the high quality of the
work carried out by the European Chemicals Bureau
(ECB) in performing its assigned tasks will be
maintained and reinforced
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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION
Proposal for a Regulation concerning REACH, May
2003
Explanatory memorandum, Article 85 Under the
present chemicals legislation, the European
Chemicals Bureau fulfils a role analogous to
that of the Agency. It will be the centre of the
Commissions detailed preparatory work for the
REACH system and, immediately following the
entry into force of the REACH system, it will
temporarily fulfil the role of the Agency.
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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION
Comparison Activities Chemicals Bureau /
Chemicals Agency
Activity ECB ECA Database(s) X
X Registration X X Evaluation X
X Restriction X X Authorisation -
X Biocides X (X) Export/Import X (X)
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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION
European Chemicals Agency

• The Agency
• is responsible for managing the operation
• of the Regulation
• works consistent and independent

• acts through the Secretariat,
• the Committees and the Forum

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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION
European Chemicals AgencyComposition
Management Board
Committee for Risk Assessment
Executive Director Secretariat (staff)
Committee for Socio Economic A.
Member State Committee
FORUM
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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION
European Chemicals Agency Management Board
Individuals from Interested Parties
Member States
European Commission
G. Vollmer 05 05 2003
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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION
European Chemicals Agency Management Board II

• The Management Board appoints
• the executive director
• the accounting officer
• the members of the assessment Committee
• and the Socio Econ. Analysis Committee
• and adopts
• the annual report
• the annual work programme
• the annual budget
• the fee structure

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European Chemicals Agency
JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION

• The Secretatiat (staff) takes care on
• procedures on Registration, data sharing,
  downstream users
• REACH-IT including harmonised CL list,
• Preparation of Guidance and Software tools
• Preparation of guidance and explanatory
  information on the present regulation

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European Chemicals Agency
JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION

• The Committees (RA, SEA and MS Comm.)
• take care on
• Evaluation
• Authorisation
• Restriction and
• CL inventory.

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European Chemicals Agency
JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION

• The Forum takes care on
• harmonisation of enforcement
• exchange of inspectors
• exchange of information

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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION
Tasks of the Agency, Pre-registration

• To record the information submitted
• To grant access to the information to the
  manufacturers/
• Importers of this substance and the
• Member States authorities

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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION
Tasks of the Agency, Registration
- To assign a number and date of registration
(date of receipt) and identify MS handling reg.
Communicate this to registrant (art. 19 (1-2)).
- To perform a computerised completeness check
and communicate result and registration to MS,
within 15 days from registration date (art 19
(3)).
- To communicate the information received from
registrant about changes in the registration to
relevant MS (art 21(1)).
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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION
Tasks of the Agency, Evaluation

• Agreement procedure (Art. 42)
• Receives draft decisions of a Member State and
  circulates it
• Agency/Member State make suggestions to modify
• Suggestions Agency (Member State Committee) to
  evaluate
• and agree
• Unanimous or not Agency to forward to the
  Commission

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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION
Tasks of the Agency, Authorisation (priority
setting)
-Identification of substances, collection of
further information -Agency to circulate to other
MS -Agency to set time frame -Agency/other MS to
comment -if comments Agency to refer to the MS
Committee (of the A.) -Agency to transmit the
opinion to the Commission (minority opinion, if
any)
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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION
Tasks of the Agency, Authorisation (granting)

• -Agency to receive and acknowledge an application
  from industry
• To make non confidential part publicly available
• To prepare an (draft) opinion (includes to check
  the application and
• if necessary to ask for additional
  information)
• -To make the opinion publicly available
• -To send the opinion to the applicant and to
  receive the reply
• -to forward the final opinion to the Commission

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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION
Tasks of the Agency, Restriction

• To receive a restriction dossier from a MS
• To appoint a Risk assessment rapporteur and
• a socio-economic analysis rapporteur
• To inform the MS suggesting restrictions whether
  the
• dossier conforms
• -To make the dossiers publicly available and to
  invite
• for comments
• -Committee for RA of the A. to prepare an opinion
• -Committee for SEA of the A. to prepare an
  opinion
• -To forward both opinions to the Commission and
  to publish

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JOINT RESEARCHCENTRE
European Chemicals Bureau
EUROPEAN COMMISSION
Future Classification and Labelling
Annex I dangerous Substances
Decisive R - phrases
Authorities Industry
Inventory Registered and Non-registered
substances issued by European Chemicals Agency
Other R - phrases
Note all dangerous substances