Professional Documents
Culture Documents
2/8/2007 1
Outline
REACH regulation: history & basic set-up
2/8/2007 3
REACH
One single and coherent system
for new and existing chemicals
Core elements:
Registration of substances ≥ 1 tonne/yr (staggered deadlines)
Information in the supply chain
Evaluation of some substances by Member States
Authorisation only for substances of very high concern
Restrictions - the safety net
Agency to manage system
Focus on priorities:
high volumes (as a proxy for potential risk)
greatest concern (substances & uses with highest risk)
Shift of responsibilities
from public authorities towards industry
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Scope of the regulation
Ö REACH applies to the manufacturing, import, placing
on the market and use of substances
2/8/2007
Ö Substance Information Exchange Fora (SIEFs) 6
Manufacturers/Importers: Registration
Timetable:
Non phase-in substances:
¾ A 67/548/EEC notification automatically becomes a registration
¾ When not already notified by the company:
registration required before production or import can take place
Phase-in substances:
benefit from transition periods if pre-registered
¾ Pre-registration: 1 June 2008 – 30 November 2008
(except where newly manufactured / imported)
– Identify substance, manufacturer, tonnage band/deadline
– Agency will publish list
¾ Registration: Transition period depending on the tonnage band
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Tasks and timelines
Timeline REACH phase-in period (not in scale)
Note that phase-in registration requires ≥ 1t/a
pre-registration! 31 May
2018
Registration of SIEF
‘new’ substances
C&L notification
(independent of tonnage)
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Downstream Users Obligations
Ö Downstream Users are users of chemical substances
that are neither manufactured nor imported by the company itself
Ö Be careful ! In case input chemical is directly imported from outside the EU:
REACH considers you as an importer and not as Downstream User!
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Substances in Articles (Article 7)
Dossier evaluation:
Checking compliance of registration dossiers
Checking of test proposals
Substance evaluation:
Checking whether there is a need
for further information on a substance
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Authorisation/Restriction
Authorisation:
for Substances of Very High Concern
Identification of SVHC
“Sunset date” after which manufacturing and use is only allowed
when covered by an authorisation
Definitions:
“per year” is taken to mean “three-year average”
terms “exposure scenario”, “use & exposure category” clarified
First registration deadline after 3 ½ years (1 Dec 2010)
which also shifts deadlines for:
Agency reaction to test proposal
Notification to the Classification & Labelling inventory
First Commission Rolling Action Plan for substance evaluation
Notification of Substances of Very High Concern in articles
PPORD exemption on registration
Also non-marketed substances may get extra 10 year extension
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Changes vis-à-vis the Common Position (2)
Extra incentives to prevent unnecessary animal testing:
Agency will publish test proposals and invite third parties to submit
data that would avoid vertebrate testing
Explicit allowance for future alternatives to in vivo tests
Regular reports from Agency and Commission on non-animal methods
Information exchange further encouraged
while safeguarding Confidential Business Information
Early registrants take part in the SIEF
Downstream Users may ask Agency to publish substance ID
when it is not pre-registered, helping to assure continued supply
Pay for studies up to 12 years
Use as intermediate is normally Confidential Business Information
Protection of IUPAC name may be claimed for substances:
¾ When non-phase-in
¾ When only used as intermediate, or for R&D and PPORD uses
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Changes vis-à-vis the Common Position (3)
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Changes vis-à-vis the Common Position (4)
Î Important:
¾ to provide key elements of the guidance by entry into force
¾ to make REACH workable for SMEs
¾ to get the Agency operational on time
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REACH Implementation Projects - RIPs
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3.1:
3.1:Preparing
Preparingthe
the
registration dossier
registration dossier
3.10:
3.10:Guidance
Guidanceonon
3.2:
3.2:Preparing
Preparing checking
checking
the
theCSR
CSR substance
substanceID ID
3.4:
3.4:Guidance
Guidanceon on
3.3:
3.3:Information
Information data-sharing
data-sharing
requirements
requirements
RIP-3: Guidance
3.5:
3.5:Guidance
Guidancefor
for Industry 3.7:
3.7:Guidance
Guidanceon
applications
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for applicationsfor
for
downstream
downstreamusers
users authorisation
authorisation
3.8:
3.8:Requirements 3.9:
Requirements
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Guidance
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articles on
onSEA
SEA
3.6:
3.6:Guidance
Guidanceon
on
C&L
C&L
under
underGHS
GHS
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RIP- 4: Guidance for Authorities
4.1:
4.1:Guidance
Guidanceon on
dossier
dossierevaluation
evaluation
4.2:
4.2:Guidance
Guidanceonon
substance
substanceevaluation
evaluation
4.5:
4.5:Priority
Prioritysetting
setting
for evaluation
for evaluation
4.3:
4.3:Inclusion
Inclusionof
of
substances in
substances in
Annex
AnnexXIV
XIV
4.4:
4.4:Preparation
Preparationof
of
Annex XV dossiers
Annex XV dossiers
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Timelines for RIP 3 projects
Timelines for RIP 3 projects
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Data sharing
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DU requirements (Final)
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SEA (Scoping)
SEA (Final)
Substance ID
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The overall guidance package
Objective:
Should allow stakeholders to quickly understand REACH and
their roles and obligations under REACH
Should be as exhaustive as possible to cover the users´ needs
Web application;
planned to be available at entry into force, 1 June 2007
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Main elements guidance package
“About REACH”
Short explanation of REACH for inexperienced users
Guidance Navigator
Based on a series of questions, the user will receive:
¾ a list and short description of his obligations
¾ references/links to the relevant parts of legislation and
guidance
Technical guidance documents
Containing all relevant information (based on the results
from RIP 3 but not necessarily identical)
Ö in addition: formats, search functions, glossary,
link to Frequently Asked Questions, helpdesk etc.
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What might the guidance look like?
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Further information on RIPs
http://ecb.jrc.it/REACH/
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Commission tasks after entry into force
“Comitology Decisions”
Apply to:
Testing methods
1. Implementing measures, e.g. Fees regulation
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Helpdesks under REACH
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The planned network
of Member States helpdesks
IT based exchange forum to discuss non-standard questions
before they are answered by the national helpdesk
Questions and answers saved in internal Q&A database
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Network of helpdesks
trade associations, industry organisations, experts
Agency Member
Member
Member
“helpdesk” State
State
State
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helpdesk
helpdesk
helpdesks 32
Enforcement of REACH
REACH Enforcement is competence of Member States;
the Agency hosts the FORUM.
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Tasks and timelines (repeat)
Timeline REACH phase-in period (not in scale)
Note that phase-in registration requires ≥ 1t/a
pre-registration! 31 May
2018
http://ec.europa.eu/enterprise/reach/index_en.htm
http://ec.europa.eu/comm/environment/chemicals/reach.htm
http://ecb.jrc.it/REACH/
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