REACH

1
REACHing the end? Jean-Claude Lahaut
2
REACH A long-distance run
Proposal DG ENV DG ENT APR 2003
Interservice Process Commission
Development of the White Paper 1999 - FEB 2001
White Paper FEB 2001
Internet Consultation MAY-JUL 2003
Proposal DG ENV DG ENT SEP 2003
Opinion Commission
Interservice Process Commission

Conciliation?
3
Reminder Political objectives of REACH

• Protection of human health and the environment
• Maintenance and enhancement of the
  competitiveness of the EU chemical industry
• Prevent fragmentation of the internal market
• Increased transparency to consumers
• Integration with international efforts
• Promotion of non-animal testing
• Conformity with EU international obligations
  under the WTO
• We still support these objectives!

4
What is settled in REACH?

• EU Regulation requiring the registration of all
  substances m/i by 2018 ( 11 years after start) as
  of 1t
• Pre-registration within 18 months
• Registration phased, time line based on volume
  and risk
• Risk assessment to be done by registrant NOT by
  competent authority
• Burden of proof with industry

5
What is settled in REACH?

• Detailed evaluation of some substances will be
  required
• Authorisation required for uses of those
  substances deemed to be of highest concern/risk
• Estimated 30,000 substances to be registered
• Strict deadlines for registration not allowed
  to market after registration deadline

6
What is settled in REACH?

• Companies submitting substance registrations and
  risk assessments must know details of uses
• Data to be obtained from customers
• If customer not willing to disclose must register
  use themselves
• Supply not permitted unless use is registered
• Use defined by exposure scenarios, which are an
  essential part of the registration
• Applies to imported substances as well as those
  producedin the EU

7
Cefics key objectives/probability of success

• Limit Scope to Substances above 1t
• Exclude Intermediates
• Exclude Polymers
• Limit Initial Data Packages Requirements
• Apply Substance Tailored Testing Requirements
• Apply Targeted Risk Assessment
• Limit Scope to CMRs and POPs
• Avoid Time Limited Authorisations
• Avoid Mandatory Substitution
• Avoid Phasing Out Strategies
• Keep the Integrity of Internal Market
• Central Organisation

8
5 Key Priorities of Cefic
COUNCIL EP
Registration/pre-registration ? ?
Duty of Care ? ?
Evaluation Role of Agency ? ?
Authorisation ? ?
CBI/Access to Information ? ?
9
Social partners ask

• Safe and workable REACH
• Meeting the original objectives of REACH
• Contributing to
• a separate occupational health legislation
• They will propose good practices in social
  dialogue
• to other industries

10
Outcome of ENVI vote on 10 Oct

• The recommendation was adopted with 42 votes in
  favour,
• 12 against and 6 abstentions
• The vote reflects a very broad majority for the
  Sacconi priorities who has seen all his major
  points get through (back to first reading
  position)
• Most amendments tabled by shadow rapporteur
  Oomen-Ruijten (and supported by industry) were
  rejected
• Strong political signal to Council and
  Commission
• Absolute majority (367 MEPs) in Plenary is
  possible
• The rapporteur Sacconi has a mandate to negotiate
• Now the Council has to move

11
Outcome of ENVI vote on 10 Oct

• Registration Am. 167 (adopted by 37 in favour
  and 21 against), additional risk-based
  prioritisation substances - in quantities below
  100 tonnes - that are toxic to aquatic organisms
  and that may cause long-term adverse effects
  should be added to the second phase of
  registration.
• Am. 170 (adopted by 41 in favour and 18
  against), manufactures or importers who do not
  intend to submit an application for registration
  of a substance or a preparation shall notify to
  the Agency and Downstream users of their
  intention..
• The Duty of Care principle has been adopted with
  a large majority
• Agency The tasks and independency of the Agency
  have been strengthened and a series of criteria
  are listed for the nomination of the
  representatives in the Board.
• Confidential Business Information Special
  provision for information to the general public.
• SMEs They ensure that REACH will not put
  additional burden for SMEs and European Union
  should provide aid and support for SMEs.
• Animal testing
• Nanoparticles now also fall under REACH and are
  considered as substances of very high concern
• 1. Ams. concerning definition and exposure
  assessment were rejected by 29 votes against 28
• 2. Ams. concerning information requirements and
  authorisation were adopted by 29 against 28

12
Outcome of ENVI vote on 10 Oct

• Authorisation and Substitution approved with
  large majority 41 -17
• Authorisation will be granted under strict
  conditions only, namely if
• suitable alternative substances or technologies
  do not exist, and measures are in place to
  minimise exposure, and
• it is demonstrated that the social and economic
  advantages outweigh the risks to human health or
  the environment which arise from the use of the
  substance, and
• the risk to human health or the environment from
  the use of a substance arising from the intrinsic
  properties specified in Annex XIV(a) is
  adequately controlled in accordance with Annex I
  section 6, and as documented in the applicants
  chemical safety report.
• .

13
Authorisation shall be granted if (Art. 59/old
Art. 57)

• CSR
• Analysis of alternatives

COUNCIL
EP
Application for A.
SUBSTANCES OF VERY HIGH CONCERN
X
Risk adequately control
Suitable alternative s/t do not exist
and
CMRs cat. I or II without threshold limits (Art.
56 a,b,c,f) OTHER PBTs, vPvBs (Art. 56
d,e) Never adequately controlled
Yes
Socio-economic advantages
and
X
Socio-economic benefits
and
Risk adequately controlled
Yes
Suitable alternative s/t
No
Time-limited review on case-by-case basis
Time-limit not exceeding 5 years
Ban Substitution without alternative
Substitution
14
Political decision

• Power game between institutions?
• Outstanding issue Authorisation substitution
• Official Council line stick to common position
• Clarification and better definition of adequate
  control without fundamentally changing the
  Council text
• Sacconi prepared to start from Council text, but
  needs something more on substitution
• What role for the Commission?
• Is Conciliation avoidable?

15
EP second reading 2006 - Timetable
Council EP
JUN Common Position adopted Environment Council (27)
OCT 18 COREPER Mandate for FIN Presidency (AUTH/SUBS excluded) 19 1st Trialogue 25 COREPER Mandate for FIN Presidency (AUTH/SUBS) 26 2nd Trialogue 31 COREPER Vote ENVI (10)
NOV 6 3rd Trialogue Vote Plenary (13-16)
DEC Vote Plenary (11-14)
16
Are there any major changes to be expected in the
next 4 weeks?
Quotes of the Finnish Presidency before the start
of EP 2nd reading There will be little or no
room for manoeuvre for the Council in these
areas At the end of the process a package
solution (including registration, authorisation
and other elements) has to be found between the
Parliament and the Council. This means that
nothing is agreed until everything is
agreed Reality check 172 amendments have been
adopted in the ENVI Committee, which gives
the EP a strong platform for further
negotiations Authorisation will become the
stumbling block for a workable REACH
17
Time is running
30.000
Individual registrations
guidance
23.000
consortia
lt 12 months
No. of consortia
Level of preparedness
SEA
CMR, PBT
4.200
2.700
18 m
Pre-registration
3 y
gt 1.000/ CMR...
6 y
100-1.000
11 y
1 - 100
Enforcement
18
Creation of ReachCentrum

• ReachCentrum is being established as an
  independent service body, which will be part of
  consistent service network provided by Cefic,
  national associations and Member State
  authorities
• Clear distinction between regular trade
  association offering (covered by regular
  membership fee) and tailor-made services to
  companies (invoiced separately)
• Potential customers include members, companies
  throughout the value chain, and non-EU chemical
  manufacturers

19
A natural logical split

• National Associations
• Front line help desk
• National language
• Link to MSCAs
• Tools and guidance

• Cefic
• Consortia management and registration service
• Provision of standard tools/formats
• Consistency custodian
• Training of other service providers
• Help desk (for smaller MSs, non-EU companies,
  affiliated organisations)