REGISTRATION, EVALUATION, AUTHORISATION
AND RESTRICTION OF CHEMICALS (REACH) (15409/03)
Letter from Lord Rooker, Minister for
Sustaintable Farming and Food, Department for Environment, Food
and Rural Affairs to the Chairman
I am writing to inform you of developments on
the above dossier, which achieved Common Position at Environment
Council on 27 June. Your Committee considered Explanatory Memorandum
15409/03 of 17 December 2003 and Supplementary Explanatory Memorandum
15409/03 of 17 April 2004 on 6 January 2004 and 27 April 2004
respectively and gave scrutiny clearance on 9 November 2005.
I last wrote to you on 24 July 2006[81]
prior to the start of formal negotiations between the Council
(under the Finnish Presidency) and European Parliament to secure
a Second Reading deal, noting that there was considerable convergence
between the positions of both institutions and that achieving
a balanced outcome to the negotiations without the need to enter
lengthy conciliation was very much in the UK's interests.
I am therefore pleased to inform you that the
negotiations were successfully concluded on 30 November, with
a Second Reading deal being agreed that maintains the good balance
of the Common Position in protecting human health and the environment,
at the same time as ensuring industry competitiveness and innovation.
The negotiations were for the most part fairly straightforward,
reflecting the closeness of the two sides' positions to start
with, but became more difficult towards the end on the central
issue of substitution as part of authorisation of hazardous chemicals
for continued use.
Throughout the process, the UK played a significant
and constructive role in developing the Presidency's negotiating
mandate, contrary to some unhelpful media briefing by NGOs, and
newspaper reporting towards the end of the process alleging efforts
by the UK to water down or even wreck the deal over the issue
of substitution. Our previously-stated commitment to REACH has
not altered in any way.
A total of 359 amendments to the REACH Common
Position text were tabled by the Parliament for consideration
at Second Reading. At the vote of the Parliament's Environment
Committee on 10 October, 172 amendments were carried, including
the package proposed by the Committee Rapporteur, Guido Sacconi
MEP (Italian Socialist). This contained some robust proposals
on authorisation and substitution, and was carried by a significant
majority of 42 votes for, 12 against, and six abstentions. In
addition to authorisation and substitution, the other main issues
of concern to the Parliament were Duty of Care; animal welfare;
communication of information, the new European Chemicals Agency
and Parliament involvement therein; registration/data sharing;
and comitology (new regulation with scrutiny procedure).
DUTY OF
CARE
While the principle of a general duty of care
is implicit throughout the REACH regulation, a specific reference
to the phrase "duty of care" would have had potentially
serious legal implications within the UK and some other Member
States having a common law system, including unlimited liability
for industry. Using a text proposed mainly by the UK, the Presidency
was able to persuade the Parliament to accept alternative language
that strengthened the principle without using the exact phrase.
ANIMAL WELFARE
In line with UK policy to minimise animal testing,
and replace it where possible with suitable alternative testing
methods, the REACH text has been strengthened in this regard,
including through enhanced sharing of test results at registration
to avoid duplication of testing, and the European Chemicals Agency
submitting a report to the Commission every three years on progress
in replacing animal testing with alternative methods.
COMMUNICATION OF
INFORMATION
A key feature of the REACH system is the production,
collation, and effective use of information on chemical risks
and how they can be managed. The text has been strengthened to
ensure that where hazardous chemicals have been used in the manufacture
of articles, information on safe use of the articles is made available
on request by consumers. The European Chemicals Agency will also
draw up relevant guidance and best practice for industry on communication
of information on the risks and safe use of chemicals. A key demand
of the Parliament to require Chemical Safety Reports for all chemicals
produced or imported under 10 tonnes per annum was resisted, thereby
preserving projected cost savings to industry (mainly SMEs) of
some 650 million Euros made originally at the First Reading of
REACH under the UK Presidency in 2005.
NEW EUROPEAN
CHEMICALS AGENCY
Implementation and effective operation of REACH
across the EU will be overseen by a new European Chemicals Agency
based in Helsinki. The Agency will work closely with the REACH
Competent Authorities appointed in each Member State to implement
the Regulation in their national contexts. The Regulation sets
out details of the Agency, including its composition and management
arrangements, key tasks, functions of its various parts, and budgetary
arrangements. The Parliament has a role in deciding the composition
of the Management Board, in line with precedence in other similar
bodies.
REGISTRATION/DATA
SHARING
The Registration element of REACH is the core
of the system and is essential to ensuring the necessary information
is generated to be able to take decisions about safe handling
and use of chemicals. A key part of this is data sharing between
registrants, to avoid unnecessary duplication of registrations
("One Substance, One Registration"), as well as tests
(including animal tests). The negotiations clarified a number
of points in regard to these aspects, including the proportionate
sharing of test costs along with sharing of the test data, and
establishing a revised timeframe of seven years for a Commission
review of the exemption from the requirement to perform a chemical
safety assessment on hazardous chemicals produced/imported in
quantities of less than 10 tonnes per annum.
Additionally, producers or importers not wishing
to register any given chemicals are encouraged to communicate
this information to their downstream users sufficiently in advance
of the relevant registration deadline to allow the users to identify
alternative sources of supply.
COMITOLOGY
In July, a new comitology procedure, Regulatory
Procedure with Scrutiny, came into effect. This gives the European
Parliament a say in the adoption of implementing measures, but
only in matters of co-decision. The Second Reading negotiations
agreed the instances within REACH when this new comitology procedure
may be used to change non-essential elements of the regulation.
AUTHORISATION AND
SUBSTITUTION
The "adequate control" and "socio-economic"
authorisation routes for continued necessary use of hazardous
chemicals are retained, but with the substitution element strengthened.
In both cases, a hazardous chemical may continue to be used for
a time even when a safer alternative is available, but when applying
for the necessary authorisation to do so, a company must now submit
a substitution plan giving details of how it will be substituted
with the alternative. This was previously voluntary.
The length of authorisation periods before first
review will be determined case by case, taking account of relevant
factors such as the required assessment of possible alternatives,
including the time likely to be needed to develop suitable alternatives
for substitution. This will provide an incentive for industry
to make genuine progress in such research and development, as
there is no presumption of authorisations being renewed automatically.
CONCLUSION
In summary, REACH has been strengthened, not
diluted, and will fill the current huge data gap covering most
of the 30,000 chemicals supplied to the EU market above 1 tonne
per year, leading to better health and environment protection
through better knowledge of the chemicals and their various exposure
risks throughout the supply chain. It will also deliver tough
new controls on the most harmful chemicals, and provides a clear
framework for their substitution with safer alternatives. At the
same time, steps are taken to minimise animal testing, with tighter
controls and closer scrutiny of any new tests that may be proposed.
The European Parliament is due to vote on the
deal in plenary on 13 December. If approved, the Council can be
expected to also formally approve it at the Environment Council
on 18 December. The expected date for entry into force, following
completion of other administrative procedures, is 1 June 2007.
12 December 2006
Letter from the Chairman to Lord Rooker
Thank you for your letter of 12 December 2006
on the subject of REACH. Your letter was considered by Sub-Committee
D at its meeting of 17 January 2007.
As you will be aware, the Committee takes this
issue very seriously. We are pleased that the Finnish Presidency
was able to reach a satisfactory agreement with the European Parliament.
From reading your letter it seems that the final agreement does
indeed strike a good balance between protecting human health and
the environment at the same time as ensuring industry competitiveness
and innovation.
In the Committee's report on EU Chemicals[82]
legislation in February 2002, it was stated (Para 209) that we
would only be satisfied with new legislation if it a) speeds the
process of identifying chemicals that require risk management,
b) enables risk reduction measures to be adopted without delay
following identification, c) creates a sense of ownership among
stakeholders and d) provides for appropriate post-marketing surveillance.
We believe that the final agreement goes some
way to meeting the first three points above but we remain concerned
about post-marketing surveillance. We would therefore request
you consider how this can be dealt with at a national level.
18 January 2007
81 Correspondence with Ministers, 40th Report of Session
2006-07, HL Paper 187, pp 271-272. Back
82
Reducing the Risk: Regulating Industrial Chemicals, 13th Report
of Session 2001-02, HL Paper 81. Back
| 
