Comment

Arthur Keith

Informations

• Publié par: Bavem
• Nombre de lectures: 660
• Langue: English

Extrait

ATLA 31, 353–364, 2003 353
CCoommmmeenntt
A Critical Assessment of the European Commission’s
Proposals for the Risk Assessment and Registration of
Chemical Substances in the European Union
Robert Combes, Jennifer Dandrea and Michael Balls
FRAME, Russell & Burch House, 96–98 North Sherwood Street, Nottingham NG1 4EE, UK
Summary — In May, 2003, the European Commission published detailed proposals relating to its 2001
White Paper – Strategy for a Future Chemicals Policy. The White Paper described a new registration system
called the REACH (Registration, Evaluation and Authorisation of Chemicals) system, for both new and exist-
ing chemicals. Subsequently, these detailed proposals were available for an eight-week consultation period
for stakeholders to voice their views and concerns. In this paper, we describe our reactions to the Com-
mission’s more-detailed proposals. These include the creation of a European Chemicals Agency to imple-
ment the REACH system in conjunction with Competent Authorities (CAs) in Member States and the
Commission itself. Unfortunately, many of our concerns and suggestions, previously voiced and shared
with several other key stakeholders, remain unanswered, but are as relevant as when the White Paper was
published. In particular, we are concerned about the lack of a clear and coherent strategy. There is no guid-
ance for registrants on intelligent testing to maximise the use of non-animal approaches to safety testing,
based on a combination of factors for estimating exposure levels, rather than mainly on production vol-
umes. We are also concerned about the absence of a clear programme for the development, improvement
and validation of new alternative methods, in conjunction with the Commission’s own unit, the European
Centre for the Validation of Alternative Methods, as well as other organisations with relevant expertise and
experience, including FRAME. Finally, we explain why such measures should be introduced, together with
clearer guidelines for the respective roles of the Agency, the CAs and the Commission in implementing and
harmonising the REACH system at the European Union and Member State levels. A series of recommenda-
tions are made, to improve the situation and to improve the risk assessment process.
Key words: animal tests, chemicals testing, EU REACH system, non-animal tests, replacement alternative
tests.
Introduction ket within the EU, together with safeguarding
human health and the environment.
While FRAME supports a unified testing systemIn 2001, the European Commission issued a White
for new and existing chemicals, we consider thatPaper entitled Strategy for a Future Chemicals
the policy based on the White Paper is ill-conceived,Policy (1). This described a new REACH (Regis-
since it is based on the unrealistic concept of a risk-tration, Evaluation and Authorisation of Chem-
icals) system that will result in the re-evaluation free environment. Furthermore, it fails to define
of up to 30,000 existing chemicals (defined as how non-animal approaches should be used in the
those registered before 1981, when new regula- REACH system to speed up testing and to maximise
tions were introduced) to meet the same stringent animal welfare.
FRAME has reviewed the views of the majorstandards as those stipulated for new chemicals
stakeholders in Europe on the White Paper (Directive 67/548/EEC).
The main objectives of the REACH system are: (Jennifer Dandrea, in preparation), and found that
a) to phase out chemicals that present unmanageable many other organisations share our concerns about
and unacceptable risks; b) to handle, in an appropri- several aspects of the REACH system. In particular,
ate manner, those chemicals for which risks can be the review revealed a widespread desire: a) to use
managed; and c) to permit the continued use of those validated alternative methods for toxicity testing,
wherever possible, and as part of an integrated test-chemicals that do not pose any insuperable prob-
lems. The legal basis of the proposals will be Article ing approach; b) to expedite the development and
95 of the European Union (EU) Treaty, which is validation of new alternatives as rapidly as possible,
designed to protect the interests of the internal mar- so that they could be ready in time for use with354 Comment
those chemicals for which testing is to be phased been taken into consideration by the Commission,
over several years; c) to use information on ton- in many cases the level of consideration has been
nage-triggers, use patterns, bioavailability, environ- unsatisfactory and the same shortcomings remain.
mental persistence and pre-existing toxicity data This paper summarises the latest proposals, out-
for prioritising levels of concern, rather than rely- lines the concerns which remain, and makes some
ing mainly on production levels; d) to have more suggestions for improving the situation.
details on how polymers and intermediates will be
treated in the REACH system; e) to insist on the
formation of consortia and on data sharing, while Summary of the Latest Proposals
safeguarding legitimate commercial interests; f) to
insist on intelligent toxicity testing that is expo- The latest EU proposals have been published in the
sure-driven, avoids tick-box approaches, and max- form of seven volumes of legal and scientific text,
imises the use of rapid predictive methods, to together with a press release, copies of speeches by
improve the risk assessment process and reduce the EU Commissioners, flow diagrams, and a list of
scope of the REACH system to manageable propor- questions and answers relating to the new Euro-
tions; and g) to provide safeguards for small–medium
sized enterprises (SMEs).
Also, to address the needs of the new legislation in
Figure 1: A simplified version of the FRAMEthe most appropriate scientific manner, FRAME
decision-tree scheme for thelaunched an initiative to define a practical way of
toxicity testing of chemicalsimplementing the REACH system. This recently pub-
lished strategy (Figure 1; 2) formed the main focus of
a stakeholders workshop organised by FRAME.
Based upon a decision-tree testing approach, the
FRAME initiative requires only the safety informa-
Compound prioritisation
tion needed to make meaningful risk assessments in (mathematical and computerised structure analysis)
any realistic situation. Combined with these data
would be specific human exposure evaluations
derived from predictions of likely chemical uptake
into the body, and production levels of the substance.
The FRAME strategy is designed to be used in Prediction of human exposure
conjunction with a comprehensive report produced (annual production + physical, chemical and structural
properties of substance)by the European Centre for the Validation of Alter-
native Methods (ECVAM), on the availability of
alternative tests that could contribute to the assess-
ment of the potential adverse effects of chemicals
on human health (3). The report assessed the cur-
Preliminary risk assessment using all available data
rent status of the development and suitability of
(shared between companies)
relevant test methods for regulatory testing. It also
included the short-, medium- and long-term
prospects for further test development, and made
recommendations for their validation, where neces-
sary, in relation to the time-frames laid down in the
Identification of missing data requiredCommission’s White Paper. The proposed FRAME
(to make or improve preliminary risk assessment)
testing strategy avoids a tick-box approach to test-
ing, by prioritising chemicals for testing on the
basis of existing safety data and likely human expo-
sure levels. This has the advantage of providing the
option of either discarding a chemical or performing
Obtaining missing hazard dataan assessment at each stage of the scheme.
(by using non-animal approaches as far as possible)On 7 May 2003, 27 months after the release of the
White Paper, the Commission announced the publi-
cation on its Web site of further detailed proposals
on how the REACH system is to be implemented
(4). The release of this information marked the
New risk assessment
start of an eight-week consultation period for stake- (by using non-animal and animal data, and predictions
holders and other interested parties to comment on from computer modelling)
the latest proposals. It is clear from these proposals
that, while some of the concerns and ideas
expressed by FRAME and other stakeholders have From reference 2.Comment 355
pean chemicals policy. These volumes contain the vidual companies will be subject to the REACH sys-
following information. tem. In addition, it can be imposed on any sub-
stance, regardless of production volume, where
— Volume 1. Lists of definitions; chemicals that there is cause for concern.
are included and exempted from the scheme; Some intermediates will also have to be regis-
how the policy is to be administered; require- tered, although they are recognised as being in a<