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PURPOSE: to
improve the protection of human health and the environment from the risks of chemicals;
to enhance the competitiveness of the EU chemicals industry; and to establish
a European Chemicals Agency. LEGISLATIVE
ACT: Regulation 1907/2006/EC of the European Parliament and of the Council
concerning the Registration, Evaluation, Authorisation and Restriction of
Chemicals (REACH) establishing a European Chemical Agency, amending Directive
1999/45/EC and repealing Council Regulation 793/93/EEC and Commission
Regulation 1488/94/EC as well as Council Directive 76/769/EEC and Commission
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. CONTENT: the
Council adopted, with unanimity, the REACH (Registration, Evaluation,
Authorisation and Restriction of Chemicals) Regulation. The new Regulation
marks a departure from the previous chemicals regulatory framework and with
its adoption replaces over forty pieces of EU chemicals legislation. The
final draft was approved following a meeting of the European Parliament, the
Council and Commission in the Conciliation Committee. The European Parliament
adopted the Regulation during its plenary session on 13 December 2006. Once in force,
REACH will require the registration of some 30 000 chemical substances in use
today. Industry has been given a number of years in which to prepare
for, and implement, the provisions set out in this Regulation, according to
the level of risk attributed to a chemical and according to the tonnage being
manufactured. Substances of high concerns are: - Carcinogens (CMR); - Mutagens (CMR); - substances which are toxic to reproduction
(CMR); - persistent, bio-accumulative and toxic-substances
(PBTs); - very persistent, bio-accumulative and toxic
substances (vPvBs); and - endocrine disrupters. REACH is based
on the idea that industry itself is best placed to ensure that the chemicals
it manufactures and puts on the market in the EU do not adversely affect
human health or the environment. As such, REACH creates a single system for
both “existing” and “new” substances. The basic
elements of the Regulation are as follows: Scope: All substances are covered by this Regulation – unless they are
explicitly exempted from its scope (i.e. radioactive material). Registration: This provision requires a manufacturer or importer of
chemicals to provide a registration dossier to the newly established European
Chemicals Agency. Manufacturers and importers of chemical substances will
need to submit a registration to the Agency for each substance manufactured
or imported in quantities of 1 tonne, or above, per year. Failure to register
will mean that the substance will be prohibited from being either
manufactured in, or imported into, the EU. Certain, well regulated products
are exempted such as medicinal products or products that present low risks
(water, oxygen etc.). Strict deadlines for registration are set out as
follows: pre-registration between 1 June 2008 and 30 November 2008 and
registration deadlines commencing from November 2010, June 2013 and June 2018
– depending on the volume band or level of concern of a particular substance. Evaluation: Two types of evaluation, both with different aims, are outlined,
The first concerns “dossier evaluation”, whereby the Agency will undertake
quality checks of the registration dossiers (i.e. compliance and checking of
testing proposals) and the second will be “substance evaluation”. Evaluation
may lead the authorities to conclude that action needs to be taken under
REACH procedures or that information needs to be passed on to other
authorities responsible for relevant legislation. One further advantage of
the evaluation procedure is that reliable and useful data is provided and
made available to the relevant bodies by the Agency. Authorisation: Substances, which are rated as being “of a very high concern”
will require authorisation. They are CMRs, PBTs and endocrine disrupters.
Substances that fall into these categories will be fed into the authorisation
system – but their use will not be banned by default. The Agency will be
responsible for publishing a list of all the properties of very high concern.
Applicants will have to demonstrate that risks associated with use of these
substances are adequately controlled or that the socio-economic benefits of
their use outweigh the risks. Applicants must also analyse whether there are
safe suitable alternative substances or technologies in existence. If there
are, they must use the alternatives. In cases where safe alternatives are not
available they are obliged to provide information to the Agency on research
to remedy this. The Commission will be allowed to amend or withdraw any
authorisation and/or review the authorisation if suitable substitutes become
available. Restrictions: The restrictions procedure allows the Community to regulate
conditions for the manufacture, placing on the market or use of certain
substances where there is an unacceptable risk to health or the environment.
Certain substances, if necessary, may be prohibited all together. The
restrictions provisions are to act as a safety net. European
Chemicals Agency: The Regulation establishes the
European Chemicals Agency (ECA), which will be based in Helsinki. Its purpose
is to manage all aspects relating to REACH. As such it will be responsible
for carrying out dossier evaluations and co-ordinating the substance
evaluation process. It is to provide expert opinions to the Commission on
authorisations and restriction procedures. Further, it will be subject to
strict confidentiality and information requirements. It will become
operational as from 1 June 2008. Classification
and labelling inventory: Industry will be
required to classify and label dangerous substances and preparations
according to standard criteria. The classification and labelling inventory
will ensure that hazard classifications of all dangerous substances
manufactured in, or imported into, the EU will available to all. Industry
will be required to submit all classifications to the Agency three and a half
years after the REACH Regulation has entered into force. Data
sharing: One of the Regulation’s main objectives
is to minimise testing on animals. As such, the Regulation provides that
animal test data must be shared. For other tests, data sharing is required on
request. Further, better information on hazards and risks and how to manage
those risks will be passed down and up the supply chain. Access to
information: All non-confidential information on
chemicals will be made openly available to the public. The Regulation
specifically seeks to balance the public’s “right to know” with the need to
keep certain information confidential. ENTRY INTO
FORCE: 1 June 2007.
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