| REACH
(Registration, Evaluation and Authorisation of Chemicals)
What
is REACH?
REACH stands for Registration, Evaluation, and Authorisation
of Chemicals. It is the new EU
Chemical legislation, which will come into force on 1
st June 2007.
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REACH
Background?
The European Commission’s (EC) White Paper of 2001 on
a ‘future chemical strategy’ proposed a system
that requires chemicals manufactured in quantities of greater
than 1 tonne to be ‘registered’, those manufactured
in quantities greater than 100 tonnes to be ‘evaluated’,
and certain substances of high concern (for example carcinogenic,
mutagenic and toxic to reproduction - CMR’s) to be ‘authorised’.
The
EC adopted its proposal for a new scheme to manage the manufacture,
importation and supply of chemicals in Europe on in October
2003. The proposal was then forwarded to the European Parliament
and EU’s Council of Ministers for adoption under the
co-decision procedure. The European Parliament formally approved
a final text of REACH in December 2006, and it will come into
force on 1 st June 2007.
The main themes of the REACH system are Registration, Evaluation,
Authorisation and restrictions, and information exchange.
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Registration
A requirement on industry to collect, collate and submit data
to the European Chemicals Agency (ECHA) on the hazardous properties
of all substances (except Polymers and non-isolated intermediates)
manufactured or imported into the EU in quantities above 1
tonne per year. and certain substances of high concern, such
as carcinogenic, mutagenic and reproductive toxic substances
(CMRs) will have to be authorised.
Chemicals
will be registered in three phases according to the tonnage
of the substance:
- More
than 1000 tonnes a year, or substances of highest concern,
must be registered in the first 3 years;
- 100-1000
tonnes a year must be registered in the first 6 years;
- 1-100
tonnes a year must be registered in the first 11 years.
In
addition, industry should prepare risk assessments and provide
controls measures for using the substance safely to downstream
users.
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Evaluation
Dossier evaluation:
- European
Chemicals Agency in Helsinki scrutinises all testing proposals
submitted with a registration dossier (primarily to ensure
no unnecessary animal testing is carried out)
- 5%
of all registration dossiers will be subject to a full compliance
check by the European Chemicals Agency
Substance
evaluation:
- Member
States and the European Commission will agree on an annual
list
of substances to be assessed in-depth
- Member
State Competent Authorities will carry out substance evaluation
- This
may lead to new control measures or to no further action
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Authorisation
Industry must gain Community-wide authorisations for the use
of substances considered to be of very high concern. These
are substances that are identified as carcinogenic, mutagenic
or toxic to reproduction (CMRs); persistent, bioaccumulative
and toxic substances (PBTs); substances that are very persistent
and very bioaccumulative (vPvBs); and substances demonstrated
to be of equivalent concern, such as endocrine disruptors.
Restrictions
The Regulation enable restrictions of use to be introduced
across the European Community where this is shown to be necessary.
Member States or the Commission may prepare such proposals.
Information
exchange
Manufactures and/or importers should develop risk reduction
measures for all known uses of the chemical including downstream
uses. Downstream users should provide detail of their uses
to their suppliers. In cases where downstream users decide
not to disclose this information, they need to produce their
own CSR.
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European
Chemicals Agency
The Regulations create a European Chemicals Agency (ECHA)
for managing the technical and administrative aspects of the
REACH system at Community level. Work is underway to establish
this central co-ordinating body, which will be operational
in 2008, and will be based in Helsinki, Finland.
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Competent
Authority
Many European regulatory systems are operated at the national
(‘Member State’) level by a Competent Authority
in each Member State. Defra announced on 10 October that HSE
has been asked to be the UK Competent Authority for REACH.
The
Competent Authority’s responsibilities under REACH will
be to:
- Provide
advice to manufacturers, importers, downstream users and
other interested parties on their respective responsibilities
and obligations under REACH (Competent Authorities’
helpdesks).
- Conduct
substance evaluation of prioritised substances and prepare
draft decisions.
- Propose
harmonised Classification and Labelling for CMRs and respiratory
sensitisers.
- Identify
substances of very high concern for authorisation.
- Propose
restrictions.
- Nominate
candidates to membership of ECA committees on Risk Assessment
and Socio-economic Analysis.
- Appoint
members for the Member State Committee to resolve differences
of opinion on evaluation decisions.
- Appoint
a member to the Forum for Information Exchange and meet
to discuss enforcement matters.
- Provide
adequate scientific and technical resources to the members
of the Committees that they have nominated.
- Work
closely with the European Chemical Agency in Helsinki.
Although REACH will not come into force until June 2007, HSE
has already set up an interim helpdesk. It can be contacted
on 0845 408 9575 or via email at ukreachca@hse.gsi.gov.uk.
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Enforcement
Enforcing this very wide-ranging new system presents new challenges
to regulators across Europe. REACH places new duties on a
range of different businesses. Mostly, the new duties will
be on manufacturers and importers of chemicals, but there
are also requirements for downstream users of chemicals to
share information with their suppliers. Although HSE will
play a key role in enforcing REACH, both as the UK Competent
Authority and more genrally as the UK occupational health
and safety regulator, enforcing REACH will fall to a number
of regulatory bodies. HSE are working closely with other regulators
to support Defra in setting up the framework for enforcing
REACH in the UK. Defra are planning to consult on enforcement
arrangements for REACH in early 2007.
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