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The REACH Regulation
The European
REACH Regulation (Registration, Evaluation, Authorisation and restriction
of Chemicals) applies to all chemical substances which are manufactured,
imported, placed on the market or used within the European Union, either on their own, in a preparation or in an article.
REACH is intended to replace the
current system in which chemical substances are covered by a patchwork of
different Directives and Regulations.
The Regulation applies to manufacturers, importers, distributors
and downstream users.
REACH entered into force in June 2007
and the Registration process will take place over a period of 11 years,
as outlined in the following timetable.
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1 Jun
2007
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Entry into force
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1 Jun
2008
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Start of pre-registration period
EC set out fees structure
ECHA board established rules for access to information
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1 Dec
2008
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End of pre-registration period
Deadline for review of criteria to define PBT and vPvB substances
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1 Jan
2009
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ECHA published list of pre-registered substances.
ECHA began compilation of candidate list of substances potentially
requiring authorisation.
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1 Dec
2010
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Registration required for: phase-in substances
manufactured or imported over 1,000 tonnes per annum (tpa); CMR category 1 and 2 over 1 tpa, and; materials with risk numbers R50/53 over
100 tpa.
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1 Jun
2012
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First report due
from EC on operation together with proposals for amendments to
Regulation.
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1 Jun
2013
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Registration required for
phase-in substances over 100 tpa.
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1 Jun
2018
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Registration required for
phase-in substances over 1 tpa.
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Abbreviations:
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CMR: Carcinogens, mutagens and materials
classes as toxic for reproduction
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ECHA: European Chemicals Agency
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PBT: Materials that are persistent, bioaccumulative and toxic
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vPvB: Materials that are very persistent and very bioaccumulative
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REACH applies a common system for new
and for existing substances, and the burden of proof for evaluating these
substances is transferred from the authorities to industry.
REACH does not apply to all substances
and there are partial or complete exemptions provided, e.g. for wastes or
radioactive materials, which are covered under other legislation, or for
materials that inherently pose minimal risk or it is considered that
registration would be inappropriate or unnecessary.
The main requirements under REACH are:
Registration: manufacturers and
importers are required to register substances, in accordance with the timetable
set out for existing substances, or prior to being placed on the market
for new substances. For quantities
> 1 tonne, a Technical Dossier must be prepared. For quantities > 10 tonnes, a
Chemical Safety Report is required.
Evaluation: The European
Chemical Agency (ECHA) and/or the Health and Safety Authority (HSA)
evaluate the data provided during the Registration process and may
Authorise or Restrict materials based on their findings.
Authorisation: this is required
for the use or placing on the market of substances of very high concern,
i.e.:
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CMR
category 1 or 2 (carcinogens, mutagens and materials classed as toxic for
reproduction).
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Persistent,
bioaccumulative and toxic (PBT).
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Very
persistent and very bioaccumulative (vPvB).
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Potentially
dangerous to health or the environment and used in dispersive form.
The authorities
will prepare a list of substances requiring Authorisation; for materials
on this list, a separate authorisation is required for each use. Restrictions may be placed on the
manufacture, placing on the market or use of certain substances where
there is an unacceptable risk to health or the environment. If necessary a prohibition may be
placed on these activities.
Most companies using chemicals will
qualify under the REACH Regulation as a downstream user of registered
substances. As the downstream
user, a company will need to be able to demonstrate that the substances
are used in a manner that has been authorised by the manufacturers or
importers of the substances.
Byrne Ó Cléirigh offer comprehensive
consultation and advice on REACH and its implications for chemical
substances in industry. For more details, please contact
Mr. Thomas Leonard on +353-1-474 1533
or email Tom.Leonard@boc.ie.
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