On 1 June 2007 the EU's Regulation on the
Registration, Evaluation and Authorisation of Chemicals
"REACH" entered into force; major duties relating to
the registration of new substances and pre-registration of
existing substances begin to take effect as from 1 June
Much of the enforcement and implementation effort will be
carried out by Member States' authorities. As such, in
December 2007 the German Government decided on a draft Bill to
harmonise national law with the REACH Regulation by amending
the existing Chemicals Act (Chemikaliengesetz). The Bill must
still be passed by the Bundesrat (the representation of the
German Federal States) which has requested some further
amendments but these are not considered to be significant.
After the Bill is passed by the Bundesrat, it will become
effective on 1 June 2008 to coincide with the new REACH
The Bill is intended to fulfil the following purposes:
Designation of competent authorities that will implement
the REACH Regulation in Germany.
The central player among the competent authorities will be
the Federal Agency for Occupational Health, Safety and Medicine
(Bundesanstalt für Arbeitsschutz und Arbeitsmedizin) in
Dortmund which is the designated Federal Agency for Chemicals
(Bundesstelle für Chemikalien). It will undertake a number
of important tasks including:
evaluation of registrants' testing
documentation as part of their registration
cooperating with the European Chemicals Agency, the
European Union and the competent authorities of other
Member States in relation to the harmonised classification
and labelling of chemicals.
commenting on draft decisions of the European Chemicals
Agency in relation to exemptions from REACH for research
and development. In addition the Agency will also:
serve as the national REACH helpdesk.
collaborate with the Federal Environmental Agency
(Umweltbundesamt), the Federal Institute for Risk
Assessment (Bundesinstitut für Risikobewertung) and
other designated experts and competent authorities that are
responsible for the evaluation of the chemicals, in each
case focusing on specific aspects like environmental,
health and occupational safety.
Determination of administrative offences, fees and
penalties in case of non-compliance. Non-compliance with the
REACH Regulation will be punishable with criminal fines up to
an amount of EUR 100,000 or with imprisonment up to two years
(five years if life or health or valuable property (worth
more than EUR 750) is put at risk). There is likely to be
significant variation in penalties in different Member States
(the UK for example is proposing unlimited fines for serious
cases) and this may well lead to concerns that some companies
will move operations to companies where penalties and / or
enforcement are lighter.
Empowering competent authorities so that they are in a
position to fulfil the duties under the REACH Ordinance, i.e.
granting rights to enter third party property, rights to
exchange information among different authorities for
monitoring purposes. The amended Chemicals Act is framed in
such a way that customs as well as other competent
authorities can forward information they have gained through
their work to the competent authorities responsible for the
implementation of REACH, which is not possible at the moment
in all cases.
As many companies prepare for their pre-registration and
registration obligations later this year under REACH, it is
important that national implementation and enforcement measures
are in place to back up this Europe-wide regime. It remains to
be seen whether the Bill will suffice in Germany to harmonise
law in relation to REACH. The Bundesrat has already stated that
further amendments of the Chemicals Act are necessary to avoid
discrepancies in wording. Thus, most likely, further amendments
of the Chemicals Act will follow in the course of this year or
Copyright Clifford Chance 2008
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