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 2008.
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 duties.
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 submissions.
- 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 next year.
Copyright Clifford Chance 2008
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