REACH
The EU's new chemicals legislation REACH stands for the Registration, Evaluation, Authorisation and Restriction of Chemicals, and it entered into force on 1 June 2007. For further information check the HSE website - www.hse.gov.uk/reach/
What are the objectives and scope of REACH?
The objectives of REACH are to:
- Protect human health and the environment
- Maintain and enhance the competitiveness of the EU chemicals industry
- Prevent the fragmentation of the internal market
- Increase transparency
- Integrate with international efforts
- Promote non-animal testing
- Comply with EU international obligations under the WTO.
By creating an EU-wide system for the management of chemicals REACH will bring together the EU chemicals legislation. REACH will no longer differentiate between so-called "existing" and "new" chemicals.
Previously all chemicals put on the market before 1981 were called "existing" chemicals while chemicals introduced after 1981 were termed "new" chemicals. New chemicals had to be tested quite rigorously under the legislative provisions which are repealed by REACH. There were no such provisions for 'existing' substances. As a result knowledge on properties and uses of “existing” substances is rather limited.
Under REACH, the burden of proof for demonstrating the safe use of chemicals will be transferred from Member States to industry.
How does REACH work?
Companies that manufacture or import one tonne or more of a chemical substance annually will be required to register it in a central database at the European Chemicals Agency. The registration procedure involves submitting a technical dossier containing information on the substance and guidance how to handle it safely. For quantities of 10 tonnes and more companies also need to submit a Chemical Safety Report to document a safety assessment of the substance demonstrating safe handling for all identified uses and manufacturing. Evaluation allows regulatory authorities to determine if further testing is needed and to assess whether information provided by industry complies with the requirements (dossier evaluation). Substances suspected to pose a risk to health or the environment will be selected for substance evaluation. This may lead to the actions under the restrictions or authorisation procedures. Substances of very high concern are subject to an authorisation procedure. Companies who apply for authorisation need to show that the risks posed by those substances are adequately controlled or that the socio-economic benefits from their use outweigh the risks. The aim is to give industry the incentive to progressively substitute these substances with safer alternatives when technically and economically feasible.
Substances of very high concern are:
- carcinogens, mutagens or toxic to the reproductive system, categories 1 and 2
- substances which are persistent, bio-accumulative and toxic
- very persistent and very bio-accumulative
- or of equivalent concern
Member States and the Agency, on a request from the Commission, can place substances on a candidate list of substances of very high concern. The first list will be available on the Agency's website from late 2008. Some 1500 substances may fall to be considered. Restrictions are the safety net of the system. Any substance on its own, in a preparation or in an article may be subject to Community-wide restrictions if its use poses unacceptable risks to health or the environment. Restrictions can be imposed on the use of a substance in certain circumstances and products, the use by consumers or even on all uses (complete ban of a substance). Restrictions and authorisations can also apply to substances produced or imported in volumes below 1 tonne per year.
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