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REACH - the new European chemicals legislation
REACH is the name for the new European chemicals legislation. It stands for Registration, Evaluation and Authorisation of CHemicals. It entered into force on 1 June 2007. In its capacity as the competent agency for the health assessment of chemicals and products, BfR played a major role in shaping the new REACH Regulation which applies equally to all Member States of the European Union.
What will change as a consequence of REACH?
For many chemicals important toxicological and ecotoxicological studies have never been carried out. As the lack of knowledge about toxicity is not labelled, these chemicals appear to be safe. The REACH Regulation will lead to far more chemicals undergoing comprehensive testing than in the past. All existing substances (i.e. substances placed on the market before 1981) with production or import volumes of more than 1 tonne per year must now be systematically tested with regard to their dangerous properties. Up to now, it is assumed that there are around 30,000 of these substances. So far only 3,000 of the so-called new substances had to undergo an assessment of health and environmental risks before being placed on the market.
Both consumers and workers who come into contact with chemicals will benefit from the new REACH Regulation which assigns far greater responsibility to industry for the safe handling of its products. Manufacturers and importers must register the approximately 30,000 chemicals with the new European Chemicals Agency and assess the risks by 2018. To this end, they must prepare chemical safety reports (CSRs) for the first time and document all known tests. Particularly dangerous substances must go through an authorisation procedure. Because of the stiff authorisation requirements, it is expected that substances of this kind will be replaced in the long run by less dangerous ones.
REACH strengthens consumer protection and animal welfare
- New and “existing substances” must be registered from a production or import volume of one tonne per year and from a volume of 10 tonnes per year they have to go through a safety evaluation.
- It is no longer the public agencies but manufacturers and importers who have to procure the necessary data and prove that the use of their chemical substances is safe (reversal of the burden of proof). Public agencies can now concentrate on assessment and control.
- There is an authorisation obligation for carcinogenic, mutagenic, reprotoxic and hormonal substances as well as for substances that are not readily degradable in the environment.
- Products must be labelled when they contain substances of very high concern that require authorisation.
- Instead of animal experiments, scientifically accepted, alternative test methods should be used as far as possible.
- Manufacturers must indicate the use to which the substances are to be put and the resulting possible exposure for humans.
- Users must inform manufacturers when they use the substances in previously unknown areas.
- Consumers are entitled to ask sellers or manufacturers for information on substances of very high concern and their use.
Consumer information on REACH
Together with the Federal Environmental Ministry, BfR has published a brochure which gives interested people a detailed overview of the principles of chemical safety and the new chemicals legislation. The brochure can be downloaded from the bottom of the page under “Documents” or ordered from the BfR Press and Public Relations Office.
Advice on REACH
A help desk has been set up as the national information office for manufacturers, importers, users of chemical substances and consumers. It is located in the Federal Institute for Occupational Safety and Health (BAuA). Experts from the Federal Institute for Risk Assessment (BfR), the Federal Environmental Agency (UBA) and the Federal Institute for Materials Research and Testing (BAM) provide backing in the form of specific information and expert knowledge.
|REACH Article 57, Buchstabe f: Non-Endocrine Disrupting Human Health Hazards Leading to SVHC Identification||
BfR Opinion No 001/2014
|REACH: Identification of Substances of Very High Concern (SVHC) by 2020||
Background Paper on the Position of German Competent Authorities
|Nanomaterials and REACH||
BfR Information Nr. 034/2010
|BfR criteria for the selection of candidate substances for the authorisation procedure under REACH||