Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH)

REACH aims to achieve these objectives by requiring producers and users of chemical substances to register chemical use in a volume-triggered system. Chemical assessment reports, containing information on the hazards, exposures and risks associated with the uses of the chemical substances, will be reviewed by government appointed expert committees. Uses of substances considered to be of very high concern must be authorized. Importantly, the proposed REACH legislation will bring to an end the different treatment of new and existing substances.
The proposed REACH regulation is currently under review and is expected to come into force in 2007.

The current EU legislative framework for chemical substances is a patchwork of many directives and legislations. As a result of this, the European Commission, together with the European Council, believed that there were gaps in the knowledge of many of the chemicals on the European market. Existing substances, for example, could be used without toxicological safety evaluation and the review of the effects of existing substances under Council Regulation 793/93/EEC proved to be slow and inefficient. In addition, the notification requirements for new chemicals inhibited R&D and stifled innovation; encouraging the use of existing chemicals rather than new ones.

As a result, the European Commission published a White Paper on the Strategy for a Future Chemicals Policy in February 2001 (COM (2001) 88), which was later endorsed by the European Council and the European Parliament. In this paper, the European Commission outlined the result of a review of the current system for chemical testing and registration and put forward ideas for a new strategy for ensuring a high level of chemical safety and a competitive chemicals industry. The REACH proposal was created out of this discussion after advice was given from technical Stakeholder Working Groups and public consultation by the Internet.

The REACH process entails:

Registration - Registration is the key component of REACH. It will be compulsory to register uses of chemical substances which are manufactured in or imported into the EU in quantities of more than one tonne per year in a central data base. Failure to register the use of a substance means that it cannot be manufactured or imported for that use. Industry is required to obtain relevant information on the substances it produces, such as on their properties and their uses, and to use that data to manage such substances safely.

A European Chemicals Agency will be established to centrally administrate the REACH process. The Agency will be responsible for managing the database, receiving registration dossiers and developing guidance to assist producers, importers and the competent authorities in implementing these provisions.

Downstream users of a chemical need to communicate with manufacturers or suppliers to make sure that the use they intend for the chemical has been tested. If not the downstream user will have to perform its own safety tests and report to the Agency.

Evaluation - Evaluation makes it possible to verify that industry is fulfilling its obligations and avoiding the use of unnecessary testing. Two types of evaluation are provided for: dossier evaluation and substance evaluation.

Dossier evaluation is to be compulsory for any proposals involving experiments on animals. It is essentially designed to minimise the need for experiments of this type by allowing information to be shared and encouraging alternative testing.

Dossier evaluation may also be carried out in order to verify the completeness of a registration. Substance evaluation will take place if a substance is suspected to have a risk to human health or the environment by requesting more information from industry.

The two types of evaluation may result in a request for additional information. The European Chemicals Agency is to take the final decision on such requests where all Member States agree. In the event of disagreement, the European Commission is to take the final decision. Importantly, the burden of proof that the safety of chemicals placed on the market is ensured will be reversed under REACH and passed from public authorities to industry.

Authorisation - Substances considered to be of very high concern are subject to authorisation by the European Commission with regard to particular uses. These are substances considered to be:

• Category 1 or 2 CMRs (carcinogenic, mutagenic or toxic to reproduction);
• PBTs (persistent, bio-accumulative and toxic);
• vPvBs (very persistent, very bio-accumulative) or
• Having serious and irreversible effects to humans and the environment

If the risks arising from the use of such a substance can be adequately managed, authorisation is to be granted. If they cannot, the European Commission is to consider the level of risk and the possible socio-economic benefits of using the substance, and whether alternatives exist. On this basis, the European Commission is to decide whether the substance should be authorised.

Restriction - The restrictions procedure provides a safety net, making it possible to manage risks which are not adequately covered by other provisions of the REACH system. Proposals for restrictions may consist of conditions for the manufacture or use of a substance and/or for placing it on the market, or possibly for prohibiting such activities, if necessary. Such proposals are to be prepared by Member States or the European Commission in the form of a structured dossier.