(Excerpts from REACH in Brief, EC – December 2006).
The two most important aims are to improve protection of human health and the environment from the risks of chemicals.
In 2001, the Commission presented new strategy of the Commission for ensuring a high level of chemicals safety though a system for the Registration, Evaluation and Authorisation of Chemicals – the REACH system.
REACH is based on the idea that industry itself is best placed to ensure that the chemicals it manufactures and puts on the market in the EU do not adversely affect human health or the environment. This requires that industry has certain knowledge of the properties of its substances and manages potential risks. Authorities should focus their resources on ensuring industry are meeting their obligations and taking action on substances of very high concern.
REACH will create a single system for both what are currently described as “existing” and “new” substances; substances are now described as non-phase-in substances (i.e. those not produced or marketed prior to the entry into force of REACH) and phase-in substances (those substances listed in EINECS, or those that have been manufactured in the Community, but not place on the Community market, in the last 15 year or the so-called “no longer” polymer of Directive 67/548).
Its basic elements are described below:
- All substances are covered by this regulation unless they are explicitly exempted from its scope.
- Registration requires manufacturers and importers of chemicals to obtain relevant information on their substances and to use that data to manage them safely, as well as informing the authorities.
- To reduce testing on vertebrate animals, data sharing is required for studies on such animals. For other tests, data sharing is required on request.
- Better information on hazards and risks and how to manage them will be passed down and up the supply chain.
- Downstream users are brought into the system.
- Evaluation is undertaken by the Agency to evaluate testing proposals made by industry or to check compliance with the registration requirements. The Agency will also coordinate substance evaluation by the authorities to investigate chemicals with perceived risks. This assessment may be used later to prepare proposals for restrictions or authorisation.
- Substances with properties of very high concern will be made subject to authorisation; the Agency will publish a list containing such candidate substances. Applicants will have to demonstrate that risks associated with uses of these substances are adequately controlled or that the socio-economic benefits of their use outweigh the risks. Applicants must also analyse whether there are safer suitable alternative substances or technologies. If there are, substitution plans must be prepared; if not, they should provide information on research and development activities, if appropriate. The Commission may amend or withdraw any authorisation on review if suitable substitutes become available.
- The Restrictions provide procedure to regulate that the manufacture, placing on the market or use of certain substances shall be either subject to conditions or prohibited. Thus, restrictions act as a safety net to manage Community wide risks that are otherwise not adequately controlled.
- The European Chemicals Agency (ECHA) will manage the technical, scientific and administrative aspects of the REACH system at Community level, aiming to ensure that REACH functions well and as credibility with all stakeholders.
- A Classification and Labelling Inventory of dangerous substances will help promote agreement within industry on classification of a substance. For some substances of high concern there may be a Community wide harmonisation of classification by the authorities.
- Access to information rules combine a system of publicly available information over the internet, the current system of requests for access to information and REACH specific rules on the protection of confidential business information.