Registration is the basis of REACH. Manufacturers and importers will be required to gather information on the properties of their substances, which will help them manage them safely, and submit the information in a registration dossier to a central data base. Companies will be required to register all substances produced or imported in volumes of 1 tonne and more per year per manufacturer or importer. A new independent agency at European level will receive the dossiers and manage the database. Information requirements will largely depend on volume, but may be tailored to the intrinsic properties and conditions of use of certain substances
Registration will involve providing information on:
• The intrinsic properties and hazards of each substance (such as physicochemical, toxicological and eco toxicological properties). This information if not already available can be found through a variety of means such as computer modelling and epidemiological studies, or through testing. Where testing is necessary and involves animals, it will be kept to a minimum by requiring companies to share existing data. This will also reduce the associated costs. Any proposals for testing on animals will also be subject to a 'dossier evaluation'.
• The use(s) of the substance identified by the importer or manufacturer or by their customers. A report of an assessment of risks for human health and the environment, and how those risks are adequately controlled, for the identified uses for substances produced or imported in volumes of 10 tonnes or more per year per manufacturer or importer (known as chemical safety reports). For lower volumes, safety information produced for the safety data sheets will be submitted as part of the technical dossiers.
To cope with the large number of 'existing' substances a phased approach is proposed. The deadlines for registration are set according to the volume of the substance on the market or the hazard. The shortest deadlines apply to very high volume substances (above 1000 tonnes), and carcinogenic, mutagenic or reproduction toxic substances above 1 tonne. These will have to be registered within 3 years.