Substances registration

There is a general obligation to register substances covered by REACH and manufactured or imported in quantities starting at 1 tonne. Failure to register means that the substance cannot be manufactured or imported.

The technical dossier includes:
(a) the identity of the manufacturer(s) or importer(s);
(b) the identity of the substance;
(c) information on the manufacture and use(s) of the substance;
This information shall represent all the registrant’s identified use(s). Manufacturers and importers shall address the risks of any use identified to them by their downstream users. However, the manufacturer is not obliged to supply a substance for a use that he feels he cannot support.
(d) the classification and labelling of the substance;
(e)guidance on safe use of the substance;
(f)summaries of the required information;
(g) robust study summaries of the required information;
(h) a statement as to whether or not information has been generated by testing on vertebrate animals;
(i) proposals for new testing where required according to manufactured or importated quantities;
The intrinsic properties and hazards of each substance (such as physicochemical, toxicological and ecotoxicological properties) – 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.
(j) a declaration authorizing or not the sharing with subsequent registrants of the summaries of tests not involving vertebrate animals. When a substance is intended to be manufactured in the Community by two or more manufacturers and/or imported by two or more importers, joint submission of data is encouraged.

For registrations of substances manufactured or imported in quantities starting at 10 tonnes per year by a manufacturer or importer, a chemical safety report (CSR), including details of risk management measures, is also required.

The Agency is the central receiving authority for all registrations. It assigns to each of them a registration number and date and performs a completeness check which is essentially an automated process (the completeness check shall not comprise an assessment of the quality or the adequacy of any data or justifications submitted). The result of the completeness check will be referred to the Member State Competent Authority in which the manufacturer or importer is established. The competent authority shall examine the registration and draft a decision if further information is required. Any proposal for testing on animals will also be subject to evaluation. Once a dossier has been evaluated the competent authority may decide to evaluate the substance in order to know if further action should be taken to manage the substance in question.

REACH phases the vast majority of substances currently being manufactured or marketed into the registration system. The registration process for phase-in substances starts with substances manufactured or imported in high volumes, given the high potential exposure, and substances with properties of very high concern.

Notes: Some substances are exempted from registration. Others are considered as already registered. Concerning the isolated intermediates, they do have to be registered but most often with limited information requirements. Hazardous substances, whose release from an article is not intended as part of its functioning, have to be notified to the Agency, if the quantity released may adversely affect human health or the environment. The Agency will decide then, whether a registration is needed or not.