Registration
Registration is of crucial importance in the REACH system. See the principle: ‘No data, no market’ (article 5).
All manufacturers and importers of chemical substances are bound to determine and manage the risks associated with the substances they manufacture and market. Substances manufactured or imported in quantities of at least one ton each year and per company must be registered by the manufacturers and importers with ECHA.
This requirement applies to substances as such or in preparations. There is a special registration system for substances in articles.
Certain substances are exempt (article 2):
- the substances in Annex IV, with a minimal risk such as amino acids, fatty acids, water, gas (CO2, argon, nitrogen), etc.;
- the substances in Annex V, being substances occurring naturally and that have not been chemically modified (including minerals, ores, certain gases, raw oil, coal, coke, clinker, etc.);
- registered substances that are exported and reimported into the European Union, etc.
For certain categories of substances special treatments or specific measures also apply: polymers, synthetic intermediate products (article 17-19), substances manufactured or imported for research and development purposes (article 9).
Substances never brought on the European market before and substances for which the transitional system applies (already on the market for a long time) and never registered before must be registered before they can be manufactured, marketed and used.
For already registered substances for which a transitional system applies and that are manufactured and imported in quantities of at least one ton each year, the registration provisions are gradually applied to facilitate the transition to REACH.
Must be registered by:
1) 1 December 2010:
- substances manufactured or imported in quantities of at least 1,000 tons a year;
- substances classified as carcinogenic, mutagenic or toxic to reproduction in categories 1a/1b (former CMR cat. 1 and 2), manufactured or imported in quantities of at least 1 ton a year;
- substances classified as dangerous to the aquatic environment H 410 (formerly R50/53) and manufactured or imported in quantities of at least 100 tons/year.
2) 1 June 2013:
substances manufactured and imported in quantities between 100 and 1,000 tons/year.
3) 1 June 2018:
substances manufactured and imported in quantities between 1 and 100 tons/year.
The manufacturers and importers must collect information on the properties of the substances with respect to health and the environment, assess the risks of their use, and obtain assurance that these are sufficiently managed.
