The REACH regulation is based on the registration of chemical substances.
In order to place on the market chemical substances, the companies, manufacturers and importer must register them with ECHA (European Chemicals Agency) if they are manufactured or imported in quantities of 1 tonne or more per year (art. 5 of the regulations: "No data, no market").
This requirement is applicable to substances themselves and to the mixtures that contain them. Manufacturers and importers must collect and provide information related to
- the identity of the substance,
- its physico-chemical properties,
- its toxicity,
- its ecotoxicity (i.e. its effect on the ecosystem)
- its environmental characteristics (degradation etc.)
- its use and its production.
Following are exempted from registration (art. 2 of the regulation):
• well known substances that are considered to cause minimum risk (amino acids, fatty acids, water, gas (CO2, argon, nitrogen), etc.) (listed in appendix IV),
• substances covered by Annex V, such as substances present in nature that are not chemically modified (including minerals, ores, some gases, crude oil, carbon, coke, clinker)
• registered substances that are exported and then re-imported in a European Community country, etc.
Some categories of substances are subject to special processes or specific measures: polymers, intermediates, substances manufactured or imported for the purpose of research and development.
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Under some conditions, the substances that were produced or marketed before REACH came into force benefit from a transitory scheme. They are called Phase-in substances). In order to fall under this transition scheme, the industries should have registered the substances in advance (pre-registration) by 1st December 2008.
This transition scheme is also applicable to the new substances produced or imported in the European territory.
1) 1st December 2010:
- the substances manufactured or imported in quantities of 1000 tonnes/year and above,
2) 1st June 2013:
3) 1st June 2018:
Substances notified under directive 67/548/EEC (former directive on dangerous substances) are not covered under this transitory procedure since they are deemed to be registered under REACH and have received a notification number.
Anybody declaring a substance must fill a registration document comprising:
- a technical document: always mandatory for all substances that are required to be registered. It contains information on:
• The identity of the substance
• Information about the manufacture and use of the substance
• Classification and labelling of the substance
• Guide on safe use
• Summarised information documents on intrinsic properties
• Proposals for additional tests, if required
- a chemical safety report required if the declaring person is manufacturing or importing a substance in quantities of 10 t/y. It contains detailed summary of information about the environmental and human characteristics that are dangerous for health, as well as an assessment of the exposure and risk when such an assessment is required.