REACH registration is required for all substances manufactured in EU or imported into EU in quantities of one tonne or more per year. This includes substances on their own, in mixtures or substances in articles when they are intended to be released under normal or reasonably foreseeable conditions of use.
For all registrations, a registration dossier has to be prepared and submitted electronically via REACH-IT to the European Chemicals Agency (ECHA). Normally, the registration must be successfully completed and a REACH registration number assigned to the registrant before a substance can be manufactured, imported or placed on the market.
Which substances need to be registered under REACH?
Registration is required for all substances manufactured or imported in quantities of one tonne or more per year per manufacturer or importer unless they are exempted. For polymers, monomers shall be registered.
The following substances are exempt from REACH registration:
- Substances exempted from REACH regulation: radio-active substances, substances under customs supervision, substances used for national defense, non-isolated intermediates, wastes, etc.;
- Substances regulated by other legislation: substances in food, medicinal products, plant protection products, etc.;
- Substances in REACH annex VI: a list of exempt substances well-known to be safe (i.e., water, nitrogen);
- Substances covered by REACH annex V: by-products, naturally occurring substances, impurities, etc.;
Who needs to register?
The following actors in the supply chain must comply with REACH registration requirements:
- EU manufacturers and importers of substances on their own or in a mixture; or
- EU producers and importers of articles containing substances intended to be released; or
- "Only representatives" established in the EU and appointed by a manufacturer, formulator or article producer established outside the EU;
Only Representative: Under REACH, a natural or legal person established outside the EU, who manufactures a substance, formulates a mixture or produces an article can appoint an only representative to carry out the required registration of the substance that is imported (as such, in a mixture or in an article) into the EU (Article 8(1)). This will relieve the EU importers within the same supply chain from their registration obligations, as they will be regarded as downstream users.
When to register?
Different deadlines have been set for phase-in substances and non-phase-in substances under REACH. Phase-in substances have to be registered according to the following schedule if they were pre-registered before pre-registration deadline 1 Dec 2008 while non-phase-in substances need to be registered immediately.
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