The REACH Regulation n ° 1907/2006 requires all companies that manufacture or import a substance on the EU market in quantities exceeding 1 ton/year to register this substance to the European Chemicals Agency (ECHA).
For legal reasons, only companies with a legal entity in Europe are authorized to submit a registration.
Registration means submitting a dossier to ECHA (European Chemicals Agency). This dossier must contain information regarding the physical / chemical, toxicological and ecotoxicological properties of the substances. Based on the tonnage band of the substance produced / imported each year (1-10 tonnes, 10-100 tonnes, 100-1000 tonnes,> 1000 tonnes) and the hazard classification, REACH provides for different levels of information and data concerning the substance.
It is also mandatory to provide a chemical safety assessment (CSA / CSR) when the substance is hazardous according to the criteria of CLP Regulation n. 1278/2008. Every identified use, along the entire supply chain must be evaluated.
Companies located outside the EU are not allowed to submit REACH registration dossiers for chemicals to ECHA, however according to art. 8 of REACH may appoint an Only Representative established in Europe to assume the tasks and responsibilities of importers in order to ensure compliance with the REACH Regulation.
CEPRA is able to provide a complete consultation service for REACH Registration
Once you know the identity of your substance, you need to see if your substance needs to be registered or if it is exempted from registration.
The first step is to check on the ECHA site if the substance has already been registered. If you have not registered yet, you can do this:
Step 1. Check if your substance as such is exempted from registration
The following substances do not need to be registered, regardless of how you use them:
- Polymers: substances meeting the definition of a polymer under REACH do not need to be registered, but the monomers and other substances used for the manufacture of the polymer may need to be registered.
- Substances covered by Annex V to REACH: this list describes 13 broad categories of substances.
- Substances included in Annex IV to REACH: this list contains 68 low-risk substances, typically of natural origin, including water.
- Radioactive substances: substances giving off such radiation that humans and the environment need to be protected are regulated by the Euratom Directive.
- Substances covered by a national exemption in the interest of defence.
Step 2. Check if the use of your substance is exempted from registration
The following substances do not need to be registered when only used as mentioned.
If you have an additional use for your substance, it will need to be registered.
- Non-isolated intermediates: intermediates that during the synthesis are not intentionally removed from the equipment in which the synthesis takes place (except for sampling).
- Substances used for product and process orientated research and development (PPORD): these substances are exempt from registration for five years (extensions possible), if you notify your PPORD activities to ECHA.
- Substances used in food or feeding stuffs (including uses as additives or flavourings).
- Substances (active substances or excipients) used in medicinal products for human or veterinary use.
- Active substances used in biocidal products or plant protection products. These are regarded as already registered.
Step 3. Check if your substance is exempted from registration because of its origin or history
The following substances do not need to be registered:
- Re-imported substances already registered.
- Substances under customs supervision, with a view to re-exportation.
- Waste: substances which are discarded as waste (from households, professionals or industry) as defined in the Waste Framework Directive do not need to be registered, but substances produced from the recovery of waste generally need to be registered, except
- Recovered substances already registered.
The following substances have some specific provisions under REACH but are not exempt from registration:
- Nano particles.
- Non-hazardous substances and not-classified substances.
- Substances in cosmetic products.
- Food contact materials.
- Substances present in preparations below certain concentration limits.
- On-site or transported isolated intermediates.
- Substances of very high concern.
- Substances subject to authorisation or restriction.
- Substances notified under Directive 67/548/EEC by someone else.
If you previously notified, your notification is now regarded as a registration under REACH and you have the obligation to keep this registration up-to-date.