The definition of substance under REACH is quite broad and it includes chemicals, dangerous and non-dangerous, and every type of a chemical that is manufactured or imported in the European Union. Therefore, it can be considered that all chemical substances fall under the provisions of REACH, besides the specific exemptions referred below.
Chemical substances which are already adequately regulated by other acts are either completely excluded from the scope of REACH or are exempted from the registration provisions (article 2). Such examples are substances which pose a minimum risk due to their intrinsic properties (e.g. water, nitrogen, e.tc.) and substances for which registration is considered to be inappropriate or unnecessary (like substances occurring in nature e.g. minerals, ores) according to Annexes IV and V of REACH respectively.
Substances Completely Excluded from REACH:
- Radio-active substances;
- Substances under customs supervision;
- Substances used in the interest of defence and covered by National exemptions;
- Waste;
- Non isolated intermediates and transported substance;
Substances Exempted from Registration:
- Substances used in food or feedingstuffs;
- Substances used in medicinal products;
- Substances included in Annexes IV and V of the REACH Regulation;
- Recycled or recovered substance already registered;
- Re-imported substance already registered;
- Polymers (however, monomer shall be registered);
- Substances used for the purposes of product and process oriented research and development (PPORD);
- Active substances for use in biocides (article 15);
- Substances for use in plant protection products;
Substances subject to Registration with reduced information requirements
- Substances in food contact materials;
- Substances in cosmetics.
More explanations on the scope of REACH are available in the Guidance on Registration. In the Guidance for Annex V there are explanations and examples for chemicals which are considered to occur in nature and are therefore exempted from the registration requirements.
In the Guidance on Monomers and Polymers specific examples on determining the registration obligations for monomers are presented.