REACH Update: Specifics for Naturals
Posted: April 8, 2008
Substances occurring in nature are exempt from registration, evaluation and downstream user obligations [Article 2(7)(a) and Annex V (7/8)] if they are not chemically modified or classified as dangerous, according to the Directive on Dangerous Substances 67/548/EEC.
Naturals, according to REACH, are defined in Article 3(39) as: Naturally occurring substances that are, as such, unprocessed or processed only by manual, mechanical or gravitational means; by dissolution in water; by flotation; by extraction with water; by steam distillation or by heating solely to remove water; or that are extracted from air by any means."
The position of the cosmetics industry in Europe, discussed at an association’s level, is the following:
- Aqueous plant extracts are exempt from registration, evaluation and downstream user obligations (Titles II, V & VI)
- Plant extracts from a solvent extraction (with glycerin, glycol, oil or alcohol, etc.) fall under REACH. They represent preparations, consisting of a solvent-free plant residue (UVCB), the solvent and potentially other additives, e.g. preservatives. A UVCB is a substance of unknown or variable composition, complex reaction products or biological materials. All components of the preparation have to be registered when exceeding the volume of one ton per year. For pre-registration, the specific EINECS numbers should be used and if not available, the general numbers for naturally occurring substances should be used (EINECS 310-127-6/CAS 999999-99-4).
- Pressed or pressed and refined fatty oils are exempt from REACH, provided they are not chemically modified or classified as dangerous.
- Nonaqueous solvent extracted fatty oils fall under REACH as UVCBs. For pre-registration, the specific EINECS number should be used and if not available, the general numbers for vegetable oils should be used: EINECS 273-313-5/CAS 68956-68-3.
Borderline cases exist. For example, wool wax (lanolin) is considered a natural when it is obtained from a process as described in Article 3(39)-REACH (see above). This includes the flotation process where detergents are used, according to a decision by the EU.
The considerations for further natural substance classes within REACH are complex:
- Protein derivatives are considered as naturals when extracted without solvents other than water or obtained from mechanical processes. They can be native proteins even if they have undergone a chemical treatment, such as the removal of impurities, so long as the chemical structure remains unchanged. In this case, the protein is exempt from REACH.
- Protein hydrolysates are considered UVCBs and must be pre-registered. A general EINECS number for protein hydrolysates is: 310-296-6/CAS 9015-54-7.
- Amino acids are usually obtained either from protein hydrolysis or another chemical modification process and as such, they fall under REACH.
- Biotechnology-derived products used as cosmetic ingredients can be polymers, regular substances or hydrolysates and are considered as UVCBs. The biotechnological process is a modification of the initial substrate and as such, the products fall under the respective REACH provisions.