REACH Update: Responsibilities for Manufacturers of Cosmetic Ingredients

Posted: December 5, 2007

Ingredients in the personal care industry have to comply with all provisions of REACH; no general exemption applies. However, ingredients often fall under exemptions specifically described in the various articles and annexes of the REACH regulation. Therefore, before preregistration or registration, the following sections of the regulation have to be researched carefully, as many substances described here are used as personal care ingredients:

- Annex IV – substances causing minimum risks
- Annex V –  substances occurring in nature
- Article 15 - Substances regarded as being registered including biocidal products
- Provisions for polymers and monomers

Further specific provisions for personal care ingredients apply at later stages of REACH:
- The Chemical Safety Report (which needs to be submitted for registration of substances manufactured or imported in quantities above 10 tons) does not need to include considerations of the risks to human health for consumers when the substance is used in cosmetic products within the scope of the Cosmetics Directive 76/768. 
- The use as an ingredient in personal care products cannot be authorized to substances included in Annex XIV (the list of substances subject to authorization) when the substances were included in this annex because of identified hazards to human health.
- The restrictions in Annex XVII that are addressing risks for human health do not apply to the use of personal care ingredients within the scope of the Cosmetics Directive 76/768.

Under the Directive on Dangerous Substances (Article 1 of Directive 67/548 as amended by Directive 92/32), non-EINECS listed ingredients did not have to be notified if they were placed on the market as cosmetic products in their final form, intended to be used by consumers. This no longer applies to REACH and these ingredients when manufactured or imported in quantities above 1 ton, in which case they have to be registered, if not falling under an exemptions as described above, as of June 1, 2008. Extended registration deadlines do not apply, as these ingredients are not phase-in substances.

The 7th amendment of the Cosmetics Directive 76/768 prohibits the performance of animal tests on ingredients for personal care products by March 2009 at the latest. REACH addresses this issue in Article 2(4)(b), where this regulation shall apply without prejudice to Directive 76/768/EEC in regards to testing involving vertebrate animals within the scope of that directive. Recital 13, a phaseout of testing on vertebrate animals for the purpose of protecting human health as specified in Directive 76/768/EEC, should take place with regard to the uses of those substances in cosmetics.