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.
Key summary:
• Ingredients for the personal care industry are subject to all provisions of REACH
• Exemptions from certain provisions apply to personal care ingredients when these are substances specifically defined in annexes or articles of the regulation.
• Certain specific provisions exist for ingredients of personal care products in relation to registration, authorization and restriction, addressing risks to human health.
• The requirements of the Cosmetics Directive 76/768 towards phasing-out of animal testing on ingredients used in personal care products is laid down in REACH.
Next month’s topic: Preparation for pre-registration and SIEF formation.
If you have questions towards REACH, contact us.
Further useful information:
The European Chemicals Agency (ECHA) has a new Web site address. The Pages of the Agency are now available in all 22 official languages of the European Union: https://echa.europa.eu/
Guidance on REACH: Eleven guidance documents are available on the ECHA Web site, http://reach.jrc.it/, for REACH, including registration, data sharing, intermediates, polymers, etc.
REACH Implementation Projects (RIP) are developing in close collaboration with all stakeholders. They are guidance documents essential to understanding the tasks under REACH and they provide IT support tools for all obligations to the agency, the industry and the authorities. The RIPs include seven main areas and a number of sub subjects including:
– RIP 1: Process descriptions
– RIP 2: Development of IT systems (IUCLID & REACH-IT)
– RIP 3: Guidance Documents for industry
– RIP 4: Guidance Documents for authorities
– RIP 5/6: Setting up the (pre-)Agency Overall Guidance package, http://ecb.jrc.it/reach/rip/
FAQs:
Do I have to preregister my substances?
Only phase-in substances can be preregistered. Preregistration allows companies to continue manufacturing and importing their phase-in substances for several years until the registration deadline is reached. These deadlines do not apply to not preregistered phase-in substances.
We are a manufacturer of preparations and located outside the EU, but we have a subsidiary within the EU. Can this subsidiary fulfill the obligations under REACH?
If the subsidiary is a separate legal entities to the parent company, (a natural or legal person as defined under applicable national law), then it may fulfill the obligations under REACH.
Will it be possible to test C&T ingredients on animals for REACH purposes?
According to the existing legislation, REACH and the Cosmetics Directive, an ingredient for cosmetics cannot be tested on animals after March 2009. REACH requires the use of alternative methods, for example, in vitro methods, qualitative and quantitative structure-activity relationship models or information from structurally related substances such as grouping or read-across. The Cosmetic Directive requires a replacement through validated alternative test methods. The responsibility for validation of alternative tests lies with the European Centre for the Validation of Alternative Methods. Alternative tests, validated as of now, can be found at http://ecvam.jrc.it/index.htm. Readers are reminded, that the text of the REACH Regulation (Regulation(EC) No 1907/2006 is the only authentic legal reference. The information in this document does not constitute legal advice.
Annelie Struessmann, PhD
CONUSBAT
Aachen, Germany
