REACH Sponsored by
Changes to the European Union’s Cosmetic Directive 76/768/EEC were a main topic of discussion at the meeting of the ASEAN Cosmetic Scientific Body (ACSB) and the ASEAN Cosmetic Council (ACC), which took place in Cambodia on July 11-12, 2012.
Cosmetics Europe—The Personal Care Association, formerly Colipa, held its annual General Assembly in Brussels, Belgium in June 2012. The scientific forum discussed topics of interest in EU legislation such as The Cosmetics Regulation, which was set to replace the Cosmetics Directive on July 11, 2013.
CONUSBAT, a regulatory affairs service provider with expertise in REACH and EU regulations for the cosmetics industry, among others, announced it has formed an alliance with Global Regulatory Services (GRS).
The new Cosmetics Regulation (EC) No. 1223/2009 defined the format of the Cosmetic Product Safety Report (CPSR) in the Regulation’s Annex I. Accordingly, the information for documenting the product’s safety is to be listed in a part A of the CPSR, and this needs to include the toxicological profiles of the ingredient substances, their physical and chemical characteristics, impurities, trace components, as well as their exposure criteria in use.
In the EU, numerous mandates for new scientific opinions have been posted in 2011, with a specification of the assessment criteria and goals. The application areas mostly focus on the new and ongoing ingredient assessments of hair dyes, preservatives and UV filters.
Responsibility for the enforcement of REACH lies with the EU Member States and is divided into two pillars—the catalogue of penalties applicable for infringements and a system of official controls.
The European Federation for Cosmetic Ingredients (EFfCI) has developed an approach for its members to address animal testing bans imposed by the 7th Amendment to the EU Cosmetics Directive.
At its Dec. 8-10, 2009, meeting, the ECHA's Forum determined that the next REACH enforcement project will be to inspect formulators of mixtures who are the first level downstream users in the supply chain.
Beginning with this column, Annelie Struessmann, PhD, will no longer focus solely on REACH regulation, but will be expanding her topics to encompass a variety of regulatory issues occurring in the European Union. Although Struessmann's columns may discuss REACH, as this feature does, future columns also will touch upon other hot button issues in the EU regulation of personal care raw materials.
The magnitude of regulatory knowledge and cutting-edge science skills required for REACH becomes evident while completing the steps toward registration. As a consequence, ECHA is extending its support for SIEFs and lead registrants.