EU Regulatory Update: Recast of the Cosmetics Directive Published

By: Annelie Struessmann, PhD, CONUSBAT

Posted: January 12, 2010

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For example, all information on cosmetic products obtained from the notification procedures will be electronically forwarded to the national competent authorities, which will use it for market surveillance and consumer information. The information also will be provided to poison centers or similar bodies, where it will be used to inform the public of appropriate medical treatments in case of adverse reactions. And as noted, the responsibilities of the actors in the supply chain will be clearly defined and assigned to a responsible person, which is a new role created with the regulation.

While the Cosmetics Directive had already required safety assessments of finished products and their documentation in information files, no specification on the details of the assessments were given. In response, a guidance document was published by the Scientific Committee on Consumer Safety (SCCS), formerly the Scientific Committee on Consumer Products (SCCP), which reflects the position of the EU and influences the provisions of the new regulation; however, this guidance document had no legal status.

As a background, the SCCP is one of several scientific committees that provide the European Commission (EC) with scientific advice when preparing policies and proposals. In 2009, the SCCP was replaced with the SCCS. SCCS members are appointed by the EC and are responsible for the ongoing assessment of cosmetic ingredients. The group's resulting opinions often lead to amendments of the directive’s annexes for the purpose of adaptations to technical progress.

As positive, negative and restricted lists for cosmetic ingredients are resumed for the new regulation with only minor changes, the SCCS’s assessments will affect the Regulation (EC) No 1223/2009’s annexes in the future. Various clarification and evaluation requests in the text of Regulation (EC) No 1223/2009 regarding safety over the use of nanomaterials or CMR substances, etc., will be directed to the SCCS.

With the deadline of July 11, 2013, the Regulation (EC) No 1223/2009’s provisions for product safety assessments and PIFs will apply according to Article 10, Article 11 and Annex I. Compliance with these requirements is seen as a major challenge with the new regulation. Therefore, it is highly recommended to begin preparations at an early stage.