| European Commission: Laurent Sellès Email: laurent.selles@ec.europa.eu Telephone: +32 (2) 296-3420 | U.S. Government: (name) Email: Telephone: |
| EU Delegation in Washington: (name) Email: Telephone: | U.S. Mission to the EU: Linda Tollefson FDA (Ashley Miller, FCS) Email: Telephone: |
Framework Annex I, B.3 (a).
Goal
To eliminate unnecessary regulatory divergences in key sectors.
Specific Objectives
Collaborate on cosmetics regulations, in particular with a view to reducing the need for animal tests by cooperating on alternative testing methods.
Progress
FDA, the European Commission and their testing validation associations ICCVAM and ECVAM have concluded an agreement to facilitate cooperation in validating alternative tests. The International Cooperation on Cosmetics Regulation (ICCR) has validated ten out of thirty-four alternatives to date.
In September 2008, the United States and the European Union together with Canada and Japan agreed on the cooperative Framework on Alternative Tests. The Framework provides the basis by which the responsible organizations for scientifically validating proposed new alternative tests will work together by setting priorities, sharing results and leveraging each other’s resources and expertise.
Next Steps
Clarify how the Commission and Member States intend to proceed with the final implementation of the ban against animal testing, scheduled to go into effect in 2013, and ensure trade is not disrupted, given that not all relevant alternative safety tests appear to be in place.
Revised EU Cosmetics legislation contains a recast of the Cosmetics Directive on nanomaterials. The Commission proposal was adopted on February 5, 2008, then negotiation at the Council and EP level resulted in a definition for “nanomaterial”** and an obligation to label in the list of ingredients the substance name and the term “nano” in brackets. DG ENT expects adoption in Fall 2009 with an application date 3 ½ years after adoption.
**"Nanomaterial" means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.” Note that the definition may be modified by the Commission through Comitology in view of technical and scientific progress and/or definitions agreed to at the international level.
International Cooperation on Cosmetics Regulation (ICCR) (EU, USA, Japan and Canada) working group meets July 8-9 in Ispra, Italy and will discuss these issues.
Discuss nanotechnology in cosmetics and alternatives to animal testing for cosmetic ingredients at the EC/EMEA/FDA annual bilateral meeting September 27-30, 2009.
