ICCR-2

International Cooperation on Cosmetic Regulation
ICCR-2

August 2008, Meeting Summary

The International Cooperation on Cosmetics Regulation (ICCR) is an international group of cosmetic regulatory authorities from the United States (Food and Drug Administration), Japan (Ministry of Health, Labour, and Welfare) , the European Union (European Commission, DG Enterprise), and Canada (Health Canada). This multilateral framework maintains the highest level of global consumer protection, while minimizing barriers to international trade. The ICCR had their second annual meeting (ICCR-2) July 30-August 1, 2008 to discuss issues related to cosmetic products. As part of this meeting, the regulators entered into a dialogue with cosmetics´ industry trade associations from each region.

The meeting focused on the following topics:

• Good Manufacturing Practice (GMP)
• Market Surveillance
• Safety of Ingredients/Authorized Substances Lists
• Sunscreens
• Alternative Test Methods
• Nanotechnology
• INCI Nomenclature

Outcome of the Meeting

1. Good Manufacturing Practice (GMP)
   The Regulators agreed to implement ISO Standard 22716 in their respective regions, wherever possible. Regulators summarized the situation in their respective regions, as follows:
   • US: agreed to take into consideration ISO International Standard 22716 and modify current FDA guidance
   • EU: will implement ISO TC-217 International Standard 22716 adopted by CEN
   • Canada: agreed to take into consideration ISO International Standard 22716 and expects to adopt voluntary GMP standards by ICCR-3
   • Japan: notified local governments that JCIA adopted ISO International Standard 22716.
2. Marketing Surveillance
   • Regulators agreed to exchange information on ingredient and product safety issues, including serious adverse event reports, within the context of their individual confidentiality arrangements and privacy requirements.
3. Safety of Ingredients/Authorized Substances Lists
   • Industry will form a working group to draft a document outlining common and general principles relevant to safety assessment of cosmetic ingredients for consideration by ICCR regulators.
4. Sunscreens
   • Regulators focused on three areas: (1) UVA and UVB test methods, (2) labeling of UVA and UVB efficacy ratings, and (3) approval of sunscreen active ingredients in each country.
   • Regulators agreed on the utility of the ongoing work within ISO to develop test methods.
   • Industry will establish a working group that will provide the ICCR regulators a summary of ISO sunscreen developments, and will keep regulators apprised of work in ISO.
   • The regulators will intensify ongoing discussions regarding efforts within each region to address sunscreen testing and labeling issues.
   • The regulators agreed to share information with each other in order to increase the number of approved sunscreen active ingredients in each region.
5. Alternative Test Methods
   • ICCR created the International Cooperation on Alternative Test Methods (ICATM) working group to enhance cooperation in replacing, reducing, and refining animal testing.
   • ICCR regulators finalized a draft ICATM framework document that will be submitted for endorsement by each region’s regulatory authority by September 2008. The document will be made public when formally adopted.
   • The ICATM framework will address three critical areas of cooperation: (1) validation studies, (2) independent peer review of the scientific validity of test methods, and (3) development of formal test method recommendations on alternative testing methods.
6. Nanotechnology
   • Industry provided a report focusing on a common definition for “Nanotechnology” that is relevant solely for cosmetic products and which describes characteristics of “Nanomaterials” useful for establishing an inventory of current applications in that area.
   • ICCR requested that Industry provide information on the nanotechnology patterns of use survey to address: (1) product categories, (2) frequency of use of nanomaterials, and (3) additional safety testing being undertaken for nanomaterials and products containing them. It was agreed that the manufacturing process will be taken into account.
   • An ICCR Nanotechnology Working Group will be convened in the Fall 2008.
7.  INCI Nomenclature
   • Industry presented preliminary results of two surveys they conducted to demonstrate the level of consumer comprehension of the INCI ingredient labeling name “aqua” on U.S. cosmetic product label ingredient declarations.
   • FDA will discuss the issue internally and invited U.S. Industry to continue discussion with them.