FDA’s Office of Cosmetics and Colors held a Public Meeting last week to provide interested parties with a summary of the International Cooperation on Cosmetics Regulation’s upcoming annual meeting (ICCR-11), which is scheduled for July 12-14, 2017 in Brazil. FDA’s meeting also provided the public with an opportunity to comment on cosmetics safety issues ahead of the ICCR’s July 2017 annual meeting. During the meeting, FDA Office of Cosmetics and Colors Director, Dr. Linda Katz, provided a summary of the organizational structure of the ICCR and outlined some of the agenda items scheduled for ICCR-11 in Brazil.

By way of background, the ICCR was established in 2006 as a voluntary international group of cosmetics regulatory authorities that includes as founding members, the pertinent regulatory bodies of the US, EU, Canada, and Japan – with Brazil joining in 2014. The ICCR meets annually at rotating international venues to discuss and update its various harmonization efforts related to cosmetics safety and regulation and the minimization of barriers to trade for personal care products. The primary focus of the ICCR is to promote and facilitate mutual understanding of cosmetics regulation and the exchange of scientific and regulatory knowledge related to cosmetics. The ICCR also works to develop harmonized cosmetic safety standards and utilizes quarterly teleconferences and Work Group meetings on issues under development/review.

The most recent annual meeting of the ICCR (ICCR-10) was held in July 2016 in Bethesda, MD and covered the following regulatory topics:

  • Integrated strategies for ingredient safety assessment;
  • Aggregate exposure assessment for ingredients – a presentation from industry;
  • International standards;
  • Product preservation;
  • Microbial contaminants – the ICCR adopted ISO – 17516, “Microbial Limits” standard;
  • Allergens – reviewed white paper entitled, “Survey of Approaches Undertaken to Develop Lists of Potential Allergens in Cosmetics; and
  • Trace substances – ICCR focusing on acceptable trace levels for 1,4-ZDioxane and Mercury.

ICCR-10 was also attended by the regulatory bodies from Columbia, Korea, Saudi Arabia, South Africa, and Taiwan, which were granted “Observer” status by the ICCR to attend the meeting. These same countries are also expected to attend ICCR-11 in Brazil.

Agenda topics for ICCR-11 include several similar issues that were discussed at ICCR-10 last summer:

  • Microbiology standards;
  • Integrated strategies for ingredient safety assessment;
  • Product preservation; and
  • Allergens.

FDA’s meeting also included presentations from Cruelty Free International and the National Center for Health Research (NCHR). Monica Engebretson from Cruelty Free stated that the ICCR should work more diligently to end animal testing on cosmetics worldwide, noting that the need for animal testing is now rare due to the many non-animal tests that have been validated and adopted over the past 15 years. Cruelty Free believes that the FDA and other regulatory bodies should follow the example of the EU, which phased-out animal testing over a 10 year period between 2004-2013. In addition, Cruelty Free does not support using testing conducted under the EU’s Reach regulation to validate ingredient safety for cosmetics.

Megan Polanin of NCHR stated that endocrine disruptors, such as parabens and phthalates, are still being widely used in cosmetic formulations, despite the growing body of scientific evidence of harmful health effects associated with human exposure to these classes of ingredients. NCHR also supports further reductions in the permitted trace amounts of lead and mercury in cosmetics. NCHR believes the ICCR should set high standards for trace levels of all ingredients of high concern. Finally, NCHR noted that “voluntary standards” without “enforcement” do not provide much benefit to consumers.

In summary, the ICCR has been working on cosmetic ingredient/product safety issues and the development of safety-related standards since its formation in 2006. This work is expected to continue this summer, July 2017 at ICCR-11, and include the following cosmetic safety-related topics: strategies for ingredient assessment; product preservation; microbiology; and allergens.