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Quick Take on the June 5 FDA ICCR-13 Preparation Meeting

For those working in the compliance function of a cosmetic company, you understand how important it is to stay on top of regulatory changes on the horizon.

I was able to be on-site last week when the FDA held an International Cooperation on Cosmetics Regulation (ICCR) preparation public meeting at the Center for Food Safety and Applied Nutrition in College Park, MD.

Here are the background and highlights you should be aware of as regulators head into the ICCR-13 meeting in Montreal, Canada next month.

Why Did this Public Meeting Take Place?

Per the FDA Federal Register announcement “The purpose of the public meeting is to invite public input on various topics pertaining to the regulation of cosmetics. We may use this input to help us prepare for the ICCR-13 meeting that will be held July 9 to 11, 2019, in Montreal, Canada.”

What is the ICCR?

Dr. Linda M. Katz, MD, MPH, Director, Office of Cosmetics and Colors, kicked-off the meeting and provided an overview of the ICCR process.

The ICCR was established in 2006 with the first meeting held in Brussels in 2007. The impetus for the ICCR was determined through the Cosmetic Harmonization and International Cooperation (CHIC). This group with regulatory representatives from Canada, EU, Japan, and the U.S. first came together in Brussels in 1999 with the objective of international harmonization in cosmetics. They met 3 times with the intention of finding cosmetic regulatory alignment and developing “Memorandum of Cooperation” (MOC) internationally. However, Dr. Katz explained, they felt they weren’t solving problems and decided to disband and instead create the ICCR.

The current members of the ICCR include Canada, EU, Japan, U.S. and Brazil (as of July 2014). The overall goals of the ICCR are to remove regulatory obstacles while still maintaining public health focus for safe products, international alignment and cooperation without “downward harmonization”, and to obtain input from industry trade associations.

Why is the ICCR Annual Meeting Important?

The group has met annually for the last 12 years and is holding its 13th annual meeting this year in Montreal. The 3-day meeting begins with a “regulators-only” meeting, with 2nd day opening up to industry with stakeholder presentations. The final day is for the regulators to assess and adopt meeting outcomes.

The ICCR-12 annual meeting was held in Tokyo, Japan in July 2018 and included many topics discussed in this ICCR press release. In addition to the member countries, “observers” from Israel, South Africa, South Korea, Taiwan, Thailand, and Columbia also attended. Topics included the following:

  • Integrated Strategies for Safety Assessments of Cosmetic ingredients
  • Analytical Test Methods
  • Cosmetic Product Preservation
  • Allergens
  • Communications
  • Microbiome
  • Update from Observing Regulators
  • Industry update on e-Commerce
  • Stakeholder Presentations

What Will Be Discussed at ICCR-13?

Many of the items from ICCR-12 are still in progress and will be part of the ICCR-13 agenda. The joint working groups (JWG) for Integrated Strategies for Safety Assessments of Cosmetics Ingredients, International Standards, Cosmetic Product Preservation, and Allergens are continuing to work on their topics. New JWGs were created on Communications and Microbiome.

The upcoming ICCR-13 Agenda includes the following:

  • Integrated Strategies for Safety Assessments of Cosmetic Ingredients
  • Cosmetic Product Preservation
  • Allergens
  • International Standards
  • Communications
  • Microbiome
  • New Proposed Agenda Items

What Happened at the June 5th FDA Public Meeting?

Here’s where last week’s FDA public meeting comes into play. The following comments were offered at the meeting and may be taken into consideration in preparation for ICCR-13:

  • Jay Ansell, PhD, Vice President of Cosmetic Programs at PCPC stressed that international harmonization is critical to level the playing field and reinforce consumer confidence in product safety. Dr. Ansell commended the ICCR and its role as an important forum to aligning regulations.
  • Deborah Campbell, CRNP, MSN from the American Cosmetic Manufacturers Association stated her group struggles with the differences in regulations between the EU and FDA. The stricter EU regulations are time-consuming and costly, especially for smaller manufacturers. Although the EU has 1300 banned ingredients to FDA’s 11, she stated some of the ingredients listed have never been used in cosmetics. The differences with OTC ingredients such as sunscreen are also very confusing for the industry. FDA treats OTC as a drug, but the EU treats it as a cosmetic based on differing definitions. Harmonization is critical to minimizing barriers to international trade.
  • Mary Hilley from The Humane Society of the United States urged the FDA to consider banning animal testing on all cosmetics and join several countries who already have as well as the state of California. The organization is partnering on an initiative with several large cosmetics and CPG companies to establish non-animal testing methods by 2023 as part of the Be Cruelty-free Campaign.

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