Beveridge & Diamond
 

U.S., EU, Japan and Canada Conclude Third International Meeting on Cosmetics

Beveridge & Diamond, P.C., October 13, 2009

The International Cooperation on Cosmetic Regulation (“ICCR”) held its third annual meeting (“ICCR-3”) September 9-11, 2009 in Tokyo, Japan to discuss issues relating to “cosmetics and cosmetic-like drug-products.”[1]  The ICCR is an international group of cosmetics regulatory authorities consisting of the U.S. Food and Drug Administration (“FDA”), the Ministry of Health, Labour and Welfare of Japan, the European Commission Directorate General Enterprise, and Health Canada.  ICCR aims “to maintain the highest level of global consumer protection, while minimizing barriers to international trade.”[2] 

Previous ICCR meetings yielded several notable benchmarks including the members’ pledge to follow the international guidelines of ISO International Standard 22716 (for the production, control, storage, and shipment of cosmetic products) wherever possible and to exchange information on cosmetic ingredient and product safety, including reports of serious adverse events.  This year, ICCR members focused on the following topics:

  • Industry groups’ proposal for oversight of ingredient safety;
  • Results of the EU workshop on nanotechnology in Ispra, Italy (July 2009);
  • Industry groups’ proposal for future ICCR work relating to cosmetics labeling;
  • ISO activity on sunscreen standards;
  • ICCR expansion; and
  • Regulators’ liaison to the Industry Technical Working Group.[3]

1.       ICCR Background and Procedure

ICCR members host annual meetings on a rotating basis.  The group, which consists of up to three representatives from each member country, works by consensus and under the assumption that all group decisions will be compatible with the laws, policies, rules, regulations, and directives in each respective jurisdiction.  In addition, members pledge to take appropriate steps to implement ICCR decisions and to seek convergence of regulatory policies and practices. 

Annual meetings follow an established structure.  The first day is a “regulators-only” caucus, where member representatives introduce the agenda for the meeting.  On the second day, industry associations are invited to participate in a structured dialogue with representatives.  Prior to the annual meeting, industry associations are asked to solicit input from affected industry sectors in respective regions and to suggest priority action items for ICCR consideration.  Industry groups have the opportunity during day two of the annual meeting to offer opinions on existing agenda items and recommend areas for future work.  On the final day of the annual meeting, representatives meet again in a “regulators-only” caucus to finalize the scope of work for the upcoming year and adopt the meeting report. 

ICCR working groups may be established on an ad-hoc basis.  Participants are appointed by consensus of the members and may be a combination of technical experts and industry representatives.  Thus far, ICCR has established working groups to address cosmetic ingredient safety assessments, ISO sunscreen developments, alternatives to animal testing, and nanotechnology uses in cosmetics.         

2.       FDA’s 2009 Preparatory Public Meeting

Prior to each annual meeting, ICCR members hold a preparatory public meeting in their respective jurisdictions in which all stakeholders may participate.  On September 2, 2009, FDA held a public meeting in preparation for the ICCR-3 meeting in Tokyo.  FDA representatives provided an overview of the ICCR process and summarized the key accomplishments of previous meetings.  According to FDA, the most significant accomplishment of ICCR to date has been the members’ agreement to implement ISO International Standard 22716, Cosmetics Good Manufacturing Practices (“GMPs”)[4] in their respective regions “wherever possible.”[5]  Although voluntary FDA GMP guidelines for cosmetics already exist in the U.S.,[6] FDA has agreed to modify the existing guidelines and to take into consideration ISO International Standard 22716.[7]   

At the meeting, FDA reviewed the ICCR agenda for 2009.  While some topics are a continuation of those discussed in earlier meetings (for example, GMPs, safety of ingredients and authorized substances lists, sunscreens, and nanotechnology), others were entirely new this year.  The 2009 agenda listed for the first time ICCR expansion to other countries and the establishment of a regulators’ liaison to the Industry Technical Working Group as items for discussion. 

At the preparatory meeting, FDA requested public input on the 2009 ICCR meeting agenda or other cosmetics-related issues.  A spokesperson for the Campaign for Safe Cosmetics advocated for U.S. alignment with the “modern” and “more effective[]” approaches of other ICCR members and the inclusion of other stakeholders, particularly consumer health organizations, in ICCR annual meeting discussions.[8]  Industry group representatives from the Personal Care Products Council and the Independent Cosmetic Manufacturers and Distributors expressed concerns regarding the burdensome nature of different regulatory requirements in different jurisdictions.  Both industry groups expressed support for the ICCR’s harmonization efforts.  FDA representatives agreed to raise the issue of broader stakeholder participation at the ICCR annual meeting and to continue working with industry to harmonize cosmetics regulations among jurisdictions.         

3.       Progress Report: ICCR-3

 Several important developments occurred at this year’s annual meeting. 

Safety of Ingredients / Authorized Substances Lists:  At the ICCR-2 annual meeting in 2008, the regulators asked industry to form a working group to draft a document outlining “the common and general principles” relevant to safety assessment of cosmetic ingredients.[9]  In response, industry submitted a proposal on regulatory oversight of ingredient safety to the regulators at ICCR-3.  After reviewing the proposal, the regulators asked industry to submit a more detailed proposal within 2-3 months following the meeting.

Nanotechnology:  In 2008, industry presented a report at the ICCR-2 meeting that focused on establishing a common definition for “nanotechnology” with respect to cosmetic products.[10]  The regulators requested additional information from industry on nanotechnology patterns of use and declared that an ICCR Nanotechnology Working Group would be convened in the fall of 2008.  It does not appear that the Nanotechnology Working Group was established in 2008 because the ICCR-3 meeting summary states that an ad hoc working group will be established to discuss criteria for nanomaterials used in cosmetics and does not reference any existing working group.  The 2009 nanotechnology discussions focused on the outcomes of the European Commission Joint Research Centre nanotechnology workshop, which may provide a basis for future ICCR work.

Cosmetics Labeling:  At the first ICCR meeting in 2007, industry advocated for a harmonized approach to cosmetic ingredient labeling.  In response, ICCR regulators invited industry to submit data establishing that U.S. consumers understand the meaning of “trivial names.”[11]  Industry presented data at ICCR-2 to demonstrate U.S. consumer comprehension of the ingredient “aqua” on cosmetic product labels.[12]  This year, industry submitted a proposal for future ICCR work relating to cosmetics labeling.  Industry has agreed to revise this proposal (at the request of regulators) to be “more specific.”[13]

Sunscreens:  The regulators discussed sunscreens in detail at the ICCR-2 meeting in 2008.  At that meeting, the regulators agreed to “intensify” ongoing discussions within each region to address sunscreen testing and labeling.  The group also agreed to share information with each other to increase the number of approved sunscreen active ingredients in each region, and requested that industry establish a working group to track ISO sunscreen developments.  This year, the ICCR-3 meeting summary states only that “industry and regulators agreed to support ISO sunscreen activities.” 

ICCR Expansion:  The regulators and industry groups concluded that it is too early for expansion of ICCR to other member countries.  However, the group did begin preliminary discussion of criteria that would apply in selecting new members.  It was agreed that an impact assessment should be developed before any potential ICCR expansion.

Regulators’ Liaison:  ICCR regulators and industry groups agreed to explore options to improve communications between the two groups in order to maintain the efficiency and productivity of ICCR.          

4.       Implications

International activity through the ICCR process has the potential to shape the direction of cosmetics regulation in the United States.  Even though ICCR decisions must be compatible with the laws and policies in each respective jurisdiction, the goal of regulatory convergence may drive U.S. cosmetics standards to meet those of other ICCR members such as the European Union.  In addition, the ICCR provides a forum where industry will continue to push for international harmonization.  It is also clear that U.S. regulators are beginning to incorporate materials generated through the ICCR process, as well as ICCR discussions, in domestic rule development.  For example, FDA has indicated that it will consider the ICCR regulators’ discussion of international standards for efficacy testing before finalizing a long-awaited regulation on over-the-counter sunscreen.[14] 

This client alert was prepared by Mark Duvall.  Lauren Hopkins assisted in its preparation.



[1] FDA, Cosmetics, International Activities, “International Cooperation on Cosmetic Regulation (ICCR-3),” September 2009, Meeting Summary, http://www.fda.gov/Cosmetics/InternationalActivities/Conferences
MeetingsWorkshops/InternationalCooperationonCosmetics
RegulationsICCR/ucm182661.htm
[hereinafter ICCR-3 Meeting Summary].

[2] Terms of Reference for the “International Cooperation on Cosmetic Regulation” (“ICCR”) among Health Canada, European Commission DG Enterprise and Industry, Ministry of Health, Labour, and Welfare of Japan, Food and Drug Administration of the United States of America, available at http://www.fda.gov/InternationalPrograms/
HarmonizationInitiatives/ucm114522.htm
.

[3] ICCR-3 Meeting Summary.

[4] ISO 22716 is available for purchase through the International Organization for Standardization website at http://www.iso.org/iso/catalogue_detail?csnumber=36437.

[5] FDA, Cosmetics, International Programs, “International Cooperation on Cosmetic Regulation ICCR-2,” August 2008, Meeting Summary, http://www.fda.gov/InternationalPrograms/HarmonizationInitiatives/
ucm114520.htm
[hereinafter ICCR-2 Meeting Summary].

[6] See FDA, Cosmetic Good Manufacturing Practice Guidelines (2008), http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatory
Information/GoodManufacturingPracticeGMPGuidelinesInspection
Checklist/default.htm
.

[7] ICCR-2 Meeting Summary.

[8] Testimony on behalf of The Campaign for Safe Cosmetics, Presentation to the ICCR Preparatory Meeting On behalf of the Campaign for Safe Cosmetics, September 2, 2009.

[9] ICCR-2 Meeting Summary.

[10] ICCR-2 Meeting Summary.

[11] FDA, Cosmetics, International Activities, “International Cooperation on Cosmetic Regulation, Outcome of Meeting, September 26-28, 2007,” http://www.fda.gov/Cosmetics/InternationalActivities/
ConferencesMeetingsWorkshops/InternationalCooperationonCosmetics
RegulationsICCR/ucm126530.htm
.

[12] ICCR-2 Meeting Summary.

[13] ICCR-3 Meeting Summary.

[14] Jennifer C. Smith, FDA Week, “FDA to Issue Final Sunscreen Rule after International Meeting” (Sept. 4, 2009).

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