FDA and the European Commission Enterprise Directorate General Bilateral Meeting: Cosmetic Breakout Meeting
October 27, 1999
During a meeting between FDA and the Enterprise Directorate General of the European Commission, in Brussels, Belgium, in October 1999, representatives of both agencies gathered in a "breakout" meeting to discuss international activities related to cosmetics. The subjects included the progress of a memorandum of cooperation (MOC), animal testing, ultraviolet (UV) filters, color additives, labeling, future steps, safety issues, priorities at FDA's Center for Food Safety and Applied Nutrition (CFSAN), safety substantiation, and harmonization in Latin America.
Memorandum of Cooperation (MOC)
The MOC had been reviewed by the European Union (EU) and US administrations and comments were received from FDA legal counsel. It was determined some additional work would be needed to finalize the MOC. In light of the development of an MOC encompassing the four administrations (US, EU, Japan, and Canada) of the Cosmetic Harmonization and International Cooperation (CHIC) initiative, it was decided that the current MOC would be developed as a bilateral document that could be expanded after consideration by Canada and Japan. It was agreed that the bilateral MOC should be implemented as soon as possible to ensure accomplishment of specific initiatives identified at the November, 1998 bilateral meeting and at this meeting.
The US cosmetics representative described the process for validation and acceptance of alternative methods and the role that the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) plays in assessing the scientific soundness of such methods for cosmetic products. It was noted that ICCVAM functions as a scientific advisory committee that then refers alternative methods to the appropriate US agencies and that each agency and specific agency program must consider how the procedure should be incorporated into their public health responsibilities. The US representatives described the different mechanisms that are available for the drug and cosmetics programs for reviewing and recognizing alternative methods and the scope of application. Of special significance is that the various avenues for submission and review (ICCVAM, petitions and New Drug Application submissions) provide reasonable options for the different regulatory structures of both the EU and US.
Because of scientific and process complexities surrounding validation and regulatory acceptance of alternative methods in the US and the EU, it was decided that the appropriate FDA and EU technical staff should interact early in the process to ensure consistency as much as possible. It was further suggested that the next CHIC meeting include a possible satellite meeting among the scientists to consider mechanisms for timely sharing of information.
The EU delegation provided a status report on the 7th Amendment to the Cosmetics Directive. Current EU law imposes a ban on the marketing of cosmetic products containing ingredients tested on animals beginning in July 2000. There have been a number of proposals for changes in this requirement that contemplate either a marketing or testing ban. The scope and impact depends, in part, on the legal interpretation of the animal testing language in the Cosmetics Directive. EU legal experts were reviewing the language and discussing the issue with the regulated industry.
Ultraviolet (UV) Filters
The EU is about to reach a final decision on several new ingredients from the list of provisionally approved UV filters. There remains an interest in exchanging UV filter approval files, although this awaits industry agreement to share information. The US delegation suggested that avobenzone would be a good candidate for information sharing since it was recently reviewed.
Other issues of approval and safety in both the US and EU were discussed. It was suggested that a joint EU/US working group be established at the scientific level as early as possible to pursue issues relative to efficacy testing with a goal of sharing information and coordinating test procedures to the degree possible. FDA noted that time was very important since the agency was obligated to meet legally established time frames. The mechanisms for doing this were discussed and respective authorities would be identified to facilitate collaboration in the identification of suitable methodologies for measurement of high SPF and UVA protection. Another group would be established to review and discuss the methodology for measurement of SPF. It was noted that the EU has not established testing methods for member states and that the current approach was to employ methods recommended by the European Cosmetic, Toiletry and Perfumery Association (COLIPA).
Another discussion item included the pending proposed rule on additional conditions for consideration in the over-the-counter (OTC) drug review. FDA agreed to provide copies to the EU delegates when this is published.
The status of sharing information on color additive approvals in the US and EU was discussed. This issue was awaiting completion of an MOC for protecting confidential information. The EU delegates noted that the EU industry has been notified of the need to agree to the release of information supporting the approval of an a typical color additive in the EU but that a response has not yet been received. Some concern was expressed that the EU industry may not agree to releasing safety approval information for EU approved colors. The US delegation suggested the possibility of analyzing several different cosmetic-grade color additives currently in use in the EU to determine their composition. It was decided to explore this possibility further.
The issue of cosmetic product labeling and ingredient nomenclature was discussed. The EU delegates noted that the EU ingredient inventory was introduced about 5 years ago as required by the Cosmetics Directive. The review committee acknowledged at the time that there were problems with the EU Ingredient Inventory. There have been approximately 1,500 new ingredients added to the inventory, based primarily on information provided by COLIPA, and this new information has been reviewed and translated. A draft update was developed about 18 months ago, with the final draft scheduled for completion in December, 1999. An English version was scheduled for posting on the Web at that time. The EU delegation agreed to provide an electronic copy of the current inventory to the US delegates and also the updated inventory when it becomes available.
The US delegates noted that they are exploring the development of a US inventory but the issue would have to be explored with the US cosmetics stakeholders.
It was agreed that the US-EU bilateral discussions have proven mutually beneficial and should continue. It was further noted that the US and EU should consider more frequent collaborations and that these should include satellite meetings scheduled during the same weeks as EU participation in the Cosmetic, Toiletry, and Fragrance Association (CTFA) [since renamed the Personal Care Products Council] quarterly nomenclature meetings. To facilitate the planning and monitoring of the various activities currently planned under the bilateral agreements, the EU delegation agreed to prepare an activity map that will be shared with the delegates.
It was noted that the EU industry suggested that a CHIC meeting be held in conjunction with the April 2000 Mutual Understanding Conference, but it was agreed that any collaborations among the administrations must remain independent.
Some concern was expressed that the US-EU bilateral program should not weaken the progress made under the CHIC program. It was noted that changes in the regulatory schemes are underway in Japan and Canada and that the US-EU bilateral should proceed but with an effort to keep the other partners informed of activities under the bilateral. To this end, the US delegates agreed to make sure that all CHIC partners receive copies of any relevant documents. The US delegates offered to host the next CHIC meeting and suggested that it be scheduled for next May or June. The US delegates agreed to draft a letter to our partners proposing the date and location of the next CHIC meeting. [Note: The CHIC meeting will be in Washington, D.C., May 8-10, 2000.]
The US delegates updated the EU delegates on the status of the safety review of alpha hydroxy acids (AHAs) and diethanolamine (DEA). It was noted that FDA intended to complete a photocarcinogenicity study of AHAs in a newly established testing facility and that this study will commence in the summer of 2000. It was noted that the cosmetics industry was considering a parallel photocarcinogenicity study incorporating sunscreens and that FDA had suggested that the additional test could be funded through the National Toxicology Program (NTP), but study capacity was not adequate for that at this time.
It was further reported that the agency was nearing completion of a risk assessment for DEA in marketed products and that, once completed, a decision regarding risk control would be made. The FDA delegates also reported that an analytical method, sensitive at the parts-per-million level, has been developed and a preliminary survey has found levels up to approximately 0.5% DEA in finished products. FDA offered to provide a description of the method to the EU.
The US delegates asked about the status of fragrance labeling in the EU and when a final decision was expected. The EU delegation said that a final opinion would be provided by the Scientific Committee for Cosmetic and Non-Food Products ( SCCNFP) in early December, 1999. It was reported that the European industry favored a voluntary labeling approach and that US industry would oppose any steps beyond a voluntary approach.
Center for Food Safety and Applied Nutrition (CFSAN), Office of Cosmetics and Colors (OCAC) Priorities
The EU delegation was provided a status report on the initiatives being proposed as high priority for the US cosmetics program. These included various ingredient safety projects, cosmetic ingredient nomenclature, surveillance and market-place monitoring, enhancing the Voluntary Cosmetic Registration Program (VCRP), consumer and industry assistance and international harmonization.
FDA noted that a review of the SCCNFP guidelines for substantiation of the safety of ingredients had been completed and that written comments would be provided. The EU delegates said that the SCCNFP is aware of the review and welcomes the comments from FDA. These comments would then be shared with the other CHIC partners.
Harmonization in Latin America
The EU delegate provided a status report on harmonization efforts in Latin America. It was reported that a meeting of Latin American authorities was scheduled for mid-November in Chile. It was further reported that the EU planned to sponsor a training session on implementation of the EU in-market control system to assist the Latin American authorities in making the transition.
The US representatives expressed concern that the Latin American authorities be aware that the EU cosmetics definition could not stand alone without an effective product information package (dossier) system. The US delegates noted that the meeting in August in Venezuela addressed the adoption of the EU cosmetics definition but did not include discussion of the accompanying safety and efficacy requirements in the EU. The EU delegates noted that this had been pointed out to the Latin American authorities in several previous meetings and expressed the belief that the shift to an in-market system would offer a substantial improvement over the current licensing systems prevalent in Latin America.