Cosmetics Harmonization and International Cooperation (CHIC) Meeting, Washington DC, May 8-9, 2000
The second Cosmetics Harmonization and International Cooperation (CHIC) meeting took place in Washington, D.C., May 8-9, 2000. Participating in the meeting were representatives of FDA, Health Canada, Enterprise Directorate General of the European Commission (EC), and Japan's Ministry of Health and Welfare (MHW).
The U.S. representative opened the meeting and reviewed the areas covered at the previous CHIC meeting, including the large number of commitments made by the group. It was noted that the previous meeting was successful in bringing together the administrations, but that the goals and tasks must be considered in light of available resources.
Highlights of the previous meeting included introductions to the regulatory schemes in the various administrations and the goal of finding areas of commonality, rather than a single global structure.
During the morning presentation, FDA's Center for Food Safety and Nutrition (CFSAN) Director Joseph Levitt addressed the group, emphasizing the need for basic trust building, finding areas of commonality, addressing reporting mechanisms, looking for opportunities to improve public health, and the different agencies' common goal of doing their job better.
It was emphasized that this initiative is for the purpose of exploring areas of commonality and possible alignment rather than harmonizing to arrive at one global definition or legislative structure.
Memorandum of Cooperation
A presentation by FDA's Office of International Programs addressed the Memorandum of Cooperation (MOC) under development. The purpose of the Agreement is to promote cooperation and exchange of information, including non-public information, among participants. The agreement supplements and streamlines existing procedures in FDA's regulations (21 CFR 20.89). The draft agreement had been proposed at CHIC I, Brussels, April 1999, as a quadrilateral agreement. Later it was redrafted as a European Union (EU)-U.S. bilateral due to a variety of transatlantic initiatives. Also, the Japanese and Canadian systems are undergoing change while the U.S. and EU systems are not. It was explained that FDA is entirely flexible as to whether to have a quadrilateral agreement with Canada, the European Commission, and Japan or to have a series of bilateral agreements. In either case, the current draft is a model that each perspective party could take back to its respective government for consideration. The possibility of a trilateral agreement also was mentioned. The EU representative expressed a preference for a quadrilateral agreement.
The Japanese officials stated that in the opinion of some, an MOC is not always necessary because each administration has rules for handling confidential information and officials in each administration have a responsibility to maintain the confidentiality of certain information. U.S. officials, on the other hand, expressed the opinion that either a confidentiality commitment under FDA regulations (21 CFR 20.89) or an MOC is a necessity if we are to be able to provide confidential commercial information to foreign regulatory partners.
It was suggested that each delegation should confer with its own administration regarding whether it preferred a series of bilateral agreements, a single quadrilateral agreement, or possibly a trilateral agreement (if three of four participants have an interest in this matter). A conference call is planned for July, to be arranged by FDA, to discuss next steps and progress made in discussions.
The EU representative reported on developments involving the draft proposal on the 7th Amendment regarding animal testing. The amendment must be agreed upon by the European Council and Parliament before it takes effect. The 7th Amendment shifts emphasis from a marketing ban, which would have been imposed by the 6th Amendment, to a testing ban. When approved, the 7th Amendment will prohibit animal testing of finished products in EU member states after December 1, 2001, with no animal testing permitted on ingredients or combinations of ingredients after December 1, 2004. As of January 5, 2004, the ban could be postponed for two years if there is a lack of validated alternatives. The Amendment also requires the use of in vitro test methods validated by the European Centre for the Validation of Alternative Methods (ECVAM).
The EU official reported that the EC would like to see other markets give thought to a similar ban and encouraged the development and validation of in vitro testing. It was noted that the marketing ban currently included in the 6th Amendment has been extended for a period of two years to allow for passage of the 7th Amendment.
The president of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) reviewed current activities and procedures, describing ICCVAM's mission as the coordination of issues relating to the development of validation, acceptance, and harmonization of test methods. ICCVAM evaluates test methods of multi-agency interest, but does not provide formal regulatory acceptance.
The possible participation of ICCVAM to facilitate the harmonization process was discussed. The ICCVAM representative stated that its test guidelines were virtually identical to those of the Organization for Economic Cooperation and Development (OECD). The EU official suggested that ICCVAM and ECVAM need to communicate at the scientific level to ensure that the two systems review the same information as soon as possible and that future agreement on validation of in vitro tests should be negotiated. The issue of transparency in the ICCVAM and ECVAM programs also was discussed.
The EU representative stressed the importance of developing and validating in vitro tests, and also the importance of collaborating within the framework of OECD. Finally, it was agreed by most participants that a statement should be made to encourage the cosmetics industry to budget development and validation of further in vitro tests.
A round-table discussion addressed the differing nomenclature needs in the various administrations. According to the U.S. official, dual declaration is generally accepted in the U.S., with the international name of the ingredient in parentheses, including Colour Index (CI) designations for color additives. The Canadian delegation explained that Canada must consider the requirements of the Office de la langue française du Québec and the Federal French Language Office. The EU official reported that the update of the ingredient inventory will include more than 7,000 names. The final review by the Scientific Committee for Consumer Products and Non-Food Products (SCCNFP) and revision by the European Cosmetic, Toiletry and Perfumery Association (Colipa) are expected by September 2000. Botanical names will change to name by genus/species, part of the plant, and type of preparation.
A presentation by a U.S. delegate covered the history of the Cosmetic Ingredient Dictionary. The current size of the dictionary has made a monograph-by-monograph review impractical. The U.S. is exploring the concept of an inventory, but must consider the legal impact and other approaches.
A U.S. representative gave a presentation on U.S. requirements for the approval of new color additives, as covered by the Code of Federal Regulations. This included a discussion of color applications over the last two years.
Tattoo colors, regulation, and enforcement were discussed. The U.S. delegation explained that FDA's interest in tattooing had increased as the popularity of tattooing had grown. Some safety concerns had been identified but not resolved. According to the EU representative, tattoo colors are not classified as cosmetics in Europe, but the EU may reconsider this. Canadian officials reported that tattooing has become more popular in Canada, similar to the U.S. The Japanese officials reported that tattoo colors are not subject to Japan's Pharmaceutical Affairs Law.
Regarding color additives in general, the U.S. official suggested that it may be helpful to develop a comparative list of color additives approved in each of the four administrations in order to identify similarities and differences.
CHIC participants will await an EU decision on the classification of tattoo colors as cosmetics. If the EU classification as cosmetics occurs, then the CHIC partners will provide available product and safety information to SCCNFP.
Regulatory Reform in Japan
The Japanese delegation discussed changes in the regulation of cosmetics in Japan. Among the changes planned are the abolition of premarket approval, the establishment of a prohibited ingredient list similar to those in the EU and U.S., the abolition of the designated ingredient list, and the new requirement for complete ingredient listings. Notification regarding this regulatory reform already has taken place through the World Trade Organization Agreement on Technical Barriers to Trade, the Japanese delegation reported. The quasi-drug category will remain but the classification of some items on the current quasi-drug category is likely to change.
The U.S. delegation addressed communication efforts at the Office of Cosmetics and Colors, discussing both the CFSAN Outreach and Information Center telephone information system and the cosmetics Web site. This was followed by a discussion of the status of Web sites at each administration. The EU and Canada reported that they are revamping their Web sites and expressed an interest in the new coverage of international activities at FDA's cosmetics Web site. It was agreed to consider developing links between the administrations.
Regulation of Nonprescription Drugs in Canada
The Health Canada delegation presented a review of nonprescription drug regulation in Canada. Among changes currently underway are a new organizational structure, including the place of cosmetics in the organizational structure, and a transition to a product licensing system. This transition involves a shift from two premarket risk categories to four. The presentation included, among other subjects, an explanation of the four drug categories recognized by Health Canada: over-the-counter (OTC) drugs (including natural health products); prescribed drugs, such as insulin, nitroglycerin, and low-dose ASA; prescription drugs, which require a written prescription; and controlled drugs and substances. An analysis of how a fast-track system is used for premarket review was presented, using anti-dandruff shampoos as an example of a Category IV monograph.
A representative of FDA's Division of OTC Drug Products addressed the status of sunscreen regulation in the U.S. The final monograph for sunscreen drug products was published in the Federal Register May 21, 1999. The effective date will be extended to December 31, 2002, in response to a petition submitted by the Cosmetic, Toiletry, and Fragrance Association (CTFA). Two main areas of concern included the testing and labeling of sunscreen drug products with SPF values above 30, and the determination of a standardized ultraviolet A (UVA) radiation testing methodology with integrated UVA/ultraviolet B (UVB) radiation labeling. One particular concern involved the possibility that a high sun protection factor (SPF) number may encourage consumers to extend their exposure to the sun.
Further concerns involved the relevance of current UVA in vivo and in vitro testing to human beings and the need for evidence to support claims for broad-spectrum protection. Claims should not be misleading, confusing, or provide a false sense of security. It also was noted that some ingredients used worldwide are non-monograph in the U.S.
The U.S. representative also discussed the proposed rule regarding additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded that have no U.S. marketing history.
During discussion that followed, the Canadian delegation noted that all sunscreen ingredients approved in Canada appear in the EC document 99/III/COS/34, which includes a list of "approved UV filters/sunscreens in three regions/countries."
The Japanese delegates noted that their administration will consider on a case-by-case basis the addition of new sunscreen ingredients based on applications from manufacturers or importers, and that an information exchange with the EU and other administrations would be useful in considering such applications. In collaboration with Colipa, the EU has sent the complete file of toxicological data of the sunscreen octocrylene to Japan in order for their safety assessors to produce a safety evaluation of this sunscreen. All the documents were translated into Japanese and are to be considered as an example to try to align the safety evaluation between Japan and the EU.
The issue of revising and reviewing the cross-reference list was discussed. The EU noted that five new sunscreen ingredients were approved in the 24th Adaptation to the Cosmetic Directive. The EU delegate noted that the EU would like to follow closely the U.S. work done on developing a method to measure high SPF claims and also the U.S. work done on the possible photocarcinogenicity of UVA. The U.S. delegate agreed to inform the EU on new developments.
OTC Drug Labeling Requirements
A representative of CDER's Division of OTC Drug Products reviewed the new OTC drug labeling requirements. Noting the differences among product categories among the various administrations -- including OTC drugs in the U.S. and Canada, pharmaceuticals in Japan, and cosmetics in the EU -- the EU representative suggested that a cross-referenced list should be developed to allow comparison for possible future alignment. It was proposed that the industry prepare this list. The aim of producing such a list should be to get an overview of the different product types, and thereby see if there are any possibilities for aligning the different legislation.
The U.S. delegation addressed the possibility of international cooperation in the area of a safety alert system, discussing possible means of sharing adverse event information. It was noted that in Japan manufacturers and importers must provide to MHW any reports of studies about adverse events they know about, but that such reports are few. The EU representative reported that member states alert other member states through a Directorate General (DG) Sanco central reporting system and that this occurs at two levels, depending on the level of concern. The EU representative stated that it is a high priority in the EU to establish a cosmetovigilance system and asked if other such systems were in place. None was identified.
The U.S. delegation provided an overview of safety substantiation in the U.S., including the requirement that cosmetics be "safe for their intended use," industry preference for self-regulation, and activities of the Cosmetic Ingredient Review (CIR). It was noted that FDA had formed an ad hoc committee to look at the Scientific Committee for Cosmetic Products and Non-Food Products Intended for Consumers (SCCNFP) Notes of Guidance for Testing of Cosmetic Ingredients and Their Safety Evaluation, that SCCNFP seemed to function similarly to the CIR, and that SCCNFP appeared to place emphasis on the safety of ingredients rather than finished products.
The EU representative distributed copies of the new "CosmetLex vol. 1, 2, and 3," of which vol. 2 is the SCCNFP safety substantiation guidelines, to CHIC participants.
Japanese and Canadian guidelines on safety substantiation are a priority at this time. Canadian guidelines are modeled after those used by the EU.
There did not appear to be a need for a single safety substantiation guideline for CHIC members. However, it was noted that the U.S. and Canada are interested in developing guidelines and would use the EU document as a model.
The EU representative addressed the issue of fragrance allergenicity, referring to the SCCNFP opinion that fragrance is a leading cause of contact allergy and that 24 fragrance ingredients were named as the main causes of fragrance allergenicity. However, data from the study were not sufficient to determine a dose-response relationship. It was noted that dermatologists use a mix of 11 common fragrances for testing consumers who report allergic reactions. SCCNFP has stated in an opinion dated April 2000 that 44 substances banned by the International Fragrance Association (IFRA) should not be used; however, the EU delegate noted that compliance with IFRA guidelines is voluntary and that manufacturers do not necessarily adhere to IFRA recommendations. The EU representative added that Colipa has submitted a voluntary proposal that would include labeling of 11 fragrance ingredients, clear selection criteria for relevant fragrance allergens, the concept of risk assessment cut-off levels, testing of new fragrances, and labeling. The proposal would take effect no later than December 2001. The member states will decide whether to accept a voluntary or mandatory system for fragrances. Other CHIC members said they would follow closely what happens in the EU. The EU delegate circulated copies of the two opinions adopted by SCCNFP and asked if fragrance allergenicity was recognized as a problem in the other administrations. The U.S. and Canada said that it was.
It was decided that the CHIC program is of continuing interest to the group and that a meeting would be planned for next year.