Cosmetics Harmonization and International Cooperation, April 7-8, 1999
The first Cosmetics Harmonization and International Cooperation (CHIC) meeting took place in Brussels, Belgium, April 7-8, 1999. Participating in the meeting were representatives of FDA, Japan's Ministry of Health Labour and Welfare (MHLW), Health Canada,and Directorate General III (DG III) of the European Commission.
Among the topics discussed were basic safety substantiation, exchange of data and information, development of an international alert system and a draft memorandum of cooperation.
Basic Safety Substantiation
The basic substantiation of safety of ingredients and products was identified as a high priority for all regulatory administrations represented and a logical starting point for all efforts in alignment among the administrations. It was determined that only after this stage has been successfully completed can the administrations consider common criteria for such concerns as approved materials and alignments of procedures.
As a starting point in these discussions, it was determined that the European Union (EU) Scientific Committee for Cosmetics and Non-Food Products (SCCNFP) Notes for Guidance on the Safety Assessment of Cosmetic Ingredients would be reviewed. The Guidelines were distributed during the meeting to be assessed for applicability within each administration, with comments to be received by DG III by November 1999. It also was determined that comments from interested parties would be reviewed.
Exchange of Data and Information
Exchange of data and scientific reviews were identified as a key priority by the administrations that would serve to reduce duplication of efforts. In addition, this would help the administrations gain closer alignment in both scientific assessments and policy decisions.
Each administration agreed to review the legislative implications of such collaborative exchanges and issues relating to protection of confidentiality. Due to the issues associated with the dissemination of intellectual property, it was planned that a "general consent document" for sponsor approval would be developed and shared with industry for comments by December 1999.
Once comments have been received from all industry parties, the delegates planned to clarify procedural rules and identification/specification of requests and working practices.
An alert system for notification of dangerous goods was identified as a high priority and the administrations discussed product recalls that had taken place independently in the different regions for the same products. Although systems already have been established in the different administrations, their compatibility was not clear. The development of a concept paper was planned for coordinating and disseminating alert information between administrations.
The administrations agreed to identify the key elements of such a system by the end of May 1999, with a draft concept paper to be prepared and distributed among the administrations by the end of September 1999. Once the review within the administrations is complete, the document was to be distributed for comment.
Memorandum of Cooperation
A draft document was prepared and discussed briefly by the delegates. The draft was to be forwarded through the respective administrations for concurrence by senior officials.
A draft table comparing the UV filters (sunscreens) permitted for use in each region was distributed in the meeting. Following preliminary discussions it was agreed that each administration would ask its respective industry to review a draft table and check it for accuracy and completeness. As a consequence of the on-going revision of Japanese regulations, the MHW planned to review the files of the candidate filters for the draft Japanese positive list, once those reviewed and approved in the EU have been submitted to the ministry by the industry.
It was planned that the table would then be reviewed by the respective administrations to confirm accuracy to develop a reference document, and that the European Cosmetic, Toiletry, and Perfumery Association (COLIPA) would be asked to coordinate the industry response. It was proposed that industry take no more than 120 days to confirm the documents after receipt.
In parallel with these discussions, a comparison of safety and efficacy testing requirements was planned between the EU and US, while acknowledging the different regulatory requirements and processes. To initiate this discussion, the Commission planned to prepare a document describing safety criteria and the efficacy methodologies employed in the region and send this document to the FDA by June 1, 1999, with responses to be received by November 1, 1999. The other administrations planned to maintain a watching brief on this work.
A file was to be exchanged for review of compatibility with respective systems, with avobenzone as the candidate. It was determined that dossiers would be exchanged after resolution of confidentiality issues; FDA would explore the feasibility of sending the medical officer report on avobenzone plus the amendment, contingent on clearance to release; and the EU would in turn send the safety review for avobenzone. Copies of files were to be exchanged by June 1, 1999; comments were to be received by February 1, 2000.
It was agreed that other file exchanges would be possible at a later date to compare current review and approval processes.
Administrations also agreed to explore collaboration on high SPF and UVA test methods to determine the feasibility of a joint scientific working group.
Lists of approved preservatives are in force only in the EU and Japan. The US industry was to be asked if this is a marketing issue for US companies.
Draft charts comparing the preservatives approved in each region were distributed among the administrations. It was decided that the industry would be asked to review and correct charts comparing the approved preservatives in respective administrations and to identify those that have been reviewed by the Cosmetic Ingredient Review (CIR); with industry input requested within 120 days of receipt.
As a consequence of the on-going revision of Japanese regulations, the MHW has proposed several EU-permitted preservatives in the candidates for the draft Japanese positive list. The MHW said it would request that industry submit the files that were reviewed and approved in the EU, thereby providing a direct comparison of assessment criteria.
This was identified as a low priority category, one that would not be actively considered until the next meeting. The administrations planned to ask industry to identify whether this is a true marketplace issue as well as to compare and contrast draft tables comparing the approved colors in each region.
Industry also was to be asked to compare practices relative to ingredient purity. COLIPA was to be asked to identify industry practices for those colors approved only in the EU. Depending upon industry response, administrations may compare safety requirements in different regions and develop common assessment and review criteria. Such criteria could be developed for colors intended only for external skin contact.
It was decided that each administration would summarize the regulatory status of these materials for information purposes only. This was identified as a category that may offer potential for future collaboration.
The issue of regulatory status and controls in each region was discussed for information purposes. No issues were identified.
International Nomenclature Cosmetic Ingredient (INCI) names were primarily an issue of acceptability of dual declaration, except in Japan. Dual declaration would be acceptable in the EU and Canada. Japan and the US had concerns about the consumer acceptability of the proposal.
It was agreed that outstanding issues that need to be resolved relate primarily to the US market, specifically to the requirements of the Fair Packaging and Labeling Act (FPLA) and the Food and Drug Modernization Act (FDAMA). The FDA and US industry planned to address these issues in separate discussions.
FDA representatives said they would apprise the delegates from the other administrations regarding the status of these issues.
The issue of animal testing in the cosmetics sector and the development of alternative methods was presented by the European Centre for the Validation of Alternative Methods (ECVAM). The international procedures for acceptance of novel, validated methods were discussed among all parties. Each administration concurred that alternative methods are scientifically desirable. The group identified the need to communicate and scientifically collaborate in this field.
It was agreed that collaboration should continue whenever possible on an informal basis and that second formal meeting be scheduled for a mutually agreeable time 2000.