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of five issues, namely, repeated dose toxicity (including skin sensitisation and carcinogenicity), reproductive toxicity and toxicokinetics, for which the deadline was extended to 11 March 2013. The consultation is related to a requirement that the Commission must inform the European Parliament and the European Council “in case alternative methods will not have been developed and validated by 2013 for the remaining endpoints that are exempted from the Cosmetic Directive’s marketing ban until 2013”. The introductory documents state that “The public is invited to comment on the five individual chapters of the draft report, each representing one human health(-related) effect. The focus of the consultation is to ensure that each chapter correctly reflects the current state of the art and the prospects. As regards prospects, the experts evaluated how long it will take to develop and optimise such approaches up to a level that fulfils the ECVAM criteria for entering prevalidation. The time required for the validation and regulatory acceptance of these alternative approaches was not considered for the purpose of this exercise. In addition, justified comments on the conclusion (i.e. the timelines given to achieve full replacement) are sought.” It is clearly indicated that “The Commission is inviting factual comments, which complement the information provided. Comments should include references and other substantiation where possible.” “Any comments and information on this public consultation should be submitted by using the provided comment template form by mail, fax or e-mail, by 15 October 2010 at the latest, to: European Commission, Health and Consumers Directorate-General (DG SANCO), Unit SANCO B2, Cosmetics and Medical Devices, B-1049 Brussels, Belgium (Fax: 00 32 (0) 2 296 64 67; E-mail: SANCO-COSMETICS-REPORT@ec.europa.eu)”. The template requires the submitters of comments to indicate their names, affiliations and types of organisation, the submission date, and whether the submission should/should not be treated as confidential. A separate template form should be submitted for each of the five chapters, and the forms have four columns, for “comment number”, “line number”, “comment and rationale”, and “proposed revised text”. The introductory documents, the five draft chapters, and the template are available at: http://ec. europa.eu/consumers/sectors/cosmetics/documents/ public_consultation/index_en.htm
FRAME’s Submission We have decided not to respond to the consultation by using the template system, but to convey our views via a Comment in ATLA, principally because
Comment
there are a number of important general points to be made, which could not readily be made via the “line number/comment and rationale/proposed revised text” template system. In addition, a detailed set of informed comments would inevitably involve many pages for each draft chapter, and it is not clear how the Commission or the authors of the chapters would handle large numbers of suggestions for “proposed revised texts”. We also doubt whether more than a handful of members of “the public” would have the competence or the information necessary for providing assurance that a chapter “correctly reflects the current state of the art and the prospects”. People more cynical than ourselves would undoubtedly be tempted to consider that the consultation has deliberately been set up in this way, in order to discourage participation. In our analysis of the draft chapters, we will focus on what the Commission will need, if it is to provide the European Parliament and the European Council with information of the necessary quality, which is specifically relevant to the safety of cosmetic products, their ingredients, their purposes and the consequences of repeated exposure to them, in relation to the Cosmetics Directive, rather than on issues related to chemicals in general and to other products, which are regulated by the REACH system and other directives. In particular, it should be remembered that a cosmetic product is defined as “any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition” (1). By contrast, a medicinal product is defined as “a) any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or b) any substance or combination of substances which may be used in or administered to human beings, either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis” (1). For the purposes of this Comment, we will go along with the current practice of the Commission and the European cosmetics industry, by avoiding the term ‘cosmeceutical’, which refers to cosmetic products containing biologically active ingredients which are claimed to have medical or drug-like benefits. Nevertheless, this issue will have to be faced up to at some time in the future, since, if the claims increasingly being made about them are genuine, these products would have to be treated as medicinal products rather than cosmetics, in the