title: Changes in European legislation make it timely to introduce a transparent market surveillance system for cosmetics.
abstract: Marketing of cosmetics often makes strong claims linked to active ingredients. This is especially so for anti-ageing products, where the presentation and content of "active" ingredients may create new difficulties in their classification as cosmetics or medicinal products. A recent change in European legislation classifies a product as medicinal by virtue of its "function", in addition to the previous definition of "presentation" (i.e. marketing linked to diseases). Thus, formulations that also restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action should henceforth be covered by the Medicinal Products Directive. A cosmetic product must be suitable for its purpose and should not lead to adverse reactions that are disproportional in relation to its intended effect. However, the forthcoming ban on animal testing of cosmetic ingredients and the new European regulation, REACH (Registration, Evaluation and Authorisation of Chemicals), which aims to ensure a high level of chemical safety to protect human health and the environment, will probably have limited impact on the safety assessment of cosmetics. In order to enable consumers to make informed purchasing decisions, greater transparency in the process of assessing the performance of cosmetics is needed. Introduction of a more transparent system, enabling consumers and professionals to examine the scientific evidence for the claimed effect and the safety assessment of cosmetics, is therefore timely. Lack of transparency increases the risk of consumers wasting money on cosmetics that do not deliver the desired effects. This may jeopardize public trust in the cosmetic industry.
authors.affiliation: Research & Development, ACO Hud Nordic AB, Upplands Väsby, Sweden. marie.loden@aconordic.com
authors.forename: Marie
authors.initials: M
authors.lastname: Lodén
authors.forename: Louise
authors.initials: L
authors.lastname: Ungerth
authors.forename: Jørgen
authors.initials: J
authors.lastname: Serup
mesh_terms: D000287:Administration, Topical; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence / Q000592:standards*; D003358:Cosmetics / Q000009:adverse effects / Q000494:pharmacology / Q000592:standards*; D004345:Drug Industry / Q000331:legislation & jurisprudence; D005062:European Union; D033161:Government Regulation; D006801:Humans; D040541:Marketing / Q000331:legislation & jurisprudence / Q000592:standards*; D011356:Product Labeling / Q000592:standards; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards*; D018570:Risk Assessment / Q000379:methods / Q000592:standards; D015595:Skin Aging / Q000187:drug effects; D018675:Toxicity Tests / Q000379:methods / Q000592:standards*
chemical_list: D003358:Cosmetics