PCS.02 Risk assessment in practice – clinical problems in ACD. Consumer perspectives

Abstract

That a cosmetic product must not cause damage to human health is enshrined in European legislation. Within the EU, the Scientific Committee for Cosmetic and Non‐food Products (SCC NFP) of the Directorate General for Consumer Safety & Health Protection provides independent risk assessments of certain cosmetic ingredients. The evaluations depend largely on the completeness of dossiers submitted by industry. Requirements for submissions are published by the SCC NFP http://europa.eu.int/comm/health/ph_risk/committees/sccp/documents/ out242_en.pdf) and cutaneous toxicology, including contact allergy, is only a part of the overall assessment.Opinions adopted by the SCC NFP are published in full (http://europa.eu.int/comm/health/ph_risk/committees/sccp/sccp_opinions_en.htm), presented to the Directorate General responsible for the legislation (Enterprise), who are risk managers, and discussed with Member States before the recommendations are included in the annexes of the Cosmetics Directive, if appropriate.The Cosmetics Directive (http://pharmacos. eudra.org/F3/cosmetic/pdf/vol_1en.pdf) contains positive lists of certain ingredient types (including preservatives, UV filters) and only those substances listed may be used. Annex 3 lists substances that may be used under certain conditions (concentration, exposure sites, warnings, age).Increasingly, revision of assessments of risks related to contact allergy have been brought about by epidemiological and robust clinical data (elicitation studies) submitted by dermatologists. As illustrated with the examples of methyldibromo glutaronitrile and Lyral®, rapid responses to protect the consumer are possible when the Commission is provided with appropriate information. Similar examples illustrate failures to predict risks for the induction of contact allergy before the consumer was excessively exposed.In contrast to the above, some permanent hair dye chemicals (for which there is, as yet, no positive list) are important and potent allergens and are permitted only because of the absence of acceptable alternatives and social need. Warnings and recommendations for testing before use have not been validated despite the long history of complaints. The ‘damage’ experienced by the consumer with an adverse reaction to a hair dye must be balanced against their possible carcinogenic potential.The consumer expects products to be safe. Why do risk assessments fail?