At its plenary meeting on 15 December 2015, the SCCS has adopted this 'Memorandum on use of human data in risk assessment of skin sensitisation'. The scope of 21-page text is to clarify issues essential for interpretation of human data and dossier results in risk assessment of contact allergens/contact sensitisation.
In its introduction, the text points out that according to the EU Cosmetic Regulation 1223/2009, it will be necessary to initiate regulatory measures on substances identified by the SCCS as likely to cause allergic reactions and/or impose certain conditions concerning them. In order to ensure that the 'end user', meaning either a consumer or professional using the cosmetic product, is adequately informed, the presence of these substances should be mentioned in the list of ingredients and consumers’ attention should be drawn to the presence of these ingredients. This information should improve the diagnosis of contact allergies among consumers and should enable them to avoid the use of cosmetic products which they do not tolerate. For substances which are likely to cause allergy to a significant part of the population, other restrictive measures such as a ban or a restriction of concentration should be considered.
This memorandum is an update of the SCCP/0919/05 Memorandum on Classification and categorisation of skin sensitizers and grading of test reactions concerning human data.
The contents
• Types of human data
> Epidemiological and clinical studies based on diagnostic patch testing
> Experimental elicitation in human dose-response and repeated open application tests
> Predictive tests in …
