This Call for Evidence issued by the Competent Authorities of Denmark, France, Germany, and Ireland is an opportunity for all sectors to provide information on the presence of skin sensitising substances in mixtures with consumer uses, including information on known safe uses. In addition, epidemiological data on allergic contact dermatitis and information on health costs are requested. This CfE allows stakeholders and contact points within relevant sectors to identify themselves for possible subsequent consultations. The information gathered will provide valuable input to assess any potential need for regulatory actions on skin sensitisers in consumer mixtures in order to prevent skin sensitisation and allergic contact dermatitis in the general population.
Moreover, this Call for Evidence is issued to assess (i) whether there are risks that are adequately controlled under specific conditions, and (ii) what impact additional regulatory risk management would have on society. The scope of the investigation comprises substances fulfilling the criteria for classification as skin sensitisers as defined by the CLP Regulation (Regulation (EC) 1272/2008) in mixtures marketed or available for consumers in the EU/EEA. Uses of substances in cosmetic products, as defined by Directive 76/768/EEC, are outside the scope of the investigation (according to the REACH Regulation, Article 67).
The objective of this Call for Evidence is to gather information on:
- the sectors, and type of uses/applications concerned,
- measures currently in place (e.g. changed formulation, reduction of concentration, specific packaging, conditions of use) to minimise consumer exposure,
- experience regarding substitution efforts, availability and costs of alternatives or reasons for non-substitution,
- the potency of the skin sensitising substances and their technical functions in the mixtures,
- on safe use of consumer products,
- epidemiology of allergic contact dermatitis and other health-related information including health costs,
- analytical methods to detect the presence of skin sensitising substances in mixtures.
For any clarifications, please contact the German Competent Authority: chemg (at) baua.bund.de