- Regulatory framework
- Scientific and technical assessment
- Cosmetic products
- Ban on animal testing
- Cooperation and trade
Sunscreen products are cosmetic products according to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products ("Cosmetics Directive 76/768/EEC"). They have an important "protective" function against UV radiation.
Therefore, the efficacy of sunscreen products, and the basis on which this efficacy is being claimed are important public health-issues.
In particular, concerns have been voiced about the following aspects:
- Products should contain protection against all dangerous UV radiation;
- The indication of the efficacy of sunscreen products should be simple, unambiguous and meaningful and based on standardised, reproducible criteria;
- Labels and claims for products should provide sufficient guidance to aid in choosing the appropriate product and to applying it correctly.
In order to address these concerns, the Commission has adopted, on 22 September 2006, a Recommendation on the efficacy of sunscreen products and the claims made relating thereto.
This recommendation sets out
- claims which should not be made in relation to sunscreen products;
- precautions to be observed including application instructions;
- the minimum efficacy standard for sunscreen products in order to ensure a high level of protection of public health;
- simple, understandable labelling to assist in choosing the appropriate product.
The testing methods referred to in this recommendation are currently subject to standardisation by the European Committee for Standardization CEN. You find the standardisation mandate [385 KB] for these testing methods in the Database for Standardisation mandates of DG Enterprise and Industry (go to free text search - "sunscreen").
Legally speaking, a recommendation is not binding. However, the Commission - who has worked closely with consumer associations as well as industry on this file - expects industry to take steps so that the recommendation becomes "visible" for the consumer in summer 2007.
In order to indicate that a sunscreen product offers the minimum UVA protection as recommended in paragraph 11 and 14 of the Commission Recommendation on the efficacy of sunscreen products and the claims made relating thereto of 22 September 2006 [56 KB] , the European Cosmetics Association (COLIPA) has issued a standardised UVA-label, the "UVA-seal". This new label is downloadable on the Colipa website.