Risk management by labelling 26 fragrances? Evaluation of Article 10 (1) of the seventh Amendment (Guideline 2003/15/EC) of the Cosmetic Directive.

BACKGROUND: Some fragrance compounds are severe contact allergens. According to the so-called "26 allergens rule" (Article 1 (10) of Directive 2003/15/EC) (EC, 2003), 26 supposedly allergenic fragrances must be listed on the containers of cosmetics products if they are present above certain mass percentages in the product. This declaration is meant to inform the consumer of potential risks of skin sensitizers in the products.

OBJECTIVE: The objective of this paper is to validate whether "the 26 allergens rule" meets the expectations to improve consumer protection.

METHODS: The method used for this validation was on one hand a reflection on the elements of the approach used in "the 26 allergens rule" and on the other hand a product analysis of 742 products by 4 large producers of cosmetic products on the German market.

RESULTS: It was found that more than 50% of these cosmetic and washing and cleansing products contain at least one of the 26 substances above the thresholds for labelling and that there are 14% of all products which contain strong allergens. Many consumers apparently still buy these products. The indirect effect that producers reduce the amounts of these fragrances to avoid declaration seems to be small.

DISCUSSION AND RECOMMENDATIONS: Several arguments were assembled which show that other instruments are needed to ensure consumer protection or protection of the environment. This paper recommends different approaches. The use of a list of single substances in such a directive is not in line with scientific standards. It is recommended to base decision making on comprehensive risk assessments or at least on valid and strong criteria. More parameters need to be involved, not only contact allergy. As illustrated in this article, the roles taken over by authorities and manufacturers in risk management of the "26 allergens" are relatively small compared with the responsibility carried by consumers. However, consumers are only able to take over their part properly if they are sufficiently trained and have the necessary infrastructure, capability and time to inform themselves. Regulations are not effective if they load the major responsibility for risk management on consumers, instead of on authorities and manufacturers. A successful risk management would include bans and restrictions of especially hazardous substances issued by governments, as well as efficient surveys to control the implementation of regulations by the responsible authorities. It would also include that producers meet the legal standards and take over voluntary action to make products safer. The evaluation of "the 26 allergens rule" is an example which can be transferred to other regulations and which could help to improve future regulatory approaches, with a focus on the roles authorities, manufacturers and consumers play in a promising risk management.