Commission to extend hair dye assessment in view of new data on sensitisation
European Commission - IP/07/439 29/03/2007
Brussels 29 March 2007
The Scientific Committee on Consumer Products (SCCP) draws the Commission's attention, in a memorandum published today, to the fact that many of the hair dye substances currently used in hair dye products have the potential to cause skin sensitisation. A person sensitised to a hair dye substance may eventually develop skin allergy to this substance. In order to fully assess the safety implications of the memorandum findings for consumers the inherent sensitising properties of these substances and the real life exposure of consumers (frequency of use, amounts used, proportion of the population potentially affected, types and severity of effects, etc) must be considered. Today, there is little systematic data on the occurrence of allergies among hair dye users. However, given the large increase in the use of hair dye products over the last ten years, the report warns of a potential problem for the health of consumers. The Commission is aware of the problem and already in 2003 has agreed with member states and stakeholders on a strategy striving for a positive list of hair dyes substances to be allowed for use in the EU. In this context the categorisation of these substances according to their sensitising properties by the SCCP provides valuable input to this exercise. Based on the memorandum, the Commission services will now extend their assessment in order to minimise possible risks of allergic reactions caused by hair dyes.
Meglena Kuneva, Commissioner for Consumer Protection, said: "Product safety goes to the heart of consumer policy – it is the number one concern. The job of the scientific committee is to draw the Commission's attention to potential safety concerns. The Commission will follow the scientific advice and work quickly to provide the necessary next step of assessment of exposure".
Markos Kyprianou, Commissioner for Health, pointed out that hair dyes are among the most popular aesthetic products in Europe. "In view of the findings of this report and the increased use of hair dyes in recent years, we need an in-depth assessment of the prevalence of hair dye allergies in the population."
The SCCP has assessed and ranked the skin sensitizing potency of 46 hair dye substances. The Memorandum draws the Commission's attention to the fact that a considerably high proportion of these substances are skin sensitizers; 10 out of 46 substances were found to be extreme sensitizers, 13 strong and 4 moderate. Given the widespread use of hair dyes, sensitization caused by these substances may affect the health of EU citizens.. Sensitization is the process through which an individual develops the ability to react to substances that are generally tolerated. Once sensitized, the person can develop allergic reaction upon re-exposure to the substance.
There is a social and cultural demand for hair dying at an increasingly earlier age. According to a recent Danish epidemiological study, the median age for the first hair dyeing is only 16 years.
Allergenic substances may be used safely if exposure is sufficiently low. Models are being developed to address this aspect of risk assessment of skin safety. The aim is to determine levels of these substances that can be safely used in products without causing skin allergies to consumers.
Following the SCCP opinion on a possible link between the long term use of permanent hair dyes and the development of bladder cancer, the Commission together with Member States and stakeholders agreed in 2003 on an overall strategy to further regulate hair dyes within Cosmetics Directive (76/768/EEC). The main element of this strategy is a three step modulated approach requiring the industry to submit safety data by certain deadlines on hair dyes to be evaluated by the SCCP. The deadline for hair dyes for which no safety files have ever been submitted was 30 September 2003. Submission of safety files according to the new SCCP requirements was required until the 31 July 2005. The deadline for submission of files on combination of substances in permanent hair dye formulations is set on 31 December 2007. The strategy foresees to ban all permanent and non-permanent hair dyes for which no safety files have been submitted or for which the SCCP gives a negative opinion. In this context, the sensitization properties have been also assessed.
Further implementation of the assessment strategy and further epidemiological studies are necessary to examine the extent of skin allergies to hair dyes in the EU's population. At the same time threshold values for sensitizers of high concern need to be determined to take appropriate measures on a possible decrease of exposure.
In the last years the Commission adopted several regulatory measures with a view to minimize possible allergic reactions to certain substances used in perfumes and as preservatives in cosmetic products. The substances are regulated in the annexes to the Directive 76/768/EEC on cosmetic products.
Work of the SCCP
The SCCP is an independent advisory body established by the Commission. Its members are chosen on the basis of scientific excellence and they advise the Commission on the health risk of consumer products.