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IP/06/1047

Brussels, 20 July 2006

Commission bans 22 hair dye substances to increase consumer safety

In order to ensure safety of hair dye products for consumers the European Commission has banned 22 hair dye substances (see list in annex) today. Today’s ban concerns 22 hair dye substances for which industry has not submitted any safety files at all. The Scientific Committee advising the Commission had recommended the ban of these substances following the conclusions of a scientific study that the long term use of certain hair dyes bears a potential risk of bladder cancer. Today’s ban is a first step in an overall strategy, agreed with Member States and stakeholders in April 2003, to establish a positive list of hair dye substances which are considered safe for human health. The ban will enter into force on 1 December 2006. In addition, the cosmetics industry submitted 115 safety files on hair dye substances for evaluation by the EU’s Scientific Committee on Consumer Products (SCCP).

European Commission Vice-President Günter Verheugen, responsible for enterprise and industry policy, said: “Substances for which there is no proof that they are safe will disappear from the market. Our high safety standards do not only protect EU consumers, they also give legal certainty to European cosmetics industry.”

The Commission’s strategy to ensure the safety of hair dye products foresees to ban all permanent and non-permanent hair dyes for which industry has not submitted any safety files and those for which the SCCP has given a negative opinion.

In a public consultation, the Commission had asked producers to provide safety files for their substances. These files, based on scientific expertise, have to prove that a substance does not pose a health risk for consumers.

Subsequently, the cosmetics industry submitted, by the end of last year, 115 files on hair dye substances for evaluation by the EU’s Scientific Committee on Consumer Products (SCCP). The scientific committee will adopt final opinions in a step by step approach ( next opinions will be emitted in October 2006). The Commission will then act accordingly.

Today’s ban concerns 22 hair dye substances for which industry has not submitted any safety files at all. This ban has also been notified under the TBT (Technical Barriers to Trade) procedure to the WTO. Since no comments were received following this notification, it can be assumed that the ban will not significantly impact the competitiveness of the hair dye manufacturers.

Presently, the safety of the before mentioned 115 hair dye substances is being assessed by the SCCP whose final opinions will serve the Commission as a basis to take further decisions on their regulation.

Background

The hair dye market in the EU was € 2.6 billion in 2004 which accounts for some 8% of the value of output of the cosmetics industry in Europe.

Permanent hair dyes account for 70-80% of the colouring product market in Europe. More than 60% of women colour their hair, 5-10% of men, the average frequency of use is 6-8 times per year.

In its opinion of 12 June 2001 the SCCP concluded that the potential risks of the use of certain, permanent hair dyes are of concern. In a second opinion of 17 December 2002, the SCCP stated that there is epidemiological evidence to indicate that the regular and long term use of hair dyes by women may be associated with the development of bladder cancer. It recommended an overall safety assessment strategy for hair dyes including the requirements for testing hair dye cosmetic ingredients for their potential genotoxicity or mutagenicity.

Following the opinions of the SCCP, the Commission together with Member States and stakeholders agreed on an overall strategy to regulate hair dyes within Directive 76/768/EEC. The main element of this strategy is a tiered, modulated approach requiring industry to submit safety files on hair dyes by certain deadlines to be evaluated by the SCCP.
Link to Hair Dye Strategy:

http://ec.europa.eu/enterprise/cosmetics/doc/hairdyestrategyinternet.pdf
Link to Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation:

http://ec.europa.eu/health/ph_risk/committees/sccp/documents/out242_en.pdf

The following substances will be banned:

Chemical name

6-Methoxy-2,3-Pyridinediamine and its HCl salt
2,3-Naphthalenediol
2,4-Diaminodiphenylamine
2,6-Bis(2-Hydroxyethoxy)-3,5-Pyridinediamine
2-Methoxymethyl-p-Aminophenol
4,5-Diamino-1-Methylpyrazole and its HCl salt
4,5-Diamino-1-((4-Chlorophenyl)Methyl)-1H-Pyrazole Sulfate
4-Chloro-2-Aminophenol
4-Hydroxyindole
4-Methoxytoluene-2,5-Diamine and its HCl salt
5-Amino-4-Fluoro-2-Methylphenol Sulfate
N,N-Diethyl-m-Aminophenol
N,N-Dimethyl-2,6-Pyridinediamine and its HCl salt
N-Cyclopentyl-m-Aminophenol
N-(2-Methoxyethyl)-p-phenylenediamine and its HCl salt
2,4-Diamino-5-methylphenetol and its HCl salt
1,7-Naphthalenediol
3,4-Diaminobenzoic acid
2-Aminomethyl-p-aminophenol and its HCl salt
Solvent Red 1 (CI 12150)
Acid Orange 24 (CI 20170)
Acid Red 73 (CI 27290)


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