WRITTEN QUESTION E-1238/00

by Karin Scheele (PSE) to the Commission

(14 April 2000)

Subject: Legal classification of tattooing dyes

The number of Europeans having themselves tattooed has been growing year by year. Tattooing involves among other things the use of azocolourants. In the Commission proposal amending for the nineteenth time Council Directive 76/769/EEC(1) relating to restrictions on the marketing and use of certain dangerous substances and preparations (azocolourants) that applies to textiles and leather goods, the Scientific Committee on Toxicity, Ecotoxicity and the Environment voices its concern that, on breakdown, azocolourants form amines that are classified as carcinogenic. In view of this possible health hazard, a legal basis is also required for azocolourants used in tattooing.

1. Have studies dealing with the health risks of tattooing dyes already been carried out or are there plans to do so?

2. Can the Commission name legal bases that include tattooing dyes in their field of application?

3. If not, is it making preparations to provide at a future date a legal classification for tattooing dyes? Will azocolourants be covered at the same time?

(1) OJ L 262, 27.9.1976, p. 201.

Answer given by Mr Byrne on behalf of the Commission

(13 June 2000)

1. The Commission is not aware of toxicological or epidemiological studies to specifically assess the health safety risks from the use of certain dyes in tattooing. Adverse effects of tattoos are well known. However the evidence is stronger for those effects arising from the tattooing procedures themselves (e.g. transmission of infectious diseases from non-sterile equipment, scarring) and less convincing for possible adverse effects arising from the tattooing dyes.

In considering possible legislative proposals on the safety of tattooing dyes, the Commission requested the opinion of the scientific committee on cosmetics and non food products (SCCNFP). In its opinion of 17 February 2000, the SCCNFP noted the large number of dyes used in tattooing for which the chemical structure, identity, and toxicological profile are incomplete or unknown, thereby precluding a proper health risk assessment. In its opinion, the SCCNFP recommended that a systematic effort be undertaken to amass the needed chemical and toxicological information on tattooing dyes so that a proper risk assessment can be conducted. In its remit to better protect public health, the Commission is currently evaluating the options to carry out this task.

As for the azo-dyes mentioned specifically by the Honourable Member, the Commission would also share the view that in theory azo dyes in tattoos will break down in a similar way as they do in leather goods to give rise to the carcinogenic amines. Confirming scientific evidence is however lacking at present. The Commission intends to include this aspect on a priority basis when assessing tattooing dyes.

2. and 3. Tattooing dyes are used for cosmetic purposes yet the route of their administration (injection) puts them outside the scope of Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States to cosmetic products(1) which considers that substances or preparations intended to be ingested, inhaled, injected or implanted in the human body do not come under the field of cosmetics. However, tattooing dyes could be considered as general consumer products and hence would fall under the scope of Council Directive 92/59/EEC of 29 June 1992 on general product safety(2) and Council Directive 76/769/EEC of 27 July 1976 relating to restrictions on the marketing and use of certain dangerous substances and preparations.

(1) OJ L 262, 27.9.1976.

(2) OJ L 228, 11.8.1992.