92000E4136

WRITTEN QUESTION E-4136/00

by Chris Davies (ELDR) to the Commission

(16 January 2001)

Subject: 28th Adaptation on Technical Progress to the Dangerous Substances Directive (67/548/EEC)

The draft 28th Adaptation on Technical Progress to the Dangerous Substances Directive (67/548/EEC)(1) proposes a Category 2 Carcinogen Classification for trichloroethylene, in place of the current Category 3 Classification.

Following extensive studies on several thousands of people, is the Commission convinced of a causal relationship between exposure to trichloroethylene and an increase in cancer?

Industry states that the criteria to the preamble of the EU Labelling Guide, which says that normal conditions of handling and use should be considered, have not been applied and that, in the two epidemiological studies carried out, 'the exposure situations that are supposed to have caused the German cancers were due to abnormally high levels of trichloroethylene far above occupational exposure standards. Furthermore, industry claims that improved practices within exposure limits should protect workers from the hazards of trichloroethylene.

What is the Commission's response to these points?

(1) OJ L 196, 16.8.1967, p. 1.

Answer given by Mrs Wallström on behalf of the Commission

(5 March 2001)

The classification of trichloroethylene is being considered in the context of Regulation (EEC) 793/93 on the evaluation and control of the risks of existing substances(1) and Directive 67/548/EEC on the classification and labelling of dangerous substances. The European Chemicals Bureau (ECB) at Ispra in Italy provides the technical/scientific support, consulting the Member States and industry via the Carcinogenicity, mutagenicity and reproductive toxicity (CMR) working group. Difficult cases, like trichloroethylene, are referred to the so-called Specialised Experts Group, made up of independent scientists from all Member States.

The Specialised Experts Group examines proposals for classification of chemicals on their scientific merits alone. In this case, the Specialised Experts, meeting on 30-31 March 2000, recommended a classification of carcinogen category 2 (R45). The CMR working group of Member State experts, meeting on 9-12 May 2000, almost unanimously supported this classification. This conclusion has been reached after several years of detailed consideration of the overall scientific evidence. This evaluation included, but was not limited to, the cited epidemiological studies. The Commission would like to draw the attention to the fact that classification as a category 2 carcinogen (classification primarily based on animal experiments) is proposed rather than as a category 1 carcinogen (classification based on epidemiological data).

The Commission would like to point out that such a classification would not automatically lead to restrictions on the marketing and use of substances. However, the Commission will examine possible marketing or use restrictions, under Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations(2). Following normal practice for substances classified as category 1 or 2 CMRs, the Commission will consider carefully the appropriateness of a possible ban on the marketing of trichloroethylene to consumers. Furthermore, the Commission committed itself to special consideration of trichloroethylene and other chlorinated solvents at the time of the adoption of Directive 94/60/EEC (the 14th Amendment to 76/769/EEC)(3). Before coming forward with a proposal, the advantages and drawbacks of any marketing and use restrictions will be considered, in consultation with the industry and other interested parties.

(1) OJ L 84, 5.4.1993.

(2) OJ L 262, 27.9.1976.

(3) OJ L 365, 31.12.1994.