91998E3558

WRITTEN QUESTION E-3558/98

by Amedeo Amadeo (NI) to the Commission

(1 December 1998)

Subject: Mutagens

Council Directive 67/548/EEC(1) on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, divides mutagens into three categories.

In reaffirming that only categories 1 and 2 are important as regards the amendment, it is stated that category 1 covers only substances whose mutagenic effects on humans have been directly proven, and that it is accepted that in practice it is extremely difficult to prove such effects. The substances that fall into category 2 are therefore of considerable practical importance. These are substances which can be shown, by means of "appropriate research using animals" and "other relevant information", to cause hereditary genetic damage.

Can the Commission, as a precautionary measure, treat these types of mutagen as carcinogens for the purposes of the directive.

Answer given by Mr Flynn on behalf of the Commission

(25 February 1999)

In the context of the programme "Europe against cancer" an action plan has been launched by Council Decisions 90/238/Euratom, ECSC, EEC(2) and 93/362/EEC(3) to focus attention on substances and preparations considered to be carcinogens. Following the adoption of Directive 94/60/EC(4), 14th amendment to Directive 76/769/EEC on restrictions on the marketing and use of dangerous substances and preparations(5), the Commission is required to propose directives prohibiting the use by consumers of substances classified as carcinogens, mutagens or toxic to reproduction categories 1 or 2. The proposals from the Commission must take account of the risks and advantages of the substances as well as of the Community legislative provisions on risks analysis.

To date, the use by consumers of about 850 substances classified as carcinogenic, mutagenic or toxic to reproduction category 1 or 2 has been prohibited.

In addition to this information, and with regard to the risks related to exposure to carcinogens at work, the Commission confirms that the Honourable Member's suggestions have already been taken into account in the amended proposal for a Council Directive(6) amending for the second time Directive 90/394/EEC on the protection of workers from the risks related to exposure to carcinogens at work, which was adopted by the Commission on 12 November 1998 following receipt of the European Parliament's opinion.

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

(2) OJ L 137, 30.5.1990.

(3) OJ L 150, 22.6.1993.

(4) OJ L 365, 31.12.1994.

(5) OJ L 262, 27.9.1976.

(6) OJ C 392, 16.12.1998.