WRITTEN QUESTION E-2545/98

by Kirsten Jensen (PSE) and John Iversen (PSE) to the Commission

(1 September 1998)

Subject: Pesticides

An article in the Danish newspaper Aktuelt of Monday, 20 July 1998 concerning the pesticide, Round-up, pointed out that pesticide manufacturers were themselves investigating the effects of their products on the environment.

What safeguards are in place to ensure that the Member States verify manufacturers' information?

What safeguards are in place in Directive 91/414/EEC(1) to ensure that the effects of the active substances on reproduction are investigated?

What safeguards are in place in Directive 91/414/EEC to ensure that the effects of the ancillary substances on reproduction are investigated?

Answer given by Mr Fischler on behalf of the Commission

(28 October 1998)

Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(2) specifies the data that have to be submitted by industry when applying for the inclusion of an active substance in its positive list or for the authorization of a plant protection product at national level. Such data include effects on reproduction of the active substance.

For "additives" (i.e. formulants in plant protection products) there is no systematic requirement to perform the same series of testing. However the Directive provides that in individual cases it may be necessary to require certain information for formulants. Before such information will be required and before possible new studies have to be performed, all information on the formulant, made available to the authority, will be considered, in particular when the use of the formulant is permitted in food, animal feeding stuffs, medicines, or cosmetics in accordance with Community legislation, or a safety data sheet has been submitted for the formulant in accordance with Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(3).

When generating such data, industry has to follow the detailed provisions of the Directive which refers to the application of internationally validated test guidelines where they exist. Moreover all testing to obtain data on the properties or safety with respect to human or animal health or the environment has to be done according to the principles of good laboratory practice (GLP). This implies a quality control system of the laboratories performing the studies.

When deciding at Community level on the inclusion of an active substance in the positive list it has to be established that, consequent on application consistent with good plant protection practice, the plant protection products and their residues containing that active substance do not have any harmful effect on human health.

Also when deciding at Member State level on the authorization of a plant protection product it has to be established, in the light of current scientific and technical knowledge that the plant protection product, when used properly, has no harmful effect on human health.

(1) OJ L 230, 19.8.1991, p. 1.

(2) OJ L 230, 19.8.1991.

(3) OJ L 196, 16.8.1967.