WRITTEN QUESTION E-2709/98

by Françoise Grossetête (PPE) to the Commission

(1 September 1998)

Subject: Assessment of the risks of biocidal products

Directive 67/548/EEC(1) establishes a single framework that applies to all chemical substances before they are placed on the Community market, if this took place after 10 September 1981. The European Inventory of Existing Commercial Chemical Substances (EINECS) lists all the substances that were on the market between 1 January 1971 and 18 September 1981, and Regulation (EEC) 793/93(2) enables the risks posed by the substances listed in EINECS to be systematically evaluated and controlled.

Of the 110 000 substances that appear in EINECS, 900 of those listed under the heading "active biocidal substances" have been singled out for evaluation using a risk assessment procedure that is entirely different from that set out in Directive 93/67/EEC(3) laying down the principles for assessment of risks to man and the environment of substances notified in accordance with Directive 67/548/EEC.

Directive 98/8/EC(4) concerning the placing of biocidal products on the market does not exempt the new active substances from the requirement that notification should be given of their being placed on the market, as already stipulated by Directive 67/548/EEC.

In view of the above and also of the European Parliament's resolution on the report of the group of independent experts on simplification of Community legislation and administrative provisions of 4 July 1996 (A4-0201/96)(5) and the new Title XIX of the Treaty of Amsterdam, Article 174(3).

Could the Commission state:

1. Why it considers that the risk assessment for these active biocidal substances cannot be carried out in line with the procedure set out in Directive 93/67/EEC and its technical annexes and how it justifies the fact that there are currently two "procedures" for carrying out risk assessments?

2. How it justifies the fact that two requirements concerning the notification of a substance being placed on the market coexist in Community legislation?

Answer given by Mrs Bjerregaard on behalf of the Commission

(30 October 1998)

Directive 98/8/EC of the Parliament and the Council of 16 February 1998 concerning the placing of biocidal products on the market provides that all biocidal products on the Community market must be authorised by Member States following a decision taken in accordance with the common principles laid down in Annex VI of the Directive.

It also provides that only those active substances listed in Annex I or IA (positive lists) can be included in biocidal products. The decision to include or not to include an active substance in Annex I or IA will be based upon the evaluation of the risks that it poses to humans and to the environment. This will initially be made by a Member State rapporteur, but the ultimate decision will be at Community level following the opinion of the standing committee on biocidal products. This is a different process from that foreseen by 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, where a substance is placed on the European market with a notification scheme and with a risk assessment carried out in only one Member State.

The Commission is developing technical notes for guidance (TNsG) to carry out a comprehensive risk assessment for biocidal active substances and biocidal products. These TNsG are based on the same principles detailed in the technical guidance document in support of Commission Directive 93/67/EEC of 20 July 1993 laying down the principles for assessment of risks to man and the environment of substances notified in accordance with Council Directive 67/548/EEC and Commission Regulation (EC) 1488/94 of 28 June 1994 laying down the principles for the assessment of risks to man and the environment of existing substances in accordance with Council Regulation (EEC) 793/93(6). However, the general nature of the technical guidance document makes it unsuitable as such for the purpose of the biocides Directive due to the often specific use pattern of biocides, the fact that biocidal active substances are placed on the market for their "cidal", i.e. killing, effect and that in some cases they are deliberately introduced in the environment or in the food processing chain. They also often come in contact with the human population, including non-professional workers and the general public. These aspects have to be carefully considered in the risk assessment.

The Commission, in accordance with Article 13, paragraph 1 fifth indent of Directive 67/548/EEC, intends to adopt a measure to exempt active substances for exclusive use as biocides from certain of the provisions of the Directive, particularly those provisions concerning notification, effective from 13 May 2000 when Directive 98/8/EC has to be implemented.

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

(2) OJ L 84, 5.4.1993, p. 1.

(3) OJ L 227, 8.9.1993, p. 9.

(4) OJ L 123, 24.4.1998, p. 1.

(5) OJ C 211, 22.7.1996, p. 23.

(6) OJ L 161, 29.6.1994.