WRITTEN QUESTION E-0242/01

by Erik Meijer (GUE/NGL) to the Commission

(7 February 2001)

Subject: Development of biological pesticides restricted by high testing costs

1. Is the Commission aware that the introduction of biological pesticides, hitherto used only on a small scale in agriculture and market gardening, is being discouraged because the testing procedure required by the authorities is the same as that required for chemical pesticides, which now enjoy a dominant market share, because inventors and producers of new biological pesticides are unable to meet the high cost of the tests?

2. Are there Member States other than the Netherlands where the approval of biological pesticides for use is being seriously hindered by the problem referred to in paragraph 1 above?

3. Does the Commission agree that it is desirable in order both to prevent chemical pesticide residues, difficult or impossible to break down as these are, from lodging in the soil, and to comply with food safety requirements to expand the market share of biological products, and, in any event, to prevent efforts to introduce them from being unnecessarily obstructed by government action?

4. Is the Commission aware of possible ways and means of enabling the use of biological pesticides to be authorised for use in Member States by providing producers and suppliers of biological pesticides with a reliable, generally recognised and affordable common European testing procedure?

Answer given by Mr Byrne on behalf of the Commission

(3 April 2001)

The Commission is aware that all plant protection products produced and used on a small scale (whether chemical, biological or physical) face an obstacle to being put on the market because of the costly requirement to submit full dossiers for evaluation of their safe use under Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products of the market(1). The Directive places the requirement to demonstrate safety of substances above the needs of agriculture and the Commission is looking at ways to simplify the process for low-risk substances without compromising on the safety aspect. The Directive does not provide for separate classifications of biopesticides, products used in organic farming and those used in integrated pest management. For micro-organisms used in plant protection and covered by the Directive, the Commission will adopt in the coming months a separate set of data requirements which should facilitate their entry into the market. Biocontrol agents (sensu stricto, invertebrates such as Ladybird beetles) are intentionally not covered under the Directive. This was done so as not to impede developments in this area and in view of the absence of the side-effects mentioned by the Honourable Member. As a result, the field is regulated by the Member States.

The Commission is not aware that the approval of biological pesticides is being seriously hindered in any Member State.

The Commission agrees that it is desirable that products without the side-effects mentioned by the Honourable Member have a greater share of the market and that they should not be impeded unnecessarily by regulatory authorities.

It is already possible to be exempted from several data requirements if a scientific justification is given. This has happened during the evaluation of micro-organisms and pheromones and the new data requirements for micro-organisms will provide for such standard exemptions. This has led to a relatively cheap registration procedure for these products. National authorities may also grant such exemptions for plant extracts when these are scientifically justified. In most Member States, no registration for invertebrate bio-control agents is necessary by far the cheapest procedure. If necessary and appropriate, the Commission could consider ways to develop reliable, generally recognised and affordable data requirements for low-risk substances.

(1) OJ L 230, 19.8.1991.