Arguments continue over authorisation rules for pesticides

The European Commission has finally issued a proposal setting down uniform principles against which the efficacy, safety and environmental standards of all new and existing pesticides will be judged under an EC-wide approval scheme which should have come into force in July.1 But the proposal has satisfied neither the agrochemical industry nor environmental groups, and its fate has become inextricably linked with the debate on the possible revision of the EC's drinking water Directive.

The uniform principles (UP) Directive will form Annex VI of the 1991 Directive on plant protection products, commonly known as the "authorisation Directive". This was adopted in 1991 and should have been brought into force on 26 July (ENDS Report 217, pp 39-40 ). To enable this to happen the UP Directive itself should have been brought into force in July 1992. However, a formal proposal for the UP Directive was only submitted to the Council this May.

The UK has not yet implemented the authorisation Directive and a spokesman for Ministry of Agriculture, Fisheries and Food (MAFF) said that this is likely to remain the case until all the technical details of the Directive, including Annex VI, have been finalised.

The primary aim of the authorisation Directive is to ensure that all new pesticides are subjected to a common battery of tests on both the active ingredient and product formulation in order to demonstrate their efficacy as well as "a high level of protection of human and animal health and the environment." The procedure will generate an EC list of approved active ingredients to be listed in an Annex I. Once an ingredient is on this list it will be free to circulate among all the Member States.

Pesticides that are already on the market are also supposed to be reviewed over a 12-year period. But before any products can be assessed, the Council needs to adopt the UP Directive which effectively dictates the standards to which the scheme will operate.

The agrochemical industry vehemently opposed earlier informal drafts of the UP Directive, largely because it adopted standards set in the EC Directive on drinking water quality. This imposed a limit of 0.1µg/litre on individual pesticides and 0.5µg/l on total pesticides. Agrochemical producers want these replaced by limits based on the toxicity of individual pesticides. They are angered too by an extension of the limits to groundwater by the UP Directive.

In response to a consultation letter from MAFF, the British Agrochemicals Association says that the Commission "has taken virtually no account" of any of the comments made on the earlier drafts by the recently formed industry lobbying group, the European Crop Protection Association.

The industry's other principal objection relates to a provision that any new pesticide should be judged against "suitable reference products" with proven track records in order to determine its likely efficacy. Producers believe that this could restrict the introduction of new pesticides that may be less effective at controlling a certain pest but offer other benefits "in terms of toxicity to man or the environment".

They also maintain that in terms of the environmental effects of pesticides, the draft UP Directive has set excessively stringent quantitative limits which, if exceeded, will mean that a product is not authorised unless extensive field trials are carried out to prove that it will not have a harmful impact on the environmental parameter concerned.

Environmental groups such as the Sustainable Agriculture, Food and Environment (SAFE) Alliance counter that the proposal does not go far enough in dealing with air pollution by pesticides. It focusses more on health and safety aspects than possible interactions of pesticides with chemicals already present in the environment and the likely aerial dispersal of pesticides.

SAFE also maintains that the proposal is flawed because it requires the efficacy of each pesticide to be considered only against other pesticides rather than non-chemical methods of pest control. The draft refers to such alternative methods it does not spell out a procedure for considering them, leaving the way open for Member States to treat them cursorily.

The explanatory memorandum accompanying the proposal takes on board some of these criticisms. It notes that the Commission is currently considering revising the drinking water Directive and pledges that should any amendments be made "the Commission will examine immediately the consequences thereof" with regard to amending the UP Directive.

The Commission is holding a confidential seminar to discuss revisions of the drinking water Directive on 23-24 September. MAFF says that the UK's negotiating position on the UP Directive will largely depend on the outcome of the seminar.

The memorandum also acknowledges that "with regard to certain items such as impact of plant protection products on non-target aquatic flora as well as fate of plant protection products in air, it has appeared that more experience is required before detailed principles on evaluation and decision making can be developed." The Commission, it says, "will follow the technical and scientific progress in these fields and as soon as possible introduce more detailed rules."

The body of the proposal comprises two key sections. These are a set of principles for evaluating each compound, together with principles for decision-making which lay down quantitative and qualitative trigger values which each pesticide will have to satisfy in order to be authorised.

These principles apply to eight parameters:

  • Efficacy.

  • Absence of unacceptable effects on plants or plant products.

  • Impact on vertebrates to be controlled.

  • Impact on human or animal health arising from the plant protection product and its residues.

  • Fate and distribution in the environment.

  • Impact on non-target species.

  • Analytical methods.

  • Physical and chemical properties.

    The decision-making principles form the teeth of the Directive. They enable Member States to apply conditions on the use of products when authorisation is granted in proportion to "the nature and extent of the expected advantages and the risks likely to arise."

    Authorised application rates must be the minimum necessary to achieve the desired effect even where higher rates would not result in unacceptable risks to human or animal health or to the environment. In any case, the amounts used should not give rise to undesirable effects such as the development of resistance.

    Wherever possible, the proposal says, the authorisation process must take into account the principles of integrated pest control. This is defined in the parent Directive as "the rational application of a combination of biological, biotechnological, chemical, cultural or plant-breeding measures whereby the use of chemical plant protection products is limited to the strict minimum necessary to maintain the pest population at levels below those causing economically unacceptable damage or loss."

    Provision is made in the decision-making principles for a product to be authorised in certain circumstances even where it fails to meet some of the criteria for efficacy, effects on treated plants and impacts on pests. This may be done where use of the product could be shown to hold advantages for integrated pest control measures or organic farming, aid strategies to minimise the risk of development of resistance, satisfy a need for greater diversity of active ingredients, or lessen risks to operators, consumers or the environment.

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