Tougher approval regime on pesticides is agreed

An EU agreement on a Directive on sustainable pesticide use and a Regulation on placing pesticide products on the market will see a more protective regime of pesticide legislation introduced in 2010.

A far-reaching package of new legislation on pesticides was agreed by the European Parliament and Council of Ministers in January.1 It aims to ensure the sustainable use of pesticides and tighten approval to exclude the most hazardous substances.

The package comes in two parts: a framework Directive on the sustainable use of pesticides and a Regulation on the placing of plant protection products on the market. The latter will repeal earlier Directives on pesticides including the 1991 plant protection products Directive. The framework Directive includes:

  • National action plans: The framework Directive on the sustainable use of pesticides will require member states to adopt national action plans to reduce the risks and impacts of pesticide use on human health and the environment. The Directive specifies "quantitative targets, measures and timetables" which may cover areas such as protection of workers’ health, protection of the environment and the reduction of residues in food crops.

    Member states must also establish "targets and timetables for the reduction of use" particularly for "priority areas", where certain substances, crops or practices are identified as problematical. The plans will have to be communicated to the Commission within three years of the Directive coming into force, and be reviewed every five years. The content of the plans will be made publicly available by the Commission.

  • Integrated pest management: The Directive aims to encourage integrated pest management practices, which are defined in an annex, and reduce dependence on pesticide products through alternatives such as natural predators and crop rotation. It requires member states to "take all necessary measures" to promote low-pesticide input pest control so professional users switch to methods that present the lowest risk to health and the environment.
  • Training and awareness: The Directive requires all professional pesticide users, distributors and advisers to have training provided by bodies designated by a competent authority. The subjects to be covered are specified in an Annex. They include pesticide legislation, hazards, environmental protection, health effects and alternative pest management techniques such as biological control and the principles of organic farming. Those selling pesticides must also be able to give advice to customers on the health and environmental risks of products and how to manage them.

    Member states meanwhile will have to take measures to inform the public about pesticide risks and publish information on pesticide poisoning incidents. Strategic guidance on monitoring and surveying impacts will be prepared.

  • Pesticide applications: Pesticide spraying equipment in professional use will need to be inspected for safety at intervals of less than five years, changing to three years after 2020. However, member states will be able to vary the inspection periods if they conduct health and environmental risk assessments to target major risks.

    The Directive bans aerial spraying, except in a narrow range of specified circumstances and requires member states to ensure appropriate protection for water supplies and the aquatic environment. This includes the use of no-spray buffer zones around watercourses and close to groundwater sources.

    Another requirement is that pesticide use is minimised or even prohibited in specific areas such as public parks and gardens, recreation grounds, school premises, healthcare facilities and drinking water protected areas.

  • Reporting and indicators: The Directive envisages the initiation of "harmonised risk indicators" that will be statistical measures of pesticide risk, though details have yet to emerge. These must be conveyed to the public, the Commission and other member states. The Commission will then calculate the indicators at community level and assess gains in achieving the Directive’s aims.

    Member states must also identify trends in the use of active substances and identify priority items such as crops, active ingredients, regions or practices that require attention, with the aim of promoting alternatives to reduce pesticide dependence.

  • The Regulation that concerns the placing of plant protection products on the market aims to ensure "a high level of protection" of health and the environment, while removing obstacles to free trade in pesticide products across the EU.

  • Authorisation: The Regulation sets out an authorisation procedure for pesticides. To gain approval, good practice in using the product must not produce residues that have harmful or cumulative effects on human or animal health or on the environment.
  • There is also a requirement for products to be "sufficiently effective", and not cause immediate or delayed harmful effects on humans or animal health. Products must also not cause unacceptable effects on plants or plant products, cause unnecessary suffering to vertebrates or have unacceptable effects on the environment. The last includes effects on biodiversity, ecosystems, non-target species or contamination of soils, waters and air, and potential impacts from long-distance dispersal.

    Active ingredients, safeners and synergists in pesticide formulations cannot be approved if they are human (category 1) or possible human (category 2) mutagens or carcinogens. Endocrine disruptors thought to adversely affect humans are also excluded.

    There is at present no consensus on a method of determining whether a substance should be regarded as an endocrine disruptor, but the Regulation commits the Commission to presenting scientific criteria to be adopted for this regulatory procedure within four years. Until then, all suspected (category 3) carcinogens and reproductive toxicants are classified as endocrine disruptors, as are any substances with toxic effects on endocrine organs.

    There are, however, derogations from these rules. If the substance is used in a way that means human exposure is negligible, such as in closed systems, then the substance may be approved. Also if the substance is needed "to control a serious danger to plant health which cannot be contained by other available means", it may be approved for a limited time not exceeding five years. However this does not apply to category 1 carcinogens, non-threshold category 2 carcinogens or category 1 reproductive toxicants.

    In the first instance, approvals will last for a maximum of ten years, but derogations will be allowed for ‘low-risk’ substances which may be authorised for 15 years. The Commission may also decide to review the authorisation of any substance at any time.

  • Candidates for substitution: Substances that meet the approval criteria may be recognised as ‘candidates for substitution’ if their toxicity is significantly greater than most other active substances in the same use category, if they meet two of the persistence, bioaccumulation and toxicity thresholds of concern, or if they have carcinogenic, mutagenic, reproductive toxicant or endocrine disrupting properties. Candidates for substitution will be authorised for a maximum of seven years.
  • Comparative assessment: Member states considering applications for authorisations of products containing active ingredients that are ‘candidates for substitution’ are required to conduct a comparative assessment considering alternatives.

    Member states are required to restrict the use of products for a crop where other, safer products exist for the same purpose; where substitution by safer products or non-chemical control methods is not disadvantageous; and where the diversity of chemical products is adequate to prevent resistance developing in pest populations.

  • Mutual recognition of authorisations: To facilitate a free market in pesticides, member states must recognise authorisations made in other member states in the same geographical zone. The European Community area is classified into three zones: north, including Denmark, Estonia, Latvia, Lithuania and Sweden; south, including Bulgaria, Greece, Spain, France, Italy, Cyprus, Malta and Portugal; and centre, including all other member states.

    Initial agreement on the Regulation and Directive was reached by MEPs and the Council of Ministers in December last year. However, the deal still needed a parliamentary rubber stamp.

  • Pesticide manufacturers, farmers and growers lobbied to make the adoption subject to a Europe-wide impact assessment because of fears over the number of active ingredients likely to be withdrawn from sale. The Horticultural Trades Association claimed that 85% of the 286 active substances used in pesticides in the UK could be lost, but the Pesticides Safety Directorate’s latest assessment is that 14-23% would fail to be authorised.2 However, MEPs passed the package as expected. The director general of the European Crop Protection Association Friedhelm Schmider, which led industry lobbying against the new regime, responded by pledging to work to implement the measures.

    "We intend to help make sure the path that is followed is based on fact, not fear," he said. "We hope that we are now leaving behind a period of sensational claims and that the approach to the application of this legislation will be one of great care and due diligence."

    The legislation now needs to be approved by the Council of Ministers but this is likely to be a formality. The measures will then be published in the Official Journal and be implemented by member states in 2010.

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