Pushing for stricter criteria for EU approvals

PAN Europe has produced a Position Paper on the European Union’s Pesticide Authorisation Directive (91/414), detailing recommendations for stricter criteria and the adoption of more stringent principles. 

The approval of agricultural pesticides has increasingly been harmonised following the European Union Directive 91/414 of 15 July 1991. Although the process is slow, the Directive has sometimes served as a progressive example for the assessment of the impacts of chemicals on health and the environment. But the risks connected with the use of pesticides prevail, and the average use of pesticides per unit of land has risen – in spite of the increasing adoption of pesticide active ingredients with a higher activity per weight of active ingredient.
    Directive 91/414 aims to harmonise the requirements, protocols, assessment criteria and decision-making processes for approval of pesticides among Member States and to ensure high standards of safety for consumers, pesticide users and the environment. Despite improvements on impact assessment of chemicals, the Directive has not led to tangible risk reduction in practice, while progress in reviewing the pre-1993 active ingredients has proceeded at a snail’s pace. Submission of incomplete dossiers by agrochemical companies or other parties on particular active ingredients has greatly slowed down the process. The European Commission (EC) is committed to produce a progress report on 91/414 by July 2001, and has introduced procedures to speed up the review process.
    The Commission’s progress report offers an opportunity to incorporate stricter assessment criteria and to integrate the precautionary principle into all aspects of pesticide authorisation, based on a more up-to-date understanding of risks and practice. The Commission held a stakeholders meeting in March 2001 to discuss its guidelines on critical areas of risk assessment, to be finalised soon. PAN Europe and its partners have called for a fundamental review of 91/414 in the progress report(1). 

PAN Europe recommendations
Future regulation should be based on the highest protection level available in existing EU legislation or international agreements, in line with the precautionary principle (see PN51 pp12-13) and should reconsider the degree of need for each individual pesticide. 

Using hazard-based criteria
Several important national and international chemical policy processes acknowledge that chemical substances with certain intrinsic properties cannot be controlled safely. They conclude that releases of substances that meet certain defined criteria for P (persistence), T (toxicity) and B (bioaccumulation) must therefore stop. Stringent cut-off points need to be defined for pesticides and used as a first screen in approval. An active ingredient which fits any one of the persistence, toxicity or bioaccumulation criteria (rather than a combination of these) should automatically disqualify from further assessment for approval. This approach would make the approval process much less time-consuming and thus more cost-effective.
    The approval process must recognize that recommended measures for reducing exposure, for example protective clothing, are not always implemented in practice. Furthermore, consumers, including vulnerable groups such as children, are exposed to pesticides in drinking water and food. PAN Europe calls for criteria to be included for substances which cause irreversible effects (carcinogenic, mutagenic, toxic to reproduction, or sensitizing) or disrupt endocrine function. A pesticide (including its metabolites) with any one of these properties should be banned or should never be approved, even for use by trained users.
    Many active ingredients are water-soluble and highly mobile and can reach surface waters, groundwater and drinking water. Pesticides currently have to be tested for their persistence in soil and in water, but persistence in water courses does not provide a criterion for non-approval. PAN Europe therefore calls for specific criteria for non-approval of pesticides, based on degradation times in soil, surface water, and sediment under aerobic and anaerobic conditions. 
    International obligations: When not including a pesticide in 91/414, the Commission should clearly indicate when this is a result of health or environmental concerns, and whether it is effectively a ban. If so, the international implications must be considered, and the Secretariat of the Prior Informed Consent Convention notified. This will alert other governments, particularly in developing countries, of European concerns.

Evaluation for approval
Even those pesticides that do not meet the hazard criteria, and which are carefully assessed before approval, may pose a considerable risk to human health and the environment once in use. Directive 91/414 includes various sections relating to pesticide approval and use such as: comparative assessment of different pesticides; transparency of the regulation process; inclusion of newly recognised pesticide effects; improper use of approved pesticides; non-compliance with Directive regulations; and responsibilities of pesticide producers, users and traders. Amongst other demands, PAN Europe calls for:

• time limiting the approval period to five years
• monitoring of active ingredients in human health, food and the environment to be financed by industry
• non-approval of pesticides which can be substituted by non-chemical methods or active ingredients that are less harmful to human health or the environment.
• a database and independent assessment of non-chemical alternatives to be set up at the European level
• access to pesticide dossiers, Directive meetings and reports of relevant bodies
• access to regulatory committees as observers and inclusion of comments given by public interest NGOs
• a pesticides database with information on production, sales and usage, and poisoning and pollution incidence reporting
• mixture toxicity effects to be introduced into approvals process
• inclusion of tests to identify toxicities to developing organisms and foetuses
• sanctions for specific non-compliance
• regular mandatory training for pesticides users and testing of application equipment
• banning of amateur pesticides used in gardens and allotments 

If the Commission takes on board some of the concerns and alternatives raised by PAN Europe and other civil society representatives in the consultation process some concrete action on reducing the hazards of pesticides in the EU may be accomplished.

Reference
1. PAN Europe Position on EU Pesticides Authorization, April 2001. Signed by: Aurel Duta MAMMA TERRA, Romania; Bond Beter Leefmilieu, Belgium; CC.OO., Spain; Coordination gegen (BAYER-Gefahren / BAYERwatch), Germany; Ekorol, Poland; European Public Health Alliance, EPHA, Belgium; For Mother Earth, Romania; General Workers Union (SID), Denmark; Green Doctors Ukraine; Inter-Environnement Wallonie, Belgium; Leefmilieu, the Netherlands; MDRGF, France; Monitoring Network Health and Environment, the Netherlands; Österreichische Bergbauernvereinigung, Austria ; PAN Belgium; PAN Germany; PAN UK; Polish Ecological Club City of Gliwice Chapter; Stichting Natuur en Milieu, the Netherlands; SLF, Svenska Lantarbetareförbundet, Sweden.

This article is an abridged version of a PAN Europe Position on EU Pesticides Authorization, by Heike Schmitt and Ute Meyer. For a full version contact: PAN Europe, Fax +49 40 360 30 38 405, coordinator@pan-europe.net, www.pan-europe.net

[This article first appeared in Pesticides News No. 52, June 2001, page 16]