Focus on

LEGISLATION

The legislation concerning the use of insecticides and related products is continuously shifting towards the use of products with a more specific action and a better understood activity.  Different directives of the European Union have a direct impact on the production and trade of agricultural commodities.  The most important directives are the Plant Protection Products directive (91/414 EEC), the biocide directive (98/8 EC) and the MRL directive (EC 396/2005).

The plant protection product directive 91/414 EEC was adopted in July 1991 and enforced from July 1993.  The emphasis of the guideline aimed at a harmonization of the process for registering products applied for insect control during field cultivation and hence on the establishment of agreed criteria for the safety of the product applied.  Nevertheless, product authorization remained the responsibility of the individual member states.

Plant protection products were defined as all products applied to protect plants, live plant parts, fresh fruit and products from plant origin that have had no or only limited processing against harmful organisms.

Although a general approach was thus realized, the availability and registration of products remained very different from country to country.

Important in the directive is Annex I that establishes a positive list of active substances with no unacceptable risk to people or the environment. Member states can only authorise the marketing and use of plant protection products after an active substance is listed in Annex I.

The biocide directive 98/8 EC was implemented in 2003.  Although the blueprint of the guideline is similar to the plant protection product directive, the biocides concern products that are used for post harvest stock protection and pest control. Next to insecticides, different other segments e.g. wood protection products, disinfectants and  rodenticides are included.

Similar to the 91/414 directive also the biocide directive include a – different – Annex I to register the accepted active substances that could be used.

For both directives, the registration of active ingredients on the respective annexes was a cumbersome process.  Today approximately 150 active ingredients have been registered for annex I of 91/414 and for 98/8 only a limited amount of products were registered. As a result many products have disappeared, for the better. However, it needs to be said that due to the extended registration time and high costs for development of new products, only few new products make their way to the market.  An important and alarming consequence entails that today only few products are available for control of insects in agricultural products. Good practices that comprise product rotation in order to avoid resistance breeding are jeopardized.

Related to the directives on the authorized use of products is the regulation 396/2005 establishing maximum levels of plant protection products on food, feed and products from plant and animal origin designated for human and animal consumption.

Maximum residue Limits or MRL’s are food/feed specific in many cases.  However, when no specific MRL is established, general levels apply.  For food and feed, an MRL of 0.01 mg/kg is set for all cases where no specific value is established.

Regulation 396/2005 has different annexes that are currently comprise only limited or temporarily registrations.  Commodities en  product groups with harmonised MRL’s are covered in Annex I while specific MRL’s are listed in Annex II.

Since toxicological information and safety information is only available to a limited extend or requires complex research, many products, even if listed on the biocide directive and plant protection directive, are subject to a general MRL.  The implementation of regulation 396/2005 will lead to a further reduction of products to control and eliminate biorisks in stored products and agricultural production.

The implementation of the directives and guidelines will be discussed in our next newsletter.

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