FOREIGN AGRICULTURAL SERVICE
U.S. MISSION TO THE EUROPEAN UNION

Last update: January 23, 2009

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PESTICIDES and MRLs

- Plant Protection Products | MRLs: Regulation 396/2005
- Import tolerances
- Official Controls of Pesticide Residues
- Reports

The currently ongoing legislative initiatives in the area of pesticides are resulting in a drastic reduction of the number of active substances. Meanwhile, maximum residue levels (MRLs) are being harmonized throughout the EU.

Plant protection products

The marketing and use of plant protection products is regulated by Council Directive 91/414/EEC. This Directive provides for the establishment of an EU positive list of active substances. Active substances are being reviewed under this Directive and may only be used in plant protection products when they are included in the positive list. Only products containing substances included in the positive list may be authorized for use in the EU.

Status of active substances under EU review (doc. 3010) on August 11, 2008.

However, the European Commission has tabled a proposal establishing new rules for the authorization of Plant Protection Products (PPPs) which will replace Council Directive 91/414/EEC. The main aim of the proposal is to facilitate the current approval and authorization procedures and to increase harmonization while maintaining a high level of protection for humans, animals and the environment. The proposal has to be adopted under the co-decision procedure.

MRLs: Regulation 396/2005

On September 2, 2008 Regulation 396/2005 (amended by Commission Regulation 839/2008) became fully applicable and replaced the old Directives 86/362/EEC, 86/363/EEC and 90/642/EEC.

Annex II (also includes Annex I) contains existing MRLs that were already harmonized at EU level and will replace the EU’s old MRL Directives (Directives 86/362/EEC, 86/363/EEC and 90/642/EEC). They may be higher than the default limit.

Annex III contains temporary MRLs and consists of two parts:

-Part A contains MRLS which were not yet harmonized at EU level, including those for active substances awaiting a decision for inclusion in Annex I of Directive 91/414 and some import tolerances.

-Part B contains all draft temporary MRLs already harmonized at the EU level before implementation of Regulation 396/2005 (and therefore included in Annex II) but in and on new commodities (for example tropical products) established in Annex I (= new pesticide/crop combinations). These MRLs will eventually be shifted to Annex II of Regulation 396/2005.

Annex IV will contain the substances for which no MRLs are required (exempt from tolerance products).

For all substances not included in these four Annexes, the MRL will be set at EU default level of 0.01 ppm (Annex V).

Official Controls of pesticide residues in and on products of plant and animal origin

Pesticide MRLs for processed or composite products are based on the MRLs for the raw agricultural ingredients. Harmonized sampling plans have been developed for the official control of residues (Commission Directive 2002/63/EC).

Import Tolerances

If there is no EU legislation in place in the importing Member State, then the exporter needs to obtain an "import tolerance". It is still possible to obtain an import tolerance, even for active substances that have not been evaluated or used in Europe before. Applications for import tolerances must be submitted to the “Rapporteur Member State” (RMS). The Commission assigns a Member State, if no RMS exists. The RMS reviewed dossiers are evaluated by the European Food Safety Authority (EFSA) before being forwarded to the Commission for consideration. Information on import tolerances can be obtained from http://www.pesticides.gov.uk/applicant_guide.asp?id=1239

Since September 2, 2008 all MRLs, including import tolerances, apply EU wide, removing possible trade problems that were the result of the previous/current situation whereby Member States can set their own national MRLs in the absence of harmonized EU MRLs.