Pesticides

The replacement of the current EU and Member State legislation on pesticide Maximum Residue Levels (MRLs) is ongoing.  This change, along with other developments in pesticide legislation in the EU, could have trade implications if the future EU harmonized MRL list does not include MRLs evaluated and authorized in the U.S. and therefore possibly found on exported U.S. agricultural commodities. 

MRLs are the upper legal levels of a pesticide residue to be found on a food or feed commodity.  For each approved active ingredient, these maximum levels are set for a list of various fruits, vegetables, cereals and animal products.  A MRL is not a toxicological limit and a violation is not necessarily a cause of concern for public or animal health.  For pesticides authorized for agricultural use, the MRLs are set at the maximum safe level that one would expect if the pesticide is used according to the rules and restrictions of the authorization (the Good Agricultural Practice approach).  EU MRLs do not take into account  GAPs in third countries.  These GAPs may be different because of third countries’ climatic or disease situations.  In such cases import tolerances may have to be established to allow trade. 

The authorization of active ingredients used in plant protection products within the European Union is covered by separate legislation.  MRL’s on non-authorized substances are set at levels that reflect the prohibition of these substances.

Current Maximum Residue Legislation

So far, Maximum Residue Levels (MRLs) for pesticide residues are only set at Community level for about 150 plant protection products.  EU harmonized MRLs can be found in the following directives:
 

Council Directive 86/362/EEC, as amended, establishes MRLs for pesticides in cereals and cereal products

Council Directive 86/363/EEC, as amended, establishes MRLs for pesticides in products of animal origin

Council Directive 90/642/EEC, as amended, establishes MRLs for pesticides in products of plant origin, including fruits and vegetables

The complete list of EU MRLs in force is also available from the European Commission’s website: EU MRLs sorted by pesticide(1265KB) (4200KB) updated 04/11/2004.

There have been several amendments to these Council Directives since the last update of the EU MRL list of Nov 4, 2004 and all the Commission Directives not yet included are presented in the following table.

See also: http://europa.eu.int/comm/food/plant/protection/pesticides/legislation_en.htm

Unharmonized products are covered by Member State legislation. Links to Member State specific information is provided on http://europa.eu.int/comm/food/plant/protection/evaluation/contact_points.xls. If there is no EU legislation in place but there is a national MRL for a specific pesticide/commodity combination in the importing Member State and the product being imported into that country conforms with it, then the product can be marketed in that country.  Importers wishing to market the product in other Community Member States may face problems.

If there is no EC legislation in place and there is no national MRL in force in the importing Member State, then the exporter needs to obtain an "import tolerance".

New EU Maximum Residue Legislation

Regulation 396/2005 of the European Parliament and of the Council is the new framework regulation on maximum residue levels in or on food and feed of plant and animal origin. When fully implemented, all MRL’s, including import tolerances, will apply EU wide, removing the trade problems that were the result of the current situation whereby Member States can set their own national MRL’s in the absence of Community MRL’s.  

The new regulation provides for the creation of two categories of EU MRLs. 'Definitive' tolerances (listed in Annex II of the new Regulation) which have been considered at EU level and 'temporary' tolerances (listed in Annex III of the new Regulation). The temporary MRLs would relate to tolerances which have not yet been considered at EU level. They will be a mix of MRLs set by member States or those required to facilitate the import of treated produce from outside the Community. Consumer safety implications will be assessed before a temporary MRL will be included in the Regulation. Temporary MRLs would gradually be reviewed and, where appropriate, transferred to the 'definitive' list.  The European Food Safety Authority (EFSA) plays an essential role in this process as EFSA’s assessment will form the basis of a proposal to change MRLs.

Implementing measures need to be developed transferring the existing EU MRLs and the national MRLs to the new legislation.  Also, a list needs to be compiled of pesticides for which it is not necessary to set MRLs (annex IV of the framework regulation).  The Regulation will only become fully applicable when all four annexes have been adopted and become applicable. At that time, the currently applicable Directives 86/362/EEC, 86/363/EEC and 90/642/EEC will become obsolete.

Status of the implementation of Regulation 396/2005

Regulation 178/2006 was published in order to establish Annex I listing the food and feed products to which maximum levels for pesticide residues apply.  The annex gives an overview of the products and product groups to which the MRLs apply and meanwhile determines the structure of the published MRL lists.  Until now, it is the first Annex that has been officially completed.

Currently, the main focus of the efforts is on Annex III in order to establish the list of temporary MRLs.  This list covers the temporary MRLs (not considered at EU level yet) as well as all the unharmonized national MRLs including import tolerances.  The Commission compiled all the information from all the member states and a comparison was made between all member state MRLs and the Codex MRLs.  From this data, a harmonized list was created maintaining the highest national MRL for each crop/active substance combination.

The list only becomes into force after it has been reviewed by EFSA, and subsequently adopted by the Commission. It has already been submitted to EFSA for consumer safety assessment. Based on the outcome of that assessment, a list of temporary MRLs will be proposed by the Commission as Annex III to Regulation EC (No) 396/2005.

Review of Active Substances / Link to MRL Legislation
 

In an ambitious work program launched in 1992, the European Commission started a Community-wide review process for all active ingredients used in plant protection products within the European Union.  In a review process based on scientific assessments set out in directive 91/414/EEC, each applicant had to prove that a substance could be used safely regarding human health, the environment, ecotoxicology and residues in the food chain. This program will be completed by 2008.  When a substance is reviewed, a decision is taken to either include or not include this substance to the positive list in the annex to Directive 91/414/EEC.  Since the program is not finalized yet, there are currently substances that have been included, substances that have not been included and substances that have not been evaluated yet.  A status list of all active substances on the EU market is available from the European Commission’s website Status of active substances under EU review (doc. 3010) (240KB)  updated 10/17/2006.

Substances that are not included in the annex to 91/414/EEC have to be withdrawn from the EU market.  Subsequently, the MRLs for these substances are set at a level that reflects the ban.  In the new EU MRL legislation, MRLs for prohibited substances and for products for which no specific MRL are set at by default at 0.01 mg/kg.  For substances that are included in the annex, companies have to provide product specific data for the establishment of product specific MRLs.  MRLs for substances that have not been reviewed yet, will be reviewed in conjunction with the review of the active substance.

The new MRL legislation stipulates that MRLs for prohibited substances will all automatically revert to the default level of 0.01 mg/kg (Article 18 (1)(b) of Regulation 396/2005). This default level will only start to apply 6 months after all MRL lists of Annex II, III and IV have been published.  

Import Tolerances
 

Import tolerances are MRLs set for imported products where the use of the active substance in a plant protection product on a given food or feed is not authorized in EU countries or where the existing MRL is not sufficient to reflect the GAP in the supplying third countries.

The Commission produced a detailed document on the issue of import tolerances (see G/SPS/GEN/557).

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

Commission Directive 2002/63/EC concerns the sampling methods for the official controls of pesticide residues in and on products of plant and animal origin. The Annex describes the sampling procedures.

Reports

GAIN Report E48060: EU-27 | EU Council stalls pesticide review 
GAIN Report E48007: EU-27 | The EU harmonization of MRLs: update 

Archive of FAS reports

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