Explanatory Notes on the Regulation on maximum residue levels of pesticides in products of plant and animal origin

Since 2005, maximum residue levels are set using a harmonised approach in the European Union, according to Regulation (EC) No 396/2005 of the European Parliament and of the Council on maximum residue levels of pesticides in or on food and feed of plant and animal origin.

Regulation (EC) No 396/2005 was introduced at a time when the approval of active substances was still carried out in accordance with the requirements of Directive 91/414/EEC. When Regulation (EC) No 1107/2009 was published, it has been clarified that references to Directive 91/414/EEC shall be construed as references to Regulation (EC) No 1107/2009. Consequently, in the following text, the new references are mentioned and old references are kept in square brackets.

As a general rule, the application for authorisation and the corresponding maximum residue level must be submitted at the same time (Article 6). Food and/or feed cannot be placed on the market without a fixed maximum level (Article 18 (1)). All active substance/product combinations without an existing authorisation of plant protection products which are not listed in Annexes I, III and V or whose active substances are not listed in Annex IV are generally controlled with a value of 0,01 mg/kg (Article 18 (1 b)). In cases of “imminent danger”, according to Article 53 of Regulation (EC) No 1107/2009 [Article 8 (4) of Directive 91/414/EEC] and Directive 2000/29/EC, deviations from the existing maximum residue level are possible (including the value of 0,01 mg/kg) (Article 18 (4)).

Structure of the Regulation

The text of the Regulation contains 36 recitals. The Regulation consists of fifty articles in ten chapters, and eight annexes:

Chapter I	Subject matter, scope and definitions
Chapter II	Procedure for applications for maximum residue levels
Chapter III	Maximum residue limits applicable to products of plant and animal origin
Chapter IV	Special provisions relating to the incorporation of existing maximum residue levels into this regulation
Chapter V	Official controls, reports and sanctions
Chapter VI	Emergency measures
Chapter VII	Support measures relating to harmonised pesticide maximum residue levels (now deleted and replaced by Regulation (EU) No 652/2014)
Chapter VIII	Coordination of applications for maximum residue levels
Chapter IX	Implementation
Chapter X	Final Provisions

Annex I	Products of plant and animal origin according to Article 2 (1)
Annex II	Maximum residue levels formerly defined under Directives 86/362/EEC, 86/363/EEC and 90/642/EEC, referred to in Article 21(1)
Annex III	Provisional maximum residue levels referred to in Article 16 (1) and Article 22 (1)
Annex IV	List of active substances of plant protection products, evaluated under Regulation (EC) No 1107/2009 and for which no MRLs are required, as referred to in Article 5 (1)
Annex V	Limits of determination above 0,01 mg/kg (Article 18 (1))
Annex VI	Specific concentration and dilution factors (Article 20 (2))
Annex VII	Fumigants: Active substance/product combinations, as referred to in Article 18(3)

The particular circumstances of Annex III are:

exceptional cases, in particular where residues may arise as a result of environmental or other contamination or from uses of plant protection products pursuant to Article 53 of Regulation (EC) No 1107/2009 [Article 8(4) of Directive 91/414/EEC],
exceptional cases,where the products concerned constitute a minor component of the diet of consumers, and do not constitute a major part of the diet of relevant subgroups, and, where relevant, of animals,
honey or herbal infusions,
where essential uses of plant protection products have been identified by a decision of non-approval [to delete an active substance from, or not to include an active substance in, Annex I to Directive 91/414/EEC]
where new products, product groups and/or parts of products have been included in Annex I, and one or more Member States so request, in order to allow any scientific studies necessary for supporting an MRL to be undertaken and evaluated, provided that no unacceptable safety concerns for the consumer have been identified.

In all cases, such a maximum quantity remains in Annex III for a maximum of ten years (depending on the circumstances), after the expiry of which a re-assessment must be carried out.

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Procedure for setting maximum residue levels

The Member States, the European Commission and the EFSA have an equal part to play in the procedure for setting maximum residue levels.

An application for the setting of a maximum residue level shall be submitted together with the application for authorisation to a Member State. Applications may be submitted by the following groups:

applicants (according to Regulation (EC) No 1107/2009 [according to Directive 91/414/EEC],
all parties demonstrating, through adequate evidence, a legitimate interest in health, including civil society organisations,
commercially interested parties such as manufacturers,growers, importers and producers of products covered by Annex I,
Member States of the European Union.

Applications can be made for

the setting of a specific maximum residue level in Annexes II, III or V for new or known active substances for use in the EU or as import tolerance
the deletion of an MRL (usually only possible when following a proceeding pursuant to Article 12)
the inclusion of an active substance in Annex IV
the adaptation of a residue definition
the inclusion of an active substance/product combination in Annex VII.

It may be possible in future to request the evaluation of the supporting data which are required when following an Article 12 - proceeding pursuant to Regulation (EC) No 396/2005.

In accordance with Article 7 of Regulation (EC) No 396/2005 an application shall consist of:

Name and address of the applicant,
the application dossier (including a summary of the application, the main arguments, a list of the documentation enclosed, a copy of Good Agricultural Practice concerning the specific intended use of the active substance),
a complete overview of all relevant concerns mentioned in the scientific literature available on the plant protection product and/or its residues,
data according to Regulations (EU) No 283/2014 and 284/2014 [Annex II and III of Directive 91/414/EEC] in the context of data requirements for setting maximum residue levels for pesticides, if applicable including toxicological data and data on routine analysis methods for use in inspection laboratories, as well as plant and animal metabolism data.

The EFSA and the European Commission will be provided with a copy of the application. This is followed by an immediate assessment by the Member State (in the case of a national authorisation procedure for a plant protection product) or the rapporteur Member State (if an import tolerance is being applied for). The assessment shall also take into account publicly available data (e.g. Codex Alimentarius, assessment according to Regulation (EC) No 1107/2009 [Directive 91/414/EEC], if they remain unexploited the reasons must be stated. The assessment report will be sent to the European Commission (but in fact directly to the EFSA).

If the rapporteur Member State is unknown at the time of application (can be researched through the EU Pesticides Database of the European Commission), the application for an import tolerance is to be submitted to the European Commission (SANTE-MRLs-applications@ec.europa.eu).

The EFSA sends an acknowledgement of receipt to the applicant, the European Commission and the rapporteur Member State. A reasoned opinion, in particular, on the risks to the consumer and where relevant to animals is published at the latest 3 months after receipt of the application, covering the following main points:

an assessment of whether the analytical method for routine monitoring proposed in the application is appropriate for the intended control purposes,
the anticipated limit of determination for the active substance/product combination,
an assessment of the risks of the acceptable daily intake or acute reference dose being exceeded as a result of the modification of the MRL; the contribution to the intake due to the residues in the product for which the MRLs was requested and
other elements relevant to the risk assessment.

The Commission must present a draft regulation within three months of the submission of the opinion. At this point, too, it is possible to request additional documents; new documents must be made available to the EFSA and the rapporteur Member State. In the case of a withdrawal of authorisation, maximum residue levels can be modified (lowered) without EFSA having been consulted.

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Control programme to ensure compliance with maximum residue levels

The control on compliance with the fixed maximum limits shall continue to be carried out in a two-step process. On the one hand, the Member States are required to ensure compliance with the provisions of the Regulation (EC) No 396/2005 by representative sampling. In that regard, the criteria set out in the EU provisions relating to official controls for food and feed are to be applied to the analysis methods. The laboratories involved in control measures are obliged to participate in proficiency testing carried out under the Commission's responsibility.

On the other hand, the Commission's coordinated monitoring programme applied so far will continue as a multi-annual programme. The objective of the program is to be able to evaluate the exposure of consumers and the application of the laws in force. In addition, Member States should establish appropriate multi-annual programmes. The annual report on the coordinated monitoring programme will be published by the EFSA.

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