EFSA Manual on the application for MRLs in accordance with Article 6 to 11 of
Regulation (EC) No 396/2005
EFSA Manual
on the
Submission of applications in accordance with Article 6 to 11 of Regulation (EC) No 396/2005
Routine MRL applications
15 July 2008
Table of Contents
Abbreviations 3
Background 4
Risk assessment 5
1. Applications 5
1.1. Who is entitled to apply for setting, amending or deleting of MRLs ? 5
1.2. To whom to submit the application ? 5
1.3. What is required for an application ? 5
1.4. Who has to be informed on the receipt of an application ? 7
1.5. Where to find information on applications made in MS ? 7
2. Evaluation 8
2.1. Who is doing the evaluation ? 8
2.2. What is the format of the evaluation report? 8
2.3. How to perform the consumer intake calculation ? 8
2.4. Does the EMS need to provide the endpoints in the format of the EFSA PROFile? 9
2.5. Deadlines for the evaluation 9
2.6. How to submit the evaluation report to EFSA ? 9
3. Risk assessment 10
3.1. How Does EFSA process the submitted evaluation reports ? 10
3.2. What is the procedure for the risk assessment in EFSA ? 10
3.2.1. Procedure to be completed within 3 months 10
3.2.2. Procedure to be completed within 6 months 11
3.3. Additional data necessary for completing the assessment 12
4. Final reasoned opinion 13
Risk management 14
Annex 1: flowchart describing the Risk assessment procedure 15
Abbreviations
ADI / Acceptable Daily IntakeARfD / Acute Reference Dose
COM / European Commission
CXL / Codex MRL
EAS / Existing Ective Substance
EMS / Evaluating Member State
ER / Evaluation Report prepared by the Evaluating Member State
GAP / Good Agricultural Practice
MRL / Maximum Residue Level
MS / Member State
NAS / New Active Substance
PRAPeR Expert Meeting / The PRAPeR Expert meeting is a meeting of experts on pesticides which is already organised on a regular basis in the framework of the peer review of Directive 91/414/EEC which are also considered appropriate for discussing issues related to Regulation (EC) No 396/2005.
PRAPeR MRL Team / PRAPeR MRL Team - part of the Pesticide Risk Assessment and Peer Review Unit managing all tasks related to Regulation (EC) No 396/2005
PRAPeR MRL Workspace / Document management system to exchange between EFSA, European Commission and Member States all information related to the tasks defined by Regulation (EC) No 396/2005.
PRIMo / Pesticide Residue Intake Model
PROFile / Pesticide Residue Overview File
Regulation / Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC, OJ L 70, 16.3.2005, p. 1.
RMS / Rapporteur Member State
Background
Chapter II (Article 6 to 11 and Article 14(1)) of Regulation (EC) No 396/2005 [1]of the European Parliament and of the Council on Maximum Residue Levels (MRLs) for pesticides describes the procedure for applications for MRLs. This new procedure will become applicable on 2September 2008. It is important to know that the overall procedure for setting MRLs has to be completed before an authorisaion or provisional authorisation can be granted by a Member State. Any delays in the procedure of MRL setting will consequently have an impact on granting authorisation of the plant protection product at national level. It is therefore essential to establish an efficiant process with defined deadlines and resposibilities to avoid unnecessary delays.
According to the legislation different tasks and responsibilities are assigned to the parties involved in the MRL setting process which are
· the applicant applying for an authorisation of a plant protection poduct in a Member State,
· other applicants: parties demonstrating a legitimate interesst in health, including civil society organisations, commercially interested parties such as manufacturers, growers, importers, producers, which are entitled to apply for setting, modifying or deletion of MRLs
· competent authorities for the application of MRLs in Member States,
· the European Commission and
· EFSA.
EFSA proposed a procedure for implementing Chapter II of the Regulation which was presented to COM and MSs during the Standing Committee on the Food Chain and Animal Health of 1 February 2008. Following this presentation MSs were invited to submit comments by 15 March 2008. Taking into account the comments received EFSA revised the proposal which is now explained in detail in this document.
The scope of this manual is to provide practical guidance to MSs regarding those steps of the procedure where exchange of information or data with EFSA is foreseen. For reasons of completness the steps which involve the data or information exchange among other parties involved in the procedure are mentioned, but are not further elaborated in detail. This manual is not meant to interfere with the risk management procedures elaborated by MSs and COM.
The manual is also not intended to provide any legally binding procedures or scientific guidance on the risk assessment of MRLs.
For exchange of information with EFSA in the framework of the MRL setting activities, the PRAPeR MRL Workspace should be used. Where relevant, the manual will provide practical guidance on the use of this communication tool.
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EFSA Manual on the application for MRLs in accordance with Article 6 to 11 of
Regulation (EC) No 396/2005
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EFSA Manual on the application for MRLs in accordance with Article 6 to 11 of
Regulation (EC) No 396/2005
Risk assessment
1. Applications
1.1. Who is entitled to apply for setting, amending or deleting of MRLs ?
An application for setting, amending or deleting of MRLs can be made by
a) the party requesting an authorisation or provisional authorisation in a MS if the GAP for which the authorisation is seeked needs a modification or the setting of a new MRL,
b) other applicants as specified in Artilce 6(2) of the Regulation, such as parties demonstrating an interest in health, including civil society organisations, commercially interested parties (manufactors, growers, importers and producers of food commodities),
c) Member States which identify the need to set, modify or delete an MRL.
1.2. To whom to submit the application ?
In case 1.1.a (application in the contaxt of an application for authorisation of a plant protection product) the applications have to be submitted to the MS in which the authorisation is seeked.
In case of an application for an import tolerance the application is submitted to the Rapporteur Member State designated in the framework of Directive 91/414/EEC. In the following the Rapporteur Member State will be refered to as the Evaluating Member State in the framework of the application procedure.
1.3. What is required for an application ?
An application for setting, amending of MRLs or for setting import toleranes consists of
a) general information on the application (applicants should contact the national authorities concerning the formats of the applications. EFSA developed an application form which includes the data relevant to EFSA. If national authorities agree this template may be used for applications. )
b) the detailed description of the GAP in the standard format related to the MRL application,
c) a dossier with the data listed in Annex II and III to Directive 91/414/EEC relevant for setting the MRLs, in particular on the following elements
· metabolism of primary crops
· metabolism in rotational corps
· metabolism in animal commodities
· nature of residues in processed commodities
· analytical methods for enforcement (plant and animal commodities)
· storage stability
· supervised field trieals
· magnitude of residues in processed commodities
· magnitude of residues in rotational crops
· feeding studies
· toxicological data to establish an ADI and an ARfD in those cases where no agreed toxicological reference values have been derived in the EU (this will mainly apply for import tolerances for active substances which are not used in Europe),
If the data relevant for the application have already been submitted and assessed in the framework of the Peer Review under Directive 91/414/EEC, it is sufficient to make a reference to these data and the respective assessment reports .
d) a summary of the dossier and
e) an index of the documentation (list of studies)
In case of an application for deletion of an MRL the applicant has to provide a scientific justification supported by the necessary documents to underpin the argumentation.
During the evaluation the EMS may ask the applicant for further information if considered necessary to complete the dossier. The EMS has to specify the time limits to provide the additional information which may not exceed a period of two years.
It is recommended that the applicant should contact the MS to which the application will be submitted to comply with the national application formats.
1.4. Who has to be informed on the receipt of an application ?
The MS receiving an application shall immediately forward a copy of the application form to the COM and EFSA. The notification to EFSA should be sent via email to the RPAPeR MRL mailbox () indicating in the subject the name of the active substance and MRL application. If a national application form is used, the EMS has to make sure that at least the information specified in the EFSA application template is submitted.
1.5. Where to find information on applications made in MS ?
Upon receipt of the notification mentioned above, EFSA will create a new project in the PRAPeR MRL Workspace (Collaborative workspace for MRL risk assessment) and upload the application form in the subfolder. The project folder will during the whole procedure provide the user all relevant information regarding the details of the application, the supporting documentation and the correspondence.
All ongoing projects are summarised in an overview table (MRL Risk Assessment Table) which can be consulted to get information on activities in another MS, e.g. on on an application related to the same active substance. It is recommended that a bilateral exchange of information should be envisaged if MS are working on the same active substance or on similar applications in order to safe resources at an early stage of the evaluation and to avoid conflicting evaluations.
2. Evaluation
2.1. Who is doing the evaluation ?
A MS to which the application has been submitted will evaluate the dossier. As mentioned before, MSs working on similar applications should come in touch to find out whether the tasks on the evaluation can be shared.
MS can contact the COM to prepare a commitology procedure to re-allocate the work where a MS encounters difficuties in evaluating an application or where a re-distribution of the tasks would avoid duplication of the work.
2.2. What is the format of the evaluation report?
The evaluation performed by the EMS shall follow the provisions of Annex VI to Directive 91/414(EEC). The format of the report is not specified in the legislation, but for reasons of comparability and compatibility with the assessments under Directive 91/414/EEC is recommended to follow the structure of the DAR. The studies and information submitted by the applicant should be reported as provided in Annex B of the DAR for the following sections:
· B.5.2 Analytical methods (residues) for plants, plant products, foodstuffs of plant and animal origin, feedingstuffs
· B.6 Toxicology and metabolism (in particular 6.10 Summary of mammalian toxicology and proposed ADI and ARfD )
· B.7 Residue data
In addition, a short summary corresponding to Volume 1 of the DAR (Reasoned statement of the overall conclusions drawn by the Evaluating Member State) should be presented.
EFSA prepared a template which may be used by MS for writing the evaluation report.
2.3. How to perform the consumer intake calculation ?
For the consumer intake calculation the most recent PRIMo (pesticide residue intake model) should be used.
2.4. Does the EMS need to provide the endpoints in the format of the EFSA PROFile?
No. The EMS does not have to fill in the PROFile for an application made in the framework of a MRL setting procedure. The PROFile has been developed for the review of MRLs in accordance with Article 12(1) and 12(2). However, for those active substances for which the re-evaluation of existing MRLs has already been completed and a revision of the PROFile is available in the PRAPeR MRL workspace, the PROFile will be updated by EFSA with the information provided by the EMS. This procedure should ensure that no conflicting versions of the PROFile are created by different MS working on applications related to the same active substance.
2.5. Deadlines for the evaluation
Article 8 of the Regulation requires that the EMS draws up the evaluation report without undue delay.
If an application is withdrawn, the EMS should inform EFSA and the COM immediately.
2.6. How to submit the evaluation report to EFSA ?
According to Article 9 of the Regulation, the EMS has to send the evaluation report (ER) to the COM which will forward it without delay to EFSA.
To simplyfiy the procedure EFSA proposes that the evaluation report and the supporting dossier should be uploaded directly in the relevant project folder on the PRAPeR MRL workspace.
3. Risk assessment
3.1. How Does EFSA process the submitted evaluation reports ?
As soon as the evaluation report is submitted and the first completness check is finished, EFSA will decide which deadline for completion of the reasoned opinion should be applied.