PESTICIDES UNIT

European Food Safety Authority – Via Carlo Magno 1/a, 43126 Parma, ITALY

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Network on Pesticides Steering Committee

Minutes of the 1st meeting on the MRLs procedures

Held on 19.06.2014-20.06.2014, Parma

(Agreed on 25.08.2014)

Participants

Network Representatives of Member States:

Country Name Country Name

Austria Christian Prohaska Greece Chris Anagnostopoulos

Belgium Nele Van Hauwe Hungary Tamás Griff

Bulgaria Alexandra Neykova Ireland John Acton

Croatia Dubravka Čelig Lithuania Eglė Vegiené

Denmark Annette Petersen Netherlands Caroline Van der Schoor

Estonia Sille Vahter Poland Katarzyna Goralczyk

Finland Tiia Mäkinen-Töykkä Portugal Beatriz Barata

France Claude Vergnet Spain Eva María Martin Cruz

Germany Kristina Schuierer United Kingdom Alison Bostock

Panel Members

-

Hearing Experts

-

European Commission and EURL representatives:

- Volker WACHTLER (DG SANCO E3)

- Carmen Ferrer Amate (EURL)

EFSA:

José Tarazona (Chair) (Head of Pesticides Unit)

Jean Pierre Cugier (Co-Chair) (Pesticides Unit, Peer Review and Art. 10 team)

Bruno Dujardin (Co-Chair) (Pesticides Unit, MRL team)

Samira Jarrah (Report Writer) (Pesticides Unit, Peer Review and Art. 10 team)

Luna Greco (Report Writer) (Pesticides Unit, MRL team)

Bénédicte Vagenende (Pesticides Unit, Coordination team)

Hermine Reich (Pesticides Unit, MRL team)

Alba Brancato (Pesticides Unit, MRL team)

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Ileana Miron (Pesticides Unit, MRL team)

Paula Medina (Pesticides Unit, MRL team)

Anja Friel (Pesticides Unit, Peer Review and Art. 10 team)

1. Welcome and apologies for absence

The Chair welcomed the participants.

Apologies were received from Ms Eleftheria Bempelou (EL) and Ms Cecilia Dahlberg (SE)

2. Adoption of agenda

The agenda was adopted without changes.

3. Declarations of interest

In accordance with EFSA’s Policy on Independence and Scientific Decision-Making Processes regarding Declarations of Interests (DoIs)1 and the Decision of the Executive Director implementing this Policy2, members of networks, peer review meetings, networking meetings and their alternates shall be invited to complete and submit an Annual Declaration of interest (ADoI).

EFSA screened the ADoI filled in by the experts invited for the present meeting. No conflicts of interests related to the issues discussed in this meeting have been identified during the screening process or at the Oral Declaration of interest (ODoI) at the beginning of this meeting.

The Chair thanked the representatives that have submitted an ADoI.

1 http://www.efsa.europa.eu/en/keydocs/docs/independencepolicy.pdf 2 http://www.efsa.europa.eu/en/keydocs/docs/independencerules.pdf

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4. Topics for discussion

Agenda item 4.1: New document management system in EFSA (DMS)

4.1.1 Implications for the Pesticides MRL Workspace

The current external platform for MS experts (Sciencenet) will be changed into a new

exchange platform (OpenText). EFSA intends to move to this new system by the end of

October 2014 and access rights for Member States (MSs) and Commission (COM) will be

transferred. When the new link is available, EFSA will send a notification to all MSs and

COM and webinar training and a user manual will be made available, explaining the

functionalities of the new system.

4.1.2 MS feed-back on the most valuable features of the current MRL Workspace

EFSA collected feedback from MSs to understand which functionalities of the current

exchange platform are considered useful and should be retained in the new exchange

platform. MS commented that the most useful functionalities are:

A database including the different MRL assessments and guiding the users to the

relevant documents. The search options are considered very useful, in particular

searching on active substance name.

Notification system, in particular everytime a new MRL assessment is initiated.

Further detailed comments about possible improvements in the new exchange platform were

provided by FR; EFSA will investigate the feasibility of these proposals.

Agenda item 4.2: Streamlining MRL applications under art.10 of Reg. No 396/2005

4.2.1 New organisational and legal framework

Based on the draft guidance document SANCO/11509/2013 – rev.1, "on the interpretation of

the transitional measures for the data requirements for chemical active substances and plant

protection products according to Regulation (EU) No 283/2013 and Regulation (EU) No

284/2013" the meeting discussed on the implementation of the "new data requirements",

having in mind that the guidance document is still under discussion and therefore, still

subject to possible changes. The old and the new data requirements for residues are more

or less the same (except new data requirements on honey and fish metabolism). The most

important difference are the different guidelines that apply:

old data requirements: EU guidelines

new data requirements: OECD guidelines

This means that the results from the studies may be handled in very different ways (e.g.

animal dietary burden calculation). This may have an impact on the outcome of the

evaluation.

4.2.1.1 Active substances (AS):

- The new data requirements (Regulation (EU) No 283/2013) are applicable to new AS

for which the dossier was submitted on or after the 1st January 2014.

- For the "existing" active substances, the new data requirements are applicable to the

active substances whose approval expires on the 1st January 2016 or later. The “old”

data requirements (Regulation (EU) No 544/2011) are therefore applicable to the AIR

2 AS. In contrast, the "new data requirements" will be applicable to the renewal of the

approval of the AIR 3 AS.

4.2.1.2 Plant protection products (PPP):

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It should be noted, as mentioned in the draft EU guidance document

SANCO/11509/2013, that when "some data requirements are at the same time,

requirements for active substances and plant protection products (e.g. for the sections

residues, analytical methods, ecotoxicology). These data should be treated as active

substance data with regard to the transitional measures". The data requirements

applicable to the section residues are therefore the data requirements applicable to the

substance active. The following different cases were discussed and pointed out:

- For the PPP containing an existing AS and in the framework of an MRL application

under Art. 10 (new use or amendment of an existing use) the "Old data requirements"

will be applicable up to the expiring date of the AS approval (e.g. up to 2021 for AIR

1, 2026 for AIR 2…).

- For the PPP containing a NAS the "Old data requirements" apply to the NAS whose

dossier for the approval was submitted before 1st January 2014, while the "New data

requirements" will be applicable to the AS, whose dossiers for the approval were

submitted from 1st January 2014.

Providing that no significant changes are introduced to the final SANCO/11509/2013, all

parties involved in the assessment of MRL dossiers (applicants, MSs, EFSA, COM…)

will have in the next ten years (and even more), to play with both, the "old" and "new"

data requirements. In summary, the data requirements applicable to the section

residues of the PPP dossier, are the data requirements that were considered for the

approval of the active substance (e.g. If the AS was approved under the old data

requirements, the old data requirements apply to the PPP dossier (residues section), up

to the expiring date of the approval).

The meeting of experts raised the following points of concern that would need

clarification in the EU guidance document on transitional measures:

- How to deal with PPPs containing different AS that fall under different processes?

- How to deal with import tolerances for AS that are not authorized within the EU?

- How to deal with applications combining both import tolerances and MRLs based on

EU uses?

4.2.1.3 Data requirements for the review of MRLs (under Article 12 of Reg. (EC)

396/2005)

The old data requirements will be used for the AS for which a dossier was introduced

before the 1st January 2014.

The meeting was of the opinion that a general agreement is requested from all MSs on

the different cases where these new data requirements have to be applied and that a

harmonised approach on how to use the new data requirements and their impact on the

overall assessment are needed.

4.2.2 MRL application included in the DAR under Regulation (EC) 1107/2009

4.2.2.1 Assessment report (AR) proposed in SANCO/12592/2012-rev.0

First, EFSA reminded that a new template is applicable to the drafting of the Assessment Report (AR) for the NAS whose dossier has been submitted from 1st January 2014, as proposed in the SANCO/12592/2012-rev.0 document. According to the new template, the "hazard assessment" and the "exposure assessment" are reported in two separate sections of the AR. The AS hazard evaluation based on the core studies (storage stability, metabolism in plants and animals, livestock feeding studies, nature of the residues in processed commodities, rotational crops) are included in Volume 3; Annex B, while, the exposure and risk assessment (definition of residues,

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identification of the critical GAPs, proposed MRLs/import tolerances, consumer exposure through diet and other sources) are reported in Volume 1; level 2.

4.2.2.2 MRL application included in the AR

In the framework of Article 8.1(g) of Regulation (EC) No 1107/2009, an MRL application can be included in the AR and the new data requirements based on the OECD guidance documents are applicable for the NAS whose dossier has been submitted on or after the 1st January 2014. EFSA presented the two possible options for the drafting of the AR:

Option 1: The MRL application is inserted in the AR; and the data related to the representative uses and MRL application are reported under distinct subsections.

Option 2: The assessment is presented under two separate documents:

- The Assessment report (AR) considering the representative uses: All “core studies” are reported and evaluated under Vol. 3, Annex B of the AR, even if they are relevant for the uses considered in the MRL application only; (See note below);

- The Evaluation Report (ER) considering the MRL application presented as an Addendum to the Assessment report. The ER should include the assessment of the residue trials, processing studies, MRL proposals for the uses related to the MRL application, consumer risk assessment including representative and MRL application uses.

Under both options, a single EFSA conclusion will be issued by EFSA and the overall assessment will be summarised in the updated list of End Points (LoEP) according to the new data requirements (see point 4.2.3.).

The majority of the MSs agreed on option 1. However, for sake of clarity, UK and France were favourable to the option 2 approach. Finally it was agreed to stand with both options, considering that option 2 could be preferable in case of very extensive MRL applications with numerous uses.

Note to MSs: It was reminded that the case where an MRL application is included in the AR for approval of a NAS, has already been presented and discussed in the PSC 11 of 25/26 October 2011. It was at that time agreed that all "core studies" (those related to the setting of the residue definitions such as; plant and animal metabolism studies, rotational crop studies, standard hydrolysis studies…) would need to be assessed all together (even those not relevant to the representative uses), in order to finalise during the peer review and as far as possible, all points related to the residue definitions. It is therefore requested to consider all “core studies” under Vol. 3, Annex B of the AR.

4.2.2.3 Import tolerances included in an MRL application

In case of import tolerances (IT), the documentation related to the registration of the AS in the exporting country shall be provided. If provided, the RMS can proceed with the assessment of the AS and therefore include the import tolerance evaluation in the AR. In contrast, if evidence of the registration has not been submitted or if the AS is not yet registered in the exporting country, such documentations have to be requested and the evaluation of the IT excluded from the Assessment Report on the active substance.

The assessment of the import tolerances will be considered further, once the documentation on registration is submitted (in an Evaluation Report dedicated to the IT that will be considered in an EFSA Reasoned Opinion). In both cases, it is highlighted that the import tolerance values requested should be consistent with the MRL values effectively published in the exporting country

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4.2.3 Common evaluation approaches (MRL calculation, animal burden calculation, conversion factors)

Under this point, the major differences between the old (EU-guidelines) and the new (OECD-guidelines) data requirements were highlighted for the different sections. EFSA presented the updated list of End Points (LoEPs) in compliance with the new data requirements. This LoEPs was already discussed and agreed at previous Pesticides Steering Committee (PSC) and will be submitted to be noted during the next SCoFCAH Legislation Meeting (July 2014). The main changes compared to the "old" data requirement were discussed and refer to the main following points:

- Primary crops: An additional “Miscellaneous" crop group is introduced. It should not be considered as a "third crop group" to conclude on an overall residue definition. There is no guidance yet on the genetically modified crops. It was agreed that studies on GMO crops when provided, fall under miceallaneous.

- Rotational crops: The DT90 of 100 days triggering the submission of rotational crop studies is no longer stated in the OECD guidelines and in the EU Regulation 283/2013 it is mentioned that studies have to be provided "if the parent compound or soil metabolites are persistent in soil or significant concentrations of metabolites in soil occur".

- Processing: Standard hydrolysis studies are now requested when residues in raw commodities are >0.01 mg/kg.

- Livestock metabolism studies: studies are required on poultry, goat, fish, and pigs (if triggered). The threshold intake for the submission of animal study is now 0.004 mg/kg bw/d, except for fish where the value of 0.1 mg/kg DM/d is still recommended in the SANCO/11187/2013 rev.3 working document on the nature of residues in fish. There are some concerns on how to assess the dietary burden for fish presented in the document SANCO/11187/2013 of 31 January 2013. DE mentioned that a dietary burden calculator for fish is currently under development.

- Residue definition (RD): The RD for enforcement should be as simple as possible and based as far as possible, on the single compound approach. EFSA highlights that according to Regulation (EC) 1107/2009, Art.12.3, the EU reference laboratories could be consulted during the commenting phase of the peer review process.

- Magnitude of the residues in rotational crops: In cases where the setting of MRLs for rotational crops is necessary, the guidelines do not provide an appropriate approach to set MRL values. However, EFSA mentioned that a Draft guidance document on rotational crops is under preparation at OECD level (probably available by 2016) where an approach for the setting of MRLs in rotational crops is considered. It is noted that the envisaged approach has already been considered by an Applicant in the dossier for the approval of a NAS.

- Storage stability of residues: Crop matrices classification has been slightly modified. The group “dry commodities" (e.g. cereal grains…) has been divided into “high protein content” commodities (dry pulses) and high starch content commodities (cereal grains). This classification also applies to the plant groups for which the analytical methods have to be validated (OECD Guidance document 39). In addition, more stability studies will be required (only 1 crop per category under the old data requirements, while up to 3 studies on 3 different crops in the high water content category under new data requirements).

- Summary of residue data from residue trials: No particular changes. However, EFSA highlighted the following points:

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- According to FAO definition, HR and STMR refer to the values calculated according to the RD for risk assessment. When necessary and to avoid any misunderstandings, the acronyms HRMo and STMRMo are proposed to differentiate the highest and median residue levels derived from the residue levels according to the RD for monitoring.

- HR and STMR values (RD-RA) derived from the supervised residue trials should be used as input values in the consumer intake calculations (instead of the HRMo/STMRMo corrected with the Conversion Factors (CF) for risk assessment).

- When residue data for the edible part of the food commodity is available (e.g. melon pulp, citrus pulp…), the HR and STMR calculated on the edible part should be used as input value (instead of the HR and STMR derived from the raw commodity, corrected by the processing factor).

- If NEU and SEU residue populations are shown to have a similar distribution (U-Test, H-Test) the residue datasets should be merged together to derive a more accurate MRL proposal (provided that based on the same GAPs).

- Conversion factors for risk assessment (CF) might be PHI-dependent. The CF values at the different PHIs should therefore be considered to derive a CF for a crop commodity. As far as possible, CFs covering several plant groups should be proposed.

- Magnitude of residues in processed commodities: Two trials only are required unless a difference of more than 50 % is observed between the two studies (based on the lowest value).

- Consumer risk assessment model: The EFSA PRIMo Model is the reference tool.

In addition, EFSA presented the following Excel spreadsheets calculators:

MRL calculation in food of plant origin:

Mann-Whitney U-Test, Kruskal-Wallis H-Test, EU/OECD MRL calculators. It is reminded that the values introduced in these calculators should be independent (e.g. not collected in the same experimental site). In addition, it is highlighted that the OECD MRL calculator might be not appropriate in case of post-harvest applications (in some particular cases such as post-harvest application, the optional calculation "3 means" should be disregarded, as resulting in a significant higher proposal than the nominal application rate). MRL proposals should rely on the OECD approach. There is no need to report anymore the Rmax and Rber calculations in the reports (unless specific case to be substantiated).

Animal burden calculation and MRL calculation in food of animal origin:

Under the new data requirements, the animal dietary burdens have to be estimated considering the OECD feedingstuff tables and OECD approaches presented in the guidance document on residue in livestock N°73. This OECD guidance is not listed in Regulation (EU) No 283/2013, as published later on July 2013, but there was a general agreement during the meeting to consider this update. EFSA has developed an Excel spreadsheet calculator taking into account the changes and approaches proposed in the OECD documents. The main changes compared to the old data requirements were presented and discussed during the meeting:

- 9 animal diets have now to be considered (4 only under the old data requirements),

- New feed items such as wheat forage, hay… have been introduced in the feedstuff tables. After discussion the meeting agreed that, by default, intended uses on cereals should be understood as "on cereal for grain production" and therefore, only residues in grains and straw considered for the animal burden calculation. Residue data at forage, silage growth stages have therefore not to be requested for uses intended on cereal

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grain. It was agreed that, when grown for forage, silage, the GAPs are different, and therefore, the GAPs proposed for cereal grains would not be relevant to derive residues in forage or silage.

- The feed items derived from imported crops have also been discussed. It was concluded that, by default, the following imported food/feed commodities and their by-products have to be included in the animal dietary burden calculations:

- citrus/apple pomace derived from imported fruits ( to be reconsidered if information is provided that the vast majority of the imported fruits are for direct human consumption and never processed)

- cereal grains, oilseeds/pulses and their by-products (meal cake),

- root and tuber crops.

In contrast, residues in straw, forage, hay, silage, beet tops… are disregarded for animal burden calculations, as not expected to be imported in EU.

- Germany informed the meeting that a dietary burden guidance for fish is currently under development.

These Excel calculators have already been circulated to some Member States following the residue expert meeting of September 2012 for commenting, but no feedback has been received. It is proposed to circulate again these calculators by mid-July to all MSs in order to collect their comments/remarks by end of August and to make available an updated version that would consider the modifications/improvements suggested by the MSs.

4.2.4 Harmonisation templates DAR Peer review/ER MRL application

A draft Evaluation report (ER) template was presented. It is proposed to base the ER on the template proposed for the LoEPs in order to keep the document as short as possible (new data requirements and revised version for old data requirements) and already discussed and approved by the PSC. The proposed template will be amended considering the comments and discussions, and based on this approach, three different templates will be submitted for commenting to the MSs by mid-July:

- ER (Appendix) included in an Assessment Report for NAS approval,

- ER for MRL application under Art. 10 (new data requirements)

- ER for MRL application under Art. 10 (old data requirements)

In order to adopt a streamlined approach for the drafting of the EFSA Reasoned Opinion on MRL applications (as it was done for the EFSA Conclusions in 2009), EFSA proposes to publish the ER as “background document” to the Reasoned Opinion. It would be therefore possible not to repeat some information already available in the ER. EFSA will inform MSs before routine publication of the ER begins.

4.2.5 Deadlines for commenting:

The following deadlines were agreed:

- PSC meeting minutes: Available by 30.06.2014 and submission of comments requested by 15.07.2014 at the latest. Publication of minutes agreed by written procedure on EFSA website

- Templates/Flow-charts/Excel calculator spreadsheets related to Art. 10, and presented during the meeting, will be updated/modified considering the outcome of the discussion and uploaded on the “MRL Workspace Platform” by mid-July. MSs will be informed when the documents are available for commenting. Submission of comments requested by 15 September 2015 at the latest.

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- The documents amended/corrected according to the MS comments will be proposed for a first discussion at the SCoFCAH Residues meeting of September 2014.

Agenda item 5.1: Streamlining the review of MRLs under Art. 12 of Reg. (EC) No 396/2005

5.1.1 Discussion and agreement on the revised procedures

EFSA presented an overview of the current status of the Art. 12 MRL review. Member States acknowledged the review under Art.12 finding it very useful for having an overview of the active substance and of all the studies evaluated. The outcome of the Art. 12 MRL review is also very much appreciated by MSs in the context of evaluating national authorisations.

In order to improve and simplify the MRL reviews, EFSA also proposed a new process (future process). Considering that for several active substances data have been already submitted, the need of a transient process (interim process) has been identified. Following the comments received, the interim and future processes as proposed by EFSA have been agreed upon with the following modifications:

a footnote reporting at which stages MSs shall contact authorisation holders has been added in both flowcharts; it has also been agreed that the RMS can share the PROFile with the authorisation holders;

in order to allow to the RMS to have a longer period for the preparation of the evaluation report in case of complex assessment, it has been reported that the RMS has 2 months or more for the preparation of the evaluation report. However, Member States should aim for two months and inform EFSA when they will not be able to meet this timeline.

The flow charts provided in Appendix A were agreed upon noting a reservation from Germany on the three weeks timeline for the MS consultation in the interim and future processes, which is considered too short for Germany.

In addition, following discussion it has been agreed that, for the interim process, GAPs and trials should be reported by the authorising country (not the RMS). MSs should keep in mind that GAPs and residue trials have to be submitted at the moment of the call for data; data provided during the Member State Consultation (MSC) will no longer be accepted, unless the omission of data at the previous stage was due to genuine mistake that needs to be corrected.

The possibility to involve the EURLs in the process has also been discussed. EFSA anticipated that the EURLs can be involved at the moment of collecting data (call for data) and in a later stage (e.g. MSC). However, this point will be further discussed trilaterally with EFSA, Commission and EURLs.

For new active substances submitted for approval under Reg. 1107/2009, it was agreed that there is in principle no need for an Art.12 MRL review because all intended uses (and not only the representative uses) should be included in the AR, but legally an Art. 12 MRL review is still triggered. EFSA and COM will discuss possible solutions for this problem bilaterally.

5.1.2 Planning and prioritisation

5.1.2.1 Transitions between the procedures (current/interim/new)

Overlap between the three different procedures may create confusion. Therefore they will be implemented in a sequential order. EFSA will therefore aim at finalising the substances under the current procedure as soon as possible and the first call for data under the interim procedure is expected in the second half of 2014. The future process will only be implemented once all the substances under the interim process have been handled (not before 2016).

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5.1.2.2 Substances to be processed under the different procedures (current/interim/new)

EFSA presented the list of the active substances to be reviewed under the current, the interim and the future processes. The list of active substances that will be reviewed under the current process has been agreed upon as proposed by EFSA.

Regarding the active substances initiating the interim and the future processes, FI asked to include in the interim process quizalofop-p, propaquizafop and clopyralid (originally included in the future process) for which the data were already submitted or are ready for submission. Similar cases were identified by Belgium for fenbutatin oxide, lenacil and myclobutanil; by the Netherlands for profoxydim, clethodim, triflumizole and pyridaben, and by Germany for metribuzin, tefluthrin, phosphane and the phosphides. It was agreed to move these substances to the interim process, except for lenacil, metribuzin and clopyralid which are included in the AIR III program (see also agenda item 5.1.2.3).

Regarding pyridalyl, AT pointed out that it is not the RMS (RMS is NL). FR also pointed out that the new RMS for tricyclazole is now IT (and no longer FR). These mistakes have been amended in the final list of active substances.

5.1.2.3 Improve coordination with the renewal of approvals

Peer review under the renewal process can have a significant impact on residue definitions and toxicological reference values which are at the basis of the strategy to be used for the assessment. Consequently, it has been agreed for all AIR III active substances to postpone the MRL review after the renewal of the approval, apart from copper compounds (for which the evaluation is in an advanced stage and no significant changes are expected during the renewal process) and deltamethrin and chloridazon (which need to be handled with high priority, due to possible consumer intake concerns). Cypermethrins, dithiocarbamates, chlorpyrifos, chlorpyrifos-methyl and triclopyr were initially also requested to be handled with higher priority but for these substances the outcome of the AIR III process will have a major impact on the strategies to be followed for the combined residue definitions, possibly making the Article 12 review obsolete. Furthermore, regardless of the AIR III process, there are still several open issues regarding the toxicological reference values for chlorpyriphos and chlorpyriphos-methyl. All these substances may therefore still be moved to the future process if it is agreed by the SCoFCAH that these active substances do not need to be processed with high priority.

Following a comment from BE, EFSA acknowledged that for the cypermethrins, the AIR III process might not solve the problem of the diverging toxicological reference values if they are being looked at separately. EFSA will therefore consider the possibility to involve the PPR panel for this group of substances.

EFSA also proposed that for the AIR III substances handled under the future process, the RMS for the renewal of the active substance would also be the most appropriate to follow the Art. 12 review. The same reasoning applies to AIR I or AIR II substances, where the review of MRLs has not yet been initiated by EFSA (e.g. imazalil).

Also considering the discussions under agenda item 5.1.2.2, the lists of substances to be processed according to the three different workflows have been agreed upon and are presented in Appendix B.

5.1.3 Discussion and agreement on the most appropriate approach for Annex IV candidates

EFSA identified and presented the list of candidate active substances for inclusion in Annex IV of Regulation (EC) No 396/2005. In order to understand if an Art. 12 review would be required for these active substances, EFSA will screen the authorised GAPs and verify

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whether they correspond to the representative uses previously evaluated by EFSA. If this is the case, EFSA will issue a statement that a review of MRLs under Article 12 is not necessary. If this is not the case, a specific assessment will be required. It is EFSA’s intention to outsource this screening exercise.

Member States agreed with the approach proposed by EFSA but COM expressed some concerns on this proposal, especially regarding the screening exercise, and will further discuss the proposal bilaterally. The outcome of this discussion will be presented at the SCoFCAH.

5.1.4 Possible improvements for comments provided by MSs and EURLs

Several points have been identified by EFSA and agreed upon to improve the comments received during the MSC.

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APPENDIX A - FLOWCHARTS Appendix A.1 - current process

Appendix A.2 - interim process

Appendix A.3 - future process

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APPENDIX A.1 - CURRENT PROCESS

Submission of the

PROFile and ER

by the RMS (*)

Completeness

check by EFSA

Further

clarifications

needed?

Drafting of the RO

by EFSA

(± 2 months)

MSC launched by

EFSA (*)

(± 2 months)

Drafting of the

MSC report by

EFSA

(± 1 month)

Further

discussion

needed?

Meeting of experts

(± 6 weeks)

Finalisation of the

MSC report by

EFSA

(± 1 month)

Further

clarifications

needed?

Submission of

clarifications by

MS

(± 2 weeks)

Finalisation of the

RO by EFSA

(± 1 month)

No

Yes

Yes

No No

Yes

Submission of

clarifications by

the RMS (*)

EFSA seeks

agreement with

RMS (*)

EFSA prepares a

revised PROFileRMS agrees?

No

EFSA confirms

completeness of

the PROFile

Yes

Reasoned opinion (contractors)

Data reception (RMS/EFSA)

(*) MSs shall contact the authorisation holders at this stage

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APPENDIX A.2 - INTERIM PROCESS

PROFile and ER

already submitted

by the RMS

Further

clarifications

needed?

EFSA confirms

completeness and

drafts the RO

(± 1 month)

MSC launched by

EFSA

(± 3 weeks)

Drafting of the

MSC report by

EFSA

(± 2 weeks)

Further

discussion

needed?

Meeting of experts

(± 6 weeks)

Finalisation of the

RO and the MSC

report by EFSA

(± 2 weeks)

No

Yes

Yes

No

Submission of

clarifications by

MSs

(≥ 3 weeks) (*)

EFSA invites all

MSs to submit

additional data

(± 2 months) (*)

First check by

EFSA

(± 1 month)

EFSA includes

new data in the

PROFile

(± 1 month)

Data reception (MS/EFSA)

Reasoned opinion (EFSA)

(*) MSs shall contact the authorisation holders at this stage

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APPENDIX A.3 - FUTURE PROCESS

Further

clarifications

needed?

EFSA confirms

completeness and

drafts the RO

(± 1 month)

MSC launched by

EFSA

(± 3 weeks)

Drafting of the

MSC report by

EFSA

(± 2 weeks)

Further

discussion

needed?

Meeting of experts

(± 6 weeks)

Finalisation of the

RO and the MSC

report by EFSA

(± 2 weeks)

No

Yes

Yes

No

Submission of

clarifications by

the RMS

(≥ 3 weeks) (*)

Data reception (RMS/MS/EFSA)

Reasoned opinion (EFSA)

EFSA notifies all

MSs that a new

Article 12 review is

initiated

RMS identifies

critical GAPs

(± 6 weeks) (*)

MSs upload their

national GAPs on

MRL Workspace

(± 1 month)

Completeness

check by EFSA

(± 1 month)

MSs upload data

supporting the

critical GAPs

(± 1 month)

RMS submits ER

and PROFile

(≥ 2 months) (*)

(*) RMS shall contact the authorisation holders at this stage

Page 16 of 23

APPENDIX B - LIST OF THE ACTIVE SUBSTANCES TO BE PROCESSED ACCORDING TO THE

CURRENT (APPENDIX B.1), THE INTERIM (APPENDIX B.2) AND THE FUTURE (APPENDIX B.3) PROCESS

Page 17 of 23

APPENDIX B.1 – ACTIVE SUBSTANCES TO BE REVIEWED UNDER THE CURRENT PROCESS

EFSA-Q-number Active substance RMS

EFSA-Q-2008-603 Pethoxamid DE

EFSA-Q-2008-633 Thiabendazole ES

EFSA-Q-2008-482 1-Methylcyclopropene UK

EFSA-Q-2009-00090 Indolylacetic acid FR

EFSA-Q-2009-00091 Indolylbutyric acid FR

EFSA-Q-2008-500 Boscalid DE

EFSA-Q-2009-00120 Abamectin NL

EFSA-Q-2008-524 Desmedipham FI

EFSA-Q-2008-604 Phenmedipham FI

EFSA-Q-2009-00065 Oryzalin FR

EFSA-Q-2008-503 Carbendazim DE

EFSA-Q-2008-637 Thiophanate-methyl DE

EFSA-Q-2010-01493 Haloxyfop-P DK

EFSA-Q-2008-514 Clothianidin BE

EFSA-Q-2008-635 Thiamethoxam ES

EFSA-Q-2008-639 Tolclofos-methyl SE

EFSA-Q-2008-560 Glufosinate SE

EFSA-Q-2008-561 Glyphosate DE

EFSA-Q-2008-612 Propiconazole FI

EFSA-Q-2008-609 Pirimiphos-methyl UK

EFSA-Q-2009-00045 Dodine PT

EFSA-Q-2008-531 Diquat UK

EFSA-Q-2009-00063 Metosulam FR

EFSA-Q-2009-00043 Diethofencarb FR

EFSA-Q-2010-01069 Bifenthrin FR

EFSA-Q-2009-00035 Carbetamide FR

EFSA-Q-2009-00028 Tritosulfuron DE

EFSA-Q-2008-629 Spiroxamine DE

EFSA-Q-2009-00128 Fenpropimorph DE

EFSA-Q-2008-585 Mesotrione UK

EFSA-Q-2009-00031 Acrinathrin FR

EFSA-Q-2010-00210 Triflusulfuron FR

EFSA-Q-2009-00081 1-Naphthylacetamide FR

EFSA-Q-2009-00082 1-Naphthylacetic acid FR

Page 18 of 23

APPENDIX B.2 – ACTIVE SUBSTANCES TO BE REVIEWED UNDER THE INTERIM PROCESS

EFSA-Q-number Active substance RMS

EFSA-Q-2008-590 Metiram (a) IT

EFSA-Q-2008-638 Thiram (a) BE

EFSA-Q-2008-648 Ziram (a) BE

EFSA-Q-2008-577 Mancozeb (a) IT

EFSA-Q-2008-578 Maneb (a) IT

EFSA-Q-2008-613 Propineb (a) IT

EFSA-Q-2008-523 Deltamethrin (b) SE

EFSA-Q-2008-487 alpha-Cypermethrin (a) BE

EFSA-Q-2008-520 Cypermethrin (a) BE

EFSA-Q-2008-643 Triclopyr (a) IE

EFSA-Q-2008-510 Chlorpyrifos-methyl (a) ES

EFSA-Q-2008-509 Chlorpyrifos (a) ES

EFSA-Q-2010-00211 zeta-Cypermethrin (a) BE

EFSA-Q-2008-511 Cinidon ethyl UK

EFSA-Q-2009-00118 Fuberidazole UK

EFSA-Q-2009-00119 Mepiquat UK

EFSA-Q-2009-00116 Fluazinam AT

EFSA-Q-2009-00135 Tralkoxydim UK

EFSA-Q-2009-00129 Fenpyroximate DE

EFSA-Q-2009-00142 Aclonifen DE

EFSA-Q-2009-00173 Magnesium phosphide DE

EFSA-Q-2009-00157 Calcium phosphide DE

EFSA-Q-2009-00151 Aluminium phosphide DE

EFSA-Q-2009-00095 Zinc phosphide incl. phosphine DE

EFSA-Q-2012-00944 Phosphane DE

EFSA-Q-2010-00192 Methomyl UK

EFSA-Q-2009-00191 Sulcotrione DE

EFSA-Q-2009-00193 Triadimenol UK

EFSA-Q-2009-00159 Cymoxanil AT

EFSA-Q-2010-00180 Bensulfuron IT

EFSA-Q-2010-00203 Sodium p-nitrophenolate EL

EFSA-Q-2010-00202 Sodium o-nitrophenolate EL

EFSA-Q-2010-00201 Sodium 5-nitroguaiacolate EL

EFSA-Q-2010-00205 Tebufenpyrad DE

EFSA-Q-2010-00181 Chlormequat UK

EFSA-Q-2010-00199 Propaquizafop IT

EFSA-Q-2010-00200 Quizalofop-P FI

EFSA-Q-2010-00183 Copper compounds (c) FR

EFSA-Q-2010-00191 Lufenuron PT

EFSA-Q-2010-00208 Tri-allate UK

EFSA-Q-2010-00197 Penconazole DE

EFSA-Q-2010-00189 Etofenprox IT

Page 19 of 23

EFSA-Q-number Active substance RMS

EFSA-Q-2010-00187 Dimethachlor DE

EFSA-Q-2010-01068 2-Phenylphenol ES

EFSA-Q-2009-00012 Triflumizole NL

EFSA-Q-2010-01077 Penoxsulam IT

EFSA-Q-2009-00026 Bromuconazole BE

EFSA-Q-2010-00209 Triflumuron IT

EFSA-Q-2009-00071 Pyridaben NL

EFSA-Q-2009-00049 Fenbuconazole UK

EFSA-Q-2009-00036 Carboxin UK

EFSA-Q-2009-00068 Pencycuron NL

EFSA-Q-2009-00087 Bromadiolone SE

EFSA-Q-2009-00038 Clethodim NL

EFSA-Q-2009-00051 Fenoxycarb NL

EFSA-Q-2009-00067 Paclobutrazol UK

EFSA-Q-2009-00041 Dazomet BE

EFSA-Q-2009-00059 Hexythiazox FI

EFSA-Q-2009-00056 Flurochloridone ES

EFSA-Q-2009-00075 Tebufenozide DE

EFSA-Q-2009-00064 Myclobutanil BE

EFSA-Q-2011-00171 Bispyribac IT

EFSA-Q-2011-00172 Profoxydim ES

EFSA-Q-2009-00076 Tefluthrin DE

EFSA-Q-2012-00450 Metam BE

EFSA-Q-2012-00741 Fenpyrazamine AT

EFSA-Q-2013-00277 Mandipropamid AT

EFSA-Q-2013-00967 Tembotrione AT

EFSA-Q-2009-00050 Fenbutatin oxide BE

EFSA-Q-2009-00100 Chloridazon (b, d) DE

EFSA-Q-2009-00143 Imidacloprid (d) DE

EFSA-Q-2009-00069 Prochloraz (d) IE

EFSA-Q-2009-00052 Fluazifop-P (d) FR

EFSA-Q-2008-562 Imazalil (d) NL

EFSA-Q-2009-00044 Dithianon (d) EL

(a): This active substance will soon be peer reviewed in view of its renewal under Regulation 1107/2009 and should preferably be handled under the future process. However, confirmation from the SCoFCAH that there is no need to handle these substances with higher priority is still needed.

(b): Although this active substance will soon be peer reviewed in view of its renewal under Regulation 1107/2009, it was still decided to process this active substance under the interim process as it needs to be handeled with higher priority.

(c): Although this active substance will soon be peer reviewed in view of its renewal under Regulation 1107/2009, it was still decided to process this active substance under the interim process considering the low probability that toxicological reference values for copper will be changed during the renewal process.

Page 20 of 23

(d): RMS did not yet provide the data for this active substance to EFSA but the substance needs to be treated with high priority. EFSA will process these substances under the interim process as soon as the data are received.

Page 21 of 23

Appendix B.3 – active substances to be reviewed under the future process

EFSA-Q-number Active substance RMS

EFSA-Q-2009-00021 Tricyclazole IT

EFSA-Q-2009-00017 Beauveria brongniartii DE

EFSA-Q-2009-00019 Potassium permanganate ES

EFSA-Q-2009-00027 Chlorates FR

EFSA-Q-2009-00089 Fatty alcohols IT

EFSA-Q-2009-00094 Quassia IT

EFSA-Q-2010-00193 Nicotine UK

EFSA-Q-2009-00148 2,5-Dichlorobenzoic acid methylester DE

EFSA-Q-2009-00160 Denathonium benzoate PT

EFSA-Q-2009-00189 Sodium aluminium silicate HU

EFSA-Q-2009-00152 Aluminium silicate HU

EFSA-Q-2009-00150 Aluminium ammonium sulfate PT

EFSA-Q-2010-00186 Difenacoum FI

EFSA-Q-2010-00182 Chlorsulfuron EL

EFSA-Q-2010-01070 Cyflufenamid UK

EFSA-Q-2010-01075 Malathion FI

EFSA-Q-2010-01073 Fluopicolide UK

EFSA-Q-2010-01078 Proquinazid UK

EFSA-Q-2010-01079 Spirodiclofen NL

EFSA-Q-2009-00029 Napropamide DK

EFSA-Q-2009-00018 Buprofezin UK

EFSA-Q-2009-00084 Aluminium sulphate NL

EFSA-Q-2009-00034 Bupirimate NL

EFSA-Q-2009-00040 Cyproconazole IE

EFSA-Q-2009-00047 Etridiazole NL

EFSA-Q-2009-00048 Fenazaquin EL

EFSA-Q-2009-00054 Fluometuron EL

EFSA-Q-2009-00074 tau-Fluvalinate DK

EFSA-Q-2010-01082 Triazoxide UK

EFSA-Q-2009-00053 Flufenoxuron FR

EFSA-Q-2011-01093 8-Hydroxyquinoline ES

EFSA-Q-2009-00055 Fluquinconazole IE

EFSA-Q-2009-00066 Oxyfluorfen ES

EFSA-Q-2009-00077 Terbuthylazine UK

EFSA-Q-2013-00803 Novaluron UK

EFSA-Q-2012-00690 Fluxapyroxad UK

EFSA-Q-2010-00185 Didecyldimethylammonium chloride NL

EFSA-Q-2012-00943 Isopyrazam UK

EFSA-Q-2013-00279 Ametoctradin NL

EFSA-Q-2013-00351 Spiromesifen UK

EFSA-Q-2013-00344 Bixafen UK

EFSA-Q-2013-00349 Potassium phosphonates FR

Page 22 of 23

EFSA-Q-number Active substance RMS

EFSA-Q-2013-00775 Fluopyram DE

EFSA-Q-2013-00779 Pyriofenone UK

EFSA-Q-2013-00776 Sedaxane FR

EFSA-Q-2013-00778 Disodium phosphonate FR

EFSA-Q-2013-00879 Penflufen UK

EFSA-Q-2014-00122 Potassium thiocyanate NL

EFSA-Q-2014-00204 Potassium iodide NL

EFSA-Q-2013-00777 Emamectin NL

EFSA-Q-2013-00909 Benalaxyl-M PT

EFSA-Q-2013-00911 Spirotetramat AT

EFSA-Q-2013-00965 Chlorantraniliprole IE

EFSA-Q-2013-00966 Penthiopyrad UK

EFSA-Q-2014-00205 Spinetoram UK

EFSA-Q-2014-00206 Pyridalyl NL

EFSA-Q-2014-00208 Thiencarbazone UK

EFSA-Q-2014-00212 Amisulbrom UK

EFSA-Q-2014-00454 Flubendiamide EL

EFSA-Q-2014-00360 Acequinocyl NL

EFSA-Q-2014-00374 Ipconazole UK

EFSA-Q-2008-518 Cyfluthrin DE

EFSA-Q-2008-498 beta-Cyfluthrin DE

EFSA-Q-2008-513 Clopyralid FI

EFSA-Q-2008-579 MCPA PL

EFSA-Q-2008-580 MCPB PL

EFSA-Q-2008-588 Methiocarb UK

EFSA-Q-2008-575 Linuron IT

EFSA-Q-2008-624 Quinoxyfen UK

EFSA-Q-2008-649 Zoxamide LV

EFSA-Q-2008-527 Dimethoate IT

EFSA-Q-2008-558 Fosthiazate DE

EFSA-Q-2008-535 Ethoprophos IT

EFSA-Q-2008-605 Phosmet ES

EFSA-Q-2008-592 Metribuzin EE

EFSA-Q-2009-00106 Fenoxaprop-P AT

EFSA-Q-2009-00109 Lenacil BE

EFSA-Q-2009-00101 Clofentezine ES

EFSA-Q-2009-00112 Picloram PL

EFSA-Q-2009-00111 Oxadiazon IT

EFSA-Q-2009-00104 Diflubenzuron EL

EFSA-Q-2009-00113 Pyriproxyfen NL

EFSA-Q-2009-00102 Dicamba DK

EFSA-Q-2009-00108 Imazaquin BE

EFSA-Q-2009-00103 Difenoconazole ES

Page 23 of 23

EFSA-Q-number Active substance RMS

EFSA-Q-2009-00127 Epoxiconazole DE

EFSA-Q-2009-00174 Metamitron UK

EFSA-Q-2009-00182 Pyrethrins IT

EFSA-Q-2010-00207 Tetraconazole IT

EFSA-Q-2010-01080 Sulfuryl fluoride UK

EFSA-Q-2009-00072 Quinmerac UK

EFSA-Q-2009-00061 Isoxaben SE

EFSA-Q-2009-00085 Azadirachtin DE

EFSA-Q-2009-00039 Cycloxydim AT

EFSA-Q-2009-00060 Hymexazol FI

EFSA-Q-2009-00042 Diclofop FR

EFSA-Q-2009-00073 Sintofen FR

EFSA-Q-2013-00520 Cyflumetofen NL

EFSA-Q-2013-00345 Halosulfuron-methyl IT

EFSA-Q-2013-00910 Pyroxsulam UK

EFSA-Q-2014-00207 Valifenalate HU

EFSA-Q-2014-00211 1,4-Dimethylnaphthalene NL