Working document (does not necessarily represent the views of the Commission services)

This draft document is subject to change!

Aide mémoire with regard to certain aspects of the procedures for the evaluation of NEW active substances in view of a possible inclusion into Annex I of Directive 91/414/EEC.

1. Completeness check of the dossier submitted by an applicant

A discussion at the Standing Committee on Plant Health (SCPH) will only take place after the Rapporteur Member State has confirmed that the dossier submitted is complete or with no substantial data gaps and after all Member States and the Commission have received the full dossier from the applicant and the completeness check from the Rapporteur Member State.

After favourable opinion of the Standing Committee on Plant Health the Rapporteur Member State should start the detailed evaluation of the dossier. It might be possible that the Standing Committee confirms that certain studies need to be submitted in order to allow granting of provisional authorisations under particular conditions. If this is the case the Commission will inform the applicant by letter and the Rapporteur Member State should contact the applicant in order to discuss these problems.

2. Preparation of draft assessment report (monograph) by Rapporteur Member State

The Rapporteur Member State should have close contacts with applicants in order to :

• identify and address already at this stage as far as possible the problems arising during the evaluation ;
• to set a deadline or, if appropriate, deadlines for receipt of any further data ;
• to check the draft assessment report on its technical aspects before its submission to the Commission

3. Data made available before submission of the draft assessment report to the Commission

New data, generated after the decision on completeness is taken and before the draft assessment report is submitted to the Commission, should be sent immediately to all Member States where an application for a provisional authorisation has been made. They should be sent, when the Rapporteur Member State submits the draft assessment report to the Commission (see point 4), as one package, to all other Member States and to the Commission. Such data, when received before the deadline(s) referred to in point (2) will be evaluated by the Rapporteur Member State and included in the draft assessment report.

4. Submission of the draft assessment report to the Commission and to the applicant

A hard copy and an electronic copy of the draft assessment report is sent by the Rapporteur Member State to the Commission and to the applicant.

Contacts between Rapporteur Member State and applicant at this stage might be useful.

At this stage the Rapporteur Member State has to inform the applicant that all new data should be available to all Member States and to the Commission (see point 3 - contact addresses see doc. 1606A3/VI/95).

5. Distribution of draft assessment reports by the Commission

The Commission arranges for distribution as soon as possible of the draft assessment report by the ECCO-team to all Member States and to the relevant Commission Services (list of contact points : see doc. 1606A3/VI/95 . This information is also available at the following hyperlink :
http://ec.europa.eu/dg24/health/lqp/pro/eva/newactive/contact/contact_en.htm

6. Consultation of draft assessment reports (now know as the draft assessment reports)

The Member States shall make available at specific request or keep available for consultation by interested parties the following information:

• the name and content of the active substance
• No confidential information can be made available (Regulation 3600/92 art. 7 (1) (d): The reference to each test and study report, for each point of Annex II to the Directive, relied on for the assessment in the form of a list of test and study reports including the title, the author(s), the date of the study or test and the date of publication, the standard to which the test or study was conducted, the holder's name and, if any, the claim made by the holder or applicant for data protection.

It is recommended that interested parties contact preferably the Rapporteur Member State.

7. Data made available after submission of the draft assessment report to the Commission and before the peer review meeting are organised.

Any such data should be sent immediately to all Member States where an application for a provisional authorisation has been made preferably as a package of all new data, by the applicant. The Rapporteur Member State will send a copy of its evaluation to all Member States and the Commission.

8. Organisation of peer review meetings

The following steps are taken for the organisation of these meetings:

• selection of active substances (by the Commission at the ECCO management meeting) and timetable for the meetings

  The applicant has to contact the ECCO-team in order to ensure that all data are available at the peer review meeting

  Member States and applicant are invited by the ECCO-team to comment on draft assessment report identifying the key issues. Comments have to be sent to the Rapporteur Member State (and a copy to the ECCO-team organising the peer review meeting for that particular active substance), as soon as possible and preferably at least 4 weeks before the meeting on the specific subjects takes place. This is the major opportunity for both applicant and Member State to comment.

• Member States are informed and invited to nominate experts
• the Commission selects the experts attending the peer review meetings and ensures that the draft assessment report is sent by the ECCO-team to the experts participating at the peer review meetings as soon as possible and at the latest 6 weeks before the meeting
• meetings are held on each of the following subjects :
  • identity, physical and chemical properties
  • impact on human and animal health
  • fate and behaviour in the environment
  • ecotoxicology
  • residues

The Rapporteur Member State should as far as possible and necessary discuss the major comments made by Member States or applicants with the applicant before the peer review meetings take place.

These meetings should:

• peer review the draft assessment report,
• agree on the endpoints both for risk assessment and hazard identification
• agree on further questions/data requirements to the applicant
• identify the main areas of concern
• identify the data which are necessary for the decision making
• agree on the claims for data protection
• agree on a recommendation for classification to be forwarded to DG ENVIRONMENT
• prepare an evaluation table including the list of intended uses.

New data available after the submission of the draft assessment report will only be discussed at the peer review meetings if the Rapporteur Member State has been able to evaluate the data. All new data tabled at the meeting will be noted in the reports of the meetings as being submitted.If it was not possible to discuss certain new data this will be mentioned in the report. The applicant has to ensure that the data are available at the peer review meeting organised by the ECCO-team.

It may be appropriate that the applicant informs the Rapporteur Member State on the name and phone number of the expert in charge in the company of the dosssier under peer review for possible consultation during the peer review meeting.

Following each peer review meeting a table with all outstanding questions (evaluation table) is sent within 2 weeks by the ECCO- team to the Rapporteur Member State.

The Rapporteur Member State should immediately after receiving these tables discuss them with the applicant in order to try to solve any questions.

The report of the meetings is sent by the ECCO-team within 4 weeks to the contact point of the Rapporteur Member State and to the experts who participated at the meeting. The ECCO reports will not contain confidential information (except if necessary in a separate annex).

The applicant has to send his comments on the evaluation tables to the Rapporteur Member State. The Rapporteur Member State should comment in the evaluation table on the arguments presented by the applicant and send it to the ECCO-team before the final overview meeting which will take place about 2 months after the 5th meeting.

The overview meeting should review the outcome of the 5 meetings, the evaluation table and the main areas of concern. The evaluation table should contain the comments of the applicant on the outstanding questions and the assessment of the Rapporteur Member State of these comments and be presented in the format as agreed (model as provided by the Commission). During the overview meeting the column concerning the recommendations from the overview meeting is completed.

The Commission will ensure that the ECCO-team sends:

i) the full report of all peer review meetings to all Member States and the relevant Commission services and the applicant;

ii) a draft of the administrative part of the review report and the evaluation table to the Commission only. The Commission will distribute these documents to all Member States in time before the active substance will be discussed at the evaluation group meetings.

9. The legislation group is informed by the Commission of the conclusion of the peer review meetings.

10. Tripartite meeting (Commission/Rapporteur Member State/applicant)

Such meetings are organised, at the request of the Commission, by the Rapporteur Member State. They are only organised if the Commission envisages an unfavourable decision. In this case the list of outstanding questions in the evaluation tables will be the basis for discussion. The aim of the meeting is to discuss any scientific and technical aspects with all relevant experts from the Rapporteur Member State including as far as possible the experts who attended the peer review meetings on the substance in question. The applicant should react to the main outstanding questions or restrictions proposed; however at these meetings no new data will be evaluated.

The applicant should present his main arguments and the results of studies or evaluations in the evaluation table, referring if necessary to background documents where a more detailed argumentation is presented. No raw data should be circulated as answer to any outstanding question because confidentiality can not be guaranteed since all comments received will be included in the background documentation supporting the review report of the active substance. The Rapporteur Member State should comment in the evaluation table on the arguments presented by the applicant.

11. Commission Evaluation Working Group (EWG) meeting

The Commission distributes as soon as possible before the meeting the evaluation table.

In principle 2 discussions will be held on this table and on the main areas of concern. The Rapporteur Member State should as far as possible present the outcome of his evaluation of new studies having been submitted and which were not considered during the peer review meetings.

At the evaluation meeting a timetable for the evaluation of any new data, submitted after the draft assessment report has been submitted to the Commission and which have not yet been evaluated by the Rapporteur Member State, will be agreed taking into account the amount of new data submitted. The meeting will also agree on a realistic timetable for any submission of further data.

The Commission will update the evaluation table and send it to the Rapporteur Member State who should if necessary contact the applicant in order to address the remaining issues. The Rapporteur Member State should update the evaluation table and send it to the Commission who will distribute it before the next meeting to all Member States.

The appendices of the review report containing the endpoints will be sent by the Commission to the Rapporteur Member State after the finalisation of the discussions in the evaluation group (unless the active substance would be suspended or withdrawn from the market). The Rapporteur Member State will update these appendices and send them back to the Commission. In principle no discussion is provided on the list of endpoints in the evaluation group meeting.

Before the finalisation of the discussion in the working group and in the Scientific Committee for Plants, the Rapporteur Member State will send to all the Member States and to the Commission its detailed evaluation on new data made available after the submission of the draft assessment report to the Commission.

The Rapporteur Member State shall ensure that the applicant submits all data made available after the submission of the draft assessment report to the Commission to all Member States and to the Commission as one package (except for the data already submitted to the Member States where an application for a provisional authorisation has been made). An update of the summary dossier has to be sent to all Member States and the Commission.

12. Information of the Commission Legislation Working Group (LWG) meeting

The Commission will explain its intention for possible decision on the active substance to the Member States.

13. Consultation of the Scientific Committee for Plants (SCP)

DG Health and Consumer Protection Unit E1 invites Unit B2 to consult the Scientific Committee for Plants (SCP). However when a non-inclusion is proposed, it may not be necessary to consult the Scientific Committee for Plants. The following information will be made available:

• the intention for possible decision or the draft decision
• the dossier provided by the applicant
• the draft assessment report prepared by the Rapporteur Member State
• the result of the peer review
• the draft review report
• the evaluation table including the list of intended uses
• documents and comments received post peer review
• the detailed evaluation from the Rapporteur Member State on new data made available after the submission of the draft assessment report to the Commission.

The Scientific Committee for Plants will complement to existing procedures avoiding any duplication.

In cases of specific questions addressed to the SCP, the Committee will issue an opinion addressing the question raised.

The Committee will act proactively and will therefore retain the right to draft or supplement questions and issue opinions accordingly.

14. Commission Legislation Working Group (WGL) meeting

Discussions can take place before the Scientific Committee on Plants (SCP) has given its opinion in order to update the "administrative" parts of the review report and its appendices (list of endpoints and list of claims.

Discussion on the draft decision and its "legislative and technical" parts will start after the Scientific Committee for Plants has given its opinion. This opinion will be made available by the Commission to the Member States in time before the meeting. The Commission will submit a draft review report. At this stage a discussion starts on the review report and on the appendices of the review report containing the endpoints.

Preparation of the final draft decision and final review report.

15. Standing Committee on Plant Health (SCPH)

Directorate General Health and Consumer Protection Unit E1 will prepare a draft decision on which internal consultations in the Commission will be organised.

The SCPH notes the final review report and gives a formal opinion on the final draft decision.

16. Finalisation of the review report

The review report contains 3 background documents:

A : the draft assessment report (draft assessment report)

B : the peer review report, including the final evaluation table and the detailed evaluation of the Rapporteur Member State of information evaluated after the submission of the draft assessment report.

C : the comments submitted after the peer review