detailed efsa procedure

1

Procedure for the approval of an a.s.

under Regulation (EC) No 1107/2009Herman Fontier, Head of PRAPeR Unit

BfR Workshop Classification Pesticides, 12/04/11, Berlin

Content

• This presentation summarises the procedure

leading to an approval of a new active

substance (a.s.) under Regulation (EC) No

1107/2009

• The procedure for the renewal of an approval is

slightly different

• In the following slides, the text in italic refers to

EFSA procedures which are not laid down in the

Regulation

2

Application

• The applicant submits a dossier to a Member

State of his choice (the Rapporteur Member

State, RMS)

• The format of the dossier shall be established in

accordance with the advisory comitology

procedure

3

Completeness check

• Within 45 days the RMS shall acknowledge

receipt of the dossier and check whether the

dossier is complete

• Where elements are missing in the dossier, the

RMS requests the applicant to complete the

dossier within 3 months

• Where at the end of this period the missing

elements are not submitted, the application is

inadmissible

4

Evaluation by the RMS

• Where the dossier is considered admissible, the

RMS shall notify the applicant, the other MSs,

the Commission and EFSA on the admissibility

of the application and start assessing the a.s.

• The applicant shall immediately forward the

dossier to the other MSs, the Commission and

EFSA

• EFSA shall make the summary dossier available

to the public

5


• Within 12 months of the notification of

admissibility, the RMS shall prepare a Draft

Assessment Report (DAR), assessing whether

the a.s. can be expected to meet the approval

criteria

• Where the criteria with regard to CMR

classification are not satisfied, the DAR shall be

limited to those parts of the assessment

• The DAR is submitted to the Commission and

EFSA6


• Where the RMS needs additional information, it

shall set a period of max. 6 months in which the

applicant must submit the additional information;

the Commission and EFSA shall be informed

• The format of the DAR shall be established in

accordance with the advisory comitology

procedure

7

EFSA peer review

• The EFSA peer review comprises the following

steps:

�Commenting

�Consideration of the comments

�Expert meetings (optional)

�Drafting of the EFSA conclusion

• The next slide shows the flowchart in case an

expert consultation is organised and additional

data are requested; the flowchart is a draft which

may be amended 8

Commenting on the DAR

• EFSA shall circulate the DAR to the applicant

and the other MSs within 30 days

• Where relevant EFSA shall ask the applicant to

circulate an updated dossier to the MSs, the

Commission and EFSA

• EFSA shall make the DAR available to the public

• A period of 60 days for submission of comments

(applicant, MSs, public) is foreseen

• EFSA also comments on the DAR10

Commenting on the DAR

• The comments are collated in a “reporting table”

• The applicant is given the possibility to react on

the comments

• The RMS is invited to address all comments

• EFSA concludes on the further way forward with

each of the comments (point closed, point to be

further considered by the RMS, point to be

scheduled in an expert meeting, additional

information requested)

11

Reporting table

12

Additional information

• Where EFSA needs additional information it

shall set a period of a maximum of 90 days for

the applicant to submit it to the MSs, the

Commission and EFSA

• The need for additional information is discussed

in a teleconference between EFSA/COM/RMS

13

Additional information

• The RMS shall assess the additional information

within 60 days

• The period for the adoption of the EFSA

conclusion is extended with the time needed to

submit and assess the additional information

14

Expert consultation

• Where appropriate, EFSA shall organise a

consultation of experts, including experts from

the RMS

• On the basis of the reporting table EFSA

decides which points need to be discussed in an

expert consultation

• These points are transferred to an evaluation

table

15

Expert consultation

• The evaluation table is further completed

throughout the peer review process (further

input from the RMS where relevant, outcome of

the discussions during the expert consultation,

final EFSA position on each issue)

• The discussions during the meeting are

documented in detail in a discussion table

16

Evaluation table

17

Discussion table

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EFSA Conclusion

• EFSA shall adopt within 120 days after the

commenting period a conclusion on whether the

a.s. can be expected to meet the approval

criteria

• This period is extended to 150 days in case an

expert consultation takes place

• Before adopting the conclusion, EFSA circulates

the draft to the MSs for a written consultation

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EFSA Conclusion

• The MS comments are collated in a table; for

each comment, EFSA indicates in the table how

the comment was addressed

• the EFSA conclusion refers to background

documents A and B; background document A is

the DAR and any addenda to it; background

document B is the compilation of all documents

generated during the peer review process

(reporting, evaluation and discussion tables)

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EFSA Conclusion

• EFSA makes the conclusion and the background

documents A and B available on its website

• Within 6 months of receiving the conclusion the

Commission shall present a review report and a

draft regulation on approval or non-approval of

the a.s. to the Standing Committee

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detailed efsa procedure

Documents