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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
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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
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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
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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
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Evaluation by the RMS
• 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
Evaluation by the RMS
• 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
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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
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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)
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Reporting table
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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
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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
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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
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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
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Evaluation table
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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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