The document summarizes discussions between EFSA and IBMA on various topics related to the review of List 4 biocontrol substances. Key points included an update from EFSA on timelines for reviews, acknowledgment of the value of a post-assessment lessons learned document, and discussions around guidance documents, data requirements and waivers, consequences of delays, and handling of substances included in the Green Track process. EFSA advised that many of the issues raised would need to be addressed by risk managers or relevant expert groups.

2.  Progress of peer reviews and EFSA
conclusions for List-4 biocontrol substances?
Information about the on-going review programme.
In this context, an up-to-date summary time table
would be welcome.
 EFSA were able to present a up to date
summary timetable

3.  IBMA propose initiation of a lessons learned
document after the conclusion of the List-4 EFSA
assessment by the end of 2012, in Q1 2013.
 EFSA acknowledged value in a Lessons Learned
document but it is early to provide a timetable. It
intends to put it to the next PSC meeting in October.
 Are there new guidance documents for micro-
organisms and other active substances in preparation?
 EFSA acknowledge the need for these documents and
will consider their development.
 Which and how fully have OECD GD’s been used for
list 4 reviews?
 EFSA advised GDs for MBCAs have not been referred
to.

4.  EFSA approach to mixtures of compounds like
plant extracts?
 Attitude to concept for characterisation of
mixtures & to lead substance concept for RA?
 Have consequences been considered for natural
substances if radio labelling is obligatory?
EFSA advised that there is another forum in
particular an expert group addressing these
specific issues.

5.  What are we waiting for?
EFSA advised the completed commenting table from RMS will be
presented by 30th April and the opinion will be delivered to EU COM
in Q4 2012
 EFSA opinion on DAR requests and Peer Review Comments
(ie. point 7 list of studies to be generated)
 When is it available?
 Is all data requested relevant?
 Will EFSA request additional data?
 How and when will any requested data be integrated?
 How can the additional data be provided?
 Relevance of SANCO/10328/2004 rev. 8 on new data evaluation?
EFSA and EU COM advised it is part of EU COM risk management. MS
will have to consider whether data gaps are relevant for the proposed
uses.
 The IBMA SCLP Task Force wish to be involved at the earliest possible
stage.
This was not addressed

6.  Product registration applications blocked in
Member States waiting for EFSA opinion and
subsequent EU Com decision.
EFSA advised this is an MS issue

7.  Studies for which no scientific or risk assessment
justification exist could be either waived or
extrapolated according to the OECD no. 12 guidance
page 20.
 The SCLP Task Force supports the grouping of
physical and chemical property data in the three
coherent groups: SCLP acetates, SCLP alcohols and
SCLP aldehydes, to be used for extrapolation to all the
single active substances in each group.
 The ranges of melting points, boiling points, partition
coefficients and flash points are predictable for each
coherent group.
EFSA advised review will recognise gaps but noted
IBMA comments on waiving possibilities

8.  IBMA raised the issue of batch analysis anomalies for
SCLPs
 EFSA advised they have noted IBMA SCLP view and will
refer to experts

9.  Consequences of delayed peer reviews and
EFSA conclusions on PPP authorization. Step 2
compliance post Annex I inclusion: dRR
submission for many BcA deadline the 30th of
April.
EFSA acknowledge the consequences for
MBCA producers
 EFSA conclusion consequence on ZRMS
evaluation: MS position on National
authorization?
It will be addressed at MS level

10.  List 4 active substance benefiting from Green
Track inclusion
 Subject to delayed peer review & EFSA
conclusion
 Consequence 1 no confirmed end points
 Consequence 2 possible data gaps
 Consequence 3 Step2 dossier based on
provisional end points and data requests
 How will MS handle this?

11.  List 4 MCBA Green Track included in Annex1
 Application for MR submitted prior to June 14th
2011 in several MS
 Some MS granted authorisation under MR
 1 MS suspended the procedure for assessment
awaiting clarification at EU level
The issues of the 2 cases were acknowledged

12.  specificity of methods to determine microbial
strains,
 validation of contaminant quantification
methods
 validation of bioassays
IBMA ask how/when to provide information?
EFSA agreed a need to develop GDs and stated it
is a risk manager issue

13. What is the current EFSA expectation,
approach and experience?
EFSA strictly apply the data
requirements. Waivers may be applied
if scientifically justification is adequate.
EU COM are awaiting outcome of EFSA
procurement on literature review of
MBCAs.
A MBCA workshop planned by SE and
supported by DK will be organised for
June 2013.