“EFSA role on the scientific assessment of the
risk of pesticides to bees”
Jose Tarazona, Head of Pesticides Unit
An agricultural model good for pollinators: the way forward
Panel 1: Definition of the existing problems with the current agricultural model, with focus on the 3
Ps: pollen, pesticides, pathogens
06.11.2013
Pesticides Unit. Regular activities
Coordinates the Peer
Review of active
substances
Provides Conclusions for
single active substances to
support the EU decisionmakers
Supports the
Scientific Panel for
pesticides PPR (Plant
Protection Product
and their Residues).
 Opinions
 Guidance documents
MRLs
 Reasoned Opinions
 Annual report
Peer review
(legal framework Regulation (EC) No 1107/2009)
Dossier
submission
1. Commenting phase
PEER
REVIEW
(EFSA, RMS, MS,
EU Commission,
Notifier, Public)
2. Evaluation of
comments
3. Expert’s consultation
4. Conclusion
Commission
DAR
EFSA
Standing Committee on the
Food Chain and Animal Health
(SCoFCAH = EC +MSs)
Approval/Non Approval
Neonicotinoids - Background
• Approved in the European Union between 2006 and
2009 (PPPs on the market since 1991);
• Numerous studies and research activities carried out in
the last years;
• High controversy over the risk;
• Regulation (EC) No 1107/2009 under Article 21
foresees the possibility to review the approval of active
substances in light of new scientific and technical
knowledge and monitoring data.
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Pesticides and bees - EFSA activities in
2012 – 2013 (1)
Under Article 21, EFSA was requested by the European
Commission to provide technical and scientific assistance on several
issues related to the risk to bees from neonicotinoid pesticides.
EFSA has published the following outputs:
•Statement on the findings in recent studies investigating sub-lethal
effects in bees of some neonicotinoids in consideration of the uses
currently authorised in Europe (EFSA Journal 2012)
•Assessment of the scientific information from the Italian project
“APENET” investigating effects on honeybees of coated maize seeds
with some neonicotinoids and fipronil (EFSA Journal 2012)
•Evaluation of the FERA study on bumble bees and consideration of
its potential impact on the EFSA conclusions on neonicotinoids
(EFSA Journal 2013)
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Pesticides and bees - EFSA activities in
2012 – 2013 (2)
In 2012, EFSA has undertaken a review of the risk to bees upon
receipt of a mandate from the European Commission.
Key elements of the EC Mandate:
• To revise the risk assessment for bees by considering:
 Acute and chronic risk on colony survival and development
(including bee larvae and bee behaviour)
 Sublethal effects
• To focus on the following routes of exposure:
 Dust
 Residue in pollen and nectar
 Guttation
• To consider the EFSA PPR Panel Opinion (Published in May 2012)
Substances: imidacloprid, clothianidin, thiamethoxam, fipronil;
all authorised uses as seed treatment and as granules.
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EFSA’s review process
• Data collection :
 studies from the applicants
 information on the authorised
uses (GAP tables), and
monitoring data from the
Member States
 published literature and
monitoring data
Data validation and scientific
evaluation
Draft Conclusions
Tiered risk assessment*
MSs consultation
Final Conclusions
(Adopted the Conclusions
on 19/12/12)
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The EFSA ‘s Conclusions
Neonicotinoids: Published 16 January 2013
Fipronil: Published 27 May 2013
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Results
Risks identified (acute risks)
DUST
Pollen and
Nectar
Guttation
Clothianidin
Maize
Cereals
OSR
OSR
Not finalised
Imidacloprid
Maize
Cereals
OSR
Cotton
OSR
Cotton
Sunflower
Not finalised
Thiamethoxam
Maize
Cereals
OSR
Cotton
Not finalised
Maize
Fipronil
Maize
Not finalised Not finalised
For many of the
authorised uses
and several
aspects of the
risk
assessments
not enough data
were available to
finalise the
evaluation or
data were not
sufficient
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Next steps
Under the Regulation EU 485/2013 (prohibiting
clothianidin, thiamethoxam and imidaclorpid) and the
Regulation EU 781/2013 (prohibiting fipronil):
 In June 2013, EFSA received a mandate to review the risk
assessment for the PPPs applied as foliar spray, containing
thiamethoxam, clothianidin and imidacloprid (deadline
October 2014)
 Within the next 2 years EFSA may be requested by the EC
to review new information it has received.
Methodological developments
EFSA PPR Panel
Scientific Opinion
Art. 29, 2012
EFSA Guidance
Art. 31, 2013
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Other bee activities of EFSA
 Internal EFSA BEE TASK FORCE, established in
2012:
May
 to identify knowledge gaps, make recommendations on
research needs
 to move towards an integrated approach to the risk
assessment of multiple stressors in bees.
EMRISK internal Task Force on bees
Objectives :
• As a first step, the TF has made an inventory of all EFSA activities and outputs
dealing with the risks posed to bees and their ecosystem services.
=> 1st Report published in Nov. 2012:
http://www.efsa.europa.eu/fr/supporting/pub/358e.htm
• As a second step, the TF is:
• Reviewing the state of the art of the work and research produced outside
EFSA in the area of bee risk assessment (e.g. DG-RI, DG-SANCO, DG-ENV,
EU bee Reference laboratory, EEA, OECD, FAO, Anses, etc.),
• Analysing the data collected to highlight cross-cutting issues in risk
assessment and data gaps and research needs,
• Will make recommendations on how to further integrate the work to
provide risk managers with comprehensive advices.
=> 2nd report end 2013
Colloquium on Bee Health
15-16 May 2013, EFSA, Italy
“Towards Holistic Approaches to the Risk Assessment of Multiple
Stressors in Bees”
• To consider Risk Assessment (RA) approaches for multiple
stressors in bees in an integrated manner, support further activities,
share EFSA developments and reinforce EFSA’s Science Strategy.
–
–
–
–
Protection of bees and pollination service
Monitoring bee populations and stressors
Testing and assessing stressors in bees
Risk assessment of multiple stressors in bees
• More than 100 participants (research institutes, universities,
companies, NGOs, MS officials,…)
• Presentations in plenary session, followed by discussion in breakout groups
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THANK YOU!
QUESTIONS?
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