1. Industry’s View on EFSA’s Contributions
to Pesticides Regulation
J.-P. Busnardo, DuPont
ECPA/IBMA Workshop
Parma, April 2012
2. Content
Processes
Active substances peer reviews
MRLs
Scientific Guidance
3. Processes
Creation of PSC welcome
Creation of Pesticides Unit welcome
Creation of application desk welcome
Should participate in Global Joint Reviews
Ability to submit new information
unnecessarily restricted (process design,
not under EFSA control)
4. Peer Review of Active Substances
Timelines overall respected
Science:
– Robust …
– …often conservative
Some important EFSA comments arrive late in
review process
– Little/no time left to applicant for adapting
– Commenting opportunity only after report issued
5. Other issues in active substance
evaluations
Amending active substance approvals
POPs-PBT
Scientific peer review open literature
6. Residues – MRL Reasoned Opinions
Timelines overall respected (new MRLs)
Article 12
– Much delayed (but largely unavoidable)
– Too many GAPs reviewed?
Science
– Robust…
– … somewhat conservative
Guidelines followed
– Outcome predictable
7. Residues – Annual Report
Very useful !
Comprehensive
Carefully written
– Limits misuse/misinterpretation
8. Scientific Guidance
Authors are not users!
Often disconnected from use context
Limited evaluation of guidance to be replaced
– No systematic justification
– No impact assessment
Too often unnecessarily:
– Conservative
– Complex
No mechanism for MS to amend EFSA opinion
Need to be peer reviewed by MS and properly
enforced
