Francesca Arena European Commission Health and Consumers Directorate General

1
Francesca ArenaEuropean CommissionHealth and
Consumers Directorate General
Possible impact of EU new pesticide authorisation
and pesticide residues legislation on Thai fruit
vegetables exporter
Doing Business with the EU New EU Legislation on
Pesticides Residues in Fruit and Vegetables
Bangkok 26 March 2009
2
Directive 91/414/EEC
What if a substance is not approved?
Draft measure notified to WTO
Reply to comments, if any
60 days
Adoption and publication of Decision
NO IMMEDIATE IMPACT on MRLs!
Although the substance is not approved in the EU,
existing import tolerances can be kept or new
ones can be set provided that they are safe
3
Impact on MRLs
What if a substance is not approved?
Non approval Decision
Submission of MRLs underlying data
1 year
EFSA evaluates existing MRLs
3 months
Commission proposal
But not final decision!

• SPS Notification (60 days)
• Consider new data submitted via SPS
• Adoption procedure

At least 6 months
Entry into force new MRLs
4
Impact on MRLs
What if a substance is not approved?
18 months
Non approval Decision
Entry into force new MRLs
If existing MRLs (import tolerances) are safe and
supported by data, they will be kept!
5
Impact on MRLs
What if a new MRL is needed?
Apply for an import tolerance
Art 6 Reg. 396/2005
6
Import tolerances When?
MRLs set for imported product to meet the need of
international trade
Can be granted for
Substances used in the EU (different crops or
same crops with different application rates)
Substance not approved in Europe for reasons
other than public health
7
Import tolerances What?
Same requirements as for uses in the EU!
(see presentation K. Hohgardt)
8
Regulation 396/2005MRL setting data
requirements

• Toxicology data to derive ADI/ARfD (only for
  substances not yet evaluated in the EU).
• Information on authorised use and Good
  Agricultural Practice.
• Supervised residue trials 8 for major crops 4 for
  minor crops (for minor crops, extrapolations may
  be possible). Plant metabolism data processing
  studies peel/pulp distribution.
• Animal feeding studies (if crop used for animal
  feed).

9
Import tolerances How long does it take?

• Normally 1 year
• However, it might take longer, depending on the
  complexity of the dossier
• E.g. Substances never evaluated in Europe (as
  never supported by industry) will take longer,
  because a full toxicological evaluation will have
  to be carried out.

10
Recent voluntary withdrawals
Review programme

• Active substances of list 3 (49) and list 4 (15)
  voluntarily withdrawn in 2007-08
• Commission Decisions
• N. 2008/934 (3rd list) N. 2008/941 (4rth list)
• National authorisations can be maintained until
  end 2010
• Period of grace for the use of existing stocks
  until end 2011

11
Recent voluntary withdrawals
Review programme

• No immediate impact on MRLs!
• These substances can be resubmitted for approval
  under an accelerated procedure
• If the new resubmitted dossier is complete and
  shows safe uses, approval could be possible by
  the end of 2010

12
Thank you for your attention!