1. Advisory group on fruit and vegetables 7 March 2008
Implementation of Reg. (EC) No 396/2005 Maximum Residues Levels of pesticides
AND
State of play concerning the review programme of Directive 91/414/EEC
Francesca Arena European Commission Health and Consumer Protection Directorate General Unit E3 - Chemicals, Contaminants and Pesticides
Advisory group on fruit and vegetables 7 March 2008

2. Pesticide Residues MRLs setting
Legislation partially harmonised
EU- MRLs
± 250 pesticides
National MRLs
± 850 pesticides
Dir. 76/895/EEC (selected fruits and vegetables)
Dir. 86/362/EEC (cereals)
Dir. 86/363/EEC (animal products)
Dir. 90/642/EEC (fruits and vegetables)
No harmonised risk assessment for EU consumers
Trade problems
4 Directives  1 Regulation 396/2005 completing process of harmonisation

3. Implementation of Reg. (EC) 396/2005
Reg. 396/2005 will be fully applicable as from 6 months from the publication of the last of the Annexes I, II, III and IV.
Annex I
Reg. (EC) No 178/2006
List of commodities
Annex II
Existing EU MRLs
Annex III
Temporary MRLs
Reg. (EC) No 149/2008
published on 1 March ‘08
Annex IV
Substances for which no MRLs are required
Annex VII
Under adoption procedure
Fumigants
Reg. (EC) N. 396/ application date: 1 September 2008

4. ANNEX I: List of commodities Regulation (EC) N. 178/2006
315 commodities – 10 main groups.
190 existing entries from current Directives.
125 new entries.
Mainly minor crops (e.g. cassava, thyme, lupins), but also cocoa, coffee, sugar plants.
Fish and plants used in animal feed listed, but for the time being exempted from MRL setting (not enough information).

5. ANNEX II: EU-MRLs First establishment - Reg. (EC) No 149/2008
238 pesticides from current MRLs Directives.
± MRLs
only existing crops under current Directives
combinations new crops/238 pesticides in Annex III B
Mostly pesticides for which EU risk assessment has been completed under Dir. 91/414/EEC.

6. ANNEX III: temporary EU-MRLs First establishment - Reg
ANNEX III: temporary EU-MRLs First establishment - Reg. (EC) No 149/2008
National MRLs collected until May 2006 on all the non-harmonised substances.
EFSA asked for an opinion (September 2006).
EFSA delivered a reasoned opinion (March 2007).
COM-EFSA-MS: refinement risk assessment (March- September 2007).
SPS notification (July 2007)

7. ANNEX III: temporary EU-MRLs Structure
Part A
MRLs Harmonisation for 167 pesticides
± MRLs
Mostly pesticides not yet evaluated under Dir. 91/414/EEC
Part B
combinations new crops/238 pesticides in Annex II
± MRLs

8. Annexes II and III Forthcoming update
Annex II
Incorporation of new MRLs set in Directives 2007/73/EC and 2008/17/EC
Annex III
National MRLs set after May 2006
Comments received from non-EU Countries (SPS)
Changes requested for 105 substances:
45 new entries (not covered by current Annex III – part A)
60 already covered by first establishment Annex III –part A
EFSA asked for an opinion
Opinion SCoFCAH: 14 March 2008

9. Harmonisation = Simplification
EU-harmonised MRLs
Annex III - Part A
National MRLs ca

10. ANNEX IV: substances for which an MRL is not necessary First establishment and forthcoming update
Reg. 149/2008:
3 Chemicals
5 Micro-organisms
Many substances candidate for Annex IV still under evaluation under Dir. 91/414/EEC.
In the forthcoming update several substances (about 40) to be introduced to Annex IV.
Opinion SCoFCAH: 14 March 2008

11. Pesticides not covered by any of the Annexes
Compliance with MRLs
Pesticides not covered by any of the Annexes
Default MRL
0,01 mg/kg

12. EU data base on MRLs
It will be publicly available on the DG SANCO Website

13. State of play concerning the review programme of Directive 91/414/EEC
Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market
Existing active substances
Stage
N° a.s.
Included
Not included (no support)
Not included after review
Pending
Deadline submission dossiers
Deadline for decision 1 90 58 32 -
1995 -
2003 2
148 31 98 19 3
391 6
253
132 4
295
202 93
Existing total
924 95
553 51
225

14. Commission Reg. (Ec) No 1095/2007
Simplification of procedures for stage 3 and 4
Commission Reg. (Ec) No 1095/2007
Article 11f: Substance fulfils criteria for clear indications of harmful effects
Non-inclusion in Annex I
Article 12 (2) (b)
Withdrawal within six months of the authorisations
Article 12 a
“…The Commission shall request the EFSA to deliver its
view on the draft review report by 31 December 2010 at the
latest….”
Article 11b: Substance fulfils criteria for clear indications of no harmful effects
Inclusion in Annex I
Draft Assessment Report
Article 12 (3) “…the latest
date for Member States to withdraw authorisations shall be 31 December 2010…”
Article 11e
Withdrawal
by notifier
Yes
Non-inclusion in Annex I No
Non-inclusion in Annex I
Article 12 (2) (b)
Withdrawal within six months of the authorisations
Article 11c
PEER REVIEW
Article 12 a
Inclusion in Annex I
Inclusion in Annex I

15. Documents on the Internet
DG SANCO webpage
Pesticide Residue Legislation
Approval of active substances
EFSA model -

16. Thank you for your attention