1. Update on the risk assessment of
maximum pesticide residue limits
(MRLs)
Aija Kazocina (pesticides.MRL@efsa.europa.eu)
Pesticides Unit, Scientific Evaluation of Regulated Products 1

2. Outline
Legal framework
Progress Article 10
Progress Article 12
Note to applicants
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3. Legal framework
Regulation (EC) No 396/2005- maximum residue levels (MRL)
of pesticides in/on feed and food of plant and animal origin
EFSA PRAS Unit (MRL Team):
 Assessment of new EU MRL proposals (Article 10)
 Review of the existing EU MRLs (Article 12)
 Preparation of Annual Report on Pesticide residues (Article 32)
EFSA is not setting the MRLs, EFSA is assessing the risks
related to the either new MRL proposals or the existing EU
MRLs
Risk management enforces those MRLs supported by data and
for which a risk assessment performed by EFSA indicates no
consumer exposure concerns
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4. Article 10
Assessment of a new MRL proposal for certain
crop/substance combination
Proposals for new MRLs (regulated under Art.6-11) are
made to accommodate:
- a more critical use (modification of an MRL)
- the international trade (import tolerance)
- a completely new use (setting of an MRL)
- exceptional circumstances (emergency authorisations)
EFSA assesses if the MRL proposal is supported by data and
safe for consumer
Any other information relevant for the crop/substance under
consideration is considered
Time for EFSA: 3 months (6 months in exceptional cases) 4

5. Progress Article 10 (2008-2012)
450 432
400
350
322
300 286
MRL applications recieved
250
RO issued
200
MRL proposals assessed
150
101 105
95
100
76
68 61 63
50
50
24 17
7 7
0
2008 2009 2010 2011 2012
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6. Progress Article 10 (2008-2012)
MS rating in submission of applications: UK(81), FR(48),
DE (47), NL(38), BE(33), ES(27), AT(14), IT(8), FI, HU,
PT, IE, DK(4)…
Top active substances: thiacloprid (12), azoxystrobin (10),
dimethomorph (9), pyraclostrobin, acetamiprid,
fludioxonil, trifloxystrobin, difenoconazole (8),
Top applicants (>35): BASF, Bayer, Syngenta
For 48 applications “clock was stopped”
1 application on microorganism
MS consultations on new a.s. or on contradicting issues
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7. Article 12
Review of the existing EU MRLs:
 reviews whether an MRL:
-accommodates a use (in EU or third country)
-is supported by data
-is safe for consumer
assesses all other relevant data
considers CXLs
derives proposals for:
-inclusion of a.s. in Annex IV
-necessity on setting/modifying/deleting an MRL
-setting of specific processing factors 7

8. Progress Article 12.2
• Substances approved before 02 September 2008
• Review of the existing MRLs for 167 substances
• Deadline: 01 September 2009
• State of Play:
 Finalised: 36 (4 in 2009; 3 in 2010; 21 in 2011; 8 in 2012
so far)
 Ongoing: 59
 Data submitted: 59
 Pending data: 13 (includes 11 possible candidates for
Annex IV)
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9. Progress Article 12.2
• Substances approved after 02 September 2008
• Review of MRLs for 243 substances so far
• Deadline: 1 year after approval of the substance
(23 in 2009; 134 in 2010; 15 in 2011; 72 in 2012)
• State of Play:
 Finalised: 15 (12 in 2011; 3 in 2012 so far)
 Ongoing: 12
 Data submitted: 65
 Pending data: 151 (includes 64 possible candidates for Annex
IV)
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10. Note to applicants
• Better planning of submissions
• Prioritisation
• Regional applications/national applications
• New MRL proposals are not considered under Art. 12
• Proposals for lowering an MRL in the Article 12 only,
unless legally binding (inclusion restrictions)
• For import tolerances the authorisation must be in place
in the country concerned
• Delays expected due to heavy workload
• Progress in Art.12 MRL would foster the Art.10 work
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11. Thank you!
pesticides.MRL@efsa.europa.eu
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