Aija Kazocina - Update on risk assessment of MRLs

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

Outline Legal framework Progress Article 10 Progress Article 12 Note to applicants 2

Legal frameworkRegulation (EC) No 396/2005- maximum residue levels (MRL) of pesticides in/on feed and food of plant and animal originEFSA 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 MRLsRisk management enforces those MRLs supported by data and for which a risk assessment performed by EFSA indicates no consumer exposure concerns 3

Article 10Assessment of a new MRL proposal for certain crop/substance combinationProposals 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 consumerAny other information relevant for the crop/substance under consideration is consideredTime for EFSA: 3 months (6 months in exceptional cases) 4

Progress Article 10 (2008-2012)450 432400350 322300 286 MRL applications recieved250 RO issued200 MRL proposals assessed150 101 105 95100 76 68 61 63 5050 24 17 7 7 0 2008 2009 2010 2011 2012 5

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, SyngentaFor 48 applications “clock was stopped”1 application on microorganismMS consultations on new a.s. or on contradicting issues 6

Article 12Review 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

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) 8

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) 9

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 10

Thank you!pesticides.MRL@efsa.europa.eu 11

Aija Kazocina - Update on risk assessment of MRLs

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