FÜR RISIKOBEWERTUNG BUNDESINSTITUT. MRLs for Biocides Establishment of an EU-wide Procedure

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1 BUNDESINSTITUT FÜR RISIKOBEWERTUNG MRLs for Biocides Establishment of an EU-wide Procedure Isabel Günther Federal Institute for Risk Assessment, Berlin, Germany Biocides 2013, Vienna

2 Introduction Certain uses of biocides can lead to residues in food, e.g. - Disinfectants in the food industry or in homes (PT 4) - Disinfectants incorporated into food contact materials (PT 4) - Insecticides in the food industry, in homes or in animal housing (PT 18) - Products for veterinary hygiene (PT 3) - In-can preservatives, e.g. in dishwashing detergents (PT 6) When residues in food occur, MRLs must be set. For biocides, an EU-wide procedure for setting MRLs has yet to be established. Several unresolved issues regarding such a procedure have been identified and will be explained in this presentation.

3 Regulatory Framework for Biocide MRLs MRL setting is required by Regulation (EU) No 528/ Art. 19(1)(e) where appropriate Applications in animal husbandry - EMA: Reg. (EC) No 470/2009 (veterinary medicinal products) All other biocidal applications - EFSA: Reg. (EC) No 396/2005 (pesticide residues) - Reg. (EEC) No 315/93 (food contaminants) - Reg. (EC) No 1935/2004 (food contact materials) - Dir. 2002/32/EC (undesirable substances in animal feed)

4 Regulatory Framework for Biocide MRLs Points to consider: Unclear which use falls under which legal framework. So far only defined for Reg. (EC) No 470/2009. Guidance needed For dual-/triple-use active substances, two or more sets of MRLs are set, which may have different values and which may not account for residues from the other uses. Effective communication necessary within EFSA and between EFSA and EMA to avoid this situation

5 Regulatory Framework for Biocide MRLs Points to consider: The MRL-setting procedures under the respective legal frameworks differ from each other: - Some involve national MS authorities, others only EU authority (EFSA), EMA appoints experts - Submission formats for application and dossier - Data requirements - Assessment concepts

6 Differences between Regulatory Frameworks Place of submission: 470/2009: MRL application submitted to EMA; evaluation by EMA-appointed rapporteur from CVMP (not member state) with help from experts 396/2005: MRL application submitted to MS; evaluation by MS and then by EFSA 1935/2004: SML application submitted to MS; evaluation by EFSA The other legal frameworks: evaluation by EFSA How can it be ensured that applicants know where to submit? Will guidance be made available?

7 Differences between Regulatory Frameworks Formats: Each framework uses different submission formats for application and dossier What formats will be used for biocide MRL applications? -Will existing formats be amended to include biocides? -Will a new format for biocides be created and apply across legal frameworks?

8 Differences between Regulatory Frameworks Assessment concepts: Toxicological reference values Plant protection products ADI and ARfD Veterinary drugs ADI (based on chronic and acute endpoints) Residue intake Chronic and acute Chronic only Consumption data National consumption data from EU member states Daily food basket (based on arbitrarily fixed high values ) All other biocidal applications? Biocidal applications in animal husbandry MRLs checked against different exposures and reference values

9 Differences between Regulatory Frameworks Other open questions: An MRL evaluation concept is so far only available for uses in animal husbandry (Reg. (EU) No 470/2009). Reg. (EU) No 470/2009 has been amended to include biocides. Reg. (EC) No 396/2005 is currently being amended to include biocides. Will the other legal texts be amended as well?

10 Coordination of MRL Evaluations MRL applications with same active substance submitted by many different companies and often in more than one Member State. AS a BP x (AP x) BP y (AP y) BP z (AP z) MRLs for AS a Effective co-ordination necessary! - Which authority? - Which database: R4BP? EFSA Extranet?

11 Timeframe for MRL Setting for Biocides Four scenarios: 1. MRL application is submitted prior to BP application (shortly after active substance approval) 2. MRL and product applications are submitted at the same time 3.MRL application submitted after BP application (necessity for MRLs seen seen during BP BP evaluation) 4. MRL application submitted after BP application (necessity for MRLs seen during mutual recognition)

12 Safe use MRL Timeframe for MRL Setting for Biocides Art. 19(1)(e): A biocidal product shall be authorised provided the following conditions are met: where appropriate, maximum residue limits have been established MRLs must be set before a biocidal product can be authorised. Authorising MS EMA / EFSA DRA finds MRLs needed MRL setting Authorisation 1 year

13 Timeframe for MRL Setting for Biocides Experience with plant protection products and veterinary medicinal products shows that it takes at least 1 year to evaluate MRL application and set MRLs. Not possible to set MRLs in time for BP authorisation no authorisation BP has to be taken off market Transition rules may be needed (e.g. temporary marketing permission without MRLs; establishment of temporary high MRLs based only on rough health assessment)

14 Timeframe for MRL Setting for Biocides Proposal: It would be most effective to set MRLs after collecting all possible uses of an active substance and set MRLs for the most critical use. Advantage: One MRL evaluation rather than several (with each BP application) Disadvantage: Information only available after BPs have been assessed during national authorisation. Transition rules needed.

15 MRL Workshop in March 2014 Many open questions! To discuss these open questions and propose solutions, the German Federal Institute for Risk Assessment with support of COM is organising a workshop. When: March 2014 (probably 18th-19th) Programme: Presentations on the existing procedures, working groups for discussion and development of recommendations on specific open questions Content: Topics to be discussed are currently being developed by a preparations committee

16 BUNDESINSTITUT FÜR RISIKOBEWERTUNG Thank you for your attention! Isabel Günther Federal Institute for Risk Assessment Max-Dohrn-Str D Berlin