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

Transcription

1 BUNDESINSTITUT FÜR RISIKOBEWERTUNG MRLs for Biocides Establishment of an EU-wide Procedure Biocides 2014, Vienna Isabel Günther Federal Institute for Risk Assessment, Berlin, Germany

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) For certain biocides, maximum residue limits (MRLs) must be set. An EU-wide procedure for setting MRLs for biocides has yet to be established. A conference was held in Berlin in March 2014 to discuss several unresolved issues regarding such a procedure.

3 Outline Regulatory background Report from the MRL conference Case studies

4 Maximum Residue Limits when are they needed? MRL setting is required by Regulation (EU) No 528/2012 Art. 19(1) states the conditions for authorisation of a biocidal products. One of the conditions is that where appropriate, MRLs have been established - Art. 19(1)(e). The term where appropriate has not been further defined, leaving open questions regarding the conditions under which MRLs for biocides need to be established. At the MRL conference, there was a wide consensus that where appropriate means MRLs should be set when uses lead to residues in food. No MRLs are set for residues from non-professional uses, because these foods are not traded and cannot be monitored. Institutional uses, e.g. in hospitals and day care centers are considered professional uses.

5 MRLs Procedure There is no separate regulation for biocide MRLs. Instead, the biocide regulation lists five possible legal texts (Art. 19(1)(e)): Reg. (EC) No 470/2009 (veterinary medicinal products) 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) Biocide uses in animal husbandry are covered by Reg. (EC) No 470/2009. For all other uses, it is not clear which legal text applies. For biocides, no EU-wide procedure for the establishment of MRLs exists.

6 The goal of the conference was to discuss the following questions: When do MRLs need to be set for biocides? How can this be accomplished in accordance with other already existing regulatory frameworks? Which areas of concern should be prioritised?

7 When do MRLs need to be set for biocides? Wide consensus that MRLs should be set for a.s. with uses that lead to residues in food and where justified by the toxicological profile (e.g. not for non-toxic substances) Biocide MRLs are required to: provide a legal tool for monitoring/enforcement ensure consumer safety apply the precautionary principle ensure adherence to best practice facilitate international trade

8 When do MRLs need to be set for biocides? Concerns that the system may become overloaded by too many MRL applications at a time Proposal to implement a prioritisation whereby MRL setting would be focused on a.s. with uses of concern for human health Seen critically because prioritisation itself would be a resourceintensive process (concern to human health can only be identified in DRA) Proposed solution: set a default MRL for all a.s. with the potential to lead to residues and then gradually set specific MRLs for a.s. for which default is not appropriate Introduce a transition period until the default comes into force, so as to not keep biocides off the market and avoid recall of food batches

9 Default value approach The majority supported the introduction of a default value Avoid having to set specific MRLs for all substances Allow additional time to set specific MRLs Helpful for enforcement Would allow handling of residues for BPs not authorised in EU Would ensure adherence to ALARA principle Some considered a default inappropriate because MRLs should only be set in case a risk for consumers is identified. The value of the default needs to be decided keeping in mind: Must be protective even for very toxic substances, but at the same time practicable so that it is not constantly exceeded Must be able to measure value analytically

10 How to decide which a.s. need a specific MRL 1. Use existing data Food industry quality control and/or other self-monitoring programmes MS monitoring programmes 2. Screen a.s. using the methods described in the ARTFood guidance documents Pro: clear procedure and can be applied immediately Con: Worst-case approach would trigger MRL evaluation for many uses 3. Set up monitoring programmes focused on identifying a.s. for which specific MRLs need to be set

11 3. Set up monitoring programmes focused on identifying a.s. for which specific MRLs need to be set Implementation difficult and resource-intensive: monitor all relevant a.s. in all relevant food commodities anlytical methods for each a.s. and all relevant food commodities sampling plan (which food commodities, when to sample) Proposal to prioritise monitoring to keep work load managable: Approach 1: according to use pattern, formulation, toxicity and phys-chem Approach 2: screening-type assessment according to ARTFood guidance No agreement was reached on which option to use

12 Legislation recommended for setting MRLs for single-use a.s. Notified active substances 300 Residue relevant 150 Specific MRLs exist in PPP and/or VMP legislation 75 Default MRL from PPP legislation applies 14 Remaining active substances without MRLs 61

13 Legislation recommended for setting MRLs for single-use a.s. MRLs for biocides used in animal husbandry are already included in the VMP legislation. For other uses, the scope of the legislation is considered too narrow. FCM not considered suitable: too narrow in scope specific maximum concentrations only exist for few FCM and only one value per a.s. is established for all foods.

14 Legislation recommended for setting MRLs for single-use a.s. CONTAM not considered suitable: It is not clear whether the legal definition of contaminants excludes biocides (as it does PPP and VMP) MRLs are set after residues in food have been detected. BPR foresees that MRLs are set prior to product authorisation No default values MS are responsible for providing residue data. BPR requires that applicant provides residue data. Timelines do not fit the BPR requirements

15 Legislation recommended for setting MRLs for single-use a.s. The majority favoured the PPP legislation: many biocide a.s. are also PPP a.s. and thus covered anyway it foresees a default needed action: extend list of food commodities (processed) Other possibilities: introduce a completely new legislation for biocide MRLs or consolidate all MRL regulations into one.

16 Considerations on how to set MRLs MRLs should be set based on the most critical use of the a.s. Identifying the critical use may be difficult because of the variable use patterns of biocides. ALARA principle should apply: residues are undesirable combined residues from different PTs and use areas must be safe ALARA will not apply to biocides in animal husbandry. Have a category no MRL required (like in PPP MRL regulation) for non-toxic a.s. (e.g. certain natural food ingredients) for those the default value should also not apply

17 Consideration on how to set MRLs Consider setting matrix-specific MRLs (e.g. oil-based, high water content) instead of MRLs for numerous single commodities. FCM simulants could be possible starting point Processed and composite foods must be considered Harmonise methodology for deriving MRLs and criteria for evaluating their safety. Consult existing methodology from other legislation (e.g. food additive DRA model) MRLs must be enforced and monitoring programms for biocides should be put into place.

18 Case studies Some examples of inquiries and product applications submitted to BfR

19 Example No 1 Inquiry from a company in February 2014 An insecticide for use on animals The company wanted to know whether an MRL application is necessary. BfR concluded yes, because the external exposure of the animal exceeded the trigger value of mg/kg bw. Current guidance states that a company has to apply for an MRL with EMA if the external exposure of the animals exceeds the trigger value of mg/kg bw. The MRL guidance is currently being revised. The revision shifts more of the assessment steps to the biocide competent authority with the aim to refer fewer cases to EMA. If the revised guidance is agreed and endorsed, the company may not have to submit an MRL application.

20 Example No 2 Inquiry from a company in February 2014 A teat dip for cows The company wants to know whether an MRL application is necessary An MRL evaluation already exists for the a.s. from uses in VMP. The evaluation resulted in no MRL required. At the moment no MRL application is necessary, because an MRL evaluation already exists. Depending on the results of the DRA during national product authorisation, it may be necessary to change the status no MRL required. In that case an MRL application has to be submitted. Otherwise not.

21 Example No 3 An application for national product authorisation for a fumigant used on stored foods. MRLs already exist for the a.s. from uses in plant protection products. It was concluded that the residue resulting from the biocide use are below the existing MRLs. Therefore, an MRL application was not necessary.

22 Example No 4 An application for national product authorisation for an insecticide with two active substances for uses in households, industrial and public areas, as well as in animal housing. MRLs already exist for both a.s. from uses in PPP and in VMP. Since no DRA was submitted, no conclusion has yet been drawn regarding the need for a change of the existing MRLs.

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