Towards EU MRLs for biocides current status Karin Mahieu
Contents 1. Food safety in the EU 2. Need for biocide MRLs 3. Overlap with other legislation 4. EU-COM Policy Approach 5. Approaches for MRL setting
1. Food safety in the EU
Veterinary medicinal products (EMA) Food additives Plant protection products Food safety Contaminants Food contact materials
2. BPR and the need for biocide MRLs
The BPR in a nutshell - Biocides in specific legislative framework - ECHA - Biocidal Product Regulation (EU) 528/2012 - September 2013 - BPs must be authorised (national, MR, Union) - AS approval (EU) - Article 19(1)(e): MRLs where appropriate.
Disinfectants Preservatives Pesticides Anti-fouling
Biocidal products Veterinary medicinal products Food safety Food additives Plant protection products Food contact materials Contaminants
EU Conference on MRL- Setting for Biocides Prioritising areas for MRLsetting for biocides and identifying consequences of integrating biocide MRLs into existing legislation 18-19 March 2014 BfR, Berlin Or use this link and then click on "conference report": http://www.bfr.bund.de/en/event/european_conference_on_mrl_setting_for_biocides-189196.html http://www.bfr.bund.de/cm/349/summary-report-of-the-european-conference-on-mrl-setting-for-biocides.pdf ides-189196.html
3. Overlap with other legislation
Biocidal products Veterinary medicinal products Food safety Food additives Plant protection products Food contact materials Contaminants
Biocidal products Veterinary Plant medicinal products protection products Food safety Biocidal products Food additives Biocidal products Food contact materials Contaminants Biocidal products
Food Additives CONTAM FCM VMP PPP 145 active substances: 61 no MRLs yet 75 specific VMP/PPP MRL 14 default PPP MRL Raw foods Processed foods
4. EU-COM Policy Approach
EU-COM policy approach (I) Balance between two objectives: effective control of pests and micro-organisms (residues in food or feed unavoidable) limit dietary exposure (residues in food or feed, ALARA) Limit dietary exposure (ALARA) Minimise biocide use by minimizing pests and micro-organism growth through proper equipment design (smooth surfaces, smooth bends) timely hygiene (clean areas, clean equipment, wash hands) proper climatic conditions (temperature, moisture) Remove biocide product before food processing
EU-COM policy approach (II) No biocide MRL required if: - Use cannot lead to residues in food or feed (e.g. disinfectant for swimming pool) - Substance is considered safe by other legislations: approved food additive of Reg 1333/2008 (e.g. benzoic acid, lactic acid, carbon dioxide, N2) Annex IV of REACH Reg 1907/2006 (-) Annex IV of PPP Reg 396/2005 (e.g. Bacillus subtilis QST713) Annex I of BPR Reg 528/2012 (e.g. lavender oil) All other cases, decision whether biocide MRLs are needed - stepwise approach
EU-COM policy approach (III) Step-wise approach for substances with possible residues: Surface biocide in FCM: biocide SML in EC 1935/2004 Use in animal husbandry: biocide MRL in EC 37/2010 -No MRL needed if animal exposure < 0.004 mg/kg bw per day, except when substance is very toxic or accumulates -No MRL needed if overall exposure < 30% ADI Dual and triple use substances -Specific MRLs for VMP or PPP applicable to biocides -Highest MRL if MRLs differ between VMP and PPP -PPP substances possibility for specific biocide MRL under 396/2005 -PPP substances default biocide MRL 0.01 mg/kg Single use substances - Under discussion
Veterinary medicine EC 37/2010 Biocide No Regulation Insecticide in cow milk or meat Plant protection product EC 396/2005
5. Approaches for MRL setting
Approaches for MRL setting Health based Threshold Concentration based No threshold No biocide MRL required if dietary exposure <x%arfd and <y%adi Default MRL set at 0.01 mg/kg (similar to PPP) Back calculation to concentration in food No biocide MRL required if residue < b mg/kg food or feed ALARA principle abandoned Specific MRL if - biocide residues cannot be avoided or - analytical method has higher LOQ ALARA principle
Approaches for MRL setting Health based Example consumption model Food additive budget method 1.5 kg solids + 6 L liquids 60 kg bw person = 0.125 kg food/ kg bw Example threshold = 10% ADI ADI = 0.01 mg/kg bw Threshold = 0.008 mg/kg food ADI = 1 mg/kg bw Threshold = 0.8 mg/kg food High threshold: no trigger to remove biocides before food processing Concentration based No threshold When in contact with food MRL is set minimum level 0.01 mg/kg, higher when necessary lower when there is a risk Intake of biocides: no more than necessary (ALARA)
Approaches for MRL setting Exposure: complete picture?
Approaches for MRL setting Health based Estimate of biocide residues in food or feed from all known product types uses Knowledge of all possible uses required; dietary exposure - depends on number and scope of biocide uses - depends on completeness of the use information provided by one or more applicants No trigger to provide accurate residue and use information no data = no MRL = no monitoring Concentration based Estimate of biocide residues in food or feed from the requested product type use No knowledge of previous uses required - just check current MRL Trigger to provide accurate residue information no data = MRL at 0.01 mg/kg (possibly too low) Compound in EU and national monitoring programs
Approaches for MRL setting Health based Reg EEC 315/93 (contaminants) or Dir 2002/32/EC (undesirable substances in feed) Estimate residues in food by targeted monitoring program All samples unknown use Huge workload (time, money, resources) Concentration based Reg EC 396/2005 (plant protection products) Estimate residues in food with a few trials at the site(s) of use All samples known use Small workload for applicants (time, money, resources)
Approaches for MRL setting Health based Dietary risk assessment after product authorisation What triggers re-evaluation? Set MRLs retrospectively? Health based limit exceeded at any point in time? Concentration based Dietary risk assessment prior to product authorisation New product application triggers re-evaluation MRLs are verified with every new product application Health based limit not exceeded at any point in time
(A) Health based approach (COM proposal) Calculation model (realistic consumer exposure estimate) Exp cons < x % ADI/ARfD Exp cons > x % ADI/ARfD Nature of residues (e.g. hydrolysis study) Analytical method Monitoring data No further assessment/ no MRL required no need for MRLs identified need for MRLs identified MRL setting
(B) Concentration-based approach (reflecting DRAWG) nature of residue studies (e.g. hydrolysis studies) Calculation model (residues in food) rinsing study analytical method residue study R food < default MRL no further assessment/ default MRL applies R food > default MRL further dietary risk assessment/ setting of specific MRLs
Summary & Conclusion EU-COM policy approach on biocide MRL setting Need to set biocides Stepwise approach - No MRL when not in contact with food or safe substance - FCM, VMP or PPP? SML and MRL as such Single use substances - targeted monitoring - health based approach - MRL as contaminants MRL derivation in future under PPP
Guidances on dietary risk assessment for biocides Guidance document Current status Assessment approach Draft Guidance on Estimating Livestock Exposure to Biocidal Active Substances (ARTFood) Guideline on Risk Characterisation and Assessment of MRLs for Biocides (EMA/CVMP) http://www.ema.europa.eu/docs/en_gb/document_lib rary/scientific_guideline/2015/01/wc500181638.pdf Draft Guidance on estimating Dietary Risk from Transfer of Biocidal Active Substances into Foods Non-professional Uses (ARTFood) http://echa.europa.eu/documents/10162/15623299/ar tfood_draft_guidance_project_en.pdf Guidance on Estimating Transfer of Biocidal Active Substances into Foods Professional Uses (ARTFood) Revision following public consultation Finalised document Public consultation of draft until June 2016 Work in progress Stepwise approach: - Estimating external livestock exposure (calculation models) Stepwise approach: - Worst case consumer exposure estimate (e.g. metabolism studies) - TMDI (residue studies) - MR setting (residue studies) Calculation models: - Exposure estimate for consumers - Refinement, if applicable To be decided. Update biocide MRLs February 2016