Maximum Residue Limits

Size: px
Start display at page:

Download "Maximum Residue Limits"

Transcription

1 Maximum Residue Limits a scientific approach to ensure consumer safety ànd (food) animal health Prof Dr Erik De Ridder 1

2 Residues & safety: ADME Metabolism Distribution Excretion Administration Absorption 2 ADME Change of druglevels (residues) over time

3 When you treat a food animal Residues present for some time Potential problem for consumer 3

4 Hazard and risk: risk assessment basics 4

5 Hazard and risk when treating food animals Hazard? Residues of the drug after a treatment still being present at the time of slaughter (or production of milk, egg, honey) Risk? Risk assessment: What is the risk that harm will be done by remaining residues? Or: what would be the level of residues that would not be harmful? Or: what is the Maximum Residue Level acceptable? Risk Management? Risk management: How can we manage so that risk remains acceptable? Or: what is the withdrawal period after treatment? 5

6 6 Legal basis in the EU

7 Safety of residues? Is zero-residue an option? Why (not)? 7

8 How can a treated animal safely enter the human food chain? With an MRL or Maximum Residue Level! Zero residue? No option, because related to LOD & LOQ of method! Alternative: can you determine a level of residue that can be safely consumed, every day of your life: a chronic ingestion approach: that is the Maximum Residue Limit or MRL approach 8

9 How to establish MRLs? Human studies forbidden, so scientific risk assessment required Chronic intake tox studies in animals! Basis to assess safety Pharmacology critical to understand: Marker residue or residue of concern? Parent, conjugate and / or metabolite(s)? Residue depletion Need analytical method to detect the marker residue validated in all tissues 9

10 How can a treated animal safely enter the human food chain? With an MRL or Maximum Residue Level! An MRL should be set for each edible tissue and is in principle species-specific muscle, fat, liver, kidney, milk, honey, eggs because ADME is species and tissue specific! MRL vs. Withdrawal period MRL = safe level of residues in food! Withdrawal time: When after treatment are residue levels safe? 10

11 Safety of residues? The route to MRLs NOEL ADI MRL Withdrawal Period what is a safe level in the most sensitive animals what is the safe amount of residues that humans can consume every day? how much residue can be in each type of animal produced food? when can I be sure that the food is safe? 11

12 Assessment of safety: NOEL and ADI For each study: no observed (adverse) effect level (NOEL), in mg/kg/day Lowest NO(A)EL from each set of studies Safety factor, ranging from 10 to 2000, depending on quality of the data and the type of the effect observed 10x10: inter- and intraspecies variation 10 or 20 if mutagenicity or teratogenicity Acceptable Daily Intake (ADI) estimates safe intake level: ADI = NOEL (mg/kg bw/day) x 60kg BW Safety factor 12

13 Determination of (which) ADI Toxicological ADI (animal chronic tox data) Microbiological ADI (effects on human gut flora): MIC, bioavailabilty, ADME Disruption of the colonization barrier Increase of the population(s) of resistant bacteria Complex set of studies: VICH GL36 Same concept of safety factors Pharmacological ADI: Data from human use or models, safety factors The lowest of the 3 is the final ADI! You can consume this amount every day of your life without any effects on your health 13

14 Safety of residues? The route to MRLs NOEL ADI MRL Withdrawal Period what is a safe level in the most sensitive animals what is the safe amount of residues that humans can consume every day? how much residue can be in each type of animal produced food? when can I be sure that the food is safe? 14

15 From safety to residues From an ADI we know IF a molecule can be used safely in a veterinary medicinal product Daily food consumption multiple types of animal derived food need to determine safe concentration of residues in each potential tissue that can be consumed daily food basket ADI ADI distributed over all types of food But first: what residues should we look at? 15

16 Towards safety of residues What studies are typically required? For setting the safe concentration or MRL Basic Toxicology Studies Comparative Metabolism-Toxicology Species Total Residue and Metabolism-Target Species Analytical Method For setting the withdrawal time Residue Depletion in the target Species 16

17 Comparison of metabolic profiles Basic question: did we study the right compound(s) in our toxicology studies in lab species? Qualitative comparison of metabolic profiles in lab species and the target species from Outcome (hopefully) : yes Impact? if profiles are not comparable, more toxicology testing may be indicated 17

18 Total Residue and Metabolism Study? What? Radiolabeled drug 1-1.5X the proposed dose Proposed route of administration Intended duration of treatment/steady state Intended species; males and females 18

19 Total Residue and Metabolism Study: why? Determines the MARKER RESIDUE = the residue that monitors the depletion of total residues in a tissue Determines the TARGET TISSUE generally, the edible tissue from which residues deplete most slowly often, liver or kidney rarely, muscle or fat Regional differences In US typically tolerance set on the target tissue In EU typically MRL set for all tissues 19

20 Total Residue and Metabolism Study: outcome? Provides the METABOLIC PROFILE in the foodproducing animal for comparison with the toxicological lab-species Establishes the MARKER:TOTAL ratio MARKER Residue TOTAL Residue Used to calculate actual exposure to residues worst case scenario Correction factor for cold depletion studies with marker residue 20

21 Analytical Methodology Why is this required? Determinative: demonstrate you can find it! measures concentrations of drug residues in tissue Confirmatory: demonstrate you can tell it was indeed the marker residue that was found verifies the identity of the drug residue Regulatory agencies and inspectorates must be able to find the residues! 21

22 Analytical method Validated analytical method Concentration range: ½ MRL, MRL, 2xMRL Specificity, accuracy, precision LOQ and LOD Applicability and practicability Stability of the analyte (residue) during sample storage and handling 22

23 From residues to consumption Some definitions used internationally TDMI: Theoretical Daily Maximum Intake The TDMI is calculated by multiplying the average per capita daily food consumption for each food by the maximum use level established by national regulations or by the proposed use levels by the animal health industry and summing the resulting exposure values to give total dietary exposure. Estimated Daily Intake (EDI) the amount ingested by the average consumer of the food based on the actual use, or an approximation as close as possible to the actual uses levels. 23

24 From residues to consumption Now we know The right marker residue and marker tissue How much of the total residue is marker residue Now we need to determine how much can be present in the different tissues Remember: SAFE CONCENTRATION The safe concentration is the amount of residue that can be eaten in any edible tissue each day for an entire lifetime without exposing the consumer to residues in excess of the ADI Need to distribute the ADI over all animal-derived food you can eat in a day Need a food basket : What do we eat on a daily basis? 24

25 From residues to consumption Here are the assumptions A healthy adult eats a daily ration containing: 1.5 kg milk(products); 300 g lean meat; 100 g liver; 50 g kidney; 2 eggs; 50 g (animal) fat and 20 g honey If you do this daily you probably look bigger than a sumo wrestler please consult your doctor urgently Why is the food basket than so big? 25

26 From residues to consumption Some differences Species: eg poultry, fish, honey-bees,... Do we eat all? 26

27 From residue and consumption to MRL (EU) 0,05 kg x 20 µg/kg 0,05 kg x 20 µg/kg x 3,95 = 3,95 = 3,95 µg µg 0,253 0,3 kg x 10 µg/kg 1 = 3 µg MRL proposed marker/ total residu Residue present in Edible Tissue Daily intake(kg) (µg/kg) ratio* food (µg) Muscle Fat Liver Kidney Eggs Total Consumption or TDMI ADI 150 % ADI used 85.55% * Ratio Marker/Total around time that total residue gets around 100% of ADI 27

28 EU approach on MRLs: using depletion studies Depletion studies for all tissues 28

29 Use of residue data: EU approach on MRLs best time to set ratio of marker to total residues 29

30 From residue and consumption to MRL (EU) Edible Tissue Daily intake(kg) MRL proposed (µg/kg) marker/ total residue ratio* Residue present in food (µg) Muscle Fat Liver Kidney Eggs Total Consumption or TDMI ADI 150 % ADI used 85.55% * Ratio Marker/Total around time that total residue gets around 100% of ADI 30

31 Classification of substances & final MRL s Previously (Reg 2377/90) Annex I: final MRLs Annex II: no MRLs needed no residues/natural substances/no concern Annex III: provisional MRLs, with expiry date Annex IV: prohibited in food producing species Currently (Reg 37/2010): Allowed Prohibited Out of scope list: mainly excipients Demonstrate absence of pharmacological activity Can be withdrawn (cfr paraben issue) 31

32 32 Table 1: Allowed substances

33 33 Tabel 2: Prohibited substances

34 34 Special entry 1: all food producing species

35 35 Special entry 2: no MRL required

36 Safety of residues? The route beyond MRLs NOEL ADI MRL Withdrawal Period what is a safe level in the most sensitive animals what is the safe amount of residues that humans can consume every day? how much residue can be in each type of animal produced food? when can I be sure that the food is safe? 36

37 When can a treated animal enter the food chain? When: as soon as residue depletion falls below MRL for every tissue after use of the product Concept of withdrawal times required (WT or WHP) Don t let treated animals enter the food chain until the withdrawal time has been respected Via residue depletion study, focused on the marker residue Time between administration and depletion of residues below MRL, plus safety factor through regression, 95% Upper Tolerance Limit of the 95th Confidence interval 37

38 When can a treated animal enter the food chain? EU: Via residue depletion study, focused on the marker residue MRL proposed by industry, decided by government Food basket used afterwards to calculate TDMI Time between administration and depletion of residues below MRL, plus safety factor through regression, 95% Upper Tolerance Limit of the 95% Confidence interval USA: also residue depletion study, focused on the marker residue in the target tissue Tolerance is Safe concentration cold residue x marker/total residue ratio 99% Upper Tolerance Limit of the 95% Confidence interval Directly linked to consumption factor or food basket Often higher than EU MRL Dairy products always get around 50 % of the ADI attributed 38

39 39 Why the upper tolerance limit of a confidence interval?

40 Special remarks Outliers can only be excluded under very strict conditions Impact of variation in data-set, especially when occurring at the ends of the observations Alternative approach allowed if UTL approach impossible e.g. all data points under MRL, even at d 0 e.g. flat slope leading to unrealistic or impossible WT Always WT for carcass (meat, fat, skin) Milk, eggs & honey have separate WT s Based upon the specific MRL s 40

41 MRL, WHP and the precautionary principle MRL & WT are classic examples of the so-called precautionary principle What safety factors are built in? 41

42 Steps in the establishment of an MRL Safety factors 1a. Toxicology studies in a panel of test species to find the noobserved-effect-level 1b. Safety Factor applied to NOEL before calculating acceptable daily intake (ADI) 2a. ADI shared out among the food items in a Standard Diet 2b. MRL set for each item in the standard diet so ADI not exceeded NOEL ADI Standard Diet MRL 1a. Use of the most sensitive test species to identify the NOEL 1b. Selection of the last test level to show no effect as the NOEL (i.e. not the true NOEL) 2. Safety factor (x100 or x1000) always applied to the NOEL 3. The Standard Diet represents the upper limits for each food commodity 4. Assumption: people eat the entire Standard Diet every day 5. Assumption that full ADI could be eaten every day of your life 6. ADI usually not 100% used for MRLs 3. Residue depletion studies (with formulated product) Withdrawal Time 7. Calculation of the withdrawal period with high safety margin 42

43 Summary of consumer safety concept NOEL ADI Food basket (assumed consumption) MRL Withdrawal time All subsequent steps in balanced and scientifically driven risk management 43

44 Regulatory aspects Food safety is top priority in the EU (and everywhere) No molecule can be registered for use in food producing species without food safety assessment (MRL) MRLs are set by CVMP upon request from: Industry applicant Member State(s) Commission Interested party or organisation (MUMS) If residues above the MRL are found: no entry into food chain 44

45 Consumer safety: 2 dossiers! MRL-submission: active substance Safety file: focus on consumer safety aspects Residue file : focus on possibility of a safe WT Outcome: ADI, MRLs and analytical method established Application for marketing authorisation: product Safety file Partly refers to MRL dossier Focus on other product safety aspects (TAS, ERA, user safety) Residue file Partly refers to MRL-dossier (or established MRLs) Focus on residue depletion after use of product Outcome: warning statements if required, and withdrawal time(s) 45

46 Reference points of action How do you handle controls on food imported into EU? May contain substances without (European) MRL, used in other parts of the world Commission decision: based on the LOQ of a validated analytical method, advice by Community reference laboratory Risk assessment by the EFSA may be requested Note: MRLs: responsibility of CVMP Residues above reference point of action: no entry into food chain 46

47 Safety of residue consumption? The route via MRLs NOEL ADI MRL Withdrawal Period what is a safe level in the most sensitive animals what is the safe amount of residues that humans can consume every day? how much residue can be in each type of animal produced food? when can I be sure that the food is safe? 47

48 Maximum Residue Limits a scientific approach to ensure consumer safety ànd (food) animal health Prof Dr Erik De Ridder 48

European public MRL assessment report (EPMAR)

European public MRL assessment report (EPMAR) 4 March 2013 EMA/CVMP/165950/2012 Committee for Medicinal Products for Veterinary Use European public MRL assessment report (EPMAR) Diclazuril (extension to poultry) On 8 February 2013 the European Commission

More information

European public MRL assessment report (EPMAR)

European public MRL assessment report (EPMAR) 10 February 2012 EMA/CVMP/504089/2010 Committee for Medicinal Products for Veterinary Use European public MRL assessment report (EPMAR) Lasalocid (bovine species) On 1 February 2012 the European Commission

More information

European public MRL assessment report (EPMAR)

European public MRL assessment report (EPMAR) 22 August 2014 EMA/CVMP/751522/2013 Committee for Medicinal Products for Veterinary Use European public MRL assessment report (EPMAR) Closantel (bovine and ovine milk) after the provisional maximum residue

More information

European public MRL assessment report (EPMAR)

European public MRL assessment report (EPMAR) 4 March 2013 Committee for Medicinal Products for Veterinary Use European public MRL assessment report (EPMAR) (extention to ovine species) On 8 February 2013 the European Commission adopted a Regulation

More information

European public MRL assessment report (EPMAR)

European public MRL assessment report (EPMAR) 22 August 2014 EMA/CVMP/649781/2013 Committee for Medicinal Products for Veterinary Use European public MRL assessment report (EPMAR) Triclabendazole (all ruminants milk) after the provisional maximum

More information

European public MRL assessment report (EPMAR)

European public MRL assessment report (EPMAR) 1 July 2016 EMA/CVMP/779158/2015 Committee for Medicinal Products for Veterinary Use European public MRL assessment report (EPMAR) (all ruminants) after provisional maximum limits (MRLs) On 3 June 2016

More information

European public MRL assessment report (EPMAR)

European public MRL assessment report (EPMAR) 15 January 2013 EMA/CVMP/71291/2012 Committee for Medicinal Products for Veterinary Use (CVMP) European public MRL assessment report (EPMAR) Sodium salicylate (turkeys) On 12 December 2012 the European

More information

European public MRL assessment report (EPMAR)

European public MRL assessment report (EPMAR) 25 April 2018 EMA/CVMP/456716/2017 Committee for Medicinal Products for Veterinary Use European public MRL assessment report (EPMAR) Fluazuron (All ruminants, except bovine and ovine, and fin fish) On

More information

European public MRL assessment report (EPMAR)

European public MRL assessment report (EPMAR) 15 November 2016 EMA/CVMP/351687/2016 Committee for Medicinal Products for Veterinary Use European public MRL assessment report (EPMAR) (bovine species) On 17 October 2016 the European Commission adopted

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines and Information Technology EMEA/CVMP/187/00-FINAL COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS NOTE FOR GUIDANCE ON THE

More information

European public MRL assessment report (EPMAR)

European public MRL assessment report (EPMAR) 11 November 2013 EMA/CVMP/685072/2013 Committee for Medicinal Products for Veterinary Use European public MRL assessment report (EPMAR) Manganese carbonate (All food producing ) On 29 October 2013 the

More information

European public MRL assessment report (EPMAR)

European public MRL assessment report (EPMAR) 31 May 2012 EMA/CVMP/88291/2011 Committee for Medicinal Products for Veterinary Use European public MRL assessment report (EPMAR) Azamethiphos (extension to fin fish) On 23 May 2012 the European Commission

More information

Guideline on risk characterisation and assessment of maximum residue limits (MRL) for biocides

Guideline on risk characterisation and assessment of maximum residue limits (MRL) for biocides 15 January 2015 EMA/CVMP/SWP/90250/2010 Committee for Medicinal Products for Veterinary Use (CVMP) Guideline on risk characterisation and assessment of maximum residue limits (MRL) for biocides Draft agreed

More information

Guidance for Industry

Guidance for Industry #3 Guidance for Industry General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals DRAFT REVISED GUIDANCE This draft revised guidance document is for comment

More information

Residue Chemistry Studies for Veterinary Drugs. Human Food Safety Assessment. Presentation Topic. Improving residue chemistry submissions

Residue Chemistry Studies for Veterinary Drugs. Human Food Safety Assessment. Presentation Topic. Improving residue chemistry submissions Residue Chemistry Studies for Veterinary Drugs Julia A. Oriani, Ph.D. Food and Drug Administration Center for Veterinary Medicine Division of Human Food Safety Human Food Safety Assessment Risk = Hazard

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines and Inspections EMEA/MRL/016/95-FINAL COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS COLISTIN SUMMARY REPORT (1) 1. Colistin

More information

Council of the European Union Brussels, 6 February 2017 (OR. en)

Council of the European Union Brussels, 6 February 2017 (OR. en) Council of the European Union Brussels, 6 February 2017 (OR. en) 5966/17 AGRILEG 28 VETER 11 COVER NOTE From: European Commission date of receipt: 3 February 2017 To: General Secretariat of the Council

More information

European public MRL assessment report (EPMAR)

European public MRL assessment report (EPMAR) 15 January 2013 EMA/CVMP/52331/2012 Committee for Medicinal Products for Veterinary Use (CVMP) European public MRL assessment report (EPMAR) Phoxim (extension to bovine On 11 December 2012 the European

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines and Inspections EMEA/MRL/175/96-FINAL December 1999 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS ALTRENOGEST SUMMARY REPORT

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines and Information Technology Unit EMEA/MRL/050/95-FINAL February 1996 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS AMINOSIDINE

More information

Evaluation of active substances in plant protection products Residues Anja Friel European Food Safetey Authority, Parma/ Italy

Evaluation of active substances in plant protection products Residues Anja Friel European Food Safetey Authority, Parma/ Italy Evaluation of active substances in plant protection products Residues Anja Friel European Food Safetey Authority, Parma/ Italy European Conference on MRL-Setting for Biocides Berlin, 18-19 March 2014 Legal

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE

COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE European Medicines Agency Veterinary Medicines and Inspections EMEA/MRL/904/04-FINAL June 2004 COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE ALTRENOGEST SUMMARY REPORT (3) 1. Altrenogest (or allyltrenbolone)

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines and Inspections EMEA/MRL/815/02-FINAL January 2002 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS COLISTIN SUMMARY REPORT

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE

COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE European Medicines Agency Veterinary Medicines and Inspections EMEA/CVMP/77290/05-FINAL March 2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE FLUAZURON SUMMARY REPORT 1. Fluazuron is an insect

More information

Chapter 2 Food Additive Intake Assessment An-Najah National university

Chapter 2 Food Additive Intake Assessment An-Najah National university Chapter 2 Food Additive Intake Assessment An-Najah National university By: M.Sc. Mohammed Sabah 1 INTRODUCTION Both international organizations and local governments generally evaluate the safety of food

More information

European Public MRL assessment report (EPMAR)

European Public MRL assessment report (EPMAR) 8 September 2015 EMA/CVMP/632934/2014 Committee for Medicinal Products for Veterinary Use European Public MRL assessment report (EPMAR) Propyl 4-hydroxybenzoate and its sodium salt (all food producing

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines Evaluation Unit EMEA/MRL/114/96-FINAL June 1996 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS EPRINOMECTIN SUMMARY REPORT

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines and Inspections EMEA/MRL/875/03-FINAL February 2004 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS MORANTEL SUMMARY REPORT

More information

11/29/2010 FOOD SAFETY CAPACITY BUILDING ON RESIDUE CONTROL

11/29/2010 FOOD SAFETY CAPACITY BUILDING ON RESIDUE CONTROL Risk Analysis and MRLs OIE Training Workshop Pretoria 23 26 th November 2010 Antoine Kabwit Nguz Content Food Safety Risk Analysis Process of setting MRLs Good practices and MRLs Conclusion 1 Food Safety

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines and Information Technology EMEA/MRL/499/98-FINAL September 1998 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS CEFACETRILE

More information

European public MRL assessment report (EPMAR)

European public MRL assessment report (EPMAR) 10 December 2015 EMA/CVMP/262442/2015 Committee for Medicinal Products for Veterinary Use European public MRL assessment report (EPMAR) Sisapronil (bovine and caprine species) On 17 November 2015 the European

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines and Inspections EMEA/MRL/451/98-FINAL June 1998 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS BACITRACIN SUMMARY REPORT (1)

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines and Inspections EMEA/MRL/839/02-FINAL September 2002 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS CEFALONIUM SUMMARY REPORT

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines Evaluation Unit EMEA/MRL/0128/96-FINAL July 1996 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS CEFAPIRIN SUMMARY REPORT (1)

More information

European Public MRL Assessment Report (EPMAR)

European Public MRL Assessment Report (EPMAR) 21 September 2016 EMA/CVMP/89165/2016 Committee for Medicinal Products for Veterinary Use European Public MRL Assessment Report (EPMAR) Hydrocortisone aceponate (all ruminants and Equidae) On 31 August

More information

Part 2. Chemical and physical aspects

Part 2. Chemical and physical aspects Part 2. Chemical and physical aspects 12. Chemical and physical aspects: introduction 12.1 Background information used The assessment of the toxicity of drinking-water contaminants has been made on the

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines Evaluation Unit EMEA/MRL/104/96-FINAL June 1996 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS FLUMEQUINE SUMMARY REPORT (1)

More information

Exposure Assessment to food flavouring substances. Davide Arcella Technical meeting on food flavourings applications 20 th January 2015

Exposure Assessment to food flavouring substances. Davide Arcella Technical meeting on food flavourings applications 20 th January 2015 Exposure Assessment to food flavouring substances Davide Arcella Technical meeting on food flavourings applications 20 th January 2015 SUMMARY Evolution of dietary exposure to flavourings Exposure assessments

More information

Regarding Establishment of a Uniform Limit in a Positive List System concerning Agricultural Chemicals Residues in Food etc.

Regarding Establishment of a Uniform Limit in a Positive List System concerning Agricultural Chemicals Residues in Food etc. Regarding Establishment of a Uniform Limit in a Positive List System concerning Agricultural Chemicals Residues in Food etc. (Final Draft) In introducing a positive list system concerning agricultural

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines Evaluation Unit EMEA/MRL/267/97-FINAL October 1997 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS FLUBENDAZOLE SUMMARY REPORT

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE

COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE European Medicines Agency Veterinary Medicines and Inspections EMEA/CVMP/36147/2005-FINAL June 2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE MORANTEL (Extension to all ruminants) SUMMARY REPORT

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines and Information Technology EMEA/MRL/754/00-FINAL July 2000 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS CEFACETRILE SUMMARY

More information

THE EU LEGISLATION FOR HONEY RESIDUE CONTROL

THE EU LEGISLATION FOR HONEY RESIDUE CONTROL APIACTA 38 (2003) 15-20 15 THE EU LEGISLATION FOR HONEY RESIDUE CONTROL Roberto Piro, Franco Mutinelli Istituto Zooprofilattico Sperimentale delle Venezie, 35020 Legnaro (PD) Italy, Tel ++39 049 8084340,

More information

EXPOSURE ASSESSMENT: CURRENT SITUATION IN THE PHILIPPINES

EXPOSURE ASSESSMENT: CURRENT SITUATION IN THE PHILIPPINES EXPOSURE ASSESSMENT: CURRENT SITUATION IN THE PHILIPPINES INTRODUCTION Risk assessments has grown significantly, even in developing countries, in light of the WTO s Agreement on the Application of Sanitary

More information

Module 34: Legal aspects, ADI and GRAS status of food additives

Module 34: Legal aspects, ADI and GRAS status of food additives Paper No.: 13 Paper Title: FOOD ADDITIVES Module 34: Legal aspects, ADI and GRAS status of food additives 34.1 Legal Aspects of Food Additives The data provided by Joint Expert Committee on Food Additives

More information

Dietary exposure assessment in the Slovak Republic

Dietary exposure assessment in the Slovak Republic Šalgovičová Danka, Pavlovičová Daniela Dietary exposure assessment in the Slovak Republic Food Research Institute - Bratislava Safefoodnet - Chemical Food Safety Network for the enlarging Europe, Bratislava,

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines Evaluation Unit EMEA/MRL/300/97-FINAL November 1997 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS AZAPERONE SUMMARY REPORT

More information

European public MRL assessment report (EPMAR)

European public MRL assessment report (EPMAR) 8 September 2015 EMA/CVMP/643658/2014 Committee for Medicinal Products for Veterinary Use European public MRL assessment report (EPMAR) Virginiamycin (Poultry) On 3 September 2015 the European Commission

More information

The regulatory landscape. The now and the not yet

The regulatory landscape. The now and the not yet The regulatory landscape The now and the not yet Perspectives Aims Promote common understanding Anticipate the coming changes Prepare for afternoon sessions Who governs pesticides? All EU legislation comes

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines Evaluation Unit EMEA/MRL/646/99-FINAL August 1999 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS CEFALONIUM SUMMARY REPORT

More information

FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT

FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS DECENTRALISED PROCEDURE FOR A VETERINARY MEDICINAL PRODUCT NEOMAY 500 000 IU/g powder for use in drinking water /milk. Date: 28/10/2016 French agency for

More information

CYPERMETHRIN First draft prepared by Adriana Fernández Suárez, Buenos Aires, Argentina Richard Ellis Washington, DC, United States

CYPERMETHRIN First draft prepared by Adriana Fernández Suárez, Buenos Aires, Argentina Richard Ellis Washington, DC, United States CYPERMETHRIN First draft prepared by Adriana Fernández Suárez, Buenos Aires, Argentina Richard Ellis Washington, DC, United States ADDENDUM to the monograph prepared by the 47th meeting of the Committee

More information

1 OJ L 354, , p OJ L 80, , p. 19.

1 OJ L 354, , p OJ L 80, , p. 19. Call for scientific and technical data on the permitted food additives E 140(i) chlorophylls, E 140(ii) chlorophyllins, E 141(i) copper complexes of chlorophylls and E 141(ii) copper complexes of chlorophyllins

More information

MUTUAL RECOGNITION PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT

MUTUAL RECOGNITION PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS AGENCE NATIONALE DU MEDICAMENT VETERINAIRE 8 rue Claude Bourgelat Parc d activités de la grande Marche Javené CS 70611 35306 FOUGERES MUTUAL RECOGNITION

More information

Maximum Residue Limits for Clinacox 0.5% (diclazuril) for turkeys for fattening, chickens for fattening and chickens reared for laying 1

Maximum Residue Limits for Clinacox 0.5% (diclazuril) for turkeys for fattening, chickens for fattening and chickens reared for laying 1 The EFSA Journal (2008) 696, 1-12 Maximum Residue Limits for Clinacox 0.5% (diclazuril) for turkeys for fattening, chickens for fattening and chickens reared for laying 1 Updated Scientific Opinion of

More information

STUDIES TO EVALUATE THE SAFETY OF RESIDUES OF VETERINARY DRUGS IN HUMAN FOOD: GENERAL APPROACH TO ESTABLISH AN ACUTE REFERENCE DOSE

STUDIES TO EVALUATE THE SAFETY OF RESIDUES OF VETERINARY DRUGS IN HUMAN FOOD: GENERAL APPROACH TO ESTABLISH AN ACUTE REFERENCE DOSE VICH GL54 (SAFETY) ARfD November 2016 For Implementation at Step 7 STUDIES TO EVALUATE THE SAFETY OF RESIDUES OF VETERINARY DRUGS IN HUMAN FOOD: GENERAL APPROACH TO ESTABLISH AN ACUTE REFERENCE DOSE (ARfD)

More information

Guideline on approach towards harmonisation of withdrawal periods

Guideline on approach towards harmonisation of withdrawal periods 1 2 3 14 July 2016 EMA/CVMP/SWP/735325/2012 Committee for Medicinal Products for Veterinary Use (CVMP) 4 5 6 Guideline on approach towards harmonisation of withdrawal periods Draft Draft agreed by Safety

More information

FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT

FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS DECENTRALISED PROCEDURE FOR A VETERINARY MEDICINAL PRODUCT Colistin 2MIU/mL concentrate for oral solution for calves, lambs, pigs, chickens and turkeys(fr)

More information

European public MRL assessment report (EPMAR)

European public MRL assessment report (EPMAR) 21 February 2014 EMA/CVMP/350579/2013 Committee for Medicinal Products for Veterinary Use Chloroform (all mammalian food producing species) On 10 January 2014 the European Commission adopted a Regulation

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines Evaluation Unit EMEA/MRL/526/98-FINAL January 1999 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS APRAMYCIN SUMMARY REPORT

More information

The Codex Alimentarius

The Codex Alimentarius The Codex Alimentarius Herman B.W.M. Koëter, MSc, DTox, ERT Managing Director and Executive Secretary of the Management Board,, vzw Codex Alimentarius A joint WHO/FAO Food Standards Programme; 171 member

More information

Prof. Marina Heinonen University of Helsinki Member of the NDA Panel and EFSA s WG on Novel Foods

Prof. Marina Heinonen University of Helsinki Member of the NDA Panel and EFSA s WG on Novel Foods Guidance on Novel Foods Composition, production process and specification Prof. Marina Heinonen University of Helsinki Member of the NDA Panel and EFSA s WG on Novel Foods Info-Session 06 March 2017 Parma

More information

Provisional Translation Original: Japanese

Provisional Translation Original: Japanese Provisional Translation Original: Japanese Regarding Establishment of the level to be determined by the Minister of Health, Labour and Welfare, at the Pharmaceutical Affairs and Food Sanitation Council

More information

European public MRL assessment report (EPMAR)

European public MRL assessment report (EPMAR) 5 March 2012 EMA/CVMP/735219/2009 Committee for Medicinal Products for Veterinary Use European public MRL assessment report (EPMAR) Octenidine dihydrochloride (all mammalian food producing species) On

More information

Codex MRL Setting and Harmonization. Yukiko Yamada, Ph.D.

Codex MRL Setting and Harmonization. Yukiko Yamada, Ph.D. Codex MRL Setting and Harmonization Yukiko Yamada, Ph.D. CCPR and JMPR Codex Committee on Pesticide Residues (CCPR) One of subsidiary bodies of the Codex Alimentarius Commission Intergovernmental meeting

More information

GSC CODEX MESSAGE CCFA48/2016/25

GSC CODEX MESSAGE CCFA48/2016/25 FORM FOR THE SUBMISSION OF SUBSTANCES TO BE EVALUATED BY JECFA In completing this form, only brief information is required. The form may be retyped if more space is needed under any one heading provided

More information

1 OJ L 354, , p OJ L 80, , p. 19.

1 OJ L 354, , p OJ L 80, , p. 19. Call for scientific and technical data on the permitted food additives sulphur dioxide (E 220), sodium sulphite (E 221), sodium bisulphite (E 222), sodium metabisulphite (E 223), potassium metabisulphite

More information

Safety Assessment of Paprika Extract EXS0570IND. Contact person(s): Céline Burgaud; Pharmanager Ingredients Céline Pozza, Pharmanager development

Safety Assessment of Paprika Extract EXS0570IND. Contact person(s): Céline Burgaud; Pharmanager Ingredients Céline Pozza, Pharmanager development Safety Assessment of Paprika Extract EXS0570IND Name of Applicant: Pharmanager Ingredients, France Contact person(s): Céline Burgaud; Pharmanager Ingredients Céline Pozza, Pharmanager development Novel

More information

College ter Beoordeling van Geneesmiddelen / Medicines Evaluation Board. Graadt van Roggenweg AH Utrecht The Netherlands

College ter Beoordeling van Geneesmiddelen / Medicines Evaluation Board. Graadt van Roggenweg AH Utrecht The Netherlands College ter Beoordeling van Geneesmiddelen / Medicines Evaluation Board Graadt van Roggenweg 500 3531 AH Utrecht The Netherlands MUTUAL RECOGNITION PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A

More information

Ongoing review of legislation on cadmium in food in the EU: Background and current state of play

Ongoing review of legislation on cadmium in food in the EU: Background and current state of play Directorate-General for Health & Ongoing review of legislation on cadmium in food in the EU: Background and current state of play - International ICCO workshop, London, 3-4 May 2012 Michael Flüh bind the

More information

COMMISSION REGULATION (EU) / of XXX

COMMISSION REGULATION (EU) / of XXX Ref. Ares(2017)4140854-23/08/2017 EUROPEAN COMMISSION Brussels, XXX SANTE/10578/2017 Rev. 2 CIS (POOL/E2/2017/10578/10578R2-EN CIS.doc) [ ](2017) XXX draft COMMISSION REGULATION (EU) / of XXX on the use

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines and Information Technology EMEA/MRL/726/00-FINAL March 2000 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS SPECTINOMYCIN (cattle,

More information

REASONED OPINION. European Food Safety Authority 2, 3. European Food Safety Authority (EFSA), Parma, Italy

REASONED OPINION. European Food Safety Authority 2, 3. European Food Safety Authority (EFSA), Parma, Italy EFSA Journal 2012;10(7):2841 REASONED OPINION Reasoned opinion on the review of the existing maximum residue levels (MRLs) for paraffin oil (CAS 64742-54-7) according to Article 12 of Regulation (EC) No

More information

Emanuela Turla Scientific Officer Nutrition Unit - EFSA

Emanuela Turla Scientific Officer Nutrition Unit - EFSA EFSA s role, experiences with the evaluation of the applications for authorisation of Novel Food or notification of Traditional Food from the third country Emanuela Turla Scientific Officer Nutrition Unit

More information

FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS La Haute Marche Javené BP FOUGERES cedex FRANCE

FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS La Haute Marche Javené BP FOUGERES cedex FRANCE FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS La Haute Marche Javené BP 90203 35302 FOUGERES cedex FRANCE DECENTRALISED PROCEDURE FOR A VETERINARY MEDICINAL PRODUCT ZURITOL 25 MG/ML ORAL SOLUTION FOR

More information

Boscalid BOSCALID (221)

Boscalid BOSCALID (221) Boscalid 55 5.3 BOSCALID (221) RESIDUE AND ANALYTICAL ASPECTS Boscalid was evaluated for the first time for toxicology and residues by the JMPR in 2006. The 2009 JMPR then derived a number of MRLs following

More information

Residues of veterinary drugs in food

Residues of veterinary drugs in food FAO Joint Secretariat to JECFA Joint FAO/WHO Expert Committee on Food Additives Residues of veterinary drugs in food FAO Guidelines for the preparation of JECFA monographs and summaries for veterinary

More information

European public MRL assessment report (EPMAR)

European public MRL assessment report (EPMAR) 26 January 2018 EMA/CVMP/208391/2017 Committee for Medicinal Products for Veterinary Use European public MRL assessment report (EPMAR) Bromelain (porcine species) On 14 September 2017 the European Commission

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines Evaluation Unit EMEA/MRL/140/96-FINAL October 1996 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS THIOMERSAL AND TIMERFONATE

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines and Inspections EMEA/MRL/606/99-FINAL June 1999 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS CYROMAZINE SUMMARY REPORT (1)

More information

1. SUMMARY OF THE DOSSIER

1. SUMMARY OF THE DOSSIER SCIENTIFIC DISCUSSION This module reflects the scientific discussion for the assessment of Aivlosin and was last updated in November 2009. For information on all changes to the marketing authorisation,

More information

EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL

EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate B - Scientific Health Opinions Unit B3 - Management of scientific committees II SCIENTIFIC COMMITTEE ON FOOD SCF/CS/ADD/MsAd/179

More information

The Second Draft of Provisional Maximum Residue Limits (MRLs) for Agricultural Chemicals in Foods

The Second Draft of Provisional Maximum Residue Limits (MRLs) for Agricultural Chemicals in Foods The Second Draft of Provisional Maximum Residue Limits (MRLs) for Agricultural Chemicals in Foods The Ministry of Health, Labour and Welfare revised Food Sanitation Law in May 2003. Based on the revised

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines and Information Technology Unit EMEA/MRL/718/99-FINAL January 2000 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS PAROMOMYCIN

More information

Estimation of animal intakes and HR, STMR and MRL calculations for products of animal origin

Estimation of animal intakes and HR, STMR and MRL calculations for products of animal origin PESTICIDES UNIT Estimation of animal intakes and HR, STMR and MRL calculations for products of animal origin September 2015 European Food Safety Authority Via Carlo Magno 1A 43126 Parma ITALY Tel. +39

More information

Science Policy Notice

Science Policy Notice Science Policy Notice SPN2002-01 Children s Health Priorities within the Pest Management Regulatory Agency (publié aussi en français) January 3, 2002 This document is published by the Submission Coordination

More information

COMMISSION REGULATION (EU) / of XXX

COMMISSION REGULATION (EU) / of XXX Ref. Ares(2017)4140854-23/08/2017 EUROPEAN COMMISSION Brussels, XXX SANTE/10578/2017 Rev. 2 CIS (POOL/E2/2017/10578/10578R2-EN CIS.doc) [ ](2017) XXX draft COMMISSION REGULATION (EU) / of XXX on the use

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines Evaluation Unit EMEA/MRL/452/98-FINAL June 1998 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS NITROXINIL SUMMARY REPORT 1.

More information

Conflict of Interest Disclosure

Conflict of Interest Disclosure Conflict of Interest Disclosure I wish to declare a potential conflict of interest, and that I have received direct industry support from the International Life Sciences Institute (ILSI) in relation to

More information

Animal Health Companies Experience. Medicines for bees What the EMEA can do to increase availability 14 th December 2009, London

Animal Health Companies Experience. Medicines for bees What the EMEA can do to increase availability 14 th December 2009, London Animal Health Companies Experience Medicines for bees What the EMEA can do to increase availability 14 th December 2009, London 1 Which? February 2006 2 Is there a willingness from our side? Beekeepers

More information

Checklist of issues to be considered by food business operators when implementing Commission Regulation (EC) No 2073/2005

Checklist of issues to be considered by food business operators when implementing Commission Regulation (EC) No 2073/2005 Checklist of issues to be considered by food business operators when implementing Commission Regulation 1. General requirements 2. Sampling foodstuffs and testing against the relevant criteria 2.1 Validation

More information

Carbofuran CARBOFURAN (096)

Carbofuran CARBOFURAN (096) Carbofuran 83 5.6 CARBOFURAN (096) RESIDUE AND ANALYTICAL ASPECTS Carbofuran, 2,3-dihydro-2,2-dimethylbenzofuran-7-yl methylcarbamate, is a systemic insecticide, nematicide, and acaricide. Its uses include

More information

Risk Assessment and FCMs the Role of EFSA

Risk Assessment and FCMs the Role of EFSA Risk Assessment and FCMs the Role of EFSA Eugenia Lampi State General Chemical Laboratory, Greece TAIEX -Workshop on materials and articles intended to come into contact with food 27-28 November 2014,

More information

Institute for State Control of Veterinary Biologicals and Medicines Ústav pro státní kontrolu veterinárních biopreparátů a léčiv

Institute for State Control of Veterinary Biologicals and Medicines Ústav pro státní kontrolu veterinárních biopreparátů a léčiv Institute for State Control of Veterinary Biologicals and Medicines Ústav pro státní kontrolu veterinárních biopreparátů a léčiv DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY

More information

5.23 PROPAMOCARB (148)

5.23 PROPAMOCARB (148) Propamocarb 291 5.23 PROPAMOCARB (148) RESIDUE AND ANALYTICAL ASPECTS Propamocarb is a systemic carbamate fungicide with specific activity against Oomycete species that cause seed, seedling, root, foot

More information

Nutrition Labeling Standard Setting & Publicity

Nutrition Labeling Standard Setting & Publicity Presentation Outline Food Safety Risk Assessment in Hong Kong Centre for Food Safety Food & Environmental Hygiene Department, HKSAR Dr. CHOW Chor-yiu Food Safety Risk Assessment Approach Risk Assessment

More information

Safety Evaluation for Substances Directly Added to Food

Safety Evaluation for Substances Directly Added to Food Safety Evaluation for Substances Directly Added to Food Teresa Croce, PhD Office of Food Additive Safety Center for Food Safety and Applied Nutrition US Food and Drug Administration How Does FDA Regulate

More information

Clothianidin 169. CCN Commodity name Origin of use MRL mg/kg STMR or STMR-P mg/kg

Clothianidin 169. CCN Commodity name Origin of use MRL mg/kg STMR or STMR-P mg/kg Clothianidin 169 CLOTHIANIDIN (238) First draft prepared by Ms T. van der Velde-Koerts, Centre for Nutrition, Prevention and Health Services (VPZ), National Institute for Public Health and the Environment

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS European Medicines Agency Veterinary Medicines and Inspections EMEA/MRL/888/03-FINAL June 2004 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS OXFENDAZOLE (Extrapolation to all ruminants) SUMMARY REPORT (4)

More information

The "Cocktail-effect" Do pesticides play a role?

The Cocktail-effect Do pesticides play a role? The "Cocktail-effect" Do pesticides play a role? /////////// Martin Larsson Researcher & Regulatory Scientist Bayer Crop Science, Denmark 9 November 2018 Talking points Why are we discussing potential

More information