The work of EFSA s Panel on Contaminants in the Food Chain (CONTAM)

Transcription

1 The work of EFSA s Panel on Contaminants in the Food Chain (CONTAM) Food Safety Authority of Ireland Seminar on Contaminants Dublin 17 November 2009 Claudia Heppner, Head of the CONTAM unit

2 Outline of presentation EFSA s mission CONTAM Panel Overview of CONTAM scientific outputs Some examples of CONTAM outputs Some examples of follow up of risk assessments Current and future work programme of the CONTAM Panel

3 EFSA's mission EFSA is the European Union's scientific risk assessment body for food and feed safety, providing the scientific basis for risk management decisions in this area (Regulation (EC) 178/2002). Provide scientific and technical advice on all matters within these fields. Communicate all scientific outputs publicly (communication task is shared with EC/MS). 3

4 EFSA tasking European Commission European Parliament Member States Question? EFSA ( self mandate ) Risk Assessment 4

5 How does EFSA work? Mainly opinions on applications Food additives and nutrient sources (ANS) Food contact materials, enzymes, flavourings (CEF) Feed additives (FEEDAP) Genetically modified organisms (GMO) Nutrition (NDA) Mainly generic opinions Animal health and welfare (AHAW) Biological hazards (BIOHAZ) Contaminants (CONTAM) Plant health (PLH) Plant protection products (PPR) Scientific Committee (SC) Since 2003 >1000 scientific outputs 5

6 CONTAM Panel

7 Mandate of the CONTAM Panel To deliver scientific opinions on contaminants in food and feed, associated areas and undesirable substances i.e. natural toxicants, mycotoxins and residues of non authorised substances not covered by another Panel. F F O F C C x S R F F O 7

8 Work areas - I Chemical compounds which are not intentionally added to food and feed such as metals and metal-organic compounds, mycotoxins and persistent organic pollutants and other compounds. Chemical compounds naturally found in food and feed such as phycotoxins, plant toxicants, or other compounds. 8

9 Work areas - II Chemical compounds formed during thermal food and feed processing. Non-authorised substances in feed and food. 9

10 Members of CONTAM Panel Chair: Dr. Josef Schlatter (CH) Vice-chairs: Dr. Diane Benford (UK), Prof. Dr. Rolaf van Leeuwen (NL) 20 Panel members More information about the CONTAM experts _PanelMembersContam.htm CONTAM A-Z 10

11 CONTAM Panel at work Panel Opinion adopted Mandate Working Group (WG) WG marine biotoxins WG lead WG previous cargoes WG melamine WG ambrosia WG brominated flame retardants AMU Unit DATEX Unit CONTAM Unit

12 An opinion is based on the four pillars of risk assessment HAZARD IDENTIFICATION EXPOSURE ASSESSMENT Levels in food in EU, EU dietary exposure (general population, high consumers, sub-groups) relevant food groups, Proxy non-food sources, time trends HAZARD CHARACTERISATION ADME, acute, subchronic & chronic toxicity human studies genotox, reprotox,immunotox, dose-response, mode/mechanism of action, selection of critical dataset, mathematical modelling (BMD), health based guidance value e.g. TDI RISK CHARACTERISATION Relating exposure to health-based guidance value or Margin of Exposure (MOE) Vulnerable groups (children high level consumers) 12

13 Requestor of opinions Requests mainly related to generic scientific opinions Art. 29 Regulation (EC) 178/

14 Overview of CONTAM outputs

15 CONTAM: 70 scientific outputs since 2003 FOOD 30 Metals Mycotoxins 3 Persistent organic pollutants 4 Marine biotoxins 8 Food processing 3 Other 9 FEED 40 Metals 4 Mycotoxins 5 Persistent organic pollutants 9 Plant toxicants 9 Coccidiostats 11 Others 2 15

16 CONTAM Panel outputs 2008 RA for EU- Consumers from contaminants in FOOD RA for animals from contaminants in FEED and impact on human health Assessment of EU limits on human health and methods of analysis for marine biotoxins Topics Nitrate in Vegetables PFOS/A Polycyclic aromatic hydrocarbons (PAH) Undesirable substances in animal feed: - Natural plant products (ricin, gossypol; theobromine, tropane alkaloids) - Mercury Marine biotoxins in shellfish (yessotoxins; azaspiracids) 3-MCPD esters (statement) Coccidiostats: halofuginone, decoquinate, robenidine, nicarbazin, diclazuril (a total 11 from 2007 onwards)

17 EFSA's rapid responses in 2008 Art. 13 b of the decision concerning the establishment and operations of the scientific committee and panels adopted by the Management Board of EFSA on 11 September 2007 provides the basis for rapid responses. Mineral oil in sunflower oil Melamine in food Dioxin in Irish pork Statements issued by EFSA and not by the CONTAM Panel. However, some experts of the scientific panels provided scientific advice to EFSA during the drafting of these statements. 17

18 CONTAM Panel outputs 2009 (status Oct) RA for EU-Consumers from contaminants in FOOD RA for animals from contaminants in FEED and impact on human health Assessment of EU limits on human health and methods of analysis for marine biotoxins Topics Cadmium Uranium in mineral water/foodstuffs Previous cargoes (criteria + evaluation) Undesirable substances in animal feed: - Natural plant products (Saponins from Madhuca longifolia) -Nitrites Marine biotoxins in shellfish (saxitoxins, pectenotoxins, domoic acid, Summary regulated marine biotoxins, Arsenic Aflatoxins in tree nuts other than almonds, hazelnuts, pistachios (statement) Influence of processing on lipophilic marine biotoxins (statement), Palytoxins

19 EFSA's rapid responses in 2009 Art. 13 b of the decision concerning the establishment and operations of the scientific committee and panels adopted by the Management Board of EFSA on 11 September 2007 provides the basis for rapid responses. Nicotine in wild mushrooms Statements issued by EFSA and not by the CONTAM Panel. However, CONTAM Panel chair provided scientific advice to EFSA during the drafting of this statement. 19

20 Some examples

21 CONTAM opinion marine biotoxins okadaic acid 27 November 2007 azaspiracids 9 June 2008 yessotoxins 2 December 2008 saxitoxins 25 March 2009 pectenotoxins 27 May 2009 domoic acid 2 July 2009 summary opinion 13 August 2009 statement on the influence of processing 25 March

22 Terms of reference EFSA has been requested by the European Commission to assess: the methods of analysis for various marine biotoxins, the current EU limits of marine biotoxins as established in the EU legislation with regard to human health, new emerging toxins.

23 Established acute reference doses (ARfD s) Toxin Species Effect ARfD Azaspiracids Human Gastrointestinal 0.2 µg AZA-1 eq/kg bw Okadaic acidgroup Human Gastrointestinal 0.3 µg OA eq/kg bw Saxitoxins Human Neurotoxicity 0.5 µg STX eq/kg bw Pectenotoxins Mouse Gastrointestinal 0.8 µg PTX-2 eq/kg bw Yessotoxins Mouse Cardiotoxicity 25 µg YTX eq/kg bw Domoic acid Humans/ Monkeys Neurotoxicty 30 µg DA/kg bw 23

24 Comparison of current EU limits with ARfD s Toxin Current EU limits Exposure by eating 400 g portion at the EU limit ARfD Max. concentration based on 400 g portion OA 160 µg OA equivalents/kg SM 64 μg OA equivalents/person (1 μg OA eq/kg bw) 0.3 μg OA equivalents/ kg bw 45 μg OA equivalents/kg SM AZA 160 µg AZA equivalents/kg SM 64 μg AZA1 equivalents/person (1 μg AZA1 eq/kg bw) 0.2 μg AZA1 equivalents/ kg bw 30 μg AZA1 equivalents/kg SM PTX 160 µg OA equivalents/kg SM 64 μg PTX2/person (1 µg PTX2 eq/kg bw) 0.8 μg PTX2 equivalents/ kg bw 120 µg PTX2 equivalents/kg SM YTX 1 mg YTX equivalents/kg SM 400 µg YTX equivalents/person (6.7 μg YTX eq/kg bw) 25 μg YTX equivalents/ kg bw 3.75 mg YTX equivalents/kg SM STX 800 µg PSP/kg SM 320 µg STX equivalents/person (5.3 μg STX eq/kg bw) 0.5 μg STX equivalents/ kg bw 75 μg STX equivalents/kg SM DA 20 mg DA/kg SM 8 mg DA/person (130 μg DA/kg bw) 30 μg DA/kg bw 4.5 mg DA/kg SM SM = shellfish meat 24

25 Performance of reference method (MBA) for lipophilic biotoxins Toxin Ability to perform at the current EU limit value Specificity OA Probability 40% at 160 µg/kg None AZA Probability 95% a) 160 µg/kg None PTX Not defined, Limited chance at 160 µg/kg None YTX Not defined None a) Steep dose response for AZA: Only 5% probability to detect 80 µg/kg 25

26 Performance of reference method (MBA) for hydrophilic biotoxins Toxin Method LOD/LOQ Specificity STX MBA LOD 370 µg STX eq/kg Limited HPLC-FLD LOD not reported LOQ STX eq/kg Adequate DA HPLC LOD mg DA/kg LOQ mg DA/kg Adequate (DA & epi-da) ELISA (screening) LOD mg DA/kg LOQ 0.01 mg DA/kg Adequate (DA) 26

27 Overall conclusions marine biotoxins Based on the available data it appears that the current EU regulatory limit values for OA-, AZA-, STX- and DA-group toxins are not sufficiently protective for consumers. For YTX and PTX the current EU limit appears to be sufficiently protective for consumers. The MBA for liphophilic marine biotoxins (OA, AZA, PTX, YTX) has shortcomings (high variablity of results, detection capacity) and is not considered an appropriate tool for control purposes. MBA is able to quantify STX-group toxins at current EU limit, but not below. 27

28 CONTAM opinion cadmium Cadmium 30 January 2009 Cd 28

29 Terms of reference EFSA has been requested by the European Commission to: Assess whether PTWI of 7 g/kg b.w. is still appropriate Updated exposure assessment on cadmium Exposure from food including drinking water Importance of other non-dietary sources (e.g. air, cigarette smoke etc.) Exposure in specific group of population (e.g. infants and children, people following specific diets) and indication of age group most exposed to cadmium Take into account biomonitoring data 29

30 Occurrence data (period ) Total of 137,202 data from 18 EU Member States Germany (32% of analysed data) Slovakia (29% of analysed data) France (13% of analysed data) Romania (9% of analysed data) Iceland Australia Three commercial organisations 30

31 Consumption data The EFSA Concise European Food Consumption database was established by EFSA to support exposure assessments in the EU - EFSA website (see Annex 3 to EFSA, 2008) French data for vegetarians - Appendix 1 of the 1 st French Total Diet Study (Leblanc et al., 2004) Food survey from the Italian Istituto Nazionale di Ricerca per gli Alimenti e la Nutrizione (INRAN) (Turrini et al., 2001; Turrini and Lombardi-Boccia, 2002) for children exposure 31

32 Exposure to cadmium from different sources Source Pathway Range of calculated or reported exposures [µg/kg b.w. per week] Adults Children Dietary exposure Food average current opinion Oral Food high current opinion Food in industrial areas Oral Extreme diets current opinion Oral Vegetarians Oral 5.47 House dust Oral Non-Dietary Exposure Air Inhalation Smoking inhalation

33 Toxicity Cadmium is primarily toxic to the kidney, especially to the proximal tubular cells. Prolonged and/or high exposure may lead to tubular damage renal impairment with decreased glomulare filtration rate renal failure Cadmium can also cause bone demineralisation either through direct bone damage or indirectly as a result of renal failure. Cd

34 Human data A large number of studies on health effects of cadmium exposure in humans in different countries investigated the relationship between urinary cadmium levels and tubular effects. Tubular damage is the earliest effect of cadmium exposure, thus the CONTAM Panel based its risk assessment on this effect. The CONTAM Panel selected beta-2- microglobulin (B2M) in relation to tubular effects as the most useful biomarker. 34

35 Meta-analysis The CONTAM Panel carried out a meta-analysis to evaluate the dose-response-relationship between the urinary cadmium and B2M. The CONTAM Panel derived a benchmark dose and its 95%- confidence lower bound (BMDL) for humans using cut off points relevant to clinical changes in the target organ (300 µg/g creatinine). The CONTAM Panel selected an overall group-based BMDL5 of 4 µg cadmium / g creatinine The CONTAM Panel applied a chemical-specific adjustment factor (CSAF) of 3.9 due uncertainties using group means and not individual data points. Dividing the BMDL5 of 4 µg cadmium/g creatinine by 3.9 (CSAF) results to urinary cadmium excretion of 1 µg/g creatinine 35

36 Meta-analysis The CONTAM Panel concluded that urinary cadmium concentrations of 1 µg per g creatinine and below would indicate that 95% of the European population would not exceed cut-off limits in the range of about 300 µg/g creatinine for B2M in urine. A one-compartment model was fitted to the data from population based Swedish mammography cohort study in order to derive a dietary cadmium intake from a urinary cadmium concentration. In order to remain below 1 µg cadmium/g creatinine the average daily dietary cadmium intake should not exceed 2.52 µg cadmium/kg b.w. per week Thus, the CONTAM Panel established a TWI of 2.5 µg/kg b.w. for cadmium. 36

37 Risk characterisation Mean dietary exposure to cadmium across Europe was estimated to be 2.3 µg/kg b.w. per week (range: 1.9 to 3.0 range) High exposure was estimated to be 3.0 µg/kg. b.w. per week (range: 2.5 to 3.9) Vegetarians have dietary exposure estimates of 5.4 µg/kg. b.w. per week. The CONTAM Panel noted that the mean dietary exposures in European countries are close or exceeding the TWI of 2.5 µg/kg. b.w. Subgroups e.g. vegetarian, children, smokers and people living in highly contaminated areas may exceed the TWI by about 2-fold. 37

38 Overall conclusions Although adverse health effects on kidney function are unlikely to occur for an individual exposed at this high level, the CONTAM Panel concluded that exposure to cadmium at the population level should be reduced. 38

39 Follow up of risk assessments

40 Risk management follow up of CONTAM opinions EXAMPLE Mycotoxins as undesirable substances in animal feed Aflatoxin B1: Deoxynivalenol Zearalenone Ochratoxin A Ergot alkaloids Fumonisins EU legislation. No need to change current maximum level (ML) in Com. Directive 2002/32/EC No EU legislation. Recommended guidance values e.g. for cereals, maize products and compound feed (Com. Recommendation 2006/576/EC) No EU legislation. Recommended guidance values e.g. for cereals, maize products and compound feed (Com. Recommendation 2006/576/EC) No EU legislation. Recommended guidance values e.g. for cereals, cereal products and compound feed (Com. Recommendation 2006/576/EC) EU legislation. Recommendation for increased monitoring and guidance values for combined ergot alkaloids in preparation No EU legislation. Recommended guidance values e.g. for maize, maize products, and compound feed (Com. Recommendation 2006/576/EC)

41 Risk management follow up of CONTAM opinions EXAMPLE unavoidable carry-over of authorised coccidiostats into non-target feed 11 Coccidiostats 3 % carry-over rate for non-sensitive non-target animal species compared to the authorised maximum concentration for feed for target animal species. 1% carry-over rate for sensitive nontarget animal species and finishing feed compared to authorised maximum concentration for feed for target animal species.

42 Work programme (ongoing and outlook)

43 *) extension of the deadline will be asked to European Commission CONTAM work programme 2009 in progress RA for EU- Consumers from contaminants in FOOD RA for animals from contaminants in FEED and impact on human health Others Topics/deadlin e Lead (WG on Lead) / Nov 2009* ) Brominated flame retardants (WG BFR) / June 2010* ) Ambrosia in animal feed (WG ambrosia)/ March 2010 Marine biotoxins in shellfish: cyclic imines, palytoxins, brevetoxins, and ciguatoxin (WG marine biotox)/ Dec 2009* ) Previous cargoes (WG previous cargoes)/ Nov 2009 Melamine (WG on melamine) March 2010

44 Possible requests in 2009/2010 FOOD Ergot alkaloids Morphine in poppy seeds Mycotoxins such as Alternaria toxins, T-2 and HT-2 toxin Aflatoxins (Aflatoxin total vs B1 for all food commodities with ML) 44

45 Possible requests in 2009/2010 FEED Mycotoxins such as Alternaria toxins, T-2 and HT-2 toxin, nivalenol. Use of glycerin from biodiesel production in animal feed 45

46 Possible requests in 2009/2010 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council Art. 19 concerns EFSA (most likely CONTAM) Possibly requests to EFSA to carry out risk assessments related to residues of veterinary medicinal products which are not authorised for use in EC. 46

47 Thank you very much for your attention! EFSA: 47