Pyrrolizidine Alkaloids and Genetically Modified Organism in Honey Allocation, European Legislation and Regulation

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1 Pyrrolizidine Alkaloids and Genetically Modified rganism in Honey Allocation, European Legislation and Regulation Intertek Food & Agri Services 1 San Cristóbal de Las Casas, Chiapas, Mexico March Director Testing & Analytics

2 Pyrrolizidine Alkaloids in Honey Current Situation C H 3 H CH 3 CH 2 H N 2

3 PAs and Toxicity Pyrrolizidine Alkaloids (PAs) can be found all over the world in almost every climatic region in Asteraceae, Boraginaceae and Fabaceae plant families PAs and their corresponding N-oxides can be transfered to honey from PA producing plants and have been related to toxic and carcinogenic effects H H H C H 3 H CH 3 H CH 3 H 3 C CH 3 H H H 3 C Me H CH 3 H CH 3 C H 3 H CH 3 CH 2 H N N N Lycopsamine (noncyclic monoester) Lasiocarpine (noncyclic diester) Seneciphylline (cyclic diester) Increasing toxicological effect 3

4 International Activities Germany: Federal Institute for Risk Assessment, BfR Expert Group on Pyrrolizidine Alkaloids Europe: European Food Safety Authority, EFSA EFSA pinion related to Pyrrolizidine Alkaloids as undesirable Substances in Animal Feeds Global: Codex Alimentarius Electronic Working Group DISCUSSIN PAPER N THE PRESENCE F PYRRLIZIDINE ALKALIDS (PAs) IN FD AND FEED AND CNSEQUENCES FR HUMAN HEALTH (Participants: National authorities, EU, Apimondia) Global: Joint FA/WH Expert Committee on Food Additives Recommendation for a revaluation of PAs by JECFA 4

5 Recommendation of BfR and EFSA Following the CT (Committee on Toxicology, UK) approach: µg/kg bw/day regarded as tolerable! daily intake of 0.42 µg PA for a person of 60 kg! PA concentration in honey of 42 µg/kg considering a consumption of 10 g/day! requirement for a monitoring including further more products Federal Institute for Risk Assessment, Germany, BfR Statement on analytics and toxicity of pyrrolizidine alkaloids in honey, Aug. 11th,

6 Market Survey and EFSA Recommendation 50*) for adults, 60 kg body weight 10.7 µg/kg = average PA concentration from market survey Consumption [g] **) Corresponding maximum PA content in honey [µg/kg] *) Maximum short-time daily consumption, 95th percentile **) Average daily consumption in Germany 6

7 Risk Assessment! Average consumption of honeys with different levels of PA concentrations does not result in an intake of more than µg PA/kg bw/d.! Average consumption of honeys with high PA levels can result in an exceedance of the recommended limit only for children.! A high consumption of honeys with higher PA contents means an exceedance of the intake of µg PA/kg bw/d. 7

8 Gentically Modified rganism European Legislation and Regulation 8

9 Legal Situation before September 6th, 2011 Honey is a pure natural product produced by bees. During their flight from flower to flower, the bees do not only gather nectar but also pollen whose grains get into the honey as well. If the pollen originates from a genetically modified (gm) plant, it can be detected in honey. EC 1829/2003 Genetically modified Food and Feed Honey, considered to be a product of animal origin, is not subject to the gmo regulation Does not apply to honey containing gm pollen, since it is neither containing, consisting of nor produced from GMs EC 1830/2003 Traceability and Labeling Labeling honey containing pollen of gm plants is generally not required according to the legal situation pollen from gm plants can be seen as an accidental, technically unavoidable intermixture for which GM labeling is not required (for this kind of intermixture the threshold value is 0.9%) 9

10 Legal Situation after September 6th, 2011 The European Court of Justice (CJEU or ECJ) decided: Honey containing pollen from genetically modified (gm) plants is categorized as food according to the European (EU) genetic engineering law (Regulations (EC) 1829/2003 and (EC) 1830/2003) and is therefore subject to authorization For further details please see: CJEU Judgement in Case C-442/09 and CJEU Press Release No 79/11 The consequences are: For gm plant pollen not approved for food in the EU, a zero tolerance rule is in force and results in the fact that honey containing such gm plant pollen is not marketable in the European Union. Honey is subject to mandatory labelling if it contains gm plant pollen which is authorized for food in the EU. No statutory transition period for the judgement of the ECJ 10

11 GM Testing on Honey No harmonized regulation or methodology for gmo testing on honey available! The German Federal ffice of Consumer Protection and Food Safety (BVL) published a Guideline on sampling and analysis for the detection of pollen from genetically modified plants in honey ( 09_Untersuchungen/Guideline_pollen_honey.html) issued on November 14th, The aim of this guideline is to harmonize sampling and testing procedures to obtain comparable and reliable data. The document is addressed to authorities and private laboratories. It does not give any information on the criteria how to interprete zero tolerance and which threshold will be used to quantify authorised gm plant pollen in honey. The European Union Reference Laboratory for GM Food and Feed (EURL-GMFF) is also working on the development of gmo testing methods, but has not published any recommendation so far. 11

12 GM Testing on Honey Labelling in case of positive findings for authorised GM plant pollen in Honey: EU Commission and German Authorities recommend a general threshold of 0.9 % gm pollen related to the total pollen content for the labelling of honey in case of a detection of gmo approved for food in the EU => No binding Decision exists! The EU Commission and the German Federal Ministry proposed not to take any action by national authorities of EU member states as long as no harmonized method is available. 12

13 Honey relevant Sequences Identification Sheet Identification Sheet rape soya maize cotton P-35-S T-NS FMV a na a na a na a na T45; TPAS19/2* X X - MS1, RF1, MS1xRF1*; MS1, RF2, MS1xRF2* , (Laurical); Falcon GS40/90; Liberator L62 (phoe6/ac) MS8, RF3, MS8xRF3 A ; A (LibertyLink); GU262 (LibertyLink) DAS 59122; Bt 176 (176; Maximer)*; T14; DAS 1507 GA 21 (Roundup Ready); MIR604 MN810; T25; 676, 678, 680; B16 (DLL25); DAS ; DBT418 (Bt-Xtra); DP ; MIR X X X - GT73; MN GT200 XY 235 MN (Roundup ready soya) W62, W98 (LibertyLink); G94-1, G94-19, G- 168 (ptimum) Bt11; MN 863 (YieldGard); MN 88017; NK 603 (Roundup Ready) CBH-351 (Starlink); MIR 80100; MN 802; MN 809; MN 832; MS 3; MS 6 LLCotton25 MN15985; MN531 X - X MN X X X X X MN89034 MN MN **; BPS-CV127-9** LY038** GHB614** x ** Legend: a= authorized in the EU na = non-authorized in the EU *provided that the presence is adventitious and unavoidable, presence up to 0.9% is allowed; not commercialized ** cannot be detected by five genetic sequence screening, not known as relevant; single event spezific detection is required 13

14 PAs and GM: Allocation in Honey from Mexico 14

15 Allocation of PAs verall Allocation of PAs (N=13000) 17% 10% 6% 4% 21% [0] µg/kg [1-4] [5-10] [11-20] [21-50] 16% [51-100] [ ] 12% 14% [>200] Mexico (N=2030) 5% 4% 4% 20% 39 µg/kg Average 33 µg/kg 12% 4930 µg/kg Max 2232 µg/kg 9 µg/kg Median 4 µg/kg 13% 22% 20% 15

16 PA Concentrations in Quarterly Study Periods Median Mean Q Q Q Q Q Q Q Q Q Q Mexico 16

17 Market Survey (N = 30) Mean values [µg/kg] Maximum values [µg/kg] July 2009 Jan April 2010 July 2010 ct Jan April 2011 July 2011 Jan July 2009 Jan April 2010 July 2010 ct Jan April 2011 July 2011 Jan

18 GM Testing on Honey Results Summary of GM Screening Results (>5000 samples) 18

19 GM Testing on Honey Results 19

20 Conclusion Pyrrolizidine Alkaloids in Honey! Data on toxicity of individual PAs and their relative potencies is still too limited to fix maximum limits! Various regional regulations to minimize the overall exposure to PAs showing genotoxic and carcinogenic effects! BfR (Germany) and EFSA (Europe) recommend a maximum daily intake of µg/kg/bw (0.42 µg/kg for a person of 60 kg)! No limit will be defined by the German Authorities at the moment! The Industry should minimize the PA concentration in honey and in products containing pollen (food supplements) 20

21 Conclusion Genetically Modified rganism in Honey! Honey containing pollen from genetically modified (gm) plants is categorized as food according to the European (EU) genetic engineering law (Regulations (EC) 1829/2003 and (EC) 1830/2003) and is therefore subject to authorization! For gm plant pollen not approved for food in the EU, a zero tolerance rule is in force and results in the fact that honey containing such gm plant pollen is not marketable in the European Union.! Honey is subject to mandatory labelling if it contains gm plant pollen which is authorized for food in the EU.! No binding Decision exists! 21

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