Novel Food, 26 October 2016, Bangkok

1. NOVEL FOODS in Europe EFSA’s Role Wolfgang Gelbmann Nutrition Unit, EFSA Novel Food, 26 October 2016, Bangkok

2. Outline • Definition and EFSA’s role • EFSA Guidance for traditional foods from 3rd countries • EFSA Guidance on other Novel Foods • EFSA‘sriskprofile on insects

3. Whatis a „Novel“ FooD in the EU? Regulation (EU) 1997/258 : a food that was not consumed to a significant degree by humans in the EU prior to 15/05/997. Regulation (EU) 2015/2283: definition unchanged Novel

4. 1997 Non sticky chewing gum base α-cyclodextrin Phytosterols Ice structuring protein Krill oil Alfaalfa Allanblackia oil Fungal oil Lycopene from B. trispora Astaxanthin from microalgae • Whatis a „Novel“ FooD in the EU? Novel Chiaseeds Baobab fruit Noni Juice Arracacha UV treated milk UV treated yeast Synthetic lycopene, Synthetic hydroxytyrosol

5. So whatisnewfromthenew Regulation ? • Applications to the Commission • Evaluation by the EFSA - 9 months • Notificationfor traditional foodsfromthird countries. Member States and EFSA 4 monthsfor dulyreasonedsafetyobjectionsoraccepted. • Time limits for each step

6. EFSA‘sRole on Novel Foods Yes • Guidelines • Safetyassessment • Communication • Collaboration Not • Legislation • Regulatorydecisions - classifcations - authorisations - conditions of authorisations - labelling, postmonitoring - foodinspections - sanctions

7. EC MANDATE FOR EFSA GUIDANCE Regulation (EU) 2015/2283 → EFSA shallconsider: • EFSA was askedtopreparetwoguidancedocuments for: • notifications of traditional foods, and • applications for novelfoods.

8. Novel for EU (1997) • Derivedfrommicroorganisms, fungi or algae; plants or animals or cell/tissue cultures • Must derivefromprimaryproduction; procecessedorunprocessed • Must have a ‘History of safe food use in a third country’ confirmed with compositional data and from experience of continued use for at least 25 years in the customary diet of a significant number of people in at least one third country • Traditional Foods from Third Countries?

9. “History of safefooduse“ • EFSA GUIDANCE ON TRADITIONAL FOODS • Introduction • Identity • Production process • Compositional data • Specifications 7. Proposed conditions of use for the EU market Target population, proposed uses and use levels, intended role in the diet, precautions and restrictions of use Data from experience of continued use for at least 25 years

10. DATA FROM EXPERIENCE OF USE 6.1. Experience of food use in a third country • Extent of use • Characteristics of the population group(s) of consumers • Role of the traditional food in the diet • Precautions for the preparation and restrictions of use • Human data (if available) 6.2. Other information (from non-food uses) ! Type of data: include scientific publications, scientific expert opinions, monographs, information from international or national organisations, governmental documentation, figures on cultivation, harvesting, sales, trade, cookbooks, recipes, anecdotal data.

11. Water chestnut: PotentiallycontaminatedwithmetacercariaeFasciolopsisbuski> boiling for 1-2 min • Information on traditional foods

12. Traditional Foods examples • Baobab dried fruit: Africa • ChiaSeeds: South America • Arracaciaxanthorrhiza: South America https://www.wikimedia.org

13. New EFSA Novel Food Guidance 1. Administrative data 2.1. Introduction 2.2. Identity of the novel food 2.3. Production process 2.4. Compositional data 2.5. Specifications 2.6.History of use of the novel food and of its source 2.7. Proposed uses and use levels and anticipated intake 2.8. Absorption, distribution, metabolism, and excretion 2.9. Nutritional information 2.10. Toxicological information 2.11.Allergenicity 2.12. Concluding remarks 3. Annexes, References

14. Critical for the development of appropriate toxicity testing • Negligible absorption: may justify not undertaking higher tiered toxicological studies. • Single substances and simple mixtures: tested according to the same principles as those applied to food additives. • complex mixtures and whole foods: but for toxicologically relevant constituents. • Kinetic data may also be relevant for nutritionally significant constituents for the evaluation of the nutritional impact of the novel food. • 2.8 ADME

15. 2.9 Nutritional information • Shouldnot be nutritionally disadvantageous • Novel food is intended to replace another food • Novel production process is applied • Nutrients, anti-nutrients, interactionwithnutrients • Effectsarisingfromproductionprocess • Studiesmaybeneededto addresspossibleeffects of anti-nutrientsand interaction

16. Main title • 2.10 Toxicology • Tiered toxicity testing approach as the default approach It integrates the core areas of: • toxicokinetics, • genotoxicity, • repeated dose toxicity testing, and • reproductive and developmental toxicity. • Additional studies may be needed: • immunotoxicity, • hypersensitivity and food intolerance, • neurotoxicity, • endocrine activity, and • mechanisms and modes of action.

17. Minimum requirement: protein content, its source, production process, available experimental and human data. • No protein → very low allergenic potential • Contains proteins → have allergenic potential (default assumption • Further testing: • (a) protein analyses • (b) human testing Potential or proven allergenicity is not a reason to say that a novel food is unsafe • Separate legislation for food allergen labellingexemption. • 2.11 ALLERGENICITY

18. In the absence of sgnificant consumption data (<'97) in the EU: • Under the current Regulation (EU) 258/1997: novel food • Under the new Regulation (EU) 2015/2283: novel food => but many insect have a history of food use outside EU may be notified as traditional foods from third countries • AndWhataboutInsects?

19. Main title

20. Biological hazards Farmed insects • EFSA Opinion on Insects • Risk profile related to production and consumption of insects as food and feed Chemical hazards As food and feed Environmental hazards Entire chain

21. Conclusions - Biological hazards • Salmonella, Campylobacter and verotoxigenic E. coli may be present in non-processed insects. • Viruses pathogenic for vertebrates can be transmitted by insects via contaminated substrates. The risk could be mitigated through effective processing. • Parasites: properly-managed closed farm environment; processing can eliminate such risks. • Mammalian prions cannot replicate in insects; studies suggested the possible role of insects as mechanical vectors Key:substrate, farmingconditions/hygiene, processing

22. Conclusions - Chemical hazards (1) • Contaminants: Heavy metals (in particular cadmium) Arsenic Toxins (produced by or accumulated by) Veterinary drugs and hormones Pesticides Dioxins and dioxin-like PCBs Polycyclic aromatic hydrocarbons Packaging migration contaminants

23. Conclusions - Chemical hazards (2) Occurrenceandaccumulation of contaminants in insect products depend on: Insect species Stage of harvest Production methods Substrate => greatest influence Processing methods

24. Allergenicity • Cases of allergic reaction and anaphylactic shock in humans • Insects may cause allergic reactions either by de novo sensitization or by cross-reactivity • No information of allergy caused in pet and farm animals Allergenicity is not a reason to conclude that a (novel) food is unsafe. But the risk Should explored by applicants, and communicted by EFSA to risk managers.

25. Nutrition ≈ 2000 ediblespecies (WHO, FAO), developmentalstage, large range of values Protein: goodbiologicalvalue, firstlimiting AS: tryptophan, lysine, histidine Fat: palmiticacid (8-38 %), oleicacid (9-48%), linoleicacid , α-linoleicacid... Carbohydrates: mostformed by chitin, effect on digestibility Minerals, traceelements, vitamines (FAO, 2013)

26. The environmental risk of insect farming is expected to be comparable to other animal production systems. • The production and processing of insects has demand for energy and water resources: this requires a risk profile on environmental impacts and mitigation. • Environmental hazards

27. www.efsa.europa.eu