Download as PDF, PPTX
Uploaded byEFSA EU
Effost 2020 novel foods
The document discusses the role of compositional data in the safety assessment of novel foods by the European Food Safety Authority (EFSA), explaining its functions and regulatory framework. It outlines how compositional data informs risk assessment processes, influencing factors such as identity, production processes, and nutritional information. Ultimately, the document emphasizes that EFSA's evaluations ensure food chain resilience and safety prior to market authorization of novel foods.
Food◦
More Related Content
Similar to Effost 2020 novel foods
Effost 2020 novel foods
- 1. The role ofcompositional data in the safety assessment of Novel Foods by the European Food Safety Authority 11th November 2020 Ermolaos Ververis Scientific Officer, Nutrition Unit 34th EFFoST International Conference Bridging high-tech, food-tech and health: Consumer-oriented innovations
- 2. Outline What is EFSA? NovelFoods & Food Chain Safety Assessment of Novel Foods The Role of Compositional Data Conclusions
- 3.
- 4. EFSA is The referencebody for risk assessment of food and feed in the European Union. Its work covers the entire food chain – from field to fork One of the number of bodies that are responsible for food safety in Europe
- 5. HEADQUARTERS in the heartof Parma
- 6. What EFSA does Providesindependent scientific advice and support for EU risk managers and policy makers on food and feed safety Provides independent, timely risk communication Promotes scientific cooperation
- 7. EFSA’s tools &partners International organisations Research institutes & academia National food safety organisations Individual experts
- 8. The Scientific Panels Plantprotection GMO Plant health Animal health & welfare Nutrition Food Packaging Animal feed Biological hazards Chemical contaminants Food additives
- 9. Novel Foods &Food Chain
- 10. What is aNovel Food? 10 New compounds New Sources Traditional Foods from non- EU countries New Processes Regulation (EU) 2015/2283 on Novel Foods
- 11. Krill oil AlfalfaLycopene from B.trispora 11 Phytosterols Non- sticky chewing gum base Ice- structuring protein Examples of Novel Foods UV-treated milk UV-treated yeast Synthetic hydroxy- tyrosol Chia seeds Baobab fruit Noni Juice traditionalfoods fromnon-EU countries newsources newcompounds newprocesses
- 12. A Novel Foodcan be… 12 Chemical substances Polymers Micro- organisms, fungi, algae From plants or their parts Of mineral origin From animals or their parts cell or tissue cultures derived from animals/ plants/fungi/ algae Engineered nanomaterials
- 13. Novel Foods inthe food chain… 13 Boosting Innovation Environmental sustainability Cultural exchange Food Security Increasing consumers’ choices …can offer possibilities for
- 14. Safety Assessment ofNovel Foods
- 15. What EFSA does? 15 ▪Legislation ▪ Regulatory decisions - Classifications - Authorisations - Conditions of authorisations - Labelling, post-monitoring - Food inspections - Sanctions ▪ Guidelines ▪ Safety assessment ▪ Collaboration ▪ Communication YESNO
- 16. Novel Food Guidance ▪Identity of NF ▪ Production Process ▪ Compositional data ▪ Specifications ▪ History of use ▪ Proposed uses- use levels & anticipated intake ▪ Nutritional information & ADME* ▪ Toxicological data ▪ Allergenicity Safety Assessment of Novel Foods (1) 16 *Absorption, Distribution, Metabolism, Excretion
- 17. Safety Assessment ofNovel Foods (2) 17 Production Process Identity Compositional Data Specifications History of use Nutritional information Proposed uses/levels & intake ADME Toxicological information Allergenicity
- 18. Safety Assessment ofNovel Foods (2) 18 Production Process Identity Compositional Data Specifications History of use Nutritional information Proposed uses/levels & intake ADME Toxicological information Allergenicity
- 19. The Role ofCompositional Data
- 20. Compositional data-requirements (1) 20 Biochemistry Physico- chemistry Qualitative & Quantitative dataon Composition Microbiology ✓Officially- recognized methods ✓new scientifically- documented & validated approaches
- 21. Compositional data-requirements (2) 21 Thelevel of NF’s complexity can affect the testing requirements Single substances & simple mixtures Whole foods Complex mixtures e.g. UV-treated mushroom powder - Proximate analysis - Vitamin D analysis - Investigation of vitamin D forms (D2 vs D4) e.g. 1-methylnicotinamide chloride - Identity tests - physicochemical properties - Solubility data - Minimum purity e.g. shrimp peptide concentrate - Qualitative & quantitative analysis of main constituents - Peptide profile analyzed by de novo sequencing
- 22. Identity can triggerthe need for more compositional data e.g. Taxonomic classification (read-across) - Primary/secondary metabolites - bioaccumulation of contaminants - endogenously produced compounds of possible concern Compositional data can provide information on identity Chemical fingerprinting of plant material (e.g. metabolomics) Genomics data can verify the production strain (e.g. algae) Identity vs Compositional data 22 examples
- 23. Production process vsCompositional data 23 examples Cultivation/growth conditions presence of toxins, bioaccumulation of environmental contaminants Chemical synthesis Formation of by- products, impurities, residual catalysts Extraction residual solvents, extraction of hazardous compounds Thermal treatment formation of processing contaminants, effect on the microflora Storage conditions microbial and chemical stability Fermenting agents Production of metabolites Formation of nanoparticles Further analytical data as per the respective EFSA guidance (nanoscience and nanotechnologies) Enzymatic treatment identification & deactivation of enzymes
- 24. Proposed uses &use levels can trigger the need for more compositional data e.g. levels of inclusion/meal replacement: further investigation of micronutrients with established tolerable upper intake levels, quality and bioavailability of macronutrients e.g. use of the novel food as ingredient in foodstuffs produced with heat-treatment: investigation of potential formation of process contaminants (e.g. acrylamide) Proposed uses & use levels vs Compositional data 24 examples Compositional data can affect the proposed uses & use levels e.g. levels of undesirable substances can limit the permitted uses/use levels
- 25. ▪ Investigate exceedanceof tolerable upper intake levels for micronutrients ▪ Qualitative & quantitative analysis of antinutritional factors (e.g. oxalates, lectin, trypsin inhibitors, phytic acid) that can inhibit absorption or modify bioavailability of nutrients ▪ Possible interactions of the NF per se with nutrients Nutritional information vs Compositional data 25 The NF must not be “nutritionally disadvantageous”
- 26. ADME & Toxicologicalinformation vs Compositional data 26 examples ▪ Thorough characterization of the NF might reduce the need for toxicological studies in some cases. ▪ Particle size can trigger ADME considerations ▪ Solubility aspects may affect ADME & toxicological strategy ▪ Chemical structure/affinity of a compound may affect the need for toxicological studies ▪ Type of extract affects toxicological profile due to e.g. polarity ▪ Need for testing specific fractions of the NF (e.g. genotoxicity)
- 27. ▪ Protein levelsin the NF ▪ Profile of proteins in the NF (molecular weight, heat stability, sensitivity to pH, digestibility by enzymes) ▪ Investigation of sequence homology of the NF protein with known allergens Allergenicity vs Compositional data 27 Potential or proven allergenicity is not a reason to say that a novel food is unsafe!
- 28.
- 29. ▪ Safety assessmentof NF by EFSA contributes to the resilience, diversity and safety of the food chain by providing risk managers and policy makers scientific advice on such products before potential EU market authorization. ▪ The respective EFSA guidance provides advice to food business operators on the NF’s characterization approach to be followed, allowing at the same time flexibility regarding data produced using new scientifically documented approaches. ▪ Compositional data: - define the scientific requirements in other areas of a NF dossier - can be defined by other scientific requirements of the NF dossier via a reciprocal relationship - are the backbone of the NF safety assessment (preparation by applicants, assessment by EFSA) Conclusions 29
- 30. ▪ EFSA NDAPanel (EFSA Panel on Dietetic Products, Nutrition and Allergies), Turck, D., Bresson, J. L., Burlingame, B., Dean, T., Fairweather-Tait, S., Heinonen, M., Hirsch- Ernst, K. I., Mangelsdorf, I., McArdle, H., Naska, A., Neuhäuser-Berthold, M., Nowicka, G., Pentieva, K., Sanz, Y., Siani, A., Sjödin, A., Stern, M., Tomé, D., Vinceti, M., Willatts, P., Engel, K.-H., Marchelli, R., Pöting, A., Poulsen, M., Salminen, S., Schlatter, J., Arcella, D., Gelbmann, W., de Sesmaisons-Lecarre, A., Verhagen, H., & van Loveren, H. (2016a). Guidance on the preparation and presentation of an application for authorization of a novel food in the context of Regulation (EU) 2015/ 2283. EFSA Journal, 14(11), e04594. https://doi.org/10.2903/j.efsa.2016.4594. ▪ Ververis, E., Ackerl, R., Azzollini, D., Colombo, P.A., de Sesmaisons, A., Dumas, C., Fernandez-Dumont, A., da Costa, L.F., Germini, A., Goumperis, T., Kouloura, E., Matijevic, L., Precup, G., Roldan-Torres, R. Rossi, A. ,Svejstil, R., Turla, E. , Gelbmann, W. 2020. Novel foods in the European Union: Scientific requirements and challenges of the risk assessment process by the European Food Safety Authority. Food Research International, 137, p.109515. https://doi.org/10.1016/j.foodres.2020.109515 References 30
- 31. Stay connectedStay connected Subscribeto efsa.europa.eu/en/news/newsletters efsa.europa.eu/en/rss Receive job alerts careers.efsa.europa.eu – job alerts Follow us on Twitter @efsa_eu @plants_efsa @methods_efsa @animals_efsa Follow us Linked in Linkedin.com/company/efsa Contact us efsa.europa.eu/en/contact/askefsa 31
- 32. The role ofcompositional data in the safety assessment of novel foods by the European Food Safety Authority (EFSA) Ververis Ermolaos1,2, Precup Gabriela1,3, Kouloura Eirini1, Matijevic Leonard1,4, Roldan-Torres Ruth1, Goumperis Tilemachos1, Albert Océane1, Alfieri Fabio1, Dumas Céline1, Germini Andrea1 1 European Food Safety Authority (EFSA), Via Carlo Magno, 1A, 43126, Parma, Italy 2 School of Medicine, National and Kapodistrian University of Athens (NKUA), Ch. Lada 6, 10561, Athens, Greece 3 Faculty of Food Science and Technology, Institute of Life Sciences, University of Agricultural Sciences and Veterinary Medicine, Cluj- Napoca (USAMVCN), 400372, Calea Mănăștur , 3-5, CJ, Romania 4 Faculty of Food Technology Osijek, J. J. Strossmayer University of Osijek (UNIOS), Franje Kuhača 20, 31 000, Osijek, Croatia 32 Thank you for your attention!