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1. P24-09: Outcome of the re-assessment of Bisphenol A (BPA) safety of use in Food Contact Materials (FCMs)

Author

Al Harraq, Z., primary, Croera, C., additional, Baviera, J. M. Barat, additional, Bolognesi, C., additional, Chesson, A., additional, Cocconcelli, P.S., additional, Crebelli, R., additional, Gott, D.M., additional, Grob, K., additional, Lambré, C., additional, Lampi, E., additional, Mengelers, M., additional, Mortensen, A., additional, Rivière, G., additional, Silano, V., additional, Steffensen, I.-L., additional, Tlustos, C., additional, Vernis, L., additional, Zorn, H., additional, Batke, M., additional, Bignami, M., additional, Corsini, E., additional, FitzGerald, R., additional, Gundert-Remy, U., additional, Halldorsson, T., additional, Hart, A., additional, Schroeder, H., additional, Scanziani, E., additional, Ulbrich, B., additional, Ntzani, E., additional, Waalkens-Berendsen, D., additional, Woelfle, D., additional, Baert, K., additional, Castoldi, A.F., additional, Carfì, M., additional, and Van Loveren, H., additional

Published
2023
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3. Safety evaluation of the food enzyme triacylglycerol lipase from non-genetically modified Limtongozyma cylindracea strain MS-5-OF

Author

Lambre, C., Barat Baviera, J. M., Bolognesi, C., Cocconcelli, Pier Sandro, Crebelli, R., Gott, D. M., Grob, K., Lampi, E., Mengelers, M., Mortensen, A., Riviere, G., Steffensen, I. -L., Tlustos, C., Van Loveren, H., Vernis, L., Zorn, H., Herman, L., Roos, Y., Andryszkiewicz, M., Gomes, A., Kovalkovicova, N., Liu, Y., di Piazza, G., Chesson, A., Cocconcelli P. S. (ORCID:0000-0003-2212-7611), Lambre, C., Barat Baviera, J. M., Bolognesi, C., Cocconcelli, Pier Sandro, Crebelli, R., Gott, D. M., Grob, K., Lampi, E., Mengelers, M., Mortensen, A., Riviere, G., Steffensen, I. -L., Tlustos, C., Van Loveren, H., Vernis, L., Zorn, H., Herman, L., Roos, Y., Andryszkiewicz, M., Gomes, A., Kovalkovicova, N., Liu, Y., di Piazza, G., Chesson, A., and Cocconcelli P. S. (ORCID:0000-0003-2212-7611)

Abstract

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with the non-genetically modified yeast Limtongozyma cylindracea strain MS-5-OF by Meito Sangyo Co., Ltd. The food enzyme is free from viable cells of the production organism. It is intended to be used in five food manufacturing processes: brewing processes, baking processes, milk processing for cheese production, production of free fatty acids by hydrolysis and production of flavouring preparations from dairy products. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 1.033 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 2,084 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, results in a margin of exposure of at least 2,017. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Published
2023

4. Safety evaluation of the food enzyme lysozyme from hens' eggs

Author

Lambre, C., Barat Baviera, J. M., Bolognesi, C., Cocconcelli, Pier Sandro, Crebelli, R., Gott, D. M., Grob, K., Lampi, E., Mengelers, M., Mortensen, A., Riviere, G., Steffensen, I. -L., Tlustos, C., Van Loveren, H., Vernis, L., Zorn, H., Andryszkiewicz, M., Kovalkovicova, N., Liu, Y., di Piazza, G., Ferreira de Sousa, R., Chesson, A., Cocconcelli P. S. (ORCID:0000-0003-2212-7611), Lambre, C., Barat Baviera, J. M., Bolognesi, C., Cocconcelli, Pier Sandro, Crebelli, R., Gott, D. M., Grob, K., Lampi, E., Mengelers, M., Mortensen, A., Riviere, G., Steffensen, I. -L., Tlustos, C., Van Loveren, H., Vernis, L., Zorn, H., Andryszkiewicz, M., Kovalkovicova, N., Liu, Y., di Piazza, G., Ferreira de Sousa, R., Chesson, A., and Cocconcelli P. S. (ORCID:0000-0003-2212-7611)

Abstract

The food enzyme lysozyme (peptidoglycan N-acetylmuramoylhydrolase; EC 3.2.1.17) is produced with hens' eggs and submitted by DSM Food Specialties BV. It is intended to be used in brewing processes, milk processing for cheese production as well as wine and vinegar production. The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 4.9 mg TOS/kg body weight per day. This exposure is lower than the intake of the corresponding fraction from eggs, for all population groups. Egg lysozyme is a known food allergen. The Panel considered that, under the intended conditions of use, the residual amounts of lysozyme in treated beers, cheese and cheese products as well as wine and wine vinegar may trigger adverse allergenic reactions in susceptible individuals. Based on the data provided, the origin of the food enzyme and an exposure to the food enzyme comparable to the intake from eggs, the Panel concluded that the food enzyme lysozyme does not give rise to safety concerns under the intended conditions of use, except for the known adverse allergic reactions that occur in susceptible individuals.

Published
2023

5. Host Resistance Assays

Author

Van Loveren, H, Vohr, H W, Assenmacher, Mario, Avraham, Hava Karsenty, Avraham, Shalom, Bala, Shukal, Barnett, John, Basketter, David, Ben-David, Yaacov, Berek, Claudia, Blümel, Jörg, Bolliger, Anne Provencher, Bolon, Brad, Bradley, S Gaylen, Brundage, Kathleen M, Brunner, Georg, Bugelski, Peter J, Burchiel, Scott W, Burns-Naas, Leigh Ann, Bussiere, Jeanine L., Cameron, Scott B, Carey, Michelle, Cederbrant, Karin, Chow, Anthony W, Cohen, Mitchell D., Colagiovanni, Dorothy, Contreras, Marcela, Cornacoff, Joel B, Corsini, Emanuela, Crevel, René, Cuff, Christopher, Czuprynski, Charles J, Damoiseaux, Jan G M C, Daniels, Geoff, Dayan, Anthony D, Dearman, Rebecca J, Dodson, Sarah V. M., Ebringer, Alan, Engel, Andrea, Esser, Charlotte, Fairley, Kimberly J, Fernandez-Botran, Rafael, Flaherty, Dennis K, Frings, Werner, Gad, Shayne Cox, Gardner, Donald E, Gardner, Susan C, Garssen, Johan, Gashev, Anatoliy A, Geffner, Jorge, Geginat, Gernot, Gemsa, Diethard, Gerberick, Frank, Germolec, Dori, Gilbert, Kathleen M., Giles-Komar, Jill, Gore, Elizabeth R, Griem, Peter, Hagelschuer, Ina, Haggerty, Helen G., Hall, Andrew, Hanneken, S., Hastings, Kenneth L, Havelaar, Arie H, Heisler, Eckhart, Helm, Ricki M, Henschler, Reinhard, Herrmann, Thomas, Herzyk, Danuta J, Higgins, Rachel R., Hitzfeld, Bettina, Holladay, Steven, Holsapple, Michael, House, Robert V, Hughes, Lucy, Jeong, Tae Cheon, Johnson, Victor J, de Jong, Wim H, de Jonge, Rob, Kamath, Arati, Kaminski, Norbert E, Kaminsky, Ronald, Karol, Meryl, Kashon, Michael L, Kerkvliet, Nancy I, Kimber, Ian, Knight, David M, Knulst, A C, Koren, Eugen, Kraal, Georg, Kretz-Rommel, Anke, Kuper, C Frieke, Ladics, Gregory, Laiosa, Michael, Landreth, Kenneth S., Lawrence, B Paige, Lawrence, David A, Lee, Byeong-Chel, Lee, William, Leino, Lasse, Lemke, Hilmar, Lewis, J G, Liebau, Jutta, Lollini, Pier-Luigi, van Loveren, Henk, Luebke, Bob, Luster, Michael I, Mage, Rose G, Maier, Curtis C., Martin, Michael U., Maurer, Thomas, McKarns, Susan C, Meade, B Jean, Moser, Bernhard, Nagata, Shigekazu, Nain, Marianne, Neumann, Norbert J., Novicki, Deborah L, Olsen, John L, Pauluhn, Jürgen, Pichler, Werner, Pieters, Raymond, Pollard, K Michael, Preissner, Klaus T, Pruett, Stephen B, Pumford, Neil R., Rashid, Taha, Ratajczak, Helen V, Redegeld, Frank A M, Regal, Jean F, Resch, Klaus, Rodgers, Kathleen, Roman, Danielle, Rose, Noel R, Rosenthal, Gary J., Sali, Tina, Samsom, Janneke N, Savelkoul, Huub F J, Schafer, Rosana, Schatz, Mark, Schild, Hansjoerg, Shepherd, David, Shiohara, Tetsuo, Silverstone, Allen, Simeonova, Petia P, Smialowicz, Ralph J, Smith, K G C, Soos, Jeanne M, Stittelaar, Koert J, Straube, Frank, Sulentic, Courtney E W, Swart, B, Takumi, Katsuhisa, Tarkowski, Maciej, Tervaert, Jan Willem Cohen, Thomas, Peter T, Tinkle, Sally S, Treacy, George, Trouba, Kevin, Tryphonas, Helen, Uguccioni, Mariagrazia, Ulrich, Peter, van der Heijden, Maurice W, Van Loveren, H, Vandebriel, Rob J, Vleminckx, Kris, Vohr, Hans-Werner, Weinbauer, Gerhard F, Weinstein, I Bernard, Weltzien, Hans Ulrich, Weston, Ainsley, White, Kimber L., Wilson, Clyde, Wing, Mark, Wolf, Anna Maria, Yaqoob, Parveenn, Yucesoy, Berran, Zawieja, David C, Zelikoff, Judith T, Zola, H, and van Zwieten, P A

Published
2005
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6. A comparison of immunotoxic effects of nanomedicinal products with regulatory immunotoxicity testing requirements

Author

Giannakou C, Park MV, de Jong WH, van Loveren H, Vandebriel RJ, and Geertsma RE

Subjects
Nanomedicine, regulatory requirements, safety, testing methods, immunotoxicity, Medicine (General), R5-920
Abstract

Christina Giannakou,1,2 Margriet VDZ Park,1 Wim H de Jong,1 Henk van Loveren,1,2 Rob J Vandebriel,1 Robert E Geertsma1 1Centre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven, 2Department of Toxicogenomics, Maastricht University, Maastricht, the Netherlands Abstract: Nanomaterials (NMs) are attractive for biomedical and pharmaceutical applications because of their unique physicochemical and biological properties. A major application area of NMs is drug delivery. Many nanomedicinal products (NMPs) currently on the market or in clinical trials are most often based on liposomal products or polymer conjugates. NMPs can be designed to target specific tissues, eg, tumors. In virtually all cases, NMPs will eventually reach the immune system. It has been shown that most NMs end up in organs of the mononuclear phagocytic system, notably liver and spleen. Adverse immune effects, including allergy, hypersensitivity, and immunosuppression, have been reported after NMP administration. Interactions of NMPs with the immune system may therefore constitute important side effects. Currently, no regulatory documents are specifically dedicated to evaluate the immunotoxicity of NMs or NMPs. Their immunotoxicity assessment is performed based on existing guidelines for conventional substances or medicinal products. Due to the unique properties of NMPs when compared with conventional medicinal products, it is uncertain whether the currently prescribed set of tests provides sufficient information for an adequate evaluation of potential immunotoxicity of NMPs. The aim of this study was therefore, to compare the current regulatory immunotoxicity testing requirements with the accumulating knowledge on immunotoxic effects of NMPs in order to identify potential gaps in the safety assessment. This comparison showed that immunotoxic effects, such as complement activation-related pseudoallergy, myelosuppression, inflammasome activation, and hypersensitivity, are not readily detected by using current testing guidelines. Immunotoxicity of NMPs would be more accurately evaluated by an expanded testing strategy that is equipped to stratify applicable testing for the various types of NMPs. Keywords: nanomedicine, regulatory requirements, safety, testing methods, immunotoxicity

Published
2016

20. Safety of frozen and dried formulations from whole house crickets (Acheta domesticus) as a Novel food pursuant to Regulation (EU) 2015/2283

Author

EFSA Panel on Nutrition, Novel Foods, Food Allergens (NDA), Turck D., Bohn T., Castenmiller J., De Henauw S., Hirsch-Ernst K.I., Maciuk A., Mangelsdorf I., McArdle H.J., Naska A., Pelaez C., Pentieva K., Siani A., Thies F., Tsabouri S., Vinceti M., Cubadda F., Frenzel T., Heinonen M., Marchelli R., Neuhauser-Berthold M., Poulsen M., Prieto Maradona M., Schlatter J.R., van Loveren H., Goumperis T., and Knutsen H.K.

Subjects
Acheta domesticus, Veterinary (miscellaneous), Population, insect powder, Novel food, Nutri1010, TP1-1185, Plant Science, Target population, medicine.disease_cause, Microbiology, 03 medical and health sciences, chemistry.chemical_compound, Ingredient, 0404 agricultural biotechnology, Chitin, medicine, TX341-641, Food science, education, 030304 developmental biology, 2. Zero hunger, 0303 health sciences, education.field_of_study, Novel Foods, biology, Nutrition. Foods and food supply, business.industry, Chemical technology, 04 agricultural and veterinary sciences, biology.organism_classification, Food safety, 040401 food science, food safety, Scientific Opinion, chemistry, Acheta, house cricket, Animal Science and Zoology, Parasitology, business, Genotoxicity, Food Science
Abstract

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Food and Food Allergens (NDA) was asked to deliver an opinion on the safety of frozen and dried formulations from house crickets (Acheta domesticus) as a novel food pursuant to Regulation (EU) 2015/2283. The NF is proposed in three formulations: (i) frozen, (ii) dried, (iii) ground. The main components of the NF are protein, fat and fibre (chitin) in the dried form of the NF, and water, protein, fat and fibre (chitin) in the frozen form of the NF. The Panel notes that the concentrations of contaminants in the NF depend on the occurrence levels of these substances in the insect feed. The Panel further notes that there are no safety concerns regarding the stability of the NF if the NF complies with the proposed specification limits during its entire shelf‐life. The NF has a high‐protein content, although the true protein levels in the NF are overestimated when using the nitrogen‐to‐protein conversion factor of 6.25, due to the presence of non‐protein nitrogen from chitin. The applicant proposed to use the NF in the form of a snack, and as a food ingredient in a number of food products. The target population proposed by the applicant is the general population. The Panel notes that, considering the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. The Panel notes that no genotoxicity and no subchronic toxicity studies with the NF were provided by the applicant. Considering that no safety concerns arise from the history of use of A. domesticus or from the compositional data of the NF, the Panel identified no other safety concerns than allergenicity. The Panel considers that the consumption of the NF might trigger primary sensitisation to A. domesticus proteins and may cause allergic reactions in subjects allergic to crustaceans, mites and molluscs. Additionally, allergens from the feed may end up in the NF. The Panel concludes that the NF is safe under the proposed uses and use levels.

Published
2021
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21. Safety of frozen and dried formulations from whole yellow mealworm (Tenebrio molitor larva) as a novel food pursuant to Regulation (EU) 2015/2283

Author

EFSA Panel on Nutrition, Novel Foods, Food Allergens (NDA), Turck D., Bohn T., Castenmiller J., De Henauw S., Hirsch-Ernst K.I., Maciuk A., Mangelsdorf I., McArdle H.J., Naska A., Pelaez C., Pentieva K., Siani A., Thies F., Tsabouri S., Vinceti M., Cubadda F., Frenzel T., Heinonen M., Marchelli R., Neuhauser-Berthold M., Poulsen M., Prieto Maradona M., Schlatter J.R., van Loveren H., Ververis E., and Knutsen H.K.

Subjects
Agriculture and Food Sciences, 0106 biological sciences, Entomophagy, Mealworm, Novel foods, Veterinary (miscellaneous), INSECTS, yellow mealworm, insect powder, Nutri1010, Novel food, TP1-1185, novel foods, Plant Science, 01 natural sciences, Microbiology, ENTOMOPHAGY, SECRETIONS, CADMIUM, 03 medical and health sciences, CYTOTOXIC MOLECULES, TX341-641, Food science, entomophagy, 030304 developmental biology, 2. Zero hunger, 0303 health sciences, Larva, biology, Nutrition. Foods and food supply, business.industry, Chemical technology, Biology and Life Sciences, biology.organism_classification, Food safety, food safety, 010602 entomology, Scientific Opinion, Tenebrio molitor larva, COLEOPTERA, Animal Science and Zoology, Parasitology, CHITIN, business, MELANOGENESIS, Food Science
Abstract

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on frozen and dried formulations from whole yellow mealworm (Tenebrio molitor larva) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The term yellow mealworm refers to the larval form of the insect species Tenebrio molitor. The NF comprises the frozen and freeze-dried formulations of the yellow mealworm, whole or in the form of powder. The frozen formulation consists mainly of water, crude protein and fat whereas the freeze-dried formulations of crude protein, fat, digestible carbohydrates and fibre (chitin). The Panel notes that the levels of contaminants in the NF depend on the occurrence levels of these substances in the insect feed. The Panel notes furthermore that there are no safety concerns regarding the stability of the NF if the NF complies with the proposed specification limits during its entire shelf-life. The dried formulations of the NF have a high protein content, although the true protein levels in the NF are overestimated when using the nitrogen-to-protein conversion factor of 6.25, due to the presence of non-protein nitrogen from chitin. The applicant proposed to use the NF as whole frozen or whole dried insect, or in the form of powder, added as an ingredient to various food products such as cereal bars, pasta, meat imitates and bakery products. The target population is the general population. The Panel notes that, considering that the NF will not be the sole source of dietary protein, and the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. The submitted toxicity studies from the literature did not raise safety concerns. The Panel considers that the consumption of the NF may induce primary sensitisation and allergic reactions to yellow mealworm proteins and may cause allergic reactions in subjects with allergy to crustaceans and dust mites. Additionally, allergens from the feed may end up in the NF. The Panel concludes that the NF is safe under the proposed uses and use levels. (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

Published
2021
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22. Safety of the extension of use of galacto-oligosaccharides as a Novel food pursuant to Regulation (EU) 2015/2283

Author

EFSA Panel on Nutrition, Novel Foods, Food Allergens (NDA), Turck D., Bohn T., Castenmiller J., De Henauw S., Hirsch-Ernst K.I., Maciuk A., Mangelsdorf I., McArdle H.J., Naska A., Pelaez C., Pentieva K., Siani A., Thies F., Tsabouri S., Vinceti M., Cubadda F., Frenzel T., Heinonen M., Marchelli R., Neuhauser-Berthold M., Poulsen M., Prieto Maradona M., Schlatter J.R., van Loveren H., Colombo P., and Knutsen H.K.

Subjects
Agriculture and Food Sciences, Veterinary (miscellaneous), Novel food, Nutri1010, TP1-1185, Plant Science, 010501 environmental sciences, Galacto-oligosaccharides, 01 natural sciences, Microbiology, Medicine and Health Sciences, TX341-641, Food science, 0105 earth and related environmental sciences, novel food, HUMAN-MILK, 2. Zero hunger, extension of use, Nutrition. Foods and food supply, Galacto‐oligosaccharides, Chemical technology, dietary fibre, GOS, 0402 animal and dairy science, Dietary fibre, 04 agricultural and veterinary sciences, Extension (predicate logic), dietary fiber, 040201 dairy & animal science, Scientific Opinion, Food supplement, food supplement, Animal Science and Zoology, Parasitology, Business, Food Science
Abstract

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the extension of use of galacto-oligosaccharides (GOS) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a syrup containing >= 57% w/w GOS (w/w dry matter), consisting of different galactosyl residues linked to a terminal glucose by a beta-glycosidic bond and also containing lactose and the constituent monomers of lactose (galactose and glucose). The NF is already authorised and included in the Union list of NFs and is produced according to the same production process. This application is limited to an assessment of the extension of use as a food ingredient in dairy confectionary, cheese and processed cheese, butter and spreads. There is a 10-30% increase in total GOS intake from the requested extension of use compared to the currently authorised uses at the highest 95th percentile. It is noted that the total intake at the highest mean (8.7-22.0 g/day) is below the adequate intake (AI) of 25 g/day for dietary fibre set to ensure a normal laxation in adults, while the highest 95th percentile (27.2-41.6 g/day) is higher than the AI. When the maximum use as a food supplement is added to the highest 95th percentile combined intake from all proposed and authorised food categories a total intake up to 58 g GOS/day is estimated. This highest intake level would exceed the AI for dietary fibre; however, no tolerable upper intake level for dietary fibre has been set and only transient gastrointestinal symptoms may be related to high intake of fibre. The Panel concludes that the NF, that is composed of >= 57% GOS dry matter, lactose and related saccharides, is safe under the proposed extension of use. (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

Published
2021
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23. Safety of pasteurised Akkermansia muciniphila as a novel food pursuant to Regulation (EU) 2015/2283

Author

EFSA Panel on Nutrition, Novel Foods, Food Allergens (NDA), Turck D., Bohn T., Castenmiller J., De Henauw S., Hirsch-Ernst K.I., Maciuk A., Mangelsdorf I., McArdle H.J., Naska A., Pelaez C., Pentieva K., Siani A., Thies F., Tsabouri S., Vinceti M., Cubadda F., Frenzel T., Heinonen M., Marchelli R., Neuhauser-Berthold M., Poulsen M., Prieto Maradona M., Schlatter J.R., van Loveren H., Ackerl R., and Knutsen H.K.

Subjects
Agriculture and Food Sciences, safety, Veterinary (miscellaneous), MUCIN, Novel food, TP1-1185, Akkermansia muciniphila, food supplement, gut microbiota, novel food, Plant Science, Gut flora, Microbiology, COLONIZATION, 03 medical and health sciences, 0302 clinical medicine, TX341-641, Food science, 030304 developmental biology, 0303 health sciences, biology, Nutrition. Foods and food supply, Chemical technology, biology.organism_classification, 3. Good health, Food supplement, BACTERIA, Animal Science and Zoology, Parasitology, 030217 neurology & neurosurgery, Food Science
Abstract

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on pasteurised Akkermansia muciniphila as a novel food (NF) pursuant to Regulation (EU) 2015/2283. A. muciniphila is a well-characterised non-toxin producing, avirulent microorganism that has been reported as part of normal gut microbiota. The NF, pasteurised A. muciniphila, is proposed by the applicant to be used as a food supplement at max. 5 x 10(10) cells/day by adults excluding pregnant and lactating women, and in foods for special medical purposes. The Panel considers that the production process of the NF is sufficiently described and that the information provided on the composition of the NF is sufficient for its characterisation. Taking into account the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. Based on literature data, and by applying an uncertainty factor of 200 to the no observed adverse effect level (NOAEL) of a 90-day repeated dose oral toxicity study in rats, the Panel concludes that the consumption of 3.4 x 10(10) cells/day is safe for the target population under the provision that the number of viable cells in the NF is < 10 colony forming units (CFU)/g (i.e. limit of detection). (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

Published
2021
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24. Safety of mung bean protein as a novel food pursuant to Regulation (EU) 2015/2283

Author

EFSA Panel on Nutrition, Novel Foods, Food Allergens (NDA), Turck D., Bohn T., Castenmiller J., De Henauw S., Hirsch-Ernst K.I., Maciuk A., Mangelsdorf I., McArdle H.J., Naska A., Pelaez C., Pentieva K., Siani A., Thies F., Tsabouri S., Vinceti M., Cubadda F., Frenzel T., Heinonen M., Maradona M.P., Marchelli R., Neuhauser-Berthold M., Poulsen M., Schlatter J.R., van Loveren H., Fernandez A., and Knutsen H.K.

Subjects
mung bean protein, novel foods, safety, Vigna radiata, ALLERGENS, 030309 nutrition & dietetics, Veterinary (miscellaneous), Novel food, Nutri1010, TP1-1185, Plant Science, DIGESTIBILITY, Biology, Microbiology, 03 medical and health sciences, 0404 agricultural biotechnology, VIGNA-RADIATA, AMINO-ACID SCORES, Medicine and Health Sciences, TX341-641, Food science, 2. Zero hunger, 0303 health sciences, Mung bean, IDENTIFICATION, Nutrition. Foods and food supply, Chemical technology, food and beverages, 04 agricultural and veterinary sciences, mung been protein, 040401 food science, LEGUMES, Scientific Opinion, SPROUTS, Animal Science and Zoology, Parasitology, Food Science
Abstract

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on mung bean protein as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF, which is the subject of the application, is mung bean protein extracted from seeds of the plant Vigna radiata. The NF is proposed to be used as a food ingredient added to 'protein products, excluding products covered in category 1.8'. The target population is the general population. The maximum estimated intake of the NF is 758 and 260 mg/kg body weight (bw) per day in children and adults, respectively. The major constituents of this NF are protein (similar to 85%), fat (3-4%) and moisture (3-5.5%). The NF is rich in protein which is well digestible and provides sufficient amounts of most essential amino acids but only limited amounts of sulfu-rcontaining amino acids. The Panel notes that the cumulative exposure to the minerals analysed does not raise concern. The reported values for the levels of antinutritional factors in the NF are comparable to those in other foodstuffs. The Panel considers that taking into account the composition of the NF and the proposed conditions of use, consumption of the NF is not nutritionally disadvantageous. No toxicological studies with the NFs were provided by the applicant; however, the Panel considers that no toxicological studies are required on this NF. This NF has the potential capacity to sensitise individuals and to induce allergic reactions in individuals allergic to soybean, peanuts, lupin and to birch pollen. The Panel considers that the NF, i.e. mung bean protein, is safe at the proposed conditions of use. (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

Published
2021
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46. Abstracts of papers and posters Pharmacological Meeting

Author

Adan, Roger A. H., Peter, J., Burbach, H., Gispen, Willem -Hendrik, Bax, Willem A., Saxena, Pramod R., Beenen, O. H. M., Pfaffendorf, M., van Zwieten, P. A., Biewenga, G. Ph., Nicastia, A. J., Haenen, G. R. M. M., Bast, A., Bouwknecht, J. A., Molewijk, H. E., van der Poel, A. M., Mos, J., Olivier, B., Broersen, L. M., Heinsbroek, R. P. W., de Bruin, J. P. C., Brouwers, D. L., Nelissen-Vrancken, H. J. M. G., Smits, J. F. M., Bruning, T. A., Kemme, M. J. B., Chang, P. C., Muizert, Y., Buckley, Theresa L., Nijkamp, Frans P., Cappendijk, S. L. T., Duval, S. Y., De Vries, R., Dzoljic, M. R., Compaan, J. C., Groenink, L., van der Gugten, J., Cox, E. H., van Hemert, A. G. N., de Jong, E., Danhof, M., Crijns, F. R. L., Wolffenbuttel, B. H. R., van Essen, H., Boudier, H. A. J. Struijker, Dam, J. P. M., Doornekamp, F. N. G., Velema, E., Post, M. J., Borst, C., de Boer, J., Meurs, H., Bottone, A. E., Koopal, M., Visser, J. C., Zaagsma, J., de Lannoy, L. M., Danser, A. H. J., Bouhuizen, A. M. B., Schoemaker, R. G., Saxena, P. R., Schalekamp, M. A. D. H., de Vlieger, J. F., van den Wijngaard, P., Koster, A. Sj., Buckley, T. L., Wilting, J., van Heuven-Nolsen, D., Nijkamp, F., Du, X. Y., Bos, E., Dubois, E. A., Vermeulen, R. J., Janssen, A. F. M., van Royen, E. A., Gaillard, P. J., de Boer, A. G., Breimer, D. D., Garrelds, I. M., de Graaf-in't Veld, C., van Wijk, R. Gerth, Zijlstra, F. J., Gerrits, Mirjam A. F. M., Patkina, Nadezda, Zvartau, Edwin E., van Ree, Jan M., Gho, B. C. G., Verdouw, P. D., Gingras, M. A., Cools, A. R., Gommans, J., Hijzen, T., Maes, R. A., Verdouw, P. M., Herremans, A. H. J., Hijzen, T. H., Slangen, J. L., Hoiting, B. H., Schuiling, M., Elzinga, C. R. S., Hoogstraate, A. J., Verhoef, J., Schrijvers, A. H. G. J., Pijpers, A., van Leengoed, L. A. M. G., Verheijden, J. H. M., Junginger, H. E., Boddé, H. E., Hüsken, B. C. P., Joordens, R. J. E., Kalkman, E. A. J., Bilgin, M. Y., Kam, K. L., Kraneveld, A. D., Muis, T., Nijkamp, F. P., Madretsma, G. S., van Dijk, A. P. M., Wilson, J. H. P., Mohede, C. M., Van Oosterhout, J. M., Niikamp, F. P., Nestby, P., Visser, D., Wardeh, G., Hogenboom, F., Mulder, A. H., Schoffelmeer, A. N. M., Oosting, J., Struijker Boudier, H. A. J., Janssen, B. J. A., Passier, P. C. J. J., Verluyten, M. J. A., Drexler, H., Daemen, M. J. A. P., Hashjin, Gudarz Sadeghi, Henricks, Paul A. J., Folkerts, Gert, Shirmohammadi, Mahnaz, Niikamp, Frans P., Santing, R. E., Olymulder, C. G., van der Molen, K., Scheerens, Heleen, Van Loveren, Henk, Sipma, H., den Hertog, A., Nelemans, A., Smit, J., Coppes, R. P., Tintelen, E. J. J. v., Roffel, A. F., Smit, M. J., Leurs, Rob, Timmerman, H., Stam, W. B., Avezaat, C. J. J., Stolte, J., Schiffers, P. M. H., Boudier, H. A. J. Struyker, ten Berge, R. E. J., Krikke, M., Teisman, B. C. H., Tjon, G. H. K., Michiels, N., Voorn, P., van Bergen, P., De Wildt, D. J., Versteeg, D. H. G., van den Tweel, M. C., Bloemen, P. G. M., Henricks, P. A. J., Engels, F., Blomjous, F. J., van der Geest, R., van Laar, T., Roos, R. A. C., van de Velde, M. J., van Kats, J. P., Sassen, L. M. A., Polak, M. P. J., Derkx, F. H. M., van Kesteren, C. A. M., Lamers, J. M. J., van Heugten, H. A. A., van Meeteren, N. L. U., Frankhuyzen-Sierevogel, A., Brakkee, J. H., Wiegant, V. M., Gispen, W. H., Vroom, M. B., van Wezel, H. B., Timmenga, E. J. F., van der Horst, C. M. A. M., Winkler Prins, E. A., Zwavelina, J., Maas, A., Zhang, J., Zwaveling, J., Jansen, F. P., Mochizuki, T., Yamatodani, A., Masereeuw, R., Moons, W. M., Russel, F. G. M., van de Meent, H., van den Berg, C., Wemer, J., Vleeming, W., Kasbergen, C. M., van der Aa, E. M., Wouterse, A. C., Peereboom-Stegeman, J. H. J. Copius, Hessel, E. M., Van Oosterhout, A. J. M., de Bie, J. J., Hofman, G., and Van Loveren, H.

Published
1994
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47. Abstracts of papers and posters

Author

Anthonio, R. L., Willemsen, A. T. M., Visser, T., van Waarde, A., Elzinga, P., Weemaes, A., Meeder, J. G., Pruim, J., Visser, G., Blanksma, P. K., Vaalburg, W., Bloemen, P. G. M., Henricks, P. A. J., van Bloois, L., van den Tweel, M. C., Nijkamp, F. P., Crommelin, D. J. A., Storm, G., de Boer, A. H., Winter, H. M. I., Lerk, C. F., de Boer, J., Meurs, H., Bottone, A. E., Koopal, M., Visser, J. C., Zaagsma, J., Borger P., Kauffman H. F., Vijgen J. L. J., Postma D. S., Vellenga E., Buckley, Theresa L., Buikema, H., van Gilst, W. H., van Veldhuisen, D. J., de Smet, B. J. G. L., Scholtens, E., Lie, K. I., Wesseling, H., Cheung, P. K., Dijkhuis, F. W. D., Bakker, W. W., Visser, J., Coopes, R. P., Benthem, L., van der Leest, J., Roffel, A. F., Coppes, R. P., Zeilstra, L. J. W., Vissink, A., Konings, A. W. T., Dijkstra, M., Veld, G. In't, Müller, M., van den Berg, G. J., Kuipers, F., Vonk, R. J., Elsinga, P. H., Franssen, E. J. F., van der Graaf, W. T. A., de Vries, E. G. E., Visser, G. M., Vos, M. G., Braker, A. H., Visser, T. J., Visser, G. M., Engels, F., van Houwelingen, A. H., van de Velde, M. J., Gansevoort, R. T., Sluiter, W. J., Hemmelder, M. H., de Zeeuw, D., de Jong, P. E., Gelissen, H. P. M. M., Henning, R. H., Epema, A. H., van Eekeren, J., Hennis, P. J., Den Hertog, A., de Graaf, S. S. N., Kellie, S. J., Bloemhof, H., Johnston, I., Besser, M., Chaseling, R. W., Ouvrier, R. A., Uqes, D. R. A., De Haan, A., Geerligs, H. J., Huchshorn, J. P., Van Scharenburg, G. J. M., Wilschut, J., Haas, M., Kluppel, C. A., Meijer, D. K. F., Moolenaar, F., Heerdink, Eibert R., Leufkens, Hubert G., Herings, Ron M. C., Stricker, Bruno H. Ch., Bakker, Albert, Heesen W. F., Beltman F. W., Smit A. J., May J. F., Meyboom-de Jong B., Duin, M., van den Akker, J., te Pas, M. F. W., van Popta, J. P., Nelemans, S. A., van der Linde, H. J., de Boer, A., Sturmans, F., Hessel, E. M., Van Oosterhout, A. J. M., Hofstra, C. L., Garssen, J., van Loveren, H., Savelkoul, H. F. J., Hoekstra, Y., Weersink, E. J. M., de Jong, J. W., van der Belt-Gritter, B., Jonkman, Lisa M., Kemner, Chantal, Koelega, Harry S., van Engeland, Herman, Verbaten, Marinus N., Kalivianakis, M., Zijlstra, I., Verkade, H. J., Elzinga, H., Stellaard, F., Kamps, J. A. A. M., Swart, P. J., Morselt, H., Scherphof, G. L., Kenemans, J. L., Lorist, M. M., Koopen, N. R., Kraneveld, A. D., Koster, A. Si., Kuipers, M. E., Groenink, M., Huisman, H., Schuitemaker, H., Lau, H. S., van den Broek, I. J. P. M., van Dijk, A., Oostinga, J., Porsius, A. J., Lin, Y., Havinga, R., Meijer, R. J., van der Mark, Th. W., Koëter, G. H., Michels, A. A., Nguyen, V. -T., Bensaude, O., Kampinga, H. H., Mohede, Inge C. M., Van Antoon J. M., Molema, Grietje, Edgington, Thomas S., Thorpe, Philip E., Olinga, P., Sandker, G. W., Slooff, M. J. H., Merema, M. T., Groothuis, G. M. M., Hofman, G., Van Ark, I., Paulussen, J. J. C., Fischer, M. J. E., de Mol, N. J., Janssen, L. H. M., Peters, E. Th. J., van der Werf, G. Th., Haaijer-Ruskamp, F. M., Pinto, Yigal M., Rooks, Gerrit, Grandjean, Jean G., Ebels, Tjark, Schunkert, H., Redegeld, Frank A., Garssen, Johan, van Loveren, Henk, Rigter, Irma M., van Groningen, Muck, Boks, Gertjan J., Tollenaere, Jan P., Trollope, Keith I., Vinter, Jeremy G., Hashjin, Gudarz Sadeghi, Folkerts, Gert, van de Loo, Peet G. F., Santing, R. E., Olymulder, C. G., van der Molen, K., Pasman, Y., Scheerens, Heleen, Van Loveren, Henk, Seppenwoolde-Waasdorp, T. J. A., de Boer, P., Van Engelen, H. M. J., Thijssen, J. H. H., Maes, R. A. A., Smit, J., Smit, J. W., Steen, H., Steurs, M. H., Kuks, P. F. M., Leusink, J. A., Szabó, Balázs M., Crijns, Harry J. G. M., Wiesfeld, Ans C. P., Talsma, H., Borchert, J. C. H., van Steenbergen, M. J., Hennink, W. E., Teeuw, K. B., Cromheecke, H., Schreudering, A., Teisman, B. C. H., Maselbas, W., Wolters-Keulemans, G. T. P., Tieleman, R. G., de Langen, C. D. J., Bel, K., Crijns, H. J. G. M., Grandjean, J., Wijffels, M., Klimp, A. H., van de Meer, P. F., Allessie, M. A., van Patot, H. A. Tissot, de Jongh, B. M., Tuininga, Y. S., Brouwer, J., Haaksma, J., Man in't Veld, A. J., Blomjous, F. J., Vingerhoeds, M. H., Belliot, S. O., Haisma, H. J., Visscher, C. A., Huisman, R. M., Navis, G. J., de Vlieger, J. F., van den Wijngaard, P., Wilting, J., van Heuven-Nolsen, D., Voors, A. A., van Brussel, B. L., Plokker, H. W. M., Van Waardenburg R. C. A. M., Meijer, Prins J., De Vries, C., Mulder N. H., Wierenga, P. K., Wilschut J., Schoen P., and Bron R.

Published
1994
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48. Abstracts of papers Pharmacological Meeting

Author

Bax, W. A., Saxena, P. R., Biewenga, Gerreke Ph., de Jong, Jan, Bast, Aalt, Bloemen, Pauline G. M., van den Tweel, Maria C., Henricks, Paul A. J., Engels, Ferdi, Nijkamp, Frans P., Molewijk, H. E., van der Poel, A. M., Olivier, B., Briejer, M. R., Schuurkes, J. A. J., Akkermans, L. M. A., Bruning, T. A., Hendriks, M. G. C., Chang, P. C., Kuypers, E. A. P., van Zwieten, P. A., Cappendijk, S. L. T., de Vries, R., Dzoljic, M. R., Bouwknecht, J. A., Crijns, F. R. L., Huijberts, M. S. P., Boudier, H. A. J. Struijker, Kruzeman, A. C. Nieuwenhuijzen, Wolffenbuttel, B. H. R., de Lannov, L. M., Danser, A. H. J., Schoemakef, R. G., Schalekamp, M. A. D. H., Du, Xiao Y., Schoemaker, Regien G., Saxena, Pramod R., Dubois, E. A., Batink, H. D., Pfaffendorf, M., van Roven, E. A., Garrelds, I. M., de Graaf-in 't Veld, C., Ziilstra, F. J., Jansen, A. P. H., van Wijk, R. Gerth, Gho, B. C. G., Schoemaker, R. G., Lee, C. v. d., Sharma, H. S., Verdouw, P. D., Groenink, L., van der Gugten, J., Zethof, T. J. J., Hasselaar, P., Jansen, J. W. C. M., van Giezen, J. J. J., Dreteler, G. H., Hulkenberq, A., Reinders, J. H., Toorop, G. P., Herremans, A. H. J., Hijzen, T. H., Slangen, J. L., Hessel, E. M., Van Oosterhout, A. J. M., Hofstra, C., Garssen, J., van Loveren, H., Savelkoul, H. F. J., Nijkamp, F. P., Hol, Thorwald, Van Ree, Jan M., Spruijt, Berry M., Hüsken, B. C. P., van Zwieren, P. A., Kalkman, E. A. J., Kam, K. L., Keuzenkamp-Jansen, C. W., De Abreu, R. A., Bökkerink, J. P. M., vd Heijden, M. A. H., Trijbels, J. M. F., Kraneveld, A. D., Buckley, T. L., van Schaik, Y., Koster, A. Sj., Mathôt R. A. A., Van den Aarsen B. C. F. M., Langemeijer M. W. E., Ijzerman A. P., Danhof M., Mohede, Inqe C. M., van Oosterhout, Antoon J. M., Monshouwer, M., Witkamp, R. F., Nijmeijer, S. M., Van Miert, A. S. J. P. A. M., Oosting, J., Janssen, B. J. A., Pijl, A. J., van der Wal, A. C., Mathy, M. -J., Pruimboom, W. M., van Dijk, A. P. M., Tak, C. J. A. M., Bonta, I. L., Wilson, J. H. P., Bac, D. J., Zijlstra, F. J., Hashjin, G. Sadeghi, Folkerts, G., Henricks, P. A. J., Santing, R. E., Pasman, Y., Olymulder, C. G., Roffel, A. F., Zaaqsma, J., Meurs, H., Scheerens, Heleen, Buckley, Theresa L., Van Loveren, Henk, Sipma, H., Duin, M., den Hertog, A., Nelemans, A., Smit, J., Coppes, R. P., Geurtsen, A., Zaagsma, J., Smit, M. J., Leurs, R., Bast, A., Timmerman, H., Stassen, F. R. M., De Mey, J. G. R., ten Berge, R. E. J., Tjon, Guno H. K., De Vries, Taco J., Ronken, Eric, Hogenboom, François, Warden, George, Mulder, Arie H., Schoffelmeer, Anton N. M., Van Bergen, P., Kleline, J. A., Janssen, P. M. L., Van Der Vaart, J. G. M., Kasbergen, C. M., Versteeg, D. H. G., De Wildt, D. J., van de Velde, M. J., Engels, F., van den Berg, C., Vleeming, W., van Amsterdam, J. G. C., Werner, J., van der Zee, L., den Hertoe, A., van Gelderen, E. Marcel, Agteresch, Hendrik J., De Bruijne, Emile L. E., Saxena, Pramod R., van Kats, J. P., Sassen, L. M. A., Admiraal, P. J. J., Verdouw, P. P., van Muiswinkel, F. L., Steinhusch, H. W. M., Drukarch, B., Sloof, J. C., de Vente, J., Vanderschuren, L. J. M. J., Van Ree, J. M., Verkade P., Verkleij A. J., Gispen W. H., Oestreicher A. B., Vermeulen, R. J., Goosen, C., Wolters, E. Ch., Stoof, J. C., Vincent, V. A. M., Schoffelmeer, A. N. M., Steinbush, H. W. M., Berlcenbosch, F., Voss, Hans-Peter, Donnell, David, Wesselman, J. P. M., VanBavel, E., Spaan, J. A. E., Zeilmaker, W. M., van 't Klooster, G. A. E., Horbach, G. J. M. J., Zhang, J., Zhang, J. S., and van Meet, J. C. A.

Published
1993
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