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      Safety of an extension of use of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283

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          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 safety of an extension of use for Yarrowia lipolytica yeast biomass as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The extension of use pertains to the use of the NF as a food ingredient in single meal replacement products for weight reduction for adults at a maximum amount of 6 g NF per day, which is the same amount of NF as already authorised in food supplements for this population group. According to the applicant, food supplements with Yarrowia lipolytica biomass (as already authorised) should not be consumed concomitantly with the meal replacement products in order not to exceed the 6 g NF per day. The Panel considers that the consumption of the NF is not nutritionally disadvantageous under the proposed conditions of use. The Panel concludes that the NF, Yarrowia lipolytica yeast biomass, is safe under the proposed conditions of use.

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          Guidance on the preparation and presentation of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283

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            • Record: found
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            Is Open Access

            Safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation ( EU ) 2015/2283

            Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on Yarrowia lipolytica yeast biomass as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is the dried and heat‐killed biomass of Yarrowia lipolytica, a yeast species that is widespread in nature and which can be found in the environment as well as in foods. The production process is sufficiently described and does not raise safety concerns. The information provided on the composition of the NF is sufficient and does not raise safety concerns. The applicant proposed to use the NF as a food supplement in the form of capsules, tablets or powder. The target population for the NF is the general population above 3 years of age. The maximum proposed daily use levels are 3 g/day for children from 3 years to less than 10 years of age and 6 g/day thereafter. Taking into account the composition of the NF and the proposed use levels, the consumption of the NF is not nutritionally disadvantageous. No relevant toxicological information was provided. The Panel considers that given the qualified presumption of safety (QPS) status for production purposes of Yarrowia lipolytica and the fact that the production process of the NF does not raise safety concerns, no toxicological studies are needed for the safety assessment of the NF. The Panel concludes that the NF, Yarrowia lipolytica yeast biomass, is safe under the proposed conditions of use.
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              Author and article information

              Contributors
              nif@efsa.europa.eu
              Journal
              EFSA J
              EFSA J
              10.1002/(ISSN)1831-4732
              EFS2
              EFSA Journal
              John Wiley and Sons Inc. (Hoboken )
              1831-4732
              28 July 2022
              July 2022
              : 20
              : 7 ( doiID: 10.1002/efs2.v20.7 )
              : e07450
              Author notes
              [*] [* ] Correspondence: nif@ 123456efsa.europa.eu
              Article
              EFS27450
              10.2903/j.efsa.2022.7450
              9332108
              35910421
              7a05732d-328c-4f19-be81-17e9d9c2f5d4
              © 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.

              This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.

              History
              Page count
              Figures: 0, Tables: 1, Pages: 7, Words: 2082
              Categories
              Scientific Opinion
              Scientific Opinion
              Custom metadata
              2.0
              July 2022
              Converter:WILEY_ML3GV2_TO_JATSPMC version:6.1.7 mode:remove_FC converted:28.07.2022

              novel foods,yarrowia lipolytica,yeast,extension of use,single meal replacement,safety

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