Safety of the extension of use of 2’‐fucosyllactose/difucosyllactose (2’‐FL/DFL) mixture and lacto‐N‐tetraose (LNT) as novel foods in food supplements for infants 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 an opinion on the safety of the extensions of use of the authorised novel foods (NFs) 2’‐fucosyllactose/difucosyllactose (2’‐FL/DFL) mixture and lacto‐N‐t...
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2022-03-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2022.7140 |
| _version_ | 1797871473455529984 |
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| author | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) Dominique Turck Torsten Bohn Jacqueline Castenmiller Stefaan De Henauw Karen Ildico Hirsch‐Ernst Alexandre Maciuk Inge Mangelsdorf Harry J McArdle Androniki Naska Carmen Pelaez Kristina Pentieva Alfonso Siani Frank Thies Sophia Tsabouri Marco Vinceti Francesco Cubadda Thomas Frenzel Marina Heinonen Rosangela Marchelli Monika Neuhäuser‐Berthold Morten Poulsen Miguel Prieto Maradona Josef Rudolf Schlatter Henk van Loveren Paolo Colombo Estefanía Noriega Fernández Helle Katrine Knutsen |
| author_facet | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) Dominique Turck Torsten Bohn Jacqueline Castenmiller Stefaan De Henauw Karen Ildico Hirsch‐Ernst Alexandre Maciuk Inge Mangelsdorf Harry J McArdle Androniki Naska Carmen Pelaez Kristina Pentieva Alfonso Siani Frank Thies Sophia Tsabouri Marco Vinceti Francesco Cubadda Thomas Frenzel Marina Heinonen Rosangela Marchelli Monika Neuhäuser‐Berthold Morten Poulsen Miguel Prieto Maradona Josef Rudolf Schlatter Henk van Loveren Paolo Colombo Estefanía Noriega Fernández Helle Katrine Knutsen |
| author_sort | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) |
| collection | DOAJ |
| description | 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 the extensions of use of the authorised novel foods (NFs) 2’‐fucosyllactose/difucosyllactose (2’‐FL/DFL) mixture and lacto‐N‐tetraose (LNT) in food supplements (FS) for infants pursuant to Regulation (EU) 2015/2283. The NFs are produced by fermentation with genetically modified strains of Escherichia coli K‐12 DH1 and already included in the EU list of NF. The applicant stated that no changes in the production process or the identity of the NFs occurred. The applicant proposes an extension of use of the NF containing 2’‐FL/DFL mixture in FS intended for infants (< 1 year), at a maximum use level of 1.6 g/day for infants ≤ 6 months and up to 1.2 g/day for infants > 6 months. The applicant also proposes an extension of use of LNT in FS intended for infants (< 1 year), at a maximum use level of 0.8 g/day for infants ≤ 6 months and up to 0.6 g/day for infants > 6 months. The intake per kg body weight of 2’‐FL/DFL and LNT from the proposed maximum use levels of the respective NFs in FS for infants does not exceed the lowest estimated mean intake of naturally occurring 2’‐FL/DFL and it is similar to the highest estimated mean intake of LNT by breastfed infants. In addition, the Panel notes that the proposed uses of the NFs in FS for infants result in lower maximum daily intakes than those from the already authorised uses of the NFs for the same population group. The Panel concludes that the uses of the NFs containing either 2’‐FL/DFL or LNT in FS for infants are safe under the proposed conditions of use. |
| first_indexed | 2024-04-10T00:44:02Z |
| format | Article |
| id | doaj.art-7ab62da4867b4912b29137541b6d9e97 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-04-10T00:44:02Z |
| publishDate | 2022-03-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-7ab62da4867b4912b29137541b6d9e972023-03-14T04:16:02ZengWileyEFSA Journal1831-47322022-03-01203n/an/a10.2903/j.efsa.2022.7140Safety of the extension of use of 2’‐fucosyllactose/difucosyllactose (2’‐FL/DFL) mixture and lacto‐N‐tetraose (LNT) as novel foods in food supplements for infants pursuant to Regulation (EU) 2015/2283EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)Dominique TurckTorsten BohnJacqueline CastenmillerStefaan De HenauwKaren Ildico Hirsch‐ErnstAlexandre MaciukInge MangelsdorfHarry J McArdleAndroniki NaskaCarmen PelaezKristina PentievaAlfonso SianiFrank ThiesSophia TsabouriMarco VincetiFrancesco CubaddaThomas FrenzelMarina HeinonenRosangela MarchelliMonika Neuhäuser‐BertholdMorten PoulsenMiguel Prieto MaradonaJosef Rudolf SchlatterHenk van LoverenPaolo ColomboEstefanía Noriega FernándezHelle Katrine KnutsenAbstract 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 the extensions of use of the authorised novel foods (NFs) 2’‐fucosyllactose/difucosyllactose (2’‐FL/DFL) mixture and lacto‐N‐tetraose (LNT) in food supplements (FS) for infants pursuant to Regulation (EU) 2015/2283. The NFs are produced by fermentation with genetically modified strains of Escherichia coli K‐12 DH1 and already included in the EU list of NF. The applicant stated that no changes in the production process or the identity of the NFs occurred. The applicant proposes an extension of use of the NF containing 2’‐FL/DFL mixture in FS intended for infants (< 1 year), at a maximum use level of 1.6 g/day for infants ≤ 6 months and up to 1.2 g/day for infants > 6 months. The applicant also proposes an extension of use of LNT in FS intended for infants (< 1 year), at a maximum use level of 0.8 g/day for infants ≤ 6 months and up to 0.6 g/day for infants > 6 months. The intake per kg body weight of 2’‐FL/DFL and LNT from the proposed maximum use levels of the respective NFs in FS for infants does not exceed the lowest estimated mean intake of naturally occurring 2’‐FL/DFL and it is similar to the highest estimated mean intake of LNT by breastfed infants. In addition, the Panel notes that the proposed uses of the NFs in FS for infants result in lower maximum daily intakes than those from the already authorised uses of the NFs for the same population group. The Panel concludes that the uses of the NFs containing either 2’‐FL/DFL or LNT in FS for infants are safe under the proposed conditions of use.https://doi.org/10.2903/j.efsa.2022.71402’‐fucosyllactose/difucosyllactoselacto‐N‐tetraoseHiMONovel Foodsfood supplementextension of use |
| spellingShingle | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) Dominique Turck Torsten Bohn Jacqueline Castenmiller Stefaan De Henauw Karen Ildico Hirsch‐Ernst Alexandre Maciuk Inge Mangelsdorf Harry J McArdle Androniki Naska Carmen Pelaez Kristina Pentieva Alfonso Siani Frank Thies Sophia Tsabouri Marco Vinceti Francesco Cubadda Thomas Frenzel Marina Heinonen Rosangela Marchelli Monika Neuhäuser‐Berthold Morten Poulsen Miguel Prieto Maradona Josef Rudolf Schlatter Henk van Loveren Paolo Colombo Estefanía Noriega Fernández Helle Katrine Knutsen Safety of the extension of use of 2’‐fucosyllactose/difucosyllactose (2’‐FL/DFL) mixture and lacto‐N‐tetraose (LNT) as novel foods in food supplements for infants pursuant to Regulation (EU) 2015/2283 EFSA Journal 2’‐fucosyllactose/difucosyllactose lacto‐N‐tetraose HiMO Novel Foods food supplement extension of use |
| title | Safety of the extension of use of 2’‐fucosyllactose/difucosyllactose (2’‐FL/DFL) mixture and lacto‐N‐tetraose (LNT) as novel foods in food supplements for infants pursuant to Regulation (EU) 2015/2283 |
| title_full | Safety of the extension of use of 2’‐fucosyllactose/difucosyllactose (2’‐FL/DFL) mixture and lacto‐N‐tetraose (LNT) as novel foods in food supplements for infants pursuant to Regulation (EU) 2015/2283 |
| title_fullStr | Safety of the extension of use of 2’‐fucosyllactose/difucosyllactose (2’‐FL/DFL) mixture and lacto‐N‐tetraose (LNT) as novel foods in food supplements for infants pursuant to Regulation (EU) 2015/2283 |
| title_full_unstemmed | Safety of the extension of use of 2’‐fucosyllactose/difucosyllactose (2’‐FL/DFL) mixture and lacto‐N‐tetraose (LNT) as novel foods in food supplements for infants pursuant to Regulation (EU) 2015/2283 |
| title_short | Safety of the extension of use of 2’‐fucosyllactose/difucosyllactose (2’‐FL/DFL) mixture and lacto‐N‐tetraose (LNT) as novel foods in food supplements for infants pursuant to Regulation (EU) 2015/2283 |
| title_sort | safety of the extension of use of 2 fucosyllactose difucosyllactose 2 fl dfl mixture and lacto n tetraose lnt as novel foods in food supplements for infants pursuant to regulation eu 2015 2283 |
| topic | 2’‐fucosyllactose/difucosyllactose lacto‐N‐tetraose HiMO Novel Foods food supplement extension of use |
| url | https://doi.org/10.2903/j.efsa.2022.7140 |
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