Safety of ashitaba sap 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 an opinion on ashitaba sap as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Ashitaba sap is collected from harvested stems of Angelica keiskei...
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Wiley
2024-03-01
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| Series: | EFSA Journal |
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| Online Access: | https://doi.org/10.2903/j.efsa.2024.8645 |
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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 Kristina Pentieva Alfonso Siani Frank Thies Sophia Tsabouri Marco Vinceti Margarita Aguilera‐Gómez Francesco Cubadda Thomas Frenzel Marina Heinonen Miguel Prieto Maradona Monika Neuhäuser‐Berthold Morten Poulsen Josef Rudolf Schlatter Alexandros Siskos Henk vanLoveren Maria Glymenaki Eirini Kouloura 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 Kristina Pentieva Alfonso Siani Frank Thies Sophia Tsabouri Marco Vinceti Margarita Aguilera‐Gómez Francesco Cubadda Thomas Frenzel Marina Heinonen Miguel Prieto Maradona Monika Neuhäuser‐Berthold Morten Poulsen Josef Rudolf Schlatter Alexandros Siskos Henk vanLoveren Maria Glymenaki Eirini Kouloura 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 ashitaba sap as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Ashitaba sap is collected from harvested stems of Angelica keiskei plants. The principal constituents of the sap with regard to the safety assessment are chalcones (1%–2.25%) and furanocoumarins (< 0.01%). The applicant proposed to use the NF in food supplements at a maximum dose of 780 mg per day. The target population is adults excluding pregnant and lactating women. Taking into consideration the composition of the NF and the proposed uses, the composition of the NF is not nutritionally disadvantageous. There are no concerns regarding genotoxicity of the NF. Based on a 90‐day oral toxicity study performed with the product as intended to be placed on the market (30% ashitaba sap powder and 70% cyclodextrins), the Panel establishes a safe dose of 0.5 mg/kg body weight (bw) per day for the product as it is intended to be placed on the market. For the target population, i.e. adults, this safe dose corresponds to 35 mg per day of the product as it is intended to be placed on the market and 137 mg per day of the NF, which is lower than the use level proposed by the applicant. The Panel concludes that the NF is safe for the target population at intake levels up to 137 mg per day. |
| format | Article |
| id | doaj-art-24abb373771a4949b3bd10fa7556bbdd |
| institution | DOAJ |
| issn | 1831-4732 |
| language | English |
| publishDate | 2024-03-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj-art-24abb373771a4949b3bd10fa7556bbdd2025-08-20T02:50:12ZengWileyEFSA Journal1831-47322024-03-01223n/an/a10.2903/j.efsa.2024.8645Safety of ashitaba sap as a Novel food 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 NaskaKristina PentievaAlfonso SianiFrank ThiesSophia TsabouriMarco VincetiMargarita Aguilera‐GómezFrancesco CubaddaThomas FrenzelMarina HeinonenMiguel Prieto MaradonaMonika Neuhäuser‐BertholdMorten PoulsenJosef Rudolf SchlatterAlexandros SiskosHenk vanLoverenMaria GlymenakiEirini KoulouraHelle 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 ashitaba sap as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Ashitaba sap is collected from harvested stems of Angelica keiskei plants. The principal constituents of the sap with regard to the safety assessment are chalcones (1%–2.25%) and furanocoumarins (< 0.01%). The applicant proposed to use the NF in food supplements at a maximum dose of 780 mg per day. The target population is adults excluding pregnant and lactating women. Taking into consideration the composition of the NF and the proposed uses, the composition of the NF is not nutritionally disadvantageous. There are no concerns regarding genotoxicity of the NF. Based on a 90‐day oral toxicity study performed with the product as intended to be placed on the market (30% ashitaba sap powder and 70% cyclodextrins), the Panel establishes a safe dose of 0.5 mg/kg body weight (bw) per day for the product as it is intended to be placed on the market. For the target population, i.e. adults, this safe dose corresponds to 35 mg per day of the product as it is intended to be placed on the market and 137 mg per day of the NF, which is lower than the use level proposed by the applicant. The Panel concludes that the NF is safe for the target population at intake levels up to 137 mg per day.https://doi.org/10.2903/j.efsa.2024.8645Angelica keiskeiashitabafood supplementnovel foodssafety |
| 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 Kristina Pentieva Alfonso Siani Frank Thies Sophia Tsabouri Marco Vinceti Margarita Aguilera‐Gómez Francesco Cubadda Thomas Frenzel Marina Heinonen Miguel Prieto Maradona Monika Neuhäuser‐Berthold Morten Poulsen Josef Rudolf Schlatter Alexandros Siskos Henk vanLoveren Maria Glymenaki Eirini Kouloura Helle Katrine Knutsen Safety of ashitaba sap as a Novel food pursuant to Regulation (EU) 2015/2283 EFSA Journal Angelica keiskei ashitaba food supplement novel foods safety |
| title | Safety of ashitaba sap as a Novel food pursuant to Regulation (EU) 2015/2283 |
| title_full | Safety of ashitaba sap as a Novel food pursuant to Regulation (EU) 2015/2283 |
| title_fullStr | Safety of ashitaba sap as a Novel food pursuant to Regulation (EU) 2015/2283 |
| title_full_unstemmed | Safety of ashitaba sap as a Novel food pursuant to Regulation (EU) 2015/2283 |
| title_short | Safety of ashitaba sap as a Novel food pursuant to Regulation (EU) 2015/2283 |
| title_sort | safety of ashitaba sap as a novel food pursuant to regulation eu 2015 2283 |
| topic | Angelica keiskei ashitaba food supplement novel foods safety |
| url | https://doi.org/10.2903/j.efsa.2024.8645 |
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