The Panel notes that on the tocopherol and tocotrienol preparations no information has been provided by the petitioner on the following: • The chemical characterisation, properties and the manufacturing process of the beta-, gamma- and delta-tocopherol, alpha-, beta-, gamma-, delta- and desmethyl-tocotrienol sources. Inability to assess the safety of beta-, gamma- and delta- tocopherol and alpha-, beta-, gamma-, delta- and desmethyl-tocotrienol as sources of beta-, gamma- and deltatocopherol and alpha-, beta-, gamma-, delta- and desmethyl- tocotrienol in food supplements • The bioavailability of beta-, gamma- and delta-tocopherol, alpha-, beta-, gamma-, delta- and desmethyl–tocotrienol from the sources. • The toxicity of the beta-, gamma- and delta-tocopherol, alpha-, beta-, gamma-, delta-,and desmethyl-tocotrienol sources. In a previous opinion the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) evaluated the safety and bioavailability of mixed tocopherols, tocotrienol tocopherol and tocotrienols as a source for vitamin E when added for nutritional purposes in food supplements (EFSA, 2008). It was concluded that bioavailability studies indicate that mixed tocopherols and tocotrienols are bioavailable although tocotrienols are bioavailable with shorter plasma half-lives and probably different tissue distribution than alpha-tocopherol. The AFC Panel also concluded that the use of mixed tocopherols and tocotrienol tocopherol as a source of vitamin E in food supplements for the general population at the proposed levels of use is not of safety concern, but that the available data were insufficient to conclude on the safety of the proposed use and use levels of the tocotrienol preparation. Mixed tocopherols evaluated in this previous AFC opinion were obtained by vacuum steam distillation of edible vegetable oil products. The tocotrienol tocopherol preparation evaluated was prepared by distillation of rice bran oil distillate. The source for production of tocotrienols evaluated was palm oil. Rice bran oil and palm oil were listed by the petitioner as possible commercial sources of the tocopherol and tocotrienols. If the tocopherol and tocotrienol preparations of the present dossiers match the specifications of the tocopherol and tocotrienol sources evaluated in the AFC opinion the conclusions of the AFC opinion would apply. However, the Panel notes that the petitioner has insufficiently characterised the products and therefore has not demonstrated that the tocopherol and tocotrienol preparations are similar to those evaluated previously. The Panel notes that it was not possible to assess the bioavailability of the tocopherols and tocotrienols from the various uncharacterised sources since no data on the bioavailability of the tocopherols and tocotrienols from these sources were provided. The Panel notes that it was not possible to assess the safety of the tocopherols and tocotrienols from the various uncharacterised sources since no data on the safety of these sources were provided. The Panel concludes that due to the lack of adequate dossiers supporting the use of beta-, gamma- and delta-tocopherol, alpha-, beta-, gamma- , delta-, and desmethyl-tocotrienol in food supplements, the safety and bioavailability of beta-, gamma- and delta-tocopherol, alpha-, beta-, delta-, gamma- and desmethyl-tocotrienol cannot be assessed.

Inability to assess the safety of beta-, gamma- and delta- tocopherol and alpha-, beta-, gamma-, delta- and desmethyl-tocotrienol added for nutritional purposes as sources of beta-, gamma- and deltatocopherol and alpha-, beta-, gamma-, delta- and desmethyltocotrienol in food supplements and the bioavailability of beta-, gamma-, delta- tocopherol and alpha-, beta-, gamma-, delta- and desmethyl-tocotrienol from the different sources, based on the supporting dossiers

GRILLI, SANDRO;
2009

Abstract

The Panel notes that on the tocopherol and tocotrienol preparations no information has been provided by the petitioner on the following: • The chemical characterisation, properties and the manufacturing process of the beta-, gamma- and delta-tocopherol, alpha-, beta-, gamma-, delta- and desmethyl-tocotrienol sources. Inability to assess the safety of beta-, gamma- and delta- tocopherol and alpha-, beta-, gamma-, delta- and desmethyl-tocotrienol as sources of beta-, gamma- and deltatocopherol and alpha-, beta-, gamma-, delta- and desmethyl- tocotrienol in food supplements • The bioavailability of beta-, gamma- and delta-tocopherol, alpha-, beta-, gamma-, delta- and desmethyl–tocotrienol from the sources. • The toxicity of the beta-, gamma- and delta-tocopherol, alpha-, beta-, gamma-, delta-,and desmethyl-tocotrienol sources. In a previous opinion the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) evaluated the safety and bioavailability of mixed tocopherols, tocotrienol tocopherol and tocotrienols as a source for vitamin E when added for nutritional purposes in food supplements (EFSA, 2008). It was concluded that bioavailability studies indicate that mixed tocopherols and tocotrienols are bioavailable although tocotrienols are bioavailable with shorter plasma half-lives and probably different tissue distribution than alpha-tocopherol. The AFC Panel also concluded that the use of mixed tocopherols and tocotrienol tocopherol as a source of vitamin E in food supplements for the general population at the proposed levels of use is not of safety concern, but that the available data were insufficient to conclude on the safety of the proposed use and use levels of the tocotrienol preparation. Mixed tocopherols evaluated in this previous AFC opinion were obtained by vacuum steam distillation of edible vegetable oil products. The tocotrienol tocopherol preparation evaluated was prepared by distillation of rice bran oil distillate. The source for production of tocotrienols evaluated was palm oil. Rice bran oil and palm oil were listed by the petitioner as possible commercial sources of the tocopherol and tocotrienols. If the tocopherol and tocotrienol preparations of the present dossiers match the specifications of the tocopherol and tocotrienol sources evaluated in the AFC opinion the conclusions of the AFC opinion would apply. However, the Panel notes that the petitioner has insufficiently characterised the products and therefore has not demonstrated that the tocopherol and tocotrienol preparations are similar to those evaluated previously. The Panel notes that it was not possible to assess the bioavailability of the tocopherols and tocotrienols from the various uncharacterised sources since no data on the bioavailability of the tocopherols and tocotrienols from these sources were provided. The Panel notes that it was not possible to assess the safety of the tocopherols and tocotrienols from the various uncharacterised sources since no data on the safety of these sources were provided. The Panel concludes that due to the lack of adequate dossiers supporting the use of beta-, gamma- and delta-tocopherol, alpha-, beta-, gamma- , delta-, and desmethyl-tocotrienol in food supplements, the safety and bioavailability of beta-, gamma- and delta-tocopherol, alpha-, beta-, delta-, gamma- and desmethyl-tocotrienol cannot be assessed.
F. Aguilar; U.R. Charrondiere; B. Dusemund; P. Galtier; J. Gilbert; D.M. Gott; S. Grilli; R. Guertler; G.E.N. Kass; J. Koenig; C. Lambré; J-C. Larsen; J-C. Leblanc; A. Mortensen; D. Parent-Massin; I. Pratt; I.M.C.M. Rietjens; I. Stankovic; P. Tobback; T. Verguieva; R.A. Woutersen.
File in questo prodotto:
Eventuali allegati, non sono esposti

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11585/101819
 Attenzione

Attenzione! I dati visualizzati non sono stati sottoposti a validazione da parte dell'ateneo

Citazioni
  • ???jsp.display-item.citation.pmc??? ND
  • Scopus ND
  • ???jsp.display-item.citation.isi??? ND
social impact