Guidance on safety evaluation of sources of nutrients and bioavailability of nutrient from the sources
Abstract Whenever new substances are proposed for use as sources of nutrients in food supplements, foods for the general population or foods for specific groups, EFSA is requested by the European Commission to perform an assessment of their safety and of the bioavailability of the nutrient from the...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2018-06-01
|
| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2018.5294 |
| _version_ | 1819320128984055808 |
|---|---|
| author | EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) Maged Younes Peter Aggett Fernando Aguilar Riccardo Crebelli Birgit Dusemund Metka Filipicč Maria Jose Frutos Pierre Galtier Ursula Gundert‐Remy Gunter Georg Kuhnle Claude Lambré Jean‐Charles Leblanc Inger Therese Lillegaard Peter Moldeus Alicja Mortensen Agneta Oskarsson Ivan Stankovic Ine Waalkens‐Berendsen Rudolf Antonius Woutersen Matthew Wright Alessandro Di Domenico Susan Fairweather‐Tait Harry McArdle Camilla Smeraldi David Gott |
| author_facet | EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) Maged Younes Peter Aggett Fernando Aguilar Riccardo Crebelli Birgit Dusemund Metka Filipicč Maria Jose Frutos Pierre Galtier Ursula Gundert‐Remy Gunter Georg Kuhnle Claude Lambré Jean‐Charles Leblanc Inger Therese Lillegaard Peter Moldeus Alicja Mortensen Agneta Oskarsson Ivan Stankovic Ine Waalkens‐Berendsen Rudolf Antonius Woutersen Matthew Wright Alessandro Di Domenico Susan Fairweather‐Tait Harry McArdle Camilla Smeraldi David Gott |
| author_sort | EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) |
| collection | DOAJ |
| description | Abstract Whenever new substances are proposed for use as sources of nutrients in food supplements, foods for the general population or foods for specific groups, EFSA is requested by the European Commission to perform an assessment of their safety and of the bioavailability of the nutrient from the proposed source. This guidance describes the scientific data required to allow an evaluation of the safety of the source within the established framework for risk assessment of food additives and novel food ingredients and the bioavailability of the nutrient from this source. This document is arranged in five main sections: one on technical data aimed at characterising the proposed source and at identifying potential hazards resulting from its manufacture and stability in food; one on existing authorisations and evaluation, providing an overview of previous assessments on the proposed source and their conclusions; one on proposed uses and exposure assessment section, allowing an estimate of the dietary exposure to the source and the nutrient based on the proposed uses and use levels; one on toxicological data, describing approaches which can be used to identify (in conjunction with data on manufacture and composition) and to characterise hazards of the source and any relevant breakdown products; the final section on bioavailability focuses on determining the extent to which the nutrient from the proposed source is available for use by the body in comparison with one or more forms of the same nutrient that are already permitted for use on the positive lists. This guidance document should replace the previous guidance issued by the Scientific Committee for Food and published in 2001. |
| first_indexed | 2024-12-24T11:14:40Z |
| format | Article |
| id | doaj.art-0f13650d43414b6ab560ae0c746328a5 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-24T11:14:40Z |
| publishDate | 2018-06-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-0f13650d43414b6ab560ae0c746328a52022-12-21T16:58:26ZengWileyEFSA Journal1831-47322018-06-01166n/an/a10.2903/j.efsa.2018.5294Guidance on safety evaluation of sources of nutrients and bioavailability of nutrient from the sourcesEFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)Maged YounesPeter AggettFernando AguilarRiccardo CrebelliBirgit DusemundMetka FilipicčMaria Jose FrutosPierre GaltierUrsula Gundert‐RemyGunter Georg KuhnleClaude LambréJean‐Charles LeblancInger Therese LillegaardPeter MoldeusAlicja MortensenAgneta OskarssonIvan StankovicIne Waalkens‐BerendsenRudolf Antonius WoutersenMatthew WrightAlessandro Di DomenicoSusan Fairweather‐TaitHarry McArdleCamilla SmeraldiDavid GottAbstract Whenever new substances are proposed for use as sources of nutrients in food supplements, foods for the general population or foods for specific groups, EFSA is requested by the European Commission to perform an assessment of their safety and of the bioavailability of the nutrient from the proposed source. This guidance describes the scientific data required to allow an evaluation of the safety of the source within the established framework for risk assessment of food additives and novel food ingredients and the bioavailability of the nutrient from this source. This document is arranged in five main sections: one on technical data aimed at characterising the proposed source and at identifying potential hazards resulting from its manufacture and stability in food; one on existing authorisations and evaluation, providing an overview of previous assessments on the proposed source and their conclusions; one on proposed uses and exposure assessment section, allowing an estimate of the dietary exposure to the source and the nutrient based on the proposed uses and use levels; one on toxicological data, describing approaches which can be used to identify (in conjunction with data on manufacture and composition) and to characterise hazards of the source and any relevant breakdown products; the final section on bioavailability focuses on determining the extent to which the nutrient from the proposed source is available for use by the body in comparison with one or more forms of the same nutrient that are already permitted for use on the positive lists. This guidance document should replace the previous guidance issued by the Scientific Committee for Food and published in 2001.https://doi.org/10.2903/j.efsa.2018.5294EFSA Panel guidancenutrient sourcesnutrientsvitaminsmineralsbioavailability |
| spellingShingle | EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) Maged Younes Peter Aggett Fernando Aguilar Riccardo Crebelli Birgit Dusemund Metka Filipicč Maria Jose Frutos Pierre Galtier Ursula Gundert‐Remy Gunter Georg Kuhnle Claude Lambré Jean‐Charles Leblanc Inger Therese Lillegaard Peter Moldeus Alicja Mortensen Agneta Oskarsson Ivan Stankovic Ine Waalkens‐Berendsen Rudolf Antonius Woutersen Matthew Wright Alessandro Di Domenico Susan Fairweather‐Tait Harry McArdle Camilla Smeraldi David Gott Guidance on safety evaluation of sources of nutrients and bioavailability of nutrient from the sources EFSA Journal EFSA Panel guidance nutrient sources nutrients vitamins minerals bioavailability |
| title | Guidance on safety evaluation of sources of nutrients and bioavailability of nutrient from the sources |
| title_full | Guidance on safety evaluation of sources of nutrients and bioavailability of nutrient from the sources |
| title_fullStr | Guidance on safety evaluation of sources of nutrients and bioavailability of nutrient from the sources |
| title_full_unstemmed | Guidance on safety evaluation of sources of nutrients and bioavailability of nutrient from the sources |
| title_short | Guidance on safety evaluation of sources of nutrients and bioavailability of nutrient from the sources |
| title_sort | guidance on safety evaluation of sources of nutrients and bioavailability of nutrient from the sources |
| topic | EFSA Panel guidance nutrient sources nutrients vitamins minerals bioavailability |
| url | https://doi.org/10.2903/j.efsa.2018.5294 |
| work_keys_str_mv | AT efsapanelonfoodadditivesandnutrientsourcesaddedtofoodans guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources AT magedyounes guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources AT peteraggett guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources AT fernandoaguilar guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources AT riccardocrebelli guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources AT birgitdusemund guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources AT metkafilipicc guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources AT mariajosefrutos guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources AT pierregaltier guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources AT ursulagundertremy guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources AT guntergeorgkuhnle guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources AT claudelambre guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources AT jeancharlesleblanc guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources AT ingerthereselillegaard guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources AT petermoldeus guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources AT alicjamortensen guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources AT agnetaoskarsson guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources AT ivanstankovic guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources AT inewaalkensberendsen guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources AT rudolfantoniuswoutersen guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources AT matthewwright guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources AT alessandrodidomenico guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources AT susanfairweathertait guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources AT harrymcardle guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources AT camillasmeraldi guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources AT davidgott guidanceonsafetyevaluationofsourcesofnutrientsandbioavailabilityofnutrientfromthesources |