Safety of a feed additive consisting of a dried aqueous ethanol extract from the leaves of Melissa officinalis L. for all animal species (Nor‐Feed SAS)

Abstract The additive under assessment is a dried aqueous ethanol extract of Melissa officinalis L. leaves, intended to be used as a sensory additive (flavouring compound) in feed for all animal species. The aqueous ethanol extract is specified to contain ≥ 10% of hydroxycinnamic acid derivatives in...

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Autores principales:	EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Mojca Fašmon Durjava, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa, Ruud Woutersen, Paul Brantom, Andrew Chesson, Johannes Westendorf, Paola Manini, Fabiola Pizzo, Birgit Dusemund
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	sensory additives flavouring compounds Melissa officinalis L. Melissa extract hydroxycinnamic acids rosmarinic acid Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185
Acceso en línea:	https://doaj.org/article/2057f62e4ffe4befb3502d5d2ab74f2e
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spelling	oai:doaj.org-article:2057f62e4ffe4befb3502d5d2ab74f2e2021-11-23T08:30:51ZSafety of a feed additive consisting of a dried aqueous ethanol extract from the leaves of Melissa officinalis L. for all animal species (Nor‐Feed SAS)1831-473210.2903/j.efsa.2021.6904https://doaj.org/article/2057f62e4ffe4befb3502d5d2ab74f2e2021-10-01T00:00:00Zhttps://doi.org/10.2903/j.efsa.2021.6904https://doaj.org/toc/1831-4732Abstract The additive under assessment is a dried aqueous ethanol extract of Melissa officinalis L. leaves, intended to be used as a sensory additive (flavouring compound) in feed for all animal species. The aqueous ethanol extract is specified to contain ≥ 10% of hydroxycinnamic acid derivatives including ≥ 3% of rosmarinic acid. In a previous assessment, considering the contradictory data from the Ames tests and uncertainty about the qualitative and quantitative presence of flavonoids and other compounds in the extract from M. officinalis L. leaves, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of the additive at the proposed use levels of up to 100 mg/kg complete feed for the target species, the consumer and the user. The new data submitted identified luteolin 3′‐glucuronide as the only flavonoid present in the additive, improved the characterisation of the hydroxycinnamates present and demonstrated that the additive is not genotoxic. The FEEDAP Panel concludes that the additive under assessment is safe up to the maximum proposed use level of 100 mg/kg complete feed for all animal species. The use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No safety concern would arise for the consumer from the use of the additive up to the highest safe level in animal nutrition. The exposure of users to dusts from the additive is not of concern. No data are provided on irritant properties for eyes or skin, thus no conclusion can be drawn on these aspects. Due to the nature of the additive, it may be assumed to be potentially both a skin and respiratory sensitiser.EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Vasileios BampidisGiovanna AzimontiMaria de Lourdes BastosHenrik ChristensenMojca Fašmon DurjavaMaryline KoubaMarta López‐AlonsoSecundino López PuenteFrancesca MarconBaltasar MayoAlena PechováMariana PetkovaFernando RamosYolanda SanzRoberto Edoardo VillaRuud WoutersenPaul BrantomAndrew ChessonJohannes WestendorfPaola ManiniFabiola PizzoBirgit DusemundWileyarticlesensory additivesflavouring compoundsMelissa officinalis L.Melissa extracthydroxycinnamic acidsrosmarinic acidNutrition. Foods and food supplyTX341-641Chemical technologyTP1-1185ENEFSA Journal, Vol 19, Iss 10, Pp n/a-n/a (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	sensory additives flavouring compounds Melissa officinalis L. Melissa extract hydroxycinnamic acids rosmarinic acid Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185
spellingShingle	sensory additives flavouring compounds Melissa officinalis L. Melissa extract hydroxycinnamic acids rosmarinic acid Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185 EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Mojca Fašmon Durjava Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Paul Brantom Andrew Chesson Johannes Westendorf Paola Manini Fabiola Pizzo Birgit Dusemund Safety of a feed additive consisting of a dried aqueous ethanol extract from the leaves of Melissa officinalis L. for all animal species (Nor‐Feed SAS)
description	Abstract The additive under assessment is a dried aqueous ethanol extract of Melissa officinalis L. leaves, intended to be used as a sensory additive (flavouring compound) in feed for all animal species. The aqueous ethanol extract is specified to contain ≥ 10% of hydroxycinnamic acid derivatives including ≥ 3% of rosmarinic acid. In a previous assessment, considering the contradictory data from the Ames tests and uncertainty about the qualitative and quantitative presence of flavonoids and other compounds in the extract from M. officinalis L. leaves, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of the additive at the proposed use levels of up to 100 mg/kg complete feed for the target species, the consumer and the user. The new data submitted identified luteolin 3′‐glucuronide as the only flavonoid present in the additive, improved the characterisation of the hydroxycinnamates present and demonstrated that the additive is not genotoxic. The FEEDAP Panel concludes that the additive under assessment is safe up to the maximum proposed use level of 100 mg/kg complete feed for all animal species. The use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No safety concern would arise for the consumer from the use of the additive up to the highest safe level in animal nutrition. The exposure of users to dusts from the additive is not of concern. No data are provided on irritant properties for eyes or skin, thus no conclusion can be drawn on these aspects. Due to the nature of the additive, it may be assumed to be potentially both a skin and respiratory sensitiser.
format	article
author	EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Mojca Fašmon Durjava Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Paul Brantom Andrew Chesson Johannes Westendorf Paola Manini Fabiola Pizzo Birgit Dusemund
author_facet	EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Mojca Fašmon Durjava Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Paul Brantom Andrew Chesson Johannes Westendorf Paola Manini Fabiola Pizzo Birgit Dusemund
author_sort	EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
title	Safety of a feed additive consisting of a dried aqueous ethanol extract from the leaves of Melissa officinalis L. for all animal species (Nor‐Feed SAS)
title_short	Safety of a feed additive consisting of a dried aqueous ethanol extract from the leaves of Melissa officinalis L. for all animal species (Nor‐Feed SAS)
title_full	Safety of a feed additive consisting of a dried aqueous ethanol extract from the leaves of Melissa officinalis L. for all animal species (Nor‐Feed SAS)
title_fullStr	Safety of a feed additive consisting of a dried aqueous ethanol extract from the leaves of Melissa officinalis L. for all animal species (Nor‐Feed SAS)
title_full_unstemmed	Safety of a feed additive consisting of a dried aqueous ethanol extract from the leaves of Melissa officinalis L. for all animal species (Nor‐Feed SAS)
title_sort	safety of a feed additive consisting of a dried aqueous ethanol extract from the leaves of melissa officinalis l. for all animal species (nor‐feed sas)
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/2057f62e4ffe4befb3502d5d2ab74f2e
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Safety of a feed additive consisting of a dried aqueous ethanol extract from the leaves of Melissa officinalis L. for all animal species (Nor‐Feed SAS)

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