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Safety and efficacy of a dried aqueous ethanol extract of Melissa officinalis L. leaves when used as a sensory additive for all animal species
Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a dried aqueous ethanol extract of Melissa officinalis L. leaves when used as a sensory feed additi...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7448011/ https://www.ncbi.nlm.nih.gov/pubmed/32874225 http://dx.doi.org/10.2903/j.efsa.2020.6016 |
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author | Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Kouba, Maryline Kos Durjava, Mojca López‐Alonso, Marta López Puente, Secundino Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Sanz, Yolanda Villa, Roberto Edoardo Woutersen, Ruud Brantom, Paul Chesson, Andrew Westendorf, Johannes Gregoretti, Lucilla Manini, Paola Dusemund, Birgit |
author_facet | Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Kouba, Maryline Kos Durjava, Mojca López‐Alonso, Marta López Puente, Secundino Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Sanz, Yolanda Villa, Roberto Edoardo Woutersen, Ruud Brantom, Paul Chesson, Andrew Westendorf, Johannes Gregoretti, Lucilla Manini, Paola Dusemund, Birgit |
collection | PubMed |
description | Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a dried aqueous ethanol extract of Melissa officinalis L. leaves when used as a sensory feed additive for all animal species. The aqueous ethanol extract is specified to contain ≥ 10% of hydroxycinnamic acid derivatives including ≥ 3% of rosmarinic acid. 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 FEEDAP Panel could not conclude on the genotoxicity of the additive under assessment. Although the identified components of the extract do not raise concerns for the safety of target species, the analysis of the extract is incomplete. In the absence of adequate analytical and safety data, the FEEDAP Panel is unable to conclude on the safety of the additive for the target species. The use of M. officinalis L. leaf dried extract in animal feed at the proposed use level does not raise significantly the exposure levels of the consumer for compounds derived from this plant. However, in the absence of adequate data on genotoxicity, the Panel cannot conclude on the safety for the consumer. In the absence of specific studies, the FEEDAP Panel cannot conclude on the safety of the additive for the user. M. officinalis L. is a native species to Europe and its use in animal nutrition is not expected to pose a risk for the environment. Since M. officinalis L. and its extracts are recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary for the extract. |
format | Online Article Text |
id | pubmed-7448011 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-74480112020-08-31 Safety and efficacy of a dried aqueous ethanol extract of Melissa officinalis L. leaves when used as a sensory additive for all animal species Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Kouba, Maryline Kos Durjava, Mojca López‐Alonso, Marta López Puente, Secundino Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Sanz, Yolanda Villa, Roberto Edoardo Woutersen, Ruud Brantom, Paul Chesson, Andrew Westendorf, Johannes Gregoretti, Lucilla Manini, Paola Dusemund, Birgit EFSA J Scientific Opinion Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a dried aqueous ethanol extract of Melissa officinalis L. leaves when used as a sensory feed additive for all animal species. The aqueous ethanol extract is specified to contain ≥ 10% of hydroxycinnamic acid derivatives including ≥ 3% of rosmarinic acid. 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 FEEDAP Panel could not conclude on the genotoxicity of the additive under assessment. Although the identified components of the extract do not raise concerns for the safety of target species, the analysis of the extract is incomplete. In the absence of adequate analytical and safety data, the FEEDAP Panel is unable to conclude on the safety of the additive for the target species. The use of M. officinalis L. leaf dried extract in animal feed at the proposed use level does not raise significantly the exposure levels of the consumer for compounds derived from this plant. However, in the absence of adequate data on genotoxicity, the Panel cannot conclude on the safety for the consumer. In the absence of specific studies, the FEEDAP Panel cannot conclude on the safety of the additive for the user. M. officinalis L. is a native species to Europe and its use in animal nutrition is not expected to pose a risk for the environment. Since M. officinalis L. and its extracts are recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary for the extract. John Wiley and Sons Inc. 2020-02-19 /pmc/articles/PMC7448011/ /pubmed/32874225 http://dx.doi.org/10.2903/j.efsa.2020.6016 Text en © 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. |
spellingShingle | Scientific Opinion Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Kouba, Maryline Kos Durjava, Mojca López‐Alonso, Marta López Puente, Secundino Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Sanz, Yolanda Villa, Roberto Edoardo Woutersen, Ruud Brantom, Paul Chesson, Andrew Westendorf, Johannes Gregoretti, Lucilla Manini, Paola Dusemund, Birgit Safety and efficacy of a dried aqueous ethanol extract of Melissa officinalis L. leaves when used as a sensory additive for all animal species |
title | Safety and efficacy of a dried aqueous ethanol extract of Melissa officinalis L. leaves when used as a sensory additive for all animal species |
title_full | Safety and efficacy of a dried aqueous ethanol extract of Melissa officinalis L. leaves when used as a sensory additive for all animal species |
title_fullStr | Safety and efficacy of a dried aqueous ethanol extract of Melissa officinalis L. leaves when used as a sensory additive for all animal species |
title_full_unstemmed | Safety and efficacy of a dried aqueous ethanol extract of Melissa officinalis L. leaves when used as a sensory additive for all animal species |
title_short | Safety and efficacy of a dried aqueous ethanol extract of Melissa officinalis L. leaves when used as a sensory additive for all animal species |
title_sort | safety and efficacy of a dried aqueous ethanol extract of melissa officinalis l. leaves when used as a sensory additive for all animal species |
topic | Scientific Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7448011/ https://www.ncbi.nlm.nih.gov/pubmed/32874225 http://dx.doi.org/10.2903/j.efsa.2020.6016 |
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