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Re‐evaluation of glycerol esters of wood rosin (E 445) as a food additive

The present opinion deals with the re‐evaluation of glycerol esters of wood rosin (GEWR, E 445) when used as a food additive. Regarding GEWR originating from Pinus palustris (longleaf pine) and Pinus elliottii (slash pine), based on the overall toxicity database, and given the absence of reproductiv...

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Autores principales: Younes, Maged, Aggett, Peter, Aguilar, Fernando, Crebelli, Riccardo, Filipič, Metka, Frutos, Maria Jose, Galtier, Pierre, Gott, David, Gundert‐Remy, Ursula, Kuhnle, Gunter Georg, Lambré, Claude, Leblanc, Jean‐Charles, Lillegaard, Inger Therese, Moldeus, Peter, Mortensen, Alicja, Oskarsson, Agneta, Stankovic, Ivan, Waalkens‐Berendsen, Ine, Woutersen, Rudolf Antonius, Wright, Matthew, Briemer, Leon, Pasquale, Mosesso, Christodoulidou, Anna, Horvath, Zsuzsanna, Lodi, Federica, Tard, Alexandra, Dusemund, Birgit
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009419/
https://www.ncbi.nlm.nih.gov/pubmed/32625997
http://dx.doi.org/10.2903/j.efsa.2018.5370
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author Younes, Maged
Aggett, Peter
Aguilar, Fernando
Crebelli, Riccardo
Filipič, Metka
Frutos, Maria Jose
Galtier, Pierre
Gott, David
Gundert‐Remy, Ursula
Kuhnle, Gunter Georg
Lambré, Claude
Leblanc, Jean‐Charles
Lillegaard, Inger Therese
Moldeus, Peter
Mortensen, Alicja
Oskarsson, Agneta
Stankovic, Ivan
Waalkens‐Berendsen, Ine
Woutersen, Rudolf Antonius
Wright, Matthew
Briemer, Leon
Pasquale, Mosesso
Christodoulidou, Anna
Horvath, Zsuzsanna
Lodi, Federica
Tard, Alexandra
Dusemund, Birgit
author_facet Younes, Maged
Aggett, Peter
Aguilar, Fernando
Crebelli, Riccardo
Filipič, Metka
Frutos, Maria Jose
Galtier, Pierre
Gott, David
Gundert‐Remy, Ursula
Kuhnle, Gunter Georg
Lambré, Claude
Leblanc, Jean‐Charles
Lillegaard, Inger Therese
Moldeus, Peter
Mortensen, Alicja
Oskarsson, Agneta
Stankovic, Ivan
Waalkens‐Berendsen, Ine
Woutersen, Rudolf Antonius
Wright, Matthew
Briemer, Leon
Pasquale, Mosesso
Christodoulidou, Anna
Horvath, Zsuzsanna
Lodi, Federica
Tard, Alexandra
Dusemund, Birgit
collection PubMed
description The present opinion deals with the re‐evaluation of glycerol esters of wood rosin (GEWR, E 445) when used as a food additive. Regarding GEWR originating from Pinus palustris (longleaf pine) and Pinus elliottii (slash pine), based on the overall toxicity database, and given the absence of reproductive and developmental toxicity data, the Panel concluded that the current acceptable daily intake (ADI) of 12.5 mg/kg body weight (bw) per day for GEWR (E 445) as established by the Scientific Committee on Food (SCF) in 1994 should be temporary pending the provision of such data. This assessment is restricted to GEWR derived from P. palustris (longleaf pine) and P. elliottii (slash pine) and with a chemical composition in compliance with GEWR used in the toxicological testing. The Panel concluded that the mean and the high exposure levels (P95) of the brand‐loyal refined exposure scenario did not exceed the temporary ADI in any of the population groups from the use of GEWR (E 445) as a food additive at the reported use levels. For GEWR originating from Pinus halepensis and Pinus brutia, the Panel noted that concentrations of the fractions of ‘glycerol monoesters’, ‘free resin acids’ and ‘neutrals’, which are considered to be of particular toxicological relevance, are not known; therefore, the evaluation of chemical equivalence with GEWR originating from P. palustris (longleaf pine) and P. elliottii (slash pine) is not possible; no data on stability were available; no toxicological data were available. Therefore, the Panel concluded that a safety assessment of GEWR originating from P. halepensis and P. brutia could not be performed. The Panel recommended the European Commission to consider an update of the definition of GEWR (E 445) in the EU specifications. It should be indicated that GEWR (E 445) (i) contain, besides the mentioned glycerol di‐ and triesters, a residual fraction of glycerol monoesters, and (ii) contain residual free resin acids and neutrals (non‐acidic other saponifiable and unsaponifiable substances).
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spelling pubmed-70094192020-07-02 Re‐evaluation of glycerol esters of wood rosin (E 445) as a food additive Younes, Maged Aggett, Peter Aguilar, Fernando Crebelli, Riccardo Filipič, Metka Frutos, Maria Jose Galtier, Pierre Gott, David Gundert‐Remy, Ursula Kuhnle, Gunter Georg Lambré, Claude Leblanc, Jean‐Charles Lillegaard, Inger Therese Moldeus, Peter Mortensen, Alicja Oskarsson, Agneta Stankovic, Ivan Waalkens‐Berendsen, Ine Woutersen, Rudolf Antonius Wright, Matthew Briemer, Leon Pasquale, Mosesso Christodoulidou, Anna Horvath, Zsuzsanna Lodi, Federica Tard, Alexandra Dusemund, Birgit EFSA J Scientific Opinion The present opinion deals with the re‐evaluation of glycerol esters of wood rosin (GEWR, E 445) when used as a food additive. Regarding GEWR originating from Pinus palustris (longleaf pine) and Pinus elliottii (slash pine), based on the overall toxicity database, and given the absence of reproductive and developmental toxicity data, the Panel concluded that the current acceptable daily intake (ADI) of 12.5 mg/kg body weight (bw) per day for GEWR (E 445) as established by the Scientific Committee on Food (SCF) in 1994 should be temporary pending the provision of such data. This assessment is restricted to GEWR derived from P. palustris (longleaf pine) and P. elliottii (slash pine) and with a chemical composition in compliance with GEWR used in the toxicological testing. The Panel concluded that the mean and the high exposure levels (P95) of the brand‐loyal refined exposure scenario did not exceed the temporary ADI in any of the population groups from the use of GEWR (E 445) as a food additive at the reported use levels. For GEWR originating from Pinus halepensis and Pinus brutia, the Panel noted that concentrations of the fractions of ‘glycerol monoesters’, ‘free resin acids’ and ‘neutrals’, which are considered to be of particular toxicological relevance, are not known; therefore, the evaluation of chemical equivalence with GEWR originating from P. palustris (longleaf pine) and P. elliottii (slash pine) is not possible; no data on stability were available; no toxicological data were available. Therefore, the Panel concluded that a safety assessment of GEWR originating from P. halepensis and P. brutia could not be performed. The Panel recommended the European Commission to consider an update of the definition of GEWR (E 445) in the EU specifications. It should be indicated that GEWR (E 445) (i) contain, besides the mentioned glycerol di‐ and triesters, a residual fraction of glycerol monoesters, and (ii) contain residual free resin acids and neutrals (non‐acidic other saponifiable and unsaponifiable substances). John Wiley and Sons Inc. 2018-07-26 /pmc/articles/PMC7009419/ /pubmed/32625997 http://dx.doi.org/10.2903/j.efsa.2018.5370 Text en © 2018 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
Younes, Maged
Aggett, Peter
Aguilar, Fernando
Crebelli, Riccardo
Filipič, Metka
Frutos, Maria Jose
Galtier, Pierre
Gott, David
Gundert‐Remy, Ursula
Kuhnle, Gunter Georg
Lambré, Claude
Leblanc, Jean‐Charles
Lillegaard, Inger Therese
Moldeus, Peter
Mortensen, Alicja
Oskarsson, Agneta
Stankovic, Ivan
Waalkens‐Berendsen, Ine
Woutersen, Rudolf Antonius
Wright, Matthew
Briemer, Leon
Pasquale, Mosesso
Christodoulidou, Anna
Horvath, Zsuzsanna
Lodi, Federica
Tard, Alexandra
Dusemund, Birgit
Re‐evaluation of glycerol esters of wood rosin (E 445) as a food additive
title Re‐evaluation of glycerol esters of wood rosin (E 445) as a food additive
title_full Re‐evaluation of glycerol esters of wood rosin (E 445) as a food additive
title_fullStr Re‐evaluation of glycerol esters of wood rosin (E 445) as a food additive
title_full_unstemmed Re‐evaluation of glycerol esters of wood rosin (E 445) as a food additive
title_short Re‐evaluation of glycerol esters of wood rosin (E 445) as a food additive
title_sort re‐evaluation of glycerol esters of wood rosin (e 445) as a food additive
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009419/
https://www.ncbi.nlm.nih.gov/pubmed/32625997
http://dx.doi.org/10.2903/j.efsa.2018.5370
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