Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use
Abstract The present scientific opinion deals with the evaluation of the safety of the food additive ethyl lauroyl arginate (E 243) in the light of a new interpretation of the available toxicological data and with respect to the proposed changes to the currently authorised conditions of use. Ethyl l...
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| Format: | Article |
| Language: | English |
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Wiley
2019-03-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2019.5621 |
| _version_ | 1819024523710693376 |
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| author | EFSA Panel on Food Additives and Flavourings (EFSA FAF Panel) Maged Younes Gabriele Aquilina Karl‐Heinz Engel Paul Fowler Maria Jose Frutos Fernandez Peter Fürst Rainer Gürtler Ursula Gundert‐Remy Trine Husøy Wim Mennes Peter Moldeus Agneta Oskarsson Romina Shah Ine Waalkens‐Berendsen Detlef Wölfle David Gott Jean‐Charles Leblanc Camilla Smeraldi Alexandra Tard Laurence Castle |
| author_facet | EFSA Panel on Food Additives and Flavourings (EFSA FAF Panel) Maged Younes Gabriele Aquilina Karl‐Heinz Engel Paul Fowler Maria Jose Frutos Fernandez Peter Fürst Rainer Gürtler Ursula Gundert‐Remy Trine Husøy Wim Mennes Peter Moldeus Agneta Oskarsson Romina Shah Ine Waalkens‐Berendsen Detlef Wölfle David Gott Jean‐Charles Leblanc Camilla Smeraldi Alexandra Tard Laurence Castle |
| author_sort | EFSA Panel on Food Additives and Flavourings (EFSA FAF Panel) |
| collection | DOAJ |
| description | Abstract The present scientific opinion deals with the evaluation of the safety of the food additive ethyl lauroyl arginate (E 243) in the light of a new interpretation of the available toxicological data and with respect to the proposed changes to the currently authorised conditions of use. Ethyl lauroyl arginate (E 243) is an already authorised food additive in the EU for use in heat‐treated meat products only, with some exceptions. The safety of ethyl lauroyl arginate (E 243) as a food additive has been evaluated in 2007 by EFSA and an acceptable daily intake (ADI) of 0.5 mg/kg body weight (bw) was set. The present assessment is based on a new interpretation of the available data elaborated by the applicant and on exposure estimates calculated by the Panel for both the current and the proposed changes to the authorised uses of this food additive. The Panel considered the new information provided, including the re‐examination of some of the results from the toxicological studies included in the original application dossier submitted for the initial evaluation of ethyl lauroyl arginate (E 243) in 2007. The Panel concluded that it does not contain new scientific evidence. The concerns and uncertainties expressed in the previous scientific opinions of the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Foods (AFC) and Panel on Food additives and Nutrient Sources added to Food (ANS) remain to be addressed and there is no justification for changing the current ADI. Based on the above, the Panel concluded that the current ADI of 0.5 mg/kg bw would be reached in toddlers and children at the 95th percentile already for exposure estimates calculated using the currently permitted maximum level (ML) for ethyl lauroyl arginate (E 243). At the proposed new uses and use levels, the ADI would be exceeded at mean level of consumption in all age groups. |
| first_indexed | 2024-12-21T04:56:09Z |
| format | Article |
| id | doaj.art-10fa023e5fcc48899a0220c6c6061028 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-21T04:56:09Z |
| publishDate | 2019-03-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-10fa023e5fcc48899a0220c6c60610282022-12-21T19:15:20ZengWileyEFSA Journal1831-47322019-03-01173n/an/a10.2903/j.efsa.2019.5621Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of useEFSA Panel on Food Additives and Flavourings (EFSA FAF Panel)Maged YounesGabriele AquilinaKarl‐Heinz EngelPaul FowlerMaria Jose Frutos FernandezPeter FürstRainer GürtlerUrsula Gundert‐RemyTrine HusøyWim MennesPeter MoldeusAgneta OskarssonRomina ShahIne Waalkens‐BerendsenDetlef WölfleDavid GottJean‐Charles LeblancCamilla SmeraldiAlexandra TardLaurence CastleAbstract The present scientific opinion deals with the evaluation of the safety of the food additive ethyl lauroyl arginate (E 243) in the light of a new interpretation of the available toxicological data and with respect to the proposed changes to the currently authorised conditions of use. Ethyl lauroyl arginate (E 243) is an already authorised food additive in the EU for use in heat‐treated meat products only, with some exceptions. The safety of ethyl lauroyl arginate (E 243) as a food additive has been evaluated in 2007 by EFSA and an acceptable daily intake (ADI) of 0.5 mg/kg body weight (bw) was set. The present assessment is based on a new interpretation of the available data elaborated by the applicant and on exposure estimates calculated by the Panel for both the current and the proposed changes to the authorised uses of this food additive. The Panel considered the new information provided, including the re‐examination of some of the results from the toxicological studies included in the original application dossier submitted for the initial evaluation of ethyl lauroyl arginate (E 243) in 2007. The Panel concluded that it does not contain new scientific evidence. The concerns and uncertainties expressed in the previous scientific opinions of the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Foods (AFC) and Panel on Food additives and Nutrient Sources added to Food (ANS) remain to be addressed and there is no justification for changing the current ADI. Based on the above, the Panel concluded that the current ADI of 0.5 mg/kg bw would be reached in toddlers and children at the 95th percentile already for exposure estimates calculated using the currently permitted maximum level (ML) for ethyl lauroyl arginate (E 243). At the proposed new uses and use levels, the ADI would be exceeded at mean level of consumption in all age groups.https://doi.org/10.2903/j.efsa.2019.5621ethyl lauroyl arginateE 243CAS: 60372‐77‐2food additivetoxicitydietary exposure |
| spellingShingle | EFSA Panel on Food Additives and Flavourings (EFSA FAF Panel) Maged Younes Gabriele Aquilina Karl‐Heinz Engel Paul Fowler Maria Jose Frutos Fernandez Peter Fürst Rainer Gürtler Ursula Gundert‐Remy Trine Husøy Wim Mennes Peter Moldeus Agneta Oskarsson Romina Shah Ine Waalkens‐Berendsen Detlef Wölfle David Gott Jean‐Charles Leblanc Camilla Smeraldi Alexandra Tard Laurence Castle Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use EFSA Journal ethyl lauroyl arginate E 243 CAS: 60372‐77‐2 food additive toxicity dietary exposure |
| title | Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use |
| title_full | Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use |
| title_fullStr | Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use |
| title_full_unstemmed | Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use |
| title_short | Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use |
| title_sort | safety of ethyl lauroyl arginate e 243 as a food additive in the light of the new information provided and the proposed extension of use |
| topic | ethyl lauroyl arginate E 243 CAS: 60372‐77‐2 food additive toxicity dietary exposure |
| url | https://doi.org/10.2903/j.efsa.2019.5621 |
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