Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive
Abstract The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg...
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2018-12-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2018.5497 |
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| author | EFSA Panel on Food Additives and Flavourings (FAF) Maged Younes Gabriele Aquilina Laurence Castle Karl‐Heinz Engel Paul Fowler Maria Jose Frutos Fernandez Peter Fürst Rainer Gürtler Ursula Gundert‐Remy Trine Husøy Wim Mennes Agneta Oskarsson Sandra Rainieri Romina Shah Ine Waalkens‐Berendsen Detlef Wölfle Polly Boon Claude Lambré Paul Tobback Matthew Wright Dimitrios Chrysafidis Ana Maria Rincon Alexandra Tard Peter Moldeus |
| author_facet | EFSA Panel on Food Additives and Flavourings (FAF) Maged Younes Gabriele Aquilina Laurence Castle Karl‐Heinz Engel Paul Fowler Maria Jose Frutos Fernandez Peter Fürst Rainer Gürtler Ursula Gundert‐Remy Trine Husøy Wim Mennes Agneta Oskarsson Sandra Rainieri Romina Shah Ine Waalkens‐Berendsen Detlef Wölfle Polly Boon Claude Lambré Paul Tobback Matthew Wright Dimitrios Chrysafidis Ana Maria Rincon Alexandra Tard Peter Moldeus |
| author_sort | EFSA Panel on Food Additives and Flavourings (FAF) |
| collection | DOAJ |
| description | Abstract The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane‐1,2‐diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short‐term studies in rats and dogs at the highest doses tested. The Panel considered that E 477 did not raise a concern for genotoxicity. No chronic toxicity, carcinogenicity, reproductive and developmental toxicity studies with propane‐1,2‐diol esters of fatty acids were available to the Panel. The Panel considered that any potential adverse effect of propane‐1,2‐diol ester of fatty acids would be due to propane‐1,2‐diol, previously re‐evaluated as a food additive and for which an ADI of 25 mg/kg bw per day was established. Considering the overall metabolic and toxicity database, the Panel confirmed the previously established ADI for propane‐1,2‐diol esters of fatty acids (E 477) of 25 mg/kg bw per day expressed as propane 1,2 diol. This corresponds to an ADI for E 477 of 80 mg/kg bw per day, based on the concentration of free and bound propane‐1,2‐diol amounting to a maximum of 31% as laid down in the EU specification. The Panel concluded that there would not be a safety concern at the reported use levels for E 477 because exposure estimates from the refined non‐brand loyal scenario did not exceed the ADI for E 477 in any of the population groups. However, the Panel aims to explore the feasibility of establishing a group ADI for those food additives that result in an exposure to propane‐1,2‐diol, such as E 477, E 1520 and E 405. Additionally, the Panel will also consider performing a combined exposure assessment to propane‐1,2‐diol resulting from the use of these food additives. The Panel also recommended some modifications of the EU specifications for E 477. |
| first_indexed | 2024-12-17T03:32:33Z |
| format | Article |
| id | doaj.art-e60a648ae908460a842363ed5d083d44 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-17T03:32:33Z |
| publishDate | 2018-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-e60a648ae908460a842363ed5d083d442022-12-21T22:05:14ZengWileyEFSA Journal1831-47322018-12-011612n/an/a10.2903/j.efsa.2018.5497Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additiveEFSA Panel on Food Additives and Flavourings (FAF)Maged YounesGabriele AquilinaLaurence CastleKarl‐Heinz EngelPaul FowlerMaria Jose Frutos FernandezPeter FürstRainer GürtlerUrsula Gundert‐RemyTrine HusøyWim MennesAgneta OskarssonSandra RainieriRomina ShahIne Waalkens‐BerendsenDetlef WölflePolly BoonClaude LambréPaul TobbackMatthew WrightDimitrios ChrysafidisAna Maria RinconAlexandra TardPeter MoldeusAbstract The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane‐1,2‐diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short‐term studies in rats and dogs at the highest doses tested. The Panel considered that E 477 did not raise a concern for genotoxicity. No chronic toxicity, carcinogenicity, reproductive and developmental toxicity studies with propane‐1,2‐diol esters of fatty acids were available to the Panel. The Panel considered that any potential adverse effect of propane‐1,2‐diol ester of fatty acids would be due to propane‐1,2‐diol, previously re‐evaluated as a food additive and for which an ADI of 25 mg/kg bw per day was established. Considering the overall metabolic and toxicity database, the Panel confirmed the previously established ADI for propane‐1,2‐diol esters of fatty acids (E 477) of 25 mg/kg bw per day expressed as propane 1,2 diol. This corresponds to an ADI for E 477 of 80 mg/kg bw per day, based on the concentration of free and bound propane‐1,2‐diol amounting to a maximum of 31% as laid down in the EU specification. The Panel concluded that there would not be a safety concern at the reported use levels for E 477 because exposure estimates from the refined non‐brand loyal scenario did not exceed the ADI for E 477 in any of the population groups. However, the Panel aims to explore the feasibility of establishing a group ADI for those food additives that result in an exposure to propane‐1,2‐diol, such as E 477, E 1520 and E 405. Additionally, the Panel will also consider performing a combined exposure assessment to propane‐1,2‐diol resulting from the use of these food additives. The Panel also recommended some modifications of the EU specifications for E 477.https://doi.org/10.2903/j.efsa.2018.5497food additivepropane‐1,2‐diol esters of fatty acidspropylene glycol esters of fatty acidsE 477 |
| spellingShingle | EFSA Panel on Food Additives and Flavourings (FAF) Maged Younes Gabriele Aquilina Laurence Castle Karl‐Heinz Engel Paul Fowler Maria Jose Frutos Fernandez Peter Fürst Rainer Gürtler Ursula Gundert‐Remy Trine Husøy Wim Mennes Agneta Oskarsson Sandra Rainieri Romina Shah Ine Waalkens‐Berendsen Detlef Wölfle Polly Boon Claude Lambré Paul Tobback Matthew Wright Dimitrios Chrysafidis Ana Maria Rincon Alexandra Tard Peter Moldeus Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive EFSA Journal food additive propane‐1,2‐diol esters of fatty acids propylene glycol esters of fatty acids E 477 |
| title | Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive |
| title_full | Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive |
| title_fullStr | Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive |
| title_full_unstemmed | Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive |
| title_short | Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive |
| title_sort | re evaluation of propane 1 2 diol esters of fatty acids e 477 as a food additive |
| topic | food additive propane‐1,2‐diol esters of fatty acids propylene glycol esters of fatty acids E 477 |
| url | https://doi.org/10.2903/j.efsa.2018.5497 |
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