Scientific Opinion on the re‐evaluation of aspartame (E 951) as a food additive
Abstract The EFSA ANS Panel provides a scientific opinion on the safety of aspartame (E 951). Aspartame is a sweetener authorised as a food additive in the EU. In previous evaluations by JECFA and the SCF, an ADI of 40 mg/kg bw/day was established based on chronic toxicity in animals. Original repor...
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| Format: | Article |
| Language: | English |
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Wiley
2013-12-01
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| Series: | EFSA Journal |
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| Online Access: | https://doi.org/10.2903/j.efsa.2013.3496 |
| _version_ | 1818561323164762112 |
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| author | EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) |
| author_facet | EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) |
| author_sort | EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) |
| collection | DOAJ |
| description | Abstract The EFSA ANS Panel provides a scientific opinion on the safety of aspartame (E 951). Aspartame is a sweetener authorised as a food additive in the EU. In previous evaluations by JECFA and the SCF, an ADI of 40 mg/kg bw/day was established based on chronic toxicity in animals. Original reports, previous evaluations, additional literature and data made available following a public call were evaluated. Aspartame is rapidly and completely hydrolysed in the gastrointestinal tract to phenylalanine, aspartic acid and methanol. Chronic and developmental toxicities were relevant endpoints in the animal database. From chronic toxicity studies in animals, a NOAEL of 4000 mg/kg bw/day was identified. The possibility of developmental toxicity occurring at lower doses than 4000 mg/kg in animals could not be excluded. Based on MoA and weight‐of‐evidence analysis, the Panel concluded that developmental toxicity in animals was attributable to phenylalanine. Phenylalanine at high plasma levels is known to cause developmental toxicity in humans. The Panel concluded that human data on developmental toxicity were more appropriate for the risk assessment. Concentration‐response modelling was used to determine the effects of aspartame administration on plasma phenylalanine using human data after phenylalanine administration to normal, PKU heterozygote or PKU homozygote individuals. In normal and PKU heterozygotes, aspartame intakes up to the ADI of 40 mg/kg bw/day, in addition to dietary phenylalanine, would not lead to peak plasma phenylalanine concentrations above the current clinical guideline for the prevention of adverse effects in fetuses. The Panel concluded that aspartame was not of safety concern at the current aspartame exposure estimates or at the ADI of 40 mg/kg bw/day. Therefore, there was no reason to revise the ADI of aspartame. Current exposures to aspartame ‐ and its degradation product DKP ‐ were below their respective ADIs. The ADI is not applicable to PKU patients. |
| first_indexed | 2024-12-14T00:49:21Z |
| format | Article |
| id | doaj.art-0b44a310172845248a8a8c8b93a3fd7f |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-14T00:49:21Z |
| publishDate | 2013-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-0b44a310172845248a8a8c8b93a3fd7f2022-12-21T23:23:55ZengWileyEFSA Journal1831-47322013-12-011112n/an/a10.2903/j.efsa.2013.3496EFSA Journal 2013;11(12):3496Scientific Opinion on the re‐evaluation of aspartame (E 951) as a food additiveEFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)Abstract The EFSA ANS Panel provides a scientific opinion on the safety of aspartame (E 951). Aspartame is a sweetener authorised as a food additive in the EU. In previous evaluations by JECFA and the SCF, an ADI of 40 mg/kg bw/day was established based on chronic toxicity in animals. Original reports, previous evaluations, additional literature and data made available following a public call were evaluated. Aspartame is rapidly and completely hydrolysed in the gastrointestinal tract to phenylalanine, aspartic acid and methanol. Chronic and developmental toxicities were relevant endpoints in the animal database. From chronic toxicity studies in animals, a NOAEL of 4000 mg/kg bw/day was identified. The possibility of developmental toxicity occurring at lower doses than 4000 mg/kg in animals could not be excluded. Based on MoA and weight‐of‐evidence analysis, the Panel concluded that developmental toxicity in animals was attributable to phenylalanine. Phenylalanine at high plasma levels is known to cause developmental toxicity in humans. The Panel concluded that human data on developmental toxicity were more appropriate for the risk assessment. Concentration‐response modelling was used to determine the effects of aspartame administration on plasma phenylalanine using human data after phenylalanine administration to normal, PKU heterozygote or PKU homozygote individuals. In normal and PKU heterozygotes, aspartame intakes up to the ADI of 40 mg/kg bw/day, in addition to dietary phenylalanine, would not lead to peak plasma phenylalanine concentrations above the current clinical guideline for the prevention of adverse effects in fetuses. The Panel concluded that aspartame was not of safety concern at the current aspartame exposure estimates or at the ADI of 40 mg/kg bw/day. Therefore, there was no reason to revise the ADI of aspartame. Current exposures to aspartame ‐ and its degradation product DKP ‐ were below their respective ADIs. The ADI is not applicable to PKU patients.https://doi.org/10.2903/j.efsa.2013.3496aspartameE 951methanolsweetenerEINECS number 245‐261‐3 |
| spellingShingle | EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) Scientific Opinion on the re‐evaluation of aspartame (E 951) as a food additive EFSA Journal aspartame E 951 methanol sweetener EINECS number 245‐261‐3 |
| title | Scientific Opinion on the re‐evaluation of aspartame (E 951) as a food additive |
| title_full | Scientific Opinion on the re‐evaluation of aspartame (E 951) as a food additive |
| title_fullStr | Scientific Opinion on the re‐evaluation of aspartame (E 951) as a food additive |
| title_full_unstemmed | Scientific Opinion on the re‐evaluation of aspartame (E 951) as a food additive |
| title_short | Scientific Opinion on the re‐evaluation of aspartame (E 951) as a food additive |
| title_sort | scientific opinion on the re evaluation of aspartame e 951 as a food additive |
| topic | aspartame E 951 methanol sweetener EINECS number 245‐261‐3 |
| url | https://doi.org/10.2903/j.efsa.2013.3496 |
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