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Re-evaluation of saccharin and its sodium, potassium and calcium salts (E 954) as food additives.

作者信息

Castle Laurence, Andreassen Monica, Aquilina Gabriele, Bastos Maria Lourdes, Boon Polly, Fallico Biagio, FitzGerald Reginald, Frutos Fernandez Maria Jose, Grasl-Kraupp Bettina, Gundert-Remy Ursula, Gürtler Rainer, Houdeau Eric, Kurek Marcin, Louro Henriqueta, Morales Patricia, Passamonti Sabina, Batke Monika, Bruzell Ellen, Chipman James, Cheyns Karlien, Crebelli Riccardo, Fortes Cristina, Fürst Peter, Halldorsson Thorhallur, LeBlanc Jean-Charles, Mirat Manuela, Lindtner Oliver, Mortensen Alicja, Ntzani Evangelia, Shah Romina, Wallace Heather, Wright Matthew, Barmaz Stefania, Civitella Consuelo, Georgelova Petra, Lodi Federica, Mazzoli Elena, Rasinger Josef, Maria Rincon Ana, Tard Alexandra, Zakidou Panagiota, Younes Maged

出版信息

EFSA J. 2024 Nov 15;22(11):e9044. doi: 10.2903/j.efsa.2024.9044. eCollection 2024 Nov.


DOI:10.2903/j.efsa.2024.9044
PMID:39553702
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11565076/
Abstract

This opinion deals with the re-evaluation of saccharin and its sodium, potassium and calcium salts (E 954) as food additives. Saccharin is the chemically manufactured compound 1,2-benzisothiazol-3(2H)-one-1,1-dioxide. Along with its sodium (Na), potassium (K) and calcium (Ca) salts, they are authorised as sweeteners (E 954). E 954 can be produced by two manufacturing methods i.e. Remsen-Fahlberg and Maumee. No analytical data on potential impurities were provided for products manufactured with the Maumee process; therefore, the Panel could only evaluate saccharins (E 954) manufactured with the Remsen-Fahlberg process. The Panel concluded that the newly available studies do not raise a concern for genotoxicity of E 954 and the saccharins impurities associated with the Remsen-Fahlberg manufacturing process. For the potential impurities associated with the Maumee process, a concern for genotoxicity was identified. The data set evaluated consisted of animals and human studies. The Panel considered appropriate to set a numerical acceptable daily intake (ADI) and considered the decrease in body weight in animal studies as the relevant endpoint for the derivation of a reference point. An ADI of 9 mg/kg body weight (bw) per day, expressed as free imide, was derived for saccharins (E 954). This ADI replaces the ADI of 5 mg /kg bw per day (expressed as sodium saccharin, corresponding to 3.8 mg /kg bw per day saccharin as free imide) established by the Scientific Committee on Food. The Panel considered the refined brand-loyal exposure assessment scenario the most appropriate exposure scenario for the risk assessment. The Panel noted that the P95 exposure estimates for chronic exposure to saccharins (E 954) were below the ADI. The Panel recommended the European Commission to consider the revision of the EU specifications of saccharin and its sodium, potassium and calcium salts (E 954).

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f5d3/11565076/2efc391c597e/EFS2-22-e9044-g026.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f5d3/11565076/ef7cf525fe0a/EFS2-22-e9044-g009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f5d3/11565076/d32b0b9f2513/EFS2-22-e9044-g018.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f5d3/11565076/33cde90b55bd/EFS2-22-e9044-g017.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f5d3/11565076/0c333ea981a7/EFS2-22-e9044-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f5d3/11565076/dc333aec5ada/EFS2-22-e9044-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f5d3/11565076/ee97b37d1444/EFS2-22-e9044-g025.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f5d3/11565076/2efc391c597e/EFS2-22-e9044-g026.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f5d3/11565076/ef7cf525fe0a/EFS2-22-e9044-g009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f5d3/11565076/d32b0b9f2513/EFS2-22-e9044-g018.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f5d3/11565076/33cde90b55bd/EFS2-22-e9044-g017.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f5d3/11565076/0c333ea981a7/EFS2-22-e9044-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f5d3/11565076/dc333aec5ada/EFS2-22-e9044-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f5d3/11565076/ee97b37d1444/EFS2-22-e9044-g025.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f5d3/11565076/2efc391c597e/EFS2-22-e9044-g026.jpg

相似文献

[1]
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[2]
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[3]
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[4]
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[5]
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[6]
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[7]
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[8]
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[9]
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[10]
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[3]
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[4]
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本文引用的文献

[1]
Re-evaluation of argon (E 938) and helium (E 939) as food additives.

EFSA J. 2024-10-28

[2]
Update of the risk assessment of inorganic arsenic in food.

EFSA J. 2024-1-18

[3]
Simultaneous analysis of natural and artificial sweeteners in sugar-free drinks and urine samples by column-switching UHPLC-charged aerosol detection method.

J Chromatogr A. 2024-1-4

[4]
Occurrence of contaminants of emerging concern and pesticides and relative risk assessment in Tunisian groundwater.

Sci Total Environ. 2024-1-1

[5]
Synthesis and characterization of TiO-carbon filter materials for water decontamination by adsorption-degradation processes.

J Environ Manage. 2023-11-15

[6]
Simultaneous determination of nine high-intensity sweeteners in liquid and powder tabletop sweeteners.

Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2023-10

[7]
Adsorption of aqueous phase contaminants of emerging concern by activated carbon: Comparative fixed-bed column study and in situ regeneration methods.

J Hazard Mater. 2023-10-5

[8]
The impact of antimicrobial food additives and sweeteners on the growth and metabolite production of gut bacteria.

Folia Microbiol (Praha). 2023-10

[9]
Comparing the effects of dietary sugars on cognitive performance and reaction time: A randomized, placebo- controlled and double-blind experimental trial.

Appl Neuropsychol Adult. 2025

[10]
Long-term aspartame and saccharin intakes are related to greater volumes of visceral, intermuscular, and subcutaneous adipose tissue: the CARDIA study.

Int J Obes (Lond). 2023-10

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