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  • 标题:Scientific Opinion on the re-evaluation of Patent Blue V (E 131) as a food additive
  • 本地全文:下载
  • 作者:Fernando Aguilar ; Riccardo Crebelli ; Birgit Dusemund
  • 期刊名称:EFSA Journal
  • 印刷版ISSN:1831-4732
  • 出版年度:2013
  • 卷号:11
  • 期号:3
  • DOI:10.2903/j.efsa.2013.2818
  • 出版社:European Food Safety Authority (EFSA), Parma
  • 摘要:The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of Patent Blue V (E 131). Patent Blue V (E 131) is a triarylmethane dye permitted for use as a food additive in the EU, that has been previously evaluated by JECFA in 1970 and 1975 and the EU SCF in 1983; JECFA established a Temporary Acceptable Daily Intake (ADI) of 0-1 mg/kg bw/day in 1970, but withdrew it in 1975. Until now JECFA has not allocated an ADI to Patent Blue V (E 131). The SCF established an ADI of 0-15 mg/kg bw/day. The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations, additional literature that became available since then and the data available following a public call for data. The Panel concluded that the present dataset provides a rationale for a re-definition of the ADI. Using the NOAEL of 500 mg/kg bw/day derived from a chronic toxicity study in mice and applying an uncertainty factor of 100 to this NOAEL, the Panel establishes an ADI of 5 mg/kg bw/day. The Panel noted that at the maximum permitted levels of use of Patent Blue V (E 131), exposure estimates for high consumers are above the ADI of 5 mg/kg bw/day in toddlers and children. At the maximum reported use levels of Patent Blue V (E 131), exposure estimates are below the ADI of 5 mg/kg bw/day for all groups of the population.
  • 关键词:Patent Blue V; E 131; CAS Registry Number calcium salt: 3536-49-0; CAS Registry Number sodium salt: 129-17-9; food colouring substance.
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