| Autor: |
EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) |
| Jazyk: |
angličtina |
| Rok vydání: |
2013 |
| Předmět: |
|
| Zdroj: |
EFSA Journal, Vol 11, Iss 3 (2013) |
| Druh dokumentu: |
article |
| ISSN: |
1831-4732 |
| DOI: |
10.2903/j.efsa.2013.2818 |
| Popis: |
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. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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