EFSA’s predecessor, the Scientific Committee for Food, last evaluated Patent Blue V in 1983 and recommended an acceptable daily intake (ADI) of 15 mg/kg bw. EFSA has now re-evaluated the safety of this food colouring, considering previous safety evaluations and newly available data. A no-observed-adverse-effect level (NOAEL) of 500 mg/kg bw/day was critical, derived from a chronic dietary study in mice, which saw haematological effects and reduced growth at the higher tested dose. The ADI was, as a result, reduced to 5 mg/kg bw. At maximum permitted use levels, exposure estimates for high consuming toddlers and children were above the new ADI, but exposure was not expected to exceed 5 mg/kg bw at maximum reported use levels.

European Food Safety Authority. Panel on Food Additives and Nutrient Sources added to Food (ANS). Scientific opinion on the re-evaluation of Patent Blue V (E 131) as a food additive. EFSA Journal 2013, 11(3), 2818.

http://www.efsa.europa.eu/en/efsajournal/doc/2818.pdf

 

The above item was taken from the April 2013 issue of Toxicology and Regulatory News which is sent automatically to  members of bibra (click here for more details).

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