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.



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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