Scientific Opinion related to a notification from DuPontNutrition Biosciences Aps on behenic acid from mustardseeds to be used in the manufacturing of certain emulsifierspursuant to Article 21(2) of Regulation (EU) No 1169/2011– for permanent exemption from labelling

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition andAllergies (NDA) was asked to deliver a scientific opinion related to a notification from DuPont NutritionBiosciences Aps on behenic acid from mustard seeds to be used in the manufacturing of certainemulsifiers pursuant to Article 21(2) of Regulation (EU) No 1169/2011 – for permanent exemptionfrom labelling. Behenic acid is produced from rapeseed–mustard seed variants prevalent in India,namely Brassica juncea (L.) Czern. (oriental mustard), Brassica rapa (L.) (brown/yellow Sarson orToria), Brassica napus (L.) (rapeseed) and Brassica nigra (L.) W.D.J.Koch (black mustard). No humanor animal allergenicity data were provided by the applic ant for either behenic acid or the emulsifiersmanufactured from beheni c acid. Based on enzyme-linke d immunosorbent assay (ELISA) data, thePanel considers that proteins and peptides may not be carried over into behenic acid after the twodistillation steps reported in the manufacturing process in amounts beyond 1 mg/kg. The Panel notesthat the maximum amount of mustard protein that could be consumed from emulsifiers manufacturedfrom behenic acid (E 470a, E 471 and E 477) on a single occasion by an adult under the proposedconditions of use would be around 0.00119 mg, which is about 1,000 times lower than the proteindoses repo rted to trigger allergic reactions in mustard-allergic individuals (around 1 mg). On the basisof the data presented, the Panel concludes that oral consumption of emulsifiers manufactured usingbehenic acid from mustard seeds (E 470a, E 471 and E 477) are unli kely to trigger an allergic reactionin susceptible individuals (i.e. mustard-allergic individuals) under the proposed conditions of use.