Scientific Opinion related to a notification from DuPont Nutrition Biosciences Aps on behenic acid from mustard seeds to be used in the manufacturing of certain emulsifiers pursuant to Article 21(2) of Regulation (EU) No 1169/2011 – for permanent exemption from labelling
Research output: Contribution to journal › Journal article › Commissioned › peer-review
Standard
Scientific Opinion related to a notification from DuPont Nutrition Biosciences Aps on behenic acid from mustard seeds to be used in the manufacturing of certain emulsifiers pursuant to Article 21(2) of Regulation (EU) No 1169/2011 – for permanent exemption from labelling. / EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA).
In: E F S A Journal, Vol. 14, No. 11, 4631, 15.11.2016.Research output: Contribution to journal › Journal article › Commissioned › peer-review
Harvard
APA
Vancouver
Author
Bibtex
}
RIS
TY - JOUR
T1 - Scientific Opinion related to a notification from DuPont Nutrition Biosciences Aps on behenic acid from mustard seeds to be used in the manufacturing of certain emulsifiers pursuant to Article 21(2) of Regulation (EU) No 1169/2011 – for permanent exemption from labelling
AU - EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)
AU - Sjödin, Anders Mikael
N1 - EFSA 2016 4631
PY - 2016/11/15
Y1 - 2016/11/15
N2 - Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion related to a notification from DuPont Nutrition Biosciences Aps on behenic acid from mustard seeds to be used in the manufacturing of certain emulsifiers pursuant to Article 21(2) of Regulation (EU) No 1169/2011 – for permanent exemption from 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 or Toria), Brassica napus (L.) (rapeseed) and Brassica nigra (L.) W.D.J.Koch (black mustard). No human or animal allergenicity data were provided by the applicant for either behenic acid or the emulsifiers manufactured from behenic acid. Based on enzyme-linked immunosorbent assay (ELISA) data, the Panel considers that proteins and peptides may not be carried over into behenic acid after the two distillation steps reported in the manufacturing process in amounts beyond 1 mg/kg. The Panel notes that the maximum amount of mustard protein that could be consumed from emulsifiers manufactured from behenic acid (E 470a, E 471 and E 477) on a single occasion by an adult under the proposed conditions of use would be around 0.00119 mg, which is about 1,000 times lower than the protein doses reported to trigger allergic reactions in mustard-allergic individuals (around 1 mg). On the basis of the data presented, the Panel concludes that oral consumption of emulsifiers manufactured using behenic acid from mustard seeds (E 470a, E 471 and E 477) are unlikely to trigger an allergic reactionin susceptible individuals (i.e. mustard-allergic individuals) under the proposed conditions of use.
AB - Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion related to a notification from DuPont Nutrition Biosciences Aps on behenic acid from mustard seeds to be used in the manufacturing of certain emulsifiers pursuant to Article 21(2) of Regulation (EU) No 1169/2011 – for permanent exemption from 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 or Toria), Brassica napus (L.) (rapeseed) and Brassica nigra (L.) W.D.J.Koch (black mustard). No human or animal allergenicity data were provided by the applicant for either behenic acid or the emulsifiers manufactured from behenic acid. Based on enzyme-linked immunosorbent assay (ELISA) data, the Panel considers that proteins and peptides may not be carried over into behenic acid after the two distillation steps reported in the manufacturing process in amounts beyond 1 mg/kg. The Panel notes that the maximum amount of mustard protein that could be consumed from emulsifiers manufactured from behenic acid (E 470a, E 471 and E 477) on a single occasion by an adult under the proposed conditions of use would be around 0.00119 mg, which is about 1,000 times lower than the protein doses reported to trigger allergic reactions in mustard-allergic individuals (around 1 mg). On the basis of the data presented, the Panel concludes that oral consumption of emulsifiers manufactured using behenic acid from mustard seeds (E 470a, E 471 and E 477) are unlikely to trigger an allergic reactionin susceptible individuals (i.e. mustard-allergic individuals) under the proposed conditions of use.
KW - Faculty of Science
KW - Behenic acid
KW - Emulsifiers
KW - Mustard
KW - Rapeseed
KW - Allergy
KW - Labelling exemption
U2 - 10.2903/j.efsa.2016.4631
DO - 10.2903/j.efsa.2016.4631
M3 - Journal article
VL - 14
JO - E F S A Journal
JF - E F S A Journal
SN - 1831-4732
IS - 11
M1 - 4631
ER -
ID: 188396510