Allergic reactions to mustard, including severe anaphylactic reactions, are well documented in clinical and laboratory studies. Mustard allergy is also encountered in children. Studies suggest
that mustard allergy may account for 1-7% of all food allergies in some European regions. Mustard allergens are resistant to heat and to enzymatic degradation, and therefore are not markedly
affected by food processing.

This notification covers mustard-derived essential oil, i.e. mustard seed oil, used as flavour in foods. The applicant claims a safe use for allergic individuals on the basis of the typically
low quantities of mustard oil in foods and of the low amount of mustard protein found in five tested mustard seed oil samples according to an ELISA test developed by the applicant (limit of
detection 1.5g/g). It should be noted that this test does not detect hydrophobic proteins preferentially present in mustard seed oil. Furthermore, the applicant has not performed any
IgE in vitro test to detect allergenic proteins and fragments thereof, nor have new laboratory and/or clinical studies been provided in order to demonstrate the lack of allergenicity.

The applicant does not take into consideration the scientific literature reporting adverse reactions to allyl isothiocyanate, which may cause immunologically-mediated adverse reactions and
systemic symptoms upon a very low exposure.

The incomplete scientific data submitted by the applicant do not allow the Panel to evaluate the likelihood that mustard seed oil will trigger an adverse allergic reaction in susceptible
individuals.

Opinion

Summary

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