EFSA issues opinions on allergen-derived ingredients

Under a 2003 amendment to the 2000 directive on food ingredients (2000/13/EC), annex IIIa includes a list of ingredients or additives known to trigger allergic reactions or intolerances in some people, for which no labelling exemptions are allowed.

However a procedure was put in place for derivatives pf listed ingredients to be temporarily exempted from labelling if it has been scientifically established that it is not possible for them to cause adverse reactions.

A temporary list of these exemptions was drawn up, but their exemption is set to expire on November 25 2007.

Companies wanting exclusion beyond that date had to submit a request including final results of notified studies.

EFSA was charges with providing scientific opinions on these submissions, through its scientific panel.

The batch of opinions, issued last week, included one on the use of mustard seed oil as a flavouring in foods, in response to a submission by International Flavors and Fragrances (IFF).

Severe anaphylactic reactions to mustard are well documented, and EFSA says that since mustard allergens are resistant to heat and enzymatic degradation, they are not markedly affected by food processing.

In its notification, IFF claimed that the use of mustard-derived essential oil was safe, since very low quantities are used.

Moreover, a test developed by IFF found a very low amount of mustard protein in five samples.

The detection limit was 1.5 micro g/g.

However EFSA said that the test did not detect hydrophobic proteins present in mustard seed oil; the company had not performed an IgE in vitro test to detect allergenic proteins or any fragments; nor did it provide any new laboratory and/or clinical studies to demonstrate lack of allergenicity.

"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 reaction in susceptible individuals," said the authority.

A spokesperson for US-based IFF could not be reached prior to publication for a comment on how the opinion may affect use of the flavouring operations in Europe.

Last week EFSA also issued a number of opinions on food ingredients that its panel judged to be unlikely to cause an allergic reaction.

For instance, the European Spirits Organisation (CEPS) submitted three dossiers relating to ingredients used in the preparation of alcoholic beverages.

The first relates to the addition of almonds, almond oils and nuts to an alcohol distillation process where they act as flavouring agents of the final distillate.

In this case, CEPS submitted further information to supplement that already delivered to EFSA to gain a temporary exemption.

EFSA said that although the analytical evidence was derived from experiments predominantly using almonds, the panel deemed an allergic reaction to be "unlikely", on the grounds that during a properly controlled distillation process proteins and peptides are not carried over into the distillate at levels over 1mg/litre.

A similar opinion was handed down for distillates made from milk-derived whey - such as gin, pastis, ouzo, anis, vodka and other spirits - since proteins and peptides are not seen to be carried over into the distillate at levels above 0.5mg/litre and lactose was not seen to be carried over at levels above 0.4mg/litre.

Likewise, distillates made from cereals, like whisky and gin, were not seen to be carried over into the distillate at levels over 1mg/litre for total proteins, and 0.4mg/kg for gluten.

In this case too, the EFSA panel's verdict was that such distillates were unlikely to trigger a severe allergic reaction in susceptible individuals.

Cognis, ADM and Cargill made two joint submissions.

These related to natural mixed tocopherols (vitamin E, E306) and a range of D-alpha tocopherols from soybean oil; and phytosterol esters from soybean oil.

In both cases the EFSA panel verdict was that the ingredients were "unlikely" to trigger severe allergic reaction.

Finally, the Association des Amidonneries de Céréales (AAC) received the "unlikely" verdict on its two submissions on wheat starch hydrolysates, one of which concerned maltodextrins in coelic disease and wheat allergy, and the other the potential effects of wheat-based glucose syrups in celiac disease and wheat allergy.