Opinion of the Scientific Panel on Dietetic products, nutrition and allergies [NDA] related to a notification from DSM on fish gelatine for use as a formulation aid (carrier) in vitamin and carotenoid preparations pursuant to Article 6 paragraph 11 of Dir

Abstract

SUMMARYFish is one of the most important allergenic foods, and allergic reactions to fish can be severe. The major allergen of fish is the muscle protein parvalbumin. Gelatine is made by denaturation of collagen. The present application concerns fish gelatine produced from fish skin for use as a formulation aid (carrier) in vitamin and carotenoid preparations.The information provided by the applicant indicates that the production process of gelatine from fish skins is well standardized. However, no analytical data regarding possible residual levels of the major fish allergen parvalbumin in fish gelatine preparations are provided. Daily fish gelatine intake from vitamin preparations intended for use in food supplements, colourings and beverages is in the low milligram range. Based on vitamin preparations available on the market, a maximum concentration of fish gelatine of 30 mg per litre is estimated, or 7.5 mg per typical 250-mL serving.There is published evidence that some fish allergic individuals have specific serum IgE reactive with fish collagen and its denatured form gelatine, but only two clinical provocation studies with fish gelatine have been reported. In one single-blind oral provocation study, three patients with IgE reactivity to fish gelatine did not react upon ingestion of 5 g gelatine. In a doubleblind placebo-controlled food challenge (DBPCFC) study of 30 patients with clinical allergy to fish, no patient reacted to a cumulative dose of 3.6 g of fish gelatine.On the basis of the data provided by the applicant, the Panel considers that it is not likely that fish gelatine, under the conditions of use specified by the applicant, will cause a severe allergic reaction in fish allergic individuals.However, appropriate analytical methods to determine residual levels of parvalbumin in fish gelatine preparations are needed to support the above conclusion. More clinical studies in fish allergic individuals sensitised to fish gelatine are needed to exclude the likelihood of adverse reactions in these individuals. KEY WORDSFish gelatine, carrier, vitamin preparations, carotenoid preparations, food allergy.