Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies related to a notification from Brewers of Europe and BFBi on isinglass used as a clarifying agent in brewing pursuant to Article 6 paragraph 11 of Directive 2000/13/EC - for permanent exemption from labellingNumero domanda: EFSA-Q-2006-312
Beer production normally includes fining of the beer. Fining is achieved by mixing fining agents with the beer during production, thereafter complexed materials are removed by sedimentation, filtration, or both. Commonly used fining agents include a collagen preparation from fish swim bladders, isinglass. Fish allergy has been reported to affect 0.2%-2.2% of the population in European countries. Fish can cause severe reactions in allergic individuals and it is appropriate to assess allergen levels in beer clarified with isinglass.
Allergens of concern in isinglass are primarily residual amounts of the major fish allergen parvalbumin, and collagen/gelatine which constitute the major component (95%) of isinglass. An industry-agreed Code of Good Manufacturing Practice (GMP) for isinglass has been adopted by the applicant to lower the content of parvalbumin in the product. This substantially reduced the levels of parvalbumin in isinglass. A history of safe use is claimed. However, there may have been a significant under-reporting of reactions against isinglass in beer, because it is uncertain whether beer drinkers and health professionals have been aware of the possible presence of fish protein in beer. Analytical data indicate a residue level of isinglass in beer up to 5 mg/L. Parvalbumin levels in isinglass ranged from 0.2 mg/Kg to 0.7 mg/Kg. The estimated maximum concentration of parvalbumin in beer is 0.005 μg/L. However, there is considerable uncertainty about the accuracy of the assays. Two new double-blind placebo-controlled food challenge studies with isinglass are reported, in which none of 21 fish allergic patients experienced any adverse effects.
On the basis of the data provided, the Panel considers that it is not very likely that isinglass used as clarifying agent in beer will trigger a severe allergic reaction in susceptible individuals under the conditions of production and use specified by the applicant.