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 labellingQuestion number: EFSA-Q-2006-312
Wine production normally includes fining of the wine. Fining is achieved by mixing fining agents with the wine during production, thereafter the complexed materials are removed by sedimentation, filtration, or both. Common fining agents include a protein preparation from fish, 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 fined wines.
The current application contains limited information regarding the manufacturing process of isinglass, which appears not to have a high level of standardization. A history of safe use of isinglass is claimed. However, it is likely that there would be a significant underreporting of reactions against isinglass in wine, because it is uncertain whether wine drinkers and health professionals have been aware of the possible presence of fish proteins in wine. In a gel electrophoresis and immunoblotting study of isinglass IgE-binding components were detected. ELISA assays which were developed were unsuitable to quantify residual amounts of isinglass in wine, and were used mainly for qualitative assessment. Of 273 wines bought in shops, 14 wines (5 %) were found to contain residues of isinglass. Of 28 wines known to be fined with isinglass, two tested positive for the fining agent. Animal model results suggested allergenic activity of wine fined with isinglass. Skin test data with isinglass-fined wines in fish allergic human subjects were inconclusive. In a double blind placebo controlled food challenge study in four fish allergic subjects, no reactions to isinglass-fined wines were observed. Regarding fish gelatine, the documentation provided only relates to isinglass.
The data submitted do not allow the Panel to assess the likelihood that isinglass used as fining agent in wine will trigger an adverse reaction in susceptible individuals under the conditions of use stated by the applicant.