European Food Safety Authority (EFSA)

Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies related to a notification from WFA and AWRI on fish products (isinglass) used in the manufacture of wine pursuant to Article 6 paragraph 11 of Directive 2000/13/EC - for permanent exemption from labelling

Question number: EFSA-Q-2006-154

Summary  (0.1Mb)

Opinion  (0.1Mb)

Summary

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 collagen preparation from fish, isinglass. Fish allergy has been reported to affect from 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. Isinglass is not characterized in terms of possible residual amounts of the major fish allergen, the muscle protein parvalbumin. Residual amounts of isinglass in the final wine have not been measured except for two samples of wine. A history of safe use is claimed. However, there may have been under-reporting of reactions against isinglass in wine, because it is highly uncertain whether wine drinkers and health professionals have been aware of the possible presence of fish proteins in wine. A laboratory study employing a basophil activation test to investigate the allergenicity of wines fined with isinglass is found to be non-informative. A double blind placebo controlled food challenge study in 10 fish allergic subjects was performed, in which no reactions to isinglass-fined wines were observed. However, the double blind placebo controlled food challenge study had methodological limitations.   

The data submitted do not allow the Panel to assess the likelihood that isinglass used as fining agent in wine will trigger an allergic adverse reaction in susceptible individuals under the conditions of use stated by the applicant.