Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion related to a notification from the International Organisation of Vine and Wine on ovalbumin/egg white to be used in the manufacture of wine as clarification processing aids pursuant to Article 6, paragraph 11 of Directive 2000/13/EC – for permanent exemption from labelling.
Taking into account the numerous and well documented reports of allergic individuals reacting to egg albumin (ovalbumin, egg white) and that the prevalence of such allergy to egg proteins has been reported to be around 0.3 % in adults, it is appropriate for the Panel to assess the likelihood of adverse reactions in allergic individuals consuming products where ovalbumin/egg white has been added during the manufacturing process.
Two applications submitted for permanent exemption from labelling were the basis for earlier EFSA assessments of egg products and albumin (egg white) used as fining agents in wine. The Panel concluded that wines fined with egg products and albumin (egg white) may trigger adverse reactions in susceptible individuals under the conditions of use stated by the applicants. The conclusion was based on the limited information provided on the characterisation of the fining agents, on the limitations of the methods used to quantify egg allergens other than ovalbumin in wine, and on clinical studies which reported allergic reactions in egg-allergic individuals following double-blind placebo controlled food challenges (DBPCFC) with wines fined with ovalbumin/egg white.
This application contains new information and data mainly with regard to the analytical methods developed for the detection of egg allergens in the fining agent and the detection of ovalbumin in wine. There were no changes in the wine manufacturing process and no new clinical studies were provided.
Hen‟s egg white albumin is in the form of either fresh or frozen egg white, or as freeze-dried powder of egg white or purified ovalbumin. Two types of preparation exist: one without added lysozyme, the other with lysozyme as a preservative. Lysozyme as an antimicrobial stabilising agent/additive is not dealt with in the present application. The commercial preparations of ovalbumin/egg white fining agents sold as “ovalbumin” may contain other proteinaceous materials in addition to ovalbumin. Egg allergens other than ovalbumin were found in every “ovalbumin” fining product tested. The Panel notes that “ovalbumin/egg white” fining agents contain other egg proteins in addition to ovalbumin, and that no quantitative information about their content in the fining agents has been provided.
Egg white albumin is particularly used for the clarification of red wines rich in tannins. The Panel notes that the recommended amounts of egg albumin/egg white to be added to wine as a fining agent, as well as the manufacturing process and steps recommended to decrease residual allergens in wine, are very variable, and that according to the applicant no changes in the manufacturing process have been introduced since the last application.
Two reports on the detection of ovalbumin in wine were provided. The Panel notes that in the new analytical studies provided by the applicant, ovalbumin was detected in trace amounts (0.2 mg/L) in one (out of four) experimental white wines fined at the excess dosage, and that the results from one study which showed no detectable amounts of ovalbumin in any of the altogether 77 commercial wines tested cannot be extrapolated to a random sample of commercial wines due to the varying use of non-mandatory manufacturing practices (microfiltration, bentonite treatment) applied to most of the wines, which may have affected proteinaceous fining agent residues in the wine. The Panel also notes that these studies do not exclude the presence in wine of other egg allergens contained in egg white, for which the ability (and limit of detection) of the analytical methods used was not reported, and that the difficulties in measuring residual fining agents in (particularly red) wine with the ELISAs (because of interference with the wine matrix) may affect the reliability of the data provided. The Panel considers that although the sensitivity and performance of the methods used for the detection of ovalbumin in wine have improved relative to the previous applications, the studies provided by the applicant do not provide sufficient information about the levels of residual ovalbumin or other egg white allergens which may be found in commercial wines fined with ovalbumin/egg white under the proposed conditions of use.
Taking into account the information provided on the characterisation of the fining agents regarding their content of egg proteins other than ovalbumin, the lack of standardisation of the wine manufacturing process, and that no new clinical data have been provided in the present application, the Panel considers that the improvement on the methods used for the detection of ovalbumin in wine, and the new analytical studies provided, are insufficient to change its previous conclusion about the likelihood of adverse reactions triggered in susceptible individuals by the consumption of wines fined with ovalbumin/egg white products.
The Panel concludes that wines fined with ovalbumin/egg white products may trigger adverse reactions in susceptible individuals under the conditions of use proposed by the applicant.