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 Oenological Products and Practices International Association (OENOPPIA) on lysozyme from hen‟s egg used in the manufacture of wine as an anti-microbial stabilizer/additive pursuant to Article 6, paragraph 11 of Directive 2000/13/EC – for permanent exemption from labelling.
Prevalence of allergy to egg proteins has been reported to be around 0.3 % in adults. Taking into account that egg allergic individuals can react to lysozyme and lysozyme-containing foods, it is appropriate for the Panel to assess the likelihood of adverse reactions in allergic individuals consuming products where lysozyme has been added during the manufacturing process.
In winemaking, lysozyme is used for the control of lactic acid bacteria. Lysozyme is allowed for use in food manufacturing (cheese and wine) in EU countries, and must follow purity specifications set forth in European legislation. The purity of only one commercial product was described in the application.
Lysozyme can be used at different stages of wine production and at different doses, and no steps are taken specifically to remove lysozyme from wine. In the studies provided by the applicant, lysozyme was detected in some of the lysozyme-treated wines under the proposed conditions of use.
The applicant stated that lysozyme is the weakest allergen among the four major egg white proteins and indicated a frequency of sensitisation to lysozyme among egg allergic subjects of 15 %, as compared to 53 % for ovotransferrin and 32 % for ovomucoid and ovalbumin. The Panel notes that IgE anti-lysozyme antibodies as markers of sensitisation have been found more often in other studies e.g. in 35 %, 53 %, and 100 % of egg allergic consumers.
The applicant cited two human studies in egg-allergic individuals undergoing skin prick testing with lysozyme-treated wines. The Panel notes that the results from these studies are consistent with the analytical findings of significant residual amounts of lysozyme in treated wines but provide no information about the clinical reactivity of egg-allergic individuals to wines treated with lysozyme when consumed orally.
The applicant acknowledged that lysozyme residues are present in lysozyme-treated wines and that lysozyme is a sensitizer. However, the applicant proposed that oral consumption of lysozyme may not elicit clinical allergic reactions in egg-allergic individuals. The Panel notes that reports (including one double-blind placebo-controlled food challenge, DBPCFC) of allergic reactions to lysozyme and lysozyme-containing foods among egg-allergic individuals are available in the literature, and that results from a clinical study on lysozyme-containing cheese do not allow conclusions about the safety of lysozyme consumption in clinically egg allergic individuals.
The Panel took into account that allergic sensitisation to lysozyme is common among egg allergic individuals, that residual amounts of lysozyme considered sufficient to trigger allergic reactions in susceptible individuals have been demonstrated in wines treated with lysozyme, and that a number of clinical reports (including one DBPCFC with lysozyme) described clinical allergic reactions to lysozyme.
The Panel concludes that wines treated with lysozyme may trigger adverse allergic reactions in susceptible individuals under the conditions of use proposed by the applicant.