Scientific Opinion related to a notification from the Oenological Products and Practices International Association (OENOPPIA) on lysozyme from hen’s egg to be 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

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 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. Allergic sensitisation against lysozyme is common among egg allergic individuals. In winemaking, lysozyme is used for the control of lactic acid bacteria, and it is considered essential to obtain consistent and high quality. 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 estimated lysozyme content in white wines with and without bentonite treatment, and in red wines without bentonite treatment. Residual amounts of lysozyme considered sufficient to trigger allergic reactions in susceptible individuals have been demonstrated in wines treated with lysozyme, and a number of clinical reports (including one double-blind placebo-controlled food challenge 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.