The European Food Safety Authority (EFSA) has concluded that a food enzyme containing endo-polygalacturonase and pectin lyase activities, produced with the non-genetically modified Aspergillus luchuensis strain NZYM-XA by Novozymes A/S, does not give rise to safety concerns under the intended conditions of use. In a scientific opinion adopted on 16 June 2026 and published on 8 July 2026, the EFSA Panel on Food Enzymes assessed the enzyme, which is intended for use in four food manufacturing processes: processing of fruits and vegetables for juices, fruit and vegetable products other than juices, wine and wine vinegar, and processing of plant- and fungal-derived products for edible oils. The dietary exposure was estimated at up to 0.155 mg Total Organic Solids (TOS) per kg body weight per day for European populations, based on three processes where TOS residues remain. Genotoxicity tests showed no safety concern, and a 90-day oral toxicity study in rats identified a no observed adverse effect level of 1718 mg TOS/kg bw per day, resulting in a margin of exposure of at least 11,084. However, the panel noted that a risk of allergic reactions cannot be excluded, as amino acid sequence homology searches found matches with one food allergen and 13 respiratory allergens. The opinion follows an application submitted by Novozymes A/S under the EU's food enzyme regulation framework, which requires all food enzymes on the EU market to undergo safety evaluation by EFSA before authorisation. The assessment was conducted in line with EFSA's guidance documents, and additional data were provided by the applicant in April 2025 following a request from EFSA in September 2023. The food enzyme was considered free from viable cells of the production organism. The panel concluded that the enzyme does not pose a safety concern under the intended conditions of use, paving the way for potential EU authorisation.
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