The European Food Safety Authority (EFSA) has concluded that the food enzyme pectin lyase produced with the genetically modified Aspergillus niger strain CCTCC M 2023341 does not raise safety concerns under its intended uses, according to a scientific opinion published on 6 July 2026. The enzyme is intended for use in processing fruits and vegetables for juice production and other fruit and vegetable products. The assessment, carried out by EFSA's Panel on Food Enzymes, estimated dietary exposure up to 1.926 mg Total Organic Solids (TOS) per kg body weight per day in European populations. Genotoxicity tests showed no safety concern, and a 90-day oral toxicity study in rats identified a no observed adverse effect level of 2000 mg TOS/kg bw per day, the highest dose tested, resulting in a margin of exposure of at least 1038. The Panel considered that a risk of allergic reactions cannot be excluded but is low. The food enzyme was found free from viable cells of the production organism and its DNA, and the genetic modifications were deemed safe.
The opinion was adopted on 18 June 2026 and follows an application submitted on 18 July 2024 by Suntaq International Limited for authorization under Regulation (EC) No 1332/2008 on food enzymes. EFSA conducted a public consultation on the non-confidential dossier from 23 April to 19 May 2025, which received no comments. Additional data were requested during the risk assessment, and a clarification teleconference was held on 15 June 2026, after which the applicant provided further information on 16 June 2026. The enzyme is produced by submerged fermentation of the GM strain, with downstream processing including ultrafiltration. The Panel concluded that the manufacturing process and quality assurance exclude issues of concern. The opinion will inform the European Commission's decision on whether to include the enzyme in the EU list of authorized food enzymes.