Zorn Holger, Barat Baviera José Manuel, Bolognesi Claudia, Catania Francesco, Gadermaier Gabriele, Greiner Ralf, Mayo Baltasar, Mortensen Alicja, Roos Yrjö Henrik, Solano Marize L M, Van Loveren Henk, Vernis Laurence, Fernàndez-Fraguas Cristina, Cavanna Daniele, Peluso Silvia, Liu Yi
EFSA J. 2025 Jul 30;23(7):e9532. doi: 10.2903/j.efsa.2025.9532. eCollection 2025 Jul.
The asparaginase (L-asparagine amidohydrolase, EC 3.5.1.1) is produced by the non-genetically modified strain ARY-2 by Renaissance BioScience Corporation. The food enzyme is not separated from the yeast cells during the enzyme production. The food enzyme is intended to be used to reduce acrylamide formation during food processing at high temperature and low moisture conditions by hydrolysing asparagine. Dietary exposure was estimated to be up to 32.246 mg TOS/kg body weight per day in European populations. Toxicity tests were considered unnecessary by the Panel because the production strain was considered safe and no issues of concern resulting from the food enzyme manufacturing process were identified. A search for the homology of the amino acid sequence of the asparaginase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.
天冬酰胺酶（L-天冬酰胺酰胺水解酶，EC 3.5.1.1）由复兴生物科学公司的非转基因菌株ARY-2生产。在酶生产过程中，该食品酶不与酵母细胞分离。该食品酶旨在通过水解天冬酰胺来减少高温低湿条件下食品加工过程中丙烯酰胺的形成。据估计，欧洲人群的膳食暴露量高达每天32.246毫克总有机固体/千克体重。专家小组认为无需进行毒性测试，因为生产菌株被认为是安全的，且未发现食品酶制造过程产生的任何问题。对天冬酰胺酶的氨基酸序列与已知过敏原进行了同源性搜索，未发现匹配项。专家小组认为，不能排除膳食接触该食品酶后发生过敏反应的风险。根据提供的数据，专家小组得出结论，在预期使用条件下，这种食品酶不会引起安全问题。
