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Safety evaluation of a food enzyme containing endo-polygalacturonase and pectin lyase activities from the non-genetically modified Aspergillus luchuensis strain NZYM-XA
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DOI：10.2903/j.efsa.2026.10173.png)
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Abstract
En 中文
The food enzyme containing endo-polygalacturonase (1,4-α-d-galacturonan glycanohydrolase; EC 3.2.1.15) and pectin lyase (1,4-6-O-methyl-α-d-galacturonan lyase; EC 4.2.2.10) activities is produced with the non-genetically modified microorganism Aspergillus luchuensis strain NZYM-XA by Novozymes A/S. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in four food manufacturing processes. Since residual amounts of Total Organic Solids (TOS) are removed in one process, dietary exposure was calculated for the remaining three food manufacturing processes. It was estimated to be up to 0.155 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1718 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 11,084. A search for the homology of the amino acid sequences to known allergens was made and matches with 1 food allergen and 13 respiratory allergens were 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.
Keywords:
1,4-6-O-methyl-α-d-galacturonan lyase
1,4-α-d-galacturonan glycanohydrolase
Aspergillus luchuensis
EC 3.2.1.15
EC 4.2.2.10
food enzyme
pectin lyase
polygalacturonase
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