Safety evaluation of the food enzyme containing endo-polygalacturonase, pectinesterase, pectin lyase and arabinan endo-1,5-α-l-arabinanase activities from the non-genetically modified Aspergillus sp. strain ASNSC.

The food enzyme containing endo-polygalacturonase (1,4-α-d-galacturonan glycanohydrolase; EC 3.2.1.15), pectinesterase (pectin pectylhydrolase; EC 3.1.1.11), pectin lyase (1,4-6-O-methyl-α-d-galacturonan lyase; EC 4.2.2.10) and arabinan endo-1,5-α-l-arabinanase (5-α-l-arabinan 5-α-l-arabinanohydrolase; EC 3.2.1.99) activities is produced with the non-genetically modified Aspergillus sp. strain ASNSC by Advanced Enzyme Technologies Ltd. The food enzyme was considered free from viable cells of the production strain. The applicant proposed the use of the food enzyme in four food manufacturing processes. Since one activity is not allowed in fruit juice production in the European Union and residual amounts of food enzyme-total organic solids (TOS) are removed in one process, dietary exposure was calculated for the remaining two food manufacturing processes. It was estimated to be up to 2.179 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 708 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 325. A search for the homology of the amino acid sequences of pectinesterase and pectin lyase to known allergens was made and no match was found. No information was provided for the two other declared activities; however, considering that the production strain belongs to an Aspergillus species, matches with allergenic polygalacturonases are expected. The Panel considered that, under the intended conditions of use, a risk of allergic reactions upon dietary exposure 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, in three food manufacturing processes (excluding the use in the production of juices).