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EU evaluates the safety of prolulanase produced by non-GMO Klebsiella pneumoniae strain AE-PUL

Food Partner Network News On May 19, 2025, the EU Food Safety Administration issued an opinion on the safety evaluation of a food enzyme, pullulanase.    It is understood that this food enzyme is produced by the non-GMO Klebsiella pneumoniae strain AE-PUL and is intended to be used in eight food production processes.    After evaluation, the expert team believes that under the expected use conditions, the risk of allergic reactions caused by dietary exposure cannot be ruled out. Based on the data provided, the evaluation team concluded that this food enzyme would not cause safety issues under the conditions of intended use. Some of the original reports are as follows:

The food enzyme pullulanase (pullulan 6-α-glucanohydrolase, EC 3.2.1.41) is produced by Amano Enzymes Inc. with the non-genetically modified Klebsiella pneumoniae strain AE-PUL, a known human pathogen. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in 10 food manufacturing processes. Since residual amounts of food enzyme—total organic solids (TOS) are removed in two processes, dietary exposure was calculated only for the remaining eight food manufacturing processes. It was estimated to be up to 0.075 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 0 124 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 1653. A search for the homology of the amino acid sequence of the pullulanase to known allergens was made and matches with two food allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure to this 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.

EU evaluates the safety of alternating sugar-sucrose enzymes produced by transgenic E. coli strain EBASSC

Food Partner Network News On April 9, 2025, the EU Food Safety Agency issued an opinion on the safety evaluation of an alternansucrase.    It is understood that this food enzyme is produced by the transgenic E. coli strain EBASSC and is intended to be used for the processing of sugars to produce maltose alternating sugar oligosaccharides.    After evaluation, the panel believes that the risk of allergic reactions caused by dietary exposure cannot be ruled out under the expected use conditions, but this possibility is considered low. Based on the data provided, the evaluation team concluded that this food enzyme would not cause safety issues under the conditions of intended use. Some of the original reports are as follows:

he food enzyme alternansucrase (sucrose:1,6(1,3)-α-d-glucan 6(3)-α-d-glucosyltransferase; EC 2.4.1.140) is produced with the genetically modified Escherichia coli strain EBASSC by Advanced Enzyme Technologies Ltd. The production strain of the food enzyme contains a known antimicrobial resistance gene. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. The food enzyme is intended to be used in the processing of sugars for the production of maltose alternan gluco-oligosaccharides. Two sets of dietary exposure estimates were made, using the default or more specific input factors. The refined dietary exposure was estimated to be up to 0.586 mg total organic solids (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 500 mg TOS/kg bw per day, the mid-dose tested, which when compared with the refined exposure estimate, results in a margin of exposure of at least 853. A search for the homology of the amino acid sequence of the alternansucrase 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, but the likelihood is low. 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.

EU assesses the safety of yuna oil as a new food

Food Partner Network News On November 27, 2024, according to the European Food Safety Authority (EFSA), the EU Nutrition, Novel Food and Food Allergens (NDA) Research Group discussed the safety of Cyperus esculentus oil as a new food express scientific opinions

After their evaluation, the expert panel concluded that the oil is safe as a novel food under the proposed conditions of use. Part of the original report is as follows:

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of Tiger nuts (Cyperus esculentus) oil as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Tiger nuts (C.?esculentus) is an edible tuber with history of consumption as food. The NF is the oil obtained from the nuts through cold pressing of the seeds flour. Oleic acid is the major component, representing 65%–69% of the oil's total fatty acids. The applicant proposed to use the NF as an ingredient in several food categories, and as a cooking oil or added as a condiment. The Panel notes that there are no safety concerns regarding stability if the NF complies with the proposed specification limits during its entire shelf-life. Taking into consideration the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. The Panel considers that, based on the production process, composition of the NF, history of use of and composition of the source, no toxicological studies are required on the NF. The Panel concludes that the NF is safe under the proposed conditions of use.

The European Union plans to set import limits for thifenacet in blackberries and raspberries

Food Partner Network News On December 2, 2024, the European Food Safety Authority (EFSA) announced that it plans to establish import limits for hexythiazox in blackberries and raspberries.

In accordance with Chapter 6 of European Commission Regulation No. 396/2005, Gowan Crop Protection Limited submitted an application to the Finnish national competent authority to establish import limits for thiafoxen in blackberries and raspberries. Based on the results of the risk assessment, EFSA concluded that, based on reported agricultural practices, the ingestion of residues resulting from the use of fenacetate is unlikely to pose a risk to consumer health. Part of the original report is as follows

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Gowan Crop Protection Limited submitted a request to the competent national authority in Finland to set an import tolerance for the active substance hexythiazox in blackberries and raspberries. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals of 3 mg/kg for raspberries and blackberries. Adequate analytical methods for enforcement are available to control the residues of hexythiazox in the plant matrices under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. based on the risk assessment results, EFSA concluded that the intake of residues resulting from the use of hexythiazox according to the reported agricultural practices is unlikely to present a risk to consumer health

EU assesses safety of protein-glutamine gamma-glutamyl transferase produced by non-GM Streptomyces moehara strain AE-BTG

Food Partner Network News On December 2, 2024, the European Food Safety Authority issued an opinion on the safety evaluation of a protein-glutamine γ-glutamyltransferase (protein–glutamine γ-glutamyltransferase).

It is understood that this food enzyme is produced by the non-GMO Streptomyces mohara strain AE-BTG and is intended for use in nine food production processes.

After evaluation, the expert panel concluded that the risk of allergic reactions from dietary exposure cannot be ruled out under the intended conditions of use. Based on the data presented, the evaluation team concluded that this food enzyme does not pose safety concerns under the conditions of intended use. Part of the original report is as follows:

The food enzyme protein-glutamine γ-glutamyltransferase (protein-glutamine: amine γ-glutamyltransferase; EC 2.3.2.13) is produced with the non-genetically modified S.mobaraensis strain AE-BTG by AJINOMOTO EUROPE SAS. The food enzyme was free from viable cells of the production organism. It is intended to be used in nine food manufacturing processes. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.398 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 538 mg TOS/kg bw per day which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 1351. A search for homology of the amino acid sequence of the food enzyme to known allergens was made and no match was found. Known sources of food allergens were used in the food enzyme manufacturing process, and the Panel considered that the risk of allergic reactions upon dietary exposure to this 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.