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EU evaluation of safety of pectin lyase produced by transgenic Trichoderma reesei strain RF6199

 foodmate 2022-12-09

On December 8, 2022, the European Food Safety Authority issued an opinion on the safety evaluation of a pectin lyase enzyme.

This food enzyme is known to be produced by the genetically modified Trichoderma reesei strain RF6199. After evaluation, the Panel concluded that the risk of allergic reactions from dietary exposure could not be ruled out under the intended conditions of use, but this likelihood was considered low. Based on the data provided, the Panel concluded that this food enzyme does not pose a safety problem under the intended conditions of use. Some of the original articles are reported below:

The food enzyme pectin lyase ((1-4)-6-O-methyl-α-D-galacturo nan lyase; EC 4.2.2.10) is produced with the genetically modified Trichoderma reesei strain RF6199 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. It is intended to be used in six manufacturing processes: fruit and vegetable processing for juice production, fruit and vegetable processing for fruit brandies, fruit and vegetable processing for products other than juices, wine and wine vinegar production, refined and unrefined sugar production and coffee bean demucilation. Foods obtained from fruit processing for fruit brandies and coffee bean demucilation, as well as refined sugars, were excluded from dietary exposure estimation. For the remaining four processes, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.2 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 1,000 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 5,000. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood of such reactions 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.

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EU evaluation of safety of pectin lyase produced by transgenic Trichoderma reesei strain RF6199

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