2023年7月26日，歐盟食品安全局就一種食品酶內(nèi)切多聚半乳糖醛酸酶和果膠裂解酶的安全性評(píng)價(jià)發(fā)布意見(jiàn)。
據(jù)了解，這種食品酶是由非轉(zhuǎn)基因塔賓曲霉菌株NZYM-PE生產(chǎn)的，旨在用于果汁生產(chǎn)的水果和蔬菜加工、果汁以外產(chǎn)品的水果和蔬菜加工、精制橄欖油生產(chǎn)以及葡萄酒和葡萄酒醋生產(chǎn)。
經(jīng)過(guò)評(píng)估，專家小組認(rèn)為，在預(yù)期的使用條件下，不能排除通過(guò)飲食接觸引起過(guò)敏反應(yīng)的風(fēng)險(xiǎn)，特別是對(duì)木瓜過(guò)敏的人，但這種風(fēng)險(xiǎn)不會(huì)超過(guò)食用木瓜的風(fēng)險(xiǎn)。此外，不能排除花粉過(guò)敏個(gè)體的口腔過(guò)敏反應(yīng)。根據(jù)所提供的數(shù)據(jù)，小組得出結(jié)論，該食品酶在預(yù)期的使用條件下不會(huì)引起安全問(wèn)題。部分原文報(bào)道如下：
The food enzyme with the declared activities 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) is produced with the non-genetically modified Aspergillus tubingensis strain NZYM-PE by Novozymes A/S. It is intended to be used in four food manufacturing processes: fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices, refined olive oil production and wine and wine vinegar production. Since residual amounts of total organic solids (TOS) are removed during production, dietary exposure was not calculated for refined olive oil production. For the remaining three food processes, it was estimated to be up to 0.132 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 (NOAEL) of 1,430 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure above 10,833. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and 13 matches were found, including one food allergen (papaya). The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, in particular for individuals sensitised to papaya, but that the risk will not exceed that of consumption of papaya. In addition, oral allergy reactions cannot be excluded in pollen-sensitised individuals. 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.
據(jù)了解，這種食品酶是由非轉(zhuǎn)基因塔賓曲霉菌株NZYM-PE生產(chǎn)的，旨在用于果汁生產(chǎn)的水果和蔬菜加工、果汁以外產(chǎn)品的水果和蔬菜加工、精制橄欖油生產(chǎn)以及葡萄酒和葡萄酒醋生產(chǎn)。
經(jīng)過(guò)評(píng)估，專家小組認(rèn)為，在預(yù)期的使用條件下，不能排除通過(guò)飲食接觸引起過(guò)敏反應(yīng)的風(fēng)險(xiǎn)，特別是對(duì)木瓜過(guò)敏的人，但這種風(fēng)險(xiǎn)不會(huì)超過(guò)食用木瓜的風(fēng)險(xiǎn)。此外，不能排除花粉過(guò)敏個(gè)體的口腔過(guò)敏反應(yīng)。根據(jù)所提供的數(shù)據(jù)，小組得出結(jié)論，該食品酶在預(yù)期的使用條件下不會(huì)引起安全問(wèn)題。部分原文報(bào)道如下：
The food enzyme with the declared activities 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) is produced with the non-genetically modified Aspergillus tubingensis strain NZYM-PE by Novozymes A/S. It is intended to be used in four food manufacturing processes: fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices, refined olive oil production and wine and wine vinegar production. Since residual amounts of total organic solids (TOS) are removed during production, dietary exposure was not calculated for refined olive oil production. For the remaining three food processes, it was estimated to be up to 0.132 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 (NOAEL) of 1,430 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure above 10,833. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and 13 matches were found, including one food allergen (papaya). The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, in particular for individuals sensitised to papaya, but that the risk will not exceed that of consumption of papaya. In addition, oral allergy reactions cannot be excluded in pollen-sensitised individuals. 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.
