Castle Laurence, Andreassen Monica, Aquilina Gabriele, Bastos Maria Lourdes, Boon Polly, Fallico Biagio, FitzGerald Reginald, Frutos Fernandez Maria Jose, Grasl-Kraupp Bettina, Gundert-Remy Ursula, Gürtler Rainer, Houdeau Eric, Kurek Marcin, Louro Henriqueta, Morales Patricia, Passamonti Sabina, Barat Baviera José Manuel, Degen Gisela, Gott David, Leblanc Jean-Charles, Moldeus Peter, Waalkens-Berendsen Ine, Wölfle Detlef, Gagliardi Gabriele, Mech Agnieszka, Smeraldi Camilla, Tard Alexandra, Zakidou Panagiota, Ruggeri Laura
EFSA J. 2025 Mar 10;23(3):e9255. doi: 10.2903/j.efsa.2025.9255. eCollection 2025 Mar.
The EFSA Panel on Food Additive and Flavourings (FAF Panel) provides a scientific opinion on the safety assessment of the proposed use of pea fibre concentrate (FIPEA) as a food additive. FIPEA is a powder consisting mainly of dietary fibres (i.e. pectin and hemicellulose), and low amounts of protein, derived from yellow pea (). The manufacturing process includes extensive heat treatments, (e.g. > 100°C for more than 40 min), conditions which lead to inactivation of lectins, that in FIPEA do not pose a safety concern. A specific α-amylase is used in the manufacturing, and this should be included in the definition of the proposed specifications. The Panel considered that the additional contribution of FIPEA to the total fibre intake in adults and toddlers would be acceptable considering the levels that are considered adequate by the NDA Panel. The Panel recommended to lower the specification limits proposed for the toxic elements. The solubility test indicates that the material does not require specific assessment at the nanoscale. No toxicological data have been submitted on FIPEA. The Panel considered that, similarly to water-soluble soybean polysaccharides, FIPEA is not absorbed intact but undergoes extensive fermentation by the intestinal microbiota in humans and is not of genotoxic concern. Dry peas (raw material) are a staple food, with a very long history of safe use in the EU. FIPEA is extracted with hot water from the insoluble fibrous material of dehulled yellow peas, therefore the structure of the fibres is not chemically modified, and no new by-products or components of toxicological concern are expected from the manufacturing process. The Panel concluded that there was no need for a numerical acceptable daily intake (ADI) and that pea fibre concentrate (FIPEA) as a new food additive does not raise a safety concern at the proposed use and use levels.
欧洲食品安全局食品添加剂和香料小组(FAF小组)就豌豆纤维浓缩物(FIPEA)作为食品添加剂的拟用安全性评估提供了科学意见。FIPEA是一种粉末,主要由膳食纤维(即果胶和半纤维素)以及少量蛋白质组成,来源于黄豌豆。制造过程包括广泛的热处理(例如,超过100°C持续40分钟以上),这些条件会导致凝集素失活,在FIPEA中这不会引起安全问题。制造过程中使用了一种特定的α-淀粉酶,应将其纳入拟议规格的定义中。小组认为,考虑到营养与膳食补充剂小组认为足够的水平,FIPEA对成人和幼儿总纤维摄入量的额外贡献是可以接受的。小组建议降低拟议的有毒元素规格限值。溶解度测试表明,该物质不需要在纳米尺度上进行特定评估。尚未提交关于FIPEA的毒理学数据。小组认为,与水溶性大豆多糖类似,FIPEA不会完整吸收,而是在人体肠道微生物群中经历广泛发酵,并且不存在遗传毒性问题。干豌豆(原材料)是一种主食,在欧盟有很长的安全使用历史。FIPEA是从去皮黄豌豆的不溶性纤维材料中用热水提取的,因此纤维结构未发生化学改性,预计制造过程中不会产生新的毒理学相关副产品或成分。小组得出结论,不需要设定数值化的每日允许摄入量(ADI),并且豌豆纤维浓缩物(FIPEA)作为一种新的食品添加剂,在所提议的使用和使用水平下不会引起安全问题。