Turck Dominique, Bohn Torsten, Cámara Montaña, Castenmiller Jacqueline, De Henauw Stefaan, Hirsch-Ernst Karen Ildico, Jos Ángeles, Maciuk Alexandre, Mangelsdorf Inge, McNulty Breige, Naska Androniki, Pentieva Kristina, Siani Alfonso, Thies Frank, Aguilera-Gómez Margarita, Cubadda Francesco, Frenzel Thomas, Heinonen Marina, Neuhäuser-Berthold Monika, Knutsen Helle Katrine, Poulsen Morten, Maradona Miguel Prieto, Schlatter Josef Rudolf, Siskos Alexandros, van Loveren Henk, Gelbmann Wolfgang, McArdle Harry J
EFSA J. 2025 Jan 27;23(1):e9162. doi: 10.2903/j.efsa.2025.9162. eCollection 2025 Jan.
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to provide an opinion on the safety of a change of the specifications of the authorised NF 'phytosterols/phytostanols' as a novel food (NF) pursuant to Regulation (EU) 2015/2283. This authorised NF concerns phytosterols extracted from plants and which may be presented as free sterols and stanols or esterified with food grade fatty acids. It has to contain less than 81% β-sitosterol, less than 35% β-sitostanol, less than 40% campesterol, less than 15% campestanol, less than 30% stigmasterol and less than 3% brassicasterol. Regarding the maximum limit of the specification parameter 'other sterols/stanols', the applicant asks for an increase from currently less than 3% to less than 7% to better reflect and cover the natural composition and proportions of sunflower-based phytosterols/phytostanols, noting that the existing specifications have been established largely based on the NF when sourced from soy. No evidence was found from the literature for the genotoxicity, subchronic toxicity, chronic toxicity and carcinogenicity, and reproductive toxicity of four phytosterols which have been identified by the applicant in the NF when produced from sunflower oil. These four phytosterols, albeit at lower concentrations, are also found in the NF if produced from soy. The Panel also notes the history of multiple safety assessments of phytosterols performed by Member States and EFSA, in addition to the group ADI established by JECFA. The Panel also considers that an increase from less than 3 to less than 7% for the maximum specification limit for 'other phytosterols' is of no relevance regarding nutritional considerations. The Panel concludes that the NF is safe under the proposed change of the specifications.
应欧盟委员会的要求，欧洲食品安全局营养、新型食品及食品过敏原专家小组（NDA）被要求就根据欧盟法规（EU）2015/2283对授权新型食品“植物甾醇/植物甾烷醇”的规格变更的安全性提供意见。这种授权新型食品涉及从植物中提取的植物甾醇，其可以以游离甾醇和甾烷醇形式呈现，或者与食品级脂肪酸酯化。它必须含有低于81%的β-谷甾醇、低于35%的β-谷甾烷醇、低于40%的菜油甾醇、低于15%的菜油甾烷醇、低于30%的豆甾醇和低于3%的油菜甾醇。关于规格参数“其他甾醇/甾烷醇”的最大限量，申请人请求从目前的低于3%提高到低于7%，以更好地反映和涵盖基于向日葵的植物甾醇/植物甾烷醇的天然组成和比例，并指出现有规格主要是基于来源于大豆的新型食品制定的。未从文献中发现申请人所确定的在由向日葵油生产的新型食品中的四种植物甾醇的遗传毒性、亚慢性毒性、慢性毒性、致癌性以及生殖毒性的证据。如果由大豆生产，这四种植物甾醇在新型食品中也会以较低浓度存在。专家小组还注意到成员国和欧洲食品安全局对植物甾醇进行的多次安全评估的历史，以及食品添加剂联合专家委员会确定的群体每日允许摄入量。专家小组还认为，将“其他植物甾醇”的最大规格限量从低于3%提高到低于7%在营养方面无关紧要。专家小组得出结论，在提议的规格变更下，该新型食品是安全的。
