2025-06-112025-06-112025-01-27Turck, D., Bohn, T., Cámara, M., Castenmiller, J., Henauw, S.d., Hirsch-Ernst, K.I.,...,McArdle, H.J. (2025). Safety of a change of specifications of phytosterols/phytostanols as a novel food pursuant to Regulation (EU)2015/2283. Efsa Journal, 23 (1), e9162. https://doi.org/10.2903/j.efsa.2025.9162.1831-4732https://hdl.handle.net/11441/174201Following a request from the European Commission, the EFSA Panel on Nutrition,Novel Foods and Food Allergens (NDA) was asked to provide an opinion on thesafety of a change of the specifications of the authorised NF ‘phytosterols/phyto-stanols’ as a novel food (NF) pursuant to Regulation (EU) 2015/2283. This author-ised NF concerns phytosterols extracted from plants and which may be presentedas free sterols and stanols or esterified with food grade fatty acids. It has to con-tain less than 81% β-sitosterol, less than 35% β-sitostanol, less than 40% camp-esterol, less than 15% campestanol, less than 30% stigmasterol and less than 3%brassicasterol. Regarding the maximum limit of the specification parameter ‘othersterols/stanols’, the applicant asks for an increase from currently less than 3% toless than 7% to better reflect and cover the natural composition and proportionsof sunflower-based phytosterols/phytostanols, noting that the existing specifica-tions have been established largely based on the NF when sourced from soy. Noevidence was found from the literature for the genotoxicity, subchronic toxicity,chronic toxicity and carcinogenicity, and reproductive toxicity of four phytosterolswhich have been identified by the applicant in the NF when produced from sun-flower oil. These four phytosterols, albeit at lower concentrations, are also foundin the NF if produced from soy. The Panel also notes the history of multiple safetyassessments of phytosterols performed by Member States and EFSA, in addition tothe group ADI established by JECFA. The Panel also considers that an increase fromless than 3 to less than 7% for the maximum specification limit for ‘other phytos-terols’ is of no relevance regarding nutritional considerations. The Panel concludesthat the NF is safe under the proposed change of the specifications.application/pdf11 p.engAttribution-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nd/4.0/Delta-7-stigmastenolNovel foodsPhytostanol estersPhytostanolsPhytosterol estersPhytosterolsSunflower oilinfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccesshttps://doi.org/10.2903/j.efsa.2025.9162