Phytosterols/phytostanols from sunflower: “other sterols/stanols” from 3.0 to < 7.0 % instead of < 3.0 % (GC-FID), about half of the fraction is Δ7-stigmastenol — exclusive to Advanced Organic Materials until 17 August 2030
Commission Implementing Regulation (EU) 2025/1509, published on 28 July 2025, adds to the Union list of novel foods a specification for phytosterols/phytostanols from sunflower extract with an “other sterols/stanols” fraction from 3.0 to < 7.0 %. For five years from 17 August 2025 only the Argentinian company Advanced Organic Materials SA may place them on the market; the generic entry with the < 3.0 % limit stays unchanged.
- Composition per the specification (GC-FID or equivalent): β-sitosterol < 81 %, β-sitostanol < 35 %, campesterol < 40 %, campestanol < 15 %, stigmasterol < 30 %, brassicasterol < 3.0 %, other sterols/stanols from 3.0 to < 7.0 %. Data protection covers, among others, the composition data and the validation report of the in-house GC method for phytosterol content (annex 17e of the application).
- EFSA data (opinion of 28 November 2024), in g/100 g: free sterol product, five batches — total sterols and stanols 92.15–94.31, β-sitosterol 56.45–58.53, “other” 5.73–6.21; ester product, five batches — total 57.83–58.51, “other” 3.33–4.28. Analyses were done by accredited laboratories using validated GC-FID methods.
- The “other” fraction consists of Δ5-avenasterol, Δ7-avenasterol, Δ7-stigmastenol, Δ5,24-stigmastadienol and unidentified sterols; the four identified ones make up at least 2/3 of the fraction, Δ7-stigmastenol alone about half (2.94–3.25 g/100 g in the free product). β-Sitostanol was reported together with Δ5-avenasterol; according to the footnotes of the EFSA tables, β-sitostanol was calculated as 0.03 × β-sitosterol and Δ5-avenasterol by difference.
- According to the applicant, the existing specifications were set mainly on soy-derived phytosterols, while sunflower oil has more Δ7-avenasterol, Δ7-stigmastenol and Δ5,24-stigmastadienol. EFSA found no evidence in the literature of genotoxicity or toxicity of these four sterols; considering the history of phytosterol assessments and the JECFA group ADI, it found the change safe and of no nutritional relevance.