Commission Implementing Regulation (EU) 2025/1509 of 25 July 2025 amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food phytosterols/phytostanols

Implementing Regulation (EU) 2025/1509 · Regulation · 5 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Only the company Advanced Organic Materials SA ( 21 ) is authorised to place on the market within the Union the novel food ‘phytosterols/phytostanols’ composed of 3,0 % to < 7,0 % of other sterols/stanols and as specified in the Annex to this Regulation for a period of five years from 17 August 2025, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of Advanced Organic Materials SA.

Article 3

The scientific data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of Advanced Organic Materials SA.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Supplementary provisions

ANNEXSupplementary provisions

ANNEX The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows: (1) in Table 2 (Specifications), the following entry for Phytosterols/phytostanols is inserted in alphabetical order: Authorised Novel Food Specifications ‘Phytosterols/phytostanols Description/Definition: Phytosterols and phytostanols are sterols and stanols that are extracted from the sunflower plant and may be presented as free sterols and stanols or esterified with food grade fatty acids. Composition (with GC-FID or equivalent method): β-sitosterol: < 81 % β-sitostanol: < 35 % campesterol: < 40 % campestanol: < 15 % stigmasterol: < 30 % brassicasterol: < 3,0 % other sterols/stanols: 3,0 % to < 7,0 % ( 1 ) ( 1 ) Authorised on 17 August 2025. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Advanced Organic Materials SA, Street 14, No 507, Parque Industrial Pilar, B1629, Provincia de Buenos Aires, Argentina. During the period of data protection, the novel food phytosterols/phytostanols composed of 3,0 % to < 7,0 % of other sterols/stanols is autho.rised for placing on the market within the Union only by Advanced Organic Materials SA, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Advanced Organic Materials SA. End date of the data protection: 17 August 2030.’

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

What to look at next

Browse all EU Legal ActsEvery instrument by type and year, full text free to read section by sectionEuropean Union legislation EU Legal Acts by type and yearGrouped by instrument type and year of enactment, so you can find others of the same kindBrowse by type and year European Union: what this database coversWhich datasets are here, which official source they come from, and how current they areEuropean Union overview