Commission Implementing Regulation (EU) 2025/1509

Contents

THE EUROPEAN COMMISSION,Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001^note, and in particular Article 12 thereof,Whereas:

(1)Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union.

(2)Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470^note has established a Union list of novel foods.

(3)The novel food phytosterols/phytostanols was authorised under certain conditions of use and maximum levels by Commission Decisions 2000/500/EC^note, 2004/333/EC^note, 2004/334/EC^note, 2004/335/EC^note, 2004/336/EC^note, 2004/845/EC^note, 2006/58/EC^note, 2006/59/EC^note, 2007/343/EC^note, 2008/36/EC^note, and previously authorised pursuant to Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council^note.

(4)The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 therefore includes phytosterols/phytostanols as an authorised novel food.

(5)On 29 June 2023, the company Advanced Organic Materials SA (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 for a change in the specifications of the novel food phytosterols/phytostanols. The applicant requested to increase the maximum level of ‘other sterols/stanols’ from 3,0 % to < 7,0 % to better reflect and cover the natural composition and proportions of sunflower-based phytosterols/phytostanols.

(6)On 29 June 2023, the applicant also made a request to the Commission for the protection of the following proprietary data: compositional data^note, a microbiological, heavy metals, pesticides, aflatoxins and sulphated ash analytical report^note, a dioxins and polychlorinated biphenyls (PCBs), polycyclic aromatic hydrocarbons (PAH) and residual solvents analytical report^note, a particle size distribution report^note, a stability study report^note, and a validation report on the in-house method for the determination of phytosterol content using gas chromatography^note.

(7)In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 4 January 2024, requesting it to provide a scientific opinion on the change of the specifications of the novel food phytosterols/phytostanols.

(8)On 28 November 2024, the Authority adopted its scientific opinion on the ‘change of specifications of phytosterols/phytostanols as a novel food pursuant to Regulation (EU) 2015/2283’^note in accordance with Article 11 of Regulation (EU) 2015/2283.

(9)In its scientific opinion, the Authority identified four phytosterols from the ‘other sterols/stanols’ fraction, representing at least two-thirds of this fraction when phytosterols/phytostanols are produced from sunflower oil. Given the higher proportion of the ‘other phytosterols’ fraction in phytosterols/phytostanols sourced from sunflower, it is deemed appropriate to increase the authorised level of ‘other sterols/stanols’ from < 3,0 % to < 7,0 %.

(10)The opinion of the Authority concluded that phytosterols/phytostanols is safe under the proposed change of the specifications. Therefore, that scientific opinion gives sufficient grounds to establish that the change to the specifications of the novel food phytosterols/phytostanols fulfils the conditions for its placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283.

(11)In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food based on the additional specification relied on scientific studies and data, specifically the compositional data and the validation report on the in-house method for the determination of phytosterol content using gas chromatography. Without that information, it would not have been possible to assess the novel food and reached a conclusion.

(12)The Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over those scientific studies and data, and to clarify their claim to an exclusive right of reference to them in accordance with Article 26(2), point (b), of Regulation (EU) 2015/2283.

(13)The applicant declared that they held proprietary and exclusive rights of reference to the scientific studies and data, specifically compositional data and the validation report on the in-house method for the determination of phytosterol content using gas chromatography at the time they submitted the application, and that third parties cannot lawfully access, use or refer to those data.

(14)The Commission assessed all the information provided by the applicant and considered that they have sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the compositional data and the validation report on the in-house method for the determination of phytosterol content using gas chromatography should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised during a period of five years from the entry into force of this Regulation to place on the market within the Union phytosterols/phytostanols that are extracted from the sunflower plant and that have equal or more than 3 % and less than 7 % of ‘other sterols/stanols’ fraction.

(15)However, the restriction to this authorisation of phytosterols/phytostanols and the reference to the scientific studies and data contained in the applicant’s file for the sole use by them does not prevent subsequent applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting such an authorisation.

(16)Under the Union list set out in the Annex to Implementing Regulation (EU) 2017/2470, the novel food ‘phytosterols/phytostanols’ that are extracted from plants, including sunflower, having ‘other sterols/stanols’ fraction less than 3,0 %, are authorised as generic, without any data protection. This existing authorisation is not affected by the present amendment.

(17)The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

(18)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1 #

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

Article 2 #

Only the company Advanced Organic Materials SA^note 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.

(1)in Table 2 (Specifications), the following entry for Phytosterols/phytostanols is inserted in alphabetical order:Authorised Novel Food | SpecificationsPhytosterols/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 %

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

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Article 2#

Article 3#

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