Commission Implementing Regulation (EU) 2026/386

Contents

THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,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(1) 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 authorised novel foods.

(3)On 19 August 2022, the company NapiFeryn BioTech Sp. z o.o. (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place rapeseed protein-fibre concentrate on the Union market as a novel food. The applicant requested rapeseed protein-fibre concentrate to be used as a food ingredient in a number of food products for the general population, in food for special medical purposes as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council^note for the general population from 10 years of age, and in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council^note, for the general population from 10 years of age.

(4)With regard to the conditions of use of the novel food in food supplements, the applicant initially proposed the maximum intake level of 30 g/day, but subsequently agreed to reduce it to 10 g/day as the substance is a source of non-digestible carbohydrates.

(5)On 19 August 2022, the applicant also made a request to the Commission for the protection of the proprietary scientific studies and data, namely, the production process (hazard analysis and critical control point plan^note, data on analytical reports^note, steps of the manufacturing process^note, the Good Manufacturing Practice certificate^note), the compositional data (analyses of protein, fat, ash, moisture and fibre, amino acids, glucosinolates, heavy metals, pesticides, phytate, erucic acid, total dietary fibre, high molecular weight insoluble dietary fibre, high molecular weight soluble dietary fibre, low molecular weight soluble dietary fibre, neutral detergent fibre, acid detergent fibre, acid detergent lignin, trypsin inhibitor activity, microbial purity, residual solvents, sodium benzoate and sulphur dioxide, and phenolic compounds, data from the analytical reports on the novel food, data on internal analytical methods, stability data of the novel food and analytical protocol^note, study on the digestibility of the novel food and analytical study^note, contract research organisation report^note, data from the analytical report on aluminium, phosphane, raw materials and water activity^note, data from the analytical report on sinapine and tannins^note), the proposed uses and use levels, and anticipated intake (raw data on dietary exposure^note), the nutritional information (a sodium dodecyl sulfate-polyacrylamide gel electrophoresis analysis^note, a digestible indispensable amino acid score report^note, raw data^note), the toxicological information^note, the allergenicity^note, the history of use^note, and supplementary information^note, in support of the application.

(6)On 26 May 2023, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of rapeseed protein-fibre concentrate as a novel food in accordance with Article 10(3) of Regulation (EU) 2015/2283.

(7)On 27 August 2025, the Authority adopted its scientific opinion on the safety of rapeseed protein-fibre concentrate as a novel food^note in accordance with Article 11 of Regulation (EU) 2015/2283.

(8)In its scientific opinion, the Authority concluded that rapeseed protein-fibre concentrate is safe under the proposed conditions of use however, provided that individuals above 10 years of age do not consume foods containing the NF and food supplements containing the NF on the same day. Therefore, that scientific opinion gives sufficient grounds to establish that rapeseed protein-fibre concentrate when used under the proposed conditions of use, fulfils the conditions for its placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283.

(9)In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on the following data: the production process (hazard analysis and critical control point plan, and steps of the manufacturing process), the compositional data (analyses of protein, fat, ash, moisture and fibre, amino acids, glucosinolates, heavy metals, pesticides, phytate, erucic acid, total dietary fibre, high molecular weight insoluble dietary fibre, high molecular weight soluble dietary fibre, low molecular weight soluble dietary fibre, neutral detergent fibre, acid detergent fibre, acid detergent lignin, trypsin inhibitor activity, microbial purity, residual solvents, sodium benzoate and sulphur dioxide, and phenolic compounds, the data from the analytical reports on the novel food, data on internal analytical methods, the stability data of the novel food and analytical protocol, the data from the analytical report on aluminium, phosphane, and water activity, the data from the analytical report on sinapine and tannins), the proposed uses and use levels, and anticipated intake (raw data on dietary exposure), the nutritional information (the digestible indispensable amino acid score report), the toxicological information, the allergenicity, and supplementary information in support of the technical dossier without which it could not have assessed the novel food and reached its conclusion.

(10)The applicant declared that they held proprietary and exclusive rights of reference to the scientific studies and data at the time they submitted the application.

(11)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 scientific studies and data, namely, the production process (the hazard analysis and critical control point plan, and steps of the manufacturing process), the compositional data (analyses of protein, fat, ash, moisture and fibre, amino acids, glucosinolates, heavy metals, pesticides, phytate, erucic acid, total dietary fibre, high molecular weight insoluble dietary fibre, high molecular weight soluble dietary fibre, low molecular weight soluble dietary fibre, neutral detergent fibre, acid detergent fibre, acid detergent lignin, trypsin inhibitor activity, microbial purity, residual solvents, sodium benzoate and sulphur dioxide, and phenolic compounds, data from the analytical reports on the novel food, data on internal analytical methods, stability data of the novel food and analytical protocol, data from the analytical report on aluminium, phosphane, and water activity, data from the analytical report on sinapine and tannins), the proposed uses and use levels, and anticipated intake (raw data on dietary exposure), the nutritional information (the digestible indispensable amino acid score report), the toxicological information, the allergenicity, and supplementary information in support of the technical dossier should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place rapeseed protein-fibre concentrate on the market within the Union during a period of five years from the entry into force of this Regulation.

(12)However, restricting the authorisation of rapeseed protein-fibre concentrate and the reference to the data contained in the applicant’s file for their sole use 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.

(13)The designation ‘rapeseed protein-fibre concentrate’ does not reflect the actual composition of the novel food, as its protein content remains below 50 % and it has not been demonstrated that the fibre component meets the definition set out in Annex I to Regulation (EU) No 1169/2011 of the European Parliament and of the Council^note. The use of the term ‘protein-fibre concentrate’ in the designation of the novel food could therefore mislead consumers as to its nutritional properties and composition. Therefore, it is appropriate to replace the term ‘protein-fibre concentrate’ with a name that accurately reflects the novel food’s true nature and composition. The applicant accepted the proposed designation ‘defatted rapeseed powder’.

(14)In accordance with the conditions of use of food ingredients and food supplements containing defatted rapeseed powder as proposed by the applicant and assessed by the Authority, it is necessary to inform consumers with an appropriate label that food ingredients and food supplements containing defatted rapeseed powder should not be used if other foods with added defatted rapeseed powder are consumed the same day by individuals above 10 years of age.

(15)The Authority also considers that the novel food is likely to trigger allergic reactions in rapeseed-allergic individuals and also in mustard-allergic individuals owing to cross-reactivity. Therefore, it is necessary to provide for the labelling requirement to allow people who are allergic to mustard to avoid consumption of the novel food.

(16)It is therefore appropriate that the inclusion of defatted rapeseed powder as a novel food in the Union list of novel foods contains the information referred to in Article 9(3) of Regulation (EU) 2015/2283.

(17)Defatted rapeseed powder should be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470. 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: