Commission Implementing Regulation (EU) 2026/386 of 20 February 2026 authorising the placing on the market of defatted rapeseed powder as a novel food and amending Implementing Regulation (EU) 2017/2470

• CELEX: Implementing Regulation (EU) 2026/386
• Articles: 5

Article 1

1.   Defatted rapeseed powder is authorised to be placed on the market within the Union.

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

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

Article 2

Only the company NapiFeryn BioTech Sp. z o.o.  ( 24 ) is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of five years from 15 March 2026, 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 NapiFeryn BioTech Sp. z o.o.

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 NapiFeryn BioTech Sp. z o.o.

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 .

Schedules & Appendices

ANNEX

ANNEX

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

(1)

in Table 1 (Authorised novel foods), the following entry is inserted in alphabetical order:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data protection

‘ Defatted rapeseed powder

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be “defatted rapeseed powder”.

The labelling of food supplements containing defatted rapeseed powder shall bear a statement

(a)

that they should not be used if other foods containing added defatted rapeseed powder are consumed the same day; and

(b)

they should not be consumed by infants and children under 10 years of age.

Any foodstuff containing “defatted rapeseed powder” from Brassica rapa L. and Brassica napus L.” shall bear a statement that this ingredient may cause allergic reaction to consumers who are allergic to mustard and products thereof. That statement shall appear in close proximity to the list of ingredients.

Authorised on 15 March 2026. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: “NapiFeryn BioTech Sp. z o.o.”, Stanisława Dubois 114/116, 93-465 Łódź, Poland. During the period of data protection, the novel food defatted rapeseed powder is authorised for placing on the market within the Union only by “NapiFeryn BioTech Sp. z o.o.” 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 “NapiFeryn BioTech Sp. z o.o.”.

End date of the data protection: 15 March 2031.’

Bakery products (bread and rolls, fine bakery wares)

20 g/100g

Bread bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Implementing Regulation (EU) No 828/2014

20 g/100g

Breakfast cereals

20 g/100g

Cereal bars

20 g/100g

Pasta

10 g/100g

Pasta products bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Implementing Regulation (EU) No 828/2014

10 g/100g

Non-alcoholic powdered drinks

5 g/100 ml (reconstituted according to the instructions)

Fruit-based liquid foodstuffs (of the “smoothie” variety)

3 g/100 g

Dairy analogues

5 g/100 g

Meat analogues

15 g/100 g

Soups (dry mixture) and (ready-to-eat)

5 g/100 ml (marketed as such or reconstituted according to the instructions)

Savoury sauces

5 g/100 g

Salad dressing

5 g/100 g

Vegetable puree

7 g/100 g

Nut spreads

7 g/100 g

Chocolate confectionary

7 g/100 g

Chips, crisps, fries and dough-based analogues

15 g/100 g

Snacks other than chips

20 g/100 g

Meat products

15 g/100 g

Foods for special medical purposes as defined under Regulation (EU) No 609/2013, excluding foods for infants and young children, and children under 10 years of age.

In accordance with the particular nutritional requirements of the persons for whom the products are intended but, in any case, not higher than 30 g/day in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

Food supplements as defined in Directive 2002/46/EC, for the general population, excluding infants and young children, and children under 10 years of age.

10 g/day for the general population above 10 years of age

(2)

in Table 2 (Specifications), the following entry is inserted in alphabetical order:

Authorised novel food

Specifications

‘ Defatted rapeseed powder

Description:

The novel food is a white to off-white dried powder remaining after aqueous and organic solvent extraction (ethanol and ethyl acetate) of hulled and dehulled cold-pressed rapeseed cake originating from non-genetically modified double low (00) cultivars of Brassica napus L. and Brassica rapa L.

Characteristics/Composition:

Crude protein (% w/w): 28-45

Fat (% w/w): ≤ 2

Ash (% w/w): ≤ 5

Moisture (% w/w): ≤ 7

Total dietary fibre  ( *1 ) (% w/w): 37–70

Total glucosinolates (mmol/kg (mg/kg)): ≤ 0,1 (≤ 40)

Phytates (% w/w): ≤ 2

Heavy and other metals:

Lead (mg/kg): ≤ 0,2

Arsenic (total) (mg/kg): ≤ 0,1

Cadmium (mg/kg): ≤ 0,1

Mercury (mg/kg): ≤ 0,02

Aluminium (mg/kg): ≤ 35

Residual solvents:

Residual ethanol (mg/kg): < 200

Residual ethyl acetate (mg/kg): < 200

Microbiological criteria:

Total plate count: ≤ 10 000 CFU  ( *2 ) /g

Enterobacteriaceae: ≤ 10 CFU/g

E.coli: Absent in 10 g

Salmonella spp.: Absence in 25 g

Yeast and moulds: ≤ 100 CFU/g

Total coliform count: ≤ 10 CFU/g

B. cereus : ≤ 100 CFU/g

( *1 )   Total dietary fibre: The EFSA Panel interprets that “dietary fibre” refers to non-digestible polysaccharides classified as dietary fibre by EFSA for the specific purpose of setting Dietary Reference Values for carbohydrates and dietary fibre (EFSA NDA Panel, 2010).

( *2 )   CFU: Colony Forming Units.’