Defatted rapeseed powder
EU authorisation 2026/386 — novel food on the Union list

Implementing Regulation (EU) 2026/386 of 20 February 2026 authorises the placing on the market of one specific novel food — defatted rapeseed powder — and amends Union list 2017/2470. The authorisation applies from 15 March 2026. It covers the NapiFeryn BioTech Sp. z o.o. ingredient in the Annex food categories and at the stated maxima, with data protection until 15 March 2031. EFSA opinion e9631 assessed safety; the market decision is the Commission act — it does not open the whole “rapeseed protein” class or health claims.

1. What exactly did the Commission authorise?

Document 32026R0386 (ELI: http://data.europa.eu/eli/reg_impl/2026/386/oj; EUR-Lex PDF: OJ:L_202600386) — Implementing Regulation (EU) 2026/386 of 20 February 2026 — authorises the placing on the market of defatted rapeseed powder and amends Implementing Regulation (EU) 2017/2470. Authorisation / list entry: from 15 March 2026 (entry into force on the twentieth day after OJ publication).

Applicant: NapiFeryn BioTech Sp. z o.o., Stanisława Dubois 114/116, 93-465 Łódź, Poland. Application filed on 19 August 2022 under Article 10(1) of Regulation (EU) 2015/2283 for “rapeseed protein-fibre concentrate” as a novel food (food ingredient for the general population; FSMP and food supplements for the population from 10 years of age).

The NDA Panel, in Safety of rapeseed protein–fibre concentrate as a novel food pursuant to Regulation (EU) 2015/2283 (EFSA Journal 2025; e9631, DOI 10.2903/j.efsa.2025.9631), adopted on 27 August 2025 (published 29 September 2025), concluded that the NF is safe under the proposed conditions of use 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 (manganese concern).

2. What EFSA established (e9631) — safety, not a claim

According to the NDA opinion, the powder (mainly protein + fibre) obtained after aqueous and organic solvent extraction of cold-pressed rapeseed cake from non-GM double-low (00) cultivars of Brassica rapa L. and Brassica napus L. is safe under the proposed conditions of use — with the same-day supplement condition (manganese). Recital (8) of the act states that this opinion gives sufficient grounds that the product fulfils Article 12(1) of Regulation (EU) 2015/2283.

The NDA assessment concerned safety; Regulation 2026/386 is the act that enters the NF on the list and opens the market under Annex conditions. The Panel considered that no toxicological studies with the NF were required, given the nature, process, composition and toxicological profile of similar rapeseed powders already assessed.

3. Categories and maxima (Annex Table 1)

Annex Table 1 to Regulation 2026/386 sets out exactly which foods may contain defatted rapeseed powder and at what maximum level. The figures below are the legal maxima from the act — not illustrative “best practice”.

What that means on the label: the official designation is “defatted rapeseed powder” — not a marketing name in place of the list entry. Food supplements must also state two concrete points: do not combine them with other foods that contain this ingredient on the same day (manganese concern), and they are not for infants or children under 10. Any food with this NF from Brassica rapa L. and Brassica napus L. must also warn — next to the ingredients list — that it may trigger reactions in people allergic to mustard and products thereof.

4. Specification (Annex Table 2)

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 from non-GM double-low (00) cultivars of Brassica napus L. and Brassica rapa L.

Composition ranges (Table 2): crude protein 28–45% w/w; fat ≤2; ash ≤5; moisture ≤7; total dietary fibre 37–70; total glucosinolates ≤0.1 mmol/kg (≤40 mg/kg); phytates ≤2%. Metals: Pb ≤0.2; As (total) ≤0.1; Cd ≤0.1; Hg ≤0.02; Al ≤35 mg/kg. Residual solvents: ethanol <200 mg/kg; ethyl acetate <200 mg/kg. The Annex also sets microbiological criteria (including Salmonella — absence in 25 g).

5. Data protection until 15.03.2031

Under Articles 26 and 27 of Regulation (EU) 2015/2283 the Commission granted five-year data protection. Beneficiary: NapiFeryn BioTech Sp. z o.o. End date: 15 March 2031. Authorisation from 15 March 2026.

Protected data include, inter alia: the production process (HACCP, manufacturing steps), compositional data, proposed uses and use levels and intake estimates, nutritional information (DIAAS), toxicological information, allergenicity and supplementary information — as in recitals (9)–(11).

During the protection period only NapiFeryn BioTech Sp. z o.o. may place this NF on the Union market, unless a subsequent applicant obtains an authorisation without reference to the protected data or with agreement. This is procedural data exclusivity for that application, not absolute exclusivity of “any rapeseed powder” beyond this entry.

6. Novel-food authorisation is not a health claim

Regulation 2026/386 is not a basis for claims about a “protein source”, fibre, satiety or a plant-based diet. Novel-food status does not automatically exclude all claims — but it is not itself a claim basis. Any such claim needs a separate basis under Regulation (EC) No 1924/2006.

7. National notification after EU authorisation

EU authorisation opens the Union market for this NF under the list conditions. A national notification (e.g. GIS in Poland) is not a second novel-food authorisation. It is a separate duty linked to placing a specific product on that national market.

The product must match the entry: designation “defatted rapeseed powder”, Table 1 category, maxima, specification, and labelling warnings (Mn / age / mustard). The official list designation must be used — not a marketing name replacing the list name.

8. Compliance conditions for the entry

1. Act and list — the legal basis is Regulation 2026/386 and the 2017/2470 entry; authorised from 15.03.2026.
2. Name — list designation “defatted rapeseed powder”.
3. Categories — only those in Table 1 and under the stated maxima.
4. Supplements — 10 g/day; labelling: do not combine with DRP-containing foods the same day; exclude under 10 years.
5. FSMP — ≤30 g/day in the ready-to-use product; exclude under 10 years.
6. Data protection — until 15.03.2031 NapiFeryn BioTech Sp. z o.o.; a later applicant may seek its own authorisation on independent data or with agreement.
7. Claims — the novel-food act is not a health-claim basis (1924/2006).
8. National duties — product notification remains a separate national obligation, not a second novel-food authorisation.

Conclusion

Defatted rapeseed powder has a full authorisation for a specific novel food and a Union-list entry under 2026/386. The market for this entry is open from 15 March 2026, but conditional: Table 1 categories and maxima, NapiFeryn BioTech Sp. z o.o. data protection until 2031, labelling warnings (Mn / age / mustard), and no automatic health claims. Authorisation opens lawful use of this ingredient under the entry — it does not open a “health” label and does not replace national notification.

Primary sources

1. Commission Implementing Regulation (EU) 2026/386 — Document 32026R0386; ELI eli/reg_impl/2026/386/oj; PDF OJ L. Authorises defatted rapeseed powder and amends list 2017/2470; authorised from 15.03.2026; data protection until 15.03.2031.
2. EFSA NDA Panel. Safety of rapeseed protein–fibre concentrate as a novel food… EFSA Journal 2025; e9631. DOI: 10.2903/j.efsa.2025.9631 — opinion adopted 27.08.2025 (publ. 29.09.2025); safe under proposed conditions of use with the Mn condition.
3. Regulation (EU) 2015/2283 — novel foods; Articles 26/27 data protection.
4. Implementing Regulation (EU) 2017/2470 — Union list of novel foods.
5. Regulation (EC) No 1924/2006 — nutrition and health claims.