cRG-I (carrot extract)
EU authorisation 2026/1306 — “extract”, not “fibre”

The point is narrow and legal: Implementing Regulation (EU) 2026/1306 is a Commission authorising act, not another scientific “green light”. From 2 July 2026 one specific novel food — cRG-I as an extract — may be placed on the EU market after inclusion in the Union list, under the name, category maxima and labelling conditions in the act. The official designation is not “carrot fibre”.

1. What exactly did the Commission authorise?

Document 32026R1306 (ELI: http://data.europa.eu/eli/reg_impl/2026/1306/oj; EUR-Lex: CELEX:32026R1306) — Implementing Regulation (EU) 2026/1306 of 11 June 2026 — authorises the placing on the market of rhamnogalacturonan-I enriched carrot extract (cRG-I) and amends Implementing Regulation (EU) 2017/2470. Placing on the market of this novel food: from 2 July 2026 (date stated in the act / list entry).

Applicant: NutriLeads B.V., Bronland 12-N, 6708 WH Wageningen, Netherlands. Application ~17 December 2022; the Commission requested an EFSA opinion on 8 November 2023. The application proposed the name “rhamnogalacturonan-I enriched carrot fibre (cRG-I)”.

The NDA Panel, in Safety of rhamnogalacturonan-I enriched carrot fibre (cRG-I) as a novel food… (EFSA Journal 2025;23:e9537, DOI 10.2903/j.efsa.2025.9537, PubMed PMID 40894468), adopted on 25 June 2025, concluded that the NF is safe under the proposed conditions of use.

2. Why did the Commission write “extract”, not “fibre”?

This is the key labelling point of the whole act. The applicant proposed “rhamnogalacturonan-I enriched carrot fibre (cRG-I)”. EFSA used that working name in opinion e9537, but did not assess whether the material meets the legal definition of dietary fibre in Annex I to Regulation (EU) No 1169/2011.

The Commission considered that using “fibre” in the novel-food designation could mislead consumers as to nutritional properties and composition. Therefore the act and the Union list use: rhamnogalacturonan-I enriched carrot extract (cRG-I), and the labelling designation of foods containing it: “Rhamnogalacturonan-I carrot extract”.

3. What EFSA established (e9537) — safety, not the market name

Per the opinion abstract: the NF is a high-molecular-weight polysaccharide / rhamnogalacturonan-rich fraction from carrot pomace (Daucus carota). The production process raises no safety concerns; consumption is not nutritionally disadvantageous; no genotoxicity concerns; the 90-day study showed no toxicologically relevant effects up to 7 753 mg/kg bw per day; the NF may retain the allergenic potential of carrots (reactions not dissimilar to carrot consumption); margins of exposure were considered sufficient; conclusion: safe under the proposed conditions of use.

EFSA opinion ≠ authorisation. Here — as with egg membrane hydrolysate — we have both layers: the safety assessment and the Commission act with a Union-list entry.

4. Categories and maxima (annex to the act)

The levels below come from the text of Regulation 2026/1306 (annex / category table). FSMP: in accordance with the particular nutritional requirements of the persons for whom the products are intended (excluding infants and young children where the act so provides).

Supplement label: must state that the supplements should not be consumed by children under 3 years of age. NF designation: “Rhamnogalacturonan-I carrot extract”.

5. Data protection until 2 July 2031

Under Articles 26 and 27 of Regulation (EU) 2015/2283 the Commission granted five years of data protection. The scope indicated in the act includes identity, compositional data and toxicological information. Beneficiary: NutriLeads B.V. End date: 2 July 2031.

During the protection period only NutriLeads B.V. may place this NF on the Union market, unless a subsequent applicant obtains authorisation without reference to the protected data or with NutriLeads’ agreement. This is protection of procedural data, not absolute exclusivity of “any carrot extract” outside this entry.

6. Novel-food authorisation ≠ health claim

Regulation 2026/1306 gives no basis for prebiotic, immune or gut claims. Novel-food status does not automatically exclude every claim — but it is not itself a claim basis. Any such statement needs a separate legal basis under Regulation (EC) No 1924/2006. “Supports immunity because novel food” has no footing in the authorising act.

Separately: caution when marketing as “dietary fibre” / nutrition claim “source of fibre” — the Commission consciously avoided “fibre” in the designation because the fibre definition was not assessed by EFSA.

7. Poland: GIS after the EU authorisation

The Union authorisation opens placing on the market of this NF in the EU under the list conditions. A notification to the Chief Sanitary Inspector (GIS) is not an additional novel-food authorisation. It is a separate duty linked to placing a specific food supplement on the Polish market.

A product notified to GIS must match the entry: designation “Rhamnogalacturonan-I carrot extract” (or language equivalent consistent with the act), dose ≤1 500 mg/day, population above 3 years, age warning, specification compliance. GIS does not “top up” the novel-food authorisation.

8. Commercial context (secondary sources — not law)

Trade press reported Ingredion’s acquisition of NutriLeads / Benicaros assets around June 2026 and a functional dose around ~300 mg. That is commercial context, not law. The legal maximum for supplements in the act is 1 500 mg/day — do not confuse a marketing dose with the regulatory ceiling.

9. Producer / importer checklist

1. Confirm the act — 2026/1306 + entry in 2017/2470. Market from 2 Jul 2026. Not opinion-only.
2. Name — “Rhamnogalacturonan-I carrot extract”. Not “fibre” as the official NF designation.
3. Supplement dose — ≤1 500 mg/day; general population above 3 years; warning: not for children under 3.
4. Other categories — apply annex maxima (incl. TDR 1 500 mg/day, meal replacement 500 mg/meal).
5. Data protection — until 2 Jul 2031 NutriLeads; own authorisation possible on independent data or with agreement.
6. Claim — the novel-food act does not give health claims or an automatic “source of fibre”.
7. GIS (PL) — notification of the specific supplement, not a second novel-food authorisation.

Conclusion

Unlike recent EFSA opinions without a Commission act, cRG-I has a specific novel-food authorisation and a Union-list entry. The market for that entry opens on 2 July 2026, but it is narrow: designation “extract” (not “fibre”), 1 500 mg/day in supplements for persons above 3 years, NutriLeads data protection until 2031, and no automatic health or fibre claims. The fairest message: the safety authorisation opens lawful use of this ingredient under the list conditions — it does not open an “immunity” label and it does not replace a GIS notification.

Primary sources

1. Commission Implementing Regulation (EU) 2026/1306 — Document 32026R1306; ELI eli/reg_impl/2026/1306/oj; EUR-Lex eng. Authorisation of cRG-I (extract) and amendment of list 2017/2470; market from 2 Jul 2026; data protection until 2 Jul 2031.
2. EFSA NDA Panel. Safety of rhamnogalacturonan-I enriched carrot fibre (cRG-I)… EFSA Journal 2025;23:e9537. DOI: 10.2903/j.efsa.2025.9537 — opinion of 25 Jun 2025; safety; 90-day study up to 7753 mg/kg bw per day; carrot allergenicity (PMID 40894468).
3. Regulation (EU) 2015/2283 — novel foods; Art. 26/27 data protection.
4. Implementing Regulation (EU) 2017/2470 — Union list of novel foods.
5. Regulation (EU) No 1169/2011 — food information; dietary-fibre definition (Annex I) — not assessed by EFSA for cRG-I.
6. Directive 2002/46/EC — food supplements.
7. Regulation (EC) No 1924/2006 — nutrition and health claims.
8. AGRINFO — Novel food: cRG-I — summary of the act (secondary source).