Novel food and food supplements — Art. 4 checklist and EU authorisation clock (2026)

Q: Catalogue vs Union list — which binds?

The Union list in Regulation (EU) 2017/2470 binds. The Commission catalogue is non-binding, non-exhaustive orientation.

Q: Is supplement-only history of use enough?

Not as automatic proof of non-novelty against the 15 May 1997 cut-off under 2015/2283. What counts is significant consumption in the Union before that date in the relevant form.

Q: Does a positive EFSA opinion allow placing on the market?

No. You need a Commission act and a 2017/2470 list entry with conditions of use. EFSA opinion ≠ authorisation.

Q: What are the statutory clocks for Art. 4, EFSA and the Commission?

Art. 4 (2018/456): 4 months from validity, optional +4. EFSA (Art. 11 of 2015/2283): 9 months from a valid application received from the Commission. Commission (Art. 12): 7 months from publication of the EFSA opinion to submit a draft implementing act. These are not launch dates.

Q: When to consider traditional food from a third country?

When you can document ≥25 years of safe food use in a third country and the profile fits Article 14 et seq. — not as an escape hatch for new extracts.

Q: What if GIS questions novel-food status under Art. 30?

Order the evidence: identity → pre-15 May 1997 history or a matching 2017/2470 entry or an Art. 4 result. An ESP acknowledgement does not accept the composition. Missing EU authorisation does not disappear via filing. See the GIS pillar.

Q: Can unauthorised novel food be fixed by GIS notification?

No. Article 29 notification is not a novel-food authorisation.

Listen to the article:

Novel food in a food-supplement formula is a gate before GIS notification, not an “ESP annex”. The cut-off date for significant human consumption in the Union is 15 May 1997 (Regulation (EU) 2015/2283). The binding instrument for authorised novel foods is the Union list in Commission Implementing Regulation (EU) 2017/2470 — with conditions of use, specifications and labelling. The Commission catalogue is an orientation tool: non-binding and non-exhaustive. A positive EFSA opinion does not open the market; only a Commission implementing act and a list entry do. A GIS filing (Art. 29 of the Polish Food Safety Act) cannot cure an unauthorised novel food. This hub combines a decision tree, the statutory clock, an Art. 4 checklist and the Art. 30 evidence order — without becoming an ingredient database.

Language versions. PL · EN · DE · FR · UKR · CS · RO. Related: GIS notification (Arts 29/30) · importer — overview · importer — playbook · health claims.

Novel food decision tree: catalogue, Union list, Art. 4, GIS stop/go — Fig. 1. FBO decision tree: catalogue (orientation) → Union list 2017/2470 (conditions) → Art. 4 consultation (2018/456) → stop/go before GIS. EFSA opinion marked as a separate timing trap.

Three hard rules. (1) The Commission catalogue is not binding; the Union list 2017/2470 is. (2) EFSA opinion ≠ Commission authorisation / list entry. (3) Unauthorised novel food cannot be cured by a GIS filing. Novel-food / additive status does not unlock health claims (1924/2006). Data protection ≠ category exclusivity.

1. Definition and cut-off date (15 May 1997)

Regulation (EU) 2015/2283 defines novel food as food not used for human consumption to a significant degree within the Union before 15 May 1997 and falling within an Article 3 category (new molecules, microorganisms, foods from plants/animals in a new form, foods from processes causing significant changes, etc.). For a supplement formulator the marketing label “botanical” is irrelevant next to the concrete form: plant part vs extract, production process, marked constituents. Supplement-only use history after 1997 does not replace evidence of pre-1997 consumption in the relevant food form. Commission hub: food.ec.europa.eu — Novel Food.

2. Catalogue vs Union list — which is binding?

The Novel Food Catalogue is an orientation tool fed in part by Member State information. It is non-binding and non-exhaustive. It helps early screening (e.g. whole plant vs extract) but does not decide your SKU and is not a market authorisation.

The Union list under Implementing Regulation (EU) 2017/2470 (Article 6 of 2015/2283) is the binding positive list of authorised novel foods. Each entry sets conditions of use (food categories, maximum levels), labelling requirements and specifications. Authorisations are generally generic unless data protection applies. If the ingredient is novel and has no matching list entry (or your dose/category/process falls outside the entry), it cannot lawfully be placed on the market as food in the EU.

Catalogue vs list. Catalogue orients. List 2017/2470 binds. Absence from the catalogue does not prove non-novelty. Presence on the list still requires reading conditions (max dose, “food supplements only”, designation).

Catalogue vs Union list and EFSA-to-Commission timeline — Fig. 2. Catalogue (non-binding) vs Union list 2017/2470 (binding) and timeline: application → EFSA opinion → Commission act → list entry. Myth “EFSA yes = market” marked separately.

3. Statutory clock: Art. 4 / EFSA / Commission

Primary numbers only — from the acts and the Commission Authorisations page. No practice wall-clock column.

Stage	What the source says	What it is not
Art. 4 consultation (2018/456)	The Member State must conclude within 4 months from the date it decided the consultation request is valid; in duly justified cases, extension by max. +4 months (Art. 7 of Reg. 2018/456)	Authorisation; market permit; “GIS green light”
EFSA assessment (Art. 10 application path)	EFSA adopts its opinion within 9 months from receipt of a valid application from the Commission (Art. 11 of Reg. 2015/2283; EC Authorisations page)	List entry; launch date
Commission draft act	Within 7 months from publication of the EFSA opinion, the Commission shall submit a draft implementing act to the Standing Committee (Art. 12 of Reg. 2015/2283; EC page)	Not yet placing on the market
Publication of the act + 2017/2470 update	Only after the implementing act is adopted and published	—
Traditional food from a third country	Art. 14 et seq. of 2015/2283 — separate notification; MS/EFSA may lodge reasoned safety objections within 4 months (EC Authorisations)	A shortcut “for every Asian botanical”

Statutory novel-food clock: Art. 4 4 months, EFSA 9 months, Commission 7 months — Fig. 3. Statutory clock: Art. 4 (4 m, optional +4) → EFSA 9 m → Commission draft 7 m → act and list. Press release, DOI and supplier slide marked as not a market gate.

EFSA ≠ Commission. EFSA opinion = safety assessment. Commission act + list entry = lawful market conditions. GIS does not shorten that timeline.

4. Article 4 consultation (2018/456) — operator checklist

Where catalogue and list screening still leave status unclear, Article 4 of Regulation 2015/2283 provides for consultation with the Member State of first intended placing on the market. Implementing Regulation (EU) 2018/456 sets the procedure. The outcome is a status determination (novel / not novel) — not an authorisation.

Identify the Member State of first intended placing. For a PL-first SKU: use the official Commission list of competent authorities for Art. 4 (List of National Competent Authorities — 2018/456; page: Legislation — consultation process). Re-check the current entry before filing.
Submit the electronic consultation request under 2018/456 (cover letter Annex I, technical dossier Annex II, supporting documents, explanatory note).
Cure deficiencies within the Member State deadline — otherwise the request is not valid.
Receive the status conclusion (novel / not novel) within the statutory clock in section 3.
If novel → full Art. 10 application (or traditional third-country path where criteria are met). Do not file ESP “to test the water”.
If not novel → separate gates remain: claims (1924/2006), Annex III to 1925/2006, vitamin/mineral forms (2002/46), establishment registration, GIS Art. 29.
An Art. 4 result does not replace reading list 2017/2470 when the status is “listed with conditions” — see section 6.

Art. 4 ≠ authorisation. A “novel food” conclusion closes the “file GIS anyway” path. A “not novel” conclusion does not waive claims, Annex III or vitamin-form rules.

5. Decision tree for formulators

Catalogue — quick orientation; note whole/extract/process distinctions.
Union list 2017/2470 — find the specific entry (not an ingredient “class”). Check category, max level, designation, warnings, population exclusions, specifications.
Formula fit — label and GIS figures must sit inside the entry limits; a different process or fraction is a different product.
Article 4 consultation — if status remains unclear (section 4).
Stop/go before GIS — go only if (a) not novel, or (b) listed and conditions met. Stop = no authorisation: pursue the application path first.

5a. What is not “history of use”

Three false shortcuts recur in supplier briefs. First: post-1997 supplement sales in the EU do not prove pre-15 May 1997 consumption. Second: history for the whole plant does not automatically cover a standardised extract, isolate or new process. Third: legality in the USA, UK (outside the EU regime) or Asia does not create Union status. Document material identity against a list entry or an application dossier — not against a catalogue screenshot. Keep medicinal borderline and Regulation 1925/2006 Annex III as separate gates.

6. A list entry ≠ automatic go for your SKU

Conditions on the list are part of the act — not a suggestion. Authorisation is a specific list entry (name, specification, process) — not a whole marketing class. Many entries limit use to food supplements (Directive 2002/46/EC), with a maximum dose and a mandatory designation.

Example (not an ingredient database): egg membrane hydrolysate (enzymatically produced) — Regulation (EU) 2026/1427 — food-supplement category, daily limit, designation “egg membrane hydrolysate” (or linguistic equivalent), warning for persons under 18 and for pregnant/lactating women. Satellite: egg membrane hydrolysate. Same condition logic in: Rhizomucor (2026/1507), cRG-I (2026/1306), inulin-propionate ester (2026/1219).

List condition	Formulator question	Typical failure
Food category	Is the SKU a food supplement under 2002/46?	Same extract in a drink/bar outside the entry
Max level	mg/day or % per portion vs label and ESP	“Standardisation” above the limit
Specification / process	Same process, fraction, strain?	Different hydrolysate / mycelium / extract
Designation	Name from the act on the PL label	Marketing name instead of designation
Warnings / populations	<18, pregnancy, etc.	Missing statement
Data protection	Is your variant covered, or do you need your own data?	Assuming category monopoly or a “free class”

7. Authorisation: EFSA → Commission act

After an application the Commission may request an EFSA safety opinion. A positive opinion is not market authorisation. Only a Commission implementing regulation amending list 2017/2470 opens lawful placing on the market under the entry conditions. Until then the ingredient remains off the EU food market — regardless of press releases, opinion DOIs or supplier slides. Same logic for “opinion pending” satellites: NMN legal status.

7a. Data protection vs generic listing

List authorisations are generally generic: after listing, another operator may place the same novel food if conditions and specifications are met. Data protection/exclusivity covers protected application data — not absolute category exclusivity. Another FBO may seek its own authorisation on independent data.

8. Traditional food from a third country (high level)

Regulation 2015/2283 provides a simplified path for traditional food from a third country (Article 14 et seq.): history of safe use in a third country for at least 25 years, notification to the Commission, possible objections by Member States/EFSA within four months. It is not a shortcut for every Asian botanical. Concentrates / new extracts / new processes usually need a full application. After a successful path the entry still lands on the Union list with conditions.

9. When GIS questions novel food under Art. 30

Article 29 of the Polish Food Safety Act is an information duty on first placing a supplement on the Polish market — not a marketing authorisation and not an EU novel-food authorisation. Filing in ESP a product with an unauthorised novel food does not legalise the composition. GIS may open a clarifying procedure (Art. 30). Full Art. 30 playbook: GIS notification procedure.

Do not treat an ESP acknowledgement (UPO) as acceptance of composition.
Order the evidence: material identity (spec, process, CoA) → pre-15.05.1997 consumption history in that form or a 2017/2470 entry with matching conditions or an Art. 4 result.
A catalogue screenshot is not evidence. The catalogue is non-binding.
USA/UK/Asia legality ≠ Union status.
The response to a GIS request must match the ESP pack; changing composition mid-stream needs a separate update or a new notification (see the GIS 18.12.2024 matrix in the GIS pillar).
Importer map: overview — orientation / UPO / Art. 30 and deep — 7-step playbook.

Art. 30 (operator view). Lack of a Union-list entry where novelty is suspected is an operator risk that an ESP acknowledgement does not cancel.

9a. Pre-screen before PL artwork

Operational order for SKUs with suspect botanicals / new ingredients: (1) material and process identity, (2) catalogue + list + Art. 4 if needed, (3) only then PL label, claims scrub and ESP. Reversing the order creates Art. 30 cost and supplier disputes. Contracts should require disclosure of process changes and novel-food status before the next batch; a “food grade” certificate does not replace a list entry. Claims are a separate layer — claims ≠ notification.

10. Cluster — satellites (related reading)

11. FAQ

Catalogue vs Union list — which binds?