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 gives formulators a decision tree and points to existing /wiedza/ satellites without duplicating their substance.
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.
2a. Article 4 status consultation (2018/456)
Where an FBO is unsure whether a food is novel, 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, not an authorisation. If the food is novel, the path is a novel-food application (or traditional food from a third country where criteria are met) — not “file GIS anyway”.
3. 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 (often food supplements only), max level per day/portion, labelling 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 after catalogue + list screening.
- Stop/go before GIS — go only if (a) not novel, or (b) listed and conditions met. Stop = no authorisation: pursue the application path first.
3a. 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; CBD/hemp needs its own analysis (see cluster satellite).
4. Typical supplement conditions of use
Conditions on the list are part of the act — not a suggestion. Many entries limit use to food supplements (Directive 2002/46/EC), with a maximum dose and a mandatory designation. Authorisation is a specific list entry (name, specification, process) — not a whole marketing class.
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 element | Formulator check | Typical failure |
|---|---|---|
| Food category | Is the SKU a food supplement? | Putting it in a drink/bar outside the entry |
| Max level | mg/day or % per portion | “Standardisation” above the limit |
| Designation | Exact name from the act | Marketing name instead of designation |
| Specification | Process, identity, ranges | Different hydrolysate / strain |
| Warnings | Excluded populations | Missing statement on the PL label |
5. 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 (or an equivalent listing act) 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.
5a. 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. Read the authorising act for protection periods; do not assume a “class” is closed or that your process variant is covered by someone else’s entry.
6. 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. It is not a shortcut for every Asian botanical. Importers consider it when the material is traditionally consumed as food (not merely a “longevity supplement”) and use history can be documented. Concentrates / new extracts / new processes usually need a full application. After a successful path the entry still lands on the Union list with conditions.
7. GIS: notification does not cure novel food
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); novel-food status is a classic pre-screen gate. Procedure detail: #1 GIS. Importer map: #3 Importer. Claims are a separate layer (1924/2006) — #5.
7a. 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.
8. Cluster — satellites (related reading)
- Rhizomucor pusillus mycelium — 2026/1507
- cRG-I — 2026/1306
- Inulin-propionate ester — 2026/1219
- Egg membrane hydrolysate (enzymatic)
- NMN — legal status 2026
- CBD / hemp — EU/USA
9. FAQ
Catalogue vs Union list — which binds?
The Union list in Regulation (EU) 2017/2470 binds. The Commission catalogue is non-binding, non-exhaustive orientation.
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.
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.
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.
What if GIS questions novel-food status under Art. 30?
That is national clarifying risk. Missing EU authorisation does not disappear via ESP filing. See #1 and #3.
Can unauthorised novel food be fixed by GIS notification?
No. Article 29 notification is not a novel-food authorisation.
Case consultation (CTA)
Novel-food screening before formulation, mapping a list entry to SKU dose, choosing full vs traditional third-country path, responding to Art. 30 status challenges — book an initial call. Manufacturers, importers and distributors only. Not for consumers. Fifteen minutes qualifies scope; it is not free legal advice or a fixed quote.
Primary sources
- Regulation (EU) 2015/2283
- Implementing Regulation (EU) 2017/2470 (consolidated)
- Implementing Regulation (EU) 2018/456
- EC Novel Food hub
- EC Union list page
- Regulation (EU) 2026/1427 — egg membrane hydrolysate
- Polish Food Safety Act — Arts 29–30
- Directive 2002/46/EC — food supplements