Food supplement notification in the EU: harmonisation vs national duties
PL–DE–SE–NO–DK–CZ–RO–AT map

Article 10 of Directive 2002/46/EC provides that Member States may require the manufacturer or the person placing a food supplement on the market to notify the competent authority by forwarding a model of the label. That is not a Union product authorisation, and there is no single EU portal for notifying every supplement SKU. Regulation (EC) No 1924/2006 (claims) and Regulation (EU) No 1169/2011 (FIC) do not create an EU product-notification duty. Vitamin and mineral sources are harmonised (Annexes I/II of the Directive); maximum levels and most botanicals / “other substances” remain largely national — subject, among other things, to Annex III of Regulation (EC) No 1925/2006.

1. What is harmonised and what is not

Harmonised or shared: lists of vitamin and mineral sources (Annexes I/II of Directive 2002/46); the nutrition and health claims framework (1924/2006 + the Union Register); food information to consumers (1169/2011); novel-food authorisation (2015/2283) as a separate Union path; restrictions on certain substances in Annex III of Regulation 1925/2006.

Not harmonised (national choice or practice): the product-notification duty itself — Article 10 is optional for each Member State; most vitamin/mineral maximum levels (the Commission has still not presented a full max/min package); most botanicals and “other substances” beyond Annex III of 1925/2006. The Commission’s Article 4(8) report did not create an EU positive list of “other substances”.

For FBOs this means separate workstreams. Claims scrub and novel-food screening sit apart from the national notification map. There is no “one EU filing” that closes both claims and product notification. Claims ≠ notification: health claims vs notification. Poland procedure: GIS notification. Germany context: Germany supplements 2025.

2. Map: where product notification exists — and where it does not

The table below is an operator decision map, not a country encyclopaedia. Norway is EEA, not EU — a separate regime; we say that once.

Poland. GIS notification before the planned first placing (Art. 29 of the Food and Nutrition Safety Act). After filing, the FBO may place the product on its own responsibility; GIS may open explanatory proceedings. This is an information duty, not a marketing authorisation and not novel-food clearance. Procedure: GIS procedure. Importer journey: importer path.

Germany. § 5 NemV requires an Anzeige to BVL at the latest on first placing on the market. If the product was already notified in another Member State, second-notification rules apply (§ 5(2)). The statute text controls over softer FAQ wording. Market context: Germany 2025.

Sweden and Austria. No product notification does not mean free composition. General food law (Regulation 178/2002), FIC, claims — and in Austria non-binding Codex recommendations on plants in NEM — still apply. FBO establishment registration (e.g. with the municipal control authority in SE) is separate from SKU notification.

Norway (EEA). The text of § 10 of the kosttilskudd regulation exists, but it enters into force only when the ministry so decides — it is not in force. A separate “andre stoffer” regime (notification / application / information duties on positive lists) may still catch the formula. The myth “every supplement in Norway must be notified” fails without checking § 10 commencement.

Denmark. Every kosttilskud needs anmeldelse at the latest at the same time as marketing (bekendtgørelse No 141 of 7 February 2023). Separately: bek. No 478 of 26 May 2026 (in force 1 July 2026) for certain “visse andre stoffer” — use after an individual anmeldelse only 6 months after a complete notification (3 months if already assessed or approved in another EU/EEA state). Plant material (fresh, dried, chopped, powdered) and simple water extracts are largely outside that measure (§ 1(2)). Do not claim that “every botanical in DK waits 6 months”.

Czechia. Notification to the Ministry of Agriculture before first placing, with Czech labelling text (§ 3d of Act No 110/1997 Coll.). Notification is not approval — SZPI stresses that. Plants/substances: Decree 58/2018 Coll. (annexes of usable vs banned substances for food manufacture).

Romania. Stricter than pure Art. 10 label-model monitoring: after notification, INSP (via the competent CRSP) issues a certificat de notificare — statutory target about 15 working days; Art. 5(7) of Law 56/2021 bars placing on the market before the certificate. CRSP tracks split by product type (vitamins/minerals vs other substances / plant–animal mixes).

3. Timing: “before”, “on the day”, “certificate”, “6 months”

A YES/NO map is not enough for a launch plan. Clocks decide whether the start week is real. Poland and Czechia require action before first placing. Germany and Denmark allow filing at the latest on first placing / marketing — in practice still leave a buffer for formal defects. Romania blocks marketing until the certificate issues. Denmark adds an optional six-month clock only on the individual andre stoffer path.

What usually blocks launch week: (1) missing Polish / Czech label specimen in the filing pack; (2) in RO — no certificate yet; (3) in DK — a formula outside bilag 1 that triggers individual andre stoffer anmeldelse; (4) a parallel novel-food gap or off-Register claim mislabelled as a “notification delay”. Separate those causes in the dossier — otherwise sales hears the wrong diagnosis.

4. Plants and “other substances”

This is where most real launch delay sits — not in the notification checkbox alone. The Union did not deliver a full positive list of “other substances” after the Article 4(8) report under Directive 2002/46. Annex III of Regulation 1925/2006 covers prohibited, restricted or under-scrutiny substances — it is not a full catalogue of botanicals allowed in supplements.

• Czechia: Decree 58/2018 — annexes of plants/substances usable under conditions vs banned for food manufacture; MZe notification does not “approve” a botanical outside the annex.
• Denmark: DVFA plants page + andre stoffer path (bek. 478/2026). General kosttilskud anmeldelse (bek. 141) remains mandatory regardless.
• Norway: andre stoffer duties (vitamins/minerals and certain other substances regulation) ≠ the unused kosttilskudd § 10.
• Austria: Codex recommendations on plants in NEM — guidance, not product Meldepflicht.
• Sweden / Austria: no product notification ≠ free composition; 178/2002 and control practice still apply.

Always separate: novel-food screen (Regulation 2015/2283, catalogue, Union list) and claims scrub (1924/2006). Novel food / importer pillars: novel food supplements · importer PL.

5. Typical operator errors

1. Assuming one EU filing or mutual recognition of goods covers DE+PL+CZ and deletes GIS.
2. Treating GIS/BVL notification as a marketing authorisation or novel-food clearance.
3. Copying “Norway must notify every supplement” without checking § 10 commencement.
4. Promising a DK launch “same day as anmeldelse” when the formula triggers the individual andre stoffer path (6-month clock).
5. Confusing health-claim authorisation (1924/2006) with product notification (Art. 10 / national law).

6. Pre-market checklist (B2B)

1. List target Member States / EEA markets (PL, DE, SE, NO, DK, CZ, RO, AT + others).
2. For each: product notify YES/NO → authority → timing → label language required in the pack.
3. Botanical / other-substance track (CZ annexes, DK bek. 478, NO andre stoffer, RO CRSP track).
4. Novel-food screen (catalogue + Union list) — separate from notification.
5. Claims scrub (Register, Art. 10 of Reg. 1924/2006, marketplace-as-labelling).
6. FBO / establishment registration if required separately (e.g. SE — business registration ≠ product notification).
7. Document primary sources (CELEX, national acts, authority pages) in the launch dossier and date the verification.

FAQ

Is food-supplement notification harmonised in the EU?

No. Article 10 of Directive 2002/46/EC only allows Member States to require notification of a label model. There is no single Union product notification for every SKU.

Which of the eight markets require product notification?

Yes: PL, DE, DK, CZ, RO. No (general product notification): SE, AT. Norway: § 10 not in force; andre stoffer separately.

Does Denmark’s 6-month rule apply to every supplement?

No — only the individual path for certain andre stoffer under bek. 478/2026. Every kosttilskud still needs anmeldelse under bek. 141/2023. Plants / simple water extracts are largely outside bek. 478.

Does GIS or BVL equal a sales authorisation or novel food?

No. It is an information duty (notification / Anzeige). Marketing authorisation and novel-food authorisation are different legal institutions.

Conclusion

Article 10 of Directive 2002/46/EC leaves product notification to the Member States. Operators build a YES/NO map, then clocks (before / on the day / certificate / 6 months), then plant and other-substance traps. Claims and FIC do not replace that map. One filing does not cover eight markets.

Primary sources

1. Directive 2002/46/EC (consolidated) — Art. 10; CELEX 02002L0046-20250316. Commission summary: Food supplements.
2. Regulation (EC) No 1924/2006 — claims, not SKU notification.
3. Regulation (EU) No 1169/2011 — FIC.
4. PL: Art. 29 Food Safety Act — biznes.gov.pl ou465.
5. DE: § 5 NemV; BVL NEM.
6. SE: Livsmedelsverket — no notification procedure.
7. NO: forskrift 2004-05-20-755; Mattilsynet guide.
8. DK: bek. 141/2023; bek. 478/2026; DVFA anmeldelse.
9. CZ: § 3d Act 110/1997 Coll.; SZÚ; MZe.
10. RO: Law 56/2021; INSP.
11. AT: verbrauchergesundheit.gv.at — no Meldepflicht.

Case consultation (CTA)

If you are building a multi-country launch map (PL/DE/Nordics/CZ/RO/AT) or closing notification, botanical and claims tracks together — book an introductory call. For manufacturers, importers and distributors. Not for consumers. An introductory call is not a free legal opinion.