The Court of Justice of the European Union, with the judgment of 21 May 2026 in Case C-626/24 (Pragon, ECLI:EU:C:2026:414), has declared that EU law precludes national rules imposing a general obligation of prior notification on all operators receiving food supplements from another Member State. The ruling dismantles the Czech system of mandatory advance reporting of intra-EU consignments and clarifies, for the first time, the strict limits set by Article 9(7) of Regulation (EU) 2017/625 on official controls: arrival notifications are admissible only in exceptional circumstances, where no less restrictive measures are available.
The judgment also offers an opportunity to reflect on a far broader anomaly. The free movement of food supplements within the single market remains, to this day, largely fictitious: 23 out of 27 Member States still require operators to notify the placing of their products on each national market, through divergent procedures that often resemble disguised pre-market authorisations. The resulting economic and bureaucratic burdens undermine the competitiveness of a growing sector, penalise SMEs above all, and restrict citizens’ access to food supplements. Hence the urgent need – examined in the author’s closing commentary – to reform Directive 2002/46/EC, replacing the patchwork of national filings with a single EU-wide notification.
The dispute
The case originated in a control performed on 7 June 2021 by the Czech agri-food inspection authority (Státní zemědělská a potravinářská inspekce) on food supplements received by Pragon s.r.o. Czech law – Section 3d(3) of Act No 110/1997 on foodstuffs, implemented by Decree No 172/2015 – requires the recipient of certain foods arriving from another Member State or a third country, including food supplements, to notify the authority through its information system ‘at least 24 hours before the arrival of the foodstuffs at the place of destination‘, indicating type, quantity, origin, supplier, recipient and date of arrival.
Pragon challenged the lawfulness of the control, arguing that the notification duty amounts to a non-tariff barrier:
- goods cannot be delivered in the Czech Republic on the day of the order, and
- foods from other Member States suffer discriminatory treatment compared with domestic ones, which ‘are not subject to any prior notification obligation and may therefore be marketed immediately‘.
The Supreme Administrative Court (Nejvyšší správní soud) referred the matter to Luxembourg, asking whether Articles 34 and 36 TFEU and Article 9(7) of Regulation (EU) 2017/625 preclude such a regime.
Exhaustive harmonisation, the Treaty steps aside
The first systemic clarification concerns the applicable yardstick. The Court holds that the conditions under which Member States may require notification of the arrival of food supplements from another Member State ‘have been the subject of exhaustive harmonisation‘ by Regulation (EU) 2017/625 (para. 36). Consequently, national measures of this kind must be assessed ‘in the light of the provisions of that regulation alone, in particular Article 9(7) thereof, and not of Articles 34 and 36 TFEU‘ (para. 37), in line with settled case-law (CIHEF and Others, C-147/21).
The point is far from academic. Once harmonisation is exhaustive, Member States can no longer invoke the public-health derogation of Article 36 TFEU to justify unilateral restrictions: the balance between free movement and health protection has already been struck by the EU legislature, and the only margin left to national authorities is the one defined – restrictively – by the regulation itself.
‘Strict necessity’ and ‘exceptional circumstances’
Article 9(7) of Regulation (EU) 2017/625 allows Member States of destination to require operators to report the arrival of goods or animals from other Member States only ‘in so far as is strictly necessary for the organisation of official controls‘. The Court reads this condition rigorously, on three converging grounds:
- first, the wording. The condition of ‘strict necessity‘ implies, in itself, ‘that there must be no less restrictive measures than such a notification obligation capable of effectively ensuring the organisation of official controls‘ (para. 41);
- second, the context. Article 9(7) derogates from the non-discrimination rule of Article 9(6), under which official controls must be performed ‘in the same way‘ irrespective of whether goods originate in the Member State of control or in another Member State. As a derogation, it must be interpreted strictly (para. 42);
- third, the preamble. Recital 37 states that competent authorities should be able to require such information only ‘in exceptional circumstances‘ (para. 44). The Court therefore concludes that Member States may impose arrival notifications ‘only in exceptional circumstances in which the obligation to make such a notification is strictly necessary, in the absence of less restrictive measures, to guarantee the effectiveness of official controls‘ for the protection of human health and consumers (para. 49).
Less restrictive tools already exist
The judgment then reviews the instruments which Regulation (EU) 2017/625 already places at the disposal of national authorities, finding that a blanket notification scheme covering ‘all food supplements from other Member States‘ and ‘all operators‘ (para. 53) is not necessary for risk-based controls. Member States already have access to:
- information on the type, number and results of official controls and infringements detected in other Member States (Article 11(1));
- the multi-annual national control plans of their peers (Article 111(1));
- intelligence on deliberate violations channelled through the administrative-assistance mechanisms of Articles 102–108 (para. 56).
They must, moreover, keep an updated register of operators (Article 10(2)), which enables targeted controls at the first stage of the agri-food chain even without any arrival notification (paras 58–59).
The Court also recalls that Article 10 of Directive 2002/46/EC already offers Member States a specific tool: the option to require the manufacturer or the person placing a food supplement on their market to notify the competent authority ‘by forwarding it a model of the label used for the product‘ (para. 60).
The Czech government’s arguments – recurrent findings of anabolic agents, pharmaceuticals, hormones, heavy metals and aromatic hydrocarbons in supplements, and frequent mismatches between labels and actual content – were not sufficient to establish ‘exceptional circumstances’ (paras 61–62). Decisive, in this respect, is the principle restated at paragraph 64, upon an observation of the European Commission: ‘the mere fact that a product originates in another Member State does not in itself mean that that product automatically presents a certain risk‘, since goods from other Member States have already been subject to harmonised EU food-safety rules.
The ruling
The operative part leaves no room for ambiguity. Article 9(7) of Regulation (EU) 2017/625 ‘precludes national legislation which imposes on every operator receiving food supplements from another Member State an obligation to give advance notification of the arrival of those supplements at their place of destination and to provide the data necessary for the analysis of the risks which they may present and for the planning of official controls‘. Generalised, systematic prior-notification regimes for intra-EU trade in food supplements are therefore incompatible with EU law, in the Czech Republic as elsewhere.
Comment. Reforming the Food Supplements Directive to restore free movement
The Pragon judgment strikes down notification at destination of individual consignments, but leaves untouched the deeper anomaly of the sector: the market-placement notification authorised by Article 10 of Directive 2002/46/EC. That faculty, conceived in 2002 ‘to facilitate efficient monitoring‘, has degenerated into a patchwork of 27 divergent national procedures which de facto fragments the internal market. An exact survey of the rules in force shows that 23 out of 27 Member States require ministerial notification of products to the competent authorities before placing them on the market – Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovakia and Spain – with Austria, the Netherlands, Slovenia and Sweden as the only exceptions.
These procedures are anything but uniform. They range from a mere submission of the label to a de facto pre-market authorisation, in some cases with a stand-still period before the product may be placed on the market. Lead times typically vary from one week to three months, and in exceptional cases up to six months, with fees of up to €250 per product; Denmark even charges annual fees per company and per registered product.
An operator wishing to serve the whole single market must thus complete up to 23 separate filings – each with its own portal, language, dossier and timing – for one identical product already lawfully marketed in its Member State of origin. The economic and bureaucratic burden is unsustainable above all for SMEs, which represent the backbone of a growing European sector, and it ultimately curtails citizens’ access to food supplements and price competition.
The logic of Pragon exposes the contradiction. If the mere provenance of a food from another Member State ‘does not in itself mean that that product automatically presents a certain risk‘, and if risk-based controls can rely on operator registers, mutual information exchange and administrative assistance, the proliferation of national pre-market notifications – often functioning as disguised authorisations – appears equally disproportionate. A reform of Directive 2002/46/EC is therefore overdue: replacing the 27 national filings with a single EU-wide digital notification, valid throughout the Union and accessible to all competent authorities, would preserve market monitoring while restoring the effective free movement of goods that the directive itself, in recital 2, identified as its very raison d’être. The European Commission, which has left the directive substantially unrevised for over two decades – including the persistent failure to harmonise maximum vitamin and mineral levels under Article 5(4) – now has a judicial compass pointing firmly towards simplification.
Provisional conclusions
The Court of Justice confirms that official controls on foods circulating within the Union must be risk-based, non-discriminatory and minimally burdensome. National administrations may no longer treat intra-EU consignments of food supplements as presumptively suspect. The next, necessary step belongs to the EU legislature: align the Food Supplements Directive with the single-market principles that the Pragon judgment has so clearly restated.
Dario Dongo
Credit cover Thomas Breher from Pixabay
References
Court of Justice of the European Union. (2026, May 21). Judgment in Case C-626/24, Pragon s.r.o. v Státní zemědělská a potravinářská inspekce (ECLI:EU:C:2026:414).
Directive 2002/46/EC of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements. Consolidated text: 26/11/2025. http://data.europa.eu/eli/dir/2002/46/2025-11-26
European Food Safety Authority. (2026, 6 January). Food supplements. https://www.efsa.europa.eu/en/topics/topic/food-supplements
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. Consolidated text: 01/01/2026 http://data.europa.eu/eli/reg/2002/178/2026-01-01
Regulation (EU) 2017/625 of 15 March 2017 on official controls and other official activities. Consolidated text: 05/01/2025 http://data.europa.eu/eli/reg/2017/625/2025-01-05
USDA Foreign Agricultural Service. (2017). Exporting food supplements to the European Union (GAIN Report). https://apps.fas.usda.gov/newgainapi/api/report/downloadreportbyfilename?filename=Exporting+Food+Supplements+to+the+European+Union_Brussels+USEU_EU-28_1-11-2017.pdf
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
