27.05.2026

The scope of the legal reporting obligation for operators receiving food supplements from another Member State

Within the broader context of the detailed regulation of the medicinal products market, there has been a constant regulatory focus on defining and organising the legal regime for a specific category of products, namely food supplements. Although these currently benefit from their own specific regulation (at national level, regulation of this matter is provided for under ordinary law by Law No 56/2021 on food supplements[1], whilst at EU level the regulation of this matter is contained in Directive 2002/46/EC[2]), there are still issues that give rise to debate in this field.

This context also includes the recent judgment of 21 May 2026 of the Court of Justice of the European Union (CJEU), delivered in Case C-626/24, PRAGON s.r.o. v Státní zemědělská a potravinářská inspekce, concerning a request for a preliminary ruling on the interpretation of Articles 34 and 36 TFEU, as well as Article 9(7) of Regulation (EU) 2017/625.

The main dispute giving rise to the referral to the CJEU stemmed from an inspection carried out by the Czech National Agri-Food Control Authority on 7 June 2021, concerning the safety of food supplements received by Pragon. This inspection was carried out in accordance with a national regulatory framework which provides that food business operators are obliged to inform the competent control authorities of the arrival, from another Member State of the Union or from a third country, of certain food products, including food supplements. Pragon challenged the inspection carried out by the national authority by bringing an action seeking protection against its unlawful interference under EU law; however, (in both instances of this dispute) the court of first instance dismissed that action by a judgment of 6 October 2022. Subsequently, Pragon lodged an appeal against the judgment of the court of first instance, in which it essentially argues that the notification requirement laid down by Czech national legislation manifestly infringes the free movement of goods, in so far as goods cannot be delivered to the Czech Republic on the day of the order, which would constitute a non-tariff barrier prohibited by EU law. Furthermore, Pragon submits that food products originating from territories outside the Czech Republic are subject to discriminatory treatment compared to that accorded to goods originating from the territory of that Member State, since the latter are not subject to a prior notification requirement and may therefore be marketed immediately.

In that context, the referring court considered it necessary to determine whether the notification requirement laid down by the Czech legislation is proportionate, in other words, to determine whether or not there is a comparable means of protecting human health, an objective which that court considers to be a e of justifying that obligation, which would affect the free movement of goods within the Union less than that provided for by the aforementioned legislation.

Specifically, the referring court in the Czech Republic has referred the following question to the Court for a preliminary ruling: ‘Does Article 34 TFEU, read in conjunction with Article 36 TFEU and Article 9(7) of Regulation [2017/625], preclude national legislation which imposes on the consignee of food supplements originating in another Member State a general obligation to notify, at least 24 hours in advance, their arrival at the place of destination, whilst also providing the information necessary for risk analysis and the planning of official controls?”

In its answer to this preliminary question, given in its judgment of 21 May 2026 in Case C-626/24, the CJEU held that Article 9(7) of Regulation (EU) 2017/625 must be interpreted as precluding national legislation which imposes on all operators receiving food supplements from another Member State an obligation to report in advance the arrival of those supplements at their place of destination and to provide the data necessary for the risk analysis of the risks they may present and for the planning of official controls.

In support of that conclusion, the Court began by noting that it is necessary to point out that, under Article 9(7) of Regulation 2017/625, Member States of destination may impose on operators receiving goods from another Member State an obligation to report the arrival of those goods only to the extent strictly necessary for the organisation of official controls. It follows from the wording of Article 9(7) of the Regulation that the obligation to report the arrival of goods from another Member State, which Member States are entitled to impose, must not only pursue the objective of ensuring the organisation of official controls, but must also be strictly necessary for that purpose. The condition of ‘strict necessity’ implies that there must be no less restrictive measures than such a reporting obligation to ensure the effective organisation of official controls.

Having examined the provisions of Regulation 2017/625 as a whole, the Court concluded that it follows that Article 9(7) of Regulation 2017/625 must be interpreted as allowing Member States to impose a reporting obligation regarding the arrival of animals or goods originating fromanother Member State only in exceptional circumstances where the obligation to make such a report is strictly necessary, in the absence of less restrictive measures, to ensure the effectiveness of official controls with a view to safeguarding, inter alia, human and consumer health. In that context, it is for the national court to determine whether the reporting obligation at issue in the main proceedings is consistent with Article 9(7) of Regulation 2017/625.

The CJEU has found, in this regard, that under Article 9(1) of Regulation 2017/625, official controls must be carried out periodically on all operators, on a risk-based basis and with appropriate frequency. However, having regard to the safeguard, exchange and information-gathering mechanisms provided for in Regulation 2017/625, the obligation to report the arrival of all food supplements originating in another Member State does not appear necessary for the organisation of official controls that meet the requirements of the Regulation. In that regard, Member States have, in principle, pursuant to Article 11(1) of Regulation 2017/625, information concerning, inter alia, the type, number and results of official controls, as well as the type and number of cases of non-compliance detected and sanctioned during a year in the other Member States. Furthermore, it follows from Article 9(2) of that Regulation that Member States also have information regarding possible cases of intentional infringement of the rules referred to in the Regulation, provided through the administrative assistance mechanisms provided for therein. All that information enables the Member State concerned to define the obligation to report the arrival of food supplements originating in another Member State, the purpose of which is to organise official controls on those goods, depending on the risks arising from that information or the absence thereof. Furthermore, in accordance with Article 10(2) of Regulation 2017/625, the competent authorities shall draw up and keep up to date a list of ‘operators’, including those who are the consignees within the territory of a Member State of food supplements originating in other Member States. Through this list, even food supplements not subject to a reporting obligation upon their arrival from other Member States may be subject, from the very first stage of the agri-food chain in the Member State of arrival, to official controls targeting the operators receiving those supplements, provided such controls are organised with appropriate frequency and on a risk-based basis.

Consequently, the mere fact that a product originates from another Member State does not unconditionally mean that that product automatically presents a particular risk, since products originating from other Member States have been subject, in those Member States, to the application of harmonised Union rules designed to ensure food safety.

Consequently, it is precisely on the basis of this harmonisation of the rules in force within the Union that the CJEU ruled in the aforementioned judgment that Article 9(7) of Regulation (EU) 2017/625 must be interpreted as precluding national legislation which imposes on all operators receiving food supplements from another Member State an obligation to report in advance the arrival of those supplements at their place of destination and to provide the data necessary for analysing the risks they may present and for planning official controls.

An article by Mircea-Bogdan Popescu, Partner,STOICA & ASOCIAȚII -bpopescu@stoica-asociatii.ro.

[1] Published in the Official Gazette of Romania, Part I, No 332 of 1 April 2021