Extending the legal reporting obligation of operators receiving food supplements from another member state
In the wider context of the detailed regulation of the medicinal market, there has consistently been a normative concern to define and organize the legal regime of a product category act, namely dietary supplements. Even if they currently benefit from their own special regulation (at the national level, the regulation of this matter is ensured, under common law, by Law no. 56/2021 on food supplements (1), while at the community level the regulation of this matter is contained in Directive 2002/46/EC (2)), there are still aspects that raise discussions regarding this field.
The recent decision of the Court of Justice of the European Union (CJEU), issued in case C-626/24, dated May 21, 2026, is also part of this framework. PRAGON sro v Státní zemědělská a potravinářská inspekcehaving as its object a request for a preliminary decision on the interpretation of articles 34 and 36 TFEU, as well as article 9 paragraph (7) of Regulation (EU) 2017/625.
The main litigation on which the CJEU referral was filed had as its generating element a check carried out by the National Agri-Food Control Authority in the Czech Republic, a check carried out on June 7, 2021 and having as its object the safety of the food supplements received by Pragon. This control was carried out in accordance with a national regulatory framework which stipulates that operators in the food sector are obliged to inform the competent control authorities about the arrival, from another member state of the Union or from a third country, of certain food products, including food supplements. Pragon challenged the control carried out by the national authority through an action aimed at obtaining protection against its unlawful interventions from the perspective of Union law, but (in both procedural cycles of this litigation) the first court rejected this action by a decision of October 6, 2022. Subsequently, Pragon filed an appeal against the decision of the first court, before which it essentially claims that the obligation to notify provided by the Czech national regulation manifestly infringes the free movement of goods, to the extent that the goods cannot be delivered to the Czech Republic on the day of the order, which would constitute a non-tariff barrier prohibited by Union law. In addition, Pragon claims that foodstuffs originating from territories located outside the Czech Republic are subject to discriminatory treatment in relation to that reserved for goods originating from the territory of that Member State, as the latter are not subject to a prior notification obligation and can therefore be marketed immediately.
In this context, the referring court considered it necessary to establish whether the notification obligation provided for by the Czech regulation is proportionate, in other words to determine whether or not there is a comparable way of protecting human health, an objective that this court considers likely to justify that obligation, which would affect less the freedom of movement of goods within the Union than that provided for by the aforementioned regulation.
Specifically, the referring court from the Czech Republic addressed the following preliminary question to the Court: “Article 34 TFEU in conjunction with Article 36 TFEU and Article 9 paragraph (7) of the Regulation [2017/625] opposes a national regulation which imposes on the recipient of food supplements from another Member State a general obligation to notify at least 24 hours in advance of their arrival at the place of destination, while providing the necessary information for risk analysis and planning of official controls?”
Through the answer formulated to this preliminary question by means of the judgment of May 21, 2026 in case C-626/24, the CJEU ruled that Article 9 paragraph (7) of Regulation (EU) 2017/625 must be interpreted in the sense that opposes a national regulation that imposes on all operators receiving food supplements from another member state o bond to report in advance the arrival of these supplements at their place of destination and to provide the data necessary to analyze the risks they may present and to plan official controls.
In arguing this solution, the Court started from the finding that it is necessary to show that, according to Article 9 paragraph (7) of Regulation 2017/625, the destination member states can impose on operators who receive goods from another member state the obligation to report the arrival of these goods only to the extent strictly necessary for the organization of official controls. Therefore, from the wording of Article 9 paragraph (7) of the regulation, it emerges that the obligation to report the arrival of goods from another Member State, which the Member States have the possibility to provide, must not only pursue the objective of ensuring the organization of official controls, but also be strictly necessary for this purpose. The condition of “strict necessity” implies that there must be no less restrictive measures than such a reporting obligation to ensure the effective organization of official controls.
Analyzing the provisions of Regulation 2017/625 as a whole, the Court concluded that it appears that Article 9 paragraph (7) of Regulation 2017/625 must be interpreted in the sense that it allows Member States to impose a reporting obligation on the arrival of animals or goods from another Member State only in exceptional circumstances where the obligation to make such reporting is strictly necessary, in the absence of less restrictive measuresto guarantee the effectiveness of official controls in order to ensure the protection of, among others, human health and consumers. In this context, it is up to the national court to determine whether the reporting obligation at issue in the main litigation complies with Article 9(7) of Regulation 2017/625.
The CJEU found, in this regard, that pursuant to Article 9 paragraph (1) of Regulation 2017/625, official controls must be carried out periodically on all operators, depending on the risks and with an appropriate frequency. However, taking into account the mechanisms of safeguarding, exchange and collection of information provided for by Regulation 2017/625, the obligation to report the arrival of all food supplements from another Member State does not seem necessary for the organization of official controls that meet the requirements of the regulation. In this sense, the Member States have in principle, pursuant to Article 11 paragraph (1) of Regulation 2017/625, information regarding, among other things, the type, number and results of official controls, as well as the type and number of cases of non-compliance found and sanctioned during a year in the other Member States. In addition, it appears from Article 9(2) of the said Regulation that Member States also have information regarding possible cases of intentional infringement of the rules mentioned in the Regulation, provided through the administrative assistance mechanisms provided for by it. All this information allows the Member State in question to define the obligation to report the arrival of food supplements from another Member State, the objective of which is to organize official controls on these goods, depending on the risks arising from said information or the absence of the latter. In addition, according to article 10 paragraph (2) of Regulation 2017/625, the competent authorities draw up and keep up to date a list of “operators”, including those who are recipients on the territory of a member state of food supplements from other member states. By means of this list, even food supplements that are not subject to a reporting obligation upon their arrival from other Member States may be subject, from the first stage of the agri-food chain in the Member State of arrival, to official controls aimed at the operators receiving these supplements, if these controls are organized with an appropriate frequency and according to the risks.
Consequently, the mere fact that a product originates in another Member State does not unconditionally mean that this product automatically presents a certain risk, since the products originating from other Member States have been subject, in these Member States, to the application of harmonized Union rules aimed at guaranteeing food safety.
Therefore, precisely starting from this harmonization of the existing regulation on the territory of the Union, the CJEU ruled in the aforementioned decision that Article 9 paragraph (7) of Regulation (EU) 2017/625 must be interpreted in the sense that it opposes a national regulation that imposes on all operators receiving food supplements from another member state an obligation to report in advance the arrival of these supplements at their destination and to provide the necessary data to analyze the risks they may present and for planning official controls.
Footnotes:
(1) Published in the Official Gazette of Romania, Part I, no. 332 of April 1, 2021
(2) Published in the Official Journal of the European Union, Series L, number 183 of July 12, 2002
An article signed by Mircea-Bogdan Popescu, Partner, STOICA & ASSOCIATES – [email protected].
Article supported by STOICA & ASSOCIAțII
