ECLI:EU:C:2026:414•Judgment of the Court (Third Chamber) of 21 May 2026.#PRAGON s.r.o. v Státní zemědělská a potravinářská inspekce, Inspektorát v Praze.#Request for a preliminary ruling from the Nejvyšší správní soud.#Reference for a preliminary ruling – Free movement of goods – Official controls on foodstuffs – Regulation (EU) 2017/625 – Article 9(7) – Exhaustive harmonisation – National legislation providing for an obligation to notify the arrival of food supplements from other Member States – Condition of strict necessity for the effective organisation of official controls in the light of imperatives relating to the protection of human health and consumers.#Case C-626/24.
Judgment of the Court (Third Chamber) of 21 May 2026.#PRAGON s.r.o. v Státní zemědělská a potravinářská inspekce, Inspektorát v Praze.#Request for a preliminary ruling from the Nejvyšší správní soud.#Reference for a preliminary ruling – Free movement of goods – Official controls on foodstuffs – Regulation (EU) 2017/625 – Article 9(7) – Exhaustive harmonisation – National legislation providing for an obligation to notify the arrival of food supplements from other Member States – Condition of strict necessity for the effective organisation of official controls in the light of imperatives relating to the protection of human health and consumers.#Case C-626/24.
ECLI:EU:C:2026:414Eu Chamb 03 CMay 21, 2026
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JUDGMENT OF THE COURT (Third Chamber)
21 May 2026 (*)
( Reference for a preliminary ruling – Free movement of goods – Official controls on foodstuffs – Regulation (EU) 2017/625 – Article 9(7) – Exhaustive harmonisation – National legislation providing for an obligation to notify the arrival of food supplements from other Member States – Condition of strict necessity for the effective organisation of official controls in the light of imperatives relating to the protection of human health and consumers )
In Case C‑626/24,
REQUEST for a preliminary ruling under Article 267 TFEU from the Nejvyšší správní soud (Supreme Administrative Court, Czech Republic), made by decision of 17 September 2024, received at the Court on 24 September 2024, in the proceedings
PRAGON s. r. o.
v
Státní zemědělská a potravinářská inspekce, Inspektorát v Praze,
THE COURT (Third Chamber),
composed of C. Lycourgos, President of the Chamber, O. Spineanu-Matei, S. Rodin (Rapporteur), N. Piçarra and N. Fenger, Judges,
Advocate General: A. Biondi,
Registrar: I. Illéssy, Administrator,
having regard to the written procedure and further to the hearing on 18 September 2025,
after considering the observations submitted on behalf of:
– PRAGON s. r. o., by M. Kadlec, advokát,
– the Czech Government, by J. Očková, M. Smolek and J. Vláčil, acting as Agents,
– the European Commission, by M. Salyková and F. Thiran, acting as Agents,
after hearing the Opinion of the Advocate General at the sitting on 18 December 2025,
gives the following
Judgment
1 The request for a preliminary ruling concerns the interpretation of Articles 34 and 36 TFEU, as well as Article 9(7) of Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ 2017 L 95, p. 1).
2 The request has been made in proceedings between PRAGON s. r. o. (‘Pragon’), a company incorporated under Czech law, and the Státní zemědělská a potravinářská inspekce, Inspektorát v Praze (State Agriculture and Food Inspection Authority, Prague Inspectorate, Czech Republic) (‘the Czech Agriculture and Food Inspection Authority’) concerning an application for protection made by that company against an alleged unlawful interference consisting of a check by that authority.
Legal context
European Union law
Primary legislation
3 Article 26(1) TFEU states:
‘The [European] Union shall adopt measures with the aim of establishing or ensuring the functioning of the internal market, in accordance with the relevant provisions of the Treaties.’
4 Article 34 TFEU is worded as follows:
‘Quantitative restrictions on imports and all measures having equivalent effect shall be prohibited between Member States.’
5 Article 36 TFEU provides:
‘The provisions of Articles 34 and 35 shall not preclude prohibitions or restrictions on imports, exports or goods in transit justified on grounds of public morality, public policy or public security; the protection of health and life of humans, animals or plants; the protection of national treasures possessing artistic, historic or archaeological value; or the protection of industrial and commercial property. Such prohibitions or restrictions shall not, however, constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States.’
6 Article 43(2) TFEU provides:
‘The European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee, shall establish the common organisation of agricultural markets provided for in Article 40(1) and the other provisions necessary for the pursuit of the objectives of the common agricultural policy and the common fisheries policy.’
7 Article 114(1) TFEU provides:
‘Save where otherwise provided in the Treaties, the following provisions shall apply for the achievement of the objectives set out in Article 26. The European Parliament and the Council shall, acting in accordance with the ordinary legislative procedure and after consulting the [European] Economic and Social Committee, adopt the measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market.’
8 Article 168(4)(b) TFEU:
‘By way of derogation from Article 2(5) and Article 6(a) and in accordance with Article 4(2)(k) the European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the [European] Economic and Social Committee and the [European] Committee of the Regions, shall contribute to the achievement of the objectives referred to in this Article through adopting in order to meet common safety concerns:
…
(b) measures in the veterinary and phytosanitary fields which have as their direct objective the protection of public health’;
Secondary legislation
– Regulation (EC) No 178/2002
9 Article 2 of 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 (OJ 2002 L 31, p. 1) provides:
‘For the purposes of this Regulation, “food” (or “foodstuff”) means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans.
…’
– Directive 2002/46/EC
10 Article 10 of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ 2002 L 183, p. 51) provides:
‘To facilitate efficient monitoring of food supplements, Member States may require the manufacturer or the person placing the product on the market in their territory to notify the competent authority of that placing on the market by forwarding it a model of the label used for the product.’
– Regulation 2017/625
11 Recitals 1 to 3, 15, 19, 20, 37, 38, 43 and 99 of Regulation 2017/625 state:
‘(1) The [TFEU] requires a high level of protection of human and animal health and of the environment to be ensured in the definition and implementation of Union policies and activities. The achievement of that objective should, inter alia, be pursued via measures in the veterinary and phytosanitary fields which have as their final objective the protection of human health.
(2) The [TFEU] also provides that the Union is to contribute to the attainment of a high level of consumer protection by the measures it adopts in the context of the completion of the internal market.
(3) Union legislation provides for a set of harmonised rules to ensure that food and feed are safe and wholesome, and that activities which might have an impact on the safety of the agri-food chain or on the protection of consumers’ interests in relation to food and food information are performed in accordance with specific requirements. Union rules exist also to ensure a high level of human, animal and plant health as well as animal welfare along the agri-food chain and in all those areas of activity where a key objective is the fight against the possible spread of animal diseases, in some cases transmissible to humans, or of pests injurious to plants or plant products, and to ensure the protection of the environment from risks that might arise from genetically modified organisms (GMOs) or plant protection products. The correct application of those rules, hereinafter collectively referred to as “Union agri-food chain legislation”, contributes to the functioning of the internal market.
…
(15) The responsibility to enforce Union agri-food chain legislation lies with Member States, whose competent authorities monitor and verify, through the organisation of official controls, that relevant Union requirements are effectively complied with and enforced.
…
(19) In order to rationalise and simplify the overall legislative framework, whilst simultaneously pursuing the objective of better regulation, the rules applicable to official controls in specific areas should be integrated into a single legislative framework for official controls. …
(20) This Regulation should seek to establish a harmonised Union framework for the organisation of official controls, and official activities other than official controls, along the entire agri-food chain, taking into account the rules on official controls laid down in Regulation (EC) No 882/2004 [of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ 2004 L 165, p. 1)] and in relevant sectoral legislation, and the experience gained from the application of those rules.
…
(37) Without prejudice to traceability requirements laid down in sectorial legislation, and to the extent strictly necessary for organising official controls, operators should be able, in exceptional circumstances, to be required by the competent authorities of a Member State to report the arrival of animals and goods from another Member State.
(38) To ensure that the Union agri-food chain legislation is correctly enforced, the competent authorities should have the power to perform official controls at all stages of production, processing and distribution of animals and goods concerned by that legislation. To ensure that official controls are thoroughly conducted and effective, the competent authorities should also have the power to perform official controls at all stages of production and distribution of goods, substances, materials or objects which are not governed by Union agri-food chain legislation in so far as it is necessary to fully investigate possible infringements of that legislation and to identify the cause of any such infringement. In order to perform those official controls efficiently, competent authorities should draw up and maintain a list or register of the operators to be controlled.
…
(43) This Regulation establishes a single legislative framework for the organisation of official controls to verify compliance with Union agri-food chain legislation in all the areas that such legislation covers. …
…
(99) Since the objective of this Regulation, namely to ensure a harmonised approach with regard to official controls and other official activities performed in view of ensuring the application of Union agri-food chain legislation, cannot be sufficiently achieved by the Member States but can rather, by reason of its effect, complexity, trans-border and international character, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 [TEU] …’
12 Under Article 1(1)(a) and (2)(a) of Regulation 2017/625:
‘1. This Regulation lays down rules for:
(a) the performance of official controls and other official activities by the competent authorities of the Member States;
…
2. This Regulation shall apply to the official controls performed for the verification of compliance with the rules, whether established at Union level or by the Member States, to apply Union legislation, in the areas of:
(a) food and food safety, integrity and wholesomeness at any stage of production, processing and distribution of food, including rules aimed at ensuring fair practices in trade and protecting consumer interests and information, and the manufacture and use of materials and articles intended to come into contact with food’.
13 Article 3(11), (12) and (29) of that regulation provides:
‘For the purposes of this Regulation, the following definitions apply:
…
(11) “goods” means all that is subject to one or more of the rules referred to in Article 1(2), excluding animals;
(12) “food” means food as defined in Article 2 of Regulation [No 178/2002];
…
(29) “operator” means any natural or legal person subject to one or more of the obligations provided for in the rules referred to in Article 1(2)’.
14 Article 9 of Regulation 2017/625 provides, in paragraphs 1, 2 and 4 to 7:
‘1. Competent authorities shall perform official controls on all operators regularly, on a risk basis and with appropriate frequency …:
…
2. Competent authorities shall perform official controls regularly, with appropriate frequencies determined on a risk basis, to identify possible intentional violations of the rules referred to in Article 1(2), perpetrated through fraudulent or deceptive practices, and taking into account information regarding such violations shared through the mechanisms of administrative assistance provided for in Articles 102 to 108 and any other information pointing to the possibility of such violations.
…
4. Official controls shall be performed without prior notice, except where such notice is necessary and duly justified for the official control to be carried out. As regards official controls upon request from the operator, the competent authority may decide whether the official controls are to be performed with or without prior notice. Official controls with prior notice shall not preclude official controls without prior notice.
5. Official controls shall be performed as much as possible in such a manner that the administrative burden and operational disruption for operators are kept to the minimum necessary, but without this negatively affecting the effectiveness of those controls.
6. Competent authorities shall perform official controls in the same manner, while taking account of the need to adapt the controls to the specific situations, irrespective of whether the animals and goods concerned are:
(a) available on the Union market, whether originating in the Member State where the official controls are performed or in another Member State;
…
7. To the extent strictly necessary for the organisation of the official controls, Member States of destination may require operators that have animals or goods delivered to them from another Member State to report the arrival of such animals or goods.’
15 Article 10(1)(a) and (c) and (2) of that regulation provides:
‘1. To the extent necessary to ascertain compliance with the rules referred to in Article 1(2), competent authorities shall perform official controls on:
(a) animals and goods at any stage of production, processing, distribution and use;
…
(c) operators as regards activities, including the keeping of animals, equipment, means of transport, premises and other places under their control and their surroundings and on related documentation.
2. Without prejudice to the rules concerning existing lists or registers established on the basis of the rules referred to in Article 1(2), the competent authorities shall draw up and keep up-to-date a list of operators. Where such a list or register already exists for other purposes, it may also be used for the purposes of this Regulation.’
16 Article 11(1) of that regulation is worded as follows:
‘Competent authorities shall perform official controls with a high level of transparency and shall, at least once a year, make available to the public, including through publication on the [I]nternet, relevant information concerning the organisation and the performance of official controls.
They shall also ensure the regular and timely publication of information on the following:
(a) the type, number and outcome of official controls;
(b) the type and number of cases of non-compliance detected;
(c) the type and number of cases where measures were taken by the competent authorities in accordance with Article 138; and
(d) the type and number of cases where the penalties referred to in Article 139 were imposed.’
17 Articles 102 to 108 of Regulation 2017/625 lay down the rules on administrative assistance and cooperation between the competent authorities of the Member States in the context of the procedures governed by that regulation.
18 Article 111(1) of that regulation provides:
‘Member States shall ensure that the [Multi-annual National Control Plan (MANCP)] provided for in Article 109(1) is made available to the public, with the exception of those parts of the plan the disclosure of which could undermine the effectiveness of official controls.’
Czech law
The Law on Foodstuffs
19 According to Paragraph 3d(3) of zákon č. 110/1997 Sb., o potravinách a tabákových výrobcích a o změně a doplnění některých souvisejících zákonů (Law 110/1997 on foodstuffs and tobacco products amending and supplementing certain related laws) of 24 April 1997 (110/1997 Sb; ‘the Law on Foodstuffs’):
‘The operator of a food company taking delivery of foodstuffs specified in an implementing legal regulation from another Member State of the European Union or from a third country at the place of destination shall report to the supervisory authority that is competent pursuant to Paragraph 16(4) or (5) about their arrival pursuant to an implementing legislative provision which, on the basis of a risk analysis in accordance with Article 3 of Regulation [No 178/2002] of the European Parliament and of the Council, lays down the type of foods, the date, the scope, and the reporting method, to the extent strictly required for the organisation of official controls.’
Decree No 172/2015
20 Under Paragraph 1 of vyhláška č. 172/2015 Sb., o informační povinnosti příjemce potravin v místě určení (Decree No 172/2015 on the reporting obligation of a recipient of foodstuffs at their place of destination), in the version in force at the time of the facts in the main proceedings (‘Decree No 172/2015’):
‘(1) This decree governs the extent of the reporting obligations of the food business operator at the place of destination … in accordance with directly applicable EU legislation.
(2) This decree applies to
…
(e) food supplements,
…
(3) This decree applies only to cases where the place of destination is the place of first reception, including any first treatment or handling in the Czech Republic of the foodstuff specified in Paragraph 2.
21 Paragraph 2(1) of Decree No 172/2015 provides:
‘The recipient of foodstuffs from another Member State of the European Union or third country at their place of destination shall, in the case of foodstuffs referred to in Paragraph 1(2)(a) to (e) and of a place of destination referred to in Paragraph 1(3), report, through the information system of the Czech Agriculture and Food Inspection Authority no later than 24 hours prior to the arrival of the foodstuffs at the place of destination, the following
(a) the type of foodstuffs arriving at the place of destination;
(b) the quantity of the foodstuffs arriving at the place of destination;
(c) the Member State of the European Union or a third country, the name and address of the food business operator delivering the food to the place of destination;
(d) the name, address and identification number of the place of destination and of the recipient of the foodstuffs at the place of destination; and
(e) the date of arrival of the foodstuffs at the place of destination.’
The dispute in the main proceedings and the question referred for a preliminary ruling
22 On 7 June 2021, the Czech Agriculture and Food Inspection Authority carried out, on the basis of Decree No 172/2015, which implements the Law on Foodstuffs, an official control of the safety of food supplements received by Pragon. That check was carried out in accordance with a national regulatory framework which, under Paragraph 3d(3) of that law, read in conjunction with Paragraph 1(2) of that decree, provides that food business operators are required to inform the competent inspection authorities of the arrival, from another Member State of the European Union or from a third country, of certain foods, including food supplements.
23 Pragon challenged the control carried out by the Czech Agriculture and Food Inspection Authority by way of an action seeking protection against unlawful intervention by that authority under EU law and brought before the Městský soud v Praze (Municipal Court, Prague, Czech Republic), which dismissed that action by judgment of 6 October 2022.
24 On 10 May 2023, following an appeal on a point of law brought by Pragon, the Nejvyšší správní soud (Supreme Administrative Court, Czech Republic) set aside that judgment on the ground that the Městský soud v Praze (Municipal Court, Prague) had wrongly concluded that it was not unlawful to carry out a control on the basis of a decree contrary to EU law. That supreme court referred the case back to the court of first instance for it to examine whether Decree No 172/2015 was compatible with EU law and whether it should be applied in the case before it.
25 By judgment of 12 October 2023, the Městský soud v Praze (Municipal Court, Prague) dismissed Pragon’s action challenging the legality of the control carried out pursuant to Decree No 172/2015. According to that court, that decree satisfies the conditions required by Article 9(7) of Regulation 2017/625, namely the existence of prior notification, by the operators concerned, of the arrival of food supplements on Czech territory for the purpose of organising official controls and the strict necessity of that notification for that purpose. The proportionality of the reporting obligation is reflected in the fact that that obligation does not apply to all foods, but only to certain categories of foods, the list of which varies according to the assessment of the risk which they present on a given date, thus constituting a targeted and not a general requirement. Furthermore, that obligation concerns only the information necessary for the risk analysis that is available to the operators subject to that obligation. Furthermore, since the notification of the arrival of foodstuffs must be made, in accordance with Paragraph 2(1) of Decree No 172/2015, by means of an online form at least 24 hours before that arrival, such an obligation is less onerous than that under the earlier legislation, which provided for an obligation to give prior notification 48 hours before that arrival. Without that information, on the other hand, it would not be possible to comply with the obligation of regular official controls without prior notice, as required by Article 9(2) and (4) of Regulation 2017/625.
26 Subsequently, Pragon brought an appeal against the judgment of 12 October 2023 before the Nejvyšší správní soud (Supreme Administrative Court), which is the referring court, before which it submits, in essence, that the notification obligation laid down by the Czech legislation manifestly infringes the free movement of goods, in so far as the goods cannot be delivered to the Czech Republic on the day of the order, which constitutes a non-tariff barrier prohibited by EU law. In addition, Pragon submits that foodstuffs originating in territories outside that of the Czech Republic are subject to discriminatory treatment by comparison with that accorded to goods originating in the territory of that Member State, in that the latter are not subject to a prior reporting obligation and may therefore be marketed immediately.
27 Among the grounds which lead it to refer a question for a preliminary ruling, the referring court points out that foodstuffs falling within a category listed in Decree No 172/2015 may, where they originate in the Czech Republic, be marketed by the recipient of those foodstuffs as soon as possible without it being necessary to fulfil any reporting obligation. By contrast, where they come from another Member State, those foodstuffs must, in accordance with that decree, be notified at least 24 hours before their arrival in the Czech Republic. Such an obligation, it submits, entails more complex planning for food business operators, since any such order could only be delivered 24 hours after that obligation had been fulfilled, which would result in additional costs and delays for the operators concerned. For those reasons, that court states that it is inclined to consider that the reporting obligation laid down in Paragraph 3d(3) of the Law on Foodstuffs, implemented by Decree No 172/2015, is liable to deter food business operators from introducing or placing on the market in the Czech Republic foodstuffs originating in other Member States and therefore constitutes a measure having equivalent effect to a quantitative restriction within the meaning of Article 34 TFEU.
28 According to the referring court, it is necessary to establish whether the reporting obligation laid down by the Czech legislation is proportionate, that is to say, to determine whether or not there is a comparable way of protecting human health, an objective which that court envisages as being capable of justifying that obligation, which would be less restrictive of the free movement of goods within the European Union than that provided for by that legislation. Given that Article 9(7) of Regulation 2017/625 makes it possible to impose a reporting obligation on the recipient of foodstuffs from another Member State, that court wonders to what extent that obligation could be of a systematic nature in the light of recital 37 of that regulation, from which it is apparent that information on the arrival of goods may be required only in exceptional circumstances. It also wonders whether a reporting obligation focused on the current risks presented by foodstuffs received or imposed only at the time of arrival of such food in the Member State of destination or at the time of specific deliveries would not constitute a sufficient alternative measure. That said, that court does not rule out the possibility that a requirement of prior notification may be regarded as proportionate, since such notification increases the chances of intercepting a foodstuff which does not comply with the requirements laid down by EU law.
29 As regards food supplements in particular, the referring court considers that they differ from fresh foodstuffs or food of animal origin by specific requirements relating to shelf life, transport, storage, form and use. Since food supplements are not perishable, it is not necessary to carry out an official control within 24 hours. It is nevertheless apparent from the Czech legislation that the maintenance of food supplements on the list of foodstuffs provided for in Decree No 172/2015, is justified by the possible presence in those supplements of anabolic agents, pharmaceutical products, hormones and other prohibited substances, by the fact that, frequently, the indication of the substances making up those supplements on the packaging does not correspond to reality or exceeds the permitted content and by the possible content of hazardous substances, such as heavy metals or aromatic hydrocarbons, and of vitamins or minerals which may have particular harmful effects in the event of excessive consumption with food. However, the referring court expresses reservations as to the necessity of carrying out, even in the light of such explanations, official checks on food supplements within such a short period after their arrival on Czech territory, which might be necessary in the case of perishable foodstuffs.
30 In those circumstances, the Nejvyšší správní soud (Supreme Administrative Court) decided to stay the proceedings and to refer the following question to the Court of Justice for a preliminary ruling:
‘Does Article 34 TFEU, having regard to Article 36 TFEU and Article 9(7) of Regulation [2017/625], preclude national legislation that imposes on a recipient of food supplements from another Member State the general obligation to report, no later than 24 hours in advance of their arrival at their place of destination, and provide the information required for carrying out a risk analysis and planning official controls?’
Consideration of the question referred
31 By its question for a preliminary ruling, the referring court asks whether Articles 34 and 36 TFEU and Article 9(7) of Regulation 2017/625 must be interpreted as precluding national legislation which imposes on any operator receiving food supplements from another Member State an obligation to report in advance the arrival of those supplements at their destination and to provide the information required to assess the risks they may pose and planning official controls.
32 As a preliminary point, it should be noted that, according to Article 1(1)(a) and (2) of Regulation 2017/625, that regulation lays down rules concerning, inter alia, the performance of official controls by the competent authorities of the Member States to verify compliance with the rules, whether established at EU level or by the Member States, in the area of food and food safety, integrity and wholesomeness at any stage of production, processing and distribution of food, including rules aimed at ensuring fair practices in trade and protecting and informing consumers.
33 In addition, it is apparent from recitals 15, 19, 20, 43 and 99 of that regulation that the rules established by that regulation constitute a single legislative framework intended to ensure a harmonised approach to the organisation, by Member States, of official controls to verify compliance with EU agri-food chain legislation in all the areas covered by that legislation.
34 Within that single legislative framework, Article 9 of that regulation sets out the general rules for official controls. In particular, paragraph 7 of that article provides that Member States may require operators that have animals or goods delivered to them from another Member State to report the arrival of such animals or goods, provided that that is strictly necessary for the organisation of the official controls.
35 It must be observed, in that regard, that food supplements fall within the concept of ‘goods’ referred to in that provision. That concept is defined, in Article 3(11) of Regulation 2017/625, as covering all that is subject to one or more of the rules referred to in Article 1(2), excluding animals. First, as is apparent from Article 3(12) of that regulation, read in conjunction with Article 2 of Regulation No 178/2002, food supplements fall within the concept of ‘food’ (see, to that effect, judgment of 6 September 2011, Bablok and Others, C‑442/09, EU:C:2011:541, paragraph 69). Secondly, Article 1(2)(a) of Regulation 2017/625 expressly refers to the rules in the field of ‘food and food safety’.
36 It is apparent from a reading of those provisions as a whole that the conditions under which Member States may, where appropriate, impose an obligation to report the arrival, at their destination, of food supplements from another Member State have been exhaustively harmonised by Regulation 2017/625.
37 Therefore, in accordance with the Court’s settled case-law, it is necessary to examine national legislation imposing such an obligation solely in the light of the provisions of that regulation, in particular Article 9(7) thereof, and not of Articles 34 and 36 TFEU (see, by analogy, judgment of 19 January 2023, CIHEF and Others, C‑147/21, EU:C:2023:31, paragraph 26 and the case-law cited).
38 In that regard, it should be noted that, according to the wording of Article 9(7) of Regulation 2017/625, it is only to the extent strictly necessary for the organisation of the official controls that Member States of destination may require operators receiving goods from another Member State to report the arrival of those goods.
39 In interpreting a provision of EU law, it is necessary to consider not only its wording but also the context in which it occurs and the objectives pursued by the rules of which it forms part (judgments of 17 November 1983, Merck, 292/82, EU:C:1983:335, paragraph 12, and of 19 June 2025, Lietuvos bankas, C‑671/23, EU:C:2025:457, paragraph 27 and the case-law cited).
40 First of all, it is apparent from the wording of Article 9(7) of Regulation 2017/625 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 also be strictly necessary for that purpose.
41 The condition of ‘strict necessity’ implies, in itself, that there must be no less restrictive measures than such a reporting obligation to ensure the effective organisation of official controls.
42 As regards, next, the context of that provision, it should be noted that that provision, in so far as it grants the Member States the option of treating goods differently according to their origin, introduces a derogation from the general rule laid down in Article 9(6) of that regulation, according to which official controls, whilst they must be adapted to different situations, must nevertheless be carried out in the same manner, regardless of whether the goods concerned originate from the Member State where the official controls are carried out or from another Member State. Therefore, the conditions for the implementation of Article 9(7) of that regulation, referred to in paragraph 40 of the present judgment, must be interpreted strictly (see, by analogy, judgment of 18 January 2001, Stockholm Lindöpark, C‑150/99, EU:C:2001:34, paragraph 25).
43 That solution is supported by certain elements of the preamble to Regulation 2017/625.
44 It is thus apparent from recital 37 of that regulation that it is ‘in exceptional circumstances’ that the competent authorities of a Member State should be able to require operators to be informed of the arrival of animals and goods from another Member State.
45 In addition, it follows from recital 38 of that regulation that it must be possible to perform official controls at all stages of production, processing and distribution of animals and goods covered by EU agri-food chain legislation. By contrast, that recital does not in any way indicate that, where those animals and goods come from another Member State, the controls relating thereto should take place systematically and necessarily as soon as those animals and goods arrive on the territory of the Member State concerned.
46 In that regard, Article 10(1) of Regulation 2017/625 requires the competent authorities to carry out, to the extent necessary, official controls on the goods covered by that regulation at all stages of their production, processing, distribution and use.
47 Lastly, as regards the objective of Regulation 2017/625, it should be noted that, first, according to recitals 1 to 3, 15 and 20 thereof, by establishing a harmonised EU framework for the organisation of official controls and other official activities along the entire the agri-food chain, that regulation seeks to ensure, in an effective manner, a high level of protection of human health, animal health and the environment and the interests of consumers. Secondly, that regulation was adopted on the basis not only of Article 168(4)(b) TFEU relating, inter alia, to the protection of public health, but also of Article 43(2) and Article 114 TFEU, which indicates that it also pursues the objective of ensuring the free movement of goods. Recital 3 of that regulation states, moreover, that the proper application of EU agri-food chain legislation contributes to the proper functioning of the internal market.
48 In view of that twofold objective, Article 9(7) of Regulation 2017/625 must be understood, as the Advocate General observed in point 36 of his Opinion, as requiring a specific balance between, on the one hand, the free movement of foodstuffs and, on the other, the protection of human and animal health, the environment and consumer interests.
49 It is apparent from all of those factors that Article 9(7) of Regulation 2017/625 must be interpreted as allowing Member States to require notification of the arrival of animals or goods from another Member State only in exceptional circumstances in which the obligation to give such notification is strictly necessary, in the absence of less restrictive measures, in order to ensure the effectiveness of official controls with a view to the protection, inter alia, of human health and consumers.
50 It will be for the referring court to determine whether the reporting obligation at issue in the main proceedings complies with Article 9(7) of Regulation 2017/625. In that regard, the Court, when giving a preliminary ruling on a reference, may give clarifications to guide the national court in its decision (judgment of 12 March 2026, Winderwill, C‑516/24, EU:C:2026:185, paragraph 42 and the case-law cited).
51 In that regard, it should be noted that, as the Czech Government has essentially argued, such a reporting obligation is capable of pursuing the objective of ensuring the effective organisation of official controls on those foodstuffs, by enabling the competent authorities, on the basis of the information resulting from the reports received, to carry out a comprehensive analysis of the risks to human health and consumers, thereby making it possible to identify the foodstuffs that must be subject to such controls at the earliest stage of the agri-food chain in the Czech Republic or prior to their distribution to final consumers.
52 Such an objective corresponds to that referred to in paragraph 49 of the present judgment. In order to fulfil that objective, an obligation to report the arrival of goods from another Member State may, under Article 9(7) of Regulation 2017/625, be imposed on the operators concerned, provided that it is strictly necessary to ensure the achievement of that objective.
53 However, it should be noted that the obligation at issue in the main proceedings concerns the arrival on the territory of the Czech Republic of all food supplements originating in other Member States and thus applies to all operators receiving such supplements.
54 In that regard, it must be noted that, under Article 9(1) of Regulation 2017/625, official controls must be organised in such a way that all operators are subject to them regularly, on a risk basis and with appropriate frequency.
55 However, in view of the mechanisms for safeguarding, exchanging and collecting information provided for by Regulation 2017/625, in particular Article 9(2), Article 10(2), Article 11(1) and Article 111(1) thereof, the notification of the arrival of all food supplements originating from another Member State, which is the responsibility of all operators receiving such supplements, does not appear necessary for the organisation of official controls meeting the requirements of Article 9(1) and Article 10(1) of that regulation.
56 First, Member States have, in principle, under Article 11(1) of Regulation 2017/625, information concerning, inter alia, the type, number and outcome of official controls and the type and number of non-compliances detected and sanctioned during one year in the other Member States and, pursuant to Article 111(1) of that regulation, of the MANCPs of the other Member States. In addition, it is apparent from Article 9(2) of that regulation that the Member States also have at their disposal information relating to possible intentional infringements of the rules referred to in Article 1(2) thereof, communicated through the mechanisms of administrative assistance provided for in Articles 102 to 108 of that regulation.
57 That information enables the Member State concerned to define the obligation to report on the arrival of food supplements from another Member State, the purpose of which is to organise official controls on those goods, on the basis of the risks arising from that information or the absence thereof.
58 Secondly, under Article 10(2) of Regulation 2017/625, the competent authorities are to draw up and keep up-to-date a list of ‘operators’, within the meaning of Article 3(29) of that regulation, including those receiving food supplements on the territory of a Member State from other Member States.
59 By means of that list, even food supplements which are not subject to a reporting obligation on their arrival from other Member States, defined on the basis of the risks arising from the information referred to in paragraph 56 of the present judgment or from the absence thereof, may be subject, from the first stage of the agri-food chain in the Member State of arrival, to official controls which target the operators receiving those supplements, provided that such controls are organised at an appropriate frequency and on a risk basis, in accordance with Article 9(1) of Regulation 2017/625.
60 Furthermore, it must be pointed out that, in order to enable the Member States to prevent, by means of effective controls, the particular risks which the placing on the market of a food supplement may entail, Article 10 of Directive 2002/46 gives them the option of requiring the manufacturer or the person responsible for placing such a supplement on the market in their territory to notify the competent authority of that placing on the market by forwarding it a model of the label used for the product.
61 In that context, the Czech Government nevertheless asserts that legislation as general as that at issue in the main proceedings is strictly necessary for the organisation of official controls on food supplements since (i) it has been repeatedly found that food supplements contain anabolic agents, pharmaceutical products, hormones and other prohibited substances, (ii) the information on their packaging frequently does not correspond to their actual contents, for example, regarding vitamin content and (iii) unauthorised forms of minerals or hazardous contaminants, such as heavy metals and aromatic hydrocarbons, are often present in those supplements.
62 However, such considerations are not such as to demonstrate, in the light of the factors referred to in paragraphs 55 to 60 of the present judgment, the existence of exceptional circumstances in which the obligation to systematically notify the arrival of food supplements from another Member State should be regarded as strictly necessary to ensure the effectiveness of official controls.
63 In particular, it does not follow from those considerations that the arrival on Czech territory of food supplements from another Member State would entail, before those food supplements reach the final consumer, real risks to the protection of human health or consumers which could not be effectively prevented by less restrictive measures such as an individualised obligation to report on arrival or official controls carried out at various stages of the agri-food chain, relying on the mechanisms referred to in paragraphs 55 to 60 of the present judgment.
64 That is all the more so since, as the European Commission rightly observed, the mere fact that a product originates from another Member State does not in itself mean that that product automatically presents a certain risk, given that products from other Member States have been subject, in those Member States, to the application of harmonised EU rules designed to ensure food safety.
65 In the light of the foregoing, Article 9(7) of Regulation 2017/625 must be interpreted as precluding national legislation which imposes on any operator receiving food supplements from another Member State an obligation to report in advance on the arrival of those supplements at their destination and to provide the data necessary for analysing the risks they may present and for planning official controls.
Costs
66 Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the referring court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.
On those grounds, the Court (Third Chamber) hereby rules:
Article 9(7) of Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation)
must be interpreted as precluding national legislation which imposes on any operator receiving food supplements from another Member State an obligation to report in advance the arrival of those supplements at their destination and to provide the information required for carrying out a risk analysis and planning official controls.
[Signatures]
* Language of the case: Czech.
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