Provisional text

OPINION OF ADVOCATE GENERAL

BIONDI

delivered on 18 December 2025 (1)

Case C‑626/24

PRAGON s.r.o.

v

Státní zemědělská a potravinářská inspekce, Inspektorát v Praze

(Request for a preliminary ruling from the Nejvyšší správní soud (Supreme Administrative Court, Czech Republic))

( Reference for a preliminary ruling – Free movement of goods – Prohibition on quantitative restrictions and measures having equivalent effect – Articles 34 and 36 TFEU – Exhaustive harmonisation – Official controls on feed and food – Regulation (EU) 2017/625 – Article 9(7) – National legislation providing for a prior notification obligation regarding the import of food supplements from other Member States )

1.        The market for food supplements is booming. In Europe, it was worth 26.6 billion United States dollars (USD) in 2024 and is forecast to grow steadily for the next 10 years. (2) Food supplements, which do not require a prescription, have become part of the daily lives of EU citizens. And it is precisely because they are so easy to access and considered safe that it has been necessary to make them subject to close oversight. While the EU legislature has established the legislative framework, it has largely relied on national authorities to implement it.

2.        The present case concerns Czech legislation which imposes a general obligation on operators receiving food supplements from another Member State to notify the competent authorities in advance. That notification must be made at least 24 hours before the arrival of the products at their place of destination and it must contain the information required for carrying out a risk analysis and for planning official controls of those supplements. The Czech authorities believe that such an arrangement ensures that supplements present in their territory are safe, but such an obligation, nevertheless, raises a number of doubts as to whether it complies with EU law.

I.      The dispute in the main proceedings, the question referred for a preliminary ruling and the procedure before the Court

3.        PRAGON s.r.o. is a Czech company that imports food supplements and sells them in physical shops and online.

4.        On 7 June 2021, the Státní zemědělská a potravinářská inspekce, Inspektorát v Praze (State Agriculture and Food Inspection Authority, Prague Inspectorate, Czech Republic) initiated a control in order to verify compliance with the obligations laid down by 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; ‘Decree No 172/2015’). (3) The decree implements zákon č. 110/1997 Sb., o potravinách a tabákových výrobcích (Law 110/1997 on foodstuffs and tobacco products; ‘the Law on Foodstuffs’). (4)

5.        The national legal framework (5) means that every arrival in the Czech Republic from another Member State or from a third country of the foodstuffs referred to in Decree No 172/2015 (6) is to be the subject of prior notification via the information system of the Czech Agriculture and Food Inspection Authority at least 24 hours before the arrival of the foodstuffs at the destination. (7) Every recipient of foodstuffs covered by the decree is required to provide the following information: the type of foodstuffs, the quantity, origin, recipient and the date of arrival at the place of destination. (8) Food supplements fall within the foodstuffs covered by Decree No 172/2015. (9)

6.        PRAGON brought an action before the Městský soud v Praze (Prague City Court, Czech Republic) challenging the control carried out on 7 June 2021. On 6 October 2022, that court dismissed the action. PRAGON then filed an appeal on a point of law before the Nejvyšší správní soud (Supreme Administrative Court, Czech Republic), which, by judgment of 10 May 2023, set aside the judgment of the Městský soud v Praze (Prague City Court) and referred the case back to the latter for it to examine, in particular, the compatibility of Decree No 172/2015 with EU law. On 12 October 2023, the Městský soud v Praze (Prague City Court) held that the obligation of prior notification was consistent with Article 9(7) of Regulation (EU) 2017/625 (10) and, consequently, it again dismissed PRAGON’s action.

7.        PRAGON therefore brought a second appeal before the referring court, in which it submits, in essence, that the reporting obligation laid down by Decree No 172/2015 means that goods may only be delivered to the Czech Republic at least 24 hours after being ordered, and that that constitutes a non-tariff barrier that breaches EU law. In addition, PRAGON submits that goods situated outside Czech territory are treated in a discriminatory manner in comparison with goods which are already within that territory, which are not subject to a prior notification requirement and may therefore be marketed immediately. PRAGON submits that Decree No 172/2015 manifestly infringes the free movement of goods.

8.        For its part, the referring court asks whether the obligation to notify the supervisory authority 24 hours in advance of any arrival from another Member State of foodstuffs covered by Decree No 172/2015 is compatible with EU law, given that a domestic delivery of goods of the same risk category is not subject to such an obligation. In addition, that reporting obligation gives rise to a more complex delivery process, which is also more costly, and could therefore deter operators in the sector from marketing the goods concerned on Czech territory. Decree No 172/2015 could therefore constitute a measure having an effect equivalent to a quantitative restriction within the meaning of Article 36 TFEU. Such a measure may, however, be justified under the conditions laid down by EU law. Equally, Article 9(7) of Regulation 2017/265 requires a certain level of proportionality. However, the systematic nature of the reporting obligation causes the referring court to have doubts as to whether it is proportional.

9.        The referring court’s uncertainty also concerns the extent of the obligation to provide information. It questions whether it would not be more appropriate and consistent with EU law to require information to be provided at the time of arrival of the goods and to focus that information on actual risks.

10.      Lastly, while the referring court has doubts as to whether the systematic prior notification obligation laid down by Decree No 172/2015 is proportionate to the attainment of the objective pursued, it finds that those doubts are even more pronounced in relation to the specific category of foodstuffs consisting of food supplements, the nature of which is significantly different from the other goods covered by the decree. The referring court notes that Decree No 172/2015 was amended in 2024. (11) The list of goods subject to prior notification was reduced to five, which still includes food supplements because of the risk of the possible presence of anabolic substances, drugs, hormones and other dangerous contaminants such as heavy metals or aromatic hydrocarbons. (12) The referring court is uncertain, however, whether that is sufficient to justify their inclusion on the list of goods to which the notification and reporting obligation applies.

11.      In those circumstances, the Nejvyšší správní soud (Supreme Administrative Court, Czech Republic) decided to stay the proceedings and, by decision received at the Court Registry on 24 September 2024, 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?’

12.      Written observations were submitted by PRAGON, the Czech Government and the European Commission, which also presented oral arguments at the hearing held before the Court of Justice on 18 September 2025.

II.    Analysis

13.      It follows from the Czech legislation that economic operators have an obligation, when importing a certain number of foodstuffs into the Czech Republic, including food supplements, to inform the Czech Agriculture and Food Inspection Authority, at least 24 hours before the arrival of those goods at the place of destination, of the imminent arrival thereof. (13) The recipient of goods from another Member State or from a third country must report to that authority the type of goods concerned; the quantity delivered; the Member State or third country of origin and the name and address of the sender; the name, address and identification number of the recipient of the goods imported; and, lastly, the date of arrival at the place of destination. That information is to be provided by means of a form that is to be filled in online. (14)

14.      As a company importing food supplements, PRAGON is therefore subject to the obligation to systematically report the arrival of any food supplements from other Member States. It stated in its written submissions that it had made 142 reports since 21 September 2016, an assertion that was not contradicted by the Czech Government.

15.      By its single question, the referring court, hearing the case for the second time in the context of the same national dispute, asks the Court of Justice whether the Czech legislation, as described above, is compatible with EU law. Since the referring court refers in its question to both provisions of primary law and to Regulation 2017/625, it is necessary to define the analytical framework to determine the rule of EU law by which the Czech legislation is to be examined.

A.      Determination of the analytical framework

16.      As a preliminary point, it should be noted that, according to settled case-law, where a sphere has been the subject of exhaustive harmonisation at EU level, any national measure relating thereto must be assessed in the light of the provisions of the harmonising measure and not those of the Treaty. (15)

17.      Like the Czech Government and the Commission, I take the view that the provisions of primary law relied on – namely Articles 34 and 36 TFEU – do not constitute the analytical framework for answering the question referred to the Court of Justice for a preliminary ruling.

18.      Indeed, official controls intended to ensure compliance with EU food law (16) constitute a harmonised area under Regulation 2017/625.

19.      Recital 3 of that regulation states that ‘Union legislation provides for a set of harmonised rules to ensure that food … [is] safe and wholesome, and that activities which might have an impact on the safety of the agri-food chain … are performed in accordance with specific requirements’. Further on, the EU legislature points out that ‘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’. (17)

20.      In addition, it is clear from recital 16 of Regulation 2017/625 that that regulation repeals and replaces Regulation (EC) No 882/2004, (18) which had ‘established a single legislative framework for the organisation of official controls’ and had ‘provided a consolidated legal framework to support an integrated approach towards the performance of official controls along the agri-food chain’. Regulation 2017/625 seeks to ‘rationalise and simplify the overall legislative framework [by integrating] the rules applicable to official controls in specific areas … into a single legislative framework for official controls’. (19)

21.      It is therefore clear from the EU legislature’s express intention that it wished to ‘establish a harmonised Union framework for the organisation of official controls … along the entire agri-food chain’ (20) and 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’. (21)

22.      Regulation 2017/625, in accordance with Article 1(1)(a) thereof, lays down rules for the performance of official controls and governs ‘official controls performed for the verification of compliance with the rules, … to apply Union legislation, in the areas of … food and food safety’. (22)

23.      Article 2(1)(a) of Regulation 2017/625 defines official controls as ‘activities performed by the competent authorities … in order to verify … compliance by the operators with this Regulation and with the rules referred to in Article 1(2)’.

24.      Article 3 of Regulation 2017/625 refers to Article 2 of Regulation (EC) No 178/2002 for the definition of food, which must therefore be understood as ‘any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans’.

25.      The inclusion of food supplements in the category of foodstuffs is, in turn, determined by 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, (23) which states that the latter are ‘foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities’. (24)

26.      It follows from the foregoing considerations that EU law and, in particular, Regulation 2017/625 have performed an exhaustive harmonisation of the rules applicable to official controls on foodstuffs, including food supplements.

27.      The requirement of the prior notification of the arrival of food supplements from a Member State of the European Union on Czech territory constitutes one of the methods for carrying out official controls under Regulation 2017/625 and was adopted, as the Czech Government observed, for the purposes of risk analysis on the basis of Regulation No 178/2002.

28.      Since it falls within the field governed by the harmonising provisions of Regulation 2017/625, the prior notification requirement must be assessed in the light of the provisions of that regulation and, in particular, of Article 9(7) thereof.

B.      Meaning and scope of Article 9(7) of Regulation 2017/625

29.      In interpreting a provision of EU law, the analytical approach traditionally requires one to begin by examining the wording. (25) I wish to point out that, under Article 9(7) of Regulation 2017/625, Member States may, ‘to the extent strictly necessary for the organisation of official controls’, require operators to report the arrival on their territory of goods coming from another Member State. It may be inferred from a reading of that provision that Regulation 2017/625 is based on the principle that such an arrival does not in general require prior notification to the competent authorities, and that it is only exceptionally that the Member States may provide for it. Member States wishing to make use of that option are required to base their practice on requirements relating to the organisation of official controls, and prior notification of the arrival of foodstuffs may be permitted only to the extent strictly necessary for the organisation thereof. As a measure that derogates from the free movement of food within the territory of the European Union, Article 9(7) of Regulation 2017/625 must be interpreted strictly.

30.      Moreover, the legislative context of Article 9(7) of Regulation 2017/625 shows that the paragraph forms part of the article on the general rules on official controls. Competent authorities must carry out official controls on all operators – who have primary responsibility for food safety (26) and who are required to cooperate for the performance of official controls (27) – regularly, on a risk basis (28) and with appropriate frequency, taking into account the risks identified, any information indicating the possibility that consumers might be misled, the operators’ past record, the reliability and results of own controls that have been performed by the operators, or any information that might indicate non-compliance with EU food law. (29)

31.      The controls are to be performed at ‘any stage of production, processing, distribution and use’ (30) of goods, and are to be adapted to the situation and, in particular, whether the goods are already in the European Union or are entering it. (31)

32.      The interpretation of Article 9(7) of Regulation 2017/625 should, moreover, be supplemented by a reading of recital 37 of that regulation, which refers to the presence of ‘exceptional circumstances’ when envisaging the possibility that Member States may require the arrival of goods from other Member States to be reported in advance. That is in clear contrast with the mandatory, systematic prior notification otherwise provided for in the regulation for certain categories of goods entering the European Union. (32)

33.      In addition, recital 34 of Regulation 2017/625 calls on the competent authorities to ‘organise and conduct official control activities taking [operators’] interests into account and limiting the said burden to that which is necessary for the performance of efficient and effective official controls’.

34.      Since the dispute in the main proceedings concerns food supplements, the legislative context of Article 9(7) of Regulation 2017/625 must be extended to include Directive 2002/46, from which it follows, first, that Member States are to ensure that food supplements may be marketed within the European Union only if they comply with the rules laid down in that directive (33) and, second, that 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 through the forwarding of a model of the label used for the product at issue. (34) I note, in that regard, that food that complies with EU sectoral requirements is to be deemed to be safe, (35) which does not prevent the competent authorities from being able to take appropriate measures to impose restrictions on it being placed on the market or to require its withdrawal from the market, but only ‘where there are reasons to suspect that, despite such conformity, the food is unsafe’. (36)

35.      As regards the teleological interpretation, Regulation 2017/625 governs official controls that are of key importance for ensuring the compliance of foodstuffs with legislation applicable within the European Union and, in particular, with the rules established to protect human health. (37) The regulation continues the approach of Regulation No 882/2004, which it replaces and which ‘significantly improved the efficiency of official controls, the enforcement of Union agri-food chain legislation and the level of protection against risks to human, animal and plant health …’. (38)

36.      Account must also be taken of the fact that Regulation 2017/625 was adopted on the basis of Article 43(2), Article 114 and Article 168(4)(b) TFEU. In enacting Article 9(7) of the regulation, the EU legislature sought to strike a specific balance between the free movement of foodstuffs and a high level of protection of both human and animal health and the environment. (39) The EU legislature also focused on guaranteeing a high level of consumer protection and maintaining consumer confidence. (40)

37.      It follows from the foregoing considerations that Article 9(7) of Regulation 2017/625 gives concrete expression in secondary law to an economic and constitutional paradigm of the European Union. Accordingly, it must be interpreted by having regard to the following fundamental factors: the pursuit of a high level of protection of human health in the context of a functioning internal market; a requirement for effective controls while protecting operators from excessive administrative burdens, and, lastly, a legal regime that makes a distinction for goods already present on EU territory and which are already subject to sectoral standards.

38.      With those fundamental elements in mind, it is now necessary to examine the legislation at issue in the main proceedings. (41)

C.      Compatibility of the national legislation at issue in the main proceedings with Article 9(7) of Regulation 2017/625

39.      According to the Czech Government, the national authorities need the prior notification and the accompanying information in order to ensure the effectiveness of controls on compliance with food law requirements and, in particular, those on food safety. It is essential, it argues, to be able to organise controls immediately from the first link in the distribution chain in the territory of the Member State concerned, since the competent authorities do not have any prior information concerning those goods.

40.      At the outset, I would point out that it is indeed true that a systematic prior notification system would enable the national authorities responsible for organising official controls to be fully informed. However, such a system would not take account, in such a case, of the other objective pursued by the EU legislature, which relates to the functioning of the internal market.

41.      Furthermore, Decree No 172/2015 does not take account of the origin of the goods and makes operators subject to one and the same prior notification obligation, whether the goods come from an EU Member State or from third countries. (42) That lack of distinction as to the origin of the foodstuffs does not comply with Regulation 2017/625. (43)

42.      Furthermore, the national legislation at issue in the main proceedings appears insufficiently targeted, both as regards the goods it covers and the alleged hazards and the period during which prior notification is required.

43.      First, making all food supplements subject to that requirement does not appear to be ‘strictly necessary’ since it must be possible to distinguish, within those supplements, those which require more surveillance, and therefore more controls. Directive 2002/46 provides, for example, that ‘Member States may, in compliance with the rules of the Treaty, continue to apply existing national restrictions or bans on trade in food supplements containing vitamins and minerals not included in the list in Annex I or in the forms not listed in Annex II’. (44)

44.      I would also point out that it is not apparent from the documents before the Court that the Czech Republic availed itself of the possibility offered by Directive 2002/46 of requiring the forwarding of a model of the label in order to facilitate controls, (45) which could itself be a primary source of advance information for the authorities. In view of that possibility offered by EU law, the Czech Government has failed to establish why making all food supplements subject to the requirement of prior notification on arrival in the territory is strictly necessary for the performance of official controls. (46)

45.      Second, as regards the alleged risks, I also find that the Czech Government relies on overly general claims that food supplements often contain doses of highly concentrated products and that anabolic substances, medicinal products, hormones and other prohibited products or other prohibited forms of minerals, metals, contaminants or aromatic hydrocarbons are often present.

46.      Lastly, a systematic prior notification obligation covering, on a permanent basis, an entire category of foodstuffs does not appear to be consistent with the spirit which led to the adoption of Article 9(7) of Regulation 2017/625, since it is the exact opposite of a measure which is ‘strictly necessary’ for the organisation of official controls, there being also no provision for the situation to be reassessed, according to a fixed and regular timetable.

47.      In addition to its being inadequately targeted, it is also difficult to be convinced that the obligation is strictly necessary, in the light of the table of statistics provided by PRAGON. (47) The table shows that 175 938 notifications were submitted to the Czech authorities in 2015 and that 3 128 inspections were performed. In 2022, those authorities received 280 202 notifications and 767 inspections were performed. The number of notifications increased by 59% between 2015 and 2022, whereas the number of controls fell by 75% over the same period. (48) The Czech Government acknowledged at the hearing that only 0.5% of the imports notified are subject to a control, explaining that the 24-hour advance notice period enabled the authorities to analyse the risks and determine whether or not an inspection was necessary on the basis of the information accompanying the notification. The Czech Government thus seems to me to have implicitly acknowledged the clear disproportion between the number of notifications that operators have had to submit over the years and the number of controls actually performed.

48.      Moreover, I recognise that the alleged danger, referred to above, (49) does not seem to me to be corroborated as such by the finding that only 0.5% of the notifications led the Czech authorities to decide to carry out an inspection. (50)

49.      It must therefore be concluded that the legislation at issue in the main proceedings does not comply with the requirement of strict necessity laid down in Article 9(7) of Regulation 2017/625, which clearly shows that the duty to report arrivals of foodstuffs cannot be systematic and continuous, but must be based on specific and temporary circumstances, solely in so far as that is essential for the performance of the official controls provided for in that regulation. (51)

III. Conclusion

50.      For all the foregoing considerations, I propose that the Court of Justice reply as follows to the question referred by the Nejvyšší správní soud (Supreme Administrative Court, Czech Republic):

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 legislation which lays down a general and continuous obligation for the systematic prior notification of the arrival on national territory of an entire category of foodstuffs, such as food supplements, accompanied by an obligation to provide the information deemed necessary for risk analysis and the planning of official controls.

1      Original language: French.

2      See https://www.towardsfnb.com/insights/europe-dietary-supplements-market.

3      It is apparent from the documents before the Court of Justice that the instrument in question is Decree No 172/2015 in the version applicable until 31 August 2024, that is to say, as amended by Decree No 141/2017.

4      Paragraph 3d(3) of the Law on Foodstuffs provides that ‘the operator of a food company taking delivery of foodstuffs, specified in an implementing regulation, from another European Union Member State or 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 (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)], shall lay down the type of foods, the date, the scope and the reporting method, to the extent strictly required for the organisation of official controls’.

5      Paragraph 1(1) of Decree No 172/2015 states that it ‘in relation to directly applicable European Union legislation, this Decree regulates the scope of the reporting obligation for an operator of a food company at the place of destination …,’. Paragraph 1(3) of that decree states that it ‘applies only to cases where the place of destination is the place of first reception’.

6      Decree No 172/2015, in the version applicable to the dispute in the main proceedings, referred to certain types of fresh fruit, certain types of fresh vegetables, potatoes, poppy seeds, food supplements, and almost all foodstuffs of animal origin.

7      As follows from Paragraph 2 of Decree No 172/2015.

8      As follows from Paragraph 2(1) of Decree No 172/2015.

9      Paragraph 1(2) of the decree lists the foodstuffs subject to an obligation to give notification prior to their arrival in Czech territory. Point (e) of that list refers specifically to food supplements.

      It follows from Paragraph 2(1)(g) of the Law on Foodstuffs that the latter are defined as ‘a food the purpose of which is to supplement regular foods and that is a concentrated source of vitamins and minerals or other substances with a nutritional or physiological effect contained in foods, separately or in combination, which is intended for direct consumption in small, measured quantities’.

10      Regulation 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). At the time when the control at issue in the main proceedings took place, Regulation 2017/625 had been amended by Commission Delegated Regulation (EU) 2019/478 of 14 January 2019 amending [Regulation 2017/625] as regards the categories of consignments to be subjected to official controls at border control posts (OJ 2019 L 82, p. 4) and by Commission Delegated Regulation (EU) 2019/2127 of 10 October 2019 amending [Regulation 2017/625] as regards the date of application of certain provisions of Council Directives 91/496/EEC, 97/78/EC and 2000/29/EC (OJ 2019 L 321, p. 111).

      Article 9(7) of Regulation 2017/625 states that ‘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’.

11      By Decree No 235/2024.

12      As follows from the statement of reasons to Decree No 235/2024, which entered into force on 1 September 2024.

13      It is apparent from the documents before the Court that the Czech legislation originally laid down an obligation to file a report 48 hours before arrival in the territory: see paragraph 5 of the request for a preliminary ruling and paragraph 46 of the written observations of the Czech Government.

14      See paragraph 5 of the request for a preliminary ruling.

15      See judgments of 14 December 2004, Commission v Germany (C‑463/01, EU:C:2004:797, paragraph 36 and the case-law cited); of 11 July 2019, Commission v Greece (Tsipouro) (C‑91/18, EU:C:2019:600, paragraph 44 and the case-law cited); of 19 January 2023, CIHEF and Others (C‑147/21, EU:C:2023:31, paragraph 26); and of 20 March 2025, Anib and Others (C‑728/22 to C‑730/22, EU:C:2025:200, paragraph 65 and the case-law cited).

16      As defined in Article 3(1) of Regulation No 178/2002. See also Article 3(1) of Regulation 2017/625.

17      Recital 15 of Regulation 2017/625.

18      Regulation 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).

19      Recital 19 of Regulation 2017/625.

20      Recital 20 of Regulation 2017/625. The idea of a single legislative framework is reiterated in recital 43 of the regulation.

21      Recital 99 of Regulation 2017/625.

22      Article 1(2)(a) of Regulation 2017/625.

23      OJ 2002 L 183, p. 51.

24      Article 2(a) of Directive 2002/46.

25      See, among a long line of decisions, the judgment of 4 September 2025, Kwizda Pharma II (C‑451/24, EU:C:2025:663, paragraph 55 and the case-law cited).

26      See recital 30 and Article 17(1) of Regulation No 178/2002. See also, with regard to EU legislation on food hygiene, judgment of 6 October 2011, Albrecht and Others (C‑382/10, EU:C:2011:639, paragraph 20).

27      See Article 15 of Regulation 2017/625.

28      Risk is defined as ‘a function of the probability of an adverse effect on human, animal or plant health, animal welfare or the environment and of the severity of that effect, consequential to a hazard’ (Article 3(24) of Regulation 2017/625). Risk analysis is defined as ‘a process consisting of three interconnected components: risk assessment, risk management and risk communication’ (Article 3(10) of Regulation No 178/2002).

29      See, respectively, Article 9(1)(a) to (e) of Regulation 2017/625.

30      Article 10(1)(a) of Regulation 2017/625.

31      See Article 9(6) of Regulation 2017/625.

32      See recital 53, Article 47(1) and Article 56(3)(a) and (4) of Regulation 2017/625. On 27 June 2024, the Commission adopted Commission Delegated Regulation (EU) 2024/2104 supplementing [Regulation 2017/625] as regards the cases where and the conditions under which competent authorities may request operators to notify the arrival of certain goods entering the Union (OJ L, 2024/2104).

33      See Article 3 of Directive 2002/46.

34      See Article 10 of Directive 2002/46.

35      See Article 14(7) of Regulation No 178/2002.

36      Article 14(8) of Regulation No 178/2002.

37      See recital 53 of Regulation 2017/625 in relation to controls on entry into the Union.

38      Recital 16 of Regulation 2017/625.

39      See, by analogy, judgment of 19 January 2023, CIHEF and Others (C‑147/21, EU:C:2023:31, paragraph 64).

40      See recitals 2 and 3, Article 1(2)(a) and Article 9(1)(b) of Regulation 2017/625.

41      As stated by the referring court, the Commission appears to have already called into question the conformity of that legislation with EU law by sending the Czech Republic a letter of formal notice on 24 January 2019. At the time of the present Opinion, the procedure (which, according to the Commission at the hearing, is for the time being ‘frozen’) is still in the pre-contentious phase and the last formal document in that procedure dates back to November 2021.

42      It may be inferred from the Commission’s intervention in adopting Delegated Regulation 2024/2104 that even goods from third countries in respect of which Regulation 2017/625 does not lay down an obligation to notify arrival in Union territory may be subject to such an obligation only under the conditions laid down in that delegated regulation.

43      See point 37 of the present Opinion.

44      Article 4(7) of Directive 2002/46.

45      See point 34 of the present Opinion.

46      I would also point out that it follows from Article 11 of Directive 2002/46 that, without prejudice to Article 4(7) of that directive, ‘Member States shall not … prohibit or restrict trade in products referred to in Article 1 which comply with this Directive’.

47      See p. 13 of PRAGON’s written observations.

48      The last column of the table shows the number of inspections on imports from other EU Member States. In 2022, a total of 667 of the 767 inspections performed concerned those imports. When asked to respond on that point at the hearing, the Czech Government stated that it did not understand that figure, given that imports from third countries were subject to systematic controls.

49      See point 45 of the present Opinion.

50      That is particularly true given that, of the 0.5% of notifications followed by an inspection, an even smaller proportion will have given rise to a finding of non-compliance.

51      On a similar note, see also judgment of 20 October 2005, Commission v Sweden (C‑111/03, EU:C:2005:619, paragraph 59).