Judgment;Summary — ECLI:EU:C:2024:259
Date: 2024-03-21
Language of the case: Romanian
Court formation: Seventh Chamber
Subject matter: Public health
Procedure: Reference for a preliminary ruling;Reference for a preliminary ruling - inadmissible
Origin: Romania

Summary C-10/23 – 1 
Case C-10/23 
Summary of the request for a preliminary ruling pursuant to Article 98(1) of 
the Rules of Procedure of the Court of Justice 
Date lodged: 
11 January 2023 
Referring court: 
Înalta Curte de Casație și Justiție (Romania) 
Date of the decision to refer: 
19 October 2022 
Appellant: 
Remia Com Impex SRL 
Respondents: 
Autoritatea Națională Sanitară Veterinară și pentru Siguranța 
Alimentelor 
Direcția Sanitară Veterinară și pentru Siguranța Alimentelor Dolj 
  
Subject matter of the main proceedings 
Appeal brought by the appellant Remia Com Impex SRL against the judgment of 
4 December 2019 of the Curtea de Apel București (Court of Appeal, Bucharest), 
which dismissed its action, directed against the Autoritatea Națională Sanitară 
Veterinară și pentru Siguranța Alimentelor (National Veterinary Health and Food 
Safety Authority (‘ANSVSA’)) and the Direcția Sanitară Veterinară și pentru 
Siguranța Alimentelor Dolj (Dolj Directorate for Veterinary Health and Food 
Safety), by which it sought: the partial annulment of Ordinul nr. 111/2008 (Order 
No 111/2008; ‘the order’) of the ANSVSA on the ground that it does not comply 
with Regulation (EC) No 853/2004; the completion of the administrative 
procedures to re-assess the establishments registered in the district of Dolj, in 
order to classify them as subject to registration or approval under Regulation (EC) 
No 852/2004 and Regulation (EC) No 853/2004; and the payment of 
compensation of 7 246 167 Romanian lei (RON) for the damage caused by the 
infringement of EU law 
EN 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-10/23 
 
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Subject matter and legal basis of the request for a preliminary ruling 
Under Article 267 TFEU, interpretation is sought of recital 13 and Article 1(1) to 
(5) of Regulation (EC) No 853/2004 
Questions referred for a preliminary ruling 
1. Must Regulation (EC) No 853/2004 as a whole, and the provisions of 
Article 1(3) to (5) in particular, be interpreted as meaning that cold stores which 
carry out retail sales activities to other retail establishments, but not to the final 
consumer, have to be approved in accordance with that regulation, when the 
activity concerned does not fall within the exceptions provided for in 
Article 1(5)(b)? 
2. Must that regulation and EU law, in general, be interpreted as meaning that 
the national authorities which are responsible for ensuring the implementation of 
the policy which constitutes the objective to be achieved by the legislation and 
ensuring compliance with the corresponding obligations of the economic 
operators concerned are required to interpret the condition relating to marginal, 
localised and restricted activity, contained in Article 1(5)(b)(ii), in the light of 
recital 13 of that regulation, or may they derogate from that interpretation by 
means of their own definitions of the terms? 
3. If the answer to Question 2 is in the affirmative, must the relevant 
definitions, contained in a national act transposing the regulation, respect the 
substance of the concepts, as described in recital 13? 
4. In view of the fact that the provisions of Article 17 of the Normele atașate 
Ordinului No 111/2008 (rules annexed to Order No 111/2008) provide that the 
activity of retail sale of products of animal origin may also include activities of 
supply and sale of products to other retail establishments throughout the territory 
of Romania without the obligation to obtain a veterinary health permit, does EU 
law and, in particular, Regulation (EC) No 853/2004, preclude such a provision 
and/or such an administrative practice? 
5. Does the principle of equivalence require that, where a measure of an 
administrative authority may be annulled on the ground that it does not comply 
with a national law, that administrative act may also be annulled on the ground 
that it does not comply with a relevant EU regulation, such as Regulation (EC) 
No 853/2004? 
Provisions of European Union law relied on 
Regulation (EC) No 853/2004 of the European Parliament and of the Council of 
29 April 2004 laying down specific hygiene rules for food of animal origin, in 
particular recital 13 and Article 1(1) to (5). 
REMIA COM IMPEX 
 
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Provisions of national law relied on 
Ordinul nr. 111/2008 al ANSVSA privind aprobarea Normei sanitare veterinare și 
pentru siguranța alimentelor privind procedura de înregistrare sanitară 
veterinară și pentru siguranța alimentelor a activităților de obținere și de vânzare 
directă și/sau cu amănuntul a produselor alimentare de origine animală sau 
nonanimală, precum și a activităților de producție, procesare, depozitare, 
transport și comercializare a produselor alimentare de origine nonanimală 
(ANSVSA Order No 111/2008 approving the veterinary health and food safety 
rules relating to the procedure for veterinary health and food safety registration of 
direct and/or retail production and sale of food of animal or non-animal origin, as 
well as the production, processing, storage, transport and sale of foodstuffs of 
non-animal origin) 
Article 2 of Order No 111/2008: ‘The veterinary health and food safety rules 
referred to in Article 1 were drawn up to establish the procedure for veterinary 
health and food safety registration of the activities of establishments directly 
selling primary products or carrying out retail sales, in accordance with the 
provisions of Article 31 of Regulation No 882/2004, as amended, and Article 1(4) 
of Regulation No 853/2004, as amended’. 
Article 17 of the veterinary health rules provide: ‘For the purposes of this Chapter, 
the following terms and expressions are defined as follows: 
(a) retail … – the supply of food of animal and non-animal origin obtained in 
establishments registered for veterinary health and food safety purposes/approved 
for veterinary health purposes or/and the restricted, localised and limited supply of 
food of animal and non-animal origin obtained in small quantities in retail 
establishments and which is sold: 
1. to the final consumer at the place of production; 
2. to other retail establishments registered for veterinary health and food safety 
purposes throughout the national territory; 
3. to catering establishments registered for veterinary health and food safety 
purposes; 
4. to the final consumer at agri-food markets as well as at markets, exhibitions, 
events organised during religious festivities or other similar public events, 
organised periodically by local/district authorities throughout the national 
territory, with the exception of fresh meat from porcine animals; 
… 
(d) restricted supply – adding value to small quantities of food of animal and 
non-animal origin for the final consumer through other retail establishments; 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-10/23 
 
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(e) localised supply – adding value to food of animal origin throughout the 
national territory, in compliance with the conditions on transport, the cold chain 
and traceability; 
(f) limited supply – obtaining at the point of sale restricted categories of food of 
animal origin intended for adding value for the final consumer through other retail 
establishments; 
… 
(h) small quantities – the following quantities of products of animal and non-
animal origin obtained in the retail establishment and which are intended for sale 
to other retail establishments, for the purpose of sale to the final consumer, 
namely: 
I. products of animal origin: 
1. cut meat, minced meat, meat preparations and/or meat products in a variety 
range limited to a maximum of 5 varieties, in total, in quantities of up to 8 000 
kg/month; 
2. cheeses – up to 1 500 kg/week, annual average; 
3. pasteurised milk and liquid dairy products – up to 3 000 kg/week; 
4. fishery products – up to 1 000 kg/week; 
5. processed fishery products – up to 2 000 kg/month; 
6. wild game – up to 300 kg/month; 
7. poultry, lagomorphs and products derived from them – up to 500 kg/month 
8. eggs intended for consumption up to 1 000 eggs/month; 
9. products of animal origin subject to the heat-treatment regime received from 
food warehouses – up to 12 tonnes/month; 
II products of non-animal origin: 
1. milled products – up to 120 tonnes/year; 
2. bread, specialities and bakery products – up to 120 tonnes/year; 
3. pasta products – up to 4 tonnes/year; 
4. confectionery and pastry products – up to 30 tonnes/year; 
5. fruit and vegetable juices – up to 12 000 litres/year; 
REMIA COM IMPEX 
 
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6. products obtained from vegetables, fruit, mushrooms – up to 10 tonnes/year; 
7. seltzer water/other bottled waters, with the exception of mineral waters and 
spring waters – up to 120 hectolitres/year; 
8. cold-pressed unrefined oils up to 600 litres/year; 
9. beer – up to 3 000 hectolitres/year; 
10. wine – up to 200 hectolitres/year; 
11. distilled alcoholic beverages – up to 50 hectolitres/year equivalent to 100% 
alcohol; 
12. ice cream – up to 15 tonnes/year …’. 
Succinct presentation of the facts and procedure in the main proceedings 
1 By an application of 9 March 2018, lodged with the Curtea de Apel București 
(Court of Appeal, Bucharest), Remia Com Impex SRL brought an action against 
ANSVSA and the Direcția Sanitară Veterinară și pentru Siguranța Alimentelor 
Dolj seeking partial annulment of Order No 111/2008 on the ground that it does 
not comply with Regulation (EC) No 853/2004; the completion of the 
administrative procedures to re-assess the establishments registered in the district 
of Dolj, for the purpose of classifying them as subject to registration or approval 
under Regulation (EC) No 852/2004 and Regulation (EC) No 853/2004; and 
payment of compensation of 7 246 167 Romanian lei (RON) for the damage 
caused by the infringement of EU law. 
2 Following the dismissal, on 4 December 2019, of that action, Remia Com Impex 
SRL brought an appeal before the referring court – the Înalta Curtea de Casație și 
Justiție (High Court of Cassation and Justice, Romania). 
3 In the grounds of the appeal, the appellant claimed that the lawfulness of the 
national provisions at issue must be assessed on the basis of EU law, which is 
binding and directly applicable in the Member States, and in particular on the 
basis of the definitions given by EU law to the concepts applicable in that case, 
and not in the light of concepts of national law which either have no 
corresponding provisions in EU law or transpose those provisions only ostensibly, 
and thus distort the meaning of certain concepts. 
4 The appellant submitted that the court adjudicating on the substance did not 
analyse those aspects at all, and wrongly asserted that the mere indication of 
Regulation No 853/2004 as the basis in the preamble to Order No 111/2008 
excluded any discussion as to whether or not the EU rules had been transposed 
and the lawfulness of the order under appeal. In the appellant’s view, according to 
the court adjudicating on the substance, not even the failure to include in the 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-10/23 
 
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content of Order No 111/2008 the exceptions to approval provided for by 
Regulation No 853/2004 was such as to lead to the conclusion that the national 
legislative act was adopted in breach of EU law or that the respondents could not 
have adopted retail legislation in Romania. 
5 In addition, the appellant submits that, in the absence of an indication from the 
court adjudicating on the substance that the national rule should be supplemented 
by the European rule, the national rule on registration covers a broader scope than 
that provided for by EU law simply because it ignores the exceptions provided for 
by that law. The direct consequence of that mechanism is the corresponding 
limitation of the scope of the EU rules on approval. Regulation No 853/2004 is 
applicable in the case of wholesale, but also in the case of retail, where that trade 
has certain characteristics (these are the exceptions expressly provided for in 
Regulation No 853/2004). 
6 Although the court adjudicating on the substance, in dismissing the appellant’s 
appeal, referred to a condition that the economic operator must engage in intra-
Community trade, the appellant emphasises that, in fact, the whole discussion 
concerns retail and the requirement for approval of that type of trade when the 
operations are not limited to storage or transport or are not marginal, localised and 
restricted activities, in accordance with Article 1(5)(b) of Regulation 
No 853/2004, regardless of whether those operations take place within the 
national territory, at intra-Community level or even towards third countries. 
7 The court adjudicating on the substance thus allegedly incorrectly limited the 
scope of the EU regulations to intra-Community trade. According to recitals 1 to 5 
of Regulation (EC) No 853/2004, the rules of that regulation are adopted in the 
context of the common agricultural policy and concern products which may 
present specific hazards to human health; their objective is the proper functioning 
of the internal market, as well as to ensure a high level of protection of public 
health. 
8 Another criticism expressed by the company concerns the complete disregard for 
the definitions in Regulation No 853/2004, by the court adjudicating on the 
substance, which gave priority to the definitions in national law, considering them 
to be clearer. According to the appellant, the issue is not the exception of 
warehouses simply because they are called warehouses and the terminology 
resembles that of the regulation (storage), but of retail when it is limited to storage 
or transport, which is the case for deliveries made by distributors or other similar 
cases.  
9 The definition of ‘retail’ in Article 3 of Regulation No 178/2002 is very important 
as it differs significantly from the meaning of the concept of retail in national law. 
Since that definition also includes activity limited to the storage of food, the 
meaning of the exception in Article 1(5)(b)(i) of Regulation No 853/2004 is that 
retail activities do not have to be approved when they are limited to storage or 
transport, without that potentially resulting in a sale of goods taking place. The 
REMIA COM IMPEX 
 
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court adjudicating on the substance misapplied that provision in holding that ‘food 
warehouses’ fell within the category of establishments for which approval is not 
necessary, without further specification. 
10 According to the appellant, the requirements laid down in Regulation 
No 852/2004 apply to retail, whereas the requirements in Regulation No 853/2004 
apply to wholesale. In the appellant’s view, retail means sale to the final 
consumer, whereas wholesale means wholesale by an establishment to another 
establishment, but not to the final consumer. However, Regulation No 853/2004 
also applies to retail where expressly indicated and where the sale is not made to 
the final consumer, but to another retail establishment, and is not limited to 
storage or transport and is not a marginal, localised and restricted supply. 
11 Consequently, whenever a retail establishment sells to another establishment and 
the supply activity is not limited to storage or transport or is not a marginal, 
localised and restricted activity of the supplier, all the provisions of Regulation 
853/2004 concerning the requirement for approval apply to those activities, as is 
the case for wholesale activities. 
12 According to ANSVSA, establishments in the food sector which are subject to 
approval in accordance with the provisions of Regulation No 853/2004 may 
engage in intra-Community trade and export to third countries, whereas food 
warehouses registered in accordance with the provisions of Order No 111/2008 
may place their products only on the national market and may not receive 
products of animal origin directly from intra-Community trade or through imports 
from third countries. Therefore, food warehouses registered for veterinary health 
purposes under Order No 111/2008 do not enjoy the same advantages as 
establishments approved for veterinary health purposes for intra-Community trade 
under ANSVSA Order No 57/2010. 
The essential arguments of the parties in the main proceedings 
13 The appellant submits that the national legislation is contrary to EU law. Indeed, 
since there is separate regulation, by means of orders issued by ANSVSA, of the 
procedures for registration (specific to sale to the final consumer) and approval of 
establishments (specific to wholesale) respectively, it becomes possible to exclude 
from the category of approved activities sales which are not made to the final 
consumer and in that way to limit the scope of Regulation No 853/2004. 
14 More specifically, even if those were to be excluded from registration and if 
approval of retail activities which do not fall within the category of exceptions in 
Article 1(5)(b) of Regulation No 853/2004 were to be required, Order 
No 111/2008 does not provide for this. 
15 Moreover, nor does Order No 57/2010, which governs the approval procedure, 
contain any provision by which retail exempt from registration is included in its 
scope. 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-10/23 
 
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16 According to the appellant, the definitions given in Article 17(d), (e) and (f) of the 
veterinary health rules of the concepts of ‘restricted supply’, ‘localised supply’ 
and ‘limited supply’ are contrary to EU law. Thus, as regards the concept of 
‘localised supply’, which, according to recital 13 of Regulation No 853/2004, 
refers to establishments situated in the immediate vicinity of that which it 
supplies, national law provides in the abovementioned Article 17(e) that localised 
supply means ‘throughout the national territory’. As regards ‘restricted supply’, 
which, according to the regulation, concerns only certain types of products or 
establishments, paragraph (d) of the same article provides that it means the adding 
value to small quantities of products through other retail establishments, without 
any connection with the types of products. ‘Limited supply’ in the veterinary 
health rules is allegedly, in fact, equivalent to ‘marginal activity’ in the regulation. 
The concept of ‘marginal activity’ in the regulation does not correspond to any 
definition in the veterinary health rules. 
Succinct presentation of the reasoning in the request for a preliminary ruling 
17 The referring court states that it is called upon to rule on the dispute as the court of 
last instance and that it is therefore obliged to make a reference to the Court of 
Justice for a preliminary ruling. 
18 In the present case, the issue of whether the national provisions are compatible 
with those of Regulation No 853/2004 arises. 
19 Although Member States have discretion in regulating national legislation as 
regards the specific hygiene rules applying to food of animal origin, they may, 
according to recital 13 of Regulation No 853/2004, limit their application only if 
they consider that the requirements of Regulation 852/2004 are sufficient to 
achieve food hygiene objectives and when the supply of food of animal origin 
from a retail establishment to another establishment is a marginal, localised and 
restricted activity.  
20 According to the referring court, that supply should be only a small part of the 
activities of the establishment concerned, the establishments supplied in that way 
should be situated in its immediate vicinity, and the supply should concern only 
certain types of products or establishments. 
21 The reflection of that exceptional situation in national law and the way in which 
the concepts of ‘marginal’, ‘localised’ and ‘restricted’ have been defined make it 
necessary to bring the matter before the Court of Justice for the purpose of 
interpreting EU law.