Pursuant to Regulation (EC) No 853/2004, Article 4(2), all establishments handling the following food of animal origin are subject to the administrative regime of “approval” – i.e. prior authorisation by the competent authority:

i. meat from domestic ungulates;
ii. meat from poultry and lagomorphs;
iii. meat from farmed game;
iv. meat from wild game;
v. minced meat, meat preparations and mechanically separated meat (MSM);
vi. meat products;
vii. live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods;
viii. fishery products;
ix. raw milk, colostrum, milk products and products derived from colostrum;
x. eggs and egg products;
xi. frog legs and snails;
xii. rendered fats of animal origin and greaves;
xiii. treated stomachs, bladders and intestines;
xiv. gelatine;
xv. collagen;
xvi. highly refined products of animal origin.

Certain food business activities, although involving the products listed above, are nevertheless exempt from the approval requirement; in this case, food business operators (FBOs) may therefore simply notify the establishment to the competent authority, in accordance with the general “registration” procedure governed by Article 6 of Regulation (EC) No 852/2004 and Article 6(2) of Legislative Decree 27/2021.

Within the scope of the above exemptions, as far as the question under consideration is concerned, the case provided for in Article 1(5) of Regulation (EC) No 853/2004 concerning “retail trade” could be particularly relevant. According to the broad definition provided in Article 3 of Regulation (EC) No 178/2002, this activity includes ‘the handling and/or processing of food and its storage at the point of sale or delivery to the final consumer, including distribution terminals, catering establishments, canteens of companies and institutions, restaurants and other similar catering establishments, shops, supermarket distribution centres’ – and, it should be noted, also “wholesale outlets”.
It should be noted, however, that retail trade, where the purpose is to supply food of animal origin not to consumers but to other establishments, benefits from the derogation only if one of the following conditions is met:

i) where the operations carried out are limited to storage or transport;
ii) or where the supply of food of animal origin is carried out solely by a laboratory attached to the retail establishment to another laboratory attached to the retail establishment and, in accordance with national legislation, such supply constitutes a marginal, localised and restricted activity.

In the opinion of the author, the second hypothesis (point ii) is not relevant to the case in question, in which – as can be inferred from the question – supplying other operators would not be a “marginal” activity, but rather the main activity of the food business. Moreover, the guidelines for the application of Regulation (EC) No 853/2004, approved by the State-Regions Conference with Agreement 253/CSR of 17 December 2009, exclude the exemption from applying whenever the supply to other retail businesses “represents the main activity of the food business in terms of volume”.
The first hypothesis (point i), referring to the storage and transport of food of animal origin only, may be more relevant.
The writer – also taking into account the guidelines expressed in the aforementioned national guidelines and by the European Commission – believes that the “wholesale trade” described in the question may reasonably benefit from this exemption, at least if all the following conditions are met:

• the activity falls within the definition of “retail trade” (as expressly required by Commission working document SANCO/10098/2009);
• the establishment is used to store and market “exclusively products of animal origin packaged or wrapped at source” (as required by the National Guidelines);
• the marketing activity is not directed towards other EU Member States or third countries (this condition is also required by the National Guidelines).

It is therefore clear that there is a need to carefully assess the specific “wholesale” methods implemented by the OSA in order to determine whether they meet the above conditions.

[1] This refers specifically to Commission staff working document SANCO/10098/2009 Rev. 2023, entitled “Guidance on the implementation of certain provisions of Regulation (EC) No 853/2004 on the hygiene of food of animal origin”.