When recognition and the ‘CE mark’ are not required

Article 4(2) of Regulation (EC) No 853/2004 provides that, in principle, all establishments handling products of animal origin for which specific hygiene requirements are laid down in Annex III are subject to “approval” by the competent authority.

Annex III lists various categories of food, including meat, meat preparations and meat products, live bivalve molluscs and fishery products, raw milk and milk products, eggs and egg products, rendered animal fats, offal, gelatine, collagen and certain refined products.

Furthermore, under Article 5, products of animal origin handled in establishments subject to “approval” may only be placed on the market if they are marked:

• in the case of domestic ungulate carcasses and game, a “health mark” affixed by an official veterinarian or under his responsibility or supervision (except in cases where the slaughterhouse staff themselves have been authorised to affix it);
• for all other products, by an “identification mark” (commonly known as the “CE mark”) affixed by the operator to the product, its wrapping or packaging, on a label or on an irremovable tag.

Without prejudice to the general rules outlined above, there are various cases of exemption in which an establishment, even though it processes foodstuffs covered by Annex III to the Regulation, is exempt from the obligation of “approval” and, consequently, from the requirement to affix the identification mark to its products.

Considering the situation described in the question, which, as far as can be understood, concerns an operator who purchases products bearing the identification mark and uses them in the preparation of other foods, the following two cases of non-applicability of the “approval” requirement may be particularly relevant:

1. that provided for in Article 1(2) of Regulation (EC) No 853/2004, ‘food containing products of plant origin and processed products of animal origin[1]’ (i.e. so-called ‘composite products’);
2. that covered by Article 1(5), in favour of ‘retail’ activities.

With regard to the first case, there are a number of institutional guidance documents that help to define the concept of “composite products” more precisely.

In particular, at national level, reference can be made to 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, Annex I of which provides the following illustrative list of products that can be considered “composite”:

• pizza;
• pasta containing processed animal products;
• ready meals;
• baked goods/biscuits with cream or butter;
• sandwiches with ham/cheese;
• milk chocolate;
• processed products in which a component has been replaced with an ingredient of plant origin (e.g. milk-based products in which the fat component has been replaced with vegetable fats or oils);
• egg preparations such as mayonnaise.

Further details are provided by the European Commission in its working document SWD (2015) 79, last revised in 2021, entitled “Guidance on conditions and controls on imports and transit of certain composite products and products that could be mistakenly considered composite products from third countries”[2].

This document highlights, among other things, the following points:

1. In order to benefit from the exemption, operators preparing compound products must use foodstuffs of animal origin that have already been “processed” upstream by their suppliers (otherwise, if operators purchase “unprocessed” products of animal origin and proceed to process them themselves in their own factory during the preparation of the compound product, they must operate under a “recognition” regime and affix the identification mark). themselves in their own establishment during the preparation of the compound product, they must operate under a “recognition” regime and affix the identification mark);
2. Foods in which the product of plant origin is added only to give particular characteristics to the product of animal origin or because it is necessary for the manufacture of the product of animal origin (which occurs, for example, in the case of cheeses with added herbs, yoghurts with added fruit or milk-based ice creams with added plant ingredients) do not constitute composite products.

However, in order to answer the specific question posed, it should be clarified that neither the legislation nor the institutional guidelines identify specific quantitative thresholds for the presence of ingredients of animal or vegetable origin in the composite product.

With regard to the second case of exemption from the recognition requirement, relating to “retail trade”, it should be noted that, pursuant to 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, company and institutional canteens, restaurants and other similar catering establishments, shops, distribution centres for supermarkets and wholesale outlets’.

At the same time, it should be noted that where “retail” is carried out for the purpose of supplying food of animal origin to other establishments, the exclusion from the requirements of Regulation (EC) No 853/2004 will only apply if:

1. the operations carried out are limited to storage or transport (in which case the specific temperature requirements laid down in Annex III shall apply), or
2. the supply of food of animal origin is carried out solely by a laboratory attached to a retail establishment to another laboratory attached to a retail establishment and, in accordance with national legislation, such supply constitutes a marginal, localised and restricted activity.

With regard to the exemption for retail trade, various institutional clarifications have been provided in the two documents mentioned above, which should be consulted:

• 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;
• the Commission staff working document SANCO/10098/2009 Rev. 2023, entitled “Guide to the implementation of certain provisions of Regulation (EC) No 853/2004 on the hygiene of food of animal origin”.

That said, it can therefore be concluded, in summary, that the food business activity presented in the question may continue to operate under the “registration” regime – i.e. without recognition and identification mark – if, after careful assessment taking into account all the elements mentioned above, it can be traced back, alternatively, to:

• the preparation of composite products only;
• retail trade.

Finally, with regard to official certificates, it should be noted that these may be required for export to third countries (to certify that products comply with the relevant health and hygiene standards), even for establishments that are not subject to “approval” under EU legislation.

The need to obtain official certificates for export and their content depend, in fact, on the provisions of individual agreements concluded between the European Union (or Italy) and the third country concerned.

In the context of these agreements, incidentally, the percentage of food of animal origin present in composite products may well be relevant in determining which regime to apply to them for export.

Any assessment in this regard should therefore be carried out on a case-by-case basis, taking into account the customs classification of the products involved.

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[1] It should be noted that the definition of “unprocessed food” is provided in Article 2(1)(o) of Regulation (EC) No 852/2004, which identifies it as “food obtained by processing unprocessed products”. Such processing takes place through “treatment”, which, according to point (m), means “any action that causes a substantial change in the initial product, including heat treatment, smoking, salting, curing, drying, marinating, extraction, extrusion or a combination of these processes”.

[2] Document SWD (2015) 79 is also explicitly referred to in Commission staff working document SANCO/10098/2009 Rev. 2023, which specifically concerns: “Guidance on the implementation of certain provisions of Regulation (EC) No 853/2004 on the hygiene of food of animal origin” .