Historial: en3R2004853

3. SCOPE (ARTICLE 1 OF THE REGULATION)

3.1. Small businesses

Until 1 January 2006, certain small businesses can only place their products on the national or local market although they have to respect food hygiene criteria, e.g.

• Under Article 4 of Directive 64/433/EEC (the fresh meat Directive) meat from low capacity slaughterhouses handling not more than 20 livestock units per week, and cutting plants which produce not more than five tonnes of boned meat per week;

• Under Article 7 of Directive 71/118/EEC (the poultry meat Directive), slaughterhouses handling under 150 000 birds per year

• Under Article 3, point A(7) of Directive 77/99/EEC (the meat products Directive), when establishments use meat that has been marked with a national health mark.

These Directives will be repealed as from 1 January 2006. From that date onwards these establishments can place their products on the Community market if they are approved by the competent authority.

From 1 January 2006, there is therefore no restriction any more as to the supply of meat for the production of meat products and the placing on the market thereof if the slaughterhouse is approved by the competent authority.

Since it is unlikely that all the administrative steps to approve small businesses have been taken on 1 January 2006, a transitional measure has been adopted that will allow current practices to continue for those small businesses that have not been approved on that date and the national health mark to be used in the meanwhile.

3.2. Establishments handling food of animal origin for which no detailed requirements are laid down

For certain products of animal origin (e.g. honey), the Regulation does not lay down detailed rules. In that event, the food of animal origin must be handled in accordance with the relevant requirements laid down in Regulation (EC) No 852/2004 and also with the general rules for products of animal origin laid down in Regulation (EC) No 853/2004 (in particular the rules on products from outside the Community referred to in Article 6).

Since for these products there are no requirements in Annex III of Regulation (EC) No 853/2004, establishments handling the products need not be approved nor need they apply an identification mark on the food.

3.3. Products covered under Regulation (EC) No 853/2004

Regulation (EC) No 853/2004 only applies to unprocessed and processed foodof animal origin.

• A (non-exhaustive) list of unprocessed products of animal origin (as defined in Article 2, point 1(n) of Regulation (EC) No 852/2004) is given in Annex I hereto.

• A (non exhaustive) list of processed products of animal origin (as defined in Article 2, point 1(o) of Regulation (EC) No 852/2004) is given in Annex II hereto.

In determining whether a product of animal origin is processed or unprocessed it is important to have regard to all the relevant definitions contained in the hygiene regulations, in particular, the definitions of ‘processing’, ‘unprocessed products’ and ‘processed products’ in Article 2 of Regulation 852/2004, and the definitions of certain processed products in Section 7 of Annex I of Regulation 853/2004. The interrelationship between these definitions will impact on the decision reached.

3.4. Food containing both products of plant origin and products of animal origin

Unless expressly indicated to the contrary, the Regulation does not apply to the production of food containing both products of plant origin and processed products of animal origin. Such exclusion from the scope is based upon the observation that the risk posed by the ingredient of animal origin can be controlled by implementing the rules of Regulation (EC) No 852/2004 without there being a need to apply more detailed specific requirements. However, Article 1, paragraph 2 of Regulation (EC) No 853/2004 clearly spells out that the processed products of animal origin used in foods containing both products of plant origin and processed products of animal origin that are exempted from the scope of Regulation 853/2004, shall be obtained and handled in accordance with the requirements of Regulation (EC) No 853/2004 e.g.

• Milk powder used to prepare ice cream must have been obtained in accordance with Regulation (EC) No 853/2004, however the manufacture of certain ice creams is performed under Regulation (EC) No 852/2004;

• Meat products used to prepare a pizza must have been obtained in accordance with Regulation (EC) No 853/2004, but the manufacture of the pizza falls under Regulation (EC) No 852/2004.

Annex III gives an overview of the scope of both Regulations (EC) No 852/2004 and 853/2004. The overview is non exhaustive and therefore purely indicative. It may be subject to review in function of experience gained with the new rules.

Remark: an establishment manufacturing both products of animal origin and other products may apply the identification mark required for products of animal origin also on the other products (see Annex II, Section I, point B.7 of Regulation (EC) No 853/2004).

3.5. Retail

Unless expressly indicated to the contrary, Regulation (EC) No 853/2004 does not apply to retail (Article 1, paragraph 5(a)).

The definition of retail sale is in Article 3, point 7 of Regulation (EC) No 178/2002. It reads as follows:

“retail” means the handling and/ or processing of food and its storage at the point of sale or delivery to the final consumer, and includes distribution terminals, catering operations, factory canteens, institutional catering, restaurants and other similar food service operations, shops, supermarket distribution centres and wholesale outlets.

As explained in recitals 12 and 13 of Regulation (EC) No 853/2004, this definition which includes wholesale operations was considered to be too wide for food hygiene purposes. In the context of food hygiene, retail should generally have a more limited meaning as follows: “activities involving direct sale or supply of food of animal origin to the final consumer”. This means that:

• For activities involving direct sale or supply of food of animal origin to the final consumer, Regulation (EC) No 852/2004 would suffice. In accordance with the definition of “retail”, the term “activities” includes processing (e.g. the preparation of bakery products containing products of animal origin, the preparation of meat products in a local butcher shop) at the point of sale to the final consumer.

• With regard to wholesale activities (i.e. when a wholesale or retail establishment carries out operations with a view to supplying food of animal origin to another establishment), Regulation (EC) No 853/2004 applies except for:

• Establishments for which the wholesale activities consist only of storage and transport. In that case, the requirements of Regulation (EC) No 852/2004, and the temperature requirements laid down in Regulation (EC) No 853/2004 apply,

• The supply is, in accordance with national law, a marginal, localised and restricted activity of a retail establishment that mainly supplies the final consumer. In that event, only Regulation (EC) No 852/2004 applies.

However, in accordance with Article 1, paragraph 5(c), Member States may decide to extend the provisions of Regulation (EC) No 853/2004 to retail establishments situated on their territory to which they would not apply. In applying this possibility, Member States should be led by the general principles of food law, i.e. proportionality and the need to have rules that are risk based.

3.6. The notion “marginal, localised and restricted activity” as referred to in Article 1 paragraph 5, point b)ii of Regulation (EC) No 853/2004.

That notion allows genuine retail shops supplying the final consumer (e.g. a butcher) to supply food of animal origin to another local retail business under the requirements of Regulation (EC) No 852/2004 only. The requirements of Regulation (EC) No 853/2004 (e.g. the approval of the establishment, the application of an identification mark) would not apply.



The notion “marginal, localised and restricted supply” stems from the observation that retail establishments supplying the final consumer as their main trade should in effect trade their products locally (even if the destination is in another Member State) and so are not engaged in long distance trade which requires more attention and supervision in particular as regards transport and cold chain conditions. In the case of a large Member State it would therefore not be in line with the Regulation to extend geographically the notion “marginal, localised and restricted supply” to the entire territory of that Member State.

The notion is further explained in recital (13), where it is spelled out that such supply should be only a small part of the supplying establishment’s business; the establishment supplied should be in its immediate vicinity, and the supply should concern only certain types of products or establishments.

In some cases retailers (e.g. butchers) may produce small quantities (in absolute terms) of food, most of which is supplied to caterers and/or to other retailers. In such cases it would be in line with the intention of the Regulation to enable the continued use of traditional methods of distribution, considering that “marginal” should include the notion of small quantities. “Marginal” should therefore be interpreted as a small amount of food of animal origin in absolute terms or as a small part of the establishment’s businesses. At any rate, the combination of the three criteria provided for by the Regulation should allow an appropriate qualification of most situations.

3.7. Primary production covered under Regulation (EC) No 853/2004

For certain products of animal origin, the notion “primary production” referred to in Regulation (EC) No 852/2004 is further developed under Regulation (EC) No 853/2004:

Live bivalve molluscs (Annex III, Section VII, point 4(a))

With regard to live bivalve molluscs, primary production covers operations that take place before live bivalve molluscs arrive at a dispatch, purification centre or processing establishment.

Fishery products (Annex III, Section VIII, point 4 and Annex III, Section VIII, points 3(a) and (b)).

With regard to fishery products, primary production:

• Includes farming/fishing/collection of live fishery products (whether from sea water or fresh water) with a view to their being placed on the market, and

• Includes the following associated operations:

• Slaughter, bleeding, heading, gutting, removing fins, refrigeration and wrapping for transport carried out on board fishing vessels,

• The transport and storage of fishery products the nature of which has not been substantially altered, including live fishery products, within farms on land, and

• The transport of fishery products (whether from sea water or fresh water) the nature of which has not substantially been altered, including live fishery products, from the place of production to the first establishment of destination.

Raw milk (Annex III, Section IX, Chapter 1)

The Regulation covers requirements to be respected at the farm, in particular with regard to the health of the animals, hygiene on milk production holdings, and criteria to be respected for raw milk.

Eggs (Annex III, Section X, Chapter 1)

The Regulation covers the handling of eggs at the producer’s premises, and lays down that eggs must be kept clean, dry, free of extraneous odour, effectively protected from shocks and out of direct sunshine.