Historial: en3R2004853

__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).

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.

__3.5. Retail__

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

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:

*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,

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.

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.

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.

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:

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.

With regard to fishery products, primary production:

*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 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.

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.