Historial: SCOPE

3. SCOPE
3.1
3.2
3.3 “Pequeñas cantidades” de productos primarios, tal y como se especifica en el artículo 1, párrafo 2c del Reglamento

El Reglamento no es de aplicación a las pequeñas cantidades de productos primarios suministrados directamente por el productor al consumidor final, o a establecimientos locales de venta al por menor que abastezcan directamente al consumidor final.

En términos generales, la noción de “pequeñas cantidades” debería ser suficientemente amplia como para permitir inter alia:

La venta por parte del granjero de productos primarios (verduras, frutas, huevos, leche cruda6, etc) directamente al consumidor final, por ejemplo en la propia granja o en mercados locales, a establecimientos minoristas locales que vendan al consumidor final, y a restaurantes locales.

Que personas que recolecten en el campo productos como setas y bayas puedan entregarlas directamente al consumidor final, o a establecimientos minoristas locales que vendan al consumidor final y a restaurantes locales.

3.1. Primary production

The Regulation covers primary production.
Primary production is defined in Article 3(17) of Regulation (EC) No 178/2002:

‘Primary production’ means the production, rearing or growing of primary products including harvesting, milking and farmed animal production prior to slaughter. It also includes hunting and fishing and the harvesting of wild products.

The rules applicable to primary production are laid down in Annex I, Part A, point I (1) of Regulation (EC) No 852/2004.

Annex I, Part A, point I (1) of Regulation (EC) No 852/2004 also covers the following operations that are associated with primary production:

• The transport, storage and handling of primary products at the place of production, provided that this does not substantially alter their nature;

• The transport of live animals, where this is necessary to achieve the objectives of this Regulation; and

• In the case of products of plant origin and fishery products: transport operations to deliver primary products, the nature of which has not been substantially altered, from the place of production to an establishment.

Therefore the term “primary production” in this guidance document should be
understood as primary products including these associated operations.


Remarks on primary production:

• General rules on primary productionare laid down in Annex I to Regulation (EC) No 852/2004. In addition, for certain food (e.g. raw milk, live bivalve molluscs), more detailed rules are laid down in Regulation (EC) No 853/2004 (see section 3.7 of the guidance document on the implementation of certain provisions of Regulation (EC) No 853/2004 on the hygiene of food of animal origin).

• Fishery products the nature of which has not been substantially altered: see guidance given under point 3.7.

• Egg packing centres: in accordance with the definitions and requirements of the new food hygiene rules, egg packing centres (even when situated at the farm of production) are not considered primary production.

• Milk collection centres: once raw milk has been collected from the farm, the product has left the level of primary production. Milk collection centres where raw milk is stored after collection from a farm and before dispatch to a milk processing establishment are not considered primary production.

• Honey and other food from bee production: all the beekeeping activities must be considered as primary production. This includes beekeeping (even if this activity extends to having bee-hives at a distance from the bee-keeper’s premises), the collection of honey and the wrapping and/or packaging at the beekeeper’s premises. Other operations outside the beekeeper’s premises (e.g. the wrapping/packaging of honey) cannot be considered as primary production.

• Freezer and factory vessels: the handling, storage and transport of fishery products on board freezer and factory vessels are not covered by the term “primary production”.

3.2. Primary products

Primary products are defined in Article 2, paragraph 1, point (b) of Regulation (EC) No 852/2004 as follows:

‘primary products’ means products of primary production including products of the soil, of stock farming, of hunting and fishing.


Remarks on primary products:

• Fresh meat is not a primary product since it is obtained after slaughter.

• Fishery products remain primary products even after slaughter, bleeding, handling, gutting, removing fins, refrigeration and placing in containers for transport at the level of primary production. The products resulting from further handling of fishery products (e.g. filleting, packaging under vacuum etc.) are not primary products.

3.3 “Small quantities” of primary products as referred to in Article 1, paragraph 2(c) of the Regulation

The Regulation does not apply to small quantities of primary products supplied directly by the producer to the final consumer or to local retail establishments directly supplying the final consumer.

In general terms, the notion “small quantities” should be broad enough to allow inter alia:

• Farmers to sell primary products (vegetables, fruits, eggs, raw milk (6) etc.) directly to the final consumer e.g. farm gate sales or sales at local markets, to local retail shops for direct sale to the final consumer and to local restaurants.
• Individuals who collect products in the wild such as mushrooms and berries to deliver their yield directly to the final consumer or to local retail shops for direct sale to the final consumer and to local restaurants.

Pursuant to Article 1, paragraph 3 of Regulation (EC) No 852/2004, it is up to Member States to further refine the notion of small quantities depending on the local situation, and to lay down under national law the rules necessary to ensure that the safety of the food is guaranteed (risk based approach).

In general, the rules under national law established by the Member States in respect of small quantities as referred to in Article 1, paragraph 2(c) should allow current practices to continue to apply, provided they ensure the achievements of the objectives of the Regulation.

3.4 Cross-border trade of small quantities of primary products

Article 1, paragraph 3 of the Regulation requires Member States to establish under national law the rules governing the supply by the producer of small quantities of primary products to the final consumer or to local retail establishments.

Occasionally, such supply may take place across borders in particular where the producer’s farm is situated in the neighbourhood of Member States’ borders.

The national rules to be adopted pursuant to Article 1, paragraph 3 of Regulation (EC) No 852/2004 must be subject to the general rules of the Treaty. El párrafo 3 del Artículo 1 del Reglamento exhorta a los Estados Miembros a establecer, con arreglo a su derecho nacional, las normas que regulen el suministro, por parte del productor, de pequeñas cantidades de productos primarios al consumidor final o a establecimientos locales de venta al por menor.

3.5 Processing of primary products at the farm

Primary products can be processed at the farm, e.g. raw milk is processed into cheese, juice is extracted from fruit. These operations fall outside the activities described as primary production and are therefore the subject of the food hygiene requirements of Annex II of the Regulation and, with regard to food of animal origin, also of the appropriate requirements in Regulation (EC) No 853/2004.

Examples:

• The preparation of fruit juice at the farm

If a farm uses its harvest or part of its harvest (e.g. apples) to produce fruit juice at its premises, such farm exceeds the level of primary production. The activity of producing fruit juice is to be considered as an activity after primary production and it is therefore subject to the appropriate requirements of Regulation (EC) No 852/2004.

• The production of cheese at the farm

Cheese is the result of processing raw or heat treated milk. Cheese is not, therefore, a primary product, even when made at the farm.

As a consequence, cheese production at the farm must comply with the appropriate requirements of food hygiene laid down in Regulation (EC) No 852/2004 and of Regulation (EC) No 853/2004.

Remarks:

1) Regulation (EC) No 853/2004 generally excludes retail (i.e. the handling and/or processing of food and its storage at the point of sale or delivery to the final consumer) from its scope. This means that where cheese is manufactured and sold entirely at the farm or at a local market (e.g. weekly market, farmers market etc.) to final consumers, these activities can be carried out in compliance with the appropriate requirements laid down in Regulation (EC) No 852/2004, in particular in its Annex II, while not having to comply with the requirements of Regulation (EC) No 853/2004 apart from the requirements for raw milk. Where appropriate, compliance will also need to be ensured with national measures established under national law in the Member States on the basis of Article 1, paragraph 5(c) of Regulation (EC) No 853/2004.

2) In order to accommodate processing at the farm or in order to preserve traditional methods of production, Member States may introduce national measures adapting the relevant infrastructural requirements in accordance with the procedure laid down for that purpose in Article 13 of Regulation (EC) No 852/2004 and in Article 10 of Regulation (EC) No 853/2004, where the traditional methods cannot be accommodated within the requirements the Regulations lay down.

3.6. Eggs and primary production

Taking into account the definition of primary production in Article 3(17) of Regulation 178/2002, and Annex I, Part A, point I(1) of Regulation 852/2004, primary production of eggs includes the handling of eggs, i.e. the collection and transport between buildings, and storage of eggs at the production site, provided that this does not substantially alter their nature. The packaging of eggs, either at the site of production or at a separate packing establishment falls outside the activities of primary production. These activities must therefore comply with the relevant requirements of Annex II to Regulation (EC) No 852/2004, and of Annex III, Section X of Regulation (EC) No 853/2004 and of Regulation (EC) No 1907/90 on certain marketing standards for eggs.

3.7. At the level of primary production, primary products may be transported, stored and handled provided that does not substantially alter their nature (see Annex I, Part A, point I.1(a) of the Regulation).

At the level of primary production, primary products are often subject to operations so as to ensure a better presentation, such as:

• Washing of vegetables, removing leaves from vegetables, the sorting of fruit, etc.
• The drying of cereals,
• The slaughter, bleeding, gutting, removing fins, refrigeration and wrapping of fish,

Such operations must be considered as normal routine operations at the level of primary production and must not lead to the need to satisfy food safety requirements in addition to the ones already applying to primary production.

On the other hand, certain operations carried out on the farm are likely to alter the products and/or to introduce new hazards to food e.g. the peeling of potatoes, the slicing of carrots, the bagging of salads and the application of preservation gases. These operations cannot be considered as normal routine operations at the level of primary production nor as operations associated with primary production.

3.8. The occasional handling, preparation, storage and serving of food by private persons

Operations such as the occasional handling, preparation, storage and serving of food by private persons at events such as church, school or village fairs are not covered by the scope of the Regulation. This is made clear in recital 9 of Regulation (EC) No 852/2004. The second sentence states that:

"Community rules should only apply to undertakings, the concept of which implies a certain continuity of activities and a certain degree of organisation".

The term “undertaking” is integrated in the definition of a “food business” (in accordance with Article 3(2) of the General Food Law (Regulation (EC) No 178/2002), a “food business” must be an “undertaking”). Somebody who handles, prepares, stores or serves food occasionally and on a small scale (e.g. a church, school or village fair and other situations such as organised charities comprising individual volunteers where the food is prepared occasionally) cannot be considered as an “undertaking” and is therefore not subject to the
requirements of Community hygiene legislation.

3.9. Food businesses and internet sales

Certain businesses offer their goods for sale via the internet. Although such trade is not specifically referred to in the Regulation, such businesses fall within the definition of a food business and the relevant requirements of food law are applicable to them.

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(6) Under Article 10(8) of Regulation 853/2004, Member States may establish national rules
prohibiting or restricting the placing on the market of raw milk intended for direct human consumption.

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