Historial: SCOPE

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.

Primary production is a term to describe activities at the farm or at a similar
level and includes inter alia:

• Production, rearing or growing of plant products such as grains, fruits, vegetables and herbs as well as their transport within and storage and handling of products (without substantially changing their nature) at the farm and their further transport to an establishment.

• Production, rearing or growing of food producing animals at the farm and any activity linked therewith as well as the transport of meat producing animals to a market, a slaughterhouse or the transport of animals between farms.

• Production, rearing and growing of snails at the farm and their possible transport to a processing establishment or to a market.

• Milking and the storage of milk at the farm.

• The production and collection of eggs at the producer’s premises, but not egg packaging operations.

• Fishing, the handling of fishery products (without changing their nature substantially) on board vessels (except freezer and factory vessels) and their transport to the first establishment (including auction halls) on land. This includes the fishing, handling and transport of fish caught in fresh water (rivers, lakes).

• Production, rearing, growing and harvesting of fish in aquaculture farms and their transport to an establishment.

• The production, rearing, growing, relaying and harvesting of live bivalve molluscs and their transport to a dispatch centre, purification centre or processing establishment.

• The harvesting of mushrooms, berries, snails etc. in the wild and their transport to an establishment.

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.

Primary products include inter alia:

• Products of plant origin, e.g. grains, fruits, vegetables, herbs, mushrooms.

• Products of animal origin, e.g. eggs, raw milk, honey, fishery products, live bivalve molluscs.

• Products harvested wild either from plant or animal origin, e.g. mushrooms, berries, snails etc.

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.

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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.