6. Registration Processes

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General Foods
Spain

This section provides information on any product notification or registration and manufacturing site registration processes.

6.1 Product Notification

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6.2 Product Registration

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6.3 Other Notes or Requirements

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6.4 Manufacturing Site Registration

According to Regulation (EC) No 853/2004 [1], a manufacturing license is required for manufacturing sites handling unprocessed animal-origin ingredients, because these are considered establishments subject to approval. A manufacturing site handling only processed ingredients of animal origin and ingredients of plant origin is not required to be approved by the EU for importing food to the EU.

All processed ingredients of animal origin (e.g. egg, dairy, meat, honey...) contained in the composite products, must come from EU-approved establishments located in countries authorized to export such processed products of animal origin to the EU, please refer to section 8. Safety parameters for further details.

An export health certificate (EHC) is an official document that confirms one’ export meets the health requirements of the destination country. FBO must apply for an EHC if it is exporting or moving live animals or animal products from GB (England, Scotland, and Wales) to, or through:

The EU
Non-EU Countries
Northern Ireland

A transit EHC is also needed to transit through an EU country.

A transit EHC may be needed to transit through a non-EU country. Check with the competent authority (the equivalent of Defra) in that country.

An EHC is needed for each:

type of animal or animal product being exported from Great Britain,
product type - if the exported consignment includes a mix of products.

In Spain, Royal Decree 191/2011, of 18 February [2], provides for the General Health Register of Food and Food Companies (RGSEAA). This register is a database of an informative nature, managed by the Autonomous Body of the Spanish Agency for Food Safety and Nutrition (AESAN OA).

In accordance with the Guidelines for the General Sanitary Register of Food and Food Businesses [3], food businesses, depending on the food sector (relating to the product category) and the stage of the food chain in which they carry out their activity, subsequent to primary production, shall be registered in one of the two registers established in article 2 of Royal Decree 191/2011.

The only necessary condition for the registration in the Sanitary Registry to be processed is to submit a prior communication to the health authorities of the Autonomous Community. This communication must be made where the company is domiciled. Although the Sanitary Registry is unique in Spain, the processing of the procedure is carried out by each Autonomous Community. In this sense, each Autonomous Community has established its specific processing and procedure. For example, in the case of Madrid, it is necessary to present:

Request for Prior Communication in the registry of companies and food establishments: For those companies that do not market products of animal origin (Ex: food supplements) or that market products of animal origin (Ex: meat products) but do not have an establishment (Ex: distributors, importers and carriers).
Application for Authorization in the register of companies and food establishments: Companies that market products of animal origin and have an establishment (EJ: manufacturer, processor, packer, and warehouseman of meat products).

In the initial communication, in any case, and regardless of the Autonomous Community to make the application in the Sanitary Registry, the below must be indicated:

Name or company name,
NIF or CIF as appropriate,
Purpose of all the activities that will be carried out by the company, and
The headquarters of the establishment or the registered office in the event that there is no establishment.

It will be necessary to identify what activity is going to be carried out (distribution, import, manufacturing, etc.) and on which scope of products will determine the class in which it is registered. Thus, for example, the key to droughts and other cereals derivatives like bread is the 20th. The keys for the Health Registry are the following:

Key 5: Food preservation
Key 10: Meat and derivatives, poultry and game
Key 12: Fish, crustaceans, mollusks, and derivatives
Key 14: Eggs and derivatives
Key 15: Milk and derivatives
Key 16: Oilseeds and edible fats
Key 20: Cereals, flours and derivatives
Key 21: Vegetables (vegetables, fruits, mushrooms, tubers, legumes) and derivatives
Key 23: Sugars, derivatives, honey, and products related to honey production
Key 24: Condiments and spices
Key 25: Stimulating foods, plant species for infusions, and their derivatives
Key 26: Prepared meals, foods for specific groups, food supplements, and other ingredients and food products
Key 27: Packaged water and ice
Key 28: Ice cream
Key 29: Non-alcoholic beverages
Key 30: Alcoholic beverages
Key 31: Technological ingredients
Key 39: Materials and objects intended to come into contact with food
Key 40: Warehouse, distribution, transport, packaging, and multipurpose import

With the application for registration in the Sanitary Registry, in addition, proof of payment of the corresponding fee must be presented. The rate will depend on each Autonomous Community. In Madrid, for example, in 2023, the rate for registration in the Sanitary Registry is 10.72 €.

Once this documentation is received, the Autonomous Community will communicate it to the Spanish Agency for Food Safety and Nutrition (AECOSAN) which will proceed to register and assign the identification number. Since each Autonomous Community has its own rules, depending on where the documentation is presented, they may ask for additional information. Thus, for example, in some Autonomous Communities there is an obligation to present a small report in which it is explained:

Activities that are going to be carried out,
Products that will be marketed,
List of suppliers, etc.

It should be considered in this regard that if the interested company does not have this information, it will not be mandatory to provide it unless expressly provided for by a rule of the Autonomous Community. In case any documentation is missing, the Administration will give a period of 10 days to provide such information.

The estimated time for resolution of registration in the Sanitary Registry is approximately 2-3 months.

6.4.1 Standard/Rules for Manufacturing Site

Food operators must comply with the general rules on the hygiene of food established in Regulation (EC) No 852/2004 [4]. Among other food hygiene requirements, this Regulation states that it is the responsibility of food business operators to ensure due diligence measures are in place and documented in Hazard Analysis and Critical Control Points (HACCP) or food safety management systems, in order to mitigate the risk in food.