Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Safety Authority Food safety and food safety procedures were the starting point for the establishment of a new framework for the regulation of food business, setting new reference concepts and defining elements of the common to the food sector as a whole. In this respect, the definitions of "food (or food product)", "food business" and "retail trade" given in this Regulation have been fundamental.

Valgan as examples of products expressly included in the definition of 'food', beverages, chewing gum and any substance, in particular water, which is voluntarily incorporated into the food during its manufacture, preparation or treatment. Among the exclusions are live animals, unless they are prepared to be marketed for human consumption, or plants before harvest.

For their part, Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs requires the food business operator to notify the authority of the The competent authorities of the Member State concerned shall ensure that the competent authorities of the Member State in which they are responsible for the production, processing and distribution of food are carried out. That Regulation lays down the added requirement for authorisation by the competent authority for those cases provided for in Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down rules specific hygiene of food of animal origin.

Also, the extensive legislative development in recent years related to food products intended for particular food, biocides and materials that can come into contact with food, takes into account the need to keep an up-to-date register with information concerning certain products and companies. However, the organization of a register for these products should take into account, first, that Royal Decree 2685/1976, of 16 October, approving the Technical-Health Regulations for the elaboration, circulation and trade of food preparations for dietetic and/or special schemes, as amended, inter alia, by Royal Decree 1809/1991 of 13 December, which incorporated into Spanish law the Community definition of foodstuffs intended for special food, sets out the categories of products to be subject to a regulation It does not require registration unless it is indicated by its specific rules; second, that the existing legislation on biocidal products already provides for a register of companies that manufacture and market these substances, when they are used, among other uses, to its use in the food industry, which has been operating since 2002, in addition to the official control of the companies that manufacture or market chemicals such as detergents, disinfectants and pesticide use in the Food industry, is focused on the danger of the substances they manufacture and therefore not the need for their registration for food safety reasons is justified; and, third, that Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food, does not apply to companies engaged in raw materials or mining activities that supply the manufacturer with products that will eventually come into contact with food.

In Spain, unlike other Member States, it can be said that there is a wide experience in the registration of companies and products through an administrative tool that has worked for more than thirty years, which is the General Health Register of Food, the last regulation of which was carried out by Royal Decree 1712/1991 of 29 November. This royal decree required, as a key element for the operation of food companies in Spain, prior health authorization by the competent authorities for the operation of any type of company.

The ultimate purpose of these records in the field of food security, in any territorial area, is the protection of health through the updated information of the vicissitudes of the companies involved in the the market, in order to ensure adequate programming of official controls and, in turn, to be an essential element for inspection services, ensuring the ability to act quickly and effectively in cases where the there is a danger to public health, without hindering the free movement of goods. All in accordance with Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls carried out to ensure the verification of compliance with feed law and food and animal health and animal welfare regulations.

Given these circumstances, given the time since the approval of Royal Decree 1712/1991 of 29 November, and given the existence of a new Community regulatory framework for food safety, makes it necessary to issue a new royal decree, to simplify the procedure established in Spain to register, on a national and public basis, the companies involved in the food chain, except for the primary production that already has its own own records of holdings, as well as products intended for food The natural mineral waters and spring waters, which are relevant, are relevant. In this sense, this royal decree also meets the requirements arising from the incorporation into the Spanish legal system of Directive 2006 /123/EC of the European Parliament and of the Council of 12 December 2006 on the services in the internal market, which has led to the amendment of Article 25 of Law 14/1986 of 25 April, General Health.

However, it does not make sense to include retail stores, restaurants, coffee shops, bars, bakeries, pastry shops, school canteens or hospitals and other establishments whose activity is located in the national registry. principal is the sale to the final consumer or the service in situ to the final consumer or to collectivities that are marketed in a local area, including the zones of special customs treatment, since for them a register of scope is sufficient autonomic territorial.

The General Register should use a terminology adjusted to the reference concepts laid down in Community legislation and should provide for the possibility of coordinating the information collected in different registers The administrative burden on operators throughout the food chain.

Finally, this new provision is adopted on a regulatory basis since, according to the Constitutional Court, this royal decree is considered to be an essential complement to ensure the common minimum. The denominator laid down in national and Community rules that apply to regulated matters.

This royal decree has been submitted to the procedure for information on technical standards and regulations and regulations relating to the services of the information society provided for in Directive 98 /34/EC of the European Parliament and of the European Parliament. Parliament and the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations, as amended by Directive 98 /48/EC of 20 July 1998 and in the Royal Decree 1337/1999, of 31 July, which regulates the referral of information in the field of standards and technical regulations and regulations relating to the services of the information society, which incorporates these directives into the Spanish legal order.

In its preparation have been consulted the autonomous communities, as well as the sectors affected, having issued report the Spanish Agency for Data Protection and the Inter-Ministerial Commission for Food Management.

In its virtue, on the proposal of the Minister of Health, Social Policy and Equality, with the prior approval of the First Vice President of the Government and Minister of the Presidency, in agreement with the State Council and after deliberation of the Council of Ministers at its meeting on 18 February 2011,

DISPONGO:

Article 1. Purpose, scope and nature of the General Health and Food Business Health Register.

1. The General Health Record of Food and Food Companies, hereinafter the Registry, attached to the Spanish Agency for Food Safety and Nutrition of the Ministry of Health, Social Policy and Equality, aims to protect the public health and consumer interests, by facilitating the official control of undertakings, establishments and products subject to registration in accordance with Articles 2 and 3.

2. The Register shall be national in nature and shall be considered as a unified State-wide register, in which the working data shall be included in the records managed by the competent bodies of the Autonomous Communities. In addition, all public administrations will cooperate in order to achieve the highest efficiency and accuracy of the Register, as well as to give adequate publicity to the data of the Registry, without prejudice to the limits established by the application to the processing of personal data.

3. The Register shall be public and informative and shall be constituted as a computerised database.

4. Registration in the Register does not exclude the full responsibility of the economic operator for compliance with food law.

Article 2. Businesses and food establishments subject to registration.

1. Each of the establishments of the food business or, where the establishments do not have establishments, the undertakings themselves shall be entered in the Register provided that they meet the following requirements:

(a) That the premises of the establishment or the registered office or registered office of the undertaking which has no establishment is in Spanish territory.

b) Your activity is intended to:

1. Food or food products intended for human consumption.

2. º Materials and objects intended to be in contact with food.

3. Technological adjuvants used for food processing.

c) That their activity can be classified in any of the following categories:

1. Production, processing, processing and/or packaging.

2. Storage and/or distribution and/or transport.

3. Import of products from non-EU countries.

2. Without prejudice to the official controls concerned, the establishments and their operators shall be excluded from the obligation to register in the Register, in the event that they are exclusively manipulated, processed, packaged, stored or stored. serve food for sale or delivery on site to the final consumer, with or without delivery at home, or to collectivities, as well as when they supply other establishments of these same characteristics, and is an activity marginal in terms of both economic and production, compared to that carried out by those, which is carried out in the area of the local health unit, health zone or territory of equal characteristics or purpose defined by the competent authority concerned.

These establishments must be registered in the autonomous registers established for this purpose, subject to the communication of the food business operator to the competent authorities due to the location of the establishment. However, in the case of establishments where food is served in situ to collectivities, the communication shall be made by the operator of the premises.

Article 3. Food products subject to registration.

The following food products shall be entered in the Register:

(a) Those intended for particular nutritional uses, where their specific rules so provide.

(b) Natural mineral waters and spring waters the extraction of which takes place in the national territory, as well as those extracted in third countries, after recognition as such by the Spanish State, unless they have already been recognised by another Member State of the European Union.

Article 4. Definitions.

For the purposes of this royal decree the definitions provided for in Articles 2 and 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the principles and the general requirements of food law, the European Food Safety Authority is established and procedures relating to food safety are laid down and those laid down in Article 2 of Regulation (EC) No 852/2004 Proposal for a European Parliament and Council Directive of 29 April 2004 on the hygiene of foodstuffs.

Article 5. Contents of the Register.

1. They shall be the subject of entry in the Register:

(a) The commencement of the activities of the undertakings and establishments related to Article 2.1, to which effect the corresponding registration shall be carried out in accordance with the procedure laid down in Article 6.

However, the establishment that is dedicated exclusively to the storage or deposit of packaged products belonging to a company that owns in the territory of the same autonomous community an establishment of Production, processing, processing or packaging shall not be the subject of an independent registration but shall be recorded in the latter establishment.

(b) The placing on the market of foodstuffs for particular nutritional uses and the authorization or recognition of natural mineral waters and spring waters, to which the relevant effect is to be applied. registration in accordance with the procedure laid down in Articles 7 and 8.

(c) The modification of any of the information required for the registration of food companies and establishments, as referred to in Article 6, and of foodstuffs for a special food and natural mineral waters and spring waters as provided for in Articles 7 and 8.

d) The definitive cessation of the economic activity of the companies and establishments that will result in the cancellation of the registration.

e) The cessation of the marketing of the food products for a special feeding and of the natural mineral waters and spring waters, which will result in the cancellation of the registration.

2. The registration of the undertakings, establishments and products referred to in paragraph 1 (a) and (b) shall be carried out at the request of the food business operators.

3. Food business operators shall communicate to the competent authority the circumstances referred to in paragraph 1 (c), (d) and (e).

Received the communication, the registration will be the object of modification or cancellation registration, depending on the cases. However, where the circumstances communicated affect any of the undertakings, establishments and products subject to administrative authorization, the amendment or cancellation shall only take place after the fact that that circumstance has been established by the competent authorities.

4. The amendment or cancellation of the registration may be made on its own initiative if the data relating to the registration or the concurrency of any of the circumstances referred to in paragraph 1 (d) and (e) are not correct.

In any event, such modification shall be made manifest to the persons concerned or, where appropriate, to their representatives, who may plead and present the justifications and documents they deem relevant.

Article 6. Procedure for the registration, modification and cancellation of businesses and food establishments.

1. The presentation of a prior communication to the competent authorities shall be a unique and sufficient condition for the registration of the undertakings and establishments in the Register and at the same time the activity may be initiated, without prejudice to the of the checks which may subsequently be carried out. The information which the operator of the undertaking must provide shall be as follows: its name or social reason, the NIF, NIE or CIF, the object of all its activities and the premises of the establishment or, in the case of undertakings which do not have any establishment, the Social address.

In the case of establishments referred to in Article 4.2 of Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for the food of animal origin, the operator shall submit an application for registration to the competent authorities of the autonomous community. In this case, the information to be provided by the competent health authority to the Spanish Food Safety and Nutrition Agency for registration shall be as provided for in the preceding paragraph.

2. Prior communication or application for registration, as well as the communication of modification of any of the mandatory information referred to in the previous paragraph or of the definitive cessation of economic activity of the establishments, submit to the competent authority of the Autonomous Community on the grounds of the location of their location, in the manner in which they are available. In the case of undertakings which do not have any establishment, they shall be directed to the competent authority of the autonomous community where their registered office is located.

3. Upon receipt of the prior notice or, if applicable, authorized registration, the autonomous communities shall inform the Spanish Agency of Food Safety and Nutrition, which shall register in the Register and the the allocation of the national identification number. The Registry shall communicate to the corresponding Autonomous Community the identification number, within 15 working days of receipt of the documentation.

4. Likewise, the communication of the modification of the data of the mandatory information necessary for the registration or the resolution of cancellation of the registration for definitive cessation of the economic activity, will be referred to the Spanish Agency Food Security and Nutrition for the purposes of the corresponding registration seat.

Article 7. Procedure for registration, modification and cancellation of food products for special food.

1. Food products for particular nutritional uses shall be entered in the Register where their specific rules so provide, subject to prior notification of the first placing on the national market by the food business operator.

2. The communication of the first placing on the Spanish market of products of national manufacture or originating in another Member State of the European Union, the manufacturer or the person responsible for having its registered office or registered office in the Spanish territory, carry out, prior to or at the same time, that first placing on the market, before the competent authority of the autonomous community, by reason of the place of location of its registered office or registered office, in the manner in which it is available. A model of product labelling should be provided as mandatory information.

The competent authority of the autonomous community shall decide on the adequacy of the labelling model submitted to the specific rules of each of the products communicated. This resolution, together with the labelling model, will be forwarded to the Spanish Food Safety and Nutrition Agency, which will register the product in the Register and assign, where appropriate, the national identification number, which shall be communicated to the corresponding autonomous community within 15 working days of receipt of the documentation.

3. The communication of the first placing on the domestic market of products from other Member States of the European Union, the manufacturer or the person responsible for not having its registered office or registered office in Spain or third countries, shall be presented to the Spanish Food Safety and Nutrition Agency, directly on its register or elsewhere than those provided for in Article 38.4 of Law 30/1992, of 26 November, of the Legal Regime of the Public Administrations and of the Common Administrative Procedure, accompanied by a model of product labelling. In addition, the electronic communication may be carried out in accordance with the provisions of Royal Decree 1671/2009 of 6 November 2009, for which the Law 11/2007, of 22 June, of electronic access of the public services.

4. In the case of products already placed on the market in the European Union, the communication with the product labelling model shall be accompanied by the indication of the receiving authority of the first communication.

5. The communication of modification of the product labelling information shall include the presentation of the new label. The cessation of the marketing of products must also be communicated. In both cases the communication shall be carried out in accordance with paragraphs 2 and 3 for the purposes of the corresponding registration seat.

Article 8. Procedure for the registration, modification and cancellation of natural mineral waters and spring waters.

1. Natural mineral waters and spring waters shall be entered in the Register:

(a) In the event that the extraction is carried out on the national territory, once the authorisation for use granted by the competent mining authority has been published in the "Official State Gazette", as set out in the applicable rules.

(b) Where they are extracted in third countries, after recognition as such by the Spanish State.

The registration of natural mineral waters, in accordance with implementing rules, will be a prerequisite for their communication to the European Commission for publication in the Official Journal of the European Union.

2. The application for the registration of natural mineral waters and spring waters extracted on national territory, as well as the communication of data modification shall be submitted to the competent authority of the autonomous community for the reason of the location. the location of the spring or the collection, in the manner in which it is available.

The registration file, once evaluated and resolved by the autonomous community, will be submitted to the Spanish Food Safety and Nutrition Agency, which will register the product in the Register and assign the registration number national identification, which shall be communicated to the relevant autonomous community within 15 working days of receipt of the documentation.

Also, the communication of modification of the data of the registration and the lower resolution of the registration for revocation of the administrative authorization for the exploitation of the natural and spring mineral waters shall be referred to the Spanish Food Safety and Nutrition Agency for the purposes of the relevant registered seat.

3. The application for registration as well as the communication of data modification of natural mineral waters and spring waters from third countries will be submitted to the Spanish Food Safety and Nutrition Agency, directly in its registration or in any other place than those provided for in Article 38.4 of Law 30/1992 of 26 November. They may also be sent by electronic means, in accordance with the provisions of Royal Decree 1671/2009 of 6 November 2009, which partially develops Law 11/2007 of 22 June 2009 on the electronic access of citizens to the public services.

Article 9. Certifications.

The Spanish Food Safety and Nutrition Agency shall provide to the person who requests it, certifications of the data obtained in the Register, without prejudice to the limits established by the rules of application to the treatment of personal data.

Additional disposition first. Registration of companies and establishments in other member states.

The Registry may also register companies and establishments located in any other Member State of the European Union which voluntarily request it from the Spanish Food Safety and Nutrition Agency, directly in their register or elsewhere than those provided for in Article 38.4 of Law No 30/1992 of 26 November 1992. To this end, they shall accompany their application with an official certificate from the competent body of the country in which the undertaking or establishment is located, stating that they are legally established. They may also send them electronically, in accordance with the provisions of Royal Decree 1671/2009 of 6 November 2009, which partially develops Law 11/2007, of 22 June, of electronic access of citizens to the public services.

If there is any doubt, the Agency will initiate the necessary steps to carry out a more detailed examination of the case in collaboration with the authorities of the Member State in which the undertaking is situated or establishment, pending the processing of the registration.

For the purposes referred to in Article 6, the holders of the undertakings or establishments registered in the Register under this additional provision shall direct the communications affecting their registration status. to the Spanish Agency for Food Safety and Nutrition.

Additional provision second. Coordination.

The Registry will coordinate with the remaining existing records of companies and products involved in the food chain, in order to ensure the data unit, performance economy and administrative efficiency.

Additional provision third. Registration of retail trade establishments of fresh meat and their derivatives.

The establishments falling within the scope of Royal Decree 1376/2003 of 7 November 2003 laying down the health conditions for the production, storage and marketing of fresh meat and meat derivatives in retail establishments shall be subject to the procedure for prior communication and registration in the autonomous registers provided for in Article 2.2 of this royal decree.

Single transient arrangement. The validity of previous entries.

The registration of companies, establishments and products currently listed in the Register will continue to be valid, without prejudice to the need for the competent authorities to carry out their trade, if necessary, the appropriate corrections to be made to the provisions of this royal decree and, where appropriate, to the cancellation of those which do not have to be included in it, from the date of entry into force, in particular those of undertakings and establishments which they have as the object of their activity, detergents, disinfectants and pesticides use in the food industry.

Single repeal provision. Regulatory repeal.

Royal Decree 1712/1991 of 29 November, on the General Health Register of Food, Article 5 of Royal Decree 3484/2000 of 29 December 2000 laying down the hygiene rules for the preparation, distribution and trade of prepared meals, and the first paragraph of Article 4 of Royal Decree 1376/2003 of 7 November 2003 laying down health conditions for the production, storage and marketing of fresh meat and its derivatives in retail trade, with the exception of the three the last paragraphs of point (c).

Final disposition first. Competence title.

This royal decree is dictated by the provisions of article 149.1.16. of the Spanish Constitution, which attributes to the State exclusive competence in the field of bases and general coordination of health.

Final disposition second. Entry into force.

This royal decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid, on February 18, 2011.

JOHN CARLOS R.

The Minister of Health, Social Policy and Equality

LEIRE PAJIN IRALA