In recent decades, the European Union (EU) has carried out extensive regulatory development on food law, with the aim, among others, to ensure the safety and safety of products. food of the European Union. In this regard, 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 are laid down in the Community framework for food regulation.

It is also important to highlight Regulations (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs; No. 882/2004 of the European Parliament and of the Council of On 29 April 2004, on the official controls carried out to ensure the verification of compliance with feed and food law and the animal health and animal welfare rules; and No 2073/2005 of the Commission of 15 November 2005 on the microbiological criteria applicable to the food products, all of which are included in the legislative package entitled "Hygiene Package".

On the other hand, in recent years the production of germinated seeds has increased as a result of the increase in consumer demand for this type of products. Their crude consumption and the characteristics of the germination process, which are favorable for microbial growth, have resulted in these foods being linked to outbreaks of food toxiinfections in man. In fact, following the outbreak of food poisoning caused by E. coli in May 2011 in the European Union, the consumption of outbreaks was identified as the most likely origin of the food crisis. This fact determined that the European Food Safety Agency ('EFSA ') issue a scientific opinion on the risk caused by E. " coli production of toxin Shiga and other pathogenic bacteria in seeds and germinated seeds in October 2011. In that opinion, EFSA noted that the most likely initial source of the food crisis mentioned above is contamination of seeds with pathogenic bacteria, and that such bacteria present in the seeds can be multiplied. during germination and will be a risk to public health due to high humidity and favorable temperatures that are reached during the germination.

In order to avoid or reduce the potential risks of contamination of germinated seeds, thereby ensuring the protection of public health in the European Union, and taking into account the EFSA opinion, they were approved in March 2013, Commission Implementing Regulation (EU) No 208/2013 of 11 March 2013 on requirements for the traceability of sprouts and seeds intended for the production of sprouts; and Regulations (EU) No 209/2013 of the European Parliament and of the Council (EU) No 209/2013, the Commission of 11 March 2013 amending Regulation (EC) No 2073/2005 as regards the microbiological criteria for outbreaks and sampling rules for poultry carcases and fresh poultrymeat; n ° 210/2013, of the Commission of 11 March 2013 on the authorisation of establishments producing them outbreaks pursuant to Regulation (EC) No 852/2004 of the European Parliament and of the Council; and of the Commission of 11 March 2013 of 11 March 2013 on the certification requirements for imports into the Union of sprouts and seeds intended for the production of sprouts.

In view of this situation, it is necessary to lay down specific provisions for the application in Spain of such legislation.

Specifically, and in accordance with Article 2 of Commission Regulation (EC) No 210/2013 of 11 March 2013, establishments should be authorised prior to the commencement of their business, with the guarantee of This means that they comply with the appropriate hygiene standards, thereby ensuring a high level of protection of public health, so that the principles of necessity and proportionality are met in this case. authorization.

This royal decree is issued under the provisions of the fifth final provision of Law 17/2011 of 5 July on food security and nutrition.

In the elaboration of this royal decree have been consulted the autonomous communities and the representative entities of the affected sectors, having issued its precept report the Inter-Ministerial Commission for the Food.

In its virtue, on the proposal of the Minister of Agriculture, Food and Environment, and the Minister of Health, Social Services and Equality, with the prior approval of the Minister of Finance and Public Administration, agreement with the Council of State, and after deliberation by the Council of Ministers at its meeting on 30 May 2014,

DISPONGO:

Article 1. Object and scope of application.

1. This royal decree aims to establish certain measures which contribute to the correct application in Spain of Commission Implementing Regulation (EU) No 208/2013 of 11 March 2013 on requirements for traceability of the outbreaks and seeds intended for the production of sprouts; and of Commission Regulations (EU) No 209/2013 of 11 March 2013 amending Regulation (EC) No 2073/2005 as regards the microbiological criteria for the production of sprouts. outbreaks and sampling rules for poultry carcases and fresh poultrymeat; n. º 210/2013 of the Commission of 11 March 2013 on the authorisation of establishments producing outbreaks pursuant to Regulation (EC) No 852/2004 of the European Parliament and of the Council; and of the Commission of 11 March 2013 of 11 March 2013, concerning the certification requirements for imports into the Union of outbreaks and seeds intended for the production of sprouts.

2. This royal decree will apply to:

a) Outbreaks.

(b) Seed intended for the production of sprouts.

3. This royal decree will not apply to outbreaks that have received a treatment that eliminates microbiological risks, compatible with European Union legislation.

Article 2. Definitions.

For the purposes of this royal decree, the definitions laid down in Article 2 of Commission Regulation (EU) No 208/2013 of 11 March 2013; in Articles 2 and 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council [13] shall apply. The European Parliament and the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in respect of the food security; Article 2 of Regulation (EC) No 852/2004 of the European Parliament and of the Council Council of 29 April 2004 on the hygiene of foodstuffs; and Article 2 of Commission Regulation (EC) No 2073/2005 of 15 November 2005 on the microbiological criteria applicable to foodstuffs food.

Article 3. Competent authorities.

1. The Directorate General of Agricultural Production of the Ministry of Agriculture, Food and the Environment, is the national competent body designated for the coordination of the actions that are regulated by this royal decree and the focal point information on this subject, without prejudice to those aspects relating to public health, which correspond to the Ministry of Health, Social Services and Equality through the Spanish Agency for Consumer Affairs, Food Safety and Nutrition.

2. For the purposes of the necessary coordination with the Ministry of Agriculture, Food and the Environment, compliance with the provisions of this royal decree and the planning and implementation of the actions and agreements to be adopted conformity with it, each autonomous community shall communicate a competent body or body which shall act as a focal point in its territorial area, without prejudice to the powers which the various bodies of the autonomous community may have in relation to with the provisions of this royal decree.

3. Within a maximum of one month from the date of entry into force of this royal decree, each autonomous community shall notify the Directorate-General for Health of Agricultural Production, the Ministry of Agriculture, Food and the Environment, the organ or competent authority referred to in the previous paragraph. Any changes to this body will be immediately communicated to the Directorate-General of the Ministry of Agriculture, Food and the Environment.

Article 4. Obligations of the operators of outbreaks.

1. Prior to the commencement of their activity, the operators of outbreaks must have, for their establishments, the corresponding authorization issued by the competent authority or body of the Autonomous Community or of the cities of Ceuta and Melilla in which they radiate the same, in accordance with Article 6 of Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004.

2. The operator of the outbreak shall accompany the application for authorisation with at least the documentation set out in Annex I.

3. The operators of outbreaks shall communicate to the competent body or body the modification of any of the data listed in Annex I, approved establishments and the definitive cessation of their economic activity. Such communication shall be made within the maximum period of one month after such modification or cessation of activity occurs.

Article 5. Authorisation and registration of outbreak-producing operators.

1. The competent bodies or entities of the autonomous communities or the cities of Ceuta and Melilla shall grant the approval to the establishments concerned, after a visit on the spot, by assigning to each approved establishment a code to ensure their unique identification with the following structure:

a) The "ES" characters that identify Spain,

b) Two digits identifying the autonomous community or city of Ceuta and Melilla, according to the codification of the National Statistics Institute,

c) Seven digits to be assigned by the competent body or entity.

2. Authorisations may be suspended or revoked when the establishment or operator ceases to comply with the requirements that justified the establishment or operator.

3. The competent bodies or bodies shall communicate to the Directorate-General for Agricultural Production of the Ministry of Agriculture, Food and the Environment the data corresponding to paragraph 1 of Annex I to all establishments. The Commission shall,

accordance with Article 4 (2) of the Treaty, adopt the following measures in accordance with Article 4 (2) of Regulation (European) No 101/2013 and the Commission shall take into account the following:

The competent authorities of the autonomous communities and the cities of Ceuta and Melilla when they authorize the establishments and these, in addition to producing the outbreaks, submit them to a treatment that eliminates the risks They shall inform the competent health authorities for the purposes of their registration in the General Health Register of Food and Food Enterprises which shall not be of an enabling nature for the exercise of the activity.

Article 6. Microbiological criteria.

1. Outbreak-producing operators shall ensure that the outbreaks they produce comply with the microbiological criteria laid down in Annex I to Commission Regulation (EC) No 2073/2005 of 15 November 2005 on the criteria for Microbiological conditions applicable to foodstuffs.

2. In order to verify compliance with the criteria set out in the previous paragraph, operators shall follow the sampling and analysis rules set out in Section 3.3 of Chapter 3 of Annex I to Regulation (EC) No 2073/2005 of the Commission of 15 November 2005 on the microbiological criteria for foodstuffs.

Article 7. Laboratories.

1. It is designated as the National Reference Laboratory for the detection and identification of the micro-organisms referred to in Article 6.1, to the Central Veterinary Laboratory, located in Algete (Madrid).

2. Laboratories for the performance of official controls shall be established, recognised or appointed by the competent bodies or bodies of the autonomous communities or the cities of Ceuta and Melilla. Tests for the detection of micro-organisms referred to in Article 6.1, assessed and accredited in accordance with the UNE-EN ISO/IEC 17025 standard of general requirements relating to the competence of the Member States, shall be operational and available. test and calibration laboratories, or to apply quality assurance systems in accordance with the same. They shall also participate in the collective detection tests organised or coordinated by the National Reference Laboratory.

3. The competent authorities of the Autonomous Communities or the cities of Ceuta and Melilla shall communicate to the Directorate-General for Agricultural Production of the Ministry of Agriculture, Food and the Environment the laboratories. referred to in paragraph 2 or its amendments in respect of ups and downs annually, before 1 January, in order to draw up by the same list of approved laboratories.

Article 8. Requirements for the traceability of sprouts and seeds intended for the production of sprouts.

1. Operators shall, at all stages of production, processing and distribution, register for each batch supplied and received from sprouts or seeds intended for the production of sprouts, as appropriate, at least the information collected in Annex II, as set out in that Annex. They shall also transmit such information on a daily basis, where appropriate, to the operator supplying the seed or sprouts. These operators must also keep the albarans or sales invoices to justify the seats in the registers for at least four years in the case of seed intended for the production of sprouts and six months in the case of of the outbreaks.

2. Operators may carry the records referred to in paragraph 1 on paper or computer support. They shall update them on a daily basis, where appropriate, and keep them available for a sufficient period of not less than four years in the case of seed intended for the production of sprouts and six months in the case of outbreaks. They shall also make such information available to the competent authority at the time it requests it.

Article 9. Certification requirements for imports of sprouts and seeds intended for the production of sprouts.

1. Consignments of sprouts and seeds intended for the production of outbreaks imported into the European Union shall be accompanied by a certificate drawn up in accordance with Article 3 of Regulation (EU) No 211/2013. Commission of 11 March 2013 on the certification requirements for imports into the EU of sprouts and seeds intended for the production of sprouts.

2. The previous paragraph shall not apply to outbreaks which have undergone a treatment for the disposal of microbiological risks compatible with the legislation of the European Union. Without prejudice to this, these outbreaks must comply with the other requirements laid down in the current legislation.

3. Operators importing sprouts or seeds intended for the production of sprouts shall keep the certificate referred to in paragraph 1 for a sufficient time not less than four years in the case of seed intended for production of outbreaks and six months in the case of outbreaks. They shall also make such information available to the competent authority at the time it requests it.

4. All operators handling imported seed intended for the production of sprouts shall supply copies of the certificate referred to in paragraph 1 to all operators to whom they supply the seed until the seed is received by the seed. producer of sprouts or until they are packaged for retail sale.

Article 10. Sanctioning regime.

In case of non-compliance with the provisions of this royal decree or in the regulations of the European Union, the regime of violations and penalties provided for in Law 17/2011 of 5 July, will be applicable in the light of the matter. Food security and nutrition; in Law 33/2011, of 4 October, General of Public Health; and in Law 14/1986, of April 25, General of Health, without prejudice to the civil, criminal or other responsibilities that may be present.

First transient disposition. Authorisation of currently operating outbreak producing operators.

The operators of outbreaks that are already developing their activity before the entry into force of this royal decree, must facilitate the competent organ or entity of the autonomous community or the cities of Ceuta and Melilla the documentation set out in Annex I, in addition to the No. of the Sanitary General Register of Food and Food Companies of the establishment, if any, within the maximum period of six months from the entry into force of this royal decree, with the purpose of which they are to be examined for the relevant authorisation.

Second transient disposition. Certification requirements for imports of sprouts and seeds intended for the production of sprouts.

The requirements for certification required for consignments of sprouts and seed intended for the production of outbreaks imported into the European Union, as provided for in Article 9, shall apply taking into account the transitional periods. to establish Community legislation in this field.

Final disposition first. Competence title.

This royal decree is issued in accordance with the provisions of Article 149.1.13. and 16. of the Constitution, which attributes to the State exclusive competence in the field of bases and coordination of the general planning of the activity. The economic and social foundations and coordination of health, respectively.

Except as provided for in Article 9, which is issued under the provisions of Article 149.1.16, first indent, of the Constitution, which attributes exclusive competence to the State in the field of external health.

Final disposition second. Ability to modify.

The holders of the Ministries of Agriculture, Food and the Environment, Health, Social Services and Equality are empowered to amend the content of the Annexes in the field of their respective powers. for adaptation to the amendments introduced by Community legislation.

Final disposition third. Entry into force.

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

Given in Madrid, 30 May 2014.

JOHN CARLOS R.

The Vice President of the Government and Minister of the Presidency,

SORAYA SAENZ DE SANTAMARIA ANTON

ANNEX I

Minimum documentation to be submitted by the outbreak producing operators when requesting approval from their establishments

1. Application for authorisation for each of its establishments, with the following minimum data:

a) Surname and name or social reason, NIF or NIE, full address and telephone of the operator.

b) Denomination and full address of the establishment.

(c) Type of production, including the taxonomic name of the plant or plants from which the seeds or sprouts are derived from their production.

2. The justification for compliance with the requirements laid down for each establishment should be indicated and, where appropriate, specify whether to carry out any treatment that eliminates the microbiological risk in the outbreaks, which is compatible with the legislation of the European Union.

ANNEX II

Minimum information to be recorded and transmitted by the operator for each batch supplied from sprouts or seeds intended for the production of sprouts

a) The common name and the taxonomic name of the seeds or the acquired buds.

b) Invoice number or purchase order.

c) Number or reference of the batch identification of the acquired seeds or sprouts.

d) The volume or quantity of seeds or buds acquired.

e) The name and address of the operator to which the seeds or sprouts are purchased.

f) The name and address of the owner, if not the same as the operator from which the seeds or sprouts are acquired.

g) The common name and taxonomic name of the seeds or outbreaks issued.

h) The invoice number or output albaran.

i) Number or reference of identification of the batch of seeds or outbreaks issued.

j) The name and address of the operator to which the seeds or sprouts are dispatched.

k) The name and address of the recipient (owner), if not the same as the operator to which the seeds or sprouts are dispatched.

l) The volume or quantity of seeds or outbreaks issued.

m) The date of issue.