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Royal Decree 821/2008, Of 16 May, Which Regulates The Conditions Of Application Of The Community Legislation On Feed Hygiene And Sets The General Register Of Establishments In The Animal Feed Sector.

Original Language Title: Real Decreto 821/2008, de 16 de mayo, por el que se regulan las condiciones de aplicación de la normativa comunitaria en materia de higiene de los piensos y se establece el registro general de establecimientos en el sector de la alimentación animal.

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Animal nutrition is an essential link in the food chain with enormous importance in ensuring food security, where numerous administrative actions are involved, including the following: to highlight the registration and approval of establishments and the communication of risks between competent authorities, associated with the consumption of feed.

In this regard Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for the hygiene of feedingstuffs lays down a number of obligations for operators of feed-producing and marketing companies, as well as for farmers in their feeding activities for animals intended for food production. This royal decree lays down specific rules for the application of the first set of rules, not regulating the obligations of farmers in relation to the feeding of animals laid down by Regulation (EC) No 2179/90. 183/2005, which are not the subject of this royal decree. In particular, in addition, Regulation (EC) No 183/2005 provides for the obligation to carry one or more records of establishments in the animal feed sector in accordance with Article 9 (3) thereof.

Law 8/2003 of 24 April on Animal Health also provides for the development of the corresponding records in Article 72.2 prior to the start of the activity of establishments in the animal feed sector. reasons for the protection of public health, animal health or the public interest.

On the other hand, Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 provides for the obligation, in Articles 19.6 and 19.7, for Member States to make available to the public: lists of establishments approved in accordance with Article 10 of that Regulation and referred to in Article 9 respectively.

In order to satisfy the objectives and obligations set out in the above mentioned rules, this royal decree provides for the implementation of appropriate measures, through the electronic registration of all the establishments involved in the animal feed sector and the establishment of a system of communication and exchange of information between the competent authorities in that sector.

Both the register of establishments and the communication of the risks associated with the consumption of feed will be supported, integrated and transmitted through the computer application called " Computer System of Registration of establishments in animal feed " (SILUM), which is created for this purpose.

In order to avoid duplicity in the performance of the Public Administration, provision should also be made to establish instruments for the exchange of information between the SILUM database and the computerised databases or other instruments. of data storage already available to the General Administration of the State, in order to facilitate the establishment of the General Register of establishments in the animal feed sector.

The adoption by royal decree of the present basic regulation, which takes its seat in the habilitation contained in article 149.1.13. and 16. of the Constitution, is based, in accordance with the doctrine of the Constitutional court, in the markedly technical character, of the object of regulation.

This provision has been submitted for consultation by the Autonomous Communities and the entities representing the interests of the sectors concerned, and the Interministerial Committee on Ordination has issued a report. Food, the Ministerial Commission of Electronic Administration and the Spanish Agency for Data Protection.

In its virtue, on the proposal of the Minister for the Environment, and the Rural and Marine Environment and the Minister of Health and Consumer Affairs, in agreement with the Council of State and after deliberation by the Council of Ministers at its meeting on May 16 of 2008,

D I S P O N G O:

Article 1. Object.

This royal decree is intended to:

(a) Establish specific provisions for the partial application of Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for the hygiene of feedingstuffs.

b) Establish and regulate the General Register of establishments in the animal feed sector.

Article 2. Definitions.

For the purposes of this Royal Decree, the definitions laid down in Article 3 of Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for the hygiene of feedingstuffs, in points (a) and (c) of Article 2 of Royal Decree 56/2002 of 18 January 2002 governing the movement and use of raw materials for animal feed and the movement of compound feedingstuffs, in the Article 3 of Law 8/2003 of 24 April of animal health and in Article 2 (e) of Regulation (EC) No 1831/2003 of 22 September 2003 on additives in animal nutrition subject to the following specific definitions:

(a) Authorisation: the act issued by the competent authority for which the feed business operator is empowered to carry out the activity in question after verification of compliance with the Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005, as provided for in Articles 10 and 13 thereof.

(b) Registration: the list of establishments which feed business operators have communicated to the competent authority in accordance with Article 9.2 of Regulation 183/2005.

(c) List of registered or approved establishments: the minimum information of the establishments which the competent authorities shall make available to the public in accordance with Article 19 of the Regulation 183/2005.

Article 3. Register of establishments.

1. All establishments dependent on the operators of a feed business shall be registered in one or more registers managed by the competent authority of the Autonomous Communities or Cities of Ceuta and Melilla or, in the case of Importers or exporters, by the Ministry of the Environment, and the Rural and Marine Environment through the Directorate-General for Agricultural and Livestock Resources.

2. Establishments carrying out a transport activity shall be registered by the competent authority in which the registered office of the feed business to which they belong resides.

3. The records shall include at least the data provided for in Annex I for the activities subject to authorisation under Article 5.1 and for establishments which do not require authorisation in accordance with paragraph 1. of this Article and develop any of the activities listed in Annex II to this Royal Decree.

Article 4. General registration of establishments in the animal feed sector.

1. The General Directorate of Agricultural and Livestock Resources of the Ministry of the Environment, and the Rural and Marine Environment, the General Register of establishments in the field of animal nutrition, is hereby established under the General Register, in which the basic data of establishments which are operators of feed businesses whose activity falls within the scope of Article 2 of Regulation (EC) No 183/2005 of the European Parliament and of the Council shall be included. of 12 January 2005.

The General Register shall, at least, integrate the data referred to in Annex I in the records managed by the competent authorities.

2. The system for the management of the records of the competent authorities shall allow the data to be collected by the competent authorities in accordance with Article 3, as well as the high, low and modifications to be made in those records, to be immediately reflected in the General Register, for which, where appropriate, the appropriate mechanisms for connection or data-dumping shall be established between the autonomous databases and the General Register to be determined by the National Commission for Coordination in the field of animal feed.

Where there are databases of establishments of feed companies, which carry out activities other than those referred to in Annex II, which operate in bodies of the General Administration of the State other than the Directorate-General for Agricultural and Livestock Resources, in the exercise of their respective competencies; the implementation of appropriate mechanisms for connecting or dumping data between their databases and the General Register will be allowed to permit the ups, downs and modifications made in those records are reflected in the Register General.

3. The General Register is constituted in the database within the computer application called "Information System for the Registration of Establishments In Animal Nutrition" (SILUM), under the Ministry of the Environment, and Rural and Rural Seaman. This Register shall be accessible to the competent authorities, and to the Security Forces and Corps.

The General Registry shall be public without prejudice to the proper protection of personal data that may operate in it, in accordance with the Organic Law 15/1999 of 13 December of the Protection of Data Personal Character.

Article 5. Approval of establishments.

1. The establishments of feed businesses which carry out any of the activities referred to in Article 10 of Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 shall be authorised.

2. The authorization shall be granted by the competent authority of the Autonomous Communities or Cities of Ceuta and Melilla, or, in the case of the importing or exporting establishments, by the Ministry of the Environment and the Rural and Marine Environment. of the Directorate-General for Agricultural and Livestock Resources.

3. A carrier which carries out some of the activities referred to in paragraph 5.1 of this royal decree shall be authorised by the competent authority in which the registered office of the feed company is resident. belong.

Article 6. Lists of registered or approved establishments.

1. The competent authority shall incorporate all the establishments registered in application of Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January into the relevant listing, in accordance with the activity they develop, and keep updated.

2. The list of establishments approved in accordance with Articles 10 and 13 of Regulation (EC) No 183/2005 shall contain at least the data set out in Annex IV and the competent authority shall assign them an identification number in accordance with paragraph 2. of that Annex.

3. The list of registered establishments carrying out any of the activities listed in Annex II shall contain at least the data set out in Annex III and the competent authority shall assign them an identification number according to the paragraph 2 of that Annex.

4. The competent authorities shall communicate to the Directorate-General for Agricultural and Livestock Resources of the Ministry of the Environment, and Rural and Marine the lists of registered or approved establishments and their updates.

5. The Ministry of the Environment, and the Rural and Marine Environment, shall draw up and make public, with the data submitted by the competent authorities, the relevant lists of registered establishments, in accordance with Article 19 of the Regulation. (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005. These lists may be advertised through the Ministry's website or, where appropriate, through other electronic means.

Article 7. Obligations and rights of feed business operators.

1. In addition to the obligations laid down in Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005, feed business operators shall keep the records referred to in the Article 6.2 of this royal decree and in Annexes I and II to Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January, a minimum of three years, without prejudice to any specific rules requiring a longer period of time.

2. In the case of feed business operators who are manufacturers of compound feed, additives or premixtures, they shall forward to the competent authority, by 31 January of each year, the data relating to the quantities of each of the products manufactured as well as the quantity of the complementary raw materials, additives, premixtures and feed used, all referred to in the preceding year.

3. Establishments of feed business operators, which are not required to make an application for authorisation in accordance with Article 5, shall be notified to the competent authority in advance at the beginning of the activity. the way in which it is determined, as referred to in Article 9 of Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005.

4. The feed business operator shall provide the competent authorities in the manner in which it is determined, prior to the commencement of the business or activities of the establishment, at least the data necessary for the registration which it is appropriate to practise, in accordance with Annex I, except those referred to in paragraphs a, d and e.

5. Feed business operators, as referred to in Article 5 and the third paragraph of this Article, shall communicate to the competent authority the cessation of their activities and any change in the name of the undertaking. feed operator or change of holder or holders thereof, or modification of the data set out in Annex I to this Royal Decree of the establishments registered in accordance with Article 4.2. Such communication shall be made within the maximum period of one month after the significant change in the activity has taken place. In the case of the start of a new activity, Article 16 of Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 shall apply.

6. The operator of a feed business shall be responsible for having the appropriate documentation to justify the registration of each establishment as the feed business has established as established by the competent authority.

Article 8. Revocation or suspension of the authorization or annotation of discharge or suspension in the registry.

1. The competent authorities may suspend or revoke the authorisations and discharge or suspend the entries in the registers, after hearing the person concerned, in accordance with Articles 14 and 15 respectively of the Regulation. (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005.

2. For the purposes of the revocation of the authorisation and the discharge in the register, the infringements referred to in Article 85 of Law 8/2003 of 24 April of animal health as well as the non-compliance with the requirements shall be construed as serious deficiencies. laid down in Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005, in accordance with Article 5 thereof, which may pose a risk to public health, animal health or the environment.

Article 9. Infringements and penalties.

In case of non-compliance with the provisions of this royal decree, the regime of violations and penalties applicable in accordance with the provisions of Law 14/1986 of 25 April, General of Health, in Law 8/2003, will apply. (a) of 24 April, of animal health, and of Royal Decree 1945/1983 of 22 June 1983 governing infringements and penalties in respect of the defence of the consumer and agri-food production, without prejudice to civil liability, criminal or other order that may be present.

Single transient arrangement. Validity of the Order of 31 October 1988.

The Order of 31 October 1988, concerning certain products used in animal nutrition, maintains its validity and the references made to it to Royal Decree 418/1987 of 20 February are to be read made to this royal decree.

Single repeal provision. Regulatory repeal.

Royal Decree 1144/2006 of 6 October 2006 on the conditions for the application of Community legislation on the hygiene of feedingstuffs, with the exception of Article 9 thereof, on the National Commission for the coordination on animal feed and the single transitional provision on imports and exports.

Final disposition first. Competence title.

The present royal decree is dictated by the provisions of Article 149.1, Rules 13 and 16. The Constitution, which attributes to the State exclusive competence in the field of bases and coordination of the general planning of the the economic activity and bases and general coordination of health.

Except for this character of basic regulation, the regulation on imports and exports, which is issued under the provisions of Article 149.1.16, first indent, of the Constitution, which attributes to the State the exclusive competence in the field of external health.

Final disposition second. Application and modification faculty.

The Ministers for the Environment, and the Rural and Marine Environment and for Health and Consumer Affairs are empowered to amend, in the field of their powers, the content of Annexes I to IV to this Royal Decree, in order to adapt them to the amendments to be 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, 16 May 2008.

JOHN CARLOS R.

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

MARIA TERESA FERNANDEZ DE LA VEGA SANZ

ANNEX I

Minimum data for the establishment and the feed business operator responsible for the establishment, to be listed in the General Register

(a) The authorisation number assigned to the establishment of the feed business operator.

(b) Surname and name or social name of the feed business operator and full address, nationality and Tax Identification Number (CIF or NIF)

c) First and last names of the legal representative of the company and its NIF.

d) Date high in the record, and if any, low and/or modification.

e) Competent authority that you enroll.

f) Activity or activities that the establishment develops.

g) The complete address of the establishment.

ANNEX II

List of activities carried out by feed business establishments shall be the subject of registration in accordance with Article 3

1. The activities of feed business operators at all stages of the process, from the primary production of feed to their placing on the market, except:

(a) Primary production as defined in Article 3.f of Regulation 183/2005, silage and storage of feed at the place of origin.

(b) The activities covered by Article 1 of Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs in accordance with the provisions of the Article 2 of Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005.

(c) The activities covered by Article 1 of Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down the health rules applicable to animal by-products intended for human consumption.

2. The import and export of feed from or to third countries.

ANNEX III

Minimum list data and identification number of registered establishments

1. List of registered feed establishments:

1

2

3

4

5

(1)

Activity (2).

Name or trade name (3).

Address (4).

Observations.

(1) As set out in section 2 of this annex.

(2) A = establishments which manufacture one of the additives referred to in Regulation (EC) No 1831/2003 or the products referred to in Directive 82/471/EEC other than those referred to in Article 10 (1) (a) Regulation (EC) No 183/2005 on the hygiene of

.

B = establishments manufacturing premixtures other than those referred to in Article 10 (1) (b) of Regulation (EC) No 183/2005 on the hygiene of feedingstuffs.

C = establishments manufacturing for the marketing of compound feed using feed additives or premixtures containing feed additives other than those referred to in Chapter 3 of Annex IV to that Regulation. Regulation 183/2005.

E = establishments that produce compound feed requirements exclusively for the needs of their holding using complementary feed or feed additives or premixtures containing feed additives other than those which is referred to in Chapter 3 of Annex IV to Regulation 183/2005.

I = establishments that perform a merchandising activity

F = establishments whose activity is not included in the preceding letters to be specified in Table 5.

IMP = establishments that perform a concurrent import activity with the activities of the preceding letters

EXP = establishments that perform a concurrent export activity with the activities of the preceding letters.

PM = establishments that manufacture and/or market medicated feed in concurrency with any of the activities of the preceding letters.

(3) Name or trade name of feed companies.

(4) Management of feed companies.

2. The identification number of registered establishments shall consist of:

1) the ESP code,

2) the national reference number, up to a maximum of eight alphanumeric characters, including:

Two digits identifying the province, according to the National Statistics Institute's coding.

Other digits will be assigned by the competent authority.

ANNEX IV

Minimum list data and identification number of authorized establishments

1. List of approved feed establishments:

5

1

2

3

4

5

Activity (2).

Name or trade name (3).

Address (4).

Observations.

(1) As set out in section 2 of this annex.

(2) A = establishments performing a manufacturing activity referred to in Article 10 (1) (a) of Regulation (EC) No 183/2005 on the hygiene of feed and additive manufacturers of Article 6.1 (e) of the Regulation. Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives in feedingstuffs.

B = establishments performing a manufacturing activity referred to in Article 10 (1) (b) of Regulation (EC) No 183/2005 on the hygiene of feedingstuffs.

C = establishments performing a manufacturing activity referred to in Article 10 (1) (c) of Regulation (EC) No 183/2005 on the hygiene of feedingstuffs, except those listed in point E of this Chapter.

E = establishments performing a manufacturing activity referred to in Article 10 (1) (c) of Regulation (EC) No 183/2005 on the hygiene of feed intended for the entire production of feed for the needs of the their operation.

I = establishments which carry out a marketing activity as referred to in Article 10 (1), (1) (b) and (1) (c) of Regulation (EC) No 183/2005 on the hygiene of feedingstuffs and placing on the market additives of (e) Article 6.1 of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives in feedingstuffs.

IMP = establishments that perform a concurrent import activity with the activities of the preceding letters

EXP = establishments that perform a concurrent export activity with the activities of the preceding letters

PM = establishments that manufacture and/or market medicated feed in concurrency with any of the activities of the preceding letters.

(3) Name or trade name of feed companies.

(4) Management of feed companies.

2. The identification number of approved establishments shall consist of:

1) the "α" character,

2) the ESP code,

3) the national reference number, up to a maximum of eight alphanumeric characters, including:

Two digits identifying the province, according to the National Statistics Institute's coding.

Other digits will be assigned by the competent authority.