Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October laying down health rules for animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Regulation on animal by-products) since 4 March 2011 constitutes the legal framework for the management of all material of animal origin which for different reasons is not intended for human consumption.

This rule has been developed by Commission Regulation (EU) No 142/2011 of 25 February 2011 laying down detailed rules for the application of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of the Council laying down the health rules applicable to animal by-products and derived products not intended for human consumption, and Council Directive 97 /78/EC as regards certain samples and units which are exempt from veterinary checks at the border by virtue of the border.

Directive 2008 /98/EC of the European Parliament and of the Council of 19 November 2008 on waste (Waste Framework Directive), transposed into Spanish national law by Law 22/2011 of 28 July 2011 on waste and contaminated soils, is applicable to all residues, including animal by-products, with the exclusion of, inter alia, faecal materials and other natural agricultural or forestry material, not dangerous, used in the agricultural and livestock holdings, in forestry or in the production of energy on the basis of this biomass, by means of procedures or methods that do not endanger human health or harm the environment.

However, the requirements laid down in both rules do not apply to animal by-products in those aspects which are already regulated by other Community or national rules, such as those covered by the Regulation. (EC) No 1069/2009, Regulation (EU) No 142/2011 or in this royal decree, except where the by-products are intended for incineration, landfill or for use in biogas or composting plants.

Without prejudice to the effectiveness and direct applicability of these regulations, it is necessary to lay down specific provisions in order to clarify the distribution of powers between the different authorities involved in the their implementation, to provide for the mechanisms for coordination and exchange of information between them and to regulate the use of certain exceptions which both rules provide for. Furthermore, in order to ensure consistency and understanding of the text, this provision partially reproduces certain aspects of these regulations, without affecting the direct applicability of these regulations. This is based on the experience in this field, which is reflected in the White Paper on the Subproducts of Animal Origin, not intended for human consumption, drawn up by the Ministry of Agriculture, Food and the Environment, and the Implementation of the Comprehensive National Plan for Non-Intended Animal Origin Subproducts for Human Consumption, approved by the Council of Ministers Agreement at its meeting of 5 October 2007, and published by Order PRE/468/2008, of 15 June 2007, February.

In Spain, Royal Decree 1429/2003 of 21 November, which regulates the conditions for the application of Community legislation on by-products of animal origin not intended for human consumption, established guidelines harmonised application of Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules for animal by-products not intended for human consumption. The entry into force of Regulation (EC) No 1069/2009, the European Parliament and the Council of 21 October makes it necessary to review these conditions and to repeal Royal Decree 1429/2003 of 21 November.

On the other hand, certain provisions relating to the collection and transport of certain animal by-products, as provided for in Royal Decree 3454/2000 of 22 December 2000, are still in force for the purpose of establishing and regulating the Integrated Programme for the coordinated surveillance and control of transmissible spongiform encephalopathies of animals, and Royal Decree 845/1987 of 15 May 1987 on the animal health regulations governing the use of such products and processing of dead animals and seizures for animal feed and other uses (i) the Commission's approach to the Royal Decree 845/1987, of 15 May, was partially repealed, in respect of animal nutrition, by Royal Decree 2224/1993 of 17 December 1993 on health rules for the disposal and processing of dead animals and waste of animal origin and protection against pathogens in feed of animal origin. For simplification it is appropriate to proceed to its complete repeal and to move the still existing provisions to this royal decree, adapting them to the new normative requirements.

This royal decree is issued under the conditions laid down in the fifth final provision of Law 8/2003 of 24 April of animal health, in the fifth final provision of Law 17/2011 of 5 July, of food security and nutrition, in paragraph 1.c) of the third final provision of Law 22/2011 of 28 July, of contaminated waste and soils, and in the final provision of the fifth of Law 33/2011 of 4 October, General Public Health.

The basic regulation contained in this provision is made by royal decree since it is a matter of a markedly technical nature and of a cyclical and changing nature, intimately linked to the development of the Community rules.

In the preparation of this provision, the autonomous communities and the representative entities of the sectors concerned have been consulted, and this provision has received a favourable report from the Agency. Data Protection Spanish.

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 Administrations, with the Council of State and after deliberation by the Council of Ministers at its meeting on 8 November 2012,

DISPONGO:

Article 1. Object.

This royal decree is intended to lay down specific provisions for the application in Spain of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October laying down health rules applicable to animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) and Regulation (EU) No 142/2011 of the Commission of 25 February 2011, laying down detailed rules for the application of the Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down the health rules for animal by-products and derived products not intended for human consumption and Council Directive 97 /78/EC as regards certain samples and units exempted from the veterinary checks at the border under the same.

Article 2. Competencies.

The competent authority empowered to ensure compliance with the requirements of this royal decree and European Union legislation on by-products of animal origin and derived products not intended for consumption SANDACH shall henceforth be the competent bodies of the autonomous communities or cities of Ceuta and Melilla, as well as of the local authorities, and the competent bodies of the General Administration of the State as regards the exchanges with third countries.

The Ministries of Agriculture, Food and Environment, and Health, Social Services and Equality, will coordinate the implementation, by the autonomous communities or cities of Ceuta and Melilla, and by local authorities, of the SANDACH regulations.

Article 3. Definitions.

For the purposes of this royal decree, the definitions provided for in Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 and of Commission Regulation (EU) No 142/2011 of 21 October 2009 shall apply. February 25, 2011.

Article 4. National Commission for by-products of animal origin not intended for human consumption.

1. The national Commission for by-products of animal origin not intended for human consumption, hereinafter referred to as the "national commission", as a collegiate body of an inter-ministerial and multidisciplinary nature, attached to the Directorate-General for Health Agrarian, Ministry of Agriculture, Food and Environment, has the following functions:

(a) The monitoring and coordination with the competent authorities of the implementation of this royal decree and of the Comprehensive National Plan for Non-Intended Animal Origin Subproducts for Human Consumption, approved by the Council of Ministers at its meeting of 5 October 2007, and published by Order PRE/468/2008 of 15 February.

b) The periodic review of the evolution of such execution, proposing the precise modifications for an effective fulfillment of the objectives.

(c) Raise the competent authorities with proposals to enable better implementation of such legislation or its implementation.

(d) To advise the competent authorities on by-products of animal origin not intended for human consumption.

e) Propose the performance of scientific studies and studies in relation to the aforementioned by-products, in particular on new methods of valorization or disposal of these products.

(f) To obtain, for the purpose of their transfer to the autonomous communities and cities of Ceuta and Melilla, the other Member States and the European Commission, the information referred to in Article 5 of this royal decree.

2. The national Commission shall be composed of the following members:

(a) President: the Director General of Agricultural Production of the Ministry of Agriculture, Food and the Environment.

b) Vice President: the Executive Director of the Spanish Agency for Food Safety and Nutrition, Ministry of Health, Social Services and Equality.

c) Vocals:

1. Twelve vowels representing the General Administration of the State, belonging to the following ministries:

i. Seven on behalf of the Ministry of Agriculture, Food and Environment, with the rank of deputy director-general.

ii. Four on behalf of the Ministry of Health, Social Services and Equality, with the rank of deputy director-general.

iii. A representative of the Ministry of Economy and Competitiveness, with the rank of deputy director-general.

Such vowels shall be designated by the Deputy Secretary of the department concerned, and in cases of absence or disease and, in general, when there is another justified cause, they may be replaced by another person. service of the unit from which they are dependent, which will be designated in the same way.

2. In representation of the autonomous communities and cities of Ceuta and Melilla that decide to integrate into it, a representative for each one of them.

3. Two vowels appointed by the Spanish Federation of Municipalities and Provinces, representing the local authorities.

(d) They may also attend meetings of the national Commission, as advisers, with a voice but without a vote, those persons who, in consideration of their professional competence, are expressly called upon by the president.

e) An official of the Ministry of Agriculture, Food and Environment, appointed by the Undersecretary of the Department of Agriculture, shall act as secretary of the national commission.

3. The national Commission shall be governed by its own rules of operation and, in all cases not expressly provided for in those rules and in this Article, shall apply as laid down in Chapter II of Title II of Law No 30/1992 of 26 November 1992. of the Legal Regime of Public Administrations and of the Common Administrative Procedure, in the field of collegiate bodies.

4. The national Commission shall meet, upon convocation of its chairman, at least once every six months, and as often as the situation requires or at the request of any of its members.

Article 5. Duty of information.

The competent authorities shall send the Ministry of Agriculture, Food and Environment, or the Ministry of Health, Social Services and Equality, on the basis of their powers, to the European Commission, the information provided for in Regulation (EU) No 1069/2009 of the European Parliament and of the Council of 21 October 2009, in particular:

(a) The text of the provisions of the autonomous right which they adopt in areas of their competence which directly affect the correct application of this royal decree or of the European Union legislation on by-products of animal origin not intended for human consumption, SANDACH hereafter.

(b) Information on authorisations granted to processing plants under the conditions specified in Article 7.2.b of this royal decree.

c) Information on authorizations granted to processing plants in accordance with Article 7.3 of this royal decree.

d) Information on authorizations granted to biogas or composting plants to use alternative parameters of transformation according to articles 8.3 and 9.2 of this royal decree.

(e) Information on authorisations granted for special uses in animal nutrition in accordance with Article 15, headings 1 and 2 of this royal decree, and on the verification measures taken to ensure that the animal by-products are used only for the authorised purposes and the conditions required to ensure the control of the risks to public health and animal health.

(f) The information required in Article 16 concerning the use of certain exceptions to the requirements for the collection, transport and disposal of certain materials.

(g) Information relating to authorisations granted in accordance with the procedure set out in Section 2.c of Chapter I of Annex XI to Regulation (EU) No 142/2011 of the Commission of 25 February 2011 for the use of other authorisations standard parameters for the treatment of manure, manure products and bat guano.

(h) Information relating to authorisations granted for the production of pet food by other treatments referred to in Annex XIII, Chapter II.3.b (iv) and (v) of Regulation (EU) No No 142/2011 of the Commission of 25 February 2011.

i) The lists of establishments, plants or operators that have been authorised or registered in their respective territories in accordance with Article 24 of this royal decree.

Article 6. Disposal of certain materials in landfill.

Without prejudice to Articles 12 and 14 (c) of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October, the competent authority may authorise the disposal in an approved landfill of the materials referred to in Article 7 of Regulation (EU) No 142/2011 of the Commission of 25 February 2011.

This disposal will be carried out under the conditions laid down in Royal Decree 1481/2001 of 27 December 2001 regulating the disposal of waste by landfill, and Decision 2003 /33/EC of the Council of 19 December 2002 laying down the criteria and procedures for the admission of waste to landfill sites.

Article 7. Processing plants.

1. Processing plants shall comply with the requirements laid down in Article 8 of Commission Regulation (EU) No 142/2011 of 25 February 2011.

2. Processing plants located at the same location as slaughterhouses or other establishments approved or registered in accordance with Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 or the Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 shall comply with:

(a) The requirements specified in Section 1, headings a.i) to .iv) of Chapter I of Annex IV to Regulation (EU) No 142/2011 of the Commission of 25 February 2011, or

(b) In the case of Category 3 processing plants, other requirements to be established by the competent authority in order to reduce the risks to public and animal health, including the risks arising from the processing of Category 3 materials from establishments registered or approved in accordance with Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 and Regulation (EC) No 853/2004 of the European Parliament European and Council of 29 April 2004, and which are located elsewhere.

3. The competent authority may authorise processing plants to apply processing methods which comply with the requirements laid down in Annex IV, Chapter III, heading G (Method 7) of Regulation (EU) No 142/2011 of the Commission of February 25, 2011. In that case, it shall inform the national Commission provided for in Article 4, the technical details of the authorised method.

Article 8. Biogas plants.

1. Requirements for biogas plants.

Biogas plants using animal by-products or derived products as raw material shall comply with the requirements laid down in Article 10 of Commission Regulation (EU) No 142/2011 of 25 February 2011.

They shall be equipped with a compulsory pasteurisation/sanitisation unit for the raw materials of animal origin which they use and which must be subjected to this treatment, in accordance with Section 1 of Chapter III of Annex V to Commission Regulation (EU) No 142/2011 of 25 February 2011, unless pasteurisation/sanitisation has been previously carried out on another approved plant or the digestion residues are to be composted, processed or subsequently disposed of in accordance with the conditions laid down in that Regulation, the SANDACH category used as raw material.

2. Standard transformation parameters.

pasteurization/sanitization will be performed in compliance with the following standard transformation parameters:

a) Maximum granulometric dimension before entering the sanitizing unit: 12 mm. This parameter shall not be required for the treatment of Category 2 materials as specified in Article 13.e.ii of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October.

b) Minimum temperature of all material in the 70º sanitizing unit, and

c) The minimum and uninterrupted length of stay of all material in the unit, at that temperature, of 60 minutes.

The following materials may be used for the production of biogas without pasteurisation or sanitisation:

(a) Category 2 material which has been processed in accordance with the processing method 1 as defined in Chapter III of Annex IV to Regulation (EU) No 142/2011 of the Commission of 25 February 2011.

(b) Category 3 material which has been processed in accordance with one of the processing methods 1 to 5 or to the processing method 7, or in the case of material from aquatic animals, to one of the methods of processing 1 to 7, as provided for in Chapter III of Annex IV to Regulation (EU) No 142/2011 of the Commission of 25 February 2011.

(c) Animal subproducts which have undergone the process of alkaline hydrolysis as defined in point A of Section 2 of Chapter IV of Annex IV to Regulation (EU) No 142/2011 of the Commission of 25 February 2011.

(d) Milk, milk products, milk products, brooths and calostra products, unless the competent authority considers that they pose a risk of the spread of serious communicable disease to persons and the animals.

e) The following animal by-products, if authorised by the competent authority:

1. º Those referred to in Article 10 (f) of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October, which have been processed in accordance with Article 2 (1) (m) of the Treaty. Regulation (EC) No 852/2004 at the time when they are intended for purposes other than human consumption.

2. The animal by-products referred to in Article 10 (g) of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009.

3. Use of alternative transformation parameters.

The competent authority may authorise the use of alternative parameters to those set out in the previous heading, provided that the data subject applying for its use demonstrates that they ensure an adequate mitigation of risks. biological. The demonstration shall include a validation to be carried out in accordance with the requirements set out in Section 2 of Chapter III of Annex V to Regulation (EU) No 142/2011 of the Commission of 25 February 2011.

4. Special assumptions for the authorisation of the production of biogas from kitchen waste.

Until the European Commission adopts specific implementing measures, the competent authorities may authorise the production of biogas in compliance with requirements other than those laid down in the headings 1 and 2, provided that ensure an equivalent effect on the reduction of pathogens, when the SANDACH used in the biogas plant consists exclusively of:

a) Kitchen waste, or

b) Kitchen wastes mixed with manure, digestive tube contents separated from the digestive tract, milk, dairy products, milk products, colostrum, colostrum-based products, eggs, products derived from the egg or animal by-products referred to in Article 10 (f) of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October which have been processed in accordance with Article 2 (1) (m) of Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004.

5. Special assumptions for the authorisation of the production of biogas from certain Category 2 and Category 3 materials.

The competent authorities may authorise the production of biogas by meeting specific requirements other than those referred to in headings 1 and 2, where:

a) The SANDACH treated in the plant consist exclusively of manure, digestive tube contents separated from the digestive tract, milk, milk products, milk products, colostrum, products to Colostrum base, eggs, egg products, animal by-products referred to in Article 10 (f) of Regulation (EC) No 1069/2009 which have been processed in accordance with the provisions of Article 2 (1) (m) of Regulation (EC) No 1069/2009 Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004, or derived products referred to in Article 10 (g) of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009.

(b) The competent authorities consider that these materials do not present a risk of spreading serious communicable disease to humans or animals; and

(c) Consider that the fermentation residues are raw material and require the operators to manipulate it in accordance with the provisions of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October, Commission Regulation (EU) No 142/2011 of 25 February 2011 and the present royal decree.

Article 9. Conditions applicable to the production of compost.

1. Raw materials suitable for compost production.

For compost production the following SANDACH can be used:

(a) Category 2 materials that have been previously transformed by pressure sterilisation.

(b) Category 2 materials specified in Article 13.e.ii) of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October, without prior transformation.

(c) Category 3 materials, which have been previously processed with one of the processing methods 1 to 5 or to the processing method 7, or in the case of material from aquatic animals, to one of the methods of processing 1 to 7, as provided for in Chapter III of Annex IV to Regulation (EU) No 142/2011 of the Commission of 25 February 2011.

d) Category 3 materials without prior transformation.

2. Requirements for composting plants.

composting plants using SANDACH shall comply with the requirements laid down in Article 10 of Commission Regulation (EU) No 142/2011 of 25 February 2011.

They will be equipped with a closed area or a closed composting reactor mandatory for SANDACH, with facilities to measure temperature over time, devices that record (continuously when (a) the results of those measurements, and a safety system to prevent insufficient heating, so as to ensure that the standard processing parameters specified in the first paragraph of Article 8.2 are met.

The competent authority may authorise the use of alternative parameters to the above on condition that the person concerned who requests their use demonstrates that they ensure adequate mitigation of the biological risks. The demonstration shall include a validation to be carried out in accordance with the requirements set out in Section 2 of Chapter III of Annex V to Regulation (EU) No 142/2011 of the Commission of 25 February 2011.

3. Authorisation of other composting systems.

The competent authority may authorise the use of other composting systems provided that the plants comply with the other relevant requirements laid down in Commission Regulation (EU) No 142/2011 of 25 December 2011. February 2011, and

(a) All material passing through the system reaches the time and temperature parameters required under heading 2, including if necessary, continuous monitoring of such parameters; or

b) To transform exclusively:

1. º The materials listed in the headings 1.a) and 1.c).

2. º The materials listed in the headings 1.b) and 1.d) if they have been subjected to pasteurisation/sanitisation in an approved plant with the standard parameters set out in heading 2.

3. The animal by-products referred to in Article 10 (f) of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October, which have been processed in accordance with Article 2, paragraph 1 (m) of Regulation (EC) No 852/2004.

4. The products referred to in Article 10 (g) of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009.

4. Authorization of special requirements for the production of compost from kitchen waste.

Until specific implementing measures are adopted by the European Commission, the competent authorities may authorise the use of special requirements other than those set out under heading 2, provided that they ensure an effective equivalent to the reduction of pathogens, when the SANDACH employees at the composting plant consist of:

a) Kitchen waste, or

b) Kitchen wastes mixed with manure, digestive tube contents separated from the digestive tract, milk, dairy products, milk products, colostrum, colostrum-based products, eggs, products derived from the egg or animal by-products referred to in Article 10 (f) of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October which have been processed in accordance with Article 2 (1) (m) of Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004.

5. Special assumptions for the production authorisation of compost from certain Category 2 and Category 3 materials.

The competent authorities may authorise the production of compost by meeting specific requirements other than those referred to under heading 2, where:

a) The SANDACH transformed into the plant consists exclusively of manure, digestive tube contents separated from the digestive tract, milk, milk products, milk products, colostrum, products based on colostrum, eggs, egg products, animal by-products referred to in Article 10 (f) of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October, which have been processed in accordance with the provisions of Article 10 (1) of Regulation (EC) No 1069/2009; in Article 2 (1) (m) of Regulation (EC) No 852/2004 of the European Parliament European and Council of 29 April 2004, or the products referred to in Article 10 (g) of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009.

(b) The competent authorities consider that such materials do not pose a risk of spreading serious communicable disease to humans or animals, and

(c) Consider that the resulting compost is raw material and require operators to manipulate it in accordance with the provisions of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009, Regulation (EU) No 142/2011 of the Commission of 25 February 2011 and this royal decree.

Article 10. Conditions applicable to digestion residues obtained in the production of biogas and compost.

The digestion residues and compost shall be sampled and comply with the standards set out in Section 3 of Chapter III of Annex V to Regulation (EU) No 142/2011 of the Commission of 25 February 2011.

When the compost samples or digestion residues taken during or at the end of the storage show the presence of Salmonella, the operators shall communicate this to the competent authority, which shall dictate the appropriate instructions in each case for the management of these materials, in accordance with the corresponding action plans approved under Royal Decree 1940/2004 of 27 September on the monitoring of zoonoses and agents zoonotic.

The digestion residues and compost produced in accordance with the headings 4 and 5 of Article 8 or the headings 4 and 5 of Article 9 may only be placed on the market within the Spanish territory. This shall be stated on the label of the product or, where applicable, in the commercial documentation, by means of the words "For sale only in Spain" or similar.

Article 11. Application to the land, without prior processing, of certain Category 2 and 3 materials.

In accordance with Articles 13 (f) and 14 (l) of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009, and with the exception of the competent authorities, if they consider that there is a risk of the spread of any disease communicable through such products for humans or animals, the application is authorised to the land without prior processing of the following materials, without prejudice to the requirements laid down in other implementing rules, in particular in the field of environmental legislation:

(a) Category 2: manure, digestive tube contents separated from the digestive tract, milk, milk-based products and colostrum.

(b) Category 3: raw milk, colostrum and its derived products.

Article 12. Use of shells of molluscs and shells of category 3 eggs.

In addition to the uses referred to in Article 14 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October the following uses are authorised for the following SANDACH, without prejudice to: the requirements laid down in other implementing rules, in particular in the environmental legislation and, where applicable, in Royal Decree 824/2005 of 8 July on fertilising products:

1. Shells of molluscs of category 3 other than those referred to in Article 2 (2) (f) of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009:

(a) Use as fertiliser or soil amendment where they come from establishments registered in accordance with Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 or Regulation (EC) No 853/2004, of the European Parliament and of the Council of 29 April 2004 and the treatment applied to the product allows the presence of risks to public health or animal health to be excluded.

(b) Use as raw material for the manufacture of products not intended for human or animal feed

2. Category 3 egg shells:

(a) Direct application to land as a fertiliser or an amendment in the livestock holding in which they have been produced, provided there are no grounds for suspecting the existence of a risk of disease transmission to the persons or animals derived from that application.

(b) Use as fertiliser or soil amendment where they come from establishments registered in accordance with Regulation (EC) No 853/2004, of the European Parliament and of the Council of 29 April 2004, and any risk to the public health or animal health.

(c) Use as raw material for the manufacture of products not intended for human or animal feed.

Article 13. Biodynamic preparations.

In accordance with Article 16 (f) of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009, unless the competent authorities consider that there is a risk of spreading any disease communicable through such products for humans or animals, the use of Category 2 and 3 materials for the preparation and application of the biodynamic preparations, as provided for in this Regulation, is authorised. Article 12 (1) (c) of Council Regulation (EC) No 834/2007 of 28 June 2007 laying down detailed rules for the  2007, on the production and labelling of organic products and repealing Regulation (EEC) No 2092/91, and without prejudice to the requirements laid down in other implementing rules, in particular environmental legislation.

Article 14. Exceptional disposal of certain animal by-products on the livestock farm itself.

Unless they consider that there is a risk of the spread of any disease communicable through such products to humans or animals, and without prejudice to the competent authorities, requirements laid down in other rules which may be applicable, in particular in environmental legislation, the removal on the holding itself, of animal by-products of categories 2 and 3 which are generated during interventions, is authorised surgical in live animals or during animal births.

Article 15. Special uses in animal feed.

1. The competent authorities may authorise and establish specific conditions for the collection and use of Category 2 material from animals which have not been slaughtered or died as a result of the actual presence or suspected of a disease communicable to humans or animals, and of Category 3 material, for the feeding of:

a) Zoo animals.

b) Circos animals.

c) Reptiles and birds of prey other than zoos or circuses.

d) fur animals.

e) Wild animals.

f) Dogs from recognised kennels or jaurias.

g) Dogs and cats in shelters.

h) Worms and earthworms for baits.

In cases (a), (d), (f), (g) and (h) those conditions shall include at least the requirements specified in Article 13 of Commission Regulation (EU) No 142/2011 of 25 February 2011.

Category 2 processing plants may also be authorised to exercise as a collection centre, as defined in Annex I to Regulation (EU) No 53 of Annex I to Commission Regulation (EU) No 142/2011 of 25 February 2011.

2. The competent authorities may authorise the feeding of zoo animals and certain protected and endangered species with whole bodies or parts of dead animals containing specified risk material at the time of the the disposal, in accordance with the conditions laid down in Article 14 of Regulation (EU) No 142/2011, of the Commission of 25 February 2011, and of Royal Decree 1632/2011 of 14 November 2011 on the supply of food for the certain species of wild fauna with animal by-products not intended for human consumption.

Article 16. Special rules for collection and disposal.

1. The competent authorities may authorise, in accordance with Article 19 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October, the elimination of:

a) The dead animals of company and equidae, by burial.

(b) Category 1 material referred to in point (a) (v) of Article 8 (a) and (b) (ii) of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 and of the materials of the Categories 2 and 3 by incineration, or burial in situ or other means, under official supervision, in remote areas to be designated by the competent authorities in accordance with Article 19.2 of Regulation (EC) No 1069/2009 of the The European Parliament and the Council of 21 October and the Royal Decree 1131/2010 of 10 September 2010 establish the criteria for the establishment of remote areas for the purpose of disposal of certain animal by-products not intended for human consumption generated on livestock holdings.

(c) Category 1 material referred to in Article 8 (b) (ii) of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 and of Category 2 and Category 3 materials, by means of incineration, or burial in situ or other means, under official supervision, in areas where access is practically impossible or possible only in circumstances which, for geographical or climatic reasons or in the wake of a natural disaster, pose risks to the health and safety of the personnel carrying out the collection, or whose access would imply a disproportionate use of collection means.

(d) animal by-products other than those of category 1 referred to in Article 8 (a) (i) of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October in the event of an outbreak of a notifiable disease, by means of incineration or burial on site under official supervision, if its transport to the approved plant for the processing or disposal of the nearest animal by-products increase the risk of spreading the health risks or exceed the disposal capacity of these plants in case of extensive outbreak of an epizootic disease.

(e) Beekeeping and by-products of beekeeping by incineration or in situ, under the conditions laid down by the competent authority to ensure the absence of risks to public or animal health or the environment.

2. The disposal of these materials shall be carried out in accordance with the requirements referred to in Article 15 of Commission Regulation (EU) No 142/2011 of 25 February 2011 and those additional requirements which the competent authority may require. can be established to ensure the absence of risks to public or animal health or the environment.

Article 17. Collection, transport and identification.

1. The collection and transport of SANDACH shall be carried out in accordance with the requirements laid down in Article 21 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October and of Article 17 of Regulation (EU) No 142/2011, of the Commission of 25 February 2011.

However:

(a) The animal by-products or derived products referred to in Article 10 (f) of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October may be carried at the same time in vehicles which are devote to the transport of products intended for human consumption, provided that there is an effective separation between these products and that cross-contamination is avoided, without prejudice to the provisions of Regulation 852/2004 of the European Parliament and of the Council Council of 29 April 2004. During their transport, these by-products shall be accompanied by a duly numbered commercial document, in accordance with the model in Annex II to this Royal Decree.

(b) Vehicles distributing food products to retail stores may collect the same and transport products of animal origin withdrawn from the sale for reasons of return to the distribution centre of origin. trade. During transport, these products must be duly identified. In the distribution centre the operator shall categorize and manage them in accordance with the conditions laid down in this royal decree and in Regulations (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 and in the Regulation (EU) No 142/2011 of the European Parliament and of the Council of 25 February 2011

2. During their collection and transport, the SANDACH shall be kept identified and separated in accordance with the requirements laid down in Article 21 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 and in the Annex VIII, Chapter II of Commission Regulation (EU) No 142/2011 of 25 February 2011. In particular, the colour code referred to in point 1.c of that Chapter shall also be used for consignments of by-products and animal products within the national territory.

3. By way of derogation from the above paragraphs:

(a) Except as against the competent authority if it considers that there is a risk of the spread of a communicable disease for humans or animals, the transport of manure between points of the same livestock holding or between them and the farmers who are users of it within the autonomous community or city may be carried out in vehicles or containers which meet different conditions as referred to in Chapter I of Annex VIII; Section 1 of Commission Regulation (EU) No 142/2011 of 25 February 2011, provided that: avoid the occurrence of unacceptable risks to public and animal health, and using means of identification other than those laid down in points 1 and 2 of Chapter II of Annex VIII. to extend this derogation to manure transported between livestock holdings and farmers who are users of the same located in their respective territories, where appropriate by establishing the conditions they deem appropriate to prevent the occurrence of the occurrence risks to public and animal health or to the environment.

(b) The label required in point 2.b.xi of Chapter II of Annex VIII to Regulation (EU) No 142/2011 of the Commission of 25 February 2011 for organic fertilisers or soil amendments to be required shall not be required. applied in the national territory if they are packaged in sacks or big-bags of not more than 1000 kg of weight, and if such packages indicate that they are not intended for application on land to which the farm animals have access.

Article 18. Commercial document and health certificate.

1. During their transport, animal by-products and derived products shall be accompanied by a commercial document and, where appropriate, a health certificate in accordance with the requirements laid down in Article 21 of Regulation (EC) No 3154/2009. The European Parliament and the Council of 21 October 2009, and Article 17 of Regulation (EU) No 142/2011 of the Commission of 25 February 2011.

2. However, the above:

(a) For the transport of SANDACH within the national territory, the competent authorities may establish a model of commercial document other than that laid down in Annex VIII, Chapter III.6 of Regulation (EU) No 64/2014. Regulation (EC) No 142/2011 of the European Parliament and of the Council of 25 February 2011. This document shall contain at least the information specified in Annex II to this royal decree.

b) For SANDACH shipments that are made within the national territory, the transmission of the information contained in the commercial document by an alternative system is authorized. The National Commission shall propose to the competent authorities the minimum technical requirements to be met by these alternative systems.

(c) By-products of animal origin from third countries shall be accompanied during the shipment from the Border Inspection Post to the first establishment of destination of the Veterinary Document Common Entry (DVCE) set out in Annex III to Regulation (EC) No 136/2004 of the Commission of 22 January 2004 laying down the procedures for veterinary inspection at the border inspection posts of the Community of products imported from third countries.

(d) products of animal origin from third countries which do not comply with the requirements laid down in Community or national legislation to authorise their introduction or importation into the national territory, and kitchen waste from means of transport operating at international level, shall be accompanied during the transfer to the destination establishment situated on the national territory of a commercial document in accordance with the model set out in Annex III of this royal decree.

e) The transport of manure between points on the same farm or between livestock farms and farmers within the same community or autonomous city may be carried out without a commercial document or certificate health, unless otherwise specified by specific provisions of the competent authority.

(f) The transport of manure between livestock farms and farmers users of different autonomous communities may be carried out without a commercial document if accompanied by a health certificate issued by the competent authority at origin, which disposes of the risk of the spread of communicable diseases for humans or animals through such material. However, in the case of neighbouring autonomous communities, the two may agree, on a bilateral basis, to permit the transport of manure without a commercial document or a health certificate between livestock farms and farmers. located in their respective territories, establishing in their case the conditions they deem appropriate to avoid the occurrence of risks to public and animal health or to the environment.

Article 19. Marking of certain derived products.

In category 1 and 2 processing plants, the derived products shall be marked in accordance with the conditions laid down in Annex VIII, Chapter V of Commission Regulation (EU) No 142/2011 of 25 February 2011. of 2011, including in the case of materials of origin and destination on national territory.

Article 20. Registration and authorization.

1. Obligation to register.

The operators, with a view to the registration required by Article 23 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October, shall notify the competent authority in their community or cities of Ceuta or Melilla, before starting operations, establishments or plants under its control which are in activity in any of the phases of generation, transport, handling, processing, storage, placing on the market, distribution, use or disposal of animal by-products and derived products.

Operators carrying out the transport of animal by-products or derived products must be registered by the competent authority of the autonomous community or cities of Ceuta or Melilla in which they have their social reason. Operators, establishments or plants approved or registered to carry out other activities with animal by-products and which carry out the transport thereof with their own means of carrying out such transport shall not require a number of Additional registration, but will be considered as one more of the activities associated with such establishment or plant.

2. Obligation to obtain prior authorisation.

The operators shall ensure that the establishments or plants under their control are authorised by the competent authority, when they carry out any of the activities listed in Article 24 of Regulation (EC) No 1069/2009, of the European Parliament and of the Council of 21 October.

The competent authorities may authorise the existence of more than one establishment or plant in the same place if the design of the same and the conditions for the handling of animal by-products and derived products exclude the occurrence of risks to public or animal health.

3. Exceptions.

By way of derogation from paragraphs 1 and 2, no authorisation or registration shall be required in the following cases:

(a) Activities in which animal by-products are generated, in establishments approved or registered in accordance with Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004, or Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004.

b) Activities involving the generation of animal by-products in situ on livestock farms.

(c) The transport of derived products which have passed the end point in the manufacturing chain established in accordance with Article 5 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October.

d) The transport of wool which meets the conditions set out in Article 23.2.b of this royal decree.

(e) Save as against the competent authority, the transport of unprocessed manure intended for agricultural use, between points of the same livestock holding or between them and the farmers who are users of it within of the autonomous community itself or cities of Ceuta and Melilla, when it is carried out as an auxiliary activity in the means of transport of the farms themselves or of the farmers. In addition, the autonomous communities adjacent to the Community may, by common accord, extend that exemption to the transport of manure from livestock holdings to farmers who are users of the same in their territories, conditions which they consider appropriate to avoid the occurrence of risks to public and animal health or to the environment.

(f) Operators handling or generating material for the production of game trophies or other preparations referred to in Annex XIII, Chapter VI of Commission Regulation (EU) No 142/2011 of 25 February 2011, for private or non-commercial use.

(g) The competent authorities may also apply that exemption to the other operators referred to in Article 20.4 of Commission Regulation (EC) No 142/2011 of 25 February 2011.

Article 21. Specific requirements for the use of certain SANDACH in the feeding of farmed animals.

1. For the use of SANDACH as feed or in the production of feed, the requirements referred to in Article 21 of Commission Regulation (EU) No 142/2011 of 25 February 2011 shall apply.

2. However, the competent authorities may authorise:

(a) The supply between livestock holdings in the same autonomous community or cities of Ceuta and Melilla of colostrum which does not meet the conditions specified in Annex X, Chapter II, Section 4, Part II. (3) Commission Regulation (EU) No 142/2011 of 25 February 2011 on the feeding of lactating animals under conditions which prevent the transmission of health risks.

(b) The use of aquatic animals and terrestrial and aquatic invertebrates, where they consider that there is no unacceptable risk to public health or animal health:

1. º As feed for farmed fish or for aquatic invertebrate animals, without such by-products having been processed in accordance with Annex X, Chapter III.1. (c) of Commission Regulation (EU) No 142/2011 of February 25, 2011.

2. º As fishing bait, including bait for aquatic invertebrate animals.

Article 22. Organic fertilisers and soil improvers.

The placing on the market and use of organic fertilisers and soil improvers shall be carried out in accordance with the conditions laid down in Article 22 of Commission Regulation (EU) No 142/2011 of 25 February 2011. 2011, as well as with the provisions of Royal Decree 824/2005 of 8 July, which include the compulsory registration in the Register of fertilizers prior to their placing on the market.

Organic fertilisers and soil improvers which are to be used in Spain and which consist of, or have been produced from, meat and bone meal derived from Category 2 materials or from proteins processed animals must be mixed with a component authorised by the competent authority, in a minimum proportion which excludes any subsequent use of the mixture for animal feeding purposes. The component shall be authorised in accordance with the requirements laid down in Section 1 (3) of Chapter II of Annex XI to Commission Regulation (EU) No 142/2011 of 25 February 2011.

The mixture shall be made in establishments or plants approved or registered in accordance with Articles 23 and 24 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009.

However, this mixture shall not be necessary for organic fertilisers and soil improvers in the cases provided for in Chapter II of Chapter II of Annex XI to Regulation (EU) No 142/2011 of the Commission of 25 February 2011. 2011.

Article 23. Pet food and other derived products.

The production, storage, transport and placing on the market of pet food and other derived products shall be carried out in accordance with the requirements laid down in Article 24 of Regulation (EU) No 139/2014. Regulation (EC) No 142/2011 of the European Parliament and of the Council of 25 February 2011. In addition, the following specific requirements shall be taken into account:

1. Requirements for skins and hides of ungulates and products derived therefrom.

The competent authority may authorise plants which handle hides and skins, including hot hides, to supply cuts of such hides and skins for the production of gelatine for animal or fertiliser consumption and Soil amendments of organic origin, under the conditions set out in Annex XIII, Chapter V. A of Commission Regulation (EU) No 142/2011 of 25 February 2011.

consignments of hides and skins treated in accordance with Annex XIII, Chapter V, C. 2, headings (c) and (d) of Commission Regulation (EU) No 142/2011 of 25 February 2011, shall be accompanied by a commercial document of in accordance with Article 19 of this royal decree when they are supplied to establishments or plants producing food for pet animals, organic fertilizers or soil improvers, or to transform such materials into biogas.

2. Requirements for wool, hair, bristles, feathers, parts of feathers and down.

(a) Except as against the competent authority, the direct consignment of feathers, parts of feathers and down which have not been dried from the slaughterhouse to a processing plant is authorised under conditions which prevent the occurrence of risks to public or animal health, provided that the following circumstances are present:

1. º As a result of the - and post-mortem inspections, any risk to public or animal health derived from such materials has been ruled out.

2. The transport will be carried out using containers or watertight vehicles, which must be cleaned and disinfected immediately after each use.

(b) The shipment within the national territory of untreated wool and hair is authorised, without restrictions arising from Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October of Regulation (EU) No 109/2009. 142/2011 of the Commission of 25 February 2011 and of this royal decree, provided that:

1. Proceed from livestock holdings or from establishments or plants approved in accordance with Article 24 (i) of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009,

2. Procedan of healthy live animals and holdings not subject to any health restrictions, and

3. The operators have a documented system that allows you to know the origin and destination of each shipment they receive, transport or issue.

3. Requirements for by-products derived from beekeeping. The competent authority may authorise within its territory the dispatch of apiculture by-products intended exclusively for use in apiculture from areas subject to restrictions due to the presence of American Loque (Penibacillus larvae larvae), taking measures to ensure the absence of risks to human or animal health, including at least:

a) An assessment of the health risk that demonstrates that this is negligible.

b) And that the authorization is granted specifically for each shipment.

Article 24. General registration of establishments, plants and operators.

1. The competent authorities shall establish and keep up to date a list of establishments, plants and operators which have been registered in accordance with Article 20 of this royal decree on their territory.

2. The minimum data to be recorded by the competent authorities for each establishment, plant or operator shall be as specified in paragraphs 1, 2 and 3 of Annex I, as appropriate; in addition, they may include information in the fields listed in Paragraph 4 of Annex I.

3. For the purposes of their registration, the holders of establishments, plants and operators shall provide the competent authorities with the data set out in paragraphs 1, 2 and 3 of Annex I (as appropriate), and where they have them, details as set out in paragraph 4 of Annex I. They shall communicate any variation in the data recorded in the register to the competent authorities within a maximum of one month, by writing to the competent authorities.

4. The competent authorities shall assign to each establishment, plant or operator a unique identification code at the national level, which shall conform to the following structure:

a) Letra "S".

b) 2 digits for the province, according to the relation of municipalities and their codes by provinces of the National Statistics Institute.

c) 3 digits for the municipality, according to the relation of municipalities and their codes by provinces of the National Statistics Institute.

d) 3 digits that will uniquely identify it within the scope, at least, municipal.

However, the register shall permit the introduction of the official number assigned to the establishment, plant or operator in accordance with other Community legislation. The codes which the competent authorities have assigned on a regional basis may be further included in the Register.

5. The General Register of establishments, plants and operators of animal by-products and derived products not intended for human consumption, attached to the Directorate-General for Agricultural Production of the Ministry of Agriculture, is hereby established. Food and the Environment. It shall be constituted in a computerised database and shall be of a public and informative nature, but the personal data of the natural persons holding the establishments shall not be made public.

6. The general register shall contain the data required in paragraph 2 for the establishments, plants and operators registered in accordance with paragraph 1.

7. The competent authorities shall have direct access to the general register to discharge, discharge or amend the data relating to the establishments, plants and operators of animal by-products or derived products registered in their territory. in accordance with paragraph 1.

Article 25. Community controls.

In carrying out the checks carried out by the experts of the European Commission, they shall accompany the representatives of the competent bodies of the autonomous communities or cities of Ceuta and Melilla, representatives of the Ministries of Agriculture, Food and the Environment, Health, Social Services and Equality and any other competent, depending on their respective responsibilities.

When such controls are carried out, the competent authorities shall provide the experts of the European Commission with all the assistance necessary for the performance of their duties and shall take the necessary measures for the correct implementation of the recommendations contained in the final inspection reports of the European Commission.

Article 26. Sanctioning regime.

In case of non-compliance with the provisions of this royal decree or in the community legislation in the field of SANDACH, the regime of infringements and penalties laid down in Law 8/2003, of the April 24, animal health, in Law 17/2011 of 5 July, of food safety and nutrition, in Law 22/2011, of July 28, of contaminated waste and soils, or in Law 33/2011, of 4 October, General of Public Health, without prejudice to possible civil, criminal, environmental or other responsibilities to which there could be.

Additional disposition first. Economic impact.

The creation and operation of the national commission of animal by-products of animal origin not intended for human consumption will not entail any increase in public expenditure, and its functioning will be met with human resources and existing materials in the Ministries of Agriculture, Food and the Environment, Health, Social Services and Equality and Economic and Competitiveness.

Additional provision second. Relationship to environmental standards.

The provisions of this Royal Decree shall be without prejudice to the application of the environmental standards that correspond to each case.

Additional provision third. Sanctioning Regulation.

Within the maximum period of two years, the Minister of Agriculture, Food and Environment will submit to the Council of Ministers a draft of the Royal Decree establishing the regime of violations and sanctions in the field of non-compliance. of this royal decree and of the community legislation in the field of SANDACH, in development of the corresponding schemes previewed in each case in Law 8/2003, of April 24, in Law 17/2011, of July 5, in Law 22/2011, of July 28, contaminated waste and soils, and in Law 33/2011 of 4 October, General Public Health.

First transient disposition. National Commission.

By way of derogation from the Single Derogation Provision, the national Commission for by-products of animal origin not intended for human consumption, established by Article 15 of Royal Decree 1429/2003 of 21 November 2009, the conditions for the application of Community legislation on by-products of animal origin not intended for human consumption are laid down, shall maintain its activity and functions until the Commission has been effectively set up in accordance with the provisions of the Article 4 of this royal decree.

Second transient disposition. Establishments, plants and operators.

The establishments, plants and operators authorized under Royal Decree 1429/2003 of 21 November, and which fulfil all the conditions laid down in this royal decree and, where appropriate, those required by the authority competent, shall be considered as registered and, where appropriate, authorised in accordance with the provisions of Article 20 of this royal decree.

Those who do not meet any of the conditions laid down in this royal decree, and are already authorized, will have a period of six months to adapt to the new requirements, maintaining their authorization during that time. After that period has elapsed without the adaptation to the new requirements, the competent authority shall withdraw the authorisation, after hearing the person concerned.

The competent authorities shall have a period of six months from the entry into force of this royal decree to communicate to the register provided for in Article 24.2 the updated data of their lists of establishments, approved or registered plants and operators.

Transitional provision third. Restrictions on animal health.

Until the measures referred to in Article 6.2 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 are adopted to prevent the spread of diseases communicable to animal by-products or products derived from susceptible species from holdings, establishments, plants or areas subject to the restrictions laid down in paragraph 1 of that Article shall not be sent to animals or to animals.

For these purposes, the safeguard health measures laid down in Article 8 of Law 8/2003 of 24 April 2003 shall apply as a transitional measure.

Transitional disposition fourth. Methods of transformation.

Those processing methods authorised as "Method 7" before 4 March 2011 may continue to be used if the competent authority so decides. If not, the competent authority shall reassess the method in accordance with Commission Regulation (EU) No 142/2011 of 25 February 2011. The competent authority shall inform the national commission provided for in Article 4, or as yet not constituted, of the national commission established by Article 15 of Royal Decree 1429/2003, of the use it makes of this provision.

Transient disposition fifth. Disposal of small quantities of certain by-products.

Until the end of the transitional period provided for in Article 36.3 of Commission Regulation (EU) No 142/2011 of 25 February 2011 and under the conditions laid down in that Article, the authorities the competent authority may authorise the collection, transport and disposal of Category 3 materials referred to in Article 10. (f) of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009, by means other than those laid down in that Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 and other than the in situ incineration or burial.

Establishments or plants that do not generate more than 20 Kg per week of the above by-products may be eligible for this possibility, regardless of the species of origin.

The collection, transportation and disposal of the above materials will be carried out in accordance with Law 22/2011 of July 28, of contaminated waste and soils.

The operators of these establishments must have up-to-date documentation to justify the delivery of these by-products to the approved company for waste management and to keep a weekly record of departures from the by-products referred to in Article 10 (f) of Regulation 1069/2009, where at least the following is indicated:

a) The quantity and type of byproduct.

b) The date of departure.

c) The approved company for the management of these by-products.

Transitional disposition sixth. Slaughterhouses or other approved or registered establishments.

As from 1 January 2013, for the purposes of Article 7.2 of this Royal Decree, Article 4 of Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 on the a function of the provisions of Article 14 of Regulation (EC) No 1099/2009 of the Council of 24 September 2009 on the protection of animals at the time of slaughter.

Single repeal provision. Regulatory repeal.

The following provisions are repealed:

(a) Royal Decree 1429/2003 of 21 November on the conditions for the application of Community legislation on by-products of animal origin not intended for human consumption.

(b) Articles 19, 20, 21, paragraph C of Annex I and Annex VI of Royal Decree 3454/2000 of 22 December 2000 establishing and regulating the coordinated comprehensive programme for the surveillance and control of encephalopathies Transmissible spongiform encephalopathy

transmissible spongiform encephalopathy)

(c) Royal Decree 845/1987 of 15 May 1987 on the animal health regulations governing the use and processing of dead animals and seizures for animal feed and other industrial uses different from the human diet.

Final disposition first. Competence title.

This royal decree is of a basic nature and is dictated by the article 149.1.16. of the Constitution, which gives the State exclusive competence in the field of bases and general coordination of health. The rules on trade with third countries, which are issued under the provisions of Article 149.1.16 (1) of the Constitution, which give the State exclusive competence in the field of competition, are exempt from the foregoing. External health care.

Final disposition second. Ability to modify.

The Ministers of Agriculture, Food and the Environment, and Health, Social Services and Equality are empowered to modify, in the field of their competences, the annexes of this royal decree for their adaptation to the Community rules.

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, on November 8, 2012.

JOHN CARLOS R.

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

SORAYA SAENZ DE SANTAMARIA ANTON

ANNEX I

Content of the Registry of Establishments, Plants, and Exploiters

1. Common mandatory content

The basic data that the competent authorities shall include at least in the register for each establishment, plant or operator, shall be as follows:

a) Name of the establishment, site, or operator.

(b) Holder of the establishment: natural or legal person or entity without legal personality that owns the establishment, whose data shall be protected in accordance with the provisions of Organic Law 15/1999 of December 13, Protection of Personal Data. The basic data to be collected will be:

-Last name and name, or social reason.

-NIF.

In addition, if these are legal persons or entities with no legal personality, the name, name and NIF of the representative or responsible person shall be registered.

c) Address of establishment.

-Address.

-Municipality.

-Postal Code.

-Province.

-Autonomous Community or cities of Ceuta or Melilla.

d) Contact phone.

e) SANDACH code (or instead, another official code assigned under other Community legislation).

f) Local code, if applicable: It is the code assigned by the autonomous community or cities of Ceuta or Melilla to an establishment, plant or operator prior to their registration in the general register, and which will be maintained for facilitate the application's query functionality.

g) Administrative body of the autonomous community or cities of Ceuta or Melilla responsible for the relevant authorisation.

h) Date of registration or in its case authorization, current status of the record or in its case of authorization (high, low, inactive), date on which the last change occurred in the state of the record or the authorization and reason of the same.

(i) Type of establishment, in accordance with the technical specifications for the format of lists of approved or registered establishments, plants and operators, handling animal by-products, prepared by the Commission European¹.

j) Code of Activity, in accordance with the technical specifications for the format of lists of approved or registered establishments, plants and operators, handling animal by-products, prepared by the Commission European¹.

k) Product type code, in accordance with the technical specifications for the format of lists of approved or registered establishments, plants and operators, handling animal by-products, prepared by the European Commission¹.

¹ "Technical specifications for the format for the lists of approved or registered establishments, plants or operators handling animal by-products inside the European Union and in third countries."

(http://ec.europa.eu/food/food/biosafety/establishments/animal_byproducts_en.htm).

2. Additional mandatory content for establishments and plants

l) Method of transformation: Procedure or procedures for which a given establishment has obtained authorization. This information shall be included only in cases where it is appropriate and shall be consistent with the type of establishment and category for which it has obtained authorisation.

m) Category or categories for which the SANDACH establishment was authorized,

3. Additional mandatory content for operators engaged in the activity of carrier, either independently, as a secondary activity or as a trader

n) Transport fleet: the data to be recorded for each of the vehicles or containers used for SANDACH transport are:

-Type of means of transport.

i. Self-propelled

ii. Trailers.

iii. Containers.

-Identification number, which shall be, for vehicles and trailers, the registration plate or the frame number (in case of no registration); and for the containers a number assigned by the company that permits identification of the individually and indelibly.

-SANDACH categories or categories for which transport are registered.

4. Optional supplementary content.

a) Email.

b) Fax.

c) GIs corresponding to the main access. It shall be the competent authority to assign that location

d) Date of the last renewal of the authorization.

e) The date the current authorization expires.

f) Official inspections: will be recorded:

• Reason

• Competent authority that performed the inspection.

• Date.

• Observations.

g) Species or animal species of origin of the raw material.

h) Transformation capacity: (transformation plants) Estimate of the maximum amount of raw material (SANDACH) that can transform the plant each day, expressed in Tm/hour.

i) Drivers: For each driver you will register your name and driving licence number in force.

ANNEX II

Minimum commercial document content for national movements

ANNEX III

Commercial document for the transport of products of animal origin from third countries which are not in conformity with Community legislation and international transport waste cooking waste