The Order of 11 October 1988, concerning undesirable substances and products in animal nutrition, was drawn up in order to incorporate into our legal system the Council Directive 74 /63/EEC of 17 December 1988. 1973, of the same title. This rule was intended to reduce the presence of undesirable substances and products in animal feed, up to a limit which would prevent the possible undesirable or harmful effects on both animal and human health.

In addition, both in Directive 74 /63/EEC of 17 December 1973 and in that Order, the obligation to make the necessary amendments to adapt these rules to the innovations that were produced was laid down. in scientific and technical knowledge.

Therefore, in view of the numerous amendments which the Order of 11 October 1988 has undergone, and in order to incorporate into our legal order Directive 1999 /29/EC of the Council of 22 April on the Undesirable substances and products in animal feed, this provision is made available, the main purpose of which is to avoid regulatory dispersion in this area, in addition to ensuring a more transparent regulation of the matter affected by the standard.

In the procedure for drawing up this standard, the Autonomous Communities and the sectors affected have been consulted.

This Royal Decree is issued in accordance with Royal Decree 418/1987 of 20 February, approving the Regulation of substances and products involved in the feeding of animals, and has been informed Endorsed by the Inter-Ministerial Committee on Food Management.

This rule is dictated by the provisions of Article 149.1.10.a, 13.a and 16.a of the Constitution, which reserve the State the exclusive powers on foreign trade, on the basis and coordination of the planning General economic activity

and on the basis and overall coordination of health, respectively.

By virtue of the proposal of the Minister for Agriculture, Fisheries and Food and the Minister for Health and Consumer Affairs, in agreement with the Council of State and after deliberation by the Council of Ministers at its meeting on 29 June 2001,

D I S P O N G O:

Article 1. Scope of application.

1. The present Royal Decree regulates undesirable substances and products in animal nutrition and the maximum tolerated percentages of undesirable products in animal nutrition, in order to protect animal health, human health and the environment.

2. This Royal Decree shall apply without prejudice to the specific legislation laid down for:

(a) Additives in animal feed.

b) The marketing of animal feed.

(c) The fixing of maximum levels for pesticide residues in and on products intended for animal nutrition, in so far as such residues are not mentioned in Annex I, Part B to this Royal Decree.

d) Micro-organisms in animal feed.

e) Certain products used in animal feed.

f) Food for animals intended for specific nutritional purposes.

Article 2. Definitions.

For the purposes of this Royal Decree the following definitions shall apply:

(a) Food for animals: Products of natural or preserved plant or animal origin, fresh or preserved, and derivatives of their industrial processing, as well as organic or inorganic substances, simple or mixed, contain or do not contain additives, which are intended for oral animal feeding.

(b) Raw materials for animal feed: The various products of natural or preserved plant or animal origin, fresh or preserved, and those derived from their industrial processing, as well as organic substances or inorganic containing or not containing additives, intended to be used for animal feed by mouth, directly in its normal state or after processing for the preparation of compound feed or to serve as a support for premixtures.

(c) Full compound feed: mixtures of animal feed which, by composition, are sufficient to ensure their daily ration.

(d) Complementary compounds: mixtures of foods containing high percentages of certain substances and which, by their composition, only ensure daily ration if they are associated with other animal feed.

(e) Compounds: mixtures of feed materials, with or without additives, intended for the feeding of animals by mouth, in the form of complete or complementary feedingstuffs.

f) Daily ration: The total quantity of food, referred to a moisture content of 12 per 100, needed as a daily average to meet the needs of an animal of a species, an age category and a performance.

g) Animals: Animals belonging to species normally fed and bred or consumed by man and animals that live freely in nature in case they are fed with feed.

(h) Company animals: Animals belonging to species that breed and have in their power normally, but are not consumed by man, with the exception of animals reared to take advantage of their skin.

Article 3. Generic requirements for raw materials for animal feed.

1. Raw materials for animal feed can only be put into circulation if they are healthy, fit and of commercial quality.

2. In particular, and without prejudice to the provisions of Part A of Annex II to this Royal Decree, raw materials for animal feed whose contents in substances or products may not be considered as sound, hair and of commercial quality. Undesirable substances are so high that they make it impossible to observe the maximum levels for compound feed, as set out in Annex I to this Royal Decree.

Article 4. Foods other than maximum content in undesirable substances.

1. The substances and products listed in Annex I to this Royal Decree shall be tolerated only in feedingstuffs under the conditions laid down therein.

2. By way of derogation from the above paragraph, the maximum levels laid down in Annex I for feedingstuffs may be exceeded provided that they are fodder produced and used without alteration on the same holding. (a) to the extent that such excess is revealed to be necessary in the light of special circumstances, and as such does not result in any adverse effects on animal or human health.

Article 5. Conditions for the putting into circulation of consignments containing undesirable substances.

1. The feed materials listed in Part A of Annex II to this Royal Decree may be put into circulation only if the content of the undesirable substance or product referred to in that Annex does not exceed the maximum content set in the same.

2. If the content of the undesirable substance or product referred to in column 1 of Part A of Annex II to this Royal Decree is higher than that laid down in column 3 of Annex I to this provision for the raw material for the animal feed, the feed material referred to in column 2 of Part A of Annex II to this Royal Decree may be put into circulation only, without prejudice to paragraph 1, as long as:

(a) This is a raw material for animal feed intended for manufacturers of compound feed falling within the meaning of Article 5 (1) (d) of Royal Decree 1191/1998 of 12 June 1998 concerning the authorisation and registration of establishments and intermediaries in the animal feed sector, or to a manufacturer of compound feed intended to satisfy the needs of their own animal husbandry as referred to in Article 5 (3) of the Royal Decree 1191/1998.

b) Be indicated in an accompanying document:

1. The raw material for animal feed is intended for manufacturers of compound feed satisfying the condition laid down in subparagraph (a) of this paragraph.

2. º That the raw material for animal feed cannot be used directly as it is for animal feed.

3. The content of the undesirable substance or product present.

3. The provisions of paragraphs (a) and (b) of the preceding paragraph shall also apply to the raw materials for animal nutrition and to the undesirable substances or products listed in Annex II, Part B to this Royal Decree, provided that they are maximum content is not limited in Part A of that Annex and, in any case where the content of the undesirable substance or product present in the feed material is higher than that set out in Annex I to that provision for this type of raw materials.

Article 6. Prohibition on mixing consignments of food or raw materials contaminated with other consignments.

The consignment of a raw material for animal feed listed in Part A of Annex II, containing a substance or an undesirable product exceeding the maximum content set out in column 3 of that Annex, must not be be mixed with other consignments of feed materials or other food items.

Article 7. Content of undesirable substances in complementary compound feed.

Additional compound feedingstuffs, in so far as there are no special provisions for them, cannot, in the light of the dilution provided for in their use, be contained in substances and products listed in Annex I above those laid down for the complete compound feedingstuffs concerned.

Article 8. Provisional reduction of the maximum content in some undesirable substance.

1. If, by virtue of new data or new assessment of the existing data, it is found that the maximum content laid down in Annexes I or II to this Royal Decree, or that a product or substance not mentioned in those Annexes, represents a danger to the animal or human health or the environment, the corresponding provision shall be made to allow for the provisional reduction of the maximum level or to prohibit its presence in feedingstuffs or raw materials for the purposes of animal feed, without prejudice to the immediate adoption of the measures as the urgency of the situation requires, in order to preserve the health of consumers, that the corresponding units of the Ministry of Health and Consumer Affairs will be given the act in the act.

2. The Ministry of Agriculture, Fisheries and Food shall, by means of the appropriate course, immediately give the other Member States and the Commission of the European Communities a statement of the reasons for such a decision.

Article 9. Implementation of the official controls.

1. Where an operator (importer, producer, etc.) or other person who, owing to his or her professional activities, has or has owned a consignment of raw materials for animal feed or animal feed, or has been in (i) direct contact with it, with the knowledge that the consignment of raw materials for animal feed is inadequate for any use in animal feed due to its contamination by a substance or product undesirable of those listed in Annexes I and II to this Royal Decree and does not therefore comply with the provisions in Article 3 (1), thus constituting a serious danger to animal or human health, or that the consignment of food for animals does not comply with the provisions of Annex I to this Royal Decree and is therefore a serious danger for animal or human health; in both cases, that person or operator shall immediately inform the competent bodies of the Autonomous Community concerned, even if the destruction of the consignment has been provided for.

2. Once the information received has been verified, and in the case of a contaminated consignment, the competent authority for the control shall take the necessary measures to ensure that the consignment is not used in animal feed, and in particular ensure that the final destination of the contaminated consignment and, where appropriate, its destruction, cannot have harmful effects on human or animal health or the environment.

3. If there is a possibility that a consignment of feed materials or a consignment of animal feed is to be issued to another Member State, having been considered not in accordance with the provisions of this Royal Decree for its high content in undesirable substances or products, the competent authority for the control shall inform the Ministry of Agriculture, Fisheries and Food, which shall, in turn, make known, through the appropriate course, without delay, the other Member States and the Commission of the European Communities, any useful information on that consignment.

4. The official control of food for animals and raw materials for food shall be adjusted, without prejudice to the provisions of the preceding paragraphs, to the provisions of Royal Decree 557/1998 of 2 April 1998 laying down the principles governing the organisation of official controls in the field of animal nutrition, with the competent authorities, the Autonomous Communities or the Ministry of Agriculture, Fisheries and Food, as the case may be, respectively, for products made in Spanish territory or from Member States of the Union European Union, or products from third countries at border inspection points.

Article 10. Application of the standard to food intended for export.

The provisions contained in this Royal Decree shall apply to foods intended for export to third countries, although the re-export/reissue of consignments of food for non-compliant animals is permitted. the requirements of this Royal Decree to third country exporting countries.

Article 11. Sanctioning regime.

Failure to comply with this provision will be sanctioned in accordance with the provisions of the Law of 20 December 1952 on Epizzotias in the Decree of 4 February 1955 on the Regulation of Epizooties, and in Royal Decree 1945/1983 of 22 June, regulating infringements and sanctions in the field of consumer protection and agri-food production.

Single additional disposition. Competitive titles.

Article 10 of this Royal Decree is dictated by Article 149.1.10.a of the Constitution, which reserves the State exclusive competence over foreign trade; the rest of the provision is of a normative nature. Article 149.1.13.a and 16.a of the Constitution, which reserve to the State the exclusive competences on the bases and coordination of the general planning of the economic activity and on the bases and general coordination of the health, respectively.

Single repeal provision. Regulatory repeal.

As many provisions of the same or lower rank are repealed as far as the provisions of this provision are concerned, and in particular:

1. Order of 11 October 1988 concerning substance and undesirable products in animal nutrition.

2. Article 1 of the Order of 11 December 1995 laying down certain provisions concerning food for animals intended for particular nutritional purposes.

3. Article 2 of the Order of 21 April 1998 amending the Orders of 23 March 1988, 11 October 1988 and 31 October 1988, for

purpose of the

adapt them to the rules on the movement of raw materials for animal feed.

4. Article 2 of the Order of 30 June 1998 amending various provisions to bring them into line with the rules on the authorisation and registration of establishments and intermediaries in animal nutrition.

Final disposition first. Faculty of development.

The Ministers for Agriculture, Fisheries and Food and Health and Consumer Affairs are empowered to adopt the provisions necessary for the development of the provisions of this Royal in the field of their respective competences. Decree and the updating of its annexes as a result of the amendments introduced by the Community legislation.

Final disposition second. Entry into force.

This Royal Decree shall enter into force on the day following that of its publication in the "Official Gazette of the State".

Given in Madrid on June 29, 2001.

JOHN CARLOS R.

The Minister of the Presidency,

JUAN JOSE LUCAS GIMENEZ

ATTACHMENTS

(SEE IMAGES, PAGE 23363 TO 23371)