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Royal Decree 465/2003 Of 25 April, On Undesirable Substances In Animal Feed.

Original Language Title: Real Decreto 465/2003, de 25 de abril, sobre las sustancias indeseables en la alimentaciĆ³n animal.

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TEXT

Royal Decree 747/2001 of 29 June, establishing the undesirable substances and products in animal nutrition, was drawn up in order to incorporate Directive 1999 /29/EC into our legal order. Council of 22 April 1999 on undesirable substances and products in animal nutrition, a rule which amended several previous ones and updated the rules with regard to the substances listed in their Annexes.

The Annexes to Royal Decree 747/2001 have been amended by Order PRE/1490/2002 of 13 June, which transpose Directive 2001 /102/EC of the Council of 27 November 2001 amending Directive 1999 /29/EC, cited above. This change is related to the maximum levels of dioxins in animal feed.

Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal nutrition repeals Directive 1999 /29/EC on the basis of the amendments and innovations it introduces As regards this and its objectives, the annexes describing the maximum limits for undesirable substances, establishing the possibilities for intervention and decontamination and banning mixtures for dilution purposes are to be harmonised.

The new information provided by the new Community legislation on the matter determines the desirability of repealing Royal Decree 747/2001, and of preparing, in its replacement, this provision, by means of which it is incorporated into national law. Directive 2002 /32/EC

the European Parliament

In the procedure for drawing up this standard, the autonomous communities and the sectors affected have been consulted and the Inter-Ministerial Commission for Food and Food Management has issued a mandatory report. Spanish Food Safety Agency.

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 25 April 2003,

DISPONGO:

Article 1. Object and scope of application.

1. This royal decree regulates undesirable substances in products intended for animal feed and the maximum tolerated levels of undesirable substances in those products, in order to protect human health, animal health and the environment.

2. This royal decree shall apply without prejudice to the following rules:

(a) Royal Decree 418/1987 of 20 February on substances and products involved in the feeding of animals.

(b) Royal Decree 2599/1998 of 4 December 1998 on additives in the feeding of animals.

(c) Royal Decree 56/2002 of 18 January governing the movement and use of raw materials for animal feed and the movement of compound feedingstuffs.

(d) Royal Decree 280/1994 of 18 February 1994 laying down maximum residue levels for pesticides and their control in certain products of plant origin and Royal Decree 569/1990 of 27 April 1990 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin, provided that such residues do not appear in the Annex to this Royal Decree.

e) The regulations on veterinary matters related to public health and animal health.

(f) Royal Decree 1999/1995 of 7 December 1995 on food for animals intended for specific nutritional purposes.

Article 2. Definitions.

For the purposes of this royal decree, it is understood by:

(a) Feed: products of plant or animal origin, in the natural state, fresh or preserved, and those derived from their industrial processing, as well as organic or inorganic substances, simple or in mixtures, with or without additives for use in animal feed by mouth.

(b) Raw materials for animal feed: the various products of plant or animal origin in a natural state, fresh or preserved, and those derived from their industrial processing, as well as organic substances or inorganic, with or without additives, intended to be used for the feeding of animals by mouth, either directly, well processed, for the preparation of compound feed or as pre-mix vehicles.

(c) Additives: the additives defined in Article 2.1 of Royal Decree 2599/1998 of 4 December 1998 on additives in the feeding of animals.

(d) Premix: a mixture of additives or a mixture of one or more additives with one or more supporting materials for the manufacture of feed.

(e) Compound feed: 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) Supplementary feed: mixtures of feed containing high percentages of certain substances and which, by their composition, only ensure daily ration if they are associated with other feed.

(g) Full feed: mixtures of feedingstuffs which, by their composition, are sufficient to ensure a daily ration.

(h) Products intended for animal feed: feed materials, premixtures, additives, feed and other products intended for animal feed or used for that purpose.

i) Daily ration: the total amount of food, calculated on the basis of a moisture content of 12%, which requires as a daily average an animal of a species, an age category and a certain yield for satisfy the set of your needs.

(j) Animals: animals belonging to species which the human being normally feeds and owns or consumes and the animals that live freely in the wild, when fed with feed.

k) In circulation or circulation: the holding of products intended for sale, including the offer for sale, or any other form of transfer, free of charge or for consideration, to third parties, as such as the sale itself or other forms of transfer.

(l) undesirable substances: any substances or products, with the exception of pathogens, present in the product intended for animal nutrition and which constitute a potential hazard to human health; animal or for the environment, or which may be harmful to livestock production.

Article 3. Requirements for the movement of products intended for animal feed.

1. Only products intended for animal nutrition which are healthy, fit and of a commercial quality and which are used correctly shall not be put into circulation or used for human health, animal health or the environment may be put into circulation or used. environment, nor can they be harmful to livestock production. In addition, products intended for animal feed which satisfy the same conditions may be entered from third countries only for use in the European Union.

2. In particular, products intended for animal feed whose content of undesirable substances does not comply with the maximum levels referred to in the Annex to this Directive may not be considered as complying with the provisions of paragraph 1. decree.

3. Products intended for animal feed which comply with this royal decree shall not be subject to other restrictions on the putting into circulation, in the case of the presence of undesirable substances, than those resulting from such restrictions. Regulation of the European Parliament and of the Council of 12 April 2002 laying down the principles governing the organisation of official controls in the field of animal

.

Article 4. Obligations relating to undesirable substances.

1. The undesirable substances listed in the Annex to this standard may be tolerated only in products intended for animal feed under the conditions laid down in that Annex.

2. In order to reduce or eliminate the sources of undesirable substances in products intended for animal feed, the Ministry of Agriculture, Fisheries and Food, in cooperation with the relevant economic operators, shall carry out investigations to determine those sources where the maximum limits laid down are exceeded and where higher levels of those substances are detected, taking into account the background levels.

The investigations referred to in the previous paragraph shall be carried out at the same time when the minimum intervention limits referred to in Directive 2002/32/EC have been established by the Community authorities, products for animal feed, undesirable substances at levels exceeding the above limits.

3. In addition, the Ministry of Agriculture, Fisheries and Food will coordinate the research which, in the field of its competences, will be carried out by the autonomous communities in the field referred to in the previous paragraph.

4. The Ministry of Agriculture, Fisheries and Food shall send, through the appropriate course, to the Spanish Food Safety Agency, the European Commission and the other Member States any relevant information, as well as (a) the information on the source and the measures taken to reduce levels or eliminate undesirable substances. This information shall be transmitted in the framework of the annual report to be submitted to the European Commission in accordance with Article 3.3 of Royal Decree 354/2002, except where it is an urgent matter for the other Member States, in which case will be sent immediately.

Article 5. Prohibition of mixtures for dilution purposes.

Products intended for animal feed, the content of which is undesirable in excess of the maximum content set out in the Annex, cannot be mixed for dilution purposes with the same product or with other products. products intended for animal feed.

Article 6. Content of undesirable substances in complementary feedingstuffs.

Supplementary feedingstuffs, in so far as there are no specific provisions applicable to them, cannot, in the light of the proportion of them prescribed for a daily ration, present a undesirable substances, as listed in the Annex, in contents higher than those laid down for complete feedingstuffs.

Article 7. Exceptional measures.

1. If, by reason of the appearance of new data or the new assessment of the existing data, there were reasonable grounds to consider that any of the maximum levels laid down in the Annex or any undesirable substance not mentioned in that Annex presents a danger to human health, animal health or the environment, will be issued by the Minister of Agriculture, Fisheries and Food, after a mandatory report of the Spanish Food Safety Agency, the corresponding (i) order by which, on a provisional basis, and as long as the authorities are not Community, the maximum content in force shall be reduced, other maximum content shall be fixed or the presence of that undesirable substance shall be prohibited in products intended for animal feed.

2. Action under the above paragraph shall be carried out without prejudice to the immediate adoption of the measures which the urgency of the situation requires, in order to preserve the health of consumers, which shall be taken into account in the event of the relevant units of the Ministry of Health and Consumer Affairs.

3. The Ministry of Agriculture, Fisheries and Food shall, through the appropriate channel, immediately inform the other Member States and the European Commission of the reasons for such a decision.

Article 8. Actions in the case of amendments to the Annex.

In the event that, as a result of the corresponding actions of the European Commission, the Annex to this standard is amended, or criteria are adopted for the acceptability of the decontamination processes to be added to the criteria for products intended for animal feed which have undergone such processes shall be carried out in order to ensure the correct application of any processes deemed acceptable, as well as the conformity, in respect of the provisions contained in the Annex, of the products intended for uncontaminated animal feed.

Article 9. Responsibility of feed business operators.

Article 20 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Agency for the Food security and procedures relating to food safety, which contains certain obligations for feed business operators, will be applied "mutatis mutandis" to the subject matter in this royal decree.

Article 10. Application of the standard to food intended for external trade.

1. The provisions contained in this royal decree shall apply to products intended for animal feed produced in the European Union which are to be exported to third countries.

2. The provisions of paragraph 1 shall not affect the re-export or re-dispatch of the products referred to in paragraph 1, which shall be carried out in accordance with the conditions laid down in Article 12 of Regulation (EC) No 178/2002.

Article 11. Sanctioning regime.

In case of non-compliance with the provisions of this royal decree, the sanctioning regime provided for in Law 8/2003 of 24 April of Animal Health, as well as in Royal Decree 1945/1983 of 22 June, will be applicable. Infringements and penalties for consumer protection and agri-food production are regulated.

Single repeal provision. Regulatory repeal.

The provisions of equal or lower rank that are contrary to the provisions of this royal decree, and in particular, Royal Decree 747/2001 of 29 June, establishing the substances and products, are repealed. undesirable in animal feed.

Final disposition first. Competency enablement.

The last sentence of Article 3 (1) and Article 10 of this royal decree are given in accordance with Article 149.1.10.a of the Constitution, which reserves the State exclusive competence in matters of foreign trade; Article 4 (2) and (3), in accordance with the provisions of Article 149.1.15.a of the same rule, which gives the State exclusive competence in the field of the promotion and general coordination of scientific and technical research; Article 149.1.13.a and 16.a of the Constitution provides for the provision of basic regulations. which reserves the exclusive powers to the State on the basis of coordination of the general planning of economic activity and on the basis and general coordination of health, respectively.

Final disposition second. Faculty of development.

The Ministers of Agriculture, Fisheries and Food and Health and Consumer Affairs are empowered to adopt, in the field of their respective powers, prior to the mandatory report of the Spanish Food Safety Agency. provisions necessary for the development of the forecasts of this royal decree and for the updating or inclusion of new annexes as a result of the amendments introduced by Community legislation.

Final disposition third. Entry into force.

This royal decree will enter into force on 1 August 2003.

Given in Madrid, 25 April 2003.

JOHN CARLOS R.

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

MARIANO RAJOY BREY

ANNEX

Pires.

Feed complete.

-Seeds oilseeds.

OMS/kg

substances

(1)

Products for power animal

(2)

Maximum content in mg/kg (ppm) in feed, referred to a moisture content of 12%

(3)

1. Arsenic

Raw materials for animal feed, except:

2

-Harinas of herbs, alfalfa and dehydrated clover, as well as dried sugar beet pulp and dried pulp with the addition of sugar beet molasses.

4

-Fosfatates and feed from the processing of fish or other marine animals.

10

feed, except:

2

fish feed.

4

feed, except:

4

-Mineral Complementary Feed.

12

2. Lead

Raw materials for animal feed, except:

10

-Forages green.

40

-Fosfatos.

30

-Levatures.

5

Pires.

5

Feed, except:

10

-Mineral Supplementary Feed.

30

3. Fluoride

Raw materials for animal feed, except:

150

-Feed animal source.

500

-Fosfates.

2000

Full feed, except:

-Full feed for cattle, sheep, and goats.

-Lactants.

30

-The others.

50

-Full pigs for pigs.

100

-Full feed for poultry.

350

-Full Pienos for Polks.

250

Supplementary Feed for Bovines, Sheep, and caprines.

2000 (1)

Other complementary feeds.

125 (2)

4. Mercury

Raw materials for animal feed. except:

0.1

-Feed obtained by transforming fish or other marine animals.

0.5

feed, except:

0.1

- Complete feed for dogs and cats.

0.4

feed, except:

-Complementary dogs and cats.

5. Nitrites

Fish flour.

60 (expressed in sodium nitrite

complete, except:

15 (expressed in sodium nitrite)

-Company animal feed (with the exception of birds and ornamental fish)

6. Cadmium

Raw materials for plant-based animal feed.

1

Commodities for animal feed of animal origin, except:

2

-Animal feed company.

Fosfates.

10 (3)

-size cattle feed. ovine and caprine animals, except:

1

-Full-on-calf feed. lambs and kids.

Other complete feeds, except:

0.5

5 (4)

5 (4)

Other complementary feed for cattle, sheep and goats.

0.5

7. Aflatoxin 61

Raw materials for animal feed, except:

0.05

- Peanut, copra, palmiste, cotton seeds, babasu, maize and the derivatives of their transformation.

0.02

feed for bovine, ovine and caprine animals, except:

-Dairy cattle.

0.005

- Calves and goats.

0.01

feed for pigs and birds (except young animals).

0.01

feed for bovine, ovine and caprine animals (except complementary dairy cattle feed, calves and kids).

0.05

feed for pigs and poultry (except young animals).

0.03

Other complementary feeds.

0.005

8. Cyanhydride acid

Raw materials for animal feed, except:

50

Flax seeds.

250

-Linen cakes.

350

-Manioc products and almond cakes.

100

Feed, except:

50

-Full Pienos for chicks.

10

9. Free Gosipol

Raw materials for animal feed, except:

20

- Cotton seed cakes.

1200

feed, except:

-Full feed for cattle, sheep, and caprines.

500

-Full feed for poultry (except laying birds) and calves.

100

-Full parts for rabbits and pigs (except piglets).

60

10. Theobromine

Full feed, except:

300

-Full feed for cattle adults.

700

11. Volatile mustard essence

Raw materials for animal feed, except:

100

-Colza Torta.

4000 (expressed in allyl isothiocyanate)

feed, except:

150 (expressed in allyl isothiocyanate)

-Full feed for cattle, sheep, and goats (except young animals).

1000 (expressed in allyl isothiocyanate

-Full feed for pigs (except piglets) and poultry.

500 (expressed in allyl isothiocyanate)

12. Vinylthiooxazolidone (Viniloxazolidine-thione)

Full feed for birds, except:

1000

-Full Pienos for laying birds.

500

13. Rye cornezuelo (Claviceps purpurea)

All feed containing unground cereals.

1000

14. Seeds of weeds and unground or crushed fruit containing alkaloids, glycosides or other toxic substances, separately or in whole, namely:

All feed.

3000

) Lollium temulentum L.

1000

) Lollium remotum Schrank,.

1000

c) Dantura stramonium L.

1000

15. Castor- Ricinus communis L.

All feed.

10 (expressed in castor shells)

16. Crotalaria spp.

All feed.

100

17. Aldrin.

(single or combined, calculated as dieldrin)

All feed, except:

18. Dieldrin. }

-Fats.

0.2

19. Canfecloro (toxafene).

All feed.

0.1

20. Clordan (sum of cis and trans isomers and oxiclordane, calculated as clordan)

All feed, except:

0.02

-Fats.

0.05

21. DDT (sum of the isomers of DDT, TDE and DDE, calculated as DDT).

All feed, except:

0.05

-Fat materials.

0.5

22. Endosulfan (sum of the alpha and beta isomers and endosulfan sulfate, calculated in the form of endosulfan)

All feed, except:

0.1

-Maiz.

0.5

-Feed complete for fish.

0.005

23. Endrin (sum of the endrin and deltacetoendrin, calculated as endrin)

All feed, except:

0.01

-Fat materials.

0.05

24. Heptacloro (sum of heptacloro and heptacloroepoxide calculated as heptacloro).

All feed, except:

0.01

-Fats.

0.2

25. Hexachlorobenzene (HCB)

All feed, except:

0.01

-Materies

26. Hexachlorocyclohexane (HCH)

26.1 alpha Isomers

All feed, except:

0.02

-Fats.

0.2

26.2 Isomers Beta

Compound Feed, except:

0.01

-Composite Feed for Livestock dairy.

0.005

materials for animal feed, except:

-Fats.

0.1

26.3 Gamma Isomers

All feed, except:

0.2

-Fats.

2.0

27. Dioxin (sum of PCDD and PCDF, expressed in international toxic equivalents) (5)

Citrus pulpa.

500 pg I-TEQ/kg (upper limit of Detection)

All raw materials for animal feed of plant origin, including vegetable oils and byproducts.

0.75 ng EQT

PCDD/F OMS/kg

ng EQT PCDD/F

milk fat and egg fat.

2.0 ng EQT PCDD/F

OMS/kg

Other animal products land, including milk and milk products, and eggs and egg products.

0.75 ng EQT

PCDD/F OMS/kg

oil.

6 ng EQT PCDD/F

OMS/kg

, other marine animals, their products and by-products, except fish oil (6).

1.25 ng EQT

PCDD/F OMS/kg

, except feed for fur, pet and fish animals.

0.75 ng EQT

Feed for Fish

Centro_table_body"> 2.25 ng EQT

PCDD/F OMS/kg

28. Apricot- Prunus armeniaca L.

29. Bitter almond- Prunus dulcis (Mill.) D.A. Webb var. Amara (DC.) Focke

(= Prunus amygdalus Batsch var. Amara (DC.) Focke)

30. Hayuco in shell- Silvatic Fagus L.

31. Camelina- Camelina sativa (L.) Crantz

32. Mowrah, Bassia, Madhuca-Madhuca longifolia (L.) Macbr. (=Bassia longifolia L. = lliped malaborum Eng.) Madhuca indicates Gmelin (= Bassia latifolia Roxb.) = Illipe latifolia (Roscb.) F. Mueller)

33. Frailejon-Jatropha curcas L.

34. Croton-Croton tiglium L.

35. Indian mustard- Brassica juncea (L.) Czern. And Coss ssp. ltegrifolia (West) Thell

36. Sarepta mustard-Brassuca hybcea (L.) Czern. and Coss. ssp. Juncea

37. Chinese mustard- Brassica juncea (L.) Cezern and Coss ssp., juncea var. lutea Batalin

38. Black mustard- Brassica nigra (L.) Koch

39. Mustard abysinia (Ethiopian)-Brassica carinata A. Braun

} All feed.

}

The seeds and fruits of the corresponding species, as well as their processed derivatives, may be present in the feed only in minimum quantities, not quantitatively determinable

(1) A maximum fluorine content equal to 1,25% of the phosphate content may also be available.

(2) Fluor content by 1% phosphorus.

(3) Maximum cadmium content equal to 0.5 mg per 1% phosphorus may also be available.

(4) Maximum cadmium content equal to 0.75 mg per 1% phosphorus may also be available.

(5) Upper bound concentrations are calculated by taking it for granted that all values of the different related substances below the limit of detection are equal to this limit.

(6) Fresh fish directly supplied and used without intermediate processing for the production of feed for fur animals is not subject to the maximum content. Processed products and proteins which have been made from these fur animals may not enter the food chain, and it is prohibited to use them in the feeding of farmed animals kept, primed or reared for food production.