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CURRENT NATIONAL LEGISLATION RELATING TO THE USE OF
CERTAIN HORMONES IN ANIMAL PRODUCTION

An annotated chronological index of legislative and
regulatory provisions of various countries

(FAO Legislation Branch, Legal Office)

INTRODUCTION

In view of the concern expressed by the Intergovernmental Group on Meat in December 1980 with regard to the use of hormones, the Director-General of FAO requested the Legal Office of the Organization to prepare a short annotated chronological index of legislation on the subject, and to submit it to the Joint FAO/WHO Expert Committee on Food Additives at its 25th Session, held in Geneva in March-April 1981. The Animal, Plant and Food Legislation Section of the Legislation Branch, Legal Office, prepared the index, which contains references to legislation enacted or amended in certain countries over the last two decades, the text of which has been received by, or brought to the attention of, FAO Headquarters, Rome.

The Index does not purport to be exhaustive: the selection of countries and of legislative provisions was determined solely by the availability of documentation. In federal countries, state or provincial legislations are cited as examples only. It will be recalled that important legislation on this subject is currently published or abstracted within the general framework of FAO's Food and Agricultural Legislation (FAL), which appears twice yearly.

AFRICA

CONGO

Decree No. 63–393, regulating the production and marketing of compound feeds in the territory of the Republic of Congo. - 30.XI.1963 - Journal officiel No. 28, 15.XII.1963, p. 1021.

Only four categories of “auxiliary substances”, not including hormones, may be added to feeds with a view to enhancing yields or protecting animals against stated diseases.

KENYA

Legal Notice No. 213: The Meat Control (Export Slaughterhouse) Regulations 1973. - 6.X.1973 - Kenya Gazette No. 50, 2.XI.1973, Supplement No. 75 (Legislative Supplement No. 56), p. 467.

Schedule B-F (3) prohibits the export of animals which have received oestrogen hormones within times prior to slaughter determined by the importing country.

MOROCCO

Decree No. 2-63-253, prohibiting the use of arsenicals, antimonials and oestrogens in the feeding or raising of specified animals. - 22.VII.1963 - Bulletin officiel No. 2649, 2.VIII.1963, p. 1240.

Concerns animals the flesh or products of which are consumed by man. Feeds intended for these animals, and foodstuffs obtained from them, may not be held for sale, placed on sale or sold if they contain, inter alia, oestrogens other than those administered for therapeutic purposes.

TUNISIA

Order of the Ministers of Agriculture and Public Health, regulating the use of oestrogens in veterinary medicine. - 26.XII.1980 - Journal officiel de la République tunisienne No. 78, 30-31.XII.1980, p. 3382.

Prohibits the administration of oestrogens to animals the flesh and products of which are intended for use as food, except as prescribed and administered exclusively by authorized veterinarians and for curative purposes for adult female animals with a view to controlling their oestral cycle. See full text in FAO's Food and agricultural legislation, Vol. XXX, No. 2.

ZIMBABWE

The Farm Feeds (Amendment) Regulations, 1970 (No. 1), made in terms of Section 24 of the Fertilizers, Farm Feeds, Seeds and Remedies Act and notified by Rhodesia Government Notice No. 306 of 1970. - (Undated) - Supplement to Rhodesia Government Gazette No. 18, 24.II.1971, p. 1341.

Constituents claimed to have growth-stimulating properties may be registered at the discretion of the Registering Officer, acting on the advice of the competent animal husbandry and veterinary authorities. In the case of hormones, the content of the active constituent must be stated in any such application for registration as well as in the labelling.

AMERICA, NORTH, CENTRAL AND SOUTH

ARGENTINA

Decree No. 4224, concerning the treatment of livestock with oestrogens. - 26.V.1961 - Boletín Oficial No. 19.545, 2.VI.1961, p.1.

Prohibits the treatment of livestock by whatever means with oestrogenic substances as growth stimulants. The therapeutic use of oestrogens in livestock for export will be covered by special regulations.

BARBADOS

Statutory Instruments 1970, No. 212: The Health Services (Control of Drugs) Regulations 1970. - Supplement to the Official Gazette No. 87, 29.X.1970.

Reg. 9, (5) and (6), provide that the milk or flesh of an animal to which certain drugs, including six hormones has been administered shall not be sold or supplied for human consumption except under a labelling bearing the appropriate instruction or direction.

BRAZIL

Decree No. 57 824, approving the Regulations for the industrial, food quality and sanitary inspection of products intended as feed for domestic animals. - 18.IX.1965 - Diário Oficial, Section 1, Part 1, No. 222, 22.XI.1965, P. 11.871.

Article 4 (4) prohibits, subject to the current conditions under law, the addition of hormones to feedstuffs.

CANADA

The Feeds Regulations (SOR/65-280). - 1.VI.1967 - Canada Gazette II, Vol. 101, No. 11, 14.VI.1967, p. 922 (as amended, inter alia, by SOR/73-258 of 22.V.1973 and SOR/77-144 of 11.II.1979 - C.G. II, Vol. 107, No. 11, 13.VI.1973 and Vol. 111, No. 4, 23.II.1977).

Regulate the importation, registration, standardization, etc., of “medicated feeds”, expression which includes, inter alia, “a hormone the function of which is to promote growth in animal body”. No feed may contain DES.

- (British Columbia)

The Veterinary Drugs and Medicated Feed Regulation (No. 808/74), made under the Pharmacy Act by Order in Council 3857. - 4.XII.1974 - The British Columbia Gazette II, Vol. 17, No. 26, 24.XII.1974, p. 1228.

DES is removed from the table of permitted feed additives.

COSTA RICA

Executive Decree No. 2769-A-SPPS. - 12.I.1973 - La Gaceta No. 16, 24.I.1973, p.349.

Prohibits the importation, processing and use of DES as part or ingredient of, or as additive in, feed mixes for livestock the meat or byproducts of which can be used for human consumption.

MEXICO

Regulations for the control of biological, pharmaceutical and food products for livestock. - 15.IV.1963 - Diario Oficial, No. 24, 29.V.1963, p.1.

Regulation 7 subjects hormone preparations, among other biological substances, to the control prescribed by the regulations.

PERU

Ministerial Resolution prohibiting the importation and sale of hormones for fattening poultry. - 13.IX.1960 - El Peruano, No. 5822, 16.IX.1960, p.1.

Prohibits the importation into, and the sale in, Peru, of oestrogenic hormones for this purpose.

UNITED STATES OF AMERICA

The Animal Drug Amendments of 1968 to the Federal Food Drug and Cosmetic Act (Public Law 90-399). - 13.VII.1968 - 62 Stat. 351.

A new Sec. 512 (k) relates to approval of animal feeds containing “new animal drugs”.

Note: Both these Orders were revoked on 24 June 1974 by the U.S. Court of Appeals for the District of Columbia Circuit. The production, sale and use (oral use and implants) of DES could accordingly be resumed.

URUGUAY

Decree regulating the prohibition and use of oestrogens for the sexual sterilization and fattening of animals the meat and by-products of which are intended for human consumption. - 5.IV.1962 - Diario Oficial, Vol. 227, No. 16390, 8.V.1962, p. 186 A.

Prohibits the production, importation, sale or use of oestrogens for these purposes. The prohibition does not extend to therapeutic purposes under certain conditions. The possession, sale or distribution of fresh or preserved meat or any products whatever of animals having been treated with natural or synthetic oestrogens is also prohibited.

ASIA

JORDAN

Ordinance No. 7 of 1961 in application of the Animal Diseases Act. - (undated) - Official Gazette, No. 1572, 19.IX.1961, p. 1254.

Prohibits the use of any natural or synthetic hormonal substances intended to promote growth or to sterilize animals the flesh of which is intended for human consumption. Also prohibits the sale and export of such meat and of milk and milk products derived from animals so treated, including domestic animals and live poultry intended for food or for sale.

LEBANON

Ordinance No. 46/1 of the Ministry of Agriculture, prohibiting the introduction of concentrated feedstuffs containing DES and similar hormones. - 21.II.1973 - Official Gazette, No. 19, 5.III.1973, p. 151.

PHILIPPINES

Administrative Order No. 194 of 1973 (Office of the Secretary, Department of Health), prohibiting the use of DES. - 18.IX.1973 - Official Gazette Vol. 69, No. 42, 1.X.1973, p.9964.

The ban concerns the rearing of farm animals and poultry and extends to the production of DES premixes.

EUROPE

(EEC Countries)

EUROPEAN COMMUNITIES

Council Directive (70/524/EEC) concerning additives in feedstuffs. - 23.XI.1970 - Official Journal of the European Communities No. L 270/1, 14.XII.1970, p.840.

The Annex contains a positive list of feed additives. The use of other feed additives may, on a temporary basis (up to 1975), also be permitted by Member States, except, however, in the case of substances “having a hormonal or anti-hormonal effect”.*

BELGIUM

Crown Order declaring meat, fat and offal, and poultry meat and edible offal obtained from animals to which hormone or anti-hormone preparations have been administered, to be unwholesome. - 3.IX.1973 - Moniteur belge No. 202, 18.X.1973, p. 11788.

Since the administration of these preparations may cause alterations in the product, the Minister for Health may prescribe laboratory techniques designed to reveal such alterations and may approve laboratories for the relevant tests.

* According to a press report (The Guardian, Frankfurter Allgemeine, 8 January 1981), the EEC Commission is considering a specific ban on the use of hormones in animal feeding, with the proviso that excepted hormone use shall be subject to precise veterinary instructions.

- Crown Order relative to certain operations concerning substances having a hormonal anti-hormonal or antibiotic action. - 12.IV.1974 - M.B. No. 87, 7.V.1974, p. 6592.

Imports and exports of these substances are subject to general authorization and the obligation of prior notification. The general authorization requirement, and a record-keeping obligation, apply to their manufacture and to holding for industrial manufacture, and wholesale marketing. In other cases of holding, and for their transport, sale, offer for sale, consignment or acquisition, the general authorization is sufficient.

DENMARK

Order No. 369, prohibiting the use of thyreostatic preparations intended for the fattening of domestic animals. 23.IX.1965 - Lovtidende A XXIII, 27.IX.1965.

- Order No. 496, restricting the use of medicaments for domestic animals. - 28.IX.1978 - Lt. A 51, 26.X.1978, p. 1692.

Seven hormones and similar products are included among the medicaments which may be used only by veterinarians.

FRANCE

Order of the Minister for Agriculture, giving the list of countries which have prohibited the use of the substances contemplated in Article 1 of Decree No. 62-827 of 21 July 1962. - 12.VIII.1976 - J.O. No. 201, 28.VIII.1976, p. 5212.

Lists 23 countries which have prohibited the use, in poultry raising and feeding, of arsenicals, antimonials and oestrogens. The Decree cited prohibits, under all customs regimes other than transit, the importation of poultry products originating in or shipped from countries where the use of these substances is not prohibited.

- Act No. 76-1067, prohibiting the use of oestrogens in veterinary medicine. - 27.XI.1976 - J.O. No. 278, 28.XI.1976, p. 6335.

Prohibits the administration of oestrogens to animals whose meat or products are intended as food, save for oestrus control in adult females. Food of animal origin containing oestrogens (whether or not steroids), at all levels exceeding those to be prescribed by decree taking into account normal physiological levels, are to be banned as food.

- Order prohibiting the use of oestrogens in veterinary medicine. - 2.II. 1978 - J.O. 25.II.1978, No. 48, p. 825.

Made under Act No. 76-1067 cited above. Animal products and products of animal origin, intended for food, may not contain synthetic oestrogens (DES, dienoestrol, hexoestrol and their derivatives, and ethynyloestradiol). The maximum rate of incorporation of natural oestrogens (oestradiol, oestrone and their derivatives) in these products is prescribed at 0.01 mg/kg in animals of reproductive age and at 0.0002 mg/kg in calves and other young animals.

- Order relating to withdrawal from consumption of meat and offal from slaughter animals to which prohibited anabolic preparations have been administered. - 20.X.1980 - J.O. No. 249, 24.X.1980, p. 2476.

Proof of such administration may be constituted by evidence of illicit implants or suspect residues in any tissues, secretions or excreta.

GERMANY (F.R.)

Ordinance concerning substances having a pharmacological effect. - 3.VIII.1977. - Bundesgesetzblatt, Part I, No. 53, 10.VIII.1977, p. 1479.

Under Article 1 and the Schedule, it is prohibited to administer oestrogens (in particular the stilbenes) and their derivatives, salts and esters, to livestock. Article 2, however, authorizes, under certain conditions, the administration of substances having an oestrogenic, androgenic or gestogenic effect and having received type approval to animals from which foodstuffs are obtained.

GREECE

Crown Decree No. 176, prohibiting the release for human consumption of meat from oestrogen-treated livestock, including poultry. - 24.II.1968 - Ephemeris tes Kuberneseos I, No. 48, 11.III.1968, p. 416.

Applies to both home and imported meats. Oestrogen treatment is understood to mean both the introduction of these products into the animal by whatever means (injection, implantation) and their administration, alone or mixed in feeds, with a view to influencing meat yield and/or the lean/fat composition thereof.

IRELAND

The Animal Remedies (Control of Oestrogenic Substances) Regulations, 1962, made under Section 7 of the Animal Remedies Act, 1956 (No. 41 of 1956). - I.VI.1962 - S.I. No. 96 of 1962.

Prohibit the manufacture, preparation, packing or sale of 12 substances specified in the Schedule and of any oestrogenic substance or preparation, natural or synthetic, which, on being administered to animals or incorporated in feeds, produces oestrogenic effects.

ITALY

Law No. 3, prohibiting the use of oestrogens as growth stimulants or sex inhibitors in animals whose meat or products are intended for human consumption. - 3.II.1961 - Gazzetta Ufficiale No. 43, 18.II.1961, p. 714.

Prohibits the use of synthetic and natural oestrogens as growth stimulants or sex inhibitors; the prohibition also covers poultry and other farm animals marketed live, as well as imported products.

- Ministerial Decree prohibiting the holding by stockbreeders, or the administration by them to animals, of substances having a hormonal or anti-hormonal action. - 15.I.1969 - C.U. No. 16, 20.I.1969, p. 366.

Prohibits the holding or administration, under any form whatsoever, of substances having a hormonal action (e.g., oestrogens, androgens, progestins) or anti-hormonal action (e.g. thyreostatics).

LUXEMBOURG

Grand-Ducal Regulation issuing revised rules governing certain substances intended for use in animal feeding. - 28.I.1971 Mémorial A, No. 9, 12.II.1971, p. 78.

Prohibits the import, transport for sale, and sale of feedstuffs containing hormones and anti-hormones, and of foodstuffs obtained from animals to which they have been administered. The presence of residues of such substances in food renders the latter unfit for consumption.

NETHERLANDS

Act No. 363, regulating trade in antibiotics, hormones, thyreostatics and chemotherapeutical products intended for or susceptible of use with livestock. - 1.VIII.1964 - Staatsblad 1964, p. 914.

Such products and preparations may be sold only to persons prescribed (e.g., veterinarians), and to approved veterinary establishments.

- Order No. J. 3328 (as amended by Order of 28.XII.1964), implementing Act Stb1. 363 of 1 August 1964 (see above). Staatscourant Nos. 239/1964 and 1/1965.

UNITED KINGDOM

Four sections of the Medicines Act 1968 respecting medicated animal feedstuffs, viz. Sec. 40 (general provisions), 42 (supplementary provisions), 62 (prohibition of sale, supply of importation) and 90 (labelling, marketing, leaflets, containers, etc.). - 25.X.1968 - Eliz. 2, ch. 6.

These provisions also apply, under the Medicines (Feeding Stuffs Additives) Order 1975 (S.I. 1975, No. 1349), to non-medicinal substances or articles incorporated in feeds for medicinal purposes.

- The Medicines (Labelling of Medicated Animal Feeding Stuffs) Regulations, 1973. - 29.VIII.1973 - S.I. 1973, No. 1530.

Detailed labelling provisions. Also regulate bulk sale or supply under specified circumstances, etc.

EUROPE

(Other Countries)

FINLAND

Resolution of the Board of Agriculture, No. 44/221-68, made under the Feeds and Fertilizers Act No. 335/68, as amended, concerning the buyer's notification of the quality of trace elements, vitamins, hormones and similar preparations, pharmaceutical substances and substances to be considered as poisons in feeds, etc. - 4.III.1969.

- Ordinance No. 281 on feed additives. - 2.V.1969 - Finlands Författningssamling No. 275-281, 8.V.1969, p. 507.

Prohibits the use of hormones in feeds.

POLAND

Order (Text No. 352) of the Minister for Agriculture amending Order (Text No. 114) of 5.XI.1952 on the control of certain animal feedstuffs. - 11.X.1962. - Monitor Polski No. 75, 20.X.1962, p. 632.

Prohibits the addition of hormonal substances to animal feeds.

SPAIN

Order prohibiting the use of arsenicals, antimonials and oestrogens in the preparation of compound feeds for use in poultry breeding, and the trade in and sale of eggs, birds and poultry for consumption when imported from countries that do not prohibit the use of such substances. - 4.III.1964 - Boletín Oficial No. 69, 20.III.1964, p. 3677.

Also prohibits the marketing of home-produced poultry (and eggs thereof) fed with these substances. For all eggs and poultry, in particular those imported, the absence of any hormonal treatment must be certified previous to shipment.

- Resolution of the Agricultural Production Department regulating the use of hormones in animal production. - 7.VII.1980 - Boletín Oficial No. 174, 21.VII.1980, p. 16 550.

Marketing and use are subject to veterinary prescription or control. Hormone preparations must be type-approved before they may be marketed.

SWITZERLAND

Order of the Federal Council amending the Federal Meat Inspection Ordinance. - 21.I.1970 - Recueil des lois fédérales No. 7, 20.II.1970, p. 160.

No substance or product liable to have an inadmissible effect on the condition or keeping quality of meat (in particular oestrogenic or thyreostatic substances) may be administered to slaughter animals.

YUGOSLAVIA

Feed Quality Regulations. - 3.IV.1978 - Sluzbeni List SFRJ No. 31, 9.VI.1978, Text No. 479, p. 1319.

Prohibits the addition to feeds of hormones, sedatives, thyreostatics or similar substances.

- Act on the wholesomeness of foodstuffs and articles of everyday use. - 3.X.1978 - S.L. SFRJ No. 55, 13.X.1978, Text No. 845, p. 220.

Hormones as well as other substances likely to have a prejudicial effect on the health of the consumer, if present in any food, render that food unwholesome. The authorities will establish permitted levels of hormones and other specified substances, as well as other conditions respecting wholesomeness, required for foods marketed in Yugoslavia.

OCEANIA

AUSTRALIA (SOUTH AUSTRALIA)

Amendments to the Stock Foods Regulations 1967. - 28.XI.1968 - South Australian Government Gazette No. 54, 28.XI.1968, p. 2325.

Schedule One prohibits the presence of anabolic agents and natural and synthetic hormones in any animal feed.

NEW ZEALAND

The Stock (Insecticides and Oestrogens) Regulations, 1961, as amended by Amendment No. 1, 1963 (SR 1961/101, 30.VIII.1961 and 1963/128, 10.VII.1963).

Except as specified, stock (cattle, sheep, or swine, of any age or sex) may not be treated with or exposed to any insecticide or oestrogen, nor may these substances be used in any slaughtering place, meat-packing house or cannery. No stock exposed or treated in accordance with regulations may be slaughtered or sold for slaughter for human consumption during the following 30 days.

- The Stock Remedies (Biochemical Substances) Regulation (Reprint of the 1951 Regulations). - 11.IV.1967 - Statutory Rules 1967/81.

The Second Schedule restricts the sale, dispensing and prescribing of hormones, as well as any preparation containing any hormone as a biochemical substance for the treatment of stock.

- The Animal Remedies Act 1967. - 16.XI.1967 - Act No. 51/1967.

Consolidates and amends the Stock Remedies Act 1934. Hormones are included in the definition of “animal remedies” and “biochemical substances”, the manufacture, importation, sale and use of which are controlled.

THE FAO TECHNICAL PAPERS

FAO ANIMAL PRODUCTION AND HEALTH PAPERS:

1. Animal breeding: selected articles from World Animal Review, 1977 (C*E*F*S*)

2. Eradication of hog cholera and African swine fever, 1976 (E*F*S*)

3. Insecticides and application equipment for tsetse control, 1977 (E*F*)

4. New feed resources, 1977 (E/F/S*)

5. Bibliography of the criollo cattle of the Americas, 1977 (Bi. E/S*)

6. Mediterranean cattle and sheep in crossbreeding, 1977 (E*F*)

7. Environmental impact of tsetse chemical control, 1977 (E*F*)

7 Rev. Environmental impact of tsetse chemical control, 1980 (E*)

8. Declining breeds of Mediterranean sheep, 1978 (E*F*)

9. Slaughterhouse and slaughterslab design and construction, 1978 (E*F*S*)

10. Treating straw for animal feeding, 1978 (C*E*F*S*)

11. Packaging, storage and distribution of processed milk, 1978 (E*)

12. Ruminant nutrition: selected articles from World Animal Review, 1978 (C*E*F*S*)

13. Buffalo reproduction and artificial insemination, 1979 (E***)

14. The African trypanosomiases, 1979 (E*F*)

15. Establishment of dairy training centres, 1979 (E*)

16. Open yard housing for young cattle, 1981 (E*F*S*)

17. Prolific tropical sheep, 1980 (E*)

18. Feed from animal wastes: state of knowledge, 1980 (E*)

19. East Coast fever and related tick-borne diseases, 1980 (E*)

20/1. Trypanotolerant livestock in West and Central Africa, 1980 (E*F*)

Vol. 1 - General study

20/2. Trypanotolerant livestock in West and Central Africa, 1980 (E*F*)

Vol. 2 - Country studies

21. Guideline for dairy accounting, 1980 (E*)

22. Recursos genéticos animales en América Latina, 1981 (S*)

23. Disease control in semen and embryos (E*F*S*)

24. Animal genetic resources - conservation and management, 1981 (E*)

25. Reproductive efficiency in cattle, 1982 (E*)

26. Camels and camel milk, 1982 (E*)

27. Deer farming, 1982 (E*)

28. Feed from animal wastes: feeding manual, 1982 (E*)

29. Echinococcosis/hydaticosis surveillance, prevention and control: fao/unep/who guidelines, 1982 (E*)

30. Sheep and goat breeds of India, 1982 (E*)

31. Hormones in animal production, 1982 (E*)

FAO PLANT PRODUCTION ADN PROTECTION PAPERS: 37 titles published

FAO CONSERVATION GUIDES: 6 titles published

FAO FORESTRY PAPERS: 32 titles published

FAO FOOD AND NUTRITION PAPERS: 23 titles published

FAO AGRICULTURAL SERVICES BULLETINS: 50 titles published

FAO IRRIGATION AND DRAINAGE PAPERS: 39 titles published

FAO SOILS BULLETINS: 47 titles published

Availability: May 1982

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