S.I. No. 258/1985:

ANIMAL REMEDIES (CONTROL OF SALE) REGULATIONS, 1985.

ANIMAL REMEDIES (CONTROL OF SALE) REGULATIONS, 1985.

I, AUSTIN DEASY, Minister for Agriculture, in exercise of the powers conferred on me by sections 5 and 7 of the Animal Remedies Act, 1956 (No. 41 of 1956), and after consultation with the Animal Remedies Consultative Committee and the Minister for Health, hereby make the following Regulations:

1. (1) These Regulations may be cited as the Animal Remedies (Control of Sale) Regulations, 1985.

(2) (a) Subject to subparagraph (b) of this paragraph, these Regulations shall come into operation on the 1st day of November, 1985.

(b) Regulations 4 and 5 of these Regulations shall, in so far as they relate to substances set out in Parts II and III of the First Schedule to these Regulations, come into operation on the 1st day of July, 1986.

2. In these Regulations "the Act" means the Animal Remedies Act, 1956 (No. 41 of 1956).

3. (1) Subject to paragraph (2) of this Regulation and Regulation 5 (2) hereof, these Regulations apply to any animal remedy which--

( a ) is an animal remedy to which section 5 of the Act relates, and

(b) comprises or contains any substance, or any substance belonging to a class of substances, set out in the First Schedule to these Regulations.

(2) Paragraph (1) of this Regulation shall not be construed as applying any provision of these Regulations to--

(a) any feeding-stuff or supplementary feeding-stuff which--

(i) comprises or contains additives, or premixtures containing additives, which in either case are at the levels permitted by and otherwise complying with the provisions of the Council Directive, and

(ii) is manufactured, placed on the market, labelled and packaged in accordance with the requirements of the Council Directive, and

(iii) does not comprise or contain an animal remedy which is not amongst the additives listed in the Council Directive, or

(b) any premixture which--

(i) comprises or contains additives at levels and under conditions which ensure that, should such premixture be incorporated into feeding-stuffs or supplementary feeding-stuffs in accordance with the relevant manufacturer's directions for use, the resulting additives in such feeding-stuffs or supplementary feeding-stuffs would then be at the levels so permitted and otherwise so comply, and

(ii) is so manufactured, placed on the market, labelled and packaged, and

(iii) does not comprise or contain an animal remedy which is not amongst the additives so listed,

or

(c) any additive so listed and so manufactured, placed on the market, labelled and packaged.

(3) In this Regulation --

"additives", "feeding-stuffs", "premixtures" and "supplementary feeding-stuffs" have the meanings assigned to them, respectively, by the Council Directive;

"the Council Directive" means Council Directive 70/524/EEC of 23 November 1970¹ as amended.

¹O.J. No. L270,14.12.1970.

4. The particulars set out in the Second Schedule to these Regulations are hereby prescribed for the purposes of paragraph (d) of section 5 (1) of the Act.

5. (1) Subject to paragraph (2) of this Regulation, the sale of any animal remedy to which these Regulations apply is hereby prohibited save under licence of the Minister.

(2) Paragraph (1) of this Regulation shall not apply to any animal remedy which--

(a) comprises or contains any substance specified in Part III of the First Schedule to these Regulations, and

(b) is marketed (whether by being packaged in a particular manner or otherwise) as an intramammary preparation for the prevention of mastitis in animals, and

(c) is intended for use exclusively as such a preparation,

and whose container and any outer wrapper bears a notice clearly indicating that the animal remedy is so marketed and is intended for such use.

6. (1) In respect of any animal remedy to which these Regulations apply, a person, whether or not he is the holder of a licence granted for the purposes of these Regulations, shall not--

(a) sell any such remedy, from a travelling shop, vehicle or an automatic vending machine, or by mail order, or

(b) make visits from house to house for the purpose of soliciting, collecting or obtaining orders for any such remedy.

(2) Paragraph (1) of this Regulation shall not apply for any of the purposes specified in subparagraph (b) of that paragraph where house to house visits are made on persons at their respective places of business and those persons are lawfully entitled to sell any such remedy from their respective places of business.

(3) In this Regulation "house" includes land.

7. In any proceedings for an offence in which a contravention of Regulation 5 of these Regulations is alleged, it shall be a defence for the defendant to prove--

(a) that the animal remedy to which the alleged offence relates was sold by wholesale to a particular person for the purpose of resale only, and

(b) that there were reasonable grounds to believe that such person was bona fide engaged in the business of purchasing animal remedies for the purpose of resale only, and

(c) either--

(i) that the Poisons Regulations, 1982 to 1984, were complied with as regards the sale, or

(ii) that those Regulations did not apply as regards the sale.

8. (1) These Regulations are in addition to and not in substitution for--

( a ) the Animal Remedies (Registration of Manufacturers, Importers and Wholesalers) Regulations, 1980 ( S.I. No. 115 of 1980 );

(b) Regulation 3 of the European Communities (Control of Stilbene and Thyrostatic Substances) Regulations, 1981 (S.I. No. 366 of 1981);

(c) Regulation 3 of the European Communities (Control of Oestrogenic, Androgenic, Gestagenic and Thyrostatic Substances) Regulations, 1982 ( S.I. No. 282 of 1982 ); and

(d) the Poisons Regulations, 1982 to 1984.

(2) Nothing in these Regulations shall be construed as affecting any provision of--

(a) the European Communities (Feeding Stuffs) (Additives) Regulations, 1974 to 1984, and

(b) the Animal and Poultry Compound Feeding Stuffs (Control of Antibiotics) Regulations, 1972 ( S.I. No. 335 of 1972 ).

9. (1) The Animal Remedies (Control of Oestrogenic Substances) Regulations, 1962 ( S.I. No. 96 of 1962 ), is hereby amended by the substitution of the following for Regulation 3--

"3. The manufacture, preparation or packing of any animal remedy to which these Regulations apply is hereby prohibited save under licence of the Minister.".

(2) The Animal Remedies (Control of Chloramphenicol) Regulations, 1974 ( S.I. No. 10 of 1974 ), are hereby revoked.

FIRST SCHEDULE

PART I

1. Substances with oestrogenic, androgenic or gestagenic action within the meaning of Council Directive 81/602/EEC of the 31st July 1981¹ (which relates to the prohibition of certain substances having a hormonal action and of any substance having a thyrostatic action) and in particular--

¹O.J. L222, 7.8.81.

Oestradiol 17B

Progesterone

Testosterone

Trenbolone and its acetate

Zeranol.

2. Chloramphenicol (including Azidamfenicol and Thiamphenicol), its salts, esters and derivatives, salts of its esters and salts of its derivatives.

PART II

1. Antibiotic substances generally (other than those set out in Part III of this Schedule) and in particular the following substances, their salts, esters and derivatives, salts of their esters and salts of their derivatives:--

Actinomycins

Amikacin

Aminoglycocides (other than those specifically set out in this Part)

Amphomycin

Amphotericins

Apramycin

Avoparcin

Bacitracin

Bambermycin

Bleomycin

Candicidin

Capreomycin

Carbenicillin

Cefaclor

Cefamandole

Cefoxitin

Cephalexin

Cephalosporins (other than those specifically set out in this Part)

Cephaloridine

Cephalothin

Cephamycins (other than those specifically set out in this Part)

Cephapirin

Cephazolin

Cephradine

Chavulanic Acid

Ciclacillin

Clindamycin

Clomocycline

Cycloserine

Daunorubicin

Demeclocycline

Dicloxacillin

Dimethylchlortetracycline

Doxorubicin

Doxycycline

Erythromycin esters

Flucloxacillin

Fumagillin

Fusafungine

Fusidic Acid

Gentamicins

Gramacidin

Griseofulvin

Hachimycin

Lincomycins

Macrolide Antibiotics (other than those specifically set out in this Part)

Mecillinam

Methacycline

Minocycline

Mithramycin

Mitomycins

Natamycin

Nystatin

Oleandomycin

Oxacillin

Paromomycin

Penicillins (other than those specifically set out in this Part)

Polymyxins

Rifamycins

Ristocetins

Spectinomycin

Talampicillin

Tetracyclines (other than those specifically set out in this Part)

Tetracycline Hydrochloride

Tiamulin

Tobramycin

Tylosin

Vancomycin

Viomycin

Virginiamycin

2. The following antibacterial substances and their salts:--

p-- Aminobenzenesulphonamide and its derivatives (where such derivatives have any of the hydrogen atoms of g the p -- amino group or of the sulphonamide group substituted by another radical)other than those specifically set out in this Part.

Carbadox

Dimetridazole

Furaltadone

Metronidazole

Nitrofurantoin

Nitroxoline

Olaquindox

Phtalylsulphacetamide

Phthalylsulphathiazole

Ronidazole

Succinylsulphathiazole

Sulfadoxine

Sulfametopyrazine

Sulfanitran

Sulfapyrazole

Sulfatroxazole

Sulphacetamide

Sulphachlorpyridazine

Sulphadiazine

Sulphadimethoxine

Sulphadimidine

Sulphaethidole

Sulphafurazole

Sulphaguanidine

Sulphaloxic Acid

Sulphamerazine

Sulphamethizole

Sulphamethoxazole

Sulphamethoxydiazine

Sulphamethoxypyridazine

Sulphamopine

Sulphamoxole

Sulphanilamide

Sulphaphenazole

Sulphaproxyline

Sulphapyridine

Sulphaquinoxaline

Sulphasalazine

Sulphasamidine

Sulphasomizole

Sulphathiazole

Sulphormethoxine

Tinidazole

PART III

The following substances and their salts:--

Amoxycillin

Ampicillin

Benzyl penicillin

Cefuroxime

Cephacetrile

Cephalonium

Cephoxazole

Chlortetracycline

Cloxacillin

Colistin

Dapsone

Dihydrostreptomycin

Epicilline

Erythromycin

Framycetin

Furazolidone

Kanamycin

Nafcillin

Neomycin

Nitrofurazone

Novobiocin

Oxytetracycline

Penethamate

Pivampicillin

Pivmicillinam

Polymyixin B

Procaine benzyl penicillin

Procaine Penicillin G

Spiramycin

Streptomycin

Ticarcillin

Trimethoprim

SECOND SCHEDULE

Particulars referred to in Regulation 4

1. Where the animal remedy is a substance or preparation to which the Poisons (Control of Residues in Foods of Animal Origin) Regulations, 1985 ( S.I. No. 257 of 1985 ), applies, particulars of the time required by those Regulations to be observed as a withdrawal period together with a statement that so observing such period is a requirement of those Regulations.

2. Where the animal remedy comprises or contains any substance specified in Part I of the First Schedule to these Regulations or any substance which is a substance of a class or description so specified, a statement that the animal remedy is to be used only by a veterinary surgeon or under the direct supervision of a veterinary surgeon.

3. (a) Subject to subparagraph (b) of this paragraph, where the animal remedy comprises or contains any substance specified in Part II or Part III of the First Schedule to these Regulations or any substance which is a substance of a class or description so specified, either a statement that the animal remedy is obtainable on prescription only or the following symbol:

(b) Subparagraph (a) of this paragraph shall not apply to any animal remedy described in Regulation 5 (2) of these Regulations.

GIVEN under my Official Seal, this 7th day of August, 1985.

AUSTIN DEASY,

Minister for Agriculture.

EXPLANATORY NOTE.

These Regulations control the sale of animal remedies containing hormones, antibiotics and antibacterial substances.