European Communities (Control of Oestrogenic, Androgenic, Gestagenic and Thyrostatic Substances) Regulations, 1988.

Date02 September 1988
Statutory Instrument No.218/1988

S.I. No. 218 of 1988.

EUROPEAN COMMUNITIES (CONTROL OF OESTROGENIC, ANDROGENIC, GESTAGENIC AND THYROSTATIC SUBSTANCES) REGULATIONS, 1988.

I, MICHAEL O'KENNEDY, Minister for Agriculture and Food, in exercise of the powers conferred on me by Section 3 of the European Communities Act, 1972 (No. 27 of 1972), for the purpose of giving effect to Council Directive No. 81/602/EEC(1) of 31 July, 1981, Council Directive No. 81/851/EEC(2) of 28 September, 1981 (insofar as it relates to substances with oestrogenic, androgenic, gestagenic or thyrostatic action), Council Directive No. 85/358/EEC(3) of 16 July, 1985, Council Directive No. 86/469/EEC(4) of 16 September, 1986, Council Directive No. 88/146/EEC(5) of 7 March, 1988, and Council Directive No. 88/299/EEC(6) of 17 May, 1988, hereby make the following Regulations:

(1)O.J. No. L222, 07.08.1981, p. 32.

(2)O.J. No. L317, 06.11.1981, p. 01.

(3)O.J. No. L191, 23.07.1985, p. 46.

(4)O.J. No. L275, 26.09.1986, p. 36.

(5)O.J. No. L70, 16.03.1988, p. 16.

(6)O.J. No. L128, 21.05.1988, p. 36.

1. (1) These Regulations may be cited as the European Communities (Control of Oestrogenic, Androgenic, Gestagenic and Thyrostatic Substances) Regulations, 1988.

(2) These Regulations shall come into operation on the 5th day of September, 1988.

2. (1) In these Regulations—

"animal consumption" includes intended for incorporation in, or manufacture into, a food intended for animal consumption and kindred words shall be construed accordingly;

"appointed person" means—

( a ) a person who is an appointed person within the meaning of the Poisons (Control of Residues in Foods of Animal Origin) Regulations, 1985 ( S.I. No. 257 of 1985 ), or

( b ) a person who for the time being stands appointed under Regulation 27 of these Regulations;

"Assistant State Chemist" means the Assistant State Chemist of the State Laboratory;

"authorised officer" means—

( a ) a person who is an authorised officer within the meaning of the Animal Remedies Act, 1956 (No. 41 of 1956), or

( b ) a person who for the time being stands appointed under Regulation 29 of these Regulations;

"authorised substance" means any substance or preparation which has oestrogenic, androgenic or gestagenic action (other than a substance or preparation which consists of or contains stilbenes, their derivatives, their salts or esters) and in respect of which there is for the time being in force a product authorisation;

"competent authority" has the meaning assigned to it by the European Communities (Veterinary Medicinal Products) Regulations, 1986 ( S.I. No. 22 of 1986 );

"Council Directives" means—

( a ) Council Directive No. 81/602/EEC of 31 July, 1981.

( b ) Council Directive No. 81/851/EEC of 28 September, 1981 in so far as it relates to substances having oestrogenic, androgenic, gestagenic or thyrostatic action,

( c ) Council Directive No. 85/358/EEC of 16 July, 1985,

( d ) Council Directive No. 86/469/EEC of 16 September, 1986,

( e ) Council Directive No. 88/146/EEC of 7 March, 1988,

( f ) Council Directive No. 88/299/EEC of 17 May, 1988, and

( g ) any act of the European Communities adopted pursuant to the provisions set out in this definition;

"document" includes computer and other recording media, and any other means by which or on which information can be recorded or stored;

"hormone legislation" means—

( a ) these Regulations,

( b ) the Animal Remedies Act, 1956 (No. 41 of 1956) and regulations made thereunder, in so far as that Act and those regulations relate to substances having oestrogenic, androgenic, gestagenic or thyrostatic action,

( c ) the European Communities (Veterinary Medicinal Products) Regulations, 1986 ( S.I. No. 22 of 1986 ) in so far as they relate to substances having oestrogenic, androgenic, gestagenic or thyrostatic action, and

( d ) the Poisons (Control of Residues in Foods of Animal Origin) Regulations, 1985 and 1986 ( S.I. No. 257 of 1985 and S.I. No. 236 of 1986 ) in so far as they relate to substances having oestrogenic, androgenic, gestagenic or thyrostatic action;

"human consumption" includes intended for incorporation in, or manufacture into, a food intended for human consumption and kindred words shall be construed accordingly;

"identity card" means an identity card or a permit issued for the purposes of the Bovine Tuberculosis (Attestation of the State and General Provisions) Order, 1978 ( S.I. No. 256 of 1978 ) or the Brucellosis in Cattle (General Provisions) Order, 1980 ( S.I. No. 286 of 1980 );

"manufacture" includes processing, compounding, formulating, filling, dividing up, packaging and labelling;

"manufacturer's licence" has the meaning assigned to it by Regulation 9 of the European Communities (Veterinary Medicinal Products) Regulations, 1986;

"Minister" means the Minister for Agriculture and Food;

"offshore installation" means any floating, fixed or other installation which is maintained in the water, or on a part of the shore or on other land which at a state or ordinary medium tide is covered by the sea, and which is not connected with land above the high water mark by a permanent structure providing access to the installation at all times and for all purposes;

"product authorisation" means an authorisation to market a veterinary medicinal product granted in accordance with Regulation 5 of the European Communities (Veterinary Medicinal Products) Regulations, 1986;

"prohibited substance" means—

( a ) any substance or preparation having thyrostatic action, or

( b ) any stilbene, stilbene derivative, their salts or esters or any preparation consisting of or containing any such substance, or

( c ) any other substance or preparation having oestrogenic, androgenic or gestagenic action which is not an authorised substance;

"sell" includes offer, expose or keep for sale, invite an offer to buy, distribute (whether for reward or not), send in the post or otherwise place on the market and kindred words shall be construed accordingly;

"State Chemist" means the head of the State Laboratory and includes any person authorised by him to make an examination, test or analysis or give a certificate for the purposes of Regulation 27 of these Regulations;

"therapeutic treatment" means the administering to an individual farm animal of any authorised substance for the purpose of treating a fertility problem diagnosed, on examination, by a veterinary surgeon;

"vehicle" includes a ship, hovercraft, aircraft and offshore installation;

"veterinary medicinal product" has the same meaning in these Regulations as it has for the purposes of the European Communities (Veterinary Medicinal Products) Regulations, 1986;

"veterinary surgeon" means a person registered in the register established under the Veterinary Surgeons Act, 1931 (No. 36 of 1931).

(2) Subject to paragraph (1), a word or expression that is used in these Regulations and is also used in the Council Directives has, unless the contrary intention appears, the meaning in these Regulations that it has in the Council Directives.

(3) In these Regulations any reference to a Regulation or Schedule shall be construed as a reference to a Regulation contained in these Regulations, or, as the case may be, to a Schedule thereto, unless it is indicated that a reference to some other provision is intended, and any reference in a Regulation to a paragraph or sub-paragraph shall be construed as a reference to a paragraph or a sub-paragraph of that Regulation, unless it is indicated that a reference to some other provision is intended.

3. A person shall not manufacture, import or sell any prohibited substance.

4. (1) The competent authority shall not grant or renew a product authorisation in relation to any veterinary medicinal product which consists of or contains any stilbene, stilbene derivative, their salts or esters, or any thyrostatic substance.

(2) Without prejudice to paragraph (1), the competent authority shall, in considering any application for the grant of or the renewal of a product authorisation in relation to a veterinary medicinal product with oestrogenic, androgenic or gestagenic action, have regard to and comply with the Council Directives in granting or renewing such authorisation.

5. A person shall not manufacture any authorised substance except in accordance with the provisions of the Council Directives and with a licence granted under Regulation 9 (1) of the European Communities (Veterinary Medicinal Products) Regulations, 1986.

6. A person shall not import any authorised substance from a country other than a Member State of the European Economic Community except in accordance with the provisions of the Council Directives and with a licence granted under Regulation 9 (1) of the European Communities (Veterinary Medicinal Products) Regulations, 1986.

7. A person shall not sell any authorised substance except in accordance with the provisions of a product authorisation granted or renewed in relation to such substance and in accordance with the provisions of the Council Directives.

8. A person shall not manufacture, import, sell, lend, hire or otherwise supply or use any plant, machinery, instrument, cartridge, container, utensil, label, package insert or other thing made or adapted for use in connection with—

( a ) the manufacture of a prohibited substance,

( b ) the administration of a prohibited substance to a farm animal, or

( c ) the administration of any stilbene, stilbene derivative, their salts or esters, or any thyrostatic substance to an animal of any species.

9. A person shall not administer to an animal of any species, any stilbene, stilbene derivative, their salts or esters, or any thyrostatic substance, or any preparation consisting of or containing any such substance.

10. (1) A person shall not—

( a ) administer to a farm animal, by any means whatsoever, any substance having an oestrogenic, androgenic...

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