S.I. No. 218/1988 - European Communities (Control of Oestrogenic, Androgenic, Gestagenic and Thyrostatic Substances) Regulations, 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.

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

2.

"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.

4.

• (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.

6.

7.

8.

( 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.

10.

( a ) administer to a farm animal, by any means whatsoever, any substance having an oestrogenic, androgenic, gestagenic or thyrostatic action;

( b ) import, export, sell or slaughter a farm animal to which any of the above mentioned substances has been administered;

( c ) import, export or sell any meat of farm animals referred to in paragraph (b);

( d ) process meat referred to in paragraph (c) or import, export or sell any meat products prepared from or with any such meat.

• (2) ( a ) This paragraph applies to the following provisions, namely—

• (i) the Food Hygiene Regulations, 1950 ( S.I. No. 205 of 1950 );

• (ii) the Agricultural Produce (Fresh Meat) Acts, 1930 to 1988 and Regulations made thereunder;

• (iii) the Abattoirs Act, 1988 (No. 8 of 1988) and Regulations made thereunder;

• (iv) the Slaughter of Cattle and Sheep Acts, 1934 to 1936;

• (v) orders made under the Agricultural and Fishery Products (Regulation of Export) Act, 1947 (No. 18 of 1947);

• (vi) the European Communities (Fresh Meat) Regulations, 1987 ( S.I. No. 284 of 1987 );

• (vii) the European Communities (Fresh Poultry Meat) Regulations, 1976 to 1982;

• (viii) the Pigs and Bacon Acts, 1935 to 1988 and Regulations made thereunder.

( b ) Subject to Regulation 12, any farm animal to which any substance have oestrogenic, androgenic, gestagenic or thyrostatic action has been administered and any meat or meat product derived from such an animal, shall, for the purposes of the provisions to which this paragraph applies, be deemed to be unfit for human consumption.

11.

• (2) ( a ) Subject to sub-paragraph (b), the administration to a farm animal of any substance referred to in paragraph (1) shall, and shall only, be effected by a veterinary surgeon.

( b ) The synchronisation of oestrus and the preparation of donors and recipients for the implantation of embryos may be effected by a person who is not a veterinary surgeon if, but only if, such synchronisation or preparation is effected under the direct responsibility of a veterinary surgeon.

• (3) The administration to a farm animal of any substance referred to in paragraph (1) shall, and shall only, be effected in accordance with the provisions of the product authorisation granted or renewed in relation to such substance and in accordance with the provisions of the Council Directives.

• (4) The veterinary surgeon referred to in paragraph (2) shall keep a register detailing in chronological order at least the following particulars in relation to each administration of an authorised substance carried out under this Regulation:

( a ) the nature of the treatment;

( b ) the nature of the authorised substance;

( c ) the date of the treatment; and

( d ) the identity of the animal or animals treated.

• (5) Nothing in this Regulation shall be construed as permitting the administration of any authorised substance—

( a ) to a farm animal intended for fattening, or

( b ) to a reproductive farm animal during the fattening period following the end of its breeding life.

12.

( a ) the exportation, importation, sale or slaughter of a farm animal treated with an authorised substance,

( b ) the exportation, importation or sale of meat or meat products derived from such an animal, and

( c ) the processing of such meat,

may take place if, and only if—

• (i) the farm animal, or the farm animal from which the meat or meat product was derived, as the case may be, was treated in accordance with Regulation 11, and

• (ii) between the time of such treatment and the time of exportation, importation, sale or slaughter, as the case may be, the waiting period laid down pursuant to the Council Directives and the product authorisation had elapsed.

• (2) Notwithstanding paragraph (1) (b), the importation, exportation or sale of high value horses, particularly race-horses, competition horses, circus horses or horses intended for stud purposes or for exhibitions, including horses in these categories to which oral preparations containing allyl trenbolone have been administered for the purposes, other than therapeutic use, mentioned in Regulation 11 (1) may take place before the end of the waiting period provided that the nature and date of the treatment are mentioned on the certificate accompanying the horses.

13.

( a ) which is intended and labelled for, and capable of use for, purposes other than agricultural or veterinary purposes, and

( b ) in respect of which there is for the time being in force a product authorisation under the Medical Preparation (Licensing, Advertising and Sale) Regulations, 1984 ( S.I. No. 210 of 1984 ).

• (2) A person shall not have in his possession or under his control any substance to which this Regulation applies or anything to which Regulation 8 refers.

• (3) Paragraph (2) shall not apply to any authorised substance—

( a ) in the possession of a veterinary surgeon and required by him solely for the purposes of his professional practice;

( b ) in respect of which the product authorisation permits the use of such substance for one or more of the purposes set out in Regulation 11 (2) (b) and the substance is in the possession of a person intending to use or so using that substance for such purpose under the direct responsibility of a veterinary surgeon in accordance with that Regulation;

( c ) in the possession or under the control of any person for the purpose of the lawful sale of such substance by that person, provided that at the time of such possession or control he was lawfully entitled to sell such substance.

• (4) Paragraph (2) shall not apply to any substance, or to anything to which Regulation 8 refers, which is in the possession or under the control of—

( a ) any person who at the time of such possession or control is the holder of a manufacturer's licence and who requires the substance or thing for the manufacture of an authorised substance;

( b ) an authorised officer, an officer of the competent authority, a member of the Garda Síochána, an officer of Customs and Excise, the State Chemist, the Assistant State Chemist, an appointed person, or any other officer of the Minister, provided that such possession or control is for the purposes of executing and enforcing the hormone legislation;

( c ) any person authorised in writing by the Minister to have possession or control of that substance or thing, provided that such conditions as the Minister may have attached to that authorisation are being complied with.

14.

( a ) the manufacture of a substance having oestrogenic, androgenic, gestagenic, or thyrostatic action,

( b ) the importation or sale of any such substances, or

( c ) the production of pharmaceutical and veterinary products based on that substance—

shall—

• (i) apply to be registered by the Minister and furnish the following particulars to him in regard to such manufacture, importation or sale—

• (I) the name and address of the manufacturer, importer or seller,

• (II) in the case of a company, the address of the registered office,

• (III) the address of the premises at which the business of manufacture, importation, sale and storage of such substance is, or is to be, carried on,

• (IV) the names and active principles of the products being, or to be, manufactured, imported or sold;

• (ii) keep a register, detailing in chronological order, quantities manufactured, imported or otherwise acquired, and those sold or used as, or for the production of, pharmaceutical and veterinary products; and

• (iii) make such returns to the Minister as and when, and in such form, as the Minister may from time to time direct him to so do.

• (2) Notwithstanding paragraph (1) (i), a person engaged in the manufacture, importation or sale of substances to which paragraph (1) refers and who is carrying on such business on the date on which these Regulations come into force shall, within two calendar months of that date, apply to be registered and furnish to the Minister the particulars required to be furnished pursuant to paragraph (1) (i).

• (3) ( a ) The Minister shall cause to be kept a register for the purposes of this paragraph.

( b ) Subject to subparagraph (c), the Minister shall cause to be entered, in the register kept for the purposes of this paragraph, the name of the person applying to be registered, and the particulars furnished, under paragraphs (1) (i) or (2).

( c ) No person shall be registered by the Minister under this paragraph unless the person applying for registration is lawfully entitled (otherwise than by reference to this Regulation) to so manufacture, import or sell, as the case may be, the substance in relation to which the application to register refers.

( d ) A person who has been registered by the Minister and who is not so lawfully entitled to manufacture, import or sell, as the case may be, the substance in relation to which the registration relates, or who has ceased to be so entitled, shall be deemed to be, and shall so be, removed from the register by the Minister.

• (4) Subject to paragraph (2), no person shall engage in the manufacture, importation or sale of any substance to which paragraph (1) refers unless and until—

( a ) he has been registered by the Minister in accordance with paragraph (3), and

( b ) such registration has been confirmed to him in writing by the Minister.

• (5) The provisions of paragraph (1) (i) shall not apply to a person who engages in, or proposes to engage in, the sale of any substance to which paragraph (1) refers and who is—

( a ) an authorised person or a registered druggist within the meaning of the Poisons Regulations, 1982 [ S.I. No. 188 of 1982 ], or

( b ) a veterinary surgeon.

15.

( a ) the manufacture, importation, handling, storage, transport, distribution or sale of a prohibited substance is or has taken place in or on or under any land or premises or in or on any vehicle, or

( b ) a contravention of the hormone legislation or the Council Directives has taken place in or on or under any land or in or on any vehicle, or

( c ) any land or premises is used for or in connection with the production or fattening of farm animals, or

( d ) any land or premises is a slaughterhouse or is used for or in connection with the slaughter of farm animals, or

( e ) there is or was in or on any land or premises or vehicle, any animal of any species to which a prohibited or authorised substance is being or has been administered, or

( f ) there is or was in or on or under any land or premises or in or on any vehicle any prohibited or authorised substance or anything to which Regulation 8 refers, or

( g ) there is or was in or on or under any land or premises or in or on any vehicle any meat or meat product

he may stop any such vehicle, enter (if necessary by force) any such land or premises, or any land or premises used in connection with such land or premises or any such vehicle, and there, or at any other place, and with such members of the Garda Síochána or officers of Customs and Excise (if any) as he considers appropriate—

• (i) search for and examine, inspect or test any animals, meat, meat products or anything he believes to be an authorised or prohibited substance or anything to which Regulation 8 refers;

• (ii) take such specimens (including blood, urine, faeces, tissue, or remains of implants) from any animals, meat or meat product, and may for that purpose perform any procedure (including surgery) as he considers necessary on such animals, meat or meat products;

• (iii) take such reasonable samples of any substances or other thing which he may consider appropriate for the purposes of these Regulations;

• (iv) seize and detain anything to which Regulation 8 refers or anything which he believes to be or to contain a prohibited substance, or to be or to contain an authorised substance kept, used, or to be used in contravention of the provisions of the Council Directives or the hormone legislation;

• (v) search for and examine any document and take extracts from and copies of any such document;

• (vi) require any person whom he suspects to be, or to have been, engaged in manufacture, handling, storage, transport, distribution, sale or use of, or any person whom he suspects to have in his possession or under his control or to have kept or to keep any prohibited or authorised substance, meat or meat product or anything to which Regulation 8 refers, or any person whom he suspects to be, or to have been, engaged in rearing, keeping, fattening, transporting, or selling, or in possession or control of, any animal—

• (I) to produce to him any documents in his possession or control or any such substance, animal, meat or meat product or anything to which Regulation 8 refers,

• (II) to furnish to him any information in relation to such substance, animal, meat, meat product, document or thing which he may require (including the source of the substance, animal, meat, meat product, document or thing), and

• (vii) require any person, being the owner or the person in charge of animals, or the owner or occupier of, or employed in or on, lands or premises so entered, or the driver or occupant or person in apparent charge or control of any vehicle so stopped or entered, to give such assistance, to carry out such instructions and to give such information as may be reasonably necessary for the purposes of paragraph (i) to (vi).

16.

( a ) evidence of or relating to the commission or intended commission of an offence under the hormone legislation is to be found in or on or under any land, premises or vehicle, or in or on or under any other thing whatsoever, or

( b ) a person is in possession of any authorised or prohibited substance in contravention of the hormone legislation, or

( c ) there is or was or is intended to be in or on or under any land, premises or vehicle, or in or on or under any other thing whatsoever, any prohibited substance, or

( d ) there is or was or is intended to be in or on or under any land, premises or vehicle, or in or on or under any other thing whatsoever, any authorised substance in relation to which a contravention of the hormone legislation is or has been or is intended to be committed, or

( e ) that a document directly or indirectly relating to, or connected with, a transaction or dealing which was, or an intended transaction or dealing which would if carried out be, an offence under the hormone legislation is in the possession of a person on any premises or in any vehicle,

such Justice or Commissioner may issue a search warrant mentioned in paragraph (2).

• (2) A search warrant issued under this Regulation shall be expressed and operate to authorised a named authorised officer, named member of the Garda Síochána, or named officer of Customs and Excise accompanied by such other members or officers as may be necessary, at any time or times within one month of the date of issue of the warrant, to enter (if need be by force) the land, premises or vehicles named in the warrant, to search the land, premises or vehicle and any persons found therein, to examine any animal, meat, meat product, substance or anything found therein, to inspect any document found thereon and, if there is reasonable ground for suspecting that an offence is being, or has been, or is intended to be committed under or in relation to the hormone legislation, or that such animal, meat, meat product, substance, thing or document may be required as evidence in proceedings for an offence under or in relation to the hormone legislation, to seize and detain such animal, meat, meat product, substance, thing, or document as the case may be.

• (3) Where any premises, land or vehicle is entered pursuant to a warrant issued under this Regulation, an authorised officer, a member of the Garda Síochána or an officer of Customs and Excise so entering may do either or all of the following:

( a ) stop and detain any person or persons found in, on or under such land, premises, or vehicle for the purpose of searching him or them;

( b ) exercise any or all of the powers referred to in Regulation 15.

17.

18.

• (2) Nothing in these Regulations shall operate to prejudice any power to search, or to seize or detain property, which may be exercised by an authorised officer, a member of the Garda Síochána or an officer of Customs and Excise apart from these Regulations.

• (3) The provisions of paragraph (1) shall, insofar as they relate to the application of the Police (Property) Act, 1897, be without prejudice to the application of Regulations 22,23, 24 and 32 to the thing so seized.

19.

( a ) an authorised officer has reasonable grounds to suspect that a contravention of the hormone legislation is being or has been committed in relation to any animal, meat, meat product, prohibited substance or authorised substance, or

( b ) in relation to a test carried out on any sample taken from any farm animal, meat or meat product there has been a result indicating that—

• (i) a prohibited substance was used in such animal or the animal from which such meat or meat product was derived, or

• (ii) residue of an authorised substance has been found either—

• (I) exceeding the maximum natural physiological level for the authorised substance, or

• (II) proving that such authorised substance was used abusively in such animal,

then an authorised officer may, by a notice in writing served on the owner or occupier of any land or premises or vehicle in or on which such animal, meat or meat product or such substance have been or happen to be, or on the owner or person in charge or control of such animal, meat or meat product or substance—

• (A) prohibit, except under and in accordance with a permit issued for the purposes of paragraph (6), the movement of all farm animals, meat or meat products, or such farm animal, meat or meat product as is or are specified in the notice, from such land or premises or vehicle or any part thereof as is or are so specified;

• (B) prohibit, except under and in accordance with a permit issued for the purposes of paragraph (6), the movement of all farm animals, meat or meat products into such land or premises or vehicle or any part thereof as is or are so specified;

• (C) require such person to comply with such other restriction of movement as may be so specified.

• (2) An authorised officer may by a notice in writing served on such owner, occupier or person in charge vary any notice served under paragraph (1).

• (3) A notice served under paragraph (1) or varied under paragraph (2) shall remain in force until it is withdrawn by an authorised officer by a notice in writing.

• (4) No person shall move any animal, meat or meat product in contravention of a notice served under this Regulation.

• (5) A notice under this Regulation may be served on the person to be affected thereby, either by delivering it to him personally, or by leaving it for him at his last known place of abode or business, or by sending it through the post in a prepaid envelope addressed to him there.

• (6) An authorised officer may issue permits for the purposes of this Regulation and may attach to such permits any conditions (including conditions to be fulfilled after the animal to which the permit relates has been moved) which he considers appropriate.

20.

( a ) where there is on that land or premises an animal in respect of which an identity card has been issued, any person having the charge or control of such identity card shall surrender the card to an authorised officer, and

( b ) the owner or occupier of that land shall make a declaration in writing, in the form specified in the notice served on him, of the number, type and species of all farm animals on such land or premises.

• (2) Where a notice has been served on the owner or person in charge of an animal in accordance with Regulation 19 then that person shall—

( a ) surrender to an authorised officer every identity card issued in respect of all animals of which he is the owner or person in charge; and

( b ) such person shall make a declaration in writing, in the form specified in the notice served on him, of all land or premises of which he is the owner or occupier and of the number, type, and species of all farm animals on such land or premises.

21.

( a ) there are reasonable grounds to believe that a prohibited substance had been administered or an analysis has revealed the presence of a prohibited substance, or

( b ) there are reasonable grounds to believe or it has been established that a condition of use of an authorised substance has not been complied with

then—

• (i) that animal and every farm animal at the farm of origin of such animal shall be marked by or under the direction of an authorised officer in one of the manners provided for in the Schedule, and

• (ii) in the case of subparagraph (a), an authorised officer shall serve a notice on the owner or person in charge of the animal and on the owner or person in charge of every farm animal at the farm of origin of such animal prohibiting the use of such animals for human or animal consumption, and

• (iii) in the case of subparagraph (b), an authorised officer shall serve a notice on the owner or person in charge of the animal and on the owner or person in charge of every farm animal at the farm of origin of such animal prohibiting the use of such animal for human consumption.

• (2) ( a ) An authorised officer may by a notice in writing served on such owner or person in charge vary, in relation to the animals to which it applies, any notice served under paragraph (1).

( b ) A notice served under paragraph (1) or varied under subparagraph (a) shall remain in force until it is withdrawn by an authorised officer by a notice in writing.

( c ) Notwithstanding subparagraphs (a) and (b), a notice shall not be varied or withdrawn in relation to any animal in respect of which an analysis has revealed the presence of a prohibited substance or in respect of which it has been established that the conditions of use of an authorised substance have not been complied with.

• (3) A person shall not mark a farm animal in any of the manners provided for in the Schedule other than under and in accordance with paragraph (1).

• (4) A person shall not have in his possession or under his control any farm animal marked in any of the manners provided for in the Schedule to these Regulations other than—

( a ) a person who was the owner or person in charge of the animal at the time the notice under this Regulation was served;

( b ) such other person as may be authorised in writing by an authorised officer; and

( c ) an authorised officer.

• (5) A person other than an authorised officer shall not purchase or sell or move into or from any farm, slaughterhouse, mart or other premises a farm animal bearing a mark provided for in the Schedule, otherwise than under and in accordance with a permit issued for the purposes of paragraph (9).

• (6) No person shall use any animal for human or animal consumption in contravention of a notice served under this Regulation.

• (7) No person shall slaughter any farm animal, or use any meat or meat product derived from such animal, for human consumption where such animal is an animal bearing a mark provided for in the Schedule.

• (8) A notice under this Regulation may be served on the person to be affected thereby, either by delivering it to him personally, or by leaving it for him at his last known place of abode or business, or by sending it through the post in a prepaid envelope addressed to him there.

• (9) An authorised officer may issue permits for the purposes of this Regulation and may attach to such permits any conditions (including conditions to be fulfilled after the animal to which the permit relates has been purchased or sold or moved) which he considers appropriate,

22.

( a ) with the consent of the owner of the animal, destroy or cause to be destroyed the animal and its carcase in such manner as the Minister may direct, or

( b ) make application to the District Court for destruction of the animal and its carcase in accordance with the provisions of this Regulation.

• (2) ( a ) Notice of an application made pursuant to paragraph (1) shall be served on the owner or person in charge for the time being of the animal to which paragraph (1) relates at least seven days prior to the hearing of the application.

( b ) The owner or person in charge of the animal to which paragraph (1) relates shall be entitled to be heard and to adduce evidence at the hearing of the application brought under paragraph (1).

• (3) Where an application is made to the District Court under paragraph (1) that Court, if it is satisfied in relation to the animal to which the application relates—

( a ) that either—

• (i) a prohibited substance had been administered to or detected in such animal, or

• (ii) it has been established that the conditions of use of an authorised substance have not been complied with,

and

( b ) that either—

• (i) in the case of subparagraph (a) (i), there are reasonable grounds to believe that the animal will be used for human or animal consumption, or

• (ii) in the case of subparagraph (a) (ii), there are reasonable grounds to believe that the animal will be used for human consumption, or

• (iii) having regard to the type of animal and the purpose for which it was being kept, there is no practical use (other than a use for human consumption or a use, in the case of subparagraph (a) (i), for animal consumption) to which such animal or its carcase could be put by a reasonable farmer acting in accordance with good farming practice,

then such Court shall order the destruction of such animal and its carcase within the time specified in such Order and in such manner as—

• (I) in the case of subparagraph (a) (i), will prevent the animal or its carcase being used for human or animal consumption, or

• (II) in any other case, will prevent the animal or its carcase being used for human consumption.

• (4) ( a ) Either party aggrieved by the Order made by the District Court on determining an application under this Regulation may, not later than the expiration of the period of seven days beginning on the date of the Order, appeal therefrom to the Judge of the Circuit Court within whose circuit is situate the courthouse in which the decision of the District Court was given, and the decision of the Judge on such appeal shall be final.

( b ) Notice of an appeal made pursuant to subparagraph (a) of this paragraph shall be served on the other party at least seven days prior to the hearing of the appeal by the Circuit Court.

( c ) The notice of appeal shall contain a statement of the grounds upon which it is alleged that the Order or any of the terms thereof are not justified.

( d ) A copy of the notice of appeal shall be lodged with the Circuit Court Clerk at least seven days prior to the hearing of the appeal.

( e ) The other party shall, as well as the appellant, be entitled to be heard and to adduce evidence at the hearing of an appeal brought under subparagraph (a).

• (5) On the hearing of an appeal under paragraph (4) the Judge of the Circuit Court may, at his discretion, confirm, with or without modification, or annul the Order of the District Court.

• (6) ( a ) Where an Order is made under this Regulation, a person shall not sell, move, dispose of or otherwise interfere or deal with the animal concerned other than in accordance with that Order.

( b ) In the event of an appeal, pursuant to paragraph (4), no person, including the person appealing, shall sell, move, dispose of or otherwise interfere or deal with the animal concerned pending the determination of the appeal otherwise than in accordance with the consent in writing of an authorised officer.

( c ) Where the terms of an Order referred to in paragraph (3) are confirmed with or without modification by the Judge of the Circuit Court hearing the appeal made under paragraph (4), no person, including the person who made the appeal, shall sell, move, dispose of or otherwise interfere or deal with the animal or carcase concerned other than in accordance with such Order as confirmed.

• (7) Where an Order made under paragraph (3) or (5) requires the animal or carcase to which it relates to be disposed of by an authorised officer or where the Order requires or indicates that the animal or carcase be disposed of at the expense of the owner, or where the consent of the owner of the animal has been obtained to destroy such animal, the cost of destruction and disposal shall be recoverable by the Minister as a simple contract debt in any court of competent jurisdiction from the person who was the owner of the animal at the time the order was made or consent was obtained.

• (8) ( a ) In this Regulation "District Court" means the Justice of the District Court having jurisdiction in the District Court District where the animal is situated or the Justice of the District Court having jurisdiction in the District Court District where the owner or person in charge of the animal ordinarily resides or carries on business.

( b ) For the purposes of subparagraph (a), an animal shall be deemed to be situated within a District Court District if it is situated on a farm or premises which lies wholly or partly within such District.

23.

( a ) require any thing specified in the notice to be done in relation to such substance or thing, before it is released by an authorised officer, a member of the Garda Síochána or an officer of Customs and Excise, and

( b ) either—

• (i) require the disposal of such substance or thing, by the person to whom the notice is given, in a manner specified in the notice and at the expense of the owner, or

• (ii) indicate the officer's or member's intention of disposing of such substance or thing, at the expense of the owner,

such disposal to be, in either case, such as will prevent the said substance from being administered to, or otherwise used in connection with, animals or the said thing from being used in contravention of Regulation 8,

and where a notice under this paragraph requires a specified thing to be done in relation to such substance or thing, an authorised officer, member of the Garda Síochána or officer of Customs and Excise shall retain control of the substance or thing to which the notice relates until the requirements of the notice have been duly complied with.

• (2) Where a notice is given under this Regulation, a person shall not, without the consent of the officer or member by whom the notice was given, sell, move, dispose of or otherwise interfere or deal with the substance or thing in any way, pending compliance with the requirements of the notice.

• (3) Any person who is aggrieved by a notice under this Regulation which either requires the substance or thing to which it relates to be disposed of or indicates an intention to dispose of such substance or thing, may not later than the expiration of the period of seven days beginning on the date of the notice, appeal to the District Court against the notice.

• (4) ( a ) Notice of an appeal made pursuant to paragraph (3) shall be served on the officer or member concerned and on the Minister at least seven days prior to the hearing of the application.

( b ) The officer or member concerned and the Minister shall be entitled to be heard and to adduce evidence at the hearing of the appeal brought under paragraph (3).

• (5) ( a ) Where an appeal is made to the District Court under paragraph (3), that Court, if it is satisfied that—

• (i) the substance or thing, to which the relevant notice under this Regulation relates, is one to which these Regulations apply, and

• (ii) (I) if such substance or thing were released, it might be used in a manner or for purposes not authorised under these Regulations, or

• (II) there has been a failure in relation to such substance or thing to comply with the provisions of these Regulations,

shall order that the substance or thing be disposed of in the manner specified in the notice, or in such other manner as may be directed by the Court and which, in the opinion of the Court, will prevent the substance from being administered to or otherwise used in connection with animals or the thing from being used in contravention of Regulation 8.

( b ) Where an order made by the District Court under this paragraph requires the substance or thing to which it relates to be disposed of by an authorised officer, a member of the Garda Síochána, or an officer of Customs and Excise or where a notice has been given under paragraph 1 (b) (ii) requiring or indicating that the said substance or thing be disposed of at the expense of the owner, the cost of such disposal shall be recoverable by the Minister as a simple contract debt in any court of competent jurisdiction from the person who was the owner of the substance or thing at the time of its seizure and detention under these Regulations.

• (6) A notice under this Regulation shall not come into force unless:—

( a ) in case an appeal is taken to the District Court against the notice, the appeal is withdrawn.

( b ) in any other case, the period during which such an appeal may be taken has expired.

• (7) ( a ) In this Regulation "District Court" means the Justice of the District Court having jurisdiction in the District Court District where the substance or thing was situated at the time of seizure or detention, or the Justice of the District Court having jurisdiction in the District Court District where the owner or person in charge of the substance or thing at such time ordinarily resides or carries on business.

( b ) For the purposes of subparagraph (a), a substance or thing shall be deemed to be situated within a District Court District if it is situated on a farm or premises which lies wholly or partly within such District.

24.

• (2) Where a prohibited substance has been administered to a farm animal, the carcase of such animal and any meat or meat product derived from such an animal may, for the purpose of the destruction or disposal of such carcase, meat or meat product, and notwithstanding that the carcase, meat or meat product is not intended for human consumption, be dealt with in accordance with the provisions set out in Regulation 10 (2) as meat intended for human consumption and unfit for such purpose.

25.

• (2) A person shall not, without lawful authority or excuse, tamper with, remove or alter a mark on any farm animal, nor sell any such animal knowing the mark to have been tampered with, removed or altered.

• (3) A person shall not, knowing it to be such, have in his possession or under his control—

( a ) a farm animal bearing a mark which has been tampered with or altered without lawful authority or excuse,

( b ) a farm animal in respect of which a mark has been removed without lawful authority or excuse, or

( c ) a document which has been altered without lawful authority or excuse or forged.

• (4) Paragraph (3) shall not apply in relation to any person to which Regulation 13 (4) (b) and (c) refers.

• (5) In this Regulation—

( a ) any reference to a document issued for the purposes of these Regulations means a notice, permit, register, label, package insert, identity card, or other document issued or kept for the purposes of these Regulations and includes any entry in any such document, and

( b ) "mark" means a mark provided for in the Schedule.

26.

• (2) Regulations 3, 6, 7 and 14 shall not apply in relation to the importation or sale of any medical preparation intended for use in human beings and in respect of which the Minister for Health has granted or renewed a product authorisation under the provisions of the Medical Preparations (Licensing, Advertising and Sale) Regulations, 1984.

27.

( a ) purports to be signed by the State Chemist or the Assistant State Chemist or by a person (in this Regulation referred to as an "appointed person") appointed by the Minister for the purposes of these Regulations, and

( b ) states that the certificate is given for the purposes of these Regulations, and

( c ) certifies—

• (i) that an examination, test or analysis of a particular sample submitted by an authorised officer, a member of the Garda Síochána or an officer of Customs and Excise was carried out, and

• (ii) the result of such examination, test or analysis

then such certificate shall, without proof of the signature of the person purporting to sign it, or, in case the certificate purports to be signed by an appointed person, proof that at the time at which the certificate purports to have been given, such person stood appointed as an appointed person, be evidence for all purposes that such test, examination or analysis was carried out and of such result unless the defendant requires the person who made the analysis to be called as a witness.

• (2) ( a ) The Minister may by an instrument in writing appoint a person to issue certificates for the purpose of these Regulations.

( b ) An appointment under this Regulation shall remain in force until it is withdrawn by the Minister by an instrument in writing.

28.

( a ) (i) purports to be signed by the Secretary of the competent authority or by a person appointed by that authority for that purpose, and

• (ii) states that the certificate is given for the purposes of these Regulations, and

• (iii) certifies that in the case of a particular substance, a manufacturer's licence or a product authorisation, as the case may be, has not been granted by the competent authority,

or

( b ) (i) purports to be signed by a person authorised by the Minister for Health for that purpose, and

• (ii) states that the certificate is given for the purposes of these Regulations, and

• (iii) certifies that in the case of a particular substance, a manufacturer's licence or a product authorisation, as the case may be, has not been granted by the said Minister

then such certificate shall, without proof of the signature of the person purporting to sign it, or, in case the certificate purports to be signed by a person appointed by the competent authority or authorised by the said Minister, proof that at the time at which the certificate purports to have been given, such person stood so appointed or authorised, be evidence for all purposes that such licence or authorisation was not granted unless the defendant requires the person who issued the certificate to be called as a witness.

29.

• (2) A person appointed under this Regulation shall be furnished with a warrant of his appointment as an authorised officer and when exercising any power conferred on an authorised officer by these Regulations shall, if requested by a person affected, produce the warrant to that person.

• (3) An appointment under this Regulation shall remain in force until it is withdrawn by the Minister by an instrument in writing.

30.

31.

( a ) in the case of a sale of a farm animal, such farm animal was not treated with any prohibited or authorised substance, and in the case of an agreement to sell a farm animal, such farm animal was not so treated and will not be so treated prior to the time when the property is to pass, and

( b ) in the case of a sale of, or an agreement to sell, meat or meat product, the farm animal from which such meat or meat product was derived had not been treated with any prohibited substance.

• (2) Any term of a contract implied by virtue of paragraph (1) may be negatived or varied insofar as it relates to an authorised substance by an express term of the contract, provided that the express term is fair and reasonable and has been specifically brought to the attention of the buyer.

• (3) Any term of a contract implied by virtue of paragraph (1) may not be negatived or varied insofar as it relates to a prohibited substance.

32.

• (2) A person who obstructs or impedes an authorised officer, a member of the Garda Síochána or an officer of Customs and Excise in the exercise of any of the powers conferred on him under these Regulations shall be guilty of an offence.

• (3) A person who fails to comply with any notice under Regulations 19, 21, or 23 shall be guilty of an offence.

• (4) A person who fails to comply with any condition attached to a permit issued under Regulation 13, 19 or 21 shall be guilty of an offence.

• (5) A person who fails to comply with any requisition under Regulation 15 shall be guilty of an offence.

• (6) A person guilty of an offence under these Regulations shall be liable on summary conviction to a fine not exceeding £1,000, or, at the discretion of the Court, to imprisonment for a term not exceeding one year or to both such fine and such imprisonment.

• (7) Without prejudice to Regulation 23, the Court—

( a ) may, at its discretion, order the forfeiture of any authorised substance in relation to which an offence has been committed, or make such other order as, having regard to Regulation 23, seems appropriate, and

( b ) shall order the forfeiture of—

• (i) any prohibited substance in relation to which an offence has been committed, and

• (ii) any thing to which Regulation 8 refers in relation to which an offence has been committed.

• (8) Notwithstanding section 10 (4) of the Petty Sessions (Ireland) Act, 1851 (1851, c. 53), proceedings for an offence under these Regulations may be instituted at any time within two years after the date of the offence.

33.

34.

• (1) the European Communities (Veterinary Medicinal Products) Regulations, 1986, and

• (2) the Animal Remedies Act, 1956 and regulations made thereunder, and

• (3) the Poisons Regulations, 1982 to 1986.

SCHEDULE

GIVEN under my Official Seal this 2nd day of September, 1988.

MICHAEL O'KENNEDY,

Minister for Agriculture and Food.

EXPLANATORY NOTE.

These Regulations control the importation, manufacture, sale, administration and possession of substances having an oestrogenic, androgenic, gestagenic or thyrostatic action. They also provide for control and disposal of animals and of meat and meat products derived from animals unlawfully treated with such substances.