S.I. No. 257/1985 - Poisons (Control of Residues in Foods of Animal Origin) Regulations, 1985.

S.I. No. 257 of 1985.

POISONS (CONTROL OF RESIDUES IN FOODS OF ANIMAL ORIGIN) REGULATIONS, 1985.

I, AUSTIN DEASY, Minister for Agriculture, in exercise of the powers conferred on me by sections 15 and 15A (inserted by the Misuse of Drugs Act, 1977 (No. 12 of 1977)) of the Poisons Act, 1961 (No. 12 of 1961), and after consultation with Comhairle na Nimheanna, hereby make the following regulations:

1. These Regulations may be cited as the Poisons (Control of Residues in Foods of Animal Origin) Regulations, 1985.

2. These Regulations shall come into operation in accordance with the timetable set out in the Fourth Schedule to these Regulations.

3. (1) These Regulations are in addition to and not in substitution for the following Regulations—

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

(b) Regulations 3 and 4 of the European Communities (Control of Oestrogenic, Androgenic, Gestagenic and Thyrostatic Substances) Regulations, 1982 ( S.I. No. 282 of 1982 );

(c) the European Communities (Feeding-Stuffs) (Additives) Regulations, 1974 ( S.I. No. 302 of 1974 ), as amended;

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

(2) (a) In this paragraph—

"the Council Directive" means Council Directive 70/524/EEC¹ of 23 November, 1970 concerning additives in feeding-stuffs, as amended;

¹O.J. No. L270, 14.12.1970, p. 1.

"additives" and "feeding-stuffs" have the meaning assigned to them by the Council Directive.

(b) These Regulations, insofar as they regulate the presence or absence of additives and marking do not apply to additives in feeding-stuffs at the levels and under the conditions permitted by the Council Directive.

(3) Nothing in these Regulations shall be construed as amending or revoking the Regulations set out in paragraph (1).

4. (1) In these Regulations, except where the context otherwise requires—

"the Act" means the Poisons Acts, 1961 and 1977;

"administration" includes in relation to an animal, oral, parenteral and topical administration or application, and administration or application by inhalation or by incorporation in food or water or by means of automatic machines or processes;

"animal" means an animal of the bovine, ovine, caprine, equine or porcine species or poultry or rabbits or deer where such rabbits or deer are intended for use as food for human consumption;

"approved method" has the meaning assigned to it by Regulation 23;

"authorised person" has the meaning assigned to it by Regulation 21;

"Bovine Tuberculosis and Brucellosis Orders" means the Bovine Tuberculosis (Attestation of the State and General Provisions) Order, 1978 ( S.I. No. 256 of 1978 ), and the Brucellosis in Cattle (General Provisions) Order, 1980 ( S.I. No. 286 of 1980 ), and includes any Order amending those Orders;

"District Veterinary Office" has the meaning assigned to it by the Bovine Tuberculosis and Brucellosis Orders;

"identity card" has the meaning assigned to it by the Bovine Tuberculosis and Brucellosis Orders

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

"meat" means any part of the carcase or offals of an animal;

"the Minister" means the Minister for Agriculture;

"offal" means any part an an animal (other than its carcase) which is capable of use as food for human consumption, and includes blood and any constituent of blood;

"permit" has the meaning assigned to it by the Bovine Tuberculosis and Brucellosis Orders;

"parenteral administration" includes administration or application by the intra mammary, intra vaginal, intra uterine or per rectum routes or by injection;

"restricted holding" has the meaning assigned to it by the Bovine Tuberculosis and Brucellosis Orders;

"to sell" includes offer, expose or keep for sale, invite an offer to buy or distribute for reward and cognate words shall be construed accordingly;

the word "tissues" includes bodily fluids;

"withdrawal period" means the period between the time at which the administration of a poison to an animal takes place, and the time at which the levels of the poison thereby introduced into that animal and the metabolites of that poison fall below a level detectable by all methods (being approved methods for the detection of such poison or metabolite) in the tissues, secreta or excreta of that animal, or, where that poison or metabolite is to be found naturally, (that is to say other than as a result of a pathological condition or as a result of the administration of a poison) in such tissue, secreta or excreta, to or below a level encountered in animals of that type;

"Veterinary Medicines Record" has the meaning assigned to it by Regulation 19;

"Veterinary Medicines Register" has the meaning assigned to it by Regulation 19;

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

(2) 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 a subparagraph shall be construed as a reference to a paragraph or a subparagraph of that Regulation, unless it is indicated that a reference to some other provision is intended.

5. The substances set out in the First Schedule are hereby declared to be poisons for the purposes of these Regulations.

6. (1) Subject to paragraph (2), the administration to any animal, or the use in any other way in connection with any animal, of any preparation or poison specified in Part I, II or III of the First Schedule shall be effected only—

(a) by, or under the direct supervision of a veterinary surgeon in relation only to animals under his professional care, or

(b) except in the case of a preparation or poison specified in the said Part I, in accordance with the terms of a prescription given by a veterinary surgeon and under the guidance of such person or class of persons as the veterinary surgeon states in the prescription as appropriate to that administration.

(2) Paragraph (1) shall not apply to the administration of any poison—

(a) which is a poison set out in Part III of the First Schedule and which consists of or is contained in a preparation marketed, and intended for use and is so used exclusively, as an intramammary preparation for the treatment or prevention of mastitis in animals and clearly labelled with a notice to that effect, and

(b) which is clearly labelled with a notice stating the manner of administration and the dose rate and withdrawal period to be observed.

(3) Paragraph (1) shall apply to any poison to which Regulation 5 of the European Communities (Control of Oestrogenic, Androgenic, Gestagenic and Thyrostatic Substances) Regulations, 1982, refers.

(4) In this Regulation "direct supervision" means in relation to the administration of a poison or a preparation, the physical presence of the veterinary surgeon actually supervising such administration and kindred words shall be construed accordingly.

7. A person shall not administer to an animal, nor use in any other way in connection with an animal, any preparation or poison specified in Part IV of the First Schedule.

8. (1) Subject to paragraphs (2) and (4), a person shall not, for the purpose of growth promotion, administer to any animal, or use in any other way in connection with an animal, any poison set out in paragraph 1 of Part I of the First Schedule.

(2) Paragraph (1) shall not apply to any animal to which Regulation 17 applies.

(3) It shall be presumed until the contrary is proved where a person administers (or uses in any other way in connection with an animal) a poison, that such person administered (or used in any other way) such poison for the purposes of growth promotion.

(4) (a) Notwithstanding the provisions of this Regulation the Minister may by licence permit the administration to an animal, or the use in any other way in connection with that animal, of a poison set out in paragraph 1 of Part I of the First Schedule for the purposes of growth promotion.

(b) The Minister shall not grant a licence under this paragraph unless he is satisfied that such administration or other use is to be carried out for the purpose of and in the interests of scientific research.

(c) The Minister may attach such conditions appropriate to any licence granted under this paragraph (including conditions requiring the identification and testing of the animal and prohibiting the use or sale of its meat, milk, eggs or other tissue as food for human consumption), may vary such conditions and may revoke any such licence.

9. A preparation consisting of or containing a poison specified in the first column of the Second Schedule at any reference number shall be administered to an animal only in the manner (if any) specified in the second column of that Schedule at that reference number and subject to such special conditions (if any) as are specified in the third column of that Schedule at that reference number.

10. (1) A person shall neither sell nor purchase an animal intended for immediate slaughter for human consumption unless the withdrawal period of any poison administered to that animal has elapsed.

(2) In any proceedings for an offence in which a contravention of this Regulation is alleged it shall be a good defence for the defendant to show that—

(a) (i) he purchased the animal to which the alleged contravention relates from a particular person or persons that he can identify in the bona fide belief after due enquiry at the time of purchase that all (if any) withdrawal periods in respect of that animal had elapsed and

(ii) subsequent to the purchase no such poison was administered to that animal (other than a preparation in respect of which the defendant has a defence under subparagraph (b) ), or

(b) (i) a preparation that he can identify was administered to the animal which consisted of or contained a poison in respect of which the alleged offence was capable of having been committed, and

(ii) (I) the prescription granted under Regulation 15 or the information given under Regulation 19 (3) (which prescription or information related to such administration) contained a recommended withdrawal period, or

(II) where subparagraph (b) (ii) (I) is not applicable, the container in which the said preparation was presented or any outer wrapper thereon bore a notice clearly indicating a recommended withdrawal period, and

(iii) it was reasonable for him at the time of the alleged offence to consider that such recommended withdrawal period was the withdrawal period required by these Regulations to be observed, and

(iv) he observed such recommended withdrawal period, and

(v) such recommended withdrawal period was not the withdrawal period required by these Regulations to be observed, and

(vi) no other preparation which consisted of or contained a poison in respect of which the alleged offence was capable of being committed had been administered to the animal (other than a preparation in respect of which the defendant has a defence under subparagraph (a)).

(3) For the purposes of this Regulation—

(a) a person who slaughters an animal with a view to purchasing its carcase shall be deemed to have purchased the animal at the time it was delivered for slaughter, and

(b) a person who delivers an animal for slaughter with a view to the sale of its carcase to another person shall be deemed to have sold the animal to that other person at the time of such delivery.

11. (1) A person shall not slaughter an animal intended for human consumption unless the withdrawal period of any poison administered to that animal has elapsed.

(2) In any proceedings for an offence in which a contravention of this Regulation is alleged it shall be good defence for the defendant to show that—

(a) (i) he took delivery of the animal to which the alleged contravention relates from a particular person or persons that he can identify in the bona fide belief after due enquiry at the time of delivery that all (if any) withdrawal periods in respect of that animal had elapsed, and

(ii) subsequent to the delivery no such poison was administered to that animal (other than a preparation in respect of which the defendant has a defence under subparagraph (b) ), or (b) (i) a preparation that he can identify was administered to the animal which consisted of or contained a poison in respect of which the alleged offence was capable of having been committed, and

(ii) (I) the prescription granted under Regulation 15 or the information given under Regulation 19 (3) (which prescription or information related to such administration) contained a recommended withdrawal period, or

(II) where subparagraph (b) (ii) (I) is not applicable, the container in which the said preparation was presented or any outer wrapper thereon bore a notice clearly indicating a recommended withdrawal period, and

(iii) it was reasonable for him at the time of the alleged offence to consider that such recommended withdrawal period was the withdrawal period required by these Regulations to be observed, and

(iv) he observed such recommended withdrawal period, and

(v) such recommended withdrawal period was not the withdrawal period required by these Regulations to be observed, and

(vi) no other preparation which consisted of or contained a poison in respect of which the alleged offence was capable of being committed had been administered to the animal (other than a preparation in respect of which the defendant has a defence under subparagraph (a)).

12. (1) A person shall not sell for the purpose of human consumption the milk of any animal unless the withdrawal period of any poison administered to that animal had elapsed prior to the milking of the animal from which the milk was derived.

(2) A person shall not sell for the purpose of human consumption the egg of any poultry unless the withdrawal period of any poison administered to the poultry had elapsed prior to the egg being laid.

(3) A person shall not sell for the purpose of human consumption the meat of any animal unless the withdrawal period of any poison administered to the animal had elapsed prior to the slaughter of that animal.

(4) In any proceedings for an offence in which a contravention of this Regulation is alleged it shall be a good defence for the defendant to show that he purchased the milk, meat or egg (as the case may be) to which the alleged contravention relates from a particular person or persons that he can identify in the bona fide belief after due enquiry at the time of purchase that all (if any) withdrawal periods in respect of the animals from which that milk, meat or egg was derived had elapsed prior to the milking of any animal for such milk, slaughtering of any animal for such meat or before the laying of such egg.

13. (1) In any proceedings for an offence under Regulations 10, 11, 12 or 16 where the prosecution proves that—

(a) in any case where a poison or a metabolite of that poison is to be found naturally (that is to say other than as a result of a pathological condition or as a result of the administration of a poison) in any meat or other tissue, milk, egg, secreta or excreta, such poison or a metabolite of that poison was present at a level in excess of the level to be found naturally in such meat or other tissue, milk, egg secreta or excreta, or

(b) in any case where a poison is not to be found naturally a poison or a metabolite of a poison was found by an approved method in any meat or other tissue, milk, egg, secreta or excreta,

it shall be presumed that at the time when the sample of such meat or other tissue, milk, egg, secreta or excreta was taken, until the contrary is shown, any withdrawal periods in respect of the said poison had not elapsed.

(2) For the purposes of this Regulation it shall be presumed until the contrary is proved that—

(a) in relation to a sample of meat or other tissue taken from a dead animal or any part of its carcase or offals, the level of poison, if any, is the same at the time when the animal died, and at the time the sample was taken and the time at which the sample was analysed, and

(b) in relation to a sample of milk or other secretion or egg or any excretion, the level of poison, if any, is the same at the time when the secretion or excretion was made and at the time the sample was taken and the time at which the sample was analysed.

14. (1) Subject to Regulation 3 and to paragraph (2), a person shall not incorporate a poison specified in Part I, II, III or IV of the First Schedule, or any thing containing such a poison, in any food for an animal, or cause or permit such a poison to be so incorporated.

(2) Paragraph (1) shall not apply to a poison specified in Part I, II or III of the First Schedule where such incorporation is by virtue of and in accordance with the terms of a prescription granted by a veterinary surgeon or a licence granted by the Minister in that behalf.

(3) The Minister may for the purposes of paragraph (2) grant a licence, attach conditions appropriate to any licence so granted, vary such conditions and revoke any such licence.

15. (1) This Regulation applies to a prescription by a veterinary surgeon to a person for the administration to any animal of a poison specified in Part II or III of the First Schedule.

(2) A veterinary surgeon shall not grant a prescription to which this Regulation applies unless—

( a ) the animals to which the prescription relates are under his professional care, and

( b ) he is satisfied that the prescription will be used (by the person to whom the prescription is granted) for such animals.

(3) A prescription to which this Regulation applies shall be in writing and shall contain at least the following particulars—

(a) the name of the poison to be administered;

(b) the manner and site of administration;

(c) the dose rate and withdrawal period to be observed;

(d) a description of the animal or animals to which the prescription relates;

(e) the person or class of persons by whom the poison is to be administered;

(f) the name and address of the person to whom the prescription has been granted;

(g) the name, address and signature of the veterinary surgeon granting the prescription;

( h ) the period during which, and the number of administrations for which, the prescription is valid; and

(i) a declaration that the prescription is granted in respect of an animal or animals under his professional care and in accordance with the directions (if any) of the Minister.

16. (1) This Regulation applies to any preparation which consists of or contains a poison,other than a poison specified in Part IV of the First Schedule, and which is intended for administration to or for use in any other way in connection with, an animal.

(2) A person shall not promote (by means of advertising or otherwise) the use of a preparation to which this Regulation applies in or on an animal unless—

(a) that preparation is clearly labelled with, or accompanied by, a notice indicating—

(i) the purpose for which the preparation is intended to be used;

(ii) the manner of administration and

(iii) the dose rate and withdrawal period to be observed, and

(b) the person has reasonable grounds for believing that the withdrawal period indicated is correct having regard in particular to the preparation, its intended purpose, the manner of its intended administration and the dose rate indicated.

(3) This Regulation shall not apply to scientific information published or caused to be published for bona fide scientific purposes by a university or professional or scientific institution or association.

(4) For the purposes of paragraph (2) of this Regulation a withdrawal period indicated on the label of or notice accompanying the preparation as the case may be shall be deemed to be correct if—

(a) the period indicated on the label or notice as the case may be is equal to or in excess of the withdrawal period required by these Regulations to be observed,

(b) no withdrawal period need be observed by virtue of these Regulations then either—

(i) the preparation is clearly labelled with or accompanied by a notice indicating that there is no withdrawal period, or

(ii) the preparation is clearly labelled with or accompanied by a notice indicating the period of time to be observed as a withdrawal period.

17. (1) This Regulation applies to—

(a) an animal of 6 weeks of age or older in respect of which an identity card has been issued, and

(b) (i) any preparation or poison specified in Part I of the First Schedule, or

(ii) any preparation set out in, or consisting of or containing any poison set out in, Part II or Part III of the First Schedule whose withdrawal period is 120 hours or greater.

(2) Notwithstanding the provisions of paragraph (1), this Regulation shall not apply to a preparation to which paragraph (2) of Regulation 6 applies.

(3) A veterinary surgeon shall not administer to an animal, or use in any other way in connection with an animal, any poison, or supervise or prescribe such administration or other use, unless—

( a ) (i) the identity card in respect of that animal has been surrendered to him, or

(ii) he has satisfied himself that the animal is on a restricted holding, or

(iii) he has been authorised by an authorised person to do so, and

(b) he has satisfied himself that such administration, supervision or prescription is not contrary to the provisions of these Regulations.

(4) Where a veterinary surgeon has administered to an animal or used in any other way in connection with an animal, any poison, or supervised or prescribed such administration or other use, he shall, subject to paragraph (5)—

(a) in case an identity card has been surrendered to him in respect of the animal, endorse the card in accordance with paragraph (7) and return it to the owner or person-in-charge of the animal;

(b) in every other case, notify the District Veterinary Office, in accordance with paragraph (7), of the identity of the animal and the name of the owner or person-in-charge of that animal.

(5) Notwithstanding the provisions of paragraph (4), a veterinary surgeon who has prescribed the administration or other use of a poison in respect of an animal shall neither endorse nor return the identity card in respect of the animal until he is satisfied that the poison has been administered or otherwise used in accordance with the provision of these Regulations and the terms of the prescription.

(6) Where any permit is issued by the Minister under the Bovine Tuberculosis and Brucellosis Orders in respect of any animal to which this Regulation applies, any withdrawal period (if any) in respect of that animal which has not expired shall be endorsed on the permit in accordance with the provisions of paragraph (7).

(7) Where, by virtue of this Regulation, an endorsement or notification is to be made, it shall include—

(a) the name of the poison which had been administered or prescribed;

(b) the date on which the withdrawal period (if any) expires; and

(c) the name of the veterinary surgeon administering, or supervising or prescribing the administration of, that poison.

(8) A person shall not slaughter such animal for human consumption unless—

(a) the person slaughtering the said animal or his agent receives the identity card or permit in respect of that animal, and

(b) the identity card or permit does not bear an endorsement showing that the withdrawal period has not expired in respect of a poison which has been administered to the said animal.

(9) Where by virtue of this Regulation a notification is to be made to a District Veterinary Office, the notification shall be made to the District Veterinary Office in the area in which the animal to which the notification relates is at the time the poison is administered to that animal.

(10) In any proceedings for an offence under this Regulation it shall be a defence for the person charged to prove that—

(a) it was necessary for the prevention of unnecessary suffering to an animal to administer to that animal, or to use in any other way in connection with that animal any poison or to supervise or prescribe such administration or other use without compliance with the provisions of this Regulation, and

(b) as soon as practicable after the administration of the poison the provisions of this Regulation were complied with.

18. (1) For the purposes of paragraph 3 (a) (iii) of Regulation 17 an authorised person shall, subject to paragraph (2) of this Regulation, grant to a veterinary surgeon authorisation empowering him to administer to or otherwise use in connection with a particular animal any poison to which Regulation 17 applies, or to supervise or prescribe such administration or other use.

(2) Where an authorised person is requested to grant an authorisation under paragraph 1—

(a) he shall not do so unless he is satisfied that the identity card in relation to that animal has been withdrawn from the owner or person-in-charge of the animal by virtue of the provisions of the Bovine Tuberculosis and Brucellosis Order, and

(b) he may attach such conditions to the authorisation as he considers necessary for the purpose of ensuring that neither the animal nor its produce will be used for human consumption until the withdrawal period of the poison administered has elapsed.

(3) (a) Where an authorisation has been granted under paragraph (1), an authorised person may require any person in whose possession the identity card in relation to the animal to which the authorisation relates happens to be to surrender to him the said identity card.

(b) Where an identity card has been surrendered in accordance with subparagraph (a) of this paragraph, it shall be endorsed in accordance with the provisions of Regulation 17 (7) and returned to the person by whom it was so surrendered.

19. (1) A veterinary surgeon who, in accordance with Regulation 6, administers or otherwise uses a poison, or supervises or prescribes such administration or use, shall enter or cause to be entered in a book kept solely for that purpose by him (to be known as the "Veterinary Medicines Register") the particulars contained in the form set out in Part II of the Third Schedule.

(2) (a) An owner or person-in-charge of an animal shall enter or cause to be entered, on each occasion on which a poison is administered or otherwise used in relation to that animal, in a book kept solely for that purpose by the owner of the animal (to be known as the "Veterinary Medicines Record") the particulars contained in the form set out in Part I of the Third Schedule.

(b) The provisions of this paragraph shall not apply to the administration or other use in respect of which an endorsement has been made on an identity card in accordance with the provisions of Regulation 17.

(3) The veterinary surgeon referred to in paragraph (1) shall give the person referred to in paragraph (2) sufficient information to enable that person comply with the provisions of paragraph (2).

20. (1) Where in proceedings for an offence under these Regulations, there is produced a certificate which—

(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 person 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.

(2) (a) The Minister may by an instrument in writing appoint a person to issue certificates for the purposes 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.

(3) In this Regulation—

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

"the 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 these Regulations.

21. (1) The Minister may appoint in writing such and so many of his officers or other persons as he thinks fit to be authorised persons for the purposes of these Regulations.

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

22. An authorised person may at all reasonable times enter any premises or other place in which he has reasonable grounds for believing that any animal to which a poison may have been administered, or the identity card or permit relating to such an animal, or any meat, milk, egg or other thing which may contain such a poison or any Veterinary Medicines Register or Record is kept, and there—

(a) make such examinations, tests and inspections as he may consider reasonable for the purposes of these Regulations;

(b) take such specimens from any animal, or such samples (without payment) of any meat, milk, egg or other thing including anything he believes to be a poison as he may consider reasonable for the purpose of these Regulations;

(c) examine and take extracts from and copies of a Veterinary Medicines Register or Veterinary Medicines Record or any record kept pursuant to these Regulations or any identity card or permit relating to an animal to which a poison may have been administered,

( d ) seize and detain anything he believes to be a poison and in respect of which he has reasonable grounds to believe an offence under these Regulations is being or has been committed,

( e ) seize and detain anything he believes to be milk, meat, or egg intended for human consumption and in respect of which he has reasonable grounds to believe that one or more withdrawal periods had not elapsed prior to the milking of any animal for such milk or the slaughter of any animal for such meat or before the laying of such egg and having so seized and detained anything treat such thing as food unfit for human consumption in accordance with the provisions of the Food Hygiene Regulations, 1950 ( S.I. No. 205 of 1950 ).

23. (1) The Minister may approve in writing of one or more methods for the detection or quantification of any particular poison or class of poisons, or the metabolites of such poisons, in the tissues, excreta or secreta of animals.

(2) An approval referred to in paragraph (1) may—

( a ) relate to the detection or quantification of any particular poison or metabolite or any class of poisons or metabolities;

( b ) relate to the analysis of particular tissue, secreta or excreta;

( c ) relate to a particular type of animal;

( d ) specify the level of poison or metabolite at which, or the result by which, the method shall be considered to have identified the presence of that poison or metabolite for the purposes of these Regulations;

( e ) relate to one or more such methods; and

( f ) contain such other requirements as the Minister considers appropriate to such an approval.

(3) A method specified in paragraph 1 approved of by the Minister under this Regulation shall be known as "an approved method".

(4) The Minister may vary in writing any approval made under this Regulation and may on notice to affected parties revoke in writing such approval or varied approval.

(5) The Minister shall cause notice of the making, variation or revocation, as the case may be, of an approval under this Regulation to be published in Iris Oifigiúil and in the case of such making or variation, the notice shall, in addition, state the place where copies of the approval or, as the case may be the approval as so varied, may be obtained.

24. In any proceedings for an offence in which a contravention of these Regulations is alleged and where, but for the identity of the specific substance involved, the alleged contravention would be proved, it shall be sufficient to show that the substance belongs to that class of poisons to which the alleged contravention relates.

25. An offence under these Regulations may be prosecuted by the Minister for Agriculture.

26. (1) Where a method or process specified in these Regulations empowers a veterinary surgeon to exercise a discretion, such discretion must be exercised in accordance with the safeguards and precautions set out in the Fifth Schedule.

(2) Chloramphenicol preparations and calf scour remedies shall not be used unless they are used in accordance with the safeguards and precautions for their use set out in the Fifth Schedule.

27. (1) A person shall not forge or utter a document knowing it to be forged purporting to be—

( a ) a prescription granted under these Regulations by a veterinary surgeon,

( b ) an identity card,

( c ) a Veterinary Medicines Register, or

( d ) a Veterinary Medicines Record

(which document is in this Regulation referred to as a forged document).

(2) A person shall not forge an endorsement or other entry purporting to be for the purposes of these Regulations on or in an identity card, or Veterinary Medicines Register, or a Veterinary Medicines Record (which document with such entry in this Regulation is referred to as a falsely endorsed document).

(3) A person shall not with intent to deceive alter—

( a ) a prescription granted under these Regulations by a veterinary surgeon,

( b ) an identity card,

( c ) a Veterinary Medicines Register, or

( d ) a Veterinary Medicines Record

(which document if so altered is in this Regulation referred to as an altered document).

(4) A person shall not utter a falsely endorsed document or an altered document knowing it to be such.

(5) A person shall not have in his possession a forged document, a falsely endorsed document or an altered document.

(6) Paragraph (5) of this Regulation shall not apply in relation to any of the following persons—

( a ) a member of the Garda Síochána when acting in the course of his duty as such;

( b ) an authorised person for the purposes of executing and enforcing these Regulations;

( c ) a person who has taken into his possession such document for the purpose of—

(i) preventing another from committing or continuing to commit an offence under the Act, or

(ii) delivering it into the custody of a person specified in paragraph (a) or (b) of this sub-paragraph.

28. (1) This Regulation applies to any preparation which consists of or contains any poison set out in Parts I, II, III or IV of the First Schedule other than—

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

( b ) any such preparation to which paragraph (2) of Regulation 6 applies.

(2) A person shall not have in his possession or under his control any preparation to which this Regulation applies in or on any premises or other land in or on which animals are kept for farming purposes.

(3) Paragraph (2) shall not apply to any preparation—

( a ) in respect of which a prescription has been granted by a veterinary surgeon provided that such prescription or sufficient other evidence of the granting of such prescription is produced by the person in possession or control of the preparation on demand being made of him by an authorised person, or

( b ) in the possession of or under the direct supervision of a veterinary surgeon and required by him solely for the purposes of his professional practice, or

( c ) in the possession of an authorised person or a member of the Garda Síochána for the purposes of executing and enforcing these Regulations.

(4) In any proceedings for an offence in which a contravention of this Regulation is alleged it shall be a good defence for the defendant to show that the preparation to which the alleged contravention relates was in his possession or under his control for the purposes of the sale of such preparation.

(5) In this Regulation "premises or other land in or on which animals are kept for farming purposes" includes any outhouses, dwellinghouses or other premises or other land ancillary to such farming purposes and any mart, market, fairground, sale yard, abattoir or slaughterhouse, lair, place of exhibition or other public or private place where animals are commonly placed before or after, or exposed for, sale, slaughter, exhibition, exportation or importation.

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 1981 concerning the prohibition of certain substances having a hormonal action and of any substance having a thyrostatic action¹, excluding those set out in Part IV of this Schedule, but including the following—

¹O.J. L222,7.8.81.p.32.

Oestradiol 17B

Progesterone

Testosterone

Trenbolone and its acetate

Zeranol.

2. Chloramphenicol (including Azidamfenicol and Thiamphenicol), its salts, its esters, its derivatives, salts of its esters, salts of its derivatives, excluding the preparation set out in Part IV of this Schedule.

PART II

1. Antibiotic substances generally; including the following substances their salts, their esters, their derivatives, salts of their esters, salts of their derivatives; but excluding those substances specifically set out in Part I or Part III:—

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

Doxvcycline

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

Talampicilfine

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

Tetracycline

Hydrochloride

Tiamulin

Tobramycin

Tyiosin

Vancomycin

Viomycin

Virginiamycin

2. The following antibacterial substances and their salts:—

p — Aminobenzenesulphonamide; derivatives of p — aminobenzenesulphonamide having any of the hydrogen atoms of 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

Sulphatroxazole

Sulphacetainide

Sulphachlorpyridazine

Sulphadiazine

Sulphadimethoxine

Sulphadimidine

Sulphaethidole

Sulphafurazole

Sulphaguanidine

Sulphaloxic Acid

Sulphamerazine

Sulphamethizole

Sulphamethoxazole

Sulphamethoxydiazine

Sulphamethoxypyridazine

Sulphamopine

Sulphamoxole

Sulphanilamide

Sulphaphenazole

Sulphaproxyline

Sulphapyriaine

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

PART IV

1. Stilbenes, stilbene derivatives, their salts and esters, and substances having a thyrostatic action within the meaning of Council Directive 81/602/EEC of the 31st July 1981 concerning the prohibition of certain substances having a hormonal action and of any substance having a thyrostatic action.

2. Any aerosol preparation consisting of or containing chloramphenicol, its salts, its esters, its derivatives, salts of its esters, salts of its derivatives.

PART V

Antibacterial substances generally,other than those set out in Part I, Part II,Part III or Part IV.

SECOND SCHEDULE

THIRD SCHEDULE

PART I

Form of entry to be made in the book to be kept in accordance with paragraph 2 of Regulation 19

PART II

Form of entry to be made in the book to be kept in accordance with paragraph 1 of Regulation 19

FOURTH SCHEDULE

Commencement

FIFTH SCHEDULE

Directions of the Minister to Veterinary Surgeon

1. Safeguards and precautions to be observed in the exercise of a discretion by a Veterinary Surgeon

(a) The veterinary surgeon should have been given responsibility for the health of the animal or herd or flock in question by the owner or the agent of the owner.

(b) for the purposes of subparagraph (a) the veterinary surgeon must at least—

(i) either, recently have seen the animal or herd or flock for the purposes of the diagnosis or prescription in question; or

(ii) have visited the farm or other premises on which the animal or herd is kept sufficiently often and recently enough to have acquired from personal knowledge and inspection, an accurate picture of the current health of animals on that farm sufficient to enable him to make a diagnosis or prescribe for the animal or herd or flock in question.

2. Safeguards and precautions to be observed in the use of Chloramphenicol preparations

(a) (i) Chloramphenicol must only be used only in conditions where it is known to be effective and other antimicrobial agents are known to be ineffective. For this reason tests for anti-microbial sensitivity should be carried out whenever practicable before such use.

(ii) In all cases where chloramphenicol has been administered the reasons for choosing chloramphenicol should be noted by the veterinary surgeon opposite the entry relating to such use in the Veterinary Medicines Register.

(b) The oral administration of Chloramphenicol to an animal to which these Regulations apply shall be prohibited save in such circumstances in which no other administration is appropriate.

(c) Chloramphenicol should be used only in the treatment of individual animals, and not for the treatment of an entire herd or flock.

3. Safeguards and precautions to be observed in the prescribing of calf scour remedies

(a) Where a herd of bovine animals is under a veterinary surgeon's professional care it should be possible for him, subject to the provisions of these Regulations and unless there are special circumstances to require otherwise, to grant repeal prescriptions to the owner or person in charge of the herd for the oral administration to calves of antibacterial substances for the purpose of treating scour in calves belonging to that herd.

(b) The provisions of subparagraph (a) of this paragraph shall not apply to—

(i) Calves reared for the production of veal, or

(ii) Products marketed and intended for use routinely in healthy calves.

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

AUSTIN DEASY,

Minister for Agriculture.

EXPLANATORY NOTE.

These Regulations declare hormones, antibiotics and other antibacterial substances to be poisons for the purposes of the Regulations and introduce controls on their use in food animals.