Control of Animal Remedies and Their Residues Regulations, 1998

• Jurisdiction: Ireland
• Citation: IR SI 507/1998
• Year: 1998

S.I. No. 507 of 1998.
CONTROL OF ANIMAL REMEDIES AND THEIR RESIDUES REGULATIONS, 1998
I, Joe Walsh, Minister for Agriculture and Food, in exercise of the powers conferred on me by section 8 of the Animal Remedies Act, 1993 (No. 23 of 1993) (as adapted by the Agriculture, Food and Forestry (Alteration of Name of Department and Title of Minister) Order, 1997 ( S.I. No. 302 of 1997 )), and, in relation to Regulation 30 of these Regulations, section 3 of the European Communities Act, 1972 (No. 27 of 1972), and for the purpose of giving effect to Council Directive 96/22/EC1 of 29 April 1996 and Council Directive 96/23/EC2 of 29 April 1996, and further effect to Council Directive No. 81/851/EEC3 of 28 September 1981, and after consultation with the Animal Remedies Consultative Committee, hereby make the following Regulations:
1 O.J. No. L125 of 23.5.96, p.3
2 O.J. No. L125 of 23.5.96, p.10
3 O.J. No. L317 of 6.11 81, p.1
	1 ..	1. (1) These Regulations may be cited as the Control of Animal Remedies and their Residues Regulations, 1998.
(2) These Regulations shall come into operation on the 28 day of December, 1998.
	2 Interpretation	2. (1) In these Regulations -
"the Act" means the Animal Remedies Act, 1993 (No. 23 of 1993);
"the Act of 1988" means the Abattoirs Act, 1988 (No. 8 of 1988);
"abattoir'' means an abattoir to which the Act of 1988 applies;
"animal remedies authorisation" has the same meaning as it has in the Regulations of 1996;
"approved laboratory" means a laboratory designated as an approved laboratory in accordance with Regulation 15;
"authorised animal remedy" has the same meaning as it has in the Regulations of 1996;
"the Council Directives" means Council Directive 96/22/EC of 29 April 1996 and Council Directive 96/23/EC of 29 April 1996;
"eartag'' means an approved eartag within the meaning of the Bovine Tuberculosis (Attestation of the State and General Provisions) Order, 1989 ( S.I. No. 308 of 1989 ), or an eartag referred to in Regulation 4 of the Bovine Tuberculosis (Attestation of the State and General Provisions) Order, 1996 ( S.I. No. 103 of 1996 ), or an eartag referred to in Article 3 of Council Regulation (EC) No 820/974 of 21 April 1997 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products;
4 O.J. No. L117 of 7.05.97, p.1
"functions" includes powers and duties and references to the performance of functions includes as respects powers and duties, references to the exercise of powers and the carrying out of duties;
"identity card" means-
(a) an identity card within the meaning of the Bovine Tuberculosis (Attestation of the State and General Provisions) Order, 1989 ( S.I. No. 308 of 1989 ), or the Brucellosis in Cattle (General Provisions) Order, 1991 ( S.I. No. 114 of 1991 ), or
(b) an animal passport to which Council Regulation (EC) 820/97 of 21 April 1997 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products applies;
"manufacturer's licence" has the same meaning as it has in the Regulations of 1996;
"maximum residue limit" has the same meaning as it has in Council Regulation (EEC) No. 2377/905 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin;
5 O.J. No. L.224 of 18.08.90, p.1
"member state" means a member state of the European Communities;
"national reference laboratory" means a laboratory designated as a national reference laboratory in accordance with Regulation 15;
"official mark" means a mark in the form set out in the Schedule;
"prescription" has the same meaning as it has in the Regulations of 1996, and cognate words shall be construed accordingly;
"the Regulations of 1996" means the Animal Remedies Regulations, 1996 ( S.I. No. 179 of 1996 );
"registered veterinary surgeon" means a person registered in The Register of Veterinary Surgeons for Ireland;
"slaughter" in relation to an animal, means slaughter for the purposes of the production of meat or other food intended for human or animal consumption.
"slaughterhouse" means -
(a) (i) an establishment approved under Regulation 4 of the European Communities (Fresh Meat) Regulations, 1997 ( S.I. No. 434 of 1997 ),
(ii) an establishment approved under Regulation 4 of the European Communities (Fresh Poultry Meat) Regulations, 1996 ( S.I. No. 3 of 1996 ), or
(iii) an establishment approved under Regulation 4 of the European Communities (Rabbit Meat and Farmed Game Meat) Regulations, 1995 ( S.I. No. 278 of 1995 ),
used for or in connection with the slaughter of animals, or
(b) an abattoir.
(2) A word or expression that is used in these Regulations and that is also used in the Council Directives has, unless the contrary intention appears, the same meaning in these Regulations as it has in the Council Directives.
(3) In these Regulations a reference to a Regulation or Schedule is a reference to a Regulation of or Schedule to these Regulations, unless it is indicated that a reference to some other provision is intended, and a reference to a paragraph or subparagraph is a reference to the paragraph or subparagraph of the provision in which the reference occurs, unless it is indicated that a reference to some other provision is intended.
	3 Restrictions on Manufacture etc. of Certain Animal Remedies	3. (1) It shall not be lawful for a person to manufacture, import, possess, sell or supply an animal remedy consisting of or containing a stilbene, stilbene derivative, salt or ester of a stilbene or stilbene derivative, or a thyrostatic substance.
(2) Subject to the provisions of this Regulation, it shall not be lawful for a person to manufacture, import, possess, sell or supply an animal remedy consisting of or containing -
(a) a beta-agonist, or
(b) a substance having an oestrogenic, androgenic or gestagenic action.
(3) A person may, in accordance with an animal remedies authorisation and a manufacturer's licence, manufacture, or import from a state other than a member state, an animal remedy consisting of or containing a substance to which paragraph (2) applies.
(4) A person may, in accordance with an animal remedies authorisation, possess, sell or supply, or import from a member state, an authorised animal remedy consisting of or containing a substance to which paragraph (2) applies.
(5) It shall not be lawful for a person to manufacture, import, sell, hire or otherwise supply or use, or have in his or her possession or under his or her control any plant, machinery, instrument, cartridge, container, utensil, label, package, package insert or other thing, made or adapted for use in connection with -
(a) the manufacture of a substance, to which paragraph (1) applies, or a prohibited animal remedy,
(b) the administration of a prohibited animal remedy to a farm or aquaculture animal, or
(c) the administration of a substance, to which paragraph (1) applies, to a farm or aquaculture animal.
(6) A person may, pursuant to a licence under Regulation 26 of the Regulations of 1996, import into the State an animal remedy within the meaning of that Regulation consisting of or containing a substance to which paragraph (2) applies.
(7) This Regulation shall not apply to a substance -
(a) that is intended to be used for and capable, of being used for, purposes other than agricultural or veterinary purposes.
(b) that is labelled as being intended for purposes other than agricultural or veterinary purposes, and
(c) in respect of which there is for the time being in force a product authorisation under the Medical Preparations (Licensing and Sale) Regulations, 1996 ( S.I. No. 43 of 1996 ).
	4 Amendment of Regulation 9 of Regulations of 1996	4. Regulation 9 of the Regulations of 1996 is hereby amended by the insertion of the following paragraphs:
"(8) The Competent Authority shall, in granting or renewing a veterinary product authorisation in respect of a veterinary medicinal product consisting of or containing a substance to which Regulation 3(2) of the Regulations of 1998, applies, comply with the provisions of the Council Directives within the meaning of those Regulations.
(9) The Competent Authority shall not grant or renew a veterinary product authorisation in respect of a veterinary medicinal product consisting of or containing a substance to which Regulation 3(1) of the Regulations referred to in paragraph (8) applies.
(10) Where the Competent Authority grants a veterinary product authorisation in respect of a veterinary medicinal product that may be administered to a farm or aquaculture animal it shall furnish the Community reference laboratories designated under Chapter 1 of Annex V of Council Regulation 96/23/EC of 29 April 1996 and the national reference laboratories designated under the plan submitted to the Commission by the Minister pursuant to Article 5 of that Directive with the routine analysis methods.''.
	5 Amendment of Regulation 23 of Regulations of 1996	5. Regulation 23 of the Regulations of 1996 is hereby amended by the substitution in paragraph (8)(b) of the following clause for clause (vi):
"(vi) if in the opinion of the Competent Authority the person is not, for any other reason (including conviction of the person concerned for an offence or a failure by him or her to comply with a condition attached to an earlier manufacturer's licence or animal remedies authorisation), or having regard to the provisions of Article 25 of Council Directive 96/23/EC of 29 April 1996, a fit and proper person to hold a manufacturer's licence.".
	6 Prohibition on Administration of Stilbenes etc.	6. (1) It shall not be lawful for a person to administer or cause to be administered to a farm or aquaculture animal an animal remedy...