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Veterinary Services Act (Cap. 437) Prohibition On The Use Of Certain Substances In Stockfarming Having A Hormonal Or Thyrostatic Effect And Of Beta-Agonists Rules 2009 (Ln 87 Of 2009 )

VETERINARY SERVICES ACT (CAP. 437)Prohibition on the Use of Certain Substances in Stockfarming having a Hormonal or Thyrostatic Effect and of Beta-agonists Rules 2009

IN exercise of the powers conferred under article 13(a) of the Veterinary Services Act, the Minister for Resources and Rural Affairs has made the following rules:-

Title, scope and commencement.

Interpretation.

(2) The scope of these regulations is to implement the rules found under the European Union Council Directive 96/22/ EEC establishing the prohibition on the use of certain substances in stockfarming, while amending these rules according to the new rules found under the European Union Parliament and Council Directive 2008/97/EC, concerning the prohibition of the use of certain substances for animals whereby such prohibition shall be limited.

(2) For the purpose of these rules, and unless the context otherwise requires:-
“the authority” means the Veterinary Services Authority in Malta as provided under article 2 of the Veterinary Services Act;
“farm animals” means domestic animals of the bovine, porcine, ovine and caprine species, domestic solipeds, poultry and rabbits, as well as wild animals of those species and wild ruminants which have been raised on a holding;
“illegal treatment” means the use of unauthorised substances or products or the use of substances or products authorised by any other law for purposes or under conditions other than those laid down in any other law;

“Member State” means a State which is a Member within the European Community;
“therapeutic treatment” means the administering prescribed under rule 6 of these rules, to an individual farm animal of an authorised substance to treat, after examination by a veterinarian, a fertility problem, including the termination of unwanted gestation, and in the case of beta-agonists, to induce tocolysis in cows when claving as well as to treat respiratory problems, navicular desease and laminitis and to induce tocolysis in equidae;
“Third country” means a state which is not a member within the European Community;
“zootechnical treatment” means the administering of any substance to an individual farm animal and in the case of aquaculture animals to a group of breeding animals for sex inversion on a veterinarian’s prescription and under his responsibility and which is prohibited under rule 7 (2) hereof.

(i) the administering to a farm or aquaculture animal, by any means whatsoever, of substances having a thyrostatic, oestrogenic, androgenic or gestagenic action and of beta- agonists;
(ii) the holding, except under official control, of animals referred to in paragraph (i) on a farm, the placing on the market or slaughter for human consumption of farm animals or of aquaculture animals which contain the substances referred to in paragraph (i) or in which the presence of such substances has been established, unless proof can be given that the animals in question have been treated in accordance with rules 6 or 7;
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Applicability.

Prohibitions.

Other prohibitions.

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(iii) the placing on the market for human consumption of aquaculture animals to which substances referred to in paragraph (i) have been administered and of processed products derived from such animals;
(iv) the placing on the market of meat of the animals referred to in paragraph (ii); and
(iv).
(v) the processing of the meat referred to in paragraph

Exemptions from prohibitions.

(i) the administering to farm animals, for therapeutic purposes, of ßoestradiol 17, testosterone and progesterone and derivatives which readily yield the parent compound on hydrolysis after absorption at the site of application:
Provided that, veterinary medicinal products used for therapeutic treatment must comply with the requirements for placing on the market laid down in European Union Directive 81/851/EEC and they must be administered only by a veterinarian, by injection or for the treatment of ovarian disfunction in the form of vaginal spirals, but not by implant, to farm animals which have been clearly identified. Treatment of identified animals must be registered by the veterinarian responsible. The latter must record at least the following details in a register, which may be the one provided for in European Union Directive 81/851/EEC:-
(a) type of treatment;
(b) the type of products authorised; (c) the date of treatment;
(d) the identity of the animals treated:
Provided also that the register must be made available to the Veterinary Services at its request:-
(ii) the administering for therapeutic purposes of authorised veterinary medicinal products containing:-

(a) allyl trenbolone, administered orally, or beta- agonists to equidae, provided they are used in accordance with the manufacturer’s instructions;
(b) beta-agonists, in the form of an injection to induce tocolysis in cows when calving. Such substances must be administered by a veterinarian or, in the case of the veterinary medicinal products referred to in paragraph (a) hereof, under his direct responsibility, treatment must be registered by the veterinarian responsible, who shall record at least the details referred to in item (i). Farmers shall be prohibited from holding veterinary medicinal products containing beta-agonists which may be used for induction purposes in the treatment of tocolysis.
(2) Without prejudice to that mentioned in the previous paragraph, therapeutic treatment of production animals, including breeding animals at the end of their reproductive life, shall be prohibited.

81/851/EEC and 81/852/EEC.
(2) In the cases provided for in this rule, the veterinarian shall make out a non-renewable prescription, specifying the treatment in question and the quantity of the product required and shall record the products prescribed:
Provided that zootechnical treatment of production animals, including during the fattening period for breeding animals at the end of their reproductive life, shall be prohibited.

81/852/EEC.
(2) Without prejudice to sub-rule (1), the following are not authorised:-
(a) the following hormonal products:
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Certain authorised treatments.

Authorisation of administration of hormonal products and Beta-agonists.

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(i) products acting as a deposit;
(ii) products with a withdrawal period of more than 15 days after the end of treatment;
(iii) products which:
(1) were authorised under rules that preceded the national legislation laying down procedures in conformity with international agreement for the authorisation and supervision of medicinal products for human and veterinary use;
(2) whose conditions of use are not known;
or
(3) which no reagents or equipment exist for use in the analytical techniques for detecting the presence of residues in excess of the permitted limits; and
(b) veterinary medicinal products containing beta- agonists which have a withdrawal period of more than 28 days after the end of treatment.

Authorisation for the placing on the market of animals for breeding.

Provided that, trade in highvalue horses, and in particular racehorses, competition horses, circus horses or horses intended for stud purposes or for exhibitions, including registered equidae to which veterinary medicinal products containing allyl trenbolone or betaagonists have been administered for the purposes referred to in rule 6, may take place before the end of the withdrawal period, provided that the conditions governing administration are fulfilled and that the type and date of treatment are entered on the certificate or passport accompanying these animals.

(2) Meat or products from animals to which substances having an oestrogenic, androgenic or gestagenic effect or beta- agonists have been administered in accordance with the dispensatory provisions of these regulations may not be placed on the market for human consumption unless the animals in question have been treated with veterinary medicinal products complying with the requirements of rule 8 and in so far as the withdrawal period laid down was observed before the animals were slaughtered.

(2) The Authority shall also without prior notice, in addition to the checks provided for in the Orders governing the placing on the market of the various products in question, carry out official checks provided for in Article 11 of Directive 96/23/EEC with a view to ascertaining:-
(a) the possession or presence of substances or products prohibited under rule 5, intended to be administered to animals for the purpose of fattening;
(b) the illegal treatment of animals;
(c) failure to observe the withdrawal periods provided for in regulation 8;
(d) failure to observe the restrictions on the use of certain substances or products laid down in rule 6.
(3) The tests for the presence of the substances referred to in sub-rule (1) in animals, in the drinking water of animals and in all places where animals are bred or kept, residues of the aforementioned substances in live animals, their excrement and body fluids and in animal tissues and products, shall be carried out in accordance with Annexes III and IV to Directive 96/23/EEC.
(4) Where the checks provided for in sub-rules (2) and (3) reveal the presence of substances or products the use or possession of which is prohibited, or the presence of residues of substances the administering of which comes under the heading of illegal treatment, such substances or products are confiscated, while
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Possession and use of substances by authorised persons.

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any animals treated or the meat therefrom is placed under official supervision until the requisite penalties have been applied.
(5) Where failure to comply with the requirements of sub-rule (2) paragraphs (b) and (c) of this rule results, the Authority shall take such appropriate measures in conformity with the gravity of the law infringement.

Keeping of registers of substances.

Failure to comply with these rules.

Limitation of importation.

(2) The information in sub-rule (1) hereof shall be made available to the competent Authority at its request and, in the case of computerised records, in the form of a print-out.

(2) In Malta, it is prohibited to import from third countries on any of the lists referred to in sub-rule (1) of:
(a) farm or aquaculture animals:

(i) to which products or substances referred to in rule 4 have been administered by any means whatsoever;
(ii) to which substances or products referred to in point (i) of rule 5 have been administered, unless those substances or products have been administered in compliance with the provisions and requirements laid down in rules 6 and 9 and the withdrawal periods allowed in international recommendations have been observed; and
(b) meat or products obtained from animals the importation of which is prohibited under paragraph (a).
(3) Without prejudice to sub-rules (1) and (2) of this rule, animals intended for breeding, breeding animals at the end of their reproductive life, or meat there from, from third countries may be imported subject to their affording guarantees at least equivalent to those laid down in these regulations or which have been established for the implementation and enforcement of Chapter V of Directive 96/23/EEC on measures to be taken in the event of law infringement.
(4) Checks on imports from third countries shall be carried out in accordance with Article 17 (2) and (3) of the Veterinary Services Act.

2005 are hereby being repealed.
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Repeal of L.N. 96 of

2005.

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Regulation 4
List of Prohibited Substances
List A: prohibited substances
- Thyrostatic Substances,
- Stilbenes, stilbene derivatives, their salts and esters,
- Oestradiol 17ß and its ester-like derivatives. List B: prohibited substances with derogations
- Beta-agonists