L.S. 437.64 Regoli dwar il-Projbizzjoni tal-Użu ta’ Ċerti Sustanzi fit-Trobbija tal-Bhejjem li jkollhom Effett Ormonali u Tireostatiku u ta’ Beta-agon

(1)The title of these rules is the Prohibition on the Use of C e r t a in Su b s ta nce s i n Sto c k f a r mi n g ha vi ng a H or m o na l or Thyrostatic Effect and of Beta-agonists Rules. Citation and scope.

(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.

(1)Unless otherwise stated in these rules, the definitions in the Veterinary Services Act shall apply. Interpretation. Cap. 437.

(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, 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; Cap. 437. 2 [ S.L.437.64 PROHIBITION ON THE USE OF CERTAIN SUBSTANCES IN STOCKFARMING HAVING A HORMONAL OR THYROSTATIC EFFECT AND OF BETA-AGONISTS "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 i n v e r s i o n o n a v e t e r i n a r i a n ’s p r e s c r i p t i o n a n d u n d e r h i s responsibility and which is prohibited under rule 7

(2). Applicability. 3. These rules shall apply to the prohibition of the use of certain substances in stockfarming whereby such application shall be limited only to animals intended for food-producing and that the prohibition for pet animals shall be withdrawn. Prohibitions. 4. The placing on the market of the substances listed in the Schedule for administering to any animals, the meat and products of which are intended for human consumption, for purposes other than those provided in rule 5 is hereby being prohibited. Other prohibitions. 5. In Malta, the following shall also be prohibited: (

1. a)the administering to a farm or aquaculture animal, by any means whatsoever, of substances having a thyrostatic, oestrogenic, androgenic or gestagenic action and of betaagonists; (
2. b)the holding, except under official control, of animals referred to in paragraph (
3. a)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 (
4. a)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; (
5. c)the placing on the market for human consumption of aquaculture animals to which substances referred to in paragraph (
6. a)have been administered and of processed products derived from such animals; (
7. d)the placing on the market of meat of the animals referred to in paragraph (b); and (
8. e)the processing of the meat referred to in paragraph (d). Exemptions from prohibitions. 6.

(1)Saving the provisions in rules 4 and 5, the following shall be authorised: (

1. a)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 PROHIBITION ON THE USE OF CERTAIN SUBSTANCES IN STOCKFARMING HAVING A HORMONAL OR THYROSTATIC EFFECT AND OF BETA-AGONISTS [ S.L.437.64 3 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: (
2. i)(
3. ii)(iii) (
4. iv)type of treatment; the type of products authorised; the date of treatment; the identity of the animals treated: Provided also that the register must be made available to the Veterinary Services at its request; (
5. b)the administering for therapeutic purposes of authorised veterinary medicinal products containing: (
6. i)allyl trenbolone, administered orally, or betaagonists to equidae, provided they are used in accordance with the manufacturer’s instructions; (
7. ii)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 sub-paragraph (i), under his direct responsibility, treatment must be registered by the veterinarian responsible, who shall record at least the details referred to in paragraph (a). 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 sub-rule

(1), therapeutic treatment of production animals, including breeding animals at the end of their reproductive life, shall be prohibited. 7.

(1)With regard to aquaculture animals, young fish may be treated for the first three months for the purpose of sex inversion with veterinary medicinal products that have an androgenous action and are authorised in accordance with European Union Directives 81/851/EEC and 81/852/EEC. Certain authorised treatments.

(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. 8.

(1)Hormonal products and Beta-agonists which are authorised in accordance with rule 6 shall be in accordance with the requirements established in European Directives 81/851/EEC and Authorisation of administration of hormonal products and Beta-agonists. 4 [ S.L.437.64 PROHIBITION ON THE USE OF CERTAIN SUBSTANCES IN STOCKFARMING HAVING A HORMONAL OR THYROSTATIC EFFECT AND OF BETA-AGONISTS 81/852/EEC.

(2)Without prejudice to sub-rule

(1), the following are not authorised: (

1. a)the following hormonal products: (
2. i)products acting as a deposit; (
3. ii)products with a withdrawal period of more than fifteen 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 betaagonists which have a withdrawal period of more than twentyeight days after the end of treatment. Authorisation for the placing on the market of animals for breeding. 9.

(1)For the purpose of trade, it is permitted, the placing on the market of animals for breeding and breeding animals at the end of their reproductive life which, during the latter period, have undergone a treatment referred to in rule 6 in order to be authorised the affixing of the health mark of Annex I, Chapter XI

(50), of Directive 64/433/EEC to meat from such animals where the conditions laid down in rule 6 and the minimum withdrawal periods laid down in rule 8

(2)(

1. a)(
2. ii)or (
3. b)respectively or the withdrawal periods provided for in the authorisation to place on the market are complied with: 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 PROHIBITION ON THE USE OF CERTAIN SUBSTANCES IN STOCKFARMING HAVING A HORMONAL OR THYROSTATIC EFFECT AND OF BETA-AGONISTS [ S.L.437.64 5 down was observed before the animals were slaughtered. 10.

(1)The competent authority shall administer the possession of substances referred to in rules 4 and 5(a) to the persons authorised by any other law in accordance with Article 1

(5)of European Directive 81/851EEC during the period of importation, manufacture, storage, distribution, sale and use of such substances. Possession and use of substances by authorised persons.

(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: (

1. a)the possession or presence of substances or products prohibited under rule 5, intended to be administered to animals for the purpose of fattening; (
2. b)the illegal treatment of animals; (
3. c)failure to observe the withdrawal periods provided for in regulation 8; (
4. 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 adm inistering o f which com es under the headi ng of il leg al treatment, such substances or products are confiscated, while 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)(

1. b)and (
2. c)results, the Authority shall take such appropriate measures in conformity with the gravity of the law infringement. 11.

(1)Without prejudice to Directive 81/851/EEC, undertakings buying or producing substances having a thyrostatic, oestrogenic, androgenic or gestagenic action and betaagonists, undertakings authorised in any capacity to market such substances a n d u n d e r t a k i n g s b u yi n g o r p r od u c i n g p h a r m a c e u t i c a l a n d veterinary medicinal products from such substances shall be required to keep registers detailing, in chronological order, quantities produced or acquired and those sold or used for the production of pharmaceutical and veterinary medicinal products and the names of the persons to whom such quantities were sold or from whom they were purchased.

(2)The information in sub-rule

(1)shall be made available to Keeping of registers of substances. 6 [ S.L.437.64 PROHIBITION ON THE USE OF CERTAIN SUBSTANCES IN STOCKFARMING HAVING A HORMONAL OR THYROSTATIC EFFECT AND OF BETA-AGONISTS the competent Authority at its request and, in the case of computerised records, in the form of a print-out. Failure to comply with these rules. Cap.

1. Limitation of importation.
2. Where the results of checks carried out by the Authority show failure to comply with the requirements of these rules in the country of origin of the animals or products, the competent authority shall have recourse to provisions taken according to the procedure laid down in article 21 of the Veterinary Services Act on mutual assistance between the administrative authorities of Malta and of the Member States to ensure the correct application of legislation on veterinary. 13.

(1)Third countries whose legislation authorizes the placing on the market and administration of stilbenes, stilbene derivatives, their salts and esters, or of thyrostatic substances for administering to animals of all species may not appear on any of the lists of countries provided for under veterinary legislation from which Malta authorizes to import farm or aquaculture animals or meat or products obtained from such animals.

(2)In Malta, it is prohibited to import from third countries on any of the lists referred to in sub-rule

(1)of: (

1. a)farm or aquaculture animals: (
2. i)to which products or substances referred to in rule 4 have been administered by any means whatsoever; (
3. ii)to which substances or products referred to in rule 5(
4. a)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 (
5. 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), 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. Cap. 437.

(4)Checks on imports from third countries shall be carried out in accordance with Article 17

(2)and

(3)of the Veterinary Services Act. PROHIBITION ON THE USE OF CERTAIN SUBSTANCES IN STOCKFARMING HAVING A HORMONAL OR THYROSTATIC EFFECT AND OF BETA-AGONISTS [ S.L.437.64 SCHEDULE 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 7