PROHIBITION ON THE USE OF CERTAIN SUBSTANCES IN STOCKFARMING HAVING A HORMONAL OR THYROSTATIC EFFECT AND OF

THYROSTATIC EFFECT AND OF BETA-AGONISTS

SUBSIDIARY LEGISLATION 437.64

PROHIBITION ON THE USE OF CERTAIN

SUBSTANCES IN STOCKFARMING HAVING A

HORMONAL OR THYROSTATIC EFFECT AND OF

BETA-AGONISTS RULES

24th March, 2009

LEGAL NOTICE 87 of 2009.

(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.

(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.

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

(1) Unless otherwise stated in these rules, the definitions

in the Veterinary Services Act shall apply.

(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;

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).

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.

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.

In Malta, the following shall also be prohibited

(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;

(b) the holding, except under official control, of animals

referred to in paragraph (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 (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;

(c) the placing on the market for human consumption of

aquaculture animals to which substances referred to in

paragraph (a) have been administered and of processed

products derived from such animals;

(d) the placing on the market of meat of the animals

referred to in paragraph (b); and

(e) the processing of the meat referred to in paragraph (d).

(1) Saving the provisions in rules 4 and 5, the following

shall be authorised

(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

THYROSTATIC EFFECT AND OF BETA-AGONISTS

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

(i)

type of treatment;

(ii)

the type of products authorised;

(iii)

the date of treatment;

(iv)

the identity of the animals treated

Provided also that the register must be made available

to the Veterinary Services at its request;

(b) the administering for therapeutic purposes of

authorised veterinary medicinal products containing

(i)

allyl trenbolone, administered orally, or

betaagonists to equidae, provided they are used

in accordance with the manufacturer’s

instructions;

(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.

(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.

(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.

(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

THYROSTATIC EFFECT AND OF BETA-AGONISTS

81/852/EEC.

(2) Without prejudice to sub-rule (1), the following are not

authorised

(a) the following hormonal products

(i) products acting as a deposit;

(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 twenty-

eight days after the end of treatment.

(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)(a) (ii) or (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

THYROSTATIC EFFECT AND OF BETA-AGONISTS

down was observed before the animals were slaughtered.

(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.

(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

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)(b) and (c) results, the Authority shall take such appropriate

measures in conformity with the gravity of the law infringement.

(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

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.

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.

(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

(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

rule 5(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

(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.

(4) Checks on imports from third countries shall be carried out

in accordance with Article 17(2) and (3) of the Veterinary Services

Act.

THYROSTATIC EFFECT AND OF BETA-AGONISTS