Hormonal or Thyrostatic Action and of Betaagonists Rules, 2005

L.N. 96 of 2005

VETERINARY SERVICES ACT, 2001

(CAP. 437)

Prohibition on the Use in Stock-Farming of Substances having a

Hormonal or Thyrostatic Action and of Betaagonists Rules, 2005

IN exercise of the powers conferred under article 13(a) of the

Veterinary Services Act, the Minister for Rural Affairs and the

Environment has made the following rules>-

(1) The title of these rules is Prohibition on the Use in Stock- Title and scope and

applicability.

Farming of Substances having a Hormonal or Thyrostatic Action and

of Betaagonists Rules, 2005.

(2) The scope of these regulations is to implement the rules

found under European Union Council Directive 96#22#EEC on the

Prohibition on the Use in Stock-Farming of Certain Substances having

a Hormonal or Thyrostatic Action and of Betaagonists.

For the purpose of these rules, and unless the context otherwise Definitions.

requires –

“the Commission” means the European Commission<

“the Community” means the European Community as

established under the Treaty establishing the European Community<

“Competent authority” means the Veterinary Services within

the territory of Malta as provided under article 2 of the Veterinary

Services Act<

“farm animals” shall mean 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” shall mean the use of unauthorised

substances or products or the use of substances or products

authorised under national legislation for purposes or under

conditions other than those laid down in national legislation<

“Member State” means a State which is a Member within the

European Community<

“therapeutic treatment” shall mean the administering under

rule 4 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 betaagonists, to induce tocolysis in cows when calving

and to treat respiratory problems and to induce tocolysis in equidae

raised for purposes other than meat production<

“Third country” means a State which is not a Member within

the European Community.

“Veterinary Services” means the competent authority within

the territory of Malta as established under article 2 of the Veterinary

Services Act.

“zootechnical treatment” shall mean the administering>

(a) to an individual farm animal of any substance

authorised under rule 6 of these rules for synchronising oestrus

and preparing donors and recipients for the implantation of

embryos, after examination of the animal by a veterinarian

or, in accordance with the second paragraph of rule 6, under

his responsibility<

(b) in the case of aquaculture animals, to a group of

breeding animals for sex inversion, on a veterinarian’s

prescription and under his responsibility.

In the territory of Malta, the following shall be prohibited -

(i) the placing on the market of stilbenes, stilbene

derivatives, their salts and esters and thyrostatic substances for

administering to animals of all species<

(ii) the placing on the market of betaagonists for

administering to animals the flesh and products of which are

intended for human consumption for purposes other than those

provided for in sub-paragraph (ii) of rule 5.

In Malta, the following shall also be prohibited -

(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 betaagonists<

(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 5 or 6<

(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) <

(v) the processing of the meat referred to in paragraph (iv).

Notwithstanding rules 3 and 4, in Malta, the following is Exemptions to

prohibitions.

authorised>

(i) the administering to farm animals, for therapeutic

purposes, of floestradiol 17, testosterone and progesterone and

derivatives which readily yield the parent compound on hydrolysis

after absorption at the site of application.

Veterinary medicinal products used for therapeutic treatment must

comply with the requirements for placing on the market laid down in

Order (81#851) and be administered only by a veterinarian, by injection

or for the treatment of ovarian dysfunction 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 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.

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

betaagonists to equidae and pets, provided they are used in

accordance with the manufacturer’s instructions<

(b) betaagonists, 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 point (i).

Farmers shall be prohibited from holding veterinary medicinal

products containing betaagonists which may be used for induction

purposes in the treatment of tocolysis.

However, without prejudice to the first subparagraph of point ii

(b), therapeutic treatment of production animals, including breeding

animals at the end of their reproductive life, shall be prohibited.

(1) Notwithstanding rule 4 (i) and without prejudice to rule

permitted within the

3, in Malta the administering to farm animals is authorised, for the

purpose of zootechnical treatment, of veterinary medicinal products

having an oestrogenic, androgenic or gestagenic action which are

authorised in accordance with Orders (81#851) and (81#852). Such

veterinary medicinal products must be administered by a veterinarian

to clearly identified animals< the treatment must be recorded by the

veterinarian responsible in accordance with rule 5 (i)>

Provided that Veterinary Services may allow the synchronisation

of oestrus and the preparation of donors and recipients for the

implantation of embryos to be effected not by the veterinarian direct,

but under his responsibility.

(2) 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 Directives 81#851#EEC and 81#852#EEC.

(3) 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 Betaagonists the administration Authorisation of

administration of

of which to farm animals is authorised in accordance with rules 5 and 6 hormonal products

must meet the requirements of Directives 81#851#EEC and 81#852#EEC. and Betaagonists.

(2) The following are not, however, authorised in

accordance with sub-rule (1)

(a)

the following hormonal products>

(i) products acting as a deposit<

(ii) products with a withdrawal period of more than

15 days after the end of treatment<

(iii) products>

(1) which 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,

(3) or which no reagents or equipment exist for

use in the analytical techniques for detecting the presence

of residues in excess of the permitted limits,

(b) veterinary medicinal products containing betaagonists

which have a withdrawal period of more than 28 days after the

end of treatment.

(1) For the purpose of trade, it is permitted in Malta, the Trade, breeding and

placing on the market of animals for breeding and breeding animals at relative

marks.

the end of their reproductive life which, during the latter period, have

undergone a treatment referred to in rules 5 and 6 and may authorise

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 rules 5 and 6 and the minimum withdrawal periods laid down in rule

7 (2), under paragraph (a) (ii) or (b) respectively or the withdrawal

periods provided for in the authorisation to place on the market are

complied with.

However, 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 5, 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 action or betaagonists

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

7 and in so far as the withdrawal period laid down was observed before

the animals were slaughtered.

Within the territory of Malta -

(i) at the time of the import, manufacture, storage,

distribution, sale and use of the substances referred to in rules 3

and 4 (i), their possession is restricted to the persons authorised

by national legislation in accordance with Article 1 (5) of Order

(81#851)<

(ii) in addition to the checks provided for in the Orders

governing the placing on the market of the various products in

question, the official checks provided for in Article 11 of Directive

96#23#EEC are carried out by the competent national authorities

without prior notice, with a view to ascertaining>

(a) the possession or presence of substances or products

prohibited under rule 3, 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 7<

(d) failure to observe the restrictions on the use of

certain substances or products laid down in rules 5 and 6<

(iii) the tests for the presence of>

(a) the substances referred to in point (i) in animals, in

the drinking water of animals and in all places where animals

are bred or kept<

(b) residues of the aforementioned substances in live

animals, their excrement and body fluids and in animal tissues

and products, are carried out in accordance with Annexes III

and IV to Directive 96#23#EEC<

(iv) where the checks provided for in points (ii) and (iii)

reveal>

(a) 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 any animals treated or the meat therefrom

is placed under official supervision until the requisite penalties

have been applied<

(b) failure to comply with the requirements of points

(ii) (b) and (c), the Veterinary Services takes appropriate

measures consistent with the gravity of the infringement.

(1) Without prejudice to Directive 81#851#EEC, Keeping of registers

undertakings buying or producing substances having a thyrostatic, of substances.

oestrogenic, androgenic or gestagenic action and betaagonists,

undertakings authorised in any capacity to market such substances and

undertakings buying or producing pharmaceutical and 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) hereof shall be made

available to the Veterinary Services at its request and, in the case of

computerised records, in the form of a print-out.

Where the results of checks carried out in the territory of

Malta show failure to comply with the requirements of these regulations

in the country of origin of the animals or products, the Veterinary

Services shall have recourse to provisions taken according to the

procedure laid down in Article RE1 of the Veterinary Framework Act

on mutual assistance between the administrative authorities of Malta

and of the Member States to ensure the correct application of legislation

on veterinary and zootechnical matters.

(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 point

(i) of rule 3 have been administered by any means whatsoever<

(ii) to which substances or products referred to in point

(i) of rule 4 have been administered, unless those substances

or products were administered in compliance with the

provisions and requirements laid down in rules 5, 6 and 8 and

the withdrawal periods allowed in international

recommendations have been observed<

(b) meat or products obtained from animals the importation

of which is prohibited under point (a).

(3) However, 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

infringement.

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

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

Framework Act.

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press