having a Hormonal or Thyrostatic Effect and of Beta-agonists

L.N. 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:-

(1) The title of these rules is Prohibition on the Use

of Certain Substances in Stockfarming having a Hormonal or

Thyrostatic Effect and of Beta-agonists Rules 2009.

(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

€0.84

(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 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.

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 –

(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;

(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

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

(iv).

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

shall be authorised:-

(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.

(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

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 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.

(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), under paragraph (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

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 (i) 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 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.

(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.

(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

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 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 RE1 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 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.

Prohibition on the Use in Stock-Farming of Substances

2005. having a Hormonal or Thyrostatic Action and of Betaagonists Rules,

2005 are hereby being repealed.

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