Residues in Meat Regulations,1998

L.N. 142 of 1998

FOOD, DRUGS AND DRINKING WATER ACT

(cAP.231)

Residues in Meat Regulations,1998

IN exercise of the powers conferred by sections 12 and 28 of

the Food, Drugs and Drinking Water Act, the Minister of Health,

Care of the Elderly and Family Affairs, on the advice of the Council

of Health and of the Malta Standardisation Authority, has made the

following regulations

-

These regulations may be cited as the Residues in Meat cirarionand

Regulations, 1998, and shall come into force on the lst October, commen@menr'

1998.

In these regulations unless the context otherwise requires- InterFetdioin.

"aquaculture animal" means live fish, crustaceans or

molluscs coming from a fish-farm, including those from the

wild intended for a farm;

"Director" means the Director of Veterinary Service;

"farm animal" means a domestic animal of the bovine,

porcine, ovine and caprine species, domestic solipeds and

rabbits, wild animals of those species and wild ruminants which

have been raised on a holding, as well as such aquaculture

animals as are used intensively;

"illegal treatment" means the use of unauthorised

substances or products, or the use of substances or products

authorised under special conditions;

"pet" means any companion animal;

"sale" includes to offer, expose, advertise or keep for sale

and supply by way of compensation or otherwise;

"therapeutic treatment" means the administering under

regulation 5 of these regulations, to an individual farm animal

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 calving, to treat respiratory problems,

and to induce tocolysis in equidae raised for specific purposes

other than meat production;

"veterinarian" means a licensed veterinary surgeon;

"zootechnical treatment" means the administering of any

substance

(a) to an individual farm animal, authorised under

regulation 6 of these regulations 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 proviso to

paragraph (1) of regulation 6, under his responsibility; and

(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.

The Director shall prohibit

(a) the placing on the market of stibenes, stilbene

derivatives, their salts and esters; thyrostatic substances; and

chloramphenicol or any salt or ester thereof, for administering

to animals of all species; and

(b) the placing on the market of beta-agonists for

administering to animals the flesh and products of which are

intended for human consumption and for other purposes other

than those provided for in paragraph (b) of regulation 5.

The Director shall furthermore prohibit

(a) the administering to a farm aquaculture animal, by

any means whatsoever, of substances having a thyrostatic,

oestrogenic, androgenic or gestagenic action, chloramphenicol

and beta-agonists;

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

referred to in paragraph (a) on a fish-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 regulation 5

or 6;

(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).

(l) Notwithstanding regulations 3 and 4 of these Limirations.

regulations the Director may authorise

(a) the administering to farm animals, for therapeutic

purposes, of oestradiol 17 B, testosterone, 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 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 therefor who shall record at least

the following details in a register

- the type of treatment,

- the type of products authorised,

- the date of treatment,

- the identity of the animals treated,

- the identity of the establishment where the animals

treated are housed.

The register must be made available to the competent

authority at its request;

(b) the administration for therapeutic purposes of

authorised veterinary medicinal products containing

(i) allyl trenbolone, administered orally, or beta-

agonists to equidae and pets 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

Provided that these 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 by such substances must be registered by the

veterinarian responsible therefor, who shall record at least the

details referred to in paragraph (a).

(2) Farmers shall be prohibited from holding veterinary

medicinal products containing beta-agonists which may be used for

induction in the treatment of tocolysis

Provided that, without prejudice to the proviso to paragraph

(b) of this regulation, the therapeutic treatment of production animals,

including breeding animals, at the end of their reproductive life,

shall be prohibited.

(1) Notwithstanding the provisions of paragraph (a) of

regulation 4 and without prejudice to regulation 3 of these

regulations, the Director may authorise the administering to farm

animals, for the pu{pose of zootechnical treatment, of veterinary

medicinal products having an oestrogenic, androgenic or gestagenic

action. Such veterinary medicinal products must be administered by

a veterinarian to clearly identified animals, and the treatment must

be recorded by the veterinarian responsible therefor in accordance

with paragraph (a) of regulation 5

Provided that the Director may allow the synchronisation of

oestrus, the interruption of pregnancy and the preparation of donors

and recipients for the implantation of embryos to be effected not

directly by the veterinarian, 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 which are authorised by the Director for that purpose.

(3) In the cases provided for in this regulation, 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.

. (a) The use of the following hormonal products is not Hormonal producrs.

authorised:-

(i) products acting as a deposit;

(ii) products with a withdrawal period of more than

15 days after the end of treatment;

(iii) products

- whose conditions of use are not known,

- for which no reagents or equipment exist to detect the

presence of residues in excess of the permitted limits in the

case of analytical techniques.

(b) The use of veterinary medicinal products containing

beta-agonists which have a withdrawal period of more than 28

days after the end of treatment is not authorised.

E. (a) For the purpose of trade, the Director may authorise rrade

the placing on the market of animals for breeding that have undergone Iequirements'

a treatment referring to in regulations 5 and 6, and may authorise

the affixing of the veterinary stamp to meat from such animals where

the conditions laid down in regulations 5 and 6 and the minimum

withdrawal periods laid down in regulation 7 under paragraphs (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 high-value horses, in particular

racehorses, competition horses, circus horses or horses intended for

study purposes or for exhibitions, including registered equidae to

which veterinary medical products containing allyl trenbolone or

beta-agonists have been administered for the purposes referred to in

regulation 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 such animals.

(b) Meat or products from animals to which substances

having an oestrogenic, androgenic or gestagenic action and to which

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 such animals have been

treated with veterinary medicinal products complying with the

requirements of regulation 7, and in so far as the withdrawal period

laid down was observed before the animals were slaughtered.

(a) Mhuwiex awtorizzat l-uiu ta' dawn il-prodotti hodoniormoniei.

ormonici li gejjin:-

(i) prodotti li jagixxu bhala depo2itu;

(ii) prodotti b'withdrawal period ta' iktar minn 15-

il gurnata wara li tintemm il-kura;

(iii) prodotti

li l-kondizzjonijiet tal-u2u taghhom ma

jkunux maghrufin;

li dwarhom ma jkunux jeiistu reagenti jew

taghmir li jikxfu l-prezenza ta' fdalijiet f'ammonti

ikbar mil-limti permessi fil-ka2 ta' teknikalitajiet

analitici.

(b) M'huwiex awtorizzat l-uiu ta' prodotti medicinali

veterinarji li jkun fihom beta-agonisrs li jkollhomwithdrawal

period ta' iktar minn 28 gurnata wara li tintemm il-kura.

(a) Ghall-ghanijiet ta' kummerc, id-Direttur jista' kummercjali'

ntig'i"t

jawtorizza li jitpoggew fis-suq dawk l-annimali tat-trobbija 1i

tkun saritilhom il-kura msemmija fir-regolamenti 5 u 6, u jista'

jawtorizza t-twahhil ta' sigill veterinarju fuq il-laham ta' dawk

l-annimali fejn il-kondizzjonijiet stabbiliti fir-regolamenti 5 u

6 u l-inqas withdrawal periods stabbiliti fir-regolament 7 taht

il-paragrafi (a) (ii) jew (b) rispettivament, jew il-withdrawal

periods li hemm provdut dwarhom fl-awtorizzazzjoni biex

jitpoggew fis-suq, ikunu gew imharsa

ILda l-kummerc fi Zwiemel ta' valur gholi, b'mod

partikolari iwiemel tat-tigrija, 2wiemel tal-kompetizzjoni,

iwiemel tac-cirku jew iwiemel mahsubin ghal ghanijiet ta'

studju u ta' esibizzjoni, inkluZi equidae registrati li lilhom ikunu

nghataw prodotti medicinali veterinarji li jkun fihom allyl

trenbolone jew beta-agonists ghall-ghanijiet imsemmija fir-

regolament 5 , jista' j sir qabel ma jintemm il-withdrawal period

sakemm ikunu gew sodisfatti l-kondizzjonijiet li jinegolaw l-

ghoti tal-medicinali u sakemm l-ghamla u d-data tal-kura

jitnizzlu fuq ic-certifikat jew il-passaport li jkunu jsiehbu lil

dawk l-annimali.

(b) Il-laham jew il-prodotti ta' annimali li jkunu

inghatawlhom sustanzi li ghandhom azzjoni estrogenika,

androgenika jew gestagenika kif ukoll beta-agonisls, skond id-

dispozizzjonijiet dispensatorji ta' dawn ir-regolamenti, ma

jistghux jitpoggew fis-suq ghall-konsum tal-bniedem kemm-il

darba dawk l-annimali ma jkunx gew ikkurati bi prodotti

medicinali veterinarji li jkunu jaqblu mal-htigiet tar-regolament

7, u sakemmil-withdrawal period stipulat ikun gie mhares qabel

ma l-annimali jkunu gew maqtula.

The Director shall ensure that

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

distribution, sale and use of the substances referred to in

regulations 3 and 4 (a), their possession is restricted to the

authorised persons;

(b) checks are carried out by the competent authorities

without prior notice with a view to ascertaining facts relating

(i) the possession or presence of substances or

products prohibited under regulation 3 intended to be

administered to animals for the purpose of fattening;

(ii) the illegal treatment of animals;

(iii) failure to observe the withdrawal periods

provided for in regulation 7;

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

substances or products laid down in regulations 5 and 6;

(c) tests are carried but to detect the presence of

(i) the substances referred to in paragraph (a) ofthis

regulation in animals, in the drinking water of animals,

and in all places where animals are bred or kept;

(ii) residues of the aforementioned substances in live

animals, in their excrement and body fluids, and in animal

tissues and products; and

(d) where the checks provided for in paragraphs (b) and

(c) of this regulation reveal

(i) the presence ofsubstances or products the use or

possession of which is prohibited, or the presence of

residues of substances the administration of which is

classified under the heading of illegal treatment, such

substances or products should be confiscated, while any

animals treated with such substances or meat therefrom

should be placed under official supervision until the

requisite penalties have been applied;

(ii) in the case of failure of compliance with the

requirements of paragraphs (b) (ii) and (iii) of this

regulation, the competent authority should take appropriate

measures consistent with the gravity of the infringement.

Undertakings buying or producing substances having a records.

Purchase and sale

thyrostatic, oestrogenic, androgenic or gestagenic action and beta-

agonists, 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 are purchased. Such information must be made available to the

Director at his request and, in the case of computerised records, it

shall be made available in the form of a print-out.

(a) Countries whose legislation authorises the placing Impon

on the market and the administration of stilbenes, stilbene requ[emenB.

derivatives, their salts and esters, thyrostatic substances or

chloramphenicol, for administering to animals of ali species,

will not appear on any of the lists which authorise the

importation of farm or aquaculture animals or meat or products

obtained from such animals.

(b) The Director shall also prohibit the importation of

(i) farm or aquaculture animals

- to which substances or products referred to in

paragraph (a) of regulation 3 have been administered

by any means whatsoever;

- to which substances or products referred to in

paragraph (a) of regulation 4 have been administered,

unless those substances or products were administered

in compliance with the provisions and requirements

laid down in regulation 5,6 and 8, and the withdrawal

periods allowed in international recommendations

have been observed; and

(ii) meat or products obtained from animals the

importation of which is prohibited under sub-paragraph

(i) hereof.

(c) Animals intended for breeding, breeding animals at

the end of their reproductive life, or meat therefrom, may be

imported from countries which provide guarantees at least

equivalent to those laid down in these regulations.

(d) Checks on imports shall be carried outby the Director.

The Residues in Meat Regulations, 1989 are hereby repealed.

1989.