MEASURES TO MONITOR CERTAIN SUBSTANCES AND RESIDUES THEREOF IN LIVE ANIMALS AND ANIMAL PRODUCTS RULES

AND ANIMAL PRODUCTS

SUBSIDIARY LEGISLATION 437.58

MEASURES TO MONITOR CERTAIN SUBSTANCES

AND RESIDUES THEREOF IN LIVE ANIMALS

AND ANIMAL PRODUCTS RULES

24th March, 2005

LEGAL NOTICE 80 of 2005.

Chapter I - Scope and Definitions

(1) The title of these rules is the Measures to monitor

certain Substances and Residues thereof in Live Animals and

Animal Product Rules.

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

found under European Union Council Directive 96/023/EEC on the

measures to monitor certain substances and residues thereof in live

animals and animal products and in accordance with article 13 of

the Veterinary Services Act.

(3) These rules are intended to implement measures in order to

monitor certain substances and residues thereof in live animals and

animal products.

GROUP A - Substances having anabolic effect and unauthorized

Substances

(1)

Stilbenes, stilbene derivatives, and their salts and esters

(2)

Antithyroid agents

(3)

Steroids

(4)

Resorcylic acid lactones including zeranol

(5)

Beta-agonists

(6) Compounds included in Annex IV to Council Regulation (EEC) No 2377/90

of 26 June 1990

GROUP B - Veterinary drugs and contaminants

(1)

Antibacterial substances, including sulphonomides, quinolones

(2)

Other veterinary drugs

(a) Anthelmintics

(b) Anticoccidials, including nitroimidazoles

(c) Carbamates and pyrethroids

(d) Sedatives

(e) Non-steroidal anti-inflammatory drugs (NSAIDs)

(f)

Other pharmacologically active substances

(3)

Other substances and environmental contaminants

(a) Organochlorine compounds including PcBs

(b) Organophosphorus compounds

(d) Chemical elements

(d) Mycotoxins

(e) Dyes

(f)

Others

AND ANIMAL PRODUCTS

For the purposes of these rules, the definitions in Directive

96/22/EC shall apply. In addition

(1) "animal" means the species covered by Directive 90/

425/EEC;

(2) "approved laboratory" means a laboratory approved by

the competent authorities of the Territory of Malta for

the purposes of examining an official sample in order

to detect the presence of residues;

(3) "batch of animals" means a group of animals of the

same species, in the same age range, reared on the

same holding, at the same time and under the same

conditions of rearing;

(4) "beta-agonist" means a beta adrenoceptor agonist;

(5) "the Community" means the European Community as

established under the Treaty establishing the European

Community;

(6) "the Commission" means the European Commission;

(7) "the competent authority" means within the territory of

Malta, the Veterinary Services as provided under

article 2 of the Veterinary Services Act;

(8) "illegal treatment" means the use of unauthorized

substances or products or the use of substances or

products authorized under Community legislation for

purposes or under conditions other than those laid

AND ANIMAL PRODUCTS

down in Community legislation or, where appropriate,

in the various national legislations;

(9) "official sample" means a sample taken by the

competent authority which bears, for the purposes of

examination of the residues or substances listed in

Schedule I, a reference to the species, the type, the

quantity concerned, the method of collection and

particulars identifying the sex of the animal and the

origin of the animal or of the animal product;

(10) "Member State" means a State which is a Member

within the European Community;

(11) "residue" means a residue of substances having a

pharmacological action, of their metabolites and of

other substances transmitted to animal products and

likely to be harmful to human health;

(12) "third country" means a State which is not a Member

within the European Community;

(13) "unauthorized substances or products" means

substances or products the administering of which to

animals is prohibited under Community legislation.

Chapter II - Monitoring plans for the detection of residues

or substances

RESIDUE OR SUBSTANCE GROUP TO BE DETECTED BY TYPE OF ANIMAL,

THEIR FEEDINGSTUFFS, INCLUDING DRINKING WATER,

AND PRIMARY ANIMAL PRODUCTS

Type of

Bovine,

animal,

Rabbit meat

ovine,

feedingstuffs

and the meat

caprine, Poultry Aquaculture

or animal

Milk

Eggs

of wild game

Honey

porcine,

animals

products

and farmed

equine

Substance

game

animals

groups

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

2a

X

X

X

X

X

b

X

X

X

X

c

X

X

X

X

d

X

e

X

X

X

X

f

3a

X

X

X

X

X

X

X

b

X

X

X

c

X

X

X

X

X

X

d

X

X

X

X

e

X

f

AND ANIMAL PRODUCTS

The production process of animals and primary products of

animal origin shall be monitored in accordance with this Chapter

for the purpose of detecting the presence of the residues and

substances listed in Schedule I in live animals, their excrement and

body fluids and in tissue, animal products, animal feed and

drinking water.

SAMPLING STRATEGY

1. The residue control plan is aimed at surveying and revealing the reasons for

residue hazards in foods of animal origin on farms, slaughterhouses, dairies, fish

processing plants, and egg collecting and packing stations.

Official samples are to be taken in accordance with the relevant chapter of

Schedule IV.

Wherever official samples are taken, sampling must be unforeseen, unexpected

and effected at no fixed time and on no particular day of the week. The territory of

Malta must take all the precautions necessary to ensure that the element of surprise

in the checks is constantly maintained.

2. For Group A substances, surveillance should be aimed at detecting the

illegal administration of prohibited substances and the abusive administration of

approved substances, respectively. The emphasis of such sampling must be

concentrated according to the relevant chapter of Schedule IV.

The samples must be targeted taking account of the following minimum criteria

sex, age, species, fattening system, all available background information, and all

evidence of misuse or abuse of substances of this group. The details of these criteria

will be laid down in the Commission Decision provided for in rule 15(1).

3. For Group B substances, surveillance should be aimed particularly at

controlling the compliance with MRLs for residues of veterinary medicinal products

fixed in Annexes I and III to Regulation (EEC) No 2377/90, and the maximum levels

of pesticides fixed in Annex III to Directive 86/363/EEC, and monitoring the

concentration of environmental contaminants.

Unless random sampling can be justified by the territory of Malta when presenting

their national plans to the Commission, all the samples shall be targeted according to

criteria laid down in the Commission Decision provided for in rule 15(1).

(1) The Veterinary Services shall assign the task of

coordinating the implementation of the inspections provided for in

this Chapter, which are carried out within Malta, to a central public

department or body.

(2)

The Veterinary Services shall be responsible for

(a) drawing up the plan provided for in rule 5 to enable the

competent departments to carry out the required

inspections;

(b) coordinating the activities of the central and regional

departments responsible for monitoring the various

residues. Such coordination shall extend to all

departments working to prevent the fraudulent use of

substances or products on stock farms;

(c) collecting the data needed to evaluate the means used

and the results obtained in carrying out the measures

provided for in these rules;

(d) sending the Commission, by not later than 31 March of

each year, the data and results referred to in paragraph

(c), including the results of any surveys undertaken.

AND ANIMAL PRODUCTS

(3) This rule shall not affect more specific rules applicable to

the monitoring of animal nutrition.

SAMPLING LEVELS AND FREQUENCY

The purpose of this Schedule is to define the minimum number of animals from

which the samples must be taken.

Each sample can be analysed for detecting the presence of one or more substances.

CHAPTER 1

Bovine, porcine, ovine, caprine and equine animals

1. Bovine animals

The minimum number of animals to be controlled each year for all kinds of

residues and substances must at least equal 0,4% of bovine animals slaughtered the

previous year, with the following breakdown

Group A: 0,25% divided as follows

-

one half of the samples are to be taken from live animals on the holding

(by derogation, 25% of samples analysed for the research of Group A 5

AND ANIMAL PRODUCTS

substances can be taken from appropriate material (feedingstuffs,

drinking water, etc.))

-

one half of the samples are to be taken at the slaughterhouse. Each sub-

group in Group A must be checked each year using a minimum of 5 %

of the total number of samples to be collected for Group A.

The balance must be allocated according to the experience and background

information of the territory of Malta.

Group B: 0,15%

30% of the samples must be checked for Group B 1 substances.

30% of the samples must be checked for Group B 2 substances.

10% of the samples must be checked for Group B 3 substances.

The balance must be allocated according to the situation in Malta.

2. Porcine animals

The minimum number of animals to be checked each year for all kinds of residues

and substances must at least equal 0,05% of the pigs slaughtered the previous year,

with the following breakdown

Group A: 0,02%

In Malta which carries out its sampling of animals at the slaughterhouse, in

addition analysis of drinking water, feedingstuffs, faeces, or all other appropriate

parameters must be undertaken at farm level. In that case, the minimum number of

farms to be visited annually must represent at least one farm per 100 000 pigs

slaughtered the previous year.

Each sub-group in Group A must be checked each year using a minimum of 5% of

the total number of samples to be collected for Group A. The balance will be

allocated according to the experience and background information about Malta.

Group B: 0,03%

The same breakdown per sub-group as for bovine animals has to be respected. The

balance will be allocated according to the situation in Malta.

3. Sheep and goats

The minimum number of animals to be checked for all kind of residues and

substances must at least equal 0,05 % of sheep and goats over three months of age

slaughtered the previous year, with the following breakdown

Group A: 0,01%

Each sub-group of Group A must be checked each year using a minimum of 5% of

the total number of samples to be collected for Group A.

The balance will be allocated according to the experience and background

information about Malta.

Group B: 0,04%

The same breakdown per sub-group as for bovine animals has to be respected. The

balance will be allocated according to the experience of Malta.

4. Equine animals

The number of samples is to be determined by the territory of Malta in relation to

the problems identified.

AND ANIMAL PRODUCTS

CHAPTER 2

Broiler chickens, spent hens, turkeys, other poultry

A sample consists of one or more animals depending on the requirements of the

analytical methods.

For each category of poultry considered (broiler chickens, spent hens, turkeys, and

other poultry), the minimum number of samples to be taken each year must at least

equal one per 200 tonnes of annual production (deadweight), with a minimum of 100

samples for each group of substances if the annual production of the category of

birds considered is over 5 000 tonnes.

The following breakdown must be respected

Group A: 50% of the total samples

The equivalent of one fifth of these samples must be taken at farm level.

Each sub-group of Group A must be checked each year using a minimum of 5% of

the total number of samples to be collected for Group A.

The balance will be allocated according to the experience and background

information about Malta.

Group B: 50% of the total samples,

30% must be checked for Group B 1 substances,

30% must be checked for Group B 2 substances,

10% must be checked for Group B 3 substances.

The balance will be allocated according to the situation in Malta.

CHAPTER 3

Aquaculture products

1. Finfish farming products

A sample is one or more fish, according to the size of the fish in question and of

the requirements of the analytical method.

Malta must respect the minimum sampling levels and frequencies given below,

depending on the production of farmed fish (expressed in tonnes).

The minimum number of samples to be collected each year must be at least 1 per

100 tonnes of annual production. The compounds sought and the samples selected

for analysis should be selected according to the likely use of these substances.

The following breakdown must be respected

Group A

one third of the total samples

all the samples must be taken at farm level, on fish at all stages of

farming, including fish which is ready to be placed on the market for

consumption.

Group B

two thirds of the total samples

the sampling should be carried out

(a) preferably at the farm, on fish ready to be placed on the market

for consumption;

(b) either at the processing plant, or at wholesale level, on fresh fish,

AND ANIMAL PRODUCTS

on condition that tracing-back to the farm of origin, in the event of

positive results, can be done.

In all cases, samples taken at farm level should be taken from a minimum of 10%

of registered sites of production.

2. Other aquaculture products

When Malta has reason to believe that veterinary medicine or chemicals are being

applied to the other aquaculture products, or when environmental contamination is

suspected, then these species must be included in the sampling plan in proportion to

their production as additional samples to those taken for finfish farming products.

(1) The Veterinary Services shall submit a plan to the

Commission setting out the national measures to be implemented

during the initial year of the plan and subsequently any update of

plans previously approved in accordance with rule 8 on the basis of

the experience of the preceding year, or years by 31 March at the

latest of the year of the update.

(2)

The plan provided for in sub-rule (1) shall

(a) provide for detection of groups of residues or

substances according to type of animal, in accordance

with Schedule II;

(b) specify in particular the measures for detection of the

presence of

(i)

the substances referred to in paragraph (a) in the

animals, in the drinking water of the animals and

in all places where the animals are bred or kept;

(ii) residues of the aforementioned substances in

live animals, their excrement and body fluids

and in animal tissues and products such as meat,

milk, eggs and honey;

(c) comply with the sampling rules and levels laid down in

Schedules III and IV.

Chapter 1

The following laboratories shall be designated Community reference laboratories

for the detection of residues of certain substances

(a) For the residues listed in Schedule I, Group A 1, 2, 3, 4, Group B 2 (d)

and Group B 3 (d)

Rijksinstituut voor Volksgezondheid en Milieuhygiëne (RIVM)

A. van Leeuwenhoeklaan, 9

NL-3720 BA Bilthoven

(b) For the residues listed in Schedule I, Group B 1 and B 3 (e) and

carbadox residues and olaquindox residues

Laboratoriesdes médicaments vétérinaires (CNEVA-LMV)

La Haute Marche, Javene

F-35135-Fougères

(c) For the residues listed in Schedule I, Group A 5 and Group B 2 (a), (b),

(e)

Bundesinstitut

für

Gesundheitlichen

Verbraucherschutz

und

Veterinärmedizin (BGVV)

Diedersdorfer Weg, 1

D-12277-Berlin

(d) For the residues listed in Schedule I, Group B 2 (c) and Group B 3 (a),

(b), (c)

Istituto Superiore di Sanità

Viale Regina Elena, 299

I-00161-Roma

The compounds included in Group A 6, B 2 (f) and B 3 (f) are allocated to the

designated Community reference laboratories, according to their pharmacological

action.

Chapter 2

The powers and operating conditions of the Community reference laboratories for

the detection of residues in live animals, their excrement and body fluids and in

tissue, animal products, animal feed and drinking water shall be as follows

1. The functions of Community reference laboratories shall be

AND ANIMAL PRODUCTS

(a) to promote and coordinate research into new analytical methods and to

inform national reference laboratories of advances in analytical methods

and equipment;

(b) to help the national reference laboratories (NRLs) for residues to

implement an appropriate quality assurance scheme system based on

good laboratory practice (GLP) principles and EN 45 000 criteria;

(c) to approve validated methods as reference methods, to be integrated

into a collection of methods;

(d) to provide the national reference laboratories with the routine analytical

methods accepted during the MRL procedure;

(e) to provide national reference laboratories with details of analytical

methods and the comparative tests to be conducted, and to inform them

of the results of the tests;

(f)

to provide national reference laboratories, at their request, with

technical advice on the analysis of the substances for which they have

been designated the Community reference laboratory;

(g) to organize comparative tests for the benefit of the national reference

laboratories, the frequency of which shall be determined in agreement

with the Commission. Consequently, the Community reference

laboratories shall distribute blank samples and samples containing

known amounts of analyte to be analysed;

(h) to identify residues and determine their concentration in cases where the

results of an analysis give rise to a disagreement between Member

States;

(i)

to conduct initial and further training courses for the benefit of analysts

from national laboratories;

(j)

to provide the Commission services, including the standards,

measurements and testing programme, with technical and scientific

assistance;

(k) to compile a report on each year’s work and transmit it to the

Commission;

(l)

to liaise, in the field of analytical methods and equipment, with the

national reference laboratories designated by third countries in the plans

to be submitted in accordance with rule 11 of these rules.

2. In order to perform the functions specified in paragraph 1, Community

reference laboratories must satisfy the following minimum requirements

(a) have been designated as a national reference laboratory in Malta;

(b) have suitable qualified staff who are adequately trained in analytical

methods used for the residues for which they have been designated the

Community reference laboratory;

(c) possess the equipment and substances needed to carry out the analysis

for which they are responsible;

(d) have an adequate administrative infrastructure;

(e) have sufficient data-processing capacity to produce statistics based on

their findings and to enable rapid communication of those statistics and

other information to national reference laboratories and the

AND ANIMAL PRODUCTS

Commission;

(f)

ensure that their staff respect the confidential nature of certain issues,

results or communications;

(g) have sufficient knowledge of international standards and practices;

(h) have available an up-to-date list of certified reference material and

reference material held by the Institute for Reference Material and

Methods, and an up-to-date list of manufacturers and vendors of that

material.

(1) The plan must conform to the sampling levels and

frequencies laid down in Schedule IV. However, at the request of

the Veterinary Services the Commission may, in accordance with

the procedure provided for in rule 32, adjust the minimum control

requirements laid down in Schedule IV provided that it is clearly

established that such adjustments increase the overall effectiveness

of the plan in respect of the territory of Malta and in no way reduce

its ability to identify residues of, or cases of illegal treatment with,

substances listed in Schedule I.

(2) Re-examination of the groups of residues to be checked for

in accordance with Schedule II and determination of the sampling

levels and frequencies covering the animals and products referred

to in rule 3 and not already laid down in Schedule IV shall take

place in accordance with the procedure provided for in Article 33

of Council Directive 96/23/EC of 29 April 1996 and on the first

occasion within a maximum of 18 months of the adoption of these

rules. In doing so, account shall be taken of experience gained

under existing national measures and information forwarded to the

Commission under existing Community requirements making such

specific product groups subject to monitoring for residues.

Correlation table

These rules

Directives 85/358/EEC and 86/469/EEC and

Decisions 89/187/EEC and 91/664/EEC

Rule 1

-

Rule 2

Article 2

86/469/EEC

Rule 3

Article 1

86/469/EEC

Article 2

85/358/EEC

Rule 4

Article 3

86/469/EEC

Rule 5

Article 4 (1) first and second indents

86/469/EEC

Rule 6

-

Rule 7

Article 4 (1) except first and second indents

86/469/EEC

Rule 8

Article 4 (2) to 4 (5)

86/469/EEC

Article 12

86/469/EEC

Article 9

85/358/EEC

Rule 9

-

Rule 10

-

Rule 11

Article 1

85/358/EEC

Rule 12

-

Rule 13

Article 3

85/358/EEC

Article 10

86/469/EEC

Rule 14 (1)

Article 8 (1) (b)

86/469/EEC

Rule 14 (2)

Article 8 (2)

86/469/EEC

Decision 91/664/EEC

Decision 89/187/EEC

Rule 15 (1)

Article 8 (3)

86/469/EEC

Article 5 (2)

85/358/EEC

Rule 15 (2)

Article 8 (3)

86/469/EEC

Article 5 (3)

85/358/EEC

Rule 15 (3)

Article 9

86/469/EEC

Rule 16

Article 9 (1) and Article 9 (2)

86/469/EEC

Article 6 (1) and Article 6 (2)

85/358/EEC

Rule 17

Article 9 (3) (a)

86/469/EEC

Article 6 (3) (a)

85/358/EEC

AND ANIMAL PRODUCTS

These rules

Directives 85/358/EEC and 86/469/EEC and

Decisions 89/187/EEC and 91/664/EEC

Rule 18

Article 9 (3) (c) and (d)

86/469/EEC

Rule 19

-

Rule 20 (1)

-

Rule 20 (2)

Article 11

86/469/EEC

Rule 21

Article 5

86/469/EEC

Rule 22

Article 7

85/358/EEC

Rule 23

Articles 9 (3) (b) (c) (d) and 9 (4), 9 (5)

86/469/EEC

Articles 6 (3) (b) (c) (d) and 6 (4)

85/358/EEC

Rule 24

Article 4

85/358/EEC

Rule 25

-

Rule 26

-

Rule 27

-

Rule 28

-

Rule 29

Article 7

86/469/EEC

Article 13

85/358/EEC

Rule 30

-

Rule 31

Article 12

85/358/EEC

Rule 32

Article 14

86/469/EEC

Article 11

85/358/EEC

Schedule I

Annex I

86/469/EEC

Schedule II

-

Schedule III

-

Schedule IV

Annex II

86/469/EEC

Schedule V Chapter 1

Decision 91/664/EEC

Schedule V Chapter 2

Decision 89/187/EEC

Schedule VI

-

The initial plan shall take into account the specific

situation of Malta and specify in particular

(a) legislation on the use of the substances listed in

Schedule I and, in particular, provisions on their

AND ANIMAL PRODUCTS

prohibition or authorization, distribution and placing

on the market and the rules governing their

administration, in so far as such legislation is not

harmonized;

(b) the infrastructure of the relevant departments (in

particular, giving details of the type and size of the

bodies involved in implementing the plans);

(c) a list of approved laboratories with details of their

capacity for processing samples;

(d) national tolerances for authorized substances where no

maximum Community residue levels have been set

under Regulation (EEC) No 2377/90 and Directive 86/

363/EEC;

(e) a list of the substances to be detected, methods of

analysis, standards for interpreting the findings and, in

the case of the substances listed in Schedule I, the

number of samples to be taken, giving reasons for this

number;

(f)

the number of official samples to be taken in relation

to the number of animals of the species concerned

slaughtered in preceding years in accordance with the

sampling levels and frequencies laid down in Schedule

IV;

(g) details of the rules governing the collection of official

samples, and in particular the rules concerning the

particulars to appear on such official samples;

(h) the type of measures laid down by the competent

authorities with regard to animals or products in which

residues have been detected.

(1) The Commission shall examine the initial plans

forwarded pursuant to rule 5(1) to ascertain whether they conform

to these rules. The Commission may ask Malta to modify or

supplement these plans to make them conform.

Once the Commission has established their conformity, it shall

submit the plans approval in accordance with the procedure

provided for in rule 32.

In order to take account of changes in the situation in Malta or in

a region thereof, of the results of national surveys or of

investigations carried out in the framework of rules 16 and 17, the

Commission may, at the request of Malta or on its own initiative,

decide, in accordance with the procedure provided for in rule 32, to

approve an amendment or addition to a plan previously approved

pursuant to sub-rule (2).

(2) Annual amendments to the initial plans communicated by

Malta, in particular in the light of the results referred to in rule

4(2)(d), shall be forwarded by the Commission to the other Member

States once the Commission has established their conformity with

these rules.

AND ANIMAL PRODUCTS

Member States shall have ten working days from receipt of those

amendments in which to inform the Commission of any comments.

If there are no comments from Member States, the amendments

to the plans shall be deemed to be approved.

The Commission shall inform the territory of Malta and the other

Member States of such approval immediately.

Where there are comments from Member States or where the

Commission deems the update not to be in conformity or

insufficient, the Commission shall submit the updated plans to the

St a n d i n g Ve t e r i n a r y C o m m i t t e e , w h i c h m u s t a c t u n d e r t h e

procedure laid down in Article 33 of Council Directive 96/23/EC of

29 April 1996.

The provisions laid down in sub-rule (3) and (4) shall apply to

the updated plans.

(3) Every six months, Malta shall inform the Commission and

the other Member States within the Standing Veterinary Committee

of the implementation of plans approved pursuant to sub-rule (2) or

of the development of the situation. Where necessary, sub-rule (4)

shall apply. By not later than 31 March each year, Malta shall

forward to the Commission the results of their residue and

substance detection plans and of their control measures.

Malta shall, for the first time by 31 March 2005, forward to the

Commission the results of their residue and substance detection

plans and of their control measures.

The territory of Malta shall make public the outcome of the

implementation of the plans.

The Commission shall inform Malta and other Member States,

within the Standing Veterinary Committee, of developments in the

situation in the various regions of the Community.

(4) Each year, or whenever it deems it necessary on public

health grounds, the Commission shall report to Malta and other

Member States within the Standing Veterinary Committee on the

outcome of the checks and surveys referred to in sub-rule (3), in

particular on

-

the implementation of national plans,

-

developments in the situation in the various regions of

the Community.

(5) The Commission shall send the European Parliament and

the Council a communication each year on the results of action

taken at regional, national or Community level, in consideration of

the report and comments made by Member States on it.

Chapter III - Self-monitoring and co-responsibility

on the part of operators

(1) Malta shall ensure that

(a) any farms which place farm animals on the market and

any natural or legal person engaged in trade in such

AND ANIMAL PRODUCTS

animals register beforehand with the competent

authorities and undertake to abide by the relevant

Community and national rules, in particular the

provisions laid down in Articles 5 and 12 of Directive

90/425/EEC;

(b) the owners or persons in charge of the establishment of

initial processing of primary products of animal origin

take all necessary measures, in particular by carrying

out their own checks, to

(i)

accept - whether by direct delivery or through an

intermediary - only those animals for which the

producer is able to guarantee that withdrawal

times have been observed;

(ii) satisfy themselves that the farm animals or

products brought into the establishment

(1) do not contain residue levels which exceed

maximum permitted limits;

(2) do not contain any trace of prohibited

substances or products;

(c)

(i) the producers or persons in charge referred to in

paragraphs (a) and (b) place on the market only

(1) animals to which no unauthorized

substances

or

products

have

been

administered or which have not undergone

illegal treatment within the meaning of these

rules;

(2) animals in respect of which, where

authorized products or substances have been

administered, the withdrawal periods

prescribed for these products or substances

have been observed;

(3) products derived from the animals referred

to in sub-paragraphs (1) and (2);

(ii) where an animal is presented at a first-stage

processing establishment by a natural or legal

person other than the producer, the obligations

laid down in sub-paragraph (i) are incumbent on

the latter.

(2) For the purposes of applying sub-rule (1), Malta shall

ensure, without prejudice to compliance with the rules laid down in

the Directives governing the placing on the market of the various

products in question, that

(a) the principle of quality monitoring of the production

chain by the different parties involved is established in

its legislation,

(b) the self-monitoring measures to be included in the

specifications for trade marks or labels are stepped up.

It shall inform the Commission and the other Member States, at

AND ANIMAL PRODUCTS

their request, of provisions laid down in this regard and in

particular of provisions adopted for checks on sub-rule (1)(c)(i)(1)

and (2).

Malta shall ensure that the terms of reference and

responsibilities of veterinarians monitoring farms are extended to

monitoring the rearing conditions and the forms of treatment

referred to in these rules.

Within this framework, the veterinarian shall enter in a register

kept on the farm the date and nature of any treatment prescribed or

administered, the identification of the animals treated and the

corresponding withdrawal periods.

The stockfarmer shall enter in the register, which may be the

register provided for in Directive 90/676/EEC, the date and nature

of the treatment administered. He shall satisfy himself that

withdrawal periods have been observed and keep the prescriptions

to prove it for five years.

Stockfarmers and veterinarians shall be required to supply any

information to the competent authority, at its request, and in

particular supply information to the official veterinarian of the

slaughterhouse, regarding a given farm’s compliance with the

requirements of these rules.

Chapter IV - Official control measures

(1) Without prejudice to the checks carried out in

connection with implementation of the surveillance plans referred

to in rule 5 or to the checks provided for in specific Directives,

Malta may have official random checks conducted

(a) during the manufacture of the substances included in

Group A in Schedule I and during their handling,

storage, transport, distribution and sale or acquisition;

(b) at any point in the animal feedingstuffs production and

distribution chain;

(c) throughout the production chain of animals and raw

materials of animal origin covered by these rules.

(2) The checks provided for in sub-rule (1) must be conducted

with a view in particular to detecting the possession or presence of

prohibited substances or products which it is intended to administer

to animals for the purposes of fattening or illegal treatment.

(3) Where fraud is suspected, and in the case of a positive

result from any of the checks referred to in sub-rule (1), rules 16 to

19 and the measures provided for in Chapter V shall apply.

The checks provided for at the slaughterhouse or on the first sale

of aquaculture animals and fishery products can be reduced to take

account of the fact that the farm of origin or departure belongs to an

epidemiological surveillance network or a quality monitoring

system as referred to in rule 9(2)(a).

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The checks provided for in these rules must be carried out

by the competent authority without prior notice.

The owner, the person empowered to dispose of the animals or

their representative shall be obliged to facilitate pre-slaughter

inspection operations, and in particular to assist the official

veterinarian or the authorized staff in any manipulation judged

necessary.

The competent authority shall

(a) where illegal treatment is suspected, ask the owner or

person having charge of the animals or the veterinarian

in charge of the farm to provide any documentation

justifying the nature of the treatment;

(b) where this inquiry confirms illegal treatment or where

unauthorized substances or products have been used,

or where there are grounds for suspecting their use,

conduct or have conducted

(i)

spot checks on animals on their farms of origin

or departure, in particular with a view to

detecting such use and in particular any traces of

implants; these checks may include official

sampling;

(ii) checks to detect substances the use of which is

prohibited or of unauthorized substances or

products on the farms where the animals are

being reared, kept or fattened (including

holdings administratively connected with such

farms) or on the animals’ farms of origin or

departure. Official samples of drinking water

and feedingstuffs are necessary for that purpose;

(iii) spot checks on animals’ feedingstuffs on their

farms of origin or departure, and on their

drinking water or

- for aquaculture animals

- from the waters in which they are caught,

(iv) the checks provided for in rule 11(1)(a);

(v) any check required to clarify the origin of the

unauthorized substances or products or that of

the treated animals;

(c) where the maximum levels laid down by Community

rules or, pending such legislation, the levels set by

national legislation have been exceeded, carry out any

measure or investigation which it may deem

appropriate in relation to the finding in question.

(1) Malta shall designate at least one national reference

laboratory. A given residue or residue group may not be assigned to

more than one national reference laboratory.

A list of such designated laboratories shall be drawn up in

AND ANIMAL PRODUCTS

accordance with the procedure laid down in Article 33 of Council

Directive 96/23/EC of 29 April 1996. These laboratories shall be

responsible for

(a) coordinating the work of the other national

laboratories responsible for residue analysis, in

particular by coordinating the standards and methods

of analysis for each residue or residue group

concerned,

(b) assisting the competent authority in organizing the

plan for monitoring residues,

(c) periodically organizing comparative tests for each

residue or residue group assigned to them,

(d) ensuring that national laboratories observe the limits

laid down,

(e) disseminating information supplied by Community

reference laboratories,

(f)

ensuring that their staff are able to take part in further

training courses organized by the Commission or by

Commission reference laboratories.

(2) The Community reference laboratories shall be those

designated in Chapter 1 of Schedule V.

The powers and working conditions of the laboratories shall be

as defined in Chapter 2 of Schedule V.

(1) Official samples must be taken in accordance with

Schedules III and IV in order to be examined in approved

laboratories.

The detailed rules for the taking of official samples and the

routine and reference methods to be employed for the analysis of

such official samples shall be specified in accordance with the

procedure laid down in Article 33 of Council Directive 96/23/EC of

29 April 1996.

Whenever an authorization is issued for the placing on the

market of a veterinary medicinal product intended for

administration to a species the meat or product of which is intended

for human consumption, the competent authorities shall forward

the routine analysis methods as laid down in Article 5, second

subparagraph, point 8 of Directive 81/851/EEC and Article 7 of

Regulation (EEC) No 2377/90 to the Community and national

reference laboratories for detection of residues.

(2) For Group A substances, all positive findings recorded

following the application of a routine method instead of a reference

method must be confirmed by an approved laboratory using the

reference methods laid down in accordance with sub-rule (1).

For all substances, if challenged on the basis of a contradictory

analysis, those results must be confirmed by the national reference

laboratory designated in accordance with rule 14(1) for the

substance or residue in question. Such confirmation must be carried

AND ANIMAL PRODUCTS

out at the plaintiff’s cost in the event of confirmation.

(3) Where examination of an official sample reveals illegal

treatment, rules 16 to 19 shall apply, together with the measures

laid down in Chapter V.

Where the examination reveals the presence of residues of

authorized substances or contaminants exceeding the levels set by

Community rules or, pending such legislation, the levels set by

national legislation, rules 18 and 19 shall apply.

Where the examination referred to in this sub-rule covers

animals or products of animal origin from another Member State,

the competent authority of the Member State of origin shall apply

rules 16(2), 17, 18 and 19 and the measures provided for in Chapter

V to the farm or establishment of origin or departure, following the

reasoned request of the competent authority having carried out the

examination.

Where the examination covers products or animals imported

from a third country, the competent authority having carried out

that examination shall refer the matter to the Commission, which

shall take the measures provided for in rule 30.

Member States shall ensure that, where positive results are

obtained as described in rule 15

(a) the competent authority shall obtain without delay

(i)

all the information required to identify the

animal and farm of origin or departure;

(ii) full details of the examination and its result. If

the controls carried out in Malta demonstrate the

need for an investigation or other action in one

or more Member States or third countries, Malta

shall inform the other Member States and the

Commission. The Commission shall coordinate

the appropriate measures taken in Member

States where an investigation or other action

proves necessary;

(b) the appropriate authority shall carry out

(i)

an investigation on the farm of origin or

departure, as appropriate, to determine the

reasons for the presence of residues;

(ii) in the case of illegal treatment, an investigation

of the source or sources of the substances or

products concerned at the stage of manufacture,

handling, storage, transport, administration,

distribution or sale, as appropriate;

(iii) any other further investigations which the

authority considers necessary;

(c) animals from which sample shave been taken are

clearly identified. They may not in any circumstances

leave the farm until the results of the checks are

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available.

Where illegal treatment is established, the competent

authority must ensure that the livestock concerned in the

investigations referred to in rule 13(b) is immediately placed under

official control. It must furthermore ensure that all the animals

concerned bear an official mark or identification and that, as a first

step, an official sample is taken from a statistically representative

sample, on internationally recognized scientific bases.

(1) Where there is evidence of residues of authorized

substances or products of a level exceeding the maximum limit for

residues, the competent authority shall carry out an investigation in

the farm of origin or departure, as applicable, to determine why the

above limit was exceeded.

In accordance with the results of that investigation, the

competent authority shall take all necessary measures to safeguard

public health which may include prohibiting animals from leaving

the farm concerned or products from leaving the farm or

establishment concerned for a set period.

(2) In the event of repeated infringements of maximum residue

limits when animals are placed on the market by a farmer or

products are placed on the market by a farmer or a processing

establishment, intensified checks on the animals and products from

the farm and, or establishment in question must be carried out by

the competent authorities for a period of at least six months,

products or carcasses being impounded pending the results of

analysis of the samples. Any results showing that the maximum

residue limit has been exceeded must lead to the carcasses or

products concerned being declared unfit for human consumption.

(1) The costs of the investigations and checks referred to

in rule 16 shall be borne by the owner or person having charge of

the animals.

Where the investigation confirms that suspicion was justified,

the costs of analyses carried out under rules 17 and 18 shall be

borne by the owner or person having charge of the animals.

(2) Without prejudice to criminal or administrative penalties,

the cost of destroying animals which have given a positive result or

animals which have been deemed positive in accordance with rule

23 shall be borne by the owner of the animals without indemnity or

compensation.

(1) Council Directive 89/608/EEC of 21 November 1989

on mutual assistance between the administrative authorities of the

M e m b e r Sta t e s a n d c oo p e r a t i o n b e t w e e n t h e l a t t e r a n d t h e

Commission to ensure the correct application of legislation on

veterinary and zootechnical matters, shall apply for the purposes of

these regulations.

(2) Where the competent authority considers that, in another

Member State, the controls provided for in these regulations are not

being, or have ceased to be, carried out, it shall inform the

AND ANIMAL PRODUCTS

competent central authority of that State accordingly. Following an

investigation carried out in accordance with rule 16(b), that

authority shall take all necessary measures and shall, at the earliest

opportunity notify the competent central authority of Malta of the

decisions taken and the reasons for those decisions.

If the competent authority fears that such measures are not being

taken or are inadequate, it shall, together with the Member State

which has been challenged, seek ways and means of remedying the

situation; if appropriate, this may involve an on-the-spot

inspection. Malta shall inform the Commission of disputes and of

solutions arrived at.

If Malta is involved in a dispute and is unable to reach

agreement, it shall bring the matter to the notice of the Commission

within reasonable period of time, and the latter shall instruct one or

more experts to deliver an opinion.

Pending that opinion, Malta may carry out checks on products

coming from any establishment or holding to which the dispute

relates and, if the result is positive, take measures similar to those

provided for in Article 7(1)(b) of Directive 89/662/EEC.

In the light of the experts’ opinion, appropriate measures may be

taken in accordance with the procedure provided for in rule 32.

Those measures may be reviewed in accordance with the same

procedure, in the light of a new expert opinion delivered within

fifteen days.

(1) To the extent necessary to ensure uniform application

of these regulations, and in cooperation with the competent

authorities of Malta, the Commission’s veterinary experts may

verify on the spot that the plans and the system for checking the

plans by the competent authorities have been uniformly

implemented. Malta, within whose territory a verification is being

carried out, shall give all necessary assistance to the experts in

carrying out their duties. The Commission shall inform Malta of the

results of the verifications carried out.

Malta shall take the measures necessary to take account of the

results of these verifications and shall notify the Commission of the

m e a s u r e s t a k e n . W h e r e t h e C o m m i s s io n c on s i de r s t h a t t h e

measures taken are insufficient, it shall, after consultation with

Malta in question and having regard to the measures necessary to

safeguard public health, take appropriate measures in accordance

with the procedure laid down in rule 32.

(2) The general rules for implementing this rule, especially as

regards the frequency and method of carrying out the verifications

referred to in the first subparagraph of sub-rule (1) (including

cooperation with the competent authorities), shall be determined in

accordance with the procedure laid down in Article 33 of Council

Directive 96/23/EC of 29 April 1996.

AND ANIMAL PRODUCTS

Chapter V - Measures to be taken in the event of infringement

Where unauthorized substances or products or substances

listed in Group A and Group B (1) and (2) of Schedule I are

discovered in the possession of non-authorized persons, those

unauthorized substances or products must be placed under official

control until appropriate measures are taken by the competent

authority, without prejudice to the possible imposition of penalties

on any offender.

(1) During the period in which animals are impounded as

provided for in rule 17, animals from the farm in question may not

leave the farm of origin or be handed over to any other person

except under official control. The competent authority shall take

appropriate precautionary measures in accordance with the nature

of the substance or substances identified.

(2) After sampling has been carried out in accordance with rule

17, if there is confirmation of a case of illegal treatment, the animal

or animals found to be positive shall be slaughtered immediately on

the spot or taken immediately to the designated slaughterhouse or

to t he knack er ’s y ard u nder cover of an official veterinary

certificate in order to be slaughtered there. Animals so slaughtered

shall be sent to a high-risk processing plant as defined by Directive

90/667/EEC.

In addition, samples must be taken at the farm’s expense from the

entire batch of animals belonging to the farm at which checks were

carried out and which may be suspect.

(3) However, if half or more of the samples taken by

representative sampling in accordance with rule 17 are positive, the

farmer may be left a choice between a check on all the animals

present on the farm which may be suspect, or slaughter of these

animals.

(4) For a further period of at least twelve months, any farm

belonging to the same owner shall be subject to more stringent

checks for the residues in question. Where an organized system of

selfmonitoring has been set up, this facility shall be withdrawn

from the farmer for that period.

(5) In view of the infringement recorded, the farms or

establishments supplying the holding concerned shall be subject to

checks in addition to those provided for in rule 11(1) to determine

the origin of the substance in question. The same shall apply to all

farms and establishments in the same supply chain of animals and

animal feed as the farm of origin or departure.

The official veterinarian of a slaughterhouse must

(a) if he suspects or has evidence that the animals

concerned have been subjected to illegal treatment or

that unauthorized substances or products have been

administered to them

(i)

arrange for the animals to be slaughtered

separately from other batches of animals

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arriving at the slaughterhouse;

(ii) impound the carcasses and offal and carry out all

sampling procedures necessary to detect the

substances in question;

(iii) if positive results are obtained, send the meat

and offal to a high-risk processing plant as

defined by Directive 90/667/EEC, without

indemnity or compensation.

In that event, rules 20 to 23 shall apply;

(b) if the suspects or has evidence that the animals

concerned have been subjected to an authorized

treatment but that the withdrawal periods have not

been complied with, postpone slaughter of the animals

until he can be satisfied that the quantity of residues

does not exceed the permitted levels.

This period may in no circumstances be less than the

withdrawal period laid down in point (b) of Article

6(2) of Directive 96/22/EC for the substances in

question, or than the withdrawal periods provided for

in the marketing authorization.

However, in an emergency or where required for the

well-being of the animals, or if the infrastructure or

equipment of the slaughterhouse is such that slaughter

cannot be deferred, the animals may be slaughtered

before the end of the ban or postponement period. The

meat and offal shall be impounded pending the

outcome of the official checks carried out by the

slaughterhouse’s official veterinarian. Only meat and

offal containing a quantity of residues not exceeding

the permitted levels shall be used for human

consumption;

(c) declare unfit for human consumption carcasses and

products in which the residue level exceeds the levels

authorized by Community or local laws.

Without prejudice to criminal penalties, where the holding,

use or manufacture of unauthorized substances or products in a

manufacturing establishment is confirmed, any authorizations or

official approval arrangements enjoyed by the establishment

concerned shall be suspended for a period during which the

establishment shall be subjected to more stringent checks.

In the case of a repeated offence, such authorizations or approval

arrangements shall be permanently withdrawn.

Rights of appeal allowed by any law in force in Malta

against decisions taken by the competent authorities under rules 23

and 24 shall not be affected by these regulations.

Without prejudice to criminal penalties, or penalties

imposed by professional bodies, appropriate administrative

measures must be taken against any person where he is responsible,

AND ANIMAL PRODUCTS

as the case may be, for the transfer or administering of prohibited

substances or products or for the administering of authorized

substances or products for purposes other than those laid down by

law.

Any failure to cooperate with the competent authority and

any obstruction by slaughterhouse personnel or the slaughterhouse

s u p e r v i s o r o r, i n t h e c a s e o f a p r i v a t e e n t e r p r i s e , b y t h e

slaughterhouse owner or owners, or by the owner of the animals or

person having charge of them, during inspection and sampling as

required for the implementation of national plans for monitoring

residues and during the investigations and checks provided for in

this rule, shall result in appropriate criminal and, or administrative

penalties being imposed by the competent authority.

If it is proven that a slaughterhouse owner or supervisor is

helping to conceal the illegal use of prohibited substances, Malta

shall deny the guilty party any opportunity of receiving or applying

for Community aid for a period of twelve months.

Chapter VI - Imports from Third Countries

(1) Inclusion and retention on the lists of third countries

provided for in Community legislation from which Malta is

authorized to import animals and animal products covered by these

rules shall be subject to submission by the third country concerned

of a plan setting out the guarantees which it offers as regards the

monitoring of the groups of residues and substances referred to in

Schedule I. This plan must be updated at the request of the

Commission, particularly when the checks referred to in sub-rule

(3) render it necessary.

The provisions of rule 8 concerning time limits for submission

and updating of plans shall apply for plans to be submitted by third

countries.

The guarantees must have an effect at least equivalent to those

provided or in these rules and must, in particular, meet the

requirements of rule 4 and specify the particulars laid down in rule

7 and meet the requirements of Article 11(2) of Directive 96/22/

EC.

The Commission shall approve the plan in accordance with the

procedure laid down in Article 33 of Council Directive 96/23/EC of

29 April 1996. Under the same procedure, guarantees alternative to

those resulting from the implementation of this rule may be

accepted.

(2) Where the requirements of sub-rule (1) are not complied

with, inclusion of a third country on the lists of third countries laid

down by Community legislation or as a result of the benefit of

prelisting may be suspended in accordance with the procedure laid

down in Article 33 of Council Directive 96/23/EC of 29 April

1996, at the request of Malta or by the Commission on its own

initiative.

(3) Compliance with the requirements of and adherence to the

guarantees offered by the plans submitted by third countries shall

AND ANIMAL PRODUCTS

be verified by means of the checks referred to in Article 5 of

Directive 72/462/EEC and the checks provided for in Directives 90/

675/EEC and 91/496/EEC.

(4) Malta shall inform the Commission each year of the results

of residue checks carried out on animals and animal products

imported from third countries, in accordance with Directives 90/

675/EEC and 91/496/EEC.

(1) Where the checks provided by Directives 90/675/EEC

and 91/496/EEC reveal the use of unauthorized products or

substances for the treatment of the animals in a given batch - batch

within the meaning of Article 2(2)(e) of Directive 91/496/EEC - or

the presence of such products or substances in all or part of a batch

originating in the same establishment, the competent authority shall

take the following measures in respect of the animals and products

involved in such use

(a) it shall inform the Commission of the nature of the

products used and the batch concerned; the

Commission shall forthwith inform all frontier posts,

(b) Malta shall carry out more stringent checks on all

batches of animals or products from the same source.

In particular, the next ten batches from the same

source must be impounded - and a deposit lodged

against inspection costs - at the frontier inspection post

for a check on residues by taking a representative

sample of each batch or of the part of the batch.

Where such additional checks demonstrate the

presence of unauthorized substances or products or of

residues of such substances or products

(i)

the batch or the part of the batch concerned must

be returned to the country of origin at the

expense of the consignor or his agent with a

clear indication on the certificate of the reasons

for rejecting the batch;

(ii) depending on the nature of the infringement

found and the risk associated with such an

infringement, it must be left to the consignor to

decide whether to send back the batch or part of

the batch concerned, to destroy it or to use it for

other purposes authorized by Community

legislation, without indemnity or compensation;

(c) the Commission shall be informed of the outcome of

the more stringent checks and on the basis of this

information shall make all necessary investigations, to

identify the reasons for and origins of the

infringements found.

(2) Where the checks provided for by Directive 90/675/EEC

reveal that the maximum residue limits have been exceeded, use

shall be made of the checks referred to in sub-rule (1)(b).

AND ANIMAL PRODUCTS

(3) If, in cases involving third countries which have concluded

equivalence agreements with the Community, the Commission,

after making enquiries of the competent authorities of the third

countries concerned, concludes that they have failed to fulfill their

obligations and the guarantees given by the plans referred to in rule

29(1), it shall cease to allow that country, under the procedure laid

down in rule 32, to benefit from the said agreements for the animals

and products in question until the third country in question has

made good its shortcomings. The suspension shall be revoked

under the same procedure.

If necessary, in order to re-establish the benefit afforded by the

said agreements, a Community deputation including experts from

the Member States shall visit the country concerned, at that

country’s expense, in order to verify that such measures have been

taken.

Chapter VII - General Provisions

The Council, acting on a proposal from the Commission,

shall amend Directive 85/73/EEC in order to provide for the

charging of a fee to cover monitoring carried out pursuant to these

rules.

Pending that decision by the Council, Malta shall be authorized

to charge national fees to cover the actual costs of such monitoring.

(1) Where the procedure laid down in this rules is to be

followed, matters shall be referred without delay to the Standing

Veterinary Committee set up by Decision 68/361/EEC, by its

Chairman, either on his own initiative or at the request of Malta.

(2) The Commission representative shall submit a draft of the

measures to be taken. The Committee shall deliver its opinion on

those matters within a time limit which the Chairman may set

according to the urgency of the matter submitted. Opinions shall be

delivered by a majority of 62 votes.

(3)

(a) The Commission shall adopt the measures and

implement them immediately where they are in

accordance with the opinion of the Committee.

(b) Where they are not in accordance with the opinion of

the Committee, or if no opinion is delivered, the

Commission shall forthwith submit to the Council a

proposal concerning the measures to be taken. The

Council shall adopt the measures by a qualified

majority.

If, fifteen days after the proposals were submitted to it,

the Council has not adopted any measures, the

Commission shall adopt the measures proposed and

implement them immediately unless the Council has

rejected those measures by a simple majority.

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