Live Animals and Animal Product Rules, 2005

L.N. 80 of 2005

VETERINARY SERVICES ACT

(CAP. 437)

Measures to monitor certain Substances and Residues thereof in

Live Animals and Animal Product Rules, 2005

IN exercise of the powers conferred by article 13 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 the Measures to monitor certain Title and scope.

Substances and Residues thereof in Live Animals and Animal Products

Rules, 2005.

(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

For the purposes of these rules, the definitions in Directive Definitions.

96#22#EC shall apply. In addition>

(1) ‘animal’ means the species covered by Directive

90#425#EEC (1)<

(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 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.

RESIDUE OR SUBSTANCE GROUP TO BE DETECTED BY TYPE OF

ANIMAL, THEIR FEEDINGSTUFFS, INCLUDING DRINKING WATER,

AND PRIMARY ANIMAL PRODUCTS

Type of

Rabbit

animal,

Bovine,

meat and

feeding-

ovine,

Aquacul-

the meat of

stuffs or

caprine,

Poultry

ture

Milk

Eggs

wild (*)

Honey

animal

porcine,

animals

game and

products

equine

farmed

Substance

animals

game

groups

Al

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

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 this Chapter<

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

each year, the data and results referred to in (c), including the results

of any surveys undertaken.

(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 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.

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 (1) , 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,

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 Pjan li jiddelinea

Commission setting out the national measures to be implemented during mi]uri nazzjonali.

the initial year of the plan and subsequently any update of plans English marginal

note Please

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.

Sampling levels and

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

(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 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 rule 33 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

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

Articles9 (3) (b) (c) (d) and 9 (4), 9 (5)

86/469/EEC

Articles6 (3) (b) (c) (d) and 6 (4) 85/358/EEC

Rule 24

Article 4

85/358/EEC

Rule 25

—

These Rules

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

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

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

Rule 33

Article 15

86/469/EEC

Article 10

85/358/EEC

Rule 34

Article 13

86/469/EEC

Rule 35

—

Rule 36

—

Rule 37

—

Rule 38

—

Rule 39

—

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

—

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

The initial plan shall take into account the specific situation

of Malta and specify in particular>

(1) legislation on the use of the substances listed in Schedule

I and, in particular, provisions on their prohibition or authorization,

distribution and placing on the market and the rules governing

their administration, in so far as such legislation is not harmonized.

(2) the infrastructure of the relevant departments (in

particular, giving details of the type and size of the bodies involved

in implementing the plans),

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

capacity for processing samples,

(4) 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 (1),

(5) 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,

(6) 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,

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

samples, and in particular the rules concerning the particulars to

appear on such official samples,

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

authorities with regard to animals or products in which residues

have been detected.

Lista ta’ Korrelazzjoni

Dawn ir-reg olament i

Direttivi 85/358/KEE u 86/469/KEE u d-

Deċiżjonijiet 89/187/KEE u 91/664/KEE

Regola1

—

Regola 2

Artikolu

Regola 3

86/469/KEE

Artikolu

Regola 4

86/469/KEE

Regola 5

Artikolu

85/358/KEE

Regola 6

Artikolu

Regola 7

86/469/KEE

Artikolu 4 (1) l-ewwel u t-tieni linja

Rego la 8

86/469/KEE

—

Artikolu 4 (1) ħlief għall- ewwel u t-tieni linja

Regola 9

86/469/KEE

Regola 10

Artikolu

(2)

sa

(5)

Regola 11

86/469/KEE

Regola 12

Artikolu

Regola 13

86/469/KEE

Artikolu

Regola 14 (1)

85/358/KEE

Regola 1 4 (2)

—

—

Artikolu 1

Regola 15 (1)

85/358/KEE

—

Regola 15 (2)

Artikolu 3

85/358/KEE

Regola 15 (3)

Artikolu 10

Regola 16

86/469/KEE

Artikolu 8 (1) (b)

Regola 17

86/469/KEE

Artikolu 8 (2)

Regola 18

86/469/KEE

Regola 19

Deċiżjoni 91/664/KEE

Regola 20 (1)

Deċiżjoni 89/187/KEE

Regola 2 0 (2)

Artikolu 8 (3)

Regola 21

86/469/KEE

Regola 22

Artikolu 5 (2)

Regola 23

85/358/KEE

Artikolu 8 (3)

86/469/KEE

Regola 2 4

Artikolu 5 (3)

Regola 2 5

85/358/KEE

Artikolu 9

86/469/KEE

Artikolu 9 (1) u l-Artikolu 9 (2)

86/469/KEE

Artikolu 6 (1) u l- Artikol u 6 (2)

85/358/KEE

Artikolu 9 (3) (a)

86/469/KEE

Artikolu 6 (3) (a)

85/358/KEE

Artikolu 9 (3) (c) and (d)

86/469/KEE

—

—

Artikolu 11

86/469/KEE

Artikolu 5

86/469/KEE

Artikolu 7

85/358/KEE

Artikli9 (3) (b) (c) (d) and 9 (4), 9 (5)

86/469/KEE

Artikli6 (3) (b) (c) (d) and 6 (4) 85/358/KEE

Artikli 4

85/358/KEE

—

Dawn ir-Regola i

Directivi 85/358/KEE u 86/469/KEE u

Deċiżjoni 89/187/KEE u 91/664/KEE

Regola 26

—

Regola 27

—

Regola 2 8

—

Regola 29

Artikolu 7

86/469/KEE

Regola 30

Artikolu 13

Regola 31

85/358/KEE

Regola 32

—

Artikolu 12

Regola 3 3

85/358/KEE

Artikolu 14

Regola 34

86/469/KEE

Regola 35

Artikolu 11

Regola 36

85/358/KEE

Regola 37

Artikolu 15

Regola 38

86/469/KEE

Regola 39

Artikolu 10

Skeda I

85/358/KEE

Skeda II

Artikolu 13

Skeda III

86/469/KEE

B

Skeda IV

—

Skeda V Kap itoli 1

—

Skeda V Kapi toli 2

—

Skeda VI

—

—

Anness I

86/469/KEE

—

—

Anness II

86/469/KEE

Deċiżjoni 91/664/KEE

Deċiżjoni 89/187/KEE

—

(1) The Commission shall examine the initial plans Commission to

forwarded pursuant to Article 5 (1) to ascertain whether they conform examine

plans.

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.

Member States shall have 10 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 Standing

Veterinary Committee, which must act under the procedure laid down

in rule 33.

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.

(1) Malta shall ensure that>

Self-monitoring and

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

any natural or legal person engaged in trade in such 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,

(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 (1) and (2) place on the market only>

(a) animals to which no unauthorized substances or

products have been administered or which have not undergone

illegal treatment within the meaning of these rules<

(b) 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<

(c) products derived from the animals referred to in

subparagraph (a) (i) and (ii)<

(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 (a) are incumbent on

the latter.

(2) For the purposes of applying sub-rule A, 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

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

provisions adopted for checks on sub-rule A (3) (a) (i) and (ii).

Malta shall ensure that the terms of reference and

Monitoring of forms

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 (1), 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.

(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 the first indent of the first subparagraph of rule 9 (B).

The checks provided for in these rules must be carried out Checks by the

competent

by the competent authority without prior notice.

authority.

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>

Illegal treatment.

(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

accordance with the procedure laid down in rule 33. 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 Official Samples.

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 rule 33.

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

(1) 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 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>

(1) the competent authority shall obtain without delay>

(a) all the information required to identify the animal and

farm of origin or departure<

(b) 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<

(2) the appropriate authority shall carry out>

(a) an investigation on the farm of origin or departure, as

appropriate, to determine the reasons for the presence of residues<

(b) 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<

(c) any other further investigations which the authority

considers necessary<

(3) 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 available.

Where illegal treatment is established, the competent

authority must ensure that the livestock concerned in the investigations

referred to in paragraph (b) of rule 13 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 Evidence of

residues.

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 Costs.

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 Mutual Assistance.

on mutual assistance between the administrative authorities of the

Member States and cooperation between the latter and the 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 competent

central authority of that State accordingly. Following an investigation

carried out in accordance with paragraph 2 of rule 16, 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(2).

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 15 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

measures taken. Where the Commission considers that the 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 rule 33.

Where unauthorized substances or products or substances Measures to be

taken in the event of

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

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 Impounded animals.

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 the

knacker’s yard under 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 12 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 self-

monitoring 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>

(1) 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>

(a) arrange for the animals to be slaughtered separately from

other batches of animals arriving at the slaughterhouse<

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

sampling procedures necessary to detect the substances in question<

(c) 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<

(2) 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<

(3) 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, Unauthorized

substances.

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 Rights of appeal.

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 Transfer etc. of

prohibited

by professional bodies, appropriate administrative measures must be substances.

taken against any person where he is responsible, 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 Failure to co-

operate.

any obstruction by slaughterhouse personnel or the slaughterhouse

supervisor or, in the case of a private enterprise, by the 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 12 months.

(1) Inclusion and retention on the lists of third countries Imports from 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 of these rules

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 rule 33. 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 pre-

listing may be suspended in accordance with the procedure laid down

in rule 33, 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

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

72#462#EEC (1) and the checks provided for in Directives 90#675#EEC

(2) and 91#496#EEC (3).

(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

Use of unauthorized

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 10 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 paragraph (b) of sub-rule (1).

(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.

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.

Standing Veterinary

(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, 15 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.