Animal Products Regulations, 2003

B

L.N. 354 of 2003

VETERINARY SERVICES ACT

(ACT NO. XXIII OF 2001)

Veterinary Checks applicable in Intra-Community Trade with Member States in

Animal Products Regulations, 2003

IN exercise of the powers conferred by article 15 of the Veterinary Services Act, 2001,

the Minister for Rural Affairs and the Environment has made the following regulations:-

Title, scope and applicability

(1) The title of these regulation is Veterinary Checks Applicable in Intra-

CommunityTrade with Member States in Animal Products Regulations, 2003.

(2) The scope of these regulations is to implement the provisions found under

European Union Council Directive 89/662/EEC concerning veterinary checks in intra-

community trade with a view to the completion of the internal market.

(3) Veterinary checks to be carried out on products of animal origin which are

covered by the European Union Directives listed in the first schedule or by regulation 13

and which are intended for trade are no longer carried out, without prejudice to regulation

6, at frontiers but are carried out in accordance with these regulations.

Definitions

VETERINARY LEGISLATION

CHAPTER I

(a) European Union Council Directive 64/433/EEC of 26 June 1964 on health conditions

for the production and marketing of fresh meat.

(b) European Union Council Directive 71/118/EEC on health problems affecting the

production and placing on the market of fresh poultry meat.

(c) European Union Council Directive 77/99/EEC on health problems affecting the

production and marketing of meat products and certain other products of animal origin.

(d) European Union Council Directive 94/65/EC laying down the requirements for the

production and placing on the market of minced meat and meat preparations.

(e) European Union Council Directive 89/437/EEC on hygiene and health problems

affecting the production and the placing on the market of egg products.

(f) European Union Council Directive 91/492/EEC laying down the health conditions for

the production and the placing on the market of live bivalve molluscs.

(g) European Union Council Directive 91/493/EEC laying down the health conditions for

the production and the placing on the market of fishery products.

(h) European Union Council Directive 91/495/EEC concerning public health and animal

health problems affecting the production and placing on the market of rabbit meat and

farmed game meat.

(i) European Union Council Directive 92/45/EEC on public health and animal health

problems relating to the killing of wild game and the placing on the market of wild game

meat.

(j) European Union Council Directive 92/46/EEC laying down the health rules for the

production and placing on the market of raw milk, heat-treated milk and milk-based

products.

(k) European Union Council Directive 72/461/EEC on health problems affecting trade in

fresh meat.

(l) European Union Council Directive 80/215/EEC on animal health problems affecting

trade in meat products.

B

(m) European Union Council Directive 91/494/EEC on animal health conditions

governing trade within the territory of Malta and with Member States and imports from

third countries of fresh poultry meat.

(n) European Union Council Directive 89/437/EEC on hygiene and health problems

affecting the production and the placing on the market of egg products.

(o) European Union Council Directive 91/67/EEC concerning the animal health

conditions governing the placing on the market of aquaculture animals and products.

(p) European Union Council Directive 91/493/EEC laying down the health conditions for

the production and the placing on the market of fishery products.

(q) European Union Council Directive 91/492/EEC laying down the health conditions for

the production and the placing on the market of live bivalve molluscs.

(r) European Union Council Directive 91/495/EEC concerning public health and animal

health problems affecting the production and placing on the market of rabbit meat and

farmed game meat.

(s) European Union Council Directive 92/45/EEC on public health and animal health

problems relating to the killing of wild game and the placing on the market of wild-game.

(t) European Union Council Directive 92/46/EEC laying down the health rules for the

production and placing on the market of raw milk, heat-treated milk and milk-based

products.

CHAPTER II

(u) European Union Council Directive 92/118/EEC laying down animal health and public

health requirements governing trade with Member States and imports into the territory of

Malta of products of animal origin not subject to the said requirements laid down in

specific other animal health and public health rules.

For the purposes of these regulations -

(1) “competent authority” is for Malta the Veterinary Services;

(2) “establishment” means any undertaking which produces, stores or processes

the products referred to in regulation 1;

(3) “official veterinarian” means the veterinarian appointed by the Veterinary

Services on the territory of Malta;

(4) “trade” means exchanges between the territory of Malta and Member States in

goods within the meaning of article 9(2) of the Treaty establishing the European

Economic Community;

(5) “trading partner” in the meaning of article 2 of the Veterinary Services Act shall

mean –

(a) Member States of the European Community;

B

(b) Third countries to the European Community;

where relevant.

(6) “Veterinary check” means any physical check and, or administrative formality

which applies to the products referred to in regulation 1(3) and which is intended for the

protection, direct or otherwise, of public or animal health;

CHAPTER I

CHECKS AT ORIGIN

Products intended for trade

PRODUCTS NOT SUBJECT TO PUBLIC HEALTH STANDARDS PROVIDED

FOR IN LEGISLATION LISTED IN SCHEDULE A, BUT TRADE IN

PRODUCTS WHICH WOULD BE SUBJECT TO THE CHECKS PROVIDED

FOR BY THESE REGULATIONS

Other products of animal origin included neither in Schedule B to these regulations nor in

the Annex to European Union Council Directive 90/425/EEC - these products will be

defined under the procedure laid down under European Community rules and in

accordance will article 10 of the Veterinary Services Act.

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

(1) In the territory of Malta, only products intended for trade are those referred

to in regulation 1(3) which have been obtained, checked, marked and labelled in

accordance with rules for the destination in question and which are accompanied to the

final consignee mentioned therein by a health certificate, animal-health certificate or by

any other document provided for by veterinary legislation listed in Schedule A.

The establishments of origin shall ensure, by constant self-supervision, that such products

satisfy the requirements of the first subparagraph.

Without prejudice to the monitoring duties assigned to the official veterinarian under

legislation, the competent authority shall carry out regular checks on establishments in

order to satisfy itself that products intended for trade comply with all requirements or, in

the cases referred to in the third paragraph of this regulation and regulation 13, with the

requirements of the Member State of destination.

Where there are grounds for suspecting that requirements are not being met, the

competent authority shall carry out the necessary checks and, if the suspicion is

confirmed, take the appropriate measures, which may include withdrawing approval.

(2) Where the transport operation involves several places of destination, products

must be grouped together in as many batches as there are places of destination. Each

batch must be accompanied by the aforementioned certificate or document.

Where the products referred to in regulation 1 are intended for export to a third country,

the transport operation must remain under customs supervision up to the point of exit

from Malta or Community territory.

(3) When the territory of Malta makes optional imports from certain third

countries, Veterinary Services shall inform the European Commission and the Member

States of the existence of such imports.

Where products are brought into the European Community by the territory of Malta,

Veterinary Services shall carry out a documentary check on the origin and destination of

the goods in accordance with regulation 6 (1).

B

When the destination of such products is the territory of Malta Veterinary Services shall

prohibit the products concerned from being sent on from the territory unless they are

bound for a Member State using the same option.

Necessary measures which must be taken by the Veterinary Services

(1) Veterinary Services shall take the necessary measures to ensure that

operators comply with veterinary requirements at all stages of the production, storage,

marketing and transport of the products referred to in regulation 1(3). In particular, they

shall ensure that -

(a) the products obtained in accordance with the legislation referred to in

Schedule A are checked in the same way, from a veterinary viewpoint, whether

they are intended for trade with Member States or for the national market,

(b) the products covered by Schedule B are not dispatched to the territory of

another Member State, if they cannot be marketed on their own territory for

reasons justified by safeguard measures on public health under the Veterinary

Services Act and as provided under article 36 of the Treaty.

(2) Appropriate administrative, legal or penal measures to penalise any

infringement of veterinary legislation by natural or legal persons where it is found that

rules have been infringed, in particular where it is found that the certificates or

documents drawn up do not correspond to the actual state of the products or that public

health stamps have been affixed to products which do not comply with those rules, shall

be taken according to the procedures laid down in Part IX of the Veterinary Services Act.

CHAPTER II

CHECKS ON ARRIVAL AT THE DESTINATION

Measures which must be implemented by the territory of Malta

(1) The following measures have to be implemented in the territory of Malta –

(a) the Veterinary Services may, at the places of destination of goods, check by

means of non-discriminatory veterinary spot-checks that the requirements of

regulation 3 to these regulations has been complied with; it may take samples

at the same time.

Furthermore, where in the territory of Malta, in transit or at destination the Veterinary

Services have information leading them to suspect an infringement, checks may also be

carried out during the transport of goods in the territory of Malta, including checks on

compliance as regards the means of transport;

(b) where the products referred to in regulation 1(3) originating in a Member

State are intended –

B

(i) for an establishment placed under the responsibility of an official

veterinarian, the latter must ensure that only products that meet the

requirements of regulation 3(1) to these regulations with respect to marking

and accompanying documents or, in the case of the products referred to in

Schedule B, are accompanied by the document established according to the

procedure laid down in article 10 of the Veterinary Services Act, are admitted

to that establishment,

(ii) for an approved intermediary who divides up the batches or for a

commercial undertaking with many branches, or any establishment not subject

to permanent supervision, the latter must check, before the batch is divided up

or marketed, that the said marks, certificate, or documents referred to in the

first indent are present and notify the Veterinary Services of any irregularity

or anomaly,

(iii) for other consignees, particularly where the batch is partially unloaded

during transport, the batch must be accompanied, in accordance with

regulation 3 (1), by the original of the certificate referred to in the first indent.

The guarantees which must be furnished by the consignees referred to in the second and

third indents shall be specified in an agreement with the Veterinary Services to be signed

at the time of the prior registration provided for in sub-regulation (3). The Veterinary

Services shall carry out random checks to verify compliance with those guarantees.

(2) Without prejudice to regulation 4, where the standards laid down by veterinary

rules have not been set and in the case provided for in regulation 13, the Veterinary

Services may require, with due regard for the general provisions of the Treaty, that the

establishment of origin must apply the standards in force under the Malta national rules.

The Veterinary Services shall ensure that the product in question complies with those

requirements.

(3) Operators who have products delivered to them from a Member State or who

completely divide up a batch of such products –

(a) shall be subject, if so requested by the Veterinary Services, to prior

registration;

(b) shall keep a register in which such deliveries are recorded;

(c) must, if so requested by the Veterinary Services, report the arrival of products

from a Member State, to the extent necessary to carry out the checks referred to in

sub-regulation (1);

(d) Keep for a period of not less than six months to be specified by the Veterinary

Services, the health certificates or documents corresponding to those referred to in

regulation 3 for presentation to the Veterinary Services should the latter so

request.

(4) The detailed rules for implementing this regulation shall be adopted in

accordance with the procedure laid down in article 15 (2) of the Veterinary Services Act.

Measures which must be taken during checks on products from third countries

brought into the territory of Malta

(1) During the checks carried out at the places where products from a third

country may be brought into the territory of Malta, such as ports, airports and inspection

sites with third countries, the following measures are taken -

(a) a documentary check is made on the products' origin;

(b) products originating in a Member State are subject to the rules on checks

provided for in regulation 5;

(c) products from third countries are subject to the rules laid down in European

Union Council Directive 97/78/EC.

(2) However, by way of derogation from sub-regulation (1), all products

transported by regular, direct means of transport linking the territory of Malta and a

Member State, shall be subject to the rules of inspection laid down in regulation 5.

Rules relating to checks carried out at a place of destination of a consignment or

during transport

(1) If, during a check carried out at the place of destination of a consignment or

during transport, the Veterinary Services establish -

(a) The presence of agents responsible for a disease named in the Second

Schedule to the Veterinary Services Act, a zoonosis or disease, or any cause likely

to constitute a serious hazard to animals or humans, or that the products come

from an area infected by an epizootic disease, they shall, except as regards

animal-health aspects, in the case of products subject to one of the treatments

referred to in article 4 of European Union Council Directive 80/215/EEC (as last

amended by European Union Council Directive 88/660/EEC), order the batch to

be destroyed or used in any other way laid down by Maltese rules.

Costs relating to the destruction of the batch shall be borne by the consignor or his

representative.

The Veterinary Services shall immediately notify the competent authorities of the other

Member States and the European Commission by telex of the findings arrived at, the

decisions taken and the reasons for such decisions.

B

The protective measures provided for in article 15 (5) of the Veterinary Services Act may

be applied.

(b) That the goods do not meet the conditions laid down by corresponding animal

health and public health legislation of Member States, or, in the absence of

decisions on standards, by Maltese national standards, they may, provided that

health and animal health considerations so permit, give the consignor or his

representative the choice of –

(i) destroying the goods; or

(ii) using the goods for other purposes, including returning them with the

authorisation of the competent authority of the country of the

establishment of origin;

(iii) however, if the certificate or the documents are found to contain

irregularities, the consignor must be granted a period of grace before

recourse is had to this last possibility.

(2) In accordance with the procedure laid down in article 15 of the Veterinary

Services Act, it may be drawn up a list may be drawn up of the agents and diseases

referred to in sub-regulation (1), and detailed rules for the application of this regulation.

Procedure by the Veterinary Services for the measures taken by the authorities of

the Member States of dispatch

(1) In the cases provided for in regulation 7, the Veterinary Services shall

contact the competent authorities of the Member State of dispatch without delay. These

will then notify the Veterinary Services about the necessary measures taken, the nature of

the checks carried out, the decisions taken and the reasons for such decisions.

If the Veterinary Services fears that such measures are inadequate, they shall with the

competent authority of the Member State of origin seek ways and means of remeding the

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

Where the checks provided for in regulation 7 show repeated irregularities, the

Veterinary Services shall inform the European Commission and the veterinary

departments of the other Member States.

The European Commission, at the request of the Veterinary Services of Malta or on its

own initiative, and taking into account the nature of the infringements established, may -

(a) send a mission of inspection to the establishment concerned; or

(b) instruct an official veterinarian, whose name shall be on a list to be prepared

by the European Commission at the suggestion of the Member States, and who is

B

acceptable to the various parties concerned, to check the facts in the establishment

concerned;

(c) request the competent authority to intensify its sampling of the products of the

establishment concerned.

It shall inform the Member States of its findings.

Where these measures are taken to deal with repeated irregularities on the part of an

establishment, the European Commission shall charge any expenses occasioned by the

application of the indents of the foregoing subparagraph to the establishment involved.

Pending the different findings, the Veterinary Services may, for their part, intensify

checks on products coming from the same establishment and if there are serious animal

health or public health grounds, suspend approval.

At the request of one of the two Member States concerned - where the irregularities are

confirmed by the expert's opinion, the European Commission must, in accordance with

European Community rules, take the appropriate measures, which may go as far as

authorising the Member States to prohibit provisionally the bringing into their territory of

products coming from that establishment. These measures must be confirmed or reviewed

as soon as possible in accordance with the appropriate European Commission procedure.

(2) Rights of appeal existing under the laws in force in the territory of Malta

against decisions by the Veterinary Services shall not be affected by these regulations

except in case covered by the sub-regulation (4).

Decisions taken by the Veterinary Services and the reasons for such decisions shall be

notified to the consignor or his representative and to the competent authority of the

Member State of dispatch.

If the consignor or his representative so requests, the said decisions and reasons shall be

forwarded to him in writing with details of the rights of appeal which are available to him

under the law in force in the territory of Malta and of the procedure and time limits

applicable.

However, in the event of a dispute, the Veterinary Services may, if the competent

authority of the Member State of origin so agree, within a maximum period of one

month, submit the dispute for the assessment of an expert whose name appears on a list

of European Community experts.

Such experts shall issue their opinions within not more than 72 hours. The parties shall

abide by the expert's opinion, with due regard for European Community veterinary

legislation.

B

(3) The costs of returning the consignment, storing the goods, putting them to

other uses or destroying them shall be borne by the consignee.

(4) The detailed rules for the application of this regulation shall be adopted in

accordance with the procedure laid down in article 15 of the Veterinary Services Act.

Checks carried out in a Member State at the place of destination of a consignment

or during transport

(1) If, during a check carried out in a Member State at the place of destination

of a consignment or during transport, the competent authority establishes -

(a) The presence of agents responsible for a disease referred to in the Second

Schedule to the Veterinary Services Act, a zoonosis or disease, or any cause likely

to constitute a serious hazard to animals or humans, or that the products coming

from the territory of Malta are contaminated by an epizootic disease,

(b) That, without prejudice to paragraph (a), the products do not meet the

conditions laid down by corresponding Member State legislation or, where the

Member State obtains additional guarantees which have been or will be adopted,

by national animal health rules, the Veterinary Services shall take all necessary

measures and notify the competent authority of the Member State of the nature of

the checks carried out, the decisions taken and the reasons for such decisions.

If the competent authority of the Member State of destination fears that such measures

are inadequate, the Veterinary Services and the competent authority of the Member State

shall together seek ways and means of remedying the situation; if appropriate, this may

involve an on-the-spot inspection.

At the request of the competent authority of the Member State of destination –

(i) inspectors may be sent, in collaboration with the Veterinary Services;

(ii) or an official veterinarian, who is acceptable to the various parties concerned,

may be instructed to check the facts on the spot;

(iii) Veterinary Services may be requested to intensify checks on the holding, the

centre, the organisation, the approved market or assembly centre on the territory

of Malta.

Pending the Member State's findings, the Veterinary Services must intensify checks on

products coming from the establishment in question of the territory of Malta, and if there

are serious public or animal health grounds, suspend its approval.

(2) In the event of a dispute, the Veterinary Services may, if the competent

authority of the Member State of destination so agrees, within a maximum period of one

month, submit the dispute for the assessment of an expert whose name appears on a list

B

of European Community experts. Such experts shall issue their opinions within not more

than 72 hours or after receiving the results of any analyses. The Veterinary Services shall

abide by the expert's opinion, with due regard for corresponding veterinary legislation.

(3) The costs of returning the consignment, holding or isolating the animals or, if

appropriate, slaughtering or destroying them shall be borne by the consignor, his

representative or the person responsible for the animals or products.

(4) The detailed rules for the application of this regulation shall be adopted in

accordance with the procedure laid down in article 15 (4) of the Veterinary Services Act.

CHAPTER III

COMMON PROVISIONS

Notification by the Veterinary Services to Member States and the European

Commission of any outbreak in the territory of Malta

(1) The Veterinary Services shall immediately notify the Member States and

the European Commission of any outbreak in the territory of Malta, other than an

outbreak of diseases referred to in the Second Schedule to the Veterinary Services Act, of

any zoonoses, diseases or other cause likely to constitute a serious hazard to animals or to

human health.

The Veterinary Services shall immediately implement the control or precautionary

measures provided for in article 6 of the Veterinary Services Act, in particular the

determination of the buffer zones provided for in those rules, or adopt any other measure

which it deems appropriate.

When, in the course of a check referred to in regulation 5, has been established the

existence of one of the diseases or causes referred to in the first subparagraph, the

Veterinary Services may, if necessary, take the precautionary measures provided for in

article 15 of the Veterinary Services Act.

The Veterinary Services may, on serious public or animal-health grounds, take interim

protective measures with regard to the establishments concerned or, in the case of an

epizootic disease, with regard to the area of protection provided for in article 5 (1) (d) of

the Veterinary Services Act.

The measures taken shall be notified to the European Commission and to the Member

States without delay.

(2) In the case provided for in the first sub-paragraph of regulation (1), one or

more European Commission representatives may go at once to the place concerned to

examine, in collaboration with the Veterinary Services, what measures have been taken

and shall issue an opinion on those measures.

B

(3) Detailed rules for the application of this regulation, and in particular the list of

zoonoses or causes likely to constitute a serious hazard to human health, shall be adopted

in accordance with the procedure laid down in article 15 (4) of the Veterinary Services

Appointment of Veterinary Services

Veterinary Services shall be appointed for collaborating with the other

Member States' inspection departments.

Powers of the officials of the Veterinary Services

In the territory of Malta, the officials of the Veterinary Services, if appropriate

in collaboration with the officials of other departments empowered to that end, are able in

particular to -

(a) Carry out inspections of premises, offices, laboratories, installations, means of

transport, plant and equipment, cleaning and maintenance products, procedures

used for the production and processing of products and the marking and labelling

and presentation of those products;

(b) Carry out checks on whether staff comply with the requirements laid down in

the texts referred to in Schedule A;

(c) Take samples from products held with a view to being stored or sold, put on

the market or transported;

(d) Examine documentary or computer material relevant to the checks carried out

further to the measures taken pursuant to regulation 3 (1).

For this purpose, they must receive from the establishments being checked the co-

operation necessary for the performance of their duties.

Trade in products listed in Schedule B

Trade in the products listed in Schedule B shall, pending the adoption of rules,

be subject to the rules on control laid down by these regulations, in particular those laid

down in regulation 5 (2).

The Veterinary Services shall notify the European Commission and the Member States of

the conditions and procedures applicable to trade in the products referred to in the first

subparagraph.

Recording of basic information by the Veterinary Services on veterinary checks

carried out under these regulations

(1) The Veterinary Services shall record basic information on veterinary

checks carried out under these regulations and communicate this information to the

European Commission and to Member States.

B

(2) Detailed rules for the application of this regulation, in particular with regard to

frequency of communication of information, the form in which it is to be given and its

nature, shall be drawn up in accordance with the procedure laid down under European

Community rules and as provided in article 15 (2) of the Veterinary Services Act.

B