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APPROVAL OF BORDER INSPECTION POSTS RESPONSIBLE FOVETERINARY CHECKS ON PRODUCTS INTRODUCED INTO THE EUROPEAN

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Laws of Malta — Subsidiary Legislation 437.45 — APPROVAL OF BORDER INSPECTION POSTS RESPONSIBLE FOVETERINARY CHECKS ON PRODUCTS INTRODUCED INTO THE EUROPEAN

INSPECTION POST IN MALTA

SUBSIDIARY LEGISLATION 437.45

APPROVAL OF BORDER INSPECTION POSTS

RESPONSIBLE FOVETERINARY CHECKS ON

PRODUCTS INTRODUCED INTO THE EUROPEAN

COMMUNITY FROM THIRD COUNTRIES VIA A

BORDER INSPECTION POST IN MALTA

REGULATIONS

12th November, 2004

LEGAL NOTICE 466 of 2004.

Laws of Malta — Subsidiary Legislation 437.45 — APPROVAL OF BORDER INSPECTION POSTS RESPONSIBLE FOVETERINARY CHECKS ON PRODUCTS INTRODUCED INTO THE EUROPEAN

(1) The title of these regulations is the Approval of Border

Inspection Posts responsible for Veterinary Checks on Products

introduced into the European Community from Third Countries via

a Border Inspection Post in Malta Regulations.

(2) The scope of these regulations is the implementation of

European Union Commission Decision 2001/812/EC of the

21st November 2001 laying down the requirements for the

approval of border inspection posts responsible for veterinary

checks on products introduced into the Community from third

countries, which finds its legal basis under article 6(5) of European

Union Council Directive 97/78/EC.

Laws of Malta — Subsidiary Legislation 437.45 — APPROVAL OF BORDER INSPECTION POSTS RESPONSIBLE FOVETERINARY CHECKS ON PRODUCTS INTRODUCED INTO THE EUROPEAN

Approval requirements for border inspection posts

To be approved and listed border inspection posts must be constructed to provide

an adequate degree of hygiene, and avoid cross contamination.

In rooms where products are to be unloaded, inspected or stored the border

inspection post or inspection centre must have -

(a) walls finished with smooth washable surfaces, which together with the

floors should be easy to clean and disinfect, and with adequate drainage;

(b) a clean and easily cleaned ceiling;

(c) adequate natural and artificial lighting;

(d) an adequate hot and cold water supply in all inspection rooms.

1. Technical equipment

(a) Border inspection posts and inspection centres must have as a minimum

the items noted below available at all times -

(i)

equipment (or access to equipment) capable of weighing

consignments subject to controls;

(ii) any equipment needed to open and examine consignments

presented for examination;

(iii) cleansing and disinfection equipment adequately housed and

appropriate to the needs of the post, or an effective and

documented system of cleansing and disinfection by an external

agent;

(iv) equipment to maintain the temperature at the appropriate level in

controlled environment rooms.

(b) In inspection rooms there must be available as a minimum -

(i)

a table to work on with smooth washable surfaces easy to clean

and disinfect;

(ii) sampling equipment - saw, knife, tin opener, a means of sampling

consignments and sample containers;

(iii) sealing tape and numbered seals or labels, clearly marked to

ensure traceability;

(iv) a thermometer to measure surface and also core temperature,

weighing scales, and for fresh products, a pH meter;

(v) thawing equipment or micro wave oven;

(vi) facilities for the temporary storage of samples under temperature

control, pending their despatch to the laboratory. Suitable

containers for transport of these samples should also be available.

(c) Border inspection posts and inspection centres with restricted listing

must have -

(i)

those articles listed in (a) and (b) above as appropriate for the

products to be handled in the post.

2. Staffing

(a) Border inspection posts shall operate under the responsibility of an

official veterinarian, or in the case of fishery products either the official

INSPECTION POST IN MALTA

veterinarian or the official agent referred to in European Union

Commission Decision 93/352/EEC, who must be present at the border

inspection post and the inspection centres during checks on products.

The post shall carry sufficient staff to carry out all the controls required

at the border inspection post.

(b) The official veterinarian may be assisted by specially trained assistants

acting under his authority in -

(i) checking documents;

(ii) carrying out identity checks and physical examinations, taking

samples and carrying out general analysis;

(iii) administrative duties and procedures.

The official veterinarian shall be responsible for the final decision.

For the staff of the border inspection post a record of the training

received in respect of veterinary checks shall be kept.

3. Documentation

The border inspection post shall keep the following information.

Pending the implementation of the Shift system, the official veterinarian

responsible for checks in the border inspection post must have at his disposal in the

designated central office at least -

(a) an up-to-date list of the third countries or parts of third countries

authorised to send products to the European Community or, where

applicable, to certain Member States;

(b) copies of the various Decisions of the European Community or Member

States specifying a specimen health or public, animal health certificate

or any other document which must accompany products from third

countries despatched to the European Community or, where applicable,

to certain Member States;

(c) an up-to-date list of establishments in third countries authorised to

despatch products to the Community; or of national authorised

establishments in the case of non harmonised products;

(d) copies of any safeguard Decisions prohibiting or restricting imports of

products to the European Community;

(e) an up-to-date list of approved border inspection posts giving all

available details of these posts;

(f)

a current list of the free zones, free warehouses, and customs

warehouses approved under article 12.4 and of operators authorised

under article 13 of European Union Council Directive 97/78/EC, in all

Member States;

(g) an up-to-date list of establishments approved for the receipt of

channelled products for that Member State, in accordance with article

8(6) in the European Union Council Directive 97/78/EC;

(h) up-to-date relevant European Community legislation relating to

products and procedures covered by veterinary checks.

4. Records

The following records must also be kept -

(a) up-to-date information on consignments of products for which import or

INSPECTION POST IN MALTA

entry into the European Community has been refused and which have

been re-despatched; each Member State shall communicate to the other

Member States and the European Commission all information

concerning the re-despatched consignments; this information shall be

communicated to each border inspection post by the central competent

authority;

(b) a register according to European Union Commission Decision 97/394/

EC of 6 June 1997 “establishing the minimum data required for the data

base on animals and animal products brought into the European

Community”;

(c) a register of all consignments either re-despatched according to

European Union Commission Decision 97/152/EC, or destroyed, or

authorised by the official veterinarian at the border inspection post for

use other than for human consumption; this register shall record all

instances where there is a deadline for action or response by the official

veterinarian in the case of goods rejected, sent in transit or channelled,

and where follow up action is required;

(d) a register of all samples taken at the border inspection post for purposes

of laboratory tests, together with details of the laboratory test requested

and the results (favourable and unfavourable) of such tests;

(e) the register required under European Union Commission Decision 94/

360/EC “on the reduced frequency of physical checks of consignments

of certain products to be implemented from third countries, under

European Union Council Directive 90/675/EEC”, if necessary in

computerised format.

5. Procedures

(a) The competent authority shall endeavour to ensure that there is close

cooperation between the various services involved in the inspection of

third country products.

(b) All physical inspections and identity checks, except for seal checks,

must take place at an inspection facility. All such checks shall be

conducted in such a manner as to avoid the possibility of cross

contamination, and where necessary shall take into account the

controlled temperature conditions under which the products are

transported. Where unpacked products for human consumption are

involved, all checks must be carried out under shelter from the weather

and provision shall be made for the hygienic handling and protection of

such products during unloading and loading.

(c) The official veterinarian must have at least an adequate knowledge of

the arrangements for the disposal of waste products of animal origin

unloaded from transports in the area under his jurisdiction. Where

disposal arrangements are further under his responsibility, records of

checks made and anomalies found must be kept. Where disposal is

under the responsibility of another competent authority, the official

veterinarian shall liaise closely with this body and have available all

necessary relevant information.

(d) The official veterinarian must have an adequate knowledge of any free

zones, free warehouses, customs warehouses or ship suppliers within, or

closely associated with, the border post area. Regular checks must be

INSPECTION POST IN MALTA

made at the warehouses or suppliers concerned and a record to

demonstrate this must be kept in the office of the border inspection post.

Laws of Malta — Subsidiary Legislation 437.45 — APPROVAL OF BORDER INSPECTION POSTS RESPONSIBLE FOVETERINARY CHECKS ON PRODUCTS INTRODUCED INTO THE EUROPEAN

(1) A border inspection post consists of facilities dedicated

to veterinary checks, placed under the responsibility of the official

veterinarian, or in the case of fishery products either the official

veterinarian or the official agent referred to in European Union

Commission Decision 93/352/EEC, and localised in a manner so

that the facilities constitute one complete working unit. In the case

where a border inspection post is made up of more than one set of

facilities but located on the same site, the geographical location of

the group will qualify the border inspection post, which shall bear a

single name.

(2) A border inspection post must include all the facilities

specified in regulation 5, where products of animal origin from

third countries can be presented for introduction into the European

Community via a border inspection post in Malta, and undergo the

necessary documentary, identity and physical checks.

(3) Where geography or size of the border location demands, or

for the efficient management of border checks, a border inspection

post may provide more than one facility or inspection centre, for

conducting as necessary the checks on the categories of products

for which the border inspection post is approved.

Laws of Malta — Subsidiary Legislation 437.45 — APPROVAL OF BORDER INSPECTION POSTS RESPONSIBLE FOVETERINARY CHECKS ON PRODUCTS INTRODUCED INTO THE EUROPEAN

(1) Without prejudice to Annex II to European Union

Council Directive 97/78/EC, all border inspection posts as referred

to in article 6 of that Directive must, in order to be approved and

listed in the Official Journal of the European Union and to maintain

INSPECTION POST IN MALTA

approval, provide the facilities, personnel, equipment, and operate

the procedures in the posts, as specified in these regulations and in

the Schedule.

(2) The premises being used as a border inspection post, or any

inspection centre within it, must be under the effective control of

the official veterinarian, or in the case of fishery products either the

official veterinarian or the official agent referred to in European

Union Commission Decision 93/352/EEC, and must be accessible

for access at all times as necessary.

Laws of Malta — Subsidiary Legislation 437.45 — APPROVAL OF BORDER INSPECTION POSTS RESPONSIBLE FOVETERINARY CHECKS ON PRODUCTS INTRODUCED INTO THE EUROPEAN

(1) The Veterinary Services of the territory of Malta may

propose to the European Commission that a border inspection post

be officially listed after approval, for the inspection of all or certain

categories of products only. In the latter case the Veterinary

Services of the territory of Malta must show that the post has the

necessary facilities, personnel and equipment to carry out the

inspection of these products.

(2) The Veterinary Services of the territory of Malta shall set

up a proposal in such a way that the border inspection posts of

Malta will be listed showing them as a port or airport, location and

that the list shall specify the categories of products for which the

post and, as appropriate, the inspection centre is approved,

including details of any further restriction on the products which

any particular border inspection post may inspect.

(3) Where a border inspection post is approved for only

restricted categories of products, the facilities provided at the

border inspection post may be limited as appropriate to those

necessary for carrying out veterinary checks on these restricted

categories of products only.

(4) However, by derogation to subregulation (3), in the case of

deep frozen semen and embryos which may be transported at

ambient temperatures in sealed, self contained temperature

regulating containers, these may be inspected in border inspection

posts listed for products not for human consumption that are at

ambient temperatures only.

(5) The Veterinary Services of the territory of Malta shall

notify the European Commission of any change in the

infrastructure or operation of a border inspection post, or of an

inspection centre within that post, that has any bearing on its

listing. Additions to the categorisation of any border inspection

post may be proposed, after the Veterinary Services have checked

that the facilities comply with these regulations, for approval and

amendment to the listing by the European Commission.

Laws of Malta — Subsidiary Legislation 437.45 — APPROVAL OF BORDER INSPECTION POSTS RESPONSIBLE FOVETERINARY CHECKS ON PRODUCTS INTRODUCED INTO THE EUROPEAN

(1) The facilities in approved border inspection posts must

be constructed, equipped, maintained and operated in line with the

requirements set down in the Schedule and in relevant European

Community legislation. For products that are not fully harmonised

from a hygiene viewpoint, additional national hygiene

requirements may be applied.

INSPECTION POST IN MALTA

(2) The minimum infrastructure for any approved border

inspection post must include the following elements within

effective working distance of each other

(a) an office with communication equipment including a

telephone, a fax, an Animo system terminal, a

photocopier, all necessary documentation, and

archiving capacity to store documents relating to the

inspection of products;

(b) social rooms consisting of changing rooms, toilets, and

hand washing facilities for the use of the personnel

working in the border inspection post, which may be

shared only with other personnel involved in official

controls;

(c) an area for unloading the means of transport of

consignments which shall be enclosed or covered by a

roof, except in the case of consignments of non

containerised wool, loose bulk processed animal

protein not fit for human consumption, loose manure

or guano, or bulk liquid oils and fats, which are

transported in boats, for which the roof requirement

may not apply;

for products under temperature control intended for

human consumption the junction between the transport

and unloading areas should be protected or sealed from

the external environment, except in the case of fish

where the derogation referred to in article 2 of

European Union Commission Decision 93/352/EEC

and Chapter II point 2 of the Annex to European Union

Council Directive 91/493/EEC shall apply;

(d) an inspection room where the products are to be

inspected and samples taken for further tests; the

sampling area need not be separate from the inspection

room;

(e) appropriate storage rooms or areas, to permit detained

consignments to be held at chilled, frozen, or ambient

temperatures at the same time, under the control of the

official veterinarian pending the results of laboratory

or other investigations.

(3) Border inspection posts approved to handle chilled, frozen

and ambient categories of product, must be able to simultaneously

store adequate volumes of product in each temperature category.

Immediate access to an adequate volume of storage shall be

available at all times as necessary for the official veterinarian.

The use of commercial storage facilities close to the border

inspection post and within the same port or customs area, is

permitted under the control of the official veterinarian, and

provided that the detained product is stored in a separate lockable

room, chamber, or zone clearly fenced off from all other products.

Storage in separate stand-alone containers permanently

placed by the unloading area is permitted provided that the

INSPECTION POST IN MALTA

containers are linked to the unloading area in such a manner that

the unloading process is under shelter from the weather. Additional

storage for each product category in the means of transport in

which a consignment was brought to the post is permitted

exceptionally under the control of the official veterinarian for

border inspection posts situated at road, rail or port locations.

(4) Products for human consumption and products not for

human consumption should be handled in separate unloading areas,

inspection rooms and storage facilities. By derogation from this

requirement in the case of border inspection posts officially

approved as restricted to packed products only, unloading areas

may be common, provided then that during and after unloading,

there is clear separation of products for human consumption and

those not for human consumption, with a view to prevent cross

contamination.

(5) By derogation from subregulation (4), border inspection

posts having a throughput of less than 500 consignments per year

may utilise the same facilities provided for unloading, inspection

and storage for all products for which the post is approved,

provided that a time separation of consignments is implemented,

and that adequate cleansing and disinfection of the premises

between arrivals of different consignments is undertaken as

necessary.

Laws of Malta — Subsidiary Legislation 437.45 — APPROVAL OF BORDER INSPECTION POSTS RESPONSIBLE FOVETERINARY CHECKS ON PRODUCTS INTRODUCED INTO THE EUROPEAN

(1) Additional inspection centres in already approved

border inspection posts, may be proposed after the Veterinary

Services have checked that they comply with these regulations, for

listing by the European Commission. The facilities at any centre

should be appropriate to the volume and type of various products

passing through the centre.

(2) When a border inspection post is split into different

inspection centres, these shall -

(a) be located within the same customs designated area or

district as the border inspection post under which the

centres are listed;

(b) be located within a reasonable working distance from

the designated central office of the border inspection

post and be demonstrably under the control of the

official veterinarian;

(c) keep a specific record of the consignments examined

at the centre.

(3)

Inspection centres do not have to provide -

(a) archiving facilities, an Animo system terminal, or a

photocopier;

(b) all veterinary checks legislation and documentation

but only documents relevant and necessary for the

veterinary checks carried out in the centre.

INSPECTION POST IN MALTA

Laws of Malta — Subsidiary Legislation 437.45 — APPROVAL OF BORDER INSPECTION POSTS RESPONSIBLE FOVETERINARY CHECKS ON PRODUCTS INTRODUCED INTO THE EUROPEAN

In the circumstances referred to in article 6.2 (b) of

European Union Council Directive 97/78/EC concerning the

reasonable time intervals to comply with the recommendations

made pursuant to inspection reports, before the European

Commission withdraws the border inspection post from the list in

full or in part, in the latter case with regard to the product

categories and, or inspection centres concerned by the

recommendations, the time limit given to the Veterinary Services

and other Ministerial departments concerned and private

companies, operators and organisations involved, will be as

follows, taken from the date of receipt of the final report in an

official language of Malta -

(a) for deficiencies in respect of facilities (construction

only) or staff numbers - six months; however, where

new, replacement facilities are under construction the

time limits for completion of action may be

determined by agreement between Malta and the

European Commission on a case by case basis;

(b) for deficiencies in respect of all other matters: three

months.

In the event of potentially serious animal or public health

risks, these time intervals may be shorter.

INSPECTION POST IN MALTA

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