Introduction of Products for Human Consumption), Rules, 2005

L.N. 145 of 2005

VETERINARY SERVICES ACT

(CAP. 437)

Animal Health (Production, Processing, Distribution and

Introduction of Products for Human Consumption), Rules, 2005

IN exercise of the powers conferred by articles 11 and 12 of the

Veterinary Services Act, the Minister for Rural Affairs and the

Environment, in agreement with the Minister of Health, the Elderly

and Community Care, has made the following rules>-

(1) The title of these rules is the Animal Health (Production, Title, scope and

Processing, Distribution and Introduction of Products for Human applicability.

Consumption), Rules, 2005.

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

found under European Union Council Rule 2002#99#EC governing the

production, processing, distribution and introduction of products of

animal origin for human consumption.

(3) These rules shall apply without prejudice to Community

or national provisions on the production, processing, distribution and

introduction of products of animal origin for human consumption.

Diseases of relevance to trade in products of animal origin and for which control measures have been

introduced under European Community legislation

DISEASE

DIRECTIVE

Classical swine fever

Council Directive 2001/89/EC on Community

measures for the control of classical swine fever

African swine fever

Council Directive 2002/60/EC laying down specific

provisions for the control of African swine fever

Foot-and-mouth disease

Council Directive 85/511/EEC introducing

Community measures for the control of foot-and-

mouth disease

Avian influenza

Council Directive 92/40/EEC introducing

Community measures for the control of avian

influenza

Newcastle disease

Council Directive 92/66/EEC introducing

Community measures for the control of Newcastle

dis ease

Rinderpest Sheep and goat plague Swine vesicular

Council Directive 92/119/EEC introducing general

disease

Community measures for the control of certain

animal diseases and specific measures relating to

swine vesicular disease

Aquaculture diseases

Council Directive 91/67/EEC concerning the animal

health conditions governing the placing on the

market of aquaculture animals and products

Council Directive 93/53/EEC introducing minimum

Community measures for the control of certain fish

diseases

Council Directive 95/70/EC introducing minimum

Community measures for the control of certain

diseases affecting bivalve molluscs

(1) For the purposes of these rules, the definitions in Rule Definitions.

(EC) No 178#2002 of the European Parliament and of the Council of 28

January 2002 laying down the general principles and requirements of

food law, establishing the European Food Safety Authority and laying

down procedures in matters of food safety and Directive 97#78#EC shall

apply as necessary.

(2) The following definitions shall also apply>

“all stages of the production, processing and distribution”

means any stage from and including the primary production of a

food of animal origin, up to and including its storage, transport,

sale or supply to the final consumer<

“introduction” means the bringing of goods into one of the

territories listed in Annex I to Directive 97#78#EC for the purpose

of placing them under the customs procedures referred to in Article

4(16)(a) to (f) of Council Rule (EC) No 2913#92 of 12 October

1992 establishing the Community Customs Code<

“official veterinarian” means a veterinarian qualified to act

in that capacity appointed by the competent authority<

“products of animal origin” means products obtained from

animals and products obtained therefrom, for human consumption,

including live animals where they are prepared for such use.

Special identification mark for meat from a territory or a part of a territory

(1) The health mark for fresh meat must bear a diagonal cross consisting of two straight lines intersecting at

the centre of the stamp and enabling the information thereon to remain legible.

(2) The mark mentioned in sub-rule 1 may also be applied using a single oval stamp, 6,5 cm wide by 4,5

cm high; the following information must appear on the mark in perfectly legible characters

(a) on the upper part, the name or ISO code of Malta in capitals

(b) in the centre, the veterinary approval number of the slaughterhouse,

(c) on the lower part, one of the following sets of initials KEE,

(d) two straight lines crossing at the centre of the stamp in such a way that the information is not

obscured.

(3)The letters must be at least,0,8 cm high and the figures at least 1 cm high.

(4)The stamp must also carry information whereby the veterinarian who inspected the meat can be

identified.

(5) The mark must be applied under the direct supervision of the official veterinarian controlling the

implementation of the animal health requirements.

(1) Malta shall take measures to ensure that at all stages of

the production, processing and distribution of products of animal origin

within the Community, food business operators do not cause the spread

of diseases transmissible to animals, in accordance with the following

provisions.

(2) Products of animal origin must be obtained from animals

which fulfil the animal health conditions laid down by the relevant

Community legislation.

(3) Products of animal origin shall be obtained from animals>

(a) which do not come from a holding, establishment,

territory or part of a territory subject to animal health restrictions

applicable to the animals and products concerned, under the rules

set out in schedule I to these rules<

(b) which, in the case of meat and meat products, were not

slaughtered in an establishment in which animals infected or

suspected of being infected with one of the diseases covered by

the rules referred to in paragraph (a) hereof, or carcasses or parts

thereof of such animals, were present during the slaughtering or

production process, unless such suspicion has been ruled out<

(c) which, in the case of aquaculture animals and products,

comply with Directive 91#67#EEC.

1. Treatments to eliminate certain animal health risks linked to meat and milk

MEAT Treatment

Foot-

Classical

Swine

African

Rinderpest Newcastle

Avian

Sheep

(*)

and-

swine

vesicular

swine

disease

influenza

and

mouth

fever

disease

fever

goat

disease

plague

(a) Heat treatment

+

+

+

+

+

+

+

+

in a hermetically

sealed container

with an F0 value

of 3.00 or more

(**)

(b) Heat treatment

+

+

+

+

+

+

+

at a minimum

temperature of 70

°C. which must

be reached

throughout the

meat

(c) Heat treatment

+

+

+

+

+

+

+

+

at a minimum

temperature of 80

°C. which must

be reached

throughout the

meat

(d) Heat

+

+

+

+

+

-

-

+

treatment in a

hermetically

sealed container

to at least 60 °C

for a minimum

of 4 hours.

during which

time the core

temperature

must be at least

70 °C for 30

minutes

(e) Natural

+

+

+

+

+

fermentation and

maturation of not

less than nine

months for

boneless meat.

resulting in the

following

characteristics

Aw value of not

more than 0.93

or a pH value of

not more than

6.0

(f) Same

+

+

+

treatment as in

(e) above

although meat

may contain

bone (*)

(g) Salami

+

+

+

+

treatment in

accordance with

criteria to be

defined by the

Article 12(2)

procedure

following an

opinion by the

relevant

Scientific

Committee

(h) Hams and

+

loins: treatment

involving natural

fermentation and

maturation

during at least

190 days for

hams and 140

days for loins

(i) Heat

+

+

treatment

ensuring a core

temperature of

at least 65 °C is

reached for the

time necessary

to achieve a

pasteurisation

value (pv)

equal to or

more than 40

MILK and milk

products

(including

cream) for

human

consumption

(a) Ultra-high

+

temperature

(UHT) (UHT =

minimum

treatment at 132

°C for at least 1

second)

(b) If the milk

+

has a pH of less

than 7.0. simple

high temperature

- short-time

pasteurisation

(HTST)

(c) If the milk

+

has a pH of 7.0

or more. double

HTST

+: Effectiveness recognised.

0: Effectiveness not recognised.

(*) All the necessary measures must be taken to avoid cross contamination.

(**) F0 is the calculated killing effect on bacterial spores. An F0 value of 3,00 means that the coldest point

in the product has been heated sufficiently to achieve the same killing effect as 121 °C (250 °F) in three

minutes with instantaneous heating and chilling.

(1) Notwithstanding rule 3 hereof and subject to compliance

with the disease control measures referred to in Schedule I, Malta may

authorise the production, processing and distribution of products of

animal origin which come from a territory or part of a territory subject

to animal health restrictions but which do not come from a holding

which is infected or suspected of being infected, provided that>

(a) before being subjected to the treatment referred to below,

the products have been obtained, handled, transported and stored

separately, or at different times, from products fulfilling all the

animal health conditions, and the conditions for transport out of

the territory subject to animal health restrictions have been

approved by the competent authority<

(b) the products which are to undergo treatment are clearly

identified<

(c) the products undergo treatment enabling the animal

health problem concerned to be eliminated, and

(d) the treatment is applied at an establishment approved

for that purpose by the Member State in which the animal health

problem occurred.

(2) The provisions of the sub-rule shall be applied in

accordance with Schedules II and III(1) hereto, or with detailed rules to

be adopted in accordance with the procedure referred to in Article 12(2)

of Directive 2002#99#EC.

(3) The production, processing and distribution of

aquaculture products not complying with the conditions laid down in

rule 3 shall be authorised, subject to the conditions laid down in Directive

91#67#EEC and, where necessary, in accordance with further conditions

to be adopted in accordance with the procedure referred to in Article

12(2) of Directive 2002#99#EC.

(4) Furthermore, where the health situation so permits,

derogations from rule 3 may be granted in certain situations, in

accordance with the procedure referred to in Article 12(2) of Directive

2002#99#EC. In such cases, particular account shall be taken of>

(a) the specific characteristics of the disease in the species

concerned, and

(b) any tests or measures to which the animals must be

subjected.

(5) Where such derogations are granted, steps must be taken

to ensure that the degree of protection from animal disease will in no

way be impaired. Any measures needed to ensure the protection of

animal health in the Community shall therefore be adopted in accordance

with the same procedure.

General principles of certification

(1) The representative of the competent authority of dispatch issuing a certificate to accompany a

consignment of products of animal origin must sign the certificate and ensure that it bears an official stamp.

This requirement applies to each sheet of the certificate if it consists of more than one.

(2) Certificates must be drawn up in the official language or languages of the Member State of destination

and those of the Member State in which the border inspection takes place, or be accompanied by a certified

translation into that language or those languages. However, Malta may consent to the use of an official

European Community language other than its own.

(3) The original version of the certificate must accompany consignments on entry into the European

Community.

(4) Certificates must consist of

(a) a single sheet of paper; or

(b) two or more pages that are part of a single and indivisible sheet of paper; or

(c) a sequence of pages numbered so as to indicate that it is a particular page in a finite sequence

(for example, "page 2 of 4 pages").

(5) Certificates must bear a unique identifying number. Where the certificate consists of a sequence of

pages, each page must indicate this number.

(6) The certificate must be issued before the consignment to which it relates leaves the control of the

competent authority of the country of dispatch.

(1) Malta shall ensure that products of animal origin intended Veterinary

for human consumption are subjected to veterinary certification where> certificates.

(a) provisions adopted for animal health reasons under

Article 9 of Directive 89#662#EEC require products of animal origin

from a Member State to be accompanied by a health certificate, or

(b) a derogation has been granted under rule 4(4).

(2) Under the procedure referred to in Article 12(2) of

Directive 2002#99#EC, detailed implementing rules, and in particular a

model for such certificates, may be drawn up taking into account the

general principles set out in Schedule IV. Certificates may include details

required in accordance with other Community public and animal health

legislation.

(1) Council Directive 72/461/EEC of 12 December 1972 on health problems affecting intra-Community

trade in fresh meat(1), as last amended by the Act of Accession of Austria, Finland and Sweden.

(2) Council Directive 80/215/EEC of 22 January 1980 on animal health problems affecting intra -

Community trade in meat products(2), as last amended by the Act of Accession of Austria, Finland and

Sweden.

(3) Council Directive 91/494/EEC of 26 June 1991 on animal health conditions governing intra-

Community trade in and imports from third countries of fresh poultrymeat(3), as last amended by Directive

93/121/EC.

(4) Council Directive 91/495/EEC of 27 November 1990 concerning public health and animal health

problems affecting the production and placing on the market of rabbit meat and farmed game meat(4), as

last amended by the Act of Accession of Austria, Finland and Sweden.

(5) Council Directive 92/45/EEC of 16 June 1992 on public health and animal health problems relating to

the killing of wild game and the placing on the market of wild-game meat(5), as last amended by Directive

97/79/EC.

(6) Council Directive 92/46/EEC of 16 June 1992 laying down the health rules for the production and

placing on the market of raw milk, heat-treated milk and milk-based products(6).

(7). Council Directive 94/65/EC of 14 December 1994 laying down the requirements for the production and

placing on the market of minced meat and meat preparations(7).

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

(1) Pending adoption of Rules of the European Parliament

and of the Council laying down specific hygiene rules for food of animal

origin and rules for controls applicable to foodstuffs and animal feed,

Malta shall ensure that official animal health controls are carried out by

their competent authorities to ensure compliance with this rule, its

implementing rules and any safeguard measures relating to products of

animal origin adopted pursuant to this rule. As a general rule, inspections

must be unannounced and checks carried out in accordance with the

provisions of Directive 89#662#EEC.

(2) Pending adoption of Rules of the European Parliament

and of the Council laying down specific hygiene rules for food of animal

origin and rules for controls applicable to foodstuffs and animal feed,

where infringements of animal health rules are identified, Malta shall

take the necessary measures to remedy the situation in accordance with

the provisions of Directive 89#662#EEC.

(3) Experts from the Commission may carry out on-the-

spot checks, including audits, in cooperation with the competent

authorities of Malta, insofar as is necessary for the uniform application

of this rule. Malta shall provide the experts if checks are being carried

out in its territory, with all the assistance necessary for carrying out

their duties. The Commission shall inform the competent authority of

the results of the checks made. If a serious animal health risk is identified

during a Commission audit or inspection, Malta concerned shall

immediately take all measures necessary to safeguard animal health. If

such measures are not taken, or if they are considered to be insufficient,

the Commission shall, in accordance with the procedure referred to in

Article 12(2) of Directive 2002#99#EC, take the measures necessary to

safeguard animal health and inform the Member States thereof.

(1) Malta shall take measures to ensure that products of

animal origin intended for human consumption are introduced from

third countries only if they comply with the requirements of this rule

applicable to all stages of the production, processing and distribution

of such products in the Community or if they offer equivalent animal

health guarantees.

(2) The rules for the application of this rule, and in particular

those governing the procedure for cooperation with the national

authorities, shall be adopted in accordance with the procedure referred

to in Article 12(2) of Directive 2002#99#EC.

(1) In order to ensure compliance with the general obligation

laid down in rule 7, the following shall be established in accordance

with the procedure referred to in Article 12(2) of Directive 2002#99#EC.

(2) In lists of the third countries or regions of third countries

from which imports of specified products of animal origin are permitted,

a third country shall appear on such lists only if a Community audit of

that country has taken place and demonstrates that the competent

veterinary authority provides appropriate guarantees as regards

compliance with Community legislation.

(3) When drawing up or updating those lists, particular

account shall be taken of>

(a)

the legislation of the third country<

(b) the organisation of the competent veterinary authority

and its inspection services in the third country, the powers of these

services, the supervision to which they are subject, and the means

at their disposal, including staff capacity, to apply their legislation

effectively<

(c) the actual animal health requirements applying to the

production, manufacture, handling, storage and dispatch of products

of animal origin intended for the Community<

(d) the assurances which the competent veterinary authority

of the third country can give regarding compliance or equivalence

with the relevant animal health conditions<

(e) any experience of marketing the product from the third

country and the results of any import controls carried out<

(f) the results of Community inspections and, or audits

carried out in the third country, in particular the results of the

assessment of the competent authorities or, where the Commission

so requests, the report submitted by the competent authorities of

the third country on the inspections which they have carried out<

(g) the health status of livestock, other domestic animals

and wildlife in the third country, with particular regard to exotic

animal diseases and any aspects of the general health situation in

the country which might pose a risk to public or animal health in

the Community<

(h) the regularity, speed and accuracy with which the third

country supplies information on the existence of infectious or

contagious animal diseases in its territory, particularly the notifiable

diseases listed by the World Organisation for Animal Health (OIE)

or, in the case of diseases of aquaculture animals, the notifiable

diseases listed in the Aquatic Animal Health Code of the OIE<

(i) the rules on the prevention and control of infectious or

contagious animal diseases in force in the third country and their

implementation, including rules on imports from other countries.

(4) The Commission shall arrange for up-to-date versions

of all lists drawn up or updated in accordance with this rule to be available

to the public. Lists drawn up in accordance with this rule may be

combined with other lists drawn up for animal and public health purposes

and may also include models of health certificates.

(5) Rules of origin for products of animal origin and the

animals from which such products are obtained shall be established in

accordance with the procedure referred to in rule 12 (2).

(6) Special import conditions for each third country or group

of third countries, having regard to the animal health situation of the

third country or countries concerned shall be established in accordance

with the procedure referred to in Article 12(2) of Directive 2002#99#EC.

(7) Where necessary>

(a)

the detailed rules for the application of this rule,

(b) criteria for classifying third countries and regions thereof

with regard to animal diseases, and

(c) specific rules concerning types of introduction or

particular products, such as the introduction of products by

travellers or the introduction of commercial samples, may be

established in accordance with the procedure referred to in Article

12(2) of Directive 2002#99#EC.

(1) A veterinary certificate meeting the requirements set out

in Schedule IV shall be presented with consignments of products of

animal origin upon their entry into the Community.

(2) The veterinary certificate shall certify that the products

(a) the requirements laid down for such products under this

rule and under the Community legislation laying down animal

health requirements or provisions that are equivalent to those

requirements< and

(b) any special import conditions established in accordance

with the procedure referred to in Article 12(2) of Directive

2002#99#EC.

(3) Documents may include details required under other

provisions of Community public and animal health legislation.

(4) In accordance with the procedure referred to in Article

12(2) of Directive 2002#99#EC>

(a) provision may be made for the use of electronic

documents,

(b) model documents may be drawn up,

(c)

rules and certification for transit may be established.

(1) Community inspections and, or audits at all stages Community

covered by this rule may be carried out in third countries by experts inspections.

from the Commission in order to verify conformity with or equivalence

to Community animal health rules. The experts from the Commission

may be accompanied by experts from Malta authorised by the

Commission to carry out such inspections and#or audits.

(2) The inspections and#or audits in third countries referred

to in sub-rule (1) hereof shall be carried out on behalf of the Community,

and the Commission shall meet the costs incurred.

(3) The procedure for carrying out the inspections and, or

audits in third countries referred to in sub-rule (1) may be established

or modified in accordance with the procedure referred to in Article 12(2)

of Directive 2002#99#EC.

(4) If a serious animal health risk is identified during a

Community inspection or audit, the Commission shall immediately take

the measures necessary to safeguard animal health, in accordance with

Article 22 of Directive 97#78#EC, and inform the Member States thereof.

(1) The Schedules hereto may be amended in accordance Update of technical

with the procedure referred to in Article 12(2) of Directive 2002#99#EC schedules.

in order to take account in particular of>

(a) scientific opinions and scientific knowledge, particularly

concerning new risk assessments<

(b) technical developments< and

(c)

the setting of safety targets for animal health.