ANIMAL HEALTH (PRODUCTION, PROCESSING, DISTRIBUTION AND INTRODUCTION OF PRODUCTS FOR HUMAN CONSUMPTION RULES *

PRODUCTS FOR HUMAN CONSUMPTION

SUBSIDIARY LEGISLATION 437.70

ANIMAL HEALTH (PRODUCTION, PROCESSING,

DISTRIBUTION AND INTRODUCTION OF

PRODUCTS FOR HUMAN CONSUMPTION RULES *

24th May, 2005

LEGAL NOTICE 145 of 2005.

(1) The title of these rules is the Animal Health

(Production, Processing, Distribution and Introduction of Products

for Human Consumption), Rules.

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

found under European Union Council Directive 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

C o un c il D i r e c t i v e 2 0 02 / 6 0/ E C l a y i ng d o wn

specific provisions for the control of African

swine fever

Foot-and-mouth disease

C o u n c i l D i r e c t i v e 8 5 / 5 11 / E E C i n t r o d u c i n g

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 disease

Rinderpest

C o u n c i l D i r e c t i v e 9 2 / 11 9 / E E C i n t r o d u c i n g

Sheep and goat plague

general Community measures for the control of

Swine vesicular disease

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

Regulation (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 Regulation (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 paragraph (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 - EEC or KEE,

PRODUCTS FOR HUMAN CONSUMPTION

(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

*These rules have been repealed by Legal Notice 77 of 2025.

PRODUCTS FOR HUMAN CONSUMPTION

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;

(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), 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 Rinder-

New-

Avian

Sheep

and-

swine vesicular swine

pest

castle influenza and goat

mouth

fever

disease

fever

disease

plague

disease

(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) ab ove altho ug h

meat may contain bone

(*)

PRODUCTS FOR HUMAN CONSUMPTION

(g) Salami

+

+

+

+

treatment in accordance

with criteria to be

defined

by

the

procedure in Article

12(2) 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 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 sub-rule (1) shall be applied in

accordance with Schedules II and III, 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

PRODUCTS FOR HUMAN CONSUMPTION

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.

PRODUCTS FOR HUMAN CONSUMPTION

(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 for human consumption are subjected to veterinary

certification where

(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, detai led im plem en ting rules, and in

particular a model for such certificates, may be drawn up taking

into account the general principles set o ut i n 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, 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, 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, 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, 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, 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.

(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.

(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

PRODUCTS FOR HUMAN CONSUMPTION

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

PRODUCTS FOR HUMAN CONSUMPTION

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 FOR HUMAN CONSUMPTION

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

satisfy

(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

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

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) 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

with the procedure referred to in Article 12(2) of Directive 2002/

PRODUCTS FOR HUMAN CONSUMPTION

99/EC 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.

PRODUCTS FOR HUMAN CONSUMPTION