PRODUCTION AND SALE OF DAIRY AND TRADITIONAL DAIRY PRODUCTS RULES

TRADITIONAL DAIRY PRODUCTS

SUBSIDIARY LEGISLATION 437.110

PRODUCTION AND SALE OF DAIRY AND

TRADITIONAL DAIRY PRODUCTS RULES

2nd February, 2023

LEGAL NOTICE 321 of 2022.

(1)

The title of these rules is the Production and Sale

of Dairy and Traditional Dairy Products Rules.

(2)

The scope of these rules is to implement national

measures, in line with Article 10 of Council Regulation (EC) No 853

of 2004 of the European Parliament and of the Council of 29 April

2004 laying down specific hygiene rules for food of animal origin,

with respect to the production and sale of dairy and traditional dairy

products manufactured in establishments in Malta.

Adoption of national measures

In terms of Article 10 of Council Regulation (EC) No 853/

2004, the following national measures adopt Annex III of the said

Regulation, as follows

In the case of sheep and goat milk used for the production of

traditional dairy products

(a)

the checks referred to in Council Regulation (EC)

No 853/2004 in Annex III, Section IX, Chapter I, Part III,

paragraph 2 shall be carried out before raw milk is to be used

for production;

(b)

the number of micro-organisms as referred to in

Council Regulation (EC) No 853/2004 in Annex III, Section IX,

Chapter I, Part III, paragraph 3 shall be set on the basis of the

result of a test on an individual sample of raw milk twice a

month;

(c)

in line with Annex III, Section IX, Chapter I,

Part IIB, paragraph 4 (b) and Annex III, Section IX, Chapter II,

TRADITIONAL DAIRY PRODUCTS

Part I, paragraph 2(b) of Council Regulation (EC) No 853/2004,

the Director authorises the use of raw milk at a temperature of

not less than 37°C within two (2) hours from milking for the

production of traditional dairy products;

(d)

in order to accommodate food business operators

in terms of Article 10, paragraph 4 of Council Regulation (EC)

No 853/2004, it shall be permissible to utilise raw milk

originating from sheep and goats which

(i)

do not show clinical signs of brucellosis

(B.melitensis);

(ii)

having been tested for brucellosis

(B.melitensis) using one of the tests listed in the Annex

to Council Decision (EC) 90/242/EEC of 21 May 1990

introducing a Community financial measure for the

eradication of brucellosis in sheep and goats at least once

every twelve (12) months, where this test results

negative;

(iii) have been tested for any other disease in

accordance with regulation 5(4) with negative results

for any disease at least once every twelve (12) months;

(iv) belong to a registered farm officially free or

free of brucellosis as stipulated under Regulation (EU)

2016/429 of the European Parliament and of the Council

of 9 March 2016 on transmissible animal diseases and

amending and repealing certain acts in the area of animal

health;

(e)

in order to enable the continued use of traditional

methods for the production of traditional dairy products in

terms of Article 10, paragraph 4, of Council Regulation (EC)

No 853/2004, it shall be permissible

(i)

that the sheep and goats are hand milked

as long as this milking takes place in an area which is not

the area where these animals are kept and bred on the

farm;

(ii)

that the milk is filtered through a sieve

preferably of food grade plastic or stainless steel and

through a clean muslin cloth that is washed and boiled;

(iii) that the milk is placed in a food grade

plastic or stainless steel container and is not cooled if it is

going to be used for the production of traditional dairy

products within two (2) hours of milking;

TRADITIONAL DAIRY PRODUCTS

(iv) that this container with milk may be

transported without being cooled as long as the trip

between the place where the milking takes place and the

place where the production of the traditional dairy

products takes place does not take longer than sixty

(60) minutes;

(v)

as soon as this milk arrives at the place

where the production of traditional dairy products takes

place, this milk is transferred into a clay, stainless steel,

aluminium or any other food grade material pot and is

heated to 37°C;

(vi) that this temperature may be measured with

thermometers that are appropriate for food preparation

procedures;

(vii)

as soon as the temperature is adequate,

‘qtar tat-tames’ or any form of other enzyme that induces

milk to coagulate shall be added in accordance with the

recipe described for the production of traditional dairy

product;

(viii) the curd that forms shall be left to stand for

thirty (30) minutes in an ambient temperature covered by

a small meshed net;

(ix) that after such time the curd is lifted with a

skimmer and placed in a form (qaleb) made of food grade

plastic or cane or reed;

(x)

that this curd is pressed also by hand to

make sure that the form is packed well and all air is

removed;

(xi) that the forms are placed in a food grade

plastic or aluminium or stainless steel tray so that the

forms of the traditional dairy product drip;

(xii) that the trays after the first half hour shall

be placed in a place where they can be cooled where the

temperature shall be kept between 7°C and 12°C;

(xiii) that these forms of the traditional dairy

product shall be turned over every two ( 2 ) hours for

three or four times to dry up in a uniform and

homogeneous manner;

(xiv) that these forms of the traditional dairy

product shall be extracted out of their containers after

TRADITIONAL DAIRY PRODUCTS

twenty-four (24) hours;

(xv) that all this process of the manufacture of

the traditional dairy product can take place in

environments that do not have temperature control;

(xvi) that the traditional dairy product that shall

be placed on the market in a fresh state can at this point

be packed in an acceptable way and as described for that

traditional dairy product;

(xvii) that in the case of a traditional dairy

product that shall be dried, this shall be placed in a place

to dry in accordance with the method described in the

recipe for the production of the traditional dairy product.

This drying can take place in a ‘qanniċ’ or

‘nemmusiera’;

(xviii) that the storage of the traditional dairy

product that has been dried or treated in any other way

may take place in a place that does not have temperature

control and may be kept in ambient temperature.

(f)

when the traditional dairy product is placed on

the market, it shall be packed bearing an identification mark

that is placed in such a way that it shall be destroyed or broken

when the packaging or the wrapping of the product is opened

or the product has to be packed and wrapped in a way that it

is sealed so that the wrapping or packaging material cannot be

used again once it is opened.

These rules shall apply in accordance with the

provisions of Council Regulation (EC) No 852/2004 of the European

Parliament and of the Council of 29 April 2004 on the hygiene of

foodstuffs, Council Regulation (EC) No 853/2004 of the European

Parliament and of the Council of 29 April 2004 laying down specific

hygiene rules for food of animal origin, and Regulation (EU) 2017/625

of the European Parliament and of the Council of 15 March 2017 on

official controls and other official activities performed to ensure the

application of food and feed law, rules on animal health and welfare,

plant health and plant protection products, amending Regulations (EC)

No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/

2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and

(EU) 2016/2031 of the European Parliament and of the Council,

Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and

Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC

and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and

(EC) No 882/2004 of the European Parliament and of the Council,

Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/

EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/

438/EEC (Official Controls Regulation), and shall comprise national

rules for the achievement of the objectives of such rules.

(1)

In these rules, unless the context otherwise

requires

" Act" means the Veterinary Services Act;

"Commission" means the Food Safety Commission

established by the Food Safety Act;

"Council Regulation (EC) No 852/2004" means Council

Regulation (EC) No 852/2004 of the European Parliament and

TRADITIONAL DAIRY PRODUCTS

of the Council of 29 April 2004 on the hygiene of foodstuffs;

"Council Regulation (EC) No 853/2004" means Council

Regulation (EC) No 853/2004 of the European Parliament and of

the Council of 29 April 2004 laying down specific hygiene rules

for food of animal origin;

"Department" means the Department responsible for

Veterinary Services;

"Director" means the Director responsible for Veterinary

Services or any authorised officer duly appointed by him;

"EEA Agreement" means the Agreement on the European

Economic Area signed at Oporto on 2nd May 1992, as adjusted

by the Protocol signed at Brussels on l7th March 1993 and as

subsequently amended;

"EFTA Member States" means states which are

members of the European Free trade Association;

"farm" means an establishment where one or more

farmed animals are kept to produce milk which shall also

include related premises;

"Farmers’ Market" means a market established in terms

of regulation 3 of the Farmers’ Markets Regulations;

"Malta" shall have the same meaning as assigned to it in

article 124 of the Constitution of Malta;

"open-air market" means any one of the markets listed

in the Third Schedule to the Trading Licences Regulations or

any market established in terms of the Farmers’ Market

Regulations;

"qaleb" means a small traditional cheese basket where

the traditional dairy product is placed;

"qanniċ" means traditional fabric used for air-drying

the traditional dairy product;

"raw cream" means the cream obtained from the fat

skimmed off raw milk;

"Regulation (EU) 2017/625" means Regulation (EU)

2017/625 of the European Parliament and of the Council of 15

March 2017 on official controls and other official activities

performed to ensure the application of food and feed law, rules

on animal health and welfare, plant health and plant protection

products, amending Regulations (EC) No 999/2001, (EC) No

TRADITIONAL DAIRY PRODUCTS

396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No

1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/

2031 of the European Parliament and of the Council, Council

Regulations (EC) No 1/2005 and (EC) No 1099/2009 and

Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/

119/EC and 2008/120/EC, and repealing Regulations (EC) No

854/2004 and (EC) No 882/2004 of the European Parliament

and of the Council, Council Directives 89/608/EEC, 89/662/

EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/

78/EC and Council Decision 92/438/EEC (Official Controls

Regulation);

"related premises" means premises belonging to the

owner of the animals of a farm or premises which are being

leased from another person for the purposes of these rules,

which is not necessarily within the perimeter of the farm, but

which is used for the processing of dairy and traditional dairy

products from milk;

"sale from the farm" means sale directly to the final

consumer at the same farm or from related premises;

"traditional dairy product" means a product made out of

milk originating from sheep, goats or cows as follows

(a)

listed in the National Register of

Traditional agro-food products of Malta in accordance

w i t h the Establishment of the National Register of

Traditional Agro-Food Products of Malta Regulations; or

(b)

registered in terms of Regulation (EU) No

1151/2012 of the European Parliament and of the Council

of 21 November 2012 on quality schemes for agricultural

products and foodstuffs; or

(c)

lawfully marketed in a Member State of the

EU or in Turkey, or which is originating and lawfully

marketed in an EFTA Member State that is a contracting

party to the EEA Agreement.

(2)

Unless the context otherwise requires, words and phrases

used in these rules which are not defined herein shall have the same

meaning assigned to them in the Act and, or Council Regulation (EC)

No 852/2004 and, or Council Regulation (EC) No 853/2004 and, or

Regulation (EU) 2017/625 and, or 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.

TRADITIONAL DAIRY PRODUCTS

(1)

No person shall sell dairy or traditional dairy

products unless produced and labelled as required and in accordance

with these rules.

(2)

The placing on the market in Malta of raw milk or raw

cream intended for direct human consumption shall be prohibited.

(1)

All producers of dairy products and traditional

dairy products shall be approved by the Department and registered with

the Commission.

(2)

Farms and, or related premises producing milk shall be

registered with the Department.

(3) Without prejudice to provisions made under the Act with

regards to the identification and registration of animals and Regulation

(EU) 2016/429 of the European Parliament and of the Council of 9

March 2016 on transmissible animal diseases and amending and

repealing certain acts in the area of animal health, all male and female

animals of the species producing milk on the farm shall be identified

and registered on the farm register and with the Department in

accordance with the provisions of the respective laws and regulations.

(4)

The animals referred to in sub-rule (3) shall be tested

regularly for any diseases which may be identified as stipulated in

Regulation (EU) 2016/429 of the European Parliament and of the

Council of 9 March 2016 on transmissible animal diseases and

amending and repealing certain acts in the area of animal health, as well

as for any other disease as may be determined by the Director from

time to time.

(5)

The procedure for effecting a registration of a farm and

animals in terms of this rule shall be determined by the Department.

The production of dairy products and traditional dairy

products s h a l l n o t be placed on the market, be sold in

wholesale or retail or directly to the final consumer from the farm or

from any related premises or from any other place unless these products

originate from establishments as described in rule 5.

Dairy products or traditional dairy products may be

produced on a farm or in a related premises outside the rules set by

Council Regulation (EC) No 852/2004 of the European Parliament and

of the Council of 29 April 2004 and Council Regulation (EC) No 853/

2004 and the provisions of these rules, if they are going to be consumed

by the owner of the animals or his direct family living in the same

household as the owner of the animals. Such a production shall only

take place under these conditions on a farm or related premises where

there are no more than seven (7) sheep or goats registered therein

Provided that all the dairy or traditional dairy products

TRADITIONAL DAIRY PRODUCTS

produced on a farm or in a related premises where there are no more

than seven (7) sheep or goats registered therein may be sold through

sale from the farm and, or from an open-air market if the farm holding

and related premises are registered in terms of Council Regulation

(EC) No 852/2004 and they fulfil the requirements established therein.

Any person placing traditional dairy products on the

market in Malta in accordance with these rules shall also abide by t h e

measures set o u t in the Schedule and any o t h er guidelines a s m a y

b e issued by the Commission, from time to time, and published in the

Gazette.

(1)

Any person transporting or storing dairy products

and, or traditional dairy products for wholesale shall be registered with

the Department and the Commission in accordance with the

Registration of Food Premises Regulations.

(2)

Any person transporting or storing dairy products or

traditional dairy products for retail shall be registered with the

Department and the Commission in accordance with the Registration

of Food Premises Regulations.

(1)

Any person who contravenes or fails to comply

with any of the provisions of these rules shall be guilty of an offence

and shall, on conviction, be liable to the punishments contemplated in

articles 35(2), 36(2), 37(2) and 38(2) of the Act which p u n i s h m e n t

may include imprisonment of not more than six (6) months or a fine

(multa) of not less than four thousand euro (€4,000) and not more than

twenty-three thousand and two hundred and ninety-three euro and

seventy-three cents (€23,293.73) or both such imprisonment and fine

(multa).

(2)

Where the Director has reasonable cause to believe that

an offence against these rules has been committed by any person and,

having regard to the previous conduct of the person concerned, it

would be appropriate to impose an administrative penalty, the Director

may decide to impose an administrative penalty in accordance with

article 61 of the Act.

(3)

In accordance with the provisions of article 57(2) of

the Act, where any person is convicted of an offence against these

rules, the Court may, in addition to any other punishment that it may

impose, order that those animals, instruments, appliances, products or

substances used in the commission of the offence shall be forfeited in

favour of the Government and, if so forfeited, shall be disposed of in

such a manner as the Court may determine on the advice of the

Director.

(4)

In the event of a second or subsequent conviction against

these rules, the provisions of article 60 of the Act shall apply.

TRADITIONAL DAIRY PRODUCTS

(5)

Without prejudice to the provisions of sub-rules (1) to (4)

and to any provision of the Criminal Code which may apply in this

regard, any person committing a breach of rules 5, 8 and 9 shall be

subject to the provisions of articles 43 and 44 of the Food Safety Act

which shall also apply in this regard together with any other

punishments that may be imposed.

(6)

The provisions of sub-rules (1) to (4) shall continue to

apply without prejudice to any pending criminal proceedings which

shall have been instituted against the offender committing an offence

against these rules.

In respect of actions and procedures for offences in

connection with these rules, the Court may award in favour of the

Government such costs and expenses incurred in relation to those

actions and procedures as it may deem fit

Provided that where the Director deems it more

appropriate to impose an administrative penalty as stipulated under

article 61 of the Act, the offender shall also pay for any costs or

expenses incurred in relation to actions and procedures carried out

during the inspection where irregularities are found.