PRESERVED MILK REGULATIONS

SUBSIDIARY LEGISLATION 449.40

PRESERVED MILK REGULATIONS

1st May, 2004

LEGAL NOTICE 215 of 2004, as amended by Legal Notices 224 of 2008

and 74 of 2026.

1. The title of these regulations is the Preserved Milk

Regulations.

1.2 These regulations implement the provisions of Council

Directive 2001/114/EEC relating to certain partly or wholly

dehydrated preserved milk for human consumption.

1.3 These regulations shall also transpose the provisions of

Directive 2024/1438/EU of the European Parliament and of the

Council amending Council Directive 2001/114/EC relating to certain

partly or wholly dehydrated preserved milk for human consumption.

Substituted by

L.N. 224 of 2008.

Definitions of products and product names

Amended by

L.N. 74 of 2026.

1. Partly dehydrated milk

This means the liquid product, whether or not sweetened, obtained by the partial

removal of water from milk, from wholly or partly skimmed milk or from a mixture

of these products, which may have an admixture of cream or of wholly dehydrated

milk or both, the addition of wholly dehydrated milk not to exceed, in the finished

products, 25% of total milk solids.

Types of unsweetened condensed milk

(a) Condensed high-fat milk

Partly dehydrated milk containing, by weight, not less than 15% fat, and

not less than 26.5% total milk solids.

(b) Condensed milk

Partly dehydrated milk containing, by weight, not less than 7.5% fat and

not less than 25% total milk solids.

(c) Condensed, partly skimmed milk

Partly dehydrated milk containing, by weight, not less than 1% and less

than 7.5% fat, and not less than 20 % total milk solids.

(d) Condensed skimmed milk

Partly dehydrated milk containing, by weight, not more than 1% fat and

not less than 20 % total milk solids.

Types of sweetened condensed milk

(e) Sweetened condensed milk

Partly dehydrated milk with an admixture of sucrose (semi-white sugar,

white sugar or extra-white sugar) and containing, by weight, not less

than 8% fat and not less than 28% total milk solids.

(f)

Sweetened condensed, partly skimmed milk

Partly dehydrated milk with an admixture of sucrose (semi-white sugar,

white sugar or extra-white sugar) and containing, by weight, not less

than 1% and less than 8% fat, and not less than 24% total milk solids.

(g) Sweetened condensed skimmed milk

Partly dehydrated milk with an admixture of sucrose (semi-white sugar,

white sugar or extra-white sugar) and containing, by weight, not more

than 1% fat and not less than 24% total milk solids.

2. Totally dehydrated milk

This means the solid product, where the water content does not exceed 5% by

weight of the finished product, obtained by the removal of water from milk, from

wholly or partly skimmed milk, from cream or from a mixture of these products.

(a) Dried high-fat milk or high-fat milk powder

Dehydrated milk containing, by weight, not less than 42% fat.

(b) Dried whole milk or whole milk powder

Dehydrated milk containing, by weight, not less than 26% and less than

42% fat.

(c) Dried partly skimmed milk or partly skimmed-milk powder Dehydrated

milk with a fat content of more than 1,5% and less than 26% by weight.

(d) Dried skimmed milk or skimmed-milk powder

Dehydrated milk containing, by weight, not more than 1,5% fat.

3. Treatments

(a) An additional quantity of lactose not greater than 0,03% by weight of

the finished product is authorised for the manufacture of the products

defined in 1(e) to (g).

(b) Without prejudice to 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( * ), the preservation of the

products referred to in paragraphs 1 and 2 shall be achieved

-

by heat-treatment (sterilisation, UHT, etc.), for the products

referred to in 1(a) to (d),

-

by the addition of sucrose, for the products referred to in 1(e) to

(g),

-

by dehydration, for the products referred to in 2.

(c) Without prejudice to the compositional requirements of points 1 and 2

of this Schedule the protein content of milk may be adjusted to a

minimum content of 34% by weight (expressed on fat free dry matter),

by the addition and/or withdrawal of milk constituents in such a way as

not to alter the whey protein to casein ratio of the milk being adjusted.

(d) Reduction of the lactose content by conversion to glucose and galactose.

Modifications in the composition of milk as a result of this treatment shall

be permitted only if they are clearly indicated on the packaging of the

product so that they can be easily visible and legible. Such indication is

without prejudice to the obligation regarding nutrition labelling in

Regulation (EU) No 1169/2011. The Food Safety and Security Authority

may limit or prohibit modifications to the composition of milk referred to

in this paragraph.

4. Authorised additions and raw materials

(a) Vitamins and minerals in accordance with Regulation (EC) No 1925/

2006 of the European Parliament and of the Council of 20 of December

2006, on the addition of vitamins and minerals and of certain other

substances to foods ( † ).

(b) Authorised raw materials for protein adjustment purposes referred to in

point 3(c) shall be as follows

(i)

Milk retentate

Milk retentate is the product obtained by concentrating milk

protein by ultra filtration of milk, partly skimmed milk, or

skimmed milk;

(ii) Milk permeate

Milk permeate is the product obtained by removing milk proteins

and milk fat from milk, partly skimmed milk, or skimmed milk by

*OJ L 139, 30.4.2004, p. 55. Corrected by OJ L 226, 25.6.2004, p. 22.

†OJ L 404, 30.12.2006, p. 26.

PRESERVED MILK

ultra filtration; and

(iii) Lactose

Lactose is a natural constituent of milk normally obtained from

whey with an anhydrous lactose content of not less than 99.0% m/

m on a dry basis. It may be anhydrous or contain one molecule of

water of crystallisation or be a mixture of both forms.

(c) Authorised food enzymes in accordance with Regulation (EC) No 1332/

2008 of the European Parliament and of the Council of 16 December

2008 on food enzymes.

(d) Authorised food additives in accordance with Regulation (EC) No 1333/

2008 of the European Parliament and of the Council of 16 December

2008 on food additives.

1. Products falling within the scope of these regulations

which do not conform with these regulations but which conform

with the provisions of the Preserved Milk Regulations (L.N. 15 of

2002), may be placed on the market until the 17th July 2004.

2.2 Products falling within the scope of these regulations

which do not conform with these regulations but which conform

with the provisions of the Preserved Milk Regulations (L.N. 15 of

2002), and which were labelled before the 17th July 2004, may

continue to be marketed until stocks are exhausted.

2.3 Products which are placed on the market or labelled before

14th June 2026 in accordance with Directive 2001/114/EC relating to

certain partly or wholly dehydrated preserved milk for human

consumption may continue to be marketed until the exhaustion of

stocks.

Amended by

L.N. 74 of 2026.

Particular designations for certain products listed in the First

Schedule

(a) The English term "evaporated milk" means the product defined in point (1)(b)

of the First Schedule containing, by weight, at least 7.5% fat and 25% total milk solids,

provided, however, that, in the case of products intended for the Maltese market, this

term may also be used as a synonym for ‘unsweetened condensed milk’, qualified by

suitable designations referring to its reduced fat content, where appropriate.

(b) The English terms ‘semi-skimmed milk powder’ or ‘dried semi-skimmed

milk’ mean the product defined in point (2)(c) of the First Schedule with a fat

content of between 14% and 16%.

1. These regulations shall apply to partly or wholly

dehydrated preserved milk defined in the First Schedule.

1. Regulation (EU) No. 1169/2011 of the European Parliament

and of the Council of 25 October 2011 on the provision of food

information to consumers shall apply to the products defined in the

First Schedule, subject to the following conditions

(a)

The product names listed in the First Schedule shall apply

only to the products referred to therein and shall,

without prejudice to paragraph (b), be used in trade to

designate them;

(b) as an alternative to the product names referred to in

paragraph (a), the Second Schedule provides a list of

particular designations. These designations may be

used in the language and under the conditions laid

down in the Second Schedule.

4.2 The labelling must state the percentage of milk fat,

expressed by weight in relation to the finished product, except in

the case of the products defined in points (1)(d), (g) and (2)(d) of

the First Schedule, and the percentage of fat-free dried milk extract

in the case of the products defined in point (1) of the First

Schedule. These particulars shall appear near the trade name.

4.3 In the case of the products defined in point (2) of the First

Schedule, the label must state the recommendations as to the

method of dilution or reconstitution, including details of the fat

content of the product thus diluted or reconstituted.

4.4 Where products weighing less than 20 g per unit are

packed in an outer packaging, the particulars required by this

regulation need appear on the outer packaging only, except for the

designation required by point 1(a).

4.5 The labelling of the products defined in point (2) of the

First Schedule shall state that the product is ‘not intended as a food

for infants under 12 months’.

PRESERVED MILK