CASEIN AND CASEINATES [ S.L.231.50 1
SUBSIDIARY LEGISLATION 231.50
CASEIN AND CASEINATES REGULATIONS
1st July, 2002
Legal Notice 113 of 2002.
Title.
Regulations.
Scope and 
applicability.
2.1 These regulations shall apply to lactoproteins, as defined in
the Schedules, which are intended for human consumption and
mixtures thereof.
Definitions.
the following definitions shall apply:
Casein:
the principal protein constituent of milk, washed and dried,
insoluble in water and obtained from skimmed milk by
precipitation:
- by the addition of acid, or
- by microbial acidification, or
- by using rennet, or
- by using other milk-coagulating enzymes, without
prejudice to the possibility of prior use of ion
exchange processes and concentration processes.
Skimmed milk:
the milk of one or more cows to which nothing has been added
and of which only the fat content has been reduced.
Caseinates:
products obtained by drying caseins treated with neutralising
agents.
Marketing of 
Lactoproteins.
4.1 The products defined in the Schedules to these regulations
may be marketed only if they conform to the definitions and rules
laid down in these regulations and the Schedules thereto.
4.2 Products which do not satisfy the criteria laid down in the
Schedules must be named and labelled in such a way that the buyer
is not misled as to their nature, quality or use.
Reserved names.
for the products defined and must be used commercially to
designate those products.
Labelling of 
Lactoproteins.
S.L.231.27
5.1 Without prejudice to the provisions of the Labelling,
Presentation and Advertising of Foodstuffs Regulations and
without prejudice to other provisions which may be adopted
concerning the labelling of foodstuffs not intended for the ultimate
consumer, the only mandatory particulars to be marked in indelible
2 [ S.L.231.50 CASEIN AND CASEINATES
characters in a clearly visible and easily legible manner on the
packages, containers or labels of the products defined in the
Schedules shall be as follows:
5.1.1 the name reserved for the products in accordance
with regulation 4.3 with, in the case of caseinates,
an indication of the cation or cations;
5.1.2 in the case of products marketed as mixtures,
- the words ‘mixture of .....’ followed by the
names of the different products which make up
the mixture, in decreasing order of weight,
- an indication of the cation or cations in the case
of caseinate or caseinates,
- the protein content in the case of mixtures
containing caseinates;
5.1.3 the net quantity expressed in kilograms or grams;
5.1.4 the name or business name and the address of the
manufacturer or packager or of a seller established
in Malta or within the European Community;
5.1.5 in the case of products imported from outside the
European Community, the name of the country of
origin;
5.1.6 the date of manufacture or some marking by which
the batch can be identified.
5.2 The marketing of edible caseins and caseinates is
prohibited if the particulars referred to in paragraphs 5.1.1, 5.1.2,
5.1.5 and 5.1.6 do not appear in at least one of the following
languages - Maltese, English or Italian - unless the information is
provided by other means.
5.3 The particulars specified in paragraphs 5.1.2, third indent,
5.1.3, 5.1.4 and 5.1.5 need appear only on an accompanying
document. For transport in bulk, this derogation shall also apply to
the particulars specified in paragraphs 5.1.2, second indent, and
5.1.6.
Heat treatment. 6.1 Without prejudice to other provisions which may be
adopted in the field of health and hygiene in connection with the
basic materials referred to in the First and Second Schedules, such
products must be subjected to heat treatment which will render the
phosphatase negative.
7.1.1 Where, as a result of new information or of a
reassessment of existing information, the
Superintendent of Public Health finds there is
detailed evidence that the use in the products
defined in the First and Second Schedules of these
Regulations of one of the substances referred to
therein or the maximum quantity of such substance
that may be used constitutes a danger to human
health, even though it complies with the provisions
of these regulations, he may, after consulting with
the Directorate responsible for foodstuffs within the
CASEIN AND CASEINATES [ S.L.231.50 3
Malta Standards Authority, suspend or restrict
application of the provisions in question.
Methods of 
analysis.
8.1 The analyses necessary for verification of the criteria set
out in these regulations shall be carried out in accordance with First
Commission Directive 85/503/EEC * .
Sampling 
procedures.
9.1 Caseins and caseinates falling within the scope of these
regulations shall be sampled in accordance with First Commission
Directive 86/424/EEC † .
*OJ L 308/12, 20.11.1985
†OJ L 243/29, 28.8.1986
4 [ S.L.231.50 CASEIN AND CASEINATES
FIRST SCHEDULE
Edible Caseins
I. NAMES AND DEFINITIONS
( a ) ‘edible acid casein’ means edible casein obtained by precipitation using the
technological adjuvants and bacterial cultures listed in Section II( d ) which comply
with the standards laid down in Section II.
( b ) ‘edible rennet casein’ means edible casein obtained by precipitation using
the technological adjuvants listed in Section III( d ) which comply with the standards
laid down in Section III.
II. STANDARDS APPLICABLE TO ‘EDIBLE ACID CASEIN’
( a ) Essential factors of composition
( b ) Contaminants
( c ) Impurities
( d ) Harmless technological adjuvants and bacterial cultures suitable for human
consumption
(e) Organoleptic characteristics
1. Maximum moisture content 10.0% by weight
2. Minimum milk protein content calculated on the dried
extract
of which minimum casein content
90% by weight
95% by weight
3. Maximum milk fat content calculated on the dried
extract
2.25% by weight
4. Maximum titratable acidity, expressed in ml of
decinormal sodium hydroxide solution per g
0.27
5. Maximum ash content (P 2 O 5  included) 2.5% by weight
6. Maximum anhydrous lactose content 1% by weight
7. Maximum sediment content (burnt particles) 22.5 mg in 25 g
Maximum lead content 1 mg/kg
Extraneous matter (such as wood or metal particles,
hairs or insect fragments)
nil in 25 g
(i) -  lactic acid (E 270)
-  hydrochloric acid
-  sulphuric acid
-  citric acid (E 330)
-  acetic acid (E 260)
-  orthophosphoric acid
(ii) -  whey
-  bacterial cultures producing lactic acid
1. Odour No foreign odours
2. Appearance Colour ranging from white to creamy white; the product must
not contain any lumps that would not break up under slight
pressure.
CASEIN AND CASEINATES [ S.L.231.50 5
III. STANDARDS APPLICABLE TO ‘EDIBLE RENNET CASEIN’
( b ) Contaminants
( c ) Impurities
( d ) Harmless technological adjuvants suitable for human consumption
( e ) Organoleptic characteristics
SECOND SCHEDULE
Edible Caseinates
I. DENOMINATIONS AND DEFINITIONS
‘edible caseinates’ means caseinates obtained from edible caseins using
neutralising agents of edible quality listed under Section II( d ) and complying with
the standards set out in Section II.
II. STANDARDS APPLICABLE TO EDIBLE CASEINATES
1. Maximum moisture content 10.0% by weight
2. Minimum milk protein content calculated on the dried
extract
of which minimum casein content
84% by weight
95% by weight
3. Maximum milk fat content calculated on the dried
extract
2% by weight
4. Maximum ash content (P 2 O 5  included) 7.50% by weight
5. Maximum anhydrous lactose content 1% by weight
6. Maximum sediment content (burnt particles) 22.5 mg in 25 g
Maximum lead content 1 mg/kg
Extraneous matter (such as wood or metal particles,
hairs or insect fragments)
nil in 25 g
-  rennet
-  other milk-coagulating enzymes
1. Odour No foreign odours
2. Appearance Colour ranging from white to creamy white; the product must
not contain any lumps that would not break up under slight
pressure.
1. Maximum moisture content 8% by weight
2. Minimum content of milk protein casein, calculated on
the dried extract
88% by weight
3. Maximum milk fat content calculated on the dried
extract
2% by weight
4. Maximum anhydrous lactose content 1% by weight
5. pH value 6.0 to 8.0
6. Maximum sediment content (burnt particles) 5 mg in 25 g
6 [ S.L.231.50 CASEIN AND CASEINATES
( b ) Contaminants
( c ) Impurities
( d ) Technological adjuvants of edible quality 
(optional neutralising and buffering agents)
( e ) Characteristics
Maximum lead content 1 mg/kg
Extraneous matter (such as wood or metal particles,
hairs or insect fragments)
nil in 25 g
hydroxides
of
sodium
carbonates potassium
phosphates calcium
citrates ammonium
magnesium
1. Odour Very slight foreign flavours and odours
2. Appearance Colour ranging from white to creamy white; the product must
not contain any lumps that would not break up under slight
pressure.
3. Solubility Almost entirely soluble in distilled water, except for the
calcium caseinate
