Caseins and Caseinates Regulations, 2016

L.N. 426 of 2016

FOOD SAFETY ACT

(CAP. 449)

Caseins and Caseinates Regulations, 2016

IN exercise of the powers conferred by article 10 of the Food

Safety Act, the Minister for Health has made the following

regulations:-

(1) The title of these regulations is the Caseins and

Caseinates Regulations, 2016.

(2) These regulations implement the provisions of Directive

2015/2203/EU of the European Parliament and of the Council relating

to caseins and caseinates for human consumption.

(3) These regulations shall apply to lactoproteins (caseins and

caseinates) as defined in the Schedules of these regulations, which are

intended for human consumption and mixtures thereof.

(4) These regulations shall be deemed to have come into force

on 22nd December, 2016

Provided that products falling within the scope of these

regulations which do not conform with these regulations but which

conform with the Casein and Caseinates Regulations, 2002, may

2002. continue to be utilised up to six months after entry into force of these

regulations.

(Regulation 1(3))

Edible Caseins

I.

Standards applicable to Edible Acid Caseins

(a)

Essential factors of composition

1. Maximum moisture content

12% by weight

2. Minimum milk protein content

calculated on the dried extract

90% by weight

of which minimum casein content

95% by weight

3. Maximum milk fat content

2% 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

For the purposes of these regulations, unless the context

otherwise requires

"edible acid casein" means a milk product obtained by

separating, washing and drying the acid-precipitated coagulum of

skimmed milk and, or of other products obtained from milk;

"edible caseinate" means a milk product obtained by action of

edible casein or edible casein curd coagulum with neutralizing agents,

followed by drying;

"edible rennet casein" means a milk product obtained by

separating, washing and drying the coagulum of skimmed milk and,

or of other products obtained from milk; the coagulum is obtained

through the reaction of rennet or other coagulating enzymes.

(Regulation 1(3)

Edible Caseinates

Standards applicable to Edible Caseinates

(a)

Essential factors of composition

1. Maximum moisture content

8% by weight

2. Minimum milk protein content

calculated on the dried extract

88% by weight

of which minimum casein content

95% by weight

3. Maximum milk fat content

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)

22.5 mg in 25 g

(b)

Contaminants

Maximum lead content

0.75 mg/kg

(c)

Impurities

Extraneous matter: such as wood or

metal particles, hairs or insect

fragments

nil in 25 g

(d)

Food additives (optional neutralizing and buffering

agents)

Hydroxides

of

sodium,

potassium,

Carbonates

calcium, ammonium,

Phosphates

magnesium

Citrates

of

sodium,

potassium,

calcium, ammonium

(e)

Characteristics

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 calcium caseinate.

€0.63

The milk products defined in regulation 2 shall be Marketing of

marketed, under the names specified therein, only if they comply with milk products.

the provisions of these regulations and the standards set out in

Schedules I and II; and caseins and caseinates which do not comply

with the standards set out in paragraphs (b) and (c) of Section I of

Schedule I, paragraphs (b) and (c) of Section II of Schedule I or

paragraphs (b) and (c) of Schedule II, shall not be used for the

preparation of food, and, where lawfully marketed for other purposes,

shall be named and labelled in such a way that the purchaser is not

misled as to their nature, quality or intended use.

The following particulars shall be marked on the packages, Particulars to be

containers or labels of the milk products defined in regulation 2 in marked

packages, etc.

easily visible, clearly legible and indelible characters

(a)

the name of the milk product as laid down in

regulation 2 with, in the case of edible caseinates, an indication

of the cation or cations as listed in paragraph (d) of Schedule II;

(b)

in the case of products marketed as mixtures

(i) the words "mixture of .............." followed by

the names of the different products of which the mixture is

composed, in decreasing order of weight;

(ii) an indication of the cation or cations, as listed

in paragraph (d) of Schedule II, in the case of edible

caseinates;

(iii) the protein content in the case of mixtures

containing edible caseinates;

(c)

the net quantity of the products, expressed in

kilograms or grams;

(d) the name or business name and the address of the

food business operator under whose name or business name the

product is marketed or, if that food business operator is not

established in the European Union, the importer into the

European Union market;

(e)

in the case of products imported from third

countries, the name of the country of origin;

(f)

the lot identification of the products or the date of

production

Provided that the particulars referred to in paragraphs (b)(iii),

(c), (d) and (e) may be marked only in an accompanying document.

(1) The marketing of milk products defined in

regulation 2 shall be prohibited if the particulars referred to in

regulation 4 are not given in English, Maltese or Italian; however

those particulars may be given in several languages.

(2) Where the minimum milk protein content set out in

paragraph (a) 2 of Section I of Schedule I, paragraph (a) 2 of Section

II of Schedule I, and paragraph (a) 2 of Schedule II is exceeded in the

milk products defined in regulation 2, this fact may, without prejudice

to other provisions, be adequately marked on the packages, containers

or labels of the products.

(1) The Casein and Caseinates Regulations, 2002,

hereinafter referred to as the revoked regulations, are hereby revoked

without prejudice to anything done or omitted to be done thereunder.

2002. (2) Any reference, in any legislation or in any instrument

having the force of law, to the revoked regulations shall be construed

as a reference to these regulations.

Maximum

sediment

content

(burnt particles)

5 mg in 25 g

(b)

Contaminants

Maximum lead content

0.75 mg/kg

(c)

Impurities

Extraneous matter: such as wood or

metal particles, hairs or insect

fragments

nil in 25 g

(d) Processing aids, bacterial cultures and authorised

ingredients

1. acids

-

lactic acid (E 270)

-

hydrochloric acid (E 507)

-

sulphuric acid (E 513)

-

citric acid (E 330)

-

acetic acid (E 260)

-

orthophosphoric acid (E 338)

2. bacterial cultures producing lactic acid

3. Whey

(e)

Organoleptic characteristics

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.

Standards applicable to Edible Rennet Caseins

(a)

Essential factors of composition

1. Maximum moisture content

12% by weight

2. Minimum milk protein content

calculated on the dried extract

84% by weight

of which minimum casein content

95% by weight

3. Maximum milk fat content

2% by weight

4. Minimum ash content (P 2 O 5

included)

7.5% by weight

5. Maximum anhydrous lactose

content

1% by weight

6. Maximum

sediment

content

(burnt particles)

15 mg in 25 g

(b)

Contaminants

Maximum lead content

0.75 mg/kg

(c)

Impurities

Extraneous matter: such as wood or

metal particles, hairs or insect

fragments

nil in 25 g

(d)

Processing aids

-

rennet meeting the

requirements

of

Regulation (EC) No 1332/2008;

-

other milk-coagulating enzymes meeting the

requirements of Regulation (EC) No 1332/2008

(e)

Organoleptic characteristics

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.