Use of Colours in Foodstuffs (Amendment) Regulations, 2011

L.N. 374 of 2011

FOOD SAFETY ACT

(CAP. 449)

Use of Colours in Foodstuffs (Amendment) Regulations, 2011

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

Safety Act, the Minister for Health, the Elderly and Community

Care, has made the following regulations:-

(1) The title of these regulations is the Use of Colours

in Foodstuffs (Amendment) Regulations, 2011, and they shall be

read and construed as one with the Use of Colours in Foodstuffs

Regulations, 1995, hereinafter referred to as “the principal

regulations”.

(2) These regulations shall be deemed to have come

into force on the 1st September 2011.

Regulation 3 implements the provisions of Commission

Directive 2011/3/EU of 17 January 2011, amending Directive

2008/128/EC, laying down specific purity criteria on colours for

use in foodstuffs.

Part II of the Sixth Schedule to the principal regulations,

shall be amended as follows

(a) For the entry on E 160, there shall be substituted

the following

“E 160 D LYCOPENE

(i) synthetic lycopene

Lycopene from chemical synthesis

Synonyms

Synthetic lycopene is a mixture of

Definition

geometric isomeres of lycopenes and is

produced by the Wittig condensation of

synthetic intermediates commonly used in

the production of other carotenoids used in

food. Synthetic lycopene consists

predominantly of all-trans-lycopene

together with 5-cis-lycopene and minor

quantities of other isomers. Commercial

lycopene preparations intended for use in

food are formulated as suspensions in

edible oils or water-dispersible or water-

soluble powder.

Colour Index No

75125

EINECS

207-949-1

Chemical name

Ψ,Ψ-carotene, all-trans-lycopene, (all-E)-

lycopene, (all-E)-2,6,10,14,19, 23,27,31-

octamethyl-

2,6,8,10,12,14,16,18,20,22,24,26,30-

dotriacontatridecaene

Chemical formula

C 40 H 56

Molecular weight

536,85

Assay

Not less than 96 % total lycopenes (not less

than 70 % all-translycopene)

E 1 cm 1 % at 465 - 475 nm in hexane (for

100 % pure all-translycopene) is 3 450

Red crystalline powder

Description

Identification

Spectrophotometry

A solution in hexane shows an absorption

maximum at approximately 470 nm

Test for carotenoids

The colour of the solution of the sample in

acetone disappears after successive

additions of a 5 % solution of sodium

nitrite and 1N sulphuric acid

Solubility

Insoluble in water, freely soluble in

chloroform

Properties of 1 % solution in

Is clear and has intensive red-orange colour

chloroform

Purity

Loss on drying

Not more than 0,5 % (40 °C, 4 h at 20 mm

Hg)

Apo-12’-lycopenal

Not more than 0,15 %

Triphenyl phosphine oxide

Not more than 0,01 %

Solvent residues

Methanol not more than 200 mg/kg,

Hexane, Propan-2-ol: Not more than 10

mg/kg each. Dichloromethane: Not more

than 10 mg/kg (in commercial preparations

only)

Lead

Not more than 1 mg/kg

(ii) from red tomatoes

Natural Yellow 27

Synonyms

Lycopene is obtained by solvent extraction

Definition

of red tomatoes (Lycopersicon esculentum

L.) with subsequent removal of the solvent.

Only the following solvent may be used

carbon dioxide, ethyl acetate, acetone,

propan-2-ol, methanol, ethanol, hexane.

The major colouring principle of tomatoes

is lycopene, minor amounts of other

carotenoid pigments may be present.

Besides the colour pigments the product

may contain oil, fats, waxes and flavour

components naturally occurring in

tomatoes.

Colour Index No

75125

EINECS

207-949-1

Chemical name

Ψ,Ψ-carotene, all-trans-lycopene, (all-E)-

lycopene, (all-E)-2,6,10,14,19, 23,27,31-

octamethyl-

2,6,8,10,12,14,16,18,20,22,24,26,30-

dotriacontatridecaene

Chemical formula

C 40 H 56

Molecular weight

536,85

E 1 cm 1 % at 465 - 475 nm in hexane (for

Assay

100 % pure all-translycopene) is 3 450.

Content not less than 5 % total colouring

matters

Dark red viscous liquid

Description

Identification

Spectrophotometry

Maximum in hexane at ca 472 nm

Purity

Solvent residues

Propane-2-ol

Hexane

Acetone

Ethanol

Methanol

Ethylacetate

Not more than 50 mg/kg, singly or in

combination

Sulphated ash

Not more than 1 %

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

(iii) from Blakeslea trispora

Natural Yellow 27

Synonyms

Lycopene from Blakeslea trispora is

Definition

extracted from the fungal biomass and

purified by crystallisation and filtration. It

consists predominantly of all-trans-

lycopene. It also contains minor quantities

of other carotenoids. Isopropanol and

isobutyl acetate are the only solvents used

in the manufacture. Commercial lycopene

preparations intended for use in food are

formulated as suspensions in edible oils or

water- dispersible or water-soluble powder.

Colour Index No

75125

EINECS

207-949-1

Chemical name

Ψ,Ψ-carotene, all-trans-lycopene, (all-E)-

lycopene, (all-E)-2,6,10,14,19, 23,27,31-

octamethyl-

2,6,8,10,12,14,16,18,20,22,24,26,30-

dotriacontatridecaene

Chemical formula

C 40 H 56

Molecular weight

536,85

Assay

Not less than 95 % total lycopenes and not

less than 90 % all-translycopene

of all colouring matters E 1 cm 1 % at 465 -

475 nm in hexane (for 100 % pure all-

translycopene) is 3 450

Red crystalline powder

Description

Identification

Spectrophotometry

A solution in hexane shows an absorption

maximum at approximately 470 nm

Test of carotenoids

The colour of the solution of the sample in

acetone disappears after successive

additions of a 5 % solution of sodium

nitrite and 1N sulphuric acid

Solubility

Insoluble in water, freely soluble in

chloroform

Properties of 1 % solution in

Is clear and has intensive red-orange colour

chloroform

Purity

Loss on drying

Not more than 0,5 % (40 °C, 4 h at 20 mm

Hg)

Other carotenoids

Not more than 5 %

Solvent residues

Propan-2-ol: Not more than 0,1 %

Isobutyl acetate: Not more than 1,0 %

Dichloromethane: Not more than 10 mg/kg

(in commercial preparations only)

Sulphated ash

Not more than 0,3 %

Lead

Not more than 1 mg/kg”.

€0.45