Colours (Use in Foodstuffs) (Amendment) Regulations, 2004

L.N. 487 of 2004

FOOD SAFETY ACT

(CAP. 449)

Colours (Use in Foodstuffs) (Amendment) Regulations, 2004

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

Act, the Minister of Health, the Elderly and Community Care has made

the following regulations>

The title of these regulations is the Colours (Use in Foodstuffs) Citation and

(Amendment) Regulations, 2004, and they shall be read and construed commencement

L.N. 107 of 1995

as one with the Colours (Use in Foodstuffs) Regulations, 1995,

hereinafter referred to as “the principal regulations”.

‘ E 160a (i) karoteni mħallta

1. KAROTENI MILL-PJANTI

CI Food Orange 5

Karoteni mħallta meħudin permezz ta’ estrazzjoni b’solventi

ta’ varjetajiet naturali ta’ pjanti li jittieklu, karrotti, żjut

veġetali, ħaxix, alfalfa (lucerne) u ħurrieq.

Il-prinċipju ewlieni li jagħti l-kulur jikkonsisti f’karotenojdi li

minnhom il-β-karotene tikkonstitwixi l-akbar parti. α, γ-

karotene u kuluri oħra jistgħu jkunu preżenti. Minbarra l-

kuluri, din is-sustanza jista’ jkollha fiha żjut, xaħmijiet u

xemgħat li jinstabu b’mod naturali fil-materjal oriġinali.

Dawn is-solventi li ġejjin biss jistgħu jintużaw fl-estrazzjoni

aċeton, methyl ethyl ketone, metanol, etanol, propan-2-ol,

ħexan ( 1 ), dikolorometan u diossidu tal-karbonju.

Karotenojd

tal-Indiċi 75130

230-636-6

β-karotene: C 40 H 56

β-karotene: 536.88

Kontenut ta’ karoteni (ikkalkulat bħala β-karotene) mhux anqas

minn 5 %. Għal prodotti meħuda permezz ta’ estrazzjoni minn

żjut veġetali: mhux anqas minn 0.2 % fi żjut li jittieklu

1 %

E 1cm

2500 fi ca 440 nm – 457 nm fi ċikloħexan

Massimu fiċ-ċikloħexan fi 440 nm – 457 nm u 470 nm – 486

nm

Aċeton

Benzene mhux aktar minn 0.05 % v/v.

Methyl ethyl ketone

Metanol

Mhux aktar minn 50 mg/kg,

Propan-2-ol

waħedhom jew flimkien

Ħexan

Etanol

Diklorometan

Mhux aktar minn 10 mg/kg

Mhux aktar minn 5 mg/kg

2. KAROTENI MILL-ALGA

Karoteni mħallta jistgħu wkoll jittieħdu mill-alga Dunaliella

salina , mkabbra ġewwa għadajjar kbar tal-ilma mielaħ li

jinsabu ġewwa Whyalla, fl-Awstralja tan-Nofsinhar. Il-Beta-

karotene tiġi estratta permezz ta’ żejt essenzjali. Il-preparat

huwa sospensjoni ta’ 20 – 30 % f’żejt li jittiekel. Il-proporzjon

ta’ iżomeri trans-cis huwa bejn 50/50 sa 71/29.

Il-prinċipju attiv li jagħti l-kulur jikkonsisti f’karotenojdi li

minnhom il-beta-karotene tikkostitwixxi l-akbar parti. Jistgħu

wkoll ikunu preżenti l-alfa-karotene, il-luteina, żeaksantina u

beta-kriptoksantina. Minbarra sustanzi li jagħtu l-kulur, din is-

sustanza jista’ jkollha żjut, xaħmijiet u xemgħat li jinstabu

naturalment fil-materjal oriġinali.

Karotenojd

Numru ta’ Indiċi 75130

Beta-karotene: C 40 H 56

Beta-karotene: 536.88

Kontenut ta’ karoteni (ikkalkulat bħala β-karotene) mhux inqas

minn 20 %.

1 %

E 1cm

2500 f’bejn wieħed u ieħor 440 nm – 457 nm fiċ-

ċikloħexan

Massimu fiċ-ċikloħexan fi 448 nm – 457 nm u 474 nm – 486

nm

Tokoferoli naturali Mhux aktar minn 0.3 %

Mhux anqas minn 5 mg/kg

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Dawn l-ispeċifikazzjonijiet japplikaw l-aktar għall-iżomeri

trans kollha ta’ beta-karotene flimkien ma’ ammonti żgħar ta’

karotenojdi oħra. Preparazzjonijiet dilwiti u stabilizzati jista’

jkollhom proporzjonijiet differenti ta’ trans-cis.

Karotenojd

Nru ta’ l-indiċi tal- 40800

230-636-6

Beta-karotene, beta,beta-karotene

C 40 H 56

536.88

Total mhux anqas minn 96 % ta’ materjal kulurit (espress bħala

beta-karotene)

1 %

E 1cm

2500 f’bejn wieħed u ieħor 440 nm – 457 nm fiċ-

ċikloħexan

Kristalli jew trab kristallin aħmar sa aħmar fil-kannella

Massimu fiċ-ċikloħexan fi 453 sa 456 nm

Mhux aktar minn 0.2 %

kulurit Karotenojdi minbarra l-beta-karotene: mhux aktar minn 3.0 %

tal-materjal kulurit totali

Mhux aktar minn 2 mg/kg

2. Beta-karotene minn Blakeslea trispora

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Meħud bi proċess ta’ fermentazzjoni billi tintuża kultura

mħallta taż-żewġ tipi sesswali (+) u (-) tal-varjetajiet naturali

tal-moffa Blakeslea trispora . Il-beta-karotene hija estratta mill-

massa bioloġika bl-aċetat tal-etil, jew bl-aċetat tal-iżobutil

segwit bl-alkoħol iżopropil, u kristallizzat. Minħabba l-proċess

naturali, madwar 3 % tal-prodott jikkonsisti f’karotenojdi

mħallta, li huwa speċifiku għall-prodott.

Karotenojd

tal-indiċi 40800

230-636-6

Beta-karotene, beta,beta-karotene

C 40 H 56

536.88

Total mhux anqas minn 96 % ta’ materjal kulurit (espress bħala

beta-karotene)

1 %

E 1cm

2500 f’bejn wieħed u ieħor 440 nm – 457 nm fiċ-

ċikloħexan

Kristalli jew trab kristallin aħmar, aħmar fil-kannella jew vjola

fil-vjola skur (il-kulur ivarja skond is-solvent ta’ l-estrazzjoni

wżat u l-kondizzjonijiet tal-kristallizazzjoni)

Massimu fiċ-ċikloħexan fi 453 nm sa 456 nm

Aċetat ta’ l-etil

Mhux aktar minn 0.8 %

Etanol

waħedhom jew flimkien

Aċetat ta’ l-iżobutil: Mhux aktar minn 1.0 %

Alkoħol iżopropil: Mhux aktar minn 0.1 %

Mhux aktar minn 0.2 %

kulurit Karotenojdi minbarra beta-karotene: mhux aktar minn 3.0 %

tal-materjal kulurit totali

Ċomb

Mhux aktar minn 2 mg/kg

Mikotossini

Aflatossina B1

Assenti

Trikoteċene (T2)

Assenti

Okratossina

Assenti

Żearalenone

Assenti

Mikrobioloġija

Mofof

Mhux aktar minn 100/g

Ħmira

Mhux aktar minn 100/g

Salmonella

Assenti f’ 25 g

Escherichia coli

Assenti f’ 5 g’

These regulations implement the provisions of Commission Scope.

Directive 2004#47#EC of the 16 th April, 2004.

These regulations shall enter into force on the 1 st April, 2005, Commencement

date.

provided that products on the market at the date or labelled before that

date which do not comply with these regulations, but which comply

with the Colours (Use in Foodstuffs) Regulations, 1995, may be

marketed until stocks are exhausted.

In part B of the Sixth Schedule to the principal regulations, Amends the Sixth

Schedule to the

for the chapter concerning E 160a (i) Mixed Carotenes and E 160 a (ii) principal

regulations.

beta-carotene there shall be substituted the following>-

“ E 160a (i) mixed carotenes

1. PLANT CAROTENES

CI Food Orange 5

Mixed carotenes are obtained by solvent extraction of natural strains of

edible plants, carrots, vegetable oils, grass, alfalfa (lucerne) and nettle.

The main colouring principle consists of carotenoids of which beta-

carotene accounts for the major part. α, γ-carotene and other pigments

may be present. Besides the colour pigments, this substance may

contain oils, fats and waxes naturally occurring in the source material.

Only the following solvents may be used in the extraction: acetone,

methyl ethyl ketone, methanol, ethanol, propan-2-ol, hexane ( 1 ),

dichloromethane and carbon dioxide.

Carotenoid

75130

230-636-6

β-Carotene: C 40 H 56

β-Carotene: 536.88

Content of carotenes (calculated as β-carotene) is not less than 5

%. For products obtained by extraction of vegetable oils: not less

than 0.2 % in edible fats

1 %

E 1cm

2500 at ca 440 nm – 457 nm in cyclohexane

Maximum in cyclohexane at 440 nm – 457 nm and 470 nm – 486

nm

Acetone

Methyl ethyl ketone

Methanol

Not more than 50 mg/kg,

Propan-2-ol

singly or in combination

Hexane

Ethanol

Benzene not more than 0.05 % v/v.

Dichloromethane

Not more than 10 mg/kg

Not more than 5 mg/kg

2. ALGAL CAROTENES

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Mixed carotenes may also be produced from the algae Dunaliella

salina, grown in large saline lakes located in Whyalla, South Australia.

Beta-carotene is extracted using an essential oil. The preparation is a

20-30 % suspension in edible oil. The ratio of trans-cis isomers is in

the range of 50/50 – 71/29.

The main colouring principle consists of carotenoids of which beta-

carotene accounts for the major part. Alpha-carotene, lutein, zeaxanthin

and beta-cryptoxanthin may be present. Besides the colour pigments,

this substance may contain oils, fats and waxes naturally occurring in

the source material.

Carotenoid

75130

Beta-carotene: C 40 H 56

Beta-carotene: 536.88

Content of carotenes (calculated as β-carotene) is not less than 20

%.

1 %

E 1cm

2500 at approximately 440 nm – 457 nm in cyclohexane

Maximum in cyclohexane at 448 nm – 457 nm and 474 nm – 486

nm

Not more than 0.3 %

Not more than 5 mg/kg

E 160 a (iii) Beta-Carotene

CI Food Orange 5

These specifications apply predominantly to all trans isomers of

beta carotene together with minor amounts of other carotenoids.

Diluted and stabilised preparations may have different trans-cis

isomer ratios.

Carotenoid

40800

230-636-6

Beta-carotene, beta,beta-carotene

C 40 H 56

536.88

Not less than 96 % total colouring matters (expressed as beta-

carotene)

1 %

E 1cm

2500 at approximately 440 nm – 457 nm in cyclohexane

Red to brownish-red crystals or crystalline powder

Maximum in cyclohexane at 453 to 456 nm

Not more than 0.2 %

Carotenoids other than beta-carotene: not more than 3.0 % of

total colouring matters

Not more than 2 mg/kg

2. Beta-carotene from Blakeslea trispora

CI Food Orange 5

Obtained by a fermentation process using a mixed culture of the

two sexual mating types (+) and (-) of natural strains of the

fungus Blakeslea trispora. The beta-carotene is extracted from

the biomass with ethyl acetate, or isobutyl acetate followed by

isopropyl alcohol, and crystallised. The crystallised product

consists mainly of trans beta-carotene. Because of the natural

process, approximately 3 % of the product consists of mixed

carotenoids, which is specific for the product.

Carotenoid

40800

230-636-6

Beta-carotene, beta,beta-carotene

C 40 H 56

536.88

Not less than 96 % total colouring matters (expressed as beta-

carotene)

1 %

E 1cm

2500 at approximately 440 nm – 457 nm in cyclohexane

Red, brownish-red or purple-violet or crystalline powder (colour

varies according to extraction solvent used and conditions of

crystallisation)

Maximum in cyclohexane at 453 nm to 456 nm

Ethyl acetate

Not more than 0.8 % singly or

in combination

Ethanol

Isobutyl acetate

Not more than 1.0 %

Isopropyl alcohol

Not more than 0.1 %

Not more than 0.2 %

Carotenoids other than beta-carotene: not more than 3.0 % of

total colouring matters

Lead

Not more than 2 mg/kg

Mycotoxins

Aflatoxin B1

Absent

Trichothecene

Absent

(T2)

Ochratoxin

Absent

Zearalenone

Absent

Microbiology

Moulds

Not more than 100/g

Yeasts

Not more than 100/g

Salmonella

Absent in 25 g

Escherichia coli

Absent in 5 g”.

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