32001L0052

Id-Direttiva tal-Kummissjoni 2001/52/KE

tat-3 ta' Lulju 2001

li temenda d-Direttiva 95/31/KE li tistabbilixxi l-kriterji speċifiċi tal-purità ta' sustanzi li jagħtu ħlewwa għall-użu f'oġġetti ta' l-ikel

(Test b'rilevanza għaż-ŻEE)

IL-KUMMISSJONI TAL-KOMUNITAJIET EWROPEJ,

Wara li kkunsidrat it-Trattat li jistabbilixxi il-Komunità Ewropea,

Wara li kkunsidrat id-Direttiva tal-Kunsill 89/107/KEE tal-21 ta' Diċembru 1988 dwar l-approssimazzjoni tal-liġijiet ta' l-Istati Membri dwar l-addittivi ta' l-ikel awtorizzati għall-użu f'oġġetti ta' l-ikel li hu maħsuba għall-konsum mill-bniedem [1], kif emendata bid-Direttiva 94/34/KE [2] tal-Parlament Ewropew u tal-Kunsill, u b'mod partikolari l-Artikolu 3(3)(a) tagħha,

Wara li kkonsultat lill-Kumitat Xjentifiku dwar l-Ikel,

Billi:

(1) Id-Direttiva 94/35/KE tal-Parlament Ewropew u tal-Kunsill tat-30 ta' Ġunju 1994 dwar is-sustanzi li jagħtu ħlewwa għall-użu f'oġġetti ta' l-ikel [3], kif emendata bid-Direttiva 96/83/KE [4], telenka dawk is-sustanzi li jistgħu jintużaw bħala sustanzi li jagħtu ħlewwa fl-oġġetti ta' l-ikel.

(2) Id-Direttiva tal-Kummissjoni 95/31/KE tal-5 ta' Lulju 1995 li tistabbilixxi l-kriterji speċifiċi tal-purità ta' sustanzi li jagħtu ħlewwa għall-użu f'oġġetti ta' l-ikel [5], kif emendata l-aħħar bid-Direttiva 2000/51/KE [6], tistabbilixxi l-kriterji ta' purità għas-sustanzi li jagħtu ħlewwa imsemmija fid-Direttiva 94/35/KE.

(3) Huwa meħtieġ, fid-dawl tal-progress tekniku, li jiġu emendati l-kriterji ta' purità stabbiliti fid-Direttiva 95/31/KE għall-'mannitol (E 421) u l-"acesulfme K" (E 950).

(4) Huwa meħtieġ li wieħed iqis l-ispeċifikazzjonijiet u l-metodi ta' teknika analitiċi għas-sustanzi li jagħtu ħlewwa kif stabbiliti fil-Codex alimentarius mill-Kumitat ta' Esperti Konġunt tal-FAO/WHO dwar l-Addittivi ta' l-Ikel (JECFA)

(5) Għaldaqstant huwa meħtieġ li wieħed jadatta d-Direttiva 95/31/KE.

(6) Il-miżuri previsti f'din id-Direttiva huma skond l-opinjoni tal-Kumitat Permanenti dwar l-Oġġetti ta' l-Ikel.

ADOTTAT DIN ID-DIRETTIVA:

L-Artikolu 1

Fl-Anness tad-Direttiva 95/31/KE, it-test li jirrigwarda l-E 421 mannitol u l-E 950 acesulfame K għandu jiġi sostitwit bit-test ta' l-Anness ta' din id-Direttiva.

L-Artikolu 2

L-Istati Membri għandhom idaħħlu fis-seħħ il-liġijiet, ir-regolamenti u d-dispożizzjonijiet amministrattivi meħtieġa sabiex jikkonformaw ma' din id-Direttiva sa l-aktar tard it-30 ta' Ġunju 2002. Huma għandhom jinfurmaw b'dan lill-Kummissjoni minnufih.

Meta l-Istati Membri jadottaw dawn id-dispożizzjonijiet, huma għandhom ikollhom referenza għal din id-Direttiva jew għandhom ikunu akkumpanjati b'tali referenza fl-okkażjoni tal-pubblikazzjoni uffiċjali tagħhom. L-Istati Membri għandhom jistabbilixxu kif għandha ssir din ir-referenza.

L-Artikolu 3

Din id-Direttiva għandha tidħol fis-seħħ fl-għoxrin jum wara l-pubblikazzjoni tagħha fil-Ġurnal Uffiċjali tal-Komunitajiet Ewropej.

L-Artikolu 4

Din id-Direttiva hija ndirizzata lill-Istati Membri.

Magħmula fi Brussel, fit-3 ta' Lulju 2001.

Għall-Kummissjoni

David Byrne

Membru tal-Kummissjoni

[1] ĠU L 40, tal-11.2.1989, p. 27.

[2] ĠU L 237, ta' l-10.9.1994, p. 1.

[3] ĠU L 237, ta' l-10.9.1994, p. 3.

[4] ĠU L 48, tad-19.2.1997, p. 16.

[5] ĠU L 178, tat-28.7.1995, p. 1.

[6] ĠU L 198, ta' l-4.8.2000, p. 41.

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L-ANNESS

"E 950 ACESULFAME K

Synonyms | Acesulfame potassium, potassium salt of 3,4-dihydro-6-methyl-1,2,3-oxathiazin-4-one, 2,2-dioxide |

Definition

Chemical name | 6-methyl-1,2,3-oxathiazin-4(3H)-one-2,2-dioxide potassium salt |

Einecs | 259–715–3 |

Chemical formula | C4H4KNO4S |

Molecular weight | 201,24 |

Assay | Content not less than 99 % of C4H4KNO4S on the anhydrous basis |

Description | Odourless, white, crystalline powder. Approximately 200 times as sweet as sucrose |

Identification

A. Solubility | Very soluble in water, very slightly soluble in ethanol |

B. Ultra violet absorption | Maximum 227 ± 2 nm for a solution of 10 mg in 1000 ml of water |

C. Positive test for potassium | Passes test (test the residue obtained by igniting 2 g of the sample) |

D. Precipitation test | Add a few drops of a 10 % solution of sodium cobaltnitrite to a solution of 0,2 g of the sample in 2 ml of acetic acid and 2 ml of water. A yellow precipitate is produced |

Purity

Loss on drying | Not more than 1 % (105 °C, two hours) |

Organic impurities | Passes test for 20 mg/kg of UV active components |

Fluoride | Not more than 3 mg/kg |

Lead | Not more than 1 mg/kg |

E 421 MANNITOL

1.Mannitol

Synonyms | D-mannitol |

Definition | Manufactured by catalytic hydrogenation of carbohydrate solutions containing glucose and/or fructose |

Chemical name | D-mannitol |

Einecs | 200–711–8 |

Chemical formula | C6H14O6 |

Molecular weight | 182,2 |

Assay | Content not less than 96,0 % D-mannitol and not more than 102 % on the dried basis |

Description | White, odourless, crystalline powder |

Identification

A. Solubility | Soluble in water, very slightly soluble in ethanol, practically insoluble in ether |

B. Melting range | Between 164 and 169 °C |

C. Thin layer chromatography | Passes test |

D. Specific rotation | [α] 20D: + 23o to + 25o (borate solution) |

E. pH | Between 5 and 8 Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH |

Purity

Loss on drying | Not more than 0,3 % (105 °C, four hours) |

Reducing sugars | Not more than 0,3 % (as glucose) |

Total sugars | Not more than 1 % (as glucose) |

Sulphated ash | Not more than 0,1 % |

Chlorides | Not more than 70 mg/kg |

Sulphate | Not more than 100 mg/kg |

Nickel | Not more than 2 mg/kg |

Lead | Not more than 1 mg/kg |

2.Mannitol manufactured by fermentation

Synonyms | D-mannitol |

Definition | Manufactured by discontinous fermentation under aerobic conditions using a conventional strain of the yeast Zygosaccharomyces rouxii |

Chemical name | D-mannitol |

Einecs | 200–711–8 |

Chemical formula | C6H14O6 |

Molecular weight | 182,2 |

Assay | Not less than 99 % on the dried basis |

Description | White, odourless crystalline powder |

Identification

A. Solubility | Soluble in water, very slightly soluble in ethanol, practically insoluble in ether |

B. Melting range | Between 164 and 169 °C |

C. Thin layer chromatography | passes test |

D. Specific rotation | [α] 20D: + 23o to + 25o (borate solution) |

E. pH | Between 5 and 8 Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH |

Purity

Arabitol | Not more than 0,3 % |

Loss on drying | Not more than 0,3 % (105 °C, four hours) |

Reducing sugars | Not more than 0,3 % (as glucose) |

Total sugars | Not more than 1 % (as glucose) |

Sulphated ash | Not more than 0,1 % |

Chlorides | Not more than 70 mg/kg |

Sulphate | Not more than 100 mg/kg |

Lead | Not more than 1 mg/kg |

Aerobic mesophilic bacteria | Not more than 103/g |

Coliforms | Absent in 10 g |

Salmonella | Absent in 10 g |

E. coli | Absent in 10 g |

Staphylococcus aureus | Absent in 10 g |

Pseudomonas aeruginosa | Absent in 10 g |

Moulds | Not more than 100/g |

Yeasts | Not more than 100/g" |

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