Commission Regulation (EU) 2015/649 of 24 April 2015 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council and the Annex to Commission Regulation (EU) No 231/2012 as regards the use of L-leucine as a carrier for table-top sweeteners in tablets (Text with EEA relevance)

• CELEX: Regulation (EU) 2015/649
• Articles: 5

Article 1

Annex II to Regulation (EC) No 1333/2008 is amended in accordance with Annex I to this Regulation.

Article 2

The Annex to Regulation (EU) No 231/2012 is amended in accordance with Annex II to this Regulation.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX I

ANNEX I

Annex II to Regulation (EC) No 1333/2008 is amended as follows:

(1)

In Part B, in Section 3 ‘Additives other than colours and sweeteners’, the following new entry is inserted after the entry for food additive E 640:

‘E 641

L-leucine’

(2)

In part E, in food category 11.4.3 ‘Table-top sweeteners in tablets’, the following new entry is inserted after the entry for food additive E 640:

‘E 641

L-leucine

50 000 ’

ANNEX II

ANNEX II

In the Annex to Regulation (EU) No 231/2012, the following new entry is inserted after the entry for E 640:

‘ E 641 L-LEUCINE

Synonyms

2-Aminoisobutylacetic acid; L-2-Amino-4-methylvaleric acid; alpha-Aminoisocaproic acid; ( S )-2-Amino-4-methylpentanoic acid; L-Leu

Definition

Einecs

200-522-0

CAS number

61-90-5

Chemical name

L-Leucine; L-2-Amino-4-methylpentanoic acid

Chemical formula

C 6 H 13 NO 2

Molecular Weight

131,17

Assay

Content not less than 98,5 % and not more than 101,0 % on the anhydrous basis

Description

White or almost white crystalline powder or shiny flakes

Identification

Solubility

Soluble in water, acetic acid, dilute HCl and alkaline hydroxides and carbonates; slightly soluble in ethanol

Specific rotation

[α] D

20 between + 14,5° and + 16,5°

(4 % solution (anhydrous basis) in 6N HCl)

Purity

Loss on drying

Not more than 0,5 % (100 °C – 105 °C)

Sulphated Ash

Not more than 0,1 %

Chlorides

Not more than 200 mg/kg

Sulphates

Not more than 300 mg/kg

Ammonium

Not more than 200 mg/kg

Iron

Not more than 10 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg’