Annex II
United Kingdom
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 C6H13NO2 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 ’