ANNEX ISupplementary provisions
ANNEX I SPECIFICATION OF ROOSTER COMB EXTRACT Definition Rooster comb extract is obtained from Gallus gallus by enzymatic hydrolysis of rooster comb and by subsequent filtration, concentration and precipitation steps. The principal constituents of rooster comb extract are the glycosaminoglycans hyaluronic acid, chondroitin sulphate A and dermatan sulphate (chondroitin sulphate B). Hyaluronic acid 60-80 % Chondroitin sulphate A Not more than 5 % Dermatan sulphate (chondroitin sulphate B) Not more than 25 % Description White or almost white hygroscopic powder. Identification pH 5,0-8,5 Purity Chlorides Not more than 1 % Nitrogen Not more than 8 % Loss on drying (105 °C for 6 hours) Not more than 10 % Mercury Not more than 0,1 mg/kg Arsenic Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Chromium Not more than 10 mg/kg Lead Not more than 0,5 mg/kg Microbiological criteria Total viable aerobic count Not more than 10 2 cfu/g Escherichia coli Absent in 1 g Salmonella spp. Absent in 1 g Staphylococcus aureus Absent in 1 g Pseudomonas aeruginosa Absent in 1 g