2013/705/EU: Commission Implementing Decision of 29 November 2013 authorising the placing on the market of rooster comb extract as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2013) 8319)

• CELEX: Regulation (EC) No 258/97
• Articles: 5

Article 1

Rooster comb extract as defined and specified in Annex I may be placed on the market as a novel food ingredient for the uses defined and at the maximum levels established in Annex II.

Article 2

The designation of rooster comb extract, authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘rooster comb extract’ or ‘cockerel comb extract’.

Article 3

This Decision is addressed to Bioiberica S.A., Plaça Francesc Macià, 7. 8B, 08029 Barcelona Spain.

Schedules & Appendices

ANNEX I

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

ANNEX II

ANNEX II

Authorised uses of rooster comb extract

Food category

Maximum use level (mg/100 g or mg/100 ml)

Milk-based drinks

40

Milk based fermented drinks

80

Yoghurt-type products

65

Fromage frais

110