Scientific Opinion on Rooster Combs Extract

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2013;11(6):3260 [22 pp.].
Possible conflict of interest
One member of the Panel did not participate in the discussion on the subject referred to above because of potential conflicts of interest identified in accordance with the EFSA policy on declarations of interests.
doi
10.2903/j.efsa.2013.3260
Panel members at the time of adoption
Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen.
Acknowledgements

The Panel wishes to thank the members of the Working Group on Novel Foods: Paul Brantom, Karl-Heinz Engel, Marina Heinonen, Hannu Korhonen, Rosangela Marchelli, Bevan Moseley, Monika Neuhäuser-Berthold, Annette Pöting, Morten Poulsen, Seppo Salminen, Josef Schlatter, Hendrik Van Loveren and Hans Verhagen for the preparatory work on this scientific opinion, and EFSA staff member Wolfgang Gelbmann for the support provided to this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2012-00613
Adopted
31 May 2013
Published in the EFSA Journal
21 June 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to carry out the additional assessment for ‘Rooster Combs Extract’ (RCE) as a food ingredient in the context of Regulation (EC) No 258/97, taking into account the comments and objections of a scientific nature raised by Member States. Rooster combs extract results from a production process involving enzymatic hydrolysis of rooster combs and subsequent filtration, concentration and precipitation steps. The principle constituents of RCE are the glycosaminoglycans hyaluronic acid, chondroitin sulphate A and dermatan sulphate. The applicant intends to add RCE to a number of dairy products with a recommended maximum intake of 80 mg RCE per portion and per day. The target population is the general population, with the exception of pregnant women, children and people with adverse reactions to sodium hyaluronate and/or avian protein. In the high intake scenario for “consumers only”, the highest daily intake would occur in adults in Belgium (0.788 g). The highest intake scenario for “all subjects” was estimated for adolescents in Denmark (0.427 g/day). The Panel notes that no adverse effects were observed at the highest tested dose of 600 mg/kg bw per day in a 90-day oral toxicity study in rats. Considering the nature, the natural occurrence and previous consumption of RCE constituents, the Panel is of the opinion that the margin between the intended as well as the estimated maximum possible intake of RCE in relation to the highest dose administered to rats without adverse effects in a subchronic oral toxicity study is sufficient. The Panel concludes that the novel food ingredient, Rooster Comb Extract, is safe under the proposed uses and use levels.

Keywords
rooster Combs, glycosaminoglycans, hyaluronic acid, chondroitin sulphate, novel food, ingredient
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Number of Pages
22