February 2011: Application from the Spanish company Bioiberica S.A. for the authorisation of Rooster Combs Extract (RCE) under the Novel Food Regulation (EC) 258/97. Status: Authorised.
This pages details on he authorisation of Rooster Combs Extract from Bioiberica S.A. RCE is an extract of rooster combs rich (60-80%) in sodium hyaluronate (SH). In addition to SH, RCE also contains glycosaminoglycans (approx. 20%) and partially hydrolysed proteins (approx. 20 %). Glycosaminoglycans are long unbranched chains of polysaccharides made up of repeating disaccharide units. The hydrolysed proteins are polypeptides, peptides and amino acids obtained by the hydrolysis of the proteins in the extract e.g. hydrolysed collagen.
These sources of SH are not consumed in all European countries and the applicant therefore proposes to incorporate RCE into certain dairy products which are consumed daily in Europe as a way of providing additional sources of SH in order to support joint health in the general population.
Before a novel food can be marketed legally in EU it requires a pre-market safety assessment under the Novel Food Regulation (EU) 2015/2283, previously 258/97 (EC). This is the Regulation establishes the legal basis for novel foods and the process for submitting a novel food authorisation(s).
One of the major changes under the revised Regulation, was the centralisation of the authorisation process at the EU level. Prior to this, applications for new novel foods were underwent initial assessment in a Member State to achieve an EU wide authorisation. This application was received by the UK under Regulation 258/97 EC and was assessed by our independent experts the Advisory Committee on novel foods and processes.
Application Status: Authorised
The application for Rooster Combs Extract was assessed by the UK under Regulation 258/97 (EC). The application was accepted in February 2011 and was reviewed by the Committee to assess it whether the proposed use met the requirements under the regulation. Namely that it is safe, not misleading and would not put consumers as a nutritional disadvantage.
The Committee completed its assessment and published its positive opinion. This opinion was shared with the other Member States resulting in the product being authorised by the EU subject to the conditions specified in the authorisation. It was authorised under Commission Implementing Decision (2013/705/EU)