May 2014: Application from the Spanish company Bioiberica S.A. to extend the use of Rooster combs extract (RCE) for use in food supplements under the Novel Food Regulation (EC) 258/97. Status - Withdrawn
Bioiberica’s RCE was authorised in 2013 as a novel ingredient to be added to various dairy products. The applicant is now seeking approval to extend the use of RCE to include food supplements. The applicant states that rooster combs have been widely consumed in Europe as part of traditional dishes. RCE is an extract of rooster combs rich (60-80%) in sodium hyaluronate (SH).
The applicant states that SH helps in lubricating and cushioning joints. The applicant mentions that foods containing SH are very limited and only rooster combs and viscera have high amounts of this substance. These sources of SH are not consumed in all European countries, therefore Bioiberica regards that incorporating RCE into dairy products and now food supplements provides increased opportunity to acquire SH in the diet, 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Application Status: Withdrawn
The application for Rooster Combs Extract was assessed by the UK under Regulation 258/97 (EC). The application was accepted in December 2013 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 did not completed its assessment and did not published an opinion. This applicaiton was withdrawn by the applicant and no further actions was taken.