D-Ribose. EC No. 90

April 2008: Application from Bioenergy, Inc., for the authorisation of D-Ribose from Bacillus subtilis under the Novel Food Regulation (EC) 258/97. Passed to the European Commission under 2015/2283 and then authroised by the European Comisison and EFSA.

Background

D-Ribose is a naturally occurring 5-carbon sugar that is present in all living cells. In the body, ribose is synthesised via the pentose phosphate pathway (PPP). The applicant states that exogenously supplemented D-ribose allows the cell to bypass the rate-limiting steps of the PPP, providing a precursor for ATP and nucleotide synthesis. D-Ribose is intended for use in conventional foods, including sports and energy drinks, foods for particular nutritional uses (PARNUTs) and food supplements.

Legal Backgroud

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: Passed to the EC

On 17 March 2008, the company Bioenergy Life Science, Inc. (‘the Applicant’), submitted a request to the ANCFP to place D-ribose on the Union market as a novel food ingredient The application for D-Ribose was assessed by the UK under Regulation 258/97 (EC).

The application 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 ACNFP requested additional information to resolve uncertainties arising from a study on reproductive toxicity. In November 2013, the applicant submitted a revised dossier to the competent authority of the United Kingdom. 

A final decision was not been taken before 1 January 2018 and the applicaiton was transferred to the EU under Regulation (EU) 2015/2283. Since then, the European Commisison and EFSA  reached a positive descision on D-ribose. 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 is authorised under COMMISSION IMPLEMENTING REGULATION (EU) 2019/506. 

Application Files