Glucosamine hydrochloride. EC No. 73

August 2006: Application from Cargill to approve glucosamine hydrochloride from Aspergillus niger as a novel food ingredient. Status: Passed to the European Commission under Regulation (EC) 2015/2283.

Background

This page details on the application for Glucosaime submitted under novel food regulation 258/97.

Glucosamine is a naturally occurring amino-sugar that is a major building block of complex proteins called glycosaminoglycans, which form a component of the structure of cartilage. The glucosamine is produced through a unique process from chitin sourced from a vegetative microorganism, Aspergillus niger, whereas all other known commercial glucosamine products are derived from shellfish.

The applicant proposes to use its Glucosamine as a novel food ingredient in a range of pasteurised food products. These will include, fruit juices and fruit juice products such as tomato, tomato mixtures and fruit; 'smoothies', dehydrated instant drink mixes, fermented milk-based products, yoghurts and fromage frais, sports drinks and iced tea drinks. 

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

Approval was sought under Novel Foods Regulation (EC) No. 258/97. Before any new food product can be introduced on the European market, it must be rigorously assessed for safety. In the UK, the assessment of novel foods is carried out by an independent committee of scientists appointed by the Food Standards Agency, the Advisory Committee on Novel Foods and Processes (ACNFP).

Following an initial public consultation on the application and the discussion of this application by the ACNFP at its meetings between September 2006 and May 2007, the committee has formulated an opinion and has concluded that the novel food application requires additional assessment, as foreseen in Article 6(3) of regulation (EC) 258/97, and that a decision on authorisation of this novel food ingredient should be taken once EFSA's advice is available. This initial opinion was forwarded by the European Commission to other Member States for comment.

Resultantly, this application was not completed prior to 1st of January 2018, and was passed to the European Commission under regulation (EC) 2015/2283. It is still undergoing evaluation there.