May 2012: Application from Dow Wolff Cellulosics for the authorisation of Methylcellulose under the Novel Food Regulation (EC) 258/97. Under evaluation.
This pages details on an application for Methylcelluose under regulation 258/97. The applicant’s intention is to market methylcellulose as a novel food ingredient to be incorporated into a range of foods (ice cream, flavoured milk drinks, cold desserts, smoothie type drinks, yoghurts and yoghurt drinks and wet soups) to function as a dietary fibre.
The applicant’s methylcellulose has the polymeric backbone of cellulose (obtained from plant material), a natural carbohydrate that contains a basic repeating structure of anhydroglucose units joined by 1-4 linkages. Each anhydroglucose unit contains hydroxyl groups at the 2,3 and 6 positions. Substitution of these hydroxyl groups creates a range of cellulose derivatives, e.g. methylcellulose. Methylcellulose is also approved as a food additive in the EU as an emulsifier, stabiliser or thickener.
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
The application for Methylcellulose was assessed by the UK under Regulation 258/97 (EC). The application was accepted in May 2012 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 drafted an opinion, that was put up for a consultation. No final opinion was reached. The application was not completed prior to 1st of January 2018, and was passed to the European Commission under regulation (EC) 2015/2283.