Initial Assessment of the Application for the Approval of Calcium-L-Methylfolate under the Novel Food Regulation (EC) No

γ-Cyclodextrin and an enzyme used in its production do not have a history of food use in the EU which means the novel ingredient falls within the scope of novel food Regulation EC No. 258/97. The application for authorisation of γ-Cyclodextrin as a novel food ingredient was prepared pursuant to Commission Recommendation 97/618/EC concerning the scientific aspects and the presentation of information in support of an application to market novel foods and novel food ingredients in the EU. The applicant considers γ-Cyclodextrin to fall within the novel food category of “foods and food ingredients with a new or intentionally modified primary molecular structure”, as set out in Article 1.2.(c) of the novel food Regulation. In order to assess wholesomeness, γ-Cyclodextrin was considered to fall into class 1.2. by the applicant; “Pure chemicals or simple mixtures from non-GM sources with no history of food use in the community”, (Commission Recommendation 97/618/EC). However, following discussions with the applicant, it was clarified that γ-Cyclodextrin is produced from starch which is derived from non-GM maize. Non-GM maize (corn) has a history of consumption within the Community and thus the novel ingredient is placed in class 1.1.