Ministerial approval is needed to authorise the Novel Food for the GB market. Approved Novel Foods will be added to the Food Standards Agency and Food Standards Scotland Novel Food register.
Ministerial approval is needed to authorise the Novel Food for the GB market. Approved Novel Foods will be added to the Food Standards Agency and Food Standards Scotland Novel Food register.
Once authorised, labelling of the Novel Food must follow assimilated regulation (EU) No 1169/2011 (GB 1169/2011).
In Northern Ireland, the corresponding EU law applies (EU 1169/2011).
Novel Foods, as any other ingredient in GB, are subject to assimilated regulation (EC) No 1924/2006 (GB 1924/2006), which provides a framework for health and nutrition claims on food. In some cases, a Novel Food might already meet the necessary claim requirements.
Failing this, the product must undergo a separate pre-market authorisation from the Novel Food application after the Novel Food has been authorised.
Market approval for a Novel Food is usually given for a specified use level and in specific defined categories of foods. It is, therefore, critical that Food Business Operators operate only within the authorised use conditions. Labelling, nutrition and health claims on a Novel Food must comply with assimilated regulations (EU) No 1169/2011 (GB 1169/2011) and (EC) No 1924/2006 (GB 1924/2006).
As with any other food or ingredient, Novel Foods can be removed from the market by the authorities if data subsequently becomes available which indicates that they may be harmful for humans or the environment.
Beside the initial cost required to prepare and submit a dossier for Novel Food pre-market approval, there are no costs after approval other than the usual validation, verification and monitoring required under Hazard Analysis and Critical Control Points (HACCP) in food risk management systems, unless post-marketing surveillance is a requirement of the authorisation.
Novel food authorisation and patents do not guarantee the same level of protection, although in the UK (and EU) Novel Food authorisation may grant market exclusivity for five years under certain conditions. Therefore, if another operator wants to use the same Novel Food before this period, they will either need to license the technology or apply for Novel Food pre-market authorisation separately.
Because Novel Foods are approved for a specific process and use, simply resembling an approved Novel Food does not grant automatic authorisation. Furthermore, in the UK and EU, a Novel Food application may include exclusive data protection for five years if authorisation depended on unique scientific data. If another food business operator wishes to use the same Novel Food within that five-year period, they must either obtain a license for the technology or submit their own pre-market authorisation application.
Once a Novel Food is authorised for use, re-submission is generally not required. However, because the authorisation covers specific uses and quantities, re-submission might be necessary if changes in the manufacturing process significantly affect its composition, or if the intended scope of use differs in level or food categories from what was originally authorised.