Overview of Pre-Market Approval Framework for Novel Food

Novel food may refer to the following:

• A substance (which may consist of, be isolated from or produced from, cell culture or tissue culture derived from animals, plants, bacteria or yeast, fungi, algae or other micro-organism) that has not been used to a significant degree as food for a period of at least 20 years, whether within or outside Singapore;
  
• A food that has been manufactured, prepared or preserved by a process that has not been previously used in food production for a period of at least 20 years, whether within or outside Singapore;
  
• A food consisting of, isolated from or produced from material of mineral origin that has not been previously used in food production for a period of at least 20 years, whether within or outside Singapore; or
  
• A food that contains or consists of engineered nanomaterials.

An applicant for pre-market approval for a novel food must provide safety assessments of the novel food that identify risks and ensure these risks are appropriately managed, accompanied by scientific evidence demonstrating that the novel food as a food or an ingredient in food does not pose a risk to human health.

Details of what is required in an application for pre-market approval can be found in the Second Schedule to the Food Safety and Security (FSSA Authorisations — Administration) Regulations 2025.

A novel food must be covered by pre-market approval from SFA before it can be lawfully supplied in Singapore, or handled (like manufacturing) for supply here, or reared or cultivated here. 

A pre-market approval for a novel food is not perpetual and may be cancelled by SFA under certain conditions set out in section 112 FSSA. 

(a) the pre‑market approval had been obtained by fraud or misrepresentation;

(b) any condition of the pre‑market approval is contravened or not complied with;

(c) after the grant of the pre‑market approval, there has been a material change to —

(i) the method by which the novel food or genetically modified food is manufactured, prepared, preserved, packaged or stored; or

(ii) any other information relating to the novel food or genetically modified food which was provided in connection with the application for the pre-market approval; or

(d) the public interest of Singapore requires the cancellation of the pre‑market approval.

The pre-market approval for a novel food also ends when the food ceases to be a novel food.