Guidelines on Applying for Pre-Market Approval for a Novel Food

Review the information listed in the Second Schedule to the Food Safety and Security (FSSA Authorisations — Administration) Regulations 2025 that must be submitted to SFA. 

Applicants are required to submit scientific evidence to demonstrate that the novel food being applied for pre-market approval does not pose risk to human health.

The scientific evidence should cover potential food safety risks such as toxicity, allergenicity, the safety of the production methods used, and dietary exposure arising from consumption. 

Additional guidance on the information required for pre-market approval can be found in the Requirements for the Safety Assessment of Novel Food and Novel Food Ingredients.

If the novel food is derived from precision/biomass fermentation, or is a form of cultivated meat/seafood, you must complete the self-assessment checklists below:

1. Self-assessment checklist for precision/biomass fermentation processes
2. Self-assessment checklist for cell-based food companies

An acknowledgement email will be sent once the self-assessment checklist is submitted. The applicant must attach the acknowledgement to the pre-approval application when the applicant submits it to SFA.

Submit the following to Authorisation@sfa.gov.sg:

• Information required as listed in the Requirements for the Safety Assessment of Novel Food and Novel Food Ingredients 

• Acknowledgements from submission of self-assessment checklist

SFA will charge an application fee of $1,750 for each application for pre-market approval of a novel food. The application fee will be payable upon the acceptance of the application.

SFA will review the safety assessments to determine if potential food safety issues have been addressed. During this time, SFA might contact the applicant if additional information is required. The evaluation timeline will be paused until the applicant provides the requested information.

An evaluation of a novel food product will take an estimated 9-12 months following SFA’s acknowledgement of the application fee payment.

During this time, SFA might contact you for more information if required.

SFA will notify the applicant whether or pre-market approval of the novel food is granted.

Applicants must seek SFA’s approval again if and when:

1. Changes have been made to the manufacturing process of the novel food product, and these changes might affect the validity of the original safety assessment submitted. For example, when the input materials (e.g. cell lines or culture media components) in the production of cultivated meat have been changed, approval must be sought again. 
   
   Until approval is granted, novel food products made using the updated manufacturing process cannot be imported, distributed, or sold in Singapore.
   
2. Expansion of the scope of the intended use of the novel food product to other food categories.