Singapore Updates Guidelines for the Safety Assessment of Novel Foods
Recently, Singapore Food Agency (SFA) published the latest guidelines for the safety assessment of novel foods, namely Requirements for the Safety Assessment of Novel Foods and Novel Food Ingredients (version dated 26 Sep 2022) (“Guidelines”)[i]. This is a revision to the previous version which was released in April 2022. In Singapore, novel foods such as cultured meat products that do not have a history of consumption as foods are subject to pre-market assessment by SFA. The Guidelines provide the requirements for the assessment process.
Under the revised Guidelines, SFA emphasized that companies should conduct and submit detailed information on safety assessments of the petitioned novel food to cover the potential food safety risks, such as toxicity and dietary exposure arising from consumption. The primary changes are summarized as follows:
- A new Chapter is added, i.e., Chapter 5 - Safety assessment approach for biological substances used in media for cultured meat/seafood production. It states that during the safety assessment evaluation, SFA will review biological substances used in the media for the production of cultured meat/seafood. Enterprises may refer to the flowchart provided in this Chapter to assess their biological substances and determine the specific information required by SFA.
- Two self-assessment checklists are newly introduced for the application of novel foods derived from precision fermentation, biomass fermentation, and cultured meat/seafood[ii].
- Additional requirements with respect to product tasting are included in Chapter 10 - Information on the sensory evaluation and tasting of unassessed novel foods. Specifically, Section 10.3 states that companies should apply for an administrative exemption from SFA for tasting the petitioned novel food that has not completed the safety assessment process, e.g., when a sensory evaluation is necessary as part of the R&D process while the safety assessment is yet to conclude.
- An online application form for SFA Novel Food Clinic is now available[iii]. Per the Guidelines, SFA conducts Novel Food Virtual Clinics on a bimonthly basis, which “serves as a platform for novel food companies in their early stages of R&D to engage with SFA, as well as for SFA to share more details on novel food regulatory framework”. Accordingly, it is highly recommended for companies to engage with SFA by using such platform.
- In the Q&A session of the revised Guidelines, SFA made it clear that, at present, SFA does not conduct inspections of novel food manufacturing sites overseas. Companies should provide detailed information on their manufacturing processes and quality controls when submitting their safety assessments for review.
Singapore, the first country to grant approval for cultured meat products, continues to optimize its regulatory requirements for alternative proteins. We will keep you updated on the latest food regulatory developments in the area of alternative proteins in Singapore and across the Asia Pacific region. Please subscribe to our newsletters, events, and webinars here. Our most recent webinar on November 10, 2022, discussed the regulatory landscape of cultured and fermented meat products in the U.S. and China. You may view the webinar recording here and enter the password “AltProtein2”, which will remain valid until December 9, 2022.
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If you need any assistance in submitting novel food applications to clear your alternative protein foods or have any questions regarding applicable food regulations, please do not hesitate to contact us. In the meantime, if you have any questions on the above, please do not hesitate to contact David Ettinger (ettinger@khlaw.com), Jenny Xin Li (li@khlaw.com), or your existing contact at Keller and Heckman LLP.
[i] https://www.sfa.gov.sg/docs/default-source/food-import-and-export/Requirements-on-safety-assessment-of-novel-foods_26Sep.pdf
[ii] Self-assessment checklist for precision and biomass fermentation, available at: https://form.gov.sg/62e87e0afedc360013e2e882
Self-assessment checklist for cultured meat/seafood, available at: https://form.gov.sg/62e3367350c94600127c2cd8