Regulatory Practices: Novel Food Approval Process in Singapore

In today’s rapidly evolving food landscape, novel foods have become increasingly prevalent, offering consumers diverse culinary experiences and nutritional benefits. As the demand for innovative food products continues to grow, Regulatory practices must keep pace to ensure these novel foods' safety and quality. This blog aims to provide insights into optimizing Regulatory practices for novel food approval process in Singapore, focusing on the roles of key Regulatory bodies and the importance of efficient and transparent processes.

The Two (02) Key Regulatory Bodies:

Singapore Food Agency (SFA)

The Singapore Food Agency (SFA) is the central Regulatory authority responsible for ensuring food safety and standards in Singapore. It assesses the safety of novel foods, approves their use, and monitors food supply to maintain high standards.

Health Sciences Authority (HSA)

The Health Sciences Authority (HSA) primarily focuses on the regulations for health supplements in Singapore. While the SFA focuses on food safety, the HSA oversees health-related claims made by food manufacturers.

The HSA ensures that health supplements and certain novel foods meet the required safety and efficacy standards. This involves reviewing scientific evidence supporting health claims and ensuring that they are accurate and not misleading.

Freyr’s Regulatory experts ensure that by working with the SFA, the HSA helps establish a comprehensive Regulatory framework that protects consumers and promotes innovation in the Singapore food industry.

What are Novel Foods?

Novel foods are defined as foods and ingredients that are not widely consumed or have undergone a significant change in their production processes. These foods may include new sources of nutrients, novel processing methods, or genetic modifications.

Examples of Novel Food Ingredients

• Plant-based Proteins: Soy and pea protein.
• Insect-based Proteins: Cricket flour.
• Lab-grown Meat: Cultivated meat produced through cellular agriculture.
• Algal Oils: Oils derived from algae.

Labeling Requirements for Novel Foods in Singapore

• Front-of-Pack (FOP) Labeling: FOP labeling refers to the nutritional information displayed prominently on the front of food packaging. This may include the use of traffic light systems, health logos, or nutrient-specific labeling to help consumers make informed choices.
• Back-of-Pack (BOP) Labeling: BOP labeling provides detailed nutritional information, ingredient lists, and allergen warnings. It also includes instructions for use, storage conditions, and manufacturer details.

Claims Involved in Novel Foods in Singapore

• Nutritional Claims: Nutritional claims are statements about the nutritional content of food, such as “high in protein” or “low in fat”.
• Health Claims: Health claims link a food or an ingredient to specific health benefits, such as “reduces cholesterol” or “supports immune function”.
• Function Claims: Function claims relate to the function of a nutrient or ingredient, such as “supports bone health” or “aids digestion”.
• Regulations Governing Claims: The SFA has established guidelines in place for substantiating and approving claims made by food manufacturers. These claims must be supported by scientific evidence and comply with local regulations.

Steps for Registering Novel Foods:

• Pre-submission Consultation: Before submitting a novel food for approval, manufacturers can engage in a pre-submission consultation with the SFA to determine the appropriate Regulatory pathway.
• Dossier Preparation: Manufacturers must prepare a comprehensive dossier that includes:
• Safety assessments, conducted in accordance with reference documents published by the United States Food and Drug Administration (US FDA), the European Food Safety Authority (EFSA), and the Food and Agriculture Organization (FAO)/World Health Organization (WHO).
• Scientific evidence reports supporting the safety and efficacy of the novel food.
• Detailed manufacturing information report, including the production process, input materials, and potential allergens.
• Submission of Dossier: The dossier is formally submitted to the SFA for review.
• Risk Assessment and Review: The SFA conducts a detailed evaluation of the submitted dossier, which may include public consultation and peer review.
• Approval and Notification: If the novel food is approved, the SFA will notify the applicant and publish the approval on its website.

Role of the Legal Representative (LR) in Singapore

In Singapore, the LR plays a crucial role in assisting manufacturers of novel foods in achieving compliance with the Regulatory requirements. Some of their key functions are:

• Assistance in Compliance: LRs can help manufacturers ensure that all Regulatory requirements are met and assist them in navigating the complexities of Singapore’s dynamic Regulatory framework.
• Dossier Preparation and Submission: LRs can assist manufacturers in compiling the necessary documents and evidence as well as provide support in managing communications with the SFA.
• Post-approval Compliance: LRs can help manufacturers maintain ongoing compliance with labeling, marketing, and claims regulations.

Challenges and Considerations

Here are some common challenges novel food manufacturers face during the Regulatory approval process in Singapore:

• Incomplete or Inadequate Dossiers: Applications can be delayed or rejected if dossiers need more information, such as safety assessments, scientific evidence, or manufacturing details.
• Need for Local Contact: In Singapore, an LR is often required. Failure to provide an LR may delay or reject the application.
• Lack of Compliance with Regulations: Compliance with regulations like the Sale of Food Act and the Feeding Stuffs Act is crucial. Non-compliance can lead to delays or rejection.
• Public Consultation and Feedback: The SFA’s public consultations can lead to delays if feedback necessitates changes.
• Risk Assessment and Evaluation: The SFA’s comprehensive risk evaluations can be time-consuming, especially if extra information is required.
• Scientific Evidence and Safety Assessments: Robust scientific evidence and safety assessments are essential, as insufficient data can cause delays.
• Regulatory Framework and Policy Updates: Changes in regulations can delay the approval process as companies adjust to them.
• Insufficient Data on Long-term Effects: Additional data on long-term health effects may be required, which cancause delays.

Impact of the New FSSB Draft on the Novel Food Approvals Timeline

The new Food Safety and Security Bill (FSSB) draft in Singapore aims to enhance food safety and security by consolidating existing regulations and introducing new requirements for novel food approvals. It proposes a new category, “Defined Food,” encompassing novel foods, genetically modified (GM) foods, and insect-like species. The bill seeks to streamline the approval process, with specific instructions for submitting pre-market approval applications and establishes penalties for non-compliance. While the FSSB draft does not drastically impact the overall timeline for novel food approvals, it introduces several changes that may affect the timeline:

• Streamlined Application Process: Improved management of novel food application procedures could lead to a more efficient process, potentially reducing approval times.
• Additional Requirements: New requirements, such as having a local contact in Singapore and ensuring complete application data, may cause delays.
• Public Consultation: The draft includes a public consultation period, which might delay the process as feedback is considered.
• Penalties for Non-Compliance: Establishing penalties for non-compliance may cause delays if enforcement actions are required.

Overall, the FSSB draft aims to improve the efficiency and transparency of the novel food approval process in Singapore, ensuring a more robust Regulatory framework and the safety and quality of novel foods.

Conclusion

In conclusion, optimizing Regulatory practices for novel food approval in Singapore is vital for fostering food innovation and ensuring safety. Engaging with Freyr will help you streamline the approval process and ensure your ongoing compliance with evolving Regulatory requirements. Our skilled Regulatory experts can help you efficiently navigate the approval process by working closely with Regulatory bodies like the SFA and HSA. This collaboration will enable you to bring exciting new novel food products into  Singapore  while maintaining compliance with local regulations. Contact us now!