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Singapore: Singapore Food Agency releases updated guidance regarding the safety assessment requirements of novel foods

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In brief

Following the growing viability of meat substitutes such as plant-based meats and cultured meats, the Singapore Food Agency (SFA) has released an updated document detailing its requirements regarding the safety assessment of novel foods (“Safety Assessment Requirements“). This document is expected to be revised periodically as the novel food space evolves to facilitate industry safety assessments and maintain food safety standards.

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The production of novel foods has been recognised by the SFA as having “great potential to solve the global food challenge” and a key area of focus for their R&D efforts to help achieve its goal of producing 30% of Singapore’s nutritional needs by 2030. To this end, the Safety Assessment Requirements aids the efforts of food businesses to innovate and develop novel food products by providing them with a greater understanding of the existing framework the SFA has in place to identify and manage food safety risks before they enter the market.

More broadly, the updated Safety Assessment Requirements appear to be the latest step of the Singapore government’s move to regulate and understand the novel foods space. In addition to a public consultation on a proposed regulatory framework for novel food and novel food ingredients being carried out in 2018, the SFA also organised a regulatory forum to discuss challenges and solutions in the safety assessment of novel food in 2019.

With the recent approval of a lab-grown cultured meat product to be sold in Singapore, food businesses involved in the novel foods space would do well to refer to the Safety Assessment Requirements and to consult the SFA at the early stages of the product development process. Doing so would assist them in understanding the information required to substantiate the safety of their novel food products, and to foster a transparent and proactive product development process.

In more detail

Following the growing viability of meat substitutes such as plant-based meats and cultured meats, the SFA has released an updated document detailing its requirements regarding the safety assessment of novel foods. This document is expected to be revised periodically as the novel food space evolves to facilitate industry safety assessments and maintain food safety standards.

The Safety Assessment Requirements apply to foods and food ingredients that do not have a history of safe use, i.e., if they have not been consumed as an ongoing part of the diet by a significant human population for a period of at least 20 years and without reported adverse human health effects. Safe use, in turn, is assessed by a variety of factors such as:

  1. the length of time that the ingredient has been consumed as food or used in food
  2. the extent to which the ingredient has been consumed or used by the population
  3. the quantity of the ingredient consumed in food
  4. the purpose or context of the ingredient’s use
  5. evidence demonstrating the lack of adverse effects to human health attributed to the substance during the specific period of use as food

Companies and businesses that intend to produce, import or sell novel foods are required to submit safety assessments of their novel food products before they are allowed for sale. The evaluation period is estimated to take between three and six months to complete and will be conducted by an expert panel of food scientists and health experts.

The information required in respect of a given safety assessment varies according to the type of novel food in question and is broadly summarised in the table below:

Novel food type Information required
Novel food and food ingredients in general
  1. information on the identity and purity of the novel food, including percentages of major components and impurities present
  2. information on the novel food’s manufacturing process and inputs used
  3. intended use and proposed use levels in food (novel foods which are intended for consumption by specific population groups should be indicated)
  4. in-vitro and in-vivo toxicity studies, where relevant
  5. metabolism or toxicokinetics studies, where relevant
  6. any safety assessment reports conducted by food safety authorities in major developed countries (Australia, Canada, New Zealand, Japan, the European Union and the United States of America)
Novel food ingredients that are chemically identical to naturally occurring substances but produced through unconventional processes Instead of a full safety assessment involving the submission of a full set of toxicity studies, the following information suffices:

  1. information to demonstrate that the ingredient is chemically identical to its naturally occurring counterpart
  2. purity information, including identity and levels of any impurities present
  3. manufacturing process of the ingredient

If the novel food ingredients are produced from a modified microorganism, the following additional information is required:

  1. safety information of the production strain
  2. allegenicity of the ingredients and residual impurities (if present)
Meat developed from animal cell culture

* The information required is subject to change based on scientific developments in cultured meat production.
  1. description of the overall manufacturing process
  2. characterisation of the cultured meat product
  3. information related to the cell lines and culture media used
  4. information related to scaffolding materials, if used
  5. information on how the cell culture’s purity and genetic stability is preserved during the manufacturing process
  6. safety assessment covering possible hazards arising from the manufacturing of the cultured meat
  7. other relevant studies to support safety such as digestibility assays, allergen profiling, genetic sequencing, among others

 

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Author

Andy Leck is the managing principal of Baker McKenzie.Wong & Leow. Mr. Leck is recognised by the world’s leading industry and legal publications as a leader in his field. Asian Legal Business notes that he “always gives good, quick advice, [is] client-focused and has strong technical knowledge for his areas of practice”. Alongside his current role as managing principal, Mr. Leck has held several leadership positions in the Firm and externally as a leading IP practitioner. He currently serves on the International Trademark Association's Board of Directors and is a member of the Singapore Copyright Tribunal.

Author

Ren Jun is an associate principal of Baker & McKenzie.Wong & Leow. Ren Jun extensively represents local and international intellectual property-intensive clients in both contentious and non-contentious IP matters, such as anti-counterfeiting; civil and criminal litigation; commercial issues; regulatory clearance; and advertising laws. Ren Jun also advises on a wide range of issues relating to the healthcare industries. These include regulatory compliance in respect of drugs, medical devices, clinical trials, health supplements and cosmetics; product liability and recall; and anti-corruption. Ren Jun is currently a member of the Firm's Asia Pacific Healthcare ASEAN Economic Community; Product Liability and Regulatory Sub-Committees.

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