April 19, 2022
New technologies and production processes in the food industry have led to novel foods becoming increasingly important to both food manufacturers and the consuming public worldwide. This is very much the case across a number of jurisdictions in Southeast Asia. “Novel foods” refer to new food production processes, foods, and ingredients that have not yet been commonly used for human consumption, so these innovative foods require safety assessments before companies can produce and market them. While rules for these safety assessments are already part of novel food regulations in several other jurisdictions—such as the novel food regulations in the United Kingdom and European Union adopted in 2003, and the major reform of food safety laws in the United States passed in 2011 under the Food Modernization Act—similar rules governing the assessment of novel foods are relatively new or yet to be introduced in many parts of Asia. Nevertheless, it is important to understand the laws and practices that apply to safety assessments and the process of bringing novel foods to market in jurisdictions in the region. This article provides some clarity in this regard by summarizing important practical information on novel foods and the relevant required safety assessments in Indonesia, Thailand, and Vietnam. Indonesia Regulator National Agency for Drug and Food Control (NADFC); frequently referred to as BPOM (Badan Pengawas Obat dan Makanan). Relevant Measures BPOM Regulation No. 27 Year 2018 concerning Public Service Standards in BPOM; Decision of the Director of Processed Food Standardization No. HK.02.02.51.511.06.21.21 Year 2021 concerning Public Service Standard Directorate Processed Food Standardization Definitions General “food ingredients” are basic fresh or processed ingredients that can be used to produce food; novel food is any food ingredient not listed in BPOM’s positive list of ingredients. Official Fees None Process and Timeline Before submitting an application for novel food safety assessment, the applicant or a representative should first consult with BPOM’s Directorate of Processed Food Standardization. This consultation can help the applicant identify the data requirements for submission. For obtaining approval of novel foods, applicants must submit the required items through the directorate’s online submission system. BPOM will then check the application to verify its completeness, and will contact the applicant within five working days either to confirm that the submission is complete or to direct the applicant to rectify any shortcomings. Once all requirements have been fulfilled, BPOM is to assess the application within 85 working days—or around 4–6 months in practice. Required Documents The application requirements differ depending on the category of novel food. There are two main categories: Novel food substances, mixtures of substances, mixtures of food ingredients, or other ingredients Novel foods sourced from plants or animals Ingredient name(s) Ingredient specification Physicochemical properties Composition Production process Certificate of analysis Toxicity data Potential allergenicity Regulation or distribution in other countries Name of type of processed food (final food product) Purpose of adding ingredients Amount of ingredients added Composition of processed food Processed food production process Use or application of processed food Suggested consumption (if any) Ingredient name(s) Parts of plant or animal used Chemical and/or nutritional content of ingredients Ingredient specifications and composition Production process Certificate of analysis History of use as food Toxicity data Potential allergenicity Regulation or distribution in other countries Name of type of processed food (final food product) Purpose of adding ingredients Amount of ingredients added Composition of processed food Processed food production process Use or application of processed food Suggested consumption (if any) Thailand Regulator Food and Drug Administration (FDA) Relevant Measures Notification of the Ministry of Public Health (No. 376) B.E. 2559 (2016) Re: Novel Food Definitions “Novel food” is any substance used as food or food ingredients that either has been used widely for human consumption for less than 15 years based on scientific or reliable evidence, or has undergone a production process not currently used, where that process gives rise to significant changes in the composition or structure of the food that affect their nutritional value, metabolism, or level of undesirable substance Official Fees THB 3,000 (approx. USD 90) Process and Timeline Seeking approval for novel foods consists of two stages. Novel food safety assessment registration In this stage, the applicant submits safety data to one of four safety assessment organizations accepted by the FDA. The maximum or estimated duration of this step depends on the organization: Bureau of Quality and Safety of Food, Ministry of Public Health – 95 business days; National Food Institute, Ministry of Industry – 93 business days Thailand Risk Assessment Center (TRAC), Mahidol University – 90 business days National Center for Genetic Engineering and Biotechnology (BIOTEC) – 7–12 months Novel foods that contain any ingredient derived from a genetically modified organism (GMO) must undergo a BIOTEC review. Novel food safety assessment registration considered by the FDA To apply for the FDA’s approval of a novel food, the applicant must submit the letter from the safety assessment organization, along with other relevant documents, to the FDA via their online system. The FDA will consider the application and make a determination within 40 business days. Required Documents General product and ingredient information Information on history of consumption as food Finished product and ingredient specifications Certificate of analysis Storage Production process, synthesis, or extraction method Basic information on chemical substances used in production Characteristics and recommendations for consumption Safety information, usually including three toxicology studies: 90-day subchronic toxicity study using rats Test for induction of gene mutations in bacteria (Ames Test, OECD Guidelines 471) In vitro assay to detect chromosomal aberrations (OECD Guideline 473), in vitro micronucleus assay (OECD Guidelines 487), or mouse lymphoma TK assay with colony sizing (OECD Guidelines 476) Nutritional data Results of safety assessments by international agencies or recognized countries. Vietnam Regulator Vietnam Food Administration (VFA) Relevant Measures No specific regulations or guidance on novel foods and ingredients; however, both imported and domestically produced food products must comply with the Law on Food Safety as well as the following measures on genetically modified organisms