Novel Food Safety Assessments in Indonesia, Thailand, and Vietnam – Lexology

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 jurisdictionssuch 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 Actsimilar 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

Process and Timeline

Before submitting an application for novel food safety assessment, the applicant or a representative should first consult with BPOMs 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 directorates 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 daysor around 46 months in practice.

Required Documents

The application requirements differ depending on the category of novel food. There are two main categories:

Thailand

Process and Timeline

Seeking approval for novel foods consists of two stages.

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:

Novel foods that contain any ingredient derived from a genetically modified organism (GMO) must undergo a BIOTEC review.

To apply for the FDAs 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

Vietnam

A genetically modified food contains one or several genetically engineered ingredients. New food additiveswhile not legally definedinclude new combinations of permitted food additives, food additives not included in the permitted list, and food additives included in the permitted list but used outside of the permitted categories.

A genetically modified food contains one or several genetically engineered ingredients. New food additiveswhile not legally definedinclude new combinations of permitted food additives, food additives not included in the permitted list, and food additives included in the permitted list but used outside of the permitted categories.

Self-declaration: None

Registered product declaration: USD 70

Process and Timeline

Conventional Foods. Every food product sold in Vietnam must have a declaration that it meets regulatory standards. For many types of food, a self-declaration procedure covers this requirement. However, some foods also require additional inspection and approval from the Ministry of Health via a registered product declaration.

GMOs. Food products based on GMOs that are on the Ministry of Agricultural and Rural Developments list of edible GMOs undergo the same approval procedure as other conventional food products. However, food products based on GMOs not on this list must first obtain certification of the GMOs eligibility for use as food before undergoing the approval procedure for conventional food products.

In order to apply for certification, Vietnams Council of Food Safety must have concluded that the GMO has no inordinate risks for human health, or the GMO must have been approved for use as food by at least five developed countries, with no adverse incidents having occurred.

If one of these conditions is met, the application can be submitted to the relevant department in the Ministry of Agricultural and Rural Development. Within seven working days of receiving a submission, the department will acknowledge the validity of the application or request additions.

Valid applications will then be appraised by the Genetically Modified Food Safety Councilan advisory council composed of representatives of the Ministries of Industry and Trade; Science and Technology; Agriculture and Rural Development; Natural Resources and Environment; and Health, in addition to other experts. For GMOs that have already been approved for use as food by at least five developed countries, without any recorded adverse incidents, appraisal of the application takes 60 days. For other GMOs, the maximum appraisal duration is 180 days.

Within 30 days of obtaining the appraisal results, the minister of the Ministry of Agricultural and Rural Development will either certify the GMOs eligibility for use as food, or issue a refusal clearly stating the reason.

Required Documents

Applications for certification of a food product as an edible GMO must include the following items:

If the applicant has any other unpublished reference or research materials, assessments, test reports, or scientific figures concluding that the genetically modified organisms do not negatively affect human health, those items should be included in the application.

Conclusion

New foods and ingredients are highly regulated in countries around the world, regardless of whether a jurisdiction has specific laws on novel foods. There are some common regulatory approaches and practices, but even in a single region such as Southeast Asia the rules and processes can vary. Indonesia, Thailand, and Vietnamthree especially active and well-developed regulatory regimes for food in the region, offer compliant food producers and importers a chance to access local consumers and markets. By first recognizing the requirements and regulations in these jurisdictions, and then seeking local expertise that can ensure the process is done correctly, businesses and investors can avoid costly interruptions or delays as they bring their products to market.

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Novel Food Safety Assessments in Indonesia, Thailand, and Vietnam - Lexology