The Minister of Public Health issued Notification (No. 431) B.E. 2565 (2022) in April, regulating foods obtained from genetically modified organisms (GMOs). The Notification prescribes supervisory measures intended to protect consumer health. These supervisory measures include the requirement that all GMOs produced, imported, or sold must pass a biological food safety assessment (Assessment) for submission to and review by the Food and Drug Administration (FDA Thailand).
This Notification prohibits the manufacture, import, or sale of GMOs with two exceptions. Those two exceptions are GMOs that have already been approved by FDA Thailand or passed the required Assessment. Approved GMOs are included in Schedule 1, annexed to the Notification No. 431, and include specific maize, soybean, and microorganism strains. Schedule 6 lists genetically modified maize and soybean strains that have not been approved, but may continue to be produced, imported, and sold while the Assessment is ongoing. This provisional permission extends for five years beyond the enforcement of the Notification No. 431, but may be revoked at any time if the food in question fails the Assessment.
The biological food safety assessment ultimately evaluates four qualities and standards. Foods obtained from GMOs must:
1. Not pose a heightened health risk in comparison to the conventional counterpart.
2. Have nutritional value or required properties equal to the conventional counterpart.
3. Meet the qualities and standards for foods as mandated in applicable Ministry of Public Health notifications.
4. Meet any other applicable qualities and standards required by the Assessment results and supporting documents or evidence.
GMOs subject to assessment are divided into 3 categories: foods obtained from genetically modified plants, microorganisms, or animals. The respective Assessments are substantially similar with a few additional requirements specific to GMO type. Assessments must be conducted by the National Center for Genetic Engineering and Biotechnology, the National Science and Technology Development Agency, or another safety assessment agency recognized by FDA Thailand. Results of the Assessment must be submitted with supporting documents and evidence to FDA Thailand for permission and approval to produce, import, and sell foods obtained from the GMO under consideration.
Assessment requirements are included in Schedules 2 through 4. Schedule 5 concerns methodology standards for academic analysis. The individual who submits the Assessment results to FDA Thailand has an ongoing duty to notify governing administrative bodies of new scientific findings relating to the GMO. All new information must be submitted to FDA Thailand, the National Center for Genetic Engineering and Biotechnology, the National Science and Technology Development Agency, or another FDA Thailand approved assessment agency without delay.
Foods obtained from GMOs which have passed biological food safety assessments conducted by the following organizations are exempt from the Assessment requirement.
1. Joint scientific advisory bodies of the Food and Agriculture Organization (FAO) and World Health Organization (WHO).
2. WHO expert advisory panels and committees.
3. Specific to enzymes used in food production, those which meet the standards detailed in the Ministry of Public Health’s Notification Governing Enzymes for Use in Food Production are also exempt.
The required supporting documents for foods obtained from genetically modified crops are listed in Schedule 2. These documents must be submitted to FDA Thailand along with the Assessment results. The documents included in Section 1 apply to GMOs in this category generally. Section 2 applies to foods obtained from stacked genetically modified plants. Stacked genetically modified plants are reproduced by conventional breeding methods between transgenic parental lines of genetically modified plants. Required documents include those that describe characteristics of the genetic modification, nutritional composition, and an assessment of the allergen risk the GMO may pose.
Schedule 3 lists the supporting documents required for foods obtained from genetically modified microorganisms. Microorganisms are divided into 4 categories:
Category 1 – Foods which contain microorganisms that can multiply or transfer genes.
Category 2 – Foods which contain microorganisms that cannot multiply or transfer genes.
Category 3 – Complex products from which any remaining microorganism or new gene has been eliminated.
Category 4 – Chemically defined compounds and substances from which any remaining microorganism or new gene has been eliminated.
Required documents include assessments of the likelihood a microorganism may inhabit the human gastrointestinal tract and develop a resistance to antibiotics.
Schedule 4 lists the supporting documents required for foods obtained from genetically modified animals. Required documents include details concerning the animal’s development and food processing information.