The Food and Drug Administration Department (“FDA“) under the Ministry of Health has issued Announcement No. 351/2026 (the “Announcement“), setting out updated documentation and compliance requirements for obtaining a domestic food production recommendation (the “Recommendation“). The Announcement provides detailed guidance on the documents that must accompany an application, the records that manufacturers are expected to maintain and present during on-site inspections, and the documents that are no longer required to be submitted as part of routine applications. The Announcement should be read together with the FDA’s E-Submission Procedures for Domestic Food Manufacturing Recommendation, 2026 (the “SOP“), which establishes the broader regulatory framework governing domestic food manufacturing approvals, business grading, approval validity periods, and post-approval compliance obligations.
At a glance
The Announcement distinguishes documents that applicants must submit, records to produce during a factory inspection, and information that need not routinely accompany an application. It calls for more specific evidence of product quality, traceability and manufacturing controls, while removing certain documentary submissions. The practical message is to simplify the application pack without reducing the underlying compliance evidence retained by the business.
Read together with the SOP and Directive No. 9/2026, the requirements form part of a wider system combining application assessment, FDA business grading based on on-site inspections, the three-year validity period of manufacturing approvals, and ongoing risk-based sampling and testing requirements. They should not be described as a new universal licensing obligation for every food manufacturer, or as a repeal of the SOP.
Who should review their compliance position?
Businesses seeking to obtain or renew a Recommendation should review their internal compliance systems against the requirements introduced by this Announcement. Particular attention should be given to manufacturers of regulated food products, including branded bottled drinking water and edible oils. Notably, the SOP expressly requires FDA manufacturing approval for branded bottled drinking water and branded edible oil designated as controlled foods under Notification No. 524/2021, while allowing other food businesses to apply voluntarily where needed for their business. Order No. 1/2024 separately requires such controlled-food manufacturers to obtain the FDA recommendation before applying for the relevant governmental production licence. Its 1 April 2024 deadline for existing licensees without an FDA recommendation is historical, not a new 2026 grace period.
Existing recommendation holders should also assess whether their current documentation, traceability systems, quality-control procedures, and inspection records satisfy the evidentiary standards expected by the FDA.
What Announcement requires in the application pack
Businesses preparing new or renewal applications should align their e-submission dossier with the following requirements.
- Labels and production process: Submit a clear photograph of the actual product or label artwork that complies with the Order on Labelling of Prepackaged Foods (Notification No. 8/2022) (the “Labelling Order“). Describe the production stages fully in writing, from raw-material selection/inspection through production to distribution/sale. Renewal applications must include complete photographic records of those stages.
- Quality controls and factory plans: Submit quality-control procedures covering raw materials, packaging materials and finished products; a site/building and operational-flow layout showing detailed dimensions; and dimensioned factory room layouts. Provide an accurate Google Maps link identifying the factory location.
- Product specifications: Provide relevant physical, chemical, microbiological, food-additive, pesticide and antibiotic-residue specifications. The minimum content includes microbiological criteria and heavy-metal limits, additive specifications where additives are used, and pesticide/antibiotic-residue limits where necessary. Include further product-specific criteria dictated by the additives and manufacturing process.
- Non-conforming materials and traceability: Describe how damaged raw materials and substandard finished products are kept from mixing with acceptable goods and removed/destroyed. Submit a traceability procedure supported by records identifying suppliers and the persons to whom products are sold.
These requirements elaborate on the SOP’s existing mandatory documentation requirements, including label artwork, production processes, quality control procedures, site and room layouts, location maps, and product specifications. In our view, the Announcement provides greater practical detail, particularly in relation to the management of non-conforming products and traceability systems, rather than establishing a standalone approval regime. Applicants should also ensure that their products comply with the applicable microbiological criteria prescribed under the Microbiological Reference Criteria of Prepackaged Foods issued under Order No. 1/2026, as non-compliance may result in enforcement action in line with the National Food Law.
Inspection readiness: maintain evidence, not just policies
The information or documents to be submitted during on-site inspection focuses on evidence that the factory’s controls operate in practice. Prepare records in four areas as follows:
- Raw materials: Retain supplier/shop/company details and purchase vouchers or other formal transaction evidence; receiving-inspection records checking mould, pests, abnormal odour and moisture/damage; and evidence of orderly off-floor/off-wall storage and stock rotation, such as first-expired-first-out (FEFO) or first-in-first-out (FIFO).
- Packaging: Keep food-grade confirmation from the seller/manufacturer, or the relevant material label, for plastic bags, glass bottles and cans. Where glass bottles or reusable containers are used, describe the disinfection and washing/cleaning method.
- Finished products: Maintain daily/batch inspection records for colour, odour, taste, weight and seal integrity; explain the testing and basis used to establish shelf life; and retain one bottle/package sample from each production batch until expiry for investigation if problems arise.
- Personal hygiene: Maintain employee personal-hygiene inspection records. The announcement expressly refers to checklist item 11 of Announcement No. 15/2025 on Minimum Compliance Points for Food Businesses (the “Minimum Compliance Points”).
The supplied Minimum Compliance Points document supports that linkage: it contains 17 sections and 72 points for food businesses, with 66 points applicable to drinking-water purification businesses. Its personnel-hygiene section addresses illness reporting, protective clothing and handwashing; it also checks incoming materials, batch identification, recall arrangements and recorded operational controls. A practical response is to map the announcement’s evidence requirements against the full checklist, not to treat its four inspection topics as an exhaustive factory standard.
Documents Not Required for Routine Submission
This Announcement identifies seven items not required to be submitted: evidence for Nutrition Facts on the label; evidence concerning added aroma/flavour; evidence for statements falling under Chapter VI, paragraph 20 of the Labelling Order; trademark registration/newspaper notices and similar material; factory entrance and compass-direction indications; compulsory graphic/computer-designed room layouts; and six-monthly employee-health medical reports. Supporting evidence relating to these Nutrition Facts, flavourings, and labelling matters need not be submitted routinely but should be retained for FDA requests in the event of a consumer dispute.
The safer reading is a relaxation of routine filing, not permission to use unsupported nutrition, flavour or certification claims. Separately, the Labelling Order requires businesses to be responsible for verified claims and to provide supporting evidence on request; it prohibits unsubstantiated claims.
Similarly, not submitting six-monthly medical reports does not remove hygiene controls: the Minimum Compliance Points still requires medical examinations where clinically or epidemiologically indicated or required by national regulations, and reporting of relevant symptoms. The SOP lists trademark registration and food-safety certificates as optional if available; applicants should not confuse optional trademark evidence with proof of ownership being unnecessary for all other legal purposes.
Interaction with Existing FDA Requirements
Although the Announcement simplifies certain filing requirements, it does not reduce manufacturers’ substantive compliance obligations. Businesses should continue to ensure that product labels comply with Notification No. 8/2022. Similarly, food manufacturers remain subject to ongoing FDA supervision, including inspections conducted under the FDA’s risk-based inspection framework introduced by Directive No. 9/2026.
Manufacturers of health supplements should also continue to comply with Announcement No. 4/2026, which requires the submission of Hazard Analysis and Critical Control Point (HACCP) Plans in connection with domestic manufacturing recommendation applications.
Key Takeaway
The Announcement does not fundamentally alter Myanmar’s food manufacturing approval regime. Instead, it provides greater clarity regarding the documentation and records expected by the FDA during the application and inspection process.
Businesses should use this opportunity to review their product specifications, traceability systems, quality control procedures, inspection records, and labelling practices to ensure continued compliance with FDA requirements and to minimise delays in obtaining or renewing Domestic Food Production Recommendations.
The information provided here is for information purposes only and is not intended to constitute legal advice. Legal advice should be obtained from qualified legal counsel for all specific situations.