Food safety and hygiene newsletter August 2026

After more than 15 years of implementation, the Law on Food Safety No. 55/2010/QH12 has established an important legal foundation for food safety management in Vietnam. However, in practice, many new issues have emerged, such as counterfeit foods, substandard foods, food trading on e-commerce platforms, the rapid growth of functional foods, and cross-border business models, making many existing regulations no longer suitable. The Ministry of Health has released the Draft Law on Food Safety (amended) dated 27 July 2026 with numerous fundamental changes in regulatory approaches and food safety control methods. The Draft not only revises individual provisions but also comprehensively restructures the management system toward modernization, digitalization, and risk-based management.

The notable new contents include:

1. Addition and Revision of Definitions

The Draft revises Article 2 by introducing additional definitions, standardizing terminology in line with international practices, and expanding the scope of food chain management. Notable changes include:

• Addition of new concepts such as:

• • Food product owner
  • Small-scale food business establishment
  • Food flavorings
  • Food ingredients

• Removal of certain definitions under the current Law, such as:

• • Food testing
  • Food business
  • Food product lot
  • Risk of food contamination
  • Shelf life of food
  • Micronutrient-fortified foods
  • Functional foods

• Revision of definitions relating to food, food additives, processing aids, contaminants, etc.

2.  Addition of the Principle of Application of the Law (Article 3)

• The Draft adds a completely new Article 3 to clearly define the legal position and application principles of the Law on Food Safety in relation to other laws.

• • Establishes the Law on Food Safety as the specialized law governing food business activities in Vietnam while being applied together with relevant laws.
  • Gives priority to the Law on Food Safety where inconsistencies exist between the Law on Food Safety and laws enacted prior to the effective date of the amended Law on Food Safety.
  • Requires any subsequently enacted law containing food safety-specific provisions different from the Law on Food Safety to clearly specify which contents are subject to the Law on Food Safety and which are subject to that specialized law, thereby avoiding legal overlaps and conflicts.
  • Separates food management from the general product and goods quality management framework and excludes the application of classification principles and management measures under the Law on Product and Goods Quality to food products.
  • Excludes the application of general technical regulation requirements to food, thereby creating a basis for a separate management and technical standards system tailored to food safety.

• This serves as an important legal basis for affirming the independence of the food safety management system and addressing overlaps between the Law on Food Safety, the Law on Product and Goods Quality, and other specialized laws in practice.

3. Principles of Food Safety Management

• The Draft renumbers Article 3 of the current Law as Article 4 and supplements several new management principles:

• • Shift to management across the entire food supply chain, from primary production to consumers.
  • Strengthen risk-based management and traceability.
  • Add requirements for inspection and supervision of food throughout its circulation in the market.
  • Clearly require that standards announced by enterprises must not be lower than corresponding technical regulations for certain food categories.
  • Emphasize the principle of a unified state management focal point for food safety.
  • Establish the legal basis for building and operating food safety information systems and databases.

4. Information Technology Application and Food Safety Database Systems

Establishes a legal basis for digital transformation in food safety management through enhanced application of digital technology and the development of a unified database system, thereby improving management efficiency, strengthening traceability, increasing transparency, and supporting inspection and supervision throughout the food supply chain.

• Application of Information Technology in Food Safety Management (Article 5)

• • Promote the application of digital technologies (AI, big data, numbering systems, barcodes, electronic labels, traceability systems, digital platforms) in food safety management.
  • Support administrative procedures, supply chain management, risk analysis, inspection, warning systems, product recalls, and violation handling.
  • Ensure information transparency, data connectivity, and data sharing while complying with cybersecurity, data security, and data protection requirements.

• Food Safety Database System (Article 6)

• • Establish a unified food safety database connected to and shared with the national database.
  • Food business establishments are responsible for storing relevant data and providing it to competent authorities according to the connection roadmap.
  • The Government will issue detailed regulations on the scope of data, information retention requirements, and system integration roadmap.

5. State Policies on Food Safety

• Add policies on digital transformation in food safety management, including online administrative procedures, traceability, inspection, supervision, and database-based warning systems.
• Add responsibility to allocate funding for food safety activities and use part of administrative penalties to strengthen infrastructure and equipment.
• Encourage green agriculture, circular economy models, supply chain development, and traceability.
• Expand the supervisory role of the Vietnam Fatherland Front, socio-political organizations, and industry associations in detecting violations, reporting violations, and communicating food safety information.

6.  Prohibited Acts

• Add management of food flavorings and prohibit the use of unsafe chemicals or chemicals of unknown origin in food production and business.
• Replace the requirement for conformity declaration registration with registration of product declarations or declaration of applicable standards under the new management mechanism.
• Add violations involving counterfeit food, unsafe food, and foods containing prohibited substances.
• Tighten operating conditions for business establishments by prohibiting operation during suspension periods, certificate revocation periods, or beyond licensed scopes.
• Prohibit the use of images, names, titles, or opinions of healthcare facilities, healthcare professionals, or patients in food advertising.
• Prohibit advertising of medical nutrition foods and nutritional products intended for children under 36 months of age.
• Clarify acts involving dissemination of misleading food safety information causing damage to businesses and consumers.

7.  Violation Handling and Penalties

• Clearly stipulates the maximum monetary penalties for food safety violations:

• • Individuals: up to VND 1 billion
  • Organizations: up to VND 2 billion

• Removes the current provision allowing penalties of up to seven times the value of the violating food products and replaces it with specific statutory maximum penalties.
• Continues to maintain administrative, criminal, compensation, and remedial measures for food safety violations.

8.  Rights and Responsibilities of Relevant Parties

• Food manufacturing establishments: Additional responsibilities for electronic data storage, notification upon business termination, and compliance with e-commerce requirements.
• Food business establishments (excluding manufacturers): Additional obligations to maintain traceability records, prove product origin, and disclose documentation when conducting sales through e-commerce.
• Consumers: Granted the right to report violations, food safety incidents, and food-related offences to competent authorities.
• Product declaration holders: For the first time, specific responsibilities are prescribed regarding declaration dossiers, product recalls, intellectual property rights, and information disclosure.
• Product owners/manufacturers authorizing another entity to submit declarations: Must notify changes to authorization arrangements and bear joint liability for food safety violations.
• E-commerce platform operators: For the first time, required to establish mechanisms for reviewing sellers’ legal documentation and bear joint liability if inadequate controls lead to food safety incidents causing consumer harm.

9. Food Safety Requirements for Food Products

• Expand the management scope from food products to include food ingredients, food additives, processing aids, and food flavorings.
• Introduce requirements for product declaration registration or declaration of applicable standards prior to market circulation for regulated products.
• Require mandatory traceability for food products and food ingredients.
• Add specific requirements for food ingredients of animal and plant origin to comply with veterinary, quarantine, and plant protection laws.
• Require scientific evidence supporting the claimed functions and dosage of certain food categories when registering product declarations.
• Add management provisions for food flavorings and require additives, processing aids, and flavorings to be included in permitted-use lists.
• Add requirements relating to maximum residue limits for veterinary drugs, pesticides, and contaminants in accordance with international standards or regulations of the producing country in certain cases.
• Simplify the structure of the Law by consolidating separate requirements for fresh foods, processed foods, functional foods, genetically modified foods, and irradiated foods into a unified regulatory framework.

10. Product Declaration and Food Circulation

• Establish three management mechanisms: product declaration registration, declaration of applicable standards, and exemption from declaration for certain food categories.
• Apply risk-based food classification, under which high-risk products or products intended for vulnerable groups must undergo product declaration registration.
• For the first time, clearly define entities eligible to stand as product declaration holders, including manufacturers, product owners, or authorized entities.
• Prescribe a validity period of five years for product declaration certificates and introduce procedures for renewal, amendment, and supplementation.
• Introduce the principle that foods subject to technical regulations are no longer required to undergo conformity declaration procedures but instead follow product declaration registration or declaration of applicable standards.
• Clearly specify circumstances requiring re-registration of declarations when there are changes in composition, formula, function, manufacturing establishment, or product name.
• Introduce a mechanism for revoking product declaration certificates and removing declaration dossiers in cases involving serious violations, falsified dossiers, counterfeit food, or unsafe food.
• Introduce measures to suspend or refuse acceptance of declaration dossiers submitted by entities violating food safety regulations; serious violators may be barred from filing dossiers for up to five years.

11. Food Safety Conditions for Food Business Establishments

• Require food business establishments to maintain adequate legal documentation, technical documents, facilities, and professional capacity appropriate to their business activities.
• Introduce obligations to retain records and information for traceability purposes throughout business operations.
• Add specific provisions for health supplements and establishments applying advanced food safety management systems (GMP, HACCP, FSSC 22000, BRCGS, IFS, etc.).
• Add management requirements for food flavorings used in food processing.
• Strengthen requirements for street food vendors and collective catering service providers, including ingredient traceability, use of compliant water sources, hygiene requirements, and notification obligations to local authorities.

12. Certificate of Eligibility for Food Safety Conditions

• Repeal detailed provisions on application dossiers, procedures, and processes for issuance of certificates currently stipulated directly in the Law on Food Safety 2010.
• Repeal provisions on reissuance procedures upon certificate expiry currently stipulated in Article 37 of the current Law.
• Delegate the Government to regulate in detail application dossiers, procedures, authority for issuance, renewal, amendment, and supplementation of certificates.
• Require establishments exempt from certification to continue complying with food safety conditions prescribed by law.
• Add provisions on grounds and authority for revocation of Certificates of Eligibility for Food Safety Conditions.

13.  Imported and Exported Food

• Replace conformity declaration registration with product declaration registration or declaration of applicable standards before importation.
• Introduce exemptions from declaration and state inspection for certain cases as prescribed by the Government.
• Recognize foreign control results under international treaties and mutual recognition agreements.
• Clearly provide for state inspection of imported food under three risk-based inspection methods: strengthened inspection, normal inspection, and reduced inspection.
• Add requirements on registration of foreign countries, territories, and establishments exporting food to Vietnam.
• For exported food, add provisions on suspension and revocation of export certificates, with detailed regulations to be issued by the Government.

14. Product Advertising and Labelling

• Transfer authority for prescribing detailed requirements regarding approval of food advertising content from the Ministries to the Government.
• Add restrictions on advertising food products containing ingredients potentially harmful to health and provisions on revocation of advertising content approvals.
• Remove specific labelling provisions for functional foods, genetically modified foods, irradiated foods, etc. from the Law and delegate detailed regulations to the Government.

15. Traceability

• Expand traceability from unsafe foods only to all food products circulating in the market.
• Introduce the “one step back - one step forward” traceability principle to ensure identification of entities throughout the food supply chain.
• Allow the use of serial numbers, barcodes, QR codes, and digital technologies in traceability activities.
• For the first time, introduce provisions on identification codes for products, batches, business establishments, and warehouses to facilitate traceability throughout the supply chain.
• Delegate the Government to establish implementation roadmaps for digital traceability by food sector.

16. Recall and Handling of Unsafe Food

• Streamline the provisions in the Law by delegating detailed regulations on recall and handling of unsafe food to the Minister of Health instead of stipulating specific recall cases and handling measures in the Law itself.
• Add a specific requirement that destruction of unsafe food must comply with environmental protection legislation.

17. Forms, Time Limits and Frequency of Food Safety Inspections

• Delegate the Government to provide detailed regulations on time limits, procedures, and processes for food inspections under the specialized inspection mechanism.
• Add provisions on annual inspection forms and inspection frequency.
• Permit intensified inspections in the following circumstances:

• • Detection of food safety violations
  • Detection of food ingredients, food additives, processing aids, or food flavorings being used for improper purposes or being abused as harmful substances

The Draft Law on Food Safety (amended) demonstrates a significant shift from pre-market control toward risk-based management, traceability, and digital transformation, while strengthening the responsibilities of businesses throughout the food supply chain. Organizations and individuals operating in the food sector should proactively review their current compliance systems to prepare for the new legal requirements when the Law is officially promulgated.

Detailed information on the Draft and submission of comments can be found at: https://vanban.chinhphu.vn/du-thao-vbqppl/du-an-luat-an-toan-thuc-pham-sua-doi-7893

Australia

Australia’s Newly Revised MRLs – Proposal M1023

US

Proposed Rule on Substances Generally Recognized as Safe (GRAS)

• RIN: 0910-AJ02
• Responsible Agency: U.S. Food and Drug Administration (FDA), Department of Health and Human Services (HHS)
• Stage: Proposed Rule Stage

1. Overview of Objectives

This draft proposes amending regulations at 21 CFR parts 170 and 570 to establish mandatory submission requirements for "Generally Recognized as Safe" (GRAS) notifications for substances used in human and animal food. The primary purpose is to enhance the transparency of food additives, assisting the FDA in more effectively controlling and accurately determining whether the use of a substance is subject to the premarket review process under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

2. Changes in Regulatory Requirements

Currently, under section 201(s) of the FD&C Act, notifying the FDA of a substance's GRAS status is voluntary. If this draft is approved:

• Submitting a GRAS notification will become a mandatory requirement for instances where substances fall under the regulated scope.
• The FDA will maintain and update a public inventory for all substances subject to mandatory notification.
• The FDA will establish a formal process to determine a "not GRAS" status for substances that do not meet these requirements.
• Substances subject to mandatory notification will be presumed by the FDA not to be generally recognized as safe if a business does not comply with the submission process.

3. Economic Impact and Compliance Costs

The draft is assessed as an economically significant regulation. Cost categories impacting businesses include:

• Initial setup costs: Including costs for researching the new regulation and updating Standard Operating Procedures (SOPs).
• Submission preparation costs: Businesses will incur costs when submitting GRAS notifications (including streamlined submissions for existing products before the rule becomes effective).
• Other incidental costs: Related administrative costs such as document translation for international businesses.
• Recurring costs: Costs for maintaining notification submissions for new substances introduced into commerce.

4. Implementation Roadmap

• Expected timeline: The Notice of Proposed Rulemaking (NPRM) is expected to be issued in December 2026.
• Legal basis: The draft is formulated based on the FDA's authority under sections 201, 402, 409, and 701 of the FD&C Act (corresponding to 21 U.S.C. 321, 342, 348, 371).

Link: https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202510&RIN=0910-AJ02

EU

Commission Regulation (EU) 2026/1546) as regards maximum residue levels Benomyl, Carbendazim and Thiophanate-methyl in or on certain products

On 9 July 2026, the European Commission (EC) adopted Regulation (EU) 2026/1546, amending Annexes II, III and V to Regulation (EC) No 396/2005 as regards maximum residue levels (MRLs) for the three pesticide active substances Benomyl, Carbendazim and Thiophanate-methyl in or on certain products. The Regulation will officially apply from 29 January 2027.

1. Benomyl

• Benomyl is a fungicide belonging to the benzimidazole group. Unlike carbendazim and thiophanate-methyl, this active substance is not approved in the EU and has never been fully assessed under the current EU legislative framework for plant protection products. The EC also notes that benomyl is classified as a mutagenic and reproductive toxic substance.
• According to Regulation (EU) 2026/1546:

• • No toxicological reference values have been established for benomyl in the EU.
  • No Codex MRL (CXL) remains in force.
  • No import tolerance has been accepted.
  • There is no scientific basis for assessing the safety of benomyl residues for consumers.

• Therefore, the EC decided to include benomyl in Annex V and apply the default MRL values in accordance with Regulation (EC) No 396/2005.

2. Carbendazim

• Carbendazim is an active substance belonging to the benzimidazole fungicide group. In the European Union, the approval of this active substance expired on 30 November 2014, and no renewal application was submitted. Consequently, carbendazim is no longer authorised for use in plant protection products in the EU.
• According to EFSA's assessment, carbendazim has shown evidence of aneugenicity and is classified under Regulation (EC) No 1272/2008 as:

• • Mutagenicity Category 1B;
  • Reproductive Toxicity Category 1B.

• Following a review of updated toxicological and metabolism data, EFSA proposed managing carbendazim and thiophanate-methyl separately rather than under the previous combined residue definition. Under the new Regulation, the residue definition for enforcement purposes for carbendazim in products of animal origin is amended to: "Sum of carbendazim and 5-hydroxy-carbendazim, expressed as carbendazim."
• In addition, Regulation (EU) 2026/1546 lowers all existing MRLs for carbendazim to the limit of determination (LOD) and transfers these values to Annex V of Regulation (EC) No 396/2005.

3. Thiophanate-methyl

• Unlike carbendazim, thiophanate-methyl underwent a full renewal assessment process.
• However, the EU decided not to renew its approval under Regulation (EU) 2020/1498. EFSA's assessment identified several significant concerns regarding the safety of this active substance:

• • Toxicological reference values could not be fully established during certain stages of the assessment.
  • Evidence of effects on genetic material was identified.
  • The substance meets the criteria for an endocrine disruptor affecting the thyroid modality.

• Under Regulation (EU) 2026/1546, all existing MRLs for thiophanate-methyl are lowered to the limit of determination (LOD) and transferred to Annex V of Regulation (EC) No 396/2005.

With Regulation (EU) 2026/1546, the EU is effectively no longer accepting the presence of benomyl, carbendazim and thiophanate-methyl in food products by lowering or applying all MRLs at the limit of determination (LOD) level. At the same time, the Regulation removes previous regulatory bases such as import tolerances and Codex MRLs, with the objective of strengthening consumer health protection in light of concerns related to mutagenicity, reproductive toxicity and endocrine-disrupting properties.

For detailed information, please refer to: https://eur-lex.europa.eu/eli/reg/2026/1546/oj/eng