Global Food Regulation Highlights | November 2025

To help stakeholders in food sector navigate the constantly evolving regulatory landscape, ChemLinked offers Global Food Regulation Highlights, a concise monthly report that focuses on key regulatory developments worldwide. Find out what's new on food regulation worldwide in November 2025 below.

China

China NHC Approves Eight New Food Additives

On November 27, 2025, China National Health Commission (NHC) approved eight new food additives. The approval includes one enzyme preparation, one food nutritional fortification substance, two food nutritional fortification substances with expanded usage scope, and four food additives with added quality specification requirements.

More highlights in Chinese Mainland:

• China SAMR Issues Two Notices Identifying Yohimbine, Sibutramine, and Related Substances as Toxic and Harmful Non-food Ingredients

• [Updated] China Novel Food Raw Materials Updates in 2025:CFSA Consulted on 7 Food Raw Materials

• [Updated] China Novel Food Raw Materials Updates in 2025: NHC Approved Three Food Raw Materials

• China Clarifies the Registration Issues for Overseas Agricultural Products Enterprises

• [Updated] 2025 China Customs Rejection Data: 410 Batches of Imported Food in October

• China SAMR Consults on New Production Licensing Rules for Foods for Special Medical Purposes (FSMP)

• China Proposes Revisions to Excessive Packaging Standard for Canned and Cereal-based Complementary Infant Foods

• China NHC Unveils Second Batch of National Food Safety Standard Plan for 2025

Highlights in other areas of China:

• Taiwan FDA Amends Test Method for Food Additive Specification, involving Annex A General Test Method, DL-Alaninem, Sodium Cyclamate, Calcium Cyclamate, L-Phenylalanine, β-Carotene, and Calcium Citrate

• Taiwan Releases the Directions for Commodity Tax Exemption for Beverages With No Added Sugar

South Korea

South Korea Overhauls Food Additive Classification System

On November 26, 2025, South Korea Ministry of Food and Drug Safety promulgated a full revision to the Food Additive Code, marking a comprehensive restructuring of the food additive regulatory framework. The overhaul reorganizes the classification system, relaxes usage standards for certain nutrient fortifiers and modified hop extract, updates enzyme specifications, and converts units into internationally recognized formats to align with global practice.

More regulation highlights in South Korea:

• South Korea Updates Market Average Values for Sodium and Sugar Reduction Claims

• South Korea Streamlines Toxicity Data Requirements for New Food Additive Recognition

• South Korea Proposes On-Site Inspection Exemption for Excellent Importers Registration

• South Korea Proposes New Labeling Requirements for Decaffeinated Coffee and Collaborative Alcoholic Beverages

• South Korea Proposes Amendments to Import Health Requirements for Pet Food

• South Korea Proposes Amendments to Enforcement Rules of Imported Food Act

• South Korea Designates Mesembrine as a Prohibited Ingredient in Directly Purchased Overseas Foods

• South Korea Releases 4th Revision of the Principles for Establishing Standards for Food, Etc. Clarifying Rules for Food Raw Materials, Additives, Cell-Cultured Foods, Contaminants, and Packaging Materials

• South Korea to Implement AI-Powered Screening System for High-Risk Imported Processed Agricultural and Fishery Products

• South Korea to Add Drunk Driving and Fetal Harm Warnings to Alcohol Beverage Containers

Japan

Japan Adds Official Test Method for PFOS and PFOA in Mineral Water

On November 14, 2025, Japan's Consumer Affairs Agency issued a notification partially revising the official testing methods for soft drinks. The primary change is the establishment of a new individual test method for perfluorooctanesulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) in mineral waters. This method specifies the use of a Liquid Chromatograph-Tandem Mass Spectrometer (LC-MS/MS).

More regulation highlights in Japan:

• Japan Amends Guidelines for Validating Analytical Methods for Hazardous Substances in Food

Southeast Asia

Thailand Issues the List on Permitted Forms of Vitamins and Minerals to Streamline Product Registration

On November 17, 2025, the Thailand Food and Drug Administration issued guidance titled Guidance on the Use of Forms of Vitamins and Minerals as Key Ingredients in Food Products. The guidance establishes positive lists of permitted chemical forms of vitamins and minerals for use in dietary supplements and general fortified foods. By using substances on these pre-approved lists, manufacturers can obtain food product registration numbers without conducting separate safety assessments.

More regulation highlights in Southeast Asia:

• Indonesia BPOM Clarifies Use of Term "Milk" for Dairy and Plant-Based Products

• Indonesia Proposes New Food Safety and Quality Assurance System (SMKPO) Certification for Processed Food Circulation

• Indonesia BPOM Amends Regulation on Online Food Sales

• Indonesia Extends Product Scope of Mandatory Halal Certification in New Draft Decree

• Thailand Proposes New Food Advertising Rules

• Thailand Proposes Amendments to Streamline Food Registration and Labeling Rules

• Thailand Expands Positive List with Four New Substances and Six Health Claims

• Thailand Amends Alcoholic Beverage Control Act, Introducing Stricter Rules on Advertising, Sales, and Seller Liability

• Thailand FDA to Brief Industry on New Food Regulations for 2026, Involving Food Labeling and Use of Food Additives

• Thailand FDA Publishes Positive List of Alternative Protein Ingredients to Accelerate Industry Growth

• Thailand Proposes New Agricultural Standard for Edible Watermeal (Pham)

• Thai FDA Seeks Industry Feedback on Market Exclusivity for New Probiotics

• Philippines FDA Reinforces Ban on Therapeutic Claims for Dietary Supplements, Highlights Labeling Compliance

• Philippines FDA Proposes Amendments to Schedule of Fees and Charges for Food and Health Products

• Vietnam to Update Decree on Sanctioning Administrative Violations in Customs

India

FSSAI Proposes Mandatory Standard Drink Labelling and Other Key Amendments to Alcoholic Beverage Regulations

On November 7, 2025, India's Food Safety and Standards Authority (FSSAI) issued a draft notification proposing amendments to the Food Safety and Standards (Alcoholic Beverages) Regulations, 2018. The draft, identified as F. No. SS-T0SP21(NOTI)/1/2025-Standard-FSSAI, focuses on enhancing consumer information and updating product standards. Key proposals include: (1) making the declaration of the number of 'standard drinks' per container on alcoholic beverage labels mandatory by changing the labelling requirement from optional to compulsory; (2) revising the standard for Brut sparkling wine by adding a 0.3% tolerance to the existing sugar content limit of below 1.2%; and (3) simplifying the definition of 'Wine-Based Beverages' by deleting the phrase 'or special wine used' from Regulation 3.1.6. FSSAI has opened a 60-day period for stakeholders to submit comments and suggestions on the draft regulations.

More regulation highlights in India:

• FSSAI Amends Food Import Regulations to Streamline Methods of Analysis

• FSSAI Clarifies Hydroxymethylfurfural (HMF) in Honey as Quality Parameter

• India Launches Pilot for FSSAI-CBIC Integration under SWIFT 2.0

• India Updates the List of FSSAI Recognized Food Testing Laboratories

• India Extends Compliance Deadline for New Alcoholic Beverage Labeling Rules Released on June 24, 2025

• FSSAI Updates Alcoholic Beverages Standards, Revising Ester Limit for Fruit Wine

• FSSAI Orders Enforcement Action Against Industrial Dye Auramine in Food Products

European Union (EU)

EU Approves Monosodium Salt of L-5-methyltetrahydrofolic Acid as New Folate Source for Use in Foods and Food Supplements

On November 6, 2025, the European Commission published Regulation (EU) 2025/2224, authorizing monosodium salt of L-5-methyltetrahydrofolic acid as a new source of folic acid/folate for use in foods and food supplements. The regulation will enter into force twenty days after its publication in the Official Journal of the European Union.

More regulation highlights in European Union (EU):

• EU Proposes to Update Protein Requirements for Infant and Follow-on Formula Manufactured from Protein Hydrolysates

• EU Authorizes Magnesium L-Threonate as a Magnesium Source in Food Supplements

• [Updated] EU Novel Food Updates in 2025: Three Amendments in November

• EU Rejects Health Claims for Joselito® Ham and Citicoline Due to Insufficient Scientific Evidence

United States (US)

U.S. FDA and CDC Conduct Outbreak Investigation of Infant Botulism

On November 26, 2025, the U.S. FDA and the CDC released an update on the ongoing investigation into a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition infant formula. Epidemiologic and laboratory evidence indicates potential contamination of the formula with Clostridium botulinum, and all ByHeart Whole Nutrition Infant Formula products have been recalled. As of November 26, 2025, 37 infants from 17 U.S. states had suspected or confirmed infant botulism after exposure to the ByHeart Whole Nutrition infant formula. FDA inspection records revealed GMP deficiencies at ByHeart's facilities.

More regulation highlights in United States (US):

• U.S. EPA Amends and Sets Tolerances for Pesticides Residues in or on Multiple Commodities

Canada

Health Canada Changes the Use Requirements for Caffeine

On November 25, 2025, Health Canada issued Notice of Modification M‑SIS‑25‑03, amending the List of Permitted Supplemental Ingredients to allow caffeine as a supplemental ingredient in hard, soft, or semi-soft candies, including gummies, under item 6 of the List of Permitted Supplemented Food Categories. At the same time, Health Canada introduced a new mandatory cautionary label for all solid supplemented foods with high caffeine content: products that contain more than 56 mg of total caffeine per serving (or per multi-serving gum package) must state, "Do not [eat/drink] on the same day as any other source of caffeine," in addition to existing warnings such as maximum daily servings and population-based restrictions.

More regulation highlights in Canada:

• Health Canada Proposes 3-Tier Risk-Based Authorization Framework for Infant Foods

• Health Canada Proposes Authorizing One New Food Enzyme

• Canada Proposes MRLs for Five Pesticides in Agricultural Products in November 2025

Australia and New Zealand

APVMA Suspends Certain Dimethoate Products Citing Worker Safety Risks

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has immediately suspended the registration and label approvals for certain dimethoate-containing agricultural products due to unacceptable worker safety risks. A risk assessment found worker exposure during mixing, loading, and application exceeds acceptable health-based guidance, meaning the products no longer meet safety criteria under the Agvet Code. Registrants are prohibited from supplying the affected products during the suspension. End-users may continue using products already in their possession only under new APVMA instructions, as existing labels are deemed inadequate. The suspension aims to mitigate risks while APVMA continues its evaluation.

More regulation highlights in Australia and New Zealand:

• FSANZ Seeks Stakeholder Feedback on Nutrition Information Panel Review, Whose Preliminary Position is That The NIP Remains Fit for Purpose, Requiring No Immediate Regulatory Changes

• FSANZ Proposes to Correct Fat Requirements for Special Medical Infant Products