This article provides a comprehensive overview of key regulatory developments in the food sector in November 2025, both in China and internationally. It focuses on updates related to new food ingredients, food additives, health foods, and feed, aiming to offer timely and in-depth regulatory alerts for enterprises engaged in food import and export.
🔘 China Three New Food Updates: Official Approval on Three New Food Ingredients
On November 27, 2025, the National Health Commission of China officially approved 14 substances as "Three-New Food", including 3 new food ingredients, 8 new food additives, and 3 new food-related products. See previous news.
🔘 China Releases Draft FSMP Production License Guidelines (2025)
On November 3, 2025, China's State Administration for Market Regulation (SAMR) released the Review Guidelines for the Production License of Formula Foods for Special Medical Purposes (2025 Edition) (Draft for Comments), Comments are welcomed until Dec 3, 2025.
Reference: https://www.samr.gov.cn/hd/zjdc/art/2025/art_04e29b97da214aa8b1605ba6daa0aed3.html
🔘 China Allows Sale of Health Foods and Pet Foods in Duty-Free Stores
On October 31, 2025, China's Ministry of Finance, Ministry of Commerce, Ministry of Culture and Tourism, General Administration of Customs, and State Taxation Administration jointly issued the Notice on Improving Duty-Free Store Policies to Support Consumption. The Notice clarifies that, starting November 1, 2025, the duty-free store policies will be updated to allow the sale of health foods and pet foods. The aim is to further leverage duty-free store policies to boost consumption and promote the healthy and orderly development of duty-free retail business.
Reference: https://gss.mof.gov.cn/gzdt/zhengcefabu/202510/t20251030_3975251.htm
🔘 China Initiates Six New National Food Standards
On November 28, 2025, the General Office of China's National Health Commission(NHC) issued the second batch of the 2025 National Food Safety Standard Establishment Plan, which includes two standards for food additives and four standards for food contact materials and articles.
Reference: https://www.nhc.gov.cn/sps/c100087/202511/cf7ba6ac611640888e32a9fafce8d061.shtml
🔘 China Issues Notice on Strengthening Trademark Usage Management
On November 17, 2025, China's National Intellectual Property Administration (CNIPA) issued the Notice from the Office of CNIPA on Strengthening Trademark Usage Management. The notice focuses on preventing and addressing illegal or non-compliant practices, particularly the use of unregistered trademarks containing prohibited or misleading terms. Key areas of concern include the use of unregistered trademarks featuring terms such as "exclusive supply," "special supply," "selenium-enriched," "organic," "zero additives," "100%," "handmade," and "hand-beaten."
Reference: https://www.cnipa.gov.cn/art/2025/11/21/art_546_202675.html
🔘 China's Non-compliant Food Imports in October 2025
On November 27, 2025, China Customs released its list of non-compliant imported food products for October 2025. A total of 410 batches from 33 countries and regions were denied entry, representing a month-on-month decrease of approximately 7.4% (down 33 batches from 443 in September) and a year-on-year increase of about 107.1% (up 198 batches from 212 in October 2024). See previous news.
🔘 EFSA Publishes Updated Guidance on Microbial Characterisation for Food Chain Products
On November 4, 2025, the European Food Safety Authority (EFSA) released the updated guidance on the characterisation of microorganisms in support of the risk assessment of products used in the food chain. The revision provides a systematic update of the scientific requirements for risk assessment of all regulated products, including both genetically modified (GM) and non-GM microorganisms. This update serves as an integration, extension, and significant supplement to existing guidance documents, aiming to enhance the consistency, scientific rigor, and transparency of risk assessments.
🔘 EU Commission Rejects Health Claim for CDP-Choline
On November 4, 2025, the European Commission published Regulation (EU) 2025/2223, refusing authorization of the health claim that "consumption of CDP-choline helps healthy older adults with age-related memory impairment maintain memory function" (EFSA-Q-2022-00411). EFSA's scientific opinion, issued on July 4, 2024, concluded that the available data did not demonstrate a causal link between CDP-choline intake and memory improvement or maintenance in this population. No comments were received from the applicant or the public, and the EU Standing Committee supported the decision.
Reference: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202502223
🔘 EU Authorizes Two New Nutrients for Use in Food Supplements
On November 5, 2025, OJEU published two implementing regulations (Reg. (EU) 2025/2224 and Reg. (EU) 2025/2225), updating EU legislation to authorize monosodium salt of L-5-methyltetrahydrofolic acid as a source of folic acid added to foods and as a source of folate used in the manufacture of food supplements, and magnesium L-threonate as a source of magnesium used in the manufacture of food supplements. These updates provide the legal basis for the compliant use of these two ingredients in the EU.
Reference:
1.https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202502224
2.https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202502225
🔘 EU Publishes Authorization for Clostridium butyricum TO-A as Novel Food
On November 6, 2025, the Official Journal of the European Union (OJEU) published Implementing Regulation (EU) 2025/2223, which authorizes Clostridium butyricum TO-A as a novel food. This regulation provides the legal basis for the compliant use of Clostridium butyricum TO-A in the EU.
Reference: https://eur-lex.europa.eu/eli/reg_impl/2025/2233/oj/eng
🔘 EU Authorizes Yellow Tomato Extract as Novel Food
On November 7, 2025, the OJEU published Implementing Regulation (EU) 2025/2242, authorizing a yellow tomato extract as a novel food. The authorization follows an application submitted by Lycored Ltd on April 30, 2024, requesting the use of the extract in food supplements for adults. The company also successfully obtained data protection for its toxicological studies, granting exclusive market rights for five years after the regulation enters into force. Subsequent applicants may submit similar applications based on legally obtained information.
Reference: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202502242
🔘 EU Revises DHA Limits for Schizochytrium sp. (ATCC PTA-9695) Oil
On November 7, 2025, the European Commission published Implementing Regulation (EU) 2025/2245, amending the use conditions of Schizochytrium sp. (ATCC PTA-9695) oil as a novel food. The DHA intake limit is now 1 g/day for the general population aged 3 and above, including pregnant and lactating women, while the 250 mg/day limit remains for children under 3. EFSA previously confirmed that 1 g/day DHA is safe, so no new safety assessment was required.
Reference: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202502245
🔘 U.S. Senator Introduces Legislation to Ensure Safer Food for American Families
On November 6, 2025, Republican Senator Roger Marshall (M.D.) from Kansas introduced the Better Food Disclosure Act (The Better FDA). The bill aims to enhance the U.S. FDA's oversight of food ingredient disclosure and review by requiring food companies to report ingredients in their supply chains.
It would also allow state officials and the public to request FDA review of existing ingredients in the food supply—such as unreported colorants or additives—to address gaps in the Generally Recognized as Safe (GRAS) framework. The legislation seeks to increase ingredient transparency, helping consumers make informed choices, and responds to state-level efforts to strengthen food safety standards. The bill has received support from community leaders involved in the "Make America Healthy Again" (MAHA) initiative.
Reference:
🔘 US CRN Updates VMS4: Vitamin K2 and Other Nutrients Safety
The Council for Responsible Nutrition (CRN) has announced updates and additions to its reference work, "Vitamin and Mineral Safety, 4th Edition" (VMS4). These revisions enhance this comprehensive and science-based resource, with key updates including the safety assessments of choline, CDP-choline, and vitamin K2 (menaquinone-7, MK-7).
Notably, through a rigorous evaluation, CRN established the maximum observed intake (MOI) for vitamin K2 (MK-7) in adults at 375 µg/day for the first time. This provides evidence-based guidance for manufacturers, regulators, and healthcare professionals, supporting a deeper understanding of this increasingly utilized nutrient.
Reference: https://www.crnusa.org/resources/vitamin-mineral-safety
🔘 Canada Updates Permitted Supplemental Ingredients List to Allow Caffeine in Certain Confectionery
On November 25, 2025, Health Canada announced an update to the List of Permitted Supplemental Ingredients, allowing caffeine—both synthetic and naturally sourced—to be added to foods listed under Category 6 of the List of Permitted Supplemented Food Categories, namely hard, soft, or semi-soft candies (excluding single-serving candies sold individually). The update also strengthens label warning requirements for high-caffeine solid supplements. The regulation took effect on the same day, while some labeling changes have a compliance deadline of January 1, 2028.
🔘 Canada Proposes Authorization of Exo-Inulinase from Trichoderma reesei AR-577
On November 20, 2025, Health Canada issued proposal P-FAA-25-01 to amend the List of Permitted Food Enzymes, seeking to authorize exo-inulinase from Trichoderma reesei AR-577 for use in bread, white and whole wheat flour, and non-standard bakery products under GMP conditions. The proposal follows Health Canada's pre-market safety and efficacy assessment, covering allergenicity, chemical, and microbiological aspects. The enzyme can hydrolyze inulin to improve dough fermentability. Public comments are open until February 3, 2026, and the CFIA will enforce the regulation once finalized.
🔘 Health Canada Issues Reminder on Upcoming Front-of-Package Label Requirements
On November 17, 2025, Health Canada issued a reminder that new front-of-package (FOP) labeling requirements will soon come into effect. Under the revised implementation plan, starting January 1, 2026, all foods imported, produced, or packaged for retail in Canada on or after that date must fully comply with the new FOP labeling requirements and follow the standard regulatory response process. Products imported, produced, or packaged before January 1, 2026 may continue to be sold and remain on store shelves.
Reference: https://inspection.canada.ca/en/food-labels/labelling/implementation-plan
🔘 Thailand Publishes Guidance on Vitamins and Minerals as Key Food Ingredients
The Thai Food and Drug Administration (FDA) has issued the "Guidance on the Use of Vitamins and Minerals as Key Ingredients in Foods", which provides a positive list of vitamin and mineral formulations permitted for use in dietary supplements and fortified foods.
Reference: https://food.fda.moph.go.th/food-law/announ-fda-vitamins-minerals
🔘 India Updates Import Food Analysis Requirements
On November 18, 2025, the FSSAI issued the First Amendment to the Food Safety Standards (Import) Regulations, 2025, amending certain provisions of the 2017 regulations, effective May 1, 2026. Key changes include prioritizing FSSAI's analytical methods, with validated international methods (AOAC, ISO, BIS, Codex) allowed if unavailable, and requiring laboratory reports (FORM-2) signed by a food analyst or director within 5 working days of sample receipt.
🔘 Australia to Strengthen Safety Controls on Vitamin B6 Products
On November 25, 2025, the TGA announced stronger safety measures for vitamin B6 products to reduce nerve damage risks from high-dose use, effective June 1, 2027.
≤50 mg/day: regular retail sale
>50–200 mg/day: non-prescription with pharmacist guidance
>200 mg/day: prescription only
🔘 New Zealand Launches Public Consultation on Digital Labelling Trial for Low-Risk Imported Foods
The Ministries of Economic Development and Safety in New Zealand have announced a public consultation on a proposal to pilot digital labels for low-risk imported products. Under the trial, authorized retailers would be temporarily exempt from certain requirements under Section 343 of the Food Act 2014, meaning not all information must be displayed on the physical packaging. The trial aims to assess feasibility and lay the groundwork for a future regulatory framework where digital labelling complements physical labels.
🔘 FSANZ Approves Two Amendments to Food Standards Code
On November 10, 2025, FSANZ issued Notification Circular 368-25, approving two updates to the Australia New Zealand Food Standards Code. Application A1324 authorizes 3-fucosyllactose, a human milk oligosaccharide produced via GM E. coli K-12, for voluntary addition to infant formula. Application A1333 approves foods derived from GM purple tomatoes (Del/Ros1 event), engineered to contain higher anthocyanins and chlorogenic acid, both safe and commonly found in foods.
Reference: https://www.foodstandards.gov.au/food-standards-code/circulars/notification-circular-368-25
*This article is compiled by ZMUni Compliance Center, based on the latest regulatory updates from food-related regulatory authorities/agencies in various countries/regions.
