This article provides a comprehensive overview of key regulatory developments in the food sector in September 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 Updates on Three New Foods in September 2025
In September 2025, China's National Health Commission (NHC) announced the termination of the review for two new food ingredient applications of D-allulose, and released a public consultation on seven new varieties of food additives, including three HMOs, two enzyme preparations, and one flavoring substance.
Official link: https://zwfw.nhc.gov.cn/kzx/slgs/slgsqb/
🔘 China Clarifies Digital Label Requirements for Prepackaged Foods
On September 8, 2025, China's NHC and the State Administration for Market Regulation (SAMR) issued a joint notice refining GB 7718-2025 digital label requirements: digital labels must exclude advertising, be clear and traceable, display information limited to physical labels, ensure compliance for special foods, and allow producer addresses to be simplified to the county level.
Official link: https://www.nhc.gov.cn/sps/c100088/202509/07b01e0a2fff482789cbb8c400c649a2.shtml
🔘 China Proposes New Dosage Forms for Coenzyme Q10 and Melatonin Health Foods
On September 19, 2025, the State Administration for Market Regulation (SAMR) of China released a draft to expand the permitted dosage forms for Coenzyme Q10 and Melatonin in the Health Food Raw Material Directory. The proposal adds powder and oral liquid forms and updates the list of allowable excipients. Public comments are open until October 28, 2025.
Official link: https://www.samr.gov.cn/hd/zjdc/art/2025/art_a2ad05e377854a128cd5fe258e3c343a.html
🔘 China Implements New National Standard for Sterilized Milk
On September 16, 2025, GB 25190-2010 National Food Safety Standard Sterilized Milk (No.1 Amendment Sheet) officially took effect, introducing three key changes:
Ban on reconstituted milk: Sterilized milk must be made exclusively from fresh cow's or goat's milk, prohibiting the use of milk powder reconstituted with water. Products containing reconstituted milk must be labeled as "formulated milk."
Strict use of fresh milk ensures product authenticity: Only fresh cow's or goat's milk may be used, with no other ingredients allowed, preserving the original quality of sterilized milk.
Enhanced labeling transparency: Packaging must clearly indicate the milk source and ingredients, helping consumers make informed choices and preventing misleading claims.
🔘 China Implements Revised National Standard for Fermented Milk
The revised National Food Safety Standard for Fermented Milk (GB 19302-2025) came into effect on September 16, 2025. The update optimizes the scope, raw material requirements, physicochemical indicators, microbial limits, and labeling rules, further standardizing production, testing, and labeling of fermented milk products. Companies should review the revisions and adjust production and quality controls to ensure compliance.
🔘 China Issues 32 New Food Safety Standards and Updates to Milk Standards
On September 25, 2025, China's NHC and SAMR jointly issued Announcement No. 6 of 2025, formally releasing 32 new national food safety standards and 2 amendment sheets. See previous news.
🔘 China Releases Updated Good Manufacturing Practice Standard for Health Foods
On September 25, 2025, China's NHC and SAMR issued the National Food Safety Standard – Good Manufacturing Practice for Health Foods (GB 17405-2025), replacing the 1998 version. Based on GB 14881, the update revises factory environment requirements and adds safety management and recall/traceability provisions, aiming to standardize production, improve the special foods regulatory framework, and support industry development.
🔘 China Issues Q&A on Two Major Food Labeling Standards, GB 7718-2025 and GB 28050-2025
On September 25, 2025, China's NHC released two official Q&A documents on major food labeling standards: GB 28050-2025 and GB 7718-2025. Both standards were part of Announcement No. 2 of 2025, issued on March 27, which introduced 50 new national food safety standards and nine amendments. The newly published Q&A clarifies their application and interpretation, helping ensure accurate implementation before they take effect on March 16, 2027. See previous news.
🔘 China's Non-compliant Food Imports in August 2025
On September 16, 2025, China's General Administration of Customs (GACC) released its list of non-compliant imported food products for August 2025. A total of 617 batches from 52 countries and regions were denied entry, representing a month-on-month increase of approximately 30% (up 141 batches from 476 in July) and a year-on-year increase of about 105% (up 316 batches from 301 in August 2024).
Detailed Analysis: Mooncakes Blocked at the Border? — China's Non-compliant Food Imports in August 2025
🔘 EFSA Publishes Three Scientific Opinions on Novel Foods in September 2025
1. Fungal biomass from Fusarium species strain flavolapis – EFSA concluded that the exposure margins between the recommended intake and the NOAEL from a 90-day study are insufficient (adolescents: 55; infants: 19). The substance may trigger allergic reactions, and its safety as a novel food could not be established.
Official link: https://www.efsa.europa.eu/en/efsajournal/pub/9536
2. Rapeseed protein–fibre concentrate – A powder mainly composed of protein and fiber, obtained from cold-pressed rapeseed cake via water and organic solvent extraction. EFSA concluded it is safe for individuals aged 10 and above under the proposed use conditions, provided foods and supplements containing it are not consumed on the same day.
Official link: https://www.efsa.europa.eu/en/efsajournal/pub/9631
3. Pasteurized Akkermansia muciniphila – EFSA concluded it is safe at 2.1×10¹⁰ cells/day for adolescents 12–14 years and 3.0×10¹⁰ cells/day for adolescents 14–18 years. Safety for pregnant or breastfeeding women has not been established.
Official link: https://www.efsa.europa.eu/en/efsajournal/pub/9632
🔘 EFSA Issues One Scientific Opinion on a Feed Additive in September 2025
Pediococcus pentosaceus NCIMB 12674 in silage: EFSA concluded that using this strain as a silage additive is safe for all animal species, consumers of animal products from treated silage, and the environment. For user safety, inhalation and skin contact may pose risks, while eye irritation potential cannot be determined. The expert panel also concluded that a minimum dose of 1×10⁹ CFU/kg fresh plant material can improve the yield and fermentation quality of silage made from moderately difficult-to-ensile plant material with 21–38.5% dry matter.
Official link: https://www.efsa.europa.eu/en/efsajournal/pub/9634
🔘 EFSA Publishes Scientific Support Report on CBD as a Novel Food
EFSA released a preparatory scientific report updating the safety assessment of cannabidiol (CBD) as a novel food. In 2022, EFSA concluded that significant uncertainties and data gaps prevented confirmation of CBD's safety. Following new research, EFSA systematically reviewed literature since 2021, including 18 human studies, focusing on potential adverse effects of oral CBD, such as liver toxicity, neurological impacts, psychological symptoms, and gastrointestinal reactions. The review confirmed that CBD’s safety remains uncertain, with some risks related to dose and duration, providing a scientific basis for EFSA's future risk assessment.
Official link: https://www.efsa.europa.eu/en/supporting/pub/en-9635
🔘 UK Proposes Ban on Sales of High-Caffeine Energy Drinks to Under-16s
The UK Department of Health and Social Care has launched a public consultation proposing to ban the sale of high-caffeine energy drinks to individuals aged 15 and under in England.
Official link: https://www.asa.org.uk/news/keeping-the-regulator-sweet.html
🔘 US FDA Proposes Revoking Authorization for Orange B Food Color
On September 17, 2025, the U.S. FDA announced a proposal to revoke the use of the petroleum-based food color "Orange B," marking a key step in the national phase-out of synthetic food dyes. The agency is currently seeking public comments, with submissions accepted until October 16, 2025.
Official link: https://www.fda.gov/food/hfp-constituent-updates/fda-proposes-revocation-authorization-orange-b-food
🔘 US FDA Publishes Proposed Food Regulatory Agenda
On September 4, 2025, the U.S. FDA released its Proposed Food Regulations as part of the biannual Unified Agenda of Regulatory and Deregulatory Actions. The agenda outlines the current planned food-related regulations.
🔘 US NPA Announces FDA Acknowledges NMN as Lawful Dietary Supplement
On September 29, 2025, the U.S. Natural Products Association (NPA) announced that the FDA had acknowledged that β‑Nicotinamide Mononucleotide (NMN) can be legally marketed as a dietary supplement.
Previously, the FDA had applied the "drug preclusion" or race-to-market clause in the Dietary Supplement Health and Education Act of 1994 (DSHEA), determining that NMN should not be sold as a supplement. The NPA challenged this through citizen petitions, litigation, and industry-consumer advocacy, ultimately leading the FDA to recognize that NMN had been marketed in the U.S. as a dietary supplement since 2017 and thus is exempt from the drug exclusion clause.
Official link: https://www.npanational.org/news/amid-pressure-from-npa-fda-declares-nmn-lawful-in-dietary-supplements/
🔘 Brazil Updates Regulations on Food Additives and Processing Aids
Brazil's National Health Surveillance Agency (ANVISA) issued Normative Instruction No. 395 (IN nº 395), amending Normative Instruction No. 211 of March 1, 2023. The updated regulation revises the technical functions, maximum permitted levels, and conditions of use for authorized food additives and processing aids.
🔘 Japan Updates Regulatory Measures for Enzyme-Based Food Additives
Japan's Consumer Affairs Agency (CAA) announced adjustments to the regulation of enzyme-based food additives due to updated microbial identification technologies. The new system allows continued use of enzymes produced by renamed microbial strains if confirmed to be identical to previously approved ones. Manufacturers must report the strains in use, and relevant information will be published on the CAA website.
Official link: https://www.caa.go.jp/policies/policy/standards_evaluation/food_additives/research_003
🔘 Indonesia Issues New Regulation on Probiotic Health Supplements
Indonesia's National Agency of Drug and Food Control (BPOM) has released Regulation No. 17/2025 on the Evaluation Guidelines for Probiotic Health Supplements, replacing the 2021 version. The regulation provides clearer technical guidance for evaluating probiotic supplements prior to market authorization.
Official link: https://www.pom.go.id/siaran-pers/bpom-terbitkan-regulasi-baru-suplemen-kesehatan-mengandung-probiotik
🔘 ASEAN Officially Endorses Guidelines on Nutrition Labelling
The ASEAN Guidelines on Nutrition Labelling were finalized at the 39th ASEAN Prepared Foodstuff Product Working Group (PFPWG) meeting in November 2024 and formally endorsed in August 2025. The Guidelines aim to harmonize nutrition labelling across member states, enhance consumer protection, and facilitate regional trade.
*This article is compiled by ZMUni Compliance Center, based on the latest regulatory updates from food-related regulatory authorities/agencies in various countries/regions.
