This article provides a comprehensive overview of key regulatory developments in the food sector in December 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: Consultations on Eight New Food Additive Varieties
In December, 2025, the China National Center for Food Safety Risk Assessment (CFSA) released draft public consultation documents covering eight new food additive varieties. The proposed additives include 3'-sialyllactose sodium salt, nitricacid, lacto-N-neotetraose, vitamin E (dl-alpha-tocopheryl acetate), and Enzymatically produced steviol glycosides, among others.
Source: 1. https://www.cfsa.net.cn/spaqbz/xzxkzqyj/2025/16027.shtml;
2. https://www.cfsa.net.cn/spaqbz/xzxkzqyj/2025/16226.shtml.
🔘 China Issues New Requirements for Infant Formula Liquid Milk Formulation Registration
On December 1, 2025, the State Administration for Market Regulation (SAMR) of China issued and implemented the Items and Requirements for Application Materials for the Registration of Infant Formula Liquid Milk Product Formulations. According to the announcement, market regulation authorities will further strengthen the review of the safety and scientific basis of infant formula liquid milk formulations and enhance risk prevention and control across the entire production and distribution chain of such products.
Source: https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/tssps/art/2025/art_a23681465a224644848d86293d86562d.html
🔘 China Seeks Public Comments on Planned National Standards for Health Foods
On December 8, 2025, China released a proposed list of 14 planned national standards related to health foods for public consultation. The proposed standards cover six ingredient standards, including lutein esters, DHA algal oil, whey protein, and soy protein isolate, as well as analytical methods for substances such as silybin and ergosterol. The list also includes the Technical Guideline for the Evaluation of Scientific Evidence Supporting Health Function Claims of Health Food Ingredients.
Source: https://std.samr.gov.cn/gb/gbSuggestionPlan
🔘 China Expands Dosage Forms for Coenzyme Q10 and Melatonin Health Foods
On December 31, 2025, China SAMR announced the expansion of permitted dosage forms and excipients for record-filed health food products containing Coenzyme Q10 and melatonin, effective March 1, 2026. The update allows powder and oral liquid forms for Coenzyme Q10–based products and oral liquid forms for melatonin-based products, providing clearer regulatory guidance for the development of health foods designed to meet the chewing, swallowing, and nutrient absorption needs of elderly consumers, while further enriching product offerings and market choices.
Source: https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/tssps/art/2025/art_960ad341a1604308955ec375e548f7c2.html
🔘 China Adds Red 2G and Sibutramine to List of Non-Food Substances
On December 15, 2025, China's SAMR and National Health Commission (NHC) added Red 2G, Methyl Yellow, Dimethyl Yellow, and Sibutramine (and its derivatives) to the List of Non-Food Substances Potentially Added to Foods, citing health risks associated with industrial dyes and appetite suppressants. Official testing methods were released alongside the update.
Source: https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/spcjs/art/2025/art_9a6decf18b48416780491d19cbe706e7.html
🔘 China Pilots Classified Management for Imported Food–Drug Substances
On December 10, 2025, the General Administration of Customs of the People's Republic of China(GACC), China NHC, China SAMR, and China National Medical Products Administration (NMPA) jointly issued a notice launching a pilot program for classified management of imported food–drug substances, introducing a regulatory reform covering 30 specified substances.
Source: http://gdfs.customs.gov.cn/customs/302249/2480148/6863625/index.html
🔘 China's Non-compliant Food Imports in November 2025
On December 25, 2025, China Customs released its list of non-compliant imported food products for November 2025. A total of 444 batches from 44 countries and regions were denied entry. Labeling issues remain the top concern, accounting for 19.8% of non-compliances, followed by sensory inspection failures and detection of unauthorized ingredients. In November, 88 batches were denied entry due to labeling problems, while the share of products containing unauthorized animal-derived ingredients or exceeding additive limits rose sharply from 0.2% last year to 4.3% and 3.2%, highlighting the need for stricter oversight. See detailed analysis.
🔘 Taiwan Proposes Use and Labeling Requirements for Genetically Fermented 2'-Fucosyllactose/Difucosyllactose
On December 16, 2025, Taiwan released a draft standard for the use and labeling of a mixture of 2'-Fucosyllactose (2'-FL) and Difucosyllactose (DFL) produced via genetically modified Escherichia coli fermentation. The proposal specifies the production process, specifications, application scope, maximum usage levels, and labeling requirements. The draft allows the mixture in infant formula and follow-on formula (up to 1.6 g/L), as well as milk or similar products for children under seven years old (up to 1.2 g/L), and opens a 60-day public consultation period.
🔘 EU Launches Food and Feed Safety Simplification Package
On December 16, 2025, the European Union introduced the Food and Feed Safety Simplification Package, a legislative proposal aimed at streamlining the EU's food and feed regulatory system, reducing administrative burden and costs for businesses while maintaining high safety standards.
Key measures include: modernization of feed additive rules with relaxed renewal requirements and digital labeling options; clarification of the legal status of fermentation products from genetically modified microorganisms (GMMs) to facilitate market access; and simplification of official reference laboratory accreditation rules, encouraging the use of new testing methods without compromising quality standards. The proposal has been submitted to the European Parliament and Council for review and approval.
Source: https://ec.europa.eu/commission/presscorner/detail/en/ip_25_3081
🔘 EFSA Publishes 5 Novel Food and 13 Feed Additive Scientific Opinions
In December 2025, the European Food Safety Authority (EFSA) released 5 novel food and 13 feed additive scientific opinions. Novel foods assessed include galacto-oligosaccharides, egg membrane collagen peptides, algal meal and oleoresin from Haematococcus pluvialis containing astaxanthin, and Rhizomucor pusillus biomass powder. Feed additive opinions cover ingredients such as spearmint essential oil, thyme essential oil, perlite, and zeolites, evaluating safety and efficacy for all relevant animal species.
Source: https://www.efsa.europa.eu/en/search
🔘 U.S. FDA Restores NMN's Dietary Supplement Status
On December 9, 2025, the U.S. Food and Drug Administration (FDA) published a response letter on Regulations.gov, addressing submissions by Chinese company SyncoZymes (Shanghai) Co., Ltd. regarding β-nicotinamide mononucleotide (NMN). The FDA reinstated NMN as a dietary supplement, reversing its prior interpretation that had excluded the ingredient under the drug preclusion clause of the Dietary Supplement Health and Education Act (DSHEA). For Further Reading.
🔘 USDA Updates Label Approval Guidance for Voluntary "Product of USA"
On December 10, 2025, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) updated its label approval guidance for voluntary "Product of USA" and similar claims. Key updates clarify that geographic images may only be used without a qualifier if the animal was born, raised, slaughtered, and processed in the U.S., while products not meeting these criteria must include a statement. Under specific conditions, multi-country origin claims including the U.S. and foreign sources are permitted, and multi-ingredient products using edible natural casings processed outside the U.S. may still make voluntary U.S. origin claims. FSIS also emphasizes that "ingredients" should be U.S.-sourced, though sub-ingredients are excluded from this requirement.
🔘 U.S. FDA Issues Letter on DSHEA Disclaimer Placement
On December 11, 2025, the U.S. FDA issued a letter to the dietary supplement industry regarding the placement of the DSHEA disclaimer on product labels, as required under the Federal Food, Drug, and Cosmetic Act, amended by the Dietary Supplement Health and Education Act of 1994 (DSHEA). The letter clarifies that, although disclaimers are generally required on every panel containing a claim, the FDA will exercise enforcement discretion and will not immediately enforce this requirement, providing temporary regulatory flexibility to the industry.
Source: https://www.fda.gov/food/hfp-constituent-updates/fda-issues-letter-industry-dshea-disclaimer
🔘 Brazil Updates Dietary Supplement Ingredient and Labeling Rules
On December 18, 2025, Brazil's ANVISA issued Normative Instruction No. 418/2025, revising IN 28/2018 to update authorized ingredients, usage limits, claims, and labeling requirements for dietary supplements. Annex I lists ingredients for general supplements (e.g., NMN, quercetin, chlorella powder, olive leaf extract), while Annex II covers supplements for infants (0–12 months) and young children (1–3 years). The update clarifies allowable substances and labeling practices to support product compliance in Brazil.
🔘 Australia TGA Approves NMN with Market Exclusivity
On December 10, 2025, Australia's Therapeutic Goods Administration (TGA) added NMN to the permissible ingredient list for listed complementary medicines. This approval establishes a clear compliance pathway for NMN-containing formulations under Australian law. For Further Reading.
🔘 Thailand Revises Nutrition Labeling Requirements for Prepackaged Foods
On December 12, 2025, Thailand's Ministry of Public Health issued Notification No. 467 B.E. 2568 (2025) under the Food Act B.E. 2522 (1979), updating nutrition labeling requirements for prepackaged foods to improve clarity for consumers. The revision standardizes the visual presentation of nutrition information, including mandatory use of a white background for the nutrition information box and Guideline Daily Amount (GDA) labels, with clear, consistent text formatting to enhance readability. Exceptions may apply for large outer packaging where a white background is not feasible. The update is effective immediately upon publication.
Source: https://food.fda.moph.go.th/food-law/category/announcement-of-the-ministry-of-public-health-1/
*This article is compiled by ZMUni Compliance Center, based on the latest regulatory updates from food-related regulatory authorities/agencies in various countries/regions.
