Food for Special Medical Purposes (FSMP)

EU Commission Proposes Amendments to Maximum Levels of 3‑MCPD and Glycidyl Esters in Certain Foods

The European Commission has proposed stricter maximum levels for 3‑MCPD and glycidyl esters in baby foods and vegetable oils, with a planned application date of January 1, 2027. Food manufacturers and oil refiners must prepare for tighter analytical compliance and potential reformulation to meet new safety thresholds for sensitive consumer categories.

29 Mar 2026, 19:25docs.wto.orgEuropean Union

China SAMR Orders Half-Year Cleanup of Prompt Language in Advertising

China's SAMR has launched a six-month enforcement campaign (March–September 2026) targeting misleading "small print" and inadequate risk disclosures in advertising. Businesses must ensure that statutory warnings and limiting conditions for complex or regulated products are prominent to avoid penalties and potential product-level enforcement.

28 Mar 2026, 20:32samr.gov.cnChina

UK Department of Health and Social Care Updates ACBS Application Guidance and Submission Deadlines

The UK has updated submission deadlines and transitioned to a fully digital application process for the Advisory Committee on Borderline Substances (ACBS) through 2027. Manufacturers of medical foods and specialized supplements must align product listing strategies with these fixed windows to ensure timely NHS Drug Tariff inclusion and market access.

25 Mar 2026, 11:44gov.ukUnited Kingdom

China CFSA Consults on Four New Food Additives Including Two HMOs

China is moving to authorize four new food additives and nutrition enhancers, including HMOs for infant formula, following successful technical safety reviews by the CFSA. This signals imminent updates to national food safety standards, expanding market access for specialized ingredients in the infant nutrition and food processing sectors.

24 Mar 2026, 09:18cfsa.net.cnChina

Japan CAA Grants Labelling Permission for One Food for Special Dietary Uses

Japan's Consumer Affairs Agency has granted specific labeling authorization for a new product under the Food for Special Dietary Uses (FOSDU) category as of March 2026. This approval reinforces the strict pre-market authorization regime for health-related claims, requiring manufacturers to secure individual product clearance before targeting specific demographic or medical segments.

11 Mar 2026, 17:21caa.go.jpJapan

Poland Publishes Monitoring Report for WHO Programme on Elimination of Industrial Trans Fats in Food

Poland has published a comprehensive monitoring report documenting its successful elimination of industrial trans fats, supporting its status as one of the first WHO-validated countries. While no new regulations are introduced, the report signals continued rigorous market surveillance and data collection ahead of a 2026 WHO re-evaluation, reinforcing the need for strict adherence to EU trans fat limits.

6 Mar 2026, 09:58pzh.gov.plPoland

Belgium AFSCA Sets Action Limits for Cereulide in Infant and Young Child Food

Belgium has established strict action limits for cereulide in infant and young child foods, effective February 2026. Exceeding these thresholds triggers mandatory market withdrawals and consumer recalls, necessitating enhanced batch testing and supply chain verification for sensitive ingredients.

3 Mar 2026, 19:40favv-afsca.beBelgium

EU Commission Implementing Regulation (EU) 2026/386 Authorises Defatted Rapeseed Powder as a Novel Food

The EU has authorized defatted rapeseed powder as a novel food for use in a wide range of food categories and supplements, effective March 15, 2026. This provides a new plant-based ingredient option but requires strict adherence to allergen labeling and respects a five-year market exclusivity period for the primary applicant.

1 Mar 2026, 11:21eur-lex.europa.euEuropean Union

Commission Implementing Regulation (EU) 2026/397 Authorising Lacto‑N‑Tetraose Produced by Derivative E. coli K‑12 MG1655 as a Novel Food

The EU has authorized Lacto-N-tetraose (LNT) produced via a specific GM E. coli strain as a novel food, effective March 16, 2026. Manufacturers gain access to a new HMO ingredient for infant formula and supplements, subject to strict purity specifications and a five-year period of market exclusivity for the applicant.

27 Feb 2026, 16:27eur-lex.europa.euEuropean Union

Korea MFDS Publishes Draft Amendment To Standards And Specifications For Food Additives (Notice 2026-084)

South Korea's MFDS proposed a draft amendment to food additive standards on February 13, 2026, aimed at relaxing usage restrictions for nutrient fortifiers and sulphites while aligning phosphate classifications with international standards. This shift toward regulatory liberalization and international harmonization provides greater flexibility for product formulation in health functional foods and medical nutrition, though new safety-driven usage limits for polyol sweeteners may require label or recipe adjustments.

17 Feb 2026, 16:01mfds.go.krSouth Korea

EFSA Rapid Risk Assessment Derives ARfD for Cereulide in Infants

EFSA has established a new acute reference dose (ARfD) for cereulide in infants, setting a strict safety threshold for this toxin in infant and follow-on formulae. Manufacturers should prepare for harmonized EU-wide risk management decisions and potential new concentration limits to ensure compliance with these updated safety benchmarks.

3 Feb 2026, 15:29efsa.europa.euEuropean Union

Mexico Draft Standard PROY-NOM-072-SSA1-2025 On Labelling of Medicines and Herbal Remedies

Mexico has proposed updated mandatory labeling requirements for medicines and herbal remedies, introducing stricter rules for warnings, QR code integration, and Braille accessibility. Pharmaceutical and healthcare companies must prepare for revised packaging standards and digital leaflet requirements to ensure continued market access and compliance with COFEPRIS sanitary regulations.

3 Feb 2026, 14:00dof.gob.mxMexico

Mexico Draft PROY-NOM-249-SSA1-2025: Requirements for Sterile Compounding and Preparation Facilities

Mexico has proposed updated sanitary and quality requirements for facilities preparing sterile nutritional and medicinal admixtures, with consultations closing in March 2026. Healthcare operators and compounding centers must prepare for stricter infrastructure and quality management standards aligned with international ISO and WHO guidelines.

1 Feb 2026, 12:33dof.gob.mxMexico

EU Amends Food Additives Regulation for Gums, Pectins and Starch Sodium Octenyl Succinate

The EU has tightened use conditions and purity specifications for several food additive gums and pectins, specifically targeting products for infants and young children, with new rules entering into force in February 2026. Manufacturers must review formulations and supply chain specifications for substances like guar gum and xanthan gum to meet stricter microbiological criteria and lower heavy metal limits.

30 Jan 2026, 17:56eur-lex.europa.euEuropean Union

Japan Consumer Affairs Agency Grants Labelling Permission For Three Foods For Special Dietary Uses

Japan's Consumer Affairs Agency has authorized specific labeling for three new products under the Foods for Special Dietary Uses (FSDU) category as of January 2026. This underscores the requirement for individual product approvals to market specialized nutritional claims, reflecting Japan's rigorous oversight of health-related food labeling.

29 Jan 2026, 19:15caa.go.jpJapan

Germany Publishes Recall Notice For BEBA And ALFAMINO Infant Formula Over Cereulide Toxin Risk

Germany has issued a nationwide recall for specific infant formula batches following the detection of cereulide toxin risks. This enforcement action underscores the critical need for stringent microbial toxin screening and supplier oversight in the highly regulated infant nutrition sector.

11 Jan 2026, 05:44lebensmittelwarnung.deGermany

Germany (BVL) Modernises Online Notification Procedures For Food Supplements And Foods For Specific Consumer Groups

Germany is transitioning all food supplement and specialized food notifications to a mandatory online-only portal, with a final deadline of July 1, 2026. Companies should update internal submission workflows and secure digital authentication to maintain market access and ensure administrative compliance.

9 Jan 2026, 13:30bvl.bund.deGermany

EFSA Updates Administrative Guidance for New Nutrient Source Dossiers (2025/2026)

EFSA has updated administrative guidance for nutrient source applications, with phased implementation starting November 2025 and January 2026. Companies must adapt dossier submissions to new transparency and data standards to ensure timely market authorization for food supplements and fortified products.

15 Dec 2025, 15:19efsa.onlinelibrary.wiley.comEuropean Union

CJEU Clarifies Labelling Rules for Special Medical Purpose Foods

The CJEU has ruled that repeating mandatory nutrition information on the front of packaging for special medical purpose foods is prohibited under EU law. Manufacturers must audit packaging layouts to ensure nutrition data is not duplicated, as the Court has strictly limited additional labeling particulars for these specialized products.

9 Dec 2025, 08:22eur-lex.europa.euEuropean Union

CJEU Interprets Rule of Precedence in Medicinal Products Law

The CJEU has clarified that the "rule of precedence" for medicinal products applies only in cases of genuine classification uncertainty between competing EU regulatory frameworks. This ruling necessitates stricter internal compliance reviews for "borderline" products to ensure correct categorization and avoid market access disruptions caused by conflicting inter-agency enforcement.

28 Oct 2025, 16:50eur-lex.europa.euEuropean Union