Consumer Health – USA, Europe, Asia, and ROW Regulatory News – April 2025

USA

Phase-Out of Petroleum-Based Synthetic Dyes in U.S. Food Supply 

The U.S. Department of Health and Human Services (HHS) and FDA announced measures to eliminate petroleum-based synthetic dyes from the nation’s food supply. Actions include revoking authorization for Citrus Red No. 2 and Orange B, eliminating six other synthetic dyes by next year, and fast-tracking natural alternatives such as calcium phosphate and butterfly pea flower extract. 

The FDA is collaborating with the National Institutes of Health (NIH) to research the impact of food additives on children’s health. Officials urge food companies to transition to natural dyes, citing growing concerns about childhood diabetes, obesity, depression, and ADHD. The initiative aims to improve public trust in food safety and strengthen evidence-based food policies for a healthier future. 

EUROPE

Safe2Eat 2025: Strengthening Consumer Confidence in EU Food Safety 

The European Food Safety Authority (EFSA) has launched Safe2Eat 2025, expanding the campaign to 23 countries to enhance consumer awareness of science-based food safety practice. Building on past success, the initiative addresses food labeling, waste reduction, and the role of science in ensuring safe food choices. In 2024, the campaign reached over 50 million people, significantly influencing consumer attitudes toward food safety. EFSA aims to make food safety information more accessible and continue fostering public trust in regulatory standards across Europe.

Regulation Updates on Cosmetic Ingredient Restrictions 

The EU has amended Regulation (EC) No 1223/2009 to impose limits on Vitamin A, Alpha-Arbutin, Arbutin, Triclocarban, 4-Methylbenzylidene Camphor, Genistein, Daidzein, Kojic Acid, and Triclosan due to potential health risks. 

– Vitamin A is capped at 0.05% in body lotions and 0.3% in other cosmetics to prevent overexposure. 

– Alpha-Arbutin and Arbutin must not exceed 2% in face creams and 0.5% in body lotions, with Arbutin limited to 7% in face creams. 

– 4-Methylbenzylidene Camphor, a UV filter, is banned for its endocrine-disrupting effects. 

– Genistein and Daidzein are restricted to 0.007% and 0.02%, respectively. 

– Kojic Acid, used in skin lightening, is limited to 1% in face and hand products. 

– Triclosan stays at 0.3% in select cosmetics, but is banned in mouthwash and toothpaste for children under 3. 

– Triclocarban remains capped at 0.2% in cosmetics and 1.5% in rinse-off products. 

These updates aim to enhance consumer safety and provide industry transition periods for compliance.

ARGENTINA

ANMAT Bans Falsely Labeled Rocío Brand Spice Product

ANMAT has prohibited the production, fractionation, and sale of the Rocío brand spice mix containing bay, rosemary, basil, white pepper, black pepper, and nutmeg. The ban applies to all batches and expiration dates due to false labeling, with non-existent RNE and RNPA registration numbers. Any product displaying RNE No. 14001856 or RNPA No. 14026785 is considered illegal and cannot be marketed nationwide.

ANMAT Bans Illegal Royal CBD Premium Line Food Products

ANMAT has prohibited the sale, production, and packaging of Royal CBD Premium Line food supplements due to their lack of health registration in Argentina. The affected products include CBD gummies labeled as “CANDY full spectrum” and “Strawberry and Watermelon.” Since these items lack proper traceability and safety guarantees, they pose a risk to public health. The ban extends to all sales, including online platforms. Consumers are advised not to purchase or consume these products and to contact health authorities for further information.

ANMAT Bans Falsely Labeled Finca Don Amancio Olive Oil

ANMAT has prohibited the production, packaging, and sale of Finca Don Amancio extra virgin olive oil due to the use of non-existent RNE and RNPA registration numbers, making it an illegal product. The ban applies to all batches and expiration dates nationwide, including online platforms. The investigation was initiated after a report from the Directorate of Food Industries and Products (DIPA) in Buenos Aires, confirming the absence of valid establishment and product records.

ANMAT Bans Unauthorized Children’s Cosmetics

ANMAT has prohibited the sale, distribution, and advertising of various children’s cosmetic products due to their lack of proper health registration. These unregulated products pose potential health risks, as children’s skin is more sensitive and prone to absorbing harmful substances. Without certification, their safety, manufacturing conditions, and compliance with regulations remain uncertain. The ban aims to protect public health and prevent exposure to potentially hazardous cosmetic ingredients.

AUSTRALIA

Updates to Australia New Zealand Food Standards 

Amendment No. 236 of the Food Standards Gazette introduces three key changes to the Australia New Zealand Food Standards Code: 

– Approval of fructosyltransferase from Aspergillus oryzae as a processing aid for manufacturing short-chain fructooligosaccharides. 

– Authorization of triacylglycerol lipase from GM Komagataella phaffii for use in bread and bakery products. 

– Addition of **herbicide-tolerant sugar beet line KWS20-1** to the list of food produced using gene technology. 

These variations were officially published in the Commonwealth of Australia Gazette on April 29, 2025.

FSANZ Advances Nutrition Labelling Review

FSANZ is reviewing front- and back-of-pack food labelling through projects focused on the Health Star Rating (HSR) system and the nutrition information panel (NIP). A recent public consultation gathered 74 stakeholder submissions, which will inform evidence-based decisions. The HSR review aims to support food ministers in considering mandatory implementation by early 2026, while the NIP report will be presented for review next year. Stakeholder engagement will continue throughout 2025.

Mandatory Energy Labelling Approved for Packaged Alcohol

The FSANZ Board has approved mandatory energy labelling for packaged alcoholic beverages under the Food Standards Code. If endorsed by food ministers, alcohol labels will display an energy statement detailing energy content per serving, per 100 mL, number of servings per package, and standard drinks per serving.

The measure aims to help consumers manage their energy intake and make informed choices. Additionally, the Board has clarified that nutrition content claims about sugar can be made on alcoholic beverages with more than 1.15% alcohol by volume.

Food ministers have 60 days to consider the decision. If no review is requested, the alcohol industry will have three years to comply with the new regulations, with certain exemptions.

BRAZIL

Anvisa Bans Dietary Supplements Containing Ora-Pro-Nóbis

Anvisa has prohibited the use of ora-pro-nóbis (Pereskia aculeata) in dietary supplements due to its lack of authorization as a food constituent. Companies must provide scientific evidence of its nutritional benefits before approval. The ban applies only to supplements and does not affect the consumption or sale of the fresh plant, which remains a traditional food source, particularly in Goiás and Minas Gerais.

New Regulatory Framework for Food and Packaging 

Anvisa will hold an event on April 14, 2025, at 2 pm in Brasília to present key updates on food and packaging regulations. Due to high demand, the session will be broadcast live on the agency’s YouTube channel. The meeting will also introduce the third version of Guide 16 on food shelf life determination and announce new training programs for its correct application.

Temporary Suspension of Siscomex Integration for Food Imports

Anvisa has temporarily suspended the integration of its systems with the Siscomex Single Portal for food imports due to systemic inconsistencies. The revised implementation schedule will be announced later.

During the suspension, existing protocols will continue to be reviewed, and importers must track their LPCO statuses. Anvisa recommends re-registering food import processes via the Solicita system using the LPCO I00046 model, following LPCO Manual guidelines.

Anvisa Discusses New Regulatory Framework for Food and Packaging 

On April 14, 2025, Anvisa held a meeting in Brasília to present updates on food and packaging regulations, focusing on electronic forms, procedures, and compliance guidelines. The event introduced the third version of Guide 16 on food shelf life determination and new training programs. 

Key regulatory changes include: 

– Registration with Anvisa for high-risk products like infant formulas. 

– Notification to Anvisa for intermediate-risk items, such as baby cereals and recycled packaging. 

– Communication to local authorities for low-risk products. 

Officials emphasized transparency, risk management, and industry collaboration. The meeting provided insights on registration process adjustments, packaging compliance, and regulatory innovations. 

Extension of Deadline for Adapting RDC 778/2023

Anvisa held a sectoral dialogue on April 22, 2025, to discuss the proposal for extending the adaptation deadline for RDC 778/2023, which regulates food additives and technological adjuvants. The meeting, attended by 260 representatives from various sectors, aimed to address industry concerns and review the proposed extension. The recording of the event is now available.

Review of Food Allergen Labeling

Anvisa will hold a virtual sectoral dialogue on April 29, 2025, from 2:30 pm to 5:00 pm, to discuss updates on allergenic food labeling. The meeting is open to all without prior registration. Topics will include Codex Alimentarius recommendations, key regulatory requirements, and the General Food Management (GGALI) plans for policy revisions. Anvisa has also prepared a basic document to support participant engagement in the discussion.

Migration of Cosmetics Registration to Solicita/Datavisa 

Anvisa has transitioned cosmetic product petitions from the Cosmetics Registration Automation System (SGAS) to the Solicita/Datavisa platform, effective April 7, 2025. Companies must now submit petitions exclusively through Solicita, improving process efficiency, security, and integration with Anvisa systems. 

New subject codes have been assigned for petitioning, and businesses must follow updated regularization procedures. Support materials, including FAQs and product classification matrices, have been provided to assist in the transition. For imported products, companies must ensure the correct registration of international manufacturers using Anvisa’s Unique Code system. 

INDIA

FSSAI Advances Sustainable Packaging with National Stakeholder Consultation

Union Minister of State for Health and Family Welfare Shri Prataprao Jadhav inaugurated FSSAI’s National Stakeholder Consultation on Sustainable Packaging in Mumbai. He emphasized the urgent need to shift towards eco-friendly, recyclable, and biodegradable packaging solutions, highlighting India’s potential to lead sustainability efforts globally.

During the consultation, stakeholders from food businesses, packaging industries, regulatory bodies, and environmental organizations discussed the latest trends and regulatory frameworks for sustainable food packaging. FSSAI introduced guidelines for rPET usage, developed through extensive stakeholder consultations, and unveiled a new logo for easy identification of sustainable food products.

Key sessions covered scientific risk assessment, global packaging standards, Extended Producer Responsibility (EPR), and industry innovations in recyclable packaging. The event reinforced collaborative efforts to advance sustainable packaging while ensuring food safety.

FSSAI Empowers Consumers to Report Misleading Food Claims

New Delhi, 30th April 2025 – The Food Safety and Standards Authority of India (FSSAI) has launched a digital tool enabling consumers to report false or misleading claims on food product labels. Complaints can be lodged through the Food Safety Connect app or the FoSCoS portal ([https://foscos.fssai.gov.in] (https://foscos.fssai.gov.in)). 

Consumers can submit details such as product images, manufacturer license number, and e-commerce URLs, helping regulators take swift action against non-compliant Food Business Operators (FBOs). This initiative strengthens transparency and aligns with FSSAI’s Advertising and Claims Regulations (2018) and Labelling and Display Regulations (2020) ensuring accurate and scientifically substantiated food claims. 

The Advertisement and Claims Monitoring Committee (AMC) will oversee compliance, reinforcing consumer protection efforts. FSSAI urges public participation to uphold integrity in food labeling and promote a healthier, informed India. The Food Safety Connect app is available on Google Play Store and Apple App Store.

INDONESIA

Warning on Processed Food Products and Food Labeling Regulations and Halal Certification Compliance 

BPOM, in collaboration with BPJPH, discovered 9 processed food products containing pork through DNA testing. Among them, 7 products were halal-certified, while 2 were not. Authorities imposed sanctions, requiring the removal of certified products from circulation and issuing warnings for non-certified products suspected of providing incorrect registration data.

Food labels and halal certification regulations, specifically PP Number 69 of 1999 concerning Food Labels and Advertisements. This regulation ensures that food products comply with labeling standards, preventing misleading claims about ingredients, origin, or halal certification.

In the case of the processed food products containing pork, halal-certified items were mislabeled, leading to product withdrawals as per PP Number 42 of 2024. For non-certified products, incorrect registration data prompted warnings and removal from circulation.

Accurate food labeling is essential for consumer protection, ensuring transparency in food safety, halal compliance, and ingredient disclosures. Authorities continue monitoring mislabeled food items, urging business compliance and public vigilance.

MALAYSIA

RiMUP Submission Now via QUEST 3+ System 

Starting April 2025, all RiMUP evaluations by the Pharmacovigilance Section must be submitted through the QUEST 3+ system, replacing manual submissions. 

– No change for products registered after 1 Jan 2014 (evaluated by PPPK). 

– New variation labels: 

  – MiV-PA3(PV) – Pharmaceutical/Biologic products. 

  – MiV-PA2(PV) – Natural products & health supplements with therapeutic claims. 

After submission, notify the team via rimup@npra.gov.my. 

RUSSIA

Rospotrebnadzor Opposes Unsafe Food Additives at Codex Alimentarius Meeting 

At the 55th meeting of the Codex Alimentarius Committee on Food Additives, held in Seoul from March 24–28, 2025, Rospotrebnadzor led the Russian delegation in discussions on food additive standards. The committee reviewed specifications, harmonized provisions, and revised maximum additive levels. 

Russia opposed the use of amaranth dye due to safety concerns, as it is banned in the Eurasian Economic Union. Additionally, Russia and other nations successfully prevented the inclusion of live GMO microorganisms in baker’s yeast standards. The committee also examined 22 recommendations and proposals related to food additives. 

Rospotrebnadzor reaffirmed its commitment to advocating for food safety at international forums. 

SOUTH KOREA

MFDS Leads Global Food Additive Standards at the 55th Codex Committee Session

The 55th Session of the Codex Committee on Food Additives (CCFA) was successfully held in Seoul from March 24-28, showcasing Korea’s leadership in food safety and regulation. The event gathered 250 participants from 55 member countries and 28 observers’ organizations to discuss international food additive standards. 

Key outcomes included: 

– Adoption of seven new food additive standards for Gochujang, boosting its global competitiveness. 

– No adoption of artificial food colors in Kimchi, reaffirming Korea’s stance on traditional food authenticity. 

– Collaboration with China and Japan to develop international standards for natural food colors used in Asian cuisine. 

– Integration of semi-dry yeast into the new baker’s yeast standard, supporting industry needs. 

– Establishment of an electronic working group to develop food safety assessment guidelines for cell-based food production. 

Discussions also focused on bioengineering and precision fermentation, emphasizing the need for global regulatory harmonization. MFDS will continue fostering internationalcooperationto strengthen Korea’s food industry competitiveness. 

VIETNAM

Food Safety Month 2025: Strengthening Inspections and Awareness

From April 15 to May 15, 2025, the Provincial Interdisciplinary Steering Committee on Food Safety is implementing the Month of Action for Food Safety, focusing on collective kitchens, catering services, and street food.

Key efforts include:

Inspections of local authorities, food production, and trading establishments to ensure compliance with food safety regulations.

Evaluation of state management agencies on their enforcement of food safety directives.

Post-inspection measures, including certification checks, staff training, and food safety testing.

Public awareness campaigns through loudspeakers, billboards, media, and educational programs.

By engaging regulators, businesses, and consumers, the initiative aims to build a safe and healthy food environment for all.

Food Safety Department Investigates Misleading Advertising for BONMAX JOINT

The Food Safety Department has discovered misleading advertising for the health protection food BONMAX JOINT, falsely claiming it has medicinal effects. Famax Pharmaceutical Joint Stock Company, responsible for the product, has denied involvement in the advertisement. Authorities are investigating and will publicly share the results on the Department’s website. Consumers are advised not to rely on illegal advertisements when purchasing, as it may pose health and financial risks.

Food Safety Department Calls for Review and Recall of Fake MSG Products

The Food Safety Department has urged the review and recall of fake MSG products from Famimoto Vietnam Co., Ltd., following reports from the Phu Tho Provincial Police. Official Dispatch No. 902/ATTP-KN (April 27, 2025) requests authorities to inspect the company’s self-declaration records, coordinate with law enforcement, and remove counterfeit products from the market. Consumers and businesses are advised not to use these fake MSG products to ensure food safety.

Warning on Misleading Advertising of Chitose Food Supplement

The Food Safety Department has identified misleading advertisements for the Chitose Food Supplement, falsely exaggerating its effects and causing confusion about its origin. Authorities are coordinating to address the issue. Consumers are advised not to trust these advertisements when purchasing the product, as they may pose health risks.

Recall of Counterfeit Powdered Milk Products

The Food Safety Department has proposed the recall of 12 counterfeit powdered milk products, following the request from the Ministry of Public Security’s Investigation Police Agency. Authorities are directed to inspect and coordinate efforts to remove these products from the market and take legal action. Consumers are advised not to use 72 dairy products currently under investigation until the Public Security Agency reaches a final conclusion. Officials are also instructed to strengthen inspections to combat poor-quality fake food. 

Workshop on Food Additives and Contaminant Regulations in Health Protection Foods

On April 16, 2025, the Department of Food Safety held a workshop in Ho Chi Minh City, attended by officials, experts, and over 50 businesses in the health protection food sector. Discussions covered food additives, processing aids, and national technical regulations on contaminant limits (QCVN). Presentations from the Food Safety Department and the National Institute for Food Safety Control focused on testing methods and regulatory compliance. Delegates engaged in in-depth discussions on applying these regulations. Concluding the event, authorities urged businesses to review technical standards, adjust operations accordingly, and ensure compliance with state management requirements. The Department of Food Safety and related agencies remain available to provide further guidance.