2024 Recap: Consumer Health key Regulation/Guidance in USA, EU, Asia and ROW

• USA
• EUROPE
• ARGENTINA
• AUSTRALIA
• BRAZIL
• CHINA
• ISRAEL
• MALAYSIA
• PHILIPPINES
• SINGAPORE
• SWITZERLAND

USA

FDA Updates “Healthy” Claim, Providing a Refreshed Tool for Consumers

Today, the U.S. Food and Drug Administration is announcing a final rule to update the definition of the nutrient content claim “healthy.” There is an ever-growing crisis of preventable, diet-related chronic diseases in the U.S. that requires immediate action. The updated “healthy” claim marks an important step in fulfilling the FDA’s nutrition priorities, which are part of a whole-of-government approach to address this crisis. This rule will help ensure that consumers have access to more complete, accurate, and up-to-date nutrition information on food labels.

FDA Lists Regulations Under Development and Updates Priority Guidance Topics for Foods Program

To increase transparency and assist stakeholders by highlighting its regulatory agenda, the U.S. Food and Drug Administration’s Foods Program has posted a new website listing regulations it plans to publish by October 2024 and longer-term regulations it is prioritizing for publication at a later date. The FDA also updated the list of guidance topics that it is considering and expects to publish by the end of 2024. The list of guidance topics was last updated in July 2023.

Outbreak Investigation of Listeria monocytogenes: Queso Fresco and Cotija Cheese (February 2024)

U.S. District Court for the Eastern District of California entered a consent decree of permanent injunction against Rizo Lopez Foods Inc.

Bright Farms, Campesino, Casa Cardenas, Dole, Don Francisco, Don Pancho, Dos Ranchitos, El Huache, Food City, Fresh & Ready Foods, Fresh Express, H-E-B, Jack & Olive, La Ordena, Marketside, Maverick Foods, President’s Choice, Ready Pac Bistro, Rio Grande, Rizo Bros, Rico, Rojos, San Carlos, Santa Maria, Sprig & Sprout (S&S), The Perfect Bite Co.,Tio Francisco, Trader Joe’s, and 365 Whole Foods Market.

FDA Takes Steps to Ensure Safety of Cinnamon Products Sold in the US

The U.S. Food and Drug Administration is taking several additional steps to address concerns about elevated lead levels in cinnamon following the recent incident associated with certain cinnamon apple sauce pouches that resulted in lead poisoning in young children. Today, the agency sent a letter to all cinnamon manufacturers, processors, distributors and facility operators in the U.S., reminding them of the requirement to implement controls to prevent contamination from potential chemical hazards in food, including ground cinnamon products. The agency is also recommending the voluntary recall of certain ground cinnamon products sold by a number of brands at six different retail chains that were found to contain elevated levels of lead.

FDA Proposes to Exempt Certain Cottage Cheese From Traceability Requirements

The Food Traceability Rule establishes additional recordkeeping requirements, beyond those in existing regulations, for those who manufacture, process, pack, or hold foods the agency has designated for inclusion on the Food Traceability List. In the final rule, the FDA announced its intention to consider exempting cottage cheese regulated under the Grade “A” Pasteurized Milk Ordinance (PMO) from the rule’s requirements. The PMO represents the most current science-based knowledge and experience concerning the safe production and processing of Grade “A” milk products, including cottage cheese. Much of the cottage cheese produced in the U.S. is regulated through the National Conference on Interstate Milk Shipments (NCIMS), which relies on the PMO. The FDA and NCIMS have together developed a cooperative, federal-state program (the Interstate Milk Shippers Program) to ensure the sanitary quality of milk and milk products shipped interstate. The proposed exemption would apply to all Grade “A” cottage cheese that appears on the Interstate Milk Shippers List.

FDA Takes Additional Steps Following Investigation of Elevated Lead and Chromium Levels in Apple Cinnamon Puree Products

The U.S. Food and Drug Administration is continuing to take steps following the investigation of lead and chromium in apple cinnamon fruit puree pouches this past fall that was prompted by findings of elevated blood lead levels in children. While initial response activities to investigate the source of the contamination and prevent additional illnesses are completed, the Agency is continuing to explore prevention, compliance, and surveillance activities going forward.

FDA Revokes Regulation Allowing the Use of Brominated Vegetable Oil (BVO) in Food

The U.S. Food and Drug Administration (FDA) is revoking the regulation authorizing the use of brominated vegetable oil (BVO) in food. Brominated vegetable oil (BVO) is a vegetable oil that is modified with bromine. The agency concluded that the intended use of BVO in food is no longer considered safe after the results of studies conducted in collaboration with the National Institutes of Health (NIH) found the potential for adverse health effects in humans.

FDA Releases Summary Report on Fresh Herbs Sampling Assignment

The U.S. Food and Drug Administration (FDA) released findings from a sampling assignment that collected and tested both domestic and imported fresh basil, cilantro, and parsley. The assignment sought to estimate the prevalence of Cyclospora cayetanensis, Salmonella spp., and Shiga toxin-producing Escherichia coli (STEC) in these herbs as part of the FDA’s ongoing effort to help proactively ensure food safety.

FDA Starts Next Phase of Sodium Reduction Efforts

FDA took another important step in its sodium reduction efforts. The agency has issued new, voluntary targets for sodium reduction in foods in a draft guidance that serves as Phase II of the agency’s ongoing work. The new targets build on the final, voluntary sodium reduction goals issued in 2021, now referred to as Phase I, to further reduce diet-related diseases associated with consuming high levels of sodium.

FDA Issues Warning Letter to Manufacturer of Apple Cinnamon Fruit Puree Products Containing Elevated Levels of Lead and Chromium0

The U.S. Food and Drug Administration issued a Warning Letter to AUSTROFOOD S.A.S. (Austrofood), the manufacturer of the apple cinnamon fruit puree pouches that were recalled last year and that were found to contain elevated levels of lead and chromium. The letter is part of the agency’s ongoing efforts to enhance the safety of cinnamon, ground spices, and other foods, particularly those consumed by babies and young children.

Youth E-Cigarette Use Drops to Lowest Level in a Decade

Half a million fewer U.S. youth reported current use of e-cigarettes in 2024 compared to 2023, according to new data from the National Youth Tobacco Survey (NYTS) released today by the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention. The nationally representative data featured in Morbidity and Mortality Weekly Report (MMWR) includes findings on e-cigarette and nicotine pouch use among U.S. youth, two categories of tobacco products the FDA and CDC are monitoring closely, particularly regarding youth use and appeal.

Outbreak Investigation of E. coli O157:H7: Onions (October 2024)

FDA is investigating slivered onions served at McDonald’s as the likely source of this
outbreak. Onions have been recalled and are no longer being used. Slivered onions previously served on McDonald’s Quarter Pounder burgers are the likely source of contamination, based on epidemiologic and traceback data. McDonald’s is no longer using slivered onions on Quarter Pounders at stores in affected states. Diced onions used at McDonald’s have not been implicated in this outbreak. As of October 30, 90 people from 13 states have been infected with the outbreak strain of E. coli O157:H7. Illnesses started on dates ranging from Sept 27, 2024 to October 16, 2024. Of 83 people with information available, 27 have been hospitalized, and 2 people developed HUS, a serious condition that can cause kidney failure. One death has been reported from an older adult in Colorado. This person is not one of those who developed HUS. More illnesses have been reported but they are from before McDonald’s and Taylor Farms took action to remove slivered onions from food service locations.

FDA Issues Final Rule to Increase Color Additive Certification Fees-Cosmetics

The U.S. Food and Drug Administration (FDA) today issued a final rule to amend the color additive regulations to increase the fees for certification services. The new fees include a $0.10 per pound increase for straight colors including lakes. There are also similar increases in fees for repacks of certified color additives and color additive mixtures. This increase will allow FDA to continue to provide, maintain, and equip an adequate color additive certification program as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act).

EU

Avian influenza: increased spread in poultry-dense areas at end 2024

Although the overall number of avian influenza cases remains low compared to previous years, the last quarter of the year saw an increase in cases in wild and domestic birds compared to the previous quarter. Most of the detections in both wild and domestic birds were found in South-Central Europe, mainly in areas with a high concentration of poultry farms. Our experts concluded that the large number of farms in these areas and the type of poultry production contributed to disease spread between farms. A(H5N5) virus, a subtype of the avian influenza virus which causes mass mortality in wild birds, has significantly expanded its geographical and species range, spreading widely in different regions and wild bird species. However, no new cases have been reported in mammals.

Perchlorate in food: draft scientific opinion for public consultation

As part of the review, experts have updated the tolerable daily intake (TDI) for perchlorate from 0.3 to 1.4 micrograms per kilogram of body weight per day. This change reflects the use of a recent model that provides greater precision in evaluating the effects of different doses of perchlorate on individuals.

The primary health concern associated with perchlorate is its impact on thyroid function. It can inhibit the uptake of iodine by the thyroid gland, which is crucial for hormone production. In foetuses and infants, thyroid hormones are critical for normal growth and development of the central nervous system.

Experts provisionally concluded that at current levels of exposure there are no health risks for the general population.

The consultation will run for 8 weeks to allow for maximum participation among interested parties. The deadline for sending comments is 11 February 2025.

Saccharin: safety threshold increased EFSA has concluded that saccharin is safe for human consumption

The ADI, which reflects the safe amount of a substance that can be consumed daily over a lifetime, covers saccharin and its sodium, calcium and potassium salts (E 954). The previous ADI was set in 1995 based on the increased incidence of bladder tumours observed in rat studies. However, there is now scientific agreement that these tumours are specific to male rats and not relevant to humans.

Navigating Novel Foods: what EFSA’s updated guidance means for safety assessments

The European Commission tasked EFSA with updating the guidance on how to prepare and submit applications to market novel foods in the EU. This update consists of two key documents:

First, the scientific guidance outlines the scientific information applicants must provide.
Second, the administrative guidance clarifies the process for applying, which is handled by our front-desk support team.
These updates will apply to all novel food applications submitted to the European Commission starting in February 2025.

EFSA identifies 12 bark and ambrosia beetle species posing high risk to EU plant health

The European Food Safety Authority (EFSA), in collaboration with the University of Padua (Italy), has identified 12 species of bark and ambrosia beetles that pose a high economic or environmental risk to plant health in the EU territory. The beetles, which attack broadleaved trees, are currently absent or not yet widespread in the EU and meet the criteria for classification as potential Union quarantine pests (QPs).

Continued efforts needed to fight antimicrobial resistance (AMR) in humans and animals

Resistance of Salmonella and Campylobacter bacteria to commonly used antimicrobials continues to be observed frequently in humans and animals, according to a report issued today by the European Food Safety Authority (EFSA) and the European Centre for Disease Prevention and Control (ECDC).

Horizon scanning in plant health: EFSA and ANSES organise first international workshop

The European Food Safety Authority (EFSA) and the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) organised the first in a series of four international workshops on horizon scanning in plant health. Held at ANSES headquarters in Paris on 9-10 April 2024, the event marked a step forward for plant health by bringing together global expertise, fostering collaboration and shaping the future of horizon scanning for possible emerging risks.

‘Safe2Eat’ 2024 Campaign: empowering consumers across Europe

From ‘EUChooseSafeFood’ to ‘Safe2Eat’: EFSA and its partners in EU Member States return with renewed commitment and expanded participation across Europe, enabling consumers to make food choices with confidence.

EFSA launches new webtool to calculate dietary exposure to food enzymes

EFSA has released an innovative new webtool designed to support industry operators and consumers estimate exposure to food enzymes through the diet.

The Food Enzyme Intake Model (FEIM) webtool marks the culmination of an extensive effort initiated in 2016, bringing together data on the use of food enzymes in various manufacturing processes with information about the exposure of different population groups to food enzymes.

ARGENTINA

Incorporation of MERCOSUR Technical Regulation on Cosmetics and Personal Hygiene Products (Published on: 04/09/2024)

The National Administration of Medicines, Food, and Medical Technology (ANMAT) has officially incorporated GMC Resolution No. 18/23 into Argentina’s legal system. This regulation, which updates the classification of personal hygiene products, cosmetics, and perfumes, repeals the previous GMC Resolution No. 07/05.

In compliance with the Ouro Preto Protocol, this new regulation will come into effect in all MERCOSUR member states 30 days after the MERCOSUR Secretariat confirms that all parties have incorporated it into their national laws. Additionally, ANMAT Provision No. 345/06, which previously incorporated the older GMC resolution, has been repealed.

This move aligns Argentina’s regulatory framework with MERCOSUR standards, ensuring consistency across the region in the classification and regulation of personal hygiene and cosmetic products.

ANMAT Trains Food Inspectors in San Juan Province (Published on: 04/09/2024)

On September 4, 2024, a training session for food inspectors was held in San Juan, led by technical and legal staff from the National Food Institute (INAL). The event, attended by key local officials including Mónica López, INAL Director, and Cecilia Clavijo, Head of the Department of Health Medicine of San Juan, focused on strengthening food inspection practices. The workshop, conducted both in-person and online, covered topics like inspection procedures, report preparation, and post-inspection actions, such as addressing sanitary deficiencies and applying sanctions. Practical exercises using real inspection reports helped harmonize national and provincial regulations.

154th Meeting of the National Food Commission (CONAL) (Published on: 12/06/2024)

On June 12, 2024, the 154th meeting of the National Food Commission (CONAL) was held at the Ministry of Health, bringing together national authorities and jurisdictional representatives from across Argentina, both in person and virtually. The meeting focused on food safety, regulatory updates, and the advancement of food health initiatives.

Key participants included Enrique Rifourcat, Undersecretary of Institutes and Oversight, who emphasized the importance of collaboration between ANMAT and local jurisdictions. Enriqueta Pearson, ANMAT’s National Deputy Administrator, highlighted the ANMAT Strategic Plan 2024-2027, focusing on regulatory convergence and resilient health systems.

During the meeting, five proposals for updating the Argentine Food Code were sent for administrative processing, including topics like flavored tea, enzymes, and peanut derivatives. The Commission also discussed the introduction of Health Property Declarations on food labels and the inclusion of new food categories for public consultation.

The meeting concluded with a strong focus on the work of INAL’s working groups and the agreements reached during the session, underscoring the importance of continuous collaboration for improving food safety and public health.

Five new tariff codes were created for procedures of the National Food Institute (Published on: 29/05/2024)

As of today, five new tariff codes have been introduced for procedures handled by the National Food Institute (INAL), as outlined in Provision No. 4708/24 by ANMAT. These codes apply to the following procedures:

1. Authorization applications for probiotics, prebiotics, and foods containing them.
2. Applications for general food authorizations.
3. Requests for reports on the regulatory framework of processed foods and non-alcoholic beverages under the Argentine Food Code (CAA).
4. Official extensions of Vegan Certification for food products.
5. Labeling procedures under the Imported Food Monitoring Program (PMI).

These updates aim to streamline administrative processes and ensure better regulation of food safety in Argentina.

New Article in the ANMAT Scientific Journal: 2023 Comprehensive Inspection Plan for Packaged Foods (Published on: 10/06/2024)

The latest issue of the ANMAT Scientific Journal (Volume 5) features a new article titled “Comprehensive Inspection Plan 2023: Implementation Process and Study of Its Relevance.” This article outlines the relaunch of Argentina’s first national plan for controlling packaged foods, focusing on the prevention of foodborne illnesses (ETA and ETCN) and the protection of public health. It also emphasizes the plan’s role in standardizing practices and fostering coordination between provinces under a federal framework.

The ANMAT Scientific Journal serves as a key platform for sharing research on regulatory activities concerning health products. It is an open-access, virtual journal with continuous publication, bringing together diverse professional insights.

INAL Supports FDA Inspections of Argentine Food Exporters (Published on: 13/05/2024)

As part of its efforts to ensure the safety of imported food, the U.S. Food and Drug Administration (FDA) has conducted inspections of Argentine food exporting companies, with support from the National Food Institute (INAL). These inspections are essential for verifying regulatory compliance and ensuring products meet U.S. standards under the Food Safety Modernization Act (FSMA) and Good Manufacturing Practices (GMP).

INAL professionals have actively participated in these inspections, facilitating the exchange of inspection techniques and fostering stronger collaboration between ANMAT and the FDA. The inspections have covered various industries, including citrus, dairy, peanuts, and honey. This partnership aims to enhance regulatory practices and strengthen the global food safety framework, benefiting both agencies and ensuring public health protection.

No Affected Batches of Nutramigen LGG Powdered Infant Formula in Argentina (Published on: 05/01/2024)

ANMAT has reassured the public that batches of Nutramigen LGG powdered infant formula, which were recently recalled in the United States due to possible contamination with Cronobacter sakazakii, have not been distributed in Argentina. The recall, issued by the U.S. Food and Drug Administration (FDA), involves specific lots of the product (expiration date 01/01/2025) from the company MEAD JOHNSON & COMPANY, LLC.

Through collaboration with MEAD JOHNSON NUTRITION ARGENTINA SA (now PHARMA ENFANT SA) and the use of the Tableau Digital System, ANMAT confirmed that the affected batches were not imported to Argentina. The public is urged to remain informed, especially those with milk allergies, as the product was marketed under the brand name Nutramigen/Nutramigen LGG in Argentina.

AUSTRALIA

Elemental impurities in traditional Chinese medicines (TCMs)

Traditional Chinese medicines (TCMs) sold in Australia are carefully regulated to ensure safety and quality. They must meet limits on impurities like lead, arsenic, cadmium, and mercury, which can be absorbed by plants. To protect consumers, the Therapeutic Goods Administration (TGA) requires TCMs to comply with national and international guidelines that set safe daily limits for these impurities.

FSANZ to advance nutrition labelling with a focus on consumers (Published on:13 AUG 2024)

Food Standards Australia New Zealand (FSANZ) is set to progress a package of work on nutrition labelling standards to better support consumers to make informed and healthy dietary choices. Australian and New Zealand food ministers recently agreed to FSANZ scoping work to improve front- and back-of-pack nutrition information labelling and finalising alcohol labelling proposals. FSANZ will begin preparatory work to support mandating the front-of-pack Health Star Rating (HSR) system should industry not meet voluntary uptake targets. The work will inform future decisions by food ministers on the HSR and support efficient implementation if the system is mandated. HSR work will be undertaken in parallel with scoping of a holistic review of the nutrition information panel (NIP) found on the back of packaged foods. Any review would be the first for the NIP in over 20 years, supporting optimised nutrition information labelling for consumers.

P1044 – Plain English Allergen Labelling (Published on: 25 FEB 2024)

New requirements for the labelling of allergens in food come into force on 25 February 2024. These requirements were developed through FSANZ Proposal P1044 – Plain English Allergen Labelling.

The new requirements include that allergen information is to be declared: 

• In a specific format and location on food labels, and 
• Using simple, plain English terms in bold font.  

The changes will help people find allergen information on food labels more quickly and easily, so they can make informed and safe food choices.  

A1274 – Food derived from disease-resistant banana line QCAV-4 (Published on: 29 April 2024)

Food Standards Australia New Zealand (FSANZ) has approved an application from the Queensland University of Technology (QUT) to permit food derived from a banana line genetically modified (GM) for resistance to Panama disease. Banana line QCAV-4 is the first whole GM fruit assessed and approved by FSANZ and the first GM banana approved in the world.

The Australian and New Zealand Food Ministers did not seek a review of the GM banana’s approval for food use.

Media statement on Avian influenza (bird flu) and food safety (Published on: 14 June 2024

Avian influenza (bird flu) is not a food safety concern and it is safe to eat properly handled and cooked chicken meat, eggs and egg products. There is no evidence to show the virus can be transmitted to people through properly prepared food.

Food Standards Australia New Zealand (FSANZ) CEO Dr Sandra Cuthbert said Australia’s world-class biosecurity and food regulation systems ensure the safety of the food supply.

FSANZ 2023-2024 Annual Report released (Published on:01 Nov 2024)

Food Standards Australia New Zealand (FSANZ) has released its 2023-24 Annual Report, highlighting the agency’s key achievements in maintaining the safety of the food supply across both countries. 

FSANZ CEO Dr Sandra Cuthbert emphasised the year’s strong performance in standards setting. 

“We delivered a 56% increase in productivity, completing 25 applications and 3 proposals that resulted in amendments to the Australia New Zealand Food Standards Code, supporting food safety, public health and industry innovation,” Dr Cuthbert said.

“This included several historic milestones, such as the world-first approval of a genetically modified banana and the establishment of a new standard for Australian native bee honey.

“In a major achievement, FSANZ also completed a comprehensive review of infant formula standards. While breastfeeding is the recommended way to feed infants, a safe and suitable alternative is required if this is not possible.

“The caregivers for this most vulnerable population can feel assured FSANZ’s review of Australia’s infant formula standards ensure the safety and suitability of these products into the future.

“The review also ensured regulations align with international best practice and caregivers have access to the information they need to choose the right product for their infant.”

From 24 April 2024: changes to AICIS categorisation, reporting & record-keeping requirements (Published on: 24 Apr 2024)

Key changes to the Rules

Written undertakings replaced with records that will make compliance easier.

Greater acceptance of International Nomenclature of Cosmetic Ingredients (INCI) names for reporting and record keeping. 

Changes to the categorisation criteria to benefit: 

Local soap makers

Introducers of chemicals in flavour and fragrance blends

Introducers of hazardous chemicals where introduction and use are controlled.

Strengthening criteria and/or reporting requirements for health and environmental protection – for example, to prevent persistent organic pollutants (POPs) from being categorised as exempted or reported introductions.

Referring to cosmetic injectables in advertising (Published on: 07 Mar 2024)

The Therapeutic Goods Administration (TGA) has updated its guidance on advertising cosmetic injectables to ensure consistent application of advertising rules across industries dealing with therapeutic goods. Previously, TGA allowed indirect references to prescription medicines, like “wrinkle reducing injections,” in advertisements for cosmetic health services, as long as specific product names (e.g., Botox) were not used. However, the TGA has now determined that advertising terms like “wrinkle reducing injections” indirectly promotes prescription medicines, which is unlawful.

The revised guidelines make it clear that promoting health services in a way that implies the use or supply of prescription medicines (such as “weight loss injections” or “medicinal cannabis”) is not allowed. The TGA emphasizes that the core legislation around cosmetic injectables has not changed, and advertising the use or supply of prescription medicines, including injectable products, through testimonials, claims, before-and-after photos, or price lists, remains non-compliant. Full details of the updated guidance are available on the TGA website.

BRAZIL

MANAGEMENT OF HYGIENE, PERFUMES, COSMETICS AND SANITIZING PRODUCTS RESOLUTION-RE No. 1,770, OF MAY 8, 2024 (Published on:08 May 2024)

This resolution declares the expiry of the registration for hygiene, perfume, cosmetics, and sanitizing products whose revalidation was not requested within the specified period under Article 12, § 6 of Law 6360/1976. The list of affected products is provided in the attached document. The resolution takes effect immediately upon publication.

COORDINATION OF COMPANY OPERATING AUTHORIZATION (Published on: 29 APR 2024)

This resolution cancels the Operating and Special Authorizations of companies listed in the annex, due to the cancellation of their CNPJs (business registration numbers) by the Brazilian Federal Revenue Service. The resolution takes effect immediately upon publication.

MANAGEMENT OF HYGIENE, PERFUMES, COSMETICS AND SANITIZING PRODUCTS (Published on: 5 JULY 2024)

This resolution declares the expiry of the registration for hygiene, perfume, cosmetics, and sanitizing products whose revalidation was not requested within the timeframe specified in § 6 of Article 12 of Law 6360/1976. The list of affected products is attached. The resolution comes into effect immediately upon publication.

RESOLUTION RDC Nº 898, OF AUGUST 28, 2024 (Published on: 22 AUG 2024)

On August 22, 2024, the National Health Surveillance Agency (ANVISA) issued a new resolution requiring that the chemical composition of personal hygiene products, cosmetics, and perfumes be listed in Portuguese on their labels. This rule applies to all products sold or delivered for consumption in Brazil, ensuring consumers have clear and accessible information about the ingredients in these products.

Key points of the resolution include:

Mandatory Portuguese Composition: Products must list their chemical composition in Portuguese, in addition to the existing requirement for the International Nomenclature of Cosmetic Ingredients (INCI).

Labelling Flexibility: The Portuguese composition can appear on the original label or as a supplementary label, provided the label’s integrity is maintained.

Digital Format: The composition may also be made available via a digital format, accessible through a mobile device scan of a code on the label.

Compliance Timeline: Companies have up to 36 months to update their labels for products regularized before October 31, 2023.

No Petition Required: Businesses need not file a petition to update labels solely for compliance with this new rule.

Non-compliance with the new labelling requirements will be considered a health violation, subject to penalties under Brazil’s health regulations. The rule revokes previous resolutions and comes into effect immediately upon publication.

CHINA

1. Published on 11 October 2024

   The “Guidelines for the Registration of Infant Formula Raw Materials and Other Matters” issued by the State Administration for Market Regulation aim to regulate and standardize the registration of infant formula production in China. Here’s a summary of the key points:

   1. Registration Requirements:
      • oManufacturers of infant formula must register their raw materials, food additives, product formulas, and labels with the local provincial market supervision department before starting production.
   2. Details for Registration:
      • Raw Materials and Additives: The registration should include information such as the name, brand, origin, packaging specifications, quality standards, and supplier and manufacturer details.
      • Product Formulas: Composition information must be provided. Adjustments can be made according to regulations during production.
      • Labels: Product labels (excluding batch numbers and production dates) must also be filed.
   3. Filing Process:
      • The guidelines outline the filing process and responsibilities of manufacturers, ensuring the safety and traceability of products throughout the supply chain.
   4. Overseas Manufacturers:
      • Foreign manufacturers are encouraged to follow these regulations and register with the provincial market supervision department where their agent, importer, or distributor is located in China.

   The guidelines aim to ensure food safety, promote product traceability, and hold manufacturers accountable for quality control throughout the lifecycle of infant formula products.

2. Published on 23 October 2024

   The “Working Procedures for the Priority Review and Approval of Special Medical Purpose Formula Foods” aim to streamline and prioritize the registration process for certain medical foods in China, especially those needed urgently for clinical nutrition. Here’s what I understood:

   1. Background:
      • The procedures were introduced in December 2023 after revisions to the Measures on special medical foods. The goal is to encourage innovation and address urgent clinical needs, particularly for rare diseases and new types of medical foods.
   2. Main Contents:
      • The procedures define how products can apply for priority review and approval, including steps like application, acceptance, public announcement, review, and objection handling.
      • It introduces two important forms: Application for Priority Review and Objection Form.
   3. Eligibility for Priority Review:
      • Products for rare diseases and new medical foods urgently needed in clinical practice (e.g., for diabetes, kidney diseases, and rare conditions) are eligible.
      • Other specific categories may also apply after consultation with the Food Review Center.
   4. Time Limits:
      • Public Announcement: 5 working days.
      • Objection Handling: 10 working days.
      • Review Time: 30 working days (includes public announcement and objection handling time).
   5. Communication:
      • A special mailbox (tyyxsp@cfe-samr.org.cn) is set up for inquiries and objections related to priority review.

These procedures are intended to speed up the registration of special medical foods that are in urgent demand, promoting innovation and research to meet critical health needs.

ISRAEL

Ministry of Health Reform in Food Business Licensing (Published on: 05.11.2024)

The Ministry of Health has unveiled a new reform aimed at modernizing food business licensing regulations in Israel. This initiative is part of a broader effort to reduce regulatory burdens, improve competition, and support local entrepreneurs while maintaining public health standards. The reform aligns Israeli regulations with European standards and focuses on training and accountability for business owners in managing risks effectively.

The reform will shift from an adversarial inspector-inspected relationship to a collaborative approach, where businesses and inspectors work together to ensure public health. The Ministry aims to streamline processes, reduce costs, and increase flexibility for businesses, which is expected to help lower prices for consumers.

The public is invited to submit comments on the reform until November 17, 2024. This is the latest in a series of reforms led by the Ministry, including those in cosmetics and food imports, designed to ease regulatory challenges for businesses while safeguarding health.

Ministry of Health Opens New Import Tracks for Food and Cosmetics Aligned with European Regulations (Published on: 31.03.2024)

The Ministry of Health has announced the opening of new import tracks for food and cosmetics in Israel, aligning with European standards. This reform aims to reduce bureaucratic burdens for importers while ensuring product safety and public health. Under the new guidelines, accredited importers will be responsible for managing product risks and quality control processes, eliminating the need for direct connections with manufacturers.

In the food sector, the Ministry will further adopt European regulations, creating clearer conditions for importing food to Israel. For cosmetics, the Ministry will allow imports based on a safety declaration and remove requirements for maintaining cosmetic files. However, importers will still be required to manage risks and respond to any product recalls or safety warnings from suppliers.

This initiative is expected to streamline the import process, reduce costs, and enhance regulatory clarity, while ensuring the safety of products sold in Israel. The changes are part of the Ministry’s broader strategy to reduce regulatory obstacles and support local businesses.

Ministry of Health Warns Against Red Yeast Rice Supplements from Kobayashi Pharmaceutical (Published on: 11/04/2024)

The Ministry of Health has issued a warning regarding food supplements manufactured by Kobayashi Pharmaceutical that contain red yeast rice. This warning follows reports from Japan’s Ministry of Health linking these supplements to five deaths and over 100 hospitalizations due to kidney damage. The affected products, which contain red yeast rice, are not approved for use in food supplements in Israel and are not legally sold in the country.

Although no related incidents have been reported in Israel, the Ministry urges caution and reminds the public that all food supplements sold in Israel must be pre-approved by the National Food Service. Importers are required to provide proof of safety and regulatory compliance as part of the approval process.

Ministry of Health Warns Against Unlawfully Imported Food Supplements (Published on: 11/04/2024)

The Ministry of Health has issued a warning about food supplements that have been imported in violation of Israeli law, following a complaint regarding side effects from their use. An inspection by the Ministry’s Food Service revealed dozens of illegally imported products, some containing prohibited substances, including medicinal ingredients not allowed in food supplements.

The Ministry emphasizes that all legally imported supplements must be approved by registered importers and licensed manufacturers. These products must also meet labeling requirements, including a breakdown of nutritional components and details about the manufacturer and importer. For more information, the public can refer to the Food Services website. Consumers are encouraged to report defective or damaged products directly to the Ministry of Health.

Ministry of Health Approves Major Reforms in Food and Cosmetics Licensing (Published on: 30.07.2024)

The Ministry of Health has announced the approval of significant reforms in food and cosmetics regulations, set to take effect on January 1, 2025. These changes aim to reduce bureaucratic burdens, increase market competition, and ensure product safety, ultimately benefiting both consumers and businesses in Israel.

In the food sector, the reform introduces a new import track based on European regulations. Importers who meet these standards will take responsibility for the safety and quality of products, allowing for a smoother import process without the need for direct manufacturer contact. This change is expected to foster regulatory certainty for the industry while maintaining high safety standards for consumers.

For cosmetics, the Ministry will now allow importers to bring in products under European regulations, provided they maintain robust safety and quality assurance programs. The reform eliminates the need for a licensing track, simplifying the process for compliant importers and harmonizing Israeli regulations with European standards. This change is expected to improve safety, streamline imports, and enhance global market competitiveness.

Minister of Health Uriel Buso emphasized that these reforms will not only simplify the regulatory process but also reduce the financial burden on Israeli consumers, contributing to the national effort to combat the cost of living. The changes are the result of extensive collaboration between the Ministry, the Prime Minister’s Office, and other government agencies.

MALAYSIA

National Pharmaceutical Regulatory Agency (NPRA) (Published on 31 May 2024 )

The National Pharmaceutical Regulatory Agency (NPRA) in Malaysia is planning to revise the timelines for variation applications for pharmaceutical products, biologics, and natural and health supplements. A pilot study will begin on June 1, 2024, to test these new timelines, which aim to improve the efficiency of the application and approval process.

The key changes are:

• New timelines for various types of variation applications, such as MiV-N, MiV-PA, MaV, and Grouping applications, which vary in duration from 10 to 150 working days depending on the product type and application category.
• Applicants can submit a limited number of concurrent applications (e.g., up to 5 for MiV-N or MiV-PA). Exceeding this limit may result in extended review timelines.
• A new “Tell & Do” category for certain safety-related changes allows immediate implementation once approved.
• Applicants must meet specific reply timelines to avoid rejection, with varying deadlines for pharmaceutical and health supplement products.
• Cover letter/summary of changes must be submitted with applications for pharmaceutical products, detailing the proposed changes and necessary approvals.

Overall, NPRA is aiming to make the variation process faster and more transparent while giving clear guidelines on how many applications can be submitted at once.

Malaysian Pharmaceutical Regulatory Authority (PBKD) ) (Published on 19 November 2024 )

The Malaysian Pharmaceutical Regulatory Authority (PBKD) has banned the use of chloroform and chloroform spirit as preservatives in pharmaceutical products, natural products, and health supplements, effective from November 7, 2024.

Key points:

• Chloroform as a preservative is no longer allowed in registered, new, or evaluated products.
• Chloroform as a solvent can still be used, but with strict justification and a control strategy, and the content must not exceed 60 ppm in the final product.
• Products currently using chloroform as a preservative will have their registration suspended, and recall actions are required. A variation application must be submitted to replace it with an alternative preservative.
• For solvents, PRHs need to provide justification and ensure the chloroform content is within limits. Variation applications should be submitted to either provide analysis certificates or switch to an alternative solvent.

PRHs must comply with these changes within the set deadlines. The move is aimed at improving product safety.

PHILIPPINES

Food and Drug Administration (FDA) (Published on 28 September 2024 )

The Food and Drug Administration (FDA) has formed a technical working group (TWG) called Taskforce Thomson to improve its regulation of traditional medicines and health supplements. The TWG will create policies based on existing laws for these products. It will draft an Administrative Order for health supplement registration under the Center for Food Regulation and Research (CFRR) and an FDA Circular for traditional medicine registration under the Center for Drug Regulation and Research.

The taskforce is named after Samuel Thomson, a 19th-century American herbalist who founded Thomsonian medicine, which was widely popular in the U.S. at the time. The goal of the initiative is to ensure the availability of only safe, effective, and high-quality products through clearer guidelines and streamlined registration processes.

Department of Health (DOH)

The Department of Health (DOH) has issued Administrative Order (AO) No. 2024-0008, which provides guidelines for establishments involved in the refilling of certain cosmetics and Household/Urban Hazardous Substances (HUHS) products. This regulation is under the jurisdiction of the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) of the Food and Drug Administration (FDA).

The main purpose of these guidelines is to promote the use of refilling stations for cosmetics and HUHS products as an eco-friendly solution to reduce single-use plastic waste. The order also ensures that the refilling activities comply with FDA standards to guarantee consumer safety.

Establishments: Only establishments that are licensed by the FDA, and their refilling stations, are authorized to carry out refilling activities for cosmetics and HUHS products.

1. Compliance with Quality Standards: These establishments must ensure that the refilled products meet good manufacturing practices and quality guidelines during production and distribution.
2. Labeling Requirements: Refilled products must have proper labeling to provide consumers with clear information about the contents of the products.
3. Post-marking Coordination: Establishments must also coordinate with the FDA for any issues that arise after the product has been marked for sale.

In addition, the FDA will issue detailed implementing rules and guidelines and will conduct a pilot phase lasting up to six months. This will initially involve local manufacturers involved in refilling cosmetic and HUHS products. A transitory period of six months will also be provided to help affected stakeholders comply with the new guidelines.

SINGAPORE

Trade Circular on Revision to The Fee for Permit to Import Frozen, Chilled and Processed Meat Products (Published on: 08 Nov 2024)

REVISION TO THE FEE FOR PERMIT TO IMPORT FROZEN, CHILLED AND PROCESSED MEAT PRODUCTS

1. SFA will revise the permit fee to import frozen, chilled and processed meat products. The revised fee     is $300 per permit and will come into effect from 18 Nov 2024 (Monday).

2. In preparation for this transition, there will be a downtime of SFA’s system from 16 Nov 2024 12pm to 18 Nov 2024 12am. Traders should avoid submitting permit application during this period.  SFA will resume the processing of permit applications after 12am on 18 Nov 2024, when the revised fee will apply. We apologise for any inconvenience caused during the transition period. 

3. The fees chargeable are shown in Annex A. SFA strongly urge traders to:

plan their permit applications around the system downtime; and to

keep a record (screen grab or system acknowledgement of the submitted permit application) should there be a need for reconciliation.

Annex A

The fees chargeable during the transition period.

Date on which permit application is approved in Trade Net*	Fee chargeable
16 Nov (Sat) before 12pm	$4.60 per 100 kg or part thereof
16 Nov (Sat) after 12pm	System downtime
18 Nov (Mon) after 12am	$300 per permit

RESUMPTION OF IMPORT OF POULTRY AND POULTRY PRODUCTS FROM HIROSHIMA PREFECTURE, JAPAN DUE TO LIFTING OF HPAI RESTRICTIONS (Published on:15 Mar 2024)

We refer to our circular dated 15 March 2024 regarding the temporary import restrictions on the importation of poultry and poultry products from Hiroshima prefecture, Japan. 2 We are pleased to inform you that the restriction on the poultry and poultry products from Hiroshima prefecture is lifted with immediate effect.

HSA Removes Over 3,000 Online Listings of Illegal Health Products in First Joint Operation with Online Platforms (Published: 27 Nov 2024)

From September 23 to October 23, 2024, the Health Sciences Authority (HSA) removed 3,336 illegal health product listings and issued 1,471 warnings to sellers on local e-commerce and social media platforms as part of a large-scale operation. This effort, in collaboration with eight online platforms (Amazon Singapore, Carousell, Ebay Singapore, Facebook, Lazada, Qoo10, Shopee, and Tiktok), targeted the illegal sale of substandard or counterfeit health products, which can pose significant health risks.

Aesthetic enhancement products made up the majority of removed listings, including injectable beauty kits and dermal fillers, along with prescription-only medicines, contraceptives, antibiotics, and other medical devices. Consumers were advised to avoid unapproved products sold online, especially those requiring professional administration or prescription. HSA stressed the risks of using such products, which have not been evaluated for safety or efficacy.

The HSA emphasized its commitment to consumer safety through ongoing collaborations with platform administrators and warned that illegal sellers could face heavy penalties, including fines and imprisonment. Recent enforcement actions included heavy fines for individuals involved in selling counterfeit or unregistered health products. Consumers were encouraged to be vigilant and only purchase from reputable sources.

Regulatory fee revision for health products (Published:08 Nov 2024)

Effective from July 1, 2024, the Health Sciences Authority (HSA) will implement a fee increase averaging 5% for various services related to health product regulation. This includes fees for registration, licensing, notifications, and permits for therapeutic products, medical devices, Chinese proprietary medicines, cosmetic products, cell, tissue, and gene therapy, oral dental gums, and retail pharmacies. The fee revision will have a minimum increase of $1 and a cap of $200 per fee item. The adjustment aims to help cover the rising costs of services provided to businesses, ensuring that the HSA can continue to maintain high standards of quality, safety, and efficacy in regulated health products.

Effective from July 1, 2024, the Health Sciences Authority (HSA) will revise the fees for cosmetic product notifications and Good Manufacturing Practice (GMP) certificates as follows:

Cosmetic Product Notification and Re-notification:

For products used around the eyes, lips, oral or dental care, or hair dyes containing diamine compounds:

First 3 variants: $28 per product

4th and subsequent variants: $8 per product

For other cosmetic products:

First 3 variants: $13 per product

4th and subsequent variants: $8 per product

GMP Certificate:

Application for a GMP Certificate: $4,440

Additional GMP Certificates (without further assessment): $220

These fee revisions help cover the costs of services related to the regulation and safety of cosmetic products.

SWITZERLAND

Switzerland Updates Law on Food Contact Materials and Packaging Inks (Published on: 22/02/2024)

Switzerland has updated its Ordinance on materials and articles intended to come into contact with food, effective February 1, 2024. The key change involves the removal of the list of unevaluated substances used in packaging inks, which were previously part of the positive list. While substances not on the list or those known to be hazardous remain allowed in packaging inks, they are now subject to a generic detection limit of 0.01 mg/kg. This update also brings Swiss regulations on silicones, plastics, and ceramics into closer alignment with EU standards, particularly the EU’s Ceramic Articles Directive (EC No 1935/2004).

This move contrasts with trends in Europe and the US, where transparency regarding chemicals in food packaging is increasing. The removal of the unevaluated substances list adds complexity for researchers tracking food contact chemicals. However, the rest of the positive lists for packaging inks, silicones, and plastics were updated to ensure ongoing compliance and safety standards.

Swiss Symposium on Endocrine Disrupting Chemicals: Key Insights and Future Directions

On October 28, 2024, the Food Packaging Forum (FPF) and ETH Zürich co-hosted the first Swiss Symposium on Endocrine Disrupting Chemicals (EDCs). Experts from around the world gathered to discuss the history, current research, and future regulatory directions surrounding EDCs.

The symposium highlighted the origins of EDC science, dating back to the 1991 Wingspread Conference, which coined the term “endocrine disruptors.” Key insights included findings from Switzerland’s NRP50 research program, which linked EDC exposure to poor sperm quality and identified new chemicals, like UV filters, as endocrine disruptors. Modern research continues to explore the link between EDCs and diseases like obesity and diabetes, with experts stressing the need for more comprehensive research on the metabolism-disrupting effects of these chemicals.

Several speakers addressed the ongoing challenges of EDC exposure from food packaging, with Sarah Stevens highlighting the risks associated with plastic materials, particularly polyvinyl chloride (PVC). Tina Bürki-Thurnherr’s work on the effects of microplastics on placenta function was another key focus, showcasing how plastic particles can cross the placenta and impact fetal development.

Additionally, researchers discussed innovative approaches like new chemical testing methods and the role of the gut microbiome in transforming “safe” chemicals into endocrine disruptors. Environmental experts also explored how EDCs affect ecosystems, stressing the need for proactive regulation to prevent chemical contamination.

The symposium concluded with a call for stronger regulatory frameworks, greater transparency in chemical use, and more research into the long-term health and environmental impacts of endocrine disruptors.