Global Food Regulation Highlights | May 2024

To help stakeholders in food sector navigate the constantly evolving regulatory landscape, ChemLinked offers Global Food Regulation Highlights, a concise monthly report that focuses on key regulatory developments worldwide. Find out what's new on food regulation worldwide in May 2024 below.

For thorough and comprehensive monitoring of developments in specific business sector and markets, we highly recommend our customized risk alert and monitoring report service. This service empowers you to effectively syta informed about all the regulatory dynamics that can impact your business. With the added advantage of expert interpretation and analysis, our service offers you a comprehensive understanding of the significance and consequences of these regulatory changes. For more detailed information, we invite you to click on the provided sample of regulatory monitoring report.

China

On May 17, 2024, the Taiwan Food and Drug Administration issued the revised Regulations for the Application of Health Food Permit, consistent with the proposed draft. In addition, as the Regulations covers provisions on extension, alteration, transference and reissuance of health food permits, the existing Guidelines on Registration for Extension, Alteration, Transference and Reissuance of Health Food Permits was abolished. The Regulations came into effect immediately.  (Read More)

Regulation highlights in Chinese Mainland:

• China Updates the Clinical Trial Quality Management Standard for Foods for Special Medical Purpose
  

• China to Optimize the Approval Procedures of Quarantine Permits for Imported Animals and Plants for Special Purposes

• CFSA Consulted on Seven New FCM Substances

• CFSA Consulted on Four New Food Additives, Involving 2'FL for Infant Formula

• China Proposes to Forbid the Sales of "Specially Supplied Liquor"

• China Announces the List of FSMP Product Subject to Priority Review

• China Launches New FSMP Registration System

• China Issues the Group Standards for Health Food Raw Materials

• China Nutriton and Health Food Association Consults on the Group Standard for Peptide Molecular Weight Characterization Methods of FSMP Products
  

Regulation highlights in other areas of China:

• Taiwan Specifies the Acceptable Physiological Functional Description of the Nutrient Selenium

• Taiwan to Raise the Fee Standards for Health Food Registration Review, Effective Since January 1, 2025

• Taiwan Unveils Common Supplementary Documents Required During the Customs Inspection of Imported Food Products

South Korea

On May 17, 2024, the Ministry of Food and Drug Safety (MFDS) released the latest revisions to Food Code. The modifications involve product standards and residual limits for pesticides and veterinary drugs. Specifically, MFDS newly recognizes the Saccharina sculpera（개다시마）and Telmessus acutiden（왕밤송이게）as approved food ingredients. Five temporarily approved food ingredients, including Abeliophyllum distichum Nakai (미선나무추출물), Kaempferia parviflora Wall. ex Baker (흑산내뿌리분말), Schizophyllum commune (치마버섯균사체배양물), concentrated separation minerals from deep ocean water (해양심층수 농축분리미네랄), and Fusarium venenatum A 3/5 (Fusarium venenatum ATCC PTA-2684), are officially included in the Food Code. Thus, these ingredients can now be used by anyone instead of the applicants only. Furthermore, the "young shoot" of the white atractylodes (삽주) are reclassified from the restricted ingredient to the allowable ingredient. (Read More)

More regulation highlights in South Korea:

• South Korea Implements Digital Inspection for All Imported Foods

• South Korea Consults on the Regulations on Import Declaration and Inspection of Imported Food

• South Korea Consults on the Food Code
  

Japan

On May 24, 2024, the Ministry of Health, Labour and Welfare (MHLW) of Japan released a proposed amendment for the Specification and Standards for Food, Food Additives, seeking for public comments till June 22. According to the proposal, MHLW plans to update Appended Table 1 - Table 2(Additives) of the positive list of FCM, including changes of the restrictions on the use of 4 substances and the addition of 13 new additives. (Read More)

More regulation highlights in Japan:

• Japan Moves to Strengthen Oversight of Functional Food Industry After Kobayashi Scandal

• Japan Enhances Supervision of Cannabis-related Controlled Products

• Japan Updates 12 New JAS Standards, with Vegetable Protein, Instant Food Involved

• Japan Plans to Revise the Residual Limit of Pesticide 2,4-D in Feed

• Japan Proposes to Revise the Usage of A Feed Additive
  

Southeast Asia 

During an internal meeting held on May 15, 2024, the Indonesian government decided to postpone the mandatory halal certification requirement for food and beverage products from micro and small enterprises (MSEs) from October 17, 2024 to 2026. Additionally, based on mutual recognition agreements, the halal certification obligation for imported products will also be shifted to 2026. (Read More)

More regulation highlights in Southeast Asia:

• Singapore Adds New Ingredients in Infant Formula and Expands Use Scope of Food Additives

• Malaysia Announces New Timeline for Variation Applications of Registered Health Supplements

• Philippines Releases Guidelines on the Issuance of Import Permit as “Samples Only” for Processed Food Intended for R&D Purposes

• Philippines to Launch Integrated System to Expedite Inspection and Monitoring of All Imports, Starting with Agricultural Products

• Thailand to Govern Plant-Based Food by Drafting New Regulations

• Indonesia Publishes Approval Procedures of Clinical Test Implementation, Involving Health Supplement and Processed Food

• Thailand to Relist Cannabis as Narcotic by the End of 2024

• Thailand Prepare to Announce Ministry of Public Health (No. 449) B.E. 2024 regarding Food Containing Pesticide Residues (No. 4)

• Vietnam Issues Decree No. 46/2024/ND-CP, Amending and Supplementing a Number of Articles of Decree No. 99/2013/ND-CP Regarding Penalties for Administrative Violations in the Field of Industrial Property

• Vietnam Collects Comments for the Draft TCVN Soft Dried Mango

European Union (EU) 

On May 24, 2024, the European Union (EU) issued Directive (EU) 2024/14381 (hereinafter “This Directive”) to amend the following directives:

1. Council Directives 2001/110/EC relating to honey;

2. Council Directive 2001/112/EC relating to fruit juices and certain similar products intended for human consumption;

3. Council Directive 2001/113/EC relating to fruit jams, jellies and marmalades and sweetened chestnut purée intended for human consumption;

4. Council Directive 2001/114/EC relating to certain partly or wholly dehydrated preserved milk for human consumption.

(Read More)

More regulation highlights in EU:

• EU Amends Purity Characteristics for Olive Oils

• EU Updates Regulation (EC) No 1333/2008 on Food Additives Regarding Food Additives tartaric acid (L(+)-) (E 334), sodium tartrates (E 335), potassium tartrates (E 336), sodium potassium tartrate (E 337) and calcium tartrate (E 354)

• EU Proposes List of Antimicrobials for Use in Animals: Banned and Authorised

• EU Publishes Initiatives to Amend Olive Oil Marketing Standards – Revision of Conformity Checks

• EU Amends Regulation (EC) No 396/2005 as Regards the Maximum Residue Levels of Pesticide in or on Certain Products: a) Commission Regulation (EU) 2024/1314; b) Commission Regulation (EU) 2024/1318; c) Commission Regulation (EU) 2024/1342; d) Commission Regulation (EU) 2024/1355; e) Commission Regulation (EU) 2024/1439.

United States (US)

U.S. Food and Drug Administration (FDA) published a Final Rule on Pre-Harvest Agricultural Water that represents an important step toward enhancing the safety of produce. The revised requirements are intended to enhance public health by improving the safety of water used in produce cultivation. The revisions are also designed to be practical across various agricultural water systems, uses, and practices, while remaining adaptable to future advancements in agricultural water quality science. Specifically, this rule establishes requirements for agricultural water assessments that evaluate a variety of factors that are key determinants of contamination risks associated with pre-harvest agricultural water. It also includes testing pre-harvest agricultural water as part of an assessment in certain circumstances, as well as requires farms to implement effective mitigation measures within specific timeframes based on findings from their assessments. Besides, new options for mitigation measures are added, providing farms with additional flexibility in responding to findings from their pre-harvest agricultural water assessments.   (Read More)

More regulation highlights in America:

• U.S. FDA Determines That Tara Flour Is an Unapproved Food Additive

• U.S. Modifies the Residual Limits of Cyflumetofen

• U.S. Cancels Residual Limits of Two Pesticides

• U.S FDA Consults on Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing

• FDA Issues Warning About Toxic Amygdalin Found in Apricot Seeds

Canada 

On March 30, 2024, Health Canada announced to modify the List of Permitted Preservatives with immediate effect, extending the uses of three preservatives, namely, natamycin, chitosan, and nisin. Also in May, Health Canada proposed to remove brominated vegetable oil (BVO) from the List of Permitted Food Additives with Other Accepted Uses. (Read More in News One and News Two)

More regulation highlights in Canada:

• Canada Proposes MRLs for Six Pesticides in Agricultural Products, Including Fluopyram, Trifloxystrobin, Picarbutrazox, Dichlorprop, Broflanilide and Metsulfuron-methyl

• Canada to Amend Fish Import Inspection Fees

• Canada Temporarily Bans the Sales of Certain Natual Health Products Containing Ephedrine or Pseudoephedrine 
  

Australia and New Zealand 

On May 8, 2024, New Zealand Associate Health Minister Casey Costello announces the decision to repeal the Therapeutic Products Act (TPA). Initially set to become effective by September 2026, the TPA encompassed regulation over natural health products (NHPs), a diverse category ranging from dietary supplements to traditional medicines. With the act's repeal, the Dietary Supplements Regulations 1985 will remain in force until they are replaced by new legislation. (Read More)

More regulation highlights in Australia and New Zealand:

• FSANZ Approves Applications Regarding Australian Native Bee Honey and Food Derived from Corn Line DAS1131

• FSANZ Proposes to Revise the Code Regarding Added Sugar Claims

• FSANZ Releases Amendment No. 228, Involving Rosemary Extract as a Food Additive, Steviol Glycosides as a Food Additive in FSMP, a Processing Aid, Food Derived from Soybean Line MON94313, and a 2'FL in Infant Formula Products.

• New Zealand Proposes to Amend the Maximum Residue Levels for Agricultural Compound Food Notice

• Australia Makes Changes to the Import Conditions on the Standard Permit for Dairy Products

Recommended reading:

• Global Food Regulation Highlights | January 2024

• Global Food Regulation Highlights | February 2024

• Global Food Regulation Highlights | March 2024

• Global Food Regulation Highlights | April 2024

• Hot topic: Global Food Regulation Highlights, 2020-2024