In 2024, Chinese regulatory bodies such as the State Administration for Market Regulation(SAMR) and the National Health Commission(NHC) released a series of policies, regulations, and standards in the food sector. Focusing on China, ZMUni Compliance Centre has summarized the key regulations and standards that had a significant impact on the industry this year, with a particular focus on Three New Foods, special food(health food, food for special medical purpose), and feed. The key highlights as follows:
On March 12, 2024, the NHC of China issued the GB 2760-2024 National Food Safety Standard for Uses of Food Additives along with 47 other food safety standards and 6 amendments (Announcement No. 1, 2024). As of the publication date, the total number of national food safety standards has reached 1,610.
The revised GB 2760-2024 is particularly noteworthy. This standard will come into effect on February 8, 2025, replacing the 2014 version. The revision will have a significant impact on the food additives and food industries.
On September 13, 2024, China’s National Center for Food Safety Risk Assessment(CFSA) issued the Application Requirements for Safety Evaluation of Genetically Modified Microorganisms for Food Processing (Trial). This document outlines the requirements for applicants submitting materials for the use of genetically modified microorganisms in producing Three New Food(new food ingredients, new varieties of food additives, and related food products,), provided that the product does not contain newly introduced genetic sequences or genetically modified microorganisms. This document paves the way for the application of synthetic biology new ingredients in the food sector.
As of December 27, 2024, China NHC has published four announcements on new food ingredients and new food additives (Announcements No. 2, 3, 5, and 6 of 2024).
New Food Ingredients: A total of 12 new food ingredients have been approved, including Dendrobium protocorm,Meso-zeaxanthin, Pichia kluyveri, Bacillus subtilis DE111, L-alpha-Glycerylphosphorylcholine, Leuconostoc pseudomesenteroides, Arabinoxylan, Bifidobacterium longum subsp. infantis M-63, Nannochloropsis qaditana oil, Procyanidins, and Camellia petelotii culture.
New Varieties of Food Additives: A total of 28 new additives were approved, including 10 cases of scope expansion (8 food additives with increased usage levels, 2 food fortifiers with expanded usage), and 18 new substance approvals (7 new food enzyme products, 6 new food fortifiers, 4 new food additives, and 1 new food flavoring agent).
Notably, since the approval of the first genetically modified microorganism-produced 2'-fucosyllactose at the end of 2023, several genetically modified microorganism-produced food additives, including seven human milk oligosaccharides (HMOs) and Enzymatically produced steviol glycosides have also been approved in 2024. More genetically modified microorganism-derived food additives and new food ingredients are expected to be approved in 2025.
On August 26, 2024, China NHC issued the announced to update the Catalogue of Substances Traditionally Considered as Both Food and Chinese Medicine, officially adding four new substances. With this update, the total number of listed substances has reached 106.
|
Substance Name |
Plant Name |
Latin Name |
|
地黄 |
地黄 |
Rehmannia glutinosa Libosch |
|
麦冬 |
麦冬 |
Ophiopogon japonicus (L.f)Ker-Gawl. |
|
天冬 |
天冬 |
Asparagus cochinchinensis (Lour.) Merr |
|
化橘红 |
化州柚 |
Citrus grandis‘Tomentosa’ |
|
柚 |
Citrus grandis（L.）Osbeck |
On April 30, 2024, China issued a regulation specifying the filing requirements for health food containing three ingredients: Ginseng, American Ginseng, and Lingzhi. The regulation stipulates five key aspects, including auxiliary materials usage, product dosage forms, product processing, product technical requirements, and others. It came into effect on May 1, 2024.
On October 11, 2024, China SAMR issued a public notice seeking comments on two draft documents: the 2024 Edition of the Dosage Forms and Technical Requirements for Health Food Filing (Draft for Comments) and the 2024 Edition of the List of Auxiliary Materials for Health Food Filing and Terms of Use (Draft for Comments).
These drafts propose the inclusion of new product forms for filing, such as candies, beverages, chocolates, jellies, and powders—forms that are more widely accepted by the public, potentially expanding the market applications of filed health foods.
On November 1, 2024, China SAMR published the Key Points for the Centralized Review of Health Food Products with No Expiry Dates and No Product Technical Requirements (referred to as "dual-no" products), which took effect immediately. This announcement provides detailed guidelines for the renewal process, officially launching the certificate renewal work. Provinces such as Guangdong, Shaanxi, and Sichuan have already released relevant renewal plans to ensure smooth policy implementation.
Earlier, on August 31, 2023, China SAMR, together with China NHC and the National Administration of Traditional Chinese Medicine, issued Health Function Catalogue Allowed for Health Food Claims - Nutrient Supplements (2023 Edition) and other associated regulations.
These regulations established the framework for the cleanup and renewal of certificates for "dual-no" products, with a transition period of five years, requiring completion by August 31, 2028.
In 2024, China SAMR released the Clinical Trial Quality Management Standard for Foods for Special Medical Purpose (Announcement No. 17, 2024, issued on April 25, 2024) and the Key Points for On-site Inspection and Judgment Principles of Clinical Trials for Registration of Special Medical Purpose Formula Food (Announcement No. 48, 2024, issued on November 11, 2024). These documents provide further details on the management requirements for clinical trials of special medical foods, laying the foundation for the standardized development of the industry.
On October 22, 2024, China SAMR released the Working Procedures for Priority Review and Approval of Registration for Food for Special Medical Purposes(FSMP) (hereinafter referred to as "Working Procedures"), which took effect immediately.
Based on the 2023 Edition of Administrative Measures for Registration of Foods for Special Medical Purpose, rare disease-related special medical foods and new types of special medical foods urgently needed in clinical practice are eligible for priority review and approval. This recent Working Procedures shortens the technical review timeline to 30 working days and prioritizes on-site verification and sampling inspections. As of the publication date, six special medical formula foods have been announced for inclusion in the priority review and approval process.
On July 19, 2024, China SAMR issued the Registration Guidelines for Electrolyte Formula Foods for Special Medical Purposes, the Registration Guidelines for Carbohydrate Component Formula Foods for Special Medical Purposes, and the Registration Guidelines for Protein Component Formula Foods for Special Medical Purposes (Announcement No. 29, 2024). These guidelines optimize the registration requirements, on-site verification, and other procedures for three categories of FSMP—protein components, carbohydrate components, and electrolyte formulas. The improvements aim to reduce R&D costs, shorten registration timelines, and enhance the overall efficiency of the review and approval process.
In 2024, China’s Ministry of Agriculture and Rural Affairs (MARA) issued three announcements on feed and feed additives (Announcements No. 744, 809, and 862 of 2024).
New feed: One feed ingredient, Methylococcus capsulatus cell protein, has been approved; 8 feed ingredients successfully passed the safety monitoring period and added to the Catalogue of Feed Additives.
New Feed additives: 14 new feed additives has been approved, including Pancreatin( from porcine pancreas ), Potassium magnesium sulfate, Stevia extract ( active substance: chlorogenic acid and its analogues ), Pyrroloquinoline Quinone Disodium salt (Source: Hyphomicrobium denitrificans FJNU-R8); Mosla chinensis Maxim extract (major active substances: thymol. caryacrol), Zinc Sucrose, Dulcitol, Egg white lysozyme oligomer, Ferrous sucrose, Iron dextran, Gallic acid (from Galla chinensis or Caesalpinia spinosa Kuntze), Red amorphous elemental selenium, Zinc valine chelate, Ferulic acid; 3 feed additives successfully passed the safety monitoring period and added to the Catalogue of Feed Additives.
In addition, the scope of application for six feed additives has been expanded, and five feed additives that have not yet been approved for use in China but have been authorized for production and use in their respective countries have been granted approval.
On March 26, 2024, MARA released the 2024 Feed Quality and Safety Supervision Plan, aiming to enhance regulatory oversight, mitigate risks, and crack down on illegal use of substances like ractopamine in livestock production.
On November 15, 2024, the General Administration of Customs of the People's Republic of China(GACC) published the Regulations on the Inspection and Quarantine of Imported and Exported Feed and Feed Additives(Draft for Comments), launching a one-month public consultation to refine inspection procedures.
On November 12, 2024, GACC announced an update to the Import Food List Subject to Quarantine Approval, removing approval requirements for several categories, including cured meat products, casings, dairy, aquatic products, and bird's nest. This move streamlines import procedures and reflects advancements in China's regulatory framework and digitalization.
In 2024, 4,200 batches of imported food rejected at customs due to quality and safety violations, representing a 78.12% increase compared to 2,358 batches in 2023.
*This article is based on our understanding of the 2024 updates to China's food-related regulations and policies, intended for learning and reference purposes. any inaccuracies or omissions are found, we welcome your feedback and suggestions. Thank you for your attention and support.
