This article focuses on summarizing the regulatory developments related to food within China and internationally in October 2024, with an emphasis on updates in regulations concerning new food ingredients, food additives, feed additives, and special foods.
China Food Regulatory Updates
1. New Food Ingredients & Food Additives
On October 10, 2024, the China National Health Commission (NHC) issued a notice on 12 Three New Food. These include two new food ingredients (Nannochloropsis qaditana oil & Procyanidins) and four new food additives (D-psicose 3-epimerase, 2’-FL, LNnT, Sodium ferrous citrate).
Relevant News on ZMUni:
https://www.zmuni.com/en/news/china-three-new-food-updates-involving-two-new-food/
On October 24, 2024, the China National Center for Food Safety Risk Assessment(CFSA) issued two notices soliciting public comments for two new food ingredients (Sakura polyphenol & Rooster comb sodium) and six new food additives respectively.
Relevant News on ZMUni:
https://www.zmuni.com/en/news/china-three-new-food-updates-cfsa-consults-on-two-new-food/
2. Special Food
On October 9, 2024, China’s State Administration for Market Regulation (SAMR) issued a notification, publishing a document titled “Guidelines for Filing Ingredients and Other Matters of Formula Foods for Infants and Young Children”. The draft encourages the direct processing of infant formula from cow's milk or goat's milk. Considering the requirements for advertising and promotion of infant formula products, the main label of formula for children over one year old may include terms like "processed from cow's milk" or "processed from goat's milk." Additionally, the draft stipulates that new applications for infant formula products using base powder must directly utilize base powder processed from cow's milk or goat's milk.
On October 11, 2024, the State Administration for Market Regulation (SAMR) of China 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) and the 2024 Edition of the List of Auxiliary Materials for Health Food Filing and Terms of Use (Draft). The 2024 Edition Drafts supplements new dosage forms for nutrient supplement health food filings, expanding options to include candy, beverages, chocolate, jelly, and powders—formats that are more readily accepted by the general public.
Relevant News on ZMUni:
https://www.zmuni.com/en/news/china-to-expand-health-food-dosage-forms-to-include-candies/
On October 22, 2024, China's State Administration for Market Regulation (SAMR) released the Working Procedures for Priority Review and Approval of Registration for Food for Special Medical Purposes (FSMP) effective immediately.
Relevant News on ZMUni:
https://www.zmuni.com/en/news/china-provides-details-on-priority-review-applications-of/
3. Food Standard
On October 8, 2024, the National Health Commission (NHC) launched a public consultation for 19 national food safety standards. The draft standards cover six related to food additives, one for contaminants, one product standard, and eleven testing standards.
Relevant News on ZMUni:
https://www.zmuni.com/en/news/china-consults-on-19-national-food-standards-for-food/
On October 11, 2024, China's National Standardization Administration issued a notice seeking public comments on 71 proposed national standard projects. Among these 71 proposed projects, eight pertain to the field of health food, covering standards for six types of health food ingredients, including red yeast rice, chromium picolinate, ophiocordyceps sinensis, glucosamine hydrochloride, chondroitin sulfate sodium, and Paecilomyces hepialis powder. Additionally, there are two standards concerning the determination of chondroitin sulfate and glucosamine in health foods. The notice also includes clinical trial technical guidelines for specific enteral nutrition formula foods related to diabetes, tumors, and kidney disease.
4. Import Food Access
On October 25, 2024, the General Administration of Customs of China released information on unapproved food and cosmetics for September 2024. In September, customs across the country detected a total of 471 batches of food that failed to meet safety and hygiene standards during port supervision, representing a month-on-month increase of 60.2% and a year-on-year increase of 56.4%. The main reasons for non-compliance included inadequate labeling, discrepancies between goods and documentation, expiration dates not meeting national food safety standards, and detection of animal diseases.
5. Updates in HongKong
On October 10, 2024, the Hong Kong Gazette published "The Preservatives in Food (Amendment) Regulation 2024," which comprehensively updates the safety standards for preservatives and antioxidants in food. The new regulations will take effect on December 30, 2024, with a 24-month transition period to provide manufacturers ample time to comply with the new requirements.
The main updates of this amendment include:
1. Updates to Definitions: The definitions of preservatives and antioxidants have been clarified, specifying that vitamins and minerals, as nutrients, are not subject to the management of preservatives and antioxidants. Additionally, food additives such as tocopherols, citrates, ascorbates, and phosphates, which are not currently regulated by existing laws, have been included in the positive list of preservatives or antioxidants.
2. Update of the Permitted List: The revised list of permitted preservatives and antioxidants now includes a total of 58 substances. Three preservatives/antioxidants, namely copper carbonate, diphenyl, and formic acid, have been removed, while four new substances, including benzoyl peroxide, lauryl arginine ethyl ester, stearoyl citrate, and rosemary extract, have been added. Tocopherols and phosphates have also been included in the management scope.
3. Revision of Maximum Permissible Levels: The maximum allowable levels of preservatives and antioxidants in specific foods have been updated, expanding the "additive-food" combinations from approximately 900 to about 2,000. This ensures that only the specified preservatives or antioxidants can be present in food, and their usage must not exceed the established limits.
4. Expansion of the GMP Additive List: Twenty-four new preservatives and antioxidants have been introduced, which can be used in ordinary foods in moderation according to Good Manufacturing Practice (GMP) principles.
Relevant link: https://www.legco.gov.hk/yr2024/english/subleg/negative/2024ln130-e.pdf
International Food Regulatory Updates
| European Union
The European Food Safety Authority (EFSA) has published new guidance on the submission of novel food applications, which will take effect in February 2025. The guidance applies to all novel food applications, including those for cell-based foods and food ingredients. The updated guidance document consists of three parts:
1. Administrative guidance for novel food applications
2. Scientific requirements for the authorization of Category 1 novel foods (new food ingredients)
3. Scientific requirements for the authorization of Category 2 novel foods (traditional foods from third countries)
Relevant link: https://www.efsa.europa.eu/en/news/navigating-novel-foods-what-efsas-updated-guidance-means-safety-assessments
On 18 October 2024, the European Commission published Regulation (EU) 2024/2694, which, in accordance with European Parliament and Council Regulation (EC) No 2015/2283, approves magnesium L-threonate as a novel food for market release and amends the annex of Implementing Regulation (EU) 2017/2470.
Relevant link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202402694
On 23 Oct 2024, The European Commission approved a specific protein hydrolysate derived from whey protein for use in infant formula and follow-on formula.
Relevant link: https://agrinfo.eu/book-of-reports/protein-hydrolysates-in-infant-and-follow-on- formula/pdf
In October 2024, the European Food Safety Authority (EFSA) published 17 scientific output announcements related to feed additives, covering a variety of substances including ammonium propionate, fumaric acid, tea tree oil, Camellia oleifera C.Abel seed extract, and Lentilactobacillus buchneri.
Relevant link: https://www.efsa.europa.eu/en/search?s=&f%5B0%5D=date%3Acustom%3A2024-10-01%3A2024-10-31&f%5B1%5D=topic%3A358
| Australia & New Zealand
On October 29, 2024, Food Standards Australia New Zealand (FSANZ) issued an official notice regarding Amendment 233 to the Australia New Zealand Food Standards Code. The related revisions include the formal inclusion of A1247, which approves D-allulose as a novel food in the Code.
Relevant link: https://gazette.govt.nz/notice/id/2024-gs5510
On October 29, 2024, Food Standards Australia New Zealand issued notification 313-24, which includes application A1315, seeking approval for chitosan and β-1,3-glucan derived from white mushrooms to be used as food additives in food and beverage products.
Relevant link: https://www.foodstandards.gov.au/food-standards-code/circulars/notification-circular-313-24
| United Kingdom
On October 3, 2024, the UK Food Standards Agency (FSA) proposed to develop guidance on allergen declarations for non-prepackaged foods, which explains 14 mandatory allergens and the written allergen information format.
Relevant link:
| Korea
On October 2, 2024, the Ministry of Food and Drug Safety (MFDS) of South Korea issued Notice No. 2024-56, amending certain provisions of the Food Additives Code. The main updates are as follows:
1. Expanding the certification standards for natural sources of preservatives.
2. Revising the usage standards for certain food additives: establishing new usage standards for six food additives, including sulfur dioxide, in fruit wines, and allowing hydroxypropyl methylcellulose phthalate to be used in the production of enteric-coated health functional foods.
3. Expanding the application scope of propylene glycol in the food industry.
4. Amending the usage standards for 16 tartrazine colorants, including Green No. 3, when used together.
5. Modifying certain terminology.
6. Revising the specifications and testing methods for certain food additives.
*This article is compiled by ZMUni Compliance Center, based on the latest regulatory updates from food-related regulatory authorities/agencies in various countries/regions.
