Monthly Collection: China and International Food Regulatory Updates in October 2023
China Food Regulatory Updates
1. The product formulation and technical requirements for registration of health food ingredients, including isolated soybean protein and whey protein, came into effect from October 1, 2023. Later on October 7, 2023, China SAMR announced the interpretation documents for this regulation.
2. On October 7, 2023, China SAMR released an interpretation document for the Health Food Ingredient Catalog of Nutrient Supplements (2023 Edition), which provides detailed requirements for the use of materials and product names for casein phosphopeptides + calcium and DHA algal oil.
- Official source: https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/tssps/art/2023/art_495b72b3f82c47b3a3c54b7ecb5b2f2d.html
3. On October 17, 2023, China SAMR invited public comments on 158 proposed national standard projects, including health food ingredients such as broken ganoderma spore powder, coenzyme Q10, spirulina, melatonin, and fish oil. The deadline for submitting comments is November 17, 2023.
- Official source: https://www.samr.gov.cn/bzjss/zqyj/art/2023/art_487a824134134fba9e0d03722cc15589.html
4. On October 17, 2023, China SAMR issued the "Guidelines for the Safety Compliance of Special Food Sold Online." The guidelines cover general requirements for sales (qualification, process management, advertising and promotion, labeling and instructions) as well as specific requirements for online traders, third-party platforms, and food producers and operators of special food sold online.
- Official source: https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/tssps/art/2023/art_60126ca45972495089b727dc116c5d3e.html
New Food Ingredients
1. On October 7, 2023, China NHC issued an announcement approving a total of 15 "novel foods" as follows:
- New food ingredients (4 types): Peach gum, oil-saury, Leuconostoc mesenteroides subsp. cremoris, and Pyrroloquinoline quinone disodium salt (PQQ).
- New varieties of food additives (6 types): Serine protease, 2'-fucosyllactose (2'-FL), lacto-N-neotetraose (LNnT), magnesium lactate, calcium lactate, and xanthan gum.
- New varieties of food-related products (5 types): C.I. Pigment Black 7, carbon black, and 5 other substances.
2. On October 26th, China released a solicitation for opinions on 8 new varieties of food additives. The feedback deadline is November 21, 2023.
The list of new varieties of food additives proposed for solicitation includes:
- New variety of food additive: Rebaudioside M.
- New varieties of enzyme preparations for the food industry:a) Cyclodextrin glucosyltransferase.b) Cellulase.
- New variety of food nutrient fortifier: 2'-Fucosyllactose.
- Expanded use of food additives: a) Tomato red. b) Polyoxyethylene (20) sorbitan monostearate (also known as Tween 80). c) Rosemary extract. d) Vitamin E (dl-alpha-tocopherol, d-alpha-tocopherol, mixed tocopherol concentrate).
1. On October 17, 2023, the China Food Additives and Ingredients Association issued a solicitation for opinions on the draft revisions of the national food safety standards for 9 emulsifiers, including "Food Safety National Standard Food Additives Mono- and Diglycerides Fatty Acid Esters," and 4 sugar alcohol sweeteners, including "Food Safety National Standard Food Additives Maltitol and Maltitol Syrup."
2. On October 18, 2023, China NHC issued 11 national standards and amendment drafts for food safety. Relevant enterprises can submit feedback online before December 15, 2023. The topics covered by these standards and drafts include:
- Tumor-specific complete nutritional formula food (new)
- Food contact silicone rubber materials and products(new)
- General safety requirements for food contact materials and products
- Modulated milk
- Raw milk (GB 19301-2010) Amendment No. 1
- Canned food
- Food additive L-malic acid
- Food additive polydextrose
- Food additive copper sodium chlorophyllin
1. On October 9, 2023, in order to further optimize the business environment for cross-border trade and facilitate trade, China GAC decided to cancel the filing requirements for the origin enterprises of exported goods starting from November 1, 2023. Applicants for certificates of origin can directly apply for the certificates through the international trade "single window," Internet plus customs, China Council for the Promotion of International Trade (CCPIT) declaration system, and other channels.
2. On October 22, 2023, China GAC released information on non-admitted imported food in September 2023. In September 2023, a total of 294 batches of imported food were found to be non-compliant with safety and hygiene requirements and were not admitted by customs at various ports across the country. Products such as Tetra Pak Pure Milk and Cadbury's Joyful Strawberry Candy were included in the list.
3. The announcement regarding quarantine, inspection, and hygiene requirements for goods imported into China in October has also been updated. For more information, free to contact us to learn.
International Food Regulatory Updates
The EU & USA
1. On October 3, 2023, Regulation (EU) 2023/2379 was published, amending the regulations on the use of food additives (Regulation (EC) No 1333/2008). The main amendment involves the removal of stearyltartrate (E483), a food additive previously approved for use in heat-treated fermented milk products, bread, baked goods, etc. The reason for the removal is that the European Union assessed the lack of sufficient toxicological data to demonstrate the safety of stearyltartrate as a food additive.
2. On October 12, 2023, the U.S. FDA issued Notice 2023-22649, which is the fourth edition of the guidance document for the Prior Notice of Imported Food. The updated guidance document includes the following main changes: (1) It stipulates that even if the FDA has determined that the regulatory system of the country of origin of the imported food is equivalent to that of the United States, it does not exempt the requirement of prior notice when importing food from that country; (2) If the FDA reaches a conclusion of refusal of entry or detention examination for the imported food subject to prior notice, the importer can request a re-examination by the FDA within 5 natural days upon receiving the conclusion.
3. On October 23 and 24, 2023, the European Commission issued relevant regulations approving the addition of two new production strains for the production of 3-FL and 6'-SL. The approved strain for 3-FL is Escherichia coli K-12 DH1 derivative strain, and the approved strain for 6'-SL is Escherichia coli W (ATCC 9637).
4. On October 23, 2023, the European Commission published Regulation (EU) 2023/2203, amending the maximum residue limits of rafoxanide in certain foodstuffs of animal origin.
Australia and New Zealand
1. On October 30, 2023, Food Standards Australia New Zealand (FSANZ) issued an official gazette regarding Amendment 222 to the Australia New Zealand Food Standards Code. The scope of these amendments includes the approval of α-glucosidase from genetically modified Aspergillus oryzae as a processing aid (A1245) and the approval of insect-resistant corn line MON95275 for use in food (A1262).
2. On October 30, 2023, FSANZ released Notification 267-23, which includes Application A1283 for the approval of 2'-fucosyllactose produced from genetically modified Escherichia coli as a novel food ingredient for infant formula.
3. On October 30, 2023, FSANZ issued Notification 267-23, which includes Application A1261 for the proposed increase in the maximum permitted energy of X-rays used in food irradiation. It is understood that Australia and New Zealand plan to increase the maximum permitted energy of X-rays from 5 MeV to 7.5 MeV.
1. On October 5, 2023, the Thai Food and Drug Administration announced its intention to revise the standards for the use of food additives. The main content involves revising the scope of use and maximum usage levels of various food additives, including potassium acesulfame, in certain food products.
2. On October 17, 2023, the Food Safety and Standards Authority of India (FSSAI) issued an announcement regarding the development of labeling requirements for non-prepackaged processed foods, which will come into effect upon publication.
3. On October 23, 2023, the Singapore Food Agency (SFA) announced the cancellation of melamine-related requirements for imported milk, dairy products, and products containing milk from China.
4. On October 23, 2023, the Ministry of Food and Drug Safety (MFDS) of South Korea issued Notice 2022-502, proposing the establishment of partial regulations for the declaration and inspection of imported food. The main content includes the unified integration of import declaration and inspection regulations for imported food, health functional food, livestock products, and aquatic products to improve administrative efficiency and provide convenience to consumers.
Sources: Regulatory Authorities in Corresponding Countries & Regions. Please refer to official real-time adjustments for information accuracy, particularly regarding relevant data.
ZMUni Compliance Center provides the following regulatory services for global food companies:
China Food Compliance Service, including:
- Registration and filing of health food
- Notification for Novel Foods
- Compliance check for prepackaged food
China Food Importation Service, including:
- Customs clearance services
- Company filing services
- Application for business licenses and permits
- Application for import permits and species certificates
- Screening services for endangered ingredients
We can also help with the EU Novel Food application and the US GRAS application.