This article focuses on summarizing the regulatory developments related to food within China and internationally in September 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 September 13, 2024, China's National Center for Food Safety Risk Assessment (CFSA), under the National Health Commission, issued a notice regarding the improvement of safety evaluation data requirements for "three new foods (new food additive, food ingredients, and food contact materials)." The release of this new regulation signifies a comprehensive opening for the application of synthetic biology new materials in the food sector!
Relevant News on ZMUni: https://www.zmuni.com/en/news/latest-requirements-in-china-for-the-application-of/
On September 26, 2024, CFSA consulted on eight new food additives for public feedback. They are:
Name |
Purpose/Type |
Notes |
Glutamine transaminase |
New varieties of enzyme preparations for the food industry.
|
Soured from Bacillus licheniformis
|
Phosphodiesterase I |
Soured from Leptographium procerum |
|
Lipase |
Soured from Komagataella phaffi
|
|
trans-Anethole |
New varieties of food flavoring agents.
|
used in various food products (excluding food categories in GB2760-2014 Table B.1). |
Hydroxycitronellal |
||
3-fucosyllactose (3-FL) |
New varieties of food nutrition fortifiers.
|
Used in infant formula and other food categories |
β-Alanine |
Excluding special dietary foods classified as 13.01-13.04 (limited to sports nutrition foods) |
|
Fructooligosaccharide |
This quality specification applies to a mixture of sucrose-derived trehalulose to sucrose-derived hexulose produced from β-fructofuranosidase sourced from Japanese Aspergillus through purification, drying, and other processes. |
In addition, the CFSA also applied to expand the usage of sucralose and acesulfame potassium, as well as to broaden the application of 2-FL to include infant cereal complementary foods (food category 13.02.01) and infant formula complementary foods (food category 13.02.02).
2. Food Standard
On September 6, 2024, the State Administration for Market Regulation released the Q&A for Amendment No. 2 of GB 23350-2021 Requirements for Restricting Excessive Packaging of Goods: Food and Cosmetics. It is specified that different thicknesses of films combined with other incompletely sealed packaging items count as one layer of packaging to prevent leakage.
3. Imported Food Access
On September 20, 2024, the General Administration of Customs of China released information on unapproved food and cosmetics for August 2024. In August, customs across the country detected a total of 301 batches of food that failed to meet safety and hygiene standards during port supervision, representing a month-on-month decrease of 23.2% and a year-on-year increase of 31.4%.
International Food Regulatory Updates
| European Union
In September 2024, the European Commission issued several regulations relating to the approval and extension of the authorisation period for animal feed additives, including:
Regulation (EU) 2024/2177 of 2 September 2024 concerning the authorisation of a preparation of 6-phytase produced with Aspergillus oryzae DSM 33737 as a feed additive for all poultry species for fattening or reared for laying or reared for breeding, sows of all Suidae species and all fin fish.
Regulation (EU) 2024/2180 of 2 September 2024 concerning the authorisation of a preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific-endo-beta-1,4-glucanase produced with Trichoderma citrinoviride DSM 33578 as a feed additive for sows of all Suidae species
Regulation (EU) 2024/2184 of 3 September 2024 concerning the authorisation of a preparation of fumonisin esterase produced with Komagataella phaffii NCAIM (P) Y001485 as a feed additive for piglets and pigs for fattening of all Suidae species.
Regulation (EU) 2024/2185 of 3 September 2024 concerning the authorisation of a preparation of Bacillus subtilis FERM BP-07462, Enterococcus lactis FERM BP-10867 and Clostridium butyricum FERM BP-10866 as a feed additive for all poultry species for fattening, all poultry species reared for laying or breeding and ornamental birds.
Regulation (EU) 2024/2385 of 9 September 2024 concerning the authorisation of 4-methyl-5-vinylthiazole as a feed additive for all animal species.
Regulation (EU) 2024/2389 of 9 September 2024 concerning the authorisation of a preparation of semduramicin sodium (Aviax 5 %) as a feed additive for chickens for fattening
Regulation (EU) 2024/2464 of 12 September 2024 concerning the authorisation of pine white essential oil from Pinus pinaster Aiton as a feed additive for all animal species
Regulation (EU) 2024/2414 of 13 September 2024 concerning the authorisation of juniper essential oil and juniper tincture from Juniperus communis L. as feed additives for all animal species
Regulation (EU) 2024/2427 of 16 September 2024 concerning the authorisation of coriander essential oil from Coriandrum sativum L. as a feed additive for all animal species
| Australia & New Zealand
No. |
Date |
Notification |
Substance |
Purpose |
1 |
September 6, 2024 |
Notification 305-24 |
Triacylglycerol lipase |
Seeking comments for use as a processing aid. |
2 |
September 9, 2024 |
Notification 306-24 |
Application for approval of genetically modified soybean line MON94637 |
For use in food. |
3 |
September 9, 2024 |
Notification 306-24 |
Application for approval of a new genetically modified Escherichia coli BL21 producing 2′-fucosyllactose (2′-FL) |
For use in infant formula products. |
4 |
September 9, 2024 |
Notification 306-24 |
Application to revise the specifications for lacto-N-tetraose produced by genetically modified Escherichia coli K-12 |
/ |
5 |
September 13, 2024 |
Notification 307-24 |
Vitamin K2 (Menaquinone-7) |
Seeking comments for use in special medical purpose foods as an allowed form of Vitamin K. |
6 |
September 16, 2024 |
Notification 308-24 |
Beet variety KSW20-1 |
Seeking comments for use in food. |
| United Kingdom
On September 5, 2024, the UK Food Standards Agency (FSA) released the Requirements for the Prevention of Food Allergy Labeling (PAL) and Allergen Thresholds.
| Canada
On September 12, 2024, Health Canada issued a document approving a genetically modified yeast (specifically, brewing yeast) formulation—Sourvisiae® for use in food.
| ASEAN
On September 23, 2024, the Indonesian Food and Drug Authority published Announcement No. 15 of 2024, revising the standards and procedures for health food registration (i.e., Regulation No. 32 of 2022). The revisions include:
1. In Appendix 1 (List of permitted vitamins and minerals in health food supplements), a new provision stating that the maximum daily intake of selenium for pregnant women and nursing mothers should not exceed 65 μg.
2. The maximum daily intake of zinc in Appendix 1 has been revised from 25 mg to 30 mg. This announcement takes effect from the date of publication in the government gazette.
| Brazil
On September 20, 2024, the National Health Surveillance Agency (ANVISA) of Brazil published Directive IN No. 318 through the government gazette, amending the regulations for food supplements (i.e., Directive No. 28 of 2018). The main revisions include:
1. Revising the standard name of the ingredient "baobab fruit powder" (Adansonia digitara) in the list of nutrients permitted for dietary supplements (excluding supplements for infants aged 0-3 years).
2. Adding Bacillus clausii UBBC-07 to the list of nutrients permitted for dietary supplements for infants aged 0-3 years.
3. Revising the minimum daily intake of EPA and DHA for the 4-8 age group from 25 mg to 30 mg in the list of minimum daily nutrient intakes through food supplements, and revising the maximum daily intake from 180 mg to 200 mg for the same age group.
4. Adding claims such as "helps in the synthesis of cysteine" for vitamin B6 to the list of allowed claims for food supplements.
5. Revising labeling regulations for food supplements to include a warning stating, "Pregnant women and nursing mothers should not consume this product; individuals who are ill or taking medications should consult a doctor before consumption" on labels of food supplements containing Bacillus clausii UBBC-07.
This directive takes effect from the date of publication in the gazette, with a transition period of 24 months.
*This article is compiled by ZMUni Compliance Center, based on the latest regulatory updates from food-related regulatory authorities/agencies in various countries/regions.