This article focuses on summarizing the regulatory developments related to food within China and internationally in July 2024, with an emphasis on updates in regulations concerning new food ingredients, food additives, feed additives and special foods.
China Food Regulatory Updates
1. Food Ingredients
On July 16, 2024, China's National Center for Food Safety Risk Assessment (CFSA) released a public consultation on the new food ingredient Camellia petelotii Culture. The deadline for feedback is August 15, 2024.
Compared to the same period last year, the number of new food ingredient applications in the first half of 2024 has increased, and the overall application process has continued to shorten.
Among them, microbial-derived ingredients have been particularly active. Pichia kluyveri, Bacillus subtilis DE111, and Leuconostoc pseudomesenteroides were approved, Bifidobacterium longum subsp. Infantis M-63 is undergoing public consultation, and Bacillus subtilis QK02 and Saccharomyces cerevisiae CNCM I-3799 have been accepted, reflecting the increasing emphasis on research and development of microbial-derived food ingredients.
In July 2024, two applications of new food ingredients, Enteromorpha polysaccharide and Pyrroloquinoline ( PQQ ) salt, have been accepted.
2. Food Additives
Compared to the same period last year, the number of new food additives received for review in the first half of 2024 grew rapidly, with an increase of nearly 50%. During the first half of 2024, there were 22 cases released for public comments, double the amount from the same period last year. The number of approvals has decreased slightly, down 11 cases from the first half of 2023, with a total of 12 cases approved.
It is worth noting that in the first half of 2024, there was a surge in the approval of human milk oligosaccharides (HMOs). During this period, there was 1 approved case, 9 cases released for public comments, and 13 cases received for review.
In July 2024, two new food additive applications, Nisin and Steviol Glycosides (Enzyme-Converted), have been accepted.
3. Feed Additives
On July 18, 2024, China's Ministry of Agriculture and Rural Affairs issued Announcement No. 809, deciding to expand the scope of application for certain feed additive varieties, and approve the following 5 as new feed additives：
-Pyrroloquinoline Quinone Disodium salt (Source:Hyphomicrobium denitrificans FINU-R8)
-Mosla chinensis Maxim extract (major active substances:thymol, carvacrol)
-Zinc Sucrose
-Dulcitol
-Egg white lysozyme oligomers
4. Special Foods
On July 19, 2024, China’s State Administration for Market Regulation issued an announcement on the "Registration Guideline for Special Medical Purpose Electrolyte Formula Foods" and other documents. This announcement mainly optimizes the requirements for registration application materials and on-site verification for the following three categories of products:
-Special medical purpose electrolyte formula foods
-Special medical purpose carbohydrate component formula foods
-Special medical purpose protein component formula foods
Relevant News on ZMUni: https://www.zmuni.com/en/news/china-streamlines-registration-of-three-types-of-foods-for/
On July 29, 2024, the China Nutrition and Health Food Association approved and released 165 group standards, including "Raw Materials for Health Foods - Panax Ginseng Leaf" (T/CNHFA 111.21-2024), which will be implemented from August 1, 2024.
In July 2024, a total of 4 special medical purpose formula foods were approved.
5. Regulations and Standards
On July 16, 2024, China released a notice outlining its 2024 Annual Food Safety National Standards Establishment Plan. According to the plan's annex, 35 new national food safety standards will be developed in 2024, covering:
5 food product standards
14 food additive quality and specification standards
1 standard for radioactive substances in food
5 physical/chemical testing method standards
2 microbiological testing method standards
1 toxicological evaluation method standard
2 production/operation norm standards
5 nutrition/special diet food standards
On July 25, 2024, China’s Ministry of Agriculture and Rural Affairs of the People's Republic of China released Maximum Residue Limits of 83 Pesticides including 2,4-Dichloroisovalerate in Food (Draft for Comments) and Maximum Residue Limits of 57 Pesticides including Famoxadone in Animal-Derived Products (Draft for Comments) for public comments. The deadline for feedback is before August 22, 2024.
International Food Regulatory Updates
| European Union
In the first half of 2024, the European Food Safety Authority (EFSA) issued scientific opinions on a total of 7 novel foods (5 new authorization applications, 1 extension application, and 1 notification of a traditional food from a third country). Among them, only 1 product's assessment conclusion was "the safety of this novel food cannot be determined", while the assessment conclusions for the rest were "the novel food is safe under the proposed conditions of use".
In July 2024, EU released 11 regulations regarding approved novel food and new feed additives, including Lacto-N-fucopentaose I and 2'-Fucosyllactose mixture produced using a derivative strain of Escherichia coli K-12 and two DHA Algal Oil from China: Schizochytrium sp. (CABIO-A-2) oil DHA
| United States
The number of substances that obtained FDA GRAS (Generally Recognized as Safe) certification in the first half of 2024 dropped significantly to 6, down from 29 in the same period of 2023. Additionally, there are currently 73 substances pending review.
| South Korea
On July 10, 2024, South Korea issued Public Notice No. 2024-35, amending parts of the Food Code. The main amendments are as follows:
New standards and specifications were established for nutrition formula foods intended for patients with lung disease.
The usage standard for Garcinia as a general food ingredient was modified: from "use no more than 5%, with intake not exceeding 6 g" to "use proportion less than 2%, with intake not exceeding 2.5 g".
The maximum residue limits were revised for 4 pesticides, including quizalofop-p-ethyl.
| Brazil
On July 1, 2024, the Brazilian Health Regulatory Agency (ANVISA) published Ordinance INNo304 through the Official Gazette, revising the regulations on food supplements (i.e. Ordinance No. 28 from 2018).
On July 3, 2024, ANVISA published Ordinance INNo306 through the Official Gazette, revising the regulations on the use of food additives (i.e. Ordinance INNo211 issued in 2023).
On July 12, 2024, ANVISA published the 4th edition of the Guidance on the Implementation of the Food Nutrition Labeling Regulations on their website (also known as the Food Nutrition Labeling Regulations Q&A), which serves as compliance guidance for manufacturers and distributors, as well as a supporting document for the regulatory authorities.
Sources: Official regulatory authorities in respective countries/regions.
