This article focuses on summarizing the regulatory developments related to food within China and internationally in August 2024, with an emphasis on updates in regulations concerning new food ingredients, food additives, feed additives and special foods.
China Food Regulatory Updates
| New Food Ingredients & Food Additives
On August 5, 2024, China's National Health Commission (NHC) announced the approval of three new food ingredients (Arabinoxylan, Bifidobacterium longum subsp. infantis M-63, N-acetylglucosamine) and four new varieties of food additives (Hydroxytyrosol, Methylene chloride, 2'-fucosyllactose, Polyglycerol polyricinoleate (PGPR).
On August 26, 2024, the National Center for Food Safety Risk Assessment (CFSA) released an analysis of common questions regarding "Three New Foods". The report focused on 25 common issues related to new food ingredients and new varieties of food additives, including how to define and manage new food ingredients and substances, whether food extracts can be used as food ingredients, and whether red ginseng can be used as a food ingredient.
| Substances Traditionally Considered as Both Food and Chinese Medicine
On August 26, 2024, China NHC announced to update the Catalogue of Substances Traditionally Considered as Both Food and Chinese Medicine by adding four new substances: Rehmannia glutinosa Libosch, Ophiopogon japonicus (L.f) Ker-Gawl, Asparagus cochinchinensis (Lour.) Merr, Citrus grandis ‘Tomentosa’.
| Special Foods
On August 6, 2024, the State Administration for Market Regulation (SAMR) of China issued the Announcement on Soliciting Suggestions for the Catalogue of Health Functions Allowed to Be Claimed by Health Food. This aims to fully utilize the research advantages of social resources, encourage and guide individuals, enterprises, research institutions, and social organizations to participate in the evaluation of the development of new health functions for health food, and promote the supply of high-quality product research and development.
Relevant News on ZMUni: https://www.zmuni.com/en/news/china-samr-calls-for-solicitation-of-new-function-claims/
| Regulations and Standards
On August 16, the Standard Technology Management Division of the China SAMR publicly solicited opinions on the draft of the recommended national standard GB/T 29602 Quality Requirements for Solid Beverages. Compared to GB/T 29602-2013 Solid Beverages, there are significant adjustments, such as changes to the terminology and definitions of "solid beverages," modifications to product classifications, and revisions to physical and chemical requirements and testing indicators.
On August 26, 2024, the General Administration of Customs of China (GACC) published the list of non-compliant food products from July 2024, rejecting a total of 392 batches of imported food from 44 countries and regions. In July, there was a significant increase in cases of non-entry due to the "use of unapproved new food ingredients" or "non-food materials" compared to previous periods.
In August, China GACC released updated notes on "frozen fruits" in the overview of the "Food List for Import to China." Frozen fruit products will no longer require quarantine entry management, which means frozen fruits from any country to be imported into China without regional restrictions!
International Food Regulatory Updates
| European Union
In August 2024, EFSA published scientific assessments on 5 feed additives, including:
1. Assessment for feed additive consisting of Levilactobacillus brevis DSM 16680 for all animal species for the renewal of its authorisation (Microferm Ltd.)
2. Safety and efficacy of a feed additive consisting of Loigolactobacillus coryniformis DSM 34345 as a silage additive for all animal species (Lactosan GmbH & Co.KG)
3. Assessment of the feed additive consisting of diclazuril (Clinacox® 0.5%) for chickens for fattening and chickens reared for laying for the renewal of its authorisation (Elanco GmbH)
4. Assessment of the feed additive consisting of sodium propionate for all terrestrial animal species for the renewal of its authorisation (BASF SE)
5. Assessment of the feed additive consisting of endo‐1,4‐beta‐xylanase (produced with Trichoderma reesei MUCL 49755) and endo‐1,3(4)‐beta‐glucanase (produced with T. reesei MUCL 49754) (AveMix® XG 10) for pigs for fattening, minor porcine species for fattening and turkeys for fattening for the renewal of its authorisation (AVEVE BV)
In August 2024, EFSA published scientific outputs on 4 novel foods, including:
1. Re‐evaluation of shellac (E 904) as a food additive and a new application on the extension of use of shellac (E 904) in dietary foods for special medical purposes
2. Safety evaluation of the food enzyme glucan 1,4‐α‐maltohydrolase from the genetically modified Saccharomyces cerevisiae strain LALL‐MA+
3. Safety evaluation of the food enzyme β‐galactosidase from the genetically modified Bacillus licheniformis strain DSM 34099.
4. Safety of glucosyl hesperidin as a Novel food pursuant to Regulation (EU) 2015/2283. The applicant proposed to use the NF in specific drinks and food supplements leading to a maximum intake of up to 364 mg per day for adults.
| Australia & New Zealand
On August 15, 2024, Food Standards Australia New Zealand (FSANZ) published the official notice regarding Amendment 230 to the Australia New Zealand Food Standards Code. The amendments detail changes to standards relating to food irradiation, ingredient specifications, processing AIDS and food produced using genetic technology.
The amendments cover a number of applications, as follows:
A1261: Increase the maximum allowable energy of X-rays during food irradiation.
A1281: Approval for the use of genetically modified maize variety DP910521 in food.
A1282: Approval of subtilis protease derived from transgenic Bacillus subtilis as a processing aid.
A1283: Consent for the use of 2' -fucosyl lactose produced by transgenic Bacillus subtilis in infant formula.
| Japan
On August 23, 2024, the Cabinet Office of Japan issued Cabinet Order No. 71, revising the food labeling standards. The revisions mainly concern the labeling system for functional foods, aimed at preventing incidents similar to those related to Kobayashi Pharmaceutical's red yeast products. Key points include:
New Compliance Requirements for Functional Food Applicants: If a functional food operator labels their product with "specific health purposes" based on the added functional ingredients, they must report any new scientific evidence to the Director-General of the Consumer Affairs Agency. For functional foods in tablet or capsule form, their manufacturing and quality management processes must comply with GMP standards. If a consumer suspects health damage after consuming a functional food—even if the causal relationship is unclear—the operator must urgently report relevant information to the authorities based on health damage information and medical diagnoses. After successful application for functional food status, operators must conduct an annual self-evaluation to determine if the functional ingredients can meet the claims on the label and report the results to the Director-General of the Consumer Affairs Agency.
Revised Labeling Requirements for Functional Foods: Given the differences in functionality and safety between functional foods and specific health foods or pharmaceuticals, labels must include information on interactions with other products and precautions against excessive intake. Additionally, functional food labels must provide basic information about the food operator, including name and contact details, safety and functional evidence, production and quality management information, and a system for collecting health hazard information, along with other necessary items.
Extended Review Period for New Functional Ingredient Applications: The review period for new functional ingredient applications has been extended from the current 60 working days to 120 working days.
The revised standards will take effect on September 1, 2024.
Sources: Official regulatory authorities in respective countries/regions.
