In 2024, major regulatory changes were driven by high-profile incidents and evolving policy landscapes. For example, Japan's red yeast rice incident prompted stricter oversight of functional food labeling regulations. Meanwhile, new regulations in Brazil and the EU on novel food are shaping future application pathways, and the U.S. FDA's shift in collaboration with AAFCO is redefining the regulatory framework for animal feed and pet food.
Focusing on global dynamics, ZMUni Compliance Centre has summarized the key global regulations and policies that have had a major impact on the industry this year, as outlined below:
On September 30, 2024, the European Food Safety Authority (EFSA) updated the Novel Food Guidelines, which took effect on February 1, 2025. The new guidelines refine the existing ones, incorporating evaluation experiences since the implementation of the Novel Food Regulation in 2018, providing clearer operational guidance for businesses.
Official source: https://www.efsa.europa.eu/en/news/navigating-novel-foods-what-efsas-updated-guidance-means-safety-assessments
In 2024, the European Commission authorized 13 novel food applications and 9 novel food revisions. The 13 applications include:
calcidiol monohydrate
beta-glucan from Euglena gracilis microalgae
3′-Sialyllactose sodium salt produced using a derivative strain of Escherichia coli W (ATCC 9637)
protein concentrate from Lemna gibba and Lemna minor
L-5-methyltetrahydrofolic acid
isomaltulose powder
Schizochytrium limacinum (TKD-1) oil
Schizochytrium sp. (CABIO-A-2) oil
juice of the stems of the Angelica keiskei plant (Ashitaba stem juice)
Lacto-N-fucopentaose I and 2'-Fucosyllactose mixture produced using a derivative strain of Escherichia coli K-12 DH1
2'-Fucosyllactose produced by a derivative strain of Escherichia coli W (ATCC 9637)
magnesium L-threonate
seeds and seed flour of Vigna subterranea (L.) Verdc.
Among these, three Human Milk Oligosaccharides (HMOs) substances were authorized, with breast milk oligosaccharides remaining prominent. Functional ingredients saw more authorizations, with plant-based substances performing well.
On July 31, 2024, the European Commission issued Regulation (EU) 2024/2063, which includes new rules for food health claims. It bans the use of the health claim “Monacolin K from red yeast rice contributes to the maintenance of normal blood LDL-cholesterol concentrations” for foods containing Monacolin K from red yeast rice. This regulation took effect 20 days after publication.
Official source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202402063
In 2024, the US FDA issued 20 GRAS (Generally Recognized as Safe) approval letters, including 3 strains for food use and 1 high-profile sweet protein among other popular ingredients. Of these, 13 were approved (FDA has no questions), while 7 were halted for various reasons (FDA ceased to evaluate this notice).
On March 5, 2024, the US FDA released the Guidance for Industry: New Dietary Ingredient Notification Procedures and Timeframes - Dietary Supplements. This Guidance finalizes the fifth section of the 2016 draft revision, "NDI Notification Procedures and Timeframes," along with addressing several other related issues from the draft guidelines.
In 2024, the US FDA responded to 20 NDINs (New Dietary Ingredient Notifications), with 11 submissions made in the same year and 9 from 2023. Of these 20 responses, only 4 ingredients were approved as NDIs, while 15 were rejected for various reasons. Additionally, 1 application involving nicotinamide mononucleotide (NMN) did not receive a substantive response from the FDA.
On August 2, 2024, the FDA announced that its long-standing Memorandum of Understanding (MOU) with the American Association of Feed Control Officials (AAFCO) would not be renewed after its expiration on October 1, 2024. This news drew significant attention in the feed and pet food industries. In a letter to stakeholders, the FDA clarified that their relationship with AAFCO is "evolving," not "ending," and that they will continue to closely cooperate with AAFCO and state authorities to ensure the safety of animal food supplies.
On August 8, 2024, the FDA announced that it was evaluating its Animal Food Additive Petition (FAP) and GRAS notification programs to determine whether changes are needed to better serve public health and improve pathways for new animal food ingredients. During this evaluation, the FDA proposed consulting with companies developing animal food ingredients through the Animal Food Ingredient Consultation (AFIC) process.
On October 23, 2024, the FDA released two draft guidance documents related to the transition phase: GFI #293: FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients, and GFI #294: Animal Food Ingredient Consultation (AFIC).
Official source: https://www.fda.gov/animal-veterinary/animal-food-feeds/evaluation-fda-pre-market-animal-food-programs-and-plan-consultations
On August 23, 2024, the Japanese Cabinet Office issued Cabinet Order No. 71, which revised the food labeling standards, primarily focusing on functional food labeling. This revision took effect on September 1, 2024, with certain provisions in Annexes 26 and 27 becoming effective from April 1, 2025.
The revision comes in response to the safety concerns exposed by the Kobayashi Pharmaceutical red yeast rice incident, highlighting risks in Japan's "functional food labeling" system. The aim of the revision is to prevent similar incidents in the future. The key changes include:
New Compliance Requirements for Functional Food Applicants:
Applicants must promptly report new scientific evidence to the relevant authorities, and for tablet or capsule forms of functional foods, manufacturing management must comply with GMP (Good Manufacturing Practice) standards.
Amended Labeling Requirements for Functional Foods:
The new labeling requirements include statements such as "The functionality and safety of this product have not been evaluated by the government," "This product is not intended for the diagnosis, treatment, or prevention of any disease," and specific usage warnings regarding drug interactions and preventing excessive intake.
Extended Submission Deadlines for New Functional Ingredients Without Performance Data:
For new functional ingredients without prior performance data, if the authorities determine that confirming the submission documents requires unusually long time, the deadline for submitting documents prior to sale can be extended from the standard 60 business days to 120 business days.
On March 20, 2024, the Ministry of Food and Drug Safety (MFDS) of South Korea issued Notice No. 2024-16, amending certain provisions of the Health Functional Food Codex to include Vitamin K2 as a newly approved ingredient in the Health Functional Food ingredient list.
On July 18, 2024, the Thai Ministry of Public Health issued Announcement B.E. 2567 (2024) under the Food Act B.E. 2522 (1979), concerning the labeling of food in containers (No. 450). The announcement took effect on July 19, 2024. However, regarding allergen labeling (which includes adding squid and its products as allergens), products that had obtained food registration numbers before July 19, 2024, are allowed to continue being sold until July 18, 2026.
On September 18, 2024, the Indonesian National Agency of Drug and Food Control (BPOM) issued Announcement No. 2024-15, amending the registration standards and procedures for health supplements (based on Regulation No. 32 of 2022). This announcement took effect immediately upon publication.
Key revisions include:
In Annex 1 (List of vitamins and minerals allowed in health supplements), a new regulation states that the daily maximum intake of selenium for pregnant women and breastfeeding mothers should not exceed 65 μg.
The daily maximum intake of zinc in Annex 1 was revised from 25 mg to 30 mg.
On March 16, 2024, the Brazilian National Health Surveillance Agency (ANVISA) implemented the Regulation on the Safety Certification and Authorization for the Use of Novel Foods and Novel Ingredients. This regulation, published on December 18, 2023, refines application requirements and introduces detailed evaluation criteria for certain new substances, such as cell culture-derived ingredients.
According to publicly available data from the ANVISA Novel Food Database, in 2023, ANVISA approved a total of 33 novel foods, nearly 50% of which were plant-based ingredients or plant extracts. However, in 2024, due to the implementation of the updated Novel Food Safety Assessment Guidelines, only one novel food has been approved so far. Nevertheless, the number of approvals is expected to increase significantly in 2025 as the policy framework stabilizes.
The novel food approved in 2024 is a Bifidobacterium blend from Morinaga Milk Industry Co., Ltd. (Bifidobacterium longum subsp. longum BB536, Bifidobacterium longum subsp. infantis M-63, and Bifidobacterium breve M-16V), intended for use in dietary supplements.
*This article is based on our understanding of the 2024 updates to global food-related regulations and policies, intended for learning and reference purposes. any inaccuracies or omissions are found, we welcome your feedback and suggestions. Thank you for your attention and support.
