China Food Regulatory Updates
On April 10, 2024, the China State Administration for Market Regulation (SAMR) approved the issuance of the First Amendment to National Metrological Technical Specification, JJF 1070-2023 Rules of Metrological Testing for Net Quantity of Products in Prepackages with Fixed Content, which will take effect on October 12, 2024.
On April 28, 2024, the China National Center for Food Safety Risk Assessment (CFSA) issued a public consultation on the proposed Nannochloropsis oil and egg yolk phospholipid and protein as new raw materials. In addition, the National Health Commission (NHC) approved rye pollen as a new food raw material in Announcement No. 3 of 2023. Based on the industry data and through the review by the Expert Review Committee, it is now proposed to revise rye pollen's content requirement of dietary fiber in the announcement to ≥30%.
On April 29, 2024, China SAMR announced the registration and filing of applications for imported health food, implementing more relaxed requirements on several documents, including the qualification certification documents, marketing and sales certification documents, quality management system certification documents of production enterprises, power of attorney (agreement), etc. For the above documents issued by countries contracting parties of Convention of 5 October 1961 Abolishing the Requirement of Legalisation for Foreign Public Documents (hereinafter referred to as Convention), only an Apostille of that country is required. Consular authentication from the government and the Chinese embassy or consulate in the local area is no longer necessary. It is worth noting that countries with a large number of filed imported health food products in China, such as the United States, Canada, Australia, New Zealand, Japan, South Korea, etc., are all on the list of contracting parties to the Convention.
On April 29, 2024, China SAMR issued a draft of the Work Procedure for Priority Review and Approval of Registration of Formula Food for Special Medical Purposes(FSMP). Public comments are now being solicited; the deadline for comments was set for May 30, 2024.
On April 30, 2024, the China State Administration for Market Regulation (SAMR) issued a regulation specifying the filing requirements for health food containing three ingredients: Ginseng, American Ginseng, and Lingzhi. The regulation stipulates five key aspects, including auxiliary materials usage, product dosage forms, product processing, product technical requirements, and others. It came into effect on May 1, 2024.
International Food Regulatory Updates
| Europe
In April, the European Commission authorised the placing on the market of monosodium salt of L-5-methyltetrahydrofolate acid, 3'-Sialyllactose sodium salt produced using a derivative strain of Escherichia coli W (ATCC 9637), beta-glucan from Euglena gracilis microalgae, and protein concentrate from Lemna gibba and Lemna minor as a novel food.
Moreover, the EU amended the specifications and conditions for using three already authorised novel foods: astaxanthin-rich oleoresin from Haematococcus pluvialis algae, lactitol, and galacto-oligosaccharide. Additionally, the EU granted new authorisation for eight feed additives.
Date |
Regulation |
Authorised Novel Food |
Applicant |
April 10, 2024 |
(EU) 2024 / 1037 |
Monosodium salt of L-5-methyltetrahydrofolic acid |
Merck & Cie KmG (Switzerland) |
April 10, 2024 |
(EU) 2024 / 1046 |
Beta-glucan from Euglena gracilis microalgae |
Kemin Foods L.C. (USA) |
April 10, 2024 |
(EU) 2024 / 1047 |
3'-Sialyllactose sodium salt produced using a derivative strain of Escherichia coli W |
Kyowa Hakko Bio Co., Ltd (Japan) |
April 10, 2024 |
(EU) 2024 / 1048 |
Protein concentrate from Lemna gibba and Lemna minor |
ABC Kroos BV (Netherlands) |
April 11, 2024 |
(EU) 2024 / 1052 |
Calcidiol monohydrate |
DSM Nutritional Products Ltd. (Switzerland) |
Date |
Regulation |
Amended Novel Food |
|
April 9, 2024 |
(EU) 2024 / 1023 |
Lactitol |
|
April 9, 2024 |
(EU) 2024 / 1026 |
Astaxanthin-rich oleoresin from Haematococcus pluvialis algae |
|
April 9, 2024 |
(EU) 2024 / 1027 |
Galacto-oligosaccharide |
|
Date |
Regulation |
Authorised Feed Additives |
|
April 3, 2024 |
(EU) 2024 / 997 |
L-valine produced by Corynebacterium glutamicum CGMCC 18932 |
|
April 10, 2024 |
(EU) 2024 / 1055 |
Iron(II) – betaine complex |
|
April 10, 2024 |
(EU) 2024 / 1056 |
Riboflavin 5'-phosphate monosodium salt (vitamin B2), produced by Bacillus subtilis KCCM 10445 |
|
April 10, 2024 |
(EU) 2024 / 1057 |
A preparation of 6-phytase produced by Komagataella phaffii CGMCC 7.19 |
|
April 18, 2024 |
(EU) 2024 / 1199 |
Manganese(II) – betaine complex |
|
April 24, 2024 |
(EU) 2024 / 1186 |
Cinnamon bark essential oil and cinnamon leaf essential oil from Cinnamomum verum J. Presl |
|
April 24, 2024 |
(EU) 2024 / 1194 |
Nicotinic acid and niacinamide |
|
April 24, 2024 |
(EU) 2024 / 1195 |
Cassia essential oil from Cinnamomum aromaticum Nees |
| Canada
On April 18, 2024, Health Canada issued document M-SIS-24-01, amending the List of Permitted Supplemental Ingredients, newly approving the use of phosphatidylserine (soy) as a kind of other supplemental ingredients in the list.
| Australia and New Zealand
On April 29, 2024, the Australia New Zealand Food Standards Authority (FSANZ) published Amendment No. 227, which contains amendments to the following Standard and Schedules in the Australia New Zealand Food Standards Code:
l Standard 1.2.1 – Requirements to have labels or otherwise provide information
l Schedule 18 – Processing aids
l Schedule 26 – Food produced using gene technology
The applications under which these amendments are made is as follows:
l A1271 Cellulase from GM Aspergillus niger as a processing aid
l A1272 Food derived from herbicide-tolerant and insect-protected corn line DP915635
l A1274 Food derived from disease-resistant banana line QCAV-4
l A1278 Beta-Fructofuranosidase from GM Trichoderma reesei as a processing aid
On April 17, 2024, the New Zealand Ministry for Primary Industries (MPI) published the amended Requirements for Registered Food Importers and Imported Food for Sale, adding new import rules for frozen berries. Changes will come into effect on August 1, 2024, with a transition period of 18 months ending on January 31, 2026.
Sources: Official regulatory authorities in respective countries/regions.