China Notifies Requirements for Safety Evaluation Materials for “Three New Foods”
On September 13, 2024, the Chinese National Center for Food Safety Risk Assessment (CFSA) published the Notice on Improving the Requirements for Safety Evaluation Materials for “Three New Foods” (i.e., new food ingredients, new food additives, and new food packaging materials)[1]. Notably, the Notice, for the first time, details the data requirements for the safety evaluation of genetically modified microorganisms (GMMs) in the Chinese petitions of these new food additives, ingredients, and packaging materials. As a result, petitioners seeking approval from China’s National Health Commission (NHC) for Three New Foods made from GMMs must prepare and submit relevant materials in accordance with these requirements, in addition to the other data that are currently required for non-GM products.
CFSA’s notification on data requirements in the Notice marks a significant milestone in China’s regulatory landscape and will allow industry to better understand the data needed for applications of food ingredients/additives and food packaging materials involving GMMs.
It is worth noting that this Notice specifically applies to products involving the use of GMMs in the production and processing stages, and the finished products must not contain any newly introduced gene fragments or GMMs. Specifically, the petitioner must provide materials related to:
- Petitioned product;
- Genetically modified microorganism
- Safety evaluation of recipient microorganism; and
- Safety evaluation of genetic manipulation.
For instance, regarding item 1) above – the materials related to the petitioned product – the petitioner must provide testing data on the composition and content of the target substance, residual data of foreign genes, residual data of the GMM, environmental risk control measures and effects, and the classification of the product (Category I for purified product and Category II for composite product). Particularly, the petitioner must describe in detail the procedures and parameters to remove foreign genes and to inactivate/remove the GMM from the product. As to the materials related to the GMM, the petitioner must submit the basic information (e.g., name, strain number, source, and use), taxonomic and identification information, biological characteristic data, etc. CFSA further elaborates on details of the safety evaluation of the GMM. It should first include materials to demonstrate the survival ability of the GMM in the natural environment and the transferability of the genetic material to other organisms and possible consequences.
The data requirements published by CFSA in the Notice appear to be similar to those for the applications for agricultural-use GMMs in China, which are governed by the Ministry of Agriculture and Rural Affairs (MARA). CFSA’s Notice does not provide any guidance on the petition submission procedure. However, as far as we understand, NHC will likely be the agency reviewing and approving Three New Foods using GMM technology without any newly introduced gene fragments or GMMs. Notably, MARA’s clearance on GMM safety was a prerequisite of NHC’s approval of these products. This change will likely ease the procedural burden for industry since NHC will review both the GMM safety and overall food safety of these products. However, in cases where there are live GMMs in a petitioned new food ingredient, MARA’s review on GMMs remains necessary.
With the notification of these new regulatory requirements, the regulatory pathway now clearly defined, the food industry is poised for a surge in innovation and development as they can finally seek approvals for GMM food additives, ingredients, and packaging materials in China. Should you have any questions about the applications for Three New Foods, please do not hesitate to contact David Ettinger (ettinger@khlaw.com), Jenny Xin Li (li@khlaw.com), or your existing contact at Keller and Heckman LLP.