China Enhances Safety Evaluation Requirements for New Food Additives, Food Raw Materials and FCM Substances

On September 13, 2024, the China National Center for Food Safety Risk Assessment (CFSA) released an announcement to enhance the safety evaluation requirements for new food additives, new food raw materials and new food-related products, specifically for products involving genetically modified microorganisms (GMMs) during production. For new food raw materials and new food-related products, applicants must include detailed data in the production process section of their submissions. For new food additives, the detailed data should be included in the safety evaluation section of the submissions.

Key documentation requirements include:

• Product Information: Applicants are required to submit the detection data on product composition, target product content, exogenous gene residues in the product, residual GMMs in the product, environmental risk control measures and results, as well as product classification explanation.

• Information on GMM: Comprehensive documentation on the taxonomy, biological characteristics, and safety assessments of GMMs is required. This includes evaluations of the microorganisms' potential survival as well as gene transfer capabilities and pathogenicity.

• Safety Evaluation of Recipient Microorganisms: This involves providing background information, biological characteristics, ecological adaptability, genetic variation, and other relevant data for the assessment of the safety level of the recipient microorganisms.

• Safety Evaluation of Genetic Modifications: Detailed descriptions of the introduced or modified traits and characteristics in food-processing GMMs are necessary. Other necessary requirements include information on the actual sequences inserted or deleted, details of the used vectors, the genetic operation methods, the genetic stability of the modifications, and the safety classification of the gene operation.