Registration Service of New Food Related Products in China
According to Food Safety Law of the People's Republic of China, to produce or import new food related products, the manufacturer/importer should submit safety assessment materials of the intended product to National Health Commission of the people’s Republic of China (NHC) for review. For applications that comply with food safety requirements, a license would be approved and publicly announced.
Definition of new food related products
• Food packaging materials, containers and their additives not listed in the national standard positive list or not permitted by NHC as an announcement
• Food packaging materials, containers and additives intended to expand the scope of applications or the dosage
• New food contact materials and additives used in tools and equipment during food production or marketing
• New raw materials not listed in the list of food disinfectants and detergents
Requirements for the use of new food related products
1、Have clear purpose and technical necessity;
2、Shall not be harmful to human health under normal and reasonable use;
3、Shall not change the composition, structure, color, flavor and other properties of food;
- The usage should be reduced as much as possible, when the expected effect is achieved.
Documents to accompany application for new food related products
- Application form
- Physical and chemical properties
- Materials or documents proving the technical necessity, intended use purpose and condition
- Production process
Raw and auxiliary materials, process flow chart, text description, and technical parameters of each process, etc.
- Documents on quality specifications, methods of assay, and test reports
Quality specifications include purity, impurity composition, and content, etc., as well as corresponding inspection methods and reports.
- Safety assessment reports of toxicology
- Migration and residue data, expected dietary exposure and its assessment methods
- Documents on safety assessment and permitted use from other countries (regions) and international organizations
- Other documents helpful to the application
For decelerating new food contact materials and additives used in tools and equipment, extended scope or amount of usage should be provided.
Those who apply for food disinfectants and detergents may be exempted from submitting the materials 7 mentioned above.
Those who apply for expanding the scope or amount of usage of food contact materials and additives used in tools and equipment, may be exempted from submitting the materials 2,4,5,8,9 mentioned above.
For new types of food related products imported for the first time, the materials below should also be provided.
- The certificate allowing this food related product to be produced or sold in the country(region) issued by the relevant department or institution of the exporting country(region)
- The certificate reviewing or certifying the manufacturer issued by the relevant institution or organization of the country(region)
3、The entrusted applicant shall provide the letter of authorization for the entrusted application
4、Chinese version shall be notarized by relevant Chinese notary organizations
• Regulatory consultation of new food related products
• Preliminary analysis and suggestions of new food related products registration
• Design of registration timeline
• Material analysis, provide guidance for customers to supply materials
• Arrange sample inspection by qualified laboratories; Track inspection process&handles problem; Inspection report review
• Documents preparation and submission
• Communication with experts and competent authorities
• Technical support; Participate in technical review meeting and help to answer technical questions
OCI was founded in Beijing in 2006. It was the trailblazer for providing chemical and food compliance service in China. OCI has a rich experience in the declaration of new food related products, and grasps the latest industry regulations in time, providing the professional, efficient and fast service for consumers who want to create more economic benefits in Chinese market.
OCI 5A Service Commitment: High Efficiency, Stage Transparency, Information Security, Risk Advisement and Value-added Service