Foods
合瑞联深耕新食品原料注册合规领域，为国内外企业提供全流程一站式注册解决方案，深度解读中国新食品原料监管法规与申报实操要点，助力企业高效完成新食品原料注册审批，推动创新食品原料合法入市、合规应用。
依据《中华人民共和国食品安全法》，我国对新食品原料实行许可审批制。利用新食品原料生产食品或进口相关食品，均需完成国家层面注册审批，未获批准的新食品原料不得用于食品生产经营。
审批主管单位为国家卫生健康委员会（卫健委），经安全性审查符合食品安全要求的新食品原料，准予许可并予以官方公布，方可合法在国内市场应用。
Reg-Compliance specializes in Novel Food Ingredient (New Food Resource) registration and compliance in China, providing end-to-end, one-stop regulatory solutions for both domestic and international companies.
With a deep understanding of China’s novel food regulatory framework and practical submission requirements, we support clients throughout the entire registration lifecycle, helping innovative food ingredients achieve lawful approval, compliant application, and successful market entry in China.
Novel Food Ingredients refer to food raw materials without a history of traditional consumption in China. They fall into four main categories:
Under the Food Safety Law of the People’s Republic of China, Novel Food Ingredients are subject to a mandatory pre-market approval system.
Any food produced using a novel food ingredient, or imported food containing such ingredients, must obtain national-level approval prior to commercialization. Ingredients that have not been approved are prohibited from use in food production or distribution.
A complete Novel Food Ingredient registration dossier typically includes:
For imported Novel Food Ingredients, the following documents are also required:
Novel Food Ingredient registration in China follows a standardized, centrally managed approval process overseen by the National Health Commission. Reg-Compliance provides full-process support and professional coordination at every stage:
Preparation and formal submission of complete regulatory documentation to the NHC.
Coordination with expert reviews organized by the China National Center for Food Safety Risk Assessment (CFSA), including responses to technical inquiries and dossier supplementation.
Monitoring official announcements and public comment procedures following successful technical review.
Continuous tracking of regulatory decisions and administrative approval progress.
Confirmation and follow-up on official approval publication to ensure compliant market implementation.
Reg-Compliance delivers full lifecycle support for Novel Food Ingredient registration, offering tailored solutions from early-stage assessment through final approval:
Professional evaluation of ingredient characteristics, R&D background, and intended use to determine regulatory eligibility and define the optimal registration pathway.
Comprehensive identification of dossier gaps and compliance risks, with clear recommendations for data supplementation and optimization.
Expert support in drafting and structuring all required regulatory documents, including manufacturing processes and safety assessments, followed by official submission management.
Real-time monitoring of review progress, professional handling of authority feedback, dossier revisions, and expert review communications to facilitate efficient approval.
Our senior regulatory experts possess extensive hands-on experience in Novel Food Ingredient approvals across China, the United States, Taiwan, Singapore, and other jurisdictions, offering strong cross-regional regulatory insight.
Deep familiarity with China’s review focus, technical challenges, and supplementation requirements enables proactive risk management and higher approval success rates.
We design customized regulatory strategies for locally developed and imported ingredients, adapting to different ingredient types, technical characteristics, and commercial objectives.
Dedicated project teams provide responsive, one-on-one support, rapid issue resolution, and continuous progress tracking, significantly shortening approval timelines and accelerating compliant market entry.
