China: A Regulatory Update

Changes in novel food regulations will impact new and existing novel food products.

22 September 2014

The recently established National Health and Family Planning Commission (NHFPC), which replaced the Ministry of Health (MOH), issued its first regulation - the "Measures on the Administration of Safety Evaluation of Novel Food Ingredient" in July, 2013. The new regulations are intended to regulate the evaluation approval process of the novel food ingredient, while increasing the scrutiny and safety of new, as well as currently marketed novel foods. Products not in compliance with the new regulations may be subject to review and enforcement action by the NHFPC.

Key changes include:

  • New definition of novel foods: covers all animal, plant or microorganism-derived foods without "traditional eating habits" in China,
  • Includes foods produced using new processes and "other newly developed foodstuffs",
  • Genetically modified (GM) foods, Health foods with health claims, new Food additives are subject to separate regulations.
  • The transparency of the food safety review process is increased by including public consultation and review by a panel of experts during the registration process. On-site evaluation/verification, requests for additional technical discussions and supplementary data can be brought forth during the review process.
  • Penalties will be levied against applicants who provide false information, including a one-year ban from re-applying for the same new food material.
  • The safety assessment procedure will follow standard risk assessment practices for novel foods that are employed globally (there is also an option for approval via a substantial equivalence approach).
  • The risk assessment opinion should be conducted by a certified institution, like the National Center for Food Safety Assessment (CFSA).

Intertek has an office in Beijing and an extensive network of contacts with Chinese academic experts and government officials that give us a unique capacity to provide companies valuable regulatory assistance for the introduction of novel food ingredients to the Chinese marketplace, as well as, continued compliance for their existing products.

Ms. Sandy Lin is a recognized regulatory expert in the area of food-related regulations, food additives, novel food ingredients and health foods in China. Her qualifications span over 20 years of industry and regulatory experience in which she worked for large international food companies both food and food ingredients industry in China.