Health food in China covers 2 categories:
- Functional health food
- Nutritional supplements
Functional health food in China is defined as “food products that claim to have specific health functions”. These specific health claims must belong to one or more of the 27 approved health claims. In addition, the health claim of the product must be supported by scientific tests which must be performed by SAMR appointed labs. In other words, it refers to a food suitable for consumption by specific groups of people and has the effect of regulating human body functions but is not used for the purpose of treating disease. SAMR certified health foods are required to use a blue hat logo in the products to identify them as ‘health foods’, hence they are sometimes referred to as ‘blue hat products’.
Nutritional supplements are characterised as ‘supplements with minerals and vitamins as the main active ingredients. Only a very limited number of vitamins, minerals and food additives can be included as nutritional supplements.
In China, consumers are concerned about the ever-present effects of pollution in the air, water, and food. The Chinese market for Health Food is extremely regulated and difficult to enter. That said, the Health Food market offers better opportunities for growth than any other markets in the world. We offer several services to prepare your products to successfully enter the Chinese market. Our Knudsen&CRC team is happy to offer assistance and guidance during the process to establish your products in China.
We Offer These Services for Health Food
Preliminary Product Evaluation
The process of preliminary product evaluation for health foods will vary between functional health foods and nutritional supplements. Knudsen&CRC can provide detailed and up-to-date guidelines regarding the process and timeline of the SAMR filing or registration. Our team can conduct Product Category Evaluations to determine product qualification as a health food.
Functional health foods must undergo SAMR registration, whereas nutritional supplements will go through SAMR filing. The documentation required for SAMR registration is often substantial and complex. According to regulations, you must use a reputable agent in China who can assist in compiling the application dossier in an efficient, correct and timely manner. Here at Knudsen&CRC, our dedicated and experienced team can help assist you successfully through this process. Our comprehensive services for SAMR filing and registration of health food products include ingredient and packaging consulting, application dossier preparation, sample test preparation and document submission.
Application Dossier Preparation
Ingredient & Packaging Consulting
Sample Test Preparation
Frequently Asked Questions
There are two categories:
1) Functional Health Food
2) Nutritional Supplements
Functional health food in China are food products that claim to have specific health functions. These specific health claims must belong to one or more of the 27 currently approved health claims. The health claim of the product must be supported by scientific tests that need to be carried out by SAMR appointed labs. In addition, functional health foods are foods that are suitable for consumption by specific groups of people, with the intention of regulating human body functions. However, they are not to be used for the purpose of treating any kind of disease or illness.
Nutritional supplements are supplements with minerals and vitamins as the main active ingredients. Only limited number of vitamins, minerals and food additives can be labelled as a “nutritional supplement.
The State Administration for Market Regulation (SAMR) is the People’s Republic of China’s governmental authority for regulating areas such as market competition, monopolies, intellectual property, and drug safety. The Administration was created in the 2018 Chinese overhaul of government administration, and merged or abolished a number of previous agencies, such as the State Intellectual Property Office
SAMR certified health foods are required to include a blue hat logo on the packaging of the products to help identify them as ‘health foods.’ This helps explain why they are sometimes referred to as ‘blue hat products.’ Nutritional supplements are ‘supplements with minerals and vitamins as the main active ingredients.’ Only a very limited number of vitamins, minerals and food additives can be labelled as a “nutritional supplement.
The filing procedure for nutritional supplements was introduced in 2016. Given that it’s much faster than functional health food registration, there large amount of interest and demand for this option from international health food companies selling in both inside and outside of China. For companies seeking this option, we highly recommend paying close attention to preparing the relevant documentation required for the filing procedures to avoid any unnecessary delays.