Comparison of Food Supplements Regulations between China and EU

 

In recent years, China's citizens have become more concerned about their health.  Food supplements are gradually changing from an optional consumer product to a must-have consumer product. Additionally, the size of the food supplements market has expanded, which is expected to reach 328.3 billion yuan in 2023.

Due to the differences in management systems, usage habits, lifestyles, and cultural backgrounds, food supplements are under different regulatory systems in different countries. ZMUni will compare the regulations of China and the EU from three aspects: definition, regulatory system and regulations, and labeling requirements. This will offer companies a better view of the food supplements landscape in China and the EU.

Definition

	China	EU
Legal Name	Food supplements	Food supplement
Definition	Food supplements are foods that have certain healthcare functions or maintain an adequate intake of vitamins and minerals. They are not medicinal products and as such cannot exert pharmacological, immunological, or metabolic action. Therefore, their use is not intended to treat or prevent diseases in humans or modify psychological functions. Additionally, their use shall not pose any risk to human health.	Food supplements are foods that are used to supplement the daily diet and contain concentrated nutrients or other substances with nutritional or physiological benefits in their individual or combined form, including but not limited to vitamins, minerals, amino acids, essential fatty acids, dietary fiber, and various plant extracts.

Regulatory System and Laws

Country / Region	Laws and Regulations	Content
China	Food Safety Law of the People's Republic of China	Specific provisions are made for food supplements and clarify the way to implement the registration and filing classification management of food supplements.
	Food Supplements Registration and Filing Management Methods	It makes specific provisions related to the registration and filing management of food supplements.
	National Standard for Food Safety Food Supplements (GB 16740)	It provides the definition of food supplements, technical requirements, and other content.
	Managing Agency State Administration for Market Regulation, as well as market regulation departments of provinces, autonomous regions and municipalities directly the central government
	Management Model 1. Registration： Food supplements (other than food supplements intending to supplement the nutrition of vitamins, minerals, etc.) imported for the first time into the Chinese market, or involving ingredients not listed in the Catalogue of Raw Materials for Food Supplements, are subject to registration 2. Notification： Food supplements intending to supplement the nutrition of vitamins, minerals, etc. are subject to notification. The substances that characterize the products shall be in the list of the Catalogue of Raw Materials for Food Supplements.
European Union	General Food Law Regulation 178/2002	Provides the basic principles and requirements.
	The EU Food Supplements Directive 2002/46/EC	It clarifies the definition of food supplements, composition requirements, labeling, and other specific provisions.
	Regulation (EC) No 1924/2006  on Nutrition and Health Claims Made on Foods	It ensures the effective functioning of the internal market as regards nutrition and health claims whilst providing a high level of consumer protection.
	Regulation (EU) No 1169/2011  on the Provision of Food Information to Consumers	It provides the basis for the assurance of a high level of consumer protection in relation to food information, taking into account the differences in the perception of consumers and their information needs whilst ensuring the smooth functioning of the internal market of the European Union.
	Managing Agency The European Commission (EC) and the competent authorities of the Member States
	Management Model Product safety and functional evaluation are primarily the responsibility of the European Food Safety Authority (EFSA), and specific supervision and management are the responsibility of each EU member state. Product Market Access： Most countries have a pre-marketing notification system. Most countries stipulate that food supplements should be notified by the manufacturer 30 days before the products are placed on the market. Applicants fill out the notification form and submit the product label and other relevant information to the government of the country. The relevant information about the filed product is published on the website. However, the government does not review and authorize it. If it has been notified in one country, the product can be circulated in the EU without having to notify other countries in the EU.

Labeling Requirements

China

The Food Supplements Registration and Notification Management Measures stipulate requirements for food supplement labels and instructions.

Product labels and instructions shall include：

• Product Name
• Raw material
• Excipients
• Efficacy ingredients
• Suitable and unsuitable groups of people
• Health function
• Dosage and method of consumption
• Specification and storage method
• Shelf life
• Precautions and other content
• Manufacturer name and address
• Sanitary Licenses Number

EU

EU Regulation (EU) No 1169/2011 sets out the general principles, requirements, and responsibilities for food labeling.

In addition, food supplement labels should also meet the special requirements of 2002/46/EC, including：

• Classification names that reflect the true properties of the nutrient or substance or the characteristics of the product
• Recommended Daily Allowance (RDA)
• Warning not to exceed the recommended daily allowance
• A statement that the food supplement is not a substitute for a varied diet
• A statement that the product is to be placed out of the reach of young children

Author：Max Beispielmann      Proofreading: Yingying