SAMR 2/4/22

2021 is a critical year for the transformation of China’s healthcare product market. In terms of policy, China’s official authorities have issued a number of them in the year 2021, among which the Nutrition Catalog of Health Food Raw Materials is of particular importance. In addition, the requirements of the dual-track system of dietary supplements in China were gradually improved, the filing catalog continued to expand, and the filing of functional raw materials such as Coenzyme Q10 was officially launched. Soy protein and whey protein may become new filing raw materials. In terms of market trends, while the supervision is becoming more and more strict, the dietary supplement industry has also ushered in many development opportunities. During the epidemic, people’s health awareness has been further elevated. In addition, consumers’ perceptions about supplement consumption are constantly changing; consumers now have more willingness to consume and purchase supplemental products; market demand is also expanding significantly. In a word, China’s dietary supplement market is undoubtedly still one of the major ones for vendors worldwide.

CCIC Chicago provides you with a comprehensive review of Chinese supplement regulations and policies of 2021 and an exhaustive review of filings status for the whole year.

1. Competent Authority Setting

The competent authorities include the Food Safety Commission of the State Council, State Administration for Market Regulation, State Health Commission and China Health Care Association. Among them, the main regulatory authority, also as the acceptance unit of the filing registration, is the State Administration for Market Regulation. The main functions of this department are to analyze and oversee the safety situation in the field of dietary supplements, formulate standards and measures for special food/supplement registration, conduct filing checks and supervision, organize investigation and punishment for related violations. Most of the regulations and policies in health care products are issued and implemented by this unit.

2. Registration and Filing Management System

Registration type dietary supplement refers to a product that uses raw materials not included in the list of raw materials catalog and health food that is trying to be imported for the first time (except vitamins, minerals, and other nutrients).

Filing type dietary supplement refers to a product whose raw materials have been listed in the dietary supplement raw material catalog. The dietary supplement is imported for the first time but belongs to vitamins, minerals, and other nutrients.

3. Summary of Filing Information in 2021

According to the published information for the dietary supplement from the official website of the SAMR, at the end of 2021, a total of 2,401 dietary supplements received approval, among which 2,359 were domestic products and 42 were import products.

Filing Records in 2021

The import filings included in the above table are from the United States, Canada, Japan, Australia, Denmark, South Korea, and New Zealand. The number of filings from the United States accounts for about 33% of all import filings. These registered applicants are from 14 companies. The USA BORNATOP INVESTMENT & MANAGEMENT CO., LTD has 11 products, with the largest filing records.

In terms of quantity, the United States has the largest filing cases, and the United States is still the country of origin with the largest efforts to enter the Chinese market. U.S. manufacturers typically file multiple products at the same time with one operator or one manufacturer. In addition, unlike filing applicants from the Canada, U.S. filing applicants and manufacturers are usually using different business entities.

Regarding the usage of nutrients, plant-based and vitamin-mineral products are the two mainstream categories, accounting for 46% and 33%, respectively. At the same time, fish oil, protein, dietary fiber, etc., are also more and more popular in the market. This trend could have been caused by specific regulations introduced in 2021. Once a product or substance has been listed as the standard, which often means that large-scale production is further developing.

4. Summary of the Regulations and Policies of SAMR in 2021

• Catalog of Five Health Food Raw Materials including Coenzyme Q10

      Release date: Dec 01, 2020

      Implementation date: Jun 01, 2021

The announcement contains five categories: Coenzyme Q10, broken Ganoderma spore powder, spirulina, fish oil, and melatonin. The principle is of one-to-one correspondence between raw materials, dosage, and efficacy. The raw material catalog specifies the name and the dosage and corresponding efficacy of the raw material. Therefore, the raw materials, dosage and corresponding efficacy listed in the catalog can only be used in dietary supplement products and cannot be used for other ordinary food products production.

• Coenzyme Q10 and Other Five Health Food Raw Materials Catalog Supporting Interpretation

      Release date: Dec 01, 2020

      Implementation date: Jun 01, 2021

The interpretation of Coenzyme Q10 and the other five raw materials in the product filing process is the official explanation for the use of the combination, functional labeling, quality control of raw materials, and other aspects.

• Coenzyme Q10 and Other Five Health Food Raw Materials for the Filling Dosage Forms and Technical Requirements

      Release Date: Feb 01, 2021

      Implementation date: Jun 01, 2021

The standard announced the technical requirements for the filing of Coenzyme Q10, broken wall Ganoderma lucidum spore powder, spirulina, fish oil, melatonin. It also introduces various types of excipients available for use for the five kinds of supplemental products, available dosage forms and other product technical requirements.

• Coenzyme Q10 and other Five Health Food Raw Materials for the Record Product Dosage Forms and Technical Requirements” Supporting Interpretation

      Release date: Feb 01, 2021

      Implementation date: Jun 01, 2021

It is the interpretation of the published filling dosage forms and technical requirements of the five health food raw materials such as the Coenzyme Q10. Interprets explicitly the use of the relevant provisions, the main production process for product filing, the use of excipients, the requirements of the technical indicators when the product is filed. The interpretation guide also includes an official explanation of the scope of the five raw materials which can be used for filed products, etc., to help market participants have a unified understanding.

• Health Food Ingredients Catalog Nutrient Supplements (2020 Edition)
• Catalog of Permissible Health Functions for Health Food Claims Nutrient Supplements (2020 Edition)

      Release date: Dec 01, 2020

      Implementation date: Mar 01, 2021

5. 2021 The General Administration of Customs Import and Export Food for Overseas Enterprise Registration Regulations Collection

• Import and Export Food Safety Management Measures of the People’s Republic of China

      Release Date: Apr 13, 2021

      Implementation Date: Jan 01, 2022

The update to the labeling section of the regulation is one of the updates of general interest, that is, Article 30: The Chinese labeling for imported health food, special dietary food products must be printed on the smallest sales packaging, no additional stickers should be added.

• Regulations of the People’s Republic of China on the Registration of Overseas Food Producers

      Release Date: Apr 13, 2021

      Implementation Date: Jan 01, 2022

The regulation is a major change for offshore producers and has drawn major attention from the industry.

• Compared with the previous regulations, the abolition of the directory registration system now requires all imported food manufacturers outside the country to apply for registration, except for infant formula, other dairy products, meat, aquatic products and bird’s nest products.

Further explanation: For the 18 types of overseas imported food production enterprises listed in Article 7, the authorities of the country (region) should be competent to allocate its registration system account; through the registration system to submit applications in accordance with the process. The General Administration of Customs shall assign the registration system account number of the overseas competent authority. Food production enterprises other than the above 18 categories outside the country should apply for their own registration system account, according to the registration system process to submit applications.

• The registration method is divided into “recommended by the competent authorities of the country (region)” and “enterprise registration”, the former is generally applicable to products with higher risk levels, the latter is generally for ordinary products.

• There are different application materials for each of the two different ways mentioned above. The detailed description of the requirements of the section is subject to further matching policies from the customs department.
• On the “Regulations of the People’s Republic of China on the registration of foreign producers of imported food” and “the People’s Republic of China Import and Export Food Safety Management Measures” implementation-related matters announcement

      Release Date: Dec 13, 2021

The Customs department issued “A Guide to the Registration of Overseas Manufacturers of Imported Food”, Product Code Inquiries, Packaging and Labeling Identification, expiration dates, and further explanation of other aspects.

6. Other Aspects

Health functions might be changed from the original 27 kinds to 24 kinds. It is planned to abolish the three old functions of promoting lactation, improving growth and development, and improving skin oil, which is inconsistent with the positioning of health care functions. At the same time, the remaining 24 health function claims terminology will be revised to make them more scientific and standardized; this adjustment is also widely expected.