In the year of 2020, China government revealed several regulations and drafts for comments about health products you are interested. Antion pulled a list for those articles and some other related information that worth to read again.

Policies & Regulations

Because of COVID-19, in order to reduce turnover, avoids personnel gathers, and prevents cross-infection, and takes into account such factor as the uncertainty in production arrangements among different local enterprises, on February 21, SAMR issued an announcement on Suspending On-site Inspection of Special Food Registration during the Outbreak.

Suspend On-site Inspection of Special Food Registration

On November 25, 2020, the State Administration for Regulation issued the announcement on Regulation of On-Site Verification for Special Food Registration (Interim), which aims to strengthen special food registration management and standardize on-site verification process.

Regulation of On-Site Verification for Special Food Registration

In accordance with Food Safety Law of the People’s Republic of China, Measures for the Administration of the Registration and Filing of Health Foods, and other relevant regulations and food safety standards, State Administration for Market Regulation together with National Health Commission and National Administration of Traditional Chinese Medicine issued the Catalogue of Ingredients of Nutrient Supplement Health Foods (2020 Revision) and Catalogue of Permitted Health Function Claims by Nutrient Supplement Health Foods (2020 Revision), which will come into effect on March 1, 2021.

Two Catalogues about Health Foods (2020 Revision) was Issued

Draft for comments

In March 2019, SAMR issued a list of health food raw materials for comments. It is proposed five raw materials including Coenzyme Q10, Fish oil, Sporoderm-broken of Ganoderma Lucidum spores powder, Spirulina and Melatonin.

SAMR |Solicit Opinions on Requirement of 5 Health Food Materials

In order to expand the formulation of filing health food products, according to relevant national food safety standards and the status of registered products, the SAMR organized draft of technical requirements for the filing of gummy and powders, and revised the Available Auxiliary Ingredients and the Use Regulations for Filing Health Food (2020 Edition) (Draft for Comments) and Dosage Form and Main Production Processes of Filing Health Food (2020 Edition) (Draft for Comments).

Gummy & Powder Plan to be included in Filling Health Food Format

Original Interpretations & Summary

In order to better help enterprises to implement laws and regulations, Antion has made a simple interpretation of the Interim Measures for the Examination and Administration of Advertisements for Medicines, Medical devices, Health Food and Food for Special Medical Purpose (hereinafter referred to as the Interim Measures) for your reference.

Analyze| Examination of Advertisement for Health Food and FSMP

Antion summarizes the requirements related to the advertisement of health foods.

Relevant Laws and Regulations on Advertisements - Health Foods

On November 24, 2020, the SAMR issued a notice for public comments on the Catalogue of Health Functions Allowed for Health Food Claims Non-Nutrient Supplements (2020 Edition) (Draft for Comments), which includes Evaluation Method of Health Food Functions (2020 Edition) (Draft for Comments), Interpretation of Health Food Function Claims (2020 Edition) (Draft for Comments) and Guidelines for Evaluation of Health Food Functions (2020 Edition) (Draft for Comments), and Guidelines for Ethical Review of People Trial of Health Food (2020 Edition) (Draft for Comments). In order to help enterprises better understand the relevant requirements, Antion will compares the Draft with the current version, and analyze and interpret the main changes and impacts of the Draft.

Analysis| SAMR Solicites Opinions on Health Functions (Blue Hat)

On December 1, 2020, the State Administration for Market Regulation, together with the National Health Commission and the National Administration of Traditional Chinese Medicine, released Catalogue of Health Food Ingredients Coenzyme Q10, Melatonin, Fish oil, Spirulina, and Sporoderm-broken of Ganoderma Lucidum spores powder, which will come into effect on March 1, 2021. This means that Coenzyme Q10, sporoderm-broken of Ganoderma Lucidum spores powder, spirulina, fish oil and melatonin can be declared as filing health foods from March 1 next year.

Analysis| Coenzyme Q10, Fish Oil and Melatonin can do filing!

Q&A

Q&A | Food and Health Food False Advertising Rectification

Q&A | Food and Health Food False Advertising Rectification II

Q&A | Name, Labeling & Advertising Requirements of Health Food

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