On October 1, 2019 the new Measures for Administration of the Catalogues of Health Food Ingredient and Function will enter into effect. As the name says, these Measures regulate the management (mainly: formulation, adjustment and publication) of these two important catalogues which regulate health foods.
As stated under the 2015 Food Safety Law, health foods using ingredients and claiming function listed on these catalogues are eligible for a simplified notification procedure, rather than the lengthy registration process.
The Catalogues are administered by SAMR (specifically, its Food Evaluation Agency), in conjunction with the National Health and Health Commission and the State Administration of Traditional Chinese Medicine.
Application for expanding the catalogue (to include new ingredients, new functions or to modify the existing catalogues) can be submitted by any person or entity.
Health Food Raw Materials Catalogue
In general, the raw materials included in the catalogue shall:
(1) have domestic and international edible history, be safe and have already been used in the approved health foods;
(2) be effective for functions already listed in the catalogue;
(3) have technical requirements, dosage ranges, functions, production processes, testing methods, etc. that can be standardized to ensure consistency of quality.
On the contrary, raw materials cannot be inserted into the catalogue if:
(1) their safety is unclear;
(2) their quality cannot be standardized for production on industrial scale.
SAMR in this case shall entrust competent technical institutions to conduct research and analysis on the use of materials for which application is made. If the requirements are met, the technical organization shall promptly propose the proposal to incorporate or adjust the health food raw materials catalogue.
Any application shall include amongst others, the range of dosage and its corresponding efficacy; process requirements, quality standards, functional ingredients, their content ranges and corresponding testing methods; suitable and unsuitable people; details of possible adverse reactions.
After positive technical evaluation by the appointed evaluation agency, SAMR may solicit public comments and – eventually – update of the Catalogue.
Beside application by a party, SAMR shall take action and re-assess raw materials in the Catalogue if:
(1) New research, or food safety monitoring, has identified potential food safety problems in these raw materials; OR
(2) New research confirms that the daily dosage range and the corresponding efficacy need to be adjusted;
(3) Other situations that require re-evaluation.
Health Food Function Catalogue
Health food function can be included in the catalogue if they:
(1) refer to the purpose of supplementing dietary nutrients, maintaining the health of the body or reducing the risk factors for disease;
(2) have sufficient scientific basis, as well as scientific evaluation methods and criteria;
(3) Have a clear and suitable population and an inappropriate population.
On the other hand, functions shall be rejected from the catalogue if:
(1) They concern prevention, treatment and diagnosis of diseases;
(2) they are related to superstition
(3) It may mislead consumers and other situations.
The procedure is very similar to the one for update of ingredients catalogue.
Application documents shall include also function research report, health function evaluation methods and standards, functional test reports, research and application of same or similar functions abroad, Relevant scientific literature and other materials.
Re-evaluation shall be carried out by SAMR mainly when
(1) Practical application and new scientific research have identified problems in the evaluation methods and criteria of the health function; OR
(2) The health function included in the health function catalogue lacks actual health consumption needs.