1. What is the purpose of developing Association Standards?
Developing Association Standards for health food is a top priority for regulatory authorities and a necessary requirement for the high-quality advancement of the health food industry. Currently, China lacks an independent and comprehensive standard system, leading to challenges in research, registration, production, and regulation of health food products. For instance, issues arise from referencing standards of other product types, inadequate implementation of quality standards, and inconsistencies or lack of standards, which impede high-quality and innovative development. Consequently, the national government encourages social organizations such as societies, associations, chambers of commerce, federations, and industrial technology alliances with relevant capabilities to collaborate and develop comprehensive standards to drive innovative growth in the market.
CNHFA has collaborated with inspection agencies, universities, research institutes, and industry enterprises to conduct research on a series of Association Standards for raw materials used in health food. This endeavor aims to enhance the regulation of health food and promote the advancement and management of health food standards. By strengthening the development of source standards, improving their quality and quantity, and establishing a robust technical foundation, it will contribute to the development of national standards. The 20 Association Standards that have been released were initiated by CNHFA and primarily drafted by the Institute of Chinese Medicine and Ethnic Medicine of National Institutes for Food and Drug Control, Beijing University of Chinese Medicine, and Shenzhen Institute for Drug Control. These standards represent CNHFA’s commitment to implementing national policies and incubating research-based Association Standards for health food raw materials.
2. How to interpret and use Association Standards?
CNHFA has established a total of 191 Association Standards for raw materials used in health food, divided into two batches. These standards are based on Annex 1 (List of substances which are medicine and food homology) and Annex 2 (List of substances which can be used for health food) of the Notice of the Ministry of Health on Further Regulation of Raw Material used in Health Food ([2002] No. 51). The Association Standards are categorized as follows: General Principles for Developing Association Standards for Raw Materials Used in Health Food (referred to as General Principles (I)) and individual Association Standards for each raw material used in health food (known as Monographs), such as Raw Materials for Health Food Lycii Fructus. In total, the 20 Association Standards that have been released include the General Principles (I) and 19 Monographs.
The General Principles (I) specifically pertain to substances falling under the category of medicine and food homology (MFH) and substances eligible for use in health food. They establish the necessary guidelines for conducting research and development on monograph Association Standards. These guidelines encompass project specifications, technical criteria, testing methods, and other related requirements. The General Principles (I) serve as a fundamental reference and framework for guiding the research, drafting, formulation, revision, review, and validation processes of monograph Association Standards.
The Monographs specifically pertain to raw materials that fall within the specifications outlined in the General Principles (I). These Monographs are developed in accordance with the requirements set forth in the General Principles (I), which entail conducting research, social surveys, and consultations tailored to the specific conditions of each raw material. The ultimate goal is to formulate a standardized document. The Monographs can be directly adopted as standards for health food raw materials and will continue to be refined and enhanced through practical application.
Moving forward, CNHFA will proactively engage in communication with regulatory and technical review departments. The objective is to explore the establishment of a technical review connection mechanism and assess the feasibility of transforming Association Standards into national standards.
3. What are the characteristics of Association Standards?
During the development of this system, the Association Standards have been formulated with due respect to tradition and the inherent properties of food. Taking into account the specific characteristics of health food raw materials and regulatory policies, these standards integrate functionality (effectiveness), safety, quality control, and industry requirements. They adhere to the principles of rigor, reasonableness, practicality, standardization, and environmental friendliness. Moreover, the standards have taken into consideration the distinctions from the Pharmacopoeia of the People’s Republic of China and other pharmaceutical standards. To address these differences, safety and functional (effectiveness) testing items have been incorporated in addition to the mandatory testing items. Thus, this comprehensive set of standards accounts for the unique characteristics of each variety and fully embodies the dual attributes of health food raw materials as MFH.
(i) Fundamental Regulations for Standard Development
The fundamental regulations governing the development of standards are as follows:
National Food Safety Standards for Mycotoxin Limits (GB 2761)
National Food Safety Standards for Contaminants (GB 2762)
National Food Safety Standards for Maximum Residue Limits of Pesticides (GB 2763)
National Food Safety Standards for Health Food (GB 16740)
Pharmacopoeia of the People’s Republic of China (2020 Edition), particularly Part I and Part IV, and other pharmacopoeia standards, as well as scientific literature
GB/T 1.1-2020 "Guidelines for Development Standards Part 1: Structure and Drafting Rules for Standard documents"
These regulations provide the foundational framework and references for the development of standards in the field of health food.
(ii) Description of Some Technical Items and Indicators
The Association Standards introduce a model that combines both mandatory and optional items outlined in the General Principles (I). This model takes into consideration the unique characteristics, safety considerations, and controllability of different raw materials. It provides principles and rationale for the selection of items and indicators within the Monographs. Some key aspects are described below:
A.Source: Determined in accordance with relevant regulations and technical review requirements for health food.
B.Moisture and ash: Variations in moisture and ash test results may occur due to different testing methods. Since there has been no specific research conducted to test the moisture and ash of Chinese herbal medicines using standardized testing methods, the Monographs indicate the testing methods and index values according to the Chinese Pharmacopoeia.
C.Lead, total arsenic, and total mercury: Lead (as Pb), total arsenic (as As), and total mercury (as Hg) are mandatory physical and chemical indicators (consistency indicators) established based on the Chinese Pharmacopoeia (2020 Edition), especially Part IV, 9302 Guidelines for the Establishment of Limits of Harmful Residues in Chinese Medicinal Materials and Tablets for Plants, which addresses the consistency of heavy metals and harmful elements. These indicators also align with the Food Safety National Standard for Health Food (GB 16740). Since the test methods for Chinese herbal medicines are essentially the same as those for food, the Monographs adopted the lead, total arsenic, and total mercury test methods from GB 5009.
D.Endogenous components: If toxicity studies in the literature provide clear results for an endogenous component, that component should be used as a quality control indicator for toxicity and safety risk assessment. Reasonable upper and lower control limits should be established for mandatory physical and chemical indicators. For example, anthraquinones in He Shou Wu (polygonum multiflorum) and pyrrolizidine alkaloids (PA) in Pei Lan (eupatorium) are both included as indicators.
E.Signature components: Encouragement is given for basic research to expand the parameters of signature components. If the test method is based on in-house research, method research, and verification materials are required.
4. How far has the research on Association Standards progressed?
(i) Association Standards for General Principles (I)
The initial set of the General Principles (I) and a total of 20 Association Standards, including "Raw Materials for Health Food Lycii Fructus", have been officially released. These standards will come into effect on April 10, 2023.
The second batch, consisting of 171 Monograph Association Standards, including "Raw Materials for Health Food: Ren Shen Ye (Ginseng Leaves)", is currently being drafted and is expected to be completed by the end of 2023.
(ii) Association Standards for Raw Material Extracts
CNHFA is actively promoting research on Association Standards for raw material extracts, aiming to establish a comprehensive set of Association Standards for raw material extracts, such as the "General Principles for the Preparation of Association Standards for Health Food Raw Material Extracts (II)". Currently, six Association Standards for extracts have been established, including the Raw Material Extracts for Health Food: Gu Sui Bu (Drynaria Fortunei J. Sm), and the research and drafting of additional standards are underway.
(iii) Association Standards for Other Raw Materials for Health Food
Apart from MFH and Chinese herbal medicines (including extracts), health food raw materials encompass various categories such as food raw materials, novel food raw materials, and nutritionally fortified food, among others. CNHFA is committed to conducting research on General Principles and Monographs Association Standards for different raw material categories, in alignment with the Group Standard System Planning for Health Food Raw Materials. Additionally, CNHFA will develop Association Standards for health food excipients, products, and testing methods, aiming to establish a comprehensive, systematic, and all-encompassing group standard system.
5. Where can I inquire about Association Standards?
For information regarding the establishment, release, and content of Association Standards, you can find detailed inquiries in the “Laws & Regulations” section on the official CNHFA website.
It is important to note that the adoption of Association Standards is voluntary. However, relevant organizations and entities are strongly encouraged to actively adopt these standards and provide feedback or comments for further improvement.
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