Some Safety ProblemsCountermeasuresthe ResearchDevelopment of Health Food
inputtime:2022-10-14 hit:


Whether it is a health food enterprise or a research and development organization, before deciding to research and develop a health food, it must first determine the functional claims of the target population and products on the basis of extensive market research, and then organize the formula under the guidance of traditional Chinese health theory or modern medicine. At this time, the main factor affecting product safety is the selection of raw materials to ensure their safety.

According to the provisions of the "Measures for the Administration of Health Food Registration", the national administrative department has implemented the "list management system" to ensure the safety of the health food raw materials used. That is to say, the raw and auxiliary materials used in the health food formula must be within the list of available materials published by the management department. Including: ordinary food raw materials; Listed in the categories of food additives and food fortifiers specified in the "Standards for the Use of Food Additives" (GB 2760-2011) and "Standards for the Use of Food Nutrition Fortifiers" (GB 14880~- 2012); List of new food resources announced; The list of probiotics and fungi that can be used in health food and other products listed in the "both food and medicine" and "articles that can be used in health food" issued by the Ministry of Health in Document No. 51.

Those who want to use the varieties beyond the above list as health food raw materials must first apply for "new food resources" or "new health food raw materials varieties", and can use them only after obtaining approval. In terms of dosage, in order to ensure the safety of the product, it is generally required that the dosage must be within 1/3~1/2 of the dosage in the pharmacopoeia. If the dosage exceeds this, scientific basis for safety shall be provided. In addition, the National Bureau has announced the upper limit of 10 kinds of raw materials. As for the types and amounts of nutrients used in nutrient supplements, the National Bureau has also made regulations and published them. Generally speaking, the use of vitamins and minerals for adults should be between the maximum and minimum use, and the special population such as children, pregnant women and nursing mothers should be between 1/3 and 1/2 of their recommended nutrient intake (RNI).

At present, from the perspective of raw materials, there are three important issues affecting the safety of products, which need to be studied in the future: first, the safety of the dosage of concentrated functional ingredients; Second, the difference between "physiological dose" and "pharmacological dose" and the problem of safe dosage; The third is the interaction of product raw materials.

Due to the above reasons, up to now, due to the lack of in-depth research on each functional ingredient (or functional factor), we have not been able to determine the following three important dose effect relationships: the lowest effective dose, the effective dose range and the safe dose. In addition, there are also problems concerning the safety of raw materials, such as endogenous toxicity of Chinese herbal medicine raw materials, safety of genetic engineering materials, external pollution of health food raw materials, especially plant raw materials, and allergens in raw materials.

It can be seen that from the perspective of "R&D", there are many influencing factors to ensure the safety of the end products, and with the passage of time and scientific progress, many new problems will arise that need us to study and summarize in depth, and keep advancing with each passing day.


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