In recent years, probiotic products have received market attention and sought after. Probiotic health foods are rising, and they have become a research and development hotspot for nutritious and health food companies. At present, there are about 100 probiotic products with health food approvals on the market in my country, but the number is not large. my country’s probiotic health food has special declaration and review regulations, and adopts a stricter market access system. In accordance with the requirements for application and approval, probiotic products must submit a shelf life long-term stability test report.
1. Requirements for product stability test in health food registration
According to the”Regulations for Health Food Registration Review and Approval Work Regulations”, in various registration applications, the stability test materials are as follows.
New domestic products registered as health food:
1. Product technical requirements research report of product development report:product stability test conditions, test items and test methods, etc., as well as the registration applicant’s stability test results System analysis and evaluation;
2. Safety and health function evaluation test materials:three batches of sample functional components or iconic components, hygiene, stability test report (for commissioned inspection, The entrusted unit should be a food inspection agency with legal qualifications);
Domestic product change registration application materials:
1. Change product specifications, storage methods, shelf life, auxiliary materials, production processes, and product technical requirements. Application for changes to other content:functional ingredients or landmarks of the three batches of samples Composition, hygiene, stability test report. If the referenced standards in the product technical requirements have been updated or replaced, and the content of the standards has not been substantially changed, it is exempted from providing three batches of sample functional or iconic ingredients, hygiene, and stability test reports.
2. Change the range of suitable people, the range of unsuitable people, the precautions or the method of eating, the application for changes in the amount of consumption:change the range of suitable people, the range of unsuitable people, The application for changes in eating methods and precautions, the safety and health function evaluation tests, as well as the hygiene and stability tests carried out at the time of the original registration application, cannot fully support the modified range of suitable people, unsuitable people, eating methods or precautions Etc., safety and health function evaluation tests or hygiene and stability tests should be supplemented;
Domestic product transfer technology registration application materials:
shall provide product formula materials, production process materials, packaging materials directly in contact with the product, functional ingredients or signatures of the three batches of samples in accordance with the requirements of new product registration application materials Ingredients, hygiene and stability test reports, sample label instructions, 3 samples of minimum sales packaging and other materials;
Imported product registration application materials:
Imported product registrant’s application for changing the production site outside of China without changing the country or region of production shall also provide the government of the country (region) where the new production site is located The certification documents issued by the competent authority or legal service agency permitting the production and sale of the product in the country (region), the actual samples of the packaging and label instructions issued by the country (region) where the new production site is located, and the food inspection agency with legal qualifications The three batches of sample efficacy ingredients or iconic ingredients, hygiene, and stability test reports produced at the new production site; if the country or region of production is changed at the same time, relevant materials shall be provided in accordance with the transfer technology registration. Evaluation test or hygiene, stability test.
2. Technical requirements for stability test of special samples
According to the”Guiding Principles for Stability Testing of Health Foods”, the specific requirements for product testing are as follows:
In the stability test, multiple inspection time points should be set, and the inspection time points should be based on the understanding of the nature of the sample (sensory, physical and chemical, biological) and its changes Trend setting.
Conduct inspections under the storage conditions specified in the instructions. If the shelf life is within 3 months, the inspection should be carried out at 0 and the end month (days) of storage; if the shelf life is longer than 3 months, the inspection should be carried out according to the principle of inspection every 3 months (including 0 and end months of storage).
should follow the method stipulated in the product quality standard to examine the hygiene of the samples submitted by the applicant and the changes in the quality-related indicators during the warranty period Detection.
(1) Confirmation of storage conditions. The results of the stability test should be referred to, combined with the conditions that may be encountered during the production and circulation of the health food, and the storage conditions of similar products on the market should be referred to for comprehensive analysis to determine the appropriate product storage conditions.
(2) Determination of packaging materials and containers that directly contact health food. Generally, suitable packaging materials should be determined according to the specific conditions of health foods and the results of stability studies.
(3) Confirmation of shelf life. The shelf life of health food should be determined comprehensively according to the specific conditions of the product and the results of stability inspection. Use short-term test or long-term test to investigate the product quality and stability of the samples. The overall inspection time should cover the expected shelf life, and the longest time point with no significant change compared with the data in 0 months should be used as a reference. According to the test results and the specific conditions of the product , To comprehensively determine the shelf life; use accelerated testing to investigate product quality stability samples, according to the accelerated test results, the shelf life is generally set to 2 years; samples that have undergone both accelerated testing and long-term testing, the shelf life is generally determined by referring to the long-term test results.
3. Stability test guidelines requirements for some countries and regions
1. World Health Organization WHO
2. United States
5.NSF certification (NSF International)
NSF International, an independent, not-for profit, non-governmental organization, is dedicated to being the leading global provider of public health and safety-based risk management solutions while serving the interests of all stakeholders.
Key aspects of their stability guidelines include:
All dietary supplement products are tested to determine to meet their label claim cell count over the shelf life at the conditions listed in the Product Description;
Products are stored for their shelf life plus six months and tested at regular intervals as specified by NSF;
The first three batches of a product are tested. This data is good for 5 years after which data on another 3 batches produced.
6. Taiwan, China
Four. Factors to be considered in the stability test of probiotics
1. Consideration of strain stability
The stability of the strain will be affected by the final packaging and form as well as the manufacturing method. The same strain produced using two different media and processing conditions will result in different stability. Conversely, if the product is registered with a specific strain and produced by a specific manufacturer, if it is replaced with another strain, it cannot be determined that the product has the same stability.
2. The influence of production conditions
Freeze-dried probiotic powder is often hygroscopic. It is generally recommended that the processing environment conditions not exceed 25°C and below 35%RH to prevent moisture absorption during processing. If the water activity of the product is similar to the previous sample study, its stability performance is expected to be similar.
3. Accelerated test
There is no clear test to prove the strong correlation between the accelerated test and the long-term stability of probiotics.
Author:Chinese Health Food Association special nutritional food ingredients former professional committee