Based on the recent consultation from the public in terms of FSMP, we found that people gradually have more comprehensive and in-depth understanding of this kind of products. To help enterprises and the public learn more about FSMP, CIRS has sorted out the most representative 11 questions and made detailed answers in this article. The questions are divided in five parts: 1) registration administration; 2) the use of food raw materials and food additives; 3) enterprises’ capacity on manufacturing/R&D/inspection; 4) product test and 5) others. This Q&A is strictly based on FSMP related regulations and standards, as well as department rules and announcements, and combined with the actual use with reasonable interpretation. If there is anything wrong, we welcome any correction and discussion.
1. Is the State Administration for Market Regulation (SAMR) or the National Medical Products Administration (NMPA) responsible for the registration administration of FSMP in China?
A: Firstly, Food Safety Law of the People's Republic of China states that, FSMP shall be “food” but not “medicines”, thus, the registration work is administered by SAMR but not NMPA. Meanwhile, FSMP, health food and infant formula are determined to be “special food” in China by the law, and are administered by Department of Special Food Safety Supervision and Administration which is subordinate to SAMR.
2. Must the applicant be the manufacturer? Can R&D enterprise be the applicant? If not, is cooperated R&D acceptable?
A: First of all, the applicant must be manufacturers, but not a R&D enterprise. Secondly, there is no explanation on the situation of "cooperative R&D" in Measures for Registration and Administration of Food for Special Medical Purposes (hereinafter referred as “the Measures”). But in practice, it is allowed and could be a way that is conducive to the development and progress of both enterprises and/or partners. Meanwhile, the legislative plan in 2020 from SAMR explicitly includes the Measures, which means it will be revised based on the current version. And we will see whether there will be any explanation on the situation of cooperative R&D.
The use of food raw materials and food additives
3. How to determine whether a food additive can be used in FSMP? e.g., stevioside
A: Firstly, it shall be determined what type the product is, and then determine if the additive is permitted to be used or not. As stevioside an example,
1) As stated in GB25596: the use of food additives in infant FSMP shall conform to GB2760. And based on GB2760, stevioside is not included in the permitted food additives for “infant FSMP (food category number 13.01.03)”, thus, it cannot be used in such products;
2) As stated in GB29922: the use of food additives in the products (for the population between 1-10 years old) can refer to GB 2760 –food additives permitted to be used in infant and young children formula; for the population over 10 years old, it can refer to the use of food additives for the products’ analogues categorized in GB 2760.
Therefore, for the products suitable for people aged 1 to 10 years old, the use of food additives can refer to all the permitted food additives for “13.01 (infant and young children formula)”, “13.01.01 (infant formula)”, “13.01.02 (older infant and young children formula)” and “13.01.03 (infant FSMP)”. However, stevioside is not included as well, thus cannot be used in such products.
For the products suitable for people aged over 10 years old, the “analogues” in the requirements means that, the main raw materials, product dosages and manufacturing techniques of them are similar. For example, if a product is similar to one kind of solid beverages, based on GB2760, stevioside can be used.
4. Is there available or prohibited food raw material list for FSMP? Our new food raw materials are in the application or approved already, are they permitted to be used in FSMP?
A: Firstly, there is no such list for FSMP. And to determine whether a raw material can be used in FSMP, a comprehensive judgment shall be made according to the announcement of approval of this material and GB25596 or GB29922.
For instance, the approved using scope of inulin is "all kinds of food, but does not include infant and young children food". Therefore, it cannot be used in FSMP for people under 3 years old. Meanwhile, inulin is a kind of dietary fiber, and GB29922 clearly indicates that dietary fiber can be added to FSMP as an optional ingredient. Therefore, to be summarized, inulin can be used as a source of dietary fiber in FSMP for people over 3 years old.
However, although the approval announcement for Haematococcus Pluvialis only states that the using scope “does not include infant and young children food ", it contains astaxanthin which is not a permitted bioactive substance required in GB25596 or GB29922, thus, it cannot be used in FSMP.
Note: CIRS had made clear and classified interpretation on the use of food raw materials and food additives (including probiotics and new food raw materials) in FSMP, for details please click:
Capacity on manufacturing/R&D/inspection
5. What requirements does China have for the manufacture, R&D and inspection capacity and personnel of FSMP enterprises?
A: The Measures clearly requires: the applicant shall have corresponding capacity on research and development as well as manufacturing of the products, establish R&D institutions with professional product development personnel (with food related professional senior title or the same competence), and production quality management system in accordance with the requirements for good manufacturing practices and with food safety professional and technical personnel. Moreover, enterprises shall have the ability to inspect all items of the products batch by batch according to GB29922 or GB25596 if the tests are conducted by enterprises themselves. And for those who do not have the capability of self-testing, they may entrust a third-party with legal qualification and corresponding testing capability to conduct the tests.
6. Do the applicants need to have certification on GMP for FSMP?
A: Firstly, there is no “GMP certification” for FSMP in China, while the Food Production License is mandatory for domestic FSMP manufacturers. When establishing the production plant, enterprises should strictly follow the Good Manufacturing Practice of Food for Special Medical Purposes (GB29923) and the General Hygiene Practice of Food Production (GB14881).
7. Is the stability test while using necessary for FSMP? What are the requirements?
A: Requirements on Stability Test of Food for Special Medical Purposes (trial, 2017 version) states that, the products shall be subject to impact factor test, accelerating test and long-term test, and other types of tests shall be selectively designed according to the characteristics, packaging and use of the products. Therefore, the impact factor test, accelerating test and long-term test are mandatory, and shall be carried out according to the specific requirements in the above regulation. However, the stability test while using is not mandatory, enterprises can conduct such tests according to the different characteristics of their own products. And since the stability test while using can include many types, such as stability test after opening package or tube feeding simulating test, etc., there are no specific test methods and conditions for such tests required in the regulation, and at the time of registration, the applicant shall provide test related materials including storage conditions, test methods, sampling points, inspection items, inspection results and evaluation methods etc.
8. Is it compulsory for enterprises to use the test methods specified in GB29922 or GB25596?
A: It’s not compulsory. However, it is definitely more reliable and more cost-effective for enterprises to use the test methods stipulated by the GB standards. And if there are certain factors that lead to the failure to use the GB methods, the materials related to the test methods used by enterprises shall be provided for technical review. Requirements on Stability Test of Food for Special Medical Purposes (trial, 2017 version) states that, where the test methods are prescribed in the GB standards but not adopted, or where the methods are not prescribed and are provided by the applicant, the sources of the methods and/or methodological verification data shall be provided.
9. Can FSMP for different ages be named stage 1, stage 2 and stage 3?
A: Such naming is not allowed for FSMP, “stage1, stage2 and stage 3” are the general names specifically for infant and young children formula in China, while the names of FSMP should reflect its real property (refer to the product dosage and classification properties, etc.), using the specified classification names or equivalent names specified in GB25596 or GB29922, such as infant lactose free formula for special medical purpose, or infant lactose free formula (powder) for special medical purpose, etc.
10. Is the age of the applicable population of FSMP over 1 years old only labeled as 1-10 years old or over 10 years old? Could there be other age groups?
A: Although GB29922 divides it into 1-10 years old and over 10 years old, enterprises can mark the age of applicable people as a smaller range according to the actual situations. For example, within the age of 1-10 years old, it can be marked as 1-3 years old, 3-7 years old, and 3-10 years old etc. While no matter which range is marked, the technical indexes of the product should meet the requirements in GB29922 for the product for 1-10 year old population. The same on products for over 10 year old population, if smaller ranges are marked, such as 10-18 years old, over 18 years old, over 50 years old, and over 65 years old, etc., the technical indexes shall meet the requirements in GB29922 for the product for over 10 year old population.
11. What are the requirements on FSMP packaging materials?
A: There are no detailed requirements for packaging materials in the relevant regulations and standards of FSMP, enterprises should choose packaging materials and containers suitable for their products. In the application of registration, the applicant needs to submit materials related to packaging including: 1) packaging materials and/or containers’ names and their quality specification; 2) depending on the types of products, the applicant should keep the results of the stability test for reference (infant FSMP and nutritionally complete food) or submit the stability test report (for specific nutritionally complete food and nutritionally incomplete food); 3) control scheme of migration of hazardous substances in packaging materials and containers. The control plan does not specified in the regulation, and the applicant should make it and conduct relevant tests based on the product characteristics and the packaging materials. In China, food contact materials and containers should be in line with GB4806.1 and the corresponding standards of the food contact materials.
The above are the answers from CIRS on the questions related to FSMP, for more information and service, please click FSMP registration requirements in China.
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