Summary of knowledge related to new food ingredients
June 26, 2024
The approval dynamics of new food ingredients have always been a hot topic of concern for enterprises. The announcement of new food ingredients means that certain or certain new food ingredients have passed safety reviews, and their application in China has become legal, which may quickly lead to a wave of certain food products going public. However, in the actual application process of new food ingredients, we may have some questions about the approval, use, and labeling of new food ingredients. Below, Food Partner Network will discuss and explain some common issues.
01
Definition, management, and inquiry of new food ingredients
1. What are new food ingredients
With the transformation of China's new food raw material management system, the name of new food raw materials has undergone a process of change from "new resource food" to "new food raw materials", and the connotation of the concept of new food raw materials has also changed accordingly. The current "Management Measures for Safety Review of New Food Raw Materials" specify that "New food raw materials refer to the following items that have no traditional eating habits in China: (1) Animals, plants, and microorganisms; (2) Components isolated from animals, plants, and microorganisms; (3) Food ingredients whose original structure has changed; (4) Other newly developed food ingredients The "traditional eating habits" refer to the production and operation of a certain food as standardized or non standardized packaging food within the provincial jurisdiction for more than 30 years, and it is not included in the Pharmacopoeia of the People's Republic of China. 2. Approval management of new food raw materials
Articles that have the characteristics of food raw materials, meet the necessary nutritional requirements, are non-toxic and harmless, do not cause any acute, subacute, chronic or other potential hazards to human health, and meet the definition of new food raw materials mentioned above. If they need to be developed for the production and operation of ordinary food, they should be applied for approval in accordance with the provisions of the "Management Measures for Safety Review of New Food Raw Materials". However, those that have been included in the National Food Safety Standard for the Use of food additives (GB 2760) and the National Food Safety Standard for the Use of Food Nutrient Fortifiers (GB 14880) are not within the scope of application. According to the requirements of the Food Safety Law, when using new food ingredients to produce food, relevant safety assessment materials for the products shall be submitted to the health administrative department of the State Council (National Health Commission) for review by the health administrative department of the State Council. The applicant shall submit the prescribed application materials to the National Health Commission in accordance with the requirements of the Regulations on the Application and Acceptance of New Food Raw Materials. The National Health Commission's Government Affairs Hall shall review the received application materials and make a decision or notice on acceptance, rejection, or correction of materials based on the review results. If the public wants to know about the approval status of new food ingredients, they can search through the government service platform of the National Health Commission: https://zwfw.nhc.gov.cn/kzx/sdxx/sdxxqb/ . The expert review committee makes technical review conclusions on new food ingredients through the review. The final approval results are divided into three types: approval announcement, no permission, and termination of review. 3. Explanation on Termination of Review
In the process of approving new food raw materials, there are three situations where the expert review committee makes a technical review conclusion of "terminating the review": after review, it is considered as ordinary food or has substantive equivalence with ordinary food; Substantial equivalence with newly announced food ingredients; Other termination of review situations. Substantive equivalence refers to the fact that if a newly declared food ingredient is similar to a food or a newly published food ingredient in terms of species, source, biological characteristics, main ingredients, edible parts, usage, scope of use, and target audience, and the process and quality requirements used are basically the same, it can be considered that they are equally safe and have substantive equivalence. Below are examples to illustrate the termination of review mentioned above. (1) After review, if it is found to be ordinary food or substantially equivalent to ordinary food: soy oligosaccharides, the termination of review opinion is "soy oligosaccharides have national standards, and when used as food raw materials, they should be executed in accordance with the relevant content of the soy oligosaccharide standard (GB/T22491-2008)." (2) Sodium hyaluronate, which is substantially equivalent to the newly announced food raw materials, is terminated with the review opinion that "this product is produced from glucose, yeast powder, peptone, etc. as the culture medium and fermented by Streptococcus equi subsp. zoonotic. It is substantially equivalent to the approved announced sodium hyaluronate (formerly Ministry of Health Announcement No. 9 of 2020). It is recommended to terminate the review and follow the relevant content of the announced sodium hyaluronate." Sodium hyaluronate, which meets the review opinion, is managed as a new food raw material. (3) Other termination of review situations: Jinlian Flower. The termination of review opinion is "Considering that Jinlian Flower has multiple single and formulated formulations included in the Pharmacopoeia of the People's Republic of China and has clear pharmacological activities, it is recommended to terminate the review." It can be clarified that Jinlian Flower does not belong to food raw materials. 4. Query of new food ingredients
If you want to know if a certain ingredient is an approved new food ingredient, or if you want to see which new food ingredients have been approved, terminated, or publicly solicited, you can search through the following channels. (1) Food Partner Network's Food Raw Material Information Database The food ingredient information database of Food Partner Network summarizes the information of new food ingredients that have been approved and terminated for review over the years, and is associated with the original text of the new food ingredient announcement and related replies, making it a very convenient query tool. (2) National Health Commission Health Administrative Licensing Public Query System In this query system, there are two categories: new resource foods approved before 2007 and new food ingredient announcement catalogs approved after 2007, as well as new food ingredient termination review catalogs. (3) Official website of the National Health Commission If you want to check the approval status and announcement details of a new food ingredient, you can also directly search for the name of the new food ingredient on the official website of the National Health Commission. (4) National Risk Assessment Center solicits opinions on administrative licensing If you want to learn about the relevant information on soliciting opinions on new food ingredients, you can learn about the relevant dynamics through the administrative licensing solicitation column of the Risk Assessment Center.
02
Fully understand the announcement content of new food ingredients
And compliant use of new food ingredients 1. Pay attention to the announcement of new food ingredients
According to the "Management Measures for Safety Review of New Food Raw Materials", the announcement of new food raw materials usually includes the name of the raw materials, source, production process, main components, quality specification requirements, labeling and labeling requirements, and other content that needs to be announced. Among them, "other situations that need to be explained" are highly variable, and requirements for unsuitable populations and special labeling are usually included in this element. When determining whether a certain ingredient belongs to a new food ingredient, we need to search for the announcement of the new food ingredient, carefully review the original announcement, fully understand the content of the announcement, including the edible part, consumption method, consumption amount, production process, quality specifications, scope of use, unsuitable population, etc., to avoid misuse of the new food ingredient. For example, "ginseng (artificially planted)" is clearly stated in the basic information column of the new food ingredient announcement: "Source: ginseng artificially planted for 5 years or less", indicating that ginseng artificially planted for more than 5 years is not included in the approved new food ingredient category. For example, "Mu Jiang Ye Ke", whose announcement clearly states that the edible part is tender leaves (buds) and the consumption method is brewing, other parts that are not within the scope of the announcement, or the consumption method is different from the announcement, are also not within the scope of the announcement for new food ingredients. In most cases, new food ingredient announcements will indicate the Latin name of the ingredient. When it is impossible to determine whether the ingredient used is the one listed in the announcement, it can be assisted by verifying whether the Latin names of the two are consistent. 2. Conversion of concentration of new food raw materials
Some new food ingredients will be produced through microencapsulation and dilution processes to produce new food ingredients with lower concentrations than announced. In this case, the consumption of new food ingredients needs to be calculated based on the product concentration conversion. Referring to the original Ministry of Health's approval announcement on lutein esters and the reply letter on the use of low concentration lutein esters: the Ministry of Health's announcement on the approval of 7 new resource foods such as Lactobacillus acidophilus (No. 12 of 2008) requires that the content of lutein dipalmitate in lutein esters should be>55.8%, and the consumption should be less than or equal to 12 mg/day; The reply from the General Office of the Ministry of Health on the use of lutein esters clearly states: "Low concentration lutein esters produced through microencapsulation and dilution processes can be used as food raw materials, and their consumption should be calculated based on the product concentration conversion.". Based on the above situation, assuming that the content of lutein dipalmitate in the diluted lutein ester is 20%, its consumption should be<(55.8% x 12/20%) (mg/day). 3. Compliance with the introduction of new food ingredients
In November 2021, the State Administration for Market Regulation responded to a public message inquiry regarding the question of whether solid beverages can be added to sports nutrition foods, which attracted attention. The original text is shown in the following figure. From this message and response, it can be seen that the attitude of market regulation is that it does not support intentionally introducing a new food ingredient that cannot be used in the final product through the use of specific ingredients.
03
How to indicate the names of new food ingredients in the ingredient list
1. Requirements for labeling new food ingredients in the ingredient list
The "Management Measures for Safety Review of New Food Raw Materials" stipulate that "if food contains new food raw materials, the product label identification should comply with national laws, regulations, food safety standards, and the requirements of the National Health and Family Planning Commission's announcement." According to this regulation, the name of new food raw materials in the food ingredient list should also meet the requirements of the announcement. Not strictly following the announcement requirements to indicate the ingredient names of new food ingredients may cause misleading information. Taking "ginseng" as an example, "ginseng" is included in the "List of Items that can be Used in Health Food", and the items listed in this list are limited to health food only; Announcement No. 17 of 2012 from the former Ministry of Health clearly stated that "ginseng (artificially planted)" will be included in the management of new food raw materials. Therefore, directly labeling "ginseng" in the ingredient list is not accurate. When applying it to food as a new food ingredient, the name "ginseng (artificially grown)" in the announcement should be indicated. 2. Indication of consumption of new food ingredients
According to the reply from the Food Department of the National Health and Family Planning Commission on the labeling of new food ingredients and issues related to oligofructose in pre packaged food (National Health and Food Standard Letter [2015] No. 279): "According to the relevant provisions of the General Rules for Labeling of Pre packaged Food in National Food Safety Standards (GB 7718-2011), the consumption method belongs to the recommended labeling content.". Pre packaged food contains new food ingredients that have been announced. If the announcement explicitly requires the labeling and instructions to indicate the amount of food consumed and the unsuitable population, it should be marked in accordance with the relevant announcement requirements; If there are requirements for consumption and unsuitable population in the announcement, but they are not required to be labeled or indicated in the label or instructions, the food production enterprise can choose whether to label them or not The original Ministry of Health's Announcement No. 12 in 2008 specified that the consumption of Curacao aloe gel should be ≤ 30g/day; However, there is no requirement in the announcement to indicate "consumption amount" on the product label. In the Announcement of the Ministry of Health and other six ministries and bureaus on the Provisions on the Food Labeling of Curacao gel (Announcement No. 1 in 2009), there is a corresponding description on the food consumption of Curacao gel: "The enterprise shall specify the daily food consumption of the food added with Curacao gel in the enterprise standard. If it is unable to ensure that the daily consumption of aloe by consumers is within the safe range, the warning message of daily consumption shall be marked on the package." Based on the above reply and announcement requirements, it can be seen that if there is no clear requirement in the new food ingredient announcement to indicate "consumption amount" on the label, it can be determined whether to indicate "consumption amount" on the label based on the announced consumption amount requirements and the final consumption situation of the food. To ensure that the daily intake of consumers is within a safe range, it is possible to choose whether to label "consumption" on the label. If it is not possible to ensure that the daily intake of new food ingredients is within a safe range, it is recommended to label the daily consumption on the packaging. 3. Identification of unsuitable population
Some new food ingredients did not provide safety assessment materials for special populations such as infants and young children, pregnant women, etc. during the declaration process, or the materials provided were insufficient to ensure the safety of consumption in special populations. Therefore, in their new food ingredient announcements, it is explicitly required to indicate the unsuitable population, such as "Baole Fruit powder", "rice bran fatty alcohol", "ginseng (artificially planted)", etc. If such new food ingredients are added to the final product, the label should indicate that they are not suitable for the intended audience as required.
Shaanxi Huike Botanical Development Co., Ltd. a integrated enterprise which is focus on natural products, Plant extract related products and services.We mainly focus on pharmaceutical, functional food, Freeze-dried powder,Natural Pigment,Homology of medicine and food,beverages and other business services.
For more information about inulin, please contact us!
Email:marketing@huikes.com
2024-06-26
Shaanxi Huike Botanical Development Co., Ltd.
