What is the knowledge related to new food ingredients?

The approval of new food ingredients has always been a hot information that companies are very concerned about, the announcement of new food ingredients means that a certain or some new food ingredients have passed the safety review, the application of China’s legalized, may quickly break out of a certain kind of food on the market boom. However, in the actual application of new food ingredients, we may have some questions about the approval of new food ingredients, the use and labeling, the following food partner network on some common problems to explore the instructions.
New food ingredients definition, management and query
First, what is new food ingredients with China’s new food ingredients management system changes, the name of the new food ingredients from the “new resource foods” to “new food ingredients” in the process of change, the connotation of the concept of new food ingredients has also changed.
The current “Administrative Measures for the Review of the Safety of New Food Ingredients” clearly states: “New food ingredients refer to the following items that have no traditional consumption habits in China: (a) animals, plants and microorganisms; (b) components separated from animals, plants and microorganisms; (c) food components whose original structure has been altered; and (d) other newly developed food ingredients. ” Which “traditional eating habits” refers to a food in the provincial jurisdiction has more than 30 years as a stereotypes or non-stereotypes of food production and management of the history of packaging, and is not included in the “Pharmacopoeia of the People’s Republic of China”.
Second, the approval and management of new food ingredients with the characteristics of food ingredients, in line with the nutritional requirements should have, and non-toxic, harmless, does not cause any acute, subacute, chronic or other potential hazards to human health, and in line with the definition of the above new food ingredients, such as the need to develop for the production of ordinary food business, should be in accordance with the “safety of new food ingredients review of the management approach” to the provisions of the declaration of approval.
However, those that have been included in the “National Standard for Food Safety, Standard for Use of Food Additives” (GB 2760) and “National Standard for Food Safety, Standard for Use of Nutritional Enrichment” (GB 14880) are not included in the scope of declaration.
According to the requirements of the Food Safety Law, the use of new food raw materials for the production of food should be submitted to the health administrative department of the State Council (the National Health and Health Commission) to assess the safety of the relevant products, and the health administrative department of the State Council to organize the review.
Applicants in accordance with the “Declaration and Acceptance of New Food Ingredients Regulations” and other regulatory requirements, to the National Health and Health Commission to submit the required declaration materials, the National Health and Health Commission Hall of Government on the receipt of the application materials for review and approval, and depending on the review to make the acceptance, inadmissibility, make corrections to the materials of the decision letter or notification. If the public wants to know the new food ingredient approval dynamics, they can query through the government service platform of the National Health Commission: https://zwfw.nhc.gov.cn/kzx/sdxx/sdxxqb/.
The Expert Review Committee makes technical evaluation conclusions on new food ingredients through evaluation. The final approval results are divided into three kinds: approval announcement, not licensed, termination of the review.
In the approval process of new food ingredients, there are three situations in which the Expert Review Committee makes the technical assessment conclusion of “termination of review”: if the food is reviewed as common food or has substantial equivalence with common food; if the food is substantially equivalent to the new food ingredients that have already been announced; and in other cases, the review is terminated. Substantial equivalence means that if a newly declared food ingredient is the same as a food or an announced new food ingredient in terms of species, source, biological characteristics, main ingredients, food parts, usage amount, scope of use and application population, etc., and the process and quality requirements adopted are basically the same, it can be regarded that they are the same and safe, and they have substantial equivalence. The following are examples for the above termination of review.
(1) Reviewed as common food or substantially equivalent to common food: soybean oligosaccharide, the termination of the review opinion is “there are national standards for soybean oligosaccharide, when used as food raw materials, it should be implemented according to the relevant content of the standard for soybean oligosaccharide (GB/T22491-2008).”
(2) Substantial equivalence with the announced new food ingredient: Sodium Hyaluronate, with the termination opinion as “This product is produced by fermentation of Streptococcus equi subspecies of Streptococcus equi with glucose, yeast powder, peptone and so on as the culture medium. It is substantially equivalent to Sodium Hyaluronate (Former Ministry of Health Announcement No. 9 of 2020) which has already been approved. It is recommended that the review be terminated and implemented in accordance with the relevant content of the published sodium hyaluronate.” Sodium hyaluronate that conforms to the review opinion is managed as a new food ingredient.
(3) Other cases of termination of the review: Lotus corniculatus, the opinion of termination of the review is “In view of the fact that Lotus corniculatus has been included in the Pharmacopoeia of the People’s Republic of China in a variety of single and prescription preparations, with clear pharmacological activity, it is recommended to terminate the review.” It can be clear that goldenseal is not a food ingredient.
Fourth, the query of new food ingredients if you want to know whether a certain raw material has been approved new food ingredients, or want to see what are currently approved, terminated review or public consultation of new food ingredients, you can query through the following ways.
(1) The Food Ingredients Information Database of FoodPartner.com The Food Ingredients Information Database of FoodPartner.com summarizes information on new food ingredients that have been approved and terminated for review in the past years, and associates the original text of the announcement of new food ingredients and the related reply letters, which is a very convenient query tool. Inquiry link: http://db.foodmate.net/xinshipin/.
(2) The Public Query System for Health Administrative License of the National Health and Wellness Commission (NHAC). In this query system, it is divided into the directory of new resource foods approved before 2007 and the directory of announcements of new food ingredients approved after 2007, as well as the directory of new food ingredients under termination of review. Inquiry link: https://slps.jdzx.net.cn/xwfb/gzcx/PassFileQuery.jsp.
(3) Official website of the NHRC If you want to check the approval status and announcement details of a certain new food ingredient, you can also search the name of the new food ingredient directly in the official website of the NHRC.
(4) National Risk Assessment Center Administrative Permit Request for Comments If you want to know the relevant information about the request for comments on new food ingredients, you can use the Administrative Permit Request for Comments section of the Risk Assessment Center to learn about the relevant developments. Inquiry link: https://www.cfsa.net.cn/Article/LawNew_List.aspx?channelcode=FD7DFE7A58DAB7788ED6929809972C8AE0FC102162B069D1&code= 9535ed5882d69ad7f633fea0205be83a.
Fully understand the content of the announcement of new food ingredients and the compliant use of new food ingredients
First, pay attention to the content of the announcement of new food ingredients according to the “new food ingredients safety review management approach”, the announcement of new food ingredients usually contains the name of the raw material, source, production process, the main ingredients, quality specifications, labeling and identification requirements and other need to be announced. Among them, “other information to be announced” is very changeable, about the unsuitable people and special labeling requirements are usually included in this element.
When we decide whether an ingredient is a new food ingredient, we need to search for the announcement of new food ingredients, carefully review the original announcement, and fully understand the content of the announcement, including the edible parts, edible methods, edible amount, production process, quality specifications, scope of use, unsuitable people, etc., to avoid misuse of new food ingredients.
For example, “Ginseng (artificial planting)”, in the basic information column of the announcement of the new food ingredient, it is clear: “Source: ginseng planted artificially for 5 years and less than 5 years”, which means that ginseng planted artificially for more than 5 years is not in the scope of approved new food ingredients. Another example is “Mujing Ye Ke”, which is clearly stated in the announcement that the edible part is young leaves (buds) and the way of consumption is brewing, so other parts that are not within the scope of the announcement, or the way of consumption is different from the announcement, also do not belong to the scope of the announcement of the new food ingredient.
Announcement of new food ingredients in most cases, will indicate the Latin name of the raw material, can not tell whether the raw material used in the announcement of the raw material, you can verify the Latin name of the two are consistent to assist in judgment.
Second, the concentration of new food ingredients conversion of certain new food ingredients will be microencapsulation and dilution process to produce a lower concentration of the announcement of new food ingredients, in this case, the consumption of new food ingredients need to be calculated according to the concentration of the product conversion.
Here, we refer to the former Ministry of Health’s announcement on the approval of lutein esters and the reply letter on the issue of the use of lutein esters at low concentration: “Announcement of the Ministry of Health on the Approval of 7 New Resource Foods, including Lactobacillus Acidophilus” (No.12, 2008), which requires that the lutein dipalmitate content of lutein esters be >55.8%, and that the consumption amount be less than ≤12 mg/day; and “Reply Letter of the General Office of the Ministry of Health on the Issues of the Use of Lutein Esters”. The Reply Letter of the General Office of the Ministry of Health on the Use of Lutein Esters specifies that “the low concentration of lutein esters produced by microencapsulation and dilution process can be used as food ingredients, and its consumption should be calculated according to the concentration of the product”.
Based on the above, assuming that the content of lutein dipalmitate in the diluted lutein ester is 20%, its consumption should be <(55.8%×12/20%)(mg/day).
Third, the compliance of the introduction of new food ingredients in November 2021, the State Administration for Market Supervision and Administration of the public message advisory response to the question of “whether solid drinks can be added to sports nutrition food”, attracted attention, the original text is shown below. Through the message and the response, it can be seen that the attitude of the market supervision: it does not support the intentional introduction of a new food ingredient that cannot be used in the final product through the use of a specific ingredient into the final product.
How to Label New Food Ingredients in the List of Ingredients
First, the labeling requirements of new food ingredients in the ingredient list “Administrative Measures for the Review of the Safety of New Food Ingredients” clearly: “Food containing new food ingredients, its product labeling and identification should be in line with national laws, regulations, food safety standards and the requirements of the announcement of the National Health and Family Planning Commission.” According to this provision, the names of new food ingredients in the food ingredient list should also comply with the requirements of the announcement.
Failure to label the names of new food ingredients in strict accordance with the requirements of the announcement may be misleading. Take “ginseng” as an example, “ginseng” is included in the “List of articles that can be used in health food”, and the articles listed in the list are limited to be used in health food; the former Ministry of Health Announcement No. 17 of 2012 specifies that “ginseng (artificially grown)” is included in the list of new food ingredients. Ginseng (Artificial)” is included in the management of new food raw materials. Therefore, it is inaccurate to label “ginseng” directly in the ingredient list, and when it is applied to food as a new food ingredient, it should be labeled with the name “ginseng (artificial cultivation)” in the announcement.
Second, the labeling of new food ingredients based on the “National Health and Family Planning Commission Food Division on prepackaged food containing new food ingredients labeling and oligofructose related issues of the reply” (National Health Food Labeling letter [2015] No. 279): “According to the ‘National Standard for Food Safety General Principles for the Labeling of Prepackaged Food’ (GB 7718-2011), the relevant provisions of consumption methods should be indicated in the announcement ‘ginseng (artificial cultivation)’. -2011), the consumption method belongs to the recommended labeling content.
If the prepackaged food contains new food raw materials that have been announced, if the announcement explicitly requires the labeling of serving size and unsuitable population in the labeling and instruction manual, it should be labeled in accordance with the requirements of the relevant announcements; if the announcement has the requirements of serving size and unsuitable population but does not require the labeling of labeling and instruction manual, it can be labeled by the food production enterprises on their own choice of whether to label or not.”
The former Ministry of Health Announcement No. 12 of 2008 specifies that the serving size of Aloe vera gel should be ≤30g/day; however, the announcement does not require that the “serving size” must be indicated on the product label.
In the Announcement of the Ministry of Health and other 6 Ministries and Bureaus on the Labeling Requirements for Foods Containing Aloe Vera Gel (Announcement No. 1 of 2009), there is a corresponding explanation on the labeling of the serving size of Aloe Vera Gel: “Enterprises should stipulate the daily serving size of food products with added Aloe Vera Gel in the enterprise standards. If it is not possible to ensure that the daily intake of aloe vera by consumers is within the safe range, a daily serving size warning should be labeled on the package.”
Combining the above reply letter and the announcement requirements, it can be seen that if the new food ingredient announcement does not explicitly require the labeling of “serving size”, it can be combined with the consumption requirements of the announcement and the final consumption of the food to determine whether or not to indicate the “serving size” on the label. “The label can be determined by taking into account the serving size requirement of the announcement and the final consumption of the food. Can ensure that the daily intake of consumers in the safe range, you can choose whether to label “serving size”, can not ensure that the daily intake of new food ingredients in the safe range of consumers, it is recommended to label the daily serving size on the package.
Third, the labeling of unsuitable groups of certain new food ingredients in the declaration of infants and young children, pregnant women and other special groups of people did not provide food safety assessment materials, or materials provided are not sufficient to ensure the safety of consumption of special groups, therefore, in its announcement of new food ingredients expressly required to indicate the unsuitable groups of people, for example, “BaoLeGuo Powder”, “rice bran fatty alkanols”, ‘ginseng (cultivated)’ etc. If such new food ingredients are added to the final product, the labeling should indicate the unsuitable population according to the requirements.
Examples of the above labeling of name, serving size and unsuitable population in the ingredient list are shown below.