After years of development, the corresponding regulations and standards for novel food ingredients in China have become more complete. As more and more novel food ingredients are approved, Antion compiled some precautions to help enterprises use novel food ingredients in a compliant and safe manner.
01 The Announcement on the Catalogue of "Three New" Food and their Related Products and Applicable Food Safety Standards updated the requirements for food safety indicators
China's regulations on the management of novel food ingredients have undergone many changes from the Measures for the Hygiene Management of Food New Resource in 1987 to the Measures for the Management of the Safety Review of New Food Ingredients in 2013, and the name has also been changed from "new resource food" to the current "new food ingredient". The food safety indicators of some previously announced "new resource foods" or "new food ingredients" may not meet the management requirements of the latest Food Safety Law and its implementing regulations. Therefore, in May 2023, the National Health Commission issued the Announcement on the Catalogue of "Three New" Food and their Related Products and Applicable Food Safety Standards (No.4 of 2023), updating the food safety indicators of 98 novel food ingredients (excluding bacterial species) from the former Ministry of Health's Announcement No.3 in 2009 to the NHC Announcement No.9 in 2021, including peroxide value, mycotoxins, contaminants and microbial limits. The Announcement requires that the relevant standards in the Announcement should be implemented in the supervision, production and use of "three new" food and their related products, and at the same time gives an 18-month transition period. Referring to the above changes, Antion recommends that enterprises communicate with raw material suppliers in advance and inspect the raw materials in accordance with the new requirements before the end of the 18-month transition period.
02 Take into account the corresponding review results in the Catalogue of Termination of Review
In addition to obtaining the form of announcement approval, the application for novel food ingredients may also receive a technical review conclusion of "termination of review", in which the results of "(I) being reviewed as general food or substantially equivalent to general food; (II) being substantially equivalent to the novel food ingredients announced" can also be used as the basis for the use of food ingredients. For example, "Idesia polycarpa Maxim. oil" and "black wolfberry" have been clearly managed as general foods in the conclusion of termination of review.
03 Pay attention to the scope of use in the approval announcements of novel food ingredients
In some announcements on novel food ingredients, in addition to the requirements of indicating "unsuitable people" and "safety indicators", there are restrictions on the consumption method. For example, the Announcement on 53 Kinds of "Three New" Foods and their Related Products including Lactobacillus helveticus R0052 (No.4 of 2020) approved the recommended consumption of Penthorum chinense Pursh. to be "≤8 g/d" and the consumption method is limited to "Soak and drink". Therefore, when using it to develop products, be careful not to use it as a raw material for direct consumption.
At the same time, as stated in Article 2, taking into account the corresponding review results in the Catalogue of Termination of Review, Penthorum chinense Pursh. is combined with the latest review results, and its scope of use is expanded to beverages. When companies are conducting research and development, they can also refer to the results of the termination of review in a timely manner in conjunction with the announcement.
04 Labeling and indication should not ignore the requirements in the approval announcements of novel food ingredients
According to Article 20 of the Measures for the Management of the Safety Review of Novel Food Ingredients, "foods containing novel food ingredients shall have their product labels and markings in compliance with national laws, regulations, food safety standards and the requirements of the announcements of the National Health and Family Planning Commission." When using novel food ingredients, it is important to note that the labels must contain the corresponding content. For example, if a product uses sodium hyaluronate, the product label should state "not suitable for infants, pregnant women and breastfeeding women, recommended consumption ≤200 mg/day".
Except for cases where there are clear requirements to indicate the scope of use and limits, when using raw materials such as "inulin" that have edible limits but no mandatory regulations, it is recommended to refer to the Announcement on the Labeling Regulations of Foods Containing Aloe Vera Gel by Six Departments including the Ministry of Health (Announcement No. 1 of 2009): "Enterprises should stipulate the daily intake of foods containing aloe vera gel in their corporate standards. If it is impossible to ensure that consumers' daily aloe vera intake is within a safe range, a daily intake warning should be marked on the packaging." The daily intake of the product should be stated on the label of the final product to inform consumers, which is also a protection for the enterprise itself.
The above are common problems encountered when using novel food ingredients. In addition, Antion will regularly release the declaration and approval status of "three new" food and their related products according to the National Health Commission, hoping to help enterprises understand the use of novel food ingredients.
Source: Antion
Note: This article is compiled by Antion. Please indicate the source for reprint.