On July 2, 2007, the former Ministry of Health formulated and issued the "New Resource Food Management Measures", which came into effect on December 1 2007. On October 1, 2013, the former National Health and Family Planning Commission revised and implemented the "Novel Food ingredients Safety Review and Management Measures" to amend "new resource food" to "Novel food ingredient" and modify its definition. Novel food ingredients refer to the following items that have no traditional eating habits in China:

1) Animals, plants, and microorganisms;

2) Ingredients separated from animals, plants and microorganisms;

3) Food ingredients whose original structure has changed, and other newly developed food ingredients.

Up to now, China has issued more than 100 novel food ingredients approval announcements. Today, Foodmate will introduce you the relevant regulations of Chinese novel food ingredients management, the identification of substantive equivalents, and the relevant procedures for the acceptance of novel food ingredient.

1. Novel Food Ingredients Management Regulations

China implements a review and approval system for novel food ingredients. On December 12, 2017, the General Office of the National Health Commission issued the "Guidelines for the Approval of Novel Food Ingredient" to guide the application and processing of novel food ingredient approval.

1) Basis of Application

According to Article 37 of the "Food Safety Law of the People's Republic of China": "Using novel food ingredinets to produce food, or to produce novel food additives or novel food-related products, shall submit the safety assessment of related products to the health administration department of the State Council. The department shall organize an examination within 60 days from the date of receipt of the application; for those that meet the food safety requirements, permit and publish; for those that do not meet the food safety requirements, they shall not grant the permit and explain the reasons in writing". Article 93: "import of foods produced by novel food ingredients or imported novel food additives or novel food-related products shall be handled in accordance with Article 37 of this Law."

2) Label identification

Article 19 of the "Administrative Measures for the Safety Review of Novel Food Ingredients" stipulates: "If the food contains novel food ingredients, the product label and identification shall comply with national laws, regulations, food safety standards and the requirements of the National Health and Family Planning Commission."

Therefore, when the pre-packaged food contains novel food ingredients that have been announced, and the announcement clearly requires to mark the consumption amount and unsuitable people in the label and instructions, it should be labeled, for example, in the announcement of "about the Approval of Ginseng (Artificial Planting) as a Novel Food ingredients”, it clearly stipulates that pregnant women, breastfeeding women and children under the age of 14 are not suitable for consumption. The labels and instructions should indicate the unsuitable population and the consumption limit. In addition, If there are requirements for consumption and unsuitable people in the announcement, but not required to indicate in the label or instruction, the food manufacturer can choose whether to indicate it or not.

2. Application for novel food ingredients

1) Application materials

The "Guidelines for the Approval Service of Novel Food Ingredients" stipulate that: the application materials for novel food ingredients should include the following content:

a. Application form;

b. Research report on novel food ingredient;

c. Safety assessment report;

d. Production process;

e. Relevant standards implemented (including safety requirements, quality specifications, inspection methods, etc.);

f. Labels and instructions;

g. Research and utilization in domestic and overseas and relevant safety assessment materials;

h. Declaration power of attorney (provided when agent declares);

i. Other materials helpful for review.

A sample of the smallest unopened package or 30 grams of raw materials should also be attached.

To apply for the import of novel food ingredients, in addition to the above-mentioned materials, the following materials should also be submitted:

a. Certificate materials issued by the relevant departments or institutions of the country (region) of importing novel food ingredients to allow the product to be produced or sold in the country (region);

b. Certification materials for the review or certification of the production enterprise issued by the relevant agency or organization of the country (region) where the imported new food raw material production enterprise is located.

2) Circumstances not approved

Under any of the following circumstances, approval shall not be granted:

a. Does not have the characteristics of food ingredients;

b. Those that have been listed in the “National Food Safety Standard, Standards for the Use of Food Additives" (GB2760) and "Standards for the Use of Food Nutrition Fortifier" (GB14880);

c. The National Health and Family Planning Commission has made a decision not to grant an administrative license;

d. Other non-compliance with relevant laws, regulations and novel food ingredient management requirements.

3) Substantive equivalent

The "Administrative Measures for the Safety Review of Novel Food Ingredient" stipulate: Substantive equivalent means that if a newly declared food ingredient is identical to the food or an already announced novel food ingredient in terms of species, source, biological characteristics, main ingredients, edible parts, the amount of use, the scope of use, and the application population are the same, and the technology and quality requirements used are basically the same. It can be considered that they are equally safe and substantive equivalent. When applying for novel food ingredients, if they are substantive equivalent to the food or the announced novel food ingredient, a decision shall be made to terminate the review and the applicant shall be notified in writing. The ingredient can be use legally.

3. Summary

The novel food ingredients have extremely strict and complicated application requirements and review procedures. It takes a long time from acceptance to final approval. This is due to the nature of the ingredients, use history, safety evaluation and other factors. Therefore, enterprises should make full preparations when applying for novel food ingredients to ensure the smooth progress of all aspects of the application.

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Business Division of Food Safety and Regulatory Compliance of Global Foodmate provides food standards & regulations research, labelling compliance consulting/Chinese label design, industry public opinion monitoring and analysis, registration services (of Infant formula, FSMP, Health food, Novel Food Ingredients, Novel Food Additives, New Varieties of Food-Related Products and Overseas manufacturers of imported food) and other comprehensive food safety solutions for domestic and overseas enterprises and institutions in food industry.

Please feel free to contact us: +86 10 68869850, E-mail: global_info@foodmate.net