The globalization of food supply and rapid advances in food science and technology have resulted in the introduction of foods or ingredients not previously available in the Chinese Market. Food Ingredients derived from sources not previously used as human foods must be evaluated for safety before consumption as they may contain toxins, contaminants, and anti-nutritional factors. This guidance is intended to assist applicants in preparing for a well-structured application of novel food ingredients in China, covering the scope and definition, required dossiers and tests, regulatory decisions, and applicable regulations.
1. Scope and Definition of Novel Food Ingredients in China
Having regard to the Food Safety Law of the People’s Republic of China, new food ingredients shall gain permission from the National Health Commission of the People’s Republic of China before being applied to food production.
Under the Administrative Measures for the Safety Review of New Food Ingredients, new food ingredients are substances with no history of traditional use, namely:
A. Animal, plants, and microorganisms;
B. Substances isolated from plants, animals, and microorganisms;
C. Food ingredients whose molecular structures have been modified;
D. Other newly innovated food ingredients ;
‘History of traditional use’ here refers to foods that have been produced and distributed as packaged food in provincial jurisdiction for more than 30 years and are included in the Pharmacopoeia of the People’s Republic of China. Additionally, new food ingredients shall have the properties of food ingredients and comply with nutritional requirements. They shall be toxicity-free and impose no acute, subchronic, chronic, or other potential risks to human health.
The following new food ingredients shall not be authorized:
A. Not having the properties of food ingredients;
B. Listed on the Standard for Food Additives (GB2760) and the Standard for Food Nutritional Fortifier (GB14880);
C. Rejected by the National Health Commission of the People’s Republic of China;
D. Non-compliant with other laws, regulations, and provisions on new food ingredients.
2. Application of Novel Food Ingredients in China
2.1 Applicant
Persons or Enterprises intend to produce, distribute or import new food ingredients to/in the territory of China.
2.2Application
It generally takes 2-4 years to obtain authorization from document preparation to official regulatory decision.
2.3 Dossier Required for Application
(1) | Application Form |
(2) | Research and Development Report of New Food Ingredients |
(3) | Safety Assessment Report |
(4) | Production Process |
(5) | Specification (Safety Requirement, Quality Standard, Testing Methods, etc) |
(6) | Label and Instructions |
(7) | Domestic and Foreign Research Report and Relevant Safety Assessment Data |
(8) | Other Materials Conducive to Application |
Notes: 1 intact sample or 30g raw materials shall be submitted with the dossier.
For imported new good ingredients, the following documents shall also be submitted in addition to the documents specified above:
A. Proof issued by the competent authorities of the exporting country(region) that allows the production and distribution of the products
B. Inspection report or authorization of the manufacturers issued by the competent authority of the exporting country (region)
2.4 Testings Required for Application
Dossier | Testing | Requirements |
Research and Development Report - Verification of Identity | Animal and plant: verification of biological source Microorganism: verification of biological source A substance with well-defined structure: verification of Substance | Testing could be conducted by the applicant or assigned to a qualified food testing institute. |
Safety Assessment Report-Compositional Analysis | Testing of key ingredients and possible hazards | Testing could be conducted by the applicant or assigned to a qualified food testing institute. |
Safety Assessment Report-Hygiene Test Report | Testing of contaminants and microorganisms from 3 batches | Testing shall be conducted by a qualified food testing institute with China Metrology Accreditation (CMA). |
Safety Assessment Report- Methodology Justification | Methodology Justification is required if the testing method is newly innovated with no available standard. | Testing could be conducted by the applicant or assigned to a qualified food testing institute. |
Safety Assessment Report- Toxicity Testing Report | Acute oral toxicity test, 3 genetic toxicity tests, 90-day oral toxicity test, teratogenicity test, reproductive toxicity test, chronic toxicity test, carcinogenicity test, and metabolism test (some tests can be exempted based on the global use of the raw materials). A microbial resistance test and a toxin-producing test are required if microorganisms are involved. | Testing shall be conducted by a qualified food testing institute with China Metrology Accreditation (CMA) or Good Laboratory Practice (GLP). |
Safety Assessment Report -Safety Assessment Opinions | Evaluation of the efficacy of the raw material. | The evaluation shall be conducted by a qualified safety assessment institute, e.g. National Food Safety Assessment Center, Provincial Center for Disease Control). |
3. Regulatory Decision
The final regulatory decision made by the competent authorities is authorization, rejection, or cessation, which is specified in the following content.
Authorization
Authorization is granted if the new food ingredients comply with all the regulations and provisions. Table 1 is the data of the authorized organisms from 2010 - 2022. Table 2 is the data of the authorized new food ingredients (except organisms) from 2018 - 2022. The reason why the data of organisms is listed separately is that the online system for the application of organisms was launched in 2010 while that for other new food ingredients was launched in 2018, therefore it might offer a clearer view of the authorization trend in this way.
Table 1 Data of the Authorized Organisms from 2010-2022
Year | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 | Total Number |
Organisms Authorized to be Applied in Food | 22 | 3 | 1 | 1 | 4 | 0 | 5 | 0 | 0 | 1 | 1 | 0 | 0 | 22+16 |
Organisms Authorized to be Applied in Food for Infants and Young Children | / | 6 | 0 | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 3 | 1 | 1 | 6+8 |
Table 2 Data of the Authorized New Food Ingredients (Except Organisms) from 2018-2022
As is demonstrated in Table 2, no approval of new food ingredients was authorized in 2015 and 2016. The possible reason was the issue of the Administrative Measures for the Safety Review of New Food Ingredients. The competent authorities were under upgrades of administration and review procedures. Meanwhile, enterprises needed time to prepare additional materials in accordance with the new regulations. This might explain the spike in 2017. However, the general trend for the authorization of new food ingredients was much lower than the one before the issue of the new regulation. This could contribute to a stricter and more refined administration system that protects the health of consumers.
Cessation
Cessation means the application of the new food ingredients is ceased to be further reviewed. The followings are the reasons for this decision.
A. They are assessed as existing foods or substantially equivalent to existing foods.
B. They are substantially equivalent to the authorized new food ingredients.
C. Other cases for cession.
‘Substantially equivalent’ to existing foods or ingredients refers to the substances submitted by applicants that are substantially equivalent to existing food or ingredients in terms of species, sources, biological traits, composition, anticipated intake, target population, etc. and they undergo basically the same production procedure and quality requirements. Apart from substantially equivalent, there are other cases for the decision of cessation, e.g. falling into the scope of general foods or local specialties. The number of each case is demonstrated in Table 3.
Table 3 The Data of Different Reasons for the Decision of Cessation
The regulatory decision of cessation can be used as substantiation to prove the safety of ingredients in case of substantially equivalent to existing food/ingredients, local specialties, and general foods.
Rejection
Rejection means the application of the new food ingredient is rejected by the technical review committee. The decision will be delivered to the applicant with the following conclusion.
A. Do not have the properties to be used as foods.
B. Do not comply with nutritional requirements.
C. safety can not be assured.
D. Do not comply with food laws, regulations, and provisions in China.
There are several reasons for the rejection collected by ZMUni technical experts for food compliance.
A. The efficacy of the ingredients falls into the scope of the drug.
B. The nutritional efficacy is not adequately substantiated.
C. The ingredients are administrated as drugs in other countries.
D. The ingredients have safety concerns. The result of the toxicity testing indicates that the ingredients have toxicity, e.g. abnormal index occurs in a 90-day feeding experiment. Or it is deemed to have safety risk under the assessment of international institutes or institutes of other countries.
4. Major Laws and Regulations that Apply to the Application of New Food Ingredients in China
* The Food Safety Law (2021)
* The Administrative Measures for the Safety Review of New Food Ingredients (2013)
* The Rules for the Application and Review of New Food Ingredients (2013)
* The Provisions for the Safety Review of New Food Ingredients (2013)
* The Guidance on the Dossier Preparation for the Safety Review of New Food Ingredients (Trial) (2014)
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