China New Food Ingredients Registration

      In recent years, companies have become more enthusiastic about applying for new food ingredients. The number of new food ingredients accepted by the National Health Commission is also growing.

      According to Article 37 of the “Food Safety Law of the People’s Republic of China”, when using new food ingredients to produce food, new varieties of food additives or new varieties of food-related products, safety assessment materials for relevant products must be submitted to the health administration department of the State Council. According to Article 93, import of food produced using new food ingredients, new varieties of food additives or new varieties of food-related products shall be handled in accordance with the provisions of Article 37 of this Law.

Definition of New Food Ingredients Registration Application

      According to the “Measures for the Administration of Safety Review of New Food Ingredients”, new food ingredients refer to the following items that have no traditional eating habits in our country：

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 raw materials.

      At the same time, new food ingredients should have the characteristics of food ingredients, meet the required nutritional requirements, be non-toxic and harmless, and not cause any acute, sub-acute, chronic or other potential harm to human health.

Not Included in the Declaration Scope of New Food Ingredients:

1. Without the characteristics of food ingredients;
2. It has been included in the national food safety standards “Standards for the Use of Food Additives” (GB2760) and “Standards for the Use of Food Nutritional Enhancers” (GB14880);
3. Ingredients that the National Health Commission has made a decision not to grant administrative licensing;
4. Others that do not comply with relevant laws, regulations and new food ingredient management requirements.

Regulatory Agency

      New food ingredients need to be reviewed and approved by the health administrative department of the State Council (i.e., the National Health Commission) before they can be used in food production in China. During the review process, the National Food Safety Risk Assessment Center will conduct a technical review.

Applicant of New Food Ingredients Registration Application

• New food ingredient manufacturers at home and abroad;
• Distributors of new food ingredients at home and abroad;
• Companies that use new food ingredients to produce food (health food), etc.

      Applicants for domestically produced/imported new food ingredients are not limited to production companies. Any legally established domestic or overseas company can be an applicant.

Relevant Regulations

• “Food Safety Law of the People’s Republic of China”
• “Measures for the Administration of Safety Review of New Food Ingredients”
• “Regulations on Application and Acceptance of New Food Ingredients”
• “Review Regulations on New Food Ingredients Safety”

Test Items Involved in Registration Application

• Ingredient analysis report: including test results and testing methods of main ingredients and possible harmful ingredients;
• Hygiene inspection report: testing results and methods of 3 batches of representative contaminant and microbial samples;
• Toxicology evaluation report (the toxicology information required to be submitted is different under different circumstances, please contact me for specific evaluation);
• Microbial resistance test report and toxigenic ability test report (only applicable to microbial new food raw materials);
• Safety assessment opinions: Carry out in accordance with the principles and methods of hazard factor identification, hazard characterization, exposure assessment, and hazard characterization.

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Q&A About New Food Ingredients Registration Application

Q1: When declaring new food ingredients, which testing institutions can issue ingredient analysis reports, toxicology reports, and hygiene inspection reports?

A1: The composition analysis report can be issued by a third-party laboratory or self-inspection. The toxicology test report and the hygiene inspection report should be issued by an inspection agency with food inspection qualifications in China. Toxicology test reports of imported new food ingredients can also be issued by foreign laboratories that meet good laboratory practices.

Q2: How to understand “substantial equivalence”?

A2: Substantial equivalence refers to the species, source, biological characteristics, main ingredients, edible parts, usage amount, scope of use and application population of a new food ingredient is nearly same as that of the traditional food, traditional food ingredients or approved new food ingredients. The processes and quality standards used are basically the same, and they can be considered to be equally safe and substantially equivalent.

Q3: Does the enzymatic hydrolyzate obtained from lactolysis need to be declared as a new food ingredient?

A3: If the milk protein is enzymatically hydrolyzed by food enzymes permitted by GB 2760, it will be managed as a normal food and there is no need to declare new food ingredients.