China NHC New Food Additive Compliance

Definition of New Food Additives in China

In the Chinese regulatory landscape, "New Food Additives" are substances that require specific administrative approval before they can be legally used in food production or imported into the country. The National Health Commission of the People's Republic of China (NHC) is the central authority responsible for the oversight, evaluation, and approval of new food additives and nutritional fortification substances.

According to the NHC, these include:

• Additive varieties that have not yet been listed in the Food Safety National Standard (GB 2760).
• Additive varieties not included in the inventory of approved substances previously announced by the NHC.
• Existing approved food additives that a manufacturer intends to use with an extended application scope or an increased amount of usage.

NHC New Food Additive Registration Requirements

Under the Food Safety Law of the People's Republic of China, any enterprise intending to produce or import a new food additive must submit a comprehensive safety assessment dossier to the National Health Commission (NHC). The NHC performs a rigorous technical review to evaluate the substance's safety and necessity.

• Approval: If the application complies with all safety requirements, the NHC issues a formal license and publicly announces the new additive.
• Disapproval: If the safety criteria are not met, the NHC provides written notice detailing the reasons for disapproval.

Relevant Regulations on New Food Additive Registration

The compliance process is governed by a series of mandatory measures and national standards:

• Measures for the Administration of New Varieties of Food Additives: Outlines the fundamental application and review procedures.
• Provisions on the Declaration and Acceptance of Food Additives: Details the specific documentation and administrative steps for filing.
• GB 2760 (Food Safety National Standard for Uses of Food Additives): The primary reference for all approved additives and their permitted limits.
• Food Safety National Standards for Uses of Nutritional Fortification Substances in Foods: Specific criteria for additives intended to enhance food nutritional value.

Registration and Technical Review Process

The path to securing approval for a new food additive in China is a multi-stage technical journey:

1. Identification and Feasibility Analysis

The process begins with a database search (including EU, US, JP, AUS, and CA standards) to determine if the substance is indeed a "new variety" in China and to assess the likelihood of approval.

2. Dossier Preparation and Submission

Applicants must compile a technical dossier that includes the additive's chemical structure, production process, toxicological safety data, and the specific technical necessity for its use in food.

3. NHC Technical Review and Testing

The NHC expert panel conducts a detailed evaluation. In many cases, test monitoring is required, where specific safety or stability tests are performed at accredited laboratories to verify the data provided in the dossier.

4. Administrative Approval and Announcement

Following a successful technical review and a public consultation period, the NHC grants administrative approval, officially adding the substance to the approved list.

Proregulations' New Food Additive Services

• Regulatory Consultation and Strategy Training
  Providing customized training and consultation on the registration procedure, toxicological requirements, and overall compliance strategies for the Chinese market.
• Identification and Database Search
  Conducting comprehensive searches of the China Database of food additives and international standards to decide whether a substance qualifies as a new food additive.
• Extension of Scope or Volume of Use
  Managing the application process for existing additives that require an extension of their current usage scope or an increase in the maximum permitted levels.
• New Food Additives Registration Management
  Providing end-to-end support for the administrative approval of new varieties, including preliminary evaluations of feasibility, timelines, and costs.
• Dossier Preparation and Test Monitoring
  Compiling all necessary technical documents and coordinating with laboratories for mandatory safety testing and monitoring required by the NHC.
• Communication with Experts and Authorities
  Acting as your technical liaison to handle all correspondence with NHC experts and competent authorities to resolve queries during the review process.

If you need to ensure your food additives meet China's NHC standards or require assistance with extending the scope of an existing additive, please contact us.