New Food Raw Material

New food raw material refers to foods that have not been traditionally consumed in China including but notlimited to the following:

(1) Animals, plant and microorganism;               

(2) Ingredients separated from animals, plant and microorganism;

(3) Ingredients with changed structure

(4) Other newly developed food raw materials

Requirements

According to Food Safety Law, for producing food with new raw material or importing food using new raw materials, the manufacturer/importer should submit safety assessment materials of the product to the NHFPC for review. For applications that comply with food safety requirements, a license shall be approved and announced to public. Otherwise, reasons for disapproval will be given in written form.

Administrative department

National Health and Family Planning Commission (NHFPC)

Relevant regulations

· Administrative measures for safety review of new raw materials

· Declaration and acceptance stipulations of new food raw materials

· Safety review procedures of new food raw materials

Penalties

According to Food Safety Law, if producers or importers violate the law by using new food materials in food production or importing food using new raw materials without an approved safety assessment, the illegally gained benefits/foods and the tools, equipment and raw material used for production or trading will be confiscated. A fine between RMB 50,000 to 100,000 will be imposed if the total value of the commodity is less than RMB 10,000, or a fine between 10 and 20 times if the total value of the commodity exceeds RMB 10,000; for severe violation of the law, the business license of food producers and traders will be revoked.

REACH24H service

Free regulatory consultation

Communication via Internet, telephone call or face-to-face

Main content:

1) Procedure of new food raw material registration

2) Toxicological data requirements of registration

3) Customized consultation and training

 Compliance review of new food raw material

Identification of new food raw material

Main content:

1) Database search

Database of existing food raw material

Database of potential new food raw material in China

Database of new food raw material in EU/US/JP/AUS/CA

2) Communication with experts and authorities

 Substantial equivalence

Definition: Substantial equivalence embodies the concept that if a new food or food component is found to be substantially equivalent to an existing food or food component, it can be treated in the same manner with respect to safety

 Purpose:

1) Get application certificate from NHFPC

2) Get confirmation from China authorities for national standard approval

 New food raw material registration

Purpose: get pre-market approval for new food raw material from NHFPC

Main content:

1) Preliminary evaluation: feasibility, timeline and cost

2) Dossier preparation and submission

3) Test monitoring for registration

4) Communication with experts and competent authorities

contact us


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