Novel food

Export procedures

1)      Legal Basis of new food raw material

Companies who plan to use new food raw materials to manufacture food products shall submit the related safety assessment material of the new food raw material to National Health Commission of the People’s Republic of China (former NHFPC).

Food Safety Law of the People‘s Republic of China (2015 version)

 

2)      Applicant

Any entity or individual that intends to engage in production, use or import of a new food raw material.

 

3)      Registration procedure of new food raw material

 


 

4)      Dossier Requirements of new food raw material registration

        Application form

        Research and development report on the new food raw material.

        Safety evaluation report.

        Production techniques

        Relevant implemented standards applied to the material (including safety requirements, quality specifications and inspection measures).

        Label and manual.

        Information on utilization thereof and domestic and international research thereon as well as relevant safety evaluation materials.

        Other materials conducive to evaluation and review.

        In addition, the applicant shall attach one sealed product sample or 30 grams of the raw material.

 

5)      Additional required documents for export new food raw materials

      Supporting documents issued by relevant authority or institution in the exporting country (region) allowing such product to be produced or sold in the exporting country (region).

       Supporting documents for review or certification of the manufacturer issued by relevant institution or organization in the country (region) where the manufacturer is located.

 

6)      Product test scope

        Components analysis report

        Hygiene test report

        Toxicology safety assessment documents

        Microbial resistance test report and toxigenicity test report

        Safety assessment

        Other test (if necessary) (e.g. method verification)

 

 

1.     Duration of new food raw material registration

Main procedures

Estimated Time

Composition analysis tests and Hygiene inspection tests

14 workdays

Toxicity tests

5-10 months

Safety assessment report

Usually within 3 months

Application acceptance

5 workdays

Technical review

60 workdays

Re-evaluation if necessary (supplement dossiers)

1 year

CFSA issues the draft approval for comments

1 month

NHC makes the final approval decision

Within 20 workdays

Total

15-25 months