On January 10,
2018, National Health and Family Planning Commission of China (NHFPC) issued a
notice to revise 7 regulations, including the Administrative Measures on the Safety Review of New Food Raw Materials,
and the Administrative Measures of New
Food Additives. All the revised regulations have come into force upon
promulgation.
For the two
measures about new food raw materials and new food additives, there are no big
changes on the application requirements. And the main changes relate to the administrative
approvals as follows.
1. Main Changes of Administrative Measures on the Safety Review of New Food Raw Materials
|
Article |
Main changes |
|
Article 5, paragraph 2 |
Modify into “The new food raw material technical review agency under NHFPC is responsible for the technical review, and propose comprehensive conclusions. |
|
After Article 14 |
Add “The comprehensive conclusions from the review agency shall include the results of safety review and social stability risk assessment”. |
|
Article 5, paragraph 2 |
Add “The applicant is forbidden to apply for the new food raw material license within 3 years if the approval license was obtained by illegal behaviors such as cheating or bribing”. |
|
Article |
Main changes |
|
/ |
Modify all “MOH (Ministry of Health)” into “NHFPC” |
|
Article 5, paragraph 2 |
Add “The new food additive technical review agency under NHFPC is responsible for the technical review, and propose comprehensive conclusions.” |
|
Article 10, paragraph 3 |
Remove “If the verification is needed, the test items, test batches and test methods shall be notified to the applicant. The verification shall be conducted by the qualified test agency. If there is no GB standard for the test method, the method shall be verified.” |
|
After Article 11 |
Add “The comprehensive conclusions from the review agency shall include the results of safety and technical necessity review and social stability risk assessment.” |
|
After Article 14 |
Add “If the applicant conceals the situation or provides false materials when apply for the approval, the NHFPC shall not accept or disapprove the application, and give a warning. The applicant is forbidden to apply for the new food additive license within 1 year”. “The applicant is forbidden to apply for the new food additive license within 3 years if the approval license was obtained by illegal behaviors such as cheating or bribing”. |
Reference
