On 12 Nov, NHFPC (former MOH) published Notice 23 containing two department rules regarding registration and safety examination of new food raw materials. Applicants are now required to submit “safety evaluation opinions” that must be issued by qualified testing institutes for pre-market registration of new food raw materials. The basic procedures of safety evaluation include hazard identification, dose-response assessment, exposure assessment, risk characterization.
2013 has seen NHFPC update the regulatory framework for novel foods in China. In July, a major legislative milestone for this food sector was passed with the issuance of the measures on the new food raw materials (see Chemlinked new on 18 Jul) which replaced and improved on many aspects found in its predecessor. The table below shows a comparison of current and previous regulations for new food raw materials in China.
| New regulations in 2013 | Effective date | Replaced old regulations in 2007 |
| NHFPC Order 1 of 2013 Measures on the Administration of Safety Examination of New Food Raw Materials | 1 Oct 2013 | MOH Order 56 of 2007 Measures on the Administration of New Resource Foods |
| NHFPC Notice 23 of 2013 Provisions on Application and Acceptance of New Food Raw Materials | 12 Nov 2013 | MOH Notice 291 of 2007 Provisions on Application and Acceptance of Hygiene Licensing of New Resource Foods |
| NHFPC Notice 23 of 2013 Safety Examination Procedures for New Food Raw Materials | 12 Nov 2013 | MOH Notice 291 of 2007 Safety Evaluation Procedures for New Resource Foods |
Under the new management system for novel foods, the scope and registration requirements are clearer. More stringent requirements regarding the level of technical information needed to substantiate safety is a major improvement in this new regulation.
The “safety evaluation opinions” mentioned above is a new part of the safety evaluation report and must be issued by certain accredited testing institutes. At present, only China National Center for Food Safety Risk Assessment (CFSA) is qualified. The toxicological, microbial drug resistance and toxin-producing ability testing reports of imported new food raw materials can be issued by overseas GLP-certified labs.
Applicants need to submit dossiers to the National Center for Health Inspection and Supervision (NCHIS) under NHFPC which will organize an expert panel to conduct a technical review within 60 days.
According to an official from CFSA, it is almost impossible for imported new food raw materials that have no history of use in foreign countries to be approved and it is very difficult for those that need lots of toxicological data to be registered. In addition, those claiming to have many biological functions are not recommended for registration. Officials also stated that NHFPC is organizing experts to make a list of new food raw materials that have already been approved to facilitate food companies in determining whether a food raw material is new or existing in China.
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