NFRM registration is a major concern for domestic food manufacturers, importers and overseas food exporters that want to sell their products in China. Foods with any food ingredients that are deemed as NFRM are not permitted to enter the Chinese market without prior to approval. A large number of goods fail to pass CIQ inspection due to the presence of NFRM every year. However, the problem can be easily avoided if traders use a experienced and trustful third party regulatory compliance agency or have a good understanding of Chinese regulations. Wang Yongfang, an official from NHFPC, presented a whole picture of NFRM regulations to the audience in attendance at China Food & FCM Regulatory Summit (see CL Food News on 20 Oct).
The evolution of NFRM regulations
According to Wang’s speech, the management of NFRMs can be traced back to 1983, the year China’s government started requiring registration. Before 2009, NFRM was called new food resource (see below):
Administrative change:
The timeline below shows management of NFRM shifting from the registration of final products to single raw materials.
Existing main regulations
Name | Document No. | Issuing date | Effective date |
Administrative Measures for Safety Examination of New Food Raw Materials | NHFPC Order No.1-2013 | 31 May 2013 | 1 Oct 2013 |
Provisions on Application and Acceptance of New Food Raw Materials | NHFPC Notice No.23-2013 | 12 Nov 2013 | 12 Nov 2013 |
NHFPC Notice No.23-2013 | 12 Nov 2013 | 12 Nov 2013 | |
CFSA | 28 Feb 2014 | 28 Feb 2014 | |
Administrative Measures for Expert Database of Registration of Food-related Products | NHFPC Notice No.24-2014 | 12 Mar 2014 | 12 Mar 2014 |
Competent authority and other parties involved
The NHFPC: final technical review and announcement of approval;
The Health Supervision Center under NHFPC: application acceptance and technical review of safety evaluation dossiers
The Risk Assessment Institutions: testing, risk assessment, issuance of reports
The NHFPC Notice No.23-2013 requires applicants to submit “safety evaluation opinions” which must be issued by accredited RA institutions however the NHFPC has never clarified how many institutes can undertake risk assessment of NFRM. At the food summit, Wang said that NHFPC is evaluating candidate testing institutes and will release the list of RA institutes in the future.
Criteria for determining NFRM
Generally, materials that are not traditionally consumed, derived or separated from animals, plants and microorganisms as well as newly developed substances in China will be regarded as a NFWM. Wang further explained criteria of traditional consumption habit of foods:
Having edible history over 30 years; and
Not included in the pharmacopoeia of the People’s Republic of China; and
Produced and sold in stereotyped or non-stereotyped packages.
On-line registration of NFRM
To streamline the application of a NFRM, NHFPC developed an on-line registration system (online registration system):
No IP Protection for approved NFRM
Food industry enterprises questioned Wang during the seminar as to why anyone can use a NFRM freely once approved and whether or not the regulator is planning to implement any protection. Initial applicants invest extensive time and finances to gain the NFRM approval, however under the current policy there is no protection safeguarding this investment. Wang outlined that the government wishes to avoid repeated application hasn’t witnessed any obvious negative outcomes from its current policy.