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NHFPC Outlines China’s New Food Raw Materials Management

1. China uses a pre-market registration system for New Food Raw Materials. 2. Overseas foods containing NFRMs cannot enter the Chinese market before the new ingredients are approved by China NHFPC. 3. There is no protection period for applicants of new FRMs, which can be used by everyone upon approval.

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

Review Procedures for Safety of New Food Raw Materials

NHFPC Notice No.23-2013 12 Nov 2013 12 Nov 2013

Guideline for Application Materials for Safety Assessment

Opinions of New Food Raw Materials (Trial)

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

  1. The NHFPC: final technical review and announcement of approval;

  2. The Health Supervision Center under NHFPC: application acceptance and technical review of safety evaluation dossiers

  3. 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:

  1. Having edible history over 30 years; and

  2. Not included in the pharmacopoeia of the People’s Republic of China; and

  3. 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.

For more comprehensive NFRM regulation, please see our encyclopedia-like articles on New Food Raw Materials in China.

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