Administrative Measures for the Safety Review of New Food Raw Materials

• Area of Law： Health and Sanitation National Security
• Level of Authority： Departmental Rules
• Date issued：12-26-2017
• Effective Date：12-26-2017
• Status： Effective
• Issuing Authority： All Commissions

Administrative Measures for the Safety Review of New Food Raw Materials
(Issued by the Order No. 1 of the National Health and Family Planning Commission on May 31, 2013 and amended according to the Order No. 18 of the National Health and Family Planning Commission, The Decision of the National Health and Family Planning Commission to Amend Seven Departmental Rules Including the Administrative Measures for the Safety Review of New Food Raw Materials on December 26, 2017)
Article 1 In order to regulate the review of materials for safety evaluation of new food raw materials, these Measures are formulated in accordance with relevant provisions of the Food Safety Law of the People's Republic of China and the Regulation on the Implementation of the Food Safety Law.
Article 2 The term “new food raw materials” refers to the following items which are not of traditional eating habits in China:
(1) Animals, plants and microorganisms.
(2) Ingredients extracted from animals, plants and microorganisms.
(3) Food ingredients the original composition of which has been changed.
(4) Other newly developed food raw materials.
Article 3 New food raw materials shall have the quality of food raw materials, satisfy necessary nutritional requirements, be non-toxic and harmless and pose no acute, subacute, chronic or other potential harm to human health.
Article 4 Only upon safety review by the National Health and Family Planning Commission, shall new food raw materials be used in food production and trading.
Article 5 The National Health and Family Planning Commission shall be responsible for the review of materials for safety evaluation of new food raw materials and issuance of license.
The technical review institution for new food raw materials (hereinafter referred to as the “review institution”) under the National Health and Family Planning Commission shall be responsible for conducting the technical review of the safety of new food raw materials and making comprehensive review conclusions and recommendations.
Article 6 Any entity or individual (hereinafter referred to as the “applicant”) that intends to engage in production, use or import of a new food raw material, shall file an application and submit the following materials:
(1) Application form.
(2) Research and development report on the new food raw material.
(3) Safety evaluation report.
(4) Production techniques.
(5) Relevant implemented standards applied to the material (including safety requirements, quality specifications and inspection measures)
(6) Label and manual.
(7) Information on utilization thereof and domestic and international research thereon as well as relevant safety evaluation materials.
(8) Other materials conducive to evaluation and review.
In addition, the applicant shall attach one sealed product sample or 30 grams of the raw material.
Article 7 When applying for import of a new food raw material, in addition to materials prescribed in Article 6, the applicant shall also submit the following materials:
(1) 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).
(2) Supporting documents for review or certification of the manufacturer issued by relevant institution or organization in the country (region) where the manufacturer is located.
Article 8 The applicant shall truthfully submit relevant materials and report true situations. The applicant shall be responsible for authenticity of contents of application materials and otherwise assume legal liability.
Article 9 When submitting materials prescribed in Items 2 through 6 of Paragraph 1 of Article 6 in these Measures, the applicant shall indicate the contents that do not involve trade secrets and may be disclosed to the public.
Article 10 Upon acceptance of applications regarding new food raw materials, the National Health and Family Planning Commission shall openly solicit opinions from the society.
Article 11 Upon acceptance of applications regarding new food raw materials, the Health and Family Planning Commission shall organize experts to review the materials for safety evaluation of new food raw materials and reach conclusions about reviews within 60 days.
Article 12 If supplemental materials are required in the review process, the Health and Family Planning Commission shall notify the applicant in writing in a timely manner and the applicant shall submit relevant supplemental materials as required in a timely manner.
Based on the needs of review work, the Health and Family Planning Commission may require an applicant to answer relevant technical questions on site and the applicant shall be cooperative.
Article 13 If on-site inspections of production techniques are required in the review process, the Health and Family Planning Commission may organize experts to inspect the sites of research, development and production of new food raw materials and present on-site inspection opinions. Experts shall bear responsibility for the on-site inspection opinions that they have presented. Health supervision authorities at the provincial level shall be cooperative.
Experts who have participated in on-site inspections of a product shall not participate in the vote for review of materials for safety evaluation of such product.
Article 14 Specific procedures for the review of materials for safety evaluation of new food raw materials and issuance of licenses shall be implemented in accordance with the provisions of the Administrative License Law, the Measures for Administration of Sanitary Administrative Licenses and relevant laws and regulations.
Article 15 The comprehensive review conclusions made by the review institution shall include safety review results and social stability risk assessment results.
Article 16 Based on conclusions about the safety review of new food raw materials, the National Health and Family Planning Commission shall grant licenses and issue announcements for the new food raw materials that comply with food safety requirements. If any new food raw material fails to comply with food safety requirements, the National Health and Family Planning Commission shall deny the license and explain reasons for denial in writing.
If a new food raw material is substantively equivalent to food or any new food raw material which has been announced, the National Health and Family Planning Commission shall make a decision to terminate review and notify the applicant in writing.
Article 17 Based on different characteristics of new food raw materials, announcements may contain:
(1) names;
(2) sources;
(3) production techniques;
(4) main ingredients;
(5) quality specification requirements;
(6) label and identification requirements; and
(7) other information which needs to be announced.
Article 18 Under any of the following circumstances, the National Health and Family Planning Commission shall organize another review for a new food raw material that has already been announced in a timely manner:
(1) As science and technology develop, there are doubts about the safety of the new food raw material.
(2) Evidence shows that there might be problems with the safety of the new food raw material. Or
(3) Other circumstances under which another review is necessary.
If such review finds that the new food raw material fails to comply with food safety requirements, the National Health and Family Planning Commission may revoke its license.
Article 19 Production entities for new food raw materials shall follow requirements in announcements for new food raw materials in production to ensure that new food raw materials are safe to consume.
Article 20 If any food contains new food raw materials, its product label and identification shall comply with requirements of state laws, regulations and food safety standards as well as announcements by the National Health and Family Planning Commission.
Article 21 If any new food raw material is produced or used without going through a safety evaluation in violation of the provisions of these Measures, punishments shall be imposed according to relevant provisions of the Food Safety Law.
Article 22 If applicants conceal relevant information or provide false materials in applying for licenses for new food raw materials, the National Health and Family Planning Commission shall refuse to accept the applications or deny the licenses. Warnings shall also be issued. And the applicants shall not apply for licenses for the same new food raw materials within a year.
If an applicant passes the safety review of new food raw materials and obtains a license by such improper means as fraud or bribery, the National Health and Family Planning Commission shall revoke its license, and the applicant shall not apply for a license for the same new food raw materials within three years.
Article 23 Meanings of the following terms in these Measures:
For the term “substantively equivalent”, if a certain new food raw material regarding which an application has just been filed and food or a new food raw material which has been announced are equivalent in terms of species, source, biological property, main ingredients, edible parts, usage amount, scope of use, potential consumers and other aspects, and they adopt basically the same techniques and quality requirements, they may be deemed as equally safe and substantively equivalent.
The term “traditional eating habits” means that a certain type of food has been produced or traded as standard-packaged food or non-standard-packaged food in a province for over 30 years and has not been listed in the Pharmacopoeia of the People's Republic of China.
Article 24 The term “new food raw materials” as mentioned in these Measures does not include new varieties of generically modified food, dietary supplements or food additives. New varieties of generically modified food, dietary supplements or food additives shall be governed by relevant state laws and regulations.
Article 25 These Measures shall come into force on October 1, 2013. The Administrative Measures for New Resource Food issued by the former Ministry of Health on December 1, 2007 shall be repealed concurrently.