Introduction to the regulation of new food raw material

时间(Date) : 2013-11-18 来源(Source) : CIRS 作者(Author) : CIRS

The Administrative Measures for Safety Review of New Food Materials have been issued by National Health and Family Planning Commission, NHFPC, on 31 May 2013. This regulation has come into force on 1 October 2013. Any companies should apply of the certificate for their new food materials prior to making the materials available on the Chinese market.

What is New Food Raw Material?

New food materials refer to the following objects/materials that are not traditionally consumed in China:
1. Animal, plant and microorganisms;
2. Substances derived from animals, plants and microorganisms;
3. Food substances whose structure has changed;
4. Other newly developed food materials.

Regulation on Application Approaches of New Food Material and Regulation on Safety Assessment of New Food Materials have been issued by NHFPC on 15 October 2013 and came into force immediately. These provisions have specified the data requirements, application, safety assessment and On-site examination.

Data Requirements

1. Component analysis report
2. Hygienic test report
3. Toxicity studies reports
4. Resistant microbe and toxin producing ability test report
5. Safety assessment report

The toxicity studies reports and the resistant microbe and toxin producing ability test report could be provided by oversea laboratories with OECD GLP qualification. Other studies should be conducted in China by test laboratories with CMAF qualification.

Toxicity Studies for Various Product Categories

In accordance with the Regulation on application approaches of new food material, the data requirements are different for various product categories of new food material application in China:

Test items		Animal and plant sources			Microorganisms sources
Is that traditionally consumed outside of China?		NO	Yes, only in few countries.	Yes, it has been widely consumed in other countries	NO	Yes, only in few countries.	Yes, it has been widely consumed in other countries
1	Acute oral toxicity test	×	×	×	×	×	×
2	Three genetic toxicity tests	×	×	×	×	×	-
3	Two genetic toxicity tests	-	-	-	-	-	×
4	90 days oral toxicity test	×	×	-	×	×	-
5	28 days oral toxicity test	-	-	×	-	-	-
6	Teratogenicity test	×	×	-	×	-	-
7	Reproductive toxicity test	×	×*	-	×	-	-
8	Chronic toxicity and carcinogenicity tests	×	-	-	-	-	-
9	Metabolic test	×	-	-	-	-	-

*In the case of there being any study reports or reference materials that can prove there is no toxic affect from this new food material, and there is no harmful reaction in long-term edible history from this new food material, the reproductive toxicity test could be exempted for Animal and Plant sources new food material, which has been traditionally consumed in few countries outside of China.

About Us and Contact

Initially set up by China Inspection and Quarantine(CIQ) Bureau in 2007 to provide REACH compliance services to Chinese chemical industry, CIRS has grown to be a leading provider of comprehensive chemical compliance services for companies doing businesses in/with China.

Our services cover new substance notification, registration of the import and export of toxic chemicals, registration of hazardous chemicals, classification and labeling in according to China GHS, Chinese SDS, risk assessment of industrial chemicals, food additives and cosmetic ingredients. We provide one-stop solutions to your regulatory issues in China.We also deliver the most up-to-date regulatory information about chemical control laws in China.

Ms. Cathy Yu, Senior Consultant, Food Safety Regulation, CIRS China
11F Dongguan Building, 288 Qiuyi Road, Binjiang District, Hangzhou, China, 310020
Tel : +86 571 8720 6538 | Fax : +86 571 8720 6533
Email: cathy.yu@cirs-group.com

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