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How to Prepare A Food Contact Substance Notification for China

By Little Pro on 2017-10-11 Views:  Update:2017-10-12

In China, a new food contact substance (i.e, those not listed in GB 9685) belongs to a new variety of food-related product and requires administrative approval by National Health and Family Planning Commission (NHFPC) before it can be used in food packaging materials and food containers. In this article, we will summarize how to prepare a food contact substance notification for China including administrative procedure, the composition of a technical dossier and toxicological data requirements. [Read more: how to comply with food contact regulations in China].

Procedure of Food Contact Substance Notification for China

An applicant (i.e., manufacturer, supplier, user) of a new food contact substance notification shall firstly submit their application through NHFPC's online application system and then deliver 1 original copy of notification dossier, 4 photocopies, 1 electronic copy (in CD-ROM) and necessary sample to the following address.

Acceptance Centre of NHFPC, No. 1 Xizhimenwai Road, Xicheng District, Beijing City, China, Tel: 010-68791409, Email: zwdt_consult@126.com

NHFPC will provide feedback about whether the dossier is complete within 5 days since all materials have been provided. If the application is complete and accepted, NHFPC will request China National Centre for Food Safety Risk Assessment (CFSA) to conduct technical review and make proposals on whether to approve the notification or not within 60 days. 

Structure of A Technical Dossier

The technical dossier consists of the following parts.

 Section Detailed Requirements
Application Form Information about applicant, substance identity, intended use and other required info.
Physio-chemical Properties
  • Substance identity: chemical name, common name, chemical structure, molecular formula, molecular weight, CAS no.
  • Physio-chemical properties: melting point, boiling point, decomposition temperature, solubility, info about possible decomposition products during production or use, info about possible interactions with food components.
Technical Necessity, Intended Use and Conditions of Use
  • Technical necessity and intended use: intended use, use scope, intended technical effect, max amount and the minimum amount needed to achieve necessary technical effect. 
  • Conditions of use: possible type of food to be in contact with, contact duration and temperature, whether repeated use is expected, surface to volume ration of finished food contact materials.
Manufacturing Process Includes all raw materials used, manufacture process diagram, text description and main technical control parameters.
Quality Specification, Analytical Method and Analytical Report Includes purity, impurities and relevant analytical methods and analytical report.
Toxicology Data Depends on migration level. Please refer to the table below.
Migration Data and Exposure Info Info about food contact substance migration and/or residue level, estimated dietary exposure level and evaluation method. Migration test report must be issued by qualified institutions.
Other Documents Proof that the new food contact substance has been approved  in other jurisdictions (i.e, EU, US, JP), certificate of free sale in the country of origin for imported new food contact substance. 

Tiered Toxicity Data Requirements

The Rules for the Registration and Acceptance of  New Varieties of Food-related Products have set out minimum requirements on toxicological data. The recommended tox data requirements increase with migration levels.

Migration level Toxicity data Remark
<0.01mg/kg
  • Qsar and literature research
 
0.01mg-0.05mg/kg
  • gene mutations in bacteria
  • bone marrow cell micronucleus test
  • in vitro mammalian chromosome aberration or in vitro mammalian cell gene mutation test
 
0.05mg-5.0mg/kg
  • All studies above +
  • 90d oral repeated dose toxicity in rat  
The results of subchronic studies may trigger longer-term or specialized safety tests (e.g., teratogenicity studies, reproductive toxicity studies).
5.0mg-60mg/kg
  • All studies above +
  • Teratogenicity
  • Reproductive toxicity
  • Oral chronic toxicity and carcinogenicity
 
For polymers, the toxicity data of monomers shall be provided. 

Reference

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