New food contact substance notification

1. Background

In accordance to Food Safety Law, companies who plan to use new substances (including new food contact resins and new food contact additives) in food contact materials or products on Chinese market must apply for and obtain a hygiene license from Health Administrative Department of the State Council- the National Health and Family Planning Commission of the People's Republic of China (NHFPC).To meet the demand of industry, to ensure the safety of new food contact material, and to standardize new food contact material application procedure, NHFPC has drawn up the ‘Administrative Permission Regulation for New Food Related Products’ which specifically stipulated the concept, application, acceptance, administration permission of new food related products.

2. Our services

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.

Depending on rich chemical registration experience and technique, CIRS has good relationship with the authority to customize the notification plan for new food related products.To promote the core competitiveness of enterprise,CIRS also provides one-stop solutions for food related product regulatory issues in China.

1.      Regulation consulting service, technical support

2.      Invite relevant experts to analysis the product notification feasibility

3.      Compile the notification dossier

4.      Foreign documents translation, correction and notarization

5.      Arrange tests and follow up communication in Chinese lab

6.      Notification dossier assessment, examination, integration and submission.

7.      Project progress tracking, and report the important progress in time 

8.      Attend the expert appraisal conferences and assist enterprise to answer the technical problems

9.      Correct and improve the notification documents according to the appraisal committee suggestions

3. Notification dossier

3.1 Required documents

Document name

Required documents

Application form

Substance name, category, applicant’s information (name, address, telephone, etc.), list of attached dossier, etc.

physicochemical property

Basic information (chemical name, common name, chemical construction, molecular formula, molecular weight, CAS number, etc.), melting point, boiling point, decomposition temperature, solubleness, chemical equations for potential side reactions occurred during manufacture or reaction with food,etc.

Technical necessity&Use condition

1.Intended use, intended technical effect,application range, maximum dosage, minimum dosage for intended technical effect.

2. Use conditionintended contact food category(Water-based foodoil foodacid foodalcohol food)contact time and temperature, the contact area/volume ratio of the contact material and food, etc.

Manufacturing technique

Raw material and accessory material, process flow diagram, technical parameters for each technical process, etc.

Qualification specification requirements

Qualification specification, test method, and test results (purity, impurity, etc.).

Toxicology safety assessment documents

1. Apply for new food contact material and food contact material additive shall provide toxicology safety assessment documents according to volume of migration.

2. Apply for the new ingredient of food use detergent and disinfectant shall provide toxicology safety assessment documents according to the food toxicology assessment analysis process and method (GB/T15193).

3. The toxicology assessment document shall be issued by GLP (good laboratory practice) laboratory.

Migration Testing & Analytical Methods&Consumer exposure

1. Provide the migration date information, testing method and testing report, according to the product use intention and use condition.

2. Residual quantity date information, testing method and testing report.

3. Consumer exposure and the assessment method information.

4. The testing report shall be issued by qualified laboratory

Documentary evidence  for domestic and overseas approval

Approved documents which were issued by aboard governmental agencies, Industry Association or international organization.

Other helpful documents

For exampleProducing or sale certificate issued by relevant agency or organization in the exporting country of origin.

3.2 Required toxicology test item

Migration quantity mg/kg

Required toxicology test items

Structure-activity analysis and literature data

Three mutagenicity test

90d Oral sub-chronic toxicity study

Reproductive toxicity

Chronic toxicity and

carcinogenicity

≤0.01

P

-

-

-

-

0.01 -0.05

P

P

-

-

-

0.05-5.0

P

P

P

-

-

5.0-60

P

P

P

P

P

High-molecular polymer b

P

-

-

-

-

a. The three mutagenicity tests include: Ames test, Bone marrow cell micronucleus test and vitro mammalian cell chromosome aberration test.

b. For the high-molecular polymer(average molecular weight above 1000 Dalton) shall provide each monomer toxicology safety assessment documents.

4. Service procedure


5. Work process of administrative approval

NHFPC: The National Health and Family Planning Commission

CFSA: China National Center for Food Safety Risk Assessment