New rules regarding food contact materials in China

In China, the food safety law is the law governing all foods and food-related products. ‘GB’ means Chinese national standard, which are the first two letters of the Chinese words. The food contact material regulatory framework (see the graphic above) includes general standards, product standards, testing standards, and manufacturing standards. We can determine the legal requirements for the product in China by reference to the specific regulation.

General Standards – GB 9685-2016 Use of Additives

To determine if the additives used in the product are compliant, it is necessary to reference GB 9685-2016, which is the practical standard for additives for food contact materials and products.

The definition of additives shown in GB 9685-2016 is, “in the process of food contact materials and product production, to meet the expected use added or added substance to help improve the quality or characteristics”. This also includes in the processing of the product, the addition of raw materials to improve the production process, rather than to improve the quality of the final product. The modification and highlights in GB 9685 are listed as follows:

• 1294 approved food contact additives
• lists the approved additives separately in table A1 to table A7
• additive categories, application scope, maximum permitted level, specific migration limit or maximum residue limit, total specific migration limit and other restrictions
• the special restrictions of metallic elements
• other allowable substances

Four Steps to Comply with the Chinese Regulations

For food contact additives, resins, and the manufacture of finished products, CIRS suggests adhering to the following four steps to comply with the Chinese requirements.

Step 1: Check the positive list

• Approved food contact additives listed in GB 9685-2016,
• Approved resins in different products standards,
• Approved food additives listed in Table A.2 of GB 2760-2014,
• Continually newly approved food contact additives and resins by NHC,
• 107 resins valid for adhesive and other FCM, invalid for plastic, coating, and rubber.

Step 2: Testing to determine compliance with the Testing Standards shown in the graphic above (A Qualified Laboratory in China)

Step 3: Declaration of compliance document

In order to ensure the transmission of information, Article 8.3 and 8.4 of GB 4806.1-2016 stipulates the requirements for the transmission of conformance statements of food contact materials and products. A Declaration of Compliance should be provided to downstream users to demonstrate that the product conforms with regulatory requirements.

Step 4: Label or instructions preparation

Using rubber products as an example, the first step is to check if the additives and resins used in this product are in the positive List and check if the use of the additives and resins are compliant with the restrictions (including application scope and permitted use level). The dosage limit and the restrictive requirement will also be checked.

After confirming that all resins and additives are included in the positive list, the second step is testing, the quality of the finished product shall also be confirmed compliant.

For this rubber product, the tests have three parts.

• Sensory index tests (include a sensory test and an immersed solution test),
• The regular physicochemical index tests.
• The analysis of additive SML requirements.

If constituent resins and additives are all included in the positive list, and the product meets the restriction requirements, the next step is issuing the Declaration of Compliance document. The regulatory compliance analysis results and test results will be included as supporting documentation.
The last step for this food contact finished product is preparing the label and instructions. According to GB 4806.1 General Safety Requirements the label must include the product name, material, name/address/contact information of manufacturer and/or distributor, production date, shelf life, instructions, food contact use.

Key Points and Advice from CIRS

According to CIRS’s experiences, companies need to first determine which standards the additives or finished products must comply with, then keep tracking the updates of these standards. The declaration of compliance must be updated if the related regulation/standards, substances/components are changed. Additionally, the product must be tested in a qualified lab in China. Finally, you must determine who will make the required declaration. The declarant can be the manufacturer, importer, Industry organisation, consulting firm, and law firm.