Update on Food contact materials general safety requirements (GB 4806.1) in China
The National Food Safety Standard: General Safety Requirements for Food Contact Materials (FCM) and Articles (GB 4806.1) is a general standard that specifies the basic requirements, limit requirements, compliance principles, test methods, traceability, and product information of FCMs. This standard is applicable to all kinds of FCM.
The current version of this standard is GB 4806.1-2016, and this version is under revision. On April 19th, 2023, the China National Center for Food Safety Risk Assessment (CFSA) published an updated draft of the GB 4806.1 standard. The deadline for public comments on this draft was 15 May 2023. This draft revises definitions, basic requirements, compliance principles, and product information.
Changes in Definitions
Modification of the definition of 'effective barrier layer' (functional Barrier)
GB 4806.1-2016 (old)
A barrier consisting of one or multiple layers of materials in the food contact materials and articles, used to prohibit the substances behind it from migrating into the food, and to ensure that the amount of the unapproved substances migrating into the food will not be more than 0.01 mg/kg. The barrier shall conform to the requirements of 3.1 and 3.2 of this Standard when the food contact materials and articles are in contact with food under the recommended use conditions.
GB 4806.1 draft (New)
A barrier composed of one or multiple layers of materials in the food contact materials and articles, used to prohibit the specific substances on the outside (non-food contact side) of it from migration and ensure that food contact materials and articles meet corresponding safety requirements.
Note: the requirement that ‘the amount of the unapproved substances migrating into the food will not be more than 0.01 mg/kg’ is now located in the compliance principles section.
Definition of ‘Complete Barrier’ added for the first time
GB 4806.1 draft (New)
A barrier composed of one or multiple layers of materials on the outside of food contact materials and articles, used to prevent the migration of all substances on the outside of it (non-food contact side) and ensure that all substances on the outside do not migrate into the food or food simulants.
Basic Requirements
Add requirements of complete barrier
GB 4806.1 draft (New)
Materials and articles outside the complete barrier are not considered food contact materials and articles. Manufacturers of food contact materials and articles must ensure the effectiveness of the complete barrier for the duration of its use.
Compliance principles
Expanded use of raw materials
GB 4806.1 draft (New)
The food raw materials approved for use in China can also be used in the production of food contact materials and articles, and the relevant raw materials shall comply with the corresponding national food safety standards and (or) relevant announcements.
GB 4806.1 draft (New)
Polymer materials such as plastics, rubber, silicone rubber, coatings, adhesives, and inks approved for used in China may be blended and used if there are no chemical reactions.
Limit requirements
Clarifies that for substances with both SML [or SML(T)] and QM requirements1, priority should be to meet the SML requirement
1 QM is the maximum permitted quantity of a type or group of residual substance in a finished material or article. It is usually expressed as mg per kg food contact materials.
GB 4806.1 draft (New)
For the same (group of) substance with SML [or SML(T)] and QM specified at the same time, if such (group of) substances have a corresponding migration test method, the SML [or SML(T)] must be met; if there is no migration test method, compliance may be verified by screening the migration level with the QM or residue level.
Specify the requirements for composite materials, combined materials and coating materials
GB 4806.1-2016 (old)
Composite materials and articles, combined materials and products, and the various types of materials in the coating products should comply with provisions in relevant national food safety standards. When different materials have limits for the same item, the food contact materials and articles as a whole should comply with the weighed sum-up value of the relevant limits. When it is not possible to calculate the weighed sum-up value, the minimum limit of the item should be adopted.
GB 4806.1 draft (New)
Composite materials and articles, combined materials and articles, coating products, and mixed materials and articles specified in 4.1.3 of this Standard should comply with provisions in relevant national food safety standards. The maximum use level, maximum residue level, and residue specifications prescribed in the corresponding national food safety standard and related announcement for each material are only applicable to such material. If various materials are subject to the migration limits for the same item, the food contact material and article as a whole must comply with the minimum limit for this item.
Product information
Improvements of product labeling requirements
The draft states that food contact materials and articles must have labeling. Product labeling must comply with laws and regulations, national food safety standards, and relevant announcements. The product labeling must include the product information, manufacturer information, the code number, and the compliance standard, etc.
Strengthening the management of Declaration of compliance (DoC)
The draft states that manufacturers and distributors shall provide the DoC. The DoC must include the product name, material types, the code number and serial number of the national food safety standards that are being followed, the list of restricted raw material substances and their restrictive requirements.
The list of restricted raw material substances and their restrictive requirements include substances listed in standards and announcements that are subject to the use level, SML, SML(T), QM, etc., together with their restrictive requirements; this also includes the list of substances like NIAS that require further downstream safety assessment and control, together with their restrictive requirements.
When there is any change in the raw materials, ingredients, production process, and other factors that may affect product safety, manufacturers of food contact materials and articles shall update the DoC in a timely manner.
It is important to note that the current draft is not final, and all content is subject to change. knoell will continue to monitor updates to this standard. To ensure that your Food Contact Materials meet China’s regulatory requirements, please contact the knoell FFCM team or find more insights on Food Contact Materials.