Supported by FIAC, the first ChemLinked (Food) workshop was held in Shanghai on Jul. 12, 2018. 3 speakers from REACH24H, Yilia Ye, Maxwell Heston, and Lily Lee, delivered keynote speeches on food ingredient requirements as well as food contact material regulation.
Ticklist when assessing ingredient/product compliance
Check if there is a corresponding product standard
Check if there is an approval announcement
Check if ingredient is included in permitted list such as “Substances Used as Both Food and Traditional Chinese Medicine”, “Bacterial Cultures that Can Be Used in Foods or Baby food in China”
foods with a history of consumption in China
Some Points to Note:
Raw materials that can only be used in health food or drug and non-common food raw materials are prohibited to be added in common food.
Regarding food additives, GB 2760 lists those permitted substances and their usage requirements.
If there is no regulation or announcement approving the use of a food ingredient, then the enterprise needs to apply for new food ingredient registration in China for the market access.
Food ingredient applied in special food
Maxwell Heston, regulatory compliance consultant from REACH24H Consulting Group, introduced the regulations of food ingredients used in infant formula, health food and food for special medical purposes. Only milk sourced from cow or goat can be used in the production of infant formula, and the food additives applied shall be compliant with GB 2760, for example, food flavoring is prohibited in infant formula of stage 1, while it is permitted in that of stage 2 and 3.
In terms of health food with functional claim, raw materials included in following lists are permitted:
General food ingredients, food additives, positive list of animal and plant materials in Chinese Pharmacopoeia
New food ingredients;
Substances traditionally used as both food and Chinese medicine (87 items);
Raw materials applied in nutritional supplements shall refer to Health Food Raw Materials Directory (1st Batch). For developing new FSMP products, selection of the simplest ingredients possible should be the guiding principle. Use of this principle simplifies regulatory compliance and also tends to reduce the risks associated with adverse outcomes in consumers.
FCM regulations and compliance challenge
In 2016, the former NHFPC unveiled 53 GB standards related to food contact materials, formulating a new FCM regulatory framework. This system is still being optimized, during the conference our expert Lily Lee revealed that the FCM ink standard is under preparation, and the draft of the adhesive standard is also pending.
Based on the sampling data of 2017 and sampling plan of 2018, plastic, paper, metal and glass products are the focuses of the national sampling inspection, and the latter two are new inspection targets in 2018. SMEs are mainly targeted for monitoring and in 2017 it accounted for nearly 80% of all inspections.
In the end, Lily Lee put forward 3 key points to overcome China’s compliance challenge under the new regulation system, which are:
New substance registration
Good Manufacturing Practice (GMP)
Please click here to download the workshop materials.