The 5th Food Packaging Forum (FPF) workshop “Scientific challenges in the risk assessment of food contact materials” took place on October 5, 2017, in Zurich, Switzerland. The talk by Marco Zhong from the National Reference Laboratory for Food Contact Materials (NRL-FCM-IQTC), Guangzhou, China, presented the currently ongoing reform of Chinese legislation for food contact materials (FCMs) and discussed the challenges for compliance and enforcement.

Before China embarked on revising its FCM legislation, it had 265 related safety standards with little harmonization among them. For example, some of these standards contained different or even conflicting limitations or restrictions for similar types of FCMs. Moreover, 80% of legislation pieces were implemented in the 1980’s and have not been updated since then. Therefore, discussions on the new FCM legislation for China were started in 2012, resulting in the release of updated regulations by the end of 2016 (FPF reported), coming into force in the course of 2017. All in all, China “aims to establish a uniform and mandatory legislation system covering various FCMs before 2018.”

The new regulation covers two main areas, namely the restriction part and the testing part. The first part includes the framework legislation (GB4806.1-2016 standard on general safety requirements), the positive list for additives (GB9685-2016), the regulation on good manufacturing practices (GMP, GB 31603-2015), and a suite of specific standards for different types of FCMs. The testing part deals with approaches and protocols for screening and migration assessment. While the old system had largely adopted the negative approach and referred mainly to finished products, the new system has adopted the positive list approach and aims to cover the whole supply chain. The updated legislation also introduces a ‘more accurate’ exposure assessment incorporating probabilistic modeling. Empirical migration testing is newly required to be done under severe conditions expected to reflect the intended use, as opposed to the simplified test conditions applied within the old regulatory system.

Having introduced the main aspects of the updated FCM regulation in China, Zhong then turned to discussing the associated challenges. He acknowledged that the schedule to fulfil the requirements of the new legislation is rather tight, with 53 safety standards first published in November 2016, most of them coming into force in April 2017, and the framework legislation becoming effective on October 19, 2017. Further specific challenges outlined by Zhong included the need for authorizing the use of many more additional chemicals. So far, >1,400 additives have been authorized, but this is “not sufficient.” Further, there is a need to define practical test conditions for demonstrating the compliance of functional barriers, and for performing the safety assessment of non-intentionally added substances (NIAS) in an affordable way. Further difficulties concern the “lack of guidance” for labeling products, and difficulties with collecting supply chain information for the declaration of compliance. Specific challenges related to official control and enforcement in a big country like China concern overall harmonization and reproducibility issues. In addition, there are also considerable practical difficulties with enforcing the requirements for testing the substances on the positive list, caused by the lack of suitable analytical methods.

Read more

Marco Zhong (2017). “The reform of Chinese FCM legislations and the challenges for compliance.” (Youtube)

Marco Zhong (2017). “The reform of Chinese FCM legislations and the challenges for compliance.” (pdf)