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FCM Regulations in East-Asia: China, Japan and South Korea
This module will look at Chinese regulations that directly impact FCMs and food contact articles. In China national standards are prefixed GB. Before taking a deep dive into the regulations, the webinar will look at how China, under the general safety standard GB 4806.1-2016 defines FCMs.
This will be followed by an overview of all China’s GB standards affecting FCMs. Among the topics to be discussed will be the draft standard on food contact adhesives – and the current regulatory status of FCM substances such as bisphenol A (BPA) and per- and polyfluoroalkyl substances (PFASs), as well as the newly approved food contact additives added to standard GB 9685-2016.
Examples of food contact additives that the Chinese authorities have already approved will be given as well.
The session will also examine the updated Japanese regulation on food safety as it impacts FCMs and food contact articles. Before taking a deep dive into the regulation, the session will look at how Japan, under its new Food Safety Law, defines FCMs.
This will be followed by several key aspects from the updated Japanese Food Safety Law affecting FCMs. Among the topics to be discussed will be already listed FCM-substances allowed in the manufacturing of utensils, containers and packaging (UCPs) of foods in Japan. Details on the newly established rules by the Japanese Ministry of Health, Labour and Welfare (MHLW) on UCPs, as of 01 June 2020, will also be discussed. Currently such rules cover base polymers used in the manufacturing of synthetic resins and coatings for food contact, allowed monomers for preparation of base polymers, as well as FCM-substances. They are used in manufacturing of additives and coating agents for food contact applications.
Additionally the course will also look into the standards and specifications for UCPs, updated in May 2020, by the Ministry of Food and Drug Safety (MFDA) of South Korea.
During this module, you will learn about:
Ioan ParaschivRegulatory Affairs Manager FCM and REACH, Knoell, Netherlands
- which Chinese standards apply to the FCMs you are interested in, including plastic resins, plastic articles, small projections on an article, ceramic, glass, paper, paperboard, paints and coatings (or films);
- what is new in the amended Food Sanitation Act in Japan, and its impact on FCMs;
- which food contact additives have already been approved in China by the country's National Health Commission (NHC);
- which FCM-substances have been placed on positive lists in Japan until 31 May 2020, and what the transition period is;
- which standards and specifications for UCPs apply in South Korea;
- what the restrictions are for certain key-listed food contact additives or FCM-substances with respect to their specific migration limits (SMLs);
- how to carry out a worst-case calculation (WCC) in cases of missing experimental or theoretical (modelling) migration data;
- what migration testing conditions are to be applied, with case study examples;
- what the analytical challenges are during the identification of non-intentionally added substances (Nias) that migrate into food under intended conditions of use;
- what the key steps are when considering the risk assessment of FCM-substances migrating into food;
- what petition steps need to be taken to get a new food contact additive listed in China;
- what are the petition steps in Japan are, under the Japan’s MHLW, for listing a new FCM-substance on a positive list;
- how to demonstrate compliance with food contact applications in the above mentioned markets.