On 28 April 2020, Japan’s Ministry of Health, Labour and Welfare (MHLW) published the MHLW Notification No. 196 of 2020, amending the MHLW Notification No. 370 of 1959. The major change is the inclusion of a positive list (i.e., only listed substances can be used for materials in contact with food). This move has been made with the intention to shift to a more up-to-date and recognized compliance system in relation to other food contact material regulations around the globe. This amendment officially entered into force on 1 June 2020. To support enterprises in complying with the new positive list requirement, TÜV Rheinland has launched the Food Contact Material (FCM) Ingredient Check.
The TÜV Rheinland FCM Ingredient Check is part of its FCM Regulatory and Compliance services. Each FCM ingredient is evaluated according to the national standard corresponding to the FCM provided by the customer to determine whether it meets the requirements of the positive list. Areas impacted by the Japan positive list include food contact products and materials. Impacted products include apparatus — tableware, kitchen utensils, and other machines, implements, and other articles which are used for collecting, producing, processing, cooking, storing, transporting, displaying, delivering, or consuming food or additives and which come into direct contact with food or additives and containers and packaging — and articles which contain or wrap food or additives and are offered “as is” when delivering food or food additives. Impacted materials include base polymers, minor monomers, additives, coating agents, etc. Enterprises need to test their FCM according to the MHLW Notification No. 370 of 1959, to verify component compliance. If a chemical substance is not included in the positive list, the enterprise can evaluate and prepare relevant technical documents as required to submit an application to the MHLW.
Since the new positive list is merely a supplement to the current food contact regulations, the current compliance requirements in Japan are still valid. Therefore, the test requirements of the MHLW Notification No. 370 of 1959 still apply, and TÜV Rheinland Hong Kong as an MHLW-approved testing laboratory may conduct tests in accordance with the requirements of Part 3: Food Contact Appliances, Containers, and Packaging of the MHLW Notification No. 370 of 1959, “Specifications and Standards for Food and Food Additives.” With its rich experience and expert network, in addition to providing food contact materials, TÜV Rheinland can provide customers with declaration of conformity (DoC) management, compliance opinion evaluation, new substance notification, and other food contact materials (FCM) supervision and compliance services. TÜV Rheinland can also help with information collection and independent evaluation of the entire customer supply chain, and can provide GMP audits and training services to enable customers to meet the new requirements of the new Japanese Food Hygiene Law.
Japan’s food contact material regulations have undergone tremendous changes, which will affect manufacturers and importers who use food contact raw materials, semi-finished products, or finished products on the Japanese market. The regulations establish a five-year transition period in order to enable regulation compliance for products already on the market. TÜV Rheinland is a trusted partner of enterprises, helping companies design compliance routes in accordance with actual circumstances and conduct tests according to Japanese food contact material compliance requirements.