On August 18, 2021, the Japanese Ministry of Health, Labor, and Welfare (MHLW) published a revised version of its positive list of substances allowed for use in food contact materials (FCMs). The regulation applies to utensils, containers, and packaging made of synthetic resins. The MHLW reviewed “all the substances for which opinions have been submitted” from the public consultation period that ran from July to October 2020. The updated positive list contains 425 new substances MHLW confirmed as safe for the use in food contact, along with notes responding to the opinions they received. The positive list is composed of four sub-lists including (i) polymer-plastics with 83 new substances; (ii) polymer-coatings, 192; (iii) polymer-trace monomers, 29; and (iv) additives, 121.
The revised list also includes updates to names, CAS identification numbers, and allowable uses of previously listed substances. Any limitations on the use of each substance such as the type of foods it can come into contact with, maximum temperature, and volume allowed in a polymer mixture, are included in the four sub-lists. The MHLW is not currently “soliciting opinions regarding additional listings and renewal of substance information” but plans to do so in the future. For all polymers and additives not included in the list the migration limit is 0.01 mg/kg food. Producers must prove compliance with this limit either though migration studies with food simulants or by computer modeling (FPF reported).In February 2019, the Ministry released a set of evaluation procedures for opinions on food contact substances that are not on Japan’s positive lists (FPF reported). The list first came into force in June 2020 (FPF reported).
