Japan Updates the Positive List of Food Contact Materials

On March 6, 2023, the Ministry of Health, Labor and Welfare (MHLW) of Japan released a revised draft of the Positive List of Substances Allowed for Food Contact Utensils, Containers and Packaging. According to the draft, MHLW newly published the 20230306 New Draft of Table 2, which contains the additives for food contact materials included as of March 6, 2023. Besides, MHLW issued 20230306 New Draft of Table 1, containing base materials compiled by March 6, 2023. The details are as follows:

1. Polymer with adsorptive or ion exchange ability (excluding those correspond to Polymer Group 1, 2 and 4)

   In principle, polymers without adsorptive or ion exchange ability are classified in other polymers that are classified in Polymer Group 3. However, when polymers are composed of one or more essential monomers and identified to have adsorption or ion exchange capacity may be classified as 3g. Notably, polymers with heat-resistant temperature over 150℃ are classified as Polymer Group 1.

2. Cross-linked polymer mainly composed of ester bonds

   MHLW expanded the definition of cross-linked polymer. In addition to cross-linking agent, it also includes cross-linked polymer produced by denaturing polymer with one or more essential monomers.

   The new definition:

   Cross-linked polymer produced by denaturing polymer composed of ester bonds of one or more acids (here refers to acids classified in 1i-1xx), or one or more acids and one or more alcohols with one or more essential monomers (acids, alcohols, and cross-linking agent).

3. Polymer used for coating involved chemical reaction during film formation

   Polymers with an unclear final structure that makes them difficult to be classified as Polymer Group 1 to 4 can be classified as Group 5, only when they are used for coating that involves chemical reactions during the coating process. Please note not to confuse them with the former Synthetic Resin Classifications 5.

   To add additives to Polymer Group 5, the use limit is shown in Table 2. For polymers whose heat resistant temperature is over 150℃, the use limit is set as per the maximum value of Polymer Group 1, 2 and 3. For polymers whose heat resistant temperature is below 150℃, the use limit is set as per the maximum value of Polymer Group 2 and 3.

4. Revision of usage limits for some substances

MHLW deleted some substances in Table 2 and modified some substances’ requirements and use limits. Find the details in the table below.