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Japan Approved Positive List System for Plastic Food Contact Materials

On 28 April 2020, the Ministry of Health, Labour and Welfare (MHLW) of Japan has published several notices to implement the new positive list system for the constituents of plastic food contact articles and packaging, effective from 1 June 2020. Here are the major changes to the food contact plastic requirements:

A. Establishing positive list system on permitted substances for manufacturing plastic food contact materials

Plastic food contact articles and packaging shall only be made of substances authorized by the Ministry. These authorized substances are grouped into 4 tables:

Table 1(1):

List of allowed substances for manufacturing food contact base polymers (substrate), with suitable food types, maximum food contact temperature and other conditions

Table 1(2):

List of allowed substances for manufacturing food contact coatings, with suitable food types, maximum food contact temperature and other conditions

Table 1(3):

List of allowed monomers used for polymerization of base polymers

Table 2

List of allowed additives with limits and conditions


Note

  1. The relevant provisions shall be added to Section 3(A)(8) of the Specifications and Standards for Foods, Food Additives, etc. (MHLW Notice No. 370 of 1959, as amended).
  2. At least 98 % of the base polymer components shall be made up of materials listed in Table 1(1) and (2), and the remaining components shall be those listed in Table 1(3).
  3. Colorants of plastic food contact materials are not regulated by the positive list system. The permitted colorants shall be specified in separate provisions.
B. Unlisted substances and their general migration limit
Substances that are not in the positive lists can only be used in materials that are not in direct contact with food. Each of these substances shall not migrate into food at concentration exceeding 0.01 mg/kg.

C. Removing redundant provisions
Some parts of the Specifications and Standards for Foods, Food Additives, etc. shall be repealed:
1. Section 3(A)(7) regarding plastic food contact materials intended for fatty foods, in particular:
  1. Prohibition of polyvinyl chloride (PVC) as constituent
  2. Prohibition of resins containing bis(2-ethylhexyl) phthalate, unless bis(2-ethylhexyl) phthalate is not leached and contact with food
2. Manufacturing specification in Section 3(F)(5) regarding prohibition of using polylactic acid with D-lactic acid content exceeding 6 % for manufacturing food contact articles intended for use at a temperature higher than 40°C

D. Transitional provisions
1. Plastic food contact articles and packaging that are placed on the market, manufactured, imported or used in business before 1 June 2020 can be consumed until stock exhaustion.
2. From 1 June 2020, plastic food contact articles and packaging can be manufactured or imported according to the previous provisions until 31 May 2025.
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