On October 4, 2023, the Ministry of Health, Labour and Welfare (MHLW) of Japan held a meeting of the Food Sanitation Subcommittee, Pharmaceutical Affairs and Food Sanitation Council. During the meeting, the revised positive list for substances allowed in food contact utensils, containers, and packaging was officially announced. Additionally, on October 12, a supplementary list of monomer combinations for base resins was added.
The revision involves the following changes:
Table 1 (Base Materials) revises the substance names from generic names to names based on the characteristics of polymers. It now includes 21 categories of synthetic resin types, which are further classified into 5 material classification groups based on their properties. Additionally, the columns indicating the permitted food types, maximum usage temperature, and remarks are removed from the table.
The following table provides a list of monomer combinations for base resins, categorized into five major groups according to the base polymer.
List of Monomer Combinations for Base Resins | ||
No. | Substances | Material classification groups |
1 | Polymer primarily composed of imide bonds. | 1 |
2 | Polymer primarily composed of ether bonds. | 1 |
3 | Crosslinked polymer primarily composed of ester bonds. | 1 |
4 | Crosslinked polymer of epoxy compounds. | 1 |
5 | Polymer primarily composed of carbonate bonds. | 1 |
6 | Polymer primarily composed of siloxane bonds. | 1 |
7 | Polymer primarily composed of sulfide bonds. | 1 |
8 | Polymer primarily composed of fluorine-substituted ethylene as a main monomer. | 1 |
9 | Polymer primarily composed of formaldehyde as a main monomer. | 1 |
10 | Polymer with ion exchange and/or adsorption capabilities. | 1 or 3 |
11 | Polymer primarily composed of urethane bonds. | 1 or 3 |
12 | Polymer primarily composed of ester bonds. | 1 or 3 |
13 | Polymer primarily composed of alkene as a main monomer. | 2 |
14 | Polymer primarily composed of conjugated diene hydrocarbons as a main monomer. | 2 |
15 | Polymer primarily composed of aromatic hydrocarbons as a main monomer.. | 2 or 3 |
16 | Polymer primarily composed of acrylic acid as a main monomer. | 3 |
17 | Polymer primarily composed of amide bonds (including polymers with aziridine or 2-ethyl-2-oxazoline as a main monomer). | 3 |
18 | Homopolymer of glucose or chemically modified cellulose. | 3 |
19 | Hydrolysis product of a polymer primarily composed of vinyl acetate as a main monomer. | 3 |
20 | Polymer primarily composed of chlorinated ethylene as a main monomer. | 4 |
21 | Polymer for coating applications with chemical reactions during film formation. | 4 or 5 |
The substance in Table 2 (Additives) has been updated, including 827 substances. The list of permitted additives specifies the name of the additives, as well as the dosage limits and specific requirements for the five categories of polymers. For example:
substances | Usage restrictions (%) by material classification | Notices | |||||
Material classification groups 1 | Material classification groups 2 | Material classification groups 3 | Material classification groups 4 | Material classification groups 5 (Limited to polymers with a heat resistance temperature of 150°C or higher.) | Material classification groups 5 (Limited to polymers with a heat resistance temperature of less than 150°C.) | ||
Isobutyl acrylate | 5.0 | 5.0 | 5.0 | － | 5.0 | 5.0 | |
2-Ethylhexyl acrylate | 5.0 | 5.0 | 5.0 | － | 5.0 | 5.0 | |
Polymer primarily composed of acrylic acid and ethylene | － | － | 1.6 | － | 1.6 | 1.6 | Limited to substances with a molecular weight below 1,000. |
Diester of acrylic acid and tripropylene glycol | 0.60 | 0.60 | 0.60 | 0.60 | 0.60 | 0.60 | |
Ester of acrylic acid and propoxylated glycerol | 0.004 | 0.002 | 0.002 | － | 0.004 | 0.002 | • Limited to substances with a minimum of four propylene oxide additions. • Limited to substances with a molecular weight of 1,000 or higher. |
Effective from June 1, 2020, Japan's Positive List has been implemented, allowing a transitional period of 5 years. After May 31, 2025, it is mandatory for manufacturers and sellers of synthetic resins to comply with the requirements. Exporting companies should prioritize their attention to this Positive List and ensure full compliance, avoiding any potential obstacles during customs clearance.
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