[Updated] Japan Approves Amendments to Positive List of Food Contact Materials

Editor's note: This article was originally published on May 31, 2024, and was updated on October 9, 2024, as per the latest developments. The updated contents are marked in red below.

On May 24, 2024, the Ministry of Health, Labour and Welfare (MHLW) of Japan released a proposed amendment for the Specification and Standards for Food, Food Additives, seeking for public comments till June 22. According to the proposal, MHLW plans to update Appended Table 1 - Table 2(Additives) of the positive list of FCM, including changes of the restrictions on the use of 4 substances and the addition of 13 new additives.

On September 27, 2024, Japan officially approved this amendment. The updates will be effective from the date of promulgation. Notably, the 2023 amendment revised by the 2024 amendment will continue to be effective from June 1, 2025.

Background

On June 1, 2020, the revised Food Sanitation Act introduced a Positive List system for synthetic resins used as primary materials in food utensils, containers and packaging. This system prohibits the use of synthetic resin materials by default, and only permits the use of substances deemed safe and explicitly listed in the Positive List .

The specific requirements are outlined in the Appended Table 1 of the Specification and Standards for Food, Food Additives, which establishes new standards for substances contained in synthetic resin raw materials, effective on June 1, 2020. However, considering the received public comments during the system's operation, a 5-year transitional period until May 31, 2025 was set. This allows the continued use of existing substances utilized prior to the new standards' implementation, while continuing to finalize these existing substances in the Positive List.

Recently, additional existing substances have been confirmed to meet certain safety requirements and need to be newly incorporated into the Positive List. Accordingly, a revision to the standards and criteria notification is under formulation, having been approved through deliberations at the Food Sanitation Council's Utensils and Containers and Packaging Subcommittee and the Cabinet Office's Food Safety Commission.

Major revisions

Modification of the use limit by polymer group

The specific details of the modifications are shown in the red parts.

Serial No.	Substance name	Use limit by Polymer Group						Requirements
Serial No.	Substance name	Polymer Group 1	Polymer Group 2	Polymer Group 3	Polymer Group 4	Polymer Group 5 (heat resistant temperature: ≧150℃)	Polymer Group 5 (heat resistant temperature: < 150℃)	Requirements
129	Polymer mainly composed of 2-ethylhexyl acrylate / diethylenetriamine / valerolactone / 2-phenoxyethanol / hexamethylene diisocyanate, ethoxylated and/or propoxylated	5.0	5.0	5.0	5.0	5.0	5.0	・The sum of ethyleneglycol and/or propyleneglycol condensate (EO, PO≥4): Not less than 50% of the polymer components ・Molecular weight (Mw): ≥1,000
143	Ethoxylated and/or propoxylated glycerol	5.0	5.0	15	1.0	15	15	Ethoxylated and/or propoxylated: EO, PO≥4
147	Polymer mainly composed of toluene diisocyanate / butanol / N,N-dimethyl-1,3-propanediamine, ethoxylated and/or propoxylated	0.95	0.40	2.0	－	2.0	2.0	・The sum of ethyleneglycol and/or propyleneglycol condensate (EO, PO≥4): Not less than 50% of the polymer components ・Mw: ≥1,000
698	Dibutyl fumarate	1.6	1.0	1.0	－	1.6	1.0	Including condensate.

Addition of substances

Serial No.	Substance name	Use limit by Polymer Group						Requirements
Serial No.	Substance name	Polymer Group 1	Polymer Group 2	Polymer Group 3	Polymer Group 4	Polymer Group 5 (heat resistant temperature: ≧150℃)	Polymer Group 5 (heat resistant temperature: < 150℃)	Requirements
828	Polymer mainly composed of 2-hydroxyethyl acrylate / butyl acrylate	1.0	1.0	1.0	1.0	1.0	1.0	Mw:<1,000
829	Polymer mainly composed of indene / benzofuran	-	-	30	-	30	30	Mw:<1,000
830	Ester of sulfosuccinic acid with ethoxylated alkyl alcohol, sodium salt	0.50	0.50	0.50	-	0.50	0.50	・Alkyl: C=12-15 and their mixture ・Ethoxylated: EO≥4
831	Polymer mainly composed of epichlorohydrin / bisphenol A	10	10	27	5.0	27	27	Limited to those without a crosslinked structure.
832	Amide of oleic acid with tetraethylenepentaamine	0.50	0.50	0.50	-	0.50	0.50
833	Hydrolyzed N-[3-(trialkoxysilyl)propyl]-ethylenediamine	1.0	-	-	-	1.0	-	Each alkoxy: C=1, 4, and their mixture
834	Polymer mainly composed of xylene / formaldehyde	20	20	10	-	20	20	Mw:<1,000
835	Acetic acid, cobalt salt	-	-	0.10	-	0.10	0.10
836	Polymer mainly composed of vinyl acetate / dicyclopentadiene	-	-	17	-	17	17	Mw:<1,000
837	Polymer mainly composed of dimethyl siloxane / 3-hydroxypropylmethylsiloxane / hydroxymethylsiloxane / methylsilsesquioxane and/or methylhydrosiloxane	10	10	10	10	10	10	・Including those that have been modified by one or more of the following substances: allyl alcohol, acetic acid, butanol, and butanediol. ・Limited to those that have undergone one or more treatments of ethoxylation and/or propoxylation ・3-hydroxypropylmethylsiloxane contains glycidyl ether. ・When the Mw is ≥1,000,the sum of ethyleneglycol and/or propyleneglycol condensate (EO, PO≥4): not less than 50% of the polymer components.
838	(2-ethylhexyl thioglycolate) mono-n-octyltin sulfide	-	-	-	1.0	-	-
839	Bis(nonylphenyl)amine	0.10	0.10	0.10	-	0.10	0.10
840	Sodium N-hydroxyethyl-ethylenediaminetriacetate	0.10	0.10	0.10	-	0.10	0.10