[Updated] Keeping Pace with Legislative Progress: Discussions on Utensils, Containers, and Packaging in Japan

Editor's Note: This article summarizes the latest legislative progress discussions in Japanese food contact materials regulation, as per the latest developments. Previous contents can be seen at the bottom of the article.

According to the latest meeting discussion process on March 19, 2024, Japan is planning to revise the Positive List, including synthetic resins and their additives.

Synthetic resins

For the management of base resins, the initial list of substances regulated as per polymer form has been continuously integrated and revised. The management approach in the current plan will be updated to a model that classifies substances according to monomer/raw material form.

The discussion outcomes indicate that revisions will be made to the classification descriptions and monomer/raw material requirements for various resin categories listed in Appendix 1 of the synthetic resin list. Furthermore, some substances will be newly added to the list. Here are the specific details:

Additives

The Positive List of additives was updated to include new categories of additives, along with changes in usage restrictions for multiple substances and usage limits within different polymer groups.

Proposed addition of 13 new additives

Serial No.	Substance name
828	Polymer mainly composed of 2-hydroxyethyl acrylate / butyl acrylate
829	Polymer mainly composed of indene / benzofuran
830	Ester of sulfosuccinic acid with ethoxylated alkyl alcohol, sodium salt
831	Polymer mainly composed of epichlorohydrin / bisphenol A
832	Amide of oleic acid with tetraethylenepentaamine
833	Hydrolyzed N-[3-(trialkoxysilyl)propyl]-ethylenediamine
834	Polymer mainly composed of xylene / formaldehyde
835	Acetic acid, cobalt salt
836	Polymer mainly composed of vinyl acetate / dicyclopentadiene
837	Polymer mainly composed of dimethyl siloxane / 3-hydroxypropylmethylsiloxane / hydroxymethylsiloxane / methylsilsesquioxane and/or methylhydrosiloxane
838	(2-ethylhexyl thioglycolate) mono-n-octyltin sulfide
839	Bis(nonylphenyl)amine
840	Sodium N-hydroxyethyl-ethylenediaminetriacetate

Proposed restrictions on one additive

The restriction indicating "It is limited to ethylene oxide and/or propylene oxide adducts with a total of four or more units" for ethoxylated and/or propoxylated glycerol will be removed.

Proposed updates to usage limits of 3 additives in different polymer groups

Serial No.	Substance name	CAS Registry No.	Use limit by Polymer Group
Serial No.	Substance name	CAS Registry No.	Polymer Group 1	Polymer Group 2	Polymer Group 3	Polymer Group 4	Polymer Group 5^a	Polymer Group 5^b
129	polymer mainly composed of 2-ethylhexyl acrylate / diethylenetriamine / valerolactone / 2-phenoxyethanol / hexamethylene diisocyanate, ethoxylated and/or propoxylated	1428963-42-1	3.0 Modified to 5.0	2.0 Modified to 5.0	4.0 Modified to 5.0	－ Modified to 5.0	4.0 Modified to 5.0	4.0 Modified to 5.0
147	polymer mainly composed of toluene diisocyanate / butanol / N,N-dimethyl-1,3-propanediamine, ethoxylated and/or propoxylated	0162568-21-0	0.90 Modified to 0.95	0.30 Modified to 0.40	2.0	－	2.0	2.0
698	dibutyl fumarate	0000105-75-9 0029014-71-9	1.6	1.0	0.50 Modified to 1.0	－	1.6	1.0
a. heat resistant temperature: ≧150℃ b. heat resistant temperature: < 150℃

Feb 15, 2024

On February 15, 2024, the Subcommittee on Utensils, Containers, and Packaging under Japan's Ministry of Health, Labour, and Welfare (MHLW) conducted an online meeting. According to the meeting materials, official adjustments were being proposed for Sections B, C, D, and E of the Ministry of Health Notice No. 370 Specification and Standards for Food, Food Additives, Etc. - Part 3: Utensils and Container Packaging.

Partial Removal of Requirements in Section E:

Strength testing for containers and packaging of high-pressure, high-temperature sterilized foods (excluding canned and bottled foods).
Standards and production method standards for dairy containers, packaging, and their raw materials.
Material restrictions on cups used in cup vending machines selling sterilized lactobacillus beverages, and container used in food vending machines for selling food.

Notably, as a result of this revision, the unnecessary items specified in the testing methods under Section B, C and E that are related to the removal of testing methods and standards will also be removed.

Adjusted Standards Management Structure:

The requirement in Section E stating that reusable glass containers for soft drinks (except for fruit juices used as raw materials) must be transparent after recycling will be moved to Section D for management.
The requirements from Standards for Containers, Packaging, and Raw Materials for Dairy Products regarding the use of colorless and transparent glass bottles with an inner diameter of 26mm or more for packaging milk, specialty milk, sterilized goat milk, modified milk, low-fat milk, skimmed milk, processed milk, and cream, as well as the requirement to use transparent glass bottles for formulated liquid milk, fermented milk, lactobacillus beverages, and milk beverages, will be moved to Section D.
The requirements from Standards for Containers, Packaging, and Raw Materials for Dairy Products regarding the reagents used in the leaching test will be modified and moved to Section B.

Introduction of Total Leachables Requirement:

In Section D, the general requirements for "2. Synthetic Resins" will be modified, proposing to replace the potassium permanganate consumption test with a total leachables test. The test procedures and reagents for the total leachables test will be introduced in Sections B and C, respectively.

In addition, for specific testing items, specifications for the potassium permanganate consumption test and specifications for the residue on evaporation test have been established for individual synthetic resin containers and packaging.

Revision of Reagents and Food Simulants for Leaching Tests

The reagents specified in Section D of the leaching tests for synthetic resins and the reagents for determining bisphenol A (including phenol and p-tert-butylphenol) in polycarbonate synthetic resins will be revised.

In Section B, the provisions for food simulants in the test solutions of total leachables will be revised. The specific types of simulants can be referred to in the following table:

Food		Food simulants
Oils, fatty foods, and creams		Heptane
Alcoholic beverages, milk, specialty milk, sterilized goat milk, modified milk, low-fat milk, skimmed milk, processed milk, cream, formulated liquid milk, fermented milk, lactobacillus beverages, milk beverages, and powdered milk preparations (hereinafter referred to as "Alcoholic Beverages, etc." in this table).		20% Ethanol
Foods other than oils, fatty foods, creams, and "Alcoholic Beverages, etc.".	Acidic Foods (Foods with a pH of 4.6 or below in the food or on the food surface.)	4% Acetic Acid
	Foods other than those mentioned above	Water

Revision of Test Methods and Their Locations

The methods of analysis by instrument, under Section D, will be presented in the form of separate notifications. Furthermore, these related methods and reagents will be removed from the existing standards. The remaining test methods will be consolidated and managed under Section B.