1. Background

The Food Sanitation Act (Act No. 233 of 1947 in Japan) is the supreme law for the hygiene and safety of food and food contact material (FCMs) in Japan, establishing basic requirements for the quality and safety of food and FCMs.

On April 30, 2020, the Ministry of Health, Labor and Welfare (MHLW) of Japan established a Positive List (PL) system, which permits the use of substances that have undergone safety assessment in food utensils, containers, and packaging. We will focus on the PL system and compliance approaches to assist companies in product compliance.

2. Definition of Food Contact Material (FCM)

In accordance with Article 4 of the Food Sanitation Act, food contact materials refer to food utensils, containers and packaging (UCP).

“Utensils” mean machines, tableware and other articles which are used for collecting, producing, processing, cooking, storing, transporting, displaying, delivering or consuming food or additives and which come into direct contact with food and additives.
Containers and packaging shall mean articles which contain or wrap food or additives and are offered “as is” when delivering food or additives.

3. Regulations on Food Contact Material

The main regulation for FCMs in Japan are the Food Sanitation Act and the Food Safety Basic Law and the Standards for Foods and Food Additives established by MHLW.

(1) In accordance with Chapter 3 of the Food Sanitation Act: UCP must not contain or have any toxic or harmful substances that may pose a risk to human health, and must not directly or indirectly contact with food additives that could harm human health. Any articles that do not conform to general specifications and specific material specifications are prohibited from being imported, produced, and sold in Japan.

(2) The Standards for Foods and Food Additives specifies the norms and standards for food utensils, containers, and packaging, including the following three categories:

Category	Description
General requirements	General specification requirements for all UCP products; General test methods for all UCP products.
Specific material specifications requirements	Requirements on food utensils, containers, and packaging made be synthetic resin (including 14 types of resins such as PVC, PEC, etc.); Substance content and migration specification for rubber products (excluding baby products); Migration specification for metal can products (excluding those in contact with dry foods).
Specification Requirements for the Final Use of Products	Specifications for containers and packaging for steamed food (excluding canned or bottled foods); Specifications for containers and packaging for soft drinks (excluding juices); Specifications for production equipment for frozen desserts; Specifications for food vending machines (limited to parts that directly contact food) and containers for storing and selling food in vending machines; Specifications for utensils, containers, and packaging for concentrated beverages in vending machines, or specifications for fully automatic beverage cooking machines.

4. Positive List System of Food Contact Materials

Under the Food Sanitation Act, the MHLW formulated a Positive List (PL) system, allowing substances that have undergone a safety assessment to be used in food utensils, containers, and packaging. On April 30, 2020, the MHLW announced the first positive list (PL) of synthetic resin materials, which was implemented on June 1, 2020. Substances sold in Japan before the implementation date were subject to existing substances, while those sold after the implementation date were subject to new substances. Existing substances had a 5-year transition period (ending on May 31, 2025), during which they should be included in the positive list. New substances had no transition period and should be included in the positive list before production or importation. The MHLW reviews substances applied for inclusion in the list and updates the positive list.

On March 6, 2023, Japan released the latest draft of the positive list and requested public comments. The positive list of the new draft consists of Table 1 and Table 2.

Table 1: 98% of the monomers in the polymer should be listed in Table 1

Table 2: List of Polymer Additives. Additives used in polymers should be listed in Table 2

Enterprises can check the following flowchart to make sure whether the substances they use are compliant:

If a substance is subject to existing substances, meaning the substances have been used in Japan before June 1, 2020, but are not listed in the positive list, then the enterprise shall submit an application during the public consultation period to include the substances in the list. The process is as follows:

Existing substance application materials

1. Application form

2. Documentation proving the substance was used before June 1, 2020

If a substance is subject to new substance or substance new uses, meaning the substance used in Japan after June 1, 2020, or the substance was used before June 1, 2020, but a new use is added, an application shall be submitted to relevant authorities before production/importation. After passing the safety assessment review, a notice will be issued to include the substance in the positive list. The process is as follows:

Application materials required by new substance/ substance for new uses
I. Qualitative and quantitative information of substances	a. Substance information
	b. Substance application and conditions
	c. Range of substance application and quantity restrictions
	d. Domestic and international application
	e. International assessment
	f. Other information
II. Migration information	a. Migration experiment data
II. Migration information	b. Cumulative dietary concentration
III. Safety Toxicology Information	a. Genotoxicity
	b. Subchronic toxicity
	c. Reproductive toxicity
	d. Developmental toxicity
	e. Chronic toxicity
	f. Carcinogenicity
	g. ADME
	h. Other (Neurotoxicity, Immunotoxicity, Endocrine activity, Bioaccumulation)

5. Good Manufacturing Practices (GMP) and Obligation of Information Convey

In accordance with Article 50, Paragraph 3 and 4 of the Food Sanitation Act, manufactures of UCP at all stages must comply with the GMP, and are obligated to convey material compliance information to downstream customers. The commonly accepted method is through the transmission of DOC files (Declaration of Conformity), informing downstream customers that their products comply with the positive list.

Information transmission from (synthetic resin) manufacturers under the PL system

Our services

Consultancy and Training for Food Contact Materials in Japan
Compliance for Food Contact Materials in Japan
New Substance Declaration for Food Contact Materials in Japan
Migration Testing for Food Contact Materials in Japan

Related Inventory

Japan-Positive List of Food Contact Materials-Base Materials

Japan-Positive List of Food Contact Materials-Additives