Japan Revises "Outline of Imported Food Prior Confirmation System"

On June 29, 2021, Japan Ministry of Health, Labor and Welfare (MHLW) released an amendment for the Outline of Imported Food Prior Confirmation System (hereinafter referred to as the Outline). The Outline spells out the application scope, the content of the prior confirmation, the application procedures for prior confirmation, the validity period of registration, the import procedures, and some other requirements. The prior confirmation system came into effect on March 29, 1994, and the amendment became effective upon its publication on June 29.

Since June 29, 2021, enterprises exporting food to Japan need to change registered information and complete a new registration according to the newly revised Outline. However, for foods whose registrations are still valid, they can continue to be processed as before during the validity period.

To ensure that the products exported to Japan meet the compliance requirements, stakeholders need to check the product registration number and validity in time, and submit the registration change application to MHLW before the registration expires.

The specific changes to the Outline are as follows:

1. Application Scope

Foods that are exempted from prior confirmation:

Before	After
Agricultural products, animal husbandry products, fishery products, and their simple processed products (products that have undergone simple processing, such as peeled, shredded, grinded, lightly salted, dried, etc.; cut or peeled products; frozen products, etc.) Foods otherwise specified	Agricultural products, animal husbandry products, fishery products, and their simple processed products (products that have undergone simple processing, such as peeled, shredded, grinded, lightly salted, dried, etc.; cut or peeled products; frozen products, etc.) *Foods subject to inspection orders based on Article 26, Paragraphs 2 and 3 of the Food Sanitation Act.*

MHLW details the scope of "Foods otherwise specified" in the new Outline, which stipulates that imported foods subject to inspection orders are not required for prior confirmation.

2. Content of the Prior Confirmation

According to the Outline, the content of prior confirmations are as follows:

Conform to the food standards based on the Food Sanitation Act listed in Attached Table 1;
Conform to the hygiene management standards for facilities, food, etc., listed in Attached Table 2;
Poisonous and harmful foods are not allowed to be sold.

As revealed by the amendment, "Dairy Product Standards (excluding label-related regulations)" required in Attached Table 1 was amended to "Ingredient Standards for Dairy and Dairy Product,". Relevant labeling requirements are also included in the table.

Before the amendment, the contents of "Attached Table 2—Sanitation Management Standards for Facilities, Food, etc.," were relatively brief and broad. But with significant revisions, the contents of each part of the facilities and food sanitation management standards were detailed.

Emphasize that sanitation management shall comply with Codex Alimentarius regulations and HACCP hygiene management standards;
In terms of food manufacturing infrastructure and equipment, cleaning requirements, anti-pollution treatment requirements, drainage capacity, etc., are specified in details;
The equipment requirements for aquatic product manufacturing and liquid egg manufacturing are newly added;
Detailed regulations have been made on the functions of different kinds of food manufacturing equipment;

3. Prior Confirmation Procedures

Before exporting, foreign manufacturers should submit a prior confirmation application to the MHLW through the exporting country's government. Besides, the manufacturer needs to attach the documents listed in Attached Table 4, including the product raw material ingredients, processing technology, use of food additives, sanitation management system, as well as certificates and reports issued by foreign officials.

According to the provisions, the certificate and report issued by foreign officials shall indicate that the product conforms to food specifications and standards and comply with the requirements specified in Appendix 1 of the Outline.

Appendix 1:

Before	After
Distilled liquor and brandy: The methanol content shall not exceed 0.1%.	Alcoholic beverages (distilled liquor such as brandy): The methanol content shall not exceed 1.2mg/ml.
Confection treated with fats and oils: The acid value of fats and oils in the product shall not exceed 5, or the peroxide value shall not exceed 50.	Replaced with the following: Foods and processed products known to contain cyanide naturally, such as flaxseed, apricot seeds, plum seeds, bitter almonds, cassava, cassava leaves, and biwa seeds: Cyanide shall not exceed 10 ppm.
Processed wild grass products (excluding water-boiled products) in Europe (West of the Urals of Turkey and the former Soviet Union: Armenia, Azerbaijan, Belarus, Estonia, Georgia, Moldova, Latvia, Lithuania, Ukraine, and West of the Urals of Kazakhstan and Russia): Cesium 134 and 137 shall not exceed 370 Bq / Kg.	Deleted
Processed jellyfish, caviar: Boron compounds shall not be used.	Deleted

4. Registration Validity Period

The changes of registration information are as follows:

Before	After
When manufacturers propose to change the registration information, they shall submit the change application listed in Attached Table 3 to MHLW through the exporting country's government before the registration expires.	When manufacturers propose to change the registration information, they shall submit the change application listed in Attached Table 3, the documents listed in Attached Table 7* to MHLW through the government of exporting country before the registration expires.

*As revealed by the provision in Attached Table 7, manufacturers who wish to renew the registered food for the first time after June 29, 2021, need to prepare two documents. One is the "Registration Renewal Application Form", the other is the document of facilities and food hygiene management standards made by the person in charge of food hygiene.