On March 28, 2024, Japan’s MHLW newly issued the Notification Requirements for Enterprises Involved in the Manufacturing of Utensils and Packaging. According to Article 57 of the Food Sanitation Act, enterprises are obligated to notify their products before the products are launched. This announcement provides a comprehensive clarification on which types of food packaging enterprises are subject to notification with the government.
Food Sanitation Act Article 57 (1)：
A person who intends to conduct business (excluding businesses prescribed in Article 54, those which have a minor impact on public health and are specified by Cabinet Order, and poultry slaughtering businesses) must notify the relevant prefectural governor in advance of the name and the location of the person's business office and other matters specified by Ministry of Health, Labour and Welfare Order, pursuant to Ministry of Health, Labour and Welfare Order.
As revealed by the announcement, enterprises intending to manufacture food utensils, containers, and packaging that fall under the Positive List are required to submit a notification. In addition, it is essential to consider the following aspects regarding the scope of enterprises involved in the manufacture of all utensils, containers, and packaging:
Facility:
For food manufacturing operators, facilities refer to where activities such as applying coatings on food contact surfaces of utensils or containers take place.
If a company does not have facilities for manufacturing utensils or containers and packaging, no matter the company sells them or not, it cannot be considered as being engaged in the business of manufacturing utensils or containers and packaging.
Engaged in the business of manufacturing utensils or containers and packaging for food or additives:
If an enterprise manufactures products such as hoses for horticultural purposes that are not intended for food or additives, it cannot be considered as being engaged in the business of manufacturing utensils or containers and packaging.
The manufactured product must be the final product:
The business of manufacturing utensils or containers and packaging primarily involves producing products that serve as the final form of utensils or containers before the sealing process takes place. In practice, this refers to manufacturing products that are supplied to food manufacturers and are used for holding food but have not yet been sealed.
Therefore, it is imperative for the manufacturers of such utensils, containers, and packaging materials to comply with the standards and manufacturing control criteria (hereinafter the "food packaging standards"), including the requirements specified in the "Positive List.".
Including cases where manufacturing operations are outsourced to other companies:
It is common for certain manufacturing tasks to be outsourced to other companies. In such cases, the responsibility for compliance with the "food packaging standards" still lies with the entruster. The manufacturing processes carried out by the trustee are considered part of the entruster's manufacturing processes.
It should be noted that if the entruster is a sales business without manufacturing facilities, the individual or entity manufacturing the final products, will be considered engaged in the business of manufacturing utensils, containers, and packaging materials.
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