Request a DemoOn June 13, 2018, Japan introduced the Food Contact Materials Positive List System, which only allows substances that have been evaluated as safe to be used in food utensils, containers, and packaging. This system went into effect on June 1, 2020, with a transitional period of 5 years. Enterprises must achieve full compliance by June 1, 2025.
1. Definition & classification
In Article 4 of the Food Sanitation Act, it is defined as follows:
Utensils
It refers to tableware, kitchen utensils, as well as other machines, equipment, and objects used for collecting, producing, processing, cooking, storing, transporting, displaying, delivering, or consuming food or additives, which come into direct contact with food or additives. However, it does not include machines, equipment, and other objects used for harvesting food in agriculture and fishery activities.
For example: cups, bowls, chopsticks, spoons, knives, cutting boards, production machinery, and transportation equipment.
It refers to objects that contain or wrap food or additives and are presented "as is" when delivering food or additives.
For example: boxes, bags, and wrapping paper.
2. Competent Authority
In Japan, the primary authorities responsible for regulating food contact materials were the Food Safety Commission of Japan (FSCJ) and the Ministry of Health, Labour and Welfare (MHLW). However, since April 1, 2024, the administration of food sanitation standards has officially transferred from the MHLW to the Consumer Affairs Agency (CAA). As a result, FSCJ and CAA are now responsible for the regulation of food contact materials.
FSCJ is mainly responsible for conducting scientific evaluations of the safety of food contact materials and assessing risks associated with their use. CAA is responsible for developing, updating and enforcing regulations and standards related to food contact materials, ensuring they comply with food safety laws.
3. Market access approval
Importers of food utensils, containers, and packaging must prepare necessary documents as below for importing according to the Food Sanitation Act, and submit an import declaration to quarantine offices.
a. Product name, manufacturer's name and address, production site name and address;
b. Material, shape, color, a color photograph of the product, and product description;
c. Instructions for use, product descriptions, etc.
If the inspection by the quarantine office is qualified, the Food Import Notification Certificate will be returned to the importer. When making customs declaration, this certificate should be attached. If the import is permitted, the sale and distribution of the item will be allowed.
4. Product compliance
The standard for food utensils, containers, and packaging is defined in part 3 of Specification and Standards for Food, Food additives, Etc., including
A. General standards
B. General test methods
C. Reagents and test solutions
D. Specifications for different materials
E. Specifications for special purpose products
F. Special Manufacturing Standards
In this context, it is important to highlight the materials included under the Positive List System.As revealed by Specification and Standards for Food, Food additives, Etc., materials covered by the Positive List System are defined as "synthetic resins". The details are as follows:
Substances covered
a. Basic substances of synthetic resins (base polymers)
b. Substances used with the intention of remaining in the final product to alter the physical or chemical properties of the synthetic resin (additives)
Substances not covered
a. Substances not intended to remain in the final product
For examples:
① Catalysts and polymerization aids used for the polymerization reaction of base polymers;
② Impurities in raw monomers of base polymers or additives;
Notably, the amount that does not pose risk to human health is defined as "0.01 mg/kg as a concentration in food." In cases where synthetic resins are not used in the parts that come into contact with food, and do not exceed this amount or leach into or mix with food, substances other than those included in the Positive List can also be used.
ChemLinked has well served hundreds of global food enterprises in terms of market access. Please feel free to contact us if you need any assistance on FCM substance, or any other related issue.
