by Xunyao Fu, PhD.
Japan’s Ministry of Health, Labour and Welfare (MHLW) published Notification No. 196 of 2020 regarding Revising Specifications and Standards for Foods, Food Additives, etc. on April 28, 2020.
In Japan, the management of food contact materials (FCM) is being switched from the negative list system to the positive list system. Synthetic resins are the first target materials for the positive list system.
The amendment contains the following 4 parts:
- Base polymers to form synthetic resins (Table 1(1))
- Base polymers to form synthetic resins for coating purpose and etc. (Table 1(2))
- Minor monomers used for polymerization of base polymers (Table 1(3))
- Additives, coating agents, etc. (Table 2)
The amendment will be effective beginning June 1, 2020 with a 5 year transition period. For utensils, containers and packaging (UCP) manufactured or imported for sale before the implementation date, even if unlisted substances are used in synthetic resins, the same type of UCP can be manufactured or imported for sale before May 31, 2025. Otherwise, only the listed materials can be used in synthetic resins.
Catalysts, polymerization aids, or substances unintentionally present in the manufacturing process, such as impurities, are exempt from the positive list system.
The positive list system will regulate the synthetic resins which are used to make UCP or coatings that are in direct contact with food on UCP made by other materials. Unlisted substances may be used if they are not used in areas with direct contact with food and do not transfer to food in quantities exceeding amounts deemed as unlikely to harm human health. The MHLW Notification No. 195 of 2020 specifies the amount being unlikely to harm human health as 0.01 mg/kg for food and the substances should also be non-genotoxic.
The official positive list doesn’t include CAS numbers and English names, but reference lists containing CAS numbers and English names are available on the MHLW’s website. However, whether or not a substance is listed on the positive list will ultimately be determined by the substance name.
Substances that are not listed in the positive list but submitted with information are included in the List of Existing Substances for Continuous Confirmation. These substances will be evaluated and added to the positive list if all of the required information for listing is submitted.
Recommended Action Items:
- Determine if any of your products are listed on the positive list or not.
- If the products are on the positive list, confirm whether or not they comply with the requirements in the positive list.
- Seek substitute material(s) if your products don’t comply with the requirements.
MHLW Notification No. 196 of 2020 published on April 28, 2020 (Japanese only) https://www.mhlw.go.jp/content/11130500/000625486.pdf
MHLW Notification No. 195 of 2020 published on April 28, 2020 (Japanese only) https://www.mhlw.go.jp/content/11130500/000625501.pdf
Information about the positive list system for UCP on the MHLW website (Japanese only) https://www.mhlw.go.jp/stf/newpage_05148.html (Reference lists containing CAS numbers and English names and List of Existing Substances for Continuous Confirmation are available on the website.)
Japan Ministry of Health, Labour and Welfare (MHLW), Food Contact Materials, Positive List, Specifications and Standards for Foods, Food Additives
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