On March 15, 2024, Japan Ministry of Health, Labor and Welfare (MHLW) issued an amendment to revise the food additive list. As per the amendment, 3,6-dimethyl-5,6,7,7a-tetrahydro-2(4H )-benzofuranone will be removed from the Essence List of 18 Kinds as of December 31, 2024.
Background
Japan's food additives are divided into designated food additives, existing food additives, natural flavoring agents, and ordinary foods used as food additives. They are regulated as per the following different lists.
Notably, within the Designated Food Additives List, there are 18 additives listed under category names. Each category contains multiple substances, including various non-toxic substances used as fragrances. The MHLW has specifically included these substances in the Essence List of 18 Kinds.
Revisions
MHLW consulted experts who suggested 3,6-dimethyl-5,6,7,7a-tetrahydro-2(4H)-benzofuranone could be mutagenic. In order to assess the safety of this substance, follow-up genetic toxicity testing is necessary. However, considering that the lack of data in Europe and the United States resulting in its removal from the list, MHLW have decided to remove it from the Essence List of 18 Kinds as of December 31, 2024.
As a result, enterprises shall refrain from manufacturing, importing, processing, using, storing, or displaying products and food containing the "3,6-dimethyl-5,6,7,7a-tetrahydro-2(4H)-benzofuranone" for sale and distribution purposes, starting from January 1, 2025. However, this restriction does not apply to food products that naturally contain "3,6-dimethyl-5,6,7,7a-tetrahydro-2(4H)-benzofuranone" or to the sale of products manufactured, imported, or distributed before December 31, 2024.
Furthermore, as per tradition, substances included in the Essence List of 18 Kinds has undergone scrutiny by providing essential details like structural formulas in conjunction with their respective names. The amendment further enhances the requirements for reviewing this information, including but not limited to the providing:
Information on purity or isomers
Information on the food products in which it is used and the usage amounts
Safety assessment status in other countries/institutions
Distribution practices and regulatory status overseas
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