Inquiries about new substances

The Positive List System has been introduced based on the Act Partially Amending the Food Sanitation Act, Etc. that was promulgated on June 13, 2018. The System permits use of only substances proven safe as raw material of food utensils, containers, and packaging (UCP). The details has been specified in the Public Notice of the MHLW No. 196, April 28, 2020.

The Positive List started with substances that have been already used as raw material of UCP since before the enforcement date of the Positive List System (June 1, 2020). These substances are hereinafter referred to as “existing substances.”

The MHLW continues to proceed procedures for the listing of substances including confirmation of the provided information on them. When the information is sufficient to listing, the MHLW will work to amend the Positive List (Appended Table 1) after comfirming a certain level of the safety.

Please refer to the following information for procedures to apply for the listing of new substances and the change of existing specifications.

New Substances

New substances are those that had not been used as raw materials of UCP before the enforcement date
Please note that because the new substances are not subject to the transitional measures, UCP containing such substances cannot be manufactured or imported for the purpose of marketing until the substances are listed in the Appended Table 1.

Application for new substances

This application is targeted at substances first used as raw materials of UCP that are manufactured or imported for the purpose of marketing on or after the enforcement date. It is not targeted at those used in UCP that have been sold, manufactured or imported for the purpose of marketing, or used in business since before the enforcement date.

Persons who want to apply for addition of new materials:Conduct prior consultation with Food Safety Standards and Evaluation Division and submit required documents by postal mail to the division.

▶The guide to prepare application documents (May 29, 2020)

[The guide to preparation of application documents required to amend specifications for substances contained in raw materials of UCP [PDF 95 KB)]