Japan Issues Updated Guidance on FCM Substance Specification Amendments

On May 28, 2025, Japan’s Consumer Affairs Agency (CAA) released a revised version of the Guidance for Applications to Amend Substance Specifications in the Food Contact Materials (FCM) Positive List. This guidance manual was originally published in May 2020, and this is its first revision. The newly released version will come into effect on June 1, 2025, replacing the previous edition.

As is well known, Japan’s Positive List for food contact materials (APPENDED TABLE 1) is divided into two tables:

1. Table 1 (Base Materials)

2. Table 2 (Additives)

Base materials can consist of various mandatory or optional monomers.

The revised guidance mainly covers:

• Amendments to the existing specifications of Additives in Table 2 and applications for the inclusion of new Additives, and

• Amendments to the existing specifications of monomers that constitute base materials and applications for the inclusion of new monomers.

It should be noted that although, in theory, the amendment or addition of base materials themselves falls within the scope of this guidance, the authorities do not appear to consider this the primary focus of the document.

So, what are the main changes in this revision? Compared to the May 2020 version, the new guidance clarifies the categories and scope of applications. Applications are now divided into two types:

• Revisions to APPENDED TABLE 1

• Revisions to monomers (as mandatory or optional components of base materials; note that these monomers are not part of APPENDED TABLE 1 per se but are treated more like supplementary data).

Furthermore, for the first time, the revised guidance provides clear documentation requirements in the form of annexes. Applicants can refer to Annex 1 (for revisions to APPENDED TABLE 1) or Annex 2 (for revisions to monomers) to prepare their application materials accordingly.

Additionally, the Safety Review of Additives, previously reported by ChemLinked, is not within the scope of this guidance. The authorities are expected to issue a separate notice regarding the Safety Review of Additives later.