Australia Adopts Rules for Chemical Introductions at Low Volumes (Updated on Nov 25, 2022)

Updates: On November 25, 2022, the Industrial Chemicals (General) Amendment (Introductions of 10 kg or Less) Rules 2022 was adopted and came into force immediately (see official circular), based on the public consultation on the proposed changes for introductions of 10 kg or less that closed in October 2022. Compared with the Draft, there are no significant changes in the official version. It should be noted that, if the introduced chemicals possess carcinogenicity, germ cell mutagenicity, or reproductive toxicity, they are not applicable to the Rules. To help stakeholders ensure their compliance, the authority also updated the corresponding guide for the categorization of chemical introduction (importation and manufacture), i.e., adding the introductions of 10 kg or less to Step 3. Click here for more details.

On September 26, 2022, the Australia Government released a public invitation for comments on the Industrial Chemicals (General) Amendment (Introductions of 10 kg or Less) Rules 2022 (hereinafter referred to as the Amended Rules), which would provide more reasonable and appropriate requirements for certain lower risk chemical introductions at low volumes in a registration year. The public consultation will end on October 11, 2022.

Background

Considering the fact that a significant number of introducers (manufacturers or importers) of chemicals at lower volumes were unable to get the required information from their suppliers to meet the categorization and record-keeping requirements under AICIS before the end of the transition period (31 August 2022), the authority drafted the Amended Rules to help them know and keep to meet their obligations.

Categorizations of Chemical Introductions under AICIS (Source: AICIS website)

The Amended Rules would apply to the followings:

1. Listed Introductions of chemicals on the AIIC at volumes of 10 kg or less in a registration year.

   The authority proposes to simplify the record-keeping requirements for these introductions in situations where it is difficult for an introducer to obtain the CAS number and name of a chemical since it is confidential or commercially sensitive to the overseas chemical supplier. Introducers of chemicals at low volumes would be required to keep "information that they should have or should be able to easily access" instead of "information that is difficult to obtain".

2. Reported Introductions of low-risk chemicals at volumes of 10 kg or less in a registration year.

   Similar changes mentioned above are also proposed for reporting or record-keeping requirements for such introductions. The authority also proposes to streamline the categorization process so that introductions meeting the eligibility criteria could be categorized as Reported Introductions. (*Introductions of certain higher concern chemicals – such as chemicals that are carcinogenic, fluorinated or persistent, bioaccumulative and toxic to the environment – would not meet the criteria.)

The authority provides various examples to illustrate the proposed changes. Click here to learn more.