Preview of Australian Industrial Chemicals Introduction Scheme (AICIS)

Australia

Preview of Australian Industrial Chemicals Introduction Scheme (AICIS)

Little Pro on 2018-12-24

Australian Industrial Chemicals Introduction Scheme (AICIS) is a new scheme for regulating the introduction (manufacture or import) of industrial chemicals in Australia. Introduced by Industrial Chemicals Bill 2017, AICIS is expected to replace Australia National Industrial Chemicals Notification and Assessment Scheme (NICNAS) from 1 July 2020 (source). In this article, we will give you a preview of AICIS and summarize the key things you need to know about this new chemical regulation.

Overview of AICIS

AICIS defines an industrial chemical and requires introducers of industrial chemicals to register their businesses before introduction. Introductions must also comply with the requirements of a category of introduction, which are based on the level of risk to human health and the environment from the introduction. Lower risk introductions (exempted and reported introductions) can be made without assessment. Medium-to-high risk introductions must be authorised and require an assessment certificate issued by regulatory authority. In addition, AICIS establishes Australian Inventory of Industrial Chemicals (AIIC) and specifies certain record keeping and reporting obligations. Finally, AICIS plans to implement a ban on the testing of cosmetics on cosmetics.

Note: Introductions include both manufacture and import.

Definition of Industrial Chemical and Exclusions

An industrial chemical is a chemical substance with a use other than the following uses:

use as an agricultural chemical product or veterinary chemical product (defined in Agvet Code) or in the preparation of such a product;
use as a therapeutic good (defined in Therapeutic Goods Act 1989) or in the preparation of such a product;
use as food intended for consumption by humans or in the preparation of such food;
use as feed intended for consumption by animals or in thepreparation of such feed;
any other use prescribed by the rules for the purposes of this paragraph.

In addition, the following chemical substances are excluded from authorisation and assessment.

a naturally-occurring chemical;
a non-isolated intermediate;
an incidentally-introduced chemical;
an industrial chemical that was released from an article that 10 was not designed to release it;

Registration of Industrial Chemical Introducers

A manufacturer or importer of industrial chemicals must register themselves with the Register of Industrial Chemical Introducers for a registration year before introducing an industrial chemical during that year. The Register will include the name and address of introducers.

Penalties apply if a person introduces an industrial chemical without being registered. A registration charge is payable for each registration year when the person applies for registration for that year.

Categorisation and Assessment of Industrial Chemicals

AICIS sets out the categories of the introduction of industrial chemicals based on the level of risk to human health and the environment from the introduction. It also sets out requirements that must be met for each category.

There are 6 categories in total: listed introductions, exempted introductions, reported introductions, assessed introductions, commercial evaluation introductions and exceptional circumstances introductions.

Risk Level	Category	Requirements
Very Low	Listed Introductions Chemical substances already listed in the Inventory (AIIC)	Comply with the terms in Inventory listings
Very Low	Exempted Introductions An exempted introduction is an industrial chemical introduction that poses a very low risk to human health and the environment. Detailed exemption rules not published yet	Record keeping needed to justify exemptions
Low	Reported Introductions An exempted introduction is an industrial chemical introduction that poses a low risk to human health and the environment. Detailed rules not published yet	Submit pre-introduction reports
Medium to High	Assessed Introductions An assessed introduction is an industrial chemical introduction that poses medium to high risk to human health and the environment. If an introduction of an industrial chemical does not fall within the definition of a listed introduction or an exempted or reported introduction, it is generally an assessed introduction.	Apply for assessment certificate Comply with the terms in assessment certificate
Medium	Commercial Evaluation Introductions The introduction is for the purpose of ascertaining the industrial chemical’s potential for commercial application; The chemical is not sold to the general public and its release and exposure is controlled.	Apply for commercial evaluation authorisation
-	Exceptional Circumstances Introductions For exceptional circumstances.	Apply for exceptional circumstances authorisation

Australian Inventory of Industrial Chemicals

A new inventory called Australian Inventory of Industrial Chemicals (AIIC) will be established. It will replace current AICS. Industrial chemicals that are listed on the AIIC can be introduced by any registered introducers. However, the introducers must comply with the terms of the listing.

Industrial chemicals for which an assessment certificate has been in force for 5 years are generally added to the Inventory. A holder of an assessment certificate can apply for early listings.

Reporting and Record-Keeping Requirements

Introducers must make an annual declaration to authorities relating to the introductions made during a registration year and the category of those introductions. For chemicals falling with the scope of reported introductions, a one-off pre-introduction report must be submitted to authority before a person starts introducing an industrial chemical in the category. There are also reporting obligations on certain introducers to report adverse effects.

Introducers are required to keep records to support the categorisation of industrial chemicals and the Executive Director of AICIS has the power to request that such information be provided.

Animal Test Ban

AICIS plans to implement a national ban on the use of new animal test data to support the introduction of chemicals used exclusively as cosmetic ingredients. This will mean that animal test data produced after 1 July 2020 cannot be used to meet the information requirements for categorisation or assessment of unlisted chemical introductions, where the only end use is cosmetics.

References

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