1/ Listed Introductions, Option 5 Record-Keeping – HTE Comment

In response to: www.industrialchemicals.gov.au/proposed-changes-categorisation-reporting-and-record-keeping-consultation/listed-introductions-more-practicable-record-keeping-requirements  (15 Sept 2023)

2 Nov 2023: The Option 5 Record-Keeping Proposal for Listed Introductions has significant changes & issues compared to the existing requirements for Written Undertakings.

The Listed Introduction chemicals that are covered by CAS No.s on the AIIC statement in Section 15 of the SDS, that are not disclosed in an SDS nor in the TDS, don’t contribute to a GHS Hazard for the product nor have specific information to that chemical in the SDS or TDS.
There may be up to 20-30 such chemicals in a product ranging from say 0.001% to 50%. The maximum concentrations of these chemicals are not normally known to an importer as this is normally Confidential Business Information (CBI). So calculating a meaningful quantity estimate for each chemical annually does not make sense.

A manufacturer is currently required (via a Written Undertaking) to provide such information confidentially direct to the AICIS (when requested). The “draft rule” now proposes that manufacturers will be expected to provide an indication of these values to the importer. This is very unlikely to be agreed to by a manufacturer, as such composition information is usually highly confidential as CBI.

So effectively (as Haztech EnvironmentaI interprets), this is the very like the current Written Undertaking required, with additional composition (maximum %s) and quantity (general) information required now to be known by the importer. This will be more complex and more time consuming for chemicals on the AIIC that don’t contribute to a GHS Hazard for the product.

The manufacturer may even be not prepared to provide such CBI information (to the importer). This may result in preventing new and existing products, with non hazardous (to the GHS) chemical ingredients, from entering Australia!

What happened to the “risk-proportionate regulatory scheme that aids” Australia test, versus the cost to obtain and maintain this degree of information, that must be legally signed off as correct each year.

Minister’s SOE Regulatory Reform Agenda: “The Government is looking at ways to boost productivity through reducing unnecessary or duplicative regulatory costs.”

AICIS’s SOI Function and Purpose: “Consistent with the policy intent and legal framework set out in the IC Act, AICIS is a risk-proportionate regulatory scheme that aids in the protection of the Australian people and their environment.

Based on the above comments, what is proposed is NOT a “risk-proportionate regulatory scheme that aids” Australia, so should not go ahead as proposed. It needs to be simplified & be risk focused for information that IS a “risk-proportionate regulatory scheme that aids” Australia. There is NIL benefit to collecting information on chemicals that are NOT GHS Hazardous at ANY percentage.

Jeff Simpson’s Full Comment on AICIS Proposed Rules-Listed Intro Option 5-2Nov2023 (2 page pdf)

2/ Decision is Needed re: Old CAS-ON-AICS Advice

From: Hazmat & Environment Notes Jan-Feb-March 2022

Editor: For several decades Australian businesses have collected and filed (many will be in old paper files in your physical  filing systems) CAS-ON-AICS signed statements and hopefully highlighted as e.g. “ON-AICS” on your Product database where the CAS No.s in your Products were entered.

An action decision is needed about updating your “ON-AICS” information to an updated and easily accessible database with the information required by the Industrial Chemicals (General) Rules, should the Australian Industrial Chemicals Introduction Scheme ask your business for this compliance information.

The old CAS-ON-AICS signed Statements management process fully ceases on the 31 Aug 2022.

The original collection of these CAS-ON-AICS signed Statements was a major activity and took several years to put in place starting around 1997 and from then, such sign-off information was added for products as needed.

The General Rules now require that the CAS No.s and Chemicals information (for chemicals that are on the Australian Inventory of Industrial Chemicals (AIIC) be available within 40 working days.

Record-Keeping Obligations for Inventory-Listed chemicals

www.industrialchemicals.gov.au/business/reporting-and-record-keeping-obligations/record-keeping-obligations-inventory-listed-chemicals

Industrial Chemicals Act and Rules (relevant parts)

Act: 25 Listed Introductions

An introduction of an industrial chemical by a person is authorised by this section if:

(a) the industrial chemical is listed on the Inventory; and

(b) the introduction is in accordance with the terms of the Inventory listing.

Rules: Ch4, Part 2 Record Keeping for Listed Introductions

2/ CAS Number & Name for the industrial chemical is

Not known: Both (i) & (ii) are required:

(i) the names by which the industrial chemical is known to the person, or the names of all products containing the industrial chemical that are imported into Australia by the person; and

(ii) a written undertaking from the chemical identity holder that the CAS name and CAS number (if assigned) for the industrial chemical will be provided to the Executive Director, if requested, within 40 working days after the day the request is made;

3/ Records to demonstrate that the industrial chemical is being introduced or used in accordance within a defined scope an Assessment (where this exists) for the industrial chemical;

4/ Records to demonstrate conditions relating to the introduction or use of the industrial chemical are being complied with;

5/ Records to demonstrate that specific requirements to provide information to the Executive Director are being met.

Act: www.legislation.gov.au/Details/C2021C00493/Download

Rules: www.legislation.gov.au/Series/F2019L01543

Editor: Obtaining a written undertaking from the chemical identity holder may be several businesses up a supply chain with significant admin time to achieve a result!

Editor: The administrative costs to create (and maintain, at least within 2 years, or annually) this database of the Written Undertakings from the chemical identity holders is a very time expensive cost, even if eventually automated, to the degree that some are considering to only do this, within the 40 working day time frame, when requested by AICIS.

 

Background:

This problem in the Industrial Chemicals Rules (that includes Cosmetic chemicals) came into place when the NICNAS Regulations were updated with new legislation in 2019/2020.

https://www.industrialchemicals.gov.au/about-us/industrial-chemicals-law-australia

The original discussions prior to the legislation being finalised did not highlight to industry the detailed level of information that was going to be required for all the industrial chemicals under the previous NICNAS Regulations, where we have already collected the previous CAS-ON-AICS signed off information over the last 25 years.

The Part of the Industrial Chemicals Act 2019, No. 12, 2019 that covers this is:

Division 3—Record keeping and information gathering
102 Information required to demonstrate categorisation
(1) A person contravenes this subsection if:
(a) the person introduces an industrial chemical during a registration year; and
(b) the rules prescribe a requirement for the purposes of this paragraph relating to information that a person must, or must not, have regard to in determining the category of the introduction; and
(c) the requirement is not complied with.

The Note above is from page 9 (print version) in my current Hazmat & Env Notes Jan to Mar 2022, that I emailed out on Wednesday 6th April 2022.