EXPLANATORY STATEMENT

Select Legislative Instrument 2011 No. 260

Industrial Chemicals (Notification and Assessment) Act 1989

Industrial Chemicals (Notification and Assessment) Amendment Regulations 2011 (No. 1)

Section 111 of the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act) provides, in part, that the Governor-General may make regulations, not inconsistent with the Act, prescribing matters required or permitted by the Act to be prescribed or necessary or convenient to be prescribed for carrying out or giving effect to the Act.  

The Act provides for a national system of notification and assessment of industrial chemicals for the purposes of aiding in the protection of the Australian people and the environment; providing information and making recommendations about industrial chemicals to Commonwealth, State and Territory bodies; giving effect to Australia’s obligations under international agreements; collecting statistics in relation to these chemicals and setting and enforcing national standards for cosmetics introduced into Australia.

The purpose of the Regulations is to amend the Industrial Chemicals (Notification and Assessment) Regulations 1990 (the Principal Regulations) consequential to amendments to the Act, which came into force on 27 September 2011.

The Regulations make a number of other administrative changes, including updates of the NICNAS address, name of the Commonwealth Environment department, and of references to overseas legislation.

In particular, the Regulations:

• consequential to the Amending Act, update definitions and information requirements in relation to ultra-violet (UV) filters in cosmetics applied to the skin; and

• consequential to the Amending Act, repeal those Regulations which refer to the summary report of an assessment.

Details of the Regulations are set out in the Attachment.

The Act specifies no conditions that need to be met before the power to make the Regulations may be exercised.

The Regulations are a legislative instrument for the purposes of the Legislative Instruments Act 2003. 

The Regulations commence on the day after registration on the Federal Register of Legislative Instruments.

Consultation

These amendments include changes that are consequential to amendments to the Industrial Chemicals (Notification and Assessment) Act 1989 as well as minor administrative changes.

The consequential amendments, though not consulted on directly, relate to changes to the Act that were developed in close consultation with stakeholders were drawn from several NICNAS advisory committees (the Cosmetics Advisory Group, the Industry Government Consultative Committee and the Community Engagement Forum) and so represented industry, community and Government interests.

The administrative changes have not been consulted on as these are of no impact to stakeholders.

Implementation of the measure addressing cosmetic regulatory reforms, which include an enabling provision to transfer chemicals onto the Inventory, were discussed and agreed through the NICNAS Cosmetics Advisory Group, comprising industry and community stakeholders, as well as the Therapeutic Goods Administration, during 2010-11.  The draft legislation relating to this measure was exposed to stakeholders in November 2010 and again in June 2011.  Issues raised through the exposure process were resolved.

The technical amendments, which relate to efficiency and alignment of data requirements, were subject to two rounds of public consultation in 2010 as detailed proposals. Submissions to the first round, received from industry stakeholders, indicated mixed support for the various amendments, and these were subsequently refined in a second round. These were discussed again, and further refined during exposure of the draft Bill in June 2011.

Authority:  Section 111 of the Industrial
                  Chemicals (Notification and
       Assessment) Act 1989

ATTACHMENT

Details of the Industrial Chemicals (Notification And Assessment) Amendment Regulations 2011 (No. 1)

Regulation 1 provides for the Regulations to be referred to as the Industrial Chemicals (Notification and Assessment) Amendment Regulations 2011 (No. 1).

Regulation 2 provides for the Regulations to commence on the day after registration on the Federal Register of Legislative Instruments.

Regulation 3 provides for Schedule 1 to amend the Industrial Chemicals (Notification and Assessment) Regulations 1990 (the Principal Regulations).

Schedule 1 –Amendments

Item [1] – Regulation 2, definition of Library

The street address of NICNAS is now level 7, 260 Elizabeth Street Surry Hills NSW 2010, where the library is located.  The definition of “library” in regulation 2 is amended to reflect this change in address.

Items [2, 3 & 4] – Paragraphs 3(1)(k), 3(1)(l)(i) and 3(1)(n)

In the Industrial Chemicals (Notification and Assessment) Amendment (Inventory) Act 2011(the amending Act), a number of the data requirements in the Schedule to the Industrial Chemicals (Notification and Assessment) Act 1990 (the Act) were amended in accordance with international best practice and consistency with equivalent industrial chemical assessment schemes overseas.

Regulation 3 lists physical and chemical data that must be provided in an application for a certificate of introduction for a new chemical and which are to be regarded as basic information for the purposes of the Act. Basic information is information that cannot be exempted from publication. 

Sub-regulation 3(1) is amended in accordance with corresponding amendments to the Schedule to the Act, namely:

(k) repealing the prescribed method of determining “flash point”;

(l) specifying information about the chemical’s flammability in terms of requirements for gases, vapours and solids; and’

(n) adding a requirement to provide data on a chemical’s explosive properties.

Item [5] – Paragraph 4(1)(b)

In the notification of a new chemical to NICNAS, an applicant must submit data in accordance with the data requirements listed in the Schedule.  Information on health effects is in accordance with the data items listed in Part C of the Schedule.  For UV filters in cosmetics applied to the skin, all of the required data items on health effects are not covered by Part C, so a new Part E of the Schedule was added in the Bill to cater for the additional health effects data.  Therefore the data required for health effects of UV filters in cosmetics applied to the skin must be in accordance with the data items listed in Parts C and E of the Schedule. 

Similarly to regulation 3, regulation 4 lists health and environmental data that must be provided in an application for a certificate of introduction for a new chemical and which are to be regarded as basic information for the purposes of the Act

As a new Part E was added to the Schedule, subregulation 4(1) is amended to cater for the health effects of UV filters in cosmetics applied to the skin.

Item [6] – Paragraph 4AA(b), including the note

The Australian Safety and Compensation Council is now Safe Work Australia.  Paragraph (b) in regulation 4AA is amended to reflect this change in name.

Items [7 & 8] – Subregulation 4(J)(2) and Paragraph 4K(2)(b)

Section 23 of the Act is amended by inserting a new subsection 23(9) to provide for specific data to be submitted in support of a notification for UV filters in cosmetics applied to the skin.  The effect of this amendment is that any notification for a new UV filter in a cosmetic applied to the skin will need to include data listed in new Part E of the Schedule.

A non-hazardous chemical is defined in subsections 5(2) of the Act which also describes the criteria that must be taken into account in determining whether a chemical should be regarded as non-hazardous. The related regulation 4J describes criteria for determining whether a chemical should be regarded as non-hazardous on the basis of environmental effects and related regulation 4K describes the matters to be taken into account in making that determination.

Consequently subregulations 4J(2) and 4K(2) are amended to cater for the data requirements under subsection 23(9) of the Act for UV filters in cosmetics applied to the skin. 

Item [9] – Subregualtion 6AB(3)

Subregulation 6AB(3) of the principal regulations, incorporates the European and US legislation for cosmetics regulation.  In both cases, the respective incorporated laws are those in force as at 30 December 1997.  As both the EU and US laws have been amended since 1997, subregulation 6AB(3) is amended to reflect the dates of the updated laws in the European Union and the US.

Item [10] – Paragraph 6B(b)

Any notification for a new UV filter in a cosmetic applied to the skin will need to include data listed in new Part E of the Schedule.  For the purposes of information for the assessment of a UV filter in a cosmetic applied to the skin, new Part E of the Schedule has the same status as Part C of the Schedule.

Consequently regulation 6B is amended to cater for an application for a controlled use permit of a UV filter in a cosmetic applied to the skin, noting that matters set out in Parts C and E of the Schedule would be required if such a chemical was to be introduced in an amount that is greater than 10 tonnes in a period of 12 months.

Item [11] – Regulation 8

In the Act, section 35 which dealt with the requirement to publish summary reports of new chemical assessments was repealed.  Therefore item 11 repeals the related Regulation 8.

Items [12, 14 & 17] –Regulation 8A, Paragraph 8C and Regulation 9B

The Commonwealth Environment department is now known as the Department of Sustainability, Environment, Water, Population and Communities. Regulation 8A, 8C and 9B are amended to reflect the change in name of the department.

Items [13 & 15] – Paragraphs 8B(e) and 8D(f) and (g)

Section 35 of the Act is repealed and the Act amended to state that the public report is published on the NICNAS website, with a notice in the Chemical Gazette to be published stating that the public report is available.  Consequently paragraph 8B(e) is amended in accordance with this change in the Act. Similarly, paragraphs 8D(f) and 8D(g) are amended in accordance with the amendments to the Act regarding summary reports.

Item [16] – Regulation 9A

In the Act, subsection 60F(5), which dealt with the requirement to publish summary reports of assessments of Priority Existing Chemicals was repealed.  Therefore item 16 repeals the related regulation 9A.

Item [18] – Regulation 10

In the Act, subsection 78(1), which dealt with a requirement to have copies of the full public assessment reports available for inspection was repealed as public assessment reports are freely available to the public via the NICNAS website.  Therefore item 18 repeals the related regulation 10.

Item [19] – Regulation 11

Consequent upon the repeal of subsection 78(1) in the Act, subsection 78(2) was renumbered as section 78, with no amendment to the text.  As a consequence, regulation 11 is amended to reflect this change in numbering in the Act.

Items [20, 21, 22 & 23] – Subparagraph 13(2)(a)(ii); After subparagraph 13(2)(a)(ii), Sub-subparagraph 13(3)(a)(i)(B) and After Sub-subparagraph 13(3)(a)(i)(B)

Section 23 of the Act is amended by inserting a new subsection 23(9) to provide for specific data to be submitted in support of a notification for UV filters in cosmetics applied to the skin.  For the purposes of assessment fees, subsection 23(9) should be regarded as having the same status as subsections 23(5) and 23(7).

Consequently paragraph (a) in subregulation 13(2) and subparagraph (a)(i) in subregulation 13(3) are amended to cater for the new notification requirements created by subsection 23(9) in the Act.