Industrial Chemicals (Notification and Assessment) Amendment Regulation 2012 (No. 1)1
Select Legislative Instrument 2012 No. 86
I, QUENTIN BRYCE, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulation under the Industrial Chemicals (Notification and Assessment) Act 1989.
Dated 24 May 2012
QUENTIN BRYCE
Governor-General
By Her Excellency’s Command
CATHERINE KING
Parliamentary Secretary for Health and Ageing
1 Name of regulation
This regulation is the Industrial Chemicals (Notification and Assessment) Amendment Regulation 2012 (No. 1).
2 Commencement
This regulation commences on 1 July 2012.
3 Amendment of Industrial Chemicals (Notification and Assessment) Regulations 1990
Schedule 1 amends the Industrial Chemicals (Notification and Assessment) Regulations 1990.
Schedule 1 Amendments
(section 3)
[1] Regulation 2
insert
comparable agency means:
(a) the Therapeutic Goods Administration under the Therapeutic Goods Act 1989; or
(b) the Australian Pesticides and Veterinary Medicines Authority under the Agricultural and Veterinary Chemicals Code Act 1994; or
(c) Food Standards Australia New Zealand under the Food Standards Australia New Zealand Act 1991; or
(d) a chemicals notification and assessment scheme operating in a member country of the European Union or the Organisation for Economic Co-operation and Development.
GHS means the document called ‘Globally Harmonised System of Classification and Labelling of Chemicals’, third revised edition, published by the United Nations.
limited application means an application that must be accompanied by a notification statement that contains the matters stated in:
(a) Parts A and B in the Schedule to the Act; or
(b) Parts A, B and D in the Schedule to the Act.
standard application means an application that must be accompanied by a notification statement that contains the matters stated in:
(a) Parts A, B and C of the Schedule to the Act; or
(b) Parts A, B, C and D of the Schedule to the Act; or
(c) Parts A, B, C and E of the Schedule to the Act; or
(d) Parts A, B, C, D and E of the Schedule to the Act.
[2] Regulation 4AA
substitute
4AA Hazardous chemical definition
(1) This regulation is made for section 5 of the Act.
(2) A hazardous chemical is a chemical that satisfies the criteria for a hazard class under the GHS, but does not include a chemical that satisfies the criteria solely for one of the following hazard classes:
(a) flammable gases, category 2;
(b) acute toxicity—oral, category 5;
(c) acute toxicity—dermal, category 5;
(d) acute toxicity—inhalation, category 5;
(e) skin corrosion/irritation, category 3;
(f) serious eye damage/eye irritation, category 2B;
(g) aspiration hazard, category 2;
(h) hazardous to the aquatic environment, category acute 1, 2 or 3;
(i) hazardous to the aquatic environment, category chronic 1, 2, 3 or 4;
(j) hazardous to the ozone layer.
[3] Regulation 11AA
omit
subregulation
insert
subsection
[4] Regulation 11AB
omit
[5] Regulation 13
substitute
13 Fees, charges and penalties
The fees, charges and penalties payable under the Act are set out in Schedule 2.
[6] Subregulation 14 (1)
omit
(1) Subject to subregulation (2), a
insert
A
[7] Subregulation 14(2)
omit
[8] Subregulations 15 (4) to (8)
substitute
(4) If:
(a) a person lodges an application or notification and pays the prescribed fee; and
(b) the Director considers that more information is needed to enable the Director to assess or otherwise process the application or notification; and
(c) the Director considers the person can give the information to the Director; and
(d) the Director gives the person a written notice specifying the information needed and requiring the person to give the information to the Director; and
(e) the person fails, within the time (of at least 14 days) specified in the written notice for giving the information:
(i) to give the Director the information; or
(ii) to satisfy the Director that the person cannot give some or all of the information;
the person is taken to have withdrawn the application or notification, and the Director must repay the prescribed fee minus the screening fee.
(5) The screening fee is an amount equal to 15% of the prescribed fee.
[9] Subregulation 15 (9)
renumber as subregulation 15 (6)
[10] Subregulation 17 (1)
omit
, (4), (5) or (6)
insert
or (4)
[11] Regulation 18
omit
[12] Schedule 1AA, clause 2 (a)
substitute
(a) is:
(i) not a hazardous chemical; or
(ii) a hazardous chemical that is classified under the GHS as ‘skin irritant, category 2’; or
(iii) a hazardous chemical that is classified under the GHS as ‘eye irritant, category 2A’; and
[13] Schedule 1AA, clause 3 (d)
substitute
(d) does not have any of the following hazard classes under the GHS:
(i) acute toxicity, category 1, 2 or 3;
(ii) skin corrosion, category 1A, 1B or 1C;
(iii) serious eye damage, category 1;
(iv) respiratory sensitisation, category 1A or 1B;
(v) skin sensitisation, category 1A or 1B;
(vi) germ cell mutagenicity, category 1A, 1B or 2;
(vii) carcinogenicity, category 1A, 1B or 2;
(viii) reproductive toxicity, category 1A, 1B or 2;
(ix) adverse effects on or via lactation;
(x) specific target organ toxicity—single exposure, category 1 or 2;
(xi) specific target organ toxicity—repeated exposure, category 1 or 2.
[14] Schedule 1AB, clause 2 (2)
omit
(2) The
insert
The
[15] Schedule 1AB, clause 2 (2) (a)
substitute
(a) the chemical does not have any of the following hazard classes under the GHS:
(i) acute toxicity, category 1, 2 or 3;
(ii) skin corrosion, category 1A, 1B or 1C;
(iii) serious eye damage, category 1;
(iv) respiratory sensitisation, category 1A or 1B;
(v) skin sensitisation, category 1A or 1B;
(vi) germ cell mutagenicity, category 1A, 1B or 2;
(vii) carcinogenicity, category 1A, 1B or 2;
(viii) reproductive toxicity, category 1A, 1B or 2;
(ix) adverse effects on or via lactation;
(x) specific target organ toxicity—single exposure, category 1 or 2;
(xi) specific target organ toxicity—repeated exposure, category 1 or 2;
[16] Schedule 2
substitute
Schedule 2 Fees, charges and penalties
(regulation 13)
Item
Fees, charges and penalties
$
1
Fee for application under section 13B of the Act that is made after 28 days of the giving of an assessment certificate
750
2
Fee for application under subsection 14 (3) of the Act for the inclusion of a chemical in the confidential section
3 500
3
Fee for application under subsection 17 (3) of the Act to be the holder of a confidence
700
4
Fee for application under subsection 18A (1) of the Act for the transfer of a chemical to the confidential section
2 100
5
Fee for statement under subsection 19 (4) of the Act setting out the reasons why a chemical should not be transferred to the non‑confidential section
3 500
6
Fee for application under section 21B of the Act:
(a) for a commercial evaluation permit
4 000
(b) for renewal of a commercial evaluation permit
2 000
7
Fee for application under section 21P, 21ZB, 22O, 25, 29, 30A, 40D, 42, 45, 50, 60, 66 or 89 of the Act that information be treated as exempt information
1 100
8
Fee for application under section 21R of the Act:
(a) for a low volume permit
4 000
(b) for renewal of a low volume permit
2 000
9
Fee for application under section 22B of the Act:
(a) for a controlled use permit
4 000
(b) for renewal of a controlled use permit
2 000
10
Fee for application under section 23 of the Act for an assessment certificate for a chemical:
(a) other than an application to which subsection 41 (3) or 44 (1) of the Act applies:
(i) for a standard application
16 800
(ii) for a limited application
12 000
(iii) for an application for a polymer of low concern
5 600
(b) to which paragraph 41 (3) (d) of the Act applies
10 400
(c) to which subsection 44 (1) of the Act applies:
(i) for a standard application
12 300
(ii) for a limited application
9 000
(iii) for an application for a polymer of low concern
3 500
(d) that is accompanied by an assessment by a comparable agency:
(i) for a standard application
13 400
(ii) for a limited application
9 600
(iii) for an application for a polymer of low concern
4 500
(e) that is accompanied by an assessment made under section 32 of the Act of a chemical that is similar to the chemical that is the subject of the application:
(i) for a standard application
10 100
(ii) for a limited application
7 200
(iii) for an application for a polymer of low concern
3 400
(f) that is made at the same time as an application for a similar chemical that has the same or similar uses:
(i) for a standard application
4 000
(ii) for a limited application, or an application for a polymer of low concern
2 500
11
Fee for application under section 23A of the Act for a self‑assessed assessment certificate for a chemical:
(a) for a polymer of low concern
3 900
(b) for a non-hazardous chemical that is a synthetic polymer with a number average molecular weight that is 1 000 or greater, other than a polymer of low concern
9 700
(c) for any other non‑hazardous chemical
10 400
12
Fee for application under section 24 of the Act to vary the requirements of section 23 of the Act
2 600
13
Fee for application under section 30 of the Act for an introduction permit
8 500
14
Fee for application under section 30A of the Act for an early introduction permit
2 300
15
Fee for application under section 37 of the Act for the variation of an assessment report
4 100
16
Fee for application under section 40 of the Act for the variation of a public report
4 100
17
Fee for application under section 40A of the Act for extension of an original assessment certificate
5 100
18
Fee for nomination of a foreign scheme under subsection 43 (3) of the Act
7 100
19
Fee for secondary notification required under section 65:
(a) for a notification relating to a new industrial chemical, other than a polymer of low concern
9 600
(b) for a notification relating to a new industrial chemical that is a polymer of low concern
4 200
20
Fee for application for registration under section 80F of the Act
395
21
Fee for application for renewal of registration under subsection 80KA (1) or 80KB (2) of the Act
395
22
Registration charge under paragraph 80T (2) (a) of the Act
1 462
23
Registration charge under paragraph 80T (2) (b) of the Act
13 905
24
Late renewal penalty under subsection 110A (1) of the Act:
(a) for the renewal of a registration under paragraph 80T (2) (a) of the Act
185
(b) for the renewal of a registration under paragraph 80T (2) (b) of the Act
1 430
(c) for any other renewal
100
Note
1. All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See www.comlaw.gov.au.
