Industrial Chemicals (Notification and Assessment) Amendment Regulations 2008 (No. 2) (Cth)

Industrial Chemicals (Notification and Assessment) Amendment Regulations 2008 (No. 2)¹

Select Legislative Instrument 2008 No. 236

I, QUENTIN BRYCE, Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Industrial Chemicals (Notification and Assessment) Act 1989.

Dated 28 November 2008

QUENTIN BRYCE

Governor‑General

By Her Excellency’s Command

JAN MCLUCAS

Parliamentary Secretary to the Minister for Health and Ageing

Name of Regulations

These Regulations are the Industrial Chemicals (Notification and Assessment) Amendment Regulations 2008 (No. 2).

Commencement

These Regulations commence on the day after they are registered.

Amendment of Industrial Chemicals (Notification and Assessment) Regulations 1990

Schedule 1 amends the Industrial Chemicals (Notification and Assessment) Regulations 1990.

Schedule 1 Amendments

(regulation 3)

[1] Regulation 2, definition of Library

substitute

Library means the library within the National Industrial Chemicals Notification and Assessment Scheme, located at 334–336 Illawarra Road Marrickville NSW 2204.

[2] Paragraphs 4AA (a) and (b), including the note

substitute

(a)a chemical that is classified as a hazardous substance under the Approved Criteria for Classifying Hazardous Substances, 3rd edition [NOHSC:1008(2004)] published in October 2004 by the National Occupational Health and Safety Commission;

(b)a chemical that is included in the Hazardous Substances Information System (HSIS) published on the website of the Australian Safety and Compensation Council.

Note These publications are available on the website of the Australian Safety and Compensation Council at

[3] Subregulations 6AB (5A) and (7)

omit

less than 100 kilograms

insert

not greater than 100 kilograms

[4] After regulation 6A

insert

6BALow volume permit guidelines

For subparagraph 21U (2) (b) (ii) of the Act, the guidelines set out in Schedule 1AA are prescribed.

[5] Regulation 6B

omit

in relation to an application for a permit by an applicant who intends to export a chemical,

[6] Paragraph 6B (i)

substitute

(i)for an application for a controlled use permit by an applicant who intends to export the chemical — the details of the country to which the chemical is to be exported;

[7] After regulation 6B

insert

6CControlled use permit guidelines

For subparagraph 22F (1) (b) (ii) of the Act, the guidelines set out in Schedule 1AB are prescribed for an application for a controlled use permit by an applicant who does not intend to export all of the chemical.

[8] After regulation 7A

insert

7BChemicals to which early introduction permit can apply

For paragraph 30A (1A) (c) of the Act, the criteria are:

(a)set out in:

(i)clauses 2 and 3 of Schedule 1AA; or

(ii)clause 2 of Schedule 1AB; and

(b)the requirement that the introduction of the chemical is consistent with the reasonable protection of occupational health and safety, public health and the environment, taking into account the following matters:

(i)the proposed nature of the use of the chemical;

(ii)the extent of the proposed use of the chemical;

(iii)the effect of the chemical on the environment;

(iv)the effect of the chemical on occupational health and safety and public health;

(v)the structure and activity of the chemical;

(vi)whether, in Australia or overseas, the chemical is the subject of:

(A)investigations initiated by a person because of concerns about a possible adverse effect on occupational health and safety, public health or the environment; or

(B)action taken by a person to control the use of, or access to, the chemical.

[9] Regulation 8A

substitute

8APrescribed authority (Act s 38 (5) (a))

For paragraph 38 (5) (a) of the Act, the Department of the Environment, Water, Heritage and the Arts is the prescribed authority of the Commonwealth.

[10] Regulation 8C

substitute

8CPrescribed authority (Act s 40G (1) (a) (i))

For subparagraph 40G (1) (a) (i) of the Act, the Department of the Environment, Water, Heritage and the Arts is the prescribed authority of the Commonwealth.

[11] Regulation 9B

substitute

9BPrescribed authority (Act s 60F (7) (a))

For paragraph 60F (7) (a) of the Act, the Department of the Environment, Water, Heritage and the Arts is the prescribed authority of the Commonwealth.

[12] Subregulation 11B (1)

substitute

(1)For paragraph 106 (1) (a) of the Act, the following are prescribed international agreements:

(a)the Rotterdam Convention;

(b)the Stockholm Convention.

[13] Subregulation 11B (2), after definition of Rotterdam Convention

insert

Stockholm Convention means the Stockholm Convention on Persistent Organic Pollutants, done at Stockholm on 23 May 2001, as amended by any amendment of the Convention that has entered into force in Australia.

[14] Subregulation 15 (6)

substitute

(6)The Director may remit up to 40% of the fee paid for an application under section 23 of the Act if satisfied that the applicant has submitted with the application an assessment of the chemical:

(a)by the Therapeutic Goods Administration under the Therapeutic Goods Act 1989; or

(b)by the Australian Pesticides and Veterinary Medicines Authority under the Agricultural and Veterinary Chemicals Code Act 1994; or

(c)by Food Standards Australia New Zealand under the Food Standards Australia New Zealand Act 1991; or

(d)by a chemicals notification and assessment scheme operating in a member country of the European Union or the Organisation for Economic Co‑operation and Development.

(7)The Director may remit:

(a)up to 40% of the fee paid for an application under section 23 of the Act if satisfied that:

(i)the applicant has submitted with the application an assessment of a chemical prepared under section 32 of the Act; and

(ii)the chemical is similar to the chemical that has been assessed under section 32 of the Act; and

(b)up to a further 20% of the fee paid for an application under section 23 of the Act if satisfied that the chemical has the same, or similar, use to the chemical that has been assessed under section 32 of the Act.

(8)The Director may remit a part, or the whole, of a fee paid for an application under section 23 of the Act if satisfied that:

(a)the application is made at the same time as an application is made for another chemical under section 23 of the Act; and

(b)the chemical is similar to the other chemical; and

(c)the chemical has the same or similar use to the other chemical.

(9)The Director may remit a part, or the whole, of a fee paid for an application made under subsection 30A (1) of the Act for a chemical mentioned in paragraph 30A (1A) (a) or (b) of the Act.

[15] Before Schedule 1

insert

Schedule 1AA Low volume permit and early introduction permit guidelines

(regulations 6BA and 7B)

Purpose of guidelines

These guidelines set out:

(a)for regulation 6BA — matters that the Director must consider for an application under subparagraph 21U (2) (b) (ii) of the Act for a low volume permit, if the total quantity of the chemical proposed to be introduced is not more than 1 000 kg; and

(b)for regulation 7B — criteria for a chemical or class of chemicals, other than a polymer of low concern or a non‑hazardous chemical, for which an application may be made under subsection 30A (1A) of the Act for an early introduction permit.

Note For paragraph (a), these guidelines only apply to the proposed introduction of more than 100 kg and up to 1 000 kg — see Act, s 21U (2) (c).

All chemicals (including polymers other than those with number average molecular weight that is 1 000 or greater)

For a chemical, including polymers other than those with number average molecular weight that is 1 000 or greater, the matters, or criteria, are that the chemical:

(a)either:

(i)is not a hazardous chemical; or

(ii)is a hazardous chemical that is classified as R36 (irritating to eyes) or R38 (irritating to skin) under the Approved Criteria for Classifying Hazardous Substances, 3rd edition [NOHSC:1008(2004)] published in October 2004 by the National Occupational Health and Safety Commission; and

(b)does not have a toxicity:

(i)to fish, using the test mentioned in paragraph (m) of Part C of the Schedule to the Act, and expressed as an LC₅₀, that is less than 100 mg/litre; and

(ii) to aquatic invertebrates, using the test mentioned in paragraph (n) of Part C of the Schedule to the Act, and expressed as an EC₅₀, that is less than 100 mg/litre; and

(iii)to algae, using the test mentioned in paragraph (p) of Part C of the Schedule to the Act, and expressed as IC₅₀, that is less than 100 mg/litre; and

(c)either:

(i)is not a dangerous good; or

(ii)is a dangerous good that is a Class 3 flammable liquid as defined in the ADG Code.

Polymers with number average molecular weight that is 1 000 or greater

For a polymer with number average molecular weight that is 1 000 or greater, the matters, or criteria, are that the polymer:

(a)has less than 10% by mass of molecules with molecular weight that is less than 500; and

(b)has less than 25% by mass of molecules with molecular weight that is less than 1 000; and

(c)has low charge density, as defined in Regulation 4C; and

(d)does not have any of the following hazard classifications for human health effects:

(i)carcinogenic effects (R40, R45, R49 as described in Approved Criteria for Classifying Hazardous Substances, 3rd edition [NOHSC:1008(2004)]);

(ii)mutagenic effects (R46);

(iii)reproductive effects (R60–64);

(iv)very toxic and toxic acute lethal effects (R23–28);

(v)corrosive effects (R34, R35, R41);

(vi)sensitising effects (R42, R43);

(vii)non‑lethal irreversible effects after a single exposure (R39, R68);

(viii)severe effects after repeated or prolonged exposure (R48).

Schedule 1AB Controlled use permit and early introduction permit guidelines

(regulations 6C and 7B)

Purpose of guidelines

These guidelines set out:

(a)for regulation 6C — matters that the Director must consider for an application under subparagraph 22F (1) (b) (ii) of the Act for a controlled use permit, if the applicant does not intend to export all of the chemical; and

(b)for regulation 7B — criteria for a chemical or class of chemicals, other than a polymer of low concern or a non‑hazardous chemical, for which an application may be made under subsection 30A (1A) of the Act for an early introduction permit.

Intended use

The matters, or criteria, are that:

(a)the chemical does not have any of the following hazard classifications for human health effects:

(i)carcinogenic effects (R40, R45, R49 as described in Approved Criteria for Classifying Hazardous Substances, 3rd edition [NOHSC:1008(2004)]);

(ii)mutagenic effects (R46);

(iii)reproductive effects (R60–64);

(iv)very toxic and toxic acute lethal effects (R23–28);

(v)corrosive effects (R34, R35, R41);

(vi)sensitising effects (R42, R43);

(vii)non‑lethal irreversible effects after a single exposure (R39, R68);

(viii)severe effects after repeated or prolonged exposure (R48); and

(b)the chemical does not have a toxicity:

(i)to fish, using the test mentioned in paragraph (m) of Part C of the Schedule to the Act, and expressed as an LC₅₀, that is equal to or less than 10 mg/litre; and

(ii)to aquatic invertebrates, using the test mentioned in paragraph (n) of Part C of the Schedule to the Act, and expressed as an EC₅₀, that is equal to or less than 10 mg/litre; and

(iii)to algae, using the test mentioned in paragraph (p) of Part C of the Schedule to the Act, and expressed as IC₅₀, that is equal to or less than 10 mg/litre; and

(c)for human exposure:

(i)there are no exposures to consumers or the general public inherent in the proposed manufacturing, processing or uses of the chemical; and

(ii)any worker exposure that is likely to occur will be adequately controlled through use of engineering controls, work practices and personal protective equipment; and

(d)for environmental exposure, all routine releases from manufacture, processing and use (including releases associated with cleaning of equipment and from disposal or cleaning of containers and packaging) have been considered and adequate controls are in place to ensure:

(i)no ambient release to surface water resulting in concentrations of the chemical above 1 part per billion; and

(ii)no ambient release to air above 1 microgram per cubic metre average annual concentration; and

(iii)no release to land or landfill unless the chemical has negligible potential for migration to groundwater.

Note

All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See