Industrial Chemicals (Notification and Assessment) Amendment Regulations 2002 (No. 1) (Cth)

Industrial Chemicals (Notification and Assessment) Amendment Regulations 2002 (No. 1)1

Statutory Rules 2002 No. 582

I, PETER JOHN HOLLINGWORTH, 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 27 March 2002

PETER HOLLINGWORTH

Governor-General

By His Excellency’s Command

TRISH WORTH

Parliamentary Secretary to the Minister for Health and Ageing

Contents

• •
• •
• •

1Name of Regulations

 These Regulations are the Industrial Chemicals (Notification and Assessment) Amendment Regulations 2002 (No. 1).

2Commencement

 These regulations commence as follows:

• (a)

  regulations 1, 2 and 3 and Schedule 1 — on gazettal;

• (b)

  Schedule 2 — on the commencement of item 5 of Schedule 1 to the Safety, Rehabilitation and Compensation and Other Legislation Amendment Act 2001. 

3Amendment of Industrial Chemicals (Notification and Assessment) Regulations 1990

 Schedules 1 and 2 amend the Industrial Chemicals (Notification and Assessment) Regulations 1990.

Schedule 1Amendments commencing on gazettal

  

(regulation 3)

[1]Regulation 2, before definition of inspection times

insert

Act means the Industrial Chemicals (Notification and Assessment) Act 1989. 

cationic means containing net positively charged atoms or associated groups of atoms covalently linked to its polymer molecule.

[2]Regulation 2, definition of the Act

omit

[3]Regulation 4A

substitute

4ASynthetic polymer of low concern — number average molecular weight less than 10 000 (Act s 5)

• (1)

  A synthetic polymer that has a number average molecular weight greater than 1 000, but less than 10 000, has the number average molecular weight for the purposes of paragraph (a) of the definition of synthetic polymer of low concern if 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)

    complies with subregulation (2), (3) or (4). 

• (2)

  The polymer must consist only of low concern reactive functional groups mentioned in column 2 of Schedule 3. 

• (3)

  If the polymer includes moderate concern reactive functional groups mentioned in column 3 of Schedule 3:

  • (a)

    the groups must have a combined functional group equivalent weight of at least 1 000; and

  • (b)

    the polymer must include no high concern reactive functional groups mentioned in column 4 of Schedule 3.

• (4)

  If the polymer includes high concern reactive functional groups mentioned in column 4 of Schedule 3, the groups must have a combined functional group equivalent weight of at least 5 000.

4BSynthetic polymer of low concern — number average molecular weight 10 000 or greater (Act s 5)

 A synthetic polymer that has a number average molecular weight that is 10 000 or greater has the number average molecular weight for paragraph (a) of the definition of synthetic polymer of low concern if the polymer:

• (a)

  has less than 2% by mass of molecules with molecular weight that is less than 500; and

• (b)

  has less than 5% by mass of molecules with molecular weight that is less than 1 000.

4CSynthetic polymer of low concern — low charge density (Act s 5)

 For paragraph (b) of the definition of synthetic polymer of low concern, a synthetic polymer has a low charge density if:

• (a)

  it is both:

  • (i)

    not cationic; and

  • (ii)

    not likely to become cationic in an aquatic environment that has a pH value greater than 4 and less than 9; or

• (b)

  it is a solid that is:

  • (i)

    not soluble or dispersible in water; and

  • (ii)

    to be used only in its solid phase; or

• (c)

  for a polymer that includes 1 or more cationic groups, the total combined functional group equivalent weight of any cationic group is at least 5 000.

4DSynthetic polymer of low concern — low residual monomer content (Act s 5)

 For paragraph (c) of the definition of synthetic polymer of low concern, a synthetic polymer has a low residual monomer content if it would not be classified as a hazardous substance in accordance with the Commission’s Standard, Approved Criteria for Classifying Hazardous Substances, that was published by the Commission in 1999.

4ESynthetic polymer of low concern — when polymer does not dissociate readily (Act s 5)

 For paragraph (d) of the definition of synthetic polymer of low concern, a synthetic polymer does not dissociate readily if it is not likely to become cationic in an aquatic environment that has a pH value greater than 4 and less than 9.

4FSynthetic polymer of low concern — low water solubility (Act s 5)

 For paragraph (e) of the definition of synthetic polymer of low concern, every synthetic polymer is taken to have low water solubility. 

4GSynthetic polymer of low concern — particle size (Act s 5)

 For paragraph (f) of the definition of synthetic polymer of low concern, a synthetic polymer may, in solid form, have any particle size.

4HSynthetic polymer of low concern — when polymer is stable (Act s 5)

 For paragraph (g) of the definition of synthetic polymer of low concern, a synthetic polymer is stable under the conditions in which it is used if, under those conditions, it does not readily break down by any process, including the following:

• (a)

  depolymerisation;

• (b)

  hydrolysis;

• (c)

  photodegradation;

• (d)

  thermal degradation.

4ISynthetic polymer of low concern — other characteristics (Act s 5)

• (1)

  For paragraph (h) of the definition of synthetic polymer of low concern, a synthetic polymer must contain as an integral part of its composition at least 2 of the following atomic elements:

  • (a)

    carbon;

  • (b)

    hydrogen;

  • (c)

    nitrogen;

  • (d)

    oxygen;

  • (e)

    silicon;

  • (f)

    sulphur.

• (2)

  For paragraph (h) of that definition, a polymer must not contain as an integral part of its composition (except as impurities) an atomic element other than the following:

  • (a)

    aluminium as the monatomic counterion Al3+;

  • (b)

    bromine as the monatomic counterion Br-;

  • (c)

    bromine covalently bound to carbon;

  • (d)

    calcium as the monatomic counterion Ca2+;

  • (e)

    carbon;

  • (f)

    chlorine as the monatomic counterion Cl-;

  • (g)

    chlorine covalently bound to carbon;

  • (h)

    fluorine covalently bound to carbon;

  • (i)

    hydrogen;

  • (j)

    iodine as the monatomic counterion I-;

  • (k)

    iodine covalently bound to carbon;

  • (l)

    magnesium as the monatomic counterion Mg2+;

  • (m)

    nitrogen;

  • (n)

    oxygen;

  • (o)

    potassium as the monatomic counterion K+;

  • (p)

    silicon;

  • (q)

    sodium as the monatomic counterion Na+;

  • (r)

    sulphur;

  • (s)

    less than 0.2% (by weight) of any combination of the following atomic elements:

    • (i)

      boron;

    • (ii)

      copper;

    • (iii)

      iron;

    • (iv)

      lithium;

    • (v)

      manganese;

    • (vi)

      nickel;

    • (vii)

      phosphorus;

    • (viii)

      tin;

    • (ix)

      titanium;

    • (x)

      zinc;

    • (xi)

      zirconium.

• (3)

  For paragraph (h) of that definition, a polymer that is capable of absorbing its own weight in water must not have a number average molecular weight that is 10 000 or greater.

[4]Paragraphs 8A (a), 8C (a) and 9B (a)

substitute

• (a)

  the following authorities are prescribed for the Commonwealth:

  • (i)

    the Department of the Environment and Heritage;

  • (ii)

    the Department of Health and Ageing; and

[5]Subregulation 11B (1)

omit

Prior Informed Consent Scheme

insert

interim PIC procedure

[6]Subregulation 11B (2)

substitute

• (2)

  In subregulation (1):

interim PIC procedure means the voluntary scheme adopted by the Resolution of the Conference of the Plenipotentiaries on the Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (the Rotterdam Convention) on 10 September 1998.

[7]Regulations 12A and 12C

omit

[8]Regulation 16

omit

[9]Subregulation 17 (1)

omit

subregulation 15 (1), (4) or (5) or 16 (1).

insert

subregulation 15 (1), (4), (5) or (6) or regulation 16A.

[10]Schedule 1, Form 1A

substitute

Form 1A

(regulation 7AA)

Industrial Chemicals (Notification and Assessment) Act 1989

STATEMENT UNDER SECTION 24A REGARDING A SYNTHETIC POLYMER OF LOW CONCERN

Applicant Details

Business Name:

Business Address (including postcode):

Postal Address (including postcode):

Phone: Fax: E-mail:

Technical Contact

Name:

Position:

Phone: Fax: E-mail:

Details of polymer

Chemical Name of Polymer:

Other Names:

Marketing Name:

CAS Number:

Justification for application under the Synthetic Polymer of Low Concern category

Does the polymer meet the criteria for a synthetic polymer of low concern in section 5 of the Act and regulations 4A to 4I of the Industrial Chemicals (Notification and Assessment) Regulations 1990?

number average molecular weight	YES/NO
polyester	YES/NO
reactive functional groups – functional group equivalent weight	YES/NO
charge density	YES/NO
residual monomer content	YES/NO
stability	YES/NO
chemical composition	YES/NO
water absorbing polymer	YES/NO

Molecular formula:

Structural formula:

Means of identification (list of spectral data available):

Number-average molecular weight (NAMW):

Weight-average molecular weight (WAMW):

Weight percentage of polymer species with MW less than 1000:

Weight percentage of polymer species with MW less than 500:

Functional group equivalent weight (FGEW):

Does the polymer contain any positively or negatively charged groups?

 For cationic polymers, please provide a calculation of the charge density (number of charges per 1000 MW) or the combined FGEW of the charged groups.

Is the polymer cationic or reasonably anticipated to become cationic in the pH range (4-9) likely to be encountered in the environment?

Table 1:

List of polymer constituents

Constituent CAS No. % Weight

Table 2:

Maximum weight percentage of residual monomers

Monomer or Impurity % Weight

Water solubility:

Particle size distribution:

Comment on the stability of the polymer:

Does the polymer contain any functional groups which are intended or can reasonably be anticipated to undergo further reaction?

 If so, give details.

Intended use(s):

Appearance of the polymer:

Estimated manufacture or import volume (during each of the first 5 years):

Site of manufacture and/or reformulation:

Melting point:

Density:

Flammability limits:

Autoignition temperature:

Explosive properties:

Reactivity (e.g. oxidation potential):

Occupational Health and Safety

What is the likely occupational exposure?

 Give details of:

(a) data about occupational exposure factors, that is:

• I.

  the number and categories of workers to be involved in working with the polymer; and

• II.

  the nature of the work to be done by them; and

• III.

  the safety procedures to be observed when handling the polymer; and

• IV.

  a brief description of the training and education in safe working practices to be given to those workers; and

• V.

  data about the occurrence of work-related injuries and diseases affecting workers dealing with the polymer; and

• VI.

  any other data relating to occupational hazards associated with the chemical; and

(b) a list of the health conditions (if any) which indicate that the polymer should not be used; and

(c) particulars of procedures for atmospheric monitoring and biological monitoring of the effects of the polymer; and

(d) information held, or reasonably obtainable, by the notifier about studies and observations of health problems or adverse symptoms occurring in humans exposed to the polymer.

Environmental Impact

What is the environmental impact?

 Provide information about the release of the polymer likely to occur at the manufacture or reformulation site and during normal end use (rather than from spills etc). Qualitative or semi-quantitative estimates only are required. Where there is both a high content of low molecular weight species and a high release to water, aquatic toxicity data for fish, daphnia and/or algae may be required. 

Public Health

What is the likely public health exposure?

  Provide a brief description of any way in which the polymer could be harmful or hazardous to the health of the public at large. Where there is both a high content of low molecular weight species and the polymer is to be used as an ingredient in a cosmetic product at 1% or more, additional information, e.g. toxicological data, may be required.

Label

Please attach labels (or copies of labels) for all products consisting of or containing the polymer.

Material Safety Data Sheet

Please provide MSDS for the polymer and all commercially available products, or substances used in the workplace, containing the polymer.

Declaration

I declare that to the best of my knowledge all the information in this form and attachments is true, correct and complete.

 I also declare that I am in possession of, and have ready access to, the raw data and am entitled to use and give the Director all information contained in this application.

Name:

Position:

Signature: Date:

NOTE:

 It is an offence under the Act to supply a statement which is false or misleading.

[11]After Schedule 2

insert

Schedule 3Reactive functional groups

(regulation 4A)

Item	Low concern	Moderate concern	High concern
1	Carboxylic acid	Pendant acrylates and methacrylates
2	Aliphatic hydroxyl	Aziridines
3	Unconjugated olefinic considered ‘ordinary’ (that is, unconjugated olefinic not specifically activated by being part of a larger functional group or by other activating influences)	Carbodi-imides
4	Butenedioic acid	Halosilanes, Hydrosilanes, Alkoxysilanes
5	Conjugated olefinic groups contained in naturally occurring fats, oils and carboxylic acids	Conjugated olefinic groups not contained in naturally occurring fats, oils and carboxylic acids	Hydrazines
6	Blocked isocyanates (including ketoxime-blocked isocyanates)	Isocyanates, isothiocyanates
7	Thiols	Alpha or beta lactones
8	Unconjugated nitriles	Vinyl sulfones or analogous compounds
9	Halogens (except reactive halogen- containing groups such as benzylic or allylic halides)	Acid halides
10	Acid anhydrides
11	Aldehydes
12	Hemiacetals
13	Methylolamides, amines or ureas
14	Cyanates
15	Epoxides
16	Unsubstituted positions ortho and para to phenolic hydroxyl
17	Allyl ethers
18	Imines (ketimines and aldimines)
19	Partially-hydrolysed acrylamides
20	Other reactive functional groups not in the low or moderate concern groups

   

Schedule 2Amendments commencing on the commencement of item 5 of Schedule 1 to the Safety, Rehabilitation and Compensation and Other Legislation Amendment Act 2001

  

(regulation 3)

[1]After regulation 4AA

insert

4ABPrescribed reactants

 For the definition of prescribed reactant in section 5 of the Act, a substance set out in Schedule 4 is prescribed.

[2]After Schedule 3

insert

Schedule 4Prescribed reactants

(regulation 4AB)

Part 1Di and Tri Basic Acids

Item	Substance	CAS no.
101	1,2-Benzenedicarboxylic acid	88-99-3
102	1,3-Benzenedicarboxylic acid	121-91-5
103	1,3-Benzenedicarboxylic acid, dimethyl ester	1459-93-4
104	1,4-Benzenedicarboxylic acid	100-21-0
105	1,4-Benzenedicarboxylic acid, diethyl ester	636-09-9
106	1,4-Benzenedicarboxylic acid, dimethyl ester	120-61-6
107	1,2,4-Benzenetricarboxylic acid	528-44-9
108	Butanedioic acid	110-15-6
109	Butanedioic acid, diethyl ester	123-25-1
110	Butanedioic acid, dimethyl ester	106-65-0
111	2-Butenedioic acid (E)-	110-17-8
112	Decanedioic acid	111-20-6
113	Decanedioic acid, diethyl ester	110-40-7
114	Decanedioic acid, dimethyl ester	106-79-6
115	Dodecanedioic acid	693-23-2
116	Fatty acids, C18-unsaturated, dimers	61788-89-4
117	Heptanedioic acid	111-16-0
118	Heptanedioic acid, dimethyl ester	1732-08-7
119	Hexanedioic acid	124-04-9
120	Hexanedioic acid, dimethyl ester	627-93-0
121	Hexanedioic acid, diethyl ester	141-28-6
122	Nonanedioic acid	123-99-9
123	Nonanedioic acid, dimethyl ester	1732-10-1
124	Nonanedioic acid, diethyl ester	624-17-9
125	Octanedioic acid	505-48-6
126	Octanedioic acid, dimethyl ester	1732-09-8
127	Pentanedioic acid	110-94-1
128	Pentanedioic acid, dimethyl ester	1119-40-0
129	Pentanedioic acid, diethyl ester	818-38-2
130	Undecanedioic acid	1852-04-6

Part 2Modifiers

Item	Substance	CAS no.
201	Acetic acid, 2,2´-oxybis-	110-99-6
202	1-Butanol (other than 1-butanol that is used to manufacture a polyester with maleic or fumaric acid)	71-36-3
203	Cyclohexanol	108-93-0
204	Cyclohexanol, 4,4´-(1-methylethylidene)bis	80-04-6
205	Ethanol, 2-(2-butoxyethoxy)-	112-34-5
206	1-Hexanol	111-27-3
207	Methanol, hydrolysis products with trichlorohexylsilane and trichlorophenylsilane	72318-84-4
208	1-Phenanthrenemethanol, tetradecahydro-1,4a-dimethyl-7-(1-methylethyl)-	13393-93-6
209	Phenol, 4,4´-(1-methylethylidene)bis-, polymer with 2,2´-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bis[oxirane]	25036-25-3
210	Siloxanes and Silicones, dimethyl, diphenyl, polymers with phenyl silsesquioxanes, methoxy-terminated	68440-65-3
211	Siloxanes and Silicones, dimethyl, methoxy phenyl, polymers with phenyl silsesquioxanes, methoxy-terminated	68957-04-0
212	Siloxanes and Silicones, methyl phenyl, methoxy phenyl, polymers with phenyl silsesquioxanes, methoxy- and phenyl-terminated	68957-06-2
213	Silsesquioxanes, phenyl propyl	68037-90-1

Part 3Monobasic Acids and Natural Oils

Item	Substance	CAS no. (if any)
301	Benzoic acid	65-85-0
302	Canola oil	120962-03-0
303	Coconut oil	8001-31-8
304	Corn oil	8001-30-7
305	Cottonseed oil	8001-29-4
306	Dodecanoic acid	143-07-7
307	Fats and glyceridic oils, anchovy	128952-11-4
308	Fats and glyceridic oils, babassu	91078-92-1
309	Fats and glyceridic oils, herring	68153-06-0
310	Fats and glyceridic oils, menhaden	8002-50-4
311	Fats and glyceridic oils, sardine	93334-41-9
312	Fats and glyceridic oils, oiticica	8016-35-1
313	Fatty acids, C16-18 and C18-unsaturated	67701-08-0
314	Fatty acids, castor-oil	61789-44-4
315	Fatty acids, coco	61788-47-4
316	Fatty acids, dehydrated castor-oil	61789-45-5
317	Fatty acids, linseed oil	68424-45-3
318	Fatty acids, safflower oil	93165-34-5
319	Fatty acids, soya	68308-53-2
320	Fatty acids, sunflower oil	84625-38-7
321	Fatty acids, sunflower-oil, conjugated	68953-27-5
322	Fatty acids, tall-oil	61790-12-3
323	Fatty acids, tall-oil, conjugated
324	Fatty acids, vegetable oil	61788-66-7
325	Glycerides, C16-18 and C18-unsaturated	67701-30-8
326	Heptanoic acid	111-14-8
327	Hexanoic acid	142-62-1
328	Hexanoic acid, 3,3,5-trimethyl-	3302-10-1
329	Linseed oil	8001-26-1
330	Linseed oil, oxidised	68649-95-6
331	Nonanoic acid	112-05-0
332	Oils, Cannabis
333	Oils, palm kernel	8023-79-8
334	Oils, perilla	68132-21-8
335	Oils, walnut	8024-09-7
336	Safflower oil	8001-23-8
337	Soybean oil	8001-22-7
338	Sunflower oil	8001-21-6
339	Tung oil	8001-20-5

Part 4Polyols

Item	Substance	CAS no.
401	1,3-Butanediol	107-88-0
402	1,4-Butanediol	110-63-4
403	1,4-Cyclohexanedimethanol	105-08-8
404	1,2-Ethanediol	107-21-1
405	Ethanol, 2,2´-oxybis-	111-46-6
406	1,6-Hexanediol	629-11-8
407	1,3-Pentanediol, 2,2,4-trimethyl-	144-19-4
408	1,2-Propanediol	57-55-6
409	1,3-Propanediol, 2,2-bis(hydroxymethyl)-	115-77-5
410	1,3-Propanediol, 2,2-dimethyl-	126-30-7
411	1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)-	77-99-6
412	1,3-Propanediol, 2-(hydroxymethyl)-2-methyl	77-85-0
413	1,3-Propanediol, 2-methyl	2163-42-0
414	1,2,3-Propanetriol	56-81-5
415	1,2,3-Propanetriol, homopolymer	25618-55-7
416	2-Propen-1-ol, polymer with ethenylbenzene	25119-62-4

Notes

1. These Regulations amend Statutory Rules 1990 No. 231, as amended by 1990 No. 440; 1991 No. 165; 1992 Nos. 29, 245 and 282; 1993 No. 35; 1994 Nos. 21, 320, 368 and 454; 1995 Nos. 81 and 358; 1997 Nos. 181, 193, 203 and 419; 1999 No. 224; 2002 No. 9.

2. Notified in the Commonwealth of Australia Gazette on 28 March 2002.