Commonwealth Numbered Regulations Commonwealth Numbered Regulations
[1] Regulation 23A, including the note
substitute
23A Listing Schedule
For subsection 56C (1) of the Code, Part 2 of Schedule 3B lists chemical products or classes of chemical products that can be granted listed registration under Part 2A of the Code.
Note 1 Schedule 3B sets out products that are listable chemical products .
Note 2 Division 4 of Part 2A of the Code provides how applications for listed registration of a listable chemical product for which there is an established standard are to be dealt with.
[2] Part 2B, including the note
substitute
Part 2B Reserved chemical products
23G Reserved Schedule
For subsection 56ZU (1) of the Code, Part 2 of Schedule 3C specifies chemical products or classes of chemical products that are reserved chemical products for the purposes of the Code.
23H Conditions for dealing with reserved chemical product -- containers for supply
(1) For subsection 56ZU (3) of the Code, a container used for the supply of a chemical product mentioned in Part 2 of Schedule 3C must:
(a) be impervious to, and incapable of chemical reaction with, its contents when under conditions of temperature and pressure that are likely to be encountered in normal service; and
(b) have sufficient strength and impermeability to prevent leakage of its contents during handling, transport and storage under normal handling conditions; and
(c) if it is intended to be opened more than once -- be able to be securely and readily closed and reclosed; and
(d) have sufficient excess capacity to prevent it from breaking if its contents expand during handling, transport or storage; and
(e) enable all or any part of its contents to be removed or discharged in such a way that, with the exercise of no more than reasonable care, the contents cannot:
(i) harm a person; or
(ii) have an unintended effect that is harmful to the environment.
(2) Nothing in subregulation (1) affects the operation of any other law that applies in relation to containers for chemical products.
23I Conditions for dealing with reserved chemical product -- labels
(1) For subsection 56ZU (3) of the Code, a label for a chemical product mentioned in Part 2 of Schedule 3C must not contain a claim about the product and its active constituents that is inconsistent with:
(a) the definition of disinfectant in section 1 of Part 1 of Schedule 3C; and
(b) the particulars of the product, and active constituents of the product, set out in Schedule 3C.
(2) For subsection 56ZU (3) of the Code, a label for a chemical product of the kind mentioned in Part 2 of Schedule 3C must include any first aid instructions and safety directions that apply to the product, based on its type and formulation, in accordance with the document entitled Handbook of First Aid Instructions, Safety Directions, Warning Statements and General Safety Precautions for Agricultural and Veterinary Chemicals , published by the Office of Chemical Safety in the Therapeutic Goods Administration of the Department of Health and Ageing, as in force from time to time.
Note The Handbook of First Aid Instructions, Safety Directions, Warning Statements and General Safety Precautions for Agricultural and Veterinary Chemicals can be found on the Therapeutic Goods Administration website at http://www.tga.gov.au .
[3] After Schedule 3A
insert
Schedule 3B Listing Schedule
(regulation 23A)
Part 1 Preliminary
1 Particulars of listable chemical products
Each chemical product, or class of chemical product, listed in this Schedule is described in a separate item in the table in Part 2 as follows:
(a) column 2 describes the product;
(b) column 3 describes the product use.
2 Active constituents in listable chemical products
(1) A substance mentioned in column 2 of an item in the table in Part 2 as an active constituent of a chemical product or class of chemical product, means the substance with that name that complies with the particulars specified for that substance in an item in a Subdivision of Part 3 of this Schedule.
(2) Each substance dealt with in a Subdivision of Part 3 is described in a separate item as follows:
(a) the first row gives the common name of the substance;
(b) the second row lists any synonyms for the substance;
(c) the third row gives the Australian approved name, if any, for the substance;
(d) the fourth row gives the chemical name or names of the substance;
(e) the fifth row gives the chemical abstract service number for the substance;
(f) the sixth row identifies the relevant monograph or compendial standard, if any, with which the substance is required to comply .
Part 2 Listable chemical products
|
Item |
Chemical product or class of chemical product |
Chemical product or class of chemical product use |
|
1 |
An agricultural chemical product or class of chemical products that: (a) destroys bacteria, viruses and protozoa; and (b) contains only 1 of the following as an active constituent: (i) calcium hypochlorite; (ii) lithium hypochlorite; (iii) sodium dichloroisocyanurate; (iv) sodium hypochlorite; (v) trichloroisocyanuric acid; and (c) does not contain stabilisers, enhancers or flocculants |
Used in home swimming pools and spas |
|
2 |
A veterinary chemical product or class of chemical products that: (a) provides an exogenous source of biologically active ingredients to help improve the health of joints in dogs or horses; and (b) contains any 1 or more of the following as an active constituent: (i) chondroitin; (ii) glucosamine |
Administered orally to dogs and horses (in the form of oral powder, chewable or non‑chewable tablets, capsules containing powder or dry medicated food) |
Part 3 Active constituents in listable chemical products
Division 3.1 Agricultural chemical products
Subdivision 3.1.1 Home swimming pool and spa products
1 Calcium hypochlorite
|
Common name |
Calcium hypochlorite |
|
Synonyms |
Bleaching powder Calcium oxychloride Chloride of lime Chlorinated lime Hypochlorous acid -- calcium salt |
|
Australian approved name |
None |
|
Chemical name |
Calcium hypochlorite |
|
Chemical abstract service (CAS) number |
7778‑53‑3 |
|
Monograph or compendial standard with which active constituent is required to comply |
None |
2 Lithium hypochlorite
|
Common name |
Lithium hypochlorite |
|
Synonym |
Hypochlorous acid -- lithium salt |
|
Australian approved name |
None |
|
Chemical name |
Lithium hypochlorite |
|
Chemical abstract service (CAS) number |
13840‑33‑0 |
|
Monograph or compendial standard with which active constituent is required to comply |
None |
3 Sodium dichloroisocyanurate
|
Common name |
Sodium dichloroisocyanurate |
|
Synonyms |
Dichloroisocyanuric acid sodium salt Sodium 1,3‑dichloroisocyanurate |
|
Australian approved name |
None |
|
Chemical name |
1,3‑dichloro‑1,3,5‑triazine‑2,4,6‑(1H,3H,5H)‑trione, sodium salt |
|
Chemical abstract service (CAS) number |
2893‑78‑9 |
|
Monograph or compendial standard with which active constituent is required to comply |
None |
4 Sodium hypochlorite
|
Common name |
Sodium hypochlorite |
|
Synonyms |
Hypochlorous acid -- sodium salt Sodium oxychloride |
|
Australian approved name |
Sodium hypochlorite |
|
Chemical name |
Sodium hypochlorite |
|
Chemical abstract service (CAS) number |
7681‑52‑9 |
|
Monograph or compendial standard with which active constituent is required to comply |
None |
5 Trichloroisocyanuric acid
|
Common name |
Trichloroisocyanuric acid |
|
Synonyms |
1,3,5--trichloroisocyanuric acid, trichloro‑s‑triazinetrione symclosene |
|
Australian approved name |
None |
|
Chemical name |
1,3,5‑trichloro‑1,3,5‑triazine‑2,4,6‑(1H,3H,5H)‑trione |
|
Chemical abstract service (CAS) number |
87‑90‑1 |
|
Monograph or compendial standard with which active constituent is required to comply |
None |
Division 3.2 Veterinary chemical products
Subdivision 3.2.1 Joint health products for dogs and horses
1 Chondroitin
|
Common name |
Chondroitin |
|
Synonyms |
Calcium chondroitin sulfate Chondroitin sulfate Chondroitin sulfate sodium Chondroitin polysulfate Chondroitin sulphuric acid Potassium chondroitin sulfate Sodium chondroitin sulfate |
|
Australian approved name |
Chondroitin sulfate |
|
Chemical names |
Chondroitin sulfate sodium -- [4)‑( b ‑D‑glucopyranosyluronic acid)‑(1 g 3)‑[2‑(acetylamino)‑2‑deoxy‑b‑D‑galactopyranosyl‑4‑sulfate] Chondroitin sulfate sodium as sodium salt -- [4)‑(b ‑D‑glucopyranosyluronic acid)‑(1g3)‑[2‑(acetylamino)‑2‑deoxy‑b‑D‑galactopyranosyl‑6‑sulfate] |
|
Chemical abstract service (CAS) numbers |
9007‑28‑7 (Chondroitin) 9082‑07‑9 (Chondroitin sulfate sodium) |
|
Monograph or compendial standard with which active constituent is required to comply |
British Pharmacopoeia (BP); or European Pharmacopoeia (EP); or United States Pharmacopoeia (USP) for chondroitin sulfate or its salts |
2 Glucosamine
|
Common name |
Glucosamine |
|
Synonym |
None |
|
Australian approved name |
Glucosamine hydrochloride Glucosamine sulfate |
|
Chemical names |
2‑ amino‑2‑deoxy‑D‑glucose hydrochloride 2‑amino‑2‑deoxy‑ b‑D‑glucopyranose hydrochloride Bis(2‑amino‑2‑deoxy‑D‑glucose) sulfate |
|
Chemical abstract service (CAS) numbers |
66‑84‑2 (Glucosamine hydrochloride) 29031‑19‑4 (Glucosamine sulfate) |
|
Monograph or compendial standard with which active constituent is required to comply |
United States Pharmacopoeia (USP) for glucosamine hydrochloride or glucosamine sulfate |
Schedule 3C Reserved Schedule
(regulation 23G)
Part 1 Preliminary
1 Definitions
In this Schedule:
disinfectant means a substance:
(a) that is recommended by its manufacturer for application to an inanimate object to kill micro‑organisms generally; and
(b) that is not represented by the manufacturer to be effective for any of the following:
(i) killing specific or named micro‑organisms;
(ii) use as a sterilant, dairy cleanser, or pool and spa sanitiser; and
(c) that is not represented by the manufacturer to be effective for internal use or application on food; and
(d) that is not promoted primarily through retailers to consumers for domestic use.
"sterilant" means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10 -6 .
2 Particulars of reserved chemical products
The particulars of a chemical product or class of chemical product listed in this Schedule are specified in an item in the table in Part 2 as follows:
(a) column 2 sets out:
(i) the product use; and
(ii) the concentration level, if any, of the active constituent in the product;
(b) column 3 sets out the active constituent or constituents of the product.
3 Active constituents in reserved chemical products
(1) A substance mentioned in column 3 of Part 2 as an active constituent of a chemical product or class of chemical product, means the substance with that name that complies with the particulars specified for that substance in an item in a Subdivision of Part 3 of this Schedule.
(2) Each substance mentioned in a Subdivision of Part 3 is described in a separate item as follows:
(a) the first row gives the common name of the substance;
(b) the second row lists any synonyms for the substance;
(c) the third row gives the Australian approved name, if any, for the substance;
(d) the fourth row gives its chemical name;
(e) the fifth row gives the chemical abstract service number for the substance;
(f) the sixth row identifies the relevant monograph or compendial standard, if any, with which the substance is required to comply.
Part 2 Reserved chemical products
|
Item |
Chemical product or class of chemical product |
Active constituent(s) of chemical product or class of chemical product |
|
1 |
An agricultural chemical product used as a disinfectant if: (a) the product contains the active constituent specified in column 3; and (b) the active constituent specified in column 3 does not make up more than 10% of the class of product |
Benzalkonium chloride |
|
2 |
An agricultural chemical product used as a disinfectant if: (a) the product contains the active constituent specified in column 3; and (b) the active constituent specified in column 3 does not make up more than 5% of the class of product |
Glutaraldehyde |
|
3 |
An agricultural chemical product used as a disinfectant if: (a) the product contains the active constituent specified in column 3; and (b) the active constituent specified in column 3 does not make up more than 6% of the class of product |
Hydrogen peroxide |
|
4 |
An agricultural chemical product used as a disinfectant if: (a) the product contains the active constituent specified in column 3; and (b) the active constituent specified in column 3 does not make up more than 3% of the class of product |
O‑benzyl‑p‑chlorophenol |
|
5 |
An agricultural chemical product used as a disinfectant if the product contains the active constituent specified in column 3 |
Ortho‑phenylphenol |
|
6 |
An agricultural chemical product used as a disinfectant if: (a) the product contains the active constituent specified in column 3; and (b) the active constituent specified in column 3 does not make up more than 10% of the class of product |
Peroxyacetic acid |
|
7 |
An agricultural chemical product used as a disinfectant if: (a) the product contains the active constituent specified in column 3; and (b) the active constituent specified in column 3 does not make up more than 35% of the class of product |
Phosphoric acid |
|
8 |
An agricultural chemical product used as a disinfectant if: (a) the product contains the active constituent specified in column 3; and (b) the active constituent specified in column 3 does not make up more than 5% of the class of product |
Sodium hydroxide |
|
9 |
An agricultural chemical product used as a disinfectant if: (a) the product contains the active constituent specified in column 3 for this item is contained; and (b) the active constituent specified in column 3 does not make up more than 20% of the class of product |
Sodium hypochlorite |
|
10 |
An agricultural chemical product used as a disinfectant if: (a) the product contains the active constituent specified in column 3; and (b) the active constituent specified in column 3 does not make up more than 10% of the class of product |
Sulfamic acid |
|
11 |
An agricultural chemical product used as a disinfectant if: (a) the product contains the active constituent specified in column 3 for this item is contained; and (b) the active constituent specified in column 3 does not make up more than 0.5% of the product |
Sulfuric acid |
Part 3 Active constituents in reserved chemical products
Division 3.1 Agricultural chemical products
Subdivision 3.1.1 Disinfectants
1 Benzalkonium chloride
|
Common name |
Benzalkonium chloride |
|
Synonyms |
Alkyl‑benzyl‑dimethylammonium chloride Alkylbenzyldimethyl chloride |
|
Australian approved name |
Benzalkonium chloride |
|
Chemical name |
Benzalkonium chloride |
|
Chemical abstract service (CAS) number |
8001‑54‑5 |
|
Monograph or compendial standard with which active constituent is required to comply |
British Pharmacopoeia (BP); or European Pharmacopoeia (EP) |
2 Glutaraldehyde
|
Common name |
Glutaraldehyde |
|
Synonyms |
Gluteraldehyde 1,3‑diformylpropane 1,5‑pentanedial 1,5‑pentanedione |
|
Australian approved name |
Glutaraldehyde |
|
Chemical name |
Glutaraldehyde |
|
Chemical abstract service (CAS) number |
111‑30‑9 |
|
Monograph or compendial standard with which active constituent is required to comply |
British Pharmacopoeia (BP) |
3 Hydrogen peroxide
|
Common name |
Hydrogen peroxide |
|
Synonym |
Hydrogen dioxide |
|
Australian approved name |
Hydrogen peroxide |
|
Chemical name(s) |
Hydrogen peroxide |
|
Chemical abstract service (CAS) number |
7722‑84‑1 |
|
Monograph or compendial standard with which active constituent is required to comply |
British Pharmacopoeia (BP); or European Pharmacopoeia (EP) |
4 O‑benzyl‑p‑chlorophenol
|
Common name |
O‑benzyl‑p‑chlorophenol |
|
Synonyms |
4‑chloro‑2‑(phenylmethyl)phenol 4‑chloro‑alpha‑phenyl‑ortho‑cresol 5‑chloro‑2‑hydroxydiphenylmethane Benzylchlorophenol Benzyl‑p‑chlorophenol Chlorophenol |
|
Australian approved name |
None |
|
Chemical name |
O‑benzyl‑p‑chlorophenol |
|
Chemical abstract service (CAS) number |
120‑32‑1 |
|
Monograph or compendial standard with which active constituent is required to comply |
None |
5 Ortho‑phenylphenol
|
Common name |
Ortho‑phenylphenol |
|
Synonyms |
(1,1‑biphenyl)‑2‑ol 1,1'‑biphenyl‑2‑ol 2‑biphenylol 2‑phenylphenol Hydroxy‑2‑phenylbenzene |
|
Australian approved name |
Ortho‑phenylphenol |
|
Chemical name |
1,1'‑biphenyl‑2‑ol |
|
Chemical abstract service (CAS) number |
90‑43‑7 |
|
Monograph or compendial standard with which active constituent is required to comply |
None |
6 Peroxyacetic acid
|
Common name |
Peroxyacetic acid |
|
Synonyms |
Acetic peroxide Acetyl hydroperoxide Peracetic acid |
|
Australian approved name |
Peracetic acid |
|
Chemical name |
Peroxyacetic acid |
|
Chemical abstract service (CAS) number |
79‑21‑0 |
|
Monograph or compendial standard with which active constituent is required to comply |
None |
7 Phosphoric acid
|
Common name |
Phosphoric acid |
|
Synonym |
Orthophosphoric acid |
|
Australian approved name |
None |
|
Chemical name |
Phosphoric acid |
|
Chemical abstract service (CAS) number |
7664‑38‑2 |
|
Monograph or compendial standard with which active constituent is required to comply |
British Pharmacopoeia (BP); or European Pharmacopoeia (EP) |
8 Sodium hydroxide
|
Common name |
Sodium hydroxide |
|
Synonym |
Caustic soda |
|
Australian approved name |
Sodium hydroxide |
|
Chemical name |
Sodium hydroxide |
|
Chemical abstract service (CAS) number |
1310‑73‑2 |
|
Monograph or compendial standard with which active constituent is required to comply |
British Pharmacopoeia (BP); or European Pharmacopoeia (EP) |
9 Sodium hypochlorite
|
Common name |
Sodium hypochlorite |
|
Synonyms |
Hypochlorous acid‑sodium salt Sodium oxychloride |
|
Australian approved name |
Sodium hypochlorite |
|
Chemical name(s) |
Sodium hypochlorite |
|
Chemical abstract service (CAS) number |
7681‑52‑9 |
|
Monograph or compendial standard with which active constituent is required to comply |
None |
10 Sulfamic acid
|
Common name |
Sulfamic acid |
|
Synonyms |
Amidosulfonic acid Amidosulfuric acid Aminosulfonic acid Sulfamidic acid Sulphamic acid |
|
Australian approved name |
Sulfamic acid |
|
Chemical name |
Sulfamic acid |
|
Chemical abstract service (CAS) number |
5329‑14‑6 |
|
Monograph or compendial standard with which active constituent is required to comply |
None |
11 Sulfuric acid
|
Common name |
Sulfuric acid |
|
Synonyms |
Hydrogen sulfate Sulphuric acid |
|
Australian approved name |
Sulfuric acid |
|
Chemical name |
Sulfuric acid |
|
Chemical abstract service (CAS) number |
7664‑93‑9 |
|
Monograph or compendial standard with which active constituent is required to comply |
British Pharmacopoeia (BP); or European Pharmacopoeia (EP) |
Division 3.2 Veterinary chemical products
Note This Division is reserved for future use.