Agricultural and Veterinary Chemicals Code Amendment Regulations 2007 (No. 1)1
Select Legislative Instrument 2007 No. 278
I, PHILIP MICHAEL JEFFERY, Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Agricultural and Veterinary Chemicals Code Act 1994.
Dated 26 September 2007
P. M. JEFFERY
Governor‑General
By His Excellency’s Command
SUSSAN LEY
Parliamentary Secretary to the Minister for Agriculture, Fisheries and Forestry
1 Name of Regulations
These Regulations are the Agricultural and Veterinary Chemicals Code Amendment Regulations 2007 (No. 1).
2 Commencement
These Regulations commence on the day after they are registered.
3 Amendment of Agricultural and Veterinary Chemicals Code Regulations 1995
Schedule 1 amends the Agricultural and Veterinary Chemicals Code Regulations 1995.
Schedule 1 Amendments
(regulation 3)
[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)‑(1g3)‑[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.
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.frli.gov.au.
