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Agricultural and Veterinary Chemicals Code Regulations 1995

Authoritative Version
  • - F2013C00473
  • In force - Superseded Version
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SR 1995 No. 27 Regulations as amended, taking into account amendments up to Agricultural and Veterinary Chemicals Legislation Amendment (2013 Measures No. 1) Regulation 2013
Principal Regulations
Administered by: Agriculture
Registered 23 Jul 2013
Start Date 01 Jul 2013
End Date 30 Jun 2014
Table of contents.

Commonwealth Coat of Arms

Agricultural and Veterinary Chemicals Code Regulations 1995

Statutory Rules No. 27, 1995 as amended

made under the

Agricultural and Veterinary Chemicals Code Act 1994

Compilation start date:                     1 July 2013

Includes amendments up to:            SLI No. 108, 2013

About this compilation

The compiled instrument

This is a compilation of the Agricultural and Veterinary Chemicals Code Regulations 1995 as amended and in force on 1 July 2013. It includes any amendment affecting the compiled instrument to that date.

This compilation was prepared on 3 July 2013.

The notes at the end of this compilation (the endnotes) include information about amending Acts and instruments and the amendment history of each amended provision.

Uncommenced provisions and amendments

If a provision of the compiled instrument is affected by an uncommenced amendment, the text of the uncommenced amendment is set out in the endnotes.

Application, saving and transitional provisions for amendments

If the operation of an amendment is affected by an application, saving or transitional provision, the provision is identified in the endnotes.

Modifications

If a provision of the compiled instrument is affected by a textual modification that is in force, the text of the modifying provision is set out in the endnotes.

Provision ceasing to have effect

If a provision of the compiled instrument has expired or otherwise ceased to have effect in accordance with a provision of the instrument, details of the provision are set out in the endnotes.

  

  

  


Contents

Part 1—Preliminary                                                                                                             1

1............ Name of Regulations........................................................................... 1

2............ Commencement................................................................................... 1

3............ Interpretation....................................................................................... 1

3A......... Meaning of reference active constituent.............................................. 8

3B......... Meaning of reference chemical product.............................................. 8

3C......... Definition of confidential commercial information—section 3 of the Code             8

4............ Definition of date‑controlled chemical product—section 3 of the Code.. 9

6............ Definition of protection period—section 3 of the Code...................... 9

7............ Definition of agricultural chemical product—section 4 of the Code.. 9

8............ Definition of veterinary chemical product—section 5 of the Code... 10

Part 2—Approvals and registration                                                                         11

Division 2.1—Granting or refusing approvals and registrations       11

Subdivision 2.1.1—Preliminary applications—summaries of applications 11

8A......... Summaries of applications for active constituents for companion animal products  11

8B......... Summaries of applications for active constituents for chemical products that are not companion animal products   11

8C......... Summaries of applications for companion animal products.............. 12

8D......... Summaries of applications for chemical products that are not companion animal products or repacks     13

8E.......... Summaries of applications for registered chemical products with new brand names                14

Subdivision 2.1.2—Grant or refusal of applications                                      15

9............ Certain agricultural products must contain dye or pigment................ 15

11.......... Labels to contain certain information................................................. 16

12.......... Labels to contain additional instructions............................................ 17

13.......... Assessment of use of active constituent as an undue hazard............. 17

14.......... Assessment of use of chemical product as an undue hazard............. 17

14A....... Assessment of chemical products manufactured outside Australia... 17

Subdivision 2.1.3—Particulars for approvals, registrations and labelling 18

15.......... Particulars of approved active constituents to be recorded................ 18

16.......... Particulars of registered chemical products to be recorded................ 18

17.......... Particulars for label........................................................................... 19

Subdivision 2.1.4—Conditions of approval—active constituents and chemical products           20

18.......... Containers for the supply of registered chemical products................ 20

Subdivision 2.1.5—Labelling standard                                                              21

18A....... Labelling standard............................................................................. 21

Subdivision 2.1.6—Conditions of approval—labels                                       21

18B....... Prescribed conditions for labels........................................................ 21

18C....... Label must be attached to containers for chemical products.............. 21

18D....... Information on label.......................................................................... 21

18E........ Labelling standards and requirements............................................... 22

18F........ Requirements for information on labels............................................ 22

18G....... Requirements about claims inconsistent with labels.......................... 23

18H....... Retention of label and information about label.................................. 23

18I......... Providing label and information about label to APVMA.................. 24

Subdivision 2.1.7—Notice of approval or registration                                  25

19.......... Information to be given in notice to approved person....................... 25

Division 2.2—Granting or refusing applications for variation of relevant particulars, or conditions, of approvals or registration                                                               27

Subdivision 2.2.1—Variation applications—summaries of applications  27

19AA.... Summaries of applications for variation of approvals for active constituents for companion animal products         27

19AB.... Summaries of applications for variation for active constituents other than for companion animal products             27

19AC.... Summaries of applications for variation for companion animal products 29

19AD.... Summaries of applications for variation for chemical products other than companion animal products   30

Subdivision 2.2.2—Grant or refusal of variation application                     31

19A....... Variation of relevant particulars or conditions of approval or registration                31

Division 2.3—Reconsideration of approval or registration                  32

20.......... Continued approval of an active constituent...................................... 32

21.......... Continued registration of a chemical product.................................... 32

22.......... Requirements for continued approval of label................................... 33

22AA.... Reconsideration by APVMA of approval of label............................ 33

Division 2.4—Limits on use of information                                                    34

22A....... Prescribed uses (Code, s 34F(5))...................................................... 34

Division 2.5—Summaries of advice on applications                                   35

22B....... Summaries of advice on applications for active constituents............. 35

22C....... Summaries of advice on applications for chemical products............. 36

Division 2.6—Late applications                                                                            39

23.......... Late applications for renewal of registration of chemical product...... 39

Part 2A—Listable chemical products                                                                      40

23A....... Listing Schedule................................................................................ 40

23AB.... Preparation of standards—prescribed matters................................... 40

23B....... Particulars of registered listed chemical products to be recorded....... 40

23C....... Containers for the supply of registered listed chemical products....... 41

23D....... Information to be given in notice to approved person....................... 42

23E........ Continued listed registration of chemical product.............................. 43

23F........ Late applications for renewal of listed registration of chemical product 43

Part 2B—Reserved chemical products                                                                   45

23G....... Reserved Schedule............................................................................ 45

23H....... Conditions for dealing with reserved chemical product—containers for supply       45

23I......... Conditions for dealing with reserved chemical product—labels........ 46

Part 3—Compensation for provider of certain information in respect of continued registration of certain chemical products                                                                                             47

Division 1—Notices                                                                                                      47

24.......... Protected registered information—notice to primary applicant.......... 47

25.......... Protected registered information—notice to secondary applicant...... 47

Division 2—Conduct of arbitration                                                                    49

26.......... Rules governing the conduct of an arbitration................................... 49

27.......... Notice of appointment of arbitrator................................................... 49

28.......... Parties to give information to arbitrator............................................. 49

29.......... Mediator to submit report.................................................................. 49

30.......... Arbitrator to conduct a hearing.......................................................... 50

31.......... Arbitrator to give the applicants notice of the hearing....................... 50

32.......... Arbitrator’s powers if applicant does not attend the hearing............. 50

33.......... Procedure at the hearing.................................................................... 50

34.......... Representation at the hearing............................................................. 50

35.......... Arbitrator may require information etc.............................................. 51

36.......... Fair proportion of cost of providing protected registration information 52

37.......... Arbitrator’s costs.............................................................................. 52

38.......... Applicants’ costs of arbitration......................................................... 53

39.......... Arbitrator exonerated from liability................................................... 53

Part 4—Control of chemical products                                                                    54

Division 1—General                                                                                                    54

40A....... Exemption of existing use active constituents................................... 54

40.......... Supply of substances for research etc for chemical products............ 54

41.......... Supply etc of substances with constituents differing from registered particulars      56

42.......... Prescribed standards for chemical products...................................... 56

43.......... When statements about chemical products can be made or reported.. 58

44.......... Record of manufacture or import of date‑controlled chemical product 58

45.......... Restricted chemical products............................................................. 59

46.......... Supply of chemical product—batch number or record of supply...... 59

Division 2—Supply of hormonal growth promotants                                62

47.......... Notice of intention to supply hormonal growth promotant................ 62

47A....... Notification number may be replaced or withdrawn.......................... 62

47AB.... Review of decision withdrawing assigned notification number........ 62

47B....... Notification number to be renewed annually..................................... 63

47C....... Hormonal growth promotant not to be supplied etc.......................... 63

48.......... Supply of hormonal growth promotant—purchaser’s declaration..... 64

49.......... Record of supply of hormonal growth promotant—manufacturer and supplier       65

50.......... Record of supply of hormonal growth promotant—importer and supplier               66

51.......... Record of supply of hormonal growth promotant—other suppliers.. 67

52.......... Record of supply of hormonal growth promotant—general requirements                68

53.......... Copy of records to be given to APVMA.......................................... 68

54.......... Copy of records etc to be kept........................................................... 69

Part 5—Analysis                                                                                                                   70

55.......... Analysis of chemical products—tests............................................... 70

56.......... Analysis at an accredited laboratory.................................................. 70

Part 6—Permits                                                                                                                     71

57.......... Additional requirement for the issue of a permit............................... 71

Part 7—Manufacture of chemical products                                                        72

58.......... Coming into force of section 121 of the Code................................... 72

59.......... Manufacture of chemical products—exempt products...................... 72

59A....... Manufacture of chemical products—exempt persons—single step... 73

59B....... Manufacture of chemical products—exempt persons—chemical product that ceases to be exempt          74

59C....... Manufacture of chemical products—exempt persons—legal personal representative etc of licence holder              74

59D....... Manufacture of chemical products—exempt persons—person that acquires business including transfer of licence.......................................................................................................... 75

59E........ Requirements for issue of licence...................................................... 76

60.......... Licence condition—holder to give information about manufacture... 76

61.......... Licence conditions—general............................................................. 77

61A....... Determination following GMP audit................................................. 81

62.......... Licence condition—naming persons in control of production etc...... 81

Part 8—Enforcement                                                                                                         82

63.......... Method of securing samples............................................................. 82

64.......... Form of search warrant..................................................................... 82

Part 9—Miscellaneous                                                                                                       83

65.......... Prescribed authorities that may require further information............... 83

66.......... Disclosure of confidential commercial information about toxicity etc 83

67.......... Disclosure of confidential commercial information about chemical products not yet registered etc          84

68.......... Disclosure of confidential commercial information to international organisations    84

69.......... Disclosure of confidential commercial information—records........... 85

70.......... Fees for applications......................................................................... 86

70A....... Fees in respect of existing use active constituents............................. 87

71.......... Modular assessment fee.................................................................... 88

71A....... Annual fees for continued registration of chemical product.............. 89

71B....... Overseas GMP compliance assessment............................................ 90

72.......... Remission of fees for applications.................................................... 91

72A....... Fees for licences................................................................................ 92

73.......... Fees for copies and extracts.............................................................. 94

74.......... Payment of fees................................................................................. 95

75.......... Notification that application has been received.................................. 95

76.......... Period within which APVMA is to determine application................ 96

77.......... Modular assessment period............................................................... 96

78.......... Commencement of period for determining applications made under section 10 of the Code    97

78A....... Commencement of period for determining other applications........... 98

79.......... Logo of the APVMA........................................................................ 99

Schedule 1—Date‑controlled agricultural chemical products             100

Schedule 2—Protected registration information—allocated points              101

Schedule 3—Definition of agricultural chemical product 104

Part 1—Preliminary                                                                                                         104

1............ Definitions...................................................................................... 104

Part 2—Substances or mixtures declared to be agricultural chemical products 105

Part 3—Substances or mixtures declared not to be agricultural chemical products        106

Schedule 3AA—Definition of veterinary chemical product  108

Part 1—Preliminary                                                                                                         108

1............ Definitions...................................................................................... 108

2............ Power to make orders..................................................................... 109

3............ Meaning of daily requirement......................................................... 109

Part 2—Substances or mixtures declared to be veterinary chemical products    110

Part 3—Substances or mixtures declared not to be veterinary chemical products            111

Schedule 3A—Prescribed uses (Code, s 34F (5))                        113

Part 1—Food crops and food crop groups                                                         113

Part 2—Animal foods and animal food groups                                               119

Part 3—Non‑food crops and situation groups                                                 120

Schedule 3B—Listing Schedule                                                                   121

Part 1—Preliminary                                                                                                         121

1............ Particulars of listable chemical products.......................................... 121

2............ Active constituents in listable chemical products............................. 121

Part 2—Listable chemical products                                                                        122

Part 3—Active constituents in listable chemical products                         123

Division 3.1—Agricultural chemical products                                            123

Subdivision 3.1.1     Home swimming pool and spa products                      123

Division 3.2—Veterinary chemical products                                               125

Subdivision 3.2.1     Joint health products for dogs and horses                  125

Schedule 3C—Reserved Schedule                                                             127

Part 1—Preliminary                                                                                                         127

1............ Definitions...................................................................................... 127

2............ Particulars of reserved chemical products....................................... 127

3............ Active constituents in reserved chemical products.......................... 128

Part 2—Reserved chemical products                                                                     129

Part 3—Active constituents in reserved chemical products                     131

Division 3.1—Agricultural chemical products                                            131

Subdivision 3.1.1     Disinfectants                                                                       131

Division 3.2—Veterinary chemical products                                               135

Schedule 4—Restricted chemical products                                      136

Schedule 5—AGVET Code—Search warrant under subsection 133(2)  137

Schedule 6—Applications—fees and assessment periods 139

Part 1—Preliminary                                                                                                         139

1.1......... Definitions...................................................................................... 139

1.2......... When chemical products are closely similar.................................... 140

1.3......... When chemical products are similar................................................ 142

1.4......... When chemical products are the same............................................. 143

1.5......... Meaning of protected information.................................................. 143

1.6......... Effect of Part 2 where information is protected information............ 144

1.7......... Fee when application for registration preceded by application for permit 144

Part 2—Table of fees and assessment periods                                                  145

Schedule 7—Table of fees and periods for completion of modules, levels and types of assessments                                                                                        150

Schedule 8—Logo of the Australian Pesticides and Veterinary Medicines Authority (APVMA)                                                                                           152

Endnotes                                                                                                                                  153

Endnote 1—Legislation history                                                                           153

Endnote 2—Amendment history                                                                         155

Endnote 3—Uncommenced amendments [none]                                        164

Endnote 4—Misdescribed amendments [none]                                           165


Part 1Preliminary

  

1  Name of Regulations

                   These Regulations are the Agricultural and Veterinary Chemicals Code Regulations 1995.

2  Commencement

                   These Regulations commence on the same day as the Agricultural and Veterinary Chemicals Code Act 1994.

3  Interpretation

             (1)  In these Regulations, unless the contrary intention appears:

Act means the Agricultural and Veterinary Chemicals Code Act 1994.

active constituent number, for an active constituent for a proposed or existing chemical product for which approval is sought in an application mentioned in section 11B of the Code, means the number that the APVMA gives to the active constituent after the application is lodged.

application number, for an application mentioned in section 11B, 28B or 34G of the Code, means the number that the APVMA gives to the application after the application is lodged.

approved active constituent means an active constituent approved under Part 2 of the Code.

Australian GMP Code means the Australian Code of Good Manufacturing Practice for Veterinary Chemical Products, published by the APVMA.

biological pesticide means an agricultural chemical product containing, or derived from, a living organism, whether or not the organism is genetically modified.

block or lick means a blend or mixture of one or more stockfood ingredients compressed or poured into a solid block form for voluntary consumption by livestock.

British Pharmacopoeia means the book of that name published for the British Pharmacopoeia Commission.

British Pharmacopoeia (Veterinary) means the book of that name published on the recommendation of the Medicines Commission of the United Kingdom.

category 1 licence means a licence issued under Part 8 of the Code to carry out steps in the manufacture of a veterinary chemical product that is:

                     (a)  registered as being, represented to be, or required to be sterile; or

                     (b)  an immunobiological product;

whether or not the licence also authorises the carrying out of steps in the manufacture of other chemical products.

category 2 licence means a licence issued under Part 8 of the Code to carry out steps in the manufacture of a veterinary chemical product, other than a veterinary chemical product mentioned in the definition of:

                     (a)  category 1 licence; or

                     (b)  category 3 licence; or

                     (c)  category 4 licence; or

                     (d)  category 6 licence.

category 3 licence means a licence issued under Part 8 of the Code to carry out steps in the manufacture of a veterinary chemical product that is an externally applied ectoparasiticide.

category 4 licence means a licence issued under Part 8 of the Code to carry out steps in the manufacture of a veterinary chemical product that is a premix or stockfood supplement.

category 6 licence means a licence issued under Part 8 of the Code to carry out only one or more of the following steps in the manufacture of a veterinary chemical product:

                     (a)  processing;

                     (b)  assembling;

                     (c)  packaging;

                     (d)  labelling;

                     (e)  storage;

                      (f)  sterilising;

                     (g)  testing;

                     (h)  releasing for supply.

chemical product number, for a chemical product for which registration is sought in an application mentioned in section 11B of the Code, means the number that the APVMA gives to the chemical product after the application is lodged.

Code has the same meaning as this Code in section 3 of the Schedule to the Act.

CSIRO means the Commonwealth Scientific and Industrial Research Organization established by the Science and Industry Research Act 1949.

current Poisons Standard has the meaning given by subsection 52A(1) of the Therapeutic Goods Act 1989.

EDTA means ethylenediaminetetraacetic acid.

emergency use, in relation to a chemical product or an active constituent, means a use of the product or constituent arising from an emergency in which there is a genuinely believed need for the use of the product or constituent.

European Pharmacopoeia means the book of that name published for the European Pharmacopoeia Commission.

FAO Specifications for Plant Protection Products means the publications of that name published by the Food and Agriculture Organization of the United Nations.

formulation change, in relation to a chemical product, means:

                     (a)  a change in the source of any active constituent of the product; or

                     (b)  a variation in the amount or concentration of one or more of the active constituents, or other constituents, of the product; or

                     (c)  the addition to the product, or removal from the product of one or more of the active constituents, or other constituents, of the product.

hormonal growth promotant means a veterinary chemical product containing a substance that is, or a mixture of substances that are, responsible for oestrogenic, androgenic or gestagenic activity to enhance growth or production in bovines or bubalines.

immunobiological product means a chemical product which, when administered to a vertebrate or invertebrate living creature, provides, induces or changes an immune response to a particular chemical or biological entity in that creature.

labelling standard means a standard determined for regulation 18A.

legal practitioner means a person who is admitted, and entitled to practise, as a barrister or solicitor in a State or Territory.

medical practitioner means a person registered or licensed as a medical practitioner under a law of a State or Territory.

minor use, in relation to a chemical product or an active constituent, means a use of the product or constituent that would not produce sufficient economic return to an applicant for registration of the product to meet the cost of registration of the product, or the cost of registration of the product for that use, as the case requires (including, in particular, the cost of providing the data required for that purpose).

modular assessment fee has the meaning given in regulation 71.

modular assessment period has the meaning given in regulation 77.

multi‑category licence means a licence issued under Part 8 of the Code to carry out steps in the manufacture of a veterinary chemical product mentioned in the definition of one of the following terms:

                     (a)  category 2 licence;

                     (b)  category 3 licence;

                     (c)  category 4 licence;

at the same premises as are used to carry out steps in the manufacture of veterinary chemical products mentioned in the definition of at least one other of those terms.

NATA means the National Association of Testing Authorities, Australia, a company having the Australian Company Number 004379748.

notification number, means a notification number assigned to a person under regulation 47.

nutritional ingredient includes, but is not limited to, the following:

                     (a)  protein meals (as a protein source);

                     (b)  fermentation products from human foods, (including brewer’s grains, yeasts and yeast extracts);

                     (c)  hay, including lucerne hay and peanut hay;

                     (d)  chaff;

                     (e)  straw;

                      (f)  grains, other similar seeds and the products of those grains or seeds;

                     (g)  vitamins, minerals and amino acids at normal nutritional levels;

                     (h)  salt, limestone and inorganic phosphorus sources;

                      (i)  fats and oils;

                      (j)  milk by‑products;

                     (k)  non‑protein nitrogen sources;

                      (l)  molasses.

poison schedule classification, in relation to a chemical product, means classification of the product or any of its constituents in the current Poisons Standard.

pool or spa hypochlorite means a chemical product that:

                     (a)  is for use in a swimming pool or spa that is for use by human beings; and

                     (b)  is a formulation of calcium hypochlorite, lithium hypochlorite or sodium hypochlorite that complies with the standard (if any) last published for that formulation by the National Registration Authority for Agricultural and Veterinary Products in the Gazette and in force on 31 October 1999.

Note:          The National Registration Authority for Agricultural and Veterinary Products is the former name of APVMA.

premix means a mixture that:

                     (a)  contains vitamins, minerals, amino acids or other substances; and

                     (b)  is intended to be added to stockfood to form a finished feed for feeding to a group of animals.

purchaser declaration number means a distinguishing number issued in respect of premises by a State or Territory or by an authority of a State or Territory, for the purpose of identifying those premises as premises where animals to be treated with a hormonal growth promotant are, or are to be, kept.

reference active constituent has the meaning given by regulation 3A.

reference chemical product has the meaning given by regulation 3B.

stockfood means a basic food or food mixture that:

                     (a)  contains one or more nutritional ingredients; and

                     (b)  is intended to be fed to animals for the maintenance of life, normal growth, production, work, reproduction or performance.

stockfood supplement means any substance or mixture of substances in the form of tablets, sachets or measures added to stockfood for administration to animals individually in order to supplement or balance that stockfood, but does not include a substance or mixture of substances in an injectable dose form, an intraruminal bolus, a block or a lick.

supply, in relation to any product or thing, includes cause or permit the supply of the product or thing.

Note:          Section 3 of the Code provides that supply includes do, or cause or permit the doing of, any of the following:

(a)    sell;

(b)    expose for sale;

(c)    send or deliver for sale or on sale;

(d)    dispose of under a hire purchase agreement;

(e)    exchange;

(f)    give;

(g)    offer to do an act that would be a supply (including an act referred to in any of the above paragraphs).

total leviable value has the same meaning as in the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994.

United States Pharmacopoeia means the book of that name published by the United States Pharmacopoeia Convention.

Note:          Several other words and expressions used in these Regulations have the meaning given by section 3 of the Code in the Schedule to the Act. For example:

·      active constituent

·      agricultural chemical product

·      approved label

·      interested person

·      label

·      relevant particulars

·      veterinary chemical product.

          (1A)  Unless the contrary intention appears, an expression used in both these Regulations and the Code has the same meaning in these Regulations as in the Code.

             (2)  Unless the contrary intention appears, a reference in these Regulations to a book or other publication is a reference to the latest edition of that book or publication as modified or amended from time to time, and includes any addendum or other addition to the book or publication.

3A  Meaning of reference active constituent

                   For these Regulations, reference active constituent, for an application mentioned in section 11B or 28B of the Code (the primary application), means an active constituent that:

                     (a)  is the subject of another application, being an application under section 10 or 27 of the Code that was lodged before the primary application; and

                     (b)  is referred to in the primary application because information that is relevant to the active constituent is also relevant to the primary application.

3B  Meaning of reference chemical product

                   For these Regulations, reference chemical product, for an application mentioned in section 11B or 28B of the Code (the primary application), means a chemical product that:

                     (a)  is the subject of another application, being an application under section 10 or 27 of the Code that was lodged before the primary application; and

                     (b)  is referred to in the primary application because information that is relevant to the chemical product is also relevant to the primary application.

3C  Definition of confidential commercial information—section 3 of the Code

                   For paragraph (e) of the definition of confidential commercial information in section 3 of the Code, the following information is prescribed:

                     (a)  the name of the applicant;

                     (b)  the application number;

                     (c)  the chemical product number;

                     (d)  the name of each of the active constituents of the chemical product;

                     (e)  a short description of the application and its purpose, including a description of the way in which the chemical product is intended to be used.

4  Definition of date‑controlled chemical product—section 3 of the Code

                   For the purposes of the definition of date‑controlled chemical product in section 3 of the Code, the following are declared to be date‑controlled chemical products:

                     (a)  each veterinary chemical product;

                     (b)  an agricultural chemical product specified in Schedule 1.

6  Definition of protection period—section 3 of the Code

             (1)  Subject to this regulation, the period, in years, in relation to protected registration information of a kind specified in columns 2 and 3 of an item in Schedule 2 is the period worked out in accordance with the formula:

                  

where:

A is the number, or the total number, as the case requires, of points allocated to that item in column 4 of Schedule 2; and

B is 600.

             (2)  If the period worked out in accordance with subregulation (1) in relation to an item is not a whole number, it is to be rounded to the nearest whole number.

             (3)  If the period worked out in accordance with subregulations (1) and (2) in relation to an item is more than 7 years, the period is taken to be 7 years.

7  Definition of agricultural chemical product—section 4 of the Code

             (1)  For subsection 4(3) of the Code, a substance or mixture of substances included in a class of substances or mixtures of substances listed in Part 2 of Schedule 3 is declared to be an agricultural chemical product.

             (2)  For paragraph 4(4)(b) of the Code, a substance or mixture of substances included in a class of substances or mixtures of substances listed in Part 3 of Schedule 3 is declared not to be an agricultural chemical product.

8  Definition of veterinary chemical product—section 5 of the Code

             (1)  For paragraph 5(3)(b) of the Code, a substance or mixture of substances included in a class of substances or mixtures of substances listed in Part 2 of Schedule 3AA is declared to be a veterinary chemical product.

             (2)  For paragraph 5(4)(b) of the Code, a substance or mixture of substances included in a class of substances or mixtures of substances listed in Part 3 of Schedule 3AA is declared not to be a veterinary chemical product.

Part 2Approvals and registration

Division 2.1Granting or refusing approvals and registrations

Subdivision 2.1.1Preliminary applications—summaries of applications

8A  Summaries of applications for active constituents for companion animal products

             (1)  This regulation applies to an application for approval of an active constituent for a proposed or existing chemical product that is a companion animal product.

             (2)  For subsection 11B(2) of the Code, the details are:

                     (a)  the name of the applicant; and

                     (b)  the application number; and

                     (c)  the name of the active constituent; and

                     (d)  the active constituent number; and

                     (e)  a short description of the application and its purpose, including the way in which the active constituent is intended to be used.

8B  Summaries of applications for active constituents for chemical products that are not companion animal products

             (1)  This regulation applies to an application for the approval of an active constituent for a proposed or existing chemical product that is not a companion animal product.

             (2)  For subsection 11B(2) of the Code, the details are:

                     (a)  the name of the applicant; and

                     (b)  the application number; and

                     (c)  the name of the active constituent; and

                     (d)  the active constituent number; and

                     (e)  a short description of the application and its purpose, including the way in which the active constituent is intended to be used; and

                      (f)  for any reference active constituent mentioned in the application:

                              (i)  the name of the reference active constituent; and

                             (ii)  if the active constituent is an approved active constituent—the distinguishing number that the APVMA gave to the active constituent when the approval was granted; and

                     (g)  a short description of each item of information contained in, or accompanying, the application in compliance with paragraph 11(1)(b) of the Code, including the details set out in subregulation (3); and

                     (h)  any other information that the APVMA considers to be relevant to its decision on the application.

             (3)  For paragraph (2)(g), the details for each item of information are:

                     (a)  the title shown on the item of information; and

                     (b)  the name of the author, or of each of the authors, of the information; and

                     (c)  the date shown on the item of information (if any); and

                     (d)  if no date is shown on the item of information—the date when the preparation of the information was completed; and

                     (e)  if the information was published:

                              (i)  the date when it was published; and

                             (ii)  the name of the publication in which it was published; and

                      (f)  the reference number shown on the item of information; and

                     (g)  the name and address of the authorising party for the information.

8C  Summaries of applications for companion animal products

             (1)  This regulation applies to an application for:

                     (a)  registration of a chemical product that is a companion animal product; or

                     (b)  approval of a label for a container for a chemical product that is a companion animal product.

             (2)  For subsection 11B(2) of the Code, the details are:

                     (a)  the name of the applicant; and

                     (b)  the application number; and

                     (c)  the chemical product number; and

                     (d)  the name of each of the active constituents of the chemical product; and

                     (e)  a short description of the application and its purpose, including the way in which the chemical product is intended to be used.

8D  Summaries of applications for chemical products that are not companion animal products or repacks

             (1)  This regulation applies to an application for:

                     (a)  registration of a chemical product that is not:

                              (i)  a companion animal product; or

                             (ii)  a chemical product mentioned in paragraph 8E(1)(a); or

                     (b)  approval of a label for a container for a chemical product mentioned in paragraph (a).

             (2)  For subsection 11B(2) of the Code, the details are:

                     (a)  the name of the applicant; and

                     (b)  the application number; and

                     (c)  the name of the chemical product; and

                     (d)  the chemical product number; and

                     (e)  the name of each of the active constituents of the chemical product; and

                      (f)  a short description of the application and its purpose, including the way in which the chemical product is intended to be used; and

                     (g)  for any reference active constituent mentioned in the application:

                              (i)  the name of the reference active constituent; and

                             (ii)  if the active constituent is an approved active constituent—the distinguishing number that the APVMA gave to the active constituent when the approval was granted; and

                     (h)  for any reference chemical product mentioned in the application:

                              (i)  the name of the reference chemical product; and

                             (ii)  if the chemical product has been registered—the distinguishing number that the APVMA gave to the chemical product when the APVMA decided to register the product; and

                      (i)  a short description of each item of information contained in, or accompanying, the application in compliance with paragraph 11(1)(b) of the Code, including the details set out in subregulation (3); and

                      (j)  any other information that the APVMA considers to be relevant to its decision on the application.

             (3)  For paragraph (2)(i), the details for each item of information are:

                     (a)  the title shown on the item of information; and

                     (b)  the name of the author, or of each of the authors, of the information; and

                     (c)  the date shown on the item of information (if any); and

                     (d)  if no date is shown on the item of information—the date when the preparation of the information was completed; and

                     (e)  if the information was published:

                              (i)  the date when it was published; and

                             (ii)  the name of the publication in which it was published; and

                      (f)  the reference number shown on the item of information; and

                     (g)  the name and address of the authorising party for the information.

8E  Summaries of applications for registered chemical products with new brand names

             (1)  This regulation applies to an application for:

                     (a)  registration of any kind of chemical product that is:

                              (i)  the same as a registered chemical product; and

                             (ii)  intended to be marketed under a brand name that is different from the brand name used for the registered chemical product; or

                     (b)  approval of a label for a container for a chemical product mentioned in paragraph (a).

             (2)  For subsection 11B(2) of the Code, the details are:

                     (a)  the name of the applicant; and

                     (b)  the application number; and

                     (c)  the chemical product number; and

                     (d)  the name of each of the active constituents of the chemical product; and

                     (e)  a short description of the application and its purpose, including the way in which the chemical product is intended to be used.

Subdivision 2.1.2Grant or refusal of applications

9  Certain agricultural products must contain dye or pigment

             (1)  For paragraph 14(3)(d) of the Code, an agricultural chemical product of a kind specified in subregulation (2), (3) or (4) must comply with the requirements prescribed by this regulation in relation to that product.

Note:          For the application of this regulation in relation to applications for variations, see regulation 19A.

             (2)  A molluscicide in the form of a bait and of which the active constituent is metaldehyde:

                     (a)  must contain sufficient green pigment or dye to colour the bait a distinctive green colour; and

                     (b)  must not contain, in the bait, any bone meal or other product of animal origin.

             (3)  A molluscicide in the form of a bait and of which the active constituent is methiocarb:

                     (a)  must contain sufficient blue pigment or dye to colour the bait a distinctive blue colour; and

                     (b)  must not contain, in the bait, any bone meal or other product of animal origin.

             (4)  An agricultural chemical product that is to be applied to seeds that are to be stored before planting or sowing must contain sufficient pigment or dye to colour the seed to which the product is applied so as to enable that seed to be readily distinguished from seed to which the product has not been applied.

11  Labels to contain certain information

             (1)  For paragraph 14(3)(d) of the Code, a label for containers for a chemical product must comply with the requirements of subregulation (2).

             (2)  A label must contain the following information:

                     (a)  the appropriate signal heading in accordance with the current Poisons Standard;

                     (b)  the name of the chemical product;

                     (c)  the name of each active constituent of the product;

                     (d)  the proportion of each active constituent of the product;

                     (e)  the name of each other constituent classified as a poison in the current Poisons Standard;

                      (f)  the proportion of any other constituent referred to in paragraph (e);

                     (k)  the name and address of the person who is primarily responsible for marketing the product;

                      (l)  the net contents of the product;

                    (m)  the distinguishing number of the label (including any distinguishing number given to the label under paragraph 178(2)(a) of the Code);

                     (n)  any other particulars of the product that the APVMA thinks appropriate.

12  Labels to contain additional instructions

             (1)  For subparagraph 14(3)(g)(x) of the Code, the following are prescribed matters:

                     (a)  if the chemical product is a veterinary chemical product, the duration of any treatment using the product;

                     (b)  any matter determined by the APVMA under subregulation (2).

             (2)  For paragraph 6(2)(c) of the Act, the APVMA may determine that a label will contain instructions about a matter.

13  Assessment of use of active constituent as an undue hazard

                   For paragraph 14(4)(e) of the Code, the method of analysis (if any) of the chemical composition of the active constituent concerned is a prescribed matter.

14  Assessment of use of chemical product as an undue hazard

                   For paragraph 14(5)(i) of the Code, the method of analysis (if any) of the chemical composition and form of the constituents of the chemical product is a prescribed matter.

14A  Assessment of chemical products manufactured outside Australia

             (1)  Subregulation (2) applies if:

                     (a)  a step in the manufacture of a chemical product occurs outside Australia; and

                     (b)  the product is not an exempt product within the meaning given by regulation 59; and

                     (c)  the product is not a listable chemical product; and

                     (d)  the product is not a reserved chemical product.

             (2)  For paragraph 14(5)(i) of the Code, a prescribed matter is whether the step complies with a standard that the APVMA has determined is comparable to the manufacturing principles and the Australian GMP Code.

Note:          Under paragraph 14(5)(i) of the Code, the regulations may prescribe matters to which the APVMA must have regard when deciding whether to register a chemical product.

Subdivision 2.1.3Particulars for approvals, registrations and labelling

15  Particulars of approved active constituents to be recorded

             (1)  For paragraph 19(2)(a) of the Code, the following particulars are prescribed:

                     (a)  if a name is given to the active constituent by the International Union of Pure and Applied Chemistry—that name;

                     (b)  if no name is given to the active constituent by the International Union of Pure and Applied Chemistry—the name given to the active constituent in an order, publication or approval referred to in regulation 42 that specifies the standard for the active constituent for the purposes of that regulation;

                     (c)  the common name for the active constituent proposed by the applicant and accepted by the APVMA;

                     (d)  the composition and purity of the active constituent;

                     (e)  the name of the manufacturer of the active constituent;

                      (f)  the address of each site at which the active constituent is manufactured by the manufacturer;

                     (g)  the name and business address of the applicant;

                     (h)  the date of entry of these particulars in the Record of Approved Active Constituents;

                      (j)  the date (if any) on which the approval ends.

             (2)  A particular mentioned in paragraphs (1)(c) to (j) is only prescribed for an active constituent approved in accordance with section 14A of the Code if the particular is readily available to the APVMA.

16  Particulars of registered chemical products to be recorded

                   For paragraph 20(2)(a) of the Code, the following particulars are prescribed:

                     (a)  the distinguishing name of the chemical product proposed by the applicant and accepted by the APVMA;

                     (b)  the constituents of the chemical product;

                     (c)  the concentration of each constituent of the chemical product;

                     (d)  if possible, the composition and purity of each active constituent of the chemical product;

                     (e)  the name and business address of the applicant;

                      (f)  the name of each State or Territory in respect of which the chemical product is registered;

                     (g)  the name of each manufacturer of the chemical product;

                     (h)  the address of each site at which the chemical product is manufactured by the manufacturer;

                      (j)  the date of entry of these particulars in the Register of Chemical Products;

                     (k)  the date on which the registration ends.

17  Particulars for label

             (1)  For paragraph 21(2)(a) of the Code, the following particulars are prescribed:

                     (a)  the appropriate signal words required by the current Poisons Standard;

                     (b)  the name of the chemical product;

                     (c)  the name of each active constituent of the product;

                     (d)  the proportion of each active constituent of the product;

                     (e)  the name of each constituent for the product that is:

                              (i)  not an active constituent; and

                             (ii)  classified as a poison in the current Poisons Standard;

                      (f)  the proportion of each constituent referred to in paragraph (e);

                     (g)  the name and address of the person who is primarily responsible for marketing the product;

                     (h)  the net contents of the product;

                      (i)  the distinguishing number of the label for the product (including a distinguishing number given to the label under paragraph 178(2)(a) of the Code);

                      (j)  particulars determined by the APVMA under subregulation (2).

Note:          The particulars prescribed in this regulation are a requirement prescribed by the regulations in relation to a label for paragraph 14(3)(d) of the Code.

             (2)  For paragraph 6(2)(c) of the Act, the APVMA may determine additional particulars to be placed on a label for a product.

Subdivision 2.1.4Conditions of approval—active constituents and chemical products

18  Containers for the supply of registered chemical products

             (1)  For paragraph 23(2)(a) of the Code, the kind of container described in this regulation is prescribed.

             (2)  The container 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 any person; or

                             (ii)  have an unintended effect that is harmful to the environment.

             (3)  Nothing in subregulation (2) is intended to affect the operation of any other law that applies in relation to containers for chemical products.

Subdivision 2.1.5Labelling standard

18A  Labelling standard

             (1)  The Chief Executive Officer may determine, by legislative instrument, any of the following requirements for a label for a container for a chemical product:

                     (a)  the presentation of the label, including the size, colour, legibility, dimensions, layout and format of the label;

                     (b)  the display of the label;

                     (c)  the information contained on the label.

Note:          A label can contain information in addition to the information required by legislation.

             (2)  A legislative instrument for this provision is called a labelling standard.

Subdivision 2.1.6Conditions of approval—labels

18B  Prescribed conditions for labels

             (1)  For paragraph 23A(1)(a) of the Code, the conditions in this subdivision are prescribed.

             (2)  For subsection 23A(3) of the Code, the conditions prescribed in this subdivision apply to a label for containers for all chemical products.

18C  Label must be attached to containers for chemical products

                   The label must be attached to the container for the chemical product to which it relates before the supply of the product.

Note:          For supply, see section 3 of the Code.

18D  Information on label

             (1)  Unless authorised by a permit, the label must state the following information:

                     (a)  the relevant particulars for the label;

                     (b)  the batch number of the chemical product;

                     (c)  the expiry date of the chemical product (if applicable);

                     (d)  the date of manufacture of the chemical product (if applicable).

Note 1:       For relevant particulars, see section 3 of the Code.

Note 2:       A label can contain information in addition to the information required by legislation.

             (2)  The label must not contain information that is contrary to the information mentioned in subregulation (1).

             (3)  The information mentioned in subregulation (1), on the label, must not be altered, defaced, obliterated, obscured or destroyed.

18E  Labelling standards and requirements

                   The label must comply with the requirements of:

                     (a)  if a labelling standard has been made by the Chief Executive Officer for regulation 18A—the labelling standard; or

                     (b)  if a labelling standard has not been made by the Chief Executive Officer for regulation 18A—either:

                              (i)  if the product is a veterinary chemical product—the Veterinary Labelling Code made by the APVMA, as in force from time to time; or

                             (ii)  if the product is an agricultural chemical product—the Agricultural Labelling Code made by the APVMA, as in force from time to time.

Note:          The Veterinary Labelling Code and the Agricultural Labelling Code are available at http://www.apvma.gov.au.

18F  Requirements for information on labels

             (1)  The label must not contain misleading or deceptive information about either:

                     (a)  a relevant particular on the label; or

                     (b)  the use, safety, environmental impact or efficacy of the chemical product to which the label relates.

             (2)  If the label is, or is required to be, attached to a container, information must not accompany or be placed on the container, including in the form of another label, if the information expressly or impliedly:

                     (a)  negates or varies information required by subregulation 18D(1) to be stated on the label; or

                     (b)  qualifies or minimises the substance or effect of the information required by subregulation 18D(1) to be stated on the label.

             (3)  To avoid doubt, the label must not contain instructions about the circumstances in which, or the purposes for which, the chemical product can be used, if those instructions are inconsistent with the instructions for use approved for the label by the APVMA.

18G  Requirements about claims inconsistent with labels

             (1)  An interested person in relation to the label must not make any claim, or cause or permit any claim to be made, about:

                     (a)  a registered chemical product; or

                     (b)  a chemical product that contains a registered chemical product;

that is inconsistent with an instruction on the label for a container for the chemical product.

             (2)  Subregulation (1) does not apply to:

                     (a)  a claim exempted by the APVMA from the operation of section 84 of the Code; or

                     (b)  a claim made in a notice published under section 55 of the Code; or

                     (c)  a claim permitted to be made under a law of the Commonwealth; or

                     (d)  a claim about conduct the person is authorised to engage in by a permit issued by the APVMA.

18H  Retention of label and information about label

             (1)  An interested person in relation to the label must:

                     (a)  retain a copy of each form of the label that is attached to a container, or a series of containers, released for supply; and

                     (b)  record either:

                              (i)  if the form of the label states a sequential batch number of the chemical product—the first batch number in the sequence for the form of label; or

                             (ii)  if the form of the label does not state a sequential batch number of the chemical product—each batch number for the form of label; and

                     (c)  record the day on which the series of containers on which the form of the label is attached is first released for supply.

             (2)  The label and information mentioned in subregulation (1) must be retained:

                     (a)  in a secure manner; and

                     (b)  for a 5 year period commencing on the last day on which the chemical product is supplied in a container with the label attached.

             (3)  For paragraphs (1)(a) and (c), a container is released for supply on the day when the container is sent from a manufacturing or packaging facility for the purposes of distribution or sale.

18I  Providing label and information about label to APVMA

             (1)  An interested person in relation to the label must, on a written request by the APVMA for:

                     (a)  a copy of a form of the label mentioned in paragraph 18H(1)(a); and

                     (b)  information about the label mentioned in paragraphs 18H(1)(b) and (c);

provide the label and information requested to the APVMA.

             (2)  If the request is for a copy of a form of a label, the copy must be accompanied by a declaration that the copy is of a form of label that has been attached to a container to which it relates.

             (3)  The label and information must be provided to the APVMA on the earlier of the following:

                     (a)  within 10 days of the day on which the request for the label and information is received;

                     (b)  on a day advised by the APVMA.

             (4)  The APVMA must not advise a date for paragraph (3)(b) unless:

                     (a)  the APVMA believes it is necessary to receive the label or information before the end of the period mentioned in paragraph (3)(a) to prevent imminent risk to public health or to occupational health or safety; and

                     (b)  the APVMA provides the reasons for the early date in the written request.

Subdivision 2.1.7Notice of approval or registration

19  Information to be given in notice to approved person

          (1A)  For subsection 24(2) of the Code, the information set out in this regulation is prescribed.

             (1)  If the notice is about the approval of an active constituent, the information is:

                     (a)  the particulars of the active constituent entered in the Record of Approved Active Constituents;

                     (b)  the date (if any) on which the approval ends;

                     (c)  any conditions of the approval under section 23 of the Code, other than a condition specifying the date on which the approval ends;

                     (d)  particulars of the notice of the approval to be published under subsection 52(1) of the Code;

                     (e)  the date on which the notice to the approved person is issued.

             (2)  If the notice is about the registration of a chemical product, the information is:

                     (a)  the matters about the approved label recorded in the relevant APVMA file under paragraphs 21(2)(c) and (d) of the Code;

                     (b)  the date of its registration under section 22 of the Code;

                     (c)  the date on which the registration ends;

                     (d)  any conditions of the registration under section 23 of the Code, other than a condition specifying the date on which the registration ends;

                     (e)  particulars of any notice of the registration to be published under subsection 52(2) of the Code;

                      (f)  any other details, entered in the Register of Chemical Products, about the chemical product that the APVMA thinks appropriate.

             (3)  If the notice is about the approval of a label for a container for a chemical product, the information is:

                     (a)  the name of the chemical product;

                     (b)  the matters about the approved label recorded in the relevant APVMA file under paragraphs 21(2)(c) and (d) of the Code;

                     (c)  the date of the label’s approval under section 22 of the Code;

                     (d)  any conditions of the approval under section 23 of the Code.

Division 2.2Granting or refusing applications for variation of relevant particulars, or conditions, of approvals or registration

Subdivision 2.2.1Variation applications—summaries of applications

19AA  Summaries of applications for variation of approvals for active constituents for companion animal products

             (1)  This regulation applies to:

                     (a)  an application for variation of the relevant particulars or conditions of the approval of an active constituent for a proposed or existing chemical product; and

                     (b)  the chemical product is a companion animal product.

             (2)  For subsection 28B(2) of the Code, the details are:

                     (a)  the name of the applicant; and

                     (b)  the application number; and

                     (c)  the name of the active constituent; and

                     (d)  the distinguishing number that the APVMA gave to the active constituent when the approval was granted; and

                     (e)  a short description of the application and its purpose, including the way in which the active constituent is intended to be used.

19AB  Summaries of applications for variation for active constituents other than for companion animal products

             (1)  This regulation applies to:

                     (a)  an application for variation of the relevant particulars or conditions of the approval of an active constituent for a proposed or existing chemical product; and

                     (b)  the chemical product is not a companion animal product.

             (2)  For subsection 28B(2) of the Code, the details are:

                     (a)  the name of the applicant; and

                     (b)  the application number; and

                     (c)  the name of the active constituent; and

                     (d)  the distinguishing number that the APVMA gave to the active constituent when the approval was granted; and

                     (e)  a short description of the application and its purpose, including the way in which the active constituent is intended to be used; and

                      (f)  for any reference active constituent mentioned in the application:

                              (i)  the name of the reference active constituent; and

                             (ii)  if the active constituent is an approved active constituent—the distinguishing number that the APVMA gave to the active constituent when the approval was granted; and

                     (g)  for any reference chemical product mentioned in the application:

                              (i)  the name of the reference chemical product; and

                             (ii)  if the chemical product has been registered—the distinguishing number that the APVMA gave to the chemical product when the APVMA decided to register the product; and

                     (h)  a short description of each item of information contained in, or accompanying, the application in compliance with paragraph 11(1)(b) of the Code, including the details set out in subregulation (3); and

                      (i)  any other information that the APVMA considers to be relevant to its decision on the application.

             (3)  For paragraph (2)(h), the details for each item of information are:

                     (a)  the title shown on the item of information; and

                     (b)  the name of the author, or of each of the authors, of the information; and

                     (c)  the date shown on the item of information (if any); and

                     (d)  if no date is shown on the item of information—the date when the preparation of the information was completed; and

                     (e)  if the information was published:

                              (i)  the date when it was published; and

                             (ii)  the name of the publication in which it was published; and

                      (f)  the reference number shown on the item of information; and

                     (g)  the name and address of the authorising party for the information.

19AC  Summaries of applications for variation for companion animal products

             (1)  This regulation applies to an application for variation of the relevant particulars or conditions of:

                     (a)  the registration of a chemical product that is a companion animal product; or

                     (b)  the approval of a label for a container for a chemical product that is a companion animal product.

             (2)  For subsection 28B(2) of the Code, the details are:

                     (a)  the name of the applicant; and

                     (b)  the application number; and

                     (c)  the name of the chemical product; and

                     (d)  if the application is in relation to the registration of a chemical product—the distinguishing number that the APVMA gave to the product when it decided to register the product; and

                     (e)  the name of each of the active constituents of the chemical product; and

                      (f)  a short description of the application and its purpose, including the way in which the chemical product is intended to be used.

19AD  Summaries of applications for variation for chemical products other than companion animal products

             (1)  This regulation applies to an application for variation of the relevant particulars or conditions of:

                     (a)  the registration of a chemical product that is not a companion animal product; or

                     (b)  the approval of a label for a container for a chemical product that is not a companion animal product.

             (2)  For subsection 28B(2) of the Code, the details are:

                     (a)  the name of the applicant; and

                     (b)  the application number; and

                     (c)  the name of the chemical product; and

                     (d)  if the application is in relation to the registration of a chemical product—the distinguishing number that the APVMA gave to the product when it decided to register the product; and

                     (e)  the name of each of the active constituents of the chemical product; and

                      (f)  a short description of the application and its purpose, including the way in which the chemical product is intended to be used; and

                     (g)  for any reference active constituent mentioned in the application:

                              (i)  the name of the reference active constituent; and

                             (ii)  if the active constituent is an approved active constituent—the distinguishing number that the APVMA gave to the active constituent when the approval was granted; and

                     (h)  for any reference chemical product mentioned in the application:

                              (i)  the name of the reference chemical product; and

                             (ii)  if the chemical product has been registered—the distinguishing number that the APVMA gave to the chemical product when the APVMA decided to register the product; and

                      (i)  a short description of each item of information contained in, or accompanying, the application in compliance with paragraph 11(1)(b) of the Code, including the details set out in subregulation (3); and

                      (j)  any other information that the APVMA considers to be relevant to its decision on the application.

             (3)  For paragraph (2)(i), the details for each item of information are:

                     (a)  the title shown on the item of information; and

                     (b)  the name of the author, or of each of the authors, of the information; and

                     (c)  the date shown on the item of information (if any); and

                     (d)  if no date is shown on the item of information—the date when the preparation of the information was completed; and

                     (e)  if the information was published:

                              (i)  the date when it was published; and

                             (ii)  the name of the publication in which it was published; and

                      (f)  the reference number shown on the item of information; and

                     (g)  the name and address of the authorising party for the information.

Subdivision 2.2.2Grant or refusal of variation application

19A  Variation of relevant particulars or conditions of approval or registration

                   For paragraph 29(1)(d) of the Code, the requirements are:

                     (a)  the requirements for agricultural chemical products in regulation 9; and

                     (b)  the requirements for a label for containers for a chemical product in regulation 11.

Division 2.3Reconsideration of approval or registration

20  Continued approval of an active constituent

                   For the purposes of paragraph 32(1)(aa) and subsection 34(5) of the Code, the requirement for continued approval of an active constituent is that the continued use of, or any other dealing with, the constituent in accordance with the instructions for its use or for such a dealing that the APVMA has approved:

                     (a)  would not be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and

                     (b)  would not be likely to have an effect that is harmful to human beings; and

                     (c)  would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; and

                     (d)  would not unduly prejudice trade or commerce between Australia and places outside Australia.

21  Continued registration of a chemical product

                   For the purposes of paragraph 32(1)(aa) and subsection 34(5) of the Code, the requirements for continued registration of a chemical product are:

                     (a)  that the continued use of, or any other dealing with, the product in accordance with the instructions for its use or for such a dealing that the APVMA has approved:

                              (i)  would not be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and

                             (ii)  would not be likely to have an effect that is harmful to human beings; and

                            (iii)  would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; and

                            (iv)  would not unduly prejudice trade or commerce between Australia and places outside Australia; and

                     (b)  that the continued use of the product in accordance with the instructions for its use that the APVMA has approved would be effective according to criteria determined by the APVMA for the product; and

                     (c)  if regulation 9 or 10 applies to the product—that the product complies with that regulation.

22  Requirements for continued approval of label

                   For paragraph 32(1)(aa) and subsection 34(5) of the Code, the requirements for the continued approval of a label are:

                     (a)  that the instructions contained on the label, for the matters set out in paragraph 14(3)(g) of the Code that the APVMA thinks are appropriate for reconsideration, are adequate; and

                     (b)  that the particulars contained on the label for regulation 17 are adequate; and

                     (c)  that the label is subject to appropriate conditions.

Note:          For conditions of approval of a label, see section 23A of the Code.

22AA  Reconsideration by APVMA of approval of label

                   For subsection 34A(1) of the Code, the prescribed matters are:

                     (a)  any matter prescribed by the regulations that is a requirement in relation to a constituent, product or label for paragraph 14(3)(d) of the Code; and

                     (b)  any matter prescribed by the regulations for subparagraph 14(3)(g)(x) of the Code.

Note 1:       See regulation 11 for requirements for paragraph 14(3)(d) of the Code.

Note 2:       See regulation 12 for matters for subparagraph 14(3)(g)(x) of the Code.

Division 2.4Limits on use of information

22A  Prescribed uses (Code, s 34F(5))

             (1)  For subsection 34F(5) of the Code, a use is prescribed if:

                     (a)  the use is:

                              (i)  a non‑major crop use (that is, a use for a food crop listed in Column 4 (‘Non‑major uses’) of Part 1 of Schedule 3A, or a non‑food crop or situation use listed in Column 4 (‘Non‑major uses’) of Part 3 of that Schedule); or

                             (ii)  a non‑major animal use (that is, a use for an animal listed in Column 4 (‘Non‑major uses’) of Part 2 of Schedule 3A); and

                     (b)  an application has been made to the APVMA, data has been submitted to the APVMA for the purposes of the application, and the data is directly and specifically relevant to the use; and

                     (c)  the data was required, and relied on, by the APVMA to grant the application; and

                     (d)  the use is specified on a label.

             (2)  For paragraph (1)(d), a non‑major crop use is taken to be specified on a label if, on the label, there is specified a crop group listed in Column 2 (‘Crop/situation group’) of:

                     (a)  the item that, in Part 1 of Schedule 3A, mentions the relevant non‑major food crop; or

                     (b)  the item that, in Part 3 of that Schedule, mentions the relevant non‑food crop or situation.

Division 2.5Summaries of advice on applications

22B  Summaries of advice on applications for active constituents

             (1)  For paragraph 34G(3)(b) of the Code, this regulation sets out the matters that must be included in the summary of the advice if the advice was for an application for:

                     (a)  approval of an active constituent for a proposed or existing chemical product; or

                     (b)  variation of the relevant particulars or conditions of the approval of an active constituent for a proposed or existing chemical product.

             (2)  The matters are:

                     (a)  the name of the applicant; and

                     (b)  the application number; and

                     (c)  the name of the active constituent; and

                     (d)  the distinguishing number that the APVMA gave to the active constituent when the approval was granted; and

                     (e)  a short description of the application and its purpose, including the way in which the active constituent is intended to be used; and

                      (f)  brief details about the APVMA’s decision to grant the approval; and

                     (g)  a summary of the advice given by the person, body or Government that the APVMA consulted, including:

                              (i)  the kind of information given to the APVMA with the advice; and

                             (ii)  any advice given in relation to any trials or related matters mentioned in the application; and

                            (iii)  a summary of the results from any trials mentioned in the advice as relevant; and

                            (iv)  the conclusions included in the advice; and

                     (h)  a list of the items of information that the person, body or Government considered relevant to giving the advice, including the details set out in subregulation (3); and

                      (i)  any other information given with the advice that the APVMA considers was relevant to its decision on the application.

             (3)  For paragraph (2)(h), the details for each item of information are:

                     (a)  the data number given to the information by the APVMA; and

                     (b)  the title shown on the item of information; and

                     (c)  the name of the author, or of each of the authors, of the information; and

                     (d)  if a date is shown on the item of information—the date shown; and

                     (e)  if no date is shown on the item of information—the date when the preparation of the information was completed; and

                      (f)  if the information was published:

                              (i)  the date when it was published; and

                             (ii)  the name of the publication in which it was published; and

                     (g)  the reference number shown on the item of information; and

                     (h)  the name and address of the authorising party for the information.

22C  Summaries of advice on applications for chemical products

             (1)  For paragraph 34G(3)(b) of the Code, this regulation sets out the matters that must be included in the summary of the advice if the advice was for an application for:

                     (a)  registration of a chemical product; or

                     (b)  variation of the relevant particulars or conditions of:

                              (i)  the registration of a chemical product; or

                             (ii)  the approval of a label for a container for a chemical product.

             (2)  The matters are:

                     (a)  the name of the applicant; and

                     (b)  the application number; and

                     (c)  the name of the chemical product; and

                     (d)  if the application was for registration of a chemical product—the distinguishing number that the APVMA gave to the product when it decided to register the product; and

                     (e)  the name of the active constituents of the chemical product; and

                      (f)  a short description of the application and its purpose, including the way in which the chemical product is intended to be used; and

                     (g)  brief details about the APVMA’s decision to grant the application; and

                     (h)  a summary of the advice given by the person, body or Government that the APVMA consulted, including:

                              (i)  the kind of information given; and

                             (ii)  any advice given in relation to any trials or related matters mentioned in the application; and

                            (iii)  a summary of the results from any trials mentioned in the advice as relevant; and

                            (iv)  the conclusions included in the advice; and

                      (i)  a list of the items of information that the person, body or Government considered relevant to giving the advice, including the details set out in subregulation (3); and

                      (j)  any other information given with the advice that the APVMA considers was relevant to its decision on the application.

             (3)  For paragraph (2)(i), the details for each item of information are:

                     (a)  the data number given to the information by the APVMA; and

                     (b)  the title shown on the item of information; and

                     (c)  the name of the author, or of each of the authors, of the information; and

                     (d)  if a date is shown on the item of information—the date shown; and

                     (e)  if no date is shown on the item of information—the date when the preparation of the information was completed; and

                      (f)  if the information was published:

                              (i)  the date when it was published; and

                             (ii)  the name of the publication in which it was published; and

                     (g)  the reference number shown on the item of information; and

                     (h)  the name and address of the authorising party for the information.

Division 2.6Late applications

23  Late applications for renewal of registration of chemical product

             (1)  For the purposes of subsection 48(3) of the Code, the APVMA may accept a late application for the renewal of the registration of a chemical product:

                     (a)  if:

                              (i)  before the end of the period for making an application referred to in subsection 48(2) of the Code, the applicant requests in writing that the APVMA accept a late application; and

                             (ii)  the APVMA agrees to that request; or

                     (b)  in any other case—if the APVMA thinks it would be unreasonable not to accept the late application.

             (2)  The fee payable for acceptance of a late application for the renewal of the registration of a chemical product (other than an application to which paragraph (1)(a) applies) is $50.

Part 2AListable chemical products

  

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.

23AB  Preparation of standards—prescribed matters

             (1)  For subparagraph 56E(1)(f)(x) of the Code, the following are prescribed matters:

                     (a)  if a label is for a container containing a veterinary chemical product, the duration of any treatment using the product;

                     (b)  any matter determined by the APVMA under subregulation 12(2).

Note:          Subregulation 12(2) provides for the APVMA to determine, for paragraph 6(2)(c) of the Act, that a label will contain instructions about a matter.

             (2)  For paragraph 56E(2)(i) of the Code, the method of analysis (if any) of the chemical composition and form of the constituents of the chemical product is a prescribed matter.

23B  Particulars of registered listed chemical products to be recorded

             (1)  For the purposes of paragraph 56M(2)(a) of the Code, the following particulars must be entered in the Register of Chemical Products in relation to the listed registration of a chemical product:

                     (a)  the distinguishing name of the product proposed by the applicant and accepted by the APVMA;

                     (b)  the constituents of the product;

                     (c)  the concentration of each constituent of the product;

                     (d)  if possible, the composition and purity of each active constituent of the product;

                     (e)  the name and business address of the applicant;

                      (f)  the name of each State or Territory in respect of which the product is registered;

                     (g)  the name of each manufacturer of the product;

                     (h)  the address of each site at which the product is manufactured by the manufacturer;

                      (i)  the date of entry of these particulars in the Register of Chemical Products;

                      (j)  the date on which the registration ends.

             (2)  Subregulation (1) does not apply in relation to particulars that are contained in the established standard for the registered listed chemical product.

23C  Containers for the supply of registered listed chemical products

             (1)  Subject to subregulation (2), for the purposes of paragraph 56O(2)(a) of the Code, a container for a registered listed chemical product 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 any person; or

                             (ii)  have an unintended effect that is harmful to the environment.

             (2)  Subregulation (1) does not apply if the established standard for the registered listed chemical product requires the product to be kept in containers that comply with requirements specified in the standard.

             (3)  Nothing in subregulations (1) and (2) is intended to affect the operation of any other law that applies in relation to containers for chemical products.

23D  Information to be given in notice to approved person

                   For the purposes of subsection 56P(2) of the Code, the following information must be contained in a notice to the approved person of the listed registration of a chemical product:

                     (a)  if the established standard that applies to the registered listed chemical product has been published in the Gazette—the date of its publication;

                     (b)  if the established standard that applies to the registered listed chemical product has not been published in the Gazette—a copy of the established standard;

                     (c)  a copy or sample of any label for the container for the registered listed chemical product, being a label that is contained in, or required by, the established standard that applies to the product;

                     (d)  the date of its registration under section 56N of the Code;

                     (e)  the date on which the registration ends;

                      (f)           any conditions of the registration under section 56O of the Code, other than a condition specifying the date on which the registration ends;

                     (g)  particulars of any notice of listed registration to be published under subsection 56ZO(1) of the Code;

                     (h)  any other details, entered in the Register of Chemical Products, about the registered listed chemical product that the APVMA thinks appropriate.

23E  Continued listed registration of chemical product

                   For the purposes of paragraph 56X(1)(b) of the Code, the requirements for continued listed registration of a chemical product are:

                     (a)  that the continued use of, or any other dealing with, the product in accordance with the instructions for its use or for such a dealing that the APVMA has approved:

                              (i)  would not be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and

                             (ii)  would not be likely to have an effect that is harmful to human beings; and

                            (iii)  would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; and

                            (iv)  would not unduly prejudice trade or commerce between Australia and places outside Australia; and

                     (b)  that the continued use of the product in accordance with the instructions for its use that the APVMA has approved would be effective according to criteria determined by the APVMA for the product.

23F  Late applications for renewal of listed registration of chemical product

             (1)  For the purposes of subsection 56ZL(3) of the Code, the APVMA may accept a late application for the renewal of the listed registration of a chemical product:

                     (a)  if:

                              (i)  before the end of the period for making an application referred to in subsection 56ZL(2) of the Code, the applicant requests in writing that the APVMA accept a late application; and

                             (ii)  the APVMA agrees to that request; or

                     (b)  in any other case—if the APVMA thinks it would be unreasonable not to accept the late application.

             (2)  The fee payable for acceptance of a late application for the renewal of the listed registration of a chemical product (other than an application to which paragraph (1)(a) applies) is $30.

Part 2BReserved 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.

Part 3Compensation for provider of certain information in respect of continued registration of certain chemical products

Division 1Notices

24  Protected registered information—notice to primary applicant

                   For the purposes of subparagraph 60(3)(a)(i) of the Code, a notice to a primary applicant must contain the following information about the secondary applicant and the secondary chemical product:

                     (a)  if the secondary chemical product is a registered chemical product:

                              (i)  the name and business address of the secondary applicant entered in the Register of Chemical Products; and

                             (ii)  the particulars of the secondary chemical product entered in the Register of Chemical Products or, if the primary applicant so requests, the particulars of the approved active constituent entered in the Record of Approved Active Constituents; and

                            (iii)  the matters about the approved label recorded in the APVMA file for paragraphs 21(2)(c) and (d) of the Code;

                     (b)  if the secondary chemical product is not a registered chemical product—the name and business address of the secondary applicant contained in the application for registration of the secondary chemical product.

25  Protected registered information—notice to secondary applicant

                   For the purposes of subparagraph 60(3)(a)(ii) of the Code, the information about each primary applicant and primary chemical product that must be contained in a notice to the secondary applicant is:

                     (a)  the name and business address of each primary applicant; and

                     (b)  the particulars of each primary chemical product, entered in the Register of Chemical Products or, if the secondary applicant so requests, the particulars of each approved active constituent, entered in the Record of Approved Active Constituents; and

                     (c)  the matters about the approved label recorded in the APVMA file for paragraphs 21(2)(c) and (d) of the Code.

Division 2Conduct of arbitration

26  Rules governing the conduct of an arbitration

             (1)  For the purposes of section 71 of the Code (which deals with the conduct of an arbitration), regulations 27 to 39 apply to an arbitration under Division 3 of Part 3 of the Code.

             (2)  A law that relates to the conduct of commercial arbitration, to the extent that it is inconsistent with any regulation mentioned in subregulation (1), does not apply to an arbitration under Division 3 of Part 3 of the Code.

27  Notice of appointment of arbitrator

             (1)  When an arbitrator is appointed for a purpose of the Code, the APVMA must give notice in writing of the appointment, stating the arbitrator’s name and address, to:

                     (a)  each primary applicant in the matter to be arbitrated; and

                     (b)  the secondary applicant in the matter; and

                     (c)  the mediator in the matter.

             (2)  The notice must be given within a reasonable period after the appointment.

28  Parties to give information to arbitrator

                   As soon as practicable after being notified of the arbitrator’s appointment, an applicant must tell the arbitrator in writing about any proposal as to the terms of compensation that was made by the applicant in the course of negotiations.

29  Mediator to submit report

                   As soon as practicable after being notified of the arbitrator’s appointment, the mediator must give a written report to the arbitrator:

                     (a)  setting out the proposals and counter proposals (if any) made by the applicants during the mediation; and

                     (b)  summarising the issues raised during the mediation.

30  Arbitrator to conduct a hearing

                   Before determining the terms of compensation (if any), the arbitrator must conduct a hearing.

31  Arbitrator to give the applicants notice of the hearing

             (1)  The arbitrator must give written notice of a hearing to each party to the arbitration, at least 14 days before the hearing.

             (2)  The notice must specify the date, time and place of the hearing.

32  Arbitrator’s powers if applicant does not attend the hearing

                   If the arbitrator has given a party to the arbitration notice of a hearing in accordance with regulation 31, the arbitrator may determine terms of compensation in accordance with Division 3 of Part 3 of the Code even if the applicant does not attend the hearing.

33  Procedure at the hearing

                   The arbitrator may determine the procedure to be observed at a hearing.

34  Representation at the hearing

             (1)  Subject to subregulation (2), a party to an arbitration must not be represented by a legal practitioner at the hearing.

             (2)  Subject to subregulation (3), the arbitrator may permit a party to be represented by a legal practitioner if, in the opinion of the arbitrator:

                     (a)  legal representation is likely to shorten the proceedings or reduce costs; or

                     (b)  the party would be unfairly disadvantaged if the party were not represented.

             (3)  The arbitrator must not permit an applicant to be represented by a legal practitioner if, in the opinion of the arbitrator, another party would be unfairly disadvantaged as a result.

35  Arbitrator may require information etc

             (1)  If the arbitrator reasonably believes that a person is able to give information or produce a document that may be used for the purpose of determining:

                     (a)  an amount referred to in subparagraph 69(1)(b)(i) or (ii) of the Code (each of which deals with the amount of the cost of obtaining protected registration information); or

                     (b)  what, for the purposes of paragraph 69(1)(b) of the Code, is a fair proportion of that amount; or

                     (c)  any other matter relevant to the determination of what is a reasonable proposal as to the terms of compensation;

the arbitrator may give notice in writing to the person in accordance with subregulation (2).

             (2)  A notice under subregulation (1) may require the person:

                     (a)  to give the information to the arbitrator within the time and in the manner specified in the notice; or

                     (b)  to attend before the arbitrator at a specified time and place and answer any question; or

                     (c)  to produce the document to the arbitrator in accordance with the notice.

             (3)  A person must not fail to comply with a notice given to the person under subregulation (1).

Penalty:  5 penalty units.

          (3A)  It is a defence to a prosecution under subregulation (3) if the defendant has a reasonable excuse.

Note:          A defendant bears an evidential burden in relation to the matter mentioned in this subregulation—see section 13.3 of the Criminal Code.

          (3B)  An offence under subregulation (3) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (4)  An arbitrator may require evidence to be given on oath or affirmation, and for that purpose, the arbitrator may administer an oath or affirmation.

36  Fair proportion of cost of providing protected registration information

                   For the purposes of subsection 69(2) of the Code, the matters to which the arbitrator must have regard in determining what is a fair proportion of an amount of the cost incurred by a primary applicant are as follows:

                     (a)  the time that has elapsed since the protected registered information was obtained by the primary applicant;

                     (b)  the value of sales of the primary chemical product concerned since the registration of the product;

                     (c)  whether the primary applicant has already received compensation for the use of the protected registered information by the APVMA;

                     (d)  the cost of obtaining the protected registered information if it were to be compiled at the time of the arbitration.

37  Arbitrator’s costs

             (1)  The parties to an arbitration are jointly and severally liable to pay any costs reasonably incurred by the arbitrator in relation to the arbitration.

             (2)  The APVMA may elect to pay the arbitrator’s costs mentioned in subregulation (1).

             (3)  If the APVMA pays the arbitrator’s costs, the APVMA may recover the costs from all or any of the applicants as a civil debt in a court of competent jurisdiction.

38  Applicants’ costs of arbitration

                   Each party to an arbitration must bear the party’s own costs relating to the arbitration.

39  Arbitrator exonerated from liability

                   No action lies against an arbitrator for anything done in the course of an arbitration, if it is done in accordance with the Code and these Regulations.

Part 4Control of chemical products

Division 1General

40A  Exemption of existing use active constituents

             (1)  Subsection 74(1) of the Code (which deals with the possession of substances for supply) does not apply to a person in relation to the person’s possession or custody of a substance to which that subsection applies, if the substance is an existing use active constituent.

             (2)  Subsection 76(1) of the Code (which deals with the supply of active constituents) does not apply to a person in relation to the supply by the person of an active constituent to which that subsection applies, if the substance is an existing use active constituent.

             (3)  In this regulation, existing use active constituent means an active constituent for a chemical product that is taken by section 172 or 174 or subsection 176(1) of the Code to have been registered under the Code.

             (4)  Subregulations (1) and (2) have effect from the commencement of the Code until the end of 12 months after that commencement.

40  Supply of substances for research etc for chemical products

             (1)  Subsections 74(1) and 75(1) of the Code (which deal with the possession of chemical products and active constituents for supply) do not apply to a person in relation to an amount of:

                     (a)  a substance that is likely to be used as an active constituent for a chemical product; or

                     (b)  an active constituent for a chemical product; or

                     (c)  a chemical product;

to which subregulation (2) applies.

             (2)  This subregulation applies to a substance, constituent or chemical product in the possession or custody of a person if:

                     (a)  the substance, constituent or product is to be used only for the purposes of research in connection with a chemical product; and

                     (b)  the amount of the substance, constituent or product does not exceed the amount specified in subregulation (5); and

                     (c)  the person complies with subregulations (6) and (8) in respect of the substance, constituent or product.

             (3)  Subsections 76(1), 77(1), 78(1) and 79(1) of the Code (which deal with the supply of chemical products and active constituents) do not apply to a person in relation to an amount of:

                     (a)  a substance that is likely to be used as an active constituent for a chemical product; or

                     (b)  an active constituent for a chemical product; or

                     (c)  a chemical product;

to which subregulation (4) applies.

             (4)  This subregulation applies to a substance, constituent or chemical product supplied by a person if:

                     (a)  the substance, constituent or product is to be used only for the purposes of research in connection with a chemical product; and

                     (b)  the amount of the substance, constituent or product supplied in any 12 month period does not exceed the amount specified in subregulation (5); and

                     (c)  the person complies with subregulations (7) and (8) in respect of the substance, constituent or product.

             (5)  For the purposes of subregulations (2) and (4), the amount of the substance, constituent or chemical product is:

                     (a)  in the case of a substance or constituent—3 kilograms; or

                     (b)  in the case of a chemical product—6 kilograms.

             (6)  A person referred to in subregulation (2) must make a record stating the amount of the substance, constituent or chemical product in the person’s possession or custody at any time.

             (7)  A person referred to in subregulation (4) must make a record that shows, at any time, the amount of the substance, constituent or chemical product supplied by the person in the preceding 12 month period.

             (8)  A record made under subregulation (6) or (7):

                     (a)  must be in a form that is readily accessible for the purposes of Part 9 of the Code (which deals with enforcement); and

                     (b)  must be kept at the business premises of the person who made it for at least 2 years after it is made.

41  Supply etc of substances with constituents differing from registered particulars

             (1)  This regulation has effect for the purposes of sections 83, 83A, 99 and 102 of the Code.

             (2)  For the purposes of paragraphs 83(1)(a), 83A(1)(a), 99(2)(a) and 102(1)(b) and (ba) of the Code, the prescribed extent, in the case of an active constituent of a registered chemical product or registered listed chemical product, is nil.

             (3)  For the purposes of paragraphs 83(1)(b), 83A(1)(b), 99(2)(b) and 102(1)(c) and (ca) of the Code, the prescribed extent, for a constituent of a registered chemical product or registered listed chemical product:

                     (a)  that is an active constituent; and

                     (b)  in respect of which a standard is prescribed under section 87 of the Code;

is the extent (if any) of variation of concentration permitted by that standard.

42  Prescribed standards for chemical products

             (1)  For the purposes of section 87 of the Code (which deals with standards for chemical products), all chemical products are prescribed.

             (2)  Section 7 of the Act (which deals with the power to make orders) applies to the specification of standards in respect of:

                     (a)  a chemical product; and

                     (b)  a constituent contained in a chemical product.

             (3)  The standard for a chemical product, or a constituent contained in a chemical product, is:

                     (a)  the standard specified in respect of the chemical product or the constituent in an order under section 7 of the Act; or

                     (c)  in the case of a veterinary chemical product or of a constituent (not being a chemical product or constituent referred to in paragraph (a) or (b)), in respect of which a standard is specified in:

                              (i)  the British Pharmacopoeia; or

                             (ii)  the British Pharmacopoeia (Veterinary); or

                            (iii)  the European Pharmacopoeia; or

                            (iv)  the United States Pharmacopoeia;

                            the standard specified in the first of those publications, in the order set out in this paragraph, that applies to the product or constituent; or

                     (d)  in the case of a chemical product or constituent (not being a product or constituent referred to in paragraph (a), (b) or (c)), in respect of which a standard is specified in any of the FAO Specifications for Plant Protection Products—that standard; or

                     (e)  in the case of a chemical product or constituent (not being a product or constituent referred to in paragraph (a), (b), (c) or (d))—the standard (if any) approved by the APVMA in respect of the product or constituent.

             (4)  If no standard is prescribed under subregulation (3) in respect of the concentration of an active constituent of a particular chemical product, the standard in respect of the concentration of that active constituent is the standard set out in the following table:

 

Concentration of each active constituent as specified on the product label (g/kg or g/L at 20˚C)

Standard (allowable variation)

500 or more

± 25 g/kg or g/L of the active constituent

From 250 up to but not including 500

± 5% of the content of the active constituent

From 100 up to but not including 250

± 6% of the content of the active constituent

Less than 100

± 10% of the content of the active constituent

43  When statements about chemical products can be made or reported

             (1)  For the purposes of subsection 89(3) of the Code, a person is not prevented from making or reporting a statement about a chemical product if the statement is not made for the purpose of promoting the product and is one of the following kinds of statement:

                     (a)  a statement made:

                              (i)  in a scientific paper or other scientific literature, or in a scientific report or presentation; or

                             (ii)  at a conference or seminar, or in an address, meeting or discussion, concerning chemical products;

                            being a statement based on data published in a reputable, refereed scientific journal or of a standard publishable in such a journal;

                     (b)  a statement made on radio or television or in a newspaper, journal or newsletter, as fair comment on any material:

                              (i)  published for the purposes of a conference or seminar; and

                             (ii)  based on data referred to in paragraph (a).

             (2)  Nothing in subregulation (1) is taken to permit a statement that would, apart from that subregulation, contravene section 84 of the Code.

44  Record of manufacture or import of date‑controlled chemical product

             (1)  For the purposes of paragraph 90(a) of the Code, a record in relation to a date‑controlled chemical product:

                     (a)  must be made:

                              (i)  in written or electronic form; and

                             (ii)  in such a way as to ensure that the record is readily accessible for the purposes of Part 9 of the Code (which deals with enforcement); and

                     (b)  must include the following particulars:

                              (i)  the name and business address of the manufacturer;

                             (ii)  if the product is imported—the name and business address of the importer;

                            (iii)  the distinguishing name of the product;

                            (iv)  if the product is a registered chemical product—the distinguishing number given to the product under section 20 of the Code;

                             (v)  the volume or quantity manufactured or imported;

                            (vi)  the batch number.

             (2)  For the purposes of paragraph 90(b) of the Code, the period for keeping a record of a date‑controlled chemical product is the period that begins when the record is made and ends 12 months after the expiry date of the product to which it relates.

45  Restricted chemical products

                   For the purposes of subsection 93(1) of the Code (which deals with restricted chemical products), a chemical product specified in Column 2 of Schedule 4 is declared to be a restricted chemical product, the APVMA having certified in writing, in respect of the product, under subsection 93(2) of the Code, that it is in the public interest for the product to be so declared.

46  Supply of chemical product—batch number or record of supply

             (1)  A person may supply a chemical product only if:

                     (a)  the container for the product has attached to it a label containing a batch number, in a form approved by the APVMA, that enables the APVMA to identify the batch of that chemical product from which the contents of the container were taken; or

                     (b)  the person makes a record, in respect of the supply, in accordance with subregulation (2).

Penalty:  10 penalty units.

          (1A)  Subregulation (1) does not apply to a chemical product in relation to which, or in relation to containers for which, registration or approval of a label by the previous registering authority was in force immediately before the commencement of the Code, if:

                     (a)  the chemical product was manufactured before 1 October 1996; and

                     (b)  the label as registered or approved does not contain provision for a batch number; and

                     (c)  under paragraph 174(1)(c) or 176(1)(d) or subsection 176(2) of the Code, the label is taken to have been approved in relation to the chemical product; and

                     (d)  when the chemical product is supplied—a label in the form taken to be approved under the Code is attached to it.

          (1B)  Subregulation (1) does not apply to a chemical product that:

                     (a)  was manufactured before 1 October 1996; and

                     (b)  is required to be registered under the Code; and

                     (c)  immediately before the commencement of the Code, was not required to be registered or approved under a corresponding previous law.

          (1C)  Subregulations (1A) and (1B) cease to have effect on 30 April 1998.

             (2)  For the purposes of paragraph (1)(b), a person who supplies a chemical product must make, as soon as practicable, a record:

                     (a)  in a form approved by the APVMA; and

                     (b)  in such a way as to ensure that the record is readily accessible for the purposes of Part 9 of the Code (which deals with enforcement); and

                     (c)  including the following particulars:

                              (i)  the name and address of the person who supplied the product;

                             (ii)  the name and address of the person to whom the product was supplied;

                            (iii)  the date of supply;

                            (iv)  the quantity of the product supplied or, if the product is supplied as part of a mixture of chemical products, the quantity of the mixture of products supplied;

                             (v)  the identification number of the container in which the product was transported or stored for the purpose of supply or, if the container is a bulk tank, the location of the container;

                            (vi)  the distinguishing name of the product supplied or, if the product is supplied as part of a mixture of chemical products, the distinguishing name of each of those products;

                           (vii)  if the batch number of the product supplied or, if the product is supplied as part of a mixture of chemical products, the batch number of each of those products supplied, is known to the person who supplied the product—that batch number, or as the case requires, those batch numbers;

                          (viii)  if the product is supplied in a refillable container—the date on which the product was placed in the container.

             (3)  A person who makes a record under subregulation (2) must keep the record for 3 years after it is made.

Penalty:  10 penalty units.

             (4)  It is a defence to a prosecution under subregulation (1) or (3) if the defendant has a reasonable excuse.

Note:          A defendant bears an evidential burden in relation to the matter mentioned in this subregulation—see section 13.3 of the Criminal Code.

             (5)  An offence under subregulation (1) or (3) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

Division 2Supply of hormonal growth promotants

47  Notice of intention to supply hormonal growth promotant

             (1)  If a person gives notice in writing to the APVMA:

                     (a)  declaring the person’s intention to supply a hormonal growth promotant; and

                     (b)  specifying each premises from which the person intends to supply the promotant;

the APVMA must assign, on payment of the prescribed application fee, a unique notification number to the person for each of those premises.

             (2)  The prescribed application fee is $305 for each premises specified in the notice.

47A  Notification number may be replaced or withdrawn

             (1)  The APVMA may, at any time, by notice in writing to the assignee of a notification number for particular premises:

                     (a)  without payment of a fee, assign a notification number for the premises in place of a notification number previously assigned; or

                     (b)  if it appears to the APVMA that the premises are no longer used for the supply of hormonal growth promotant—inform the assignee that it intends, after a specified period, to withdraw the assigned notification number.

             (2)  If, within the specified period, the assignee does not satisfy the APVMA that the premises are still used for the supply of hormonal growth promotant, the APVMA may withdraw the assigned notification number.

47AB  Review of decision withdrawing assigned notification number

                   Application may be made under the Administrative Appeals Tribunal Act 1975 to the Administrative Appeals Tribunal for review of a decision of the APVMA under paragraph 47A(b) withdrawing an assigned notification number.

47B  Notification number to be renewed annually

             (1)  Assignment of a notification number:

                     (a)  begins to have effect on the day of the assignment; and

                     (b)  unless continued under subregulation (2)—ceases to have effect at the end of 1 year after that day.

             (2)  A person to whom a notification number has been assigned for premises may continue the assignment of that number for those premises by giving notice in accordance with subregulation 47(1), and paying the prescribed fee under subregulation 47(2), on or before the day on which the assignment ceases to have effect.

47C  Hormonal growth promotant not to be supplied etc

             (1)  A person may supply a hormonal growth promotant only if:

                     (a)  a notification number has been assigned to the person for the premises from which the supply occurs; and

                     (b)  the notification number has not been withdrawn; and

                     (c)  the assignment of the notification number has not ceased to have effect.

Penalty:  10 penalty units.

          (1A)  It is a defence to a prosecution under subregulation (1) if the defendant has a reasonable excuse.

Note:          A defendant bears an evidential burden in relation to the matter mentioned in this subregulation—see section 13.3 of the Criminal Code.

          (1B)  An offence under subregulation (1) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (2)  For the purposes of subregulation (1), premises from which supply occurs are premises from which the promotant is first taken:

                     (a)  in response to a particular request for supply; and

                     (b)  in the form and container in which it is supplied.

48  Supply of hormonal growth promotant—purchaser’s declaration

             (1)  A person may supply a hormonal growth promotant only if:

                     (a)  the recipient gives to the supplier, at the time of acquisition, a declaration that:

                              (i)  is in a form approved by the APVMA; and

                             (ii)  states:

                                        (A)  the total quantity and type of the promotant acquired; and

                                        (B)  the batch number of the promotant; and

                                        (C)  the purchaser declaration number for the premises where animals proposed to be treated with the promotant are to be kept; and

                            (iii)  acknowledges that the recipient is aware that an animal treated with a hormonal growth promotant must be marked as an animal so treated, as required by the law of this jurisdiction (that is, by making in its ear an equilateral triangular hole 20 millimetres on each side); or

                     (b)  the recipient has been assigned a notification number that has not ceased to have effect and has not been withdrawn.

Penalty:  10 penalty units.

             (2)  It is a defence to a prosecution under subregulation (1) if the defendant has a reasonable excuse.

Note:          A defendant bears an evidential burden in relation to the matter mentioned in this subregulation—see section 13.3 of the Criminal Code.

             (3)  An offence under subregulation (1) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

49  Record of supply of hormonal growth promotant—manufacturer and supplier

             (1)  A person who manufactures and supplies a hormonal growth promotant must make, on each occasion on which the promotant is supplied to another person (in this regulation called the recipient), a record containing the following particulars:

                     (a)  the distinguishing name of the promotant entered in the Register of Chemical Products;

                     (b)  the name and address of the manufacturer;

                     (c)  the notification number assigned to the premises from which the promotant was supplied to the recipient;

                     (d)  the quantity of the promotant supplied;

                     (e)  the date of manufacture of the promotant;

                      (f)  the batch number of the promotant;

                     (g)  the quantity of promotant manufactured in that batch;

                     (h)  the date of supply of the promotant;

                      (i)  the name and address of the recipient;

                      (j)  if 1 or more notification numbers have been allotted to the recipient:

                              (i)  the notification number, and address, of each premises to which the promotant is supplied; and

                             (ii)  the quantity of the promotant supplied to each of those premises;

                     (k)  if no notification number has been allotted to the recipient—the purchaser declaration number for the premises where animals treated with the promotant are to be kept.

Penalty:  10 penalty units.

Note:          Regulation 52 sets out further requirements regarding the form of the record.

             (2)  It is a defence to a prosecution under subregulation (1) if the defendant has a reasonable excuse.

Note:          A defendant bears an evidential burden in relation to the matter mentioned in this subregulation—see section 13.3 of the Criminal Code.

             (3)  An offence under subregulation (1) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

50  Record of supply of hormonal growth promotant—importer and supplier

             (1)  A person who imports and supplies a hormonal growth promotant must make, on each occasion on which the promotant is supplied to another person (in this regulation called the recipient), a record containing the following particulars:

                     (a)  the distinguishing name of the promotant entered in the Register of Chemical Products;

                     (b)  the name and address of the importer;

                     (c)  the notification number assigned to the premises from which the promotant was supplied to the recipient;

                     (d)  the quantity of the promotant supplied;

                     (e)  the date of importation of the promotant;

                      (f)  the batch number of the promotant;

                     (g)  the quantity of promotant imported from that batch;

                     (h)  the date of supply of the promotant;

                      (i)  the name and address of the recipient;

                      (j)  if 1 or more notification numbers have been allotted to the recipient:

                              (i)  the notification number, and address, of each premises to which the promotant is supplied; and

                             (ii)  the quantity of the promotant supplied to each of those premises;

                     (k)  if no notification number has been allotted to the recipient—the purchaser declaration number for the premises where animals treated with the promotant are to be kept.

Penalty:  10 penalty units.

Note:          Regulation 52 sets out further requirements regarding the form of the record.

             (2)  An offence under subregulation (1) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

51  Record of supply of hormonal growth promotant—other suppliers

             (1)  This regulation applies to a person (in this regulation called the supplier) who:

                     (a)  receives a hormonal growth promotant from another supplier (in this regulation called the previous supplier); and

                     (b)  supplies the promotant to another person (in this regulation called the recipient).

             (2)  When the promotant is supplied, the supplier must make a record containing the following particulars:

                     (a)  the distinguishing name of the promotant entered in the Register of Chemical Products;

                     (b)  the name and address of the supplier;

                     (c)  the notification number assigned to the premises from which the promotant was supplied to the recipient;

                     (d)  the batch number of the promotant;

                     (e)  the name and address of the recipient;

                      (f)  the date of supply of the promotant to the recipient;

                     (g)  the quantity of the promotant supplied to the recipient;

                     (h)  the total quantity of the promotant remaining in the supplier’s possession after supply;

                      (i)  the name and address of the previous supplier;

                      (j)  the notification number (if any) assigned under this Division to the previous supplier for the premises from which the promotant was supplied by the previous supplier;

                     (k)  the date of supply of the promotant by the previous supplier;

                      (l)  the total quantity of the promotant supplied by the previous supplier;

                    (m)  if 1 or more notification numbers have been allotted to the recipient:

                              (i)  the notification number, and address, of each premises to which the promotant is supplied; and

                             (ii)  the quantity of the promotant supplied to each of those premises;

                     (n)  if no notification number has been allotted to the recipient—the purchaser declaration number for the premises where animals treated with the promotant are to be kept.

Penalty:  10 penalty units.

Note:          Regulation 52 sets out further requirements regarding the form of the record.

             (3)  It is a defence to a prosecution under subregulation (2) if the defendant has a reasonable excuse.

Note:          A defendant bears an evidential burden in relation to the matter mentioned in this subregulation—see section 13.3 of the Criminal Code.

             (4)  An offence under subregulation (2) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

52  Record of supply of hormonal growth promotant—general requirements

                   For the purposes of regulations 49, 50 and 51, a record must be made:

                     (a)  in written or electronic form; and

                     (b)  in such a way as to be readily accessible for the purposes of Part 9 of the Code (which deals with enforcement).

53  Copy of records to be given to APVMA

             (1)  A person who makes a record under regulation 49, 50 or 51 must give a copy of the record to the APVMA within 14 days after the end of the month in which it was made.

             (2)  A person must not fail to comply with subregulation (1).

Penalty:  10 penalty units.

             (3)  It is a defence to a prosecution under subregulation (1) if the defendant has a reasonable excuse.

Note:          A defendant bears an evidential burden in relation to the matter mentioned in this subregulation—see section 13.3 of the Criminal Code.

             (4)  An offence under subregulation (2) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

54  Copy of records etc to be kept

             (1)  A person who makes a record under regulation 49, 50 or 51 must keep the record for 2 years after it is made.

             (2)  A person to whom a declaration is given under subparagraph 48(1)(b) must keep the declaration for 2 years after it is given.

             (3)  A person must not fail to comply with subregulation (1) or (2).

Penalty:  10 penalty units.

             (4)  It is a defence to a prosecution under subregulation (1) or (2) if the defendant has a reasonable excuse.

Note:          A defendant bears an evidential burden in relation to the matter mentioned in this subregulation—see section 13.3 of the Criminal Code.

             (5)  An offence under subregulation (3) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

Part 5Analysis

  

55  Analysis of chemical products—tests

             (1)  Section 7 of the Act (which deals with the power to make orders) applies to prescribing tests for the analysis of samples of substances or mixtures of substances for the purposes of the Code.

             (2)  For the purposes of Part 5 of the Code, a sample of a substance or mixture of substances must be analysed by means of any of the following tests that apply to the substance or mixture:

                     (a)  a test prescribed in an order made under section 7 of the Act;

                     (b)  if the substance or mixture is a chemical product in respect of which a test is accepted by the APVMA for the purposes of registration of that chemical product—that test;

                     (c)  a test specified in:

                              (i)  the CIPAC Handbook and Addenda published by the Collaborative International Pesticides Analytical Council Limited; or

                             (ii)  the AOAC Manual and Addenda published by the Association of Official Analytical Chemists;

                            (iii)  the British Pharmacopoeia; or

                            (iv)  the British Pharmacopoeia (Veterinary); or

                             (v)  the European Pharmacopoeia; or

                            (vi)  the US Pharmacopoeia;

                     (d)  any other test approved by the APVMA as equivalent to a test specified in paragraph (a), (b) or (c).

56  Analysis at an accredited laboratory

                   For the purposes of paragraph 99(4)(c) of the Code (which deals with requirements for analysis), a prescribed laboratory, in relation to the analysis of a substance or mixture of substances, is a laboratory accredited by NATA, or approved by the APVMA, to carry out an analysis of that kind.

Part 6Permits

  

57  Additional requirement for the issue of a permit

                   For the purposes of paragraph 112(2)(h) of the Code (which deals with the grant and refusal of permit applications), in the case of an application for a permit in respect of the use of:

                     (a)  a chemical product that is not a registered chemical product; or

                     (b)  an active constituent for a proposed or existing chemical product that is not an approved active constituent; or

                     (c)  a registered chemical product or approved active constituent for a proposed or existing chemical product, otherwise than in accordance with any conditions on the approved label for containers for that product;

the use of the product as proposed in the application must be:

                     (d)  a minor use; or

                     (e)  an emergency use; or

                      (f)  for the purpose of research.

Part 7Manufacture of chemical products

  

58  Coming into force of section 121 of the Code

                   For the purposes of subsection 120(3) of the Code, the date on which section 121 of the Code (which deals with offences relating to manufacture and licences) comes into force is the date of commencement of the Code.

59  Manufacture of chemical products—exempt products

             (1)  For the purposes of paragraph 121(4)(a) of the Code (which deals with exempt products and persons in relation to manufacture), the following are exempt products:

                     (a)  any agricultural chemical product;

                     (b)  an ingredient used in the manufacture of a chemical product if the ingredient:

                              (i)  does not have a therapeutic or biological effect on a plant or animal; or

                             (ii)  is a herb, or an oil extracted from a herb, the sole use of which is as a starting material for use in the manufacture of a chemical product;

                     (c)  any product prepared in a research facility or pilot plant solely for experimental use;

                     (d)  any veterinary homeopathic preparation that:

                              (i)  is more dilute than a one thousandfold dilution of a mother tincture; and

                             (ii)  is not required to be sterile;

                     (e)  any skin cleanser or shampoo;

                      (f)  any coat conditioner intended for external use only;

                     (g)  any equine hoof protectant;

                     (h)  any sheep branding substance;

                      (i)  a substance of any of the following kinds that is intended to be added to stockfood:

                              (i)  organic acids;

                             (ii)  antioxidants;

                            (iii)  pellet‑binding products;

                            (iv)  mould inhibitors;

                             (v)  preservatives;

                            (vi)  feed handling improvers;

                           (vii)  colouring agents;

                          (viii)  anticaking agents;

                            (ix)  deodorising agents;

                             (x)  flavours;

                            (xi)  flavour enhancers;

                           (xii)  sweeteners;

                          (xiii)  aromatic substances;

                          (xiv)  appetising substances.

             (2)  In paragraph (1)(d):

mother tincture means a liquid prepared by the process of solution, extraction or trituration.

veterinary homeopathic preparation means a preparation:

                     (a)  formulated for use on the principle that it is capable of producing in a healthy animal symptoms similar to those which it is administered to alleviate; and

                     (b)  prepared according to the practices of homeopathic pharmacy using the method of:

                              (i)  serial dilution and succussion of a mother tincture in water, ethanol, aqueous ethanol or glycerol; or

                             (ii)  serial trituration in lactose.

59A  Manufacture of chemical products—exempt persons—single step

                   For the purposes of paragraph 121(4)(a) of the Code, a person who performs only a single step in the manufacture of a product is an exempt person in relation to the manufacture if:

                     (a)  the step consists only of:

                              (i)  packaging or labelling, or both packaging and labelling, the product; or

                             (ii)  analysing or testing the product; and

                     (b)  either:

                              (i)  the licence that authorises the manufacture of the product (being a licence held by another person) permits the first‑mentioned person to perform the step for the product; or

                             (ii)  the step consists only of applying a label that contains only a name and address, or the registration number of the product, or both, to a package, or packages, of the product.

59B  Manufacture of chemical products—exempt persons—chemical product that ceases to be exempt

                   For the purposes of paragraph 121(4)(a) of the Code, if a product ceases to be an exempt product under this Part, each person that:

                     (a)  performs a step in the manufacture of that product; and

                     (b)  is not the holder of a licence authorising the performance of that step in relation to the product; and

                     (c)  applied, before the product ceased to be an exempt product, for a licence authorising the performance of that step in relation to the product;

is an exempt person in relation to that product during the period beginning when the product ceases to be exempt and ending when the APVMA gives notice of its decision on the application.

59C  Manufacture of chemical products—exempt persons—legal personal representative etc of licence holder

             (1)  The legal personal representative of a licence holder who dies is an exempt person in relation to the manufacture of a product the production of which is authorised by the licence, subject to the following conditions:

                     (a)  that he or she gives the APVMA notice, in writing, of the grant of probate or administration not later than 3 months after it occurs;

                     (b)  that he or she complies with the terms of the licence as if he or she were the holder of the licence;

                     (c)  that he or she complies with the Code and these Regulations as if he or she were the holder of the licence.

             (2)  The trustee in bankruptcy of a licence holder is an exempt person in relation to the manufacture of a product the production of which is authorised by the licence, subject to the following conditions:

                     (a)  that he or she gives the APVMA notice, in writing, of the bankruptcy not later than 3 months after it occurs;

                     (b)  that he or she complies with the terms of the licence as if he or she were the holder of the licence;

                     (c)  that he or she complies with the Code and these Regulations as if he or she were the holder of the licence.

             (3)  An exemption under this regulation has no effect if the licence issued to the deceased person or the bankrupt (as the case may be) is not in force.

             (4)  If the APVMA reasonably requires the legal personal representative or trustee in bankruptcy to provide further information, or documents, relating to a grant of probate or letters of administration, or a trusteeship (as the case requires), and that request is not complied with within the time allowed by the APVMA, the exemption ceases to have effect at the end of that time.

             (5)  The time allowed to comply with a request under subregulation (4) must not be shorter than 1 month from the date of the request.

59D  Manufacture of chemical products—exempt persons—person that acquires business including transfer of licence

             (1)  A person who is the transferee of a business:

                     (a)  involving the manufacture of chemical products; and

                     (b)  in relation to which a licence has been issued;

is an exempt person in relation to the manufacture of a product the production of which is authorised by the licence, subject to the following conditions:

                     (c)  that the person notifies the APVMA, in writing, of the transfer not later than 6 weeks after it is agreed;

                     (d)  that the person complies with the terms of the licence as if he or she were the holder of the licence;

                     (e)  that the person applies for a licence in relation to the business, in accordance with section 122 of the Code, within 3 months after acquiring the business.

             (2)  An exemption under subregulation (1):

                     (a)  ceases to have effect if the person’s application under paragraph (1)(e) is refused by the APVMA; and

                     (b)  has no effect if the licence referred to in paragraph (1)(b) is not in force.

59E  Requirements for issue of licence

                   It is a requirement for the issue of a licence that, if directed to do so by the APVMA CEO, the applicant for the licence:

                     (a)  undergoes an audit by an APVMA inspector, or another person authorised in writing by the APVMA, of the facilities, equipment, systems, processes, procedures and personnel to be used in the manufacture of the chemical products; and

                     (b)  demonstrates to the satisfaction of the APVMA that the applicant will comply with the conditions to be imposed on the licence if the licence is issued.

60  Licence condition—holder to give information about manufacture

                   For the purposes of paragraph 126(4)(b) of the Code (which deals with additional conditions of a licence), it is a condition of each licence that the holder of the licence must give the APVMA on or before each anniversary of the day on which the licence comes into force:

                     (a)  the name, qualifications and details of the relevant experience of any person nominated by the holder of the licence as the person having control of:

                              (i)  the production of the chemical products manufactured by or on behalf of the holder of the licence; and

                             (ii)  the quality control measures that are, or are to be, employed in the manufacture of the chemical products; and

                     (b)  if the APVMA so requests—details of chemical products manufactured by or on behalf of the holder of the licence during the previous 12 months.

61  Licence conditions—general

             (1)  For the purposes of paragraph 126(4)(b) of the Code (which deals with conditions in licences), the following subregulations set out conditions to which each licence to manufacture chemical products is subject.

             (2)  A holder of a licence must display publicly, at the premises to which the licence relates, a copy of the licence and of any notice issued by the APVMA imposing, varying or removing the conditions applicable to the licence.

             (3)  A holder of a licence must make records showing:

                     (a)  the materials used in the manufacture of the chemical products, the supplier and quantities of the materials used and details of the tests performed on those materials; and

                     (b)  the procedures and controls employed in the manufacture of the chemical products, including the results of tests carried out during the processing of the chemical products; and

                     (c)  details of the tests performed on the chemical products and the results of those tests; and

                     (d)  the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the chemical products;

                     (e)  any complaint or product failure in relation to the chemical products, and the investigations and actions undertaken in relation to the complaint or product failure.

          (3A)  The holder of a licence must manufacture the chemical products in accordance with:

                     (a)  the manufacturing principles; and

                     (b)  the Australian GMP Code.

             (4)  If the chemical products are produced in identifiable batches, the holder of the licence must assign a batch number to each batch of the finished products.

             (5)  A holder of a licence must keep at the premises to which the licence relates:

                     (a)  the records specified in subregulation (3); and

                     (b)  if it is not unreasonable in the circumstances—a sample from each batch of the finished products;

for at least 12 months after the expiry date of the products to which they relate or, if there is no expiry date, for at least 6 years after the date on which the manufacture of the products was completed.

             (6)  The holder of the licence must ensure that a person nominated by the holder as having control of the production of the chemical products or of the quality control measures that are to be employed in the manufacture of the products maintains that control.

             (7)  If a licence allows a person other than the licence holder (in this subregulation called the contractor) to perform a step of a kind set out in paragraph 59A(a) in the manufacture of a chemical product, the licence holder:

                     (a)  must supervise the performance of that step; and

                     (b)  must ensure that the respective responsibilities of the contractor and the licence holder in relation to the step are recorded in writing; and

                     (c)  must ensure that the contractor maintains any records that, under the licence condition imposed by subregulation (3), the licence holder would be required to maintain if the licence holder performed the step; and

                     (d)  must ensure that:

                              (i)  the premises at which the contractor performs the step; and

                             (ii)  the records referred to in paragraphs (b) and (c);

                            are made accessible to a person appointed by the APVMA to inspect the operations of the licence holder.

          (7A)  The holder of a licence may sub‑contract the manufacture of the chemical products only to:

                     (a)  a manufacturer, or laboratory, licensed by the APVMA to perform a step in the manufacture of the chemical products; or

                     (b)  a manufacturer or laboratory located outside Australia that the APVMA has determined complies with a standard of manufacture comparable to the manufacturing principles and the Australian GMP Code.

             (8)  If directed by the APVMA CEO, the holder of a licence must:

                     (a)  undergo an audit by an APVMA inspector, or another person authorised in writing by the APVMA (an auditor), of the facilities, equipment, systems, processes, procedures and personnel used in the manufacture of the chemical products (a GMP audit); and

                     (b)  demonstrate to the satisfaction of the APVMA that the holder is complying with the following conditions of the licence:

                              (i)  any conditions imposed on the licence under subsections 126(1) and (2) of the Code;

                             (ii)  the condition mentioned in paragraph 126(4)(a) of the Code, if the licence is subject to that condition;

                            (iii)  any of the conditions mentioned in subregulations (3) to (7A) to which the licence is subject.

          (8A)  For the purposes of a GMP audit, the holder of the licence:

                     (a)  must give the auditor access to all facilities, equipment, systems, processes, procedures and personnel used in the manufacture of the chemical products, and any information relevant to the GMP audit; and

                     (b)  must not conceal or withhold relevant information from the auditor.

          (8B)  If the audit identifies a non‑conformance by the holder of the licence that, in the auditor’s opinion, is a critical non‑conformance, the holder must notify the APVMA in writing of the critical non‑conformance within 3 working days of being told of the critical non‑conformance by the auditor.

          (8C)  Following a GMP audit of the holder of a licence, the holder must:

                     (a)  within the period determined by the APVMA, give to the APVMA:

                              (i)  the original audit report, signed by the auditor, and any associated audit report supplements; and

                             (ii)  details of the corrective action the holder proposes to take in relation to any non‑conformance identified in the audit report; and

                            (iii)  a proposed period for taking the corrective action; and

                     (b)  implement the corrective action within the period agreed to or specified by the APVMA; and

                     (c)  give to the APVMA evidence demonstrating that the holder is complying with the following conditions of the licence:

                              (i)  any conditions imposed on the licence under subsections 126(1) and (2) of the Code;

                             (ii)  the condition mentioned in paragraph 126(4)(a) of the Code, if the licence is subject to that condition;

                            (iii)  any of the conditions mentioned in subregulations (3) to (7A) to which the licence is subject.

             (9)  If the holder of a licence:

                     (a)  changes his, her or its name; or

                     (b)  being a corporation that has amalgamated with another corporation, carries on business under a name that is different from the name of the holder stated on the licence;

the holder must give notice in writing to the APVMA of the new name, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.

           (10)  If a body corporate that is the holder of a licence becomes an externally‑administered body corporate, within the meaning of the Corporations Law, the person responsible for its administration must notify the APVMA, in writing, that the body corporate has become an externally‑administered body corporate within 3 months after that occurrence.

61A  Determination following GMP audit

             (1)  For paragraph 6(2)(c) of the Act, this regulation applies if the holder of a licence is directed by the APVMA CEO to undergo a GMP audit under subregulation 61(8).

             (2)  On receipt of the information mentioned in subregulation 61(8C), the APVMA must:

                     (a)  assess the information, having regard to the following:

                              (i)  whether the audit report identified any non‑conformances;

                             (ii)  whether any non‑conformances identified in the audit report have been rectified following corrective action;

                            (iii)  any other matters the APVMA considers relevant; and

                     (b)  determine whether the APVMA is satisfied that the holder is complying with the following conditions of the licence:

                              (i)  any conditions imposed on the licence under subsections 126(1) and (2) of the Code;

                             (ii)  the condition mentioned in paragraph 126(4)(a) of the Code, if the licence is subject to that condition;

                            (iii)  any of the conditions mentioned in subregulations 61(3) to (7A) to which the licence is subject.

62  Licence condition—naming persons in control of production etc

                   For the purposes of paragraph 126(4)(b) of the Code (which deals with conditions in licences), if:

                     (a)  an applicant for a licence to manufacture chemical products nominates a person as the person having control of the production of chemical products or of the quality control measures to be employed in the manufacture of the chemical products; and

                     (b)  the licence is granted; and

                     (c)  the applicant wishes to replace the nominated person with another person;

it is a condition of the licence that the licence holder must inform the APVMA as soon as practicable of the name, qualifications and experience of that other person.

Part 8Enforcement

  

63  Method of securing samples

                   An inspector who takes a sample of any substance or mixture of substances for the purposes of section 131 or 132 of the Code (which deal with powers of search and seizure) must ensure that:

                     (a)  the sample is contained and sealed in an appropriate vessel or package; and

                     (b)  the vessel or package is so marked as to clearly identify the sample; and

                     (c)  the vessel or package cannot be opened, or the identification of the sample removed, without breaking the seal; and

                     (d)  the sample is stored and transported in such a way that the composition of the sample is not altered.

64  Form of search warrant

                   For the purposes of subsection 133(2) of the Code (which deals with the form of a search warrant), the form of warrant in Schedule 5 is prescribed.

Part 9Miscellaneous

  

65  Prescribed authorities that may require further information

                   For the purposes of subsection 159(1) of the Code (which deals with notices to give further information), each of the following authorities is prescribed:

                     (a)  the Department of Health and Ageing of the Commonwealth;

                     (b)  the Department of the Environment and Heritage of the Commonwealth;

                     (c)  the National Occupational Health and Safety Commission established by the National Occupational Health and Safety Commission Act 1985;

                     (d)  an authority in this jurisdiction having any function or power in relation to a matter referred to in paragraph 159(a), (b), (c) or (d) of the Code.

66  Disclosure of confidential commercial information about toxicity etc

             (1)  For the purposes of subparagraphs 162(3)(a)(iii) and 162(3)(b)(iii) of the Code, this regulation prescribes the conditions under which confidential commercial information of a kind described in those subparagraphs may be disclosed by the authorised person about a chemical product or any of its constituents.

             (2)  Information about a protected chemical product that is compensatable protected registration information may be disclosed to a person (the requesting person) on request if the requesting person signs and gives to the APVMA, before the information is disclosed, a declaration stating that the information will not be used in connection with an application for registration, in Australia or elsewhere, of another chemical product, except with the consent of the interested person in relation to the protected chemical product.

             (3)  Information about a chemical product that is not compensatable protected registration information, may be disclosed to a person on request by making it available to that person, for the purpose of reading only, at the premises of the APVMA or, if the APVMA thinks it appropriate, at other premises.

             (4)  Despite subregulations (2) and (3), information about a constituent of a chemical product other than an active constituent may be disclosed to a medical practitioner, in connection with his or her professional duties.

             (5)  In this regulation, compensatable protected registration information means protected registration information in respect of which compensation for provision of the information would be payable under Part 3 of the Code.

67  Disclosure of confidential commercial information about chemical products not yet registered etc

                   For the purposes of subparagraph 162(3)(c)(iii) of the Code a prescribed person is:

                     (a)  in the case of a chemical product in respect of which an application for registration has been made—a person who is expressly authorised to obtain the information by the applicant for registration; or

                     (b)  in the case of an active constituent in respect of which an application for approval has been made—a person who is expressly authorised to obtain the information by the applicant for approval.

68  Disclosure of confidential commercial information to international organisations

                   For the purposes of subparagraph 162(3)(d)(ii) of the Code, the following organisations are prescribed:

                     (a)  the World Health Organization;

                     (b)  the Food and Agriculture Organization of the United Nations;

                     (c)  the International Labour Organization;

                     (d)  the United Nations Environment Programme;

                     (e)  the United Nations International Programme on Chemical Safety;

                      (f)  the Organization for Economic Co‑operation and Development;

                     (g)  any international organisation established jointly by 2 or more of the international organisations mentioned in paragraphs (a), (b), (c), (d), (e) and (f);

                     (h)  any international organisation that is an agency or committee of an international organisation mentioned in paragraph (a), (b), (c), (d), (e), (f), or (g).

69  Disclosure of confidential commercial information—records

             (1)  The APVMA must make a record, on each occasion on which confidential commercial information is disclosed, of:

                     (a)  the name and address of the person to whom the information is disclosed; and

                     (b)  the nature of the information disclosed; and

                     (c)  the date on which the information was disclosed.

             (2)  A record made under subregulation (1) must be kept for a period of 10 years.

             (3)  A person must not disclose any information contained in a record made under subregulation (1) to a person who is not a member of the staff of the APVMA.

Penalty:  10 penalty units.

          (3A)  It is a defence to a prosecution under subregulation (3) if the defendant:

                     (a)  has a reasonable excuse; or

                     (b)  has the permission in writing of the Minister or a person authorised under subregulation (4).

Note:          A defendant bears an evidential burden in relation to the matters mentioned in this subregulation—see section 13.3 of the Criminal Code.

          (3B)  An offence under subregulation (3) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (4)  The Minister may, in writing, authorise a person for the purposes of subregulation (3).

             (5)  In this regulation the Minister means the Minister for Primary Industries and Energy.

70  Fees for applications

             (1)  For the purposes of section 164 of the Code, this regulation provides for the fees payable in respect of applications under the Code.

Note:          Regulations 70A, 71, 71A, 72 and 72A make further provision regarding fees payable in respect of applications under the Code.

             (2)  The fee payable in respect of an application of a kind specified in Column 2 of an item in Part 2 of Schedule 6 is the fee (if any) specified for the item in Column 4 of that Schedule.

             (3)  A reference in Column 4 of an item in Part 2 of Schedule 6 to a modular assessment fee, is a reference to the modular assessment fee in respect of the application to which that item refers, worked out in accordance with regulation 71.

             (4)  The fee that is required to be paid at the time of making an application of a kind specified in an item in Part 2 of Schedule 6 is:

                     (a)  if a modular assessment fee is payable for the application—$535; or

                     (b)  if a fee is specified in Column 4 of the item—the fee specified in that column.

Note:          Paragraph 11(1)(d) of the Code states that an application must be accompanied by:

(i)     if only part of the prescribed fee is required to be paid at the time of making the application—the amount required to be paid; or

(ii)    otherwise—the whole of the prescribed fee (if any).

             (5)  For the purposes of subsection 11A(4) of the Code, the component of the fee in respect of the preliminary assessment of an application made under section 10 of the Code (that is, the component of the fee paid under subregulation (4) in respect of the application that will not be repayable if the APVMA rejects an application on the ground that the application has not been properly made) is:

                     (a)  in the case of an item in Part 2 of Schedule 6 for which a modular assessment fee is payable—$535; and

                     (b)  in the case of an item in Part 2 of Schedule 6 for which the fee specified in Column 4 is nil or less than $535—that fee specified in that column; and

                     (c)  in the case of an item in Part 2 of Schedule 6 for which the fee specified in Column 4 is $535 or more—$535.

             (6)  No fee is payable in respect of an application for a permit:

                     (a)  if:

                              (i)  the applicant is:

                                        (A)  the Commonwealth, a State or Territory; or

                                        (B)  an authority or agency of the Commonwealth, a State or a Territory; or

                                        (C)  an officer or employee of the Commonwealth, a State or a Territory, or of an authority or agency of the Commonwealth, a State or a Territory; and

                             (ii)  the permit is in support of the Commonwealth’s, State’s or Territory’s core activities; and

                            (iii)  the permit is for a use that does not have a commercial benefit; or

                     (b)  in respect of an emergency use of a chemical product.

70A  Fees in respect of existing use active constituents

             (1)  Despite regulation 70, no fee is payable under that regulation in respect of an application for approval of an active constituent for a chemical product if:

                     (a)  the active constituent is an existing use active constituent within the meaning of subregulation 40A(3); and

                     (b)  immediately before the commencement of the Code:

                              (i)  a clearance for registration that the APVMA granted under section 15 of the repealed Act in respect of the chemical product was in force; or

                             (ii)  an application under section 12 of the repealed Act for a clearance for registration of the chemical product had been made and had not been refused or withdrawn; and

                     (c)  full technical details of the active constituent had been given, before the commencement of the Code, to a relevant body; and

                     (d)  the application for approval is made within 6 months after the commencement of the Code.

             (2)  In paragraph (1)(c):

full technical details, in relation to an active constituent, includes, but is not limited to, the following:

                     (a)  details of the chemistry of the active constituent;

                     (b)  details of the manufacture of the active constituent;

                     (c)  the site at which the active constituent is manufactured;

                     (d)  a declaration of composition of the active constituent;

                     (e)  a batch analysis of the active constituent.

relevant body means any of the following:

                     (a)  the body known as the Technical Committee on Agricultural Chemicals;

                     (b)  the body known as the Technical Committee on Veterinary Drugs;

                     (c)  the Australian Agricultural and Veterinary Chemicals Council established under the repealed Act;

                     (d)  the APVMA.

71  Modular assessment fee

             (1)  Schedule 7 sets out the assessment modules that may be necessary to determine an application for which a modular assessment fee is payable.

             (2)  An assessment module may have different levels or types of assessment.

             (3)  The fee payable for a module, level or type of assessment is set out in Column 4 of Schedule 7.

             (4)  The modular assessment fee for an application is the sum of the fees payable for:

                     (a)  the screening assessment module in item 1 in Schedule 7; and

                     (b)  the other modules, levels and types of assessment that the APVMA considers necessary for the application to undergo; and

                     (c)  the type of finalisation assessment module in items 11.1 to 11.4 in Schedule 7 that the application must undergo.

Note 1:       The Agricultural and Veterinary Chemicals Code Instrument No. 2 (Modular Assessment Fees) 2010 sets out criteria for working out which fee applies under regulation 71 in a particular case.

Note 2:       Under subregulation 70(5), the APVMA will retain the $535 that, under subregulation 70(4), accompanied an application for which a modular assessment fee is payable if the APVMA rejects the application on the ground that the application had not been properly made.

             (5)  For the purposes of subsection 164(2) of the Code, any balance of the modular assessment fee is due and payable on the date specified by the APVMA in a notice under paragraph 78(3)(b) or subregulation 78A(2).

71A  Annual fees for continued registration of chemical product

             (1)  For paragraph 49(1)(d) of the Code, the fee payable for an application for the renewal of the registration of a chemical product in respect of the financial year commencing on 1 July 2005 or any subsequent financial year is $430.

             (2)  In addition, for section 164 of the Code, an annual fee (the overseas GMP compliance assessment fee) is payable by the interested person, in relation to the registration of a veterinary chemical product, for each site outside Australia at which:

                     (a)  the product is manufactured; or

                     (b)  a step in the manufacture of the product occurs.

             (3)  However, the overseas GMP compliance assessment fee is not payable:

                     (a)  in relation to a site if the interested person has, in the financial year in respect of which the fee is payable, already paid an overseas GMP compliance assessment fee in relation to another chemical product manufactured at the same site; or

                     (b)  in relation to a chemical product that is:

                              (i)  an exempt product within the meaning given by regulation 59; or

                             (ii)  a listable chemical product; or

                            (iii)  a reserved chemical product; or

             (4)  The amount of the overseas GMP compliance assessment fee is $1 000 for each financial year for which the registration is in force.

             (5)  The overseas GMP compliance assessment fee is payable on the date on which the interested person makes an application for renewal of the registration of the chemical product.

71B  Overseas GMP compliance assessment

             (1)  This regulation applies in relation to the registration of a veterinary chemical product if:

                     (a)  the product is manufactured outside Australia; and

                     (b)  the product is not:

                              (i)  an exempt product within the meaning given by regulation 59; or

                             (ii)  a listable chemical product; or

                            (iii)  a reserved chemical product; and

                     (c)  the registration of the product is subject to a condition that each step in the manufacture of the product complies with any of the following:

                              (i)  the Code;

                             (ii)  the manufacturing principles;

                            (iii)  the Australian GMP Code;

                            (iv)  any standards that apply to the chemical products;

                             (v)  any standard determined by the APVMA to be comparable to the manufacturing principles or the Australian GMP Code; and

                     (d)  the registration of the product is subject to a condition that the interested person in relation to the registration must, if directed by the APVMA CEO, give to the APVMA, or arrange for the manufacturer of the product to give to the APVMA, evidence of compliance with the condition mentioned in paragraph (c).

             (2)  For paragraph 6(2)(c) of the Act, subregulations (3) and (4) apply if the APVMA CEO has directed the interested person to provide evidence of compliance with the condition mentioned in paragraph (1)(c).

             (3)  If a GMP audit was carried out, and a report of the audit has been given to the APVMA, the APVMA must assess the report having regard to:

                     (a)  whether the audit report identified any non‑conformances; and

                     (b)  whether any non‑conformances identified in the audit report have been rectified following corrective action; and

                     (c)  any other matters that the APVMA considers relevant.

             (4)  The APVMA must:

                     (a)  assess any evidence of compliance with the condition given to the APVMA by the interested person or on behalf of the interested person; and

                     (b)  determine whether the APVMA is satisfied that the condition has been complied with.

             (3)  In this regulation:

GMP audit has the meaning given by paragraph 61(8)(a).

72  Remission of fees for applications

             (1)  For the purposes of paragraph 164(8)(b) of the Code, a circumstance in which the APVMA may remit the whole or part of a fee paid:

                     (a)  in respect of an application under the Code, other than an application:

                              (i)  for the renewal of the registration of a chemical product; or

                             (ii)  for a permit; or

                     (b)  for a module of assessment;

is that:

                     (c)  in the case of an application—the application is not determined within the period specified or worked out in respect of that application under regulation 76; or

                     (d)  in the case of a module of assessment specified in Schedule 7—the module is not completed within the time specified for the module in that Schedule.

             (2)  For the purposes of paragraph 164(8)(b) of the Code, the APVMA may waive or remit, up to $100, the whole or part of a fee payable or paid under the Code.

72A  Fees for licences

             (1)  For section 164 of the Code, this regulation prescribes matters relating to fees payable in respect of licences issued under Part 8 of the Code.

Fee for licence application

             (2)  The fee payable for an application for the issue of a licence is $900.

Annual licence fee

             (3)  The holder of a licence must pay an annual licence fee, for each financial year in which the licence is held, as follows:

                     (a)  for a category 1 licence—$7 500;

                     (b)  for a category 2, 3 or 4 licence—$5 000;

                     (c)  for a category 6 licence—$1 800;

                     (d)  for a multi‑category licence—$7 500.

             (4)  However, if a licence is issued on a date other than on 1 July in a financial year, the annual licence fee payable for the first financial year of the licence is a pro rata amount of the fee mentioned for the licence in subregulation (3) for the number of whole months of the financial year remaining on the date the licence is issued.

             (5)  The annual licence fee payable for a licence for the second financial year, and each subsequent financial year, in which the licence is held is reduced by 50% if the licence holder gives the APVMA satisfactory evidence that the total notional wholesale value of the chemical products manufactured under the licence in the previous financial year was less than $50 000.

             (6)  If a licence is not in force on 1 July of a financial year because the licence is suspended:

                     (a)  an annual licence fee is not payable for the licence for that financial year unless the suspension is revoked later in the financial year; and

                     (b)  the amount payable is a pro rata amount of the fee mentioned for the licence in subregulation (3) for the number of whole months of the financial year remaining on the date of the revocation.

             (7)  The annual licence fee is payable on receipt of an invoice for the fee issued by the APVMA.

Fee for variation of licence

             (8)  An additional fee of $1 800 is payable in respect of a licence if:

                     (a)  the holder of the licence requests that the APVMA vary the licence; and

                     (b)  the APVMA determines that a GMP audit is required in order to assess the request.

             (9)  The APVMA must waive any licence fees payable before 1 July 2013 under regulation 72A, as in force immediately on 30 June 2013, that are unpaid on 1 July 2013.

           (10)  In this regulation:

GMP audit has the meaning given by paragraph 61(8)(a).

notional wholesale value has the same meaning as in the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994.

           (11)  In subregulation (5):

                     (a)  the notional wholesale value of a batch of a veterinary chemical product is the notional wholesale value at the time of completion of manufacture of the batch; and

                     (b)  a reference to the chemical products manufactured does not include veterinary chemical products that are:

                              (i)  exempt products within the meaning given by regulation 59; or

                             (ii)  listable chemical products; or

                            (iii)  reserved chemical products.

Note:          Section 3 of the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994 has the following definition:

                   notional wholesale value, in relation to a chemical product at a particular time, means the amount that the APVMA determines would have been received:

(a)    if the product is an Australian product—by the manufacturer; or

(b)    if the product is an imported product—by the importer;

                   in respect of the product if, at that time, the product had been sold by the manufacturer or importer, as the case may be, by wholesale to a person with whom the manufacturer or importer was dealing at arm’s length.”

73  Fees for copies and extracts

             (1)  Subject to subregulation (3), the fee payable:

                     (a)  under subsection 17(5) of the Code—for a copy of, or extract from, a part of the Record of Approved Active Constituents in respect of an active constituent; or

                     (b)  under subsection 18(5) of the Code—for a copy of, or extract from, a part of the Register of Agricultural and Veterinary Chemical Products in respect of a chemical product; or

                     (d)  under subsection 97(4) of the Code—for a copy of a certificate in respect of an analysis; or

                     (e)  under subsection 113(6) of the Code—for a copy of a permit; or

                      (f)  for the disclosure, under section 162 of the Code, of confidential commercial information:

                              (i)  of a kind described in subparagraphs 162(3)(a)(iii) or 162(3)(b)(iii) of the Code, other than to a medical practitioner referred to in subregulation 66(4); or

                             (ii)  to a person referred to in subparagraph 162(3)(c)(ii);

is the fee worked out in accordance with subregulation (2).

             (2)  For the purposes of subregulation (1), the fee is the sum of the following:

                     (a)  $95; and

                     (b)  $95 for each additional hour or part of an hour, after the first hour, of work done by the APVMA to make the copy or extract available; and

                     (c)  20 cents for each photocopied page in excess of the first 100 pages; and

                     (d)  $4.40 for each page of a copy, other than a photocopy, of a document; and

                     (e)  $4.40 for each page of a transcript of:

                              (i)  a sound recording; or

                             (ii)  a document in shorthand.

             (3)  No fee is payable:

                     (a)  for a copy or extract referred to in paragraph (1)(a) or (b)—by the person who applied for registration or approval of the constituent, product or label; or

                     (b)  for a copy referred to in paragraph (1)(e)—by the person who applied for the permit; or

                     (c)  in respect of any matter referred to in subregulation (1)—by an authority in this jurisdiction having any function or power in relation to a matter referred to in paragraph 159(a), (b), (c) or (d) of the Code.

74  Payment of fees

                   A fee payable under these Regulations is payable to the APVMA.

75  Notification that application has been received

                   Within 10 days of receiving an application under the Code, the APVMA must notify the applicant that the application has been received.

76  Period within which APVMA is to determine application

             (1)  For the purposes of section 165(1) of the Code, the APVMA must determine an application of a kind specified in Column 2 of an item in Part 2 of Schedule 6 within the period (if any) specified for the item in Column 3 of that Schedule.

             (2)  A reference in Column 3 of an item in Part 2 of Schedule 6 to a modular assessment period, is a reference to the modular assessment period in respect of the application to which that item refers, worked out in accordance with regulation 77.

             (4)  Despite subregulation (1), if:

                     (a)  the APVMA receives an application for a permit in respect of a chemical product; and

                     (b)  the application is in respect of an emergency use of the chemical product;

the APVMA must determine the application as soon as is practicable in the circumstances of the case.

Note 1:       Subsection 165(2) of the Code provides that in working out a period for the purposes of an application, no regard is to be had to certain periods that would otherwise be part of that period, including any period during which a requirement made by the APVMA has not been complied with.

Note 2:       For the period within which an application for the renewal of the registration of a chemical product must be granted, see subsection 49(4) of the Code.

77  Modular assessment period

             (1)  In addition to setting out the fees for modules, levels and types of assessment, Schedule 7 sets out in Column 3 of the Schedule the period within which some of those modules, levels and types must be completed.

             (2)  The modular assessment period referred to in Column 3 of an item in Part 2 of Schedule 6 (that is, the period within which an assessment of an application must be completed) is the sum of:

                     (a)  the longest of the periods for such other modules or levels of assessment in other items in Schedule 7 that the APVMA considers necessary for the application to undergo; and

                     (b)  the period for the type of finalisation assessment module in items 11.1 to 11.4 in Schedule 7 that the application must undergo.

78  Commencement of period for determining applications made under section 10 of the Code

             (1)  In the case of an application of a kind specified in item 1, 3, 4, 5, 6, 7, 8, 15, 16 or 17 in Part 2 of Schedule 6, the period specified in Column 3 of the item commences at the first moment of the day after the later of:

                     (a)  the day on which the APVMA gives notice under subsection 11A(2) of the Code that the application has passed preliminary assessment; and

                     (b)  the day on which the correct fee specified in respect of the application is paid.

             (2)  In the case of an application of a kind specified in item 2, 10 or 24 in Part 2 of Schedule 6, the modular assessment period commences immediately after the day on which the balance of the modular assessment fee is paid.

Note:          Notice of passing preliminary assessment for, or rejection of, applications made under section 10 of the Code are given under subsections 11A(2) and (5) of the Code, respectively.

             (3)  If the APVMA gives notice under subsection 11A(2) of the Code in relation to an application, the APVMA must also notify the applicant in writing:

                     (a)  that if, under section 159 of the Code, the APVMA requires a person to give further information about the application, consideration of the application may be suspended, or the application may be treated as withdrawn, if the person fails to comply with the requirement; and

                     (b)  if the application is of a kind specified in item 2, 10 or 24 in Part 2 of Schedule 6:

                              (i)  of the modules that the application must undergo; and

                             (ii)  of the balance of the modular assessment fee payable; and

                            (iii)  that the balance is due and payable on the date specified in the notice.

Note:          The balance payable in relation to an application for which a modular assessment fee is payable is the difference between the modular assessment fee and the $535 that accompanied the application.

78A  Commencement of period for determining other applications

             (1)  In the case of an application of a kind specified in item 9, 11, 12, 13, 14, 18, 19, 20, 21, 23 or 25 in Part 2 of Schedule 6, the period specified in Column 3 of the item commences at the first moment of the day after the later of:

                     (a)  the day the APVMA gives notice under subregulation (2) that the APVMA will proceed with the technical evaluation and assessment of the application; or

                     (b)  the day on which the correct specified fee (if any) in respect of the application is paid.

             (2)  The APVMA must, within 1 month after receiving an application referred to in subregulation (1), notify the applicant in writing:

                     (a)  whether the APVMA will proceed with the technical evaluation and assessment of the application; and

                     (b)  that if, under section 159 of the Code, the APVMA requires a person to give further information about the application, consideration of the application may be suspended, or the application may be treated as withdrawn, if the person fails to comply with the requirement; and

                     (c)  if the APVMA will proceed with technical evaluation and assessment and a modular assessment fee is payable for the application:

                              (i)  of the modules that the application must undergo; and

                             (ii)  of the balance of the modular assessment fee payable; and

                            (iii)  that the balance is due and payable on the date specified in the notice.

Note 1:       The balance payable in relation to an application for which a modular assessment fee is payable is the difference between the modular assessment fee and the $535 that accompanied the application.

Note 2:       For an application of a kind specified in item 22 in Part 2 of Schedule 6 (permit if the proposed use a chemical product or active constituent is determined by the APVMA to be an emergency use), subregulation 76(4) states that the APVMA must determine the application as soon as is practicable in the circumstances of the case.

79  Logo of the APVMA

                   For the definition of protected symbol in subsection 170A(5) of the Code, the logo of the APVMA is set out in Schedule 8 of these Regulations.


Schedule 1Date‑controlled agricultural chemical products

(paragraph 4(b))

  

  

 

1

An agricultural chemical product containing organisms (including, in particular, nematodes, bacteria, viruses, fungi, algae or protozoa)

2

An agricultural chemical product containing bacillus thuringiensis

3

An agricultural chemical product containing mancozeb

4

An agricultural chemical product containing zineb

5

An agricultural chemical product containing diazinon

6

An agricultural chemical product containing dimethoate

Schedule 2Protected registration information—allocated points

(regulation 6)

  

  

 

Column 1
Item

Column 2
Study

Column 3
Species

Column 4
Points

 

TOXICOLOGY

 

 

 

Acute Studies

 

 

1.

Acute oral (technical)

rabbit, rodent, dog

3

2.

Acute dermal (technical)

rabbit, rodent

5

3.

Acute inhalation (technical)

rabbit, rodent

9

4.

Eye irritation (technical)

rabbit, rodent

3

5.

Dermal irritation (technical)

rabbit, rodent

3

6.

Dermal sensitization (technical)

rabbit, rodent

2

7.

Acute oral (formulated)

rabbit, rodent

3

8.

Acute dermal (formulated)

rabbit, rodent

5

9.

Acute inhalation (formulated)

rabbit, rodent

9

10.

Eye irritation (formulated)

rabbit, rodent

1

11.

Dermal irritation (formulated)

rabbit, rodent

1

12.

Dermal sensitisation (formulated)

rabbit, rodent

4

 

Short Term

 

 

13.

Oral (90 day)

rabbit, rodent, dog

100

14.

Dermal (90 day)

rabbit, rodent

100

15.

Inhalation (90 day)

rabbit, rodent

200

16.

Dermal (21 day)

rabbit, rodent

25

17.

Inhalation (21 day)

rabbit, rodent

50

 

Long Term

 

 

18.

1 year chronic feeding

rabbit, rodent, dog

425

19.

Lifetime oncogenicity

rabbit, rodent

600

20.

Combined chronic and oncogenicity

rabbit, rodent

825

 

Special Studies

 

 

21.

Multi‑generation reproduction

rabbit, rodent

270

22.

Teratogenicity

rabbit, rodent

70

23.

In vitro mutagenicity
Point mutation

microbial
mammalian

20
20

24.

Chromosome aberration

 

15

25.

DNA repair

 

15

26.

Delayed neurotoxicity

bird

45

27.

Exposure studies

 

150 (each study)

28.

In vivo genotoxicity

 

30

29.

Other

 

30

 

METABOLISM

 

 

30.

Metabolism (labelled)

rabbit, rodent,
bird, cattle, goat

100
100

31.

Metabolism (labelled)

plants

100

32.

Pharmacokinetic (unlabelled)

 

80

33.

Other

 

30

 

ENVIRONMENTAL CHEMISTRY

 

34.

Hydrolysis

 

15

35.

Vapour pressure

 

15

36.

Photodegradation

soil
aqueous
air

80
25
15

37.

Solubility in water

 

25

38.

Octanol/water partition coefficient

 

5

39.

Mobility: absorption/desorption

 

35

40.

Leaching
lab study (cold)
field (labelled)

 


40
150

41.

Soil metabolism

aerobic/anaerobic

40

42.

Soil dissipation study or crop rotation study

 

60

43.

Soil accumulation

 

60

44.

Pond study (run‑off)

 

75

45.

Aquatic degradation and persistence

aerobic

30

46.

Other

 

30

 

ENVIRONMENTAL TOXICOLOGY

 

47.

Acute oral

bird

5

48.

Sub‑acute oral

bird

5

49.

Avian reproduction study

 

15

50.

Acute toxicity

fish

5

51.

Acute toxicity

insect

10

52.

Toxicity

insect

5

53.

Toxicity: non‑target terrestrial invertebrate

 

20

54.

Toxicity: non‑target

plant/algal inhibition test

30

55.

Other

 

30

 

RESIDUES

 

 

56.

Residue Trials

 

50
(per trial or test)

 

OTHER

 

 

57.

Other

 

30


Schedule 3Definition of agricultural chemical product

(regulation 7)

Part 1Preliminary

  

1  Definitions

                   In this Schedule:

air conditioning means any cooling, heating or ventilation system that modifies the condition of the air.

cooling tower means:

                     (a) a device for lowering the temperature of water or other liquid by evaporative cooling; and

                     (b)  an evaporative condenser that incorporates a device containing a refrigerant or heat exchanger.

open water cooling system means a water cooling system through which water flows once with no recirculation.

ore extraction and processing means the crushing and separating of ore into valuable substances or waste.

sewage means waste matter, including, but not limited to, household waste liquid from toilets, baths, showers, kitchens and sinks, that is disposed of using sewers.

sewage treatment means the physical, chemical and biological processes applied to sewage to remove physical, chemical and biological contaminants to produce wastewater, and a solid waste or sludge, suitable for disposal or re‑use in the environment.

wastewater means the water remaining at the end of sewage treatment that may be released into the environment for re‑use.

water cooling system means a cooling tower and its associated equipment and pipe work.


Part 2Substances or mixtures declared to be agricultural chemical products

 

Item

Class of substance or mixture of substances

1

Dairy cleansers for on‑farm use

2

Any substance used in conjunction with an agricultural chemical product to identify areas treated with that product

3

Insect repellents for use on human beings

4

Sanitisers for use in swimming pool or spa water, including chlorine‑based swimming pool and spa products

5

Any biocidal substance contained or used in a device for the sanitising of swimming pool or spa water

6

Parts of a vertebrate animal, material produced from a vertebrate animal or matter the production of which involves the use of a vertebrate animal, if represented supplied or used for a purpose mentioned in subsection 4(2) of the Code

Part 3Substances or mixtures declared not to be agricultural chemical products

 

Item

Class of substance or mixture of substances

1

Any mould inhibitor for use in the manufacture of paper, paper pulp, glue, plywood, carpets, plastics, glass, fabrics, domestic items, bedding material, leather goods or surface coatings (including paint but excluding antifouling paint), if:

(a) the mould inhibitor is incorporated into the product during manufacture for the protection of the goods; and

(b) the mould inhibitor is not released into the environment from the manufactured product; and

(c) the manufactured product is not claimed to have any effect as a pesticide

2

Any fungicide, bactericide or deodorant for use in footwear and clothing

3

Any soil ameliorant, conditioner or fertiliser applied to soil or other growing media if the product is not claimed to have any effect as a regulator of plant growth

4

Invertebrate pest management lures based on food and not containing any active constituent

5

Vertebrate pest management lures

6

Any disinfectant, mould inhibitor, air freshener or sanitiser sold by retailers, or presented or promoted primarily through retailers, to consumers for domestic use, except any sanitiser for use in swimming pool or spa water

7

Cyanuric acid for use in swimming pools as a chlorine stabiliser

8

Cut flower preservatives

9

Any hay inoculant, silage inoculant or legume inoculant, if the product is based on bacteria, enzymes or both

10

Any predatory insect, predatory mite or macroscopic parasite

11

The nematode Deladenus siricidicola for the control of Sirex species wood wasps in pine plantations

12

Any industrial biocide used in the manufacture of paper pulp

13

Head lice or body lice treatments for human beings

14

Substances that present a physical barrier to a pest that:

(a) do not contain a biocide; and

(b) do not otherwise affect the pest; and

(c) are not released into the environment

15

Products (such as soils and potting mixtures) that contain naturally occurring Trichoderma species, if the product:

(a) does not control or claim to control specific diseases; and

(b) does not claim to promote plant growth; and

(c) is not otherwise represented, supplied or used as an agricultural chemical product

16

Substances used to adjust the pH of swimming pool or spa water

17

Ozone generated on site for treatment of swimming pool or spa water

18

Hot water and steam treatments solely based on water and not containing other constituents

19

Any product for domestic use by householders in controlling a plant disease or pest, that:

(a) is a food normally consumed by human beings; and

(b) is not a plant extract or other manufactured compound; and

(c) is not claimed to have effect as an agricultural chemical product; and

(d) is not expressly supplied as an agricultural chemical product

20

Biocides used to control organisms in air conditioning or water‑cooling systems, other than open water‑cooling systems through which water flows once with no recirculation

21

Biocides used in sewage treatment to control organisms in sewage and wastewater

22

Biocides used to control organisms in water effluent from ore extraction and processing

23

Biocides to control organisms in water, used for the purpose of maintaining equipment associated with the extraction of coal seam gas in serviceable condition

24

Whole vertebrate animals if represented, supplied or used for a purpose mentioned in subsection 4(2) of the Code


Schedule 3AADefinition of veterinary chemical product

(regulation 8)

Part 1Preliminary

1  Definitions

                   In this Schedule:

direct‑fed microbial product means a chemical product that:

                     (a)  contains viable micro‑organisms; and

                     (b)  is intended for oral administration to animals.

medicated block or lick means a block or lick incorporating a veterinary chemical product.

medicated premix means a premix that incorporates one or more veterinary chemical products for the purpose of:

                     (a)  preventing or treating disease; or

                     (b)  enhancing growth, production, work or performance; or

                     (c)  altering reproductive physiology.

medicated stockfood means a ready‑to‑use stockfood that incorporates one or more veterinary chemical products for the purpose of:

                     (a)  preventing or treating disease; or

                     (b)  enhancing growth, production, work or performance; or

                     (c)  altering reproductive physiology.

stockfood non‑active constituent means any organic acid, antioxidant, pellet binding product, mould inhibitor, preservative, feed handling improver, colouring agent, anticaking agent, deodorising agent or other substance or mixture of substances intended to be added to stockfood for continuous, long‑term administration to animals for a purpose other than:

                     (a)  preventing or treating disease; or

                     (b)  enhancing growth, production, work or performance; or

                     (c)  altering reproductive physiology.

Note:          Several other words and expressions used in this Schedule have the meaning given by regulation 3. For example:

block or lick

premix

stockfood

stockfood supplement.

2  Power to make orders

                   Section 7 of the Act applies to the prescription of stockfood non‑active constituents excluded from the class described in item 4 of Part 2 of this Schedule.

3  Meaning of daily requirement

                   For item 3 of Part 3 of this Schedule, the daily requirement of a vitamin, mineral or amino acid is the amount of the vitamin, mineral or amino acid specified as the daily requirement by:

                     (a)  if the species is a dog, cat or horse—the National Research Council of the National Academy of Sciences (United States of America); or

                     (b)  if the species is a ruminant—Nutrient Requirements of Domesticated Ruminants published by CSIRO in 2007; or

                     (c)  if the species is a pig—the standard Feeding Standards for Australian Livestock: Pigs published by CSIRO in 1987; or

                     (d)  if the species is poultry—the standard Feeding Standards for Australian Livestock: Poultry published by CSIRO in 1987.


Part 2Substances or mixtures declared to be veterinary chemical products

 

Item

Class of substance or mixture of substances

1

Allergenic substances supplied or used for administration to an animal by any means, or for consumption by an animal

2

Medicated blocks or licks

3

Enzymes supplied or used for administration to an animal by any means, or for consumption by an animal

4

Stockfood non‑active constituents, except stockfood non‑active constituents excluded from this class by an order under section 7 of the Act

5

Direct‑fed microbial products

6

Sheep branding substances

7

Teat sealants

8

Parts of a vertebrate animal, material produced from a vertebrate animal or matter the production of which involves the use of a vertebrate animal, if represented supplied or used for a purpose mentioned in subsection 5(2) of the Code

Part 3Substances or mixtures declared not to be veterinary chemical products

 

Item

Class of substance or mixture of substances

1

Stockfoods that are not medicated stockfoods

2

Medicated stockfoods and medicated premixes, if:

(a) any veterinary chemical product that is incorporated in the medicated stockfood or medicated premix:

(i) is a registered chemical product; and

(ii) is incorporated at a rate of use in accordance with the approved label for containers for that registered chemical product; and

(b) the container for the medicated stockfood or medicated premix is labelled in accordance with the instructions on the approved label for that registered chemical product

3

Blocks and licks (other than medicated blocks and licks), premixes and stockfood supplements, if:

(a) the only claim on the label of the product consists of the words ‘to supplement diets where levels may be low’, or words to that effect; and

(b) for any vitamin, mineral or amino acid listed on the label, the product incorporates not less than 25% of the daily requirement of that vitamin, mineral or amino acid for the species for which the product is intended

4

Colour intensifiers for aviary birds

5

Any bitterant product for application to a building, piece of equipment or other object, that:

(a) is solely for reducing or preventing animals that are not food producing species from biting or chewing the building, piece of equipment or other object; and

(b) contains no antiseptic, antimicrobial, antibiotic or other active constituent other than a bitterant

6

Any product applied topically to the teeth, hair, fur or intact skin of an animal to cosmetically alter the animal’s appearance or odour, that:

(a) contains no antiseptic, antimicrobial, or antibiotic active constituent, and

(b) is solely for cosmetic purposes; and

(c) is not claimed to have any benefits other than cosmetic benefits; and

(d) is not supplied or used for any therapeutic benefit other than to cosmetically alter the animal’s appearance or odour

7

Any product for topical application to an animal to provide a physical barrier, that:

(a) is chemically inert; and

(b) does not act by biochemical means; and

(c) is not a teat sealant; and

(d) contains no antiseptic, antimicrobial, antibiotic or other active constituent; and

(e) is not claimed to have any effect other than as a physical barrier

8

Any autograft, allograft or xenograft product supplied to veterinary surgeons for surgical procedures, except blood, blood products, stem cells or stem cell products

9

Any product for use as an extender for sperm, ova or semen, if:

(a) the product contains no ingredients other than antibiotics, albumins, electrolytes, amino acids, EDTA, buffers or stabilising agents; and

(b) any antibiotic in the product is not at a concentration greater than 0.1 mg/mL or 0.1mg/g

10

Any product for topical application to an animal to act as a lubricant, that:

(a) is chemically inert; and

(b) does not act by biochemical means; and

(c) is not a teat sealant; and

(d) contains no antiseptic, antimicrobial, antibiotic or other active constituent; and

(e) is not claimed to have any effect other than as a lubricant

11

Semen, ova or embryos if represented, supplied or used for the purpose of reproduction

12

Whole vertebrate animals if represented, supplied or used for a purpose mentioned in subsection 5(2) of the Code

Schedule 3APrescribed uses (Code, s 34F (5))

(regulation 22A)

Note:       The text of Parts 1 and 2 of this Schedule is derived from that of the Codex Alimentarius. The ‘Codex number’ column and the ‘Major uses’ column are included because they are of assistance to users of the Codex. The food crops listed in the ‘Major uses’ column of Part 1of this Schedule are also used for the purposes of the definition of major food crop in Schedule 6.

Part 1Food crops and food crop groups

 

CODEX no.

Crop/situation group

Major uses

Non‑major uses

01           Fruits

001

Citrus fruits

Orange, mandarin (tangerine)

Grapefruit, lemon, lime, shaddock (pomelo)

002

Pome fruits

Apple, pear

Crab‑apple, loquat (Japanese medlar), medlar, nashi pear, quince

003

Stone fruits

Apricot, cherry, nectarine, plum, peach

Sloe

004

Berries and other small fruits

Grape, strawberry

Blueberry, bearberry, bilberry, blackberry, boysenberry, cloudberry, cowberry, cranberry, blackcurrant, red currant, white currant, dewberry (olallie berry), elderberry, gooseberry, huckleberry, juneberry, loganberry, mulberry, rose hip


005

Assorted tropical and sub‑tropical fruits—edible peel

None specified

Ambarella, arbutus berry, Barbados cherry, bilimbi, carambola, caranda, carob, cashew apple, black Chinese olive, white Chinese olive, coco plum, date, desert date, fig, grumichama, hog plum, jaboticaba, Chinese jujube, Indian jujube, kumquat, Natal plum, olive, Otaheite gooseberry, Japanese persimmon, pomerac, rose apple, sea grape, Surinam cherry, tree tomato

006

Assorted tropical and sub‑tropical fruits—inedible peel

Avocado, banana, mango, pineapple

Akee apple, breadfruit, canistel, cherimoya, custard apple, doum palm (dum palm), durian, elephant apple, feijoa, guava, ilama, jackfruit, jambolan, Java apple, kiwifruit, longan, litchi, mammey apple, mangosteen, marmaladebox, yellow mombin, naranjilla, papaya, passionfruit, American persimmon, Japanese persimmon, plantain, pomegranate, prickly pear, pulasan, rambutan, sapodilla, black sapote, green sapote, mammey sapote, white sapote, sentul, soursop, Spanish lime, star apple, sugar apple, tamarind, tonka bean

02           Vegetables

009

Bulb vegetables

Onion

Fennel bulb, garlic, great‑headed garlic, kurrat, leek, Chinese onion, Welsh onion, shallot, spring onion, silverskin onion, tree onion

010

Brassica (cole or cabbage) vegetables, head cabbages, flowerhead cabbages

Cabbage (head), broccoli, cauliflower

Chinese broccoli, Brussels sprout, cabbage (savoy), kohlrabi

011

Fruiting vegetables—cucurbits

Pumpkin, melon (except watermelon)

Apple and pear balsam, bottle gourd, chayote, cucumber, West Indian gherkin, gherkin, angled loofah, smooth loofah, snake gourd, summer squash, watermelon, zucchini

012

Fruiting vegetables other than cucurbits

Mushrooms, pepper (sweet capsicum), tomato

Egg plant, edible fungi, ground cherry, okra, pepino, pepper (chilli), roselle, sweet corn

013

Leafy vegetables (including brassica leafy vegetables)

Lettuce

Amaranth, balsam pear leaves, betel leaves, box thorn, box thorn (gow kee, matrimony vine), cassava leaves, chard (silver beet, spinach beet, Swiss chard), chervil, chicory leaves (red‑leaved chicory, sugar loaf), Chinese cabbage (pak‑tsai, pak‑tsoi, pak‑soi), choisum (tsai shim, tsoi sum), corn salad (lamb’s lettuce), cos lettuce, garden cress, dandelion, dock, endive, goosefoot, grape leaves, Indian mustard, Japanese greens (various species), kale (collards, curly kale, Scotch kale, thousand‑headed kale), kangkung (water spinach), komatsuma (mustard spinach), mallow, marsh marigold, mustard greens, New Zealand spinach, nightshade, black orach, pak‑choi or paksoi (celery mustard), papaya leaves, pepper leaves, plantain leaves, pokeweed (poke‑berry leaves), purslane, winter radish leaves, rape greens, roselle leaves (Jamaican sorrel), rucola (rocket salad, roquette), rutabaga greens, salsify leaves, sea kale, senna leaves, sowthistle, spinach, Indian spinach (vine spinach), sweet potato leaves, tannia leaves (yautia leaves), taro leaves, turnip greens (namenia, tendergreen), watercress

014, 015

Legume vegetables, pulses

Beans (common bean, dwarf bean, field bean, flageolet, French bean, haricot bean, kidney bean, lima bean, mat bean, moth bean, navy bean, runner bean, snap bean, tepary bean), peas (edible‑
podded pea, garden pea, mangetout pea, podded pea, sugar pea, wrinkled pea), chick‑pea (garbanzos, gram), field pea, lupin, mung bean (green gram)

Adzuki bean, bambara groundnut, black gram (urd bean), broad bean (fava bean, horse bean, pigeon bean), cluster bean (guar), cowpea (black‑eyed pea, catjang cowpea), Goa bean (asparagus pea, four‑angled bean, Manila bean, winged bean), horse gram, hyacinth bean (bonavist bean, lablab), jack bean, Kersting’s groundnut (geocarpa groundnut, geocarpa bean), lentil, lima bean (butter bean, sieva bean), mung bean, navy bean, pigeon pea (Angola pea, cajan pea, red gram, rice bean), scarlet runner bean, soya bean (soybean), sword bean, winged pea, yard‑long bean (asparagus bean)

016

Root and tuber vegetables

Carrot, potato

Alocasia, arracacha, arrowhead, arrowroot, beetroot (red beet), edible burdock (greater burdock), edible canna (achira, gruya, Queensland arrowroot), cassava (bitter or sweet—tapioca, manioc), celeriac, chayote root (christophine), turnip‑rooted chervil, chicory root, chufa, greater galangal, lesser galangal, Goa bean root, horseradish, Japanese artichoke, Jerusalem artichoke, leren, oca, turnip‑rooted parsley, parsnip, black radish, Japanese radish, Chinese radish, daikon, rampion roots, salsify (oyster plant), Spanish salsify, scorzonera (black salsify), skirrit (skirret), sugar beet, swede (rutabaga), sweet potato, tannia (tanier, cocoyam, yautia), taro (dasheen, eddoe, cocoyam), tiger nut, topee tambu, turnip, ullucu, yams, yam bean (jicama, potato yam)

017

Stalk and stem vegetables

Asparagus

Globe artichoke, bamboo shoots, cardoon, celery, celtuce, palm hearts, rhubarb, witloof chicory sprouts

03           Grasses

020

Cereal grains

Barley, maize (corn), oats, rice, sorghum (chicken corn, dari seed, durra, feterita, guinea corn, Kaffir corn, kaoliang, milo, shallu, sorgo), triticale, wheat (including durum wheat, emmer, spelt)

Buckwheat, cañihua, hungry rice (acha, fonio, fundi), job’s tears (adlay), millet, popcorn, quinoa, rye, teff (tef), teosinte, wild rice

021

Grasses, for sugar or syrup production

Sugar cane

Sorgo (sweet sorghum)

04           Nuts and seeds

022

Tree nuts

Almonds, macadamia nuts (brush nut, Queensland nut)

Beech nuts, Brazil nut, butter nut, cashew nut, chestnuts (chinquapin), coconut, hazelnuts (filberts), hickory nuts, Japanese horse‑chestnut, pachira nut, paradise nut, pecan, pine nuts (pignolia, pignoli, pinocchi, piñon nut), pili nuts (Java almonds), pistachios, sapucaia nut, tropical almond, walnuts

023

Oilseed

Cotton seed, rape seed (canola, colza), sunflower

Mustard seeds, ben moringa seed (drumstick tree seed, horseradish tree seed), kapok, linola, linseed (flax‑seed), Niger seed, palm nut, peanut (groundnut), poppy seed, safflower seed, sesame seed, shea nuts

024

Seed for beverages and sweets

None specified

Cacao beans, coffee beans, cola nuts (kola)

05           Herbs and spices

027

Herbs

None specified

Angelica (including garden angelica), balm leaves, basil, bay leaves, borage, great burnet, salad burnet, burning bush (Cretan dittany), catmint (catnip), celery leaves, chives (including Chinese), curry leaves, dill, fennel, horehound, hyssop, lavender, lovage, marigold flowers, marjoram (oregano—sweet and wild), pennyroyal mint, peppermint, spearmint, nasturtium, parsley, rosemary, rue, sage (clary and related salvia species), sassafras leaves, summer savory, winter savory, sorrel, sweet cicely (myrrh), tansy (costmary and related species), tarragon (estragon), thyme, common winter cress, American winter cress, wintergreen leaves, woodruff, wormwoods (mugwort, southernwood)

028

Spices

None specified

Angelica, aniseed, calamus, caper, caraway, cardamom, cassia, celery seed, cinnamon bark, cloves, coriander, cumin, dill, elecampane, fennel seed, fenugreek, galangal rhizomes, ginger root, grains of paradise, juniper, liquorice, lovage, mace, nasturtium, nutmeg, black pepper, white pepper, long pepper, pimento, turmeric, vanilla

Part 2Animal foods and animal food groups

 

CODEX no.

Crop/situation group

Major uses

Non‑major uses

06           Mammalian products

030, 031, 032, 033

Meat, mammalian fats, edible offal, milk

Cattle, sheep, pigs

Goats (including feral goats), llamas, alpacas, deer, camels, buffalos, horses, kangaroo, deer, rabbits

07           Poultry products

036, 037, 038, 039

Poultry meat, poultry fats, poultry edible offal, eggs

Chickens

Turkeys, ostriches, emus, squab pigeons, game birds, ducks, geese

08           Aquatic animal products

040, 041, 042, 043, 044, 045

Freshwater fish, diadromous fish, marine fish, fish roe, marine mammals, crustaceans

 

All aquatic animals used for food production

09           Amphibians and reptiles

048

Amphibians and reptiles

 

All amphibians and reptiles used for food production

10           Invertebrate animals

049

Invertebrate animals

 

All invertebrate animals used for food production

11           Animal feed crops

050, 051, 052

Animal feed crops

Legume animal feeds, grass and grain animal feeds, miscellaneous fodder and forage

 

Part 3Non‑food crops and situation groups

CODEX no.

Crop/situation group

Major uses

Non‑major uses

n/a

Pesticidal and medicinal oil crops

None specified

All pesticidal and medicinal oil crops

n/a

Ornamentals

Ornamentals (when applied for as a group)

Individual ornamental species

n/a

Other situations

Agricultural non‑crop areas (including land associated with farmland but not used for regular cultivation and/or grazing); commercial forests (including plantations grown specifically for timber production); fallow land; commercial and industrial areas (including factories, factory land, industrial sites, parking plots, fuel tank farms, outside chemical storages); domestic and public service areas (including houses, residential subdivisions, schools, hospitals, restaurants, hotels, motels, cafes, rubbish tips and playground and recreational areas such as golf courses, municipal parks and gardens, etc.); non‑crop areas (including areas of lands not being used or intended to be used for cropping or grazing—these areas include industrial sites, timber yards, areas around farm buildings, along fences and roadsides, rights‑of‑way, storage areas, wastelands, vacant lots, cemeteries, etc); bushland and native forests (including natural forest areas used for recreational or scenic purposes, national parks, etc); turf areas (including commercial turf farms, sports ovals, bowling greens, general lawn areas, etc); aquatic areas (including irrigation channels, streams, lakes, dams and drainage ditches)

 


Schedule 3BListing Schedule

(regulation 23A)

Part 1Preliminary

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 2Listable 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 3Active constituents in listable chemical products

Division 3.1Agricultural 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 3.2Veterinary 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 3CReserved Schedule

(regulation 23G)

Part 1Preliminary

  

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 2Reserved 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 3Active constituents in reserved chemical products

Division 3.1Agricultural 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 3.2Veterinary chemical products

Note:       This Division is reserved for future use.

Schedule 4Restricted chemical products

(regulation 45)

  

  

 

1

A chemical product containing ethylene dibromide (also known as EDB)

2

A chemical product containing chlordane

3

A chemical product containing heptachlor

4

A chemical product containing sodium monofluoroacetate (also known as 1080)

5

A chemical product containing acrolein

6

A chemical product that is a pre‑construction termiticide product containing bifenthrin

7

A chemical product that is a pre‑construction termiticide product containing chlorpyrifos

8

A chemical product containing endosulfan

9

A chemical product containing pindone that is a concentrate and for which the relevant label instructions require further mixing with carriers before it is ready to use as a bait

10

A chemical product containing mevinphos

11

A chemical product containing rabbit haemorrhagic disease virus (RHDV) (also known as rabbit calicivirus) that is in injectable form and requires mixing with carriers such as oats or carrot before it is ready to use as a bait

12

A vertebrate pest control chemical product containing fenthion, alphachloralose or 4‑aminopyridine

13

All chemical products with formulations containing, as active constituents, all 3 of the following in various chemical forms:

(a) copper;

(b) chromium;

(c) arsenic

Schedule 5AGVET Code—Search warrant under subsection 133(2)

  

  

(regulation 64)

AGVET CODE OF

[NAME OF JURISDICTION]

SEARCH WARRANT UNDER SUBSECTION 133(2)

TO (name and address of inspector), an inspector within the meaning of section 3 of the Agvet Code of [name of jurisdiction] (‘the Code’):

 

1.

This warrant is issued on the basis that:

(a) I am satisfied, by information on oath, that there are reasonable grounds for suspecting that there is, or may be within the next 72 hours, at the premises mentioned below, a particular thing that may be evidence of the commission of an offence against the Code; and

(b) I have been given, either orally or by affidavit, the further information (if any) that I required about the grounds on which the issue of this warrant is being sought.

2.

The nature of the offence in relation to which this warrant is issued is (state the nature of the suspected offence).

3.

The purpose for which this warrant is issued is set out in clause 4.

4.

This warrant authorises you, with any help, and using any force, that is necessary and reasonable, * at any time of the day or night / * during the following hours of the day or night (specify the hours):

(a) to enter the premises at (address); and

(b) exercise the powers referred to in paragraphs 132(1)(c), (d) and (e) of the Code in respect of the particular thing, namely (specify the particular thing).

Note:       Paragraphs 132(1)(c), (d) and (e) of the Code empower an inspector to:

(c)            search the premises for the thing; and

(d)           if the thing is found, take photographs (including video recordings) of the premises or thing, take samples of the thing, seize the thing or undertake more than one of those activities; and

(e)            give any directions for, or with respect to, the detention of a thing that has been seized under paragraph (d).

THIS WARRANT CEASES TO HAVE EFFECT ON
(date not later than 7 days after the day of issue of the warrant).

Issued by me (full name and designation of magistrate).

On (date)                     .

(signature of magistrate)

* Omit whichever is inapplicable.


Schedule 6Applications—fees and assessment periods

(regulations 70, 76, 77, 78 and 78A)

Part 1Preliminary

  

1.1  Definitions

                   In this Schedule:

closely similar, used of 2 chemical products, has the meaning given in section 1.2.

major change, in relation to a registered chemical product or approved label, means a change to a registered chemical product or its approved label that is expected to require data for technical assessment of one or more of the following:

                     (a)  efficacy;

                     (b)  potential risks to the safety of humans, the environment or the host crop or animal;

                     (c)  potential risks to Australian trade.

major food crop means a food crop listed in Column 3 (‘Major uses’) of Part 1 of Schedule 3A.

maximum residue limit means the maximum concentration of a residue, resulting from the officially authorised safe use of an agricultural or veterinary chemical, that is recommended to be legally permitted or recognised as acceptable in or on a food, agricultural commodity, or animal feed.

minor change means a change that is not a major change.

protected information has the meaning given in section 1.5.

similar, used of 2 chemical products, has the meaning given in section 1.3.

the same, used of 2 chemical products, has the meaning given in section 1.4.

1.2  When chemical products are closely similar

             (1)  Subject to subsection (2), an agricultural chemical product (the proposed chemical product) and a reference chemical product are closely similar if:

                     (a)  the active constituents in the proposed chemical product are the same as the approved active constituents in the reference chemical product; and

                     (b)  the concentration of the active constituents referred to in paragraph (a) are the same; and

                     (c)  either:

                              (i)  the other ingredients in the formulations of the proposed and reference chemical products are the same; or

                             (ii)  if the other ingredients in the formulations of the proposed and reference chemical products are different, those other ingredients perform similar functions (for example, as emulsifiers, surfactants, dyes or solvents); and

                     (d)  the formulation type of the proposed and reference chemical products are the same; and

                     (e)  the label of the proposed chemical product refers to the same crops, situations and pests as the approved label of the reference chemical product (that is, the proposed chemical product must have no uses additional to those of the reference chemical product); and

                      (f)  the label of the proposed chemical product includes similar instructions on how to use the product, and precautionary or safety instructions, as the approved label of the reference chemical product; and

                     (g)  either:

                              (i)  the claims on the labels of the proposed and reference chemical products are the same; or

                             (ii)  if the claims are different, the claims on the label of the proposed chemical product are fewer or reduced compared to the claims on the approved label of the reference chemical product.

             (2)  However, the proposed agricultural chemical product and the reference chemical product are taken not to be closely similar if information about the reference chemical product is protected information.

             (3)  Subject to subsection (4), a veterinary chemical product (the proposed chemical product) and a reference chemical product are closely similar if:

                     (a)  the active constituents in the proposed chemical product are the same as the approved active constituents in the reference chemical product; and

                     (b)  the concentration of the active constituents referred to in paragraph (a) are the same; and

                     (c)  either:

                              (i)  the non‑active constituents in the formulations of the proposed and reference chemical products are the same, or are equivalent substances, at the same or equivalent concentrations; or

                             (ii)  if the non‑active constituents in the formulations of the proposed and reference chemical products are neither the same nor equivalent, the differences in the formulations are minor and are not expected to have adverse implications on product quality or biological activity in terms of efficacy, safety or residues; and

                     (d)  either:

                              (i)  the proposed and reference chemical products specifications (including release and expiry limits and test methods) and physico‑chemical properties (including pH, particle size, crystal form and, where applicable, dissolution profile, payout rate and payout period) are the same or equivalent; or

                             (ii)  if the specifications and physico‑chemical properties of the proposed and reference chemical products are neither the same nor equivalent, the differences in the specifications and properties are minor and are not expected to have adverse implications for product quality or biological activity in terms of efficacy, safety or residues; and

Note for paragraphs (c) and (d):         Efficacy, safety and residues data are not required to demonstrate similarity of the proposed chemical product to the reference chemical product.

                     (e)  the dose form and formulation type of the proposed and reference chemical products are the same; and

                      (f)  the use patterns (including target animal species, dose rates, routes of administration and withholding periods) and instructions on the labels of the proposed and reference chemical products are the same; and

                     (g)  either:

                              (i)  the claims on the labels of the proposed and reference chemical products are the same; or

                             (ii)  if the claims are different, the claims on the label of the proposed chemical product are fewer or reduced compared to the claims on the approved label of the reference chemical product.

             (4)  However, the proposed veterinary chemical product and the reference chemical product are taken not to be closely similar if information about the reference chemical product is protected information.

1.3  When chemical products are similar

                     (1)  Subject to subsection (2), an agricultural chemical product (the proposed agricultural chemical product) and a reference chemical product are similar if the conditions in paragraphs 1.2(1)(a), (d), (e), (f) and (g) are complied with in relation to the products.

             (2)  However, the proposed agricultural chemical product and the reference chemical product are taken not to be similar if information about the reference chemical product is protected information.

             (3)  Subject to subsection (4), a veterinary chemical product (the proposed veterinary chemical product) and a reference chemical product are similar if:

                     (a)  the conditions in paragraphs 1.2(3)(a), (b), (e), (f) and (g) are complied with in relation to the products; and

                     (b)  the non‑active constituents in the proposed and reference chemical products have similar properties and are in similar proportions; and

                     (c)  efficacy, safety or residues data is required to demonstrate similarity of the proposed chemical product to the reference chemical product.

             (4)  However, the proposed veterinary chemical product and the reference chemical product are taken not to be similar if information about the reference chemical product is protected information.

1.4  When chemical products are the same

             (1)  Subject to subsection (2), a proposed chemical product and a reference chemical product are the same if they are the same in all respects except their names, their distinguishing numbers, and the name and business address of the applicant.

             (2)  However, a proposed chemical product and a reference chemical product are taken not to be the same if information about the reference chemical product is protected information.

1.5  Meaning of protected information

                   For this Schedule, information is protected information if:

                     (a)  it is information about an approved active constituent, a registered chemical product or an approved label for containers for a chemical product; and

                     (b)  any of the following provisions limits its use by the APVMA:

                              (i)  Division 4A of Part 2 of the Code;

                             (ii)  Part 3 of the Code;

                            (iii)  Part 7B of the Agricultural and Veterinary Chemicals (Administration) Act 1992.

1.6  Effect of Part 2 where information is protected information

             (1)  If information about an active constituent is protected information, the fee payable for an application that would otherwise rely on or utilise that information is to be determined as if the active constituent were not approved.

             (2)  If information about a registered chemical product is protected information, the fee payable for an application that would otherwise rely on or utilise that information is to be determined as if the chemical product were not registered.

             (3)  If information about an approved label for containers for a chemical product is protected information, the fee payable for an application that would otherwise rely on or utilise that information is to be determined as if the label were not approved.

1.7  Fee when application for registration preceded by application for permit

                   If:

                     (a)  an application for the registration of a chemical product is preceded by an application for a permit in relation to the product; and

                     (b)  the assessment of the permit is relevant to, and included as, part of the assessment of the product;

despite anything else in Part 2 or in Schedule 7, the fee for the application for the registration of the product is to be worked out using the modular assessment fee only for any additional assessments that are actually undertaken by the APVMA at the time of the assessment.


Part 2Table of fees and assessment periods

Column 1
Item

Column 2
Description of application

Column 3
Assessment period

Column 4
Fee ($)


Applications for approval of active constituent contained in a chemical product, registration of the chemical product and approval of the product label

1

Application for approval of an active constituent contained in a chemical product, registration of the associated chemical product and approval of the product label requiring a full assessment of the active constituent and chemical product

15 months

72 100

2

Application for approval of an active constituent contained in a chemical product, registration of the associated chemical product and approval of the product label requiring less than full assessment of the active constituent and chemical product

The modular assessment period

The modular assessment fee


Applications for registration of a chemical product containing an approved active constituent and approval of the product label

3

Application for registration of a chemical product containing an approved active constituent, and approval of the product label, if:

(a) there is no registered chemical product containing the active constituent; and

(b) a full assessment of the chemical product is required

15 months

48 465

4

Application for registration of a chemical product containing an approved active constituent, and approval of the product label, if:

(a) there is a registered chemical product containing the active constituent; and

(b) the chemical product is to be used on a major food crop; and

(c) there are no relevant maximum residue limits; and

(d) poison schedule classification is required

15 months

27 505

5

Application for registration of a chemical product containing an approved active constituent, and approval of the product label, if:

(a) the chemical product is similar to a registered chemical product; and

(b) chemistry and manufacture, efficacy or target species safety data is the only data required to demonstrate the similarity of the chemical product to the registered chemical product

5 months

3 655

6

Application for registration of a chemical product containing an approved active constituent, and approval of the product label, if:

(a) the chemical product is closely similar to a registered chemical product; and

(b) efficacy and safety data are not required to demonstrate the similarity of the chemical product to the registered chemical product; and

(c) chemistry and manufacture data are required

5 months

3 220

7

Application for registration of a chemical product containing an approved active constituent, and approval of the product label, if:

(a) the chemical product is closely similar to a registered chemical product; and

(b) efficacy and safety data are not required to demonstrate the similarity of the chemical product to the registered chemical product; and

(c) chemistry and manufacture data are not required

3 months

1 315

8

Application for registration of a chemical product containing an approved active constituent, and approval of the product label, if:

(a) the chemical product is the same as a registered chemical product; and

(b) the chemical product is to be registered with a different name

3 months

1 250

9

Application for a listed registration of a chemical product containing an approved active constituent and approval of a product label for which an established standard has been approved in accordance with section 56D of the Code

3 months

1 195

10

Application for registration of a chemical product containing an approved active constituent (or an active constituent for which the APVMA has received an application for approval) and approval of the product label for all situations other than those described in items 3 to 9

The modular assessment period

The modular assessment fee


Applications to vary a registration or label approval

11

Application to vary particulars or conditions of registration or label approval where the variation is to extend the use of the chemical product to a new major food crop

8 months

21 460

12

Application to vary particulars or conditions of registration or label approval if:

(a) the variation is to allow a minor change; and

(b) no data of a technical nature is required

3 months

875

13

Application to vary particulars or conditions of registration or listed registration or label approval if:

(a) the variation is to allow a minor change; and

(b) no data of a technical nature is required; and

(c) the variation is a change required by the APVMA

3 months

nil


Applications to change relevant particular of an approval or registration

13A

Application to change a relevant particular of an approval or registration where the relevant particular is set out in a legislative instrument made for section 26A of the Code

2 months

385

14

Application to vary particulars or conditions of registration or listed registration or label approval if the application is not of a kind described in any of items 11 to 13

The modular assessment period

The modular assessment fee

Applications for approval of an active constituent

15

Application for approval of an active constituent requiring a full assessment

12 months

25 775

16

Application for approval of an active constituent requiring less than full assessment but requiring a toxicological assessment

8 months

14 105

17

Application for approval of an active constituent requiring less than full assessment but not requiring a toxicological assessment

5 months

2 365

Applications for variation to an approved active constituent

18

Application to vary particulars or conditions of an approved active constituent

5 months

1 850


application for a permit

19

Application for a permit to possess or supply, other than for use in Australia, an active constituent that is not an approved active constituent or a chemical product that is not a registered chemical product

3 months

350

20

Application for a permit where a previous assessment remains valid and no data of a technical nature is required

3 months

350

21

Application for a permit where the proposed use is a minor use

The modular assessment period

350

22

Application for a permit in respect of a chemical product or an active constituent if the proposed use of the chemical product or active constituent is determined by the APVMA to be an emergency use

Not applicable
—(see subregulation 76(4))

nil—(see paragraph 70(6)(b))

23

Application for a permit in respect of a chemical product or an active constituent if the application is not of a kind described in any of items 19 to 21

The modular assessment period

The modular assessment fee

Other applications

24

Application made under section 10 of the Code (other than those of the kinds described in any of items 1, 2, 3, 4, 5, 6, 7, 8, 10, 15, 16 or 17) requiring assessment of a technical nature

The modular assessment period

The modular assessment fee

25

Any other application:

(a) that is not made under section 10 of the Code; and

(b) that is not of a kind listed in an item of this Schedule;

requiring assessment of a technical nature

The modular assessment period

The modular assessment fee

Schedule 7Table of fees and periods for completion of modules, levels and types of assessments

(regulations 71 and 77)

  

 

Column 1
Item

Column 2
Module, level or type

Column 3
Period for completion

Column 4
Fee ($)

1

Screening

 

535

2

Chemistry

 

 

2.1

Chemistry—level 1

12 months

6 915

2.2

Chemistry—level 2

8 months

2 305

2.3

Chemistry—level 3

5 months

1 185

2.4

Chemistry—level 4

3 months

570

3

Toxicology (not requiring poison schedule classification)

 

 

3.1

Toxicology—level 1

12 months

20 940

3.2

Toxicology—level 2

8 months

14 620

3.3

Toxicology—level 3

4 months

3 035

4

Toxicology (requiring poison schedule classification)

12 months

2 435

5

Residues

 

 

5.1

Residues—level 1

12 months

13 630

5.2

Residues—level 2 (registration only)

6 months

7 895

5.3

Residues—level 3 (permit only)

6 months

6 150

5.4

Residues—level 4 (registration only)

3 months

5 600

5.5

Residues—level 5 (permit only)

3 months

1 500

6

Occupational health and safety

 

 

6.1

Occupational health and safety—level 1

12 months

4 310

6.2

Occupational health and safety—level 2

6 months

2 900

6.3

Occupational health and safety—level 3

4 months

2 985

7

Environment

 

 

7.1

Environment—level 1

12 months

19 795

7.2

Environment—level 2

6 months

5 485

7.3

Environment—level 3

4 months

1 290

8

Efficacy and safety

 

 

8.1

Efficacy and safety—level 1

5 months

1 865

8.2

Efficacy and safety—level 2

4 months

750

8.3

Efficacy and safety—level 3

3 months

500

9

Non‑food trade

5 months

1 175

10

Special data

 

 

10.1

Special data—level 1

12 months

nil

10.2

Special data—level 2

6 months

nil

10.3

Special data—level 3

6 months

nil

11

Finalisation

 

 

11.1

Finalisation—type 1

3 months

3 040

11.2

Finalisation—type 2 (registration only)

2 months

1 175

11.3

Finalisation—type 3 (permit only)

2 months

645

11.4

Finalisation—type 4

2 months

570

12

Data protection

 

345

Schedule 8Logo of the Australian Pesticides and Veterinary Medicines Authority (APVMA)

(regulation 79)

 

 


Endnotes

 

Endnote 1—Legislation history

This endnote sets out details of the legislation history of the Agricultural and Veterinary Chemicals Code Regulations 1995.

 

Number and year

Gazettal or FRLI registration date

Commencement
date

Application, saving and transitional provisions

1995 No. 27

28 Feb 1995

15 Mar 1995 (see r. 2)

 

1995 No. 54

29 Mar 1995

15 Mar 1995 (see r. 1)

1995 No. 137

15 June 1995

rr. 4 and 5: 1 July 1995
Remainder: 15 June 1995

1995 No. 187

4 July 1995

4 July 1995

1996 No. 83

5 June 1996

5 June 1996

1996 No. 111

20 June 1996

20 June 1996

r. 9

1996 No 162

24 July 1996

24 July 1996

1996 No. 216

2 Oct 1996

2 Oct 1996

1997 No. 264

24 Sept 1997

24 Sept 1997

1999 No. 215

16 Sept 1999

16 Sept 1999

1999 No. 247

27 Oct 1999

31 Oct 1999

2002 No. 60

5 Apr 2002

5 Apr 2002

2002 No. 207

12 Sept 2002

12 Sept 2002

2003 No. 8

27 Feb 2003

27 Feb 2003

2004 No. 224

28 July 2004

28 July 2004

2004 No. 225

28 July 2004

28 July 2004

2004 No. 251

26 Aug 2004

1 Jan 2005 (see r. 2)

2004 No. 353

23 Dec 2004

23 Dec 2004

2004 No. 354

23 Dec 2004

1 Jan 2005 (see r. 2)

2005 No. 105

9 June 2005 (see F2005L01410)

Schedule 2: 1 July 2005
Remainder: 10 June 2006

2005 No. 152

12 July 2005 (see F2005L01916)

13 July 2005

2006 No. 75

19 April 2006 (see F2006L01163)

20 Apr 2006

2007 No. 278

27 Sept 2007 (see F2007L03839)

28 Sept 2007

2009 No. 1

9 Feb 2009 (see F2009L00269)

10 Feb 2009

2009 No. 341

15 Dec 2009 (see F2009L04598)

16 Dec 2009

2010 No. 75

11 May 2010 (see F2010L00976)

12 May 2010

2010 No. 108

4 June 2010 (see F2010L01482)

5 June 2010

2010 No. 144

29 June 2010 (see F2010L01805)

1 July 2010

2011 No. 16

17 Mar 2011 (see F2011L00441)

18 Mar 2011

2012 No. 72

28 May 2012 (see F2012L01093)

1 July 2012

108, 2013

17 June 2013 (see F2013L01016)

Schedule 1 (items 6–29): 1 July 2013

 

Endnote 2—Amendment history

This endnote sets out the amendment history of the Agricultural and Veterinary Chemicals Code Regulations 1995.

 

ad. = added or inserted    am. = amended    rep. = repealed    rs. = repealed and substituted    exp. = expired or ceased to have effect

Provision affected

How affected

Part 1

 

r. 1......................................

rs. 1999 No. 215

r. 3......................................

am. 1996 No. 83; 1999 No. 247; 2004 Nos. 353 and 354; 2005 No. 105; 2010 Nos. 75 and 108; 2011 No. 16; No. 108, 2013

Note to r. 3(1).....................

ad. 2011 No. 16

r. 3A....................................

ad. 2004 No. 354

r. 3B....................................

ad. 2004 No. 354

r. 3C....................................

ad. 2011 No. 16

r. 5......................................

rep. No. 108, 2013

r. 7......................................

rs. 2010 No. 75

r. 8......................................

am. 2004 No. 225

 

rs. 2010 No. 75

Part 2

 

Division 2.1

 

Heading to Div. 2.1.............
of Part 2

ad. 2011 No. 16

Subdivision 2.1.1

 

Heading to Subdiv. 2.1.1.....
of Div. 2.1 of Part 2

ad. 2011 No. 16

r. 8A....................................

ad. 2004 No. 354

 

am. 2011 No. 16

Heading to r. 8B..................

rs. 2011 No. 16

r. 8B....................................

ad. 2004 No. 354

 

am. 2011 No. 16

r. 8C....................................

ad. 2004 No. 354

 

am. 2011 No. 16

Heading to r. 8D..................

rs. 2011 No. 16

r. 8D....................................

ad. 2004 No. 354

 

am. 2011 No. 16

Heading to r. 8E..................

rs. 2011 No. 16

r. 8E....................................

ad. 2004 No. 354

 

am. 2011 No. 16

Subdivision 2.1.2

 

Heading to Subdiv. 2.1.2.....
of Div. 2.1 of Part 2

ad. 2011. No. 16

r. 9......................................

am. 2004 No. 225; 2011 No. 16

Note to r. 9(1).....................

ad. 2011 No. 16

r. 10....................................

am. 2004 Nos. 225 and 353

 

rep. 2009 No. 1

r. 11....................................

am. 2004 Nos. 225 and 353; 2011 No. 16

r. 11A..................................

ad. 1999 No. 247

 

am. 2004 No. 225

 

rep. 2011 No. 16

r. 12....................................

am. 2004 Nos. 225 and 353

 

rs. 2011 No. 16

r. 13....................................

am. 2004 No. 353

 

rs. 2011 No. 16

r. 14....................................

am. 2004 Nos. 225 and 353

 

rs. 2011 No. 16

r. 14A..................................

ad. No. 108, 2013

Subdivision 2.1.3

 

Heading to Subdiv. 2.1.3.....
of Div. 2.1 of Part 2

ad. 2011. No. 16

r. 15....................................

am. 2004 Nos. 225 and 353; 2011 No. 16

r. 16....................................

am. 2004 Nos. 225 and 353; 2011 No. 16

r. 17....................................

rep. 2004 No. 225

 

ad. 2011 No. 16

Subdivision 2.1.4

 

Heading to Subdiv. 2.1.4.....
of Div. 2.1 of Part 2

ad. 2011. No. 16

r. 18....................................

rs. 2011 No. 16

Subdivision 2.1.5

 

Heading to Subdiv. 2.1.5.....
of Div. 2.1 of Part 2

ad. 2011. No. 16

r. 18A..................................

ad. 2011 No. 16

Subdivision 2.1.6

 

Heading to Subdiv. 2.1.6.....
of Div. 2.1 of Part 2

ad. 2011. No. 16

r. 18B..................................

ad. 2011. No. 16

r. 18C..................................

ad. 2011. No. 16

r. 18D..................................

ad. 2011. No. 16

r. 18E..................................

ad. 2011. No. 16

r. 18F..................................

ad. 2011. No. 16

r. 18G..................................

ad. 2011. No. 16

r. 18H..................................

ad. 2011. No. 16

r. 18I...................................

ad. 2011. No. 16

Subdivision 2.1.7

 

Heading to Subdiv. 2.1.7.....
of Div. 2.1 of Part 2

ad. 2011. No. 16

Heading to r. 19...................

rs. 2004 No. 225

r. 19....................................

am. 2004 Nos. 225 and 353; 2011 No. 16

Division 2.2

 

Heading to Div. 2.2.............
of Part 2

ad. 2011 No. 16

Subdivision 2.2.1

 

Heading to Subdiv. 2.2.1.....
of Div. 2.2 of Part 2

ad. 2011 No. 16

r. 19AA...............................

ad. 2004 No. 354

 

rs. 2011 No. 16

r. 19AB...............................

ad. 2004 No. 354

 

am. 2011 No. 16

r. 19AC...............................

ad. 2004 No. 354

 

am. 2011 No. 16

r. 19AD...............................

ad. 2004 No. 354

 

am. 2011 No. 16

Subdivision 2.2.2

 

Heading to Subdiv. 2.2.2.....
of Div. 2.2 of Part 2

ad. 2011. No. 16

r. 19A..................................

ad. 2004 No. 225

 

rs. 2011 No. 16

Division 2.3

 

Heading to Div. 2.3.............
of Part 2

ad. 2011 No. 16

r. 20....................................

am. 2004 Nos. 225 and 353

r. 21....................................

am. 2004 Nos. 225 and 353

r. 22....................................

rs. 2004 No. 225

 

am. 2004 No. 353

 

rs. 2011 No. 16

r. 22AA...............................

ad. 2011 No. 16

Division 2.4

 

Heading to Div. 2.4.............
of Part 2

ad. 2011 No. 16

r. 22A..................................

ad. 2004 No. 354

 

rs. 2005 No. 105

Division 2.5

 

Heading to Div. 2.5.............
of Part 2

ad. 2011 No. 16

r. 22B..................................

ad. 2004 No. 354

 

rs. 2005 No. 105

r. 22A..................................

ad. 2004 No. 251

 

rep. 2005 No. 105

r. 22C..................................

ad. 2005 No. 105

Division 2.6

 

Heading to Div. 2.6.............
of Part 2

ad. 2011 No. 16

r. 23....................................

am. 2004 No. 353; 2005 No. 105

Part 2A

 

Part 2A................................

ad. 2004 No. 225

r. 23A..................................

ad. 2004 No. 225

 

rs. 2007 No. 278

r. 23AB...............................

ad. 2011 No. 16

r. 23B..................................

ad. 2004 No. 225

 

am. 2004 No. 353

r. 23C..................................

ad. 2004 No. 225

r. 23D..................................

ad. 2004 No. 225

 

am. 2004 No. 353

r. 23E..................................

ad. 2004 No. 225

 

am. 2004 No. 353

r. 23F..................................

ad. 2004 No. 225

 

am. 2004 No. 353, 2005 No. 105

Part 2B

 

Part 2B................................

rs. 2007 No 278

Heading to Part 2B...............

ad. 2004 No. 225

 

rs. 2007 No. 278

r. 23G..................................

ad. 2007 No. 278

r. 23H..................................

ad. 2007 No. 278

R.23I...................................

ad. 2007 No. 278

Note to Part 2B....................

ad. 2004 No. 225

 

rep. 2007 No. 278

Part 3

 

Division 1

 

r. 24.................................... ............................................

am. 2011 No. 16

r. 25....................................

am. 2011 No. 16

Division 2

 

r. 27....................................

am. 2004 No. 353

r. 35....................................

am. 2002 No. 60

r. 36....................................

am. 2004 No. 353

r. 37....................................

am. 2004 No. 353

Part 4

 

Division 1

 

r. 40A..................................

ad. 1995 No. 54

r. 41....................................

am. 2004 No. 225

r. 42....................................

am. 2004 No. 353; 2011 No. 16

r. 45....................................

am. 2004 No. 353

r. 46....................................

am. 1996 No. 111; 2002 No. 60; 2004 No. 353

Division 2

 

r. 47....................................

rs. 1996 No. 111

 

am. 2004 No. 353; 2005 No. 105; 2010 No. 144

r. 47A..................................

ad. 1996 No. 111

 

am. 1997 No. 264; 2004 No. 353

r. 47AB...............................

ad. 1997 No. 264

 

am. 2004 No. 353

r. 47B..................................

ad. 1996 No. 111

r. 47C..................................

ad. 1996 No. 111

 

am. 2002 No. 60

r. 48....................................

rs. 1996 No. 111; 2002 No. 60

 

am. 2004 No. 353

r. 49....................................

rs. 1996 No. 111

 

am. 2002 No. 60

r. 50....................................

rs. 1996 No. 111

 

am. 2002 No. 60

r. 51....................................

rs. 1996 No. 111

 

am. 2002 No. 60

Heading to r. 53...................

rs. 2004 No. 353

r. 53....................................

am. 2002 No. 60; 2004 No. 353

r. 54....................................

am. 2002 No. 60

Part 5

 

r. 55....................................

am. 1996 No. 111; 2004 No. 353

r. 56....................................

am. 2004 No. 353

Part 7

 

r. 59....................................

am. 1996 No. 162

r. 59A..................................

ad. 1996 No. 162

r. 59B..................................

ad. 1996 No. 162

 

am. 2004 No. 353

r. 59C..................................

ad. 1996 No. 162

 

am. 1997 No. 264; 2004 No. 353

r. 59D..................................

ad. 1996 No. 162

 

am. 2004 No. 353

r. 59E..................................

ad. No. 108, 2013

r. 60....................................

am. 2004 No. 353

r. 61....................................

am. 1996 No. 162; 2004 No. 353; No. 108, 2013

r. 61A..................................

ad. No. 108, 2013

r. 62....................................

am. 2004 No. 353

Part 9

 

r. 65....................................

am. 2004 No. 225

r. 66....................................

am. 2004 No. 353

r. 69....................................

am. 2002 No. 60; 2004 No. 353

r. 70....................................

am. 1995 No. 137; 1996 No. 83; 2004 No. 225; 2005 No. 105; 2010 No. 144; No. 108, 2013

Note to r. 70(1)...................

ad. 1996 No. 83

 

rs. 2005 No. 105

r. 70A..................................

ad. 1995 No. 54

 

am. 2004 No. 353

r. 71....................................

rs. 2005 No. 105

Note 1 to r. 71(4)................

rs. 2010 No. 144; 2011 No. 16

Note 2 to r. 71(4)................

am. 2010 No. 144; No. 108, 2013

r. 71A..................................

ad. 1996 No. 83

 

am. 1999 No. 247; 2004 No. 225

 

rs. 2005 No. 105

 

am. 2010 No. 144; No. 108, 2013

Note to r. 71A(7).................

rep. 2004 No. 225

r. 71B..................................

ad. 1996 No. 83

 

rep. 2005 No. 105

 

ad. No. 108, 2013

r. 72....................................

am. 2004 No. 353; 2005 No. 105

r. 72A..................................

ad. 1996 No. 162

 

am. 2004 No. 353; 2005 No. 105; 2010 No. 144

 

rs. No. 108, 2013

Note to r. 72A(3).................

am. 2010 No. 75

 

rep. No. 108, 2013

r. 73....................................

am. 2004 No. 353; 2005 No. 105; No. 108, 2013

r. 74....................................

am. 2004 No. 353

r. 75....................................

am. 2004 No. 353

Heading to r. 76...................

rs. 2004 No. 353

r. 76....................................

am. 2004 No. 353; 2005 No. 105

Note 1 to r. 76.....................

am. 2004 No. 353

r. 77....................................

rs. 2005 No. 105

r. 78....................................

am. 1999 No. 247; 2004 Nos. 225 and 353

 

rs. 2005 No. 105

Note to r. 78(3)...................

am. 2010 No. 144; No. 108, 2013

r. 78A..................................

ad. 2005 No. 105

Note 1 to r. 78A(2)..............

am. 2010 No. 144; No. 108, 2013

r. 79....................................

ad. 2004 No. 224

Schedule 1

 

Schedule 1...........................

rs. 1997 No. 264

Schedule 3

 

Schedule 3...........................

rs. 2010 No. 75

 

am. 2010 No. 108; No. 108, 2013

Schedule 3AA

 

Schedule 3AA.....................

ad. 2010 No. 75

 

am. 2010 No. 108; No. 108, 2013

Schedule 3A

 

Schedule 3A........................

ad. 2004 No. 251

Note to Schedule 3A............

rs. 2005 No. 105

Schedule 3B

 

Schedule 3B........................

ad. 2007 No. 278

Schedule 4

 

Schedule 4...........................

am. 1995 No. 187

 

rs. 1997 No. 264

 

am. 1999 No. 215; 2002 No. 207; 2003 No. 8; 2006 No. 75; 2009 No. 341; 2012 No. 72

Schedule 6

 

Schedule 6...........................

am. 1995 No. 137; 1996 No. 216; 1999 No. 247; 2004 Nos. 225 and 353

 

rs. 2005 No. 105

 

am. 2005 No. 152; 2010 No. 144; 2011 No. 16; No. 108, 2013

Schedule 7

 

Schedule 7...........................

am. 1995 No. 137; 1996 No. 216; 2004 No. 353

 

rs. 2005 No. 105

 

am. 2010 No. 144; No. 108, 2013

Schedule 8

 

Schedule 8...........................

ad. 2004 No. 224

Endnote 3—Uncommenced amendments [none]

There are no uncommenced amendments.

 

Endnote 4—Misdescribed amendments [none]

There are no misdescribed amendments.