Export Control (Processed Food) Orders 1992 (Cth)

Export Control (Processed Food) Orders

as amended

made under regulation 4 of the

Export Control (Orders) Regulations

This compilation was prepared on 19 September 2001
taking into account amendments up to Export Control (Processed Food) Amendment Orders 2001 (No. 1)

Prepared by the Office of Legislative Drafting,
Attorney-General’s Department, Canberra

Contents

Page

Part 1 Preliminary

1 Citation [see Note 1] 9

2 Commencement 9

3 Incorporation with Prescribed Goods (General) Orders 9

4 Schedules 9

5 Contravention for purposes of the Regulations 9

6 Application 9

7 Operation of other laws 10

8 Interpretation 10

Part 2 Additional conditions or restrictions on the export of processed food

9 Prohibition on export of processed food for human consumption 21

10 Processed food intended for export 21

11 Enter for export 21

Part 3 Registered establishment

12 Preparation in a registered establishment 22

13 Applications for registration of establishments — further requirements 22

Part 4 Approval to prepare processed food in an unregistered establishment

14 Application 23

15 Approval 23

16 Restrictions on grant of approval 24

17 Compliance with Orders 24

18 Entry to unregistered establishments preparing processed food for export 24

19 Revoking approval 24

Part 5 Export standards for processed food

20 Preparation in a registered establishment 25

21 Preparation in accordance with operational requirements 25

22 Compliance with product standards 25

Part 6 Packaging processed food

23 Packaging requirements 25

Part 7 Trade descriptions

24 Trade descriptions 26

25 Registered Establishment Number 26

26 Trade description: canned processed food 26

27 Trade descriptions not required for bulk processed food 27

28 Country of origin 27

29 Country of origin of fish 28

30 Identification of lot 28

31 Application of official marks 28

Part 8 Net contents

32 Net contents and drained mass 28

33 Average net contents and drained mass 29

34 Declaration of net contents of an outer container 29

35 Foreign country requirements 30

Part 9 Notice of intention to export and export permits

Part 10 Alternative export clearance procedures and certification

36 Alternative Export Clearance Procedures 30

37 Orders not to apply 30

38 Certification of processed food 31

Part 11 Audit and inspection procedures

39 Inspection systems 31

40 Other inspection arrangements 31

41 Additional inspection on occupier’s request 32

42 Additional inspection 32

Part 12 Inspection of fishing vessels

43 Fishing vessel inspection at sea 32

44 Fishing vessel inspection 33

45 Catcher boats to comply with certain requirements 34

Part 13 Reconsideration of inspection or audit decisions

Division I Reconsideration by senior authorised officer

46 Application for reconsideration by senior authorised officer 34

47 Form and lodgement of application 34

48 Senior authorised officer to reconsider decision 35

49 Initial decision ceases to have effect 35

50 Senior authorised officer to advise of decision 35

Division II Reconsideration by the Secretary

51 Application to the Secretary 35

52 Form and lodgement of application 35

53 Secretary to reconsider decision 36

54 Initial decision ceases to have effect 36

55 Secretary to advise of decision 36

Division III Inspection or audit not reviewable by Administrative Appeals Tribunal

56 No review by AAT 36

Part 14 Sampling and analysis

57 Sampling 37

58 Analysis, etc of samples 37

59 Certificates of analysis 37

60 Copy of certificate of analysis prepared at the Department's expense 38

61 Analysis of samples for compliance with these Orders 38

62 NATA analysis of samples for certification as to a particular condition 38

Part 15 Documentation requirements

63 Records 39

64 Production records 39

65 Stock control records and transfer certificates 39

66 Records of maintenance and repair 40

67 Recording or measuring devices 40

Part 16 Storage, loading, transport and security of processed food

68 Storage 40

69 Transport 40

Part 17 Use of official marks (seals)

70 Use of official marks (seals) 41

71 Sealing of premises 41

72 Removal of seals 41

73 Seals not to be removed, altered or interfered with 41

74 Breakage of seals during transport 42

Part 18 Processed food rejected or prohibited for export

Division I Processed food rejected for export

75 Rejection of processed food for export 42

Division II Processed food prohibited for export

76 Processed food prohibited for export 42

Division III Processed food resubmitted for inspection

77 Food prohibited for export resubmitted for inspection 43

Part 19 Processed food unfit for human consumption

Division I Fitness for human consumption

78 Fitness for human consumption 44

79 Goods unfit for human consumption 44

Division II Manufacturing grade processed food

80 Export of manufacturing grade processed food 44

81 Certification of manufacturing grade processed food 45

82 Product and packaging standards 45

Part 20 Transitional

83 Repeal 45

84 Transitional approval of premises 46

85 Other transitional approvals 47

86 Scheduled thermal process 48

87 Cannery person 48

88 Product Monitoring System 48

Schedule 1 Application for Registration 49

Schedule 2 Structural requirements for processed food establishments 53

Part 1 General requirements 56

Part 2 Additional requirements for particular types of establishment 71

Schedule 3 Operational requirements for processed food establishments 81

Part 1 General requirements 84

Part 2 Specific requirements 95

Schedule 4 Product Standards 111

Part 1 General product standards 116

Part 2 Methods for the microbiological examination of processed food 119

Part 3 Abalone 124

Part 4 Canned processed food 124

Part 5 Dried processed food (except dried milk and milk products) 128

Part 6 Live fish 128

Part 7 Uncooked fish 129

Part 8 Cooked fish 130

Part 9 Shellfish 132

Part 10 Pasteurisation standard 135

Part 11 Sterilised and UHT dairy produce 137

Part 12 Milk and liquid milk products 138

Part 13 Cream, cultured cream and cream products 139

Part 14 Condensed milk 140

Part 15 Dried milk and other dried milk products 141

Part 16 Caseins and related products 143

Part 17 Butter, modified butter and related products 143

Part 18 Cheese and cheese products 144

Part 19 Yoghurt and yoghurt products 145

Part 20 Ice cream mixes 146

Part 21 Eggs and egg products 147

Schedule 5 Measurement of contents 149

Part 1 Preliminary 151

Part 2 Net contents declared by number 151

Part 3 Net contents declared by mass or volume 152

Schedule 6 Sampling 161

Schedule 7 FPA system of inspection 167

Part 1 Application and approval 170

Part 2 FPA preparation control documentation 173

Part 3 Amendment of FPA preparation control documentation 178

Part 4 Foreign country authority requirements 181

Part 5 Compliance with FPA system 181

Part 6 FPA system of inspection 182

Part 7 Suspension and revocation 194

Schedule 8 AQA system of inspection 199

Part 1 Application and approval 201

Part 2 Quality manual 204

Part 3 Amendment of quality manual 207

Part 4 Foreign country authority requirements 209

Part 5 Compliance with AQA system 210

Part 6 Audit 210

Part 6A Other audit arrangements 214

Part 7 Suspension and revocation 227

Schedule 9 Trade description 232

Part 1 Information required 234

Part 2 Trade description requirements for particular processed food 241

Part 3 Non-edible processed food 243

Schedule 10 Packaging requirements 245

Schedule 11 Use of official marks 249

Schedule 12 Transport of processed food within Australia 252

Part 1 Application 254

Part 2 Processed food entering the export chain 254

Part 3 Transfer certificates 255

Part 4 Use of transfer certificates 256

Part 5 Approved system of recording transfers 261

Part 6 Conditions of transfer 262

Part 7 Requirements for vehicles 263

Part 8 Transport to a ship or aircraft for export 264

Schedule 13 Alternative export clearance procedures and certification 266

Part 1 Alternative export clearance procedures 269

Part 2 Authorised signatories 279

Part 3 Certification 284

Schedule 14 Product monitoring system 291

Part 1 General 293

Part 2 Establishments preparing fish 294

Part 3 Establishments preparing dairy produce, eggs or egg products 299

Notes 307

Part 1 Preliminary

Citation [see Note 1]

These Orders may be cited as the Export Control (Processed Food) Orders.

Commencement

These Orders commence on 18 January 1993.

Incorporation with Prescribed Goods (General) Orders

These Orders must be read as one with the Prescribed Goods (General) Orders.

Schedules

4.1 The Schedules of these Orders have the same force and effect as the Orders.

4.2 In addition to any other requirement of these Orders, a person must comply with a provision in the Schedules that is applicable to that person.

Contravention for purposes of the Regulations

In a provision of these Orders or the Schedules of these Orders, the words ‘Penal provision’ when set out at the foot of a provision indicate that any contravention of that provision is a contravention for the purposes of regulation 4 of the Regulations.

Application

6.1 These Orders apply to the following prescribed goods:

(a) dairy produce; and

(b) eggs; and

(c) egg products; and

(d) fish.

6.2These Orders do not apply to prescribed goods processed in establishments registered under the Export Control (Quality Assured Foods) Orders.

6.3 These Orders (except Part 19 and subclauses 29.1 and 30.1 of Schedule 9 (Trade Description)) do not apply to food for animals unless the food is prepared in an establishment preparing other processed food for export intended for human consumption.

Note Food for animals is prescribed by paragraph 6(a) of the Prescribed Goods (General) Orders. Parts 8, 9 and 10 of the Prescribed Goods (General) Orders apply to food for animals. See also subparagraph 84(a)(i) of the Prescribed Goods (General) Orders.

Operation of other laws

7.1 These Orders do not exclude the operation of a provision of a law of a State or Territory with respect to fisheries that relates to the enforcement of a provision of that law concerning the taking of fish.

7.2 Processed food must not be prepared from materials which have been received, taken or processed in contravention of any law of the Commonwealth, a State or Territory.

Interpretation

8.1 In these Orders, unless the contrary intention appears:

amenities include, but are not limited to, toilets, showers, locker rooms, change rooms, canteens, kitchens, smoking rooms for staff and sleeping quarters on a vessel.

approved means approved by the Secretary by instrument in writing.

AQA Handbook means the QA Handbook (September 1996) published by the Department.

AQA system of inspection means an Approved Quality Assurance system of inspection approved under Schedule 8 (AQA System of Inspection) of these Orders.

authorised signatory means a person (except an authorised officer) approved to issue Export Clearance Notices or commercial certificates of a type specified in the instrument of approval.

batch means processed food of the same type consisting of one or more lots, or parts of lots, from the same registered establishment.

butter means the fatty product obtained from cream by churning or an equivalent process.

butter product means a product prepared from milk fat with or without the addition of other food ingredients of which milk fat is the major component.

can means an immediate container made of metal, glass or other material suitable as a hermetically sealed container.

canned means preserved by thermal processing and enclosed in a hermetically sealed can.

casein means the dried product obtained from the protein precipitated in skim milk by the addition of:

(a) acid, either added or formed by souring; or

(b) rennet; or

(c) any other enzyme.

caseinate means the product obtained by drying dispersions of acid casein and alkali in water.

catcher boat means a ship that is used solely for:

(a) catching fish; or

(b) catching and chilling fish; or

(c) one or more of the following: catching, bleeding, gilling, heading, gutting or chilling scale fish.

cheese means a solid or semi-solid product obtained by:

(a) coagulating milk, skim milk, partly skimmed milk, cream, whey or buttermilk, or a mixture of these materials, through the action of protein coagulating enzymes, heat or acid; or

(b) processing techniques involving coagulation of milk or materials obtained from milk that give an end product that has the same essential physical, chemical and organoleptic characteristics as the product obtained in accordance with paragraph (a);

chilled, in relation to processed food, means cooled so that the temperature of the food is held at a temperature:

(a) for all processed food except cheese and abalone — between -1°C and +4°C (inclusive); or

(b) for abalone — between -1°C and +6°C (inclusive); or

(c) for cheese — appropriate to the particular kind of cheese.

clean means remove soil, food residues, dirt, grease or other objectionable matter that may cause contamination of processed food.

Codex means the document Codex Alimentarius published by the Codex Alimentarius Commission of the United Nations, and includes all corrigenda to Codex Alimentarius published immediately prior to the commencement of these Orders.

cold store means premises in which chilled or frozen product is stored.

commercial certificate means a certificate issued in relation to statements about the condition (including all matters contained in the definition of trade description in the Act) of processed food for export which is:

(a) not required by the foreign country authority to be issued by a representative of the Australian Government; and

(b) approved by the Secretary.

commercially sterile means, in relation to food, food that is free of micro‑organisms which are capable of growing under the conditions the processed food is likely to encounter during storage and distribution.

condensed, in relation to a processed food, means subjected to a process by which a portion of the water content of the food is removed by evaporation.

condensed milk means a product obtained by:

(a) condensing milk, skim milk or partially skimmed milk; or

(b) condensing milk, skim milk or partially skimmed milk and mixing it with an approved ingredient; or

(c) mixing milk, skim milk or partially skimmed milk with an approved ingredient and condensing the mixture; or

(d) any other means that produces a similar end product.

container, in relation to a processed food, means the principal covering in which the food is packed.

cream includes reduced cream, thickened cream, whipped cream and any similar product.

critical control point means a factor, practice, procedure, process, or location, that can be controlled in order to prevent, reduce or eliminate a hazard, or minimise the likelihood of its occurrence.

critical step means a step in the preparation of processed food identified as having the ability to give rise to a hazard.

cultured means intentionally soured by the use of lactic acid producing bacteria.

dairy blend means the product prepared from milk fat, edible vegetable oil or oil, and water, in the form of a solid or semi-solid emulsion.

dairy ice mix means a mixture of ingredients intended for the preparation of a frozen food, of which the major component is milk fat only.

dairy produce means milk, or a product made from milk of which the major component is derived from milk, but does not include ice cream.

declared net contents means a declaration in a trade description of the net contents of an immediate container of processed food.

defective, in relation to a sample unit of processed food, means the sample unit fails to meet one or more of the:

(a) tolerances; or

(b) sample plans;

for conditions specified in Schedule 4 (Product Standards) applicable to that processed food or its immediate container.

disinfect means reduce, by means of hygienically satisfactory chemical agents or physical methods or both, the number of micro‑organisms to a level that will not lead to harmful contamination of processed food.

dried milk product means a dried product of which milk or a constituent of milk is a major component (except dried thickened cream, caseins and casein-related products, dried ice cream mix, dried dairy ice mix and dried ice confection mix).

dried thickened cream means a homogenised, dried mixture of cream and total milk solids non-fat, either with or without the addition of another ingredient.

egg means the whole or part of an egg from a hen of the species Gallus gallus.

egg product means dried egg or liquid egg, or a product wholly or mainly made from dried egg or liquid egg.

essential services include, but are not limited to, water, gas, electricity, sewerage, drainage and waste disposal.

export certification means an Export Clearance Notice or a commercial certificate.

fillet means a portion of the flesh removed from one side of the length of the backbone with or without skin or bone or both.

fish means:

(a) live, fresh, imported or processed fish, or part of any such fish (except fish skins not intended for human consumption), and includes crustaceans, molluscs, aquatic reptiles and all other forms of amphibious or aquatic animal life except aquatic mammals, oyster spat, live fish ova, aquarium fish, and shells from which the fish has been removed; or

(b) fish products (except fish meal, fish oil and fish skins not intended for human consumption).

fish product means a product of which fish is the major component.

follow-up formula means a food intended for use as a part of the weaning diet for infants 6 months of age or older and for young children up to 3 years of age.

food grade means suitable for use in the manufacture of food for human consumption.

food handling area means an area in an establishment in which raw materials or processed food is processed or packed.

Food Standards Code means the Food Standards Code adopted by the Australia New Zealand Food Standards Council on 24 November 2000 and published in Gazette No. P30 on 20 December 2000.

FPA preparation control documentation means the documentation prepared in accordance with Part 2 of Schedule 7 (FPA System of Inspection) of these Orders and includes all manuals, books, documents or work instructions to which it makes reference.

FPA system of inspection means the Food Processing Accreditation System of inspection approved under Schedule 7 (FPA System of Inspection) of these Orders.

freezer means a chamber or item of equipment used solely for the purpose of freezing processed food.

frozen, in relation to a processed food, means cooled so that the temperature of every part of the food is -18°C or less after thermal stabilization.

Good Manufacturing Practice (GMP) means compliance by an establishment with the:

(a) structural requirements set out in Schedule 2 (Structural Requirements for Processed Food Establishments); and

b) operational hygiene requirements set out in Part 1, Schedule 3 (Operational Requirements for Processed Food Establishments);

of these Orders.

government certificate means a certificate which is:

(a) required by the foreign country authority to be issued by a representative of the Australian Government in relation to statements about the condition of processed food for export; and

(b) approved by the Secretary.

HACCP table means a Hazard Analysis Critical Control Point table prepared in accordance with Part 2 of Schedule 7 (FPA System of Inspection) of these Orders.

hazard means any potential risk:

(a) to the safety or wholesomeness of processed food or its ingredients that may arise from a biological, microbiological, chemical or physical property:

(i) present; or

(ii) present above acceptable levels having regard to the likely end use of the food;

during the preparation of the food; or

(b) that processed food will not be processed in accordance with these Orders.

high risk processed food means the processed food listed in the column entitled ‘High risk’ in Table 3 of Schedule 7 (FPA System of Inspection) of these Orders.

ice cream means a frozen product, not otherwise defined, prepared from milk or cream, or from milk products of which milk or milk products are the major components.

ice cream mix means a milk product intended for use as the major component in preparing ice cream.

ice confection means a frozen product prepared from water and milk or water and milk products.

ice confection mix means a product intended for use as the major component in preparing ice confection.

immediate container, in relation to a processed food, means the container of the food that is not separated from the food by any intervening covering except lining material.

industry body, in relation to commercial certificates, means an organisation that is representative of:

(a) an industry; or

(b) a major part of an industry.

infant formula means a human breast milk substitute formulated to satisfy the normal nutritional requirements of infants up to 12 months of age.

ingredient, in relation to a processed food, means any substance (including a food additive):

(a) that is a constituent of the food; or

(b) that is present in the food as a result of processing the food.

issued, in relation to export certification, means completed, dated and signed.

issued, in relation to a transfer certificate, means completed in accordance with clauses 3, 9 and 10 of Schedule 12 (Transport of Processed Food within Australia).

liquid egg means the edible portion of eggs that remains after the shells have been removed.

liquid milk product means flavoured milk, skim milk or modified milk.

lot means a quantity of processed food of the same type produced under essentially the same conditions during a particular time interval not exceeding 24 hours (if the processing time of a particular processed food exceeds 24 hours, the Secretary may determine in writing the time interval during which a lot is produced), and usually from a particular processing line or other identifiable processing unit.

low risk processed food means the processed food listed in the column entitled ‘Low risk’ in Table 3 of Schedule 7 (FPA System of Inspection) of these Orders.

major component, in relation to processed food, means the ingredient in the food which:

(a) comprises the largest proportion of the food by weight or volume; or

(b) is in such a proportion by weight or volume that if the ingredient was withdrawn from the food, the food would no longer have the stated or implied described characteristics.

manufacturing grade processed food means processed food that is:

(a) not fully processed; or

(b) damaged; or

(c) unfit for human consumption.

but is suitable for further processing which will make the food fit for human consumption.

milk means the lacteal secretion obtained from a bovine.

milk fat means the fat obtained from butter, cream or milk by removing the water and non-fat solids.

modified milk means a liquid mixture derived from milk, either with or without the addition of another ingredient, except:

(a) condensed milk and condensed milk products; or

(b) cream and cream products; or

(c) ice cream mix and related products; or

(d) flavoured milk;

NATA means the National Association of Testing Authorities.

pasteurised means heat treated at temperatures and for periods specified in Division IV, Part 2 of Schedule 3 (Operational Requirements for Processed Food Establishments), and, in the case of dairy produce, meeting the standard set out in subclause 60.2 of Schedule 4 (Product Standards).

pest includes an insect, rodent, bird or other vermin.

PMS means the Product Monitoring System of inspection determined by Schedule 14 (Product Monitoring System).

potable water means water meeting the standard specified in Schedule 2 (Structural Requirements for Processed Food Establishments).

practically free, in relation to an offending characteristic in processed food, means that the characteristic is not present in the food at a level that would affect the food’s fitness for human consumption.

prawns includes shrimp.

preparation, in relation to processed food, includes the processing, packing, storage, handling or loading of the food.

processing, in relation to processed food, includes blending, dismembering, shucking, sorting, grading, cleaning, chilling, treating, freezing, drying, salting, smoking, cooking, canning, purifying, or any other means of preserving the food.

processing date means, the date on which the processed food is finally processed.

processed food means prescribed goods to which these Orders apply under order 6.1.

quality manual means the quality manual prepared in accordance with Part 2 of Schedule 8 (AQA System of Inspection) of these Orders and includes all manuals, books, documents or work instructions to which it makes reference.

regional office means the office of the Department administering these Orders for the State or Territory where the establishment is located, or the vessel is based, as the case may be.

registration number, in relation to an unregistered establishment, means the temporary number assigned to the unregistered establishment by the Secretary.

salt means food grade sodium chloride.

sample unit means one immediate container and its contents drawn at random from a batch of processed food.

scalded cream means cream that has been obtained by subjecting milk or cream to a process of heating and cooling.

scheduled process means the thermal process required to achieve at least commercial sterility for a given processed food in a given container.

serial number means a number or combination of letters and numbers that together with a trade description uniquely identifies a carton.

shellfish means oysters, mussels, clams, cockles or scallops (except where the final product is solely the adductor muscle of a scallop).

sound means free from disease, damage, mould, decay or deterioration, which would render the product unfit for human consumption.

special purpose food means:

(a) food for specific dietary uses; or

(b) low joule food; or

(c) carbohydrate modified food; or

(d) formula dietary food; or

(e) canned food for infants and young children; or

(f) cereal-based food for infants and young children; or

(g) infant formula; or

(h) low sodium and low salt content food;

as defined in Part R of the Food Standards Code.

State authority means an authority of a State or Territory that has powers, functions or duties in relation to processed food in that State or Territory.

sterilisation means, if the sterilising medium is water, heat treated by the application of or immersion in water at a temperature of 82°C or higher.

storage area means an area solely used for the storage of packed processed food, packaging materials and ingredients.

thermal process means the heat sterilization process in which a container of food is exposed to a defined heating medium at a specified temperature for a specified time so that the food is made commercially sterile.

transfer certificate means a transfer certificate issued in accordance with Schedule 12 (Transport of Processed Food within Australia).

UHT, in relation to processed food, means heated, chilled and packed as described in subclause 57.2 in Schedule 3 (Operational Requirements for Processed Food Establishments).

wholesome, in relation to a processed food or an ingredient of a processed food, means clean, free from adulteration or contamination and otherwise suitable for human consumption.

yoghurt means the coagulated milk product obtained by lactic acid fermentation of a preparation of milk or milk products through the action of lactic acid bacteria, and includes frozen yoghurt and yoghurt that has been modified by the addition or subtraction of one or more ingredients.

8.2 In these Orders, unless the contrary intention appears a reference to these Orders is a reference to the Export Control (Processed Food) Orders and its Schedules only.

8.3 In these Orders, a note is not to be taken as part of these Orders. Notes are intended as guidance only.

Note Notes are italicised for ease of reading.

Part 2 Additional conditions or restrictions on the export of processed food

Prohibition on export of processed food for human consumption

9.1 The export of a processed food from Australia is prohibited unless the food and each establishment in which it is prepared comply with the conditions or restrictions expressed in these Orders that are applicable to the food in addition to complying with any conditions or restrictions specified in the Prescribed Goods (General) Orders that are applicable to the food.

9.2 Suborder 9.1 does not apply to:

(a) processed food that is not intended for human consumption; or

(b) processed food that is not intended for use in preparing food intended for human consumption.

Processed food intended for export

For the purposes of these Orders, processed food that is prepared in a registered establishment for which a FPA system of inspection, AQA system of inspection, Product Monitoring System or another approved inspection arrangement exists, is taken to be intended for export unless:

(a) the occupier of the establishment has given the Secretary written notice before the preparation begins giving details of the processed food to be prepared in the establishment that is not for export; or

(b) the processed food is clearly labelled as being not for export.

Enter for export

Processed food prepared in a registered establishment is taken to be entered for export each time documentation is prepared that indicates or confirms that the establishment, or the preparation of the food, complies with the conditions and restrictions expressed in these Orders that are applicable to the establishment or the food.

Part 3 Registered establishment

Preparation in a registered establishment

Processed food intended for export must be prepared in a registered establishment except where:

(a) approval to prepare the food in an unregistered establishment has been granted under order 15; or

(b) the establishment is only used for growing or holding live fish (excluding shellfish); or

(c) fish are:

(i) caught; or

(ii) caught and chilled;

on a catcher boat; or

(d) scale fish are caught, bled, gilled, headed, gutted or chilled on a catcher boat; or

(e) crocodiles are:

(i) killed in a growing or holding pen; or

(ii) bled at an unregistered establishment; or

(f) liquid milk is stored or chilled at a dairy or milking facility; or

(g) eggs are stored or chilled at a hennery.

Applications for registration of establishments — further requirements

An application for the registration of an establishment used for the preparation of processed food must comply with Schedule 1 (Application for Registration) of these Orders in addition to complying with Part 5 of the Prescribed Goods (General) Orders.

Part 4 Approval to prepare processed food in an unregistered establishment

Note The intention of this part is to recognise and facilitate the export of small volumes of processed food from unregistered establishments for the purpose of testing the markets for new products while ensuring that public health standards are maintained.

Application

14.1 A person may apply to the Secretary for approval to prepare processed food for export in an unregistered establishment.

Note For other grounds of exemptions, see order 12 of the Prescribed Goods (General) Orders.

14.2 An application must:

(a) be given to an authorised officer at least ten clear working days before the day on which it is intended to begin to prepare the processed food; and

(b) be in writing in an approved form; and

(c) give the applicant’s name and address; and

(d) give the name and address of each establishment in which the processed food will be prepared; and

(e) specify the type of the food; and

(f) describe each process that will be used in preparing the food; and

(g) give a description of the intended market for the food.

Approval

15.1 The Secretary may grant approval for the processed food to be prepared in the unregistered establishment if:

(a) the establishment complies with Schedule 2 (Structural Requirements for Processed Food Establishments); and

(b) the food will be prepared in accordance with Schedule 3 (Operational Requirements for Processed Food Establishments); and

(c) the processed food complies with Schedule 4 (Product Standards).

15.2 The Secretary must specify in the instrument of approval:

(a) the period within which the food must be exported, being a period of not more than 12 months after the day on which the approval is granted; and

(b) the number of lots (being not more than 5) of the processed food that may be prepared for export in the establishment.

16 Restrictions on grant of approval

The Secretary must not:

(a) grant the applicant more that one approval for processed food for export to be prepared in the unregistered establishment specified in the application; or

(b) grant the applicant more than one approval to export the type of processed food specified in the application.

Compliance with Orders

Except as otherwise provided in this Part or in the approval, the grant of the approval does not exempt the processed food or the establishment from compliance with any provisions of these Orders and of the Prescribed Goods (General) Orders that are applicable to the food or the establishment.

Entry to unregistered establishments preparing processed food for export

An unregistered establishment approved under suborder 15.1 is deemed:

(a) for the purposes of paragraph 10 (3) (a) and subsection 10 (1) of the Act, to be registered; and

(b) to have a registration number.

Revoking approval

The Secretary may revoke the approval if:

(a) the unregistered establishment ceases to comply with Schedule 2 (Structural Requirements for Processed Food Establishments) or Schedule 3 (Operational Requirements for Processed Food Establishments); or

(b) the processed food contravenes Schedule 4 (Product Standards); or

(c) the period within which the food must be exported ends.

Part 5 Export standards for processed food

Preparation in a registered establishment

Processed food must be prepared in premises that:

(a) are hygienic; and

(b) subject to order 84, comply with Schedule 2 (Structural Requirements for Processed Food Establishments).

Preparation in accordance with operational requirements

Processed food must be prepared in accordance with Schedule 3 (Operational Requirements for Processed Food Establishments).

Compliance with product standards

Processed food must:

(a) be prepared in accordance; and

(b) comply;

with Schedule 4 (Product Standards).

Part 6 Packaging processed food

Packaging requirements

23.1 Processed food must be packaged in accordance with Schedule 10 (Packaging Requirements).

23.2 Part 6 of the Prescribed Goods (General) Orders does not apply to the packaging of processed food.

Part 7 Trade descriptions

Trade descriptions

24.1 A processed food and its packaging must comply with any provisions of Schedule 9 (Trade Description) that are applicable to the food or the packaging, in addition to complying with Part 7 of the Prescribed Goods (General) Orders (except orders 66 and 67) that are applicable to the food or the packaging.

24.2 Orders 66 and 67 of the Prescribed Goods (General) Orders do not apply to the packaging or trade descriptions of processed food.

Registered Establishment Number

The registration number of the last establishment in which a processed food is processed before being exported must be shown on the immediate container of the food preceded by one of the following phrases or abbreviations:

(a) ‘Registered Establishment Number’; or

(b) ‘Reg. Est. No.’; or

(c) ‘Reg. No.’; or

(d) ‘Est. No.’.

Trade description: canned processed food

26.1 If a can of processed food is not permanently marked with the complete trade description at the time of filling, the letters ‘EX’ followed by the registered number of the last establishment in which the food is processed must be embossed or otherwise permanently marked on the can.

26.2 If processed food is to be exported in cans without labels:

(a) the cans must be embossed or otherwise permanently marked with:

(i) a product cypher that can be used to identify the product; and

(ii) the abbreviation ‘EX’ followed by the registration number of the last establishment in which the food is processed; and

(iii) the word ‘AUSTRALIA’ or one of the abbreviations ‘AU’ or ‘AUS’; and

(iv) the processing date, approved date code or serial number; and

(b) a full trade description in accordance with these Orders and the Prescribed Goods (General) Orders must be applied to the outer container of the cans.

Trade descriptions not required for bulk processed food

A trade description is not required to be applied to:

(a) unwrapped processed food bulk loaded into container system units; or

(b) fish bulk loaded into container system units if the fish is wrapped or enclosed in clear plastic and is clearly identifiable as to type and form through the wrapping; or

(c) container system units bulk loaded with unwrapped processed food; or

(d) unlabelled canned processed food identified in accordance with suborder 26.1.

Country of origin

28.1 The trade description applied under paragraph 60 (e) of the Prescribed Goods (General) Orders to imported processed food that is repacked in Australia without being altered by further processing in Australia must indicate the last country in which the food was processed before being imported into Australia.

28.2 Despite paragraph 60 (e) of the Prescribed Goods (General) Orders, a person must not indicate that Australia is the country of origin of a processed food if the food was imported from another country and repacked in Australia without being altered by processing in Australia before it is repacked.

Country of origin of fish

29.1 For the purposes of these Orders, the country of origin of fish must be taken to be Australia if:

(a) the fish were taken in Australia; or

(b) the fish were first landed in Australia; or

(c) the fish were imported into Australia and processed in such a manner that the nature of the fish was changed.

29.2 For the purposes of paragraph 29.1 (b), fish first brought into a port and transferred from one ship to another in Australia are deemed to have been landed in Australia.

Identification of lot

The immediate container of a processed food must be embossed or otherwise permanently marked with a serial number, date code or cypher sufficient to identify the lot in which the food was processed.

31 Application of official marks

An official mark in accordance with the design specified in Schedule 6 (Sampling) to the Prescribed Goods (General) Orders may be applied to the immediate container of a processed food.

Part 8 Net contents

Net contents and drained mass

32.1 For the purposes of paragraph 60 (c) of the Prescribed Goods (General) Orders, the:

(a) net contents; and

(b) where applicable, drained mass;

of an immediate container of processed food and its tolerance must be accurately calculated in accordance with Schedule 5 (Measurement of Contents) unless:

(c) the food is to be exported to a foreign country where an alternative method is permitted by the foreign country authority of that country; and

(d) the net contents is determined by the alternative method.

32.2 The:

(a) net contents; and

(b) where applicable, drained mass;

of a container of processed food and their declaration must comply with the provisions in Schedule 5 (Measurement of Contents) applicable to the food, and its immediate and outer container.

Average net contents and drained mass

33.1 The:

(a) average net contents; and

(b) where applicable, average drained mass;

of a batch of processed food and its tolerance must be accurately calculated in accordance with Schedule 5 (Measurement of Contents).

33.2 The:

(a) average net contents; and

(b) where applicable, average drained mass;

of a batch of processed food must comply with the provisions in Schedule 5 (Measurement of Contents) applicable to the food or its immediate and outer container.

Declaration of net contents of an outer container

If an outer container contains a number of immediate containers that are labelled with the net contents of those containers, the contents declaration on the outer container must indicate the number of immediate containers and their net contents.

35 Foreign country requirements

The trade description applied to processed food in accordance with order 60 of the Prescribed Goods (General) Orders is not required to contain a declaration of the net contents of the container if:

(a) the importing country authority accepts an alternative method of declaring the contents of the container; and

(b) the container is marked in accordance with the authority’s requirements.

Part 9 Notice of intention to export and export permits

Note The provisions of Part 8 (Notice of Intention to Export Prescribed Goods), Part 9 (Export Permits) and Part 10 (Re-inspection of Goods) of the Prescribed Goods (General) Orders apply in relation to the export of processed food from Australia unless the Secretary has approved alternative export clearance procedures for an occupier of a registered establishment.

Part 10 Alternative export clearance procedures
and certification

Alternative Export Clearance Procedures

Alternative export clearance procedures may be approved by the Secretary and processed food exported in accordance with Schedule 13 (Alternative Export Clearance Procedures and Certification) of these Orders.

Orders not to apply

If alternative export clearance procedures are approved by the Secretary under suborder 36.1, paragraphs 11.1 (j) and (k), and Parts 8, 9 and 10 of the Prescribed Goods (General) Orders do not apply to processed food exported in accordance with the approved procedures.

Certification of processed food

Certificates for processed food must be issued in accordance with Schedule 13 (Alternative Export Clearance Procedures and Certification) of these Orders.

Part 11 Audit and inspection procedures

Inspection systems

39.1 Processed food prepared at a registered establishment for export must be inspected in accordance with:

(a) an FPA system of inspection approved under Schedule 7 (FPA System of Inspection); or

(b) an AQA system of inspection approved under Schedule 8 (AQA System of Inspection); or

(c) the Product Monitoring System under Schedule 14 (Product Monitoring System); or

(d) another inspection arrangement approved by the Secretary under order 40.

Penal provision

Note The Product Monitoring System (PMS) will cease to be an approved inspection option within 12 months of the commencement of these Orders.

39.2 Suborder 39.1 does not apply to a registered establishment if the establishment is a vessel in which fish is prepared for later inspection or processing at another registered establishment in which there is an approved inspection system as mentioned in suborder 39.1.

Other inspection arrangements

The Secretary may determine appropriate inspection arrangements if circumstances render inspection under an AQA system of inspection or an FPA system of inspection unsuitable for a particular processed food or registered establishment.

Additional inspection on occupier’s request

41.1 In addition to any other inspections provided for under these Orders, the occupier of a registered establishment may request additional inspection at a registered establishment than is required under either an AQA system of inspection or an FPA system of inspection, the Product Monitoring System or other inspection arrangement approved by Secretary under paragraph 39.1(d).

41.2 The Secretary may agree to the request subject to the payment of the fee payable under the Export Control (Fees) Orders.

41.3 The Secretary may at any time withdraw the additional inspection.

Additional inspection

42.1 Despite anything else in these Orders, an authorised officer may carry out an inspection, in addition to any inspection carried out under an inspection arrangement that applies to the establishment, that:

(a) is necessary to ensure compliance with these Orders; or

(b) is necessary to ensure compliance with the requirements of a foreign country authority.

Part 12 Inspection of fishing vessels

Note For the purpose of performing the function of an authorised officer or exercising a power of an authorised officer, an authorised officer may board or enter any ship (see paragraph 10 (3) (c) of the Export Control Act 1982) or enter registered premises (see paragraph 10 (3) (a) of the Export Control Act 1982).

Fishing vessel inspection at sea

43.1 A fishing vessel preparing processed food for export must be inspected, or in the case of an AQA system of inspection, audited during processing operations at sea at least once in a 12 month period or such other longer period as the Secretary approves.

Note The balance of the inspections (or audits) will usually be carried out in port.

43.2 If a registered fishing vessel fails to be inspected or audited at sea at least once in a 12 month period or such other period as the Secretary has approved, the Secretary may suspend registration of the vessel until the vessel is inspected or audited at sea.

Note Inspections of fishing vessels at sea will be carried out within the operational constraints of the inspection service. If it is not possible to inspect at sea an authorised officer may substitute an inspection at a port. The suspension power in suborder 43.2 will not be invoked if inspections at sea cannot be carried out because of these operational constraints.

Fishing vessel inspection

44.1 An authorised officer may request in writing the operator or owner of a fishing vessel to present the vessel for inspection, or in the case of an AQA system of inspection, audit at a specified place within a reasonable time specified by the authorised officer.

44.2 If the operator or owner of a registered fishing vessel fails to present the vessel for inspection or audit at the specified place within the time specified by the authorised officer, registration of the vessel is suspended until the vessel is presented for inspection or audit at the specified place.

44.3 If the operator or owner of an unregistered fishing vessel fails to present the vessel for inspection at the specified place within the time specified by the authorised officer, any fish caught by the vessel or bled, gilled, headed, gutted or chilled on the vessel from the date of the request until the vessel is presented for inspection at the specified place may not be:

(a) sent to a registered establishment; or

(b) prepared at a registered establishment.

Penal provision

Catcher boats to comply with certain requirements

45.1 A catcher boat must:

(a) be maintained in a hygienic and clean state at all times during the catching, bleeding, gilling, heading, gutting, chilling and transportation of fish; and

(b) have effective means for storage of fish to prevent deterioration.

45.2 Fish from a catcher boat that does not meet the requirements of suborder 45.1 must not be accepted into a registered establishment.

Part 13 Reconsideration of inspection or audit decisions

Division I Reconsideration by senior authorised officer

Application for reconsideration by senior authorised officer

An occupier whose interests are affected by a decision made under:

(a) Part 6 of Schedule 7 (FPA System of Inspection); or

(b) Part 6 of Schedule 8 (AQA System of Inspection); or

(c) Parts 2 or 3 of Schedule 14 (Product Monitoring System) (except subclauses 16.1 and 34.1);

may apply to the senior authorised officer of the regional office for a reconsideration of that decision.

Form and lodgement of application

An application made under order 46 must:

(a) be in writing; and

(b) set out a statement of the reasons for the application; and

(c) be lodged with the senior authorised officer within 7 days after the date on which the initial decision first came to the notice of the occupier or within such further period as the senior authorised officer allows.

Senior authorised officer to reconsider decision

The senior authorised officer must upon receipt of an application made under order 47 reconsider the initial decision and may make any decision that the authorised officer who performed the inspection or audit could have made in the first instance.

Initial decision ceases to have effect

If the senior authorised officer makes a decision under order 48, the initial decision that the senior authorised officer has reconsidered ceases to have effect.

Senior authorised officer to advise of decision

The senior authorised officer must, by notice in writing as soon as practicable and not later than 14 days after the day on which an application under order 47 has been received, inform the applicant of the decision made under order 48 in respect of the application and of the reasons for the decision.

Division II Reconsideration by the Secretary

Application to the Secretary

An occupier whose interests are affected by a decision made by the senior authorised officer under order 48 may apply to the Secretary for review of that decision.

Form and lodgement of application

An application made under order 51 must:

(a) be in writing; and

(b) set out a statement of the reasons for the application; and

(c) be lodged with the Secretary within 7 days after the date on which the decision made by the senior authorised officer first came to the notice of the occupier or within such further period as the Secretary allows.

Secretary to reconsider decision

The Secretary must upon receipt of an application made under order 52 reconsider the decision made by the senior authorised officer and may make any decision that the authorised officer who performed the inspection or audit could have made in the first instance.

Initial decision ceases to have effect

If the Secretary makes a decision under order 53, the decision that the Secretary has reconsidered ceases to have effect.

Secretary to advise of decision

The Secretary must, by notice in writing as soon as practicable and not later than 28 days after the day on which an application under order 52 has been received, inform the occupier of the decision made under order 53 in respect of the application and of the reasons for the decision.

Division III Inspection or audit not reviewable by Administrative Appeals Tribunal

No review by AAT

Despite Part 20 of the Prescribed Goods (General) Orders, a decision made under:

(a) Part 5 of Schedule 7 (FPA System of Inspection); or

(b) Part 6 of Schedule 8 (AQA System of Inspection); or

(c) Parts 2 or 3 of Schedule 14 (Product Monitoring System) (except subclauses 16.1 and 34.1); or

(d) Part 13 of these Orders;

is not reviewable by the Administrative Appeals Tribunal.

Note The power to suspend or revoke systems of inspection or registration has been excluded from suborder 56.1 and are reviewable by the AAT.

Part 14 Sampling and analysis

Sampling

If sampling in accordance with Schedule 6 (Sampling) is required to be carried out by:

(a) these Orders; or

(b) by a system of inspection (including FPA preparation control documentation, quality manual or other inspection system documentation) approved by the Secretary;

the provisions in Schedule 6 (Sampling) must be complied with.

Penal provision

Note See also Part 15 (Sampling and Analysis) of the Prescribed Goods (General) Orders.

Analysis, etc of samples

58.1 In addition to order 96 of the Prescribed Goods (General) Orders, a sample that is taken by an authorised officer under subsection 10 (3) of the Act may be analysed, inspected or examined by a laboratory approved by NATA for that test or analysis.

58.2 For the purposes of order 97 of the Prescribed Goods (General) Orders, an approved analyst also includes a person employed by a laboratory approved by NATA for that test or analysis.

Certificates of analysis

The:

(a) occupier of an establishment preparing processed food for export; or

(b) exporter of processed food; or

(c) agent of the occupier or exporter;

must, at their expense, provide to an authorised officer such certificates of analysis by such approved laboratories as are required by the Secretary.

Penal provision

Copy of certificate of analysis prepared at the Department's expense

60.1 If processed food has been analysed at the direction of an authorised officer for the purposes of these Orders and at the expense of the Department, a copy of the certificate of analysis may, at the written request of:

(a) the occupier of the establishment preparing the food for export; or

(b) the exporter of the food;

be supplied to the occupier or exporter upon payment of a fee calculated to recover the cost of the analysis.

60.2 Order 98 of the Prescribed Goods (General) Orders does not apply to certificates of analysis in relation to processed food.

Analysis of samples for compliance with these Orders

An analysis of a sample must be made in accordance with:

(a) the method of analysis specified by these Orders; or

(b) if a method of analysis is not specified by these Orders:

(i) any relevant standard published by the Standards Association of Australia as in force immediately before the commencement of these Orders; or

(ii) any other method approved by the Secretary.

Penal provision

NATA analysis of samples for certification as to a particular condition

If a statement as to a particular condition of processed food is made on a certificate for the purposes of these Orders, the laboratory analysis must be carried out in a laboratory approved by NATA for that test or analysis.

Penal provision

Part 15 Documentation requirements

Records

63.1 Records required to be kept under these Orders:

(a) must be accurate, legible, dated and in English; and

(b) must be retained:

(i) for at least 3 years; or

(ii) in the case of records relating to the preparation of processed food — for the shelf life of the food, or for 3 years, whichever is longer.

Penal provision

63.2 The records must be kept on the establishment and must be made available to an authorised officer on request.

Penal provision

Production records

Accurate processing and production records must be maintained in accordance with Division V, Part 1 of Schedule 3 (Operational Requirements for Processed Food Establishments) of these Orders.

Penal provision

Stock control records and transfer certificates

Accurate records of the movement of raw material and processed food into and out of a registered establishment must be maintained in accordance with Schedule 12 (Transport of Processed Food within Australia).

Penal provision

Records of maintenance and repair

66.1 The occupier must keep accurate records of the repair and maintenance of equipment used for preparing processed food.

66.2 The occupier must make a report from a repairer, tradesmen, engineer, consultant or expert relating to equipment (particularly the water supply, retorts or refrigeration plant) used for preparing processed food available to an authorised officer on request.

Penal provision

Recording or measuring devices

A recording or measuring device required by these Orders must not be altered or tampered with so as to give a false or misleading reading.

Penal provision

Part 16 Storage, loading, transport and security of processed food

Storage

Processed food must be stored in accordance with Schedule 2 (Structural Requirements for Processed Food Establishments) and Schedule 3 (Operational Requirements for Processed Food Establishments).

Transport

Processed food must be transported between registered establishments in accordance with Schedule 12 (Transport of Processed Food within Australia) of these Orders.

Part 17 Use of official marks (seals)

Use of official marks (seals)

An official mark may be applied for the purposes of these Orders in accordance with Schedule 11 (Use of Official Marks) of these Orders by a person specified in that Schedule.

Sealing of premises

A registered establishment, ship, container, vehicle, aircraft, or anything else used in connection with the preparation or transport of processed food for export may be sealed in accordance with Schedule 11 (Use of Official Marks) of these Orders by a person specified in that Schedule.

Removal of seals

An official mark or seal may be removed only in accordance with Schedule 11 (Use of Official Marks) of these Orders by a person specified in that Schedule.

Seals not to be removed, altered or interfered with

A person must not remove, break, alter or otherwise interfere in any way with an official mark unless the person is:

(a) an authorised officer; or

(b) a person directed by an authorised officer to remove, break, alter or otherwise interfere with the mark; or

(c) a person performing the duties of a position at a registered establishment operating under an AQA arrangement, being a position that is nominated in the establishment's quality manual for the purposes of this paragraph; or

(d) an analyst who breaks or removes the mark for the purpose of carrying out an analysis at:

(i) the Australian Government Analytical Laboratories; or

(ii) a NATA accredited laboratory; or

(iii) a laboratory approved by the Secretary.

Note See order 93 of the Prescribed Goods (General) Orders.

Penal provision

Breakage of seals during transport

If an official mark has been applied to a vehicle transporting processed food and the vehicle arrives at its destination with the mark removed, broken, altered or otherwise interfered with, a person must not touch the food until an authorised officer arrives.

Penal provision

Part 18 Processed food rejected or prohibited for export

Note See also Part 10 (Reinspection of Goods) and Part 11 (Prescribed Goods not fit for Export but fit for Human Consumption) of the Prescribed Goods (General) Orders.

Division I Processed food rejected for export

Rejection of processed food for export

If an authorised officer inspects processed food that does not meet the requirements of these Orders, the officer must reject the food for export.

Processed food which has been rejected for export must be clearly identified and kept separate from other food intended for export until:

(a) an authorised officer is satisfied it meets the requirements of these Orders; or

(b) the food is clearly identified as not for export.

Penal provision

Division II Processed food prohibited for export

Processed food prohibited for export

Processed food which is prohibited for export must be clearly identified and kept separate from other food intended for export until an authorised officer is satisfied it meets the requirements of these Orders.

Penal provision

Division III Processed food resubmitted for inspection

Food prohibited for export resubmitted for inspection

If processed food that:

(a) has been rejected for export; or

(b) is prohibited for export;

is resubmitted by the occupier of the establishment preparing the food for export or exporter of the food to an authorised officer for inspection, the occupier or exporter must:

(c) advise the authorised officer in writing that the goods have been resubmitted for inspection; and

(d) indicate the nature of any further preparation or processing operations that have been undertaken in relation to the food to render it fit for export; and

(e) provide evidence that the further preparation or processing has resulted in the food being suitable for export.

Penal provision

Note Re-assessment will only take place when the re-processing is likely to render the food satisfactory for export.

Part 19 Processed food unfit for human consumption

Note See also Part 12 (Prescribed Goods not fit for Human Consumption) of the Prescribed Goods (General) Orders.

Division I Fitness for human consumption

Fitness for human consumption

Processed food must not be exported unless the food is fit for human consumption unless the food is:

(a) prominently described as not fit for human consumption; or

(b) in a form that renders it not fit for human consumption.

Penal provision

Note See clauses 29 and 30 of Schedule 9 (Trade Description) in relation to labelling which may satisfy the requirement in paragraph 76.1(a).

Goods unfit for human consumption

Processed food that is prepared in a registered establishment and is found by an authorised officer as being unfit for human consumption must:

(a) be segregated from other food intended for export; and

(b) be clearly labelled as not fit for human consumption; and

(c) not be removed from the registered establishment without the written consent of an authorised officer; and

(d) not be reprocessed before an authorised officer is notified in writing.

Division II Manufacturing grade processed food

Export of manufacturing grade processed food

80.1 The Secretary may approve the export of manufacturing grade processed food and issue an export permit if:

(a) the food is prominently described as:

(i) not fit for human consumption; and

(ii) manufacturing grade; and

(b) former trade description material referring to quality, grade and fitness for human consumption is removed, defaced or overstencilled.

Note Despite paragraph 80.1 (b), an accurate trade description must be applied to the processed food. In the case of manufacturing grade cheese, there is no requirement to specify the variety of the cheese or cheeses in the trade description.

80.2 Stickers may not be used to remove, deface or overstencil former trade description material referring to quality, grade and fitness for human consumption.

Penal provision

Certification of manufacturing grade processed food

81.1 Manufacturing grade processed food cannot be issued with:

(a) government to government health certification; or

(b) certification that the condition of the food meets the requirements of these Orders.

81.2 Despite suborder 81.1, the Secretary may issue a certificate that describes the nature and actual condition of manufacturing grade processed food.

Product and packaging standards

Processed food for export described as manufacturing grade is not required to meet the product standards (including microbiological standards) and packaging standards in these Orders.

Part 20 Transitional

Repeal

The following Orders made under the Export Control (Orders) Regulations are repealed:

(a) Export Control (Fish) Orders; and

(b) Dairy Produce Orders; and

(c) Egg Orders.

Transitional approval of premises

84.1 A registered establishment preparing processed food for export is deemed to comply with the provisions of Schedule 2 (Structural Requirements for Processed Food Establishments) of these Orders for a period of three years from the commencement of these Orders if:

(a) before the commencement of these Orders, the establishment complied with:

(i) in the case of an establishment preparing fish, Schedules 1 and 2 of the Export Control (Fish) Orders; or

(ii) in the case of an establishment preparing dairy produce, Schedule 1 of the Dairy Produce Orders; or

(iii) in the case of an establishment preparing eggs or egg products, Schedule 1 of the Egg Orders; and

(b) after the commencement of these Orders, the establishment would comply with the Schedules of the relevant former Orders specified in paragraph 84.1 (a); and

(c) alteration of or construction at such an establishment, pursuant to any plans and specifications for alteration of or construction at the establishment approved under the relevant former Orders, was carried out according to the plans and specifications.

84.2 A newly constructed establishment intended for preparing processed food for export is deemed to comply with the provisions of Schedule 2 (Structural Requirements for Processed Food Establishments) of these Orders for a period of three years from the commencement of these Orders if:

(a) before the commencement of these Orders, any plans and specifications for construction of such an establishment were approved under:

(i) in the case of an establishment intended for preparing fish, Schedules 1 and 2 of the Export Control (Fish) Orders; or

(ii) in the case of an establishment intended for preparing dairy produce, Schedule 1 of the Dairy Produce Orders; or

(iii) in the case of an establishment intended for preparing eggs or egg products, Schedule 1 of the Egg Orders; and

(b) the construction was carried out according to the plans and specifications.

Other transitional approvals

An approval in writing made by the Secretary under the Export Control (Fish) Orders, Dairy Produce Orders or Egg Orders in force immediately prior to the commencement of these Orders, belonging to one of the following classes of approvals:

(a) ingredients to be added to fish, dairy produce, eggs or egg products; or

(b) substances and food additives to be added to fish, dairy produce, eggs or egg products; or

(c) date codes or cyphers for the date of processing or packaging; or

(d) Approved Quality Assurance arrangements (including quality control systems but not interim approvals); or

(e) forms for use as transfer certificates; or

(f) analytical specifications for casein, caseinates, coprecipitates and related products; or

(g) processes for reconditioning or cleaning of packaging to be re-used; or

(h) methods for taking samples from a lot of fish, dairy produce, eggs or egg products; or

(i) methods for removing glucose from liquid egg; or

(j) alternative methods for pasteurising (or heat treating eggs or egg products) by heating and cooling (including combinations of temperature and time);

continues in force for a period of 3 years under these Orders, or until a substituted approval comes into operation or the approval is repealed, rescinded or revoked (whichever is the shorter period).

Scheduled thermal process

If, prior to the commencement of these Orders:

(a) a scheduled process for thermal processing was determined by a qualified cannery person; and

(b) the Secretary was advised of the F₀ value under clause 1.3 of Schedule 2 of the Export Control (Fish) Orders;

the scheduled process is approved for the purposes of paragraph 34.1 (b) of Schedule 3 (Operational Requirements for Processed Food Establishments) of these Orders for a period of 3 years, or until a substituted approval comes into operation or the approval is repealed, rescinded or revoked (whichever is the shorter period).

Cannery person

If, prior to the commencement of these Orders, a person possessed qualifications approved under the Export Control (Fish) Orders in cannery technology appropriate to canned fish, the person is approved as a cannery person for the purposes of paragraph 34.1(a) of Schedule 3 (Operational Requirements for Processed Food Establishments) of these Orders for a period of 3 years, or until a substituted approval comes into operation or the approval is repealed, rescinded or revoked (whichever is the shorter period).

Product Monitoring System

Fish, dairy produce, eggs or egg products prepared under the Product Monitoring System of the Export Control (Fish) Orders, Dairy Produce Orders or Egg Orders immediately prior to the commencement of these Orders will be inspected under Schedule 14 (Product Monitoring System) of these Orders for a period of 15 months from the commencement of these Orders or until other inspection arrangements are approved by the Secretary (whichever is the shorter period).

Note Subclauses 13.2 and 32.2 in Schedule 14 (Product Monitoring System) contain transitional provisions in relation to the commencement level of PMS.

Schedule 1 Application for Registration

TABLE OF CONTENTS

Clause

1. General requirements

2. Establishment to be constructed, altered or extended in accordance with plans

3. Detail of the plans and specifications

4. Plans — land based establishments

5. Plans — vessels

6. Specifications to accompany the application

7. Specifications to be accompanied by refrigeration statement

General requirements

1.1 The occupier of an establishment in which it is proposed to prepare processed food for export must apply for registration of the establishment in accordance with Part 5 of the Prescribed Goods (General) Orders.

1.2 An application for registration must be accompanied by two identical copies of plans and specifications of the establishment.

1.3 The application must be forwarded to the senior authorised officer at the regional office.

Establishment to be constructed, altered or extended in accordance with plans

2.1 An establishment must be constructed, altered or extended in accordance with the plans and specifications submitted.

Detail of the plans and specifications

3.1 The plans and specifications must be sufficiently detailed to show whether the establishment will, when constructed, altered or extended in accordance with the plans and specifications, be suited for preparing the processed food to be prepared in the establishment in accordance with these Orders.

Note The plans and specifications are examined only in relation to hygiene issues.

Plans — land based establishments

4.1 In the case of a land based establishment, plans must include but are not limited to:

(a) a locality map showing the site; and

(b) a site plan at a scale of at least 1:500 showing:

(i) the layout of the entire premises; and

(ii) roads; and

(iii) water supply; and

(iv) stormwater drainage; and

(v) waste water drainage; and

(vi) on site waste disposal (if any); and

(vii) all salient features of the site; and

(viii) adjoining sites including location of adjacent establishments; and

(ix) north compass point; and

(x) scale; and

(c) a floor plan of food handling and auxiliary areas (including laboratories, stores, cold stores and amenities), at a scale of at least 1:100, showing all permanent fixtures and layout of equipment; and

(d) a product flow chart and the main features of product flow; and

(e) descriptive information on all major items of equipment used in processing the food and the water supply.

4.2 The occupier must:

(a) notify the senior authorised officer in writing of any factories or industries within 2 km of the establishment that may affect the hygienic preparation of the processed food; and

(b) clearly mark the location of the factories or industries on the locality map referred to in paragraph 4.1(a).

Plans — vessels

5.1 In the case of vessels, plans must include but are not limited to:

(a) above and below deck layout of the vessel, including position of all major facilities associated with processed food handling; and

(b) a product flow chart and the main features of product flow; and

(c) descriptive information on all major items of equipment used in processing the food and the water supply.

Specifications to accompany the application

6.1 The specifications must show details of the following:

(a) construction materials; and

(b) construction materials of the equipment used in food handling areas; and

(c) surface finishes; and

(d) surfaces which contact processed food or ingredients; and

(e) essential services; and

(f) operating temperatures, freezing rate and storage capacity of all refrigeration equipment and refrigerated rooms, holds and tanks; and

(g) where there is more than one room, hold or tank having a similar function, the rooms, holds and tanks must be individually numbered; and

(h) in the case of vessels, number of crew and processing personnel.

Plans to be accompanied by refrigeration statement

7.1 The specifications must be accompanied by a statement from a qualified refrigeration engineer detailing the following:

(a) in relation to each cold store and chiller, the:

(i) method of refrigeration; and

(ii) capacity in kilograms of relevant processed food; and

(iii) holding temperature; and

(b) in relation to each freezer, the:

(i) method of refrigeration; and

(ii) capacity in kilograms of relevant processed food; and

(iii) time required to reduce a full load of a stated processed food (prepared at the establishment and to be stored in the freezer) from a stated initial temperature to a temperature of -18°C.

Note Structural and operational requirements are detailed in Schedules 2 (Structural Requirements for Processed Food Establishments) and 3 (Operational Requirements for Processed Food Establishments).

Schedule 2 Structural requirements for processed food establishments

TABLE OF CONTENTS

Clause

PART 1 — GENERAL REQUIREMENTS

Division I — Building, facilities and location

1. Location

2. Immediate surrounds of registered establishments

3. Buildings and facilities

Division II — Food handling areas

4. Floors

5. Floor Drains

6. Internal walls

7. Ceilings

8. Windows, doors, external walls and vents

9. Stairs, platforms and stands

10. Design, construction and installation of equipment and services

11. Use of timber

12. Hand washing facilities

13. Cleaning and disinfecting facilities

14. Sterilising facilities

Division III — Refrigeration, storage and other areas

15. Refrigeration facilities

16. Non-refrigerated storage facilities

17. Carton, wrapping material and food container stores

18. Changing facilities, toilets, living areas and handwashing facilities

Division IV — Services

19. Effluent and waste disposal

20. Facilities for storage of waste and inedible material

21. Lighting

22. Ventilation

23. Water supply

24. Potable water standard

25. Notification of failure to meet the potable water standard

26. Water recirculation

27. Steam

28. Compressed air and other gases

PART 2 — ADDITIONAL REQUIREMENTS FOR PARTICULAR TYPES OF ESTABLISHMENT

Division I — Requirements for storage establishments

29. Application of this Division

30. Refrigerated storage

31. Non-refrigerated storage

Division II — Requirements for fishing vessels

32. Application of this Division

33. Design and construction of fish handling areas on a vessel

34. Water supply on a vessel

35. Lighting on a vessel

36. Refrigeration facilities on a vessel

37. Chillers on a vessel

38. Freezers on a vessel

39. Cold storage on a vessel

40. Amenities on a vessel

41. Vessels processing within 0.5 nautical miles of land

42. Exemptions for small vessels

Division III — Requirements for brine freezing facilities for bulk whole fish

43. Brine freezing facilities

Division IV — Requirements for shellfish depuration plants

44. Shellfish depuration plants

Division V — Requirements for live fish packing establishments

45. Requirements for live fish packing establishments

Division VI — Requirements for abalone shucking establishments

46. Requirements for abalone shucking establishments

Division VII — Requirements for storing dairy products

47. Application of this Division

48. Storage tanks for dairy produce

Division VIII — Requirements for crocodile processing establishments

49. Application of this Division

50. Bleeding of crocodiles

51. Preparation of crocodile hides

52. Tables and hanging rails

53. Chill rooms

54. Handwashing facilities

55. Steriliser facilities

Note The specific requirements for particular types of establishment in Part 2 must be read together with the general requirements of Part 1.

Part 1 General requirements

Division I Building, facilities and location

Location

1.1 A registered establishment must be located in a suitable area which is free from:

(a) objectionable odours; and

(b) smoke; and

(c) dust; and

(d) other contaminants; and

(e) flooding.

Immediate surrounds of registered establishments

2.1 Areas immediately surrounding buildings, roads, pathways and other areas serving a registered establishment must be suitably paved, graded, grassed, landscaped or otherwise treated and kept clean and tidy to avoid the risk of dust, pests or other objectionable contaminants entering food handling and storage areas.

2.2 There must be adequate drainage of the surrounds and provision must be made to allow for cleaning of surrounds.

2.3 Where vehicles are cleaned on an establishment, a paved and drained area must be provided for the purpose.

Buildings and facilities

3.1 Buildings and facilities must be of sound construction and maintained in good repair.

3.2 All construction materials must be such that they do not transmit any undesirable substances to the food.

3.3 Adequate working space must be provided to allow for satisfactory performance of all operations connected with the preparation of processed food.

Penal provision

Division V Suspension and revocation of authorised signatories

Employment of authorised signatory ceases

36.1 If a person employed by an occupier of a registered establishment preparing processed food for export and approved as an authorised signatory for the occupier ceases employment with the occupier, the approval of the person as an authorised signatory ceases from the day after the date on which the employment ceased.

36.2 The occupier must notify the Secretary within three working days from the day after the date on which the employment ceased.

Penal provision

Grounds for suspension or revocation

37.1 The Secretary may, by instrument in writing, suspend or revoke the approval of an authorised signatory if the Secretary has reasonable grounds to believe that:

(a) the authorised signatory has failed to comply with:

(i) a requirement of these Orders; or

(ii) a requirement of a foreign country authority; or

(iii) a condition to which the approval of the authorised signatory is subject; or

(iv) a condition to which the approval of the:

(A) FPA system of inspection; or

(B) AQA system of inspection

is subject; or

(v) the:

(A) FPA preparation control documentation; or

(B) quality manual; or

(b) the system of preparation of processed food in place at the establishment is unreliable or not effective in ensuring that:

(i) processed food prepared in the establishment for export, and the preparation:

(A) comply with these Orders; or

(B) comply with the requirements of the foreign country authority; or

(ii) there is a sound basis for export certification issued by an authorised signatory; or

(c) the authorised signatory issued export certification:

(i) which is incorrect; or

(ii) for which there was no basis for its issuing; or

(iii) when alternative export clearance procedures were suspended or revoked in relation to the occupier; or

(d) a defect in relation to alternative export clearance procedures identified in an AQA or FPA corrective action request has not been rectified on or before the corrective action date specified in the request by the authorised officer; or

(e) alternative export clearance procedures are suspended or have been revoked in relation to an occupier.

Notice of suspension or revocation

38.1 If the Secretary has suspended or revoked the approval of an authorised signatory, the Secretary must notify the authorised signatory in writing of:

(a) the reason for the suspension or revocation; and

(b) if an authorised signatory has been suspended — the period of the suspension.

Period of suspension

39.1 If the Secretary has suspended the approval of an authorised signatory, the period of suspension must not exceed 6 months and must not be extended.

Part 3 Certification

Division I General

Application for a certificate

40.1 For the purposes of section 23 of the Act, a person may apply to the Secretary for a certificate in respect of processed food that is to be exported from Australia.

40.2 An application for a certificate must be made on a form approved by the Secretary.

40.3 A person must not make a false or misleading statement in an application for the issuing of a certificate.

Penal provision

40.4 An application for the issue of a certificate is deemed to be a declaration for the purposes of the orders.

Note See section 16 of the Export Control Act 1982.

Issuing of a certificate

41.1 An authorised officer may issue a government certificate in respect of processed food that is appropriate for the foreign country authority or for a commercial requirement if the authorised officer has reasonable grounds to believe that:

(a) the certificate correctly describes the condition of the food; and

(b) the food and its preparation:

(i) meet the requirements imposed by the foreign country authority; and

(ii) comply with:

(A) these Orders; and

(B) if relevant, its FPA preparation control documentation or quality manual.

41.2 An authorised officer may issue a certificate in respect of processed food for a commercial requirement if the authorised officer has reasonable grounds to believe that the certificate correctly describes the condition of the food.

41.3 Despite subparagraph 41.1 (b) (ii), the Secretary may issue a government certificate for processed food if:

(a) the requirements imposed by the foreign country are of a different standard than these Orders or any relevant FPA preparation control documentation or quality manual; and

(b) the requirements of paragraph 41.1 (a) and subparagraph 41.1 (b) (i) are met.

Note A certificate issued pursuant to subclause 41.3 cannot certify that these Orders have been complied with.

Cancellation of a certificate

42.1 The Secretary may cancel a government or commercial certificate issued in respect of processed food if the Secretary is satisfied that the information contained in that certificate is incorrect in a significant respect.

42.2 In addition to subclause 42.1, the Secretary may cancel a government or commercial certificate issued in respect of processed food if:

(a) an export permit issued in relation to the food has been revoked; or

(b) an Export Clearance Notice issued in relation to the food has been revoked; or

(c) there are reasonable grounds to believe that a false or misleading statement was made in the application for the issue of the certificate; or

(d) any of the circumstances specified in paragraphs 43 (a), (b), (c), (d), (f), (g) or (h) of the Prescribed Goods (General) Orders, (except subparagraphs 43 (f) (iii) and (vi)), have occurred or exist; or

(e) the occupier of the establishment has failed to comply with:

(i) a requirement of these Orders; or

(ii) a requirement of the foreign country authority; or

(iii) a condition to which the approval of the FPA system of inspection or AQA system of inspection is subject; or

(f) the occupier of the establishment has failed to prepare processed food for export in accordance with its FPA preparation control documentation or quality manual; or

(g) the system of preparation of processed food or quality assurance system in place at the establishment is unreliable or not effective in ensuring that:

(i) processed food prepared in the establishment for export, and the preparation:

(A) comply with these Orders; or

(B) comply with the requirements of the foreign country authority; or

(ii) there is a sound basis for certification.

Return of a certificate

43.1 If a certificate is cancelled by the Secretary, the person to whom the certificate was issued must, if practicable, return the certificate to an authorised officer within three working days.

Penal provision

Division II Government to government certification

Approval of a government certificate

44.1 The Secretary may approve a government certificate.

Authorised officer to issue government certificates

45.1 A government certificate may only be issued by an authorised officer.

Penal provision

45.2 An authorised signatory or other person must not issue:

(a) a government certificate; or

(b) any other certification required by a foreign country authority to be issued by a representative of the Australian Government.

Penal provision

Government certificates not to be altered

46.1 A government certificate must not be issued with an alteration.

46.2 If a government certificate has been issued, a person must not alter it.

Penal provision

Division III Commercial certification

Approval of a commercial certificate

47.1 The Secretary may, subject to such conditions as the Secretary thinks fit, approve a commercial certificate (including its design).

Note Designs of commercial certificates to be issued by authorised signatories or industry bodies which resemble government certificates will not be approved.

Serial number or alphanumeric code

48.1 Each commercial certificate of a particular approved type must bear a unique serial number or alphanumeric code.

Foreign country authority requirement may preclude a commercial certificate

49.1 A commercial certificate in relation to the condition of processed food must not be issued if the foreign country authority requires a representative of the Australian government to certify the condition of the food.

Penal provision

Approval of an authorised signatory or industry body

50.1 The Secretary may, subject to such conditions as the Secretary thinks fit, approve:

(a) an authorised signatory; or

(b) an industry body;

to issue a commercial certificate.

Note The Secretary may reserve the issue of some types of commercial certificates to authorised officers.

Issuing of a commercial certificate

51.1 A commercial certificate must correctly describe the condition of the processed food.

Penal provision

51.2 A commercial certificate may be issued by an:

(a) authorised officer; or

(b) authorised signatory approved to issue that certificate; or

(c) industry body approved to issue that certificate.

51.3 A person issuing a commercial certificate must record on the certificate the date when it was signed.

Issuing of unapproved commercial certificates

52.1 A person must not issue an unapproved commercial certificate which represents or implies that the certificate has been approved by the Secretary.

Penal provision

Records of commercial certificates must be kept

53.1 An authorised signatory must keep records at the establishment of:

(a) applications for the issue of commercial certificates; and

(b) commercial certificates issued by the authorised signatory; and

(c) commercial certificates cancelled by the authorised signatory; and

(d) any laboratory examination or analysis needed to validate the statements in a commercial certificate;

for a period of 3 years.

Penal provision

53.2 An approved industry body must keep records at its premises of:

(a) applications for the issue of commercial certificates; and

(b) commercial certificates issued by the industry body; and

(c) commercial certificates cancelled by the industry body; and

(d) any laboratory examination or analysis needed to validate the statements in a commercial certificate;

for a period of 3 years.

Penal provision

False or misleading statements must not be made

54.1 A person must not make a false or misleading statement to an industry body in an application for the issuing of a commercial certificate.

Penal provision

54.2 An authorised signatory or approved industry body must not make a false or misleading statement in a commercial certificate.

Penal provision

Commercial certificate is a declaration

55.1 An application to an industry body for the issue of a commercial certificate is deemed to be a declaration for the purposes of the orders.

55.2 A commercial certificate issued by an authorised signatory or approved industry body is deemed to be a declaration by the authorised signatory or approved industry body for the purposes of the orders.

Note See section 16 of the Export Control Act 1982.

Commercial certificates must not be altered

56.1 A commercial certificate must not be issued with an alteration.

Penal provision

56.2 If a commercial certificate has been issued, a person (including an authorised officer, authorised signatory or approved industry body) must not alter it.

Penal provision

Printing of blank certificates

57.1 A person must not print (or cause to be printed) unapproved blank certificate stationery which represents or implies that the certificate has been approved by the Secretary.

Penal provision

Locked and secure container

58.1 Unused commercial certificates must be kept in a locked and secure container.

Penal provision

Note A lockable drawer or filing cabinet will satisfy the requirement in subclause 58.1.

Schedule 14 Product monitoring system

TABLE OF CONTENTS

Clause

PART 1 — GENERAL

Division I — Foreign country requirements

1. Foreign country requirements

Division II — Suspension and revocation

2. Grounds for suspension or revocation

3. Notice of suspension or revocation

PART 2 — ESTABLISHMENTS PREPARING FISH

Division I — Application

4. Application of this Part

5. Interpretation

Division II — Levels of inspection intensity

6. Levels of inspection intensity

7. Tightened

8. Normal

9. Reduced

10. Entry to system

Division III — Movement Between PMS Inspection Intensities

11. Inspection intensity

12. Tightened to normal

13. Normal to reduced

14. Reduced to normal

15. Normal to tightened

16. Tightened to suspension or revocation

17. Suspension or revocation to tightened

Division IV — Assessment procedures

18. Request for assessment

19. Normal or reduced inspection intensity

20. Batch inspection

PART 3 — ESTABLISHMENTS PREPARING DAIRY PRODUCE,

EGGS OR EGG PRODUCTS

Division I — Application

21. Application of this Part

22. Interpretation

Division II— Levels of inspection intensity

23. Levels of inspection intensity

24. Different inspection intensity for each food or line of foods

25. Sampling rates

26. Tightened

* Sampling rates table for processed food on tightened PMS

27. Normal

* Sampling rates table for processed food on normal PMS

28. Reduced

* Sampling rates table for processed food on reduced PMS

29. Entry to system

Division III — Movement Between PMS Inspection Intensities

30. Tightened to normal

31. Normal to reduced

32. Reduced to normal

33. Normal to tightened

34. Tightened to revocation

35. Suspension or revocation to tightened

Division IV — Assessment procedures

36. Inspection arrangements

37. Lot inspection and further sampling

38. Rejected for export

39. Inspection report

Division V — Establishment Monitoring

40. Premises inspection

41. Construction and operational requirements must be followed

Part 1 General

Note The Product Monitoring System (PMS) will cease to be an approved inspection system 12 months after the commencement of these Orders.

Division I Foreign country requirements

Foreign country requirements

1.1 If the requirements of a foreign country preclude importation into that country of a processed food prepared under a Product Monitoring System of inspection, a Product Monitoring System of inspection must not be approved in respect of the preparation of that food for export to that country at an establishment.

Note This paragraph would cover situations where, for example, a foreign country requires continuous inspection of processed food by the Department.

1.2 If the requirements of a foreign country preclude importation into that country of a processed food prepared under a Product Monitoring System of inspection, a person must not export such food to that country.

Penal provision

Division II Suspension and revocation

Grounds for suspension or revocation

2.1 If there are reasonable grounds to believe that:

(a) any of the circumstances specified in order 43 of the Prescribed Goods (General) Orders have occurred or exist; or

(b) any of the circumstances specified in order 48 of the Prescribed Goods (General) Orders have occurred or exist; or

(c) incorrect certification has been issued by an authorised officer after reliance on the Product Monitoring System of inspection at the establishment or information provided by the occupier; or

(d) an authorised officer has been prevented, by the use of force or intimidation, from performing that officer's duties in respect of inspection of the preparation of processed food at a registered establishment; or

(e) a foreign country authority requires that the Product Monitoring System of inspection at the establishment be revoked;

the Secretary may, by instrument in writing, suspend or revoke the Product Monitoring System of inspection of the establishment, in full or in part, in respect of one or more of the processed foods prepared at the establishment.

Notice of suspension or revocation

3.1 If the Secretary has suspended or revoked a Product Monitoring System of inspection the Secretary must notify the occupier of the establishment in writing of:

(a) the reason for the suspension or revocation; and

(b) if a Product Monitoring System of inspection has been suspended — the period of the suspension.

Part 2 Establishments preparing fish

Division I Application

Application of this Part

4.1 This Part applies to a land-based registered establishment preparing fish for export inspected in accordance with a Product Monitoring System of inspection.

Interpretation

5.1In this Part, unless the contrary intention appears:

meeting the export standard means, in relation to a batch of processed food selected for inspection, the batch of processed food:

(a) is accepted as meeting the requirements of the applicable product standard in accordance with clause 3 of Schedule 6 (Sampling); and

(b) meets the applicable product standards in Schedule 4 (Product Standards) in relation to microbiological examination and chemical analysis.

rejection occurs when a batch of processed food submitted for inspection and assessment fails to meet the export standard.

Division II Levels of inspection intensity

Levels of inspection intensity

6.1 The three levels of inspection intensity for land-based establishments preparing processed food for export inspected in accordance with PMS are: tightened, normal and reduced.

6.2 A single level of inspection intensity will apply to each registered establishment inspected in accordance with PMS in respect to all processed food prepared at that establishment.

Tightened

7.1 If a land-based establishment preparing processed food for export is inspected in accordance with PMS at the tightened level of intensity, every batch of food submitted for assessment must be inspected.

Normal

8.1 If a land-based establishment preparing processed food for export is inspected in accordance with PMS at the normal level of intensity, two in three batches of food submitted for assessment, determined randomly, must be inspected.

Reduced

9.1 If a land-based establishment preparing processed food for export is inspected in accordance with PMS at the reduced level of intensity, one in three batches of food submitted for assessment, determined randomly, must be inspected.

Entry to system

10.1 Subject to subclause 10.2, all establishments which are to be inspected under PMS must enter PMS at the tightened level of inspection intensity.

10.2 If a land-based establishment preparing processed food for export was being inspected in accordance with the Product Monitoring System of the former Export Control (Fish) Orders immediately before the commencement of these Orders:

(a) the establishment commences in the PMS at the level of inspection intensity which it had been classified at under the former PMS immediately before the commencement of these Orders; and

(b) for the purposes of this Schedule — the establishment is not regarded as entering the PMS.

Division III Movement Between PMS Inspection Intensities

Inspection intensity

11.1 For the purposes of PMS, the number of batches of processed food assessed as meeting the export standard and the time period in relation to an establishment must both:

(a) commence at zero on entry to PMS; and

(b) revert to zero at every reclassification of inspection intensity.

Tightened to normal

12.1 Subject to subclauses 12.2 and 12.3, an establishment on the tightened inspection intensity of PMS must be reclassified to normal when 48 successive batches of processed food are submitted for inspection and assessed as meeting the export standard over a minimum period of two months.

12.2 If 48 successive batches of processed food are submitted for inspection and assessed as meeting the export standard in less than two months, inspection intensity will continue at the tightened level until either two months is reached or a rejection occurs.

12.3 If any batch of processed food submitted for inspection from an establishment on the tightened level of inspection intensity fails to meet the export standard, both the number of batches of processed food submitted for inspection by that establishment and assessed as meeting the export standard and the time period revert to zero.

Normal to reduced

13.1 Subject to subclauses 13.2 and 13.3, an establishment on the normal inspection intensity of PMS must be reclassified to reduced when 60 successive batches of processed food are submitted for inspection and assessed as meeting the export standard over a minimum period of three months.

Note All batches of processed food submitted for inspection in accordance with clause 11 count towards the 60 batches of processed food even if they are not inspected due to the application of the random number table.

13.2 If 60 successive batches of processed food are submitted for inspection and assessed as meeting the export standard in less than three months, inspection intensity will continue at the normal level until either three months is reached or a rejection occurs.

13.3 If any batch of processed food submitted for inspection from an establishment on the normal level of inspection intensity fails to meet the export standard, both the number of batches of processed food submitted for inspection by that establishment and assessed as meeting the export standard and the time period revert to zero.

Reduced to normal

14.1 An establishment on the reduced level of inspection intensity must be immediately reclassified to normal after a rejection.

Normal to tightened

15.1 An establishment on the normal level of inspection intensity must be immediately reclassified to tightened if:

(a) two rejections occur in any nine successive batches of processed food; or

(b) three rejections occur within any two month period.

Tightened to suspension or revocation

16.1 If an establishment on the tightened level of inspection intensity submits five consecutive batches of processed food that are rejected, operations at the establishment may be suspended or revoked.

Suspension or revocation to tightened

17.1If the registration of an establishment on PMS is reinstated after suspension or revocation, the establishment must re-enter PMS at the tightened level of inspection.

Division IV Assessment procedures

Request for assessment

18.1 The occupier of an establishment must request assessment of a batch of processed food by submitting a Request for Assessment form containing full details of the batch of food.

Normal or reduced inspection intensity

19.1 In the case of an establishment inspected in accordance with PMS at the normal or reduced level of intensity, an authorised officer will decide whether a batch of processed food will be inspected by reference to a table of randomly generated numbers provided by the Department that relate to the establishment preparing the batch of processed food.

Note Despite subclause 19.1, processed food prepared at the establishment may be inspected in accordance with orders 40, 41 and 42.

Batch inspection

20.1 A batch of processed food selected for inspection must be sampled in accordance with Schedule 6 (Sampling) to determine whether it is accepted as meeting the requirements of the applicable product standard in accordance with clause 3 of Schedule 6 (Sampling).

20.2 If an occupier has processed food reassessed in accordance with clauses 11 and 12 of Schedule 6 (Sampling) the initial rejection will not be counted against the establishment for the purposes of PMS.

Note Rejection after reassessment does count against the establishment.

20.3 A batch of processed food selected for inspection may be required by an authorised officer to be sampled for the purpose of microbiological examination or chemical analysis.

20.4 If an authorised officer requires a batch of processed food to be sampled for the purpose of microbiological examination or chemical analysis, sampling must be carried out in accordance with the applicable Australian Standards specified in Schedule 4 (Product Standards).

Part 3 Establishments preparing dairy produce, eggs or egg products

Division I Application

Application of this Part

21.1 This Part applies to a registered establishment preparing dairy produce, eggs or egg products for export inspected in accordance with a Product Monitoring System of inspection.

Interpretation

22.1In this Part, unless the contrary intention appears:

quarter means the period of three months beginning on 1 January, 1 April, 1 July or 1 October in any year.

health standards mean the standards in Schedule 4 (Product Standards) of these Orders relating to Coagulase-positive Staphylococci, E. coli, Coliforms, Listeria monocytogenes, Salmonella, inhibitory substances (such as iodine or antibiotics), phosphatase, and microbial growth, applicable to a processed food.

non health standards means the standards in these Orders other than health standards.

22.2In this Part, unless the contrary intention appears, a reference to processed food includes a line of similar processed foods.

Division II Levels of inspection intensity

Levels of inspection intensity

23.1 The three levels of inspection intensity for processed food prepared at an establishment for export inspected in accordance with PMS are: tightened, normal and reduced.

Different inspection intensity for each food or line of foods

24.1 A level of inspection intensity will allocated to:

(a) each individual processed food; or

(b) at the discretion of an authorised officer, each line of similar processed foods;

prepared at an establishment inspected in accordance with PMS.

Note The levels of inspection intensities allocated to each individual processed food or lines of processed foods prepared at an establishment may be different.

Sampling rates

25.1 If an establishment preparing processed food for export is inspected in accordance with PMS, from the sampling rates table relevant to the inspection intensity of the food, the number of lots applicable to the number of lots prepared per quarter by the establishment (column 1), and specified in:

(a) column 2, must be inspected in accordance with the health standards that apply to that food; and

(b) column 3, must be inspected in accordance with the non health standards that apply to that food.

25.2 If practicable, the lots required by subclause 25.1 to be inspected must be drawn randomly.

25.3 Lots inspected for non health standards may be drawn from lots inspected for health standards and vice versa.

25.4 The number of lots of processed food prepared per quarter (column 1) in the tables of sampling rates for an establishment must be estimated by an authorised officer, in consultation with the occupier of the establishment taking into account but not limited to:

(a) the number of lots of the food prepared by the establishment during the previous quarter; and

(b) the number of lots of the food prepared by the establishment for the current quarter of the previous year; and

(c) the amount of ingredients and the food stored at the establishment; and

(d) the contractual obligations of the occupier to accept ingredients and to export the food.

Tightened

26.1 If processed food prepared at an establishment for export is inspected in accordance with PMS at the tightened level of intensity, the relevant sampling rates table is as follows:

Column 1	Column 2	Column 3
Lots to be inspected for:
Lots prepared per quarter	Health standards	Non health standards
2	all	all
2 - 8	all	all
9 - 15	all	8
16 - 20	all	8
21 or more	20	8

Sampling rates table for processed food on tightened PMS

Normal

27.1 If processed food prepared at an establishment for export is inspected in accordance with PMS at the normal level of intensity, the relevant sampling rates table is as follows:

Column 1	Column 2	Column 3
Lots to be inspected for:
Lots prepared per quarter	Health standards	Non health standards
2	all	all
2 - 8	all	up to 5
9 - 15	up to 13	5
16 - 20	13	5
21 or more	13	5

Sampling rates table for processed food on normal PMS

Reduced

28.1 If processed food prepared at an establishment for export is inspected in accordance with PMS at the reduced level of intensity, the relevant sampling rates table is as follows:

Column 1	Column 2	Column 3
Lots to be inspected for:
Lots prepared per quarter	Health standards	Non health standards
2	all	all
2 - 8	up to 5	2
9 - 15	5	2
16 - 20	5	2
21 or more	5	2

Sampling rates table for processed food on reduced PMS

Entry to system

29.1 Subject to subclause 29.2, all establishments and processed food which are to be inspected under PMS must enter PMS at the tightened level of inspection intensity.

29.2 If an establishment preparing processed food for export was being inspected in accordance with the Product Monitoring System of the former Dairy Produce Orders or Egg Orders immediately before the commencement of these Orders:

(a) the processed food commences in the PMS at the level of inspection intensity which the food had been classified at under the former PMS immediately before the commencement of these Orders; and

(b) for the purposes of this Schedule, the establishment and the processed food is not regarded as entering the PMS.

Division III Movement Between PMS Inspection Intensities

Tightened to normal

30.1 The inspection intensity of a processed food subject to the tightened inspection intensity of PMS must be reclassified to normal if:

(a) in respect of health standards, no lot fails inspection for four full consecutive quarters; and

(b) in respect of non health standards, no more than one lot in each quarter fails inspection in the last two full consecutive quarters of the period specified in paragraph 30.1 (a).

Normal to reduced

31.1 The inspection intensity of a processed food subject to the normal inspection intensity of PMS must be reclassified to reduced if:

(a) in respect of health standards, no lot fails inspection for two full consecutive quarters; and

(b) in respect of non health standards, no more than one lot fails inspection in the period specified in paragraph 31.1 (a).

Reduced to normal

32.1 The inspection intensity of a processed food subject to the reduced level of inspection intensity must be immediately reclassified to normal if one or more lots fail inspection for a health or non health parameter.

Normal to tightened

33.1 The inspection intensity of a processed food subject to the normal level of inspection intensity must be immediately reclassified to tightened if:

(a) in respect of health standards, one or more lots fail inspection; or

(b) in respect of non health standards, two or more lots fail inspection in a quarter.

Tightened to revocation

34.1 The Secretary may suspend or revoke the registration of an establishment preparing processed food subject to the tightened level of inspection intensity if:

(a) there is no improvement in the food perceived by an authorised officer for eight consecutive quarters that would be sufficient to qualify the food to move back to the normal level of inspection intensity; or

(b) six or more lots fail inspection in any quarter.

Suspension or revocation to tightened

35.1If the registration of an establishment on PMS is reinstated after suspension or revocation, all processed food must re-enter PMS at the tightened level of inspection.

Division IV Assessment procedures

Inspection arrangements

36.1 An authorised officer will decide when to inspect processed food prepared for export by an establishment which is inspected in accordance with a Product Monitoring System of inspection.

36.2 If practicable, an authorised officer may decide whether a lot of processed food will be inspected by reference to a table of randomly generated numbers provided by the Department that relate to the establishment preparing the lot.

Note Despite subclauses 36.1 and 36.2, processed food prepared at the establishment may be inspected in accordance with orders 40, 41 and 42.

36.3 The occupier of an establishment may request:

(a) a more intensive level of inspection; or

(b) additional inspection;

of processed food.

Lot inspection and further sampling

37.1 A lot selected for inspection may be appropriately sampled by an authorised officer and the samples tested.

37.2 An authorised officer may require the occupier of the establishment to provide certificates of analysis in accordance with orders 57, 58, 59 and 60 in relation to the samples drawn.

Rejected for export

38.1 If a lot of processed food fails inspection, the lot must be rejected for export.

Inspection report

39.1 If an authorised officer inspects one or more lots of processed food, the officer must complete an inspection report in respect of each lot inspected and provide a copy of the reports to the occupier of the registered establishment where the inspection took place.

Division V Establishment Monitoring

Premises inspection

40.1 If processed food is inspected at an establishment in accordance with PMS, the premises and equipment at an establishment must be inspected as follows:

(a) if all processed food prepared at the establishment is inspected at reduced inspection intensity, a major annual inspection of the premises, construction since the last major inspection and equipment (primarily for the purpose of re-registration); or

(b) if one or more processed foods at the establishment is inspected at normal or tightened inspection intensity, inspection specified in paragraph 40.1 (a) and, in addition, random surveillance by an authorised officer or officer of a State authority (with a minimum of one visit each quarter).

40.2 If one or more processed foods prepared at the establishment is inspected at tightened inspection intensity, the Secretary may specify such:

(a) additional inspection; or

(b) conditions in relation to the use of the premises or equipment at the establishment;

that the Secretary considers appropriate to the particular construction or operational problems at the establishment.

Construction and operational requirements must be followed

41.1 Despite the inspection intensity applicable to processed food prepared at an establishment, the Secretary may revoke the registration of the establishment for failure to comply with constructional and operational requirements of these Orders.

Notes to the Export Control (Processed Food) Orders

Note 1

The Export Control (Processed Food) Orders (in force under the Export Control (Orders) Regulation) as shown in this compilation comprise Orders No. 9 of 1992 amended as indicated in the Tables below.

Table of Orders

Number and year	Date of notification in *Gazette*	Date of commencement	Application, saving or transitional provisions
No. 9 of 1992	13 Jan 1993	18 Jan 1993 (see Gazette 1993 No. GN 1)
No. 1 of 1999	10 Mar 1999	10 Mar 1999 (see Gazette 1999 No. GN10)	—
No. 1 of 2001	12 Sept 2001	12 Sept 2001 (see Gazette 2001 No. GN36)	—

Table of Amendments

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected	How affected
O. 8..........................................	am. No. 1 of 1999; No. 1 of 2001
Schedule 3
C. 21.....................................	am. No. 1 of 2001
Schedule 8
C. 21.....................................	am. No. 1 of 1999
Part 6A ................................ (cc. 30A–30Z)	ad. No. 1 of 1999
Cc. 30A–30Z ......................	ad. No. 1 of 1999

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Citations

Export Control (Processed Food) Orders 1992 (Cth)

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