Part 2 Approval to prepare processed food in an unregistered establishment
Note The intention of this Part is to 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 fitness for human consumption is maintained. See further order 34.
Application for approval for limited num Application for approval for limited number of exports
Application for approval for limited number of exports
7.1 A person who is or is to be the occupier of an establishment may apply to the Secretary for approval to prepare processed food of the kind specified in the application for export in an unregistered establishment.
Note For other grounds of exemptions, see Division VI of Part 2 of these Orders.
7.2 The application must:
(a) describe each process to be used in preparing the food; and
(b) identify the country to which it is intended to export the food.
Approval Approval
Approval
8.1 If the Secretary is satisfied that the applicant will comply with:
(a) the requirements of Part 3 of these Orders; and
(b) applicable importing country requirements;
the Secretary may give the applicant approval to prepare at the unregistered establishment processed food for export as food to a country specified in the approval.
8.2 The approval takes effect:
(a) when written notice of it is given to the applicant; or
8.3 The notice must specify:
(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 consignments (being not more than five) of the processed food that may be prepared for export in the establishment; and
(c) an identification number assigned by the Secretary to the establishment.
Note A reference in these Orders to a registration number includes the registration number referred to in paragraph 8.3 (c), see the meaning of registration number in order 8.
8.4 No more than one approval may be given under subclause 8.1 for processed food prepared in the unregistered establishment being processed food of the kind specified in the application that is for export to the country specified in the application.
8.5 If the Secretary decides not to give approval under subclause 8.1 the Secretary must give the applicant written notice of:
(a) the decision; and
Part Part 2 - Export Control (Dairy, Eggs and Fish) Orders 2005 - Approval to prepare processed food in an unregistered establishment | Zoe
(b) the reasons for the decision.
Exemption from compliance with orders Exemption from compliance with orders
Exemption from compliance with orders
9.1 The Secretary may:
(a) specify in the approval given under subclause 8.1 of this Schedule that the establishment is exempt from one or more of the requirements of Schedule 2 specified in the approval; and
(b) by written notice vary or revoke the specification made under paragraph 9.1 (a).
9.2 If the approval has effect the requirements specified in the notice do not apply to establishment.
Approval may be subject to conditions Approval may be subject to conditions
Approval may be subject to conditions
10.1 The Secretary may:
(a) give approval under subclause 8.1 of this Schedule subject to conditions specified in the notice of approval; and
(b) by written notice given to the occupier impose new conditions or vary or revoke the conditions.
10.2 The conditions must be for the purpose of ensuring compliance by the occupier with one or more of the objectives specified in suborders 3.1 and 3.2.
Revocation of approval Revocation of approval
Revocation of approval
11.1 The Secretary may revoke an approval given under subclause 8.1 of this Schedule if the Secretary has reasonable grounds to believe:
(a) a circumstance specified in paragraphs 21.1 (a) to (e) of Schedule 2 exists; or
(b) the person to whom the approval is given ceases to be the occupier of the establishment.
11.2 The revocation takes effect:
(a) when written notice of it is given to the person to whom the notice of the approval was given under subclause 8.2; or
Termination of approval Termination of approval
Termination of approval
12.1 The occupier may terminate the approval by giving the Secretary written notice of the termination.
12.2 The termination takes effect:
(a) 7 days after the notice is given to the Secretary; or
(b) on a later day specified in the notice.
Effect of revocation or termination Effect of revocation or termination
Effect of revocation or termination
13.1 On revocation or termination:
(a) the approval ceases to have effect; and
(b) the orders that are specified under subclause 9.1 as not applying apply.
Occupier’s commitment Occupier’s commitment
Occupier’s commitment
1.1 The commitment of the occupier of an establishment used to prepare processed food for export as food to:
(a) the objectives specified in suborders 3.1 and 3.2; and
(b) compliance with the requirements of these Orders and applicable importing country requirements;
must be documented.
Note 1 For the meaning of occupier see order 8.
Note 2 The occupier of a registered establishment and of an unregistered establishment with approval to prepare processed food given under Part 2 of Schedule 1 must comply with this Schedule, see suborder 37.1. For exemptions from compliance with specified requirements of this Schedule given to the occupier who has approval to prepare processed food in an unregistered establishment see clause 9 of Schedule 1.
Note 3 For when the occupier of an unregistered establishment (ie a catcher boat) need not comply with this Schedule see suborder 37.2.
Division II Approved arrangements
Minimum requirements for approved arrang Minimum requirements for approved arrangements
Minimum requirements for approved arrangements
2.1 An arrangement for the preparation of processed food at an establishment that is required for the purposes of order 36 of these Orders must cover each step of the preparation of processed food undertaken at the establishment and must:
(a) contain a HACCP plan referred to in clause 3 of this Schedule; and
(b) document the controls used to ensure that the applicable requirements of these Orders (other than a requirement of Schedule 3) are complied with at the establishment; and
(c) identify the applicable importing country requirements and document the controls used to ensure compliance with these requirements; and
(d) document any other measures necessary to ensure there is a sound basis for giving any export permit or issuing any government certificate for processed food prepared at the establishment.
Note 1 For the requirement for the occupier to have an approved arrangement see order 36.
Note 2 For the meaning of export permit, government certificate, HACCP and importing country requirement see order 8.
Note 3 For requirements for ascertaining export eligibility to a particular country see clause 53 of Schedule 5. For the issue of a government certificate required by an importing country authority see Part 2 of Schedule 9.
2.2 Paragraphs 2.1 (c) applies only to each importing country requirement for which compliance with these Orders would not be sufficient to result in compliance with the importing country requirement.
Note 1 For example subclause 2.2 refers to importing country requirements that are in addition to or more stringent than the requirements of these Orders.
Note 2 For regulatory arrangements where compliance with an importing country requirement would not result in compliance with these Orders see order 87.
HACCP plan HACCP plan
HACCP plan
3.1 The HACCP plan must identify each of the steps in the preparation of the food.
Note For guidance see the Codex requirements for a HACCP plan. A flow chart may be used.
3.2 For each step the HACCP plan must identify the potential hazards that may reasonably be expected to occur.
Note For the meaning of hazard see order 8.
3.3 The HACCP plan must identify the means of control of each potential hazard.
3.4 Despite subclause 3.3 hazards controlled by meeting the operational hygiene requirements of these Orders need not be identified as part of the HACCP plan.
Note For examples of operational hygiene requirements referred to in subclause 3.4 see the requirements in Schedule 4 for cleaning, pest controls, hazardous substances and the like which must be included as part of the approved arrangement, see paragraph 2.1 (b) of this Schedule.
3.5 For each significant hazard that is identified the HACCP plan must identify:
(a) the critical control points; and
(b) the critical limits; and
(c) the procedures to be used to monitor the potential hazards to ensure compliance with each critical limit including:
(i) the frequency with which these procedures are to be performed; and
(ii) the person, or persons included in a class of persons, who are to carry out these procedures; and
(d) the corrective action to be taken if a critical limit is exceeded.
Note For the meaning of critical control point, critical limit and monitor see order 8.
3.6 The action that referred to in paragraph 3.5 (d) includes:
(a) action to address the fact the critical limit is exceeded; and
(b) action to ensure that the exceeding of the critical limit does not recur; and
(c) an assessment of the effectiveness of the action taken.
3.7 The HACCP plan must identify procedures used to verify compliance with the HACCP plan and the frequency with which these procedures are to be performed.
3.8 The HACCP plan must provide for records to be made and documents to be kept to demonstrate compliance with the HACCP plan and its effectiveness.
Note For requirements for validation see for example clause 12 of Schedule 4 and clauses 24 to 31 and 39 to 41 of Schedule 5.
3.9 In this clause:
a significant hazard means a hazard (or a hazard in combination with other hazards) that is of such a nature that its elimination, control or reduction to an acceptable level is essential to the production of safe food.
Management practices, organisational structure, resources and competence
4.1 The management practices, organisational structure, provision of resources and the provision of personnel and their competence (including knowledge, training, skills and experience) must:
(a) be documented; and
(b) be appropriate to ensure each of the following are met:
(i) the applicable requirements of these Orders;
(ii) the applicable importing country requirements.
Person in management or control must be Person in management or control must be present
Person in management or control must be present
5.1 A person in management or control of the operations must be present whenever operations to prepare processed food for export as food are in progress.
Note For the meaning of person in management or control see order 8.
5.2 If an occupier of an establishment, who must under suborder 37.1 ensure the requirements of this Schedule are complied with, fails to comply with a requirement of subclause 5.1 the occupier is guilty of an offence.
Level 3 penal provision
Note A level 3 penal provision means a person who is guilty of the relevant offence is punishable by a fine of 30 penalty units, see Regulation 4 of the Export Control (Orders) Regulations 1982.
Verification Verification
Verification
6.1 Whether the following are complied with must be verified:
(a) the applicable requirements of Division III of Part 3 of these Orders; and
(b) the importing county requirements identified in the approved arrangement.
Note For the meaning of verify see order 8. Verification could for example include sampling procedures.
6.2 A written record must be made of:
(a) the methods, procedures, tests, monitoring and other evaluations used to verify compliance; and
(b) the results of the verification.
Corrective and preventative action Corrective and preventative action
Corrective and preventative action
7.1 If a requirement of Division III of Part 3 of these Orders or an importing country requirement identified in the approved arrangement is not complied with or is not likely to be complied with:
(a) action must be taken:
(i) to address the fact the requirement is not complied with or is not likely to be complied with; and
(ii) to ensure that the failure to comply with the requirement, or the likelihood that it is not complied with, does not recur; and
(b) the effectiveness of the action taken must be assessed.
Note For directions to take action to correct or prevent the recurrence of a non compliance see Part 8 of these Orders.
7.2 A written record must be made of the action referred to in paragraph 7.1 (a) that is taken and the assessment of its effectiveness.
Internal audit and management review Internal audit and management review
Internal audit and management review
8.1 Internal audits and management reviews of the effectiveness of the management practices at the establishment in meeting:
(a) the requirements of Division III of Part 3 of these Orders; and
(b) the importing country requirements identified in the approved arrangement;
must be conducted at least once every twelve months.
Note For external audits see Part 6 of these Orders.
8.2 A written record must be made of:
(a) the internal audits and managements reviews conducted; and
(b) the results of the audits and reviews.
Note 1 For other examples of requirements to make records see subclause 3.8 and clause 17 of this Schedule, clause 1 of Schedule 4 and clause 5 of Schedule 8. See also order 83.
Note 2 For making electronic records see subsection 12 (1) of the Electronic Transactions Act 1999.
8.3 For an establishment employing less than three people subclause 8.1 is taken to be satisfied if a management review is conducted.
Sampling and analysis Sampling and analysis
Sampling and analysis
9.1 Sampling and the analysis of a sample made for the purposes of these Orders must be made in accordance with the method for sampling and analysis specified in these Orders.
Note For an example of methods of sampling and analysis specified in these Orders see clause 4 of Schedule 6.
9.2 If a method of sampling and analysis is not specified in these Orders the sampling and analysis must be made in accordance with:
(a) an applicable method specified in the Food Standards Code; or
(b) an applicable method specified in a relevant standard published by Standards Australia; or
(c) any other validated science based method that is appropriate for the sample to be tested and that ensures the accuracy of the results obtained.
Notifiable diseases Notifiable diseases
Notifiable diseases
10.1 If an animal from which processed food is derived:
(a) is at an establishment used to prepare processed food for export; and
(b) is affected by or is suspected of being affected by a notifiable disease;
the occupier of the establishment must notify an authorized officer without delay.
Note For the meaning of notifiable disease see order 8.
10.2 If an occupier of an establishment, who must under suborder 37.1 ensure the requirements of this Schedule are complied with, fails to comply with a requirement of subclause 10.1 the occupier is guilty of an offence.
Note A level 5 penal provision means a person who is guilty of the relevant offence is punishable by a fine of 50 penalty units, see Regulation 4 of the Export Control (Orders) Regulations 1982.
Requirement to retain documents Requirement to retain documents
Requirement to retain documents
11.1 Each document that:
(a) is made by the occupier of an establishment or that comes into the possession of the occupier of an establishment used for the preparation of processed food; and
(b) is relevant to whether the occupier complies with:
(i) the requirements of the Act, these Orders or the occupier’s approved arrangement or a condition of that arrangement; and
(ii) the importing country requirements identified in the approved arrangement;
must be retained for a period of not less than three years from the time the document is made by the occupier or comes into the occupier’s possession (as the case may be).
Note 1 For retaining records electronically see subsection 12 (2) of the Electronic Transactions Act 1999.
Note 2 For suspension or revocation of an approved arrangement if the occupier fails to make available to an authorized officer documents the occupier is required to retain see paragraph 21.1 (e) of this Schedule.
Note 3 For audit of these documents see Part 6 of these Orders.
11.2 If an occupier of an establishment, who must under suborder 37.1 ensure the requirements of this Schedule are complied with, fails to comply with a requirement of subclause 11.1 the occupier is guilty of an offence.
Note A level 5 penal provision means a person who is guilty of the relevant offence is punishable by a fine of 50 penalty units, see Regulation 4 of the Export Control (Orders) Regulations 1982.
Part 2 Approved arrangements
Division I Approval of arrangements
Application for approval Application for approval
Application for approval
12.1 A person who is or is to be the occupier of an establishment may apply to the Secretary for approval of an arrangement for the preparation of processed food.
Note A person includes a body politic as well as a natural person, see paragraph 22 (1) (a) of the Acts Interpretation Act 1901. (See also section 13 of the Legislative Instruments Act 2003.)
12.2 The arrangement for which approval is sought must:
(a) accompany the application; or
(b) be made available for evaluation by the Secretary.
Assessment of application and Secretary’ Assessment of application and Secretary’s decision
Assessment of application and Secretary’s decision
13.1 For the purposes of assessing the application the Secretary must:
(a) evaluate the arrangement in a desk audit; and
(b) conduct an inspection of the establishment, facilities, equipment and services to be used in the operations.
13.2 The Secretary may in order to consider the application request any of the following that the Secretary reasonably requires:
(a) further information or documents of the kind specified by the Secretary;
(b) a demonstration of the operations and procedures to be followed;
(c) the applicant’s consent to the use (at the applicant’s expense) of an appropriately qualified person nominated by the Secretary in any inspection, evaluation or demonstration.
13.3 If the Secretary has not made a decision on whether to approve the arrangement within 60 days after the day the application is received (not including any period between the Secretary making a written request under subclause 13.2 and the applicant meeting the request) the Secretary is taken to have refused the application.
When the Secretary may approve the arran When the Secretary may approve the arrangement
When the Secretary may approve the arrangement
14.1 The Secretary may by written notice given to the applicant approve the arrangement if the Secretary is satisfied that:
(a) the arrangement complies with subclause 2.1 of this Schedule; and
(b) compliance with the controls specified in the arrangement will ensure that:
(i) the requirements of these Orders will be complied with at the establishment; and
(ii) the applicable importing country requirements will be complied with at the establishment; and
(iii) there is a sound basis for giving any export permit or issuing any government certification for processed food prepared at the establishment; and
(c) the occupier will comply with the arrangement.
14.2 The approval takes effect:
(a) when written notice of it is given to the applicant; or
Notice of decision not to approve an arr Notice of decision not to approve an arrangement
Notice of decision not to approve an arrangement
15.1 If the Secretary decides not to approve an arrangement, the Secretary must give the occupier written notice of the decision.
15.2 The notice must:
(a) set out the reason for the decision; and
(b) tell the occupier of his or her right to apply for reconsideration of the decision.
Note For reconsideration and review of the Secretary’s decision, see Part 16 of the Export Control (Prescribed Goods — General) Order 2005 and see orders 98 and 99 of these Orders.
Approved arrangement may be subject to c Approved arrangement may be subject to conditions
Approved arrangement may be subject to conditions
16.1 The Secretary may:
(a) approve an arrangement subject to conditions specified in the notice of approval; and
(b) by written notice given to the occupier of an establishment impose new conditions or vary or revoke the conditions.
16.2 The conditions must be for the purpose of ensuring compliance with the matters specified in subparagraphs 14.1 (b) (i), 14.1 (b) (ii) and 14.1 (b) (iii) of this Schedule.
Note If there is non compliance with the arrangement or its conditions (including with an importing country requirement specified in the approved arrangement) the Secretary may suspend or revoke the arrangement, see paragraph 21.1 (a) of this Schedule. Non compliance may preclude the issue of an export permit, see Division IV of Schedule 9 or the issue of a government certificate, see Part 2 of Schedule 9. For audit of compliance with an approved arrangement see Part 6 of these Orders. For directions to take action to correct or prevent the recurrence of a non compliance see Part 8 of these Orders.
Division II Variation of approved arrangement
Variations to be recorded Variations to be recorded
Variations to be recorded
17.1 The occupier must make a record of each variation of an approved arrangement.
Level 2 penal provision
Note A level 2 penal provision means a person who is guilty of the relevant offence is punishable by a fine of 20 penalty units, see Regulation 4 of the Export Control (Orders) Regulations 1982.
Variations requiring notification and ap Variations requiring notification and approval before implementation
Variations requiring notification and approval before implementation
18.1 A proposed variation (or a proposed variation in combination with other variations) to an arrangement that has the potential to adversely affect:
(a) the likelihood of compliance with the requirements of these Orders or an applicable importing country requirement; or
(b) the fitness for human consumption or integrity of processed food at the establishment; or
(c) an accurate assessment being made as to whether:
(i) there is compliance with requirements of these Orders or an applicable importing country requirement; or
(ii) processed food at the establishment is fit for human consumption and its integrity is assured;
must not be implemented unless:
(d) the occupier of the establishment make a written application to the Secretary for approval to vary the arrangement; and
(e) the Secretary gives the occupier a written notice approving the variation.
Note 1 A level 5 penal provision means a person who is guilty of the relevant offence is punishable by a fine of 50 penalty units, see Regulation 4 of the Export Control (Orders) Regulations 1982.
Note 2 Variations (including variations not covered by clause 18) need to be recorded (see clause 17 of this Schedule). Variations not covered by clause 18 are to be considered for approval by the auditor at the time of audit.
18.2 A proposed variation of a provision of an approved arrangement (or a proposed variation in combination with other variations) that:
(a) identifies persons in management or control or their functions (including as it designates persons who may make declarations or possess, alter, interfere with or apply an official mark) under these Orders; or
(b) relates to any of the following:
(i) an alternative, procedure, standard or other requirement referred to in suborder 86.5 of these Orders;
(ii) a control referred to in suborder 87.6 of these Orders;
(iii) an alternative requirement or control referred to in these Orders;
(iv) a matter referred to in subclause 11.2 of Schedule 9;
must not be implemented unless:
(c) the occupier of the establishment makes a written application to the Secretary for approval to vary the arrangement; and
(d) the Secretary gives the occupier a written notice approving the variation.
Note 1 A level 5 penal provision means a person who is guilty of the relevant offence is punishable by a fine of 50 penalty units, see Regulation 4 of the Export Control (Orders) Regulations 1982.
Note 2 For the meaning of person in management or control see order 8.
Note 3 For an example of an alternative requirement or control referred to in subparagraph 18.2 (b) (iii) see subclause 24.1 of Schedule 5 and subclauses 1.3, 2.3, 3.3 or 4.3 of Schedule 6.
Variations required by the Secretary Variations required by the Secretary
Variations required by the Secretary
19.1 The Secretary may give the occupier of an establishment a written notice requiring the occupier to submit a variation of an approved arrangement if:
(a) circumstances relating to the preparation of the food at the establishment change; or
(b) the Secretary is not satisfied that compliance with the controls specified in the approved arrangement for the preparation of processed food ensures that the matters specified in subparagraphs 14.1 (b) (i), 14.1 (b) (ii) and 14.1 (b) (iii) of this Schedule are complied with; or
(c) an applicable importing country authority requirement changes; or
(d) the person to whom the Secretary gives the approval of an arrangement under clause 14 of this Schedule ceases to be the person in charge of the operations to prepare processed food at the establishment.
Note For the requirement to notify the Secretary of changes persons in management or control see Division 4.4 of Part 4 of the Export Control (Prescribed Goods — General) Order 2005.
19.2 The notice must:
(a) specify the variation required; and
(b) specify the period within which the variation must be submitted to the Secretary.
19.3 The Secretary may give the occupier a notice approving the variation submitted.
19.4 An occupier who is given a notice under subclause 19.1 must not fail to submit the variation specified in the notice within the period specified.
When an arrangement includes a variation When an arrangement includes a variation
When an arrangement includes a variation
20.1 An approved arrangement includes a variation to the arrangement.
20.2 If a variation is of a kind referred to in subclauses 18.1, 18.2 or 19.1 of this Schedule, then the approved arrangement includes the variation only when the Secretary gives a notice approving the variation in accordance with paragraphs 18.1 (e) or 18.2 (d) or subclause 19.3 (as the case may be).
Division III Suspension and revocation
Grounds for suspension or revocation Grounds for suspension or revocation
Grounds for suspension or revocation
21.1 The Secretary may give the occupier of an establishment written notice suspending or revoking the approval of an arrangement if the registration of the establishment is revoked or the Secretary has reasonable grounds to believe that:
(a) a requirement of any of the following is not complied with by the occupier:
(i) these Orders;
(ii) the occupier’s approved arrangement or a condition of that arrangement (including an importing country requirement identified in that arrangement); or
(b) compliance with the controls specified in the approved arrangement is unreliable or not effective in ensuring that the matters specified in subparagraphs 14.1 (b) (i), 14.1 (b) (ii) or 14.1 (b) (iii) of this Schedule are met; or
(c) the occupier or a person in management or control of the establishment has, in an application or other document given to the Secretary or in a document or information that must under a requirement these Orders or the occupier’s approved arrangement or a condition of that arrangement be made or given, made a statement:
(i) that is false, misleading, or incomplete; or
(ii) for which there is no sound basis for making the statement; or
(d) the occupier fails to provide such assistance to an auditor as is reasonably necessary to enable the auditor to perform an audit of the establishment; or
(e) the occupier fails to make available to an authorized officer a document that, under a requirement of these Orders or the occupier’s approved arrangement or a condition of that arrangement, the occupier is required to retain; or
(f) the person to whom the Secretary gives the approval of the approved arrangement ceases to be the person in charge of the operations to prepare processed food at the establishment.
Note 2 For penal provisions relating to requirements to give information or documents to an authorized officer or the Secretary see Part III, Division 7 of the Act.
Note 3 For requirements to retain documents see clause 11 of this Schedule.
Note 4 For the requirement to notify the Secretary of changes to persons in management or control etc see Division 4.4 of Part 4 of the Export Control (Prescribed Goods — General) Order 2005.
21.2 The Secretary may suspend or revoke the approval of an arrangement at the written request of the occupier.
21.3 The suspension or revocation of the approval of the arrangement may be:
(a) in full; or
(b) in part, in respect of:
(i) one or more of the processed foods prepared at the establishment; or
(ii) one or more of the stages of preparation of the food.
21.4 The suspension or revocation takes effect:
(a) when written notice of it is given to the person to whom the approval was given under clause 14.2; or
Notice of suspension or revocation Notice of suspension or revocation
Notice of suspension or revocation
22.1 If the Secretary suspends or revokes the approval of an arrangement, the Secretary must give the occupier written notice of:
(a) the reason for the suspension or revocation; and
(b) the occupier’s right to apply for reconsideration of the decision to suspend or revoke; and
(c) if the approval is suspended — the period of the suspension.
Note For reconsideration and review of the Secretary’s decision see Part 16 of the Export Control (Prescribed Goods — General) Order 2005. See further orders 98 and 99 of these Orders.
22.2 A period of suspension must not exceed 12 months and may be extended only if the total period does not exceed 12 months.
Revocation of suspended arrangement Revocation of suspended arrangement
Revocation of suspended arrangement
23.1 The Secretary may revoke an approval of an arrangement that is suspended despite the fact that the period of suspension has not expired.
23.2 The Secretary may revoke an arrangement that is suspended on grounds that are the same as or similar to the grounds for the suspension.
Termination Termination
Termination
24.1 An occupier may terminate the occupier’s approved arrangement:
(a) in full; or
(b) in part, in respect of:
(i) one or more of the processed foods prepared at the establishment; or
(ii) one or more of the stages of preparation of the food;
by giving the Secretary written notice of the termination.
24.2 The termination takes effect:
(a) 7 days after the notice is given to the Secretary; or
(b) on a later day specified in the notice.
Secretary may require the occupier to ta Secretary may require the occupier to take action
Secretary may require the occupier to take action
25.1 If the approval of an arrangement (or part of an arrangement) at an establishment:
(a) is suspended or revoked; or
(b) is terminated;
the Secretary may, by giving the occupier of the establishment a notice, require the occupier to take action within the period specified in the notice in respect of any of the following:
(c) any official marks held by the occupier;
(d) any export permits or government certificates the Secretary has issued or given to the occupier under these Orders;
(e) any processed food at the establishment.
25.2 The action referred to in subclause 25.1 must be action to ensure compliance by the occupier with one of more of the objectives specified in suborders 3.1 and 3.2.
Occupier must comply with notice Occupier must comply with notice
Occupier must comply with notice
26.1 An occupier who is given a notice under subclause 25.1 must take the action specified in the notice within the period specified.
Note A level 5 penal provision means a person who is guilty of the relevant offence is punishable by a fine of 50 penalty units, see Regulation 4 of the Export Control (Orders) Regulations 1982.
When an approved arrangement ceases to h When an approved arrangement ceases to have effect
When an approved arrangement ceases to have effect
27.1 An approval of an arrangement (or a part of an arrangement) ceases to have effect if the approval of the arrangement (or that part of the arrangement) is revoked or terminated.
Note For revocation or termination in part see subclause 21.3 and clause 24 of this Schedule.
27.2 An approval of an arrangement (or a part of an arrangement) ceases to have effect for the period of its suspension.
Provision of facilities and equipment Provision of facilities and equipment
Provision of facilities and equipment
1.1 Establishments used to prepare processed food must have the premises, facilities, equipment and vehicles that are necessary to ensure the preparation of processed food is conducted in accordance with the requirements of these Orders.
Note 1 Premises includes for example a ship, a building and any part of a building (eg fittings and fixtures) see section 3 of the Act.
Note 2 For the meaning of equipment and vehicle see order 8.
Note 3 For when Part 1 of this Schedule does not apply to catcher boats, registered fishing vessels and live fish packing establishments see Part 2 of this Schedule.
Construction of premises Construction of premises
Construction of premises
2.1 The premises and their construction must:
(a) facilitate the preparation of processed food that is fit for human consumption; and
(b) be fit for the purpose for which they are used; and
(c) have sufficient capacity for the maximum quantity of processed food prepared at the premises at any one time; and
(d) permit the premises to be effectively cleaned and, if necessary, sanitised if there is a risk they may cause contamination of processed food; and
(e) permit the premises to be effectively accessed, inspected and monitored; and
(f) not permit the harbourage of pests; and
(g) to the extent that is practicable:
Note For the meaning of construction, pest, sanitise and substance see order 8.
Construction must comply with plans and Construction must comply with plans and specifications
Construction must comply with plans and specifications
3.1 The construction of the premises and equipment must, in the case of registered establishments, comply with the plans and specifications in relation to which the Secretary registers the establishment.
Note For plans and specifications see Part 1 of Schedule 1.
3.2 Alterations or additions for which a proposal is required under section 4.20 of the Export Control (Prescribed Goods — General) Order 2005 must comply with the plans and specifications in relation to which approval for the proposal is given.
Immediate surrounds Immediate surrounds
Immediate surrounds
4.1 Areas immediately surrounding buildings, roads and other areas serving land based premises used to prepare processed food must:
(a) be paved, graded, landscaped or otherwise treated so as to minimise the risk of dust, pests or contaminants entering food handling areas; and
(b) be adequately drained.
Floors Floors
Floors
5.1 Floors must be constructed in a way that is appropriate for the preparation of processed food at the premises.
5.2 Floors (including stairs, platforms and the like) in food handling areas, areas used for cleaning and sanitising and areas for personal hygiene must:
(a) be able to be effectively cleaned and if necessary, sanitised if there is a risk they may cause contamination of processed food; and
(c) allow for adequate drainage; and
(d) not permit the harbourage of pests; and
(e) to the extent that is practicable:
Note For the meaning of food handling area see order 8.
5.3 Subclause 5.2 does not apply to floors in food handling areas on ships that are not enclosed.
5.4 Subclause 5.2 does not apply to areas for cleaning vehicles.
5.5 The floors of areas for cleaning vehicles must:
(a) be able to be effectively cleaned; and
(b) have impervious surfaces; and
(c) be drained.
Walls and ceilings Walls and ceilings
Walls and ceilings
6.1 Walls and ceilings must:
(a) be provided where they are necessary to protect processed food or ingredients from contamination; and
(b) be constructed in a way that is appropriate for the activities conducted at the premises.
6.2 Walls and ceilings in food handling areas and in areas used for cleaning and sanitising and for personal hygiene must:
(a) be able to be effectively cleaned and if necessary, sanitised if there is a risk they may cause contamination of processed food; and
(c) to the extent that is practicable:
(iii) minimise the accumulation of contaminating substances (including condensation).
6.3 Subclause 6.2 does not apply to areas for cleaning vehicles.
6.4 The walls and ceilings of areas for cleaning vehicles must:
(a) be able to be effectively cleaned; and
(b) have impervious surfaces.
Fixtures, fittings and equipment — gener Fixtures, fittings and equipment — general requirement
Fixtures, fittings and equipment — general requirement
7.1 The fixtures, fittings and equipment (including in refrigeration chambers and storage areas) must:
(a) facilitate the preparation of processed food that is fit for human consumption; and
(b) be fit for the purpose for which they are used; and
(c) have sufficient capacity for the maximum quantity of processed food prepared at any one time using the fixtures, fittings and equipment concerned.
Note 1 For the meaning of refrigeration chamber and storage area see order 8.
Note 2 For example refrigeration chambers need to have adequate capacity. For validation of refrigeration chambers see clause 12 of Schedule 4.
Construction of fixtures, fittings and e Construction of fixtures, fittings and equipment
Construction of fixtures, fittings and equipment
8.1 The fixtures, fittings and equipment must be constructed so that:
(a) they do not cause contamination of processed food; and
(b) they are able to be easily and effectively cleaned, and if necessary, sanitised if there is a risk they may cause contamination of processed food; and
(c) adjacent floors, walls, ceilings and other surfaces are able to be easily and effectively cleaned; and
(d) they can be effectively accessed, inspected and monitored; and
(e) to the extent practicable they:
(ii) do not permit the entry or harbourage of pests; and
8.2 Food contact surfaces of fixtures, fittings and equipment must:
(a) be able to be easily and effectively cleaned and, if necessary sanitised, if there is a risk they may cause contamination of processed food; and
(c) be constructed of materials that do not contaminate processed food.
Note 1 Equipment includes implements but does not include vehicles used to transport processed food, see order 8. However equipment does include things used to handle and load processed food during transport. For requirements for vehicles used to transport processed food clause 9 of this Schedule.
Note 2 For the meaning of food contact surface see order 8.
Food carrying compartments, container sy Food carrying compartments, container system units and vehicles
Food carrying compartments, container system units and vehicles
9.1 Container system units and the food carrying compartments of vehicles used for the transport of processed food must be designed and constructed:
(a) to protect processed food if there is a likelihood of its being contaminated during transport; and
(b) so that they are able to be effectively cleaned.
9.2 Food contact surfaces of:
(a) container system units; and
(b) the food carrying compartments referred to in subclause 9.1;
must be constructed so that they are able to be effectively cleaned and if necessary sanitised.
9.3 Container system units and the food carrying compartments of vehicles used for the transport of chilled or frozen processed food must be effectively insulated, constructed and equipped to maintain the food at the temperatures required in clause 28 of Schedule 5.
9.4 The food carrying compartment need not comply with subclauses 9.1 or 9.3 if the processed food is transported in a container system unit that meets the requirements of subclause 9.1 or 9.3 (as the case may be).
Note 1 For the meaning of container system unit, food carrying compartment and vehicle see order 8.
Note 2 Clause 9 applies to all food carrying compartments used to transport processed food including live fish.
Note 3 For transport see further clause 4 of Schedule 4, Parts 5 and 6 of Schedule 5 and clause 14 of Schedule 8.
Measuring devices Measuring devices
Measuring devices
10.1 Measuring instruments that are relevant to whether the requirements of these Orders are complied with must:
(a) enable measurements to be accurately calculated using standard units of measurement; and
(b) meet levels of tolerance that are appropriate to the measurements taken; and
(c) be able to be easily read.
Note For the calibration of measuring devices see clause 11 of Schedule 4.
10.2 Temperature measuring devices must be able to measure the temperature of processed food to an accuracy of +/-1°C.
10.3 Refrigeration chambers and other equipment used for controlling the temperature of processed food must have a readily accessible temperature measuring device.
Note 1 For guidance on Australian legal units of measurements and tolerances, reference may be had to the National Measurement Act 1960. For the application of the National Measurement Act 1960 in relation to contracts, dealings or transactions made or entered into in connection with the exportation of goods, see section 13 of that Act.
Note 2 For validation of refrigeration chambers see clause 12 of Schedule 4.
Storage facilities for items other than Storage facilities for items other than processed food
Storage facilities for items other than processed food
11.1 The premises must have adequate facilities for the storage of items that could contaminate processed food, including chemicals, clothing and personal belongings.
11.2 The facilities must be located where there is no risk of stored items contaminating processed food.
Division II Cleaning and sanitising facilities
Cleaning and sanitising premises and equ Cleaning and sanitising premises and equipment
Cleaning and sanitising premises and equipment
12.1 The premises must have appropriate facilities for cleaning and sanitising premises and equipment.
12.2 Facilities for cleaning and sanitising equipment in contact with processed food must be located where they can be readily accessed by food handlers engaged in activities that require the cleaning and sanitising of the equipment.
Note 1 For the meaning of food handler see order 8.
Note 2 For floors, walls and ceilings in areas used for cleaning see clauses 5 and 6 of this Schedule.
Note 3 See further clauses 8 and 9 of Schedule 4 for requirements for the use and storage etc of chemicals and other hazardous substances.
Hand washing facilities Hand washing facilities
Hand washing facilities
13.1 The premises must have handwashing facilities.
13.2 The hand washing facilities must be located near or adjacent to areas where food handlers work if there is a risk that their hands could be a source of contamination of processed food or ingredients.
13.3 The hand washing facilities must:
(a) have an adequate supply of warm, or hot and cold potable water over a sink; and
(b) have a suitable hand sanitising preparation; and
(c) have suitable and sufficient hygienic means of drying hands; and
(d) have non hand operated taps (other than in an establishment preparing milk and milk products); and
(e) be clearly designated for the sole purpose of washing hands, arms and face.
Note For when catcher boats, registered fishing vessels and live fish packing establishments need not comply with the requirements of this clause see Part 2 of this Schedule.
Division III Amenities
Amenities Amenities
Amenities
14.1 The premises must have adequate and conveniently located amenities for the use of food handlers.
Note For the meaning of amenities see order 8.
14.2 The amenities must:
(a) be physically separated from food handling areas and must not open directly onto these areas; and
(b) be well lit and ventilated; and
(c) not be a source of contamination of processed food.
Note For the removal and storage of waste see clauses 16 and 17 of this Schedule.
14.3 Hand washing facilities must be provided near toilets.
14.4 The hand washing facilities must have:
(a) an adequate supply of warm, or hot and cold potable water over a sink; and
(b) a suitable hand sanitising preparation; and
(c) suitable and sufficient hygienic means of drying hands.
Note 1 Contrast requirements in clause 13 of this Schedule for hand washing facilities.
Note 2 For when catcher boats, registered fishing vessels and live fish packing establishments need not comply with the requirements of this clause see Part 2 of this Schedule.
Division IV Essential services
General requirement General requirement
General requirement
15.1 The premises must have the essential services that are necessary to ensure the preparation of processed food for export as food that is fit for human consumption.
Note For the meaning of essential services see order 8.
Effluent and waste Effluent and waste
Effluent and waste
16.1 The premises must have a sewerage and waste system that:
(a) effectively disposes of and, if necessary, treats all sewage and waste, including during peak load; and
(b) prevents the sewage or waste polluting the establishment’s water supply or contaminating processed food; and
(c) ensures that discharge:
(i) is contained; and
(ii) is directed to the drainage system.
Note 1 Subparagraph 16.1 (c) (ii) would require for example that discharge from refrigeration be directed to the drainage system.
Note 2 For when catcher boats, registered fishing vessels and live fish packing establishments need not comply with the requirements of subparagraph 16.1 (c) (ii) see Part 2 of this Schedule.
Facilities for storage of waste and ined Facilities for storage of waste and inedible material
Facilities for storage of waste and inedible material
17.1 The premises must have facilities for the separation and storage of waste and inedible material prior to its removal from the premises that adequately contain the volume and type of waste and inedible material on the premises.
17.2 The facilities and containers used for the waste and inedible material must:
(a) prevent access to waste or inedible material by pests; and
(b) prevent the waste or inedible material polluting the water supply or contaminating processed food; and
(c) be clearly identified as for use for storage of waste and inedible material.
Lighting Lighting
Lighting
18.1 The premises must have a lighting system that provides sufficient natural or artificial light for the activities conducted at the premises.
Note See for example AS 1680 Part 1-1990 Interior lighting: General principles and recommendations and AS/NZ 1680.2.4 1997 Industrial tasks and Processes.
18.2 The lighting system must not be a source of contamination.
Note Subclause 18.2 would require for example that light bulbs and lighting fixtures suspended over processed foods be protected.
Ventilation Ventilation
Ventilation
19.1 The premises must have adequate ventilation (natural or mechanical):
(a) to effectively minimise the risk of airborne contamination (such as steam, smoke and condensation) of processed food; and
(b) where appropriate, to control ambient temperature.
Water supply Water supply
Water supply
20.1 The premises must have a supply of potable water that is available for use at a volume, pressure and temperature that is adequate for the purposes for which the water is used.
Note 1 For the meaning of potable see order 8.
Note 2 For operational requirements for the use of water see clause 14 to 19 of Schedule 4.
20.2 Potable and non potable water must be supplied in separate lines (including outlets) that are readily identifiable as being for use for potable or non potable water (as the case may be).
20.3 Re-circulated water must have a separate distribution system which can be readily identified.
Part 2 Application of Schedule: catcher boats, registered fishing vessels and live fish packing establishments
Catcher boats Catcher boats
Catcher boats
21.1 Part 1 of this Schedule (other than clause 1) does not apply to a catcher boat.
21.2 Despite subclause 21.1 Part 1 of this Schedule applies to a catcher boat if the catcher boat is a registered fishing vessel.
21.3 Catcher boats and their construction must:
(a) be appropriate for the activities for which the catcher boat is used; and
(b) be able to be effectively cleaned; and
(c) to the extent practicable not permit the entry or harbourage of pests; and
(d) have the necessary facilities and equipment to:
(i) prevent the contamination of fish during preparation and transport on the catcher boat; and
(ii) ensure the requirements for placing the fish under temperature controls are met.
Note For requirements to place fish under temperature controls see Part 2 of Schedule 5.
22.1 On written application by the occupier of a registered fishing vessel the Secretary may by written notice given to the occupier specify that one or more requirements of any of the following clauses of this Schedule do not apply to the registered fishing vessel:
(a) clause 13;
(b) clause 14;
(c) subparagraph 16.1 (c) (ii).
Note For the meaning of registered fishing vessel see order 8.
22.2 The Secretary must not give the notice under subclause 22.1 unless the Secretary is satisfied that:
(a) it would be impracticable for the registered fishing vessel to comply with the requirement; and
(b) non compliance with the requirement does not jeopardise the fitness for human consumption of fish prepared on the registered fishing vessel.
22.3 The Secretary may amend or revoke the notice by giving the occupier of the registered fishing vessel a further written notice.
Live fish packing establishments Live fish packing establishments
Live fish packing establishments
23.1 Areas of an establishment used solely for the following purposes:
(a) to pack live fish (other than shellfish);
(b) to grow and hold live fish prior to packing at the establishment;
are exempt from the requirements of paragraph 13.3 (d) of this Schedule.
Note For the meaning of shellfish see order 8.
23.2 On written application by the occupier of an establishment referred to in subclause 23.1 the Secretary may by written notice given to the occupier specify that one or more requirements of any of the following clauses of this Schedule do not apply to the establishment:
(a) clause 13 (other than paragraph 13.3 (d));
(b) clause 14;
(c) subparagraph 16.1 (c) (ii).
23.3 The Secretary must not give the notice under subclause 23.2 unless the Secretary is satisfied that:
(a) it would be impracticable for the establishment to comply with the requirement; and
(b) non compliance with the requirement does not jeopardise the fitness for human consumption of fish for export as food prepared at the establishment.
23.4 The Secretary may amend or revoke the notice by giving the occupier of the establishment a further written notice.
Hygiene control program Hygiene control program
Hygiene control program
1.1 A program of operational controls for the hygienic preparation of processed food must be documented and in place at premises used to prepare processed food.
Note 1 Premises includes a ship see section 3 of the Act.
Note 2 See the requirements in clause 2 of Schedule 2 for how the approved arrangement must document the controls used to ensure that the requirements of these Orders are met.
Standard of cleanliness Standard of cleanliness
Standard of cleanliness
2.1 The premises must be maintained to a standard of cleanliness where there is no accumulation of:
(a) garbage, except in garbage containers; or
(b) recycled matter, except in recycling containers; or
(c) food waste; or
(d) dirt; or
(e) grease; or
(f) other visible matter that could contaminate processed food.
2.2 Equipment used for the preparation of processed food must be maintained to a standard of cleanliness where there is no accumulation of:
(a) food waste; or
(b) dirt; or
(c) grease; or
(d) other visible matter that could contaminate processed food.
Note Equipment includes implements but does not include vehicles used to transport processed food, see order 8. For requirements for vehicles used to transport processed food see clause 4 of this Schedule.
Requirement to clean and maintain Requirement to clean and maintain
Requirement to clean and maintain
3.1 The following must be cleaned and sanitised whenever it is necessary to do so to prevent the contamination of processed food:
(a) floors, walls, ceilings, other fixtures and fittings in the following areas:
(i) food handling areas; and
(ii) areas used for cleaning and sanitising equipment, vehicles and protective clothing;
(iii) personal hygiene amenities; and
(b) equipment and food contact surfaces.
3.2 Equipment used for killing, bleeding, skinning or eviscerating a crocodile or removing meat from its carcase must be cleaned and sanitised whenever necessary to ensure that there is no cross contamination between carcases and carcase parts from different crocodiles.
3.3 Subclauses 3.1 and 3.2 do not apply to a single-use item that is disposed of after use or when contaminated.
Note For the meaning of single-use item see order 8.
3.4 The surrounds of land based premises used to prepare processed food must be cleaned to the extent necessary to ensure the surrounds are not a source of contamination of processed food.
3.5 Premises and equipment must be maintained in a good state of repair and working order to the extent necessary to facilitate the hygienic preparation of the food.
Vehicles etc for the transport of proces Vehicles etc for the transport of processed food
Vehicles etc for the transport of processed food
4.1 The following must be cleaned and sanitised whenever it is necessary to do so to prevent the contamination of processed food:
(a) container system units, food carrying compartments and vehicles used for the transport of processed food; and
(b) equipment used to handle food during loading and transport.
Note For the meaning of container system unit, food carrying compartment, and vehicle see order 8.
4.2 The following must be maintained in a good state of repair and working order to the extent necessary to ensure the fitness for human consumption of processed food is not adversely affected during transport:
(a) container system units, food carrying compartments and vehicles used for the transport of processed food; and
(b) equipment used to handle food during loading and transport.
5.1 Effective measures must be taken to ensure processed food is not contaminated by environmental contamination (including air borne or water borne contamination).
Exclusion of animals Exclusion of animals
Exclusion of animals
6.1 Live animals (other than animals for processing as processed food at the premises) must not be permitted to enter premises used for the preparation of processed food.
6.2 Subclause 6.1 does not apply to the entry of guard dogs in the perimeter area provided the area is not used:
(a) as a food handling area; or
(b) for cleaning and sanitising equipment or for personal hygiene.
Pests Pests
Pests
7.1 To the extent practicable, the entry of pests into premises and equipment used for the preparation of processed food must be prevented.
7.2 The harbourage of pests in the premises and equipment must be prevented.
Hazardous substances Hazardous substances
Hazardous substances
8.1 Hazardous substances must:
(a) not contaminate processed food; and
(b) be stored in containers that:
(i) are labelled with the name of the substance and a warning about its toxicity and use; and
(ii) are not used for any purpose other than the storage of hazardous substances.
Use and storage of substances which coul Use and storage of substances which could cause contamination
Use and storage of substances which could cause contamination
9.1 Except when necessary for hygienic or preparation purposes, substances which could contaminate processed food must not be used or stored in food handling areas.
Division II Hygiene requirements for processing
Measures to prevent contamination Measures to prevent contamination
Measures to prevent contamination
10.1 Effective measures must be taken to:
(a) prevent the contamination of processed food for export as food and its ingredients by any thing or activity; and
(b) minimise the growth in processed food for export as food and its ingredients of pathogens that could adversely affect the fitness for human consumption of the food given the conditions under which it is to be stored, handled and transported; and
(c) ensure that the fitness for human consumption of:
(i) processed food for export as food; and
(ii) ingredients;
are not otherwise adversely affected.
Note 1 For the meaning of ingredient see order 8.
Note 2 Paragraph 10.1 (a) requires for example that processed food and ingredients not be contaminated by:
Note: (a) procedures for the preparation of processed food; or
Note: (b) cleaning, sanitising or maintenance activities; or
Note: (c) handling or use etc of equipment, ingredients or packaging materials.
Note 3 Paragraph 10.1 (a) also requires for example that processed food and ingredients not be cross contaminated by animal food or processed food that is unfit for human consumption. See further Part 7 of Schedule 5.
10.2 Without limiting the generality of subclause 10.1 effective measures must be taken to prevent processed food that is not ready for human consumption contaminating processed food that is ready for human consumption.
Calibration of measuring instruments Calibration of measuring instruments
Calibration of measuring instruments
11.1 Measuring instruments that are relevant to whether the requirements of these Orders are complied with must be accurately calibrated.
Refrigeration chambers Refrigeration chambers
Refrigeration chambers
12.1 The approved arrangement must validate that refrigeration chambers achieve the applicable temperature controls for chilling, freezing and maintaining processed food, taking account of the maximum quantity of processed food to be chilled, frozen or maintained at any one time using the chamber.
Ingredients Ingredients
Ingredients
13.1 Ingredients must:
(a) be fit for the purpose for which they are used; and
(b) be labelled, stored and handled in a way that ensures their identity can be ascertained.
Note For requirements for ingredients to comply with product standards see Schedule 6.
Water must be potable Water must be potable
Water must be potable
14.1 All water used at premises used to prepare processed food (including reused water, recirculated water and ice) must be potable unless:
(a) the water is only used in circumstances where there is no risk of the water coming into contact with or contaminating processed food; and
(b) the approved arrangement expressly provides for the use of the non-potable water in the circumstances in which it is used.
Note 1 For the meaning of potable water see order 8.
Note 2 Paragraph 14.1 (a) covers a risk of water contaminating processed food even if it does not come into contact with the food.
Note 3 For requirements for potable water for handwashing facilities and amenities see subclauses 13.3 and 14.4 of Schedule 3.
Microbial limits Microbial limits
Microbial limits
15.1 Water required under these Orders to be potable must not contain any Escherichia coli per 100 millilitres.
15.2 The examination of water for the purpose of verifying whether the requirements of subclause 15.1 are complied with must in the case of milk and milk products be performed by a laboratory accredited by NATA to perform the examination.
Note 1 For verification see subclause 3.7 and clause 6 of Schedule 2.
Note 2 For when the approved arrangement must identify any applicable importing country requirements for the examination of water, see paragraph 2.1 (c) of Schedule 2.
Note 3 For guidance see the Australian Drinking Water Guidelines 1996 jointly published by the National Health and Medical Research Council and the Agriculture and Resource Management Council of Australia and New Zealand. For these guidelines see the NHMRC website http://www.health.gov.au/nhmrc.
Note 4 For when the Secretary may give the occupier a notice enabling the use of another laboratory to perform the examination, see alternative compliance under order 86.
Note 5 For special requirements for water for depuration and for wet storage of live fish see Divisions IV and V of Part 1 of Schedule 5. For requirements for water used to cool canned product see clause 35 of Schedule 5.
Use of clean sea water Use of clean sea water
Use of clean sea water
16.1 Notwithstanding subclause 14.1 of this Schedule clean sea water may be used at premises used to prepare fish (other than crocodiles) if the applicable approved arrangement expressly provides for the use of the clean sea water in the circumstances in which it is used.
16.2 The clean sea water must not adversely affect the fitness for human consumption of the fish.
Note 1 For special requirements for water for depuration and for wet storage of live fish see Divisions IV and V of Part 1 of Schedule 5.
Note 2 For verification see subclause 3.7 and clause 6 of Schedule 2.
The supply of potable and non potable wa The supply of potable and non potable water
The supply of potable and non potable water
17.1 The reticulation system must prevent the back siphonage of used or contaminated water.
17.2 Non potable water reticulation systems for an establishment must not contaminate the establishment’s potable and water reticulation systems.
Steam Steam
Steam
18.1 Steam used in contact with processed food or food contact surfaces must be free from substances which may:
(a) be hazardous to health; or
(b) contaminate the food.
Note See Standard 1.3.3 of the Food Standards Code for requirements for processing aids and see further Schedule 6.
Compressed air and other gases Compressed air and other gases
Compressed air and other gases
19.1 Compressed air or other processing gases that come into contact with processed food must be free from substances which may:
(a) be hazardous to health; or
(b) contaminate the food.
Note See Standard 1.3.3 of the Food Standards Code for requirements for processing aids and see further Schedule 6.
Division III Personal hygiene and health requirements
Meaning of food handling area Meaning of food handling area
Meaning of food handling area
20.1 In this Division food handling area means an area (including a refrigeration chamber or storage area) used for exposed processed food or ingredients.
Note Contrast the meaning of food handling area in order 8.
Food borne diseases Food borne diseases
Food borne diseases
21.1 A person known or suspected to be suffering from, or to be a carrier of a disease likely to be transmitted through processed food must not work in any food handling area in any capacity in which there is any risk of such a person directly or indirectly contaminating the food with pathogens.
21.2 A person known or suspected to be suffering from, or to be a carrier of a disease likely to be transmitted through processed food must immediately report their disease to a person in management or control of an establishment engaged in the preparation of processed food if:
(a) the person is at the establishment; or
(b) the person suspects that the disease may have resulted in the contamination of processed food at the establishment.
Note 2 For the occupier’s liability if the requirements of this Division are not complied with see suborder 39.1.
Conditions and injuries Conditions and injuries
Conditions and injuries
22.1 A person who has a condition and who handles processed food must take all practical measures to prevent the condition resulting in contamination of processed food.
Note For the meaning of condition see order 8.
22.2 Coverings used for conditions must:
(a) be effective in preventing contamination of processed food; and
(b) be waterproof, firmly secured and conspicuous in colour.
Personal cleanliness Personal cleanliness
Personal cleanliness
23.1 A person in a food handling area must:
(a) take all practicable measures to ensure his or her body, anything from his or her body and anything he or she is wearing does not contaminate processed food or food contact surfaces; and
(b) take all practicable measures to prevent unnecessary contact with processed food; and
(c) ensure his or her outer clothing is of a level of cleanliness that is appropriate for the handling of processed food that is being conducted.
23.2 A person in a food handling area must not engage in:
(a) behaviour which could result in contamination of processed food, such as eating, smoking, chewing, spitting, sneezing or coughing over unprotected processed food or food contact surfaces; or
(b) any other behaviour likely to adversely affect the fitness for human consumption of processed food.
Note 1 For guidance see Standard 3.2.2 of the Food Standards Code.
Note 2 A person in a food handling includes a visitor to the area.
23.3 A person engaged in handling food must wash (using a sanitising agent) and dry thoroughly his or her hands:
(a) on entering the food handling area; and
(b) immediately after using the toilet; and
(c) after touching the nose or mouth; and
(d) after handling contaminated material; and
(e) whenever necessary to avoid contaminating the food.
Note The wearing of gloves does not remove the obligation to wash hands.
23.4 A person engaged in skinning or eviscerating a crocodile or removing meat from its carcase must wash (using a sanitising agent) and dry thoroughly his or her hands between each crocodile carcase.
Personal effects and clothing Personal effects and clothing
Personal effects and clothing
24.1 Personal effects and clothing must not be stored in food handling areas.
Note For storage facilities for personal effects and clothing see clause 11 of Schedule 3.
Protective clothing Protective clothing
Protective clothing
25.1 A person in a food handling area must at all times wear protective clothing (including a hair covering) and footwear.
25.2 The protective clothing and footwear must:
(a) be suitable (including appropriately designed) to prevent anything from the person’s body contaminating processed food; and
(b) be maintained in good repair and in a clean and sanitary condition so as not to present a risk of contamination of processed food or food contact surfaces.
Part 2 Application of Schedule: catcher boats
Presence of potentially harmful substanc Presence of potentially harmful substances
Presence of potentially harmful substances
1.1 Processed food for export as food must not be sourced from or washed using water from areas where there are reasonable grounds to believe that any of the following are present and could result in unacceptable levels in the food:
(a) potentially harmful pathogens; or
(b) potentially harmful substances such as pesticides, fungicides, heavy metals, natural toxicants or other contaminants.
Sourcing processed food Sourcing processed food
Sourcing processed food
2.1 Processed food for use in preparing processed food must be sourced only from:
(a) a registered establishment; or
(b) an unregistered establishment in relation to which an approval given by the Secretary in accordance with clause 8 of Schedule 1 has effect; or
(c) an establishment to which, under orders 23 to 26, these Orders do not apply or an unregistered establishment that is a catcher boat.
2.2 Subclause 2.1 applies only to processed food sourced from establishments in Australia.
Division II Sourcing and handling eggs
Sourcing eggs Sourcing eggs
Sourcing eggs
3.1 Eggs sourced directly from an establishment engaged in the collection, storing and chilling of eggs (including an establishment to which these Orders do not apply) must be sourced only from an establishment with:
(a) disease management controls in place that ensure that only healthy flocks are used for laying; and
(b) effective measures in place that ensure:
(i) flocks for laying are not given feed or treated with a substance that could adversely affect the fitness for human consumption of eggs; and
(ii) the collection of eggs is done under conditions that ensure the fitness for human consumption of the eggs is not adversely affected; and
(iii) as soon as practicable after laying, the eggs are placed under temperature controls that minimise the growth of pathogens that could adversely affect the fitness for human consumption of the eggs.
Note For when these Orders do not apply to establishments engaged in storing and chilling of whole eggs at the premises at which the eggs are laid see order 23. For the application of these Orders see also the meaning of preparation in section 3 of the Act.
Cracked eggs Cracked eggs
Cracked eggs
4.1 Cracked eggs must:
(a) be segregated from uncracked eggs; and
(b) not contaminate other eggs.
Note For the meaning of cracked egg see order 8.
4.2 If the membrane of a cracked egg is leaking, the contents of the egg must be dealt with as processed food that is not for export as food.
Note 1 For identification and segregation requirements for processed food that must be dealt with as not for export as food see clause 50 of this Schedule.
Note 2 Cracked eggs cannot be exported as a whole egg, see clause 6 of this Schedule.
Cleaning and cracking eggs Cleaning and cracking eggs
Cleaning and cracking eggs
5.1 The cleaning and cracking of eggs must be done in a way that minimises the risk of contamination of their contents.
Whole eggs Whole eggs
Whole eggs
6.1 Eggs for export as food as whole eggs must have shells that:
(a) are not cracked or broken; and
(b) are free from stain, dirt, blood, faecal matter and any foreign matter.
Note For the meaning of whole egg see order 8.
Fertilised eggs Fertilised eggs
Fertilised eggs
7.1 Fertilised eggs must be dealt with as processed food that is not for export as food.
Note 1 For identification and segregation requirements for processed food that must be dealt with as not for export as food see clause 50 of this Schedule.
Note 2 For requirements for pasteurisation or other treatments for eggs see Division III of Part 3 of this Schedule.
Division III Harvesting and sourcing fish
Dead or diseased fish and species affect Dead or diseased fish and species affected by ciguatoxin
Dead or diseased fish and species affected by ciguatoxin
8.1 Fish that:
(a) are dead at the time of harvest; or
(b) are diseased;
must not be prepared for export.
Note 1 For the meaning of diseased and fish see order 8.
Note 2 For notification if animals from which processed food is derived are suspected of being affected with a notifiable disease see clause 10 of Schedule 2.
Note 3 Fish that are crocodiles are treated separately see Division VI of this Part.
8.2 All practical measures for harvesting fish of a species that can be affected by ciguatoxin (being measures that are necessary to minimise the risk of the harvest and preparation for export of fish affected by ciguatoxin) must be taken.
Note Practical measures could for example include controls on fish size and location of harvest.
Shellfish harvest areas Shellfish harvest areas
Shellfish harvest areas
9.1 Shellfish for export as food must not be harvested from:
(a) a Prohibited area for the purposes of the Australian Shellfish Quality Assurance Program — Export Standards; or
(b) any other area in contravention of a requirement for harvesting from that area that is specified under the Australian Shellfish Quality Assurance Program — Export Standards.
Note For the meaning of Australian Shellfish Quality Assurance Program — Export Standards and shellfish see order 8.
9.2 Subclause 9.1 does not apply to:
(a) scallops if the final product is only the adductor muscle; and
(b) shellfish harvested from off-shore locations;
unless the off-shore location is classified as an Off-shore harvesting area in accordance with the Australian Shellfish Quality Assurance Program — Export Standards.
Segregation of shellfish Segregation of shellfish
Segregation of shellfish
10.1 Shellfish must:
(a) be identified by lot; and
(b) be kept separate from shellfish from any other lot.
10.2 Shellfish must not be held in the same storage tank as other fish.
10.3 In subclause 10.1:
lot means a single species of shellfish harvested from a particular harvesting area and designated by a single harvest record number.
Sourcing fish from establishments to whi Sourcing fish from establishments to which these Orders do not apply and catcher boats
Sourcing fish from establishments to which these Orders do not apply and catcher boats
11.1 Fish (other than crocodiles) for export as food that are sourced directly from:
(a) an establishment to which under order 24 these Orders do not apply; or
(b) an unregistered establishment that is a catcher boat that need not be registered under order 35;
must be sourced only from an establishment:
(c) with disease management controls in place that ensure that only healthy fish are harvested for food; and
(d) with effective measures in place to ensure:
(i) the fish are not given feed or treated with a substance that could adversely affect the fitness for human consumption of the fish; and
(ii) the harvesting, growing, relaying, killing, bleeding, gilling, heading, gutting, sorting, grading, washing and icing for transport of the fish is done under conditions that ensure the fitness for human consumption of the fish is not adversely affected; and
(iii) as soon as practicable after harvesting, the fish are placed under temperature controls that minimise the growth of pathogens that could adversely affect the fitness for human consumption of the fish; and
(e) in the case of shellfish — where the harvester is given approval by the relevant State or Territory authority responsible for regulating the growing and harvesting of the shellfish (however this is expressed).
Growing and harvesting at establishments Growing and harvesting at establishments to which these Orders apply
Growing and harvesting at establishments to which these Orders apply
12.1 Fish harvested at an establishment to which these Orders apply must:
(a) be healthy at the time of harvest; and
(b) not be fed or treated with a substance that could adversely affect the fitness for human consumption of the fish; and
(c) be harvested, grown, held, killed and otherwise prepared under conditions that ensure the fitness for human consumption of the fish is not adversely affected; and
(d) in the case of shellfish — must be harvested only by a person who is given approval by the relevant State or Territory authority responsible for regulating the growing and harvesting of the shellfish (however this is expressed).
Note For the requirement to place the fish under temperature controls see Part 2 of this Schedule.
Division IV Depuration of shellfish
When depuration is required When depuration is required
When depuration is required
13.1 Shellfish must be depurated unless they are sourced:
(a) from an area in an open status that is classified for the purposes of the Australian Shellfish Quality Assurance Program — Export Standards as:
(i) an Approved, Conditional Approved or Off-shore harvesting area; or
(ii) an Approved Remote area; or
(b) from a fishery located off-shore.
Note For the meaning of depuration and off-shore see order 8.
Shellfish for depuration Shellfish for depuration
Shellfish for depuration
14.1 Shellfish for depuration must be clean and practically free of mud and weed.
14.2 Depurated shellfish must be kept separate from undepurated shellfish.
Water used for depuration Water used for depuration
Water used for depuration
15.1 Water used for depuration must:
(a) be practically free from turbidity; and
(b) be of a salinity, temperature, dissolved oxygen level and pH necessary for the normal physiological functioning of the shellfish.
15.2 Unless water for depuration is sourced from an area in an open status that is classified for the purposes of the Australian Shellfish Quality Assurance Program — Export Standards as:
(a) an Approved or Conditional Approved harvesting area; or
(b) an Approved Remote area;
the water must be treated so that it does not contain detectable levels of the coliform group per 100ml.
Note This provision requires for example the treatment of water from an area that is classified for the purposes of the Australian Shellfish Quality Assurance Program — Export Standards as a Restricted or Conditional Restricted harvesting area when in an open status.
Depuration must be effective Depuration must be effective
Depuration must be effective
16.1 The depuration of the shellfish must achieve an effective reduction of pathogens in the shellfish.
16.2 Subclause 16.1 is taken to be complied with if the Escherichia coli is reduced to the applicable level specified in Standard 1.6.1 of the Food Standards Code.
16.3 Subclause 16.2 does not preclude other methods of validation of compliance with subclause 16.1.
16.4 Shellfish must be depurated for at least 36 hours and if any interruption occurs, the process of depuration must be restarted.
16.5 Sufficient water must be provided in a manner that accomplishes effective depuration.
Division V Wet storage of shellfish
Wet storage Wet storage
Wet storage
17.1 The fitness for human consumption of shellfish must be maintained during wet storage.
17.2 Shellfish must:
(a) be clean prior to being placed in a wet storage tank; and
(b) be handled and stored in such a manner that their physiological activity is not adversely affected prior to or during wet storage.
17.3 Unless water for the wet storage of shellfish is sourced from an area in an open status that meets the Approved classification criteria under Australian Shellfish Quality Assurance Program — Export Standards the water must be treated so that it does not contain detectable levels of the coliform group per 100ml.
Note The Approved classification criteria apply to the Approved or Conditional Approved harvest areas and the Approved Remote area. This provision requires for example the treatment of water from an area that is classified for the purposes of the Australian Shellfish Quality Assurance Program — Export Standards as a Restricted or Conditional Restricted harvesting area when in an open status.
17.4 Water used for the wet storage of shellfish must not result in the contamination of the shellfish.
17.5 If a multiple tank system with a common water supply is used for the wet storage, water from a tank containing fish other than shellfish must be effectively disinfected before entering a tank containing shellfish.
Division VI Sourcing, killing and initial processing of crocodiles
Sourcing crocodiles and crocodile meat Sourcing crocodiles and crocodile meat
Sourcing crocodiles and crocodile meat
18.1 The following:
(a) crocodiles for slaughter for crocodile meat; and
(b) crocodile meat;
that are sourced directly from an establishment engaged in growing, killing or bleeding of crocodiles (including from an establishment to which these Orders do not apply) must be sourced only from an establishment with:
(c) disease management controls in place to ensure only healthy animals are killed for crocodile meat; and
(d) effective measures in place to ensure:
(i) crocodiles are not given feed or treated with a substance that could adversely affect the fitness for human consumption of crocodile meat derived from the crocodiles; and
(ii) the killing of crocodiles and bleeding is done under conditions that ensure the fitness for human consumption of the crocodile meat is not adversely affected; and
(iii) as soon as practicable after killing the crocodile from which the crocodile meat is derived, the meat is placed under temperature controls that minimise the growth of pathogens that could adversely affect the fitness for human consumption of the meat.
Note 1 For the meaning of crocodile meat see order 8.
Note 2 For when these Orders do not apply to establishments engaged in killing and bleeding crocodiles see order 25.
Note 3 See also requirements for the killing of crocodiles in clause 19 of this Schedule and the temperature controls for crocodile meat in Part 2 of this Schedule.
Killing, skinning, evisceration and remo Killing, skinning, evisceration and removal of meat
Killing, skinning, evisceration and removal of meat
19.1 The following must not be killed for processed food for export as food:
(a) moribund or diseased crocodiles;
(b) crocodiles fed or treated with a substance referred to in subparagraph 18.1 (d) (i) of this Schedule;
(c) crocodiles rejected for slaughter for human consumption.
Note For the meaning of diseased see order 8.
19.2 The killing, bleeding, skinning and evisceration of crocodiles and the removal of their meat must be done in accordance with procedures that minimise or eliminate the risk of contamination of crocodile meat.
Note For guidance on how to comply with this provision see the Australian Standard for Hygienic Production of Crocodile Meat For Human Consumption. For example feed should be withheld from crocodiles at least 2 days before they are killed. Localised abscesses encountered during skinning should be removed by trimming.
19.3 During skinning, evisceration and the removal of meat there must be no contact between the carcases and carcase parts of different crocodiles.
19.4 Crocodile meat for export as food must not be contaminated by:
(a) crocodile carcases and carcase parts that are not washed, skinned and eviscerated; or
(b) external crocodile skin surfaces or by the contents of the gut, oesophagus and cloaca; or
(c) other foreign matter.
Post mortem controls Post mortem controls
Post mortem controls
20.1 Effective measures must be taken to ensure:
(a) an accurate post mortem disposition can be applied to all crocodile carcases and carcase parts; and
(b) only crocodile carcases and carcase parts that are not diseased and are fit for human consumption are processed for human consumption.
20.2 Crocodile carcases and carcase parts must:
(a) be passed for human consumption; or
(b) be passed for animal food; or
(c) be condemned;
in accordance with the criteria specified in the Australian Standard for Hygienic Production of Crocodile Meat For Human Consumption.
Note 1 For the meaning of animal food, Australian Standard for Hygienic Production of Crocodile Meat For Human Consumption and condemned see order 8.
Note 2 For identification requirements applying to animal food and to processed food not fit for human consumption see Part 7 of this Schedule.
Diseased and condemned material Diseased and condemned material
Diseased and condemned material
21.1 Diseased crocodile carcases and carcase parts must be condemned or downgraded for animal food.
Note For the meaning of diseased see order 8.
21.2 Condemned crocodile carcases and carcase parts must:
(a) be identified as condemned; and
(b) be denatured or destroyed to prevent use as food or for animal food.
Division VII Sourcing milk
Sourcing milk Sourcing milk
Sourcing milk
22.1 Milk sourced directly from an establishment engaged in milking and storing and chilling milk (including from an establishment to which these Orders do not apply) must be sourced only from an establishment with:
(a) disease management controls in place to ensure only healthy animals are used for milking; and
(b) effective measures in place to ensure:
(i) animals for milking are not given feed or treated with a substance that could adversely affect the fitness for human consumption of milk; and
(ii) the collection of milk is done under conditions that ensure the fitness for human consumption of the milk is not adversely affected; and
(iii) as soon as practicable after milking, the milk is placed under temperature controls that minimise the growth of pathogens that could adversely affect the fitness for human consumption of the milk.
Note 1 For when these Orders do not apply to establishments engaged in storing or chilling milk provided no part of the premises are used for any preparation of processed food other than storing and chilling milk, see order 26.
Note 2 For temperature controls for milk see Part 2 of this Schedule.
Part 2 Chilling, freezing, thawing and tempering
Division I Chilling and freezing
Processed food must be placed under temp Processed food must be placed under temperature controls
Processed food must be placed under temperature controls
23.1 Processed food must be placed under temperature controls:
(a) for eggs — as soon as practicable after laying; and
(b) for fish (other than crocodiles) — as soon as practicable after the fish are harvested; and
(c) for crocodile meat — as soon as practicable after the crocodile from which the meat is derived is killed; and
(d) for milk — as soon as practicable after milking.
Chilling Chilling
Chilling
24.1 Processed food that is to be chilled must:
(a) be cooled:
(i) for whole eggs — to a temperature of 15°C or less; and
(ii) in any other case — to a temperature of 5°C or less; or
(b) be cooled in accordance with the alternative temperature controls specified for chilling the food in the applicable approved arrangement.
24.2 If paragraph 24.1 (b) applies, the applicable approved arrangement must validate that:
(b) the way in which the chilling is to be done;
minimises the growth of pathogens that could adversely affect the fitness for human consumption of the food given the conditions under which the food is to be stored, handled, loaded and transported.
Rate of chilling Rate of chilling
Rate of chilling
25.1 The chilling of processed food must be performed with sufficient rapidity so as to minimise the growth of pathogens that could adversely affect the fitness for human consumption of the food given the conditions under which the food is to be stored, handled, loaded and transported.
25.2 The applicable approved arrangement must validate that the rate of chilling achieves the outcome specified in subclause 25.1.
Chilling crocodile meat exposed to sparg Chilling crocodile meat exposed to sparganosis
Chilling crocodile meat exposed to sparganosis
26.1 In addition to clause 24.1 the meat of a crocodile exposed to or suspected of being infested by Spirometra erinacei (sparganosis) must:
(a) immediately after processing be placed in a refrigeration chamber; and
(b) be:
(i) rapidly dropped and held at a temperature of minus 12°C or cooler at the site of microbiological concern for a minimum of 5 days; or
(ii) subjected to such other temperature controls that achieve a reduction in the level of Spirometra erinacei (sparganosis) at the site of microbiological concern that is equivalent to that achieved under subparagraph 26.1 (b) (i).
Note For the meaning of site of microbiological concern see order 8.
26.2 If subparagraph 26.1 (b) (ii) applies, the applicable approved arrangement must validate that:
(b) the way in which the controls are to be applied;
achieves a reduction in the level of Spirometra erinacei (sparganosis) at the site of microbiological concern that is equivalent to that achieved under subparagraph 26.1 (b) (i).
Freezing Freezing
Freezing
27.1 The freezing of processed food must achieve:
(a) a temperature at the site of microbiological concern of:
(i) for crocodiles — minus 15°C or cooler; and
(ii) in any other case — minus 18°C or cooler; or
(b) the alternative temperature specified for freezing the food in the applicable approved arrangement.
27.2 If paragraph 27.1 (b) applies, the applicable approved arrangement must validate that:
(b) the way in which the freezing is to be done;
minimises the growth of pathogens that could adversely affect the fitness for human consumption of the food given the conditions under which the food is to be stored, handled, loaded and transported.
27.3 The freezing of processed food must be performed with sufficient rapidity to minimise the growth of pathogens that could adversely affect the fitness for human consumption of the food given the conditions under which the food is to be stored, handled, loaded and transported.
27.4 The applicable approved arrangement must validate that the rate of freezing achieves the outcome specified in subclause 27.3.
Storage, handling, loading and transport Storage, handling, loading and transport of chilled or frozen processed food
Storage, handling, loading and transport of chilled or frozen processed food
28.1 Chilled and frozen processed food must be maintained during storage, handling, loading and transport at:
(a) temperatures specified for chilling or freezing the food in paragraph 24.1 (a) or paragraph 27.1 (a) (as the case may be) of this Schedule; or
(b) the alternative temperature specified for maintaining the food in the applicable approved arrangement.
Note For the meaning of chilled and frozen see order 8.
28.2 If paragraph 28.1 (b) applies the applicable approved arrangement must validate that:
(a) maintaining the food at the alternative temperature; and
(b) the way in which this is to be done;
minimises the growth of pathogens that could adversely affect the fitness for human consumption of the food given the conditions under which the food is to be stored, handled, loaded and transported.
Division II Thawing and tempering
Thawing and tempering Thawing and tempering
Thawing and tempering
29.1 Frozen processed food must be thawed and tempered under temperature controls that minimise the growth of pathogens that could adversely affect the fitness for human consumption of the food.
29.2 The applicable approved arrangement must validate that the temperature controls for the thawing and tempering achieve the objective specified in subclause 29.1.