i  
 
9 October 2015  
[25–15] 
 
Call for submissions  – Proposal  P1039  
 
Microbiological Criteria for Infant Formula  
 
 
FSANZ has assessed a  proposal prepared to consider food safety microbiological criteria for infant 
formula, aligning with international (Codex)  standards  and has prepared a draft food regulatory 
measure . Pursuant to section 6 1 of the Food Standards Australia New Zealand Act 1991 (FSANZ 
Act), FSANZ now calls for submissions to assist consideration  of the draft food regulatory measure . 
 
For informa tion about making a  submission , visit  the FSANZ website at  information for submitters . 
 
All submissions on applications and proposals will be published on our websit e. We will not publish material 
that is provided in -confidence, but will record that such information is held. In -confidence submissions may 
be subject to release under the provisions of the Freedom of Information Act 1991 . Submissions will be 
published as  soon as possible after the end of the public comment period. Where large numbers of 
documents are involved, FSANZ will make these available on CD, rather than on the website.  
 
Under s ection 114 of the FSANZ Act, some information provided to FSANZ cannot b e disclosed. More  
information about the disclosure of confidential commercial information is available on the FSANZ 
website at  information for submitters . 
 
Submissio ns should  be made in writing ; be marked clearly with the word ‘Submission’ and quote the 
correct project number and name . While FSANZ accepts submissions in hard copy to our offices, it is 
more convenient and quicker to receive submissions electronically through the FSANZ website via the 
link on documents for public comment . You can also  email your submission directly to 
submissions@foodstandards.gov.au .  
 
There is no need to send a hard copy of your submission if you have  submitted it by email or via the 
FSANZ website . FSANZ endeavours to formally acknowledge receipt of submissions within 3 
business days.  
 
DEADLINE FOR SUBMISSIONS :  6pm (Canberra time) 20 November 2015  
 
Submissions received after this date will not be considered unless  an extension ha d been given before 
the closing date . Extensions will only be granted due to extraordinary  circumstances during the 
submission period . Any agreed extension will be notified on the FSANZ website and will apply to all 
submitters.  
 
Questions about  making submissions or the application process can be sent to  
standards.management@foodstandards.gov.au .  
 
Hard  copy submissions may be sent to one of the following addresses:  
 
Food Standards Australia New Zealand  Food Standards Australia New Zealand  
PO Box 7186  PO Box 10559  
CANBERRA  BC  ACT  2610  The Terrace WELLINGTON 6143  
AUSTRALIA  NEW ZEALAND  
Tel +61 2  6271 2222   Tel +64 4  978 5630  
 1 Table of Contents  
EXECUTIVE SUMMARY  ................................ ................................ ................................ ...............................  2 
1 INTRODUCTION  ................................ ................................ ................................ ................................ ... 3 
1.1 THE CURRENT STANDARD  ................................ ................................ ................................ .....................  3 
1.2 REASONS FOR PREPARING THE PROPOSAL ................................ ................................ ..........................  3 
1.3 PROCEDURE FOR ASSESSM ENT ................................ ................................ ................................ ............  3 
2 SUMMARY OF THE ASSES SMENT  ................................ ................................ ................................ ... 4 
2.1 RISK ASSESSMENT  ................................ ................................ ................................ ................................  4 
2.2 RISK MANAGEMENT  ................................ ................................ ................................ ...............................  4 
2.2.1  Consultation paper  ................................ ................................ ................................ .........................  4 
2.2.2  Microbiological criteria framework  ................................ ................................ ................................  5 
2.2.3  Powdered infant formula  ................................ ................................ ................................ ...........  7 
2.2.4  Proposed microbiological criteria  ................................ ................................ .............................  8 
2.3 RISK COMMUNICATION ................................ ................................ ................................ .........................  10 
2.3.1  Consultation ................................ ................................ ................................ ................................ ... 10 
2.3.2  World Trade Organization (WTO)  ................................ ................................ ..............................  10 
2.4 FSANZ  ACT ASSESSMENT REQUIR EMENTS  ................................ ................................ .......................  11 
2.4.1  Section 59  ................................ ................................ ................................ ................................ ...... 11 
2.4.2  Subsec tion 18(1)  ................................ ................................ ................................ ...........................  11 
2.4.3  Subsection 18(2) considerations  ................................ ................................ ................................  12 
3 DRAFT VARIATION  ................................ ................................ ................................ ............................  13 
4 REFERENC ES ................................ ................................ ................................ ................................ .... 13 
ATTACHMENT A – DRAFT VARIATION TO TH E AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE  ............  14 
ATTACHMENT B – DRAFT EXPLANATORY STATEMENT  ................................ ................................ ....................  17 
 
 
Supporting doc uments  
 
The following documents  which informed the assessment of this Proposal  are available on 
the FSANZ website at  
http://www.foodstandards.gov.au/code/proposals/Pages/P1039MicroReviewInfantFormula.as
px 
 
SD1 Scientific evidence informing the proposed m icrobiological criteria for infant 
formula  
SD2 Process hygiene c riteria  
 
 
   2 Executive s ummary  
The microbiological limits in the  current  Australia New Zealand Food Standards Code  (the 
Code) and associated guidelines were developed before 2000. Since then, a preventative 
through -chain approach to food safety has evolved and work has progressed internationally 
to further  inform our understanding of pathogen management in the food chain, including the 
management of ‘emerging’ pathogens.  
 
Internationally, the Codex Alimentarius and the International Commission on Microbiological 
Specifications for Foods (ICMSF) have provid ed the lead on contemporary food safety 
management approaches and the application of microbiological criteria. An important 
principle is that a microbiological criterion is established at a specified point in the food chain 
for a particular purpose. In gen eral, this is to establish the safety of a food or to verify that the 
food safety control system or elements of it are working as  intended. The terms food safety 
criteria and process hygiene criteria have been used internationally to differentiate the 
intended purpose of specific criteria .   
 
FSANZ ’s risk management approach is to establish  microbiological criteria as either : 
 
 food safety criteria  or 
  
 process hygiene criteria   
 
Together , these microbiological criteria should provide a “fit for purpose” sui te of decision 
criteria appropriate to the microbiological testing needed to  support the safe production of a 
food as depicted below.   
 
In 2008, the Codex Committee on Food Hygiene (CCFH) revised the Code of hygienic 
practice for powdered infant formulae f or infants and young children  (CAC/RCP 66 - 2008)  in 
response to the emergence of Cronobacter  species (referred to as Enterobacter sakazakii  
prior to 2008) as an important pathogen for infants fed with powdered infant formula (PIF). 
The revised code introd uced a set of microbiological criteria for Cronobacter spp. in PIF, and 
reconfirmed the application of a set of microbiological criteria for Salmonella  spp. in both PIF 
and follow -up formula (FUF).  
 
Proposal P1039 has been prepared to  review  microbiological limits in Standard 1.6.1 and the 
associated Schedule 27 in light of these approaches. The principles underpinning the second 
stage of the review of microbiological criteria were consulted on in early 20151 and the 
submissions from this con sultation informed the work on powdered infant formula under 
Proposal P1039.  
 
Aligning with the outcomes from the Codex risk assessment, FSANZ has prepared a draft 
variation to the Code to include only food safety microbiological criteria, with process hyg iene 
criteria (which should not be used for regulatory purposes)  being removed . To support this 
approach a draft guidance document Compendium of Microbiological Criteria for Food  has 
been developed and is provided for comment as Supporting Document 2 (SD2). 
  
                                                
1 http://www.foodstandards.gov.au/code/microbiollimits/Pages/Re view-of-microbiological -criteria -(second -
stage).aspx    3 1 Introduction  
The existing microbiological limits in the Code  and associated guidelines were developed 
before 2000. Since then, a preventative through -chain approach to food safety has evolved 
and work has progressed internationally through Codex Alim entarius (Codex) to further 
inform our understanding of pathogen management in the food chain, including the 
management of ‘emerging’ pathogens.  
 
Proposal P1039 has been prepared to  review  microbiological limits in Standard 1.6.1 and the 
associated Schedu le 27 in light of these approaches. FSANZ consulted on t he principles 
underpinning the second stage of the review of microbiological criteria in early 20152 and the 
resulting submissions have informed  our work on th is Proposal.  
 
A revised Code was gazetted in April 2015 and will take effect on 1 March 2016. The 
microbiological criteria for infant formula are listed in Schedule 27 in the revised Code . 
 
As the expected gazettal date of any approved draft variations arising from this Proposal is 
after the revised Code takes effect, all references to the Code in this summary are to the 
revised Code . 
1.1 The c urrent Standard  
The current infant formula limits in Schedule 27 do not reflect recent scientific knowledge and 
approaches to foo d safety ( i.e. they are not fit for purpose)  because : 
  
 the limits are out of step with more recent international risk assessment work and 
microbiological criteria developed by Codex for powdered infant formula for the 
pathogens Cronobacter species and Salmonella  
 limits are included for indicator tests that are not appropriate as pass/fail criteria for a 
lot of food  
 limits are included for pathogens which do not represent a direct threat to the health of 
infants . 
1.2 Reasons for preparing the Proposal  
Proposal P1039 was prepared  to amend the Code to include food safety microbiological 
criteria for powdered infant formula products, aligning with : 
 
 international standards established by Codex Alimentarius (Codex)  
 current scientific knowledge   
 best practi ce manufacturing processes  
 the transition to outcomes based risk management processes.  
1.3 Procedure for assessment  
The Proposal is being assessed under the General Procedure.  
 
                                                
2 http://www.foodstandards.gov.au/code/microbiollimits/Pages/Review -of-microbiological -criteria -(second -
stage).aspx    4 2 Summary of the a ssessment  
2.1 Risk assessment  
FSANZ has prepared a summary of the risk assessment work undertaken to inform the 
Codex risk management approach; in particular, the information supporting establishment of 
microbiological criteria  (refer to S D1).  
 
In 2008, the Codex Committee on Food Hyg iene (CCFH) revised the Code of Hygienic 
Practice for Powdered Infant formulae for Infants and Young Children  (CAC/RCP 66 - 2008)  
in response to the emergence of Cronobacter  species (referred to as Enterobacter sakazakii  
prior to 2008) as an important path ogen for infants fed with powdered infant formula (PIF). 
The revised code introduced a set of microbiological criteria for Cronobacter spp. in PIF, and 
reconfirmed the application of a set of microbiological criteria for Salmonella  spp. in both PIF 
and fol low-up formula (FUF).  
 
Codex based these criteria on scientific advice and a risk assessment model undertaken by 
the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) 
through a series of joint expert meetings. The expert cons ultations concluded that intrinsic 
contamination of powdered infant formula with E. sakazakii  (Cronobacter  spp.) and 
Salmonella  spp. had been a cause of infection and illness in infants, including severe 
disease which can lead to serious developmental sequ elae and death. Although the rate of 
incidence was low, neonates and immunocompromised infants were at the greatest risk of 
Cronobacter  infection.  
 
The FAO/WHO expert consultations identified the organisms of concern in infant formula and 
the relevant cont rol measures throughout the food chain to reduce the risks for infants 
associated with consumption of infant formula. Guidance on how a microbiological criterion 
could be used to reduce relative risk was also considered in the expert consultations . This 
was achieved  by providing examples of how effective ly different sampling plans are able to 
reject lots through detecting elevated levels of contamination and the corresponding 
predicted reduction in relative risk.  
2.2 Risk m anagement  
2.2.1  Consultation pape r 
In January 2015 FSANZ released a consultation paper, Consultation Paper on Completing 
the Review of Microbiological Criteria , outlining and seeking comment on the approach and 
guiding principles for completing the review of Standard 1.6.1. FSANZ  received  17 
submissions  from various sectors including from the New Zealand  Ministry for Primary 
Industries ( MPI), Australian jurisdictions, industry and industry groups and individuals . Those 
submissions are available on the FSANZ website3. 
 
The submissions received on the consultation paper supported that the review of 
microbiological limits for powdered infant formula products progress as a priority. Most 
submissions also supported  the development of food safety criteria and process hygiene 
criteria  (discus sed under Section 2. 2.2.2), consistent wit h the Codex general principles. The 
assessment of P1039 will provide a model for the remaining review of microbiological limits.  
  
                                                
3 http://www.foodstandards.gov.au/code/microbiollimits/Pages/Review -of-microbiological -criteria -(second -
stage).aspx    5 2.2.2 Microbiological criteria framework  
2.2.2.1 Establishing microbiological cri teria  
Microbiological criteria are established to support decision making  about a food or process  
following microbiological testing.  FSANZ applies the Codex Principles and Guidelines for the 
Establishment and Application of Microbiological Criteria for Foo ds (CAC/GL 21 – 1997 
[revised and renamed 2013]) in establishing criteria. These principles include:  
 
 A microbiological criterion should be appropriate to protect public health and where 
appropriate, also ensure fair practices in trade . 
 
 A microbiological criterion should be practical and feasible and established only whe n 
necessary . 
 
 The purpose of establishing and applying a microbiological criterion should be clearly 
articulated.  
 
 The establishment of microbiological criteria should be based on scientific information 
and analysis and follow a structured and transparent approach.  
 
 Microbiological criteria should be established based on knowledge of the 
microorganisms and their occur rence and behaviour along the food chain.  
 
 The intended as well as the actual use of the final product by consumers needs to be 
considered when setting a microbiological criterion.  
 
 The required stringency of a microbiological criterion used should be app ropriate to its 
intended purpose.  
 
Each microbiological criterion  should include the following components:  
 
 the purpose of the microbiological criterion  
 the food or process to which it applies  
 the specified point in the food chain where it applies  
 the m icroorganism of concern or its toxin/metabolite  
 the microbiological limits considered appropriate to the food at the specified point(s) of 
the food chain  
 a sampling plan ( the number of samples to be taken ; the size of the analytical unit;  the 
number of ana lytical units that should conform to the limits  specified)  
 the method of analysis and its sensitivity.  
 
Additionally, a criterion  should also include  a statement of the corrective actions to be taken 
when limits are not met (e.g. rejection of a lot or adju stment of process) .   
2.2.2.2 The use of microbiological criteria in food safety management  
Microbiological food safety management has moved from a reactive approach based on 
inspection and compliance with end product testing to a preventative approach where control 
measures are implemented by industry throughout the food chain. The role of microb iological 
testing in this context may fit different purposes as defined by the microbiological criteria 
applied.  
 
   6 Internationally, the Codex Alimentarius and the International Commission on Microbiological 
Specifications for Foods (ICMSF) have provided the lead on contemporary food safety 
management approaches and the application of microbiological criteria. An import ant 
principle is that a microbiological criterion is established at a specified point in the food chain 
for a particular purpose. In general this is either to establish the safety of a food or to verify 
that the food safety control system or elements of it  are working as  intended. The terms food 
safety criteria and process hygiene criteria have been used internationally to differentiate the 
intended purpose of specific criteria .   
 
FSANZ ’s risk management approach is to establish  microbiological criteria as  either : 
 
 food safety criteria  (included in the Code and applied to determine the safety of a 
food lot) or  
  
 process hygiene criteria  (provided in guidance an d applied to verify hygiene 
measures  or control of process).  
 
Together these microbiological crit eria should provide a “fit for purpose” suite of decision 
criteria appropriate to the microbiological testing needed to  support the safe production of a 
food as depicted below.   
 
 
2.2.2.3 Codex Alimentarius  
The Codex Committee on Food Hygiene (CCFH) has a  role in recommending microbiologica l 
criteria at the international  level. National governments  may choose to adopt Codex 
microbiological criteria into their national systems or use them as a starting point for 
addressing  their intended public health goals . The ICMSF  has been instrumental in 
introducing the concepts and principles that Codex has developed.  
 
Internationally agreed microbiological criteria have been established for powdered infant 
formula by Codex  and included in the  Codex Code of Hygienic Pr actice for Powdered 
Formulae for Infants and Young Children  (CAC/RCP 66 -2008) .   
 7 These include food safety criteria for Salmonella  and Cronobacter  and process hygiene 
criteria for  Enterobacteriacea a nd Mesophilic Aerobic Bacteria  (MAB) . A change from 
coliforms to Enterobacteriac ea as a better defined group was recommended based on the 
outcomes of the FAO/WHO expert meetings.  
2.2.3  Powdered infant formula  
2.2.3.1 Food safety management  
The manufacture of powered infant formula does not include a proces sing step that can 
eliminate all microbiological hazards – it is not a sterile product. This means that the 
microbiological safety of powdered infant formula must be ensured through good hygienic 
practices during both manufacture and use.  
 
There are four routes by which the primary pathogens of concern ( Salmonella  and 
Cronobacter ) can contaminate powdered formula ( Codex, 2008 ): 
 
 through  the ingredients added in dry mixing operations during manufacture   
 through contamination from the processing environment in the steps during or following 
drying   
 through  contamination after the package is opened  
 through contamination during or after  reconstitution by the caregiver prior to feeding.  
 
As such , through chain risk m anagement  measures are essential to manage microbiological 
hazards including:  
 
 implementation of good manufacturing and hygienic practices and food safety control 
systems by ingredient manufacturers  
 implementation of good manufacturing and  hygienic practi ces and food safety control 
systems by infant formula manufacturers  
 education and guidance on the safe preparation, storage and use of powdered infant 
formula . 
 
The Code of Hygienic Practice for Powdered Formulae for Infants and Young Children  
(CAC/RCP 66 – 2008)  was prepared  to provide guidance on the hygienic  manufacture of 
powdered infant formula  and on the subsequent hygienic preparation, handling and use of 
reconstituted formula  products . Such measures are covered in Australia and New Zealand by 
food safety and labelling requirements in the Code and, additionally in New Zealand, the 
Food Act 2014  and the Animal Products Act 1999 . Industry food quality assurance systems 
and food safety mana gement systems  such as HACCP, S QF 2000, ISO 9001 and ISO 
22000 are also widely implemented.  
2.2.3.2 Role of microbiological testing  
The ICMSF (2011) provide a good overview on the use of microbiological sampling and 
testing of powdered infant formula produ ct, including appropriate sampling plans. Sampling 
and testing may be utilised by infant formula manufacturers from supply of ingredients 
through to the final product as part of monitoring and verification of the food safety control 
system :   
 
 Ingredients  – microbiological sampling and testing of ingredients may be  undertaken  as 
part of supplier assurance to ensure ingredients have been manufactured in 
accordance with good hygienic practice and  that final product criteria can be met. This 
is particularly important for dry -mix ingredients as there is no kill step during 
manufacture.    8  Processing Environment  – sampling and testing of environmental samples can help 
verify  the effectiveness of the control measures in place to prevent entry  and 
establishment of Salmonella  and Cronobacter  spp. in the processing environment.  
 
 In process  – testing of in -process samples can help verify that the potential for  
recontamination  is being controlled effectively . This may involve taking  representative  
samples at critical steps along the processing line, from the drying step to the filling of 
the finished product  and include testing for Salmonella , Cronobacter  and 
Enterobacteriaceae .   
 
 Final product  – testing of the final product for indicators (e.g. Mesophilic Aerobic 
Bacteria (MAB)  and Enterobacteriacea) is useful as  verification of process control and 
for trend analysis.  Testing of pathogens in the final product should be integrated with 
in-process sampling and environmental monitoring. For example any positive results 
for Salmonella  in the processing environment or in -process sample should  result in 
increased sampling regime of the final product.  
2.2.4  Proposed microbiological criteria  
2.2.4.1  Food safety criteria  
As outlined in Section 2.2, t wo FAO/WHO meetings of experts on the microbiological safety 
of powdered infant formula products (FAO/WHO, 2004 and 2006) identified Salmonella  and 
Cronobacter  as the two primary hazards of concern in infant formula products.  In relation to 
Cronobacter  the FAO/WHO expert meetings identified all infants (<12 months of age) as the 
population at particular risk for Cronobacter infections. Among this group, those at greatest 
risk are neonates (<28 days), particularly pre -term, low -birthweight (<2500 g), and  those less 
than 2 months of age . 
 
This work supported the development of f ood safety criteria for Salmonella  and Cronobacter  
in the  Codex Code of Hygienic Practice for Powdered Formulae for Infants and Young 
Children . Criteria  for Salmonella were develope d for all powdered infant formula products. A 
criterion for Cronobacter  was developed for powdered infant formula  only as it does not apply 
to follow -on formula.  
 
Proposal P1039 proposes replacing  the existing microbiological limits for powdered infant 
formula and follow -on formula with criteria for Salmonella  and Cronobacter  as follows:  
 
Powdered Infant formula  (n) (c) (m) 
    
Cronobacter  30 0 not detected in 10g  
    
Salmonella  60 0 not detected in 25 g  
 
Powdered follow -on formula   (n) (c) (m) 
    
Salmonella  60 0 not detected in 25 g  
 
Where:  n = number of sample units  
   c = the number of sample units allowed to exceed m  
                 m = the acceptable microbiological limit  
 
These food safety criteria apply to the finished product (powder form) after packaging and at 
any stage from that point to the point when the primary package is opened.   
 
   9 The stringency of th ese sampling plan s (n=30 and n= 60) assumes the history of the l ot is not 
known.  This is discussed further under section 2.3.3.3.  
 
Schedule 27 currently contains microbiological limits for B. cereus  and S. aureus . The 
FAO/WHO expert consultation s found that, while  S. aureus and B. cereus may be 
occasionally present at low levels, they do not represent a direct threat to the health of 
infants. It is generally accepted that low levels are acceptable (<100 cfu/g) and will not lead 
to illness as long as the product is prepared and handled acco rding to the recommendations. 
As such, food safety criteria for B. cereus  and S. aureus  are not necessary and limits for 
these microorganisms will be removed from the Code.  
2.2.4.2  Process hygiene criteria  
Safe production of powdered infant formula depend s on maintaining a high level of hygiene 
control to prevent entry and establishment of Salmonella  and Cronobacter  in processing 
areas. Testing of infant formula product s, both end product and during processing, for 
Enterobacteriacea and MAB  is useful  to ve rify that the hygiene measures in place within a 
manufacturing facility are working  as intended.  This provides assurance that  the potential for  
pathogens such as  Salmonella  and Cronobacter  to be in the processing environment and to 
cross -contaminate infant formula products  is being controlled . Failure to meet criteria for 
Enterobacteriacea and MAB may be a trigger to examine environmental and process 
hygiene controls and to increase samplin g for the pathogens of concern.  
 
Powdered infant formula   (n) (c) (m) (M) 
     
Mesophilic Aerobic Bacteria  5 2 500/g  5000/g  
     
Enterobacteriaceae  5 2 0/10g  N/A 
 
Where:  n = number of sample units  
   c = the number of sample units allowed to exceed m  
                 m = the acceptable microbiological limit  
  M = the limit which must not be exceeded  
 
These process hygiene criteria apply to the finished product or at any other point in 
manufacture that provides the information necessary to verify process control.  
 
Process hygiene criteria for Mesophilic Aerobic Bacteria  and Enterobacteriaceae  in 
powdered infant formula e will be incorporated into a guidance document that will be available 
on the FSANZ website and is presented  in Supporting Document 2.  
2.2.4.3  Sampling plans  
There are a number of factors to take into account when choosing a sampling plan including 
(ICMSF, 2002):  
 
 the risk posed by the hazard (severity and likelihood of occurrence)  
 the susceptibility of the tar get group  
 the desired statistical probability of accepting/rejecting a contaminated lot.  
 
The ICMSF recommend sampling plans based on the degree of concern (e.g. severity of the 
hazard) and the conditions in which food is expected to be handled and consum ed (e.g. if it 
will be eaten cooked so that the risk is reduced or whether there is potential for growth prior 
to consumption and therefore an increase in risk). These are described as “cases” with the 
highest, case 15, being the most stringent sampling pl an and applicable to sever e hazards 
and foods for susceptible populations.    10 Salmonella  and Cronobacter  are severe hazards for infants. As such, very stringent sampling 
plans were  proposed for these pathogens in powdered infant formula to provide an 
appropr iate level of assurance that, if tested, a contaminated batch of powdered infant 
formula would be detected. For example a case 15 sampling plan (where n=60 and c=0 ) 
provides a 95% probability that a contaminated lot will be detected if the mean concentrati on 
of the pathogen is at least 1.9 cfu per 1000g (1 cfu in 526g). Conversely, if the pathogen is 
present at a lower concentration tha n this, then there is a greater that 5% probability that it 
would not be detected and the lot would be accepted (ICMSF, 200 2). 
 
For Salmonella , which may grow in prepared formula if not handled correctly, a case 15 
sampling pla n is recommended, where n=60 and  c=0. For Cronobacter  a case 14 sampling 
plan has been recommended , where n=30 and c=0. Case 14 provides a 95% probabili ty that 
a mean concentration of Cronobacter  of 1 cfu in 340g will be detected.  
 
These sampling plans are based on the premise  that the history of the lot is unknown.  
Alternate sampling criteria would be appropriate where the history of the product is known 
e.g. it is produced under a validated and verified food safety system such as HACCP where 
manufacturers apply integrated sa mpling plans with in -process and environmental samples.  
2.3 Risk communication  
2.3.1 Consultation  
Consultation is a key part of FSANZ’s standards development process. The process by 
which FSANZ considers standard development matters is open, accountable,  consultative 
and transparent. Public submissions are called to obtain the views of interested parties on 
issues raised by this Proposal and the effects of regulatory options. Every submission is 
reviewed by FSANZ staff, who examine the issues identified a nd prepare a response to 
those issues. While not all comments may be taken on board during the process, they are 
valued and all contribute to the rigour of our assessment.  
 
FSANZ develops communication plans to ensure stakeholders are aware of proposed 
changes to the Code. All calls for submissions are notified through the FSANZ Notification 
Circular, media release, FSANZ’s social media tools and Food Standards News . A dedicated 
web page on the review of microbiological limits is available on the FSANZ webs ite. For this 
proposal, FSANZ will  also carry out targeted consultation with the Infant Nutrition Council 
(INC).  
 
The draft variations will be considered for approval by the FSANZ Board taking into account 
comments received following this call for submissi ons. Anyone who is an interested party or 
who makes a submission will be notified at each stage of the assessment. Subscribers and 
interested parties are also notified by email about the availability of reports for public 
comment.  
 
If the draft variations to the Code are approved by the FSANZ Board, that decision will be 
notified to the Australia and New Zealand Ministerial Forum on Food Regulation. If the 
decision is not subject to a request for a review, stakeholders will be notified of the gazettal 
of the variations to the Code in the national press and on the FSANZ website.  
2.3.2 World Trade Organization (WTO)  
As members of the World Trade Organization (WTO), Australia and New Zealand are obliged 
to notify WTO member s where proposed mandatory regulatory measures are inconsistent 
with any existing or imminent international standards and the proposed measure may have a 
significant effect on trade.    11 The draft variations to Schedule 27 are consistent with the principles un derpinning the Codex 
Code of Hygienic Practice for Powdered Formulae for Infants and Young Children  (CAC/RCP 
66 – 2008)  and will potentially be a trade facilitating measure. Notification under the WTO 
Sanitary and Phytosanitary Measures Agreement has been made to  facilitate transparency 
and enable other WTO member countries to comment on the draft variations.  
2.4 FSANZ Act assessment requirements  
When assessing this Proposal and the subsequent development of a food regulatory 
measure, FSANZ has had regard t o the following matters in section 59 of the FSANZ Act:  
2.4.1 Section 59  
2.4.1.1 Cost benefit analysis  
The proposed changes that would arise from a food regulatory measure developed or varied 
as a result of the proposal are unlikely to have material impacts on businesses, governments 
or community and are largely minor and machinery in nature.  
Primarily, these changes involve moving  the process hygiene criteria from S chedule 27  to 
the associated guidance document  which wi ll prevent food recalls being undertaken 
unnecessarily  and also  remove the ne ed for redundant testing , reducing the number of 
expensive micro biological  tests required by the businesses.  This will potentially lead to less 
destruction of food , and recalls which are not related to community safety. The additional 
testing for Cronobacte r and Enterobacteriacea is already undertaken by the industry as it is 
required for international trade, and to meet customer expectations of food safety.  
Consultation to date ha s found industry supports  the proposed amendments. It also identified 
that infant formula manufacturers currently undertake a range of microbiological testing, both 
in-process and end -product testing, in order to meet internal food safety controls, regulat ory 
(domestic and international) and customer requ irements. All feedback received from the 
industry has indicated that they are already undertaking testing as per the criteria outlined in 
the proposed changes in order to meet international standards.  
The O BPR assessment is that a Regulation Impact Statement is not required (OBPR  
reference 19531 ). 
2.4.1.2 Other measures  
There are no  other measures (whether available to FSANZ or not) that would  be more cost -
effective than a food regulatory measure developed or varied as a result of the Proposal.  
2.4.1.3 Any relevant New Zealand standards  
Standard 1.6.1 and the associated Schedule 27, establishes microbiological limits for food for 
sale in Austra lia and New Zealand.  
2.4.1.4 Any other relevant matters  
There are no other relevant matters.  
2.4.2 Subsection 18(1)  
FSANZ has also considered the three objectives in subsection 18(1) of the FSANZ Act 
during the assessment.    12 2.4.2.1 Protection of public health and safety  
FSANZ considers that prepar ing the draft variation is consistent with this objective. The 
emergence of  Cronobacter as an opportunistic pathogen with potential severe 
consequences, including permanent disability or fatality, led to its inclusion in the criteria for 
pathogenic microorganisms for powdered infant formula in the Codex Code of Hygienic 
Practice for Powdered Formulae for Infants and Young Children  (CoHP).  As Schedule 27 
(currently Standard 1.6.1) predates the development  of the CoHP it does not currently 
provide a microbiological limit for Cronobacter . This is out of step with international 
approaches which co uld potentially be putting infants at greater risk of contracting foodborne 
illness.  The draft variation addresses this . 
 
Establishing app ropriate microbiological limits  for foods is an important element  in a risk 
management framework for a safe  food suppl y.  
2.4.2.2 The provision of adequate information relating to food to enable consumers to 
make informed choices  
The provision of adequate information relating to food is not directly relevant to the draft 
variation to Standard 1.6.1.  
2.4.2.3 The prevention of misleading or deceptive conduct  
No issues were identified.  
2.4.3 Subsection 18(2) considerations  
FSANZ has also had regard to:  
 
 the need for standards to be based on risk analysis using the best available 
scientific evidence  
 
Several risk ass essments have been undertaken internationally by the FAO/WHO which led 
to the development of the current Codex standards.  FSANZ has had regard to this risk 
assessment work in assessing P1039 and is satisfied that it reflects the best available 
scientific e vidence.  
 
 the promotion of consistency between domestic and international food 
standards  
 
The preparation of a draft variation to Schedule 27  that establishes appropriate food safety 
microbiological criteria for two pathogens of concern is in line with the  approach agreed 
internationally (through Codex) for the food safety management of infant formula.  
 
 the desirability of an efficient and internationally competitive food industry  
 
Aligning microbiological criteria with an internationally agreed approach is  supportive of an 
efficient and internationally competitive food industry. Australian producers are already 
meeting criteria as presented in the proposed changes to meet the international regulatory 
requirements.  
 
 the promotion of fair trading in food  
 
No issues were identified.    13  any written policy guidelines formulated by the Ministerial Council4 
 
There are no written policy guidelines relevant to the assessment of this Proposal.  
 
3 Draft variation  
The draft variation to the revised Code is at Attachment A. The variation is intended to take 
effect on gazettal . 
 
The draft Explanatory Statement is at Attachment B. An explanatory statement is required to 
accompany an instrument if it is lodged on the Federal Register of Legislative Instruments  
(FRLI) .  
 
4 References  
Codex (2008) Code of hygienic practice for powdered infant formulae for infants and young children  
(CAC/RCP 66 – 2008 ), http://www.codexalimentarius.org/standards/list -standards/en/?no_cache=1  
accessed 28 July 2015.  
 
Codex (2013) Principles and Guidelines for the Establishment and Application of Microbiological 
Criteria for Foods (CAC/GL 21 – 1997 [revised and renamed 2013] ). Codex Alimentarius Commission, 
Geneva, Switzerland.  
 
International Commission on Microbiological Specifications for Foods  (2002) Microorg anisms in Foods 
7: Microbiological Testing in Food Safety Management . Springer, New York.   
International Commission on Microbiological Specifications for Foods (2011) Microorganisms in Foods 
8: Use of Data for Assessing Process Control and Product Acceptance . Springer, New York.  
Attachments  
 
A. Draft variation to the Australia New Zealand Food Standards Code  
B. Explanatory Statement  
 
                                                
4 Now known as the  Australia and New Zealand Ministerial Forum on Food Regulation (convening as the 
Australia and New Zealand Food Regulation  Ministerial Council)   14 Attachment A – Draft variation to the  Australia New Zealand Food 
Standards Code   
 
 
Food Standards (Proposal P1039 – Microbiological Criteria for Infant Formula) Variation  
 
 
The Board of Food Standards Australia New Zealand gives notice of the making of this variation under 
section 92 of the Food Standards Australia New Zealand Act 1991 .  The variation commences on the 
date specified in clause 3 of this variation.  
 
Dated [To b e completed by Standards Management Officer]  
 
 
 
 
 
Standards Management Officer  
Delegate of the Board of Food Standards Australia New Zealand  
 
 
 
 
 
Note:    
 
This variation will be published in the Commonwealth of Australia Gazette No. FSC XX on XX Month 
20XX . This means that this date is the gazettal date for the purposes of clause 3 of the variation.  
 
  
 15 1 Name  
This instrument is the Food Standards (Proposal P1039 – Microbiological Criteria for Infant Formula) 
Variation . 
2 Variation to a Standard in the Australia New Zealand Food Standards Code  
The Schedule varies Standards in the Australia New Zealand Food Standards Code . 
3 Commencement  
The variation commences on the date of gazettal.  
4 Effect of the variations to the Code  
Section 1.1.1 —9 of the Code  does not apply to the variations made by this instrument.  
 
Schedule  
 
[1] Standard 1.1.1 is varied by omitting from subsection 1.1.1 —2(2) the words “Standard 
1.6.1  Microbiological limits in food”, substituting “Standard 1.6.1  Food safety microbiological 
criteria” . 
[2] Standard 1.1.2 is varied by  omitting the definition of SPC from s ubsection 1.1.2 —2(3), 
substituting  
“SPC means a standard plate count at 30 C with an incubation time of 72 hours. ” 
[3] Standard 1.6.1 is varied by  omitting the words “Microbiological limits in food” from the 
title of the Standard, substituting “Food safety microbiological criteria” . 
[4] Schedule 27 is varied by   
[4.1] omitting the note to section S27 —2, substituting  
“Note  In this Code (see section 1.1.2 —2): 
 SPC means a standard plate count at 30 C with an incubation time of 72 hours.”  
[4.2] omitting section S27 —3, substituting  
“S27—3 Omitted ” 
[4.3] omitting the following from the table to section S27 —4 
“ 
Powdered infant formula products  
Bacillus cereus  5 0 102/g  
Coagulase -positive 
staphylococci  5 1 not detected in 1 g  10/g 
Coliforms  5 2 less than 3/g  10/g 
Salmonella  10 0 not detected in 25 g   
SPC 5 2 103
/g 104
/g 
” 
substituting  
“ 
Powdered infant formula*  
Cronobacter  30 0 not detected in 10g   
Salmonella  60 0 not detected in 25 g    16 Powdered follow -on formula*  
Salmonella  60 0 not detected in 25 g   
” 
   17 Attachment B – Draft Explanatory Statement  
1. Authority  
 
Section 13 of the Food Standards Australia New Zealand Act 1991  (the FSANZ Act) provides 
that the functions of Food Standards Australia New Zealand ( the Authority ) include the 
development of standards and variations of standards for inclusion in the Australia New 
Zealand Food Standards Code  (the Code).  
 
Division 2 of Part 3 of the FSANZ Act specifies that the Authority may prepare a proposal for 
the development or variation of food regulatory measures, including standards. This Division 
also stipulates the procedure for considering a proposal for the development or variation of 
food regulatory measures .  
 
The Authority has considered the Proposal P1039  in accordance with Division 2 of Part 3 
and prepared  a draft variation .  
 
2. Purpose  
 
The purpose of this variation is to amend the Code (Standard 1.6.1 and Schedule 27) to align 
the food safety microbiological criteria for powdered infant formula products with international 
(Codex) standards .  
 
The amendments made by P1039  are not subject to the stock in trade exemption provided 
by section  1.1.1 —9 of Standard 1.1.1 . 
 
 
3. Documents in corporated by reference  
 
The variation does not incorporate any documents by reference .  
 
4. Consultation  
 
In accordance with the procedure in Division 2 of Part 3 of the FSANZ Act, the Authority ’s 
consideration of Proposal P1039  will include one round of public consultation following an 
assessment and the preparation of a draft variation to the Code  and an associated report.  
 
A Regulation Impact Statement was not required because the proposed variations to 
Standard s 1.1.1, 1.1.2  and 1.6.1  and Schedule 27  are likely to have a minor impact on 
business and individuals .  
 
5. Statement of compatibility with human rights  
 
This instrument is exempt from the requirements for a statement of compatibility with human 
rights as it is a non -disallowable instrument under section 9 4 of the FSANZ Act.  
 
6. Variation  
 
Item [1] varies subsection 1.1.1 —2(2) of Standard 1.1.1 to change the reference to Standard 
1.6.1  in that subsection  to reflect the variation made by item [3] below .  Item [3] changes the 
name of Standard 1.6.1 . 
 
Item [2] varies subsection 1.1.2 —2(3) of Standard 1.1.2 by replacing  the definition for SPC. 
The new definition  reflects the variation made by  item [4.2] below , which  removes the limit for 
SPC in powdered infa nt formula from the Code .    18 Item [3] varies  Standard 1.6.1 to change its title from “Microbiological limits in food” to “Food 
safety microbiological criteria” . 
 
Item [4] varies Schedule 27.  
 
Item [4.1] replaces the Note to section 27 —2 to reflect the variation made by item [2] above. 
The new Note refers to the  amended definition of SPC in subsection 1.1.2 —2(3) of Standard 
1.1.2 . 
 
Item [4.2] omits section S27 —3. Section S27 —3 provides that the  limit for SPC in section 
S27—4 does not appl y to powdered infant formula products  that contain lactic acid producing 
microorganisms . This  exemption is no longer required as item [4.3] removes the limits for 
SPC in powdered infant formula from the Code.  
  
Item [4.3] varies the table to section S27 —4. The variation : 
 
 separate s the microbiological limits for powdered infant formula products in the table 
into two new food categories: powdered infant formula and powdered follow -on 
formula ; 
 
 removes  the current limits sp ecified in the table for Coliforms , Coagulase -positive 
staphylococci , Bacillus cereus  and SPC in respect of these foods ; 
 
 amend s the sampling plan for Salmonella  in these foods  by repl acing 10 with 60 in 
Column 2(n) in the table ; and  
 
 inserts  new limits fo r Cronobacter  in powdered infant formula , where  the number of 
sample units (n) is 30,  the acceptable microbiological limit (m) is ‘not dete cted in 10g’, 
and the number of sam ple units allowed to exceed that acceptable microbiological limit 
(c) is 0. These limits do not apply to powdered follow -on formula .