Proposed framework for the 
manufacture, importation and sale of 
raw milk products 
Consultation Process and Invitation for Public Comment  
NZFSA Public Discussion Document No 04/08 
August 2008 
ISBN 978-0-478-32218-7 (Print) 
ISBN 978-0-478-32219-4 (Online) 
 
ISSN 1174-961X (Print)  
ISSN 1177-7478 (Online) 
  Proposed framework for the manufacture, importation and sale of raw milk products  
 
Consultation Process and Invitation for Public Comment  
NZFSA Public Discussion Document No 04/08 1 August 2008 
    
 
 
 
 
IMPORTANT DISCLAIMER  
 
Every effort has been made to ensure the information in this report is accurate. 
 
NZFSA does not accept any responsibility or liability whatso ever for any error of fact, omission, interpretation or 
opinion that may be present, however it may have occurred. 
  
 
Further copies 
 
Requests for further copies  should be directed to:   
New Zealand Food Safety Authority 
P O Box 2835 
WELLINGTON 
Telephone: (04) 894-2500 
Fax: (04) 894-2501 
 
Website 
A copy of this document can be found at  www.nzfsa.govt.nz   Proposed framework for the manufacture, importation and sale of raw milk products  
 
Consultation Process and Invitation for Public Comment  
NZFSA Public Discussion Document No 04/08 2 August 2008 
   Table of Contents 
1 Executive summary.............................................................................................................. .....4 
1.1 Purpose of this document ....................................................................................................4  
1.2 Raw milk products and the scope of this propos al ..............................................................4  
1.3 Background to th is proposal ................................................................................................6  
1.3.1 Current availability of raw milk  products in Ne w Zealand........................................6  
1.3.2 The impetus fo r change...........................................................................................7  
1.4 NZFSA proposal ................................................................................................................. .8 
2 Consulta tion................................................................................................................... ..........11  
2.1 Requirements for submissions...........................................................................................11  
2.2 Address for s ubmissions....................................................................................................11  
2.3 Closing date for submissions.............................................................................................11  
2.4 Official Info rmation Act....................................................................................................... 11 
2.5 Process after submissions.................................................................................................12  
3 Background..................................................................................................................... .........13  
3.1 General info rmation ...........................................................................................................1 3 
3.1.1 Pasteurisation and othe r heat treat ments .............................................................13  
3.1.2 Arguments made to NZFSA in s upport of raw mi lk cheese ..................................14  
3.1.3 Microbiologica l hazards.........................................................................................14  
3.1.4 Risk factors............................................................................................................15  
3.1.5 An acceptable leve l of safety.................................................................................15  
3.2 Current legislativ e requirem ents ........................................................................................16  
3.2.1 New Zeal and..........................................................................................................16  
3.2.2 Australia.................................................................................................................19  
3.2.3 Collaboration with  Australia...................................................................................20  
3.2.4 Imports from ot her count ries..................................................................................20  
3.2.5 Relevant national and in ternational standards ......................................................21  
4 The reasons for the development of the proposed framework for raw milk products ....24  
5 Proposed framework for raw milk products .........................................................................26  
5.1 Proposed framework for raw milk pr oducts .......................................................................26  
5.1.1 Risk assessment ...................................................................................................26  
5.1.2 Proposed categor y approach ................................................................................27  
5.1.3 Description of categories.......................................................................................28  
5.1.4 Categorisation of ra w milk pr oducts ......................................................................30  
5.2 Preliminary risk management options for ca tegories.........................................................31  
5.2.1 Category  2 .............................................................................................................31   Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   5.3 Other risk mitigati on considerations...................................................................................32  
5.3.1 Consumer educati on programme..........................................................................32  
5.3.2 Consumer survey ..................................................................................................33  
5.3.3 Labelling ................................................................................................................34  
5.4 Imported food standard fo r raw milk products ...................................................................34  
5.5 Exports........................................................................................................................ .......35  
5.6 Cost recovery.................................................................................................................. ...36 
6 Possible options considered by NZFSA and analysis of their imp acts.............................37  
6.1 Analysis of  options ............................................................................................................ .37 
6.1.1 Option 1: To maintain  the status  quo ....................................................................37  
6.1.2 Option 2: To maintain the status quo an d, in addition, not consider any further 
applications for case-by-case assessments that could allow importation of raw milk products 
not already available in New Z ealand................................................................................39  
6.1.3 Option 3: To develop a framework, base d on risk to consumers, which would 
facilitate both New Zealand production of some  raw milk products and the importation of a 
similar range of raw milk products, while ma intaining an acceptable  level of consumer 
protection for Ne w Zealan ders...........................................................................................40  
6.1.4 Option 4: To allow for all types of raw milk  products to be both made in New Zealand 
and imported into New Zealand,  regardless of risk ...........................................................41  
7 Conclusion ..................................................................................................................... ..........43  
8 Questions and subm ission exam ple .....................................................................................44  
9 Glossary ....................................................................................................................... ............46  
  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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NZFSA Public Discussion Document No 04/08 4 August 2008 
   1 Executive summary 
1.1 Purpose of this document 
The purpose of this discussion document is to provide information and seek submissions on a 
proposed framework (the framework) developed by the New Zealand Food Safety Authority (NZFSA) 
that, if progressed, would facilitate the manufacture  and domestic sale or export of some raw milk 
products for human consumption, and the importation and sale of a similar range of raw milk products.   
Submissions on this discussion document are invited to be made to NZFSA by 30 September 2008.  
All submissions received will be analysed and a de cision then taken about whether to progress the 
proposed framework for raw milk products. 
Should the framework be progressed,  then a second round of consultation would be initiated in 2009 
on the specific detail of the variou s elements that would be necessar y to implement the framework.  
These elements would likely include: 
• the additional technical requirements that woul d apply to any raw milk products able to be 
produced in New Zealand; 
• how the requirements would be implement ed in New Zealand food legislation;  
• the interface with the implementation of the Imported Food Review, including the proposed high, 
medium and low regulatory interest categories of  imported foods and the possible need to review 
any applicable biosecurity import health standards; and 
• measures that would be introduced to mitigate poten tial risks that raw milk products can pose to 
vulnerable consumers eg labelling, and education programmes. 
This document refers to some technical terms and reade rs should refer to the glossary in Section 9 for 
definitions. 
1.2 Raw milk products and the scope of this proposal   
All foods have the potential to cause foodborne illnes s and milk and milk products are no exception.  
Dairy animals may carry human pathogens (organism s which can cause a foodborne illness) that can 
be present in the milk used to produce dairy products.  The composition of some dairy products (eg  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   soft cheeses) means that they provide a good environ ment for the growth of any pathogens that may 
have been present in the milk used to produce them. 
Some heat treatments such as pasteurisation raise t he temperature of the milk used to produce dairy 
products to a degree that is sufficient to kill or inactivate pathogens, making these products low risk1.  
However, other dairy products are made from milk  that has not undergone such a heat treatment.  
Broadly speaking these products are generally referred to  as raw milk products, but it is important to 
note that there is no universally agreed definition of raw milk products, with several technical 
definitions in use internationally, including on e used by the Codex Alimentarius, which is the 
international food standards setting body (see Section 3.2.5.1). 
This document does not propose a definition for ra w milk products for New Zealand purposes (this 
would instead be developed as part of the more specific  technical work that could follow if a decision is 
taken to adopt the framework).  However, this do cument does outline what is meant by raw milk 
products in order to explain the scope of the fram ework that is proposed.  Raw milk products are 
defined for the purposes of this document as produc ts that have been produced from milk that has not 
been pasteurised or thermised in accordance with  the Food (Milk and Milk Products Processing) 
Standard 2007.  The framework pr oposed in this document would cover products for human 
consumption that have been manufactu red from the raw milk of a number of milking animals including 
cow, goat, sheep, buffalo, horse and camel.  These products would include cheeses and yogurts. The 
proposal does not, however, make any change to t he existing allowance under Section 11A of the 
Food Act 1981 for up to five litres of raw milk to be purchased for personal consumption from the farm 
gate. 
Some raw milk products can be made in such a way that pathogens that may have been present in 
the raw milk used to produce them are eliminated or have their growth inhibited.  As a result, raw milk 
products such as cheeses present a range of food safe ty risks, from those that are as safe as cheese 
made from pasteurised milk (such as certain hard and very hard raw milk cheeses), to those that pose 
a higher risk to all consumers (such as soft unripened raw milk cheeses). 
NZFSA believes it is possible to allow the importatio n of a wider range of raw milk products than is 
currently provided for, and to enable the product ion of equivalent products in New Zealand, by 
ensuring they are made from milk produced under particularly stringent conditions of animal health, 
and by following appropriate processing hygiene and cont rols.  The types of products permitted under 
the proposed NZFSA framework wo uld therefore be those that ac hieve an acceptable level of 
microbial safety for the general population. 
                                                      
1 This does not preclude contami nation during processing or pos t processing which is a risk for all dairy products.  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   Some vulnerable groups in the populat ion can potentially face greater ri sks (serious or life-threatening 
illness) from eating raw milk products, just as they  face similar risks from eating some other commonly 
available foods, such as raw shellfish.  These vulnerable groups consist of babies and toddlers, 
expectant mothers, the frail elderly, and any one whose immune system may be compromised 
because of a chronic illness, long term medication or  a recent operation.  For example, these groups 
are highly susceptible to some microbiological hazards (eg Listeria, Salmonella, Escherichia coli ) that 
may be present in raw milk products.  The NZFSA pr oposal set out in this discussion document is 
based upon mitigating the risks to vulnerable consumers by educating them about the risks associated 
with those raw milk products that pose a higher risk than pasteurised and thermised products, and by 
labelling such products so vulnerable consumers can avoid them.   
It is also possible that many raw milk products woul d have a niche market status (ie made or imported 
in limited quantities and be highly priced).  As such th e availability of these pr oducts, and therefore the 
exposure of the majority of the New Zealand population to them, would be limited, thus also limiting 
the probability of any impact occurring fr om any risk the products may pose. 
1.3 Background to this proposal 
1.3.1 Current availability of ra w milk products in New Zealand 
Currently all dairy products manufactured in New Zealand are made from pasteurised or thermised 
milk.2  The only exception to this is the “Five-Litre” Rule, which is provided for in Section 11A of the 
Food Act and allows producers to sell up to five litres of raw milk at any one time from their farm gate 
to people who intend to consume it themselves or provi de it to their family.  The only raw milk products 
that can legally be imported and sold in New Zealand are a limited variety of cheeses, following case-
by-case assessments of the risks that the particular  cheeses pose to consumers and attestation that 
any relevant import health standards can be attained.   
Domestic dairy producers can apply to NZFSA for a pproval to manufacture raw milk products under a 
Risk Management Programme (RMP) under the An imal Products Act 1999 or a Food Safety 
Programme (FSP) under the Food Act 1981.  Howeve r, there are no technical criteria or other 
guidance material in place to assist with the devel opment, evaluation, assessme nt for registration and 
subsequent verification of such a programme.  This has contributed to the fact that no manufacturer 
has applied to NZFSA for registration of a programme to cover the manufacture of raw milk products in 
New Zealand.   
                                                      
2 For an explanation of this and other technical terms, refer to the Glossary in Section 9.   Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   New Zealand food legislation currently permits the importation and sale of the following raw milk 
cheeses: three named hard and very hard Swiss cheeses, extra-hard Parmesan style grating 
cheeses, and Roquefort cheese.  The hard, very hard and extra-hard grating cheeses were only 
allowed to be sold in New Zealand (and Australia) following risk assessments carried out by Food 
Standards Australia New Zealand (FSANZ)3.  These cheeses have low moisture content and a very 
long storage period and are not considered to pose a risk to consumers.  As a semi-hard raw milk 
cheese, Roquefort has different properties than the hard and extra-hard cheeses and, therefore, 
NZFSA conducted its own risk assessment of Roquef ort, prior to recommending its direct importation 
and sale in New Zealand.  The NZFSA risk assessment of Roquefort indicated that consumption 
would constitute a low risk to most New Zealand consumers but a higher risk to vulnerable groups.  
These vulnerable groups are highly susceptible to some microbiological hazards (particularly Listeria ) 
that may be present in raw milk products.  Risk management measures, including a consumer 
education programme, have been introduced to mitigate the risks to these vulnerable groups. 
1.3.2 The impetus for change 
In some parts of the world there is a culinary traditi on of raw milk products (particularly cheeses), and 
such products are widely available.  In recent ye ars there has been increasing interest in the 
availability of raw milk products within New Zealand.  Requests have been made to NZFSA to allow 
more raw milk products (particularly cheeses) to be imported, and to develop the relevant technical 
criteria and other guidance material that would allow for the domestic manufacture and sale of raw 
milk products. 
This interest in raw milk products comes from co nsumers, importers and domestic manufacturers.  
Some consumers want a wider range of products to be available in New Zealand as they are in other 
countries, and may consider that raw milk products are superior in flavour and texture, as well as 
offering health benefits.  Importers see potential  business opportunities, for example to supply 
gourmet speciality cheeses, and are concerned about  the restrictions imposed by the current 
regulatory regime.  New Zealand dairy manufacturers, including smaller specialist cheese makers, are 
concerned about the inequity of the current situation whereby importatio n of some raw milk cheeses is 
allowed, but no provision for the manufacture of  similar cheeses in New Zealand has been made.  
Such manufacturers have expressed an interest in producing raw milk cheeses and see this as a 
business opportunity, both in terms of sales in the do mestic market and possibly in export markets.   
                                                      
3 FSANZ is responsible for developing food standards for both New Zealand and Australia (see Section 3.2.1.1. for more  
information).  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   In relation to imported products, NZFSA must also  ensure that import standards and requirements 
meet the World Trade Organization (W TO) Sanitary Phytosanitary Agreement and obligations under 
the European Commission/New Zealand Sanitary Agreement.  New Zealand’s current import 
requirements have allowed some raw milk products to be imported on the basis of individual risk 
assessments (including Roquefort cheese), but not ot hers (see Section 3.2.1.2 for the background to 
these decisions).  Some of New Zealand’s trading partners have questioned why this is the case.  
Completing the individual risk assessments for these imported cheeses has also been resource 
intensive and has resulted in decisions being made on a case-by-case basis.  
Australia is also considering new legislation to allo w the production and importation of a wider range of 
raw milk products.  Under the Trans-Tasman Mutual  Recognition Agreement (TTMRA) food produced 
in New Zealand or imported into New Zealand that meets New Zealand's legal requirements, may also 
be sold in Australia and vice versa.  There are so me exceptions, however, with for example, high-risk 
foods listed in either country requiring certification or testing before being permitted entry.  The limited 
range of raw milk cheeses currently able to be imported into New Zealand is included on the high risk 
list. 
As a result of all these factor s, NZFSA has been investigating ways of expanding the regulatory 
framework, should a decision be taken to allow a wide r range of raw milk products to be manufactured 
in, and imported into, New Zealand. 
In developing this framework and now providing an opportunity for a consultation process, NZFSA 
does however acknowledge that some New Zealanders may not support raw milk products becoming 
more widely available in New Zealand. 
1.4 NZFSA proposal 
NZFSA commenced consideration of a range of options relating to the domestic production and importation of raw milk products following the 2007 risk assessment and risk management decision for 
Roquefort cheese.  These options are outlined in de tail in Section 6 of this document.  NZFSA’s 
preferred option is to develop an appropriate regulatory framework that would allow for both New 
Zealand production of some raw milk products and the importation of a sim ilar range of raw milk 
products, without the need for full individual risk  assessments on a product-b y-product basis, while 
maintaining an acceptable level of consumer protection. 
To support the development and analysis of options  related to raw milk production and importation, 
NZFSA is undertaking a portfolio of risk assessment  work concerned with the public health risks 
associated with the consumption of raw milk and raw milk products.  Further details about this work 
are provided in Section 5.1.1.  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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NZFSA Public Discussion Document No 04/08 9 August 2008 
   NZFSA is working in collaboration with Australi a on a proposed framework based on a ‘category 
approach’.  Instead of case-by-case  assessments, raw milk products would be placed in one of three 
categories according to their food safety risk to human health.  The categories would be used as the 
basis for determining the additional requirements, if any, necessary to produce raw milk products with 
a low or acceptable food safety risk.  Under this fram ework, it is expected that  some types of raw milk 
products would still not be able to be im ported or made in New Zealand.   
The categories are defined depending on the effect that production and processing techniques, and 
the intrinsic characteristics of the final products, have on the survival and growth of pathogens that 
may be present in the raw milk.  Raw milk product s which allow for the survival and/or growth of 
pathogens pose a greater food safety risk, compared  to products where pathogen growth and survival 
is less likely.  
The potential food safety risk associated with each  Category increases from Category 1 to Category 3 
as illustrated below: 
Category 1 
Products where intrinsic 
characteristics and/or processing techniques eliminate pathogens that 
may have been present in the raw 
milk  
Category 2 
Products where intrinsic 
characteristics and/or processing 
techniques may allow the survival of pathogens that may have been 
present in the raw milk but do not 
support the growth of these pathogens 
Category 3 
Products where intrinsic 
characteristics and/or processing conditions are likely to allow the 
survival of pathogens that may have 
been present in the raw milk and may support the growth of these 
pathogens.    
 
The category approach would assist NZFSA with developing risk management measures; for example 
such measures would be more comprehensive for Ca tegory 2 products than for Category 1 products.   Products of increasing risk  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   It is considered that Category 1 products would be able to be safely produced or imported without 
additional control measures being required. 
The focus of regulatory control would be on Category  2 products, with regulatory measures expected 
to be developed relating to the harvesting of raw milk on farms and the processing into the resulting 
products. 
Category 3 products would not be able to be produced or imported into New Zealand, given the level 
of safety currently seen as acceptable for Ne w Zealanders.  These pr oducts would include raw 
drinking milk. 
Further details of this framework, including examples of products likely to fall under each Category, are 
provided in Section 5. 
NZFSA considers it important that, if this category ap proach is adopted, it is introduced simultaneously 
with a range of strategies designed to mitigate th e risks that the consumption of some raw milk 
products (likely to be those products in Category 2), would pose to vulnerable groups of consumers.  
These strategies would include the broadening of  NZFSA’s consumer education programme and the 
commissioning of a consumer survey to inform educ ative material and to provide input into decisions 
about appropriate labelling for raw milk products.  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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NZFSA Public Discussion Document No 04/08 11 August 2008 
   2 Consultation 
Comments and suggestions on the proposal outlined in this document are invited from industry, 
consumers, importers, key trading partners, public health specialists and other interested parties.  
2.1 Requirements for submissions 
Submissions are invited from any in terested party, whether representing an organisation or acting as 
an individual.  When sent on behalf of an organisati on, the submission should include the position in 
the organisation of the person signing the submissi on and the extent of internal consultation 
undertaken in preparing the submission.  All submi ssion formats will be accepted.  A guide to the 
content of submissions is provided in Section 8,  but you are welcome to comment on any additional 
matter relating to the proposal. 
2.2 Address for submissions 
Please send your submission on this proposal to: 
Technical Standards and Systems Team 
New Zealand Standards Group 
New Zealand Food Safety Authority 
PO Box 2835 
Wellington – New Zealand 
Facsimile: (04) 894 2643 
Email: TSS@nzfsa.govt.nz  
2.3 Closing date for submissions 
The closing date for submissions is 30 September 2008. 
2.4 Official Information Act 
The Official Information Act 1982 (OIA) states that information is to be made available unless there are 
grounds for withholding it.  Grounds for withholding info rmation are in the OIA.  Submitters may wish to 
indicate grounds for withholding information contai ned in their submission.  Reasons for withholding  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   information could include that information is comm ercially sensitive or that the submitters wish 
personal information such  as names or contact details to be withheld.  NZFSA will take such 
indications into account when determining whether or not to release information.  Any decision to 
withhold information requested under the OI A may be reviewed by the Ombudsman. 
2.5 Process after submissions 
After the closing date, submissions received will be analysed and taken into account when providing 
advice to the Minister for Food Safety and in making any subsequent recommendations to the 
Government.  NZFSA will publish a summary of the submissions receiv ed on this document.  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   3 Background 
Many of New Zealand’s trading par tners, particularly European countries, have a long culinary 
tradition of producing and consuming raw milk produ cts, especially cheeses, and such products are 
widely available in these countries. However, in  New Zealand, all dairy products manufactured and 
sold domestically or exported, and most imported dairy products, are made from pasteurised or 
thermised milk.  While legislation allows the dome stic manufacture and sale of raw milk products 
under a registered Risk Management Programme (RMP) or an approved Food Safety Programme 
(FSP), there are currently no approved technical crit eria or other guidance material that can be used 
by producers or processors to develop an FSP or  RMP and against which such programmes could be 
evaluated, assessed for regist ration and verified.  This has contribu ted to the fact that no manufacturer 
has applied to NZFSA for registration of a programme to cover the manufacture of raw milk products in 
New Zealand. 
Only limited varieties of cheeses made from raw milk can be imported and sold in New Zealand, 
following case-by-case assessments of the risks that  the particular products pose to consumers and 
attestation that any relevant import health standards have been attained.  
3.1 General information 
3.1.1 Pasteurisation and other heat treatments 
Pasteurisation is a well established and highly effe ctive process for assuring the safety of milk and 
milk products.  It involves heating milk to a spec ified temperature for a specified period of time - 
usually a high temperature for a sh ort period of time - to kill or i nactivate foodborne microbiological 
pathogens. 
The pasteurisation of milk has been progressively introduced in New Zealand since the 1890s for 
public health reasons, so that today it is the pr edominant heat treatment method used for processing 
dairy products. 
Some hard cheeses manufactured in New Zealand are also allowed to be produced using 
thermisation (heating the milk to lower temperatur es than pasteurisation) provided the cheese is 
stored at a specified temperature for not less than 90  days.  This combination of control measures for 
these types of cheeses are considered to provide an  equivalent level of safety to pasteurisation.   Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   3.1.2 Arguments made to NZFSA in support of raw milk cheese  
Raw milk cheese is made from milk that  has not been pasteurised or thermised4 and some people 
maintain that raw milk cheese has a particular flav our and/or texture.  While pasteurisation destroys 
potentially harmful pathogens, raw milk cheese enthusi asts contend that heat treatment also alters the 
natural composition and microflora of the milk (i ncluding the natural defences of the milk) and 
ultimately the flavour and health properties of the cheese.  There is also the contention that, while 
pasteurisation eliminates the pathogens that may be present in the raw milk, it does not guarantee a 
safe cheese as post-pas teurisation contamination5 can occur.6 
However, these views need to be considered in conjunction with the information about microbiological 
hazards and risk factors outlined below. 
3.1.3 Microbiological hazards 
Pathogenic bacteria have been identified as the major ha zard in raw milk.  As raw milk products are 
made from milk that has not been pasteurised or undergone any treatment that has an equivalent 
effect, they have a higher likelihood than pasteurised  products of containing pathogens that may have 
been present in the raw milk such as Listeria monocytogenes , Salmonella , Escherichia coli  and the 
tubercule bacillus (causative agent of tuberculosis).   
These pathogens can cause serious illnesses and can be life-threatening for vulnerable population 
groups – namely babies and toddlers, expectant mo thers, the frail elderly, and anyone whose immune 
system may be compromised because of a chronic illnes s, long term medication or a recent operation.  
While no food can ever be considered 100 percent sa fe, heating milk in the pasteurisation process 
destroys the harmful pathogens and elimi nates many of these hazards.   
                                                      
4 Note discussion on description of scope of this pr oposal and raw milk products in Section 1.2.  
5 Manufacturers in New Zealand and many overseas countries ar e, however, very aware of the possibility of contamination of 
dairy products and apply strict hygiene practices to ensure thi s does not occur.  Scientific evidence shows that pasteurised da iry 
products are very safe to consume. 
6 This view does not necessarily represent the views of NZFSA.  Please note NZFSA’s purpose in this paragraph is to describe 
views held by those who advocate wide r availability of raw milk products.  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   3.1.4 Risk factors 
In recent years, many nations have improved animal health and milk harvesting practices, and this 
development has increased the safety of the result ing raw milk products (although many raw milk 
products still pose higher risks than equivalent pasteurised products). 
A variety of factors can affect the safety of raw milk and the products manufactured from it.  Risk 
factors that may introduce pathogens into raw milk an d/or allow them to multiply include poor animal 
health, faecal contamination, environmental contamin ation, and inadequate temperature control during 
production, processing, storage and transport. 
Once pathogenic bacteria are present in raw milk, they may then contaminate the products made from 
it.  The extent to which they then survive and grow  is influenced by the manufacturing process and 
intrinsic properties of the product—for example, mo isture content, pH (acidity) and salt concentration—
and conditions during maturation and ripening, especially storage times and temperatures. 
While processing conditions for some products ca n prevent survival and growth of pathogenic 
bacteria, conditions associated with  other products may facilitate surv ival and/or possible growth of 
pathogenic bacteria.  For example, the high moisture content and high pH of soft unripened raw milk 
cheeses may allow bacteria to survive and grow an d such products are, ther efore, likely to pose a 
higher risk to consumers than hard raw milk cheeses, which have lower moisture content and lower 
pH.  Longer storage times during maturation and ripening may also  assist in controlling pathogen 
levels, as harmful bacteria may die off because of su ch factors as increasing acidity and salt content. 
3.1.5 An acceptable level of safety 
While some raw milk products do pose inherently higher food safety risks than products that have 
been produced with pasteurised or thermised milk (due to the survival of pathogens from the raw milk), 
there is evidence that some can be  manufactured so as to provide an acceptable level of protection for 
consumers. 
NZFSA proposes that it would be acceptable for ra w milk products, including cheeses, manufactured 
in New Zealand or imported into New Zealand to, at most, either: 
• pose only a minimal or low risk to the entire population, including vulnerable groups; or 
• pose only a low risk to the general population but a hi gher risk to vulnerable populations (similar to 
other foods commonly available in New Zealand such  as raw shellfish.)  In such cases, it is 
essential that the presence in the market of such products be accompanied by strategies to 
mitigate the risks to vulnerable consumers, eg education programmes and labelling that would  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   enable vulnerable consumers to avoid consumption of  such products.  It was on this basis that 
NZFSA recommended, and obtained Government agreement, to the importation into New Zealand 
of the semi-hard cheese Roquefort. 
Other raw milk products which pose greater heal th risks to the general population would not be 
permitted in New Zealand under the proposed framework. 
3.2 Current legislative requirements 
3.2.1 New Zealand 
3.2.1.1 Overview 
Under an Agreement Between the Government of Aust ralia and the Government of New Zealand 
Concerning a Joint Food Standards System  (the Food Treaty) signed in 1995, New Zealand and 
Australia have a joint food standards setting system which resulted in the Australia New Zealand Food 
Standards Code (the Code).  The Code, which is developed and published by FSANZ, covers the 
content, limits for food chemical and microbiological contaminants and additives, and labelling of food 
sold in New Zealand and Australia.  However, the Fo od Treaty does not apply to requirements for food 
safety, agricultural compounds, or th ird country trade; in these area s each country operates under its 
own legislation and therefore the Code’s Standards relating to food safety (Chapters 3 and 4, and 
Standard 1.6.2) do not apply in New Zealand. 
As a result, in New Zealand, processing requirements for milk and milk products are regulated under 
the Animal Products Act 1999 (APA) and the Food Act 1981.  The APA co vers all dairy processing in 
New Zealand and requires most dairy processors  to operate under a registered Risk Management 
Programme (RMP).  The dairy pr ocessing requirements is sued under the APA cover a wide scope of 
activities – from farm through to export or the point  of sale.  However, an exclusion under the APA 
also allows dairy processors supplying only the domestic market and Australia to operate under an 
approved Food Safety Programme (FSP) under the Food Act 1981.  This exclusion applies to all dairy 
processors except for farm dairy operators (ie milk harvesters).  Farm dairy operators harvesting milk 
for human consumption must operate under an RMP, regardless of whether the milk is intended for 
the domestic market or export.  An exemption from  the requirement to have an FSP and an RMP is 
also available for dairy products sold and totally  consumed on the manufacturing premises (eg cheese 
made in a restaurant) under the Animal Products (Exemptions and Inclusions) Order 2000. 
The Food (Milk and Milk Products Processing) Standard 2007 under the Food Act requires dairy 
products manufactured in New Zealand to be made from pasteurised milk; from milk which complies  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   with the requirements for “cheese treatment” (two  treatments are specified: thermisation and the 
treatment used to produce extra-hard grating chees es); or under a registered RMP or approved FSP 
as noted above.  The only exception to this is the “Five-Litre” Rule, which, under Section 11A of the 
Food Act 1981, allows producers to sell up to five litres of raw milk (which has been harvested under 
an appropriate RMP) at any one time from their fa rm gate to people that intend to consume it 
themselves or provide it to their family – this pr ovision is being considered in the Domestic Food 
Review and is outside the scope of this proposal. 
Both RMPs and FSPs are risk-based management pr ogrammes designed to identify and control 
hazards and other risk factors relating to the produc tion and processing of dairy products, other animal 
products, and food products in order to ensure that  the resulting products are safe and suitable.  
RMPs and FSPs are either developed by individual pr oducers to meet their sp ecific requirements, or 
are based on templates and codes of practices approved by NZFSA. RMPs developed by the 
individual operator must be independently evaluated before  registration is granted.  In all cases, once 
a programme is registered or approved and is operating,  it is subject to verification on a regular basis. 
Although domestic dairy producers can apply to NZFSA for approval to manufacture raw milk products 
under an RMP or FSP, there are no technical criteria or  other guidance material in place to assist with 
the development, evaluation, assessment for regi stration and subsequent verification of such a 
programme.  This has contributed to the fact that no such RMP or FSP applications have been 
received by NZFSA and so there have be en no approvals of such programmes. 
3.2.1.2 Imported raw milk products 
Currently, only limited varieties of cheeses made from raw milk can be imported and sold in New 
Zealand, following case-by-case assessments of the risk that the particular products pose to 
consumers.  All other imported dairy products are made from pasteurised or thermised milk. 
The requirements for importers relating to pasteuris ation and other heat treatments are set out in the 
Food (Milk and Milk Products Processing) Standard 2007 issued under the Food Act.   
Until July 2007, the only raw milk cheeses that were able to be legally imported into New Zealand 
were three specific hard and very hard Swis s cheeses—Emmental, Gruyere and Sbrinz.  These 
cheeses have low moisture content and a very long storage period, which means NZFSA views them 
as similar in risk to cheeses made from pasteurised milk.   
In 2007, following consultation, NZFSA amended the New Zealand (Milk and Milk Processing) Food 
Standard 2007 and the Food (Prescribed Foods) Standar d 2007 to permit the import of Roquefort and 
extra-hard raw milk grating cheeses into New Zeal and.  NZFSA conducted its own risk assessment of 
Roquefort prior to recommending the direct importat ion and sale of this cheese in New Zealand.  The  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   assessment was prompted in part by a request in 2004 from the French Government, following a 
decision by the Australian Government to allow t he importation of Roquefort into Australia.   
The hard and very hard Swiss raw milk cheeses and extra-hard grating raw milk cheeses are 
manufactured by heating the curd and have very low moisture content and long maturation/ripening 
periods.  Risk assessments conducted by FSANZ concluded that cheeses manufactured to these 
criteria, using good hygienic and manufacturing practices, pose a low food safety risk because the 
cooking of the curd and the long storage periods control/destroy bacterial pathogens and the low 
moisture content inhibits their subsequent growth.  As a result, these specific varieties of hard and 
extra-hard raw milk cheeses are considered to have a similar level of microbiological safety to 
products derived from pasteurised milk.  It was on this basis that a change was made to allow for their 
importation and sale into New Zealand. 
The importation and sale of Roquefort was allowed on the basis that it should be accompanied by 
appropriate risk mitigation measur es, including an education campaign for vulnerable consumers on 
the possibility of foodborne risks associated with t he consumption of Roquefort.  NZFSA noted during 
consultation that, while the risk assessment indica ted that appropriate risk  management measures 
applied to the production of Roquefort cheese woul d minimise risks to the general New Zealand 
consumer to a level similar to other higher risk fo od types such as raw shellfish, a low (unquantified) 
level of foodborne risk remained. 
As a semi-hard raw milk cheese, Roquefort carries a higher risk for some consumers.  Softer raw milk 
cheeses are of higher risk than hard raw milk chee ses as their additional moisture content can allow 
pathogens to more readily survive and possibly grow. 
The NZFSA risk assessment of Roquefort indicated t hat consumption would constitute a low risk to 
most New Zealand consumers but a higher risk to  vulnerable consumers.  Although production 
methods for Roquefort minimise the risks, they are not lowered to the same level as pasteurised dairy 
products. 
NZFSA is not aware that the subsequent presence on the New Zealand market of Roquefort has 
provoked any rise in related foodborne illness. 
3.2.1.3 Raw milk products for animal consumption 
The framework proposed in this document addresses  raw milk products for human consumption only.  
Requirements for the processing and sale or export of  dairy products intended for animal consumption 
are already addressed by the Animal Products Act 1999 and the Agricultural Compounds and 
Veterinary Medicines Act 1997.  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   Processors of dairy material intended for anima l consumption are required to operate under an 
independently evaluated and NZFSA registered RMP unl ess exempt.  Section 8B(2) of the Animal 
Products (Exemptions and Inclusions) Order 2000 pr ovides an exemption for processors of dairy 
material for animal consumption from the requireme nt to operate under a RMP provided that no other 
operations at the same place require an RMP and the product is for sale in New Zealand or Australia.  
However, regardless of any exemption, the require ments or duties set out in the Animal Products 
(Dairy) Regulations 2005 and, for use within New Ze aland, the Agricultural Compounds and Veterinary 
Medicines Regulations 2001 apply. 
Currently, the most common trade of raw dairy materi al for animal consumption is thought to relate to 
raw colostrum for calf rearing and raw milk or unpasteurised products for pigs.  Any change to enable 
the manufacture of raw milk products in New Zealand is not expected to have any impact on the 
manufacture of animal feeds. 
3.2.2 Australia 
Like New Zealand, Australia does not currently al low production of raw milk products, with the 
exception of the production for sale of raw goat  milk which is permitted in New South Wales, 
Queensland, South Australia and Western Australia.   Australia does permit the importation of the 
same raw milk cheeses as New Zealand—namely three specific Swiss hard cheeses, extra-hard 
Parmesan-style grating cheeses and the French semi-hard cheese Roquefort. 
Australian legislative requirements fo r the production of dairy products are set out in the Australia New 
Zealand Food Standards Code (the Code).  The Code requires that milk and liquid milk products in 
Australia must be pasteurised (or undergo an equiva lent treatment), “unless an applicable law of a 
State or Territory otherwise  expressly provides”.  As a result, St ates or Territories are responsible for 
giving permission to produce and sell raw milk and the production of raw drinking goat milk for sale for 
human consumption is permitted in four States. 
FSANZ has developed a number of national standard s through its work on primary production and 
processing standards for identified primary industry  sectors. The Primary Production and Processing 
Standard for Dairy Products, Standard 4.2.4, was gazetted in the Code on 5 October 2006 and comes 
into effect in Australia on 5 October 2008.  Standar d 4.2.4 contains measures to address food safety 
in the dairy industry from production of milk th rough to processing, including the manufacture of 
specified dairy products. These measures include pasteurisation or an equivalent process.  Standard 
4.2.4A in the Code applies to Australia only and a llows the importation and sale of Roquefort cheese 
and the same three raw milk Swiss cheeses allowed to be imported and sold in New Zealand.  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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NZFSA Public Discussion Document No 04/08 20 August 2008 
   FSANZ has recently commenced work on developing a framework that would a llow the production and 
importation of a wider range of raw milk products in Australia.  This proposal (Proposal P1007) 
includes addressing: public health and safety issues; existing applications that FSANZ has received to 
allow the production/import and sale of raw milk prod ucts; and regulatory inconsistencies.  FSANZ is 
currently consulting on Proposal P1007. 
3.2.3 Collaboration with Australia 
As noted in Section 1.3.2, under TTMRA food that can be legally sold in one country may be legally 
sold in the other.  There are some exceptions, ho wever, with for example, high-risk foods listed in 
either country requiring certificat ion or testing before being permitted entry.  Australia and New 
Zealand are committed to removing regulatory barriers to the movement of goods and service 
providers between Australia and Ne w Zealand and so facilit ate trade between the two countries.  To 
this end NZFSA and FSANZ have been cooperating in the area of high-risk foods to allow the removal 
of ‘risk-goods’ from the exemption schedule of the TTMRA. 
Australia is facing similar issues to New Zealand in that there is domestic demand for raw milk 
products, but legal restrictions on the production  and importation of such products.  NZFSA and 
FSANZ have recognised that both are proposing to ta ke a similar approach to raw milk products and 
have therefore been working collaboratively on the devel opment of a technical framework for raw milk 
products. 
Although there is potential for differences in appr oach, FSANZ and NZFSA will continue to consult and 
collaborate on a technical level, recognizing that  risk management measures may be enacted 
differently in the respective countries. 
3.2.4 Imports from other countries 
NZFSA is in the process of implementing the outcome of the Imported Food Review.  This includes the 
categorisation of foods into those of High, Medium and Low interest.  Should the proposals set out in 
the discussion paper proceed, then NZFSA will need to  consider the interface with the imported foods 
categorisation.  Many foods imported to New Zealand must also comply with Import Health Standards 
set by the Ministry of Agricult ure and Forestry (MAF) Biosecurit y New Zealand.  Implementation of 
these proposals, should they proc eed, will also therefore need to include consideration of whether any 
Import Health Standards need to be developed or revi ewed and the timeframe that needs to be 
allowed for this work to occur (refer also to Section 5.4).  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   3.2.5 Relevant national and international standards 
3.2.5.1 Codex Alimentarius 
The Codex Alimentarius (Latin for ‘food code’ or ‘f ood book’) is an international food standards code 
developed and maintained by the Codex Alimentariu s Commission.  The Commission was established 
and is jointly run by the Food and Agriculture Organi zation (FAO) of the United Nations and the World 
Health Organization (WHO).  The Commission devel ops standards that are designed to protect the 
health of consumers and promote fair practices in food trade and that may be used as a base for 
national legislation by all of its member nations  (New Zealand has been a member of Codex since 
1964). 
Provisions for raw milk products, with the specific exclusion of raw drinking milk, are included in the 
Commission’s Code of Hygienic Practice for Milk and Milk Products (CAC/RCP 57-2004).  Raw milk is 
defined in the Commission’s  Code as milk that has not been heated beyond 40 degrees Celsius or 
undergone any treatment that has an equivalent e ffect.  The Commission’s Code emphasises strict 
hygiene conditions for the harvesting of milk and on-f arm activities to ensure that, in combination with 
control measures during processing, raw milk prod ucts are safe and suitable for human consumption. 
The Commission’s Code also contains a requirement for the labelling of the product to make it clear 
that the milk has not been heat-treated. 
3.2.5.2 European Union 
The European Union (EU) is a political and econom ic community of twenty-seven member states. The 
EU has developed a single market through a standardis ed system of laws which apply in all member 
states, guaranteeing the freedom of mo vement of people, goods, services  and capital.  EU legislation 
is set by the European Community (EC). 
Many European countries have a tradition of pr oducing a wide range of raw milk products7 (particularly 
cheeses) and these products are permitted for sale in  the EU.  EC legislation sets out microbiological, 
food safety and process hygiene criteria governing the production and labelling requirements for raw 
milk products.  Specific provisions for raw m ilk production include: animal health requirements; 
hygiene of milking; storing and collection operations;  and health and hygiene of personnel.  Member 
                                                      
7 Defined as products made from milk that has not been heated beyond 40 degrees Celsius or  undergone any tr eatment that 
has an equivalent effect. 
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   states then develop their own laws, regulations and administrative provisions, which must comply with 
the EC regulations.  Where the manufacturing pr ocess does not include any heat treatment, or 
physical or chemical treatment, pr oducts made with raw milk must be clearly labelled with the words 
‘made with raw milk’. 
The European Union (EU) permits the sale of raw m ilk products subject to the following EC sanitary 
and food hygiene regulations: 
• Commission Regulation (EC) 852/2004 on the hy giene of foodstuffs (lays down the hygiene 
requirements for all food business operators); 
• Commission Regulation (EC) 853/2004: specific hygi ene rules for food of animal origin (lays down 
specific requirements for food businesses dealing with foods of animal origin); and 
• Commission Regulation (EC) 854/2004: specific ru les for the organisation of official controls on 
products of animal origin intended for human consumption. 
These regulations took effect in member countries on 1 January 2006. Following publication of the consolidated EC Food Hygiene Regulations in 2004, a number of 
implementing regulations and transitional measures that support the application of the EC regulations 
have also been published, including Commission Re gulation (EC) No 2073/2005 on microbiological 
criteria for foodstuffs. 
New Zealand and the EC have a Treaty level Sani tary Agreement which recognises EC sanitary 
measures (including food controls) for animals and animal products as equivalent to New Zealand 
requirements.  Once a product or class of produ cts is acknowledged as being included under this 
Agreement, that product or class of product can be imported to New Zealand. 
3.2.5.3 United States of America 
In the United States of America (USA), the produc tion of raw milk products is regulated by individual 
states, some of which allow for their manufacture and sale.  For example, the sale of raw drinking milk 
is legal in 26 of the 50 states in the USA.  T he raw milk regulations differ between states but can 
contain requirements for warning labels; licensing; restri ction of sales to the farm gate or to individuals 
who have a signed prescription from a physician; an d limits on the period that raw milk can be sold 
from the time when a farmer fills a milk container. 
Federal law bans the movement between states of all locally manufactured or imported raw milk 
products, except for certain cheeses which must be aged for a minimum of 60 days at a set 
temperature.   Proposed framework for the manufacture, importation and sale of raw milk products  
 
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NZFSA Public Discussion Document No 04/08 23 August 2008 
   3.2.5.4 Canada 
The sale of raw drinking milk is strictly prohi bited under Canadian Food and Drug Regulations.  
However, like the USA, some Canadian provinces pe rmit the sale of some raw milk cheeses that have 
been stored for at least 60 days at a set temperat ure.  There is also an agreement between the 
Canadian Food Inspection Agency and French authoriti es which allows for the importation of raw milk 
soft and semi-soft cheeses and exempts these French pr oducts from having to satisfy the requirement 
for 60 days storage. 
Canada has recently attempted tighter regulatory cont rol with respect to soft and semi-soft cheeses.  
For this purpose, a Code of Hygienic Practice, de veloped by Health Canada, has been distributed for 
comment amongst provincial and territorial governments. 
Canada has also developed education campaigns th at attempt to raise awareness of the potential 
hazards associated with raw milk cheeses.  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   4 The reasons for the development of the 
proposed framework for raw milk products 
There has been increasing in terest in the availability in New Zealan d of raw milk products, particularly 
cheeses, with requests being made to NZFSA that it allow for the domestic manufacture, sale and 
export of raw milk products and for the importation of  a similar range of products.  The requests have 
come from several sources: 
• Some New Zealand consumers consider raw milk products to be superior in taste, texture and 
quality than pasteurised dairy products.  Others believe  it is their right to have access to the same 
choice of foods as is available overseas.  A fu rther group of consumers consider that there are 
health benefits to be derived from consuming ra w milk products, including improvements in the 
symptoms of arthritis, asthma and eczema, and boosting of the immune system.  Some in the 
gourmet food sector would also welcome access to raw milk products for use in their food 
products. 
• Some New Zealand dairy manufacturers, especially specialist cheese makers, have indicated an 
interest in producing raw milk cheeses.  T hey have expressed concern about the inequity and 
inconsistency of the current situation whereby some raw milk cheeses can be imported but may 
not be manufactured in New Zealand, and are in terested in developing markets for raw milk 
products, both in New Zealand and overseas. 
• Importers are concerned about the restrictions  imposed by the current regulatory regime and 
would like to bring other types of raw milk cheeses into New Zealand in order to satisfy demand for 
gourmet foods, without the need for the indi vidual assessment of such products. 
• A number of EU member countries are interested in exporting raw milk cheeses to New Zealand, 
and the decision to allow French Roquefort cheese to be imported in 2007 has increased this 
interest. 
Other factors that have supported a review of the availability of raw milk products in New Zealand 
include that: 
• There is evidence that some raw milk products , other than those already available on the New 
Zealand market, are safe for human consumption, ei ther because of their intrinsic characteristics, 
or because of steps that are followed during their production process. 
• Current New Zealand legislation does allow for domestic dairy producers to apply to NZFSA for 
approval to manufacture raw milk products under an RMP or FSP.  However, because there are  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   no technical criteria or other guidance material in place to assist with the development, evaluation, 
assessment for registration and subsequent veri fication of such programmes, New Zealand 
manufacturers have not applied to NZFSA for the registration of programmes for the manufacture 
of raw milk products. 
• The production of raw milk products (with the specific exclusion of raw drinking milk), under 
appropriate hygienic conditions, is recognised  in the Codex Alimentarius Code of Hygienic 
Practice for Milk and Milk Products.  New Zealand is a member of the Codex Alimentarius 
Commission. 
• The New Zealand/European Community (EC) S anitary Agreement recognises EC sanitary 
measures (including food controls) for animals and animal products as equivalent to New Zealand 
requirements.  This is relevant because, should a framework to allow wider importation of raw milk 
products be introduced, it is likely that many of the new types of raw milk products that would be 
imported into New Zealand would originate from Europe. 
• Australian legislation allows the importation of the same raw milk cheeses that can be imported 
into New Zealand.  However in response to domes tic demand, Australia is considering developing 
standards to allow the production and importation of a wider range of raw milk products.  Under 
the TTMRA, food that can be legally sold in Australi a can be legally sold in New Zealand, and vice 
versa.  There are some exceptions, however, wi th for example high-risk foods listed in either 
country requiring certification or testing before  being permitted entry.  Australia and New Zealand 
are committed to removing regulatory barriers to the movement of goods and service providers 
between Australia and New Zealand and so facilitate trade between the two countries.  To this 
end, NZFSA and FSANZ have been co-operating in the area of high-risk foods. 
• Continuing to assess on a case-by-case basis wh ether raw milk products manufactured overseas 
are suitable for import into New Zealand, as has been done for Roquefort and the hard and very 
hard Swiss cheeses and extra-hard grating cheeses, is  not practical.  It is resource intensive and 
allows for potential inconsistencies between the treatment of imported and domestic products, and 
between different imported products.  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   5 Proposed framework for raw milk products 
NZFSA is proposing to introduce a framework (the fr amework) that would allow for raw milk products 
to be assessed as to whether they can be safely  produced, imported, exported and sold in New 
Zealand, and to identify the specific requirement s that would apply to such products.  While the 
framework would cover all raw milk products, only those that could be produced to an acceptable level 
of safety (that is, present a low food safety risk to  the general human population) would be able to be 
legally produced and imported. 
If, following the consultation initiated by this discu ssion document, a decision is taken to advance the 
proposed framework, then a second  round of public consultation would be initiated providing further 
details of the framework (for example the criteria for categorising raw milk products) and the draft 
technical and legal requirements necessary to impl ement the framework.  The framework would apply 
to products that fall under the Animal Products Ac t 1999, the Food Act 1981 and the proposed new 
Food Bill. 
5.1 Proposed framework for raw milk products 
The proposed framework is based on a ‘category approach’, with raw milk products being grouped into one of three categories according to their food sa fety risk.  The proposed framework includes the 
following elements: 
• three risk categories for raw milk products; 
• processes to categorise products into these three categories; 
• education of vulnerable consumers; 
• labelling of raw milk products that pose a higher risk to vulnerable consumers; and 
• revised import standards reflec ting the category approach.   
5.1.1 Risk assessment 
To inform the development of the proposed framew ork, NZFSA is undertaking a portfolio of risk 
assessment work concerned with pu blic health risks associated with t he consumption of  raw milk and 
milk products.  This includes: 
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   • various Risk Profiles including; Listeria mono cytogenes in low moisture cheese, Listeria 
monocytogenes in soft cheeses, Mycobacterium bovis in milk and Shiga toxin-producing 
Escherichia coli (STEC) in raw milk; 
• a review of the science supporting the curre nt dairy pasteurisation time and temperature 
parameters; 
• a qualitative risk assessment of the risk to Ne w Zealand consumers from the consumption of 
Roquefort cheese; 
• a Quantitative Risk Assessment (QRA) to assess  the risk to New Zealand consumers from the 
consumption of raw milk and raw milk produ cts (see 5.1.4. for further information); 
• scientific studies relating to heat inactivation of pat hogens in raw milk (in partnership with Fonterra) 
from which data was generated to provide paramet ers for the Quantitative Risk Assessment; and 
• Systematic Review of the human disease evidence  associated with the consumption of raw milk 
and raw milk cheese. 
FSANZ is also undertaking microbiological risk and social science assessments relating to the 
consumption of raw milk and some raw milk cheese s, and NZFSA will be closely monitoring the results 
of this work. 
5.1.2 Proposed category approach 
The proposed category approach for raw milk products has been developed after consideration of: 
• the existing legal requirements for raw milk cheese s currently able to be sold in New Zealand and 
Australia, and the risk assessm ent advice used to determine th ese requirements, which examined 
production factors and the intrinsic prop erties of selected dairy products; and 
• FSANZ and EU assessments available for other European-style raw milk cheeses. 
Raw milk products would be categorised into one of th ree categories on the basis of food safety risk to 
human health.  This is determined by the effect that the production methods and the intrinsic 
characteristics of the final products have on pa thogen survival and growth.  Processing factors 
include: curd cooking temperature, acidification an d storage time.  Intrinsic characteristics include: 
water activity, moisture content, acidity and salt co ncentrations.  As illustrated below, the potential 
food safety risk associated with the products in each category would increase from Category 1 to 
Category 3, with Category 1 products having the lowest risk to human health and Category 3 the 
highest.  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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Category 1 
Products where intrinsic 
characteristics and/or processing techniques eliminate pathogens that 
may have been present in the raw 
milk  
Category 2  
Products where intrinsic 
characteristics and/or processing 
techniques may allow the survival of pathogens that may have been 
present in the raw milk but do not 
support the growth of these pathogens 
Category 3 
Products where intrinsic 
characteristics and/or processing conditions are likely to allow the 
survival of pathogens that may have 
been present in the raw milk and may 
support the growth of these 
pathogens.    
 
Risk management options for each category would vary and be more comprehensive for higher risk 
products.  The category approach would assist  NZFSA to develop risk management options for 
groups or categories of raw milk products, removing  the need for resource intensive and ad hoc case-
by-case assessments of indi vidual processes and products. 
Prior to the importation of any overseas-made raw mi lk products not already available in New Zealand, 
MAF Biosecurity New Zealand would also need to be involved in any necessary revision and/or 
development of biosecurity import health standards. 
5.1.3 Description of categories 
The proposed three categories for raw milk products are described below.  The descriptions in bold 
apply to products at the end of the manufacturing  process—this includes any maturation of the 
products as is, for example, required for many cheeses.  Also included are some examples of 
products that could be included in each of the cat egories and some indication of the risk management 
options that could apply. Products of increasing risk  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   5.1.3.1 Category 1 
Category 1 products are defined as those products where intrinsic  characteristics and/or 
processing  techniques  eliminate pathogens that may have been present in the raw milk. 
Examples of products in Category 1 would include the extra hard grating cheeses, which are made 
from raw milk by heating the curd and have a long ma turation/ripening period.  These steps result in 
the death of pathogens and mean that  these cheeses have an equivalent level of safety to pasteurised 
products. 
Category 1 raw milk products would pose a low risk (similar to pasteurised and thermised products) to 
all New Zealand consumers, including vulnerable populations.  As a result, they would be able to be 
produced and imported safely, without addi tional control measures being required. 
5.1.3.2 Category 2 
Category 2 products are defined as those products where intrinsic characteristics and/or 
processing techniques may allow the survival of pathogens that may have been present in the 
raw milk but do not support the growth of these pathogens. 
This Category would apply to products where there is possible survival, but not growth of micro-
organisms such as Salmonella , Listeria monocytogenes , Campylobacter  or Staphylococcus aureus .  A 
combination of control measures and verification procedures (including of on farm practices)  
additional to those currently applied to dairy products , would be applied to the production of Category 
2 products to provide an acceptable level of micr obial safety for consumption by the general public. 
Based on the previous risk assessments of imported Roquefort cheese, this could be an example of a 
Category 2 product. 
The focus of NZFSA regulatory control would be on allowing the safe production and importation of 
products in Category 2 (see Section 5.2).  Some raw milk products would be assigned to Category 2 
with the development of technical criteria to assist in the design, evaluation and verification of FSPs 
and RMPs for these products. 
Products in Category 2 would pose a low food safety risk to the general population, but would 
potentially be of higher risk to vulnerable groups.  The introduction of such products would need to 
coincide with risk mitigation strategies including education and labelling, to ensure that vulnerable 
consumers can identify raw milk products in this Category and are aware of the risks posed by their 
consumption.  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   5.1.3.3 Category 3 
Category 3 products are defined as those products where intrinsic characteristics and/or 
processing techniques are likely to allow the survival of pathogens that may have been present 
in the raw milk and may support the growth of these pathogens. 
Category 3 products are those that are not subj ect to any control measures that would reduce 
pathogens to an acceptable level.  In general, if pathogens are present, they would be expected to 
multiply during any processing, maturation or stora ge steps and in the final product.  This Category 
would include products such as raw drinking milk and would be likely to include high moisture content cheeses, such as unripened cheeses. 
Category 3 products would not be able to be legally produced in New Zealand or imported because 
there are no appropriate processing techniques t hat could ensure such products are safe for 
consumption by the general New Zealand population, given the level of safety currently seen as 
acceptable to New Zealanders. 
5.1.4 Categorisation of  raw milk products 
NZFSA proposes to develop tools to assist wi th categorisation of raw milk products. 
It is proposed initial categorisation of products in to Category 1 be determined by a filter based on 
processing factors and product characteristics (e.g. pH, salt level, moisture).  Raw milk products that 
did not meet the criteria of Category 1 would fall into  either Category 2 or Category 3.  A second filter 
will be necessary to categorise many of the raw milk products into either Cate gory 2 or Category 3. 
The second filter will include a Quantitative Risk As sessment (QRA) that has been developed in order 
to assess the risk to New Zealand consumers from the consumption of raw milk and raw milk cheeses. 
The QRA takes a farm-to-fork approach from prim ary production, through milk processing, product 
manufacture, sale and consumption. The results from  the QRA will then aid the categorisation of the 
product into either Category 2 or Category 3. 
However, for some products manufacturers or importers will need to provide NZFSA with additional 
evidence to demonstrate that processing factors and  the intrinsic characteristic of a product/category 
of product can provide for an acceptable level of safety. 
Raw milk products that are placed in Category 3 would not be able to be produced or imported given 
the level of safety currently seen as acceptable for New Zealanders.  Those wanting to manufacture or 
import a product in Category 3 would be required to specify additional processing steps that would be 
introduced to increase the safety of the product and show how these steps would be validated.  If 
NZFSA accepts that the product could be produced to an acceptable level of safety with these  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   additional controls, then it would be moved into Category 2.  If not, the product would remain in 
Category 3. 
It is likely that ongoing monitoring will be required  to confirm that parti cular products have been 
categorised correctly and that these categories remain valid. 
5.2 Preliminary risk management options for categories 
Raw milk products that can be produced safely wit hout additional control measures would fall into 
Category 1, whilst Category 3 products would not be able to be manufactured or imported for sale.  As 
a result, the regulatory framework would focus on Category 2 products and the additional control 
measures or requirements that wo uld be necessary to produce Cat egory 2 products to an acceptable 
level of safety.  It is likely that  measures relating to Category 2 milk harvesting and milk processing 
would also require closer monitoring and control th roughout the production life cycle, compared to 
Category 1. 
5.2.1 Category 2 
NZFSA has undertaken some preliminary work to consider what additional measures or requirements 
might be necessary to ensure that Category 2 raw milk products have an acceptable level of safety 
(whilst acknowledging that these measure would on ly need to be introduced if the framework is 
agreed).  NZFSA has split the process into two st ages: milk harvesting and milk processing.  The 
following is an indication of what NZFSA may propose. 
Milk Harvesting: 
At present, requirements related to the harvesting of  milk on the farm are set out under the Animal 
Products Act 1999.  If the proposed framework is agreed, there would need to be additional 
requirements for the harvesting of the m ilk used to produce raw milk products. 
Current milk harvesting requirement s are based on the assu mption that the milk will be pasteurised, 
which kills or inactivates foodborne pathogens.  As  raw milk products are not subjected to this 
processing step, it is crucial that t he levels of pathogens in raw milk are kept as low as possible.  The 
areas that would need to be considered when det ermining the requirements for raw milk production 
are still to be finalised, but would include animal  health, feeding, transport and storage times, 
temperature control and registration of farm dairies. 
The requirements for raw milk harvesting would be based on the guidelines established for raw milk 
products by the Codex Alimentarius Commission.  This approach is considered appropriate due to:  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   • the clear and existing guidance on risk management options for raw milk products provided in the 
Codex Code of Hygienic Practice for Milk and Milk Products; 
• the large number of milk harvesting operations in New Zealand, which require a detailed approach 
to ensure the methods that are used to achieve food safety are consistent and effective; and 
• the proposed approach needing to be consistent wi th the current mandate of the Animal Products 
Act, because milk harvesting does not fall within the scope of the Food Act. 
Milk Processing: 
The proposed processing requirements for the manufacture of raw milk products would most likely be 
more outcome based and less detailed than the requir ements applied at the milk harvesting stage.  
NZFSA considers that this is appropriate due to the diversity of processing conditions that are 
potentially available and that could be us ed to safely produce raw milk products. 
Processing controls that may be required could include: the use of starter cultures in fermented 
products; acid production including target pH values and the time for acid development; salting 
procedures and salt levels; and curing or ripening conditions. 
Should the proposed framework for raw milk products be agreed, NZFSA would need to consider how 
these processing requirements would be implemented under both the Animal Products Act and the 
Food Act. 
5.3 Other risk mitigation considerations 
As part of the proposed framework, NZFSA has been undertaking preliminary consideration of ways of 
helping to mitigate the risks associ ated with consumption of raw milk products.  Raw milk products can 
contain harmful pathogens that may cause serious illn esses and be life-thre atening to vulnerable 
groups.  In countries where raw milk cheeses are part of the culture, the longsta nding culinary tradition 
means there is widespread awareness  of the risks of consuming raw milk products.  However, as 
these products are new to New Zealand, raising p ublic awareness of the risks involved in their 
consumption by vulnerable groups is very important. 
5.3.1 Consumer education programme 
NZFSA operates an education programme for vulnerable groups to communicate information about 
public food safety risks to both vulnerable groups (the young, frail elderly, expectant mothers and the 
immune-compromised), and other  members of the community.  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   In 2007 NZFSA broadened its education programme to include the raw milk cheese Roquefort, 
following amendments to the legislation that allowed the direct importation and sale of this product.  
Activities included articles in NZFSA publications and consumer magazines, media releases, and 
flyers displayed at points-of-sale.  In addition,  NZFSA specifically targeted at-risk groups by 
distributing information to every medical centre and midwife in New Zealand.  
Should the framework for raw milk products be agr eed, NZFSA would further utilise its education 
programme for vulnerable groups to communicate the risks associated with raw milk products 
generally in order to ensure consumers make informed choices.  NZFSA is currently reviewing the effectiveness of the education programme for Roquefort cheese.  This will a ssist in determining if any 
changes or additions to the programme may be required in future. 
As part of the consultation process initiated by  this discussion document, NZFSA would welcome 
feedback on effective and equitable strategies to communicate with vulnerable groups. 
5.3.2 Consumer survey 
To enhance the design and effectiveness of its educ ation programme and to gain more information on 
New Zealand consumers’ understanding of raw milk products, NZFSA is commissioning a survey of 
consumers, the hospitality and reta il trade, and health professionals. 
The primary objectives of the NZFSA consumer su rvey are to determine public awareness and 
understanding: 
• of terms such as ‘raw milk’, ‘un-pasteurised milk’, ‘pasteurised milk’ and ‘raw milk cheese’; 
• of the risks associated with the co nsumption of raw milk products; and 
• that raw milk products pose relatively greater risks to some vulnerable population groups.   
The survey will also ask particip ants about their current and expected future consumption of raw milk 
products, and their expectations about labelli ng and the content and placement of information 
material. 
In association with the survey, NZFSA will also use small focus gr oups to discuss labelling options, 
including the need for advisory statements, wordin g for labelling and the effectiveness of NZFSA’s 
education materials for vulnerable consumers. 
FSANZ is also commissioning research into Australian consumer behaviours and motivations in 
respect of raw milk prod ucts, and NZFSA will be taking an interest in the findings of the FSANZ 
research with the view to better informing New Zealand education strategies.  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   5.3.3 Labelling 
The labelling requirements for all food (including dairy products) sold in New Zealand are set out in the 
Australia New Zealand Food Standards Code (the Code).  Among other things, the Code requires that 
the label on a package of food for retail sale must include the name of the food and a list of its 
ingredients.  In the case of raw milk product s, the list of ingredients would include raw (or 
unpasteurised) milk. 
Mandatory advisory statements are used when consum ption of a food exposes the general population 
or a population subgroup to a health and safety risk , or where guidance about a food is needed to 
maintain public health and safety.  The list of foods  that are required by the Code to have a mandatory 
advisory statement includes unpasteurised milk and li quid milk products, but does not currently include 
raw milk cheeses or other raw milk products.  This means that the labelling on unpasteurised milk and 
liquid milk products must include an advisory statem ent “to the effect that the product has not been 
pasteurised”, but that no such mandatory advisory st atements nor any other warnings are required on 
the labels of raw milk cheeses or other raw milk products. 
The consumer survey being commissioned by  NZFSA will provide data about New Zealand 
consumers’ understanding of raw m ilk products.  Combined with the feedback received in response to 
this discussion document, this is expected to as sist with determining whether the current labelling 
requirements for raw milk products are considered su fficient, or whether these requirements should be 
strengthened and if so how this may be achieved.  One possibility is  the use of mandatory advisory 
statements to more clearly differentiate raw milk products. 
The need for any change to the current labelling requirements is also an area in which NZFSA will 
continue to collaborate and consult with FSANZ. 
5.4 Imported food standard for raw milk products 
Raw milk cheeses are currently included in the Fo od (Prescribed Foods) Standard 2007 as they are 
considered a high risk food.  This recognises that some foods, because of their nature or the way in 
which they are handled, can pose an increased ri sk of illness to consumers.  The Prescribed Food 
Standard details which foods are pres cribed and also the hazards for which they can be monitored. 
New Zealand legislation permits the importation a nd sale of three named hard and very hard Swiss 
raw milk cheeses, extra-hard raw milk Parmesan st yle grating cheeses, and Roquefort cheese.  These 
cheeses are listed in the Food (Milk and Milk Produ cts Processing) Standard 2007.  Raw milk cheeses 
can only be imported from an exporting country that  operates a production pr ogramme that has been  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   assessed and recognised as equivalent to, or comp lying with, New Zealand’s standards, through a 
country-to-country arrangement. 
Development of a future import standard for raw mi lk products would be based on the outcome of any 
New Zealand processing standard for raw milk products, with the same category approach (as 
outlined in Section 5.1) being applied.  Under the new Imported Food Regime, which is currently in the 
process of being implemented, many raw milk product s are likely to be classed as high regulatory 
interest foods.  This means such products would only be able to be imported from countries with which 
New Zealand has a country-to-country  arrangement.  This would provide a high level of food safety 
assurance prior to these pr oducts entering New Zealand. 
MAF Biosecurity New Zealand (MAFBNZ) is responsi ble for ensuring all New Zealanders, our natural 
resources, plants and animals are protected from the potential introduction of pests and diseases.  
MAFBNZ develops Import Health Standards which ar e issued under the Biosecurity Act 1993.  They 
state the requirements that must be  met before goods identified as a risk to our biosecurity can be 
imported into New Zealand.  In order for a wider range of raw milk products to be introduced, MAFBNZ 
would need to develop Import Health Standards for these products and the development of such Import Health Standards would need to be prioriti sed against other projects on the MAFBNZ work 
programme. 
5.5 Exports 
If permitted, the New Zealand manufacture and export of raw milk products could potentially open new 
export market opportunities, since previously all dai ry products exported from New Zealand have been 
pasteurised. The possible future volumes/value of ex ports of raw milk products are not able to be 
precisely quantified at this time by NZFSA.  Initially  such trade is likely to be small, but potentially it 
could grow considerably.  Balanced against this bene fit there is, however, a need to ensure that the 
current significant export trade in pasteurised prod ucts is protected, as a damaging food safety 
incident relating to an exported raw milk product co uld impact not only on raw milk product exports, 
but on all New Zealand dairy exports. 
All food products exported from New Zealand must be produced in accordance with New Zealand 
legislative requirements and also meet the legislat ive requirements of the importing country.  Should 
the proposal outlined in this discussion document  proceed, the development of general export 
standards for raw milk products may be necessary but would be dependent on the outcome of the 
New Zealand standard for such products.  Any additi onal export requirements would most likely relate 
to verification activities from fa rm through to export, the separation and identification of raw milk 
products post manufacture, and official certification.   However, it is likely that any additional general 
export requirements would be minimal.  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   NZFSA is also undertaking initial review of other el ements that could impact on any future export of 
raw milk products including: 
• Labelling: Since all dairy products exported from New Zealand have, to date, been pasteurised, it 
may be prudent to provide clear information on the la bel of all unpasteurised export dairy products 
to prevent misconception by importing countries unaware of the change in New Zealand policy.  
This would also ensure that foreign consum ers are made aware of any  risks posed by the 
consumption of New Zealand raw milk products. 
• Export certificates: NZFSA is reviewing export cert ificate templates for dairy products to ensure 
declarations would be compatible with the certific ation of both raw milk and pasteurised products 
processed in New Zealand.  
• Export requirement notices: These generally sp ecify whether or not dairy products must be 
pasteurised, and for many countries, this requir ement has been established for many years.  
NZFSA is obtaining updated information on the im port requirements for raw milk products in 
potentially important export markets such as the EU, the USA and Canada.  Requirements for 
other markets would be established or reviewed on  a country by country basis, on request from 
exporters prior to export, and the relevant ex port requirement notice amended accordingly. 
5.6 Cost recovery 
If a decision is taken to facilitate the local production of raw milk products and the importation of a 
similar range of such products, NZFSA would a pply its cost recovery policy and framework to 
determine which of the associated activities need to be funded privately or through industry, rather 
than through Crown funding.  Further information about any fees, charges or levies relating to raw milk 
products would be discussed during the second round of consultation, should this proceed.8 
                                                      
8 For further details on the NZFSA cost recovery policy and framework, see the NZFSA Background Paper No 06/04: Cost 
Recovery Policy and Framework at http://www.nzfsa.govt.nz/policy-law/publications /reports/cost-recovery/index.htm  
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   6 Possible options considered by NZFSA and 
analysis of their impacts 
In considering the approach to take with regard to the New Zealand production and importation of raw 
milk products, NZFSA considered four possible options: 
• Option 1: To maintain the status quo; 
• Option 2: To maintain the status quo and, in addition, not consider any further applications for 
case-by-case assessments that could allow importat ion of raw milk products not already available 
New Zealand;   
• Option 3:  To develop a framework, based on ri sk to consumers, which would allow both New 
Zealand production of some raw milk products and the importation of a similar range of raw milk 
products while maintaining an acceptable level of protection for consumers; and 
• Option 4: To allow all types of raw milk products to be both made in New Zealand and imported 
into New Zealand, regardless of t he risk they pose to consumers. 
The potential positive and negativ e impacts of each of these options are analysed below. 
The preferred option of NZFSA is Option 3. 
6.1 Analysis of options 
6.1.1 Option 1: To maintain the status quo 
Potential positive impact s of Option 1 include: 
• A small range of raw milk cheeses would continue to be available in New Zealand, maintaining 
some limited access to raw milk pr oducts for New Zealand consumers. 
• There would be no need for resources to be devoted to developing either a framework for raw milk 
products, or the necessary standards to implement this framework.  
Potential negative impacts of Option 1 include:  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   • The restrictions on the range of raw milk prod ucts available would be unpopular with those who 
advocate consumer choice, or those who consider  raw milk products have desirable flavour, 
quality or health properties. 
• New Zealand legislation would continue to allow for domestic dairy producers to apply to NZFSA 
for approval to manufacture raw milk products under an RMP or FSP, but in practice there would still be no technical criteria or ot her guidance material to assist with the development, evaluation, 
assessment for registration and subsequent verifica tion of such a programme.  This would be 
likely to deter local production, as has been the case in the past, and to prevent local 
manufacturers from diversifying into new market  niches, both in New Zealand and overseas.   
• NZFSA would continue to assess, on a case-by- case basis, any additional raw milk products 
which importers might apply to bring into New Zeala nd.  This is a slow, resource intensive process 
that can potentially result in inconsistencies between the treatment of imported and domestic 
products, and between different imported products.   
• Overseas suppliers wishing to export raw milk pr oducts to New Zealand (other than those varieties 
approved by case-by-case assessments) would be unable to do so. 
• Australia is considering developing a regulatory framework which, if approved, would allow for the 
production and importation of a wider range of raw mi lk products in Australia.   Should this occur, 
NZFSA and FSANZ would need to work to facilit ate trade of these products.  This would 
exacerbate the anomalous situation for those intere sted in manufacturing raw milk products in 
New Zealand, or create an anomaly for those inte rested in importing such products directly from 
markets other than Australia. 
• The EC and some EU member states have expr essed interest in New Zealand allowing a wider 
range of raw milk products to be more readily imported; but this option would not facilitate such 
trade.  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   6.1.2 Option 2: To maintain the status quo and, in addition, not consider any 
further applications for case-by-case ass essments that could allow importation 
of raw milk products not already available in New Zealand 
Potential positive impact s of Option 2 include: 
As for Option 1 above, but would also include that: 
• Some local manufacturers may consider this Op tion more equitable than Option 1.  This is 
because no further varieties of raw milk produc ts, other than those already on the New Zealand 
market, could be imported in the future. 
• Those that consider that raw m ilk products pose significant health risks to vulnerable consumers 
(despite proposed risk mitigation strategies) ma y welcome this Option as it would prevent wider 
importation and production of raw milk products. 
Potential negative impacts of Option 2 
As for Option 1 above, but would also include that: 
• Some commentators could consider this Option to be inconsistent with New Zealand’s obligations 
under the World Trade Organization Sanitary and Phytosanitary Agreement. 
• Under this Option, no further case-by-case asse ssments of overseas made raw milk products 
would be undertaken.  Whilst this would remove t he potential for inconsistencies to arise between 
the treatment of imported and domestic raw milk products, it would also mean that New Zealand 
consumers would not have access to any other ty pes of overseas raw milk products, other than 
those varieties already available.   Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   6.1.3 Option 3: To develop a framework, based on ri sk to consumers, which 
would facilitate both New Zealand produc tion of some raw milk products and 
the importation of a similar range of ra w milk products, while maintaining an 
acceptable level of consumer protection for New Zealanders 
This is NZFSA’s preferred option. 
Potential positive impact s of Option 3 include: 
• New Zealand consumers would have access to a wi der range of raw milk products.  This would be 
welcomed by those who advocate consumer choi ce and those who consider that raw milk 
products have desirable flavour, quality and/or health properties. 
• New Zealand manufacturers could produce some raw milk products.  This could allow local 
manufacturers to take advantage of new business  opportunities both in domestic and export 
markets, and would ensure there is no inequity between the treatments of overseas and locally 
made raw milk products. 
• The framework proposed by this Option would categorise raw milk products according to the level 
of risk that their consumption poses to human health.  As a result, those raw milk products that 
pose higher levels of risk to New Zealand consumers would be unable to be made in, or imported 
into, New Zealand unless manufacturers or impo rters could demonstrate that processing steps 
could be followed to ensure products were produc ed to an acceptable level of safety.  The 
framework proposed by this Option includes risk mitigation strategies (for example, consumer 
education and labelling), which would o ffer protection for public health. 
• New Zealand importers could import a wider range of raw milk products directly from their 
countries of origin (once any Import Health Standards have been reviewed or developed by MAF 
Biosecurity New Zealand, as may be required).  
• NZFSA would assess the risks posed by import ed raw milk products according to the new 
framework, instead of the current  case-by-case basis.  The cu rrent case-by-case system is 
resource intensive and allows for potential inco nsistencies to arise between the treatment of 
imported and domestic products, and between different imported products.  
• This Option would remove the potential for an anom aly to be created if a local manufacturer was to 
apply to have an RMP registered or an FSP approved for raw milk products, only to find that no 
technical criteria exist against which such a pr ogramme could be evaluated, assessed or verified.  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   • If Australia proceeds with plans to allow for the production and importation of a wider range of raw 
milk products, then New Zealand and Australian rule s for the importation and manufacture of raw 
milk products would remain similar.  
• New Zealand trading partners may welcome this Option. 
Potential negative impacts of Option 3 include: 
• Those who may consider that raw milk products pose significant health risks to vulnerable 
consumers (despite the proposed risk framework an d risk mitigation strategies) may be concerned 
that an increased variety of raw milk pro ducts would be available in New Zealand. 
• Raw milk products classified under NZFSA’s proposed new framework as Category 3, or high risk 
products, would be unable to be manufactured or im ported (see Section 5.1.3 for a description of 
these categories).  Whilst some may consider this  to be an advantage, others, such as local 
manufacturers and those who contend that all raw milk products can provide health benefits to 
consumers may oppose this restriction. 
• This Option would require resources to be devoted to developing the risk management framework, 
developing the standards necessary to implemen t the framework, and to educating consumers 
about raw milk products.   
• Manufacturers and importers of raw milk product s would have to follow technical criteria, and/or 
demonstrate that these have been met, and would need to commit resources to this process. 
• This Option would require that agencies and persons are available, or can be trained, to provide 
verification and related services for raw milk products.  
6.1.4 Option 4: To allow for all types of raw milk produc ts to be both made in 
New Zealand and imported into Ne w Zealand, regardless of risk 
Potential positive impact s of Option 4 include: 
• New Zealand consumers would have access to a full range of raw milk products.  This could be 
welcomed by those who advocate consumer choi ce and those who consider that raw milk 
products have desirable flavour, quality and/or health properties. 
• New Zealand manufacturers could produce raw mi lk products without any restriction and there 
would be no inequity between the treatment of ov erseas and locally made raw milk products.  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   • New Zealand importers could import the full range of  raw milk products directly from their countries 
of origin.  
Potential negative impacts of Option 4 include: 
• In the absence of a framework based on ri sk, all types of raw milk products could be 
manufactured, and imported into New Zealand, rega rdless of the risks that they pose to public 
health.  As some types of raw milk products do pose  high risks, this could result in serious health 
consequences for the New Zealand population. 
• An outbreak of illness associated with consum ption of raw milk products could damage New 
Zealand’s reputation as a reliable and trusted supplier of safe and suitable food. 
• If raw milk products that pose high risks to cons umers were to be exported from New Zealand, a 
negative incident related to any such products could have a substantial and damaging impact on 
New Zealand’s reputation as an international export er of food, and especially as an exporter of 
milk products.  The success of the New Zealand dai ry industry is linked to its reputation as a high 
quality and safe provider of products, both to export markets and to the New Zealand domestic 
market. 
• RMPs and FSPs require that food safety ri sk factors are identified and controlled and/or 
eliminated.  Allowing all types of raw milk product s to be available in New Zealand, regardless of 
the risks that they pose, would therefore be out of step with cu rrent food safety policy and would 
require amendment to, or exemption from, existing legislation. 
• This proposal is out of step with government policy and the approach taken in other food related 
legislation.  Some raw milk products are a threat  to public health, as evidenced by outbreaks in 
other countries.  To knowingly allow these products to be manufactured or imported into New 
Zealand would expose NZFSA, and possibly the go vernment, to a charge of relinquishing 
responsibility. 
• New Zealand does not operate a ‘buyer beware’ approach to food – therefore importers and/or 
manufacturers of products that were identifi ed as causing illness or death would be open to 
prosecution unless the relevant legislation (the Food Act and Animal Products Act) was amended 
to remove such a liability. 
The scale and significance of the po tential negative impacts of Option 4 calls into question the viability 
of this Option.  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   7 Conclusion 
NZFSA’s preferred option is to enable the manufacture and sale (both within New Zealand and for 
export) of some raw milk products, and allow for the importation and sale of a similar range of raw milk 
products, while maintaining an acceptable level of consumer protection. 
NZFSA is proposing to introduce a framework that w ould allow for the assessment and identification of 
those raw milk products that could be safely produced, imported and sold in New Zealand, and any 
specific requirements that would need to apply to th ese products.  While the framework would cover 
all raw milk products for human consumption, only those that could be produced safely (that is, 
present a low food safety risk to the general popula tion) would be able to be legally produced and 
imported.  If the proposed framework was to be progressed, regulations and associated guidance 
information would then be introduced to enable its implementation.  The framework would include 
provision for consumer education and info rmative labelling of raw milk products. 
The proposed framework is based on a ‘category ap proach’ with raw milk products being placed in 
one of three categories according to their food safety risk.  The category approach has been 
developed after consideration of the FSANZ and NZFSA risk assessments of raw milk cheeses 
currently able to be sold in New Zealand and Aust ralia, and EU assessments for other European-style 
raw milk cheeses.  It has also been informed by other NZFSA risk assessment work on the public 
health risks associated with the consumption of ra w milk and raw milk products.  The category 
approach would assist NZFSA to develop risk ma nagement options for each of the categories, 
removing the need for case-by-case assessments of some individual processes and products.  It is 
likely that technical criteria would not be initially developed for all raw milk products categories, with 
priority instead being given to raw milk cheeses. 
If, following the consultation initiated by this discu ssion document, a decision is taken to advance the 
proposed framework for raw milk products, a second round of public consultation would be initiated on 
the draft technical and legal requirements necessary to implement the framework outlined in this 
document.  The proposed regulatory framework would apply to products that fall under the Animal 
Products Act 1999, the Food Act 1981 and the proposed new Food Bill.  Associated implementation 
matters including the interface with the Imported Food Review, MAF Biosecurity Import Health 
Standards, and any monitoring programmes needed, al ong with a regulatory impact assessment on 
any proposed regulations, would also be consi dered in the preparation for any further public 
consultation.   Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   8 Questions and submission example 
NZFSA seeks your views on the proposal in this document.  The following form has been provided to 
assist you in making a submission, but comm ents in other formats will also be welcome. 
If you have any queries about the NZFSA proposal or other information in this document, please 
contact the Technical Standards and Systems Team on 04 894 2467 or TSS@nzfsa.govt.nz 
 
Name: 
Organisation’s Name (if applicable): 
Contact details (including phone, email if available): 
Please comment under any or all of the following headings: 
1. The consultation process 
2. Support for and against raw milk products:  
• Consumers may wish to provide information on matters such as whether: 
− you perceive a demand for raw milk products in your community;  
− you currently consume such products;  
− you would consume such products if  they were more widely available; 
− such products appeal to you; and 
− you have a greater demand for some ra w milk products (such as cheeses) 
than others. 
• Industry may wish to provide information on matters such as whether: 
− you support the proposed new framework for raw milk products;  
− you wish to make or import raw milk  products and if so what type(s); and 
− the proposed framework would have an impact on your business.  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   3. Proposed framework: 
Please provide comments on the NZFSA proposal, including: 
• the suggested framework and categories for raw milk products; 
• the preliminary risk management options for categories and  
• other risk mitigation considerations, including suggestions on: 
−  how best to communicate wi th vulnerable groups,  and 
− effective labelling for raw milk products  (for example is a warning statement 
needed on raw milk products? What is the best term to use to describe such 
products?) 
4. Alternative options: 
• Are there other feasible opti ons that have not been canvassed? 
• Do you have any comments to add to the analysis of the options? 
5. Please provide any other comments or information that could supplement the 
analysis in this discussion document. 
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   9 Glossary 
Australia New Zealand Food Standards Code (the Code) : A collection of individual food standards 
developed by FSANZ (see below).  As a result of an Agreement Between the Government of Australia 
and the Government of New Zealand Concerning a Joint Food Standards System  (the Food Treaty), 
signed in 1995, New Zealand and Australia have a joint food standards setting system which resulted 
in the Australia New Zealand Food Standards Code (The Code).  The Code covers the content and 
labelling of food sold in New Zealand and Australia.  However, the Food Treaty does not apply to 
requirements for food safety, maximum residue leve ls, or third country trade; in these areas each 
country operates under its own legislation and theref ore the Code’s Standards relating to food safety 
(Chapters 3 and 4, and Standard 1. 6.2) do not apply in New Zealand.   
Extra hard grating cheeses:   These cheeses are often referred to as extra hard Parmesan style 
grating cheeses as they are so hard they require gr ating to serve.  The treatment required to produce 
these cheeses is defined in the Food (Milk and Milk Products Processing) Standard 2007 as: 
“Method B 
(i) The heating of the curd to a temperature of not less than 48 degrees Celsius; and 
(ii) The cheese or cheese product is stored at a temperature of not less than 10 degrees Celsius for a 
period of no less than 6 months from the date of manufacture.” 
Food Safety Programme (FSP) :  A programme as required by Section 4A of the Food Act 1981, 
designed to identify and control food sa fety risk factors in order to establish and maintain food safety.   
Food Standards Australia New Zealand (FSANZ) :  An independent statutory agency, established by 
the Food Standards Australia New Zealand Act 1991 (Australian Commonwealth legislation), which 
sets food standards covering the content of labelli ng of food, for both countries (see Australia New 
Zealand Food Standards Code). 
New Zealand Food Safety Authority (NZFSA) :  The government department with a role of protecting 
and promoting public health and facilitating access to markets for New Zealand’s food and food 
related exports. 
Pasteurisation :  The term “pasteurisation” for milk or a m ilk product is defined in the Food (Milk and 
Milk Products Processing) Standard 2007 as treatmen t according to one of the following methods -  
“(i) The holding method, by which the milk or milk pr oduct is rapidly heated to a temperature of not less 
than 63 degrees Celsius and not more than 66 degrees Celsius, retained at that temperature for not 
less than 30 minutes, and then -  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   (a) immediately and rapidly reduced to 5 degrees Celsius or less in the case of milk or milk 
products other than cream, or to 7 degrees Cels ius or less in the case of cream; and 
(b) maintained at or below that temperature until the milk or milk produc t is removed from the 
premises for delivery; 
(ii) The high-temperature short-time method, by whic h the milk or milk product is rapidly heated to a 
temperature of not less than 72 degrees Celsius, re tained at that temperature for not less than 15 
seconds, and then treated in accordance with sub paragraphs (a) and (b) of the method in paragraph 
(i); 
(iii) Any other heat treatment method t hat is as effective in terms of bacterial reduction as methods (i) 
and (ii).” 
Pathogenic and Non-pathogenic organisms :  Pathogenic organisms (pathogens) include bacteria, 
viruses or cysts, which are capable of causing diseases  (for example, typhoid, cholera, dysentery) in a 
host (such as a person).  Non-pathogenic organisms do not cause disease. 
Risk Management Programme (RMP) :  A programme as defined by Section 12 of the Animal 
Products Act 1999, designed to identify, and control,  manage and eliminate or minimise, hazards and 
other risk factors in relation to the production and processing of animal material and animal product in 
order to ensure that the resulting animal  product is fit for intended purpose.   
Thermisation is a heat treatment and is included in the definition of cheese treatment method A 
defined in the Food (Milk and Milk Products Processing) Standard.  The Standard states: 
“Method A 
“(i) The rapid heating of milk or a milk product to be used in the manufacture of cheese to a 
temperature of not less than 64.5 degrees Celsius, reta ining it at that temperature for not less than 16 
seconds; and 
(ii) Storing the cheese prior to sale at a temperat ure of not less than 7 degrees Celsius for not less 
than 90 days from the date of co mmencement of manufacture.” 
Subsection (i) is thermisation and (ii) is the storage requirement that must occur in conjunction with 
this treatment.  Cheeses that have been treated and stored as per this requirement are known as 
thermised cheeses.  
The Trans-Tasman Mutual Recognition Arrangement (TTMRA):  A non-treaty arrangement 
between the New Zealand and Australian governments that aims to remove regulatory barriers to the 
movement of goods and thus facilitate trade between  the two countries—goods that may legally be 
sold in New Zealand may be sold in Australia and vice versa, regardless of any differences in 
standards or other sales-related regulatory requi rements.  Goods need only comply with the standards 
or regulations applying in the jurisdiction in wh ich they are produced or through which they are  Proposed framework for the manufacture, importation and sale of raw milk products  
 
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   imported before they can be sold in another participat ing jurisdiction.  There are limited exemptions to 
these provisions.  Implemented in New Zealand by  the Trans-Tasman Mutual Recognition Act 1997.