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Proposed regulatory framework for unpasteurised milk products

NZFSA Public Discussion Paper No 02/09
May 2009

ISBN number 978-0-478-32274-3 ( Print) ISBN number 978-0-478-32275-0 (Online)

ISSN number 1174-961X (Print) ISSN number 1177-7478 (Online)

Important Disclaimer

Every effort has been made to ensure the information in this report is accurate.

NZFSA does not accept any responsibility or liability whatsoever 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

Table of Contents

1 Executive summary 5

2 Introduction 8

3 Submissions 10

3.1 Requirements for submissions on this paper 10

3.2 Address for submissions 10

3.3 Closing date for submissions 11

3.4 Official Information Act 11

3.5 Process after submissions 11

4 Background 12

4.1 Current availability of unpasteurised milk products in New Zealand 12

4.1.1 Manufacturing in New Zealand 12

4.1.2 Sale of liquid raw milk 12

4.1.3 Importation of unpasteurised milk cheeses 13

4.2 Requests for New Zealand restrictions on unpasteurised milk products to be lifted 13

4.3 Options for a regulatory framework for unpasteurised milk products 14

4.4 Proposed regulatory framework as described in the first discussion paper 15

4.5 Developments since the release of the first discussion paper 15

4.5.1 Submissions received on the first discussion paper 15

4.5.2 Decision to continue work on the proposed framework 16

4.6 Results of research 16

4.6.1 Systematic review of the human disease evidence associated with the consumption of raw milk and raw milk cheese 17

4.6.2 Report on on-farm provisions for raw milk production 18

4.6.3 Pathogens in raw milk 18

4.6.4 Risk profiles on the risks associated with milk products 19

4.7 Survey of consumer awareness and understanding of unpasteurised milk products 19

5 Risk management 22

5.1 An overview of the risks associated with unpasteurised milk products 22

5.1.1 Milk as a source of pathogens 22

5.1.2 Reducing the levels of pathogens in milk 22

5.1.3 Extending the shelf life of milk by converting it into dairy products 23

5.1.4 Raw milk in cheese making 23

5.1.5 Risk assessments of unpasteurised milk products 25

5.1.6 What we do know about the risks associated with milk products 25

5.2 Managing the hazards associated with unpasteurised milk products 26

5.2.1 Risk communication 27

5.2.2 Risk communication for unpasteurised milk products 27

5.2.3 Labelling 28

6 Proposed regulatory framework 31

6.1 Definitions of milk product categories 31

6.2 Requirements for unpasteurised milk products 33

6.2.1 Products that can be produced under existing dairy regulatory requirements 33

6.2.2 Raw Milk Products that can be produced under the proposed specifications 34

6.2.2.1 Requirements in the proposed specifications for raw milk products 34

6.3 Approval processes for unpasteurised products 35

6.4 The use of a predictive mathematical model to assist operators 36

6.5 Application to imported products 36

7 Technical requirements and controls for raw milk products 38

7.1 Current regulatory requirements for dairy products made in New Zealand 38

7.2 Technical requirements proposed 38

7.2.1 Processors of unpasteurised milk products able to be produced under existing regulatory requirements 38

7.2.2 Processors of raw milk products that can be produced under the proposed specifications 39

8 Legal issues 41

8.1 Proposed Animal Products (Raw Milk Products Specifications) Notice 2009 41

8.2 Amendment to the Food (Milk and Milk Products Processing) Standard 2007 42

8.3 Amendment to the Food (Prescribed Foods) Standard 2007 43

8.4 Other legal requirements for New Zealand producers and retailers of unpasteurised milk products 43

8.4.1 Farm gate sales of unpasteurised drinking milk 43

8.4.2 Evaluation, auditing and verification requirements 43

8.4.3 The Australia New Zealand Food Standards Code (the Code) and labelling 44

8.4.3.1 Compliance with the Code 44

8.4.3.2 Labelling 44

8.5 Importation of unpasteurised milk products 45

8.5.1 Legal requirements 45

8.5.2 Biosecurity Import Health Standards 46

8.6 Export of unpasteurised milk products 46

9 Implementation of the framework for unpasteurised milk products 49

9.1 Familiarisation for industry, importers and third parties 49

9.1.1 Guidance material 49

9.1.2 Workshops 49

9.2 Costs 50

9.3 Risk communication and consumer education 51

10 Regulatory impact statement 52

11 Questions and submission example 60

12 Glossary 61

Appendix 1: Draft Animal Products (Raw Milk Products Specifications) Notice 2009 64

Appendix 2: Draft Food (Imported Milk and Milk Products) Standard 2009 74

Appendix 3: Draft Amended Food (Prescribed Foods) Standard 2009 81

Appendix 4: Standards and requirements for unpasteurised and raw milk products set by a selection of overseas countries and international bodies 85

1 Executive summary

This discussion paper provides details of a regulatory framework, being proposed by the New Zealand Food Safety Authority (NZFSA), which would further facilitate the New Zealand manufacture, domestic sale, and export of unpasteurised milk products for human consumption, and the importation of a similar range of such products.

This is the second discussion paper that NZFSA has released on unpasteurised milk products. An earlier discussion paper was released in August 2008 and can be viewed at: http://www.nzfsa.govt.nz/consultation/unpasteurised-milk-products-round-1/discussion-paper/discussion-document-on-raw-milk-products-final-aug-2008.pdf.

Currently, only a small variety of unpasteurised milk products are available in New Zealand. These products consist of a few cheese varieties imported into New Zealand under the Food (Milk and Milk Products Processing) Standard 2007, and limited farm gate sales of liquid raw milk permitted under section 11A of the Food Act 1981 (the Food Act).

Otherwise, all New Zealand dairy products are made from pasteurised milk, except for some cheeses that are subjected to alternative treatments to pasteurisation during manufacture. These alternative treatments have been approved by NZFSA and combine processing and product compositional factors which contribute to pathogen death and result in processes with an equivalent food safety outcome to pasteurisation.

New Zealand processors of dairy products are able to apply to NZFSA to manufacture unpasteurised milk products under a risk management programme (RMP) under the Animal Products Act 1999 (APA) or a food safety programme (FSP) under the Food Act. However, until now, no technical criteria or guidance material for operators have been developed to assist with the development, evaluation, assessment for registration or approval, and verification or auditing of such programmes. Emphasis has instead been given to facilitating production of, and trade in, pasteurised milk products.

In recent years NZFSA has received requests that it should both permit a wider range of unpasteurised milk products to be imported into New Zealand, and develop the technical criteria and guidance material that would enable the local manufacture, sale and export of a similar range of such products. These requests have come from consumers, the food and retail trade, local manufacturers, importers, and overseas trading partners. In part, they reflect the fact that unpasteurised milk products are already produced and consumed safely in many other parts of the world. The international food safety standard setting agency, the Codex Alimentarius Commission, provides for the manufacture of such products in its Code of Hygienic Practice for Milk and Milk Products and Australian authorities are also considering making changes to allow more unpasteurised milk products on to the Australian market.

In response to these developments, NZFSA is proposing the introduction of a regulatory framework that covers all unpasteurised milk products, and would allow those that can be produced to an acceptable level of safety (that is, that pose a low level of risk to the general population) to be produced, sold, exported and imported.

The framework acknowledges that unpasteurised milk products pose varying levels of hazards to human health. There is potential for pathogens present in raw milk (such as Listeria monocytogenes, Campylobacter spp. and Escherichia coli) to multiply in some unpasteurised milk products to levels in excess of acceptable food safety criteria. However, many other unpasteurised milk products have intrinsic compositional characteristics and/or undergo processing steps which ensure that pathogens are either eliminated from the end products, or are unable to multiply to levels in excess of food safety criteria.

The framework proposed by NZFSA, and outlined in this discussion paper, consists of:

• processes to group unpasteurised milk products according to the hazards they pose;

• requirements relating to on-farm and processing techniques, with which producers of some unpasteurised milk products would need to comply;

• proposed new specifications, to be issued under the APA, that would apply to some unpasteurised milk products;

• revised import standards relating to unpasteurised milk products;

• risk communications and educative material targeted at vulnerable consumers; and

• labelling to indicate products contain unpasteurised milk.

This discussion paper also provides information about the research and risk profiling that NZFSA has undertaken or commissioned to inform the development of the proposed framework, and provides an overview of the risks associated with unpasteurised milk products.

NZFSA is responsible for administering the APA and Food Act, and would implement the proposed new framework for unpasteurised milk and raw milk products. NZFSA would develop guidance materials to familiarise industry operators, importers, third party agencies and other interested parties with the relevant technical and legal requirements for manufacturing and importing unpasteurised milk products. NZFSA would also run information and training workshops about these requirements. NZFSA’s risk communications strategy would evolve to include resources to educate consumers about unpasteurised milk products.

A second round of public consultation on the framework will be initiated by the release of this discussion paper. During the consultation period for this paper, NZFSA will host workshops in regional centres to familiarise stakeholders with the proposal and to seek feedback. Submissions on the discussion paper are invited from all interested parties.

Dependent on the results of consultation and decisions by government, the proposed regulatory framework could be introduced in the latter part of 2009.