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Proposed regulatory framework for unpasteurised milk products

8 Legal issues

In 1995, New Zealand and Australia agreed to establish a joint food standards setting system under an Agreement Between the Government of Australia and the Government of New Zealand Concerning a Joint Food Standards System (the Food Treaty). As a result, the Australia New Zealand Food Standards Code (the Code) was introduced. The Code covers the content, limits for food chemical and microbiological contaminants and additives, and labelling for food sold in New Zealand and Australia. However the Food Treaty does not apply to requirements for food safety, agricultural compounds, or third country trade and instead, in these areas, each country operates under its own legislation.

In New Zealand, processing requirements for milk and milk products are regulated under the APA and Food Act. Facilitating the domestic production, sale and export of a wider range of unpasteurised and raw milk products, and the importation of a similar range of such products, will require changes to be made to New Zealand law, namely the introduction of a proposed Animal Products (Raw Milk Products Specifications) Notice 2009 (the Notice), and the amendment of the Food (Milk and Milk Products Processing) Standard 2007 and the Food (Prescribed Foods) Standard 2007.

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

It is proposed that the Chief Executive of NZFSA will issue specifications under the APA, to be known as the ‘Animal Products (Raw Milk Products Specifications) Notice 2009’ (the Notice). The Notice will set out mandatory requirements to be met by producers of those raw milk products which fall under the following definition (as opposed to all unpasteurised milk products):

‘raw milk product means a processed dairy product-

(a) that has not received a pathogen elimination step; and

(b) in which as a result of its nature and the manner in which it is processed, may allow the survival of pathogens, but in the case of pathogens specified in the food safety criteria, will not support their growth or allow their survival, to levels that exceed those specified in the food safety criteria; and

(c) that is not raw drinking milk; and

(d) that is not made from colostrum.’

The proposed Notice will be issued pursuant to section 167(1)(h) of the APA which provides for the Chief Executive of NZFSA ‘setting specifications and providing for matters of detail in relation to animal product standards in accordance with section 45’.

Section 45 of the APA provides for the Chief Executive of NZFSA to set specifications and other detailed requirements that ‘are specified or contemplated by or necessary to give effect to any standard prescribed under section 44 and are necessary or desirable to amplify the manner in which any such standard may or must be achieved’. In this case, the Chief Executive would issue specifications in the proposed Notice to give effect, in relation to raw milk products, to the Animal Products (Dairy) Regulations 2005.

As the proposed Notice will set out mandatory requirements for raw milk products, rather than only matters or items that must be included in an RMP, it will apply regardless of whether such products are made under an RMP under the APA or an FSP under the Food Act.

A draft of the proposed Notice is attached as Appendix 1.

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

The Food (Milk and Milk Products Processing) Standard 2007 (the Standard), issued pursuant to section 11C of the Food Act, is the legal instrument which permits the importation into New Zealand of a small range of unpasteurised milk cheeses that have been produced according to permitted methods of processing. These cheeses are: three hard and very hard Swiss unpasteurised milk cheeses; extra-hard unpasteurised milk Parmesan style grating cheeses, and Roquefort cheese.

NZFSA proposes that the Standard be replaced by the Food (Imported Milk and Milk Products) Standard 2009 to allow for the importation of unpasteurised milk products that meet current dairy requirements and raw milk products that meet the requirements proposed in the ‘Animal Products (Raw Milk Products Specifications) Notice 2009’.

NZFSA proposes that the Imported Milk and Milk Products Standard allow unpasteurised milk products produced under an overseas processing standard to be imported, where the food safety outcome will be at least an equivalent level of safety for consumers as that which is achieved by the domestic New Zealand milk and milk products processing requirements. The Chief Executive will be given the authority to approve such overseas process standards and products following an assessment by NZFSA.

The current references to the three named hard and very hard Swiss unpasteurised milk cheeses, extra-hard unpasteurised milk Parmesan style grating cheeses, and Roquefort cheese will remain in the Standard with their associated permitted methods of processing. Existing pre-clearance arrangements in place with exporting countries such as the European Union are recognised in the Standard. A draft of the Food (Imported Milk and Milk Products) Standard is attached as Appendix 2.

8.3 Amendment to the Food (Prescribed Foods) Standard 2007

The Food (Prescribed Foods) Standard 2007 allows for unpasteurised milk cheeses that have not undergone pasteurisation or cheese treatment (as defined in the Food (Milk and Milk Processing) Standard 2007) to be monitored for the presence of pathogenic organisms. This is because there are hazards that need to be managed during the production of unpasteurised milk cheeses that make some products of regulatory interest. Unpasteurised milk cheeses were added to the prescribed food list to allow for the importation of Roquefort cheese following an NZFSA risk assessment.

Replacing the Food (Milk and Milk Products Processing) Standard 2007 (as described in Section 8.2 above) with the Food (Imported Milk and Milk Products) Standard will broaden the scope of unpasteurised milk products that can be imported. NZFSA proposes to expand the prescribed food standard to take into account the new Imported Milk and Milk Products Standard by amending the current reference to raw milk cheese.

A draft of the amended Food (Prescribed Foods) Standard 2007 is attached as Appendix 3.

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

8.4.1 Farm gate sales of unpasteurised drinking milk

Section 11A of the Food Act contains a provision allowing raw milk to be sold at a producer’s dairy premises in a quantity not exceeding five litres at any one time to a person intending the milk for personal consumption, or for consumption by their family. Such milk must have been harvested in accordance with an approved RMP under the APA. No change is currently proposed to this section of the Food Act.

NZFSA has undertaken a Domestic Food Review and, as a result, has designed and consulted on a proposed new domestic food regime. If the new food regime is progressed, it is intended that farm gate sales of raw milk would continue.

8.4.2 Evaluation, auditing and verification requirements

New Zealand processors of unpasteurised and raw milk products will be required to operate under registered RMPs under the APA or approved FSPs under the Food Act. As such, they will be subject to the legal requirements relating to evaluation, auditing and verification set by the APA and Food Act.

Under the APA, an RMP for dairy processing must be evaluated by an evaluator recognised for this purpose by NZFSA. The evaluator recommends registration of the RMP to NZFSA once all regulatory requirements have been addressed in the RMP. If this proposal progresses, for raw milk products covered by the proposed Notice, the RMP will need to take account of the requirements set out in the Notice. An RMP must be verified by an agency recognised for this purpose by NZFSA, using a performance-based verification system. The recognised agency also has responsibility for reporting any critical non-compliance to NZFSA.

Under the Food Act, an FSP covering the manufacture of dairy products must be audited annually by a dairy FSP auditor approved by NZFSA. The auditor recommends approval of the dairy FSP to NZFSA and the auditor has a responsibility to inform NZFSA if any critical non-compliance is identified. If this proposal progresses, any FSP for raw milk products covered by the proposed Notice would again, prior to approval, need to take account of the requirements for ‘raw milk products’ set by the Notice.

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

8.4.3.1 Compliance with the Code

All unpasteurised products (i.e. including raw milk products) sold in New Zealand will be required to comply with Chapters 1 and 2 of the Code which cover General Food Standards and Food Production Standards. NZFSA is responsible for administering the Code in New Zealand.

NZFSA is in the process of seeking a review of the microbiological limits applying to food contained in the Code (Section 1.61 of the Code) with FSANZ.

8.4.3.2 Labelling

The labelling requirements for all food (including dairy products) sold in New Zealand are set out in 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.

Standard 1.2.4 of the Code further requires that ingredients must be declared using the common name of the ingredient, or a name that describes the true nature of the ingredient, or if applicable a generic name. This requirement means that in relation to products made from raw or unpasteurised milk, the ingredient declaration should include a statement that the milk is ‘raw’ or ‘unpasteurised’. In the case of products made other than from cows’ milk, labels should also include the common name of the species from which the milk is sourced.

It is also proposed that the new Notice (referred to under section 8.1 above) will include a section on labelling, that will require ‘the use of raw milk as an ingredient to be declared in the statement of ingredients in accordance with clause 4 paragraph (b) of 1.2.4 of the Food Standards Code.’

As described in section 5.2.3 above, NZFSA intends to continue to collaborate and consult with FSANZ about the possibility of introducing a requirement for a mandatory advisory statement that would apply to raw milk products covered by the proposed new Notice under the APA and be issued under the Code. Any such requirement, if agreed, would not be introduced until FSANZ has finalised its future policy on unpasteurised milk products.

8.5 Importation of unpasteurised milk products

8.5.1 Legal requirements

The importation into New Zealand of the extra hard grating, Swiss and Roquefort unpasteurised milk cheeses is currently managed by the Food Act and two food standards issued under the Act: the Food (Milk and Milk Products Processing) Standard 2007 and the Food (Prescribed Foods) Standard 2007. Amendments are proposed to both these standards to allow for a wider range of unpasteurised milk products to be imported and for these products to be monitored according to their level of risk.

Prescribed foods are imported into New Zealand in accordance with notified Imported Food Requirements (IFR) which specify the conditions under which these products can be imported. Currently a limited range of unpasteurised milk products can only be imported from an exporting country that operates a production programme that has been assessed and recognised as complying with New Zealand standards, or that has been recognised as meeting an equivalent outcome. NZFSA proposes that the same approach be applied to a wider range of unpasteurised milk products proposed for import under this framework.

Countries that are interested in exporting unpasteurised milk products to New Zealand will need to apply to NZFSA for recognition of their public health production programme. NZFSA is the lead agency for assessment of human health risks of the exporting country. When undertaking its food safety assessment, NZFSA will take into account the Ministry of Agriculture and Forestry Biosecurity New Zealand (MAFBNZ) assessment of the animal health risks and any resulting import health standards (see section 8.5.2 below).

The recognition of compliance or equivalence, and any associated pre-clearance conditions, is formalised in country-to-country arrangements between New Zealand and the competent authority of the recognised exporting country. Each arrangement is specific in terms of scope and import conditions.

8.5.2 Biosecurity Import Health Standards

In order for a wider range of unpasteurised milk products to be introduced, animal and human health risks other than food safety also need to be managed. MAFBNZ is responsible for ensuring New Zealanders, our natural resources, our plants and animals are all kept safe and secure from damaging pests and diseases. It is the lead organisation for the assessment of animal health risks of the exporting country. Currently, MAFBNZ has import health standards that allow for the importation of Roquefort, extra hard grating cheeses and the three Swiss hard and extra hard cheeses.

Countries that are interested in exporting unpasteurised milk products to New Zealand will need to have their animal health risk and control programmes assessed by MAFBNZ against New Zealand’s animal outcomes before NZFSA public health assessment and import can take place. MAFBNZ, in accordance with their standards development process, will develop the necessary standards for animal health.

8.6 Export of unpasteurised milk products

If this proposal is progressed, New Zealand producers of unpasteurised milk products may take advantage of new export market opportunities, since until now all dairy products exported from New Zealand have been pasteurised. Whilst it is not possible to precisely quantify the volumes and values of any such future exports of unpasteurised milk products, it is likely that such trade would initially be quite limited but could have the potential to expand substantially over time. The benefits that could arise from any future export trade in New Zealand unpasteurised milk products do, however, need to be balanced against the need to ensure that the current significant New Zealand export trade in pasteurised dairy products is safe guarded. A damaging food safety incident related to an exported unpasteurised milk product could possibly have the potential to impact not only on unpasteurised milk product exports, but on all New Zealand dairy exports. However, NZFSA does not believe there would be any difference in impact between a damaging food safety incident related to a pasteurised dairy product and one related to an unpasteurised product.

Food products exported from New Zealand must be produced in accordance with New Zealand legislative requirements. Export products must also meet the legislative requirements of the importing country.

Details of Codex standards, and some overseas country standards and requirements for unpasteurised milk products are attached as Appendix 4¹¹.

Any future exported unpasteurised milk products would need to be manufactured in compliance with the proposed Animal Products (Raw Milk Products Specifications) Notice 2009. In addition, the development of general export standards for unpasteurised milk products may be necessary. Any additional export requirements would most likely relate to verification activities from farm through to export, the separation and identification of raw milk products post manufacture, labelling, and official certification. However, it is likely that any such additional general export requirements would be minimal.

Labelling is one area where additional requirements may be required for all unpasteurised milk export product compared to product sold in New Zealand. Product exported in bulk does not have the same labelling requirements as consumer packs. The product must be labelled with a product designation and an ingredient list, including ‘unpasteurised milk’, does not need to be included. If product is exported in consumer packs, these packs will be labelled according to the national legislation of the market country, and the consumer packs will be packaged in an outer package for shipping. As interested overseas authorities and importers have to date been told that all New Zealand dairy products are pasteurised, it may be prudent to provide clear information on the labels of all exported unpasteurised milk products to make this change clear to importing countries unaware of the revised New Zealand policy towards unpasteurised milk products.

NZFSA notifies exporters of certain legislative requirements made by or agreed with importing countries, or requirements deemed necessary, through Export Requirement Notices. When an importing country requires that raw milk or unpasteurised products are labelled as such, this will be included in the country specific Export Requirement Notice.

Export Requirement Notices usually specify whether or not dairy products must be pasteurised and, for numerous countries, the requirement for pasteurisation has been established for many years. Such Export Requirement Notices will make reference to export certificate declarations associated with heat treatment of milk and milk products, such as pasteurisation, where such declarations form part of the requirements set by importing countries. Subsequent to a New Zealand producer stating their intention of manufacturing unpasteurised milk product/s, NZFSA will review export certification templates for dairy products to ensure declarations are compatible with the certification of both unpasteurised milk and pasteurised products processed in New Zealand.

NZFSA liaises with competent authorities in export markets. For the potentially important export markets of the European Union, the United States of America and Canada, this would include obtaining an understanding of import requirements for unpasteurised milk products. This information will facilitate the potential review of Export Requirement Notices for these markets if a New Zealand producer of unpasteurised milk products expresses an intention to export to these markets.

Export Requirement Notices for unpasteurised milk products would be reviewed on a country by country basis, on request from New Zealand producers prior to export, and the relevant Notice amended accordingly. Future exporters of unpasteurised milk products need to be aware that negotiations with importing country authorities, and the establishment of export requirements for unpasteurised milk products, may be a lengthy process. Export requirements for unpasteurised milk products are likely to be part of a package of requirements relating to a wider range of export products, and negotiation of any new requirements for unpasteurised milk products should also take into account more general dairy industry strategies. As such, appropriate allowances for these activities should be made in any timelines for the development of export markets.

¹¹ Appendix 4 is drawn largely from information released in the first discussion paper.