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Proposal (P291) – Review of novel food standard - Initial Assessment Report

2 March 2005

Dear Sir/Madam

Thank you for the opportunity to comment on this application/proposal. The New Zealand Food Safety Authority (NZFSA) has the following comments to make.

NZFSA sees it as key to the review that the purpose statement is worded so as to ensure that the focus is on foods that may pose risks to consumers because of their novel nature so that these are subjected to appropriate assessment and risk management options. Considerations relating to the traditional nature of a food should be integral to the assessment process and should not be allowed to deflect from the purpose of the standard. The definition of novel should ensure that foods produced by new technologies and processing techniques could be considered for assessment. The continued development of tools, such as decision trees to minimise the number of foods subjected to the prescreening process is strongly supported.

We have the following specific comments in response to the numbered questions in the IAR:

1. Has the inclusion of considerations with respect to novelty on the FSANZ website been helpful?

Yes.

2. Are there other strategies that can be employed to assist?

The guideline document entitled “General information to assist in applying to amend the ANZFSC...” should be reviewed, revised and linked on the website to the associated document “Format for applying to amend the ANZFSC...”

3. Are there any other comments on the general history and operation of the Standard, including determinations with respect to novelty?

No

4. Is there support for the development of a more comprehensive decision-tree, which draws on the experience of addressing a large number of inquiries in relation to the novel foods standard?

Yes, strongly support. However NZFSA would see this tree as providing stronger guidance on principles that are applied at each stage rather than on detailed criteria. The decision-tree will thus clearly illustrate the basis for the decisions made at each stage but would not be prescriptive as novelty may not be due to a single factor but to the sum of the characteristics of the food. It is suggested that consideration be given to developing flow charts for several examples of common inquiries to allow some specific detail to be included. It is difficult to put sufficient detail on one decision tree for the diverse range of potential inquiries.

5. Is there any support for investigating the establishment of an expert panel to assist in making determinations?

NZFSA does not see any value in the ongoing retention of an expert panel at the present time. However NZFSA does support there being a list of relevant experts who could be consulted by the NFRG on a needs basis. It would be expected that on occasion an expert advisory group would be convened to deal with a specific novel food application or proposal

6. Is there support for investigating education for industry on the regulations? Is this likely to reduce the number of inquiries received in relation to the Standard? Are there suggestions as to how such an education initiative could be handled most effectively?

The larger companies will be aware of the standard and how it works and can be readily updated on developments via industry association and FSANZ forums and publications. The smaller companies, including importers will be more difficult to reach and there may be limited value in trying to specifically educate them. Regardless of extra information available, they will still seek assurances. Directing industry to previous decisions will however be a useful way of helping to educate them

7. What are your views on the purpose of regulating novel foods, i.e. a risk-based assessment process to ensure the safety of novel foods prior to sale in Australia and New Zealand?

There is a need to protect the consumer and ensure a safe food supply. This is appropriately done via a risk-based assessment process

8. Does the current Standard support this purpose?

Yes

9. Would you support the suggested wording, or something similar (depending on the outcomes of the review), for inclusion in the purpose clause of the Standard?

Yes

10. Do you have any alternative suggestions for the wording of the purpose clause?

Consideration could be given to expand the wording to ensure that the standard captures foods produced by new or novel technologies, including breeding where the safety concerns are unknown and not only the known (“features or characteristics which raise safety concerns”)as the purpose statement currently states.

11. Is there a need to define ‘non-traditional food’ or is it sufficient to define ‘novel food’ and incorporate the element of the absence of a history of safe use into that definition?

NZFSA would prefer to focus on the novel aspect and incorporate non-traditional use into the definition as one of the determining factors.

12. What does ‘history of significant consumption’ mean in the definition for ‘non-traditional food’? Could either, or a combination, of the following, be used as a guide:

• a specified number of generations (e.g. 1-3) of use?

• a specified number of sub-groups within a population?

How could a ‘generation’ be defined?

A starting point for a definition could be that traditional usage is defined as three or more generations. This is because there must be confidence that there is an established oral and/or written tradition that is being applied within the community, of which a significant number of food preparers have the relevant level of awareness.

A generation could be based on 20-30 years

13. What does ‘broad community in Australia or New Zealand’ mean in the definition for ‘non-traditional’? To what extent is use by indigenous or immigrant populations taken into account? What level of use would constitute extensive use by those population sub-groups?

Broad community will mean that the food is freely available for purchase by most if not all sectors of society. The extent to which the food is consumed safely by a sub-group would contribute to the assessment process but should not preclude the need to consider concerns about safe preparation and consumption; nor should consumption by a sub-group necessarily mean the food was novel.

Where a food is very unlikely to be consumed outside a small indigenous or immigrant population, education of that group about safe use may still be needed.

14. There may be varied interpretations of ‘insufficient knowledge in the broad community to enable safe use’ as included in the definition for novel food. There may be a need to distinguish between documented knowledge (e.g. in the form of recipes) from anecdotal reports of knowledge

While this could be important in making risk management decisions, it is preferable not to define this but include it as one aspect of the information that is collected to assist with risk assessment process. The extent to which the knowledge needs to be documented will be related to the severity of any risks associated with the food.

15. Is there support for developing a decision-tree, based on experience since the introduction of Standard 1.5.1 and advice from SDAC members, to support the definition(s)?

Definitely support extending the decision tree in this manner. See question 4.

16. Is there support for addressing foods requiring specific preparation in Standard 1.2.6 – Directions for Use and Storage – of the Code and making this clear in the regulation for novel food?

NZFSA believes that the regulation of novel foods under 1.5.1 should take into account a variety of risk management options, including labelling. Inclusion of the food in Standard 1.5.1 should be only one of the options available.

17. What other issues are relevant to improving the clarity of the definition(s)?

Consideration should be given to the issue of foods that are produced by technologies that substantially change their characteristics as in EC definition. At present this is discussed in the guideline document on the website but poorly captured in the standard.

18. Are there any particular issues unique to enforcement agencies that are important for consideration when reviewing the definitions?

None known

19. Do submitters have information about the safety of any of these new technologies?

No, other than what is already published

20. If there is a need to regulate the foods produced from these new technologies?

Application of a new technology to any food or of an established technology to a new food should not automatically require an assessment. However, where there is evidence of substantial differences between the food produced using conventional and new technologies, assessment may be required.

21. If there is a need to regulate the resultant foods is it appropriate to consider these with novel foods or is it preferable to introduce specific standard(s) for different processes based on an identified safety concern?

See response to Q20

22. Do submitters agree that any reference to classes or categories of novel foods is more appropriately included in the guidelines rather than the regulation?

Yes as it is not exhaustive and some foods may not be included only assisting with interpretation. If the reference is in the standard, it would be best as an editorial note within the Standard.

23. Are the current classes in the guidelines helpful?

Yes

24. FSANZ will consider the current classes identified in the guidelines and use the inquiries dealt with by the NFRG as a guide. Are there any comments on appropriate classes that could assist FSANZ in this exercise?

Consideration should be given to including a reference to foods produced by new breeding and processing technologies.

25. What are your views on issues related to data requirements and data protection that are relevant to the assessment of novel foods?

Unless patents or other legal constraints apply the decisions relating to novel foods should be made public.

26. What are your views on applying the approach of substantial equivalence in undertaking a risk assessment for certain novel foods, where appropriate?

Equivalence should be taken into account in making risk management decisions for the food as it provides a precedent to assist with the decision making.

27. Is there any additional information relevant to the uptake of existing permissions for novel foods by industry including quantitative data on sales and market share?

N/A

28. Are there any additional regulatory options that should be considered?

None additional to those already identified.

29. Are there any additional non-regulatory initiatives that could be considered?

The current guideline material on the FSANZ website is useful and contains a lot of very helpful information but is not easy to follow and so should be reviewed to clarify the process flow. Other educational tools using case studies could be helpful.

30. If an education program was implemented to assist industry in understanding the regulations for novel foods, who should conduct this (FSANZ, FSANZ and enforcement agencies, or enforcement agencies alone) and what industry sectors would benefit most?

There is probably limited value in undertaking a major education programme but every opportunity should be taken to communicate the standard to appropriate audiences such as industry and agency conferences. The programme would need to be targeted at companies interested in functional foods and food-type dietary supplements and the suppliers of ingredients that could be used in these foods. Food importers would be another sector who should be targeted for education on specific issues relating to their interests

31. Would industry benefit from such an initiative?

Yes

32. What are the current and potential costs and benefits associated with each of the regulatory options proposed for each of the affected parties?

Unknown

33. What is your preferred regulatory option? Please provide reasons.

Option 3 is NZFSA’s preferred option. NZFSA prefers to see the emphasis of the standard to be placed on novelty rather than the traditional nature of foods, as undue emphasis on the latter detracts from the purpose of the standard which is to identify foods that may need to be subjected to specific risk management options to ensure their safe and appropriate use.

The development of supporting material and improving the decision making process should be the immediate priority for FSANZ. Further developments of the Standard and the assessment process should follow on where TAG, NFRG and other interested parties identify a need for these improvements.

NZFSA believe that there should be more emphasis on the inclusion of a food in Standard 1.5.1 as being only one of several risk management options for addressing issues raised when new or novel foods enter the general food supply.

Yours sincerely