Please refer to anzfa’s guide to applications and proposals for a more detailed explanation of the process on how to undertake

Abbreviations and Acronyms

ABS Australian Bureau of Statistics

AHMAC Australian Health Ministers’ Advisory Council

AHMC Australian Health Ministers’ Conference

DALY Disability adjusted life year

DFE Dietary folate equivalent

EAR Estimated average requirement

FRSC Food Regulation Standing Committee

FSANZ Food Standards Australia New Zealand

LOAEL Lowest observed adverse effect level

Ministerial Council Australia and New Zealand Food Regulation Ministerial Council

MRC Medical Research Council

NATSINSAP National Aboriginal and Torres Strait Islander Nutrition Strategy and Action Plan

NHANES National Health and Nutrition Examination Survey

NHMRC National Health and Medical Research Council

NNS National nutrition survey

NOAEL No observed adverse effect level

NRV Nutrient reference value

NTD Neural tube defect

NZMoH New Zealand Ministry of Health

PGA Pteroylmono-glutamic acid

RDI Recommended dietary intake

SDAC Standards Development Advisory Committee

UL Upper level of intake

USCDC United States Centers for Disease Control

WTO World Trade Organization

UNITS

µg micrograms

mg milligrams

g grams

1 Bread is defined as ‘the product made by baking a yeast-leavened dough prepared from one or more cereal flours or meals and water.’

2 Bread is defined as ‘the product made by baking a yeast-leavened dough prepared from one or more cereal flours or meals and water.’

3 Bread improvers are combinations of ingredients, such as enzymes, emulsifiers and antioxidants that are added to dough to modify its characteristics and those of the bread in order to improve keeping quality, texture and flavour.

4 The effectiveness of mandatory fortification as a public health strategy to increase nutrient intakes, with reference to iodine and folate. Expert public health advice prepared for AHMAC, June 2005.

5 Case studies of public health interventions to increase nutrient intakes were used to generate effectiveness criteria.

6 The EAR is the daily nutrient level estimated to meet the requirements of half the healthy individuals in a particular life stage and gender group.

7 The RDI is the average daily dietary intake level that is sufficient to meet the nutrient requirements of nearly all (97-98%) healthy individuals in a particular life stage and gender group.

8 The UL is the highest average daily nutrient intake likely to pose no adverse health effects to almost all individuals in the general population.

9 The NHMRC document Nutrient Reference Values for Australia and New Zealand including recommended dietary intakes is available online at http://www.nhmrc.gov.au/publications/synopses/n35syn.htm

10 DFEs is a term used to accommodate the various bioavailabilities of folate. One µg DFE = 1 µg food folate = 0.5 µg of folic acid on an empty stomach = 0.6 µg of folic acid with meals.

11 Total births = live births + stillbirths.

12 Codex Alimentarius CAC/GL 09/1987 (amended 1989, 1991).

13 ‘Fortification’ or ‘enrichment’ means the addition of one or more essential nutrients to a food for the purpose of preventing or correcting a demonstrated deficiency of one or more nutrients in the population or specific population groups.

14 Food Safety Authority of Ireland. Report of the National Committee on Folic Acid Food Fortification 2006 http://www.fsai.ie/publications/reports/folic_acid.pdf

15 In the United States, ‘enriched’ refers to the addition of a nutrient to a food that has been lost during the course of food processing or during normal storage and handling, up to the nutrient’s level in the food before the processing, storage and handling.

16 In New Zealand, 800 µg is recommended as a 400 µg folic acid supplement is not available (NZMoH, 2003).

17 New Zealand Dietary Supplement Regulations 1985 http://www.legislation.govt.nz/browse_vw.asp?content-set=pal_regs

18 FSANZ commissioned report available at www.foodstandards.gov.au

19 The median intake is the point at which 50% of the surveyed population is below this amount and 50% is above it.

20 FSANZ commissioned report available at www.foodstandards.gov.au

21 FSANZ commissioned report available at www.foodstandards.gov.au

22 FSANZ commissioned report available at www.foodstandards.gov.au

23 In Ontario, Canada, there has been a mean increase in folate status (mean red cell folate) of 41% since mandatory fortification was introduced in 1998 (Ray et al., 2002) and in the United States, the folate status (mean serum folate) in all age and sex groups has more than doubled (Dietrich et al., 2005).

24 Food intake data are derived from the 1995 and 1997 Australian and New Zealand national nutrition surveys. Estimates of folic acid intake are based on the current uptake by industry of voluntary permissions outlined in Standard 1.3.2 of the Food Standards Code.

25 FSANZ commissioned report available at www.foodstandards.gov.au

26 The UL (see Section 5.2.2), which is based on masking the diagnosis of vitamin B₁₂ deficiency, has been set for different age groups on a relative body weight basis (see Figure 1, Attachment 6).

27 The methodology used to assess folic acid intake among New Zealand children differed from the FSANZ modelling in that it used different levels of fortification, involved a more restricted group of mandatorily fortified foods and excluded the contribution to folic acid intake from voluntary fortification.

28 Access Economics, report for FSANZ, Attachment 11.

29 The Australian Baking Industry: A Profile, DAFF 2003; personal communication NZ Association of Bakers 2006.

30 Brooke-Taylor & Co Pty Ltd, Report prepared for FSANZ, Attachment 10 Appendix 1.

31 Brooke-Taylor & Co Pty Ltd, Report prepared for FSANZ, Attachment 10 Appendix 1.

32 Premixes are purchased blends of some, or all, of the dry minor and micro ingredients of bread, such as raising agents, processing aids, additives and ingredients, possibly including bread improvers used for bread, cakes and biscuits prior to developing the dough.

33 Bread improvers are combinations of ingredients, such as enzymes, emulsifiers and antioxidants that are added to dough to modify its characteristics and those of the bread in order to improve keeping quality, texture and flavour.

34 Brooke-Taylor & Co Pty Ltd, Report prepared for FSANZ, Attachment 10 Appendix 1

35 Brooke-Taylor & Co Pty Ltd, Report prepared for FSANZ, Attachment 10 Appendix 1.

36 Bread Research Institute Report on Australian Baking Industry, 2003

37 Brooke-Taylor & Co Pty Ltd, Report prepared for FSANZ, Attachment 10 Appendix 1

38 A compound ingredient means an ingredient of a food which is itself made from two or more ingredients. Standard 1.2.4 of the Code requires the components of a compound ingredient to be labelled where the amount of compound ingredient in the food is 5 % or more.

39 The effectiveness of mandatory fortification as a public health strategy to increase nutrient intakes, with reference to iodine and folate. Expert public health advice prepared for AHMAC, June 2005.

40 Case studies of public health interventions to increase nutrient intakes were used to generate effectiveness criteria.

41 NHMRC. Dietary Guidelines for Australian Adults. Commonwealth of Australia, 2003; Ministry of Health. Food and Nutrition Guidelines for Healthy Adults: A background paper. Wellington. Ministry of Health, 2003.

42 Folic acid will be required to be listed as an ingredient unless it is part of a compound ingredient making up less than 5% of the food. Standard 1.2.4 defines a compound ingredient as an ingredient of a food which is itself made from two or more ingredients.

43 Brooke-Taylor & Co Pty Ltd, Report for FSANZ , August 2006 Attachment 10 Appendix 1

44 In Australia, 800 µg folic acid supplements can be purchased by peri-conceptional women, however the recommended supplements contain 500 µg of folic acid. For the purpose of the dietary intake assessment, only 200 µg and 500 µg supplements were modeled for Australia.

45 Bread as defined in the Code – see Section 9.1.2.

46 Brooke-Taylor & Co Pty Ltd, Report prepared for FSANZ, Attachment 10, Appendix 1

47 Folic acid has been permitted to be voluntarily added to flour, savoury biscuits, breads, breakfast cereals, pasta, fruit and vegetable juices and drinks, fruit cordials, beverages derived from legumes and legume analogues of dairy foods and meat.

48 Medsafe – New Zealand Medicines and Medical Devices Safety Authority.

49 NZMoH (1997).

50 Trade Practices Act 1974, State and Territory Fair Trading legislation and Fair Trading Act 1986.

51 Personal communication, NZ Association of Bakers & ANZBAKE. August 2006.

52 Within the context of this policy ‘Fortification’ is to be taken to mean all additions of vitamins and minerals to food including for reasons of equivalence or restoration.

53 The principle of Modified Restoration as derived from The FSANZ document Regulatory principles for the addition of vitamins and minerals to foods. (Canberra, 2002) is as follows:

Vitamins and minerals may be added, subject to no identified risks to public health and safety, at moderate levels (generally 10-25% Recommended Dietary Intake (RDI) per reference quantity) to some foods providing that the vitamin or mineral is present in the nutrient profile, prior to processing, for a marker food in the food group to which the basic food belongs. The vitamin or mineral must be naturally present at a level which would contribute at least 5% of the RDI in a reference quantity of the food. This regulatory principle is based on the restoration or higher fortification of the vitamin or mineral to at least pre-processed levels in order to improve the nutritional content of some commonly consumed basic foods.

54 Folic acid intake from fortified foods was assessed using a quantified food frequency questionnaire.

55 Incidence of NTDs is the number of live births, stillbirths and terminations affected by an NTD expressed as a rate per 1,000 total births.

56 FSANZ commissioned report available at www.foodstandards.gov.au

57 Birth prevalence of NTDs is the number of live births and stillbirths affected by an NTD expressed as a rate per 1,000 total births.

58 FSANZ commissioned report available at www.foodstandards.gov.au

59 FSANZ commissioned report available at www.foodstandards.gov.au