New directions for infant formula products
The ANZFA Board, at its February 2002 meeting, has recommended the Supplementary Final Assessment (Inquiry-s.24) of Proposal P93 - Review of Infant formula, which includes a draft revised Australian and New Zealand food standard for infant formula products. This new draft standard has now been recommended to the Australia New Zealand Food Standards Council (ANZFSC) for adoption into the Food Standards Code (Volume 2). When approved by Ministers, manufacturers will have a 2-year transition period to comply with the new standard.
Standard 2.9.1 - Infant Formula Products is the result of nine years of work by ANZFA staff in conducting a thorough and comprehensive review of infant formula regulation, which has included the active involvement of stakeholders. The purpose of the review was to:
- protect the health and safety of formula-fed infants;
- provide carers with sufficient information about infant formula products to enable them to make appropriate choices in feeding their infant and in the safe use of products;
- develop unambiguous food regulations that reflect contemporary scientific knowledge; and
- harmonise the food regulations applying to infant formula products in Australia and New Zealand.
What are infant formula products?
Infant formula products are designed especially to meet the nutritional requirements of infants up to the age of 12 months. They include formula for healthy babies such as infant formula and follow-on formula (for babies over 6 months); as well as formulas for infants with special nutritional requirements, including soy-based, lactose-free and low-lactose formulas and formulas for special dietary purposes.
Are they a substitute for breast milk?
Breast milk is undeniably the ' gold standard' food for babies. The evidence of the health benefits to infants of breast milk is overwhelming and this is clearly indicated by current health guidelines [i] . However, when an infant is unable to be breast fed, infant formula products are recognised as the most suitable and safe replacement for breast milk. There are limits though to how closely infant formula can replicate breast milk and it has been necessary to consider this in the review of infant formula.
What are the present requirements for infant formula and why the need for change?
Currently all infant formulas are required to comply with existing standards, Standard R7 - Infant Formula, Australian Food Standards Code (Volume 1) in Australia and New Zealand or Regulation 242 - Infant Formula, New Zealand Food Regulations 1984, in New Zealand. To date, these standards have adequately protected the health and safety of formula-fed infants. These standards however were developed more than ten years ago and are now out of date. They do not reflect current scientific knowledge and technological advances in the safety and nutritional quality of infant formula products.
What are the major changes to the regulation of infant formula?
In addition to harmonising the regulation of infant formula products between Australia and New Zealand, Standard 2.9.1 - Infant Formula Products offers considerable improvements over existing standards. These include:
- recognition of a wider range of infant formula products available on the market, including formulas for special dietary purposes;
- greater compositional control of nutrients including protein, fat and vitamins and minerals to make infant formulas safer and healthier;
- a required protein quality profile that more closely reflects that of human milk;
- the requirement for novel foods and ingredients to be assessed for safety before being permitted in infant formula;
- permission for the voluntary addition, including prescribed maximum and minimum levels, of nutritive substances that may be of benefit to infant health;
- a limit on the aluminium content of infant formula and new extra labelling for formulas with high fluoride levels; and
- greater clarity of labelling whilst maintaining adherence to the requirements of theWHO International Code of Marketing Breast-milk Substitutes [ii] .
A more comprehensive summary of improvements is available in the document Improvements to the regulation of Infant Formula Products by draft Standard 2.9.1available on the ANZFA website or by contacting the ANZFA Information Officer (See details below).
How will Australian and New Zealand infant formula requirements compare with those overseas?
The Codex standard for infant formula was developed in 1981 and is currently in the early stages of review. Standard 2.9.1 has additional compositional and labelling requirements to that of the Codex standard. As the majority of infant formulas are manufactured overseas, the inclusion of these additional requirements is seen as important to the health and safety of infants in Australia and New Zealand. These requirements however are not considered too restrictive as to threaten the supply of infant formula products into Australia and New Zealand.
Are manufacturers able to meet the new requirements?
Yes. The infant formula manufacturers of Australia and New Zealand have been actively involved in the review process and have indicated that infant formula products will be able to meet the requirements of the new standard.
How did ANZFA decide on what changes to make to the regulation of infant formula products?
The review of infant formula has been a long process that has relied on the assistance of various individuals and groups. This has included the formation of an expert panel, consultant reports, an external advisory group, a stakeholder forum and the comments provided from a large number of submitters in three rounds of public consultation. This input has greatly assisted ANZFA in development of the safety, technological and nutritional aspects of the new standard.
Do health professional support the changes?
Health professionals generally support the adoption of the new standard as the existing standards are considered out of date and there are benefits to infant health to be gained by the new standard. However, some health professionals consider the revised standard falls short in optimising the health benefits for formula-fed infants. Many of their concerns relate to nutritional aspects of infant formula where either scientific data was lacking or manufacturing practicalities prevent infant formula replicating the ' gold standard ' of breast milk.
ANZFA acknowledges that there is a need to actively monitor international and scientific developments and will seek to revise the new standard when new evidence is available which will benefit infants in Australia and New Zealand.
Further information including the full report of the Supplementary Final Assessment (Inquiry-s.24) for Proposal P93 - Review of Infant Formula is available on our website www.foodstandards.gov.au or www.foodstandards.govt.nz (publications/fact sheets) or from the ANZFA Information Officer.
| ANZFA Australia PO Box 7186 Canberra BC ACT 2610 Australia Ph:61 2 6271 2222 Fax:61 2 6271 2278 Email: info@foodstandards.gov.au | ANZFA New Zealand PO Box 10559 The Terrace Wellington 6036 New Zealand Ph:64 4 473 9942 Fax:64 4 473 9855 Email: nz.reception@foodstandards.gov.au |
( March 2002 )