SUPPLEMENTARY FINAL ASSESSMENT (Inquiry - s.24) REPORT
13 March 2002
08/02
Full Assessment Report [ pdf 1077 kb ]
Executive Summary
This Proposal makes recommendations on draft standard (Standard 2.9.1 - Infant Formula Products) for adoption into Volume 2 of the Food Standards Code (Volume 2) and a variation to Standard A11 of Volume 1 of the Food Standards Code (Volume 1).
The specific objectives of the review of infant formula regulation are 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.
The review of the standard for infant formula (Proposal P93) has been in progress since 1993. Public submissions were received in the preparation of the Proposal in 1993, at Full Assessment in 1995 and at Preliminary Inquiry in May 1999. The Australia New Zealand Food Authority (ANZFA) completed an Inquiry into the proposed draft standard in November 1999. However, industry requested further consultation on the draft standard as proposed at Inquiry (Nov 1999).
Therefore, this Supplementary Final Assessment (Inquiry - s.24) Report (Feb 2002) consolidates ANZFA' s assessment of all issues raised following Preliminary Inquiry (May 1999), including those issues raised by industry following Inquiry (Nov 1999) and recommends the draft standard to the Ministerial Council (ANZFSC) for adoption into Volume 2, and an amendment to Standard A11 of Volume 1. An assessment of the issues raised since Preliminary Inquiry is given at Attachment 1, and a summary of changes to the draft standard since Full Assessment (1995) and the rationale for these changes is provided in the Statement of Reasons at Attachment 5.
This report also includes at Attachment 2, a safety assessment of certain microbial oils (DHASCO and ARASCO) that are currently added to infant formula as sources of long chain polyunsaturated fatty acids (LCPUFA). The regulation impact statement as assessed at Preliminary Inquiry (May 1999) has been revised in recognition of the significant time delay and changes that have been made to the draft standard as proposed at Preliminary Inquiry and is at Attachment 3.
In conclusion, ANZFA proposes that draft Standard 2.9.1 - Infant Formula Products, as proposed at Supplementary Final Assessment (Inquiry - s.24) (Attachment 4), be adopted into Volume 2 and that Standard 1.3.4 of Volume 2 and Standard A11 of Volume 1 be amended to include specifications for DHASCO and ARASCO oils.
SUPPLEMENTARY FINAL ASSESSMENT (Inquiry - s.24) REPORT
Full Assessment Report [ pdf 1077 kb ]
- Final Assessment Report [ PDF format 76 kb ]
- Attachment 1 - Assessment of Issues [ PDF 273 kb ]
- Attachment 2 - Safety Assessment Report [ PDF 282 kb ]
- Attachment 3 - Regulation Impact Statement [ PDF 32 kb ]
- Attachment 4 - Draft Variations to Volume 1 and Volume 2 of the Food Standards Code
[ PDF 69 kb ] - Attachment 5 - Statement of Reasons [ html | PDF 117 kb ]
- Attachment 6 - Summary of Issues from the Infant Formula Manufacturers' Association of Australia ( IFMAA ) and New Zealand Infant Formula Marketers' Association ( NZIFMA ) [ PDF 16 kb ]
- Attachment 7 - Summary of Submissions to the Preliminary Inquiry ( May 1999) [ PDF 224 kb ]