23February2016.docx

 PAGE \* MERGEFORMAT 2 23 February 2016 SD1 Attachment A1.1 – Nutrition Assessment – Proposal P1028 Infant Formula Executive Summary Infant formula contains macronutrients, vitamins, minerals, and other nutritive substances that are required for growth and development of infants. For each nutrient, a minimum amount is generally defined to ensure an infant receives adequate amounts. A maximum amount is also defined for some nutrients to ensure an infant does not receive unsafe amounts. In addition, permitted forms, specific components (e.g. amino acids or fatty acids), conversion factors, ratios to other nutrients, and other restrictions may also be important to consider. Where these considerations apply in the standards regulating infant formula nutrient composition varies and depends on the specific nutrient. Nutrient composition of infant formula is prescribed in the Australia New Zealand Food Standards Code (the Code) Standard 2.9.1 – Infant Formula Products (and Schedule 29 in the revised Code) and in the Codex Alimentarius Standard 72-1981 Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants (Codex STAN 72-1981). The two standards are aligned or comparable for most nutrients. However, there are some inconsistencies. New science has emerged since the standards were implemented, and some issues continue to be debated within the scientific community. Thus, the evidence base that underpins infant formula composition in Standard 2.9.1 may have changed since it was last reviewed in the late 1990s. This assessment reviewed infant formula nutrient composition with the aim of determining whether harmonising with the compositional requirements in Codex STAN 72-1981 would pose a risk of nutritional inadequacy or harm to Australian and New Zealand (ANZ) infants. A comparative analytical approach was used in which the Codex STAN 72-1981 provision for each nutrient was assessed against a set of criteria that would indicate potent