Table 8.1: Comparison of the infant formula food additive permissions in the Code and Codex standards The Code Codex Alimentarius (cell entries only if different from the Code) Amendments that would be required if Std 2.9.1 in the Code was to align with Codex Food additive name INS MPL1 (mg/L) Food(s) Food additive name2 INS MPL1 (mg/L)3 Food(s) Ascorbyl palmitate 304 10 All infant formula products 304i 10 INS number to 304i. Tocopherols concentrate, 307b 10 All infant formula products Mixed tocopherol concentrate 304i Carrageenan 407 300 Liquid infant formula products 300 Regular milk- and liquid infant formula Citric acid 330 GMP All infant formula products No change Citric and acid esters of glycerol 472c 9000 Infant formula products for specific dietary use based on protein substitutes 7500 All of powder infant formula Amend to provide a permission for citric and fatty acid esters of glycerol to be used in powder and liquid infant formula with MPLs of 7500 mg/L and 9000 mg/L respectively. 9000 All types of liquid infant formula Guar gum 412 1000 All infant formula products Liquid formulas containing hydrolysed4 protein Consider this in later work which looks at IFPSDU.
Lecithin 322 5000 All infant formula products Lecithins 50005 All types of infant formula Amend the name of the food additive to ‘Lecithins’ (plural); this incorporates ‘lecithin, partially hydrolysed’. Locust bean (carob bean) gum 410 1000 All infant formula products Carob bean gum (Locust bean gum) All types of infant formula Amend the name of the food additive to ‘Carob bean gum (Locust bean gum)’. Mono- and of fatty acids 471 4000 All infant formula products Mono- and di-glycerides 40005 All types of infant formula No change Starch sodium octenyl succinate 1450 No permission Hydrolysed4 protein-based infant formula Consider this in later work which looks at IFPSDU. Sodium phosphates 339 No permission Sodium dihydrogen phosphate 339i 4506 All types of infant formula Amend to provide new permissions for all sodium phosphates and potassium phosphates, singly or in combination to a MPL of 450 mg/L. Amend names and INS numbers (i.e. separate individual chemicals with Roman numeral suffixes; noting the Code currently does not do this). Disodium hydrogen phosphate 339ii Trisodium phosphate 339iii Potassium phosphates 340 No permission Potassium dihydrogen phosphate 340i Dipotassium hydrogen phosphate 340ii Tripotassium phosphate 340iii
Distarch phosphate 1412 5000 infant formula 5000 Soy-based infant formula Remove the qualification statement that subclause 6(1) applies, as it automatically applies for all four of the starches. Lower the MPL for hydroxypropyl starch (1440) for use in soy-based infant formula from 25000 to 5000 mg/L, singly or in combination. Phosphated distarch phosphate 1413 Soy-based infant formula Acetylated distarch phosphate 1414 infant formula Hydroxypropyl starch 1440 250007 Soy-based infant formula Potassium citrate 332 GMP All infant formula products No change Sodium citrate 331 GMP All infant formula products Sodium dihydrogen citrate 331i the name and INS number (i.e. separate individual chemicals with Roman numeral suffixes; noting the Code currently does not do this). Trisodium citrate 331iii Sodium carbonates 500 No permission Sodium carbonate 500i Sodium hydrogen carbonate 500ii Potassium carbonates 501 No permission Potassium carbonate 501i Potassium hydrogen carbonate
Year Study type Finding Baydar et al. (1997), Fein & Falci (1999) Survey When infant was 2 months old, 43% of mothers did not boil tap water before use. Kwon (2002) Survey 19% of mothers used boiled water. 36% used filtered or bottled water. Define Research & Insight (2006) 2006 Qualitative (focus groups) UK Majority reported they boiled water, then let it cool for 30-40 minutes. Some added boiling water to formula Bolling et al. (2007) 2005 Survey UK 59% of mothers followed recommendations to use water boiled and left to cool for less than 30 minutes. 40% left it to cool for longer than 30 minutes Carletti & Cattaneo (2008) 2006 Survey 22% of parents used water at 70 degrees Celsius or warmer to prepare formula Herbold & Scott (2008) 2004 study 40% of observed participants brought the water to the boil before use. One used bottled water et al. (2008) Survey When infant was 1.5–4.5 months old, 30% of mothers boiled tap water before use Lennox et al. (2011) 2011 Survey UK When making up formula, 68% used that had been boiled and left to cool for no more than 30 minutes. McAndrew et al. (2012) 2010 Survey UK 71% of mothers (of 4–10 week old infants) used water that had been boiled and left to cool for 30 minutes or less 29% left it to cool for longer than 30 minutes Redmond & Griffith (2013c) Qualitative (focus groups) UK All parents reported preparing with boiled water. Redmond & Griffith (2013a) 2010 study UK 100% of parents prepared the feeds used boiled tap water. 70% followed the recommendation to cool the water for less than 30 minutes before using it to prepare the formula. Redmond & Griffith (2013b) 2010 15% of feeds were prepared with boiled water cooled for less than 30 minutes. 85% prepared using boiled water cooled for more than 30 minutes. 2.2.2 Storing prepared infant formula at room temperature Caregivers were generally aware that infant formula should not be kept at room temperature once prepared (see Table A2.2, below), and most reported only leaving prepared infant formula at room temperature for two hours or less. However, no Australian or New Zealand studies explored this behaviour. Table A2.2: Storing prepared infant formula at room temperature Year type Finding US US
& Griffith (2013b) 2010 UK Of the 143 feeds prepared, 62% spent at least some time in a refrigerator. Refrigeration storage times ranged from 2 hrs 17 minutes to 19 hrs and 44 minutes. Again, the findings regarding caregivers storing prepared infant formula in the refrigerator suggest the importance of this is well understood. Although there are no Australian or New Zealand studies examining this, all four studies did have similar (positive) findings. 2.2.4 Discarding unfinished feeds Only four studies investigated whether caregivers discarded unfinished formula, left over from a feed (see A2.4). These found caregivers generally discarded the formula, although one New Zealand study found that some parents did not throw it away, generally because they were concerned about wasting money. No Australian studies examined whether caregivers discarded leftover infant formula. A2.4: Discarding unfinished feeds Study Year collected Study type Country Finding Define Research & Insight (2006) 2006 Qualitative (focus groups) UK Participants tended to throw unfinished milk away immediately. Although some left it for 30–60 minutes before discarding or using it. et al. (2008) 2005-07 Survey USA 85% of mothers believed it was very important to follow instructions to refrigerate or discard prepared formula Winstanley & Cressey (2008) 2008 Qualitative (focus groups) NZ Parents generally discarded unfinished feeds. Among those who did not, this was generally for cost reasons Redmond & Griffith (2013d) 2008 Survey UK 73% of parents were aware of the recommendation to “Discard any feed that has not
development) Must be referenced to human milk A relationship between the substance and human milk would be expected, and similarly that the proposed level would be modelled after human milk. A relationship between the substance and human milk would be expected, and similarly that the proposed level would be modelled after human milk. Transparency of permissions Part 182 of 21 CFR lists some common substances that are generally recognised as safe. The on the FDA web site contains GRAS notices received from companies since 1998, and FDA's response. Approved food additives are issues a regulatory number (parts 170-180 of 21 CFR). Food Additive Status List is also available on the FDA website at: Post-market monitoring Although a substance may have GRAS status, the FDA may at any time prohibit its use or conduct further studies to determine its safety if new evidence suggests that a product already in use may be unsafe or if consumption levels have changed. The status of a food additives may be amended or removed from regulation if there are safety concerns, in accordance with 21 CFR 571.130(a). Pre-market notification of an infant formula product: Process Prior to marketing a new infant formula in the US, a manufacturer must register with, must notify, and must submit written verification to, FDA (sections 106.110 and 106.120 of 21 CFR). The notification must occur at least 90 days before marketing the product. A ‘new infant formula’ includes an infant formula manufactured by a person which has previously manufactured infant formula and in which there has been a major change, in processing or formulation, from a current or any previous formulation produced by such manufacturer. Data & information requirements for inclusion in any notification/ assessment documents Section 106.120 of 21 CFR outlines that the notification must include: The quantitative formulation of the infant formula; A description of any reformulation of the formula or change in processing of the infant formula; Assurances that the infant formula will not be marketed unless it the quality factors and the nutrient requirements of the Act; and
Process Pre-market notification for a new novel food (Division B.28.002-3): The manufacturer or importer of the novel food must notify the Director (of Health Canada) in writing of their intention to sell or advertise for sale the novel food, with accompanying information. Within 45 days receiving a notification, the Director will review the information and either notify the applicant that the information is sufficient to establish that the novel food is safe for consumption, or that additional information is necessary in order to assess the safety of the novel food. Within 90 days of receiving the additional information requested the Director shall assess it and, if it establishes that the novel food is safe for consumption, notify the applicant in writing that the information is sufficient. Pre-market assessment for new substances than novel foods and food additives: Presently there is no published pre-market assessment procedure for new substances (other than novel foods and food additives) for use in infant formula. Specific guidance is provided on a case-by-case basis to companies. Health Canada also reviews packaging materials for infant formulas, and this review and approval is considered as a pre-requisite to submitting a pre-market notification for an infant formula product. Data & information requirements for inclusion in any notification/ assessment documents: Assessment criteria is outlined in the Guidelines for the Safety Assessment of Novel Foods: If a manufacturer/seller of the food wishes for it to be used in infant formula, then evidence for safety in infants is required. At present, there is no relevant published guidance for the pre-market assessment for new substances. However, a pre-market notification for an infant formula product would not be accepted by Health Canada unless the following information had been assessed. Must show evidence to support safety Must show evidence of efficacy (level/form to achieve stated purpose) While the novel food regulations are silent on efficacy, a notification for an infant formula product must include evidence relied on to establish that the infant formula is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions of use. Form and amount of the substance in achieving the stated purpose would be considered.