ARCHIVED - Trace Metal Analysis - Infant Formula

The Bureau of Chemical Safety in the Food Directorate of the Health Products and Food Branch has investigated the aluminium, cadmium and lead content of various types of infant formula. The samples were collected during the period 1999 - 2001 and the actual analyses were performed in Health Canada's Health Products and Food Branch Regional Laboratory in Longueuil, Québec (See table attached). It is recognized that metals such as aluminium, cadmium and lead are found throughout the environment and are present in virtually all food at the extremely low levels shown in the table. Nevertheless, surveys of this nature are conducted on a routine basis to monitor the levels of selected chemical substances of concern in various types of foods. The data are used to determine the intake of such substances, analyze trends in the levels reported, identify any point sources of contamination and minimize human exposure to the extent possible.

The survey results indicate that the levels of these metals are similar to or lower than findings from surveys conducted previously. Preliminary analysis of the results indicates that these levels are unlikely to pose any risk to the health of infant consumers. For example the highest mean levels of cadmium and lead detected in the different products analyzed were 1.72 parts per billion (ppb) and 1.85 ppb respectively. These mean levels are lower than results reported in previous surveys and the reported maximum levels for lead are well below the limit of 0.02 parts per million (ppm) which was recently established at the international level by the Codex Committee on Food Additives and Contaminants. No limits have been established for cadmium in infant formula. However, even the highest level of cadmium found (i.e. 3.47 ppb) is not considered to pose a health risk to infant consumers.

The results for aluminium in infant formula showed a similar decline in comparison to earlier surveys. For example, in 1992, soy-based ready-to-use formulae were found to contain a mean aluminium level of 1.62 ppm with a range of 0.23 to 5.2 ppm. In the current survey, the mean level found was 0.73 ppm with a range of 0.23 to 1.1 ppm. Similar reductions were found in milk-based ready-to-use formula.

A tolerable daily intake (TDI) for aluminum of 1 milligram per kilogram of body weight per day has been established by an international committee of experts under the auspices of the World Health Organization and the Food and Agricultural Organization of the United Nations. (The TDI is an estimate of the daily intake of a chemical contaminant that can occur over a lifetime without appreciable health risk.) Even at the highest level reported (i.e., 3.4 ppm for one sample of ready-to-use, milk based formula) in this recent survey, intake of aluminum is well below the tolerable daily intake. It is important to note for this particular product category that the average is 0.37 ppm, indicating that the other results are much lower.

These current findings will be subjected to more detailed analysis and the final study results will be submitted for publication in a peer-reviewed scientific journal upon completion of this assessment.

Bureau of Chemical Safety
Food Directorate
Health Products and Food Branch
Health Canada
February 5, 2003

Table. Results of Health Canada survey of infant formula.1

Type of formula No. of samples Aluminium, ng/g Cadmium, ng/g Lead, ng/g
    Mean Minimum Maximum Mean Minimum Maximum Mean Minimum Maximum

Electrolyte

13

48

3

263

0.01

0.01

0.01

0.16

0.04

0.41

Electrolye, flavoured

8

39

3

282

0.01

0.01

0.01

0.16

0.03

0.24

5% glucose

6

73

5

239

0.01

0.01

0.01

0.09

0.05

0.15

Concentrate liquid, milk based

44

131

2

796

0.13

0.02

2.03

0.32

0.06

0.85

- plain 12 33 2 74 0.04 0.03 0.07 0.26 0.18 0.38
- with iron 22 90 2 228 0.08 0.02 0.36 0.28 0.06 0.54
- lactose free 7 467 136 796 0.37 0.06 2.03 0.50 0.20 0.85

Concentrated liquid, soya based

12

706

266

1047

1.11

0.76

1.70

1.19

0.88

1.54

- plain 9 688 266 1047 1.18 0.76 1.70 1.25 0.90 1.54

Powdered, milk based

57

177

2

1004

0.17

0.01

1.21

0.65

0.16

3.46

- plain 15 18 2 48 0.04 0.01 0.07 0.23 0.17 0.42
- with iron 24 128 2 463 0.10 0.01 0.31 0.46 0.16 1.39
- lactose free 6 462 174 1004 0.48 0.19 1.21 1.50 0.46 3.46
- hypoallergenic 6 518 394 628 0.53 0.32 0.80 1.58 1.06 2.20

Powdered, soya based

15

733

199

1461

1.56

1.07

3.47

0.72

0.79

1.90

- plain 9 619 199 1068 1.72 1.07 3.47 1.42 0.91 1.90
- with iron 6 905 598 1461 1.31 1.11 1.57 1.16 0.79 1.38

Ready to Use, milk based

67

437

10

3442

0.23

0.03

1.26

0.90

0.14

2.46

- plain 19 379 10 955 0.21 0.03 0.68 0.96 0.23 2.46
- with iron 28 372 11 3442 0.11 0.03 0.38 0.73 0.14 1.80
- lactose free 6 622 371 896 0.20 0.07 0.28 1.10 0.86 1.22
- hypoallergenic 10 814 458 1310 0.67 0.16 1.26 1.12 0.49 1.78

Ready to Use, soya based

14

730

234

1121

1.18

0.71

2.95

1.45

1.10

2.10


1 Shaded lines indicate composite results for a category, and results are shown only when there are 4 or more samples in a category or sub-category.
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