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ARCHIVED - PSL Assessment Report for Aluminum Salts

3.3 Conclusion

CEPA 1999 64(a) and 64 (b): Based on the available data, it is proposed that the three aluminum salts, aluminum chloride, aluminum nitrate and aluminum sulphate, are not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends.

CEPA 1999 64(c): Based on available data concerning the exposure of the Canadian population to aluminum chloride, aluminum nitrate and aluminum sulphate, and in consideration of the health effects observed in humans and in experimental animals, it is proposed that these aluminum salts are not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

It is therefore proposed that the three aluminum salts, aluminum chloride, aluminum nitrate and aluminum sulphate, do not meet the definition of "toxic" as set out in section 64 of CEPA 1999.

Notwithstanding the above proposed conclusion, the human health risk assessment carried out on the basis of total aluminum exposure suggests thata proportion of individuals, particularly in the younger age groups, may be exposed to levels of total aluminum that, when compared to the exposure level of concern (derived from studies in experimental animals measuring neurotoxic effects), results in margins that may not be adequate.  For most age groups, food is estimated to be the primary source of exposure to aluminum.  In addition, sub-populations exposed to aluminum through the use of aluminum-containing over-the-counter oral therapeutic products would likely have higher exposure to aluminum.

As the three aluminum salts on the Priority Substances List are not significant contributors to Canadians' exposure via the principal media of total aluminum exposure, they are not considered to be significant contributors to the overall health risk.

Food additives in Canada are regulated under the Food and Drugs Act. The Food Directorate of Health Canada is currently re-evaluating dietary exposure to aluminum and reviewing current uses of aluminum-containing food additives, following a decision by the Joint Expert Committee on Food Additives (JECFA) of the World Health Organization to reduce the Provisional Tolerable Weekly Intake (PTWI) for aluminum to 1.0 mg/kg bw. As part of this project, the Food Directorate is conducting a probabilistic assessment of aluminum exposure via foods using the latest data from the Canadian Total Diet Study and from the Canadian Community Health Survey - Cycle 2.2 on Nutrition. The probabilistic exposure assessment will provide a more accurate estimate of the full range of dietary intakes of aluminum, including the proportion of the population that may be exceeding the PTWI. The results of this project will serve as the basis for updating the regulatory provisions (including the maximum levels of use) for aluminum-containing food additives. Further information can be found via Health Canada's Food Additives webpage: http://www.hc-sc.gc.ca/fn-an/securit/addit/index-eng.php.

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