ARCHIVED — Health Canada Requests Information from Industry on the Use of Aluminum-Containing Food Additives

Overview

In July 2008, Health Canada’s Bureau of Chemical Safety distributed a letter to industry stakeholders requesting information on the use of aluminum-containing food additives in Canadian food products. The letter was triggered by the 2006 Joint FAO/WHO Expert Committee on Food Additives (JECFA) reduction of the Provisional Tolerable Weekly Intake (PTWI) for aluminum from 7 mg/kg body weight per week to 1 mg/kg body weight per week, which prompted Health Canada to review whether dietary aluminum exposure among Canadians is acceptable and whether the existing Maximum Levels of Use under Division 16 of the Canadian Food and Drug Regulations remain appropriate. The accompanying Table 1 enumerates every aluminum-containing food additive permitted in Canada at the time of the request, with functional class and food-by-food maximum levels of use. The page is archived (Date modified 2017-05-04) and is preserved here as a record of the Canadian regulatory baseline for aluminum food additives as of 2008.

Key numbers

JECFA PTWI reduction context (p. 1):

• Pre-2006 PTWI for aluminum from all sources (including food additives): 7 mg/kg body weight per week.
• 2006 revised PTWI: 1 mg/kg body weight per week (a 7-fold reduction).

Canadian Food and Drug Regulations Division 16 — aluminum-containing food additives permitted in Canada under certain conditions (Table 1, pp. 4-6):

GMP = Good Manufacturing Practice (no numerical ceiling; only the amount necessary to achieve the intended technical effect). Percentages are weight-per-weight unless otherwise specified. The 900 ppm cap on flour/whole-wheat-flour applies separately to sodium aluminum sulphate and to potassium aluminum sulphate when used as a carrier of benzoyl peroxide; in each case the cap is qualified by the ”**” footnote (“in accordance with other sections — standards of identity/composition — contained in the Food and Drug Regulations”).

Canadian Environmental Protection Act, 1999 (CEPA 1999) context (p. 2):

• In 1995, aluminum sulphate, aluminum chloride, and aluminum nitrate were added to the Second Priority Substance List (PSL2).
• A State of the Science report on these aluminum salts was published in 2000.
• The PSL2 draft assessment on aluminum salts was scheduled for publication by November 29, 2008.
• Of the three PSL2 aluminum salts, only aluminum sulphate (including its potassium and sodium salts) is permitted as a Canadian food additive; aluminum chloride and aluminum nitrate are not permitted food additives in Canada.

Industry response window: letter distributed July 03, 2008; responses requested by August 22, 2008 (p. 1, 4). Responses directed to bcs-bipc@hc-sc.gc.ca, Bureau of Chemical Safety, Food Directorate.

Methods (brief)

Regulatory document, not an analytical study. No analytical methods, sampling design, or measurement instruments are described — the document is an industry consultation letter accompanied by a tabulation of Division 16 maximum levels of use for aluminum-containing food additives. The maximum levels enumerated in Table 1 are excerpted directly from the Canadian Food and Drug Regulations as in force in 2008; the document does not report any new contamination measurements.

Limitations

• The document captures the 2008 Canadian regulatory baseline for aluminum food additives; subsequent Division 16 amendments after the 2008 PSL2 assessment publication are not reflected here and should be verified against the current Food and Drug Regulations.
• Maximum Levels of Use are upper regulatory ceilings on intentional additive use, not measured occurrence values. Actual aluminum content in finished foods depends on manufacturer formulation practice within the GMP/percentage ceiling and on co-contributions from naturally occurring aluminum and food-contact materials.
• The 350 ppm potassium aluminum sulphate ceiling for sea urchin roe was an Interim Marketing Authorization (IMA) pending regulatory amendment at the time of the letter; the disposition of that IMA is not stated in the document.
• The asterisked footnotes in Table 1 condition many entries on compliance with other standards of identity/composition elsewhere in the Food and Drug Regulations; readers must consult the full Regulations text for the operative permitted-use determination.
• The page is archived (“we have archived this page and will not be updating it”); the figures stand as a 2008 snapshot.

Implications

• Microbiome: Not directly addressed by the document.

Related evidence

• regulations/canada-food-drug-regulations-division-16-aluminum
• JECFA aluminum evaluations by meeting
• Aluminum
• EFSA — Aluminium Tolerable Weekly Intake (1 mg/kg b.w./week)

Update history

The five most recent substantive edits to this page, classified major (evidence or structure moved), correction (a published value or statement was wrong and has been fixed), or minor (narrative rewritten without changing the underlying evidence). Each description is derived from what the edit did to this page; the linked commit is the authoritative record, routine regeneration passes are excluded, and the full version history lives in git.