Canada | Investigations and recommendations for the substance sucrose acetate isobutyrate

Whereas a summary of the draft screening assessment conducted on sucrose acetate isobutyrate pursuant to paragraphs 68(b) and (c) of the Act is annexed hereby;

And whereas it is proposed to conclude that the substance does not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Minister of the Environment and the Minister of Health (the ministers) propose to take no further action on this substance at this time.

Public comment period

Any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Canada.ca (Chemical Substances) website. All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be addressed to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by fax to 819‑938‑5212, by email to eccc.substances.eccc@canada.ca, or by using the online reporting system available through Environment and Climate Change Canada’s Single Window.

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

Jacqueline Gonçalves
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment

Greg Carreau
Acting Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

Summary of the draft screening assessment of sucrose acetate isobutyrate

Pursuant to section 68 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment of α-D-Glucopyranoside, 6-O-acetyl-1,3,4-tris-O-(2-methyl-1-oxopropyl)-β-D-fructofuranosyl, 6-acetate 2,3,4-tris(2-methylpropanoate), hereinafter referred to as sucrose acetate isobutyrate (SAIB). The Chemical Abstracts Service Registry Number (CAS RN) for SAIB is 126-13-6. This substance was identified as a priority for assessment on the basis of other human health concerns identified in 2006.

SAIB does not occur naturally in the environment. According to information submitted in response to a CEPA section 71 survey in 2011, there were no reports of manufacture of SAIB in Canada, but 0.1 kg was imported. SAIB is used as an adhesive and film forming agent in cosmetics, and is a permitted food additive on the List of Permitted Food Additives with Other Accepted Uses (Lists of Permitted Food Additives) as a density adjusting agent in beverages containing citrus or spruce oils. It is also listed as a stabilizing agent in the Natural Health Products Ingredients Database.

The ecological risks of SAIB were characterized using the ecological risk classification of organic substances (ERC), which is a risk-based approach that employs multiple metrics for both hazard and exposure, with weighted consideration of multiple lines of evidence for determining risk classification. Hazard profiles are based principally on metrics regarding mode of toxic action, chemical reactivity, food web–derived internal toxicity thresholds, bioavailability, and chemical and biological activity. Metrics considered in the exposure profiles include potential emission rate, overall persistence, and long-range transport potential. A risk matrix is used to assign a low, moderate or high level of potential concern for substances on the basis of their hazard and exposure profiles. Based on the outcome of the ERC analysis, SAIB is considered unlikely to be causing ecological harm.

Considering all available lines of evidence presented in this draft screening assessment, there is a low risk of harm to the environment from SAIB. It is proposed to conclude that SAIB does not meet the criteria under paragraph 64(a) or (b) of CEPA as it is 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.

Exposure of the general population to SAIB from environmental media is not expected to be significant. For the general population in Canada, potential exposure to SAIB can result from the consumption of certain flavoured alcoholic and non-alcoholic beverages, use of cosmetic products such as nail polish, lipsticks, eye shadows, face stickers, body tattoos, and artificial skin products in spray formulations.

In 1993, the toxicological profile of SAIB was reviewed internationally by the Joint Food and Agriculture Organization of the United Nations/World Health Organization Expert Committee on Food Additives, in which Health Canada had actively participated. SAIB is considered to have a low hazard potential. In short-term and chronic toxicity studies (in relevant animal species through oral route), it did not cause genotoxic, carcinogenic, reproductive, developmental or any other adverse effects relevant to human health up to a dose of 2 000 mg/kg bw/day. No adverse effects were observed in humans when administered a daily dose of up to 20 mg/kg bw/day. Exposure estimates for SAIB from the consumption of food or use of cosmetics and natural health products are not presented as the risk to human health is considered to be low.

On the basis of the information presented in this draft screening assessment, it is proposed to conclude that SAIB does not meet the criteria under paragraph 64(c) of CEPA as it is 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.

Proposed overall conclusion

It is proposed to conclude that SAIB does not meet any of the criteria set out in section 64 of CEPA.

The draft screening assessment for this substance is available on the Canada.ca (Chemical Substances) website.