Ethyl carbamate in alcoholic and non-alcoholic beverages, vinegars, grain based breads and crackers and soy based products - April 1, 2016, to March 31, 2018 and April 1, 2020, to March 31, 2022

Targeted surveys are used by the CFIA to focus its surveillance activities on areas of highest health risk. The information gained from these surveys provides support for the allocation and prioritization of the agency's activities to areas of greater concern. Originally started as a project under the Food Safety Action Plan (FSAP), targeted surveys have been embedded in our regular surveillance activities since 2013. Targeted surveys are a valuable tool for generating information on certain hazards in foods, identifying and characterizing new and emerging hazards, informing trend analysis, prompting and refining health risk assessments, highlighting potential contamination issues, as well as assessing and promoting compliance with Canadian regulations.

Food safety is a shared responsibility. We work with federal, provincial, territorial and municipal governments and provide regulatory oversight of the food industry to promote safe handling of foods throughout the food production chain. The food industry and retail sectors in Canada are responsible for the food they produce and sell, while individual consumers are responsible for the safe handling of the food they have in their possession.

The main objectives of this targeted survey were to generate further baseline surveillance data on the level of EC in alcoholic and no-alcoholic beverages, culinary vinegars, grain based breads and cracker and soy products on the Canadian retail market, and to compare the prevalence of EC in foods targeted in this survey with that of similar products in other targeted surveys and scientific literature.

EC is formed unintentionally during fermentation by the spontaneous reaction of urea and ethanol. During fermentation, some strains of yeast naturally produce urea and ethanol, which can react together to form EC^{Footnote 3, Footnote 4}. EC levels in foods can be affected by a wide range of factors, including processing and storage temperature, strain of yeast present, crop fertilization and exposure to sunlight^{Footnote 2, Footnote 3, Footnote 4, Footnote 5, Footnote 6}.

EC is classified as 'probably carcinogenic to humans' by the International Agency for Research on Cancer (IARC)^{Footnote 7}. As such, Health Canada has set in place Maximum Levels (ML) for EC in various alcoholic beverages^{Footnote 8}. Due to this potential health risk, the CFIA considered it important to examine EC levels in other fermented foods available on the Canadian retail market.

A variety of domestic and imported fermented products including alcoholic and no-alcoholic beverages, culinary vinegars, grain based breads and cracker and soy products were sampled from April 1 to March 31 over the following survey years: 2016, 2017, 2020, and 2021. Samples of products were collected from local/regional retail locations located in 11 major cities across Canada. These cities encompassed 4 Canadian geographical areas:

• Atlantic (Halifax and Moncton)
• Quebec (Montreal and Quebec City)
• Ontario (Toronto and Ottawa)
• West (Calgary, Saskatoon, Vancouver, Victoria and Winnipeg)

The number of samples collected from these cities was in proportion to the relative population of the respective areas. The shelf life, storage conditions, and the cost of food on the open market were not considered in this survey. Refer to Table 1 for the product types collected in this survey.

Samples were analyzed by an ISO 17025 accredited food testing laboratory under contract with the Government of Canada. The results are based on the food products as sold and not necessarily as they would be consumed.

Chemical contaminants in foods have regulatory levels established by Health Canada. Currently, these have been established for the presence of EC in certain types of alcoholic beverages. Health Canada has determined a maximum level (ML) of 35 ppb for EC in table wine, 100 ppb in fortified wines, 150 ppb in distilled spirits, 400 ppb in fruit brandies and liqueurs and 200 ppb in sake (rice wine)^{Footnote 8}. Refer to Appendix A, Table A-1 for tabular format of MLs in alcoholic beverages established by Health Canada. Compliance is assessed against the established ML available when the survey was carried out. In the absence of a specific ML, the levels of EC may be assessed by Health Canada on a case-by-case basis using the most current scientific data. Any high results of EC are reviewed by Health Canada's Bureau of Chemical Safety to determine if the levels are harmful to consumers. Note that there are no Canadian regulatory limits for the remaining categories of products included in the survey.

Of the 1488 samples tested, most (86%) did not have detected levels of EC. Table 2 illustrates the range of concentrations detected in the survey samples by product type.

A wide variety of alcoholic beverages and distilled spirits were sampled within the following the following categories: 135 ciders, 151 distilled spirits, 65 fortified wines, 21 fruit brandies, 27 liqueurs, 54 sakes (rice wine) and 161 table wines. The highest level of EC was found in an imported sake wine (15.5% alcohol) at 128 ppb which was below Health Canada's ML of 200 ppb. All other alcoholic beverage samples that tested positive for EC were found to contain levels below the MLs, with the exception of 1 imported fortified plum wine (14% alcohol) which exceeded the ML of 100 ppb at 127ppb. Within the category of fortified wines, the compliance rate was 64 out of 65 samples screened or 98.5%, and 100% for all other categories of alcoholic beverages as no other samples exceeded the ML. Refer to Appendix A, Table A-1 for a detailed breakdown of the minimum, maximum, average levels of EC detected within each category of alcoholic beverages in ppb, as well as the number of compliant samples and percent compliance.

Although the rate of detection (percent positive samples) for alcoholic beverages is highest across all product types in Table 2, the majority of samples (72%) did not contain EC and the average level of EC detected was well below the ML and the maximum level detected. Refer to Appendix A, Table A-3 for additional detection rates.

A total of 134 non-alcoholic beverages were tested and included: 15 non-alcoholic ciders, 19 non-alcoholic table wines, 35 soft drinks and 65 fermented beverages; 52 of which were kombucha. Of the products tested, 2 samples were observed to contain EC levels, 1 of which was an imported de-alcoholized wine product at 7.0 ppb, and the other was in an imported fermented kombucha beverage at 6.0 ppb. Note that there were 19 non-alcoholic (de-alcoholized) wine samples tested, and 52 kombucha samples tested in this survey. The majority of samples tested in the non-alcoholic beverages category (98%) did not test positive for EC.

Culinary vinegars

A total of 50 culinary or cooking vinegars were tested. The category included 23 apple cider vinegars, 6 balsamic, 16 wine vinegars and 5 grain vinegars (grain and rice). There was a 0% detection rate for EC in culinary vinegars in this targeted survey.

Grain based breads and crackers

A total of 286 grain based products were tested. The products tested included 47 breads/buns, 44 bagels, 41 english muffins/crumpets, 36 flatbreads and 119 crackers/crisps. None of the grain based samples tested contained detectable levels of EC.

Soy based Products

A total of 404 fermented soy products were tested. Product categories tested included: 74 soy sauces,186 plant based protein sources (for example, tofu or tempeh), and 143 bean: curds, pastes, spreads and miso. In total, 37 samples were found to contain levels of EC ranging from 4 to 520 ppb. All of the samples that tested positive were imported products with the exception of 1 domestic plant-based protein product in which EC was detected at 7 ppb.

The highest levels of EC were detected in the soy product sub-category of bean curds. Of the 20 bean curds tested, 14 or 70% tested positive for EC and values ranged 19 ppb to 520 ppb, with 7 samples equal to or exceeding 100 ppb. All of the bean curds that contained EC were imported products outside of Canada and the United States.

The main objectives of this targeted survey were to expand upon the baseline data regarding the levels of EC in selected fermented foods on the Canadian retail market. The detection rates and the levels recorded for EC in the products tested in this targeted survey were comparable to those previously found in similar product types in previous surveys and in the scientific literature^{Footnote 9, Footnote 10, Footnote 11, Footnote 12, Footnote 13, Footnote 14, Footnote 15, Footnote 16}. Refer to Table 3 below. Some differences observed may be due to the specific type of product tested or the sample size.

The levels of EC observed in this survey were within the range reported in the literature in similar products^{Footnote 9, Footnote 10, Footnote 11, Footnote 12, Footnote 13, Footnote 14, Footnote 15, Footnote 16}. The larger sample sizes in this multi-year survey confirms that the occurrence of EC in products available on the Canadian market is low across product categories. The overall compliance rate for all alcoholic beverages with ML's included in this survey was 99.8%, which was due to one fortified wine sample exceeding the ML by 27 ppb, as noted in Appendix A, Table A-1.

Health Canada determined the levels of EC in food observed in this multi year survey are not expected to pose a concern to human health, therefore there were no product recalls resulting from this survey. Future EC surveys will look to broaden the CFIA's baseline knowledge on the levels present in fermented soy products and cooking wines.