Phthalates in Flatbread and Vegan Products – April 1, 2018 to March 31, 2019

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.

Phthalates (also called plasticizers) are chemicals used to make plastics more flexible and harder to break. They are commonly used in PVC (polyvinyl chloride plastics). They have a wide variety of industrial uses that include the manufacture of household and consumer goods such as lubricating oils, solvents, personal care products and food packaging. Phthalates can migrate from plastic food packaging and from the gaskets of lids for glass containers into foods, particularly those foods that are oily or that have a high fat content. Noteworthy, phthalates in non-fatty foods including bread were as reported a significant source of phthalates^{Footnote 3}. Previous CFIA surveys identified flatbreads as the grain product with the highest phthalate levels^{Footnote 4}.

Exposure to phthalates is of concern, because these substances are linked to reduced reproductive health and development in animal studies. In people, increased levels of phthalates are associated with adverse health effects, for example obesity and reduced masculinization in newborn boys. Phthalates encompass a broad range of compounds. For certain phthalates, food is believed to be the main source of exposure. Increased phthalate levels in human blood and urine have been associated with the consumption of specific foods, especially fatty foods^{Footnote 1, Footnote 2, Footnote 3}. DEHP is the most commonly used and best-studied of the phthalates^{Footnote 2}. Recently, a dietary exposure assessment to DBP, BBP, DEHP and DINP was carried out by the European Food Safety Authority (EFSA) where the concentration is expressed as DEHP equivalents^{Footnote 3}. In this survey, 6 phthalates were examined. They included BBP, DBP, DNOP, DEHP, DINP and DIDP. The phthalate concentration is reported as the sum of the concentrations of all phthalate forms observed.

The main objectives of this targeted survey were to generate additional baseline surveillance data on the level of phthalates available on the Canadian retail market, and to compare the phthalate levels in foods in this survey with that of previous targeted surveys.

A variety of domestic and imported flatbreads and vegan products (dairy/meat alternatives, vegan mayonnaise and tofu) were sampled between April 1, 2018 and March 21, 2019. Samples of products were collected from local/regional retail locations located in 6 major cities across Canada. These cities encompassed 4 Canadian geographical areas:

• Atlantic (Halifax)
• Quebec (Montreal)
• Ontario (Toronto and Ottawa)
• West (Vancouver and Calgary)

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 the food on the open market were not considered in this survey.

Samples were analyzed by an ISO/IEC 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.

Currently, no maximum level, tolerance, or standard has been established by Health Canada for phthalate levels in food; therefore, compliance with numeric Canadian regulations was not evaluated in this survey. The European Union has set migration limits for phthalates from food contact materials: 0.3 mg per kg of food for BBP, 1.5 mg per kg of food for DEHP, 9 mg per kg of food DINP and DIDP, and 30 mg per kg of food for DBP^{Footnote 3}. The United States has set a limit of 0.006 milligram per liter (0.6 ppb) in bottled water^{Footnote 5}.

In the absence of a specific maximum level, the levels of phthalates detected were assessed by Health Canada on a case-by-case basis using the most current scientific data available.

A total of 599 domestic and imported flatbreads and 391 vegan products (dairy alternatives, mayonnaise, meat alternatives and tofu) were tested for 6 phthalates in this targeted survey. Of these samples, 526 (88%) did not contain detectable levels of phthalates. The phthalate concentration is reported as the sum of the concentrations of all phthalate forms observed. The phthalate levels ranged from 0.5 ppm to a maximum of 24 ppm. Table 2 illustrates the phthalate levels found.

BINP was the most commonly detected phthalate, found in 9% of samples. DEHP was the second most frequently detected phthalate (4% of samples). BDP and DIDP were only found in 4 and 2 samples, respectively. No other compounds were detected in the products tested.

The levels of phthalates found in this targeted survey were compared to those previously found in similar product types^{Footnote 4}. In the 2012 to 2015 survey years, the grain products with highest phthalate levels detected were flatbreads, therefore these products were targeted in this survey year. The maximum levels of phthalates found closely matched those previously observed.

In previous survey years, nut and seed butters were found to contain high levels of phthalates^{Footnote 4}. In this survey vegan products that are also often derived from nuts and seeds were tested. In comparison to previous survey years, the detection rate and the average phthalate levels in this product type were lower. In the 2012 to 2015 survey years, the highest phthalate levels detected in nut and seed butters were associated with DIDP. In that survey, DIDP was most frequently detected in oils and fats. This indicates that DIDP is highly lipophilic and therefore, as observed,  products tested in the current survey with lower fat content were expected to have lower total phthalate levels than pure nut butters.

Currently, no maximum level, tolerance, or standard has been established by Health Canada for phthalate levels in food and therefore, compliance with a numerical standard was not evaluated in this survey. All levels of phthalate found in the products tested in this survey were evaluated by Health Canada and deemed safe for consumption by Canadians; no product recalls were required.