Occurrence and dietary exposure to phthalates in the US population – a contextual review

Abstract

Esters of 1,2-benzene dicarboxylic acid (or phthalates) are general purpose plasticizers used in multiple polyvinyl chloride (PVC) consumer applications. Some of these plasticizers are permitted for safe use in a narrow subset of food packaging applications by global regulatory agencies, including the US FDA. Several US studies have reported the presence of trace concentrations of phthalates (parts per billion) in the diet. These findings have prompted calls for regulatory action based on the potential for adverse impacts on public health. These claims are misguided. Global food safety regulatory frameworks are designed with the expectation that low concentrations of food contact materials may be present in food. These frameworks include guardrails (in the form of content limits and/or migration limits) to minimize the potential for dietary risk. This concept of exposure and risk is often missing in many studies identifying low concentrations of phthalates in food. Dietary risk assessments, based on total diet studies, have been published by food safety agencies in the EU, Australia, New Zealand, UK, and Canada. Without exception, all risk assessments confirm that concentrations of phthalates in food are low and do not pose a public health concern. In this review, we calculate dietary risk estimates for concentrations of high molecular weight phthalates reported in some US food articles. The results confirm that dietary exposures, even in the most conservative scenarios, are below levels of concern.

Keywords:

• Phthalates
• dietary exposure
• fast food
• exposure modelling

Disclosure statement

Dr. Adenuga is a toxicologist employed by the ExxonMobil Product Solutions Company, a division of ExxonMobil Corporation, which is a United States (US) manufacturer of di-isononyl phthalate (DINP).

Notes

1 See full definitions for food ingredients, including food contact substances, materials and articles at Food Ingredient & Packaging Terms | FDA.

2 See prior reference.

3 Phthalates in Food Packaging and Food Contact Applications | FDA.

4 Food contact materials | EFSA (europa.eu).

5 Testing Finds Industrial Chemical Phthalates in Cheese (kleanupkraft.org).

6 Center for Food Safety | Press Releases | | Toxic Industrial Chemicals Found in 10 Varieties of Macaroni and Cheese Powders.

7 Macaroni and cheese: Are there phthalates are in there? | CNN.

8 The Chemicals in Your Mac and Cheese - The New York Times (nytimes.com).

9 How Scared Should You Be of Macaroni and Cheese? - The Atlantic.

10 Don’t panic over the chemicals in your mac and cheese. (slate.com).

11 Candidate List of substances of very high concern for Authorisation - ECHA (europa.eu).

12 FDA Limits the Use of Certain Phthalates in Food Packaging and Issues Request for Information About Current Food Contact Uses and Safety Data | FDA.

13 P1034 – Chemical Migration from Packaging into Food (foodstandards.gov.au).

14 P1034 Abandonment.pdf (foodstandards.gov.au).

15 Assuming a 150 ng g⁻¹-bw/day TDI for DINP/DIDP, and that a 60 kg European adult consumes 1 kg food/day, the maximum allowable limit (or SML) of DINP/DIDP in food can be calculated as [150 ng g⁻¹ × 60,000 g]/1 kg food = 9 mg kg⁻¹ food.

16 Calling on Kraft-Heinz to find and remove dangerous phthalates - EHN

17 While not explicitly stated, EHN appears to be referencing oral chronic reference doses (RfD_oc) for certain phthalates as listed in the EPA’s Risk Assessment Information System (RAIS).

18 Family Size Original Cheddar 24 oz. | Kraft Macaroni & Cheese (kraftmacandcheese.com).

19 We selected a young child here because infants and children are considered to be the most sensitive subpopulation to phthalate exposure. Children also have a higher exposure burden compared to adults, due to size differences.

20 We excluded infants <1 year old since they would be unlikely to eat solid food at that age.

21 150 ng g⁻¹ body weight ADI DINP × 15.15 kg body weight for toddler = 2272.5 µg ADI DINP for a toddler. (2272 µg ADI DINP toddler)/(57 µg DINP/kg burrito) = 40 kg of burritos/day for a toddler to exceed the safe limit.