Sunscreens: Benzene Exposure Risk

PRACTICE POINT

COMMUNIQUE TO CDA MEMBERS

Sunscreens: Benzene Exposure Risk

Released: July 15, 2021 | Reviewed April 2022

A recent independent US investigation of 294 unique batches of sunscreen and after-sun products found detectable levels of benzene, a known carcinogen, in 78 products (27%).  Of these, 32 of the 40 most contaminated products (80%) were sprays with levels of benzene greater than 0.1 ppm.

On May 24, 2021, Valisure, an independent US pharmaceutical product testing company, submitted a Citizen Petition to the US Food and Drug Administration (FDA) requesting the FDA recall 78 sunscreen and after-sun care products that were found to have levels of benzene in concentrations of 0.1 ppm or greater.

The petition stated that 78 of the 294 sunscreen and after-sun batches (27%) tested by Valisure had detectable levels of benzene. Of the 78 identified, 14 had levels of benzene over 2 ppm, 26 had levels between 0.1 ppm and 2.0 ppm, and 38 had levels under 0.1 ppm. Additionally, 32 of the 40 most contaminated products (80%) were sprays.

The authors of the report suggested the presence of benzene was likely due to contamination during the manufacturing process for several reasons:

• Benzene was not a listed ingredient
• Levels of benzene varied significantly from batch to batch, even within a single brand; and
• Degradation of ingredients with similar chemical structures to benzene – avobenzone, oxybenzone, octisalate, octinoxate, homosalate, and octocrylene – did not cause benzene to form.

Resultantly, Valisure has called on the FDA to investigate the manufacturing processes of sunscreen manufacturers, develop guidance documents for the analysis of benzene in sunscreen products, define a reasonable limit of detection, and revise the sunscreen monograph with the issues identified.

Class action lawsuits against several of the named sunscreen brand owners have since been launched.

It is important to note this investigation was only performed in the United States on sunscreens manufactured in the United States. To date, no similar independent investigation has been performed on Canadian sunscreens.

Practice Points:

• The use of sunscreen products and other sun safety measures should be continued. Benzene was not detected in 73% of the sunscreen products tested (217 batches from 66 brands). Avoiding an effective preventative measure against UV radiation could be more harmful than exposure to trace amounts of benzene.
• Sunscreens are a very important, effective, and scientifically-based way to prevent the harmful effects of the sun. Wearing of sun-protective clothing, a wide-brimmed hat, sunglasses, and seeking shade between 11 am and 3 pm, especially around midday, are also appropriate and timely sun safe measures that can be taken.
• Sunscreen formulations such as creams/lotions/gels should be considered until more is known about the disproportionately high number of sunscreen sprays found to contain benzene.
• It appears this is a problem within the manufacturing process, not with sunscreen products themselves. The investigation has underscored a need for further regulatory review which the CDA will be monitoring closely.
• Currently there are no benzene concentration limits in sunscreen. Inhalation and ingestion exposure (e.g., vehicle emissions and contaminated drinking water) have been the primary focus of toxicology investigations. There is likely no safe level of benzene and the CDA will be monitoring closely for recommendations.
• There is no direct data on systemic absorption of benzene from applying sunscreen with this contaminant. There is indirect data demonstrating sunscreen users of any frequency were less likely to have elevated blood concentrations of benzene compared to never users, suggesting that risk of systemic benzene exposure from sunscreen use may be low (Chang MS, Moore KJ, Trepanowski N, Koru-Sengul T, Hartman RI. Sunscreen use is not associated with increased blood concentrations of benzene among adults in the United States: Data from the National Health and Nutrition Examination Survey 2003-2006 and 2009-2018. J Am Acad Dermatol. 2021 Sep 10:S0190-9622(21)02444-0.).
• Avobenzone, oxybenzone, octisalate, octinoxate, homosalate, and octocrylene were not found to play a role in the formation of benzene. CDA recognized sunscreens with one or more of these active ingredients are still considered safe and effective. CDA recognized sunscreens can be found on the CDA website at https://dermatology.ca/recognized-products/sunscreen/.
• Product lot numbers for tested sunscreen and after-sun products can be found on the Valisure website at https://www.valisure.com/.

Additional Information About Benzene:

• Benzene is a clear, colorless, highly flammable and volatile, liquid aromatic hydrocarbon with a gasoline-like odor. Benzene is produced by both natural and man-made processes.
• Benzene is used mainly as a starting material in manufacturing other chemicals, including detergents, pesticides, plastics and resins, synthetic rubber, aviation fuel, pharmaceuticals, dye, explosives, PCB gasoline, flavours and perfumes, paints and coatings, nylon intermediates, photographic chemicals. Other natural sources include gas emissions from volcanoes and forest fires. Other than being present in ambient and indoor air, a major additional source of being exposed to benzene is traveling in motor vehicles.
• Benzene is a known human carcinogen and is linked to an increased risk of developing lymphatic and hematopoietic cancers, acute myelogenous leukemia, as well as chronic lymphocytic leukemia. Benzene association with disorders affecting the lymphohaemopoietic system are mostly linked to long term inhalation exposure.
• Long-term (a year or more) exposure to benzene causes neurological symptoms and affects the bone marrow causing aplastic anemia, granulocytopenia, lymphocytopenia, and/or thrombocytopenia. Exposure can include inhalation, skin absorption, ingestion, and skin and/or eye contact. Repeated skin contact can cause redness, blistering, and dry, scaly dermatitis.
• Most of the exposure resulting in bone marrow depression were noted in workers exposure to long term inhalation of benzene concentrations approximately above 40 ppm. In workers exposed to levels up to 1 ppm, no differences were found. Therefore, the WHO Task Group drew the conclusion that bone marrow depression is not expected to occur for exposure levels of 1 ppm or less for about 10 years. The exposure levels found to be carcinogenic are difficult to ascertain due to cohort studies showing inconsistent results.
• Resources:
  • https://pubchem.ncbi.nlm.nih.gov/compound/Benzene
  • https://www.cdc.gov/niosh/topics/benzene/
  • https://www.ccohs.ca/oshanswers/chemicals/chem_profiles/benzene.html
  • https://www.who.int/publications/i/item/WHO-CED-PHE-EPE-19.4.2
  • https://www.euro.who.int/__data/assets/pdf_file/0017/123056/AQG2ndEd_5_2benzene.pdf

Valisure Findings on Sunscreens Manufactured in the United States

For complete data, see https://www.valisure.com/wp-content/uploads/Valisure-Citizen-Petition-on-Benzene-in-Sunscreen-and-After-sun-Care-Products-v9.7.pdf.

Table 2: Benzene detected in concentrations at 2 ppm or higher (14 products)

*    Results from testing site: Chemical and Biophysical Instrumentation Center, Yale University
**   Results from testing site: Boston Analytical

Table 3: Benzene detected in concentrations between 0.1 ppm to 2 ppm (26 products)

* Results from testing site: Chemical and Biophysical Instrumentation Center, Yale University

Table 4: Benzene detected in concentrations below lower limit of quantification (38 products)

Approved and released by the Canadian Dermatology Association 15 July 2021
Reviewed April 2022