Benzene Contamination in Sunscreen Products in the US
Benzene is a chemical that is widely used in some industries. However, benzene is a known human carcinogen and therefore its use or trace presence in cosmetics and personal care products is not allowed. In the U.S., a recent report has identified 78 sun care products contaminated with benzene, requiring their recall by the FDA in order to protect consumers.
Marta Pinto

Marta Pinto

Regulatory Affairs Associate

BENZENE IN U.S. SUNSCREEN PRODUCTS

A testing and consumer protection organization located in the U.S. has detected high levels of Benzene in several brands and batches of sunscreen (classified as drug products by the FDA) and after-sun products (generally regulated as cosmetics by the FDA). The company analysed 294 unique batches from 69 different companies, observing significant variability from batch to batch, even within a single company. According to the study, 27% of the samples tested, representing a total of 78 sun care products, contained benzene. Some batches contained up to three times the conditionally restricted FDA concentration limit (2 ppm). Benzene was detected in sprays, gels, and lotions (with both chemical and mineral-based formulations).

Since benzene is one of the most studied and concerning human carcinogens known to science, with numerous studies showing its association with blood cancers in humans even at trace levels of parts per million and below, the presence of this carcinogen in products widely recommended for the prevention of skin cancer and that are regularly used by adults and children is very troubling.

Study authors are currently pushing for a recall of all the contaminated batches and asking the FDA to better define limits for Benzene contamination in drug and cosmetic products. In March 2021, a petition had already been issued (2021 Citizen Petition) on benzene contamination in hand sanitizer and there were several recalls of contaminated hand sanitizer products.

Since the report was published, the U.S. Food and Drug Administration started investigating the root cause of benzene found these sunscreen products. Some brands already started voluntarily recalling the products and advised consumers to stop using them. Despite this, the agency continued advising patients to use broad spectrum sunscreens with SPF 15 or higher in conjunction with other sun protective measures.

BENZENE TOXICOLOGICAL PROFILE

Benzene is a chemical that can be found in nature and manufactured products. It is used as a chemical intermediate to make several industrial chemicals. Smaller amounts are often used in chemical laboratories as solvent and reagent. Moreover, benzene is used as a constituent in motor fuels, in the extraction of oils from seeds and nuts, in the manufacture of detergents, explosives and pharmaceuticals, for example. Benzene is used as a starting material for synthetic fragrances. Trace levels of benzene may be found in cigarette smoke, gasoline, glues, adhesives, cleaning products, and paint strippers.

Individuals that work in industries that manufacture or use benzene may be exposed to highest levels of this compound, being occupational exposure one of the main concerns of the toxicity of benzene. Tobacco smoke also contains benzene and represents one of the most significant sources of exposure. People may also be exposed to benzene by consuming contaminated water.

Benzene is rapidly absorbed through skin from both liquid and vapour phases, as shown in human and experimental studies. Although dermal absorption is minimal when compared with inhalation or oral absorption because it rapidly volatilizes in the skin, it still has toxic effects associated to dermal exposure. Benzene was irritating to the mucous membranes of eyes, mouth, respiratory tract and skin in rodents.

Human exposure to benzene occurs primarily via inhalation in the workplace, from gasoline vapors, tobacco smoke and automotive emissions. People exposed to the chemical exhibit bone marrow depression (evidenced by anemia), leukopenia and/or thrombocytopenia. Inhalation of exposure can cause neurological symptoms like drowsiness, dizziness, headaches and unconsciousness in humans. Liquids and vapours containing benzene have shown to irritate the skin, eyes and upper respiratory tract. Benzene causes both structural and numerical chromosomal aberration in humans.

Exposure to benzene can cause acute nonlymphocytic leukemia and other blood disorders (preleukemia and aplastic anemia), as shown in human epidemiologic studies of highly exposed occupational cohorts. Studies in humans and experimental animals have demonstrated that this compound may also cause hematotoxicity (changes in blood and bone marrow).

Benzene is a “known human carcinogen by all routes of exposure”, according to the U.S. Environmental Protection Agency (EPA). Benzene is defined as a carcinogen by the National Institute for Occupational Safety and Health (NIOSH) which lists “inhalation, skin absorption, ingestion, skin and/or eye contact” as exposure routes. The International Agency for Research on Cancer (IARC) classifies Benzene as a Group 1 human carcinogen.

BENZENE IN COSMETIC PRODUCTS

According to the European Regulation (EC) No 1223/2009 on cosmetic products, Benzene is included in the list of substances prohibited in cosmetic products (Annex II). This means that in the European Union, Benzene is not allowed in cosmetics and personal care products, as it is classified as a Carcinogen Category 1A.

The U.S. Food and Drug Administration (FDA) lists Benzene as a Class 1 solvent “that should not be employed in the manufacture of drug substance. However, if their use is unavoidable in order to produce a drug product with a significant therapeutic advance, then their levels should be restricted”. For these particular situations, Benzene is restricted to 2 parts per million (ppm).

Because of its toxicity, the FDA has determined that Benzene can not be used in pharmaceutical production. However, there is no exposure limit established for Benzene, and the 2ppm limit only applies in special circumstances.

If you wish to get more information on Benzene or other subjects related to the EU Cosmetics Regulation, do not hesitate to contact us at info@criticalcatalyst.com.

References:

  1. Valisure Detects Benzene in Suscreen. May 25, 2021. Valisure News. Available from: https://www.valisure.com/blog/valisure-news/valisure-detects-benzene-in-sunscreen/
  2. Toxicological Review of Benzene (Noncancer Effects) – (CAS No. 71-43-2). In Support of Summary Information on the Integrated Risk Information System (IRIS). October 2002. Available from: https://cfpub.epa.gov/ncea/iris/iris_documents/documents/toxreviews/0276tr.pdf
  3. Opinion on the results of the Risk Assessment of: Benzene. Human Health Part. CAS Nº: 71-43-2. EINECS Nº: 200-753-7. Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE). 2003. Available from: https://ec.europa.eu/health/archive/ph_risk/committees/sct/documents/out207_en.pdf

further
reading

cosmetic products

New Amendments to the European Cosmetics Regulation – CMR Substances

The European Commission published the Commission Regulation (EU) 2022/1531, which amends Regulation (EC) No 1223/2009 in regards to the use in cosmetic products of certain substances classified as CMR. This amendment introduces new entries to Annex II and Annex III and revises an entry to Annex V to Regulation (EC) No 1223/2009.

Read More »
medical devices

EUDAMED – harmonized practices and alternative solutions for IVDR until the database is fully functional

EUDAMED is one of the key aspects of the new rules on in vitro diagnostic medical devices – Regulation (EU) 2017/746. However, it is only expected to achieve full functionality by the second quarter of 2024. Until then, how is the information submitted and/or exchanged between manufacturers, notified bodies and competent authorities?

Read More »
medical devices

EUDAMED – update on timelines

EUDAMED is one of the key aspects of the new rules on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746), and it is expected to achieve full functionality by the second quarter of 2024.

Read More »
cosmetic products

UK OPSS call for data on six cosmetic ingredients

On 14 July 2022, the Office for Product Safety and Standards (OPSS – the UK regulator for cosmetic products) issued a call for data on the safety of the following six cosmetic ingredients to investigate any suspected endocrine disrupting properties. 

Read More »
cosmetic products

European Commission Recommendation on the Definition of Nanomaterial

Nanomaterials are increasingly used in cosmetics and personal care products. They are similar to other chemicals/substances, but with specific risks associated to their use. The European Commission has published a new Recommendation to clarify the definition of ‘nanomaterial’. This definition may serve different policy, legislative and research purposes when addressing materials or issues concerning products of nanotechnologies.

Read More »
cosmetic products

Expected Restriction on the Use of Methyl Salicylate

The European Commission has notified the World Trade Organization (WTO) of a draft amendment to the Regulation (EC) No. 1223/2009 on cosmetic products. Annex III to Regulation will be amended, and the use of Methyl Salicylate in cosmetic products will be restricted.

Read More »