Key takeaway
The evaluation of 1-phenylethanol (EC 202-707-1, CAS 98-85-1), completed by Italy in September 2024, highlights significant health risks associated with its widespread use in consumer and industrial products. Used in cleaning agents, cosmetics, fragrances, and pharmaceuticals, the substance was found to pose carcinogenic and eye irritation risks, as well as acute toxicity and liver damage with repeated exposure. Italy has proposed harmonised classification for 1-phenylethanol, including Category 2 carcinogen and Category 4 acute toxicity, to ensure better regulation and safety.
1-Phenylethanol is widely used across various industries due to its versatile properties. It is a key component in cleaning products, such as washing agents and polishes, and is commonly found in perfumes, fragrances, and air care products like scented candles and air fresheners. In the pharmaceutical sector, it serves as a chiral building block in the production of active ingredients. The substance is also used in cosmetics and personal care products, including skin and hair care formulations. Additionally, it plays an important role in industrial chemical manufacturing and health services, where it is utilised for its chemical properties and fragrance capabilities. Its widespread use across consumer, professional, and industrial settings raises concerns about potential direct exposure to both consumers and workers.
Following Italy’s evaluation of 1-phenylethanol, several regulatory actions have been proposed to address the health risks it poses. The evaluation confirmed concerns regarding its carcinogenicity, acute toxicity, and eye irritation, prompting recommendations for harmonised classification under the CLP regulation. Italy has proposed that 1-phenylethanol be classified as a Category 2 carcinogen, Category 4 for acute toxicity, and Category 2 for eye irritation, with further classification for Specific Target Organ Toxicity (STOT RE 2) due to liver damage observed from repeated exposure. While no immediate restrictions are planned, ongoing monitoring and further regulatory risk management measures could be implemented in the future if additional data supports stricter controls. These actions aim to protect consumers, workers, and the environment from the identified risks associated with 1-phenylethanol.
Italy has concluded its evaluation of 1-phenylethanol (EC 202-707-1, CAS 98-85-1), a substance commonly used in consumer and industrial products, under the REACH regulation. The evaluation, finalised in September 2024, highlights health concerns, particularly regarding carcinogenicity and eye irritation, raising the need for harmonised classification across the EU.
1-Phenylethanol is a versatile chemical used across various sectors. It is primarily found in:
Cleaning products: including washing agents and polishes used in households and by professional workers.Fragrances and perfumes: where it acts as a fragrance component in personal care products and cosmetics.Pharmaceuticals: used as a chiral building block for the synthesis of active pharmaceutical ingredients.Cosmetics and personal care products: widely used in skin and hair care products, air fresheners, and other scented items.Air care products: released from items like scented candles, toys, and paper products.
In addition to consumer use, 1-phenylethanol plays a significant role in industrial applications, where it is employed in the manufacture of chemicals, as well as in health services and formulation processes.
Selected for substance evaluation under the Community Rolling Action Plan (CoRAP) in 2019 due to its wide use and potential risks, 1-phenylethanol was evaluated for carcinogenic and mutagenic properties, as well as its impact on workers and the environment. Its presence in products used by consumers and professional workers increases the likelihood of direct exposure, particularly through skin contact and inhalation.
A study conducted by the National Institute of Health in Italy confirmed that 1-phenylethanol could be classified as a Category 2 carcinogen. The findings are based on evidence of kidney adenomas and adenocarcinomas in male rats during oral testing. Additionally, the chemical displayed acute toxicity, falling into Category 4 based on lethal doses in animal studies.
Besides its carcinogenic potential, 1-phenylethanol was confirmed to cause eye irritation, leading to its classification under Category 2. Studies on repeated exposure in rats demonstrated signs of liver toxicity, suggesting its classification as STOT RE 2 (Specific Target Organ Toxicity – Repeated Exposure), particularly affecting the liver.
As a result of the evaluation, Italy has proposed harmonised classification and labelling for 1-phenylethanol across the EU. The following classifications are recommended:
Carcinogenicity, Category 2Acute Toxicity, Category 4Eye Irritation, Category 2STOT RE 2 (Liver)
Although no immediate restrictions are planned, the substance remains under observation, with the possibility of further regulatory risk management if new data confirms additional concerns.
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