Essential oils under EU scrutiny as natural cosmetics face stricter safety demands

The EU’s Scientific Committee on Consumer Safety (SCCS) has issued a draft opinion advising limiting the use of tea tree oil in cosmetics to lower concentrations due to potential health effects. Moreover, the European Federation of Essential Oils (EFEO) is working to form a consortium that would submit a safety dossier to the SCCS to defend acetophenone’s continued use in cosmetics, following its classification as reprotoxin earlier this year.

Acetophenone is a naturally occurring compound found in several essential oils and botanical extracts that qualify as Natural Complex Substances (NCS), meaning they are mixtures of multiple chemical components derived from natural sources.

The European Chemicals Agency (ECHA) has already classified acetophenone as a Category 1B reprotoxin. However, it has not been banned in cosmetics. 

A ban would only take effect once the classification is legally added to Annex VI of the Classification, Labeling, and Packaging Regulation (CLP), triggering a 15–month window for the European Commission to either prohibit its use or grant an exemption.

To qualify for an exemption, the industry must demonstrate that no safer alternatives exist, exposure is limited, and the substance has been evaluated as safe by the SCCS.

The EFEO-led consortium aims to meet these requirements and prevent a blanket ban on all essential oils containing acetophenone, such as labdanum, benzoin resin, cassie flower, ylang-ylang, cinnamon bark, and heliotrope.

The SCCS’ deadline for submitting this dossier is September 10, 2025.

Tea tree oil on trial

According to the SCCS, tea tree oil is a “moderate skin sensitizer,” meaning it can trigger allergic reactions.

The SCCS’s draft scientific opinion concludes that tea tree oil should only be used at up to 2% in shampoos, 1% in shower gels and face washes, and 0.1% in face creams to be considered safe. These additions are only allowed if the substance meets the ISO 4730:2017 standard and remains chemically stable throughout the product’s shelf life.

According to the SCCS, tea tree oil is a “moderate skin sensitizer,” for triggering allergic reactions.The Committee points out that no data was submitted on how well tea tree oil holds up under typical conditions such as exposure to light, air, or moisture, which it says raises questions about the oil’s stability in finished products.

Moreover, the SCCS states that its safety opinion does not apply to aerosol or spray products due to the risk of inhalation exposure.

This narrowing of acceptable use cases could create new constraints for formulators. While tea tree oil has long been marketed as a natural antimicrobial, the SCCS’ opinion now highlights concerns about ingredient stability and places emphasis on manufacturers’ ability to ensure consistent quality over time.

The SCCS’s opinion on tea tree oil is part of a wider shift in how the EU is reviewing natural ingredients in cosmetics, especially essential oils. Under the European Commission’s new Omnibus Act, which aims to simplify chemical laws, some natural substances are being reviewed more closely as they contain trace amounts of chemicals that could be harmful.

A recently leaked EU document revealed that tea tree oil was among over 100 substances being reviewed for possible health risks. While previous scientific evidence debunked fears that tea tree oil is an endocrine disruptor in children, the EU document instead outlines the ingredient’s risk of harming fertility and causing cancer.

Race to defend

At the same time, acetophenone is facing potential restrictions in cosmetics. The compound occurs naturally in several botanical families and is a component in many essential oils used in perfumery and skin care. NCS containing acetophenone could be banned without a successful exemption process, which would force reformulations across a range of fragrance and active ingredient applications.

Earlier this year, the ECHA’s Risk Assessment Committee (RAC) classified acetophenone as Reprotoxic Category 1B, meaning it may damage sexual function, fertility, and development.

Under the EU Cosmetics Regulation, any substance classified as a Category 1 CMR (carcinogenic, mutagenic or reprotoxic) must be banned from cosmetic use unless an exemption is granted.

To obtain such an exemption, the industry must submit a complete safety dossier and receive a positive opinion from the SCCS.Tea tree oil has long been marketed as a natural antimicrobial.

The EFEO is now forming a consortium to prepare this dossier and apply for the exemption. The cost of participating is estimated between €80,000 and €95,000 (US$93,000 and US$110,600), which includes admin fees and scientific preparation.

Questioning “natural”

The SCCS’s opinion on tea tree oil and the focus on acetophenone highlight a growing belief that “natural” is not a guarantee of safety. However, that claim is also being scrutinized for falsely being associated with “sustainable.”

Essential oils and botanical extracts often require large amounts of land, water, and plant material to produce, raising concerns about deforestation, biodiversity loss, and waste. 

Earlier this month, Personal Care Insights spoke to Thomas Collier, CEO at Levur, who told us it takes approximately 250,000 rose petals to produce 5 ml of rose oil. In contrast, over 90% of plant biomass used in essential oil extraction is typically discarded.