Essential Oil Regulations in the European Union: An Overview

Essential oils can contain substances that are subject to various restrictions. These restrictions concern substances that are flammable, harmful to humans, labelling requirements, and documentation.

In this guide, we explain how regulations such as the CLP Regulation, Cosmetics Regulation, and REACH relate to essential oils. We also list a few standards and test methods relevant to essential oils.

What are Essential Oils?

The European Chemicals Agency (ECHA) defines essential oils as “a volatile part of a natural product”. These oils mostly consist of volatile hydrocarbons and can be obtained from various parts of plants, the essence of which can be acquired in one of three ways:

• Distillation
• Steam distillation
• Expression (for citrus fruits)

The term “essential” comes from the fact that the oil contains the essence of a specific plant.

REACH

The REACH Regulation restricts the usage of many substances that deemed dangerous. This also includes substances that might be found in essential oils.

Substance restrictions

Essential oils and their constituent may be subject to restriction conditions under Annex XVII or registration requirements relevant to substances in the SVHC Candidate List.

Annex XVII

Annex XVII to REACH contains hazardous substances, such as those that might be used in essential oils – as well as their restriction conditions. During our research, we could only find a restriction for soap bark powder (Quillaja saponaria) and its derivatives, which – per ECHA – can be found in essential oils.

Specifically, the restriction condition for Quillaja saponaria contains a prohibition from use in mixtures or products meant for hoaxes or jokes. This restriction doesn’t apply to stink bombs that contain an amount of liquid of 1.5 ml or less.

Note that restrictions for other substances that might be used in essential oils might exist.

Candidate List

Substances of Very High Concern (SVHCs) are listed on the Candidate List when they are deemed to seriously, permanently, and negatively impact human health and the environment.

During our research, we could only find one substance, that is nitrobenzene, that is listed on the Candidate List and is commonly used in essential oil. Nitrobenzene, also, known as “essence of mirbane”, is toxic to reproduction and suspected to be carcinogenic.

The ECHA requires importers and manufacturers to register their products in the SCIP database if they contain concentrations of SVHC exceeding 0.1% weight by weight (w/w).

Guidance on substance identification

The ECHA made available a guidance document for identifying substances in essential oils.

This guidance document include:

a. EFEO and IFRA’s Guidelines for identifying substances and the sameness of natural complex substances (NCS) under CLP and REACH.

b. ECHA’s guidance for identifying and naming substances under CLP and REACH.

Note that, while regulations might be written in a general fashion, guidance documents might help you to interpret specific requirements, such as identifying substances in essential oils.

Testing labs may also use these guidance documents helpful in determining which tests must be carried out.

Classification, Labelling and Packaging Regulation

The Classification, Labelling and Packaging (CLP) Regulation sets requirements for dangerous substances (which includes substances that might be used in essential oils).

Substance examples

There are several substances that are listed on the C&L Inventory and can be used in essential oils. Here we list a few examples:

• Spearmint, Mentha spicata crispa, ext
• Mentha cardiaca
• Citrus aurantium var. amara or Bigaradia (Rutaceae)
• Rose hips, extract
• Lavender, Lavandula angustifolia, ext.
• Thyme, Thymus zygis, ext.

Requirements

The CLP sets requirements regarding the documentation, classification, labelling and packaging of substances. You can learn more about the specific requirements in this article.

You can also browse the C&L Inventory to find out about the hazards and labelling requirements for each listed substance. Here we provide 2 examples.

Spearmint, Mentha spicata crispa, ext

According to the C&L Inventory , this substance might be fatal, when it is swallowed or inhaled.

As such, the pictogram concerning “Serious health hazard” should be affixed in the packaging.

Mentha cardiaca

According to the C&L Inventory , this substance:

• Might be fatal, when it is swallowed or inhaled
• Is toxic to aquatic life
• Is flammable
• Is harmful if swallowed, and it might cause allergic skin reaction

As such, the packaging label should include the following pictograms:

• Serious health hazard
• Hazardous to the environment
• Flammable
• Health hazard/Hazardous to the ozone layer

Hazards

The EU’s Safety Gate alert system lists several essential oils that were recalled due to non-compliance with the CLP Regulation requirements due to reasons such as the following:

• No child-resistant seal
• No sufficient danger warning
• No safety warning
• Potential ingestion dangers
• Potential allergen for sensitive individuals

Cosmetics Regulation

The Cosmetics Regulation sets requirements that cover cosmetic products manufactured and imported for sale in the EU. Specifically, it prohibits the use of several ingredients in essential oils.

Prohibited substances

Annex II lists substances and ingredients that prohibited from use in cosmetic products, including the following:

• Chenopodium ambrosioides L. (essential oil)
• Juniperus sabina L. (essential oil)
• Inula helenium L. (alanroot oil, used as a fragrance ingredient)
• Lippia citriodora Kunth. (verbena oil, used as a fragrance ingredient)
• Saussurea lappa Clarke (costus root oil, used as a fragrance ingredient)

Guidance document

Importers and manufacturers can use guidance documents to supplement regulatory requirements, as some regulations may be written in general fashion and be opened to interpretation.

The European Directorate for the Quality of Medicines & HealthCare (EDQM) published a Guidance on Essential Oils in Cosmetic Products, which:

a. Explains why the quality of essential oils is important.

b. Covers why the quality of the essential oils’ starting materials is important.

c. Provides recommendations regarding risk assessments for essential oils.

d. Sets forth proposals regarding the possible repercussions of including essential oils in cosmetic products.

General Product Safety Regulation

The General Product Safety Regulation (GPSR), which replaces the General Product Safety Directive (GPSD) and will apply from 13 December 2024, aims to ensure that products are safe for use.

While some aspects of essential oils might be covered by other regulations (e.g., REACH), this regulation still applies to safety aspects that are not taken into account by other regulations.

Flammability risks

For example, some essential oils have a flashpoint, that is, the minimum temperature at which a liquid forms vapours that can be ignited, that is quite low (e.g., around 37-45 Celsius degree).

This makes them extremely flammable and, thus, dangerous for consumers. Although the GPSR doesn’t specifically mention essential oils, it does make it clear that all products must be safe.

Safety can be achieved by designing the product so that risks are minimised (e.g. increasing the flashpoint of you oil). Another way to mitigate risks is to provide relevant warnings and instructions.

Standards

We are not aware of any standards that provide methods to assess flammability specifically for essential oils. However, you can potentially use standards that are partially relevant to your product, in order to assess the safety of your product.

Here are some examples:

a. ISO 3679 – Determination of flash point – Method for flash no-flash and flash point by small-scale closed cup tester

b. ISO 1516 – Determination of flash/no flash – Closed cup equilibrium method

c. ISO 2592 – Determination of flash and fire points – Cleveland open cup method

EU Ecolabel

The EU Ecolabel sets voluntary criteria to encourage eco-friendly best practices. It applies to various product categories, including personal and animal care products. This category covers oils such as palm oil and palm kernel oil, which might be used in essential oils.

Substance restrictions

Palm oil should have an impurity threshold of:

a. 0.01% w/w for rinse-off cosmetic products and animal care products.

b. 0.001% w/w for leave-on cosmetic products.

Palm oil should also meet sustainable sourcing requirements of a certification scheme (e.g., RSPO).

Standards

Importers and manufacturers of essential oil products can use standards, including voluntary standards, to meet various safety or quality requirements.

EN ISO 3218 – Essential oils – Principles of nomenclature

EN ISO 3218 is an example of a standard relevant to essential oils. The standard establishes principles for labelling and marking essential oils in English and French language.

ISO Standards

The International Standards Organisation lists numerous standards that importers and manufacturers can use to determine the quality of their essential oils. Here we list several of those standards:

a. ISO 1342 – Essential oil of rosemary (Rosmarinus officinalis L.)

b. ISO 210 – Essential oils — General requirements and guidelines for packaging, conditioning and storage

c. ISO 1272 – Essential oils — Determination of content of phenols

d. ISO 4735 – Oils of Citrus — Determination of CD value by ultraviolet spectrometric analysis

e. ISO 17494 – Aromatic extracts, flavouring and perfuming compounds — Determination of ethanol content — Gas chromatographic method on packed and capillary columns

Lab testing

Importers and manufacturers often need to ensure that they have their essential oils tested so they can prove their products’ compliance with relevant requirements under regulations such as REACH and CLP.

They can also test their essential oils to determine their quality, which might result on a competitive advantage against competitors.

When essential oil products pass testing, importers and manufacturers receive a test report proving those products’ compliance with relevant requirements.

Test methods

Here are a few test methods relevant to essential oils:

a. Determination of acid value by manual and automatic titration methods

b. Determination of water content — Karl Fischer method

c. Analysis by gas chromatography on chiral capillary columns — General method

Testing labs

We could only find a company that offers to test essential oils against EU regulations, that is, Eurofins.

However, the following companies offer testing for cosmetics products, which might also include essential oils:

• Intertek
• QIMA
• SGS
• Bureau Veritas