Classification of products containing essential oils in Switzerland

In June 2024, Swissmedic published together with other competent authorities a guidance document on the classification of products containing essential oils. Fact sheet: Classification of essential oils aims to ensure uniform regulatory procedures and clarify the criteria to consider when classifying such products. Depending on their intended use, different laws might apply to products with essential oils. Overall, essential oils can be classified as:

• medical devices
• cosmetics
• medicinal products
• foodstuffs
• chemicals and biocidal products

Medical devices containing essential oils

Generally, products used on humans with a physico-chemical or mechanical mode of operation are medical devices. Medical devices can achieve their intended purpose also with the support of pharmacological, immunological, or metabolic action, for instance, with essential oils. In Switzerland, the EU Medical Devices Regulation (MDR) sets criteria for the classification of such devices with essential oils. In this sense, Article 15 of the Swiss Medical Devices Ordinance specifies that the classification of medical devices must comply with the provisions of Annex VIII to the EU MDR.

The classification assessment typically occurs case-by-case and the product’s intended use, components, and mode of action must be taken all-together into account. When different classification rules apply, the strictest one must be the determinant rule. In the case of medical devices containing essential oils, the possible applicable rules are:

• Rule 14: “Devices incorporating integral medicinal substance and that has an action ancillary to that of the devices”
• Rule 21: “devices composed of substances or of combinations of substances to be introduced into the human body via a body orifice or applied to the skin and absorbed by or locally dispersed in the human body”

Medical devices containing essential oils

Generally, products used on humans with a physico-chemical or mechanical mode of operation are medical devices. Medical devices can achieve their intended purpose also with the support of pharmacological, immunological, or metabolic action, for instance, with essential oils. In Switzerland, the EU Medical Devices Regulation (MDR) sets criteria for the classification of such devices with essential oils. In this sense, Article 15 of the Swiss Medical Devices Ordinance specifies that the classification of medical devices must comply with the provisions of Annex VIII to the EU MDR.

The classification assessment typically occurs case-by-case and the product’s intended use, components, and mode of action must be taken all-together into account. When different classification rules apply, the strictest one must be the determinant rule. In the case of medical devices containing essential oils, the possible applicable rules are:

• Rule 14: “Devices incorporating integral medicinal substance and that has an action ancillary to that of the devices”
• Rule 21: “devices composed of substances or of combinations of substances to be introduced into the human body via a body orifice or applied to the skin and absorbed by or locally dispersed in the human body”

Cosmetics with essential oils

The use of essential oils in cosmetics is very common, for instance in perfumes and soaps. Pure essential oils are rarely classified as cosmetics and sometimes sold as bath additive to dilute in water. Nonetheless, essential oils to mix with other components in a cosmetic formula are precursors or raw materials and provisions of chemicals law apply.

Essential oils as medicines

Products of chemical or biological origin intended or presented to have a medicinal effect on humans are medicinal products and regulated by the Swiss Therapeutic Products Act. Medicines requires the authorisation of Swissmedic before being placed on the Swiss market. However, some medicines’ groups can be subject to a simplified authorisation procedure, including essential oils.

Foodstuffs: flavourings, novel foods, food supplements

As for other products, also the classification of foodstuffs occurs case-by-case.

Interestingly, essential oils used as flavourings are subject to different provisions depending on whether they are obtained from foodstuffs or from plant substances. In the latter case, no further measures are necessary to use the flavouring extracts, whereas in the case of plat substances’ extractions, an authorisation is required if this flavouring is not already listed in Annex 3 to the Flavourings Ordinance. Also, when essential oils are used in food not as flavouring substance, the novel foods’ provisions apply.

Lastly, FDHA Ordinance on Food Supplements sets the provisions for food supplements, with Annex 1 Part B listing restrictions. Essential oils are not part of this list and food supplements can contain essential oils if the manufacturer, importer, or distributor can demonstrate and document their safe use and compliance with the applicable food laws.

Essential oils as chemical and biocides

Overall, essential oils are regulated by the chemicals legislation when they are not foodstuffs, cosmetics, medicines, or medical devices. Some common examples of essential oil classified as chemicals are room fragrances. On the other hand, when essential oils are used to repel or kill mosquitoes, bacteria, etc. or have disinfectant properties are classified as biocides and must comply with the Swiss Ordinance on Biocidal Products.

Simona Varrella

Expert Consultant of Regulatory Intelligence & Innovation department

24.06.2024

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