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Q Do pure essential oils need to be labelled in accordance with the CLP Regulation?

The obligations under CLP apply to any hazardous substance or mixture that is not regulated by product-specific EU legislation with more specific rules on classification and labelling.

Pure essential oils are placed on the market for several different uses. They may, for example, be intended for use as a cosmetic product. The intended use will determine whether a particular product is subject to product-specific legislation.

For instance, if a pure essential oil falls under the definition of a cosmetic product*, the product also has to fulfil all the requirements of the Cosmetic Products Regulation (CPR, Regulation No 1223/2009).

A cosmetic product is excluded from the scope of CLP if all of the following three conditions are cumulatively met:

  1. The product falls within the definition of a cosmetic product according to the CPR. If the CPR applies, all requirements set out in that regulation have to be fulfilled, otherwise the cosmetic product will be considered as incompliant. This means that, among other things, the cosmetic product must have been assessed and notified as defined in Article 10 and Article 13 of the CPR, respectively, as well as be fully labelled in accordance with the regulation with the appropriate label information and instructions for use.
  2. At the moment of placing on the market, the product is intended for the end user, i.e. either a consumer or professional ultimately using the cosmetic product. 
  3. The product is in the finished state, i.e., its final formulation, as placed on the market and made available to the end user.

In fulfilling all of the above, the cosmetic product would be meeting the conditions for exemption provided in Article 1(5) of CLP, i.e., being in the finished state and intended for the final user.

The obligation to label an essential oil in accordance with CLP applies unless the product is outside the scope of CLP. To be outside the scope of CLP, the product must be covered by any of the product-specific pieces of legislation specified in Article 1(5) of CLP, must have undergone the processes defined in the relevant regulation or directive, and at the moment of the placing on the market must be in its finished state and intended for the final user.

*Definition of ‘cosmetic product’, Article 2(1)(a) of the CPR: "Any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours."

Muokkauspäivä: 08/08/2019
Topic: CLP
Scope: Scope and exemptions under CLP
ID: 1536
Versio: 1.0
This answer has been agreed with national helpdesks.

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