Substances and mixtures applied on skin

Aromatherapy, well-being and mood-enhancing products are considered ‘substances/mixtures applied on the skin. Though, they are not automatically considered as cosmetic products as many of them do not strictly fit with its legal definition.

Most often (exceptions are always possible), aromatherapy falls under the scope of the General Product Safety Directive 2001/95/EC.

Also, scented products (non-cosmetic) are required to be classified, and if hazardous, labeled according to the same Classification, Labelling and Packaging (CLP) Regulation.
This regulation is implemented the same way in all EU Member States and requires manufacturers, importers or downstream users of substances or mixtures to classify, label and package their hazardous chemicals appropriately before placing them on the market.

BIORIUS can verify that your products are safe, properly labeled and can be placed on the EU Market without taking any risk!

The Regulatory Process

The regulatory process performed on those products consists of a formula review, a risk assessment and a label review following the above-mentioned regulations.

The responsible person for this product category is the importer.

The process is thus divided into two phases: the risk assessment, including a formula review, and the label review:

  • Formula Review & Risk Assessment: A toxicological assessment of the substances in each ingredient, identification and classification of hazards while taking into consideration application to the skin.
  • Label & Claims Review: Evaluation of the product label (required information, symbols and claims). 


Upon conclusion of the evaluation, a report is issued, which highlights the following points:

  • Required elements
  • Presence of required elements (primary packaging, secondary packaging & leaflet)
  • Symbols
  • Claims
  • Substantiation
  • Expert comments – strategic recommendations for updating the labels
  • The corresponding warnings and symbols are provided


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