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How to check the safety of animal cosmetics

Animal cosmetics are different by legal definition from human cosmetics and therefore require a different approach to check their safety

Definition of animal cosmetics

Animal cosmetics are products intended to be used on animals for non-medicinal purposes. Since these products are to be used on animals, these products do not fall under the Cosmetics Regulation. The EU Cosmetic Regulation is specifically aimed at humans only, which means that animal cosmetics are not considered cosmetic products by law. This means that animal cosmetics require a different approach to comply with legislation.

Applicable legislation

Animal cosmetics have to comply with the following legislations:

  • Directive 2001/95/EC - the General Product Safety Directive (GPSD) (Dutch: Warenwet)
    • The General Product Safety Directive (GPSD) is a wide-scope regulation that has the purpose of ensuring that all products sold in the EU are safe. This applies also in the case of products for which no specific safety standards have been defined yet, such as animal cosmetics. Hence, the GPSD is applicable to this product category
  • Regulation EC 1272/2008 - the Classification, Labelling and Packaging of substances and mixtures (CLP), for correct labelling of the products

Legislation that does not apply to animal cosmetics

  • Regulation EC 1223/2009 - the Cosmetic Regulation; as explained above, this legislation is only for human cosmetics, not for products intended for animals
  • Regulation EC 2019/6 - the veterinary medicinal product Regulation. When an animal product is medicinal, it must comply with this veterinary medicinal law and cannot marketed as a animal cosmetic. A product is considered medicinal if it contains medicinal substances and/or is marketed as a medicinal product e.g. via claims made on the artwork

How to compile a dossier for animal cosmetics

Dossier elements

Under the GPSD and CLP legislation, we recommend the following dossier elements for animal cosmetics. Since there is no strict legislation on how to compile an animal dossier, these elements are based on our experience with human cosmetics:

  • Toxicological evaluation of the formula (safety assessment) (obligatory)
  • Artwork assessment incl. claims according to CLP legislation (obligatory)
  • Product testing, including stability, compatibility, microbiology (optional)
  • Raw material assessment (optional)
  • Packaging material assessment (optional)

The optional elements are included to give the most robust and thorough assessment. Again, since the GPSD legislation does not give strict instructions on this, the manufacturer may decide by themselves on how thoroughly they want to assess the safety of their products.

How to test the expiration date and shelf life for animal cosmetics

Following certain EN standards is generally voluntary (unless required by a directive/product regulation). That said, EN standards can be utilized at a product design stage to ensure that the product is safe to use.

To ensure the product is safe, stability/compatibilty and microbial challengetests (if applicable) can be performed

Artwork

The artwork must be in compliance with the CLP regulation. In general, it is similar to the rules of the human cosmetics regulation, with a few additions:

  • Company must be stated with a telephone number (in addition to their address)
  • Ingredient declaration may be shortened to a maximum of 4 ingredients. The 4 ingredients that must be listed are determined by their hazard, and are stated on a Safety Data Sheet (SDS)

Claims

As mentioned, and similar to the human cosmetics law EC 1223/2009, animal cosmetics claims cannot be medicinal as this is regulated by veterinary medicines. Therefore, medicinal claims cannot be used. At SkinConsult, we use various reference lists to check whether a claim may be considered medicinal.