Introduction to regulation of cosmetic products

Cosmetic products include a broad spectrum of pharmaceutical forms, such as creams, gels, powders, soaps etc., and it should be stressed that all product features must be taken into account for its categorisation, since cosmetic products may also be subject to regulations relating to medicinal products, medical devices and biocides.

Marketed cosmetic products must be manufactured in accordance with good manufacturing practice and should be safe in normal or reasonably foreseeable conditions of use. In order to demonstrate that a cosmetic product complies with these conditions, the qualified person must ensure that product safety assessment is performed by a formally qualified person.

In addition, the qualified person must maintain the product information file (PIF) after product marketing and notify the competent authority of any undesirable effects occurred during product use.

Prior to cosmetic product marketing, it is required to notify the product in CPNP (Cosmetic Products Notification Portal) to ensure product monitoring. Products containing substances classified as carcinogenic, mutagenic or toxic to reproduction or substances in the form of nanomaterials are monitored in particular.

Iva Jurković Tretinjak, MPharm / Regulatory Affairs Associate