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The importance of Cosmetovigilance

In the pursuit of beauty and well-being, cosmetic products have become an integral part of our daily routines. However, amid the glamour of radiant skin and smooth hair, concerns have emerged regarding the potential undesirable effects of these products which has led to an increased focus on cosmetovigilance. 

What does Cosmetovigilance mean?  

Cosmetovigilance is defined as the collection, evaluation and monitoring of spontaneous reports of undesirable events observed during or after normal or reasonably foreseeable use of a cosmetic product.  

What is an undesirable effect? 

“Undesirable effect" means an adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product.  

Undesirable effects include but are not limited to irritant or allergic reactions that can affect the skin, eyes or mouth. Harsh chemicals, fragrances, and preservatives present in cosmetics can trigger adverse responses in sensitive individuals, underscoring the need for heightened awareness and scrutiny. 

Beyond immediate skin reactions, certain ingredients in cosmetics have raised concerns about their long-term health implications. Parabens, phthalates, and other potentially harmful substances have been linked to hormone disruption and even carcinogenic effects. 

“Serious undesirable effect" means an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death. 

What are the obligations of the Responsible Person regarding undesirable effects? 

Cosmetovigilance is a legal obligation under Article 23 of Regulation (EC) No. 1223/2009.  

«In the event of serious undesirable effects, the responsible person and distributors shall without delay notify the following to the competent authority of the Member State where the serious undesirable effect occurred: 

(a) all serious undesirable effects which are known to him or which may reasonably be expected to be known to him; 

(b) the name of the cosmetic product concerned, enabling its specific identification; 

(c) the corrective measures taken by him, if any.» 

All available data on the undesirable effects and serious undesirable effects of the cosmetic product or, where relevant, other cosmetic products must be included in the Cosmetic Product Safety Report (CPSR)

Although cosmetic products are not expected to cause harm to the consumer, undesirable effects arising from the use of these products should not be overlooked.  

Together with other resources, cosmetovigilance plays a critical role in post-marketing surveillance, serving as an indispensable tool to ensure consumer safety through vigilant monitoring, prompt reporting, and effective management of undesirable effects.  

As awareness regarding product safety grows and regulatory frameworks evolve, the cosmetic industry can seize the chance to prioritise safety, transparency, and responsible and ethical marketing practices, ensuring that the pursuit of beauty does not compromise safety.  


SCCS (Scientific Committee on Consumer Safety), SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation 12th revision, 15 May 2023, corrigendum 26 October 2023, SCCS/1647/22 

Regulation (EC) No 1223/2009 of 30 November 2009 on cosmetic products 

Commission Implementing Decision of 25 November 2013 on Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (2013/674/EU) 

Cosmetics Europe: Guidelines on the management of undesirable effects and reporting of serious undesirable effects in the European Union, 2016

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