Cosmetovigilance and adverse event reporting policy
Commitment and Regulatory framework
Commitment and Regulatory Framework
Legal Definitions
Legal Definitions
Reporting procedure for Clients / Users
Reporting procedure for Clients / Users
Processing and follow-up of reports
Processing and follow-up of reports
Notification to competent authorities
Notification to competent authorities
Protection of health data
Protection of health data
Effective Date: September 1, 2026
Company: MTHV Sàrl (DROO Hair) – Responsible Person / Operator
Registered Office: Route du Bout du Monde 7a, 1206 Geneva, Switzerland
EU Cosmetovigilance representative: Droo, 26 rue Bosquet, 75345, Paris, France
Applicable Standards: Ordinance of the FDBI on Cosmetics (VKOS - Switzerland) & Regulation (EC) No 1223/2009 (EU)
Contact Email: hello@droohair.com
Commitment and Regulatory framework
The safety of our consumers is the absolute priority of MTHV Sàrl (DROO Hair). In accordance with Swiss cosmetic product regulations (VKOS) and European regulations (Regulation EC No 1223/2009), the Company enforces a rigorous cosmetovigilance procedure designed to record, evaluate, analyze, and report all adverse events related to the use of our hair care products.
Legal Definitions
Adverse Effect (AE): An adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product (e.g., redness, scalp irritation, severe itching, burning sensation, allergic reaction, abnormal hair loss).
Serious Adverse Effect (SAE): An adverse effect that results in temporary or permanent functional incapacity, significant discomfort, hospitalization, severe aesthetic consequences, or requires emergency medical consultation or curative medical treatment.
Reporting procedure for Clients / Users
If you experience a skin reaction, allergy, or any other adverse effect during or after using a DROO Hair product, please follow these instructions immediately:
Step 1: Immediate Precautions
Immediately discontinue use of the product concerned.
Thoroughly rinse the affected area (scalp, hair, skin) with lukewarm water.
In case of severe or persistent symptoms or major discomfort, consult a medical doctor or dermatologist immediately.
Step 2: Submitting a Report
Promptly inform our team by sending an email to hello@droohair.com (stating "Cosmetovigilance" or "Health Report" in the subject line). To enable us to process your case efficiently, please include the following details:
Your Contact Details: Full name, phone number, and email address.
Product Identification: Exact product name, volume, and batch/lot number (Lot Number stamped or printed under the bottle or packaging).
Description of Symptoms: Nature of the reaction, area affected, time elapsed between application and onset of symptoms, and duration of the reaction.
Medical Information (if applicable): Medical consultation details, prescribed treatments, and photos of the reaction (subject to your explicit consent).
History: Known allergic history to specific cosmetic ingredients.
Processing and follow-up of reports
Upon receipt of your notification:
Acknowledgment and Initial Review: A vigilance officer will contact you within 24 to 48 business hours to confirm receipt and, if necessary, gather additional details.
Product Retention: You may be requested to keep the product in question and not dispose of it. The Company may organize the collection of the product at its own expense to conduct microbiological and physico-chemical testing on the manufacturing batch.
Scientific Assessment: The file will be submitted to our safety assessor / toxicologist expert to establish the degree of causality between the product and the observed reaction.
Notification to competent authorities
If the reaction is classified as a Serious Adverse Effect (SAE) following scientific evaluation:
In Switzerland: MTHV Sàrl will promptly report the incident to the Federal Food Safety and Veterinary Office (FSVO / OSAV) and the competent Cantonal Chemist (Canton of Geneva) in compliance with VKOS obligations.
In the European Union: The Company will submit the required regulatory declaration to the competent authority of the relevant Member State via the dedicated European portal (SUE / Serious Undesirable Effects notification).
Protection of health data
All information collected within the scope of cosmetovigilance is handled with strict confidentiality, in accordance with the Swiss Federal Act on Data Protection (FADP / nLPD) and the General Data Protection Regulation (GDPR) where applicable. Medical data provided is exclusively accessed by authorized personnel within the Company and relevant health authorities for the sole purpose of product safety evaluation. It is never used for commercial purposes.
