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Cosmetovigilance: Are You Confident You're Managing the Risks Linked to Your Products?

  • Mar 28
  • 8 min read

Since 2013, with the enforcement of Regulation (EC) No. 1223/2009, the cosmetics industry has evolved under stricter and more harmonized legislation across the European Union.

Yet, one crucial aspect is often overlooked: cosmetovigilance.


An unexpected consumer reaction? Redness, an allergy, irritation?

Without an efficient monitoring system, these incidents can quickly turn into a regulatory nightmare and harm your brand’s reputation.


So what are your obligations when an incident is reported?

How can you anticipate risks to protect your consumers and secure your products?


That’s where Vigicare, the solution developed by Reguloo, comes in—to centralize, analyze and report incidents related to cosmetic products smoothly and compliantly.



What is Cosmetovigilance, and Why Is It Essential?


Cosmetovigilance is the system for monitoring adverse effects related to the use of cosmetic products.

It helps detect potential safety concerns and take appropriate action to protect consumers' health.


An adverse effect can be mild (e.g., redness, temporary irritation) or more serious (e.g., severe allergic reactions, burns). The goal of cosmetovigilance is to collect, analyze, and report such cases to identify potentially risky substances and improve product safety.


Why is this important?

Even when a cosmetic product is formulated to be safe and compliant, some reactions remain unpredictable. Every consumer’s skin reacts differently, and monitoring adverse effects helps identify risk patterns and act quickly.


With Vigicare, reports are tracked in real time, ensuring a fast and effective response.



Article 23 of Regulation 1223/2009: A Transparency Obligation for Serious Adverse Effects


Under Article 23 of Regulation 1223/2009, Responsible Persons and distributors are required to report any serious adverse effects related to the use of a cosmetic product to the competent authorities. This report must be made without delay and must include:


  • A list of the serious adverse effects identified or likely to be known.

  • The exact name of the product concerned, allowing for unambiguous identification.

  • The corrective measures implemented, such as reformulation, additional warnings, or market withdrawal.


This procedure has strengthened cosmetovigilance, which now functions as a centralized system at the European level. It ensures a swift reaction in case of alerts, thus enhancing consumer protection.


In this context, the Responsible Person plays a crucial role: they must act immediately when an issue is detected by correcting non-compliance or, if necessary, withdrawing the product from the market.



This process also highlights the importance of Safety Assessments and Good Manufacturing Practices (GMP), detailed in Article 8 of the same regulation.

Each EU country has a dedicated authority to centralize reports and implement appropriate corrective actions.


With Vigicare, you can manage all of this in just a few clicks, in a centralized and secure space.



Adverse Effects of Cosmetics: Understanding and Preventing Risks


When a cosmetic product is placed on the market, it must be safe for consumer health. However, some individuals may experience adverse reactions, either mild or more serious.

The most common effects include allergies and irritant or allergic contact dermatitis (ICD & ACD).


Even though these reactions are unpredictable, reporting and monitoring them allows identification of recurring causes and implementation of preventive measures.


This is where the Scientific Committee on Consumer Safety (SCCS) plays a key role: it regularly analyzes cosmetic ingredients and available scientific data. When the same ingredient is repeatedly reported for adverse effects, its use may be restricted or even banned to improve consumer safety.



What Types of Adverse Effects Are Concerned?


There are two main categories of adverse effects that may result from the use of a cosmetic product:


🔹 Adverse Effects (AE): Harmful reactions to health, occurring under normal or reasonably foreseeable use of the product. These effects are typically reversible and moderate.


🔹 Serious Adverse Effects (SAE): Major reactions that may cause:

  • Temporary or permanent functional incapacity

  • Disability, hospitalization, congenital malformations, life-threatening situations, or even death


While the consumer is usually the first to notice and assess the severity of an adverse effect, a healthcare professional should always be consulted for a precise medical evaluation.



How to Set Up an Effective Cosmetovigilance System?


In the EU, any adverse effect observed during the use of a cosmetic product must be reported through official platforms provided by each Member State.


This can be done by:

  • The final consumer, observing an unusual reaction

  • A healthcare professional (pharmacist or doctor), who can identify and assess the effect

  • A manufacturer, distributor, or Responsible Person, made aware of a product issue


Once the form is completed, it is sent to the Ministry of Health, which may alert the Competent Authorities and, if necessary, share the information with other EU Member States for swift action.


Note: Responsible Persons and distributors must only report serious adverse effects.

However, consumers and healthcare professionals may report both mild and serious effects, contributing to better monitoring.


The 4 Key Steps for Managing Adverse Effects Effectively


To ensure effective management of adverse effects and guarantee consumer safety, companies should follow these 4 essential steps:


1️⃣ Facilitate Adverse Effect Reporting

Make it easy and accessible for consumers and professionals to report suspected effects:

✔ Provide a dedicated online form

✔ Add a specific email address on your brand’s website

✔ Train customer service in incident reporting


2️⃣ Analyze and Document Reported Cases

Each report should be thoroughly investigated to determine if the product is responsible:

  • Collect key info: product name, symptoms, usage frequency/duration

  • Centralize and archive the data for proper analysis


3️⃣ Report Serious Effects to Authorities

If a reported effect is deemed serious, it must be immediately reported to the authorities, who will assess the risk and may require corrective measures.


4️⃣ Take Corrective Action When Needed

Depending on the severity, various actions can be taken:

✔ Add warning labels

✔ Reformulate the product

✔ Withdraw the product from the market if it poses a proven health risk


➡️ All of this is made easier with Vigicare, ensuring transparent and responsive management.



Assessing the Link Between a Cosmetic Product and an Adverse Effect


When a serious adverse effect is reported, it is essential to determine whether it is actually caused by the cosmetic product in question. A causality assessment must be carried out in line with European Commission guidelines.


This assessment has two main goals:

✔ To confirm or rule out a cause-and-effect relationship between the product and the reported reaction

✔ To limit false or misleading reports that could distort safety evaluations and generate unnecessary alerts


The evaluation is based on two key criteria:


1️⃣ Chronological Analysis of the Causal Link

The objective is to assess the time correlation between the product's use and the appearance of the adverse effect.


Based on this, the link can be classified as:

 ✔ Compatible – The reaction is plausible based on the symptoms

✔ Partially compatible – The timeline is unusual or unclear

✔ Unknown – There is insufficient information to establish a link

✔ Incompatible – The effect occurred before the product was used, or too long after to reasonably assume a connection


💡 Example: If a skin reaction appears two weeks after the cosmetic was last used, it is unlikely to be directly related to the product.


2️⃣ Semiological Analysis of the Causal Link

This analysis relies on medical and scientific evidence to evaluate the consistency between the observed effect and the use of the product.


It is based on:

 ✔ The nature of the symptoms – They must match the product’s use and characteristics

✔ Medical examinations – These help provide objective evidence of the reaction

✔ Re-exposure to the product – If symptoms reappear when the user applies the product again, it reinforces the assumption of a link


The 5 Levels of Causality Probability


By combining the chronological and semiological analyses, the adverse effect is assigned one of five probability levels:

🔹 Very likely – Strong causal relationship

🔹 Likely – The association is plausible but needs more investigation

🔹 Not clearly attributable – Insufficient data to draw a conclusion

🔹 Unlikely – The effect probably has another cause

🔹 Excluded – No possible link with the cosmetic product


Why Is This Evaluation Essential?

A rigorous causality assessment helps prevent unjustified product withdrawals, while ensuring a rapid response when cosmetic products actually pose a health risk.

This process ensures effective and objective monitoring of adverse effects related to cosmetic products.



Actions to Take When Adverse Effects Are Reported


When adverse effects are reported, various measures must be implemented by the relevant stakeholders to ensure consumer safety and cosmetic product compliance.


Responsibilities of the Responsible Person


According to Regulation 1223/2009, the Responsible Person is required to:

✔ Analyze reported adverse effects to assess their severity and origin

✔ Update the Product Information File (PIF) by including new safety-related data

✔ Take corrective measures, such as:

  • Reformulating the product if an ingredient is identified as the cause

  • Updating warnings and usage precautions on the product labeling

  • Withdrawing the product from the market if it poses a proven health risk to consumers


With Vigicare, the Responsible Person has access to a structured tool to collect, analyze, and archive these reports.


Role of Health Authorities


Health authorities are responsible for:

✔ Reviewing the reports and, if necessary, sharing information with other Member States for coordinated action at the European level

✔ Monitoring suspected ingredients and assessing their safety

✔ Taking regulatory decisions, which may include:

  • Restricting or banning the use of certain ingredients

  • Ordering the withdrawal of a product from the market if its danger is confirmed


Vigicare facilitates communication between companies and authorities by centralizing reports and ensuring fast and secure information sharing.


Thanks to this collaboration between companies and authorities, cosmetovigilance enables effective responses to alerts and helps reinforce product safety across the cosmetics market.



Cosmetovigilance: A Key Commitment for Brands


💡 Beyond a legal obligation, cosmetovigilance is a sign of professionalism and trust for a brand.


✔ It protects consumer health by identifying risks early

✔ It helps improve formulations and remove hazardous ingredients

✔ It builds customer confidence through transparency


📌 Vigicare supports brands by offering a centralized platform to track, analyze and report adverse effects, enabling proactive and compliant management.


Brands that take cosmetovigilance seriously stand out through their commitment to quality and their ability to react efficiently to incidents.

Ensuring the safety of cosmetic products does not stop at market launch. Cosmetovigilance ensures continuous monitoring of consumer reactions and enables swift intervention when needed.


Vigicare automates adverse reaction tracking, helping brands take action quickly when a problem arises.


This system is inspired by pharmacovigilance methods, even though cosmetics are not medicines.

Its goal: to detect, analyze and prevent any potential risks to ensure safe use.


Example: The MIT (Methylisothiazolinone) Case


This preservative was restricted and eventually banned in some types of cosmetics after numerous reports from consumers.


Why Was MIT Banned?

MIT was used as an antimicrobial preservative in leave-on cosmetics (creams, lotions, baby wipes, etc.).It caused a rise in skin allergies and contact eczema reported by consumers and dermatologists.


The ANSM (French Health Authority) and the SCCS (Scientific Committee on Consumer Safety) assessed the reports and confirmed a high risk of skin sensitization.


Measures Taken:

  • 2015: Use of MIT was banned in leave-on cosmetics in the EU

  • 2017: The ban was extended to rinse-off cosmetics, except at very low concentrations (0.0015%)


Industry Impact:

  • Brands had to withdraw or reformulate products containing MIT

  • Many manufacturers switched to alternative, safer preservatives


This example shows the key role of cosmetovigilance, since it was consumers and dermatologists who first raised the alarm—leading to the eventual ban.



Key Takeaways

✔ Cosmetovigilance is mandatory in Europe and requires strict monitoring of adverse effects

✔ Brands must implement effective systems to collect and analyze reports

✔ Serious effects must be reported to authorities and may require corrective actions

✔ Good cosmetovigilance is a major asset for brand reputation and reliability



📩 Want to ensure your brand complies with cosmetic regulations?

At Reguloo, we help you implement an effective and compliant cosmetovigilance system.


📢 Contact us today for an audit or personalized support!



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