Solutions / Cosmetovigilance
Cosmetovigilance for cosmetic products
Undesirable effect intake, causality assessment, serious undesirable effect notification and trend monitoring for cosmetic and personal care brands.
What is cosmetovigilance?
Cosmetovigilance is the collection, evaluation and monitoring of reports of undesirable effects observed during or after normal or reasonably foreseeable use of cosmetic products. It helps brands protect consumers, improve formulations and meet regulatory obligations.
Most reports come directly from consumers through customer service, websites and social media, rather than from healthcare professionals. Most are non-serious, but serious undesirable effects must be notified to authorities, and patterns across products and ingredients must be watched.
The main requirements
| Region | Regulation | Key obligations |
|---|---|---|
| European Union | Regulation (EC) 1223/2009 on cosmetic products, Article 23 | Responsible person notifies serious undesirable effects to the competent authority without delay |
| United States | Modernization of Cosmetics Regulation Act of 2022 (MoCRA) | Serious adverse event reports to FDA within 15 business days; record keeping |
| Other markets | National cosmetic regulations | Local notification rules and formats |
A summary for orientation, not legal advice. Always check the current regulations and guidance for each market.
What makes cosmetovigilance hard
Consumer language
Reports describe reactions in everyday words, often without medical detail.
Many channels
Customer service, email, websites, retail partners and social media.
Large product ranges
Many products, variants and formulations sharing ingredients.
Causality
Assessing whether a reaction is linked to the product, its use or other causes.
Mostly non-serious
Large volumes of minor reactions hide the few serious cases.
Different teams
Consumer care, regulatory and safety teams must work from the same data.
One platform for cosmetovigilance
The same modules, intelligence and controls used across every vigilance domain, configured for this one.
Why teams choose vGenix Ai
Consumer-ready intake
Consumers describe reactions in their own words. Those descriptions are turned into structured, coded data that safety teams can assess and analyse.
- Reports from customer service, email, web and social channels
- Everyday language mapped to medical terms
- Product, variant and batch identified
- Missing information requested in follow-up
Event: Erythema, pruritus, skin burning sensation
Onset: next day
Body site: face
Seriousness: assess
Serious cases surfaced
Most cosmetic reactions are mild. The serious undesirable effects that must be notified are flagged quickly, so they are not lost in the volume.
- Seriousness criteria applied to every report
- Serious undesirable effects flagged at intake
- Routed for notification within each market’s timeline
- Non-serious cases kept for trend analysis
Report 1 · mild rednessNon-seriousTrendReport 2 · itching, resolvedNon-seriousTrendReport 3 · facial swelling, hospital visitSerious undesirable effectNotifyReport 4 · product smellNot an undesirable effectCloseIngredient-level view
Products share ingredients. Linking each product to its formulation means a pattern can be seen across every product that contains the same ingredient.
- Products linked to their ingredients
- Reactions analysed by ingredient, not just product
- Patterns across variants and ranges
- Evidence for reformulation decisions
One record for every team
Consumer care, regulatory affairs and safety teams work from the same case, so nothing is re-entered and everyone sees the latest status.
- Consumer care logs the report once
- Safety assesses causality and seriousness
- Regulatory handles notification
- Everyone sees the same status and history
Market-specific rules
Notification rules differ between markets. Each market’s requirements are configured, so the right reports reach the right authority on time.
- EU serious undesirable effect notification
- US serious adverse event reporting under MoCRA
- Other national requirements configured
- Record keeping in line with each market
| Market | What is reported | Timeline |
|---|---|---|
| European Union | Serious undesirable effects | Without delay |
| United States | Serious adverse events | 15 business days |
| [Market] | [Local rule] | [Timeline] |
Scales with your range
New products, variants and markets are added through configuration, so growth in your range does not mean new processes or new tools.
- New products added to the product catalogue
- Variants and formulations linked
- New markets configured, not rebuilt
- Same controls across the whole range
[Confirm which domain-specific terminologies, forms and gateways are live for cosmetovigilance before publishing.]
One platform for every vigilance domain
Run all your vigilance domains on the same data model, rules engine and audit trail.
Intelligent safety should be one connected operation
Automate the work. Keep the decisions with your experts. Keep the evidence traceable. See it on your own data in six weeks.
6-week pilot on literature monitoring
- Baselines agreed up front
- Configured to your SOPs
- Measured on your own data
- Validation evidence from day one