Undesirable effects and cosmetovigilance after product launch
How to receive, assess, document and report undesirable and serious undesirable effects associated with cosmetic products in the EU.
Read the guide →Service area 06 · specialist support
Cosmetic product labelling and claims
Labelling and marketing communication must be truthful, supportable and consistent with the PIF and safety assessment. We review the complete presentation before print and publication.
Scope of support
What we can deliver for your project
Regulatory review of labels, INCI lists, mandatory particulars and substantiation for cosmetic claims on packaging, websites and advertising.
- 49Complete regulatory review of product labelling
- 50Preparation or correction of the INCI list
- 51Review of nominal content
- 52Review of minimum durability and PAO labelling
- 53Review of warnings and conditions of use
- 54Review of country-of-origin statements
- 55Review of Responsible Person details
- 56Review of fragrance allergen labelling
- 57Regulatory review of translations for individual EU markets
- 58Final artwork review before printing
- 59Review of websites, catalogues and advertisements
- 60Review of influencer and social media communication
- 61Preparation of claim substantiation documentation
- 62Assessment of claims such as “dermatologically tested”, “hypoallergenic”, “natural”, “free from”, “clean” and “anti-ageing”
- 63Assessment of the boundary between cosmetic and medicinal claims
- 64Planning of instrumental, clinical or consumer studies
Project outcomes
From a question to an actionable regulatory solution
The exact scope is confirmed after reviewing the product, target markets and available documentation.
01
Verified label and INCI list
02
Clear warnings and conditions of use
03
Assessment of claim substantiation
04
Aligned packaging and digital communication
Frequently asked questions
Before the project starts
Does every claim require a clinical study?+
Not necessarily. The level and type of evidence depend on the claim, the product and the reasonable expectations of the average end user.
Do you review websites and advertisements?+
Yes. Claims are assessed regardless of whether they appear on packaging, websites, social media or promotional material.
Can a product name itself be a claim?+
Yes. The entire presentation is assessed, including the name, imagery and context.
New fragrance allergen labelling requirements: 2026 and 2028 deadlines
What Regulation (EU) 2023/1545 changes for fragrance allergen labelling, which thresholds apply and how to prepare formulas and labels for 2026 and 2028.
Read the guide →Reformulating a cosmetic product after regulatory change
How to plan reformulation after an ingredient restriction and align testing, CPSR, PIF, labelling, CPNP and packaging stocks.
Read the guide →Next step
Do you have a product or portfolio for the EU market?
Send us the essential product details, target markets and available documentation. We will respond by email.