The safety of a cosmetic product is non-negotiable. Before reaching the market, every formulation must undergo a rigorous scientific assessment designed to ensure that it is safe for consumers under normal and reasonably foreseeable conditions of use. This process, known as Safety Testing, is one of the core pillars of Regulation (EC) 1223/2009, the legal framework governing cosmetic products in the European Union.
In a context marked by the rise of new ingredients, evolving “clean beauty” concepts, stricter purity requirements, and tighter limits for allergenic substances, Safety Testing has become an essential tool for protecting consumers and ensuring regulatory compliance. The technical approach, data quality, and expertise of the safety assessor determine the robustness of the final safety dossier.
This article provides an in-depth overview of what Safety Testing is, the elements that compose it, how the safety dossier is structured, and its role in post-marketing surveillance. It also explains how a solid safety evaluation facilitates access to international markets and strengthens the scientific credibility of a cosmetic product.
What Is Safety Testing In Cosmetics?
Safety Testing comprises the toxicological, analytical, and technical evaluations required to determine whether a cosmetic product can be considered safe for the end user.
This process goes far beyond verifying the good condition of the final formula: it assesses each ingredient, its concentration, impurities, exposure routes, and realistic conditions of use.
Its main goals are to ensure:
- Safety for human health
- Absence of unacceptable risk under normal or reasonably foreseeable use
- Compliance with the requirements of Regulation (EC) 1223/2009
- Complete traceability of the scientific evaluation
The outcome of Safety Testing is documented in the Product Information File (PIF), specifically in Part B of the Cosmetic Product Safety Assessment (CPSA), signed by a qualified safety assessor.
Legal Framework: Safety Testing Under Regulation 1223/2009
Regulation (EC) 1223/2009 establishes clear obligations regarding safety:
- No cosmetic product can be placed on the market without a prior Safety Assessment.
- The Responsible Person must ensure that the formulation is safe for its intended use.
- Every ingredient must undergo detailed analysis regarding exposure, toxicity, and impurities.
- Animal testing is prohibited in the EU for both ingredients and finished products intended for cosmetic use.
- All Safety Testing documentation must remain available to authorities for 10 years after the product’s last placement on the market.
In addition, Safety Testing must be updated when:
- Regulatory limits change (e.g., fragrance allergens, UV filter impurities, metals)
- New SCCS opinions are published
- The formula is modified
- New post-marketing surveillance data emerges
Key Components Of Safety Testing
Safety Testing is structured around a series of elements that constitute Part A of the safety report. Each one evaluates a different dimension of risk.
Ingredient Assessment
This includes:
- Concentration in the formula
- Purity and relevant impurities
- Available toxicological data
- LOAEL / NOAEL
- DNEL and MOS (Margin of Safety)
- SCCS monographs and scientific opinions
- Use restrictions defined in Annex III
- Substances prohibited under Annex II
- Preservatives authorised in Annex V
- Approved UV filters listed in Annex VI
Relevant endpoints include irritation, sensitisation, reproductive toxicity, genotoxicity, carcinogenicity, systemic toxicity, impurities, and degradation.
Microbiological Assessment
Covers tests such as:
- Challenge test (EN ISO 11930)
- Total viable count
- Absence of pathogenic microorganisms
- Microbial stability under stress conditions
This is particularly critical for formulations with high water content or sensitive raw materials.
Physicochemical Stability
Ensures that the product remains stable throughout its shelf life:
- Accelerated stability tests
- Packaging compatibility studies
- Measurement of key parameters (pH, viscosity, colour, odour, phase separation)
Stability data supports safety, efficacy, and legal compliance.
Exposure Assessment
Includes modelling of:
- Area of application
- Frequency of use
- Amount applied
- Exposure route (oral, dermal, inhalation)
- Skin penetration
- Target population (adults, children, pregnant women)
This information is essential to calculate the Margin of Safety (MOS).
Packaging Assessment
The packaging must be:
- Compatible with the formula
- Suitable to prevent migration or leaching
- Stable under foreseeable storage and use conditions
EU law requires packaging to be evaluated as part of the overall safety assessment.
Assessment Of Impurities And Nanoforms
Ingredient purity is now one of the most tightly regulated areas in the EU:
- Heavy metals
- Unwanted impurities
- Synthesis residues
- Nano-ingredients (labelled as nano in the INCI list)
Nanoforms often have additional requirements and may need specific notifications.
In Vivo Tests In Cosmetic Safety Evaluation
Within the Safety Testing process, in vivo studies play a crucial role in demonstrating real-world product tolerance under normal conditions of use. In the European Union, in vivo refers exclusively to tests conducted on human volunteers, since animal testing is prohibited for ingredients and finished cosmetic products intended for the EU market.
These tests provide direct information on how the skin, eyes, or application area responds to the cosmetic product, complementing both the toxicological evaluation and in vitro data. Their purpose is to confirm that the product is safe, tolerable, and suitable for its intended use.
Types Of In Vivo Safety Tests
In vivo studies comprise several standardised tests that evaluate tolerance, irritation, compatibility, and overall performance on human volunteers. The most common ones include:
- Skin Irritation Test (Patch Test)
Evaluates:
- Local irritation
- Erythema reactions
- Sensitivity on normal or sensitive skin
This is one of the most frequently used in vivo tests.
- Specific-Area Tolerance Tests
Designed for products intended for sensitive areas:
- Periocular region
- Lips
- Underarms
- Scalp
- Intimate area
These tests ensure adequate tolerance even in higher-risk zones.
- Home-Use Tests (Real-World Application)
Volunteers use the product for days or weeks, recording:
- Adverse reactions
- Sensory responses
- Comfort of use
- Unexpected side effects
These tests provide real-life insight beyond controlled laboratory conditions.
- Ocular Compatibility Tests
Applies to:
- Makeup removers
- Eye-area products
- Mascaras and lash treatments
- Shampoos
Evaluates tearing, irritation, stinging, and overall acceptability.
- Comedogenicity / Acne Tests
Performed on volunteers with acne-prone or sensitive skin:
- Confirms the product does not clog pores
- Verifies it does not increase comedone formation
- Sensory Efficacy Tests
Assesses user experience:
- Smoothness after application
- Absorption
- Texture and finish
- Freshness or comfort sensation
Although not toxicological, they contribute to the overall evaluation of safe use.
How In Vivo Data Supports Cosmetic Safety Testing
All in vivo results are incorporated into the Safety Report:
- Part A → technical data, raw results
- Part B → expert conclusion and justification
While in vivo tests do not replace toxicology, they provide real human-use data, essential for validating the final safety conclusion.
If any reaction is observed during in vivo testing, the assessor must review:
- Exposure modelling
- Target population
- Required warnings
- Safe-use recommendations
The Cosmetic Safety Assessment (Part B)
Part B represents the formal Safety Assessment, signed by a qualified professional. It includes:
- Safety conclusion
- Scientific justification
- Labelling requirements
- Mandatory warnings
- MOS calculations
- Considerations for vulnerable consumer groups
- Conditions for safe use
This document is essential for CPNP notification and EU market compliance.
Safety Testing And International Market Access
While the EU framework is one of the strictest, other regions also require comprehensive technical documentation:
- United Kingdom: UK SCP + SCPN notification
- United States: FDA requirements + MoCRA
- Mercosur: national RDC and toxicological analysis
- Middle East: SASO and SFDA
- Asia: China, Korea, Japan, ASEAN regulations
A well-structured Safety Testing dossier facilitates global expansion.
Post-Marketing Surveillance And Continuous Safety Evaluation
Once on the market, the Safety Assessment must be updated if:
- Undesirable effects are reported
- Toxicological data changes
- The formula is modified
- New SCCS opinions emerge
- RASFF or RAPEX alerts are issued
Safety is a continuous process, not a one-time requirement.
Benefits Of A Strong Safety Testing Strategy
A robust evaluation provides:
- Reduced legal and regulatory risks
- Fewer product withdrawals
- Scientifically supported product launches
- Enhanced consumer trust
- Access to EU and global markets
- Support for responsible claims and marketing
- Smooth handling of audits and inspections
For brands, manufacturers, and laboratories, Safety Testing is a strategic tool rather than merely a legal obligation.
Conclusion: Safety As A Foundation In The Cosmetic Industry
Safety Testing is not a simple administrative step—it is the foundation upon which trust, transparency, and quality are built in the cosmetics sector. In an evolving regulatory landscape where ingredients, toxicological data, and purity requirements change year after year, maintaining robust and up-to-date safety evaluations is essential.
Cosmetic products that successfully pass a thorough Safety Testing process not only comply with the law but also communicate responsibility, scientific commitment, and genuine respect for consumer health.