Cosmetic safety assessment
Introduction
Cosmetic safety assessment is the crucial step in ensuring that cosmetic products are safe for consumers. It is enshrined in law in the EU Cosmetics Regulation (EC) No. 1223/2009 and requires that every product be assessed by a competent person before it is placed on the market. This assessment covers not only the ingredients, but the entire product – from its composition and packaging to possible side effects.
What data must a safety assessor use?
A well-founded safety assessment for cosmetics is based on a wide range of data that the safety assessor carefully reviews and documents. This includes:
- Product composition: All ingredients with their exact concentration and function.
- Physical and chemical properties: Stability, pH value, viscosity, colour, odour.
- Toxicological profiles: Risks of individual ingredients, possible allergic reactions or irritations.
- Exposure assessment: How much of the product comes into contact with the skin or mucous membranes during normal use?
- Side effect data: Information on known undesirable effects, especially serious cases.
- Stability and preservation tests: Testing of shelf life and microbiological safety.
These points form the core of every cosmetic safety assessment.
What documentation is required for each raw material?
For a complete cosmetic safety assessment, the following documentation must be available for each raw material used:
- INCI name and CAS and EINECS/ELINCS number.
- Detailed composition including possible trace substances or impurities.
- Function in the product (e.g. preservative, moisturiser, colourant).
- Toxicological data from studies or recognised databases.
- Purity criteria and limit values for impurities.
- Safety data sheets (SDS).
Without these documents, a legally compliant safety assessment for cosmetics is not possible.
Training and qualifications of a safety assessor
The safety assessment of cosmetics may only be carried out by persons who have undergone appropriate training in accordance with the EU Cosmetics Regulation. As a rule, a university degree in one of the following subjects is required:
- Pharmacy
- Toxicology
- Medicine
- or a comparable scientific discipline.
In addition, the safety assessor must be able to carry out a risk analysis and prepare the safety report with comprehensible reasoning. This requires both scientific expertise and practical experience in the evaluation of cosmetic ingredients.
Procedure for a safety assessment
A typical safety assessment for cosmetics follows this pattern:
- Collection of all raw material and product data.
- Analyse the toxicological properties of each ingredient.
- Evaluate the product formulation in terms of exposure and potential risks.
- Prepare the safety report with conclusions, warnings and recommendations for use.
- Archive in the product information file (PIF).
Here you will find a checklist for a safety assessment of cosmetics, including a download
| Checklist – Safety assessment for cosmetics | |||
|---|---|---|---|
| © Cosmacon GmbH – Development and consulting for innovative cosmetics | |||
| Status | Checkpoints | Comments | |
| ☐ | General product information | ||
| ☐ | Product name & category | ||
| ☐ | Intended use | ||
| ☐ | Packaging description | ||
| ☐ | Full composition | ||
| ☐ | INCI list of all ingredients | ||
| ☐ | Quantity in % | ||
| ☐ | Raw material documentation | ||
| ☐ | INCI name | ||
| ☐ | Safety data sheet (SDS) | ||
| ☐ | Technical data sheet | ||
| ☐ | Specifications | ||
| ☐ | Toxicological data | ||
| ☐ | Information on impurities (e.g. heavy metal content in pigments) | ||
| ☐ | Stability report | ||
| ☐ | pH value | ||
| ☐ | Viscosity | ||
| ☐ | Colour, odour | ||
| ☐ | Stability | ||
| ☐ | Compatibility with packaging | ||
| ☐ | Microbiological safety | ||
| ☐ | Challenge test / preservation stress test | ||
| ☐ | Archiving | Can be provided by Cosmacon | |
| ☐ | Complete storage in the PIF | ||
| ☐ | Accessibility for authorities |
checklist for a safety assessment of cosmetics
Conclusion
The safety assessment of cosmetics is much more than a formal step – it is a guarantee of consumer safety. Only through comprehensive data collection, professional analysis and the work of a qualified safety assessor can it be ensured that a cosmetic product complies with legal requirements and can be safely placed on the market.
Literature:
- EU Regulation (EC) No. 1223/2009 on cosmetic products
https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=CELEX:32009R1223
- European Commission – Guidelines on the safety information file for cosmetic products
https://health.ec.europa.eu/system/files/2016-11/cosmetic_prod_safety_report_de_0.pdf
- Sicherheitsbewerter.info – Technical information and checklists
https://sicherheitsbewerter.info
- Tentamus Group – Safety assessment for cosmetics
https://www.tentamus.de/laboranalysen/kosmetikanalyse/sicherheitsbewertung-kosmetik
- Certified Cosmetics – Safety testing and PIF documentation