Under this regulation, preservatives are defined as substances exclusively or mainly intended to inhibit the development of microorganisms in cosmetic products. Their use is essential: without effective preservation, products—especially those containing water—can become unsafe due to microbial contamination.
The regulation adopts a positive list approach, meaning that only preservatives explicitly authorized may be used in cosmetic formulations. This list is contained in Annex V of the regulation.
Annex V: The Positive List of Preservatives
Annex V specifies which preservatives are allowed, along with their conditions of use. Each entry includes:
- The substance name (often with INCI denomination)
- Maximum permitted concentration
- Restrictions depending on product type (e.g., rinse-off vs leave-on)
- Specific warnings or labeling requirements
This approach ensures that every permitted preservative has undergone a safety assessment by the Scientific Committee on Consumer Safety (SCCS) or its predecessor bodies.
Importantly, the list is not static. It is regularly updated to reflect new scientific evidence, meaning that formulators must stay informed about amendments.
Before a preservative is included in Annex V, it must undergo a comprehensive risk assessment evaluating its toxicological profile, exposure scenarios, margin of safety for consumers and potential for sensitization or irritation
Only substances considered safe under defined conditions are approved. If new data suggests a risk, substances can be restricted further or removed entirely.
A well-known example is the evolving regulation of parabens, where certain compounds have been banned or restricted while others remain permitted within strict concentration limits.
Key Considerations for Formulators
Compliance is not only about choosing an approved preservative. Formulators must ensure that the final product remains safe throughout its shelf life and use.
This includes:
- Using preservatives within permitted concentrations
- Considering combined effects when multiple preservatives are used
- Performing microbiological challenge tests (preservative efficacy testing)
- Ensuring compatibility with packaging and formulation matrix
Even if a preservative is listed in Annex V, improper use can still lead to non-compliance.
Use of Preservatives in Cosmetic Products
Preservatives play a critical role in ensuring the safety and stability of cosmetic products. In the EU, their use is tightly controlled through a robust regulatory framework grounded in scientific evaluation.
For manufacturers, compliance requires more than simply selecting ingredients from a list. It involves understanding regulatory conditions, applying good formulation practices, and staying informed about ongoing scientific and legislative developments.
By aligning with Regulation (EC) No 1223/2009, companies not only meet legal requirements but also contribute to a higher standard of consumer protection across the cosmetic industry.
