BS ISO 10130:2009

Overview

BS ISO 10130:2009 provides a comprehensive analytical method for the detection and determination of N-nitrosodiethanolamine (NDELA) in cosmetics. This standard is crucial for manufacturers and regulatory bodies aiming to ensure the safety and compliance of cosmetic products. NDELA is a potential carcinogen, and its presence in cosmetics raises significant health concerns. The standard outlines a method using High-Performance Liquid Chromatography (HPLC) coupled with post-column photolysis and derivatization, ensuring accurate and reliable results.

Key Requirements

The standard specifies the following key requirements for the analytical method:

• Sample Preparation: Guidelines for preparing cosmetic samples to ensure accurate detection of NDELA.
• HPLC Conditions: Detailed parameters for HPLC operation, including column type, mobile phase composition, and flow rates.
• Post-column Photolysis: Procedures for the photolysis step that enhances the detection of NDELA.
• Derivatization: Techniques for chemical modification of NDELA to improve detection sensitivity.
• Validation Protocols: Requirements for validating the method to ensure reliability and reproducibility of results.

Implementation Benefits

Implementing BS ISO 10130:2009 offers several benefits to cosmetic manufacturers and compliance professionals:

• Enhanced Safety: By detecting NDELA, manufacturers can mitigate potential health risks associated with cosmetic products.
• Regulatory Compliance: Adhering to this standard helps ensure compliance with relevant regulations and guidelines, reducing the risk of penalties.
• Market Confidence: Demonstrating compliance with recognised standards enhances consumer trust in product safety.
• Quality Assurance: The rigorous analytical method supports quality control processes, ensuring consistent product safety and performance.

Compliance Value

Compliance with BS ISO 10130:2009 is essential for cosmetic manufacturers aiming to meet both national and international safety standards. The presence of NDELA in cosmetic products can lead to significant legal and financial repercussions. By adopting this standard, companies can:

• Reduce Liability: Minimise the risk of litigation arising from health issues related to cosmetic products.
• Facilitate Market Access: Ensure products meet the requirements of various markets, including the EU and other regions with stringent regulations.
• Improve Product Development: Use the standard as a benchmark for developing new formulations that are safe and compliant.

In conclusion, BS ISO 10130:2009 is a vital standard for the cosmetic industry, providing a robust method for detecting NDELA. Its implementation not only enhances product safety but also supports compliance with regulatory requirements, ultimately fostering consumer trust and market success.