EN 16343:2013

Overview

EN 16343:2013 is a European Standard developed by CEN that specifies a precise analytical method for the quantitative determination of 3-iodo-2-propynyl butylcarbamate (IPBC) in cosmetic products. IPBC is a widely used preservative regulated under Annex V No. 56 of Regulation (EC) No 1223/2009 on cosmetic products. The standard outlines an LC-MS (liquid chromatography-mass spectrometry) and LC-MS/MS method applicable for measuring IPBC concentrations ranging from 0.005 g/100 g to 0.1 g/100 g in cosmetic preparations.

This method ensures accurate, reproducible, and legally compliant detection of IPBC, supporting quality control and regulatory safety assessments for cosmetics across European markets.

Key Topics

• Scope and Purpose
  Focuses on the quantitative analysis of IPBC in various cosmetic matrices, providing a validated protocol aligned with European regulatory requirements for preservatives.

• Analytical Principle
  IPBC is extracted from cosmetic samples using methanol, followed by separation via reverse phase high-performance liquid chromatography (RP-HPLC) and detection through mass spectrometry (LC-MS or LC-MS/MS). Quantification is conducted through external calibration or standard addition techniques.

• Sample Preparation
  Cosmetics samples are accurately weighed and extracted with methanol and tetrahydrofuran or alternatively 2-propanol for poorly soluble matrices. Ultrasonic treatment and filtration through 0.2 µm membrane filters ensure sample cleanliness for LC-MS analysis.

• Chromatographic Conditions
  The method defines a detailed gradient elution program, column specifications (RP 18 phase, 5 µm particles), and operational parameters such as flow rate and temperature to ensure optimal IPBC separation.

• Detection Modes
  IPBC is monitored either in Selected Ion Monitoring (SIM) mode targeting m/z 282 and m/z 304 ions or in Multiple Reaction Monitoring (MRM) mode focusing on specific fragment ions for enhanced specificity and sensitivity.

• Evaluation and Calculation
  IPBC concentration is calculated by correlating sample peak areas with calibration standards, using a formula that considers dilution factors and sample weight, ensuring reliable reporting of preservative content (g/100 g).

• Inter-Laboratory Validation
  The method has been tested with 13 laboratories demonstrating high repeatability, reproducibility, and recovery rates above 100%, confirming robustness and consistency for routine testing.

Applications

• Cosmetic Product Quality Control
  Assists manufacturers and testing laboratories in accurately quantifying IPBC levels to ensure compliance with prescribed limits, preventing product recalls and regulatory penalties.

• Regulatory Compliance
  Enables cosmetic companies to meet European Union safety regulations stipulated by Regulation (EC) No 1223/2009, facilitating product market authorization within member states.

• Consumer Safety Assurance
  By monitoring IPBC concentrations, this standard supports the safety evaluation of cosmetic preservatives, minimizing risks associated with preservative misuse or overuse.

• Research and Development
  Useful for formulation scientists assessing preservative stability and effectiveness during product development cycles.

Related Standards

• Regulation (EC) No 1223/2009 on Cosmetic Products
  Governs safety aspects and permissible concentrations of cosmetic ingredients, including preservatives like IPBC.

• CEN/TC 392 - Cosmetics Standardization
  Other technical standards from the same committee cover analytical methods for different cosmetic ingredients and safety assessments.

• ISO Standards in Cosmetic Analysis
  Complements ISO standards related to cosmetic product testing and quality assurance protocols.

Keywords: EN 16343:2013, 3-iodo-2-propynyl butylcarbamate, IPBC, cosmetics analysis, LC-MS method, cosmetic preservatives, Regulation EC 1223/2009, quantitative determination, cosmetic product testing, European Standard, cosmetic safety testing.