EN 16343:2013

Cosmetics - Analysis of cosmetic products - Determination of 3-iodo-2-propynyl butylcarbamate (IPBC) in cosmetic preparations, LC-MS methods

This European Standard specifies a method for the quantitative determination of 3 iodo 2 propynyl butylcarbamate (IPBC) in the concentration range from 0,005 g/100 g to 0,1 g/100 g - Annex V No. 56 in Regulation (EC) No 1223/2009 on cosmetic products.

Kosmetische Mittel - Untersuchung von kosmetischen Mitteln - Bestimmung von 3-Iod-2-propinylbutylcarbamat (IPBC) in kosmetischen Mitteln, LC-MS-Verfahren

Diese Europäische Norm legt ein Verfahren zur quantitativen Bestimmung von 3-Iod-2-propinylbutylcarbamat (IPBC) im Konzentrationsbereich von 0,005 g/100 g bis 0,1 g/100 g — geregelt in Anhang V, Nr. 56 der Verordnung (EG) Nr. 1223/2009 für kosmetische Mittel — fest.

Cosmétiques - Analyse des produits cosmétiques - Détermination quantitative du carbamate 3-iodo-2-propynylbutyle (IPBC), méthodes CL-SM

La présente Norme européenne spécifie une méthode de détermination quantitative pour le carbamate de 3 iodo-2-propynylbutyle (IPBC) dans une gamme de concentration allant de 0,005 g/100 g à 0,1 g/100 g - Annexe V No 56 du Règlement (CE) No 1223/2009 relatif aux produits cosmétiques.

Kozmetika - Analiza kozmetičnih izdelkov - Določevanje 3-jodo-2-propinilbutilkarbamata (IPBC) v kozmetičnih pripravkih s tekočinsko kromatografijo z masno spektrometrijsko detekcijo (LC-MS)

Ta evropski standard določa metodo za kvantitativno določevanje 3-jodo-2-propinilbutilkarbamata (IPBC) v koncentraciji od 0,005 g/100 g do 0,1 g/100 g – dodatek V št. 56 v
Uredbi (ES) št. 1223/2009 o kozmetičnih izdelkih.

General Information

• Status: Published
• Publication Date: 21-May-2013
• Withdrawal Date: 29-Nov-2013
• ICS: 71.100.70 - Cosmetics. Toiletries
• Technical Committee: CEN/TC 392 - Cosmetics
• Drafting Committee: CEN/TC 392/WG 1 - Analytical methods
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Start Date: 18-Feb-2025
• Completion Date: 18-Mar-2026
• Ref Project: SIST EN 16343:2013 - Cosmetics - Analysis of cosmetic products - Determination of 3-iodo-2-propynyl butylcarbamate (IPBC) in cosmetic preparations, LC-MS methods

Overview

EN 16343:2013 is a European Standard developed by CEN that details a laboratory method for the quantitative determination of 3-iodo-2-propynyl butylcarbamate (IPBC) in cosmetic preparations. This standard supports compliance with Regulation (EC) No 1223/2009, specifically Annex V, No. 56, which governs restricted substances in cosmetic products within the European Union. Using advanced LC-MS (Liquid Chromatography-Mass Spectrometry) techniques, this standard is essential for regulatory compliance, quality control, and consumer safety in the cosmetics industry.

Key Topics

• Quantitative Determination of IPBC: The standard outlines procedures for accurately measuring IPBC concentrations in the range of 0.005 g/100 g to 0.1 g/100 g within cosmetic products.
• Sample Preparation and Extraction: Guidance on preparing cosmetic samples and extracting IPBC using solvents like methanol, ensuring reliable analysis.
• LC-MS Analysis: Utilizes reverse phase high-performance liquid chromatography (HPLC) coupled with mass spectrometry (MS or MS/MS) for separation and detection of IPBC.
• Calibration and Validation: External calibration and standard addition methods for quantification, with provisions for avoiding systematic errors caused by matrix effects.
• Reporting Requirements: Specifies detail for documenting sample identification, methodology, calibration, results, and any deviations from the established laboratory procedure.

Applications

EN 16343:2013 is widely used by laboratories, cosmetic manufacturers, and regulatory agencies for:

• Regulatory Compliance: Ensuring product formulations adhere to EU regulations regarding IPBC, a preservative with concentration limits in cosmetics.
• Quality Assurance: Supporting manufacturers and suppliers in verifying the safety and compliance of their products before they reach the market.
• Consumer Safety: Maintaining low and regulated levels of preservatives like IPBC, which contributes to product efficacy and safety.
• Inter-Laboratory Validation: Facilitating standardized methods that are reproducible across different laboratories, as demonstrated by inter-laboratory testing referenced in the standard.

Related Standards

Organizations seeking comprehensive compliance and analytical rigor may also reference:

• Regulation (EC) No 1223/2009: The core legislation on cosmetic product safety in the European Union.
• EN ISO 21148 – Cosmetics – Microbiology – General instructions for microbiological examination.
• EN 14885 – Chemical disinfectants and antiseptics – Application of European Standards for chemical disinfectant and antiseptic products.
• ISO/IEC 17025 – General requirements for the competence of testing and calibration laboratories.

By following the protocols in EN 16343:2013, stakeholders in the cosmetics sector ensure robust protection of consumer health and full regulatory compliance-demonstrating responsible and consistent quality management in cosmetic product analysis. This standard is a key resource for cosmetic testing laboratories, quality assurance teams, and regulatory compliance consultants aiming to maintain best practices in preservative analysis using LC-MS methods.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.NRKosmetische Mittel - Untersuchung von kosmetischen Mitteln - Bestimmung von 3-Iod-2-propinylbutylcarbamat (IPBC) in kosmetischen Mitteln, LC-MS-VerfahrenCosmétiques - Analyse de produits cosmétiques - Détermination quantitative du carbamate 3-iodo-2-propynylbutyle (IPBC), méthodes CL-SMCosmetics - Analysis of cosmetic products - Determination of 3-iodo-2-propynyl butylcarbamate (IPBC) in cosmetic preparations, LC-MS methods71.100.70SULSRPRþNLCosmetics. ToiletriesICS:Ta slovenski standard je istoveten z:EN 16343:2013SIST EN 16343:2013en,fr,de01-julij-2013SIST EN 16343:2013SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 16343
May 2013 ICS 71.100.70 English Version
Cosmetics - Analysis of cosmetic products - Determination of 3-iodo-2-propynyl butylcarbamate (IPBC) in cosmetic preparations, LC-MS methods
Cosmétiques - Analyse des produits cosmétiques - Détermination quantitative du carbamate 3-iodo-2-propynylbutyle (IPBC), méthodes CL-SM
Kosmetische Mittel - Untersuchung von kosmetischen Mitteln - Bestimmung von 3-Iod-2-propinylbutylcarbamat (IPBC) in kosmetischen Mitteln, LC-MS-Verfahren This European Standard was approved by CEN on 25 April 2013.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
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