ISO 10130-2009 PDF

Full title and description

ISO 10130:2009 — Cosmetics — Analytical methods — Nitrosamines: Detection and determination of N‑nitrosodiethanolamine (NDELA) in cosmetics by HPLC, post‑column photolysis and derivatization. The standard specifies a validated laboratory procedure using reversed‑phase HPLC with post‑column UV photolysis and Griess derivatization for the detection and quantification of NDELA in cosmetic products and raw materials.

Abstract

ISO 10130:2009 describes a method for the detection and quantification of N‑nitrosodiethanolamine (NDELA) in cosmetics and cosmetic raw materials by high‑performance liquid chromatography (HPLC) coupled with post‑column photolysis and chemical derivatization (Griess reaction), enabling spectrophotometric measurement of the resulting azo dye. The method is specific to NDELA (not other nitrosamines) and is an alternative to methods such as ISO 15819 where appropriate. It is not applicable to matrices containing oxidation dyes.

General information

• Status: Published (International Standard; under periodic systematic review stage as listed by ISO).
• Publication date: December 2009 (published 2009‑12; catalog listings show 3 December 2009 as the publication date).
• Publisher: International Organization for Standardization (ISO), prepared by ISO/TC 217 (Cosmetics).
• ICS / categories: 71.100.70 (Cosmetics; analytical methods).
• Edition / version: Edition 1 (2009).
• Number of pages: 13 pages (official ISO listing).

Scope

This standard specifies a laboratory procedure for detecting and quantifying N‑nitrosodiethanolamine (NDELA) in cosmetics and raw materials used in cosmetics. It applies when a product may be contaminated by NDELA from ingredients or where NDELA formation is possible from ingredient composition. The method is limited to NDELA (it does not cover other nitrosamines) and is not applicable to sample matrices that contain oxidation dyes. It may be used as an alternative to other NDELA methods (for example, LC–MS/MS approaches).

Key topics and requirements

• Analytical principle: reversed‑phase HPLC separation followed by post‑column photolysis (UV) to convert N‑nitroso groups to nitrite, then Griess derivatization to form a coloured azo dye for spectrophotometric detection.
• Instrumentation: HPLC system with a suitable reversed‑phase column, a post‑column UV photolysis unit (specified wavelength/conditions), and a post‑column derivatization/detection system (Griess reagents and visible‑range detector).
• Specificity checks: procedures to confirm that the detected peak is NDELA (for example, repeat analysis without photolysis to verify absence of the signal).
• Applicability limits: method restricted to NDELA; not suitable for matrices with oxidation dyes and not intended for other nitrosamines without adaptation.
• Role as alternative method: described as an alternative to other ISO methods (notably ISO 15819, which uses LC–MS/MS-based approaches).

Typical use and users

ISO 10130:2009 is intended for analytical and quality‑control laboratories in the cosmetics industry, regulatory testing laboratories, contract testing providers, and research groups concerned with nitrosamine contamination in cosmetic formulations and raw materials. It is used when manufacturers or testing bodies need a validated HPLC‑based procedure for NDELA detection where LC‑MS instrumentation may not be available or when the photolysis‑Griess approach is preferred.

Related standards

Relevant or related standards include ISO 15819 (methods for NDELA using HPLC–MS/MS; later editions provide an LC–MS/MS based approach and may be used for quantitative determination), other ISO/TC 217 test methods for cosmetic analysis, and national/adopted versions of ISO 10130 published by national bodies (e.g., NEN, BSI translations/adoptions). Users should consult the current ISO catalogue and national standards bodies for adopted or revised editions.

Keywords

NDELA, N‑nitrosodiethanolamine, nitrosamines, cosmetics, analytical methods, HPLC, post‑column photolysis, Griess derivatization, ISO 10130, ISO/TC 217.

FAQ

Q: What is this standard?

A: ISO 10130:2009 is an ISO international standard that specifies an HPLC with post‑column photolysis and derivatization method for the detection and determination of N‑nitrosodiethanolamine (NDELA) in cosmetics and cosmetic raw materials.

Q: What does it cover?

A: It covers the analytical procedure (sample preparation guidance, HPLC separation, post‑column UV photolysis, Griess derivatization and spectrophotometric detection) for NDELA only, including specificity checks and applicability limits; it explicitly excludes other nitrosamines and matrices containing oxidation dyes.

Q: Who typically uses it?

A: Cosmetic manufacturers, quality control and R&D laboratories, contract testing laboratories, and regulatory testing bodies use this method where NDELA testing is required and where the HPLC/post‑column photolysis approach is suitable.

Q: Is it current or superseded?

A: ISO 10130:2009 is listed as a published ISO International Standard (publication December 2009). Standards are subject to periodic ISO review; the ISO catalogue shows the document as published and under systematic review stage at the time of the catalogue entry. For detection/quantification of NDELA alternative ISO documents such as ISO 15819 (LC–MS/MS method; later edition 2014) also exist and may be preferred for certain quantitative applications. Users should check the ISO catalogue or their national standards body for the most recent status or revisions.

Q: Is it part of a series?

A: It sits within the portfolio of ISO/TC 217 cosmetics analytical methods addressing nitrosamines and related contaminants; other ISO methods (for example ISO 15819) address the same analyte by different instrumental techniques. National adoptions/versions (BS, NEN, etc.) may also exist.

Q: What are the key keywords?

A: Key keywords include NDELA, nitrosamines, cosmetics, HPLC, post‑column photolysis, Griess derivatization, analytical methods, ISO 10130.