ISO TR 14735-2013 PDF

Full title and description

ISO/TR 14735:2013 — Cosmetics — Analytical methods — Nitrosamines: Technical guidance document for minimizing and determining N-nitrosamines in cosmetics. This technical report gives practical guidance on strategies to reduce the formation of N‑nitrosamines in cosmetic products and summarizes analytical approaches for their detection and quantification.

Abstract

ISO/TR 14735:2013 aims to provide general advice on measures to minimise the likelihood of N‑nitrosamine formation in cosmetics and to describe analytical methodologies available for reliable determination of N‑nitrosamines in finished products and raw materials. It discusses method relevance and limitations and proposes an analytical approach for total N‑nitroso compounds and for specific analytes such as N‑nitrosodiethanolamine (NDELA).

General information

• Status: Published (Technical Report).
• Publication date: April 2013 (Edition 1: 2013-04).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 71.100.70 — Cosmetics. Toiletries.
• Edition / version: Edition 1 (2013).
• Number of pages: 9 pages.

Scope

The report covers approaches to reduce or eliminate adventitious nitrite sources and secondary amine precursors in cosmetic formulations, the incorporation of inhibitors of N‑nitrosamine formation, and analytical methodologies for both total N‑nitroso compounds and specific determination of NDELA. It is intended as guidance for manufacturers, testing laboratories and regulators rather than as a prescriptive test standard.

Key topics and requirements

• Overview of factors leading to N‑nitrosamine formation in cosmetic matrices (nitrite sources, secondary amines, formulation and process controls).
• Preventive strategies: raw material control, formulation choices, storage and process hygiene to minimise nitrosation risk.
• Use of inhibitors and formulation measures to lower N‑nitrosamine formation potential.
• Analytical approaches: screening methods for total N‑nitroso compounds and specific procedures for NDELA and other individual nitrosamines (discusses HPLC-based, photolysis/derivatization and mass-spectrometric methods where relevant).
• Guidance on selecting appropriate methods for laboratories given sample matrix, sensitivity needs and regulatory limits.

Typical use and users

Manufacturers of cosmetic and personal‑care products, quality control and analytical laboratories, regulatory agencies and conformity assessment bodies use this technical report as practical guidance to reduce N‑nitrosamine risk in formulations and to choose appropriate analytical strategies for monitoring and verification.

Related standards

ISO/TR 14735:2013 complements and references analytical test methods and related documents such as ISO 10130 (detection and determination of NDELA by HPLC with post‑column photolysis/derivatization) and ISO 15819 (detection/determination of NDELA by HPLC‑MS/MS). National adoptions and publisher-specific designations (for example PD ISO/TR 14735:2013 by BSI and GOST/identical adoptions) are also available.

Keywords

nitrosamines, N‑nitrosodiethanolamine (NDELA), cosmetics, analytical methods, nitrite control, formulation guidance, ISO/TC 217, quality control, prevention, HPLC, mass spectrometry.

FAQ

Q: What is this standard?

A: ISO/TR 14735:2013 is a technical report providing guidance on minimising the formation of N‑nitrosamines in cosmetic products and on analytical approaches for detecting and determining N‑nitrosamines.

Q: What does it cover?

A: It covers risk‑reduction strategies (controlling nitrite sources and amine precursors, using inhibitors, formulation and process controls) and summarizes analytical methods for total N‑nitroso compounds and specific methods (notably for NDELA). It is advisory rather than a prescriptive test specification.

Q: Who typically uses it?

A: Cosmetic product manufacturers, raw‑material suppliers, QC/analytical laboratories and regulators use the report to inform risk‑management practices and to select suitable analytical techniques for monitoring N‑nitrosamines.

Q: Is it current or superseded?

A: As published in April 2013, ISO/TR 14735:2013 is an issued technical report. Users should check national adoption status and any later ISO activity or newer analytical standards for updates (see related standards such as ISO 10130 and ISO 15819 for specific methods).

Q: Is it part of a series?

A: It is part of ISO technical work in the cosmetics domain under ISO/TC 217 and complements other ISO analytical standards addressing N‑nitrosamines (for example ISO 10130 and ISO 15819) rather than forming a numbered multi‑part series itself.

Q: What are the key keywords?

A: Nitrosamines, NDELA, cosmetics, analytical methods, nitrite control, formulation, HPLC, mass spectrometry, ISO/TC 217.