CEN/TC 347 - Methods for analysis of allergens

This document specifies a method for simulating the release of nickel from all post assemblies which are inserted into pierced ears and other pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin in order to determine whether such articles are in compliance with No. 27 in Annex XVII of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (REACH).
Spectacle frames and sunglasses are excluded from the scope of this document.
NOTE   Spectacle frames and sunglasses are subject to the requirements of EN 16128.

This document provides a screening test based upon the use of dimethylglyoxime for detecting the presence of nickel in articles that are inserted into pierced parts of the human body and those that are intended to come into direct and prolonged contact with the skin.
This screening test is suitable for manufacturers and importers as a qualitative method for detecting the presence of nickel in articles.
NOTE   The reference method for the measurement of nickel release is EN 1811, or for spectacle frames and sunglasses, EN 16128.

The present method permits the identification and quantification of the volatile compounds suspected as allergens, which are present in the fragrance compounds and fragrance raw materials used in cosmetic products. The analysis is performed by gas chromatography and mass spectrometry (GC-MS) on matrix samples which are "ready to be injected" and which are compatible with gas chromatography.
The analytes covered by this procedure are based on the contents of Tables 13.1 and 13.2 in the SCCS 1459/11 opinion document (1) and as listed in the legislation proposed by the European Commission. The rationale behind the final choice of procedure analytes is given in the table found in Annex J.
The method was validated at IFRA and CEN level.

This document specifies a method for the simulation of accelerated wear and corrosion, to be used prior to the detection of nickel release from coated articles that come into direct and prolonged contact with the skin. According to the Commission Regulation (EC) No 1907/2006 (REACH), articles with an outer coating containing nickel and those which are inserted into pierced ears and other parts of the human body are excluded from the scope of this document.

This European Standard specifies a method for simulating the release of nickel from all post assemblies which are inserted into pierced ears and other pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin in order to determine whether such articles are in compliance with the Commission Regulation (EC) No 552/2009 amending Regulation (EC) No 1907/2006 on REACH as regards Annex XVII. Spectacle frames and sunglasses are excluded from the scope of this European Standard. NOTE Spectacle frames and sunglasses are subject to the requirements of EN 16128:2011 which provides an unchanged re-publication of the technical requirements that had previously been specified in EN 1811:1998, but restricted in scope to apply only to spectacle frames and sunglasses.

This European Standard specifies a method for accelerated wear and corrosion, to be used prior to the detection of nickel release from coated items that come into direct and prolonged contact with the skin.

This European Standard specifies a method for simulating the release of nickel from all post assemblies which are inserted into pierced ears and other pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin in order to determine whether such articles are in compliance with No. 27 Annex XVII of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (REACH).
Spectacle frames and sunglasses are excluded from the scope of this European Standard.
NOTE   Spectacle frames and sunglasses are subject to the requirements of EN 16128:2011 which provides an unchanged re-publication of the technical requirements that had previously been specified in EN 1811:1998, but restricted in scope to apply only to spectacle frames and sunglasses.

This European Standard presents a quick screening method, based on the use of dimethylglyoxime, sutable for the evaluation of nickel release from items that come into direct and prolonged contact with the skin, with special reference to nickel allergy.

This European Standard describes a method for the identification and determination of 24 volatile suspected allergens from ready-to-inject cosmetics and raw materials used in cosmetic products and are compatible with GC analysis. This analysis uses GC-MS after sample preparation. The 24 suspected allergens are restricted under Council Directives (7th amendment to the Cosmetic Directive 2003/15/EC).
This European Standard does not include requirements for the preparation of samples in matrices for which direct injection in GC is not feasible.

This European Standard specifies a method for accelerated wear and corrosion, to be used prior to the detection of nickel release from coated items that come into direct and prolonged contact with the skin.

CEN/TC - Modifications in list entries 5.8 and 5.9.

This European Standard specifies a method for simulating the release of nickel from all post assemblies which are inserted into pierced ears and other pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin in order to determine whether such articles are in compliance with the Commission Regulation (EC) No 552/2009 amending Regulation (EC) No 1907/2006 on REACH as regards Annex XVII.
Spectacle frames and sunglasses are excluded from the scope of this European Standard.
NOTE   Spectacle frames and sunglasses are subject to the requirements of EN 16128:2011 which provides an unchanged re-publication of the technical requirements that had previously been specified in EN 1811:1998, but restricted in scope to apply only to spectacle frames and sunglasses.

This European Standard specifies a method for simulating the release of nickel from articles intended to come
into direct and prolonged contact with the skin in order to determine whether such items release nickel at a
rate greater than 0,5 µg/cm2/week.

This European Standard specifies a method for accelerated wear and corrosion, to be used prior to the detection of nickel release from coated items that come into direct and prolonged contact with the skin.