EN 16274:2012
(Main)Methods for analysis of allergens - Quantification of suspected fragrance allergens in consumer products - Step 1: GC analysis of ready-to-inject sample
Methods for analysis of allergens - Quantification of suspected fragrance allergens in consumer products - Step 1: GC analysis of ready-to-inject sample
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.
Analyseverfahren für Allergene - Quantifizierung von mutmaßlichen Allergie auslösenden Duftstoffen in Verbrauchsgütern - Stufe 1: GC-Analyse von einspritzfertigen Proben
Diese Europäische Norm beschreibt ein Verfahren zur Identifizierung und Bestimmung von 24 flüchtigen mutmaßlichen Allergenen in einspritzfertigen kosmetischen Mitteln und Ausgangsstoffen, die in kosmetischen Produkten verwendet werden und die für die GC-Analyse geeignet sind. Bei dieser Analyse wird nach der Probenvorbereitung GC MS angewendet. Die Verwendung der 24 mutmaßlichen Allergene wird durch Richtlinien des Rates (7. Änderung zur Kosmetik-Richtlinie 2003/15/EG) eingeschränkt.
Das Verfahren, das in dieser Europäischen Norm beschrieben wird, enthält keine Anforderungen an die Herstellung von Proben in Matrices, bei denen ein direktes Einspritzen in den GC nicht durchführbar ist.
Méthodes d'analyse des allergènes - Quantification des fragrances allergènes suspectées dans les produits de consommation - Étape 1 : Analyse par GC d'échantillons prêts à être injectés
La présente Norme européenne décrit une méthode permettant d’identifier et de déterminer 24 allergènes volatils suspectés, dans des produits cosmétiques prêts à être injectés ou dans des matières premières utilisées dans les produits cosmétiques, et qui sont compatibles avec une analyse chromatographique en phase gazeuse. Après préparation de l’échantillon, l’analyse est réalisée par GC-MS. Les 24 allergènes suspectés sont réglementés en vertu d’une Directive du Conseil (7ème amendement à la Directive 2003/15/CE relative aux produits cosmétiques).
La présente méthode ne comprend pas d’exigences pour la préparation d’échantillons de matrices ne pouvant pas être injectées directement en GC.
Analizne metode za alergene - Kvantitativno določevanje domnevnih dišavnih alergenov v izdelkih za potrošnike - Stopnja 1: Plinsko kromatografska analiza vzorcev, ki so pripravljeni za injeciranje
Ta evropski standard opisuje metodo za identificiranje in določitev 24 hlapnih alergenov, ki so v kozmetičnih proizvodih, pripravljenih za vbrizganje, in surovinah, uporabljenih v kozmetičnih proizvodih, in ki so združljivi z analizo s plinsko kromatografijo. V tej analizi je uporabljen GC-MS po pripravi vzorca. 24 alergenov omejujejo direktive Sveta (7. sprememba direktive o kozmetičnih izdelkih 2003/15/ES). Metoda, opisana v tem evropskem standardu, ne vključuje zahtev za pripravo vzorcev v matricah, za katere neposredni vbrizg v GC ni izvedljiv.
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Analyseverfahren für Allergene - Quantifizierung von mutmaßlichen Allergie auslösenden Duftstoffen in Verbrauchsgütern - Stufe 1: GC-Analyse von einspritzfertigen ProbenMéthodes d'analyse des allergènes - Quantification des fragrances allergènes suspectées dans les produits de consommation - Analyse par CG d'échantillons prêts à être injectésMethods for analysis of allergens - Quantification of suspected fragrance allergens in consumer products - Step 1: GC analysis of ready-to-inject sample71.100.70SULSRPRþNLCosmetics. ToiletriesICS:Ta slovenski standard je istoveten z:EN 16274:2012SIST EN 16274:2012en,fr,de01-december-2012SIST EN 16274:2012SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 16274
September 2012 ICS 71.100.60 English Version
Methods for analysis of allergens - Quantification of suspected fragrance allergens in consumer products - Step 1: GC analysis of ready-to-inject sample
Méthodes d'analyse des allergènes - Quantification des fragrances allergènes suspectées dans les produits de consommation - Étape 1 : Analyse par GC d'échantillons prêts à être injectés
Analyseverfahren für Allergene - Quantifizierung von mutmaßlichen Allergie auslösenden Duftstoffen in Verbrauchsgütern - Stufe 1: GC-Analyse von einspritzfertigen Proben This European Standard was approved by CEN on 4 August 2012.
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
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
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Avenue Marnix 17,
B-1000 Brussels © 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 16274:2012: ESIST EN 16274:2012
Column performances . 17Annex B (informative)
SIM windows . 19Annex C (informative)
Example of chromatographic separation . 20Annex D (normative)
Decisional tree . 22Bibliography . 23SIST EN 16274:2012
The final result depends on the agreement of the different ion ratios obtained for both injections according to specific requirements. 3 Reagents Unless otherwise stated, use only reagents of recognised analytical grade. The solvent shall be of quality for GC-MS analysis. 3.1 Solvents 3.1.1 Methyl pivalate, CAS no: [598-98-1], analytical grade or higher. 3.1.2 Ortho-fluorotoluene, CAS no: [95-52-3], analytical grade or higher. 3.1.3 Acetone, CAS no: [67-64-1], analytical grade or higher. IMPORTANT — if other solvents are used, their inertness with the analytes shall be demonstrated. In any case, the same solvent shall be used both for calibration and determination. 3.2 Fragrance (suspected allergen) standards 3.2.1 Amylcinnamic alcohol, CAS no: [101-85-9], with known purity. NOTE Possibly two isomers. 3.2.2 Amylcinnamic aldehyde (flosal®), CAS no: [122-40-7], with known purity. NOTE Possibly two isomers. 3.2.3 Anisyl alcohol, CAS no: [105-13-5], with known purity. 3.2.4 Benzyl alcohol, CAS no: [100-51-6], with known purity. 3.2.5 Benzyl benzoate, CAS no: [120-51-4], with known purity. SIST EN 16274:2012
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