BS EN 16274:2021

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Method for analysis of allergens. Quantification of an extended list of 57 suspected allergens in ready to inject fragrance materials by gas chromatography mass spectrometry

Published By	Publication Date	Number of Pages
BSI	2021	74

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Categories: 71.100.60 - Essential oils, BSI

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Description

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.

PDF Catalog

PDF Pages	PDF Title
2	undefined
8	1 Scope 2 Normative references 3 Terms and definitions 4 Principle
9	5 Reagents 5.1 Solvents 5.1.1 Methyl pivalate 5.1.2 Tert-Butyl Methyl Ether (MTBE) 5.2 Reference samples (suspected allergens) 5.2.1 General
13	6 Apparatus 6.1 Gas chromatograph equipped with flame ionization detector (GC-FID) 6.2 Gas chromatograph coupled to a mass spectrometer (GC-MS) 6.2.1 General 6.2.2 GC-MS system 6.3 Capillary columns for GC
14	6.4 Analytical balance 7 Stock and sample solutions – preparation and storage 7.1 General information 7.1.1 Choice of the solvent
15	7.1.2 Miscellaneous 7.2 Preparation of stock solutions from reference samples 7.3 Preparation of internal standard solutions and calibration solutions 7.3.1 General 7.3.2 Stock Solutions of Internal Standards (1g/kg equivalent) 7.3.3 Calibration Solutions Concentrations
16	7.3.4 Preparation of Calibration solutions
18	8 Mass spectrometer acquisition conditions 8.1 Establishment of retention times and SIM chromatograph windows
19	8.2 SIM Window – Set up and criteria 8.3 GC-MS scan mode verification 9 Sample analysis 9.1 General 9.2 Sample preparation for analysis
20	9.3 Sequence 9.3.1 Blank 9.3.2 Calibration solutions 9.3.3 Check solution
21	9.3.4 Samples 10 Data validation and treatment 10.1 General 10.2 Examination of Q values
22	10.3 Relative intensity of characteristic ions in SIM 10.4 Relative ion intensity using scan data
23	10.5 Data verification scheme and reporting of final concentration 10.6 GC-MS scan mode verification 10.7 Mass spectrum evaluation in SCAN mode 11 Test report
24	Annex A (informative)Determination of calibrant and reference sample purity A.1 General information
26	A.2 Full characterization of the volatile constituents A.2.1 Identification of the individual constituents of the reference samples by GC-MS A.2.2 Calculation of predicted RRF (RRFpred)
27	A.2.3 Calculation of the amount of volatile constituents in the individual reference samples
28	A.3 Determination of purity (%) from RRF or % FID area
31	Annex B (informative)GC capillary column parameters
32	Annex C (informative)SIM Ions for SIM or SIM-SCAN Use
39	Annex D (informative)Example of SIM windows
48	Annex E (informative)Example of chromatograms
50	Annex F (normative)Decisional tree for quantification of suspected allergens
51	Annex G (informative)Preparation of stock solutions from reference samples G.1 General Information G.2 Reference sample purity
52	G.3 Stock solutions G.3.1 Separated stock solutions of allergens (10 g/kg) G.3.1.1 Weighing G.3.1.2 Preparation
56	Annex H (informative)Calibration methods and approach H.1 Plotting of calibration curve H.1.1 General H.1.2 Peak Skewness and Impact on Calibration H.1.3 Selection of the internal standard
57	H.1.4 Selection of the internal standard
58	Annex I (informative)Quantification of allergens I.1 General information
59	I.2 Determination of C0
60	I.3 Assessment of the analytical measurement I.4 Examination of Q values
61	Annex J (informative)Suspected allergens selected as analytes targets – Rationale
71	Annex K (informative)Other general information

Additional information

Status	Definitive
Pages	74
Publication Date	2021-05-11
ISBN	978 0 539 06749 1
Standard Number	BS EN 16274:2021
Title	Method for analysis of allergens. Quantification of an extended list of 57 suspected allergens in ready to inject fragrance materials by gas chromatography mass spectrometry
Identical National Standard Of	EN 16274
Replaces	BS EN 16274:2012
Descriptors	Perfumes, Biochemical methods of analysis, Food testing, Food products, Allergies
Publisher	BSI
Committee	CW/217
ICS Codes	71.100.60 - Essential oils

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BS EN 16274:2021

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