Standard No.:	GB 31604.59-2023
English Name:	National food safety standard - Food contact materials and products - General rules for verification of chemical analysis methods
Chinese Name:	食品安全国家标准 食品接触材料及制品 化学分析方法验证通则
Chinese Classification:	X09    Hygiene, safety and labor protection
Professional Classification:	GB    National Standard
Source Content Issued by:	NHC; SAMR
Issued on:	2023-9-6
Implemented on:	2024-9-6
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	8500 words
Translation Price(USD):	255.0
Delivery:	via email in 1 business day

GB 31604.59-2023 National food safety standard -Food contact materials and articles - General rules for verification of methods for chemical analysis 1 Scope This standard specifies the general requirements for the verification of methods for chemical analysis of food contact materials and articles. This standard is applicable to the verification during the formulation and revision of methods for chemical analysis of food contact materials and articles in the national food safety standards. 2 Terms and definitions For the purposes of this document, the terms and definitions given in GB 5009.295-2023 and the following apply. 2.1 chemical alternative solvent chemical solvents, such as 95% (volume fraction) ethanol solution, isooctane, n-hexane and n-heptane used to replace food simulants containing oil (vegetable oil) in chemical solvent substitution test 2.2 soaking solution solution obtained from food contact materials and articles through the migration test with food simulant or chemical alternative solvent 3 General requirements for verification of methods for chemical analysis of food contact materials and articles 3.1 For qualitative methods, the intra-laboratory and inter-laboratory verification parameters shall include the specificity and limit of detection of the methods. 3.2 For quantitative methods, the intra-laboratory verification parameters shall include specificity, limit of detection, limit of quantification, determination range, accuracy and repeatability of the methods, while inter-laboratory verification parameters shall include limit of detection, limit of quantification, determination range, accuracy and reproducibility of the methods. 3.3 If the analysis method is sensitive to small changes in test conditions such as temperature, humidity and illumination, the robustness of the method and the intermediate precision index shall be investigated. 3.4 When there are two or more applicable methods for the same target analyte, it is necessary to verify the equivalence of different methods. 3.5 When the stability data of reference materials are unavailable, their stability shall be verified. 3.6 See Table 1 for the selection of intra-laboratory and inter-laboratory verification parameters. 4 Verification of residue analysis method 4.1 Selection of representative materials (or articles) and requirements for verification samples 4.1.1 Selection of representative materials (or articles) 4.1.1.1 For the selection of representative materials (or articles) for method verification, the properties of the target analyte and the characteristics of food contact materials shall be considered first, and then the classes of food contact materials, processing technology and classes of high-risk food contact materials involved in the regulatory limit requirements shall be considered. See Annex A for the selection of representative materials (or articles). 4.1.1.2 For intra-laboratory verification, in principle, the classes of representative food contact materials shall be verified according to the application scope of the method, at least one subclass of each food contact material class shall be selected, and at least one representative material (or article) of each subclass shall be selected. 4.1.1.3 For inter-laboratory verification, if there are no more than 3 classes of food contact materials applicable to the method, all classes shall be verified; otherwise, at least 3 classes shall be verified. At least one subclass of each food contact material class shall be selected, and at least one representative material (or article) of each subclass shall be selected.

1 Scope 2 Terms and definitions 3 General requirements for verification of methods for chemical analysis of food contact materials and articles 4 Verification of residue analysis method 4.1 Selection of representative materials (or articles) and requirements for verification samples 4.1.1 Selection of representative materials (or articles) 4.1.2 Requirements for verification samples 4.1.3 Storage and transportation of samples 4.2 Verification of performance parameters of residue analysis method 4.2.1 Specificity 4.2.2 Limit of detection 4.2.3 Limit of quantification 4.2.4 Determination range 4.2.5 Accuracy 4.2.6 Precision 4.2.7 Stability 4.2.8 Robustness 4.3 Verification of method equivalence 4.3.1 Verification requirements 4.3.2 Verification method 4.4 Data processing requirements 5 Verification of specific migration analysis method 5.1 Selection of representative materials (or articles) and food simulants as well as requirements for soaking solution for verification 5.1.1 Selection of representative materials (or articles) 5.1.2 Selection of food simulants 5.1.3 Requirements for soaking solution for verification 5.1.4 Storage and transportation of samples 5.2 Verification of performance parameters of analysis method for target analyte content in soaking solution 5.2.1 Specificity 5.2.2 Limit of detection 5.2.3 Limit of quantification 5.2.4 Determination range 5.2.5 Accuracy 5.2.6 Precision 5.2.7 Stability 5.2.8 Robustness 5.3 Conversion of target analyte content in soaking solution to specific migration 5.4 Verification of method equivalence 5.4.1 Verification requirements 5.4.2 Verification method 5.5 Data processing requirements Annex A Classification of materials for verification of methods for chemical analysis of food contact materials and articles