Name: CEN/TR 15356-1:2006
Brand: CEN

Validation and interpretation of analytical methods, migration testing and analytical data for materials and articles in contact with food - Part 1: General considerations

Published date

15-03-2006

Publisher

Comite Europeen de Normalisation

Foreword
Introduction
1 Scope
2 Form of regulations
3 Terms and definitions
4 Analytical tolerances
5 Limits
6 Existing general legislation
7 Difficulties with present situation regarding method
   validation
8 Analytical interpretation of results and limits
9 Single laboratory method validation - General protocol
10 Single laboratory and second laboratory validation - For the
   food contact materials sector
11 FDA requirements with respect to validation of analytical
   methods
12 Recovery
13 Reference materials
14 Costs
15 Sampling
16 Enforcement
17 Conclusions
Annex A (informative) Food contact materials and articles: EU
        legislation
Annex B (informative) List of methods currently available
Annex C (informative) Codex proposed draft guidelines on
        measurement uncertainty
Annex D (informative) Characteristics of available certified
        reference materials
Bibliography

This Technical Report gives guidance in support of Directives adopted by the European Union in the Food Contact Materials Sector and is intended to aid Food Control Authorities and industry enforce and comply with those Directives.

Committee	CEN/TC 194
DocumentType	Technical Report
PublisherName	Comite Europeen de Normalisation
Status	Current

Standards	Relationship
FD CEN/TR 15356-1 : 2006 FD	Identical
I.S. CEN TR 15356-1:2006	Identical
NEN NPR CEN/TR 15356-1 : 2006	Identical
PD CEN/TR 15356-1:2006	Identical
DIN-Fachbericht CEN/TR 15356-1:2006-06	Identical
DIN-Fachbericht CEN/TR 15356-1:2006-06	Corresponds

ISO/IEC Guide 58:1993	Calibration and testing laboratory accreditation systems General requirements for operation and recognition
EN 45003 : 1995	CALIBRATION AND TESTING LABORATORY ACCREDITATION SYSTEM - GENERAL REQUIREMENTS FOR OPERATION AND RECOGNITION
EN 45002:1989	GENERAL CRITERIA FOR THE ASSESSMENT OF TESTING LABORATORIES
ISO/IEC Guide 25:1990	General requirements for the competence of calibration and testing laboratories
EN 45002:1989	GENERAL CRITERIA FOR THE ASSESSMENT OF TESTING LABORATORIES
ISO 5725:1986	Precision of test methods Determination of repeatability and reproducibility for a standard test method by inter-laboratory tests
EN 45001 : 1989	GENERAL CRITERIA FOR THE OPERATION OF TESTING LABORATORIES