Certification of the Mass Fractions of Vitamins in Whole Milk Powder - Certified Reference Material ERM®-BD600

This report describes the production of the reference material ERM-BD600, a whole milk powder certified for the mass fractions of water- and fat-soluble vitamins. All the required steps during the production were conducted according to ISO Guides 34 and 35 [1,2] to ensure the high quality of the final product, including matrix material processing, homogeneity and stability studies and value assignment. The matrix material, a spray dried whole milk powder, was packed into sachets containing approximately 100 g of powder, and stored at -30 ºC. Dedicated studies confirmed the homogeneity and stability of the vitamins in the milk powder under the conditions evaluated. The characterisation of the material, organised and coordinated by IRMM, was done by an inter-laboratory comparison. The certified and indicative values were obtained as the unweighted mean of the laboratory means of the accepted sets of results for each analyte, and the expanded uncertainty associated (k = 2) includes contributions from the homogeneity, the long term stability and the characterisation of the material.JRC.D.2-Reference material

Guidance Document on the Use of Reference Materials in Genetic Testing

The aim of this guidance document is to provide a short and user-friendly support to genetic testing laboratories. It is based on internationally harmonised basic concepts and terminology for quality assurance and control (QA/QC). Relevant terms of the International Organization for Standardization (ISO) and the International Vocabulary of Metrology (VIM) are explained and references to other expert texts are provided. The document includes discussion and clarification of several often misunderstood issues. It takes into account the current scientific knowledge and the existing technological capabilities. This document may be revised and constitutes a deliverable of th NoE EuroGentest.JRC.D.2-Reference material

The Certification of the Mass Fraction of Chloramphenicol in Pork Meat - Certified Reference Material ERM®-BB130

This report describes the preparation of the pork meat matrix reference material ERM-BB130 and the certification of the content (mass fraction) of chloramphenicol. The preparation and processing of the material, homogeneity and stability studies, and the characterisation are described hereafter and the results are discussed. Uncertainties were calculated in compliance with ISO Guide 98-3, Guide to the Expression of Uncertainty in Measurement (GUM) [1] and include uncertainties due to possible heterogeneity, instability, and characterisation.JRC.DG.D.2-Reference material

The Certification of the Mass Fraction of Oxytetracycline in Partially Skimmed Milk - Certified Reference Materials ERM®-BB492 and ERM®-BB493

This report describes the preparation of two milk powder matrix reference materials (ERM-BB492 and ERM-BB493) and the certification of their content (mass fraction) of oxytetracycline. The preparation and processing of the material, homogeneity and stability studies, and the characterisation are described hereafter and the results are discussed. Uncertainties were estimated in compliance with ISO Guide 98-3, Guide to the Expression of Uncertainty in Measurement (GUM) [1]. For ERM-BB492, the uncertainty contains contributions from possible heterogeneity, instability, characterisation, and purity of the common calibrant.JRC.DG.D.2-Reference material

Certification of Plasmidic DNA containing MON 810 Maize DNA fragments, Certified Reference Materials ERM-AD413

This report describes the preparation, homogeneity, stability and certification studies of a plasmidic deoxyribonucleic acid (DNA) (ERM-AD413) containing a defined DNA fragment specific for a genetic modification present in Zea Mays MON 810 event (1) as well as a defined DNA fragment specific for the Zea Mays taxon. The CRM was processed in 2005 and certified in 2007 by the European Commission, Directorate General Joint Research Centre, Institute for Reference Materials and Measurements (IRMM) in Geel, Belgium. The CRM is available in plastic tubes containing 500 µL of the plasmidic DNA in 1 mmol/L EDTA pH 7.0 buffer. Each tube contains approximately 10 to the power of 9 copies of the ERM-AD413 plasmid which correspond approximately to 3.41 ng of DNA. The plasmid contains a 170 bp fragment of the MON 810 5' plant-P35S junction and a 351 bp fragment of the maize endogenous high mobility group gene (hmg) (2). both DNA sequences originated from DNA extracted from MON 810 seeds supplied by RAGT Semences (Rodez, France). The certified value is the number of each cloned DNA fragments per plasmid. The number ratio between those two DNA fragments is given as an indicative value measured by duplex and simplex real-time PCR.JRC.D.2-Reference material