The certification of different mass fractions of MON-Ø4Ø32-6 in soya bean powder Certified Reference Materials ERM®-BF410ap, ERM®-BF410bp, ERM®-BF410cp, ERM®-BF410dp and ERM®-BF410ep

This report describes the production of a set of Certified Reference Materials (CRMs), ERM BF410ap, bp, cp, dp and ep, which are certified for their GTS 40-3-2 soya bean (unique identifier MON-Ø4Ø32-6) event mass fractions. These materials were produced following ISO Guide 34:2009 and are certified in accordance with ISO Guide 35:2006. The materials are intended for the calibration or quality control of real-time PCR measurements to identify GTS 40-3-2 soya bean and quantify its mass fraction. As with any reference material, they can also be used for establishing control charts or for carrying out validation studies. The CRMs were accepted as European Reference Material (ERM®) after peer evaluation by the partners of the European Reference Materials panel.JRC.F.6-Reference Material

Certification of the Mass Concentrations of Ammonium, Chloride, Fluoride, Magnesium, Nitrate, Ortho-Phosphate, Sulfate and of pH and Conductivity in Simulated Rainwater - Certified Reference Material ERM®-CA408

This report presents the preparation and certification of the simulated rainwater certified reference material ERM-CA408. All the steps required for the production of this water-matrix certified reference material are described in detail, from the preparation of the simulated rainwater until the characterization exercise that lead to the final assignment of the certified values, following ISO Guide 34:2009 [1] and ISO Guide 35:2006 [2]. Homogeneity and stability of the water material were investigated with dedicated studies and the certification campaign for the material characterisation was based on an inter-comparison among several experienced laboratories. IRMM organised and coordinated all the phases of this project including evaluation of data. The certified values were calculated as the unweighted mean of the laboratory means of the accepted sets of results for each parameter, see below. Uncertainties were calculated in compliance with the Guide to the Expression of Uncertainty in Measurement (GUM, ISO/IEC Guide 98-3:2008) [3]. The stated expanded uncertainties include contributions from characterisation, homogeneity and stability.JRC.DG.D.2-Reference material

Certification of Plasmid DNA containing NK603 Maize DNA Fragments - Certified Reference Material ERM®-AD415

This report describes the preparation, characterisation, stability and suitability studies of the certified reference material (CRM) ERM-AD415 which contains a plasmid (pIRMM-0086) carrying a defined deoxyribonucleic acid (DNA) fragment specific for a genetic modification present in Zea Mays L. line NK603 as well as defined DNA fragments specific for the Zea mays taxon, of which one has been certified. The CRM was processed in 2009 and certified in 2010 by the European Commission, Joint Research Centre, Institute for Reference Materials and Measurements (IRMM), Geel, BEJRC.DG.D.2-Reference material

Preparation and Certification of the Isotopic Reference Material IRMM-049d

A highly enriched 242Pu Isotopic Reference Material (IRMM-049d) has been prepared and certified for the 242Pu isotope amount content. The certified value of 3.666 8(18) x 10-7 mol 242Pu per g of solution was established by Isotope Dilution Mass Spectrometry (IDMS). The plutonium isotopic composition was determined by Thermal Ionization Mass Spectrometry (TIMS) and calibration of these measurements by means of synthetic mixtures. The IRMM-049d Isotopic Reference Material is supplied in a glass ampoule with a screw cap seals containing about 10 mL of 5 mol x L-1 nitric acid with plutonium. The content of each vial is approximately 1 mg 242Pu. This Isotopic Reference Material is the product of a systematic IRMM programme to supply Isotopic Reference Materials of various isotopes at different concentrations.JRC.D.2-Reference material

Certification of C-reactive Protein in Reference Material ERM-DA472/IFCC

The production and certification of ERM-DA472/IFCC, a new reference material certified for C-reactive protein (CRP), is described. ERM-DA472/IFCC was characterised using the reference material ERM-DA470 as calibrant. This achieved using a value transfer protocol that can be considered as a reference procedure. the principles used to measure the CRP concentration were immunonephelometry and immunoturbidimetry. The measurements were performed with different platform/reagent combinations (Abbott, Beckmann Immage, BN II, different Hitachi instruments, and Olympus AU640). In total 8 laboratories participated in the value assignment. The certified CRP mass concentration is 41.8 mg/L, the expanded uncertainty (k = 2) 2.5 mg/L.JRC.D.2-Reference material

Certification of Plasmid DNA containing 98140 Maize DNA Fragments - Certified Reference Material ERM®-AD427

This report describes the preparation, characterisation, stability and suitability of the certified reference material (CRM) ERM-AD427, which contains a plasmid (pIRMM-0090) carrying a defined 2'-desoxyribonucleic acid (DNA) fragment specific for a genetic modification present in Zea mays L. line 98140, as well as defined DNA fragment specific for the Zea Mays taxon. The CRM was processed in 2008 and certified in 2010 by the European Commission, Joint Research Centre, Institute for Reference Materials and Measurements (IRMM), Geel, BEJRC.DG.D.2-Reference material

Certification of a Reference Material with Candida Albicans (NCPF 3179) at a Target Level of 1000 Colony Forming Units per Material Sphere, IRMM-354

This report describes the certification of a reference material (IRMM-354) of Candida albicans. Certified Reference Materials (CRMs) for microbiological analysis are indispensible tools for development and validation of detection methods and for the implementation and support of internal and external quality control inthe area of microbiological analysis. Each vial of IRMM-354 contains one material sphere of Candida albicans. The homogeneity and stability (at -20 °C and -70 °C) of the batch was assessed by counting colony forming units (cfu) per material sphere on nutrient agar (NA) and Oxytetracyclin-Glucose-Yeast Extract (OGYE) agar. The material is stable when stored at a maximum temperature of -20 °C for up to 18 months. the batch was characterised by six laboratories to establish a certified value of cfu per material sphere on Na and OGYE agar. The certified value for NA is 917 cfu per material sphere with an expanded uncertainty of 168. The certified value for OGYE agar is 912 cfu per material sphere with an expanded uncertainty of 173. In both cases, a coverage factor k = 2 is used, corresponding to a level of confidence of about 95 %. The authenticity of the material was confirmed by DNA sequence analysis of the coding region for the hwpl gene.JRC.D.2 - Reference material

Use of Certified Reference Materials for the Quantification of GMO in DNA Copy Number Ratio

This application note provides guidance on the correct use of European Reference Materials certified for their GM (genetically modified) copy number fraction of a specific GM event. The details given below refer particularly to the use of the CRMs ERM-BF413d and ERM-AD412 and the upcoming CRMs certified for copy number ratio.JRC.D.2-Reference material

Certification of Reference Materials of Maize Seed Powder containing Genetically Modified MON 810 Maize: Certified Reference Materials ERM®-BF413k (ERM®-BF413ak, ERM®-BF413ck, ERM®-BF413ek, ERM®-BF413gk)

The report describes the processing and certification of four maize seed powder Certified Reference Materials (CRMs) containing different mass fractions of genetically modified (GM) MON 810 maize (ERM-BF413ak, ck, ek, gk). The materials were processed and certified in 2007/2008 by the European Commission, Joint Research Centre, Institute for Reference Materials and Measurements IRMM, Geel, Belgium), according to the principles of ISO Guide 34. The four CRMs belonging to the ERM-BF413k series replace the earlier produced series ERM-BF413 which is exhausted. The four CRMs have been accepted as European Reference Material (ERM®) after peer evaluation by the partners of the European Reference Materials consortium.JRC.D.2-Reference material

Certification of Reference Materials of Cotton Seed Powder with Different Mass Fractions of the Cotton Event T304-40 - Certified Reference Materials ERM®-BF429 (ERM®-BF429a, ERM®-BF429b, ERM®-BF429c)

This report describes the processing and certification of three cotton seed powder Certified Reference Materials (CRMs) containing different mass fractions of genetically modified (GM) T304-40 cotton (ERM-BF429a, b, c). The materials were prepared and certified in 2009/2010 by the European Commission, Joint Research Centre, Institute for Reference Materials and Measurements (IRMM, Geel, Belgium), according to the principles of ISO Guide 34.JRC.DG.D.2-Reference material