key briefing on jrc's activities on reference materials
TRANSCRIPT
EUROPEAN COMMISSION DIRECTORATE GENERAL JOINT RESEARCH CENTRE Directorate D - Institute for Reference Materials and Measurements
Key Briefing
on
JRC's Activities on Reference Materials
Max Planck (Nov. 1941): "An experiment is a question which science poses to nature, and a
measurement is the recording of nature’s answer"
JRC-IRMM: Confidence in Measurements®
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Table of Contents
1 Introduction .................................................................................................................................... 3
2 Reference materials: Concepts and terminology ........................................................................... 4
3 Reference Materials at JRC ............................................................................................................. 6
3.1 Brief history ............................................................................................................................. 6
3.1.1 The beginning .................................................................................................................. 6
3.1.2 Enlargement of CRM portfolio – from CBNM to JRC-IRMM ............................................ 6
3.1.3 Handover of BCR CRMs to JRC-IRMM ............................................................................. 7
3.1.4 The evolution from BCR to IRMM and ERM CRMs .......................................................... 8
3.2 The JRC as reference material producer ................................................................................. 8
3.2.1 RM development and production process ...................................................................... 8
3.2.2 Related quality management ........................................................................................ 10
3.2.3 Collaborators and partnerships for RM production ...................................................... 11
3.2.4 RM customers ............................................................................................................... 12
3.3 The JRC involvement in RM standardisation and coordination ............................................ 14
3.3.1 Participation in related international committees ........................................................ 14
3.3.2 Knowledge transfer activities on RMs provided by the JRC .......................................... 15
3.4 JRC reference material production infrastructure and resources ........................................ 16
3.4.1 Staff ............................................................................................................................... 16
3.4.2 Budget ........................................................................................................................... 17
3.4.3 Infrastructure and laboratories ..................................................................................... 18
4 The intervention logic for the JRC activities on reference materials ............................................ 20
4.1 Legal considerations ............................................................................................................. 20
4.2 Economic considerations ...................................................................................................... 21
4.3 Intervention logic for production of RMs by the JRC ............................................................ 22
5 Positioning of JRC's activities on reference materials .................................................................. 24
5.1 JRC’s priority setting for the RM activities ............................................................................ 24
5.2 Food & feed reference materials .......................................................................................... 26
5.3 Health related reference materials ....................................................................................... 29
5.4 Environmental reference materials ...................................................................................... 31
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5.5 Engineering reference materials ........................................................................................... 34
5.6 Nuclear reference materials ................................................................................................. 36
6 Outlook into JRC's activities on reference materials .................................................................... 38
Annex .................................................................................................................................................... 41
Table A1: Food & feed CRMs released by JRC-IRMM in 2006-2015 ......................................... 42
Table A2: Food & feed RMs (non-certified) released by JRC-IRMM in 2006-2015 ................... 46
Table A3: Health diagnostic CRMs released by JRC-IRMM in 2006-2015 ................................. 51
Table A4: Environmental CRMs released by JRC-IRMM in 2006-2015 ..................................... 52
Table A5: Environmental RMs (non-certified) released by JRC-IRMM in 2006-2015 ............... 53
Table A6: Engineering CRMs released by JRC-IRMM in 2006-2015 .......................................... 54
Table A7: Engineering RMs (non-certified) released by JRC-IRMM in 2006-2015 .................... 57
Table A8: Nuclear CRMs released by JRC-IRMM in 2006-2015 ................................................ 58
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1 Introduction
The European Commission's Joint Research Centre (JRC) has a well-established capability for the
development and production of reference materials. It started with the Central Bureau of Nuclear
Measurements (CBNM) as part of the Commission's tasks under the Euratom Treaty signed in 1957
The CBNM located in Geel, Belgium, officially started its work in 1960. It changed its name in 1993
into the JRC-Institute for Reference Materials and Measurements (IRMM).
In 1973, the European Commission established a Community Bureau of Reference (Bureau
Communautaire de Référence - BCR) with the mandate to organise interlaboratory studies and to
certify reference materials using existing laboratories in the Member States. The programme was
supported by activities carried out at various JRC Institutes (Ispra, Petten and Geel). From 1987-
2002, the BCR became part of the research framework programmes of the European Community. In
1995, the JRC-IRMM took over the full responsibility for the management of the certified reference
materials (CRMs) released by the BCR, i.e. their storage, distribution and stability monitoring after
certification and the renewal of exhausted certified reference materials. BCR-related activities
outside the JRC were completely stopped at the end of 2002 following the closure of the Standards,
Measurements & Testing (SMT) programme of DG RTD.
Since the 1970s the JRC's portfolio of reference materials was enlarged from the nuclear area to the
fields of environment, food and feed, health diagnostics and key enabling technologies (KETs) such
as bio- and nanotechnology. Today, the JRC-IRMM offers about 800 different materials, available
under the BCR®, IRMM and ERM®1 brands of which about 100 materials are for nuclear safeguards.
The JRC is currently establishing a long-term strategy, which requires substantiation and a regular
update of the rationale and vision for the various fields in which the JRC is active. For this purpose,
the JRC is evaluating its activities in the area of reference materials, also in line with the
recommendation of the Ex-post Framework Programme 7 Evaluation that the JRC should conduct
dedicated sectorial evaluations.
This document is providing corresponding background information, facts and figures on JRC's
reference material activities during 2006-2015.
1 ERM is the registered trademark for European Reference Materials
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2 Reference materials: Concepts and terminology
Reference materials (RMs) play a crucial role in establishment and dissemination of metrological
traceability and further quality assurance, such as method validation, laboratory-internal quality
control and proficiency tests2. RMs are of particular importance when it comes to the measurements
of complex matrices such as environmental, food or clinical samples, but also for the
characterisation of functional properties of advanced materials.
There exists a multitude of different terms for reference materials required for various parts of the
measurement process, such as measurement standard, laboratory standard, reference standard,
analytical standard, reference substance, standard material, quality control material, proficiency
testing material, laboratory control material, or calibration material. However, they are all based on
the same scientific-technical concepts. In recent years, international understanding, harmonisation
and cooperation on reference materials have advanced globally, mainly to allow for the recognition
of measurement results across borders and to reduce technical barriers to trade.
In fact, there is a close relation between the intended use of a reference material in a given
measurement procedure and the required material characteristics. In this context, it should be
noted that the term 'Reference Material' is both used as generic, i.e. a family name for different
groups of such materials, and as a label for a sub-group. The current conceptual approach as
described in ISO Guides 30, 31, 33 and 34 is summarised in the following Figure 1.
Figure 1: Family of reference materials (QA/QC = Quality Assurance / Quality Control)
2 Specific type of interlaboratory comparisons, also called round robins or comparative testing
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In the following, the definitions set for RMs by ISO Guide 30:2015 are listed:
• Reference material (RM): "material, sufficiently homogenous and stable with respect to one
or more specified properties, which has been established to be fit for its intended use in a
measurement process".
• Certified reference material (CRM): "reference material (RM) characterized by a
metrologically valid procedure for one or more specified properties, accompanied by an RM
certificate that provides the value of the specified property, its associated uncertainty, and a
statement of metrological traceability".
Consequently, CRMs are a sub-group of RMs which come with additional characteristics and
information (see figure above). This qualifies CRMs to be also used for calibration (provided that the
knowledge of the property value is sufficiently precise for the specific purpose) and for checking the
trueness of measurement results in method validation and quality control. In this briefing, the other
RM sub-group is referred to as 'non-certified RMs' for clarity purposes.
It has to be noted that there is still some confusion in the literature and other communications
about the terminology regarding RMs and their classification. A major reason is that various aspects
are often mixed. In dependence on the intended use reference materials can be classified according
to their:
• Role in the measurement process
- calibrant/calibration material
- quality control material
- proficiency testing material
• Composition
- pure substances (and their solutions)
- matrix materials (complex materials such as blood or sediments)
• Tested/certified property
- presence/absence of a material component (e.g., chemical element, isotope, chemical
compound, physical particles)
- identity of a material component (e.g., DNA sequence, specified microorganism)
- concentration of a material component
- functional material property (e.g., hardness, enzyme activity)
• Application sector, e.g.
- food analysis
- environmental analysis
- nuclear safeguards measurements
- engineered material characterisation
- health diagnostics
In the following chapters the fundamental classification into certified and non-certified RMs will be
used, and the focus of JRC's RM activities on selected application sectors will be explained.
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3 Reference Materials at JRC
3.1 Brief history
3.1.1 The beginning
The JRC's Central Bureau of Nuclear Measurements (CBNM) officially started its activities in 1960 on
the grounds of the Belgian communities of Mol and Geel. The focus of the CBNM was on nuclear
measurements, particularly on nuclear reference data to support nuclear energy production. In
performing such measurements, special samples with relevant nuclides were needed. These first
reference samples were prepared and certified based on the needs of the CBNM scientists, and
subsequently on specifications required by the scientific community worldwide.
Consequently, sophisticated RM production techniques were developed and moreover, metrological
measurement capabilities became established at the CBNM. During 1963 to 1969, about 17 000
samples with users from 12 countries were prepared and certified. These samples could be seen as
the precursors of certified RMs, as produced today following established international guidelines.
The CBNM's first non-nuclear RMs were designed to support the special Eurisotop3 programme for
international interlaboratory comparisons. These RMs – for the determination of the oxygen content
in non-ferrous metals - were released in 1973, just before the European Commission set up the
Bureau Communautaire de Référence (BCR) service, which was dedicated to the certification of RMs.
In 1974, the Eurisotop certificates were changed into BCR certificates.
Consequently, the CBNM relabelled its first CRMs as BCR CRMs and they were stored and distributed
on behalf of the BCR. The CBNM, together with other JRC-Institutes at the sites of Ispra (Italy) and
Petten (The Netherlands) became increasingly involved in the certification activities of the BCR.
3.1.2 Enlargement of CRM portfolio – from CBNM to JRC-IRMM
In 1984, it was decided that all BCR CRMs stored until then in other European institutions that
participated in the BCR programme were to be centralised in and distributed from the CBNM in
Geel. Moreover, it was planned that the CBNM was to become the European Commission's support
laboratory for the BCR activities, particularly for the preparation of special materials, their storage,
and distribution.
As a result, a building dedicated for this purpose was established at the JRC-Geel site in 1986.
Significant investments were made in both storage facilities and processing equipment (clean cells,
jet mills, freeze dryers, etc.). The equipment was financially supported by the BCR programme.
Subsequently, all BCR CRMs were transferred to the CBNM, making it the reference centre for BCR
CRM customers.
3 The Eurisotop Office was created in 1960 as a division of Euratom to promote the use of nuclear techniques
in industry.
7
Meanwhile, the CBNM started the preparation of materials for environmental monitoring and food
analysis, on behalf of not only the BCR programme, but also on request of other Directorates
General (DGs) of the European Commission, such as DG Agriculture as well as for external
customers. Together with the preparation of CRMs , the in-house expertise in measurements was
increased. This paved the way for the widening of CBNM's activities, from a nuclear focus to a
horizontal measurement Institute that was also reflected in the change of name: from CBNM to JRC-
IRMM (Institute for Reference Materials and Measurements) in 1993.
3.1.3 Handover of BCR CRMs to JRC-IRMM
The initial BCR programme underwent a continuous process of name-changing; from BCR to
Measurement and Testing (MT) to Standard, Measurement and Testing (SMT), but will be called for
simplicity BCR in the following. As the preparation of CRMs is not a short-term project, the BCR,
hosted by DG Research could no longer carry out the responsibility of managing its CRMs. The need
to co-ordinate the BCR activities with other RM related programmes had been mentioned in the
evaluation report of the indirect action programme 1975-19784.
Meanwhile, as the JRC-IRMM was well equipped with appropriate facilities and competences, it took
over in 1995 the full responsibility for the management of the BCR CRMs, including storage,
distribution and stability monitoring. The agreement between DG Research and the JRC included
that the JRC-IRMM would also be responsible for certifying new BCR CRMs in replacement of those
exhausted. As a consequence, the JRC-IRMM developed not only its storage and processing facilities
further, but also advanced the BCR certification approaches further. Moreover, the distribution of
CRMs to customers worldwide was increased by the nomination of 'authorised distributors',
operating under strict control of the JRC-IRMM regarding their storage and distribution conditions
for the CRMs.
New CRMs developed by the JRC-IRMM aiming to support the implementation of EU policies were
labelled as IRMM CRMs. The JRC-IRMM continued to develop and provide nuclear reference
materials in close consultation, coordination and cooperation with EURATOM safeguards authorities
and some key international nuclear agencies, like the French Atomic Energy and Alternative Energies
Commission (CEA), the International Atomic Energy Agency (IAEA), the United States Department of
Energy (US-DOE), the New Brunswick Laboratory (NBL) in the US and others worldwide.
In 2002, the BCR programme stopped altogether and since 2003, the tasks of development,
production and distribution of CRMs assigned by the European Commission are performed only by
the JRC-IRMM.
4 Commission of the European Communities, Research Evaluation-Report No. 3, EUR 7422 EN/FR
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3.1.4 The evolution from BCR to IRMM and ERM CRMs
In 1996, the JRC-IRMM signed a collaboration agreement with the International Federation of
Clinical Chemistry and Laboratory Medicine (IFCC), stipulating the development and production of
joint IRMM/IFCC CRMs, a privilege which so far had been restricted to the World Health
Organisation (WHO). When the labelling of genetically modified organisms (GMOs) became a
political issue, the JRC-IRMM began developing reference materials for GMOs in 1997 and was the
first institute worldwide to prepare and release such CRMs.
In addition to the CRM portfolio extension, the JRC-IRMM became more actively involved in new
concepts for RM certification, such as the inclusion of measurement uncertainties in accordance
with the Guide for Expression of Uncertainty in Measurement (GUM)5 and the estimation of
uncertainties related to homogeneity and stability statements in the certification process. Today,
these concepts are used worldwide and are mirrored in various guides published by the ISO
Committee on Reference Materials (ISO/REMCO).
Because of the enormous need for well-characterised CRMs at the internationally established quality
level, the JRC-IRMM joined forces with two other well recognised RM producers in Europe: the
German Federal Institute for Materials Research and Testing (BAM) and LGC Ltd in the UK. In 2003, a
Memorandum of Understanding marking the birth of European Reference Materials (ERM®) was
signed between the partners. They agreed on technical guidelines for CRMs to carry the trademark
ERM and assuring high-quality CRMs, prepared following ISO Guide 34. This ERM co-operation is
open for new members fulfilling the criteria as published (www.erm-crm.org).
3.2 The JRC as reference material producer
3.2.1 RM development and production process
The development and realisation of a new RM is a multistage process requiring a range of scientific-
technical and management competences. At JRC-IRMM each production of a (C)RM (non-certified
RM or certified RM) is managed as a separate project taking into account the main steps as
schematically shown in Figure 2.
5 ISO/IEC Guide 98-3 (1995) Uncertainty of measurement-part 3: guide to the expression of uncertainty in
measurement (GUM)
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Figure 2: RM development and production process at JRC-IRMM
After initial research to explore the required characteristics of a newly demanded RM, to identify
and develop techniques for homogenising and stabilising a potential starting material as well as
analytical methods to characterise the targeted material properties, it takes on average about 4
years from the planning to the release of the RM.
During the planning phase of a RM project the potential demand for this RM, the estimated costs
and the scientific-technical challenges are investigated. The staff members involved in a possible RM
project discuss in detail the design and specificities of each RM project. This planning phase may
involve feasibility studies to refine the planning. The project responsible summarises the information
in a Project Planning Form (PPF), which answers the most important questions, such as:
• In which type of analytical measurement shall the RM be used and what is it specific
function (e.g., quality control or calibration)? Is a certified reference material needed or can
a non-certified RM be used?
• What would be a suitable starting material for the RM (e.g., fish liver vs. whole fish vs. edible
part of a fish)? Are there any Intellectual Property Rights (IPRs) or personal data protection
needs (e.g., materials for clinical diagnostics) linked to the selected starting material? How
closely can or should the chosen starting material resemble a routine test sample?
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• What would be a suitable certified value (i.e. 1 % (m/m) GMO or 10 % (m/m)) taking into
account, e.g., threshold values in legislation?
• What is an acceptable uncertainty for a certified value, seen the repeatability of the routine
analytical techniques applied by the control laboratories (i.e., is it worthwhile and possible
to lower the uncertainty of the certified value)?
• How much time, staff and budget resources will be needed from the planning to the release
of the RM (what are the estimated costs for one unit of the RM)?
• Can measurement laboratories use other already available RMs? How many units of the RM
will most likely be needed per year and how many units should be produced (what is the
anticipated stability of the material)?
• What is the best processing technique to maintain the required characteristics of the RM?
Which impact does this have on the stability? What is a suitable containment for the RM?
What should be the size of an individual unit?
• Are there specific health and safety precautions which have to be taken into account (during
processing, characterisation, storage or shipment of the RM)?
With the approval of the project plan, a project responsible is assigned who coordinates the
necessary steps and actions in a RM project, from the sourcing of starting materials, via processing,
homogeneity and stability studies to the value assignment. The project responsible finally drafts the
documentation accompanying the RM after its release.
The documentation of the RM (certification report and certificate in case of a CRM, report and
material information sheet in case of a non-certified RM) is subjected to several internal and
external reviews. At least two JRC-IRMM experts, who are not involved in the specific RM project,
perform a comprehensive internal review.
The resulting draft is then reviewed by the corresponding Team Leader (the co-ordinator for the
scientific area concerned), the Quality Manager for ISO Guide 34 and in case of CRMs by a panel of
three external experts specialised for the parameters to be certified. Afterwards the revised draft is
reviewed and authorised for release by the JRC-IRMM co-ordinator for ISO Guide 34 activities. There
is an additional external review cycle by experts from the ERM partners in case of ERM branded
CRMs, concluded by the approval of the ERM Panel.
3.2.2 Related quality management
In order to fulfil its role as reference material producer the JRC-IRMM established a comprehensive
and transparent quality system according to the most advanced international standards. Since 2004
it is accredited to ISO Guide 34 which prescribes the required competences for RM producers (ISO
Guide 34:2009 - General requirements for the competence of reference material producers).
Analytical measurements performed in the frame of RM characterisation are carried out at JRC-
IRMM under ISO/IEC 17025 accreditation (ISO/IEC 17025:2005 - General requirements for the
competence of testing and calibration laboratories). Furthermore, the JRC-IRMM holds an
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accreditation as proficiency testing provider according to ISO/IEC 17043 (ISO/IEC 17043:2010 -
Conformity assessment - General requirements for proficiency testing). All staff involved in RM
activities is regularly trained on the corresponding procedures and qualified auditors of JRC-IRMM
perform annually the required internal audits. The follow-up is managed by JRC-IRMM's Quality
Group and the management. Besides the JRC-IRMM Quality Manager, who looks also to the
adherence to ISO/IEC 17025, there are appointed quality experts for technical issues of ISO Guide 34
and ISO/IEC 17043, respectively, as well as quality management co-ordinators at Head of Unit level
for the three standards.
JRC-IRMM's quality system is subject to regular audits of the Belgian accreditation body BELAC,
which has been employing international experts as technical auditors, as well as to the reviews of
the EURAMET Technical Committee on Quality.
3.2.3 Collaborators and partnerships for RM production
The (C)RM projects at JRC-IRMM are planned and executed mostly in form of JRC-led international
collaborative projects. They involve hundreds of expert laboratories all over the world which have
been on beforehand assessed for their scientific-technical competence for the envisaged task
according to the most recent international standards (ISO Guide 34, ISO/IEC 17025, ISO 15189 etc.).
As mentioned above, in 2003 the JRC has established a network of leading RM Producers in the EU
(ERM® – European Reference Material cooperation) for advancing the early-on coordination of RM
projects, sharing best practises and experiences and optimising the use of specialised competences.
Three major European reference materials producers, JRC-IRMM, BAM and LGC, have combined
forces to establish the ERM® brand. ERM® CRMs are materials which undergo uncompromising peer
evaluation and offer highest quality and reliability. They are distributed under the ERM® brand
which is a trademark owned by the European Union.
Moreover, the JRC-IRMM cooperates with other leading RM producers worldwide such as the US
National Institute for Standards and Technology (NIST), where a Co-operation Agreement was
established in 2007, the National Research Council (NRC) Canada, the Korea Research Institute of
Standards and Science (KRISS) and the National Measurement Institute of Australia (NMIA). These
strategic bilateral partnerships are used to avoid overlaps, exchange experiences and undertake
common (C)RM projects. They are also exploited periodically for getting access to complementary
capabilities.
A regular exchange of information on ongoing and just finalised (C)RM productions and production
experiences is also taking place at the annual meetings of the ISO Committee on Reference Materials
(ISO/REMCO), the Consultative Committee on Amount-of-Substance: Metrology in Chemistry and
Biology (CCQM) of the International Committee for Weights and Measures (CIPM), the Joint
Committee on Traceability in Laboratory Medicine (JCTLM), and the Versailles Project on Advanced
Materials and Standards (VAMAS), as well as at scientific conferences (e.g. BERM) and other publicly
open events.
In the nuclear field the main co-operations are laid down in respective cooperation agreements of
the European Commission or the JRC:
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• European Commission – IAEA Cooperative agreement from 1976; with a statement on
reinforcing cooperation between the IAEA and the European Commission in 2008;
• Collaboration Agreement CEA- JRC-IRMM for the development and production of a 243Am
CRM (2015-2018);
• Agreement between the US Department of Energy and the European Atomic Energy
Community represented by the European Commission in the field of Nuclear Material
Safeguards and Security Research and Development (2010); Action Sheet 43 for
Collaboration on CRM Development and Safeguards Measurement Quality Assurance;
• JRC framework sales contract with Japan Nuclear Fuel Limited (JNFL);
• JRC - Japan Atomic Energy Agency (JAEA) collaboration agreement in the field of Nuclear
Safeguards, Security and Non-Proliferation (1990).
3.2.4 RM customers
There are currently about 800 different CRMs available from JRC-IRMM (catalogue available at
https://ec.europa.eu/jrc/en/reference-materials/catalogue) of which about 21 000 units are
distributed per year by the JRC and its five authorised distributors. The latter distributed 60 % of the
samples in 2015. A summary on the number of distributed CRM units is provided in Figure 3.
Figure 3: Number of CRMs distributed by JRC-IRMM and its authorised distributors in 2006-2015
Figure 4 shows that the RM customers are located all over the world as illustrated by the
geographical distribution for the ones which have ordered CRMs directly from JRC-IRMM in 2015.
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Figure 4: Geographic location of customers who have ordered non-nuclear CRMs directly
from JRC-IRMM in 2015
Structured customer feedback is sought via regular customer satisfaction surveys, and the results
are considered in the planning and execution of RM activities.
In 2015, the largest number of distributed CRMs was for food/feed safety and quality control
including genetically modified organisms (GMOs), followed by healthcare diagnostics, engineering
(advanced) materials including nanomaterials and CRMs for environmental analysis.
Figure 5: Application fields for JRC-IRMM's CRMs distributed in 2015
Approximately 340 CRMs are currently distributed under the BCR brand, mostly originating from the
BCR and SMT programmes of the European Commission. About 255 materials are distributed under
the ERM brand and about 200 materials under the IRMM brand. The contribution of units from
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CRMs released since 2006 on the number of distributed CRM units was 58 % in 2015 as outlined in
Figure 6.
Figure 6: Legacy of CRMs distributed in 20156
More detailed information on the development and application sectors of JRC's RMs is given in the
Chapter 5.
3.3 The JRC involvement in RM standardisation and coordination
3.3.1 Participation in related international committees
As already mentioned in Chapter 3.1, the JRC-IRMM work on RMs is performed in collaboration with
institutions and scientific organisations worldwide. This concerns not only the development and
production of specific RMs, but also the advancement of a common understanding of underlying
scientific-technical concepts and approaches, as well as the development and agreement of
terminology and RM-related documentary standards.
Consequently, the JRC is represented on selected committees and working groups of relevant
international organisations. In recent years, the JRC has been increasingly requested as coordinator
and facilitator of discussions and consensus-building activities in such international communities.
These include not only international standardisation organisations such as ISO and CEN (European
Committee for Standardization) but also the Codex Alimentarius, AOAC International and the Clinical
and Laboratory Standards Institute (CLSI). Moreover, the JRC-IRMM is strongly interlinked with
6 CRMs released before 2003: mainly from BCR/SMT projects; 2003-2006: Transition period, where JRC-IRMM finalised
quite some BCR/SMT projects; since 2006: CRMs planned, developed and produced by JRC-IRMM
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metrology organisations (EURAMET and CIPM), pre-normative bodies such as the Versailles Project
on Advanced Materials and Standards (VAMAS) and the International Federation of Clinical
Chemistry and Laboratory Medicine (IFCC). In this frame, the JRC has also contributed to the shaping
of the strategies and work programmes of such international organisations in the areas of
metrology, standardisation, and pre-normative research.
An example is the JRC work in the ISO Committee on Reference Materials (ISO/REMCO). During the
period 2006-2015, the committee developed new international guides for reference materials and
revised all of its existing guides with major input from the JRC. Experts from JRC-IRMM acted as Vice
Chair (2006-2008), Chair (2009-2014), and convenors of ISO/REMCO working groups on 'competence
of RM producers', 'RM distribution and transport', and 'RMs for qualitative properties'. Since 2014, a
JRC-IRMM expert is chairing the Joint Working Group 43 of ISO/REMCO and the ISO Committee on
Conformity Assessment (CASCO) which is tasked with the transformation of ISO Guide 34:2009 into
an international standard ISO 17034. The JRC-IRMM also closely collaborates in the revision of
ISO/IEC 17025, e.g. for interlinking it with ISO 17034.
Moreover, the international harmonisation of RM-related concepts, as well as quality and
assessment criteria is included in JRC co-operations with:
− the European Committee for Standardisation (CEN);
− the European Directorate for the Quality of Medicines (EDQM);
− the International Atomic Energy Agency (IAEA);
− the Commission for the Establishment of Analytical Methods (CEA/CETAMA) that resides
within the French Atomic Energy and Alternative Energies Commission (CEA);
− the US-DOE- New Brunswick Laboratory (NBL);
− the Joint Committee on Traceability in Laboratory Medicine (JCTLM).
3.3.2 Knowledge transfer activities on RMs provided by the JRC
Since 2004, the JRC is organising a training course entitled 'Use of Reference Materials and the
Estimation of Measurement Uncertainty'. It is targeting laboratory managers and practitioners in
analytical laboratories, as well as auditors of accreditation bodies who need to assess the estimation
of measurement uncertainties and the correct selection and application of RMs. This course strongly
emphasises the practical application of theoretical concepts and each lecture is accompanied by
exercises in small groups supported by a trainer. During 2006-2015, there have been 283 external
participants from all over the world including regular attendance from the European Commission's
DG Energy (European Nuclear Safeguards) and EDQM (European Pharmacopeia).
The development and use of nuclear RMs is part of the ESARDA course syllabus on Nuclear
Safeguards and Non-Proliferation under quality control and confidence in analytical measurement
results7. Furthermore, training in the preparation of nuclear RMs is given by the JRC in cooperation
7 Nuclear Safeguards and Non-proliferation, Course Syllabus, Editor G. Janssens-Maenhout; Working Group on
Training and Knowledge Management Hosted by the Joint Research Centre, December 2008
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with EURATOM, the IAEA, CEA/CETAMA and the US-DOE under Joint Outreach and Training on
Nuclear Safeguards.
Major training and knowledge transfer activities on RMs were performed in the frame of a three-
year capacity building programme for Turkey by JRC-IRMM in 2009-2012. This included long-term
training stays of Turkish scientists in Geel, dedicated workshops and project planning support in
Turkey, as well as support for the establishment of RM production facilities and the corresponding
quality management system at the Turkish National Metrology Institute UME.
3.4 JRC reference material production infrastructure and resources
3.4.1 Staff
The scientific-technical staff working on RM activities at JRC-IRMM is multidisciplinary with
competencies in analytical chemistry and bioanalysis, biology, pharmacy, biochemistry,
microbiology, life sciences, food chemistry and technology, material sciences, engineering, physical
chemistry, radiochemistry and nuclear sciences. The already highly qualified JRC staff is further
internally trained on the most advanced knowledge on metrological aspects, RM production,
standardisation and corresponding quality management, hence, specific and cutting-edge education
and training that are not available externally. Moreover, a systematic training programme for
continuous improvements is designed and executed for all staff on an annual basis.
The staff of JRC-IRMM which has been involved in RM development and production activities is
summarised in the following table:
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Table 1: Number of JRC-IRMM staff involved in RM activities
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
non-nuclear RM activities
Permanent scientists8 19 20 22 21 21 20 21 20 21 20
Permanent technical
support staff8
24 26 24 23 20 20 23 22 20 22
Temporary staff
(mainly Postdoc scientists)
16 19 19 21 27 22 22 19 19 13
nuclear RM activities
Permanent scientists 2 2 2 2 1 1.5 2.5 2.5 2.5 2
Permanent technical
support staff 5 5 3.5 5 5 4.5 5 5 6 5
Temporary staff
(mainly Postdoc scientists) 0.5 1 1 0.5 0.5 1.5 2.5 2.5 3 2
It should be noted that the table includes 6 staff (1 scientist, 4 permanent technical/administrative
support staff, 1 temporary support staff), who are in charge of the storage, distribution and post-
certification monitoring for non-nuclear RMs, and that a reduction of 5 staff during 2016 is already
announced.
3.4.2 Budget
In addition to the staff costs, the budget for JRC-IRMM's activities on RMs is composed of three main
components:
− JRC institutional budget (so-called 'specific credits') from the Framework Programmes (FP)
on Research and Technology Development of the European Commission;
− JRC institutional budget (specific credits) from the EURATOM Programme;
− Additional income from the distribution of reference materials.
An overview on the RM-related specific credits from FP 7 and Horizon 2020, respectively, during
2006-2015 is provided in the following table.
8 Staff number given as 'head counts' and not as full time equivalents (FTE)
18
Table 2: Institutional JRC budget attributed to RM activities
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Specific credits/FP
(kEUR)
1850 2002 1761 1838 1971 2188 2200 2170 2200 2236
Specific credits/EURATOM
(kEUR)
252 242 270 464 590 530 350 363 363 364
The additional income generated by the distribution of CRMs is shown in Figure 7.
Figure 7: Additional income generated from the distribution of CRMs
Moreover, the JRC participated to a very limited extent in collaborative projects funded in the
context of the Framework Programmes (FP 7, Horizon 2020) or the Article 185 initiative 'European
Metrology Research Programme' (EMRP) which aimed, among other goals, also to study the
feasibility to develop a few selected new RMs. The RM-related additional income from those
projects was about EUR 1 million during 2006-2015.
3.4.3 Infrastructure and laboratories
The JRC's RM activities are carried out in state-of-the-art laboratory facilities including various
analytical laboratories (trace element analysis, organic analysis, nucleic acid analysis, protein
analysis, microbiological and pathogen analysis and engineering material analysis) and unique
processing facilities for the necessary manipulation and manufacturing of the wide range of liquid
and solid materials. A dedicated Reference Material Production Building hosts the majority of the
RM processing activities, and recent refurbishments of the nucleic acid analysis and organic analysis
laboratories have ensured that JRC's laboratory facilities are state-of-the-art.
The JRC laboratories focus on specific tasks for which either no external expert contractor can be
found (e.g. for specialised R&D tasks, new and/or unique processing procedures, certain high-
19
accuracy measurements), which are time-critical (e.g. processing controls) or which have to be
performed in-house because of contractual constraints (e.g. Intellectual Property Right (IPR) issues in
GMO CRM projects).
Overall, the vast majority of technical tasks for RM projects are currently outsourced, particularly the
sampling of the starting materials, most homogeneity and stability measurements, and
interlaboratory studies for RM characterisation. However, the limitations for outsourcing have
increased in recent years as, for instance, external pilot processing facilities were diminished in
various industrial branches, or external laboratories tend to deliver routine measurement services at
an insufficient performance level for RM projects. Therefore, the appropriate balance between own
and outsourced tasks has to be found for each RM project, taking into account the necessary quality
criteria for the final product with sufficient control over critical steps in the process and the
corresponding international standards for RM producers.
The development of nuclear CRMs is exclusively carried out in the JRC-IRMM's nuclear chemistry and
nuclear mass spectrometry laboratories. These nuclear -controlled area laboratories are providing,
together with a clean laboratory area, the necessary infrastructure to carry out in a safe and secure
manner actinide chemical separation, accurate weighing of actinides, mass spectrometric analysis of
actinide samples ranging from nuclear fuel material to the low environmental level, computerised
automated dispensing of actinide solutions, and production of actinide reference particles.
JRC-IRMM has a storage building dedicated to its reference materials. It has compartments and
equipment to store materials at temperatures from -70 oC to +18 oC at controlled humidity. Some
(C)RMs are even stored at -190 oC in special containers. The building also hosts the distribution
activities for non-nuclear RMs, which are shipped via contracted courier services. The nuclear CRMs
are separately stored in JRC-IRMM's nuclear zone and are distributed directly from the JRC-IRMM to
customers.
20
4 The intervention logic for the JRC activities on reference materials
4.1 Legal considerations
Standards and reliable measurements are essential to verify that products and services comply with
legislation that has been put in place to protect consumers, citizens and the environment by
minimising the exposure to risks and ensuring their safety. They are also of relevance for regulations
for preventing fraud and putting in place of conditions for trade and taxation require monitoring by
measurements.
The analysis of the EUR-LEX database of the European Union (EU) revealed that around 3500 EU
legislative acts make reference to standardisation, including 20 % of all Directives. The role of
standardisation shall also remain high on the policy agenda. In his Political Guidelines published in
July 2014, the President of the European Commission Juncker stated: "Jobs, growth and investment
will only return to Europe if we create the right regulatory environment and promote a climate of
entrepreneurship and job creation" and further "we should ensure that Europe maintains its global
leadership in strategic sectors with high-value jobs". To accelerate EU growth, industries need
framework conditions that provide them with the basis upon which to invest, to innovate and to
gain global market share in an increasingly competitive world. Standards are a cornerstone of these
conditions and are an integral part of Horizon 2020, the EU Framework Programme for Research and
Innovation.
It is widely accepted that roughly 50 % of legislation globally involves measurements that are often
technologically cutting-edge and in most cases comparative. Their correct application and
interpretation require state-of-the-art knowledge and equipment. This role is performed by the so-
called infrastructure technologies that provide, among others, quality assurance, production control
and market acceptance. RMs, being a member of the infrastructure-technology family, play a pivotal
role in assuring accuracy and traceability of measurement results, thus of their comparability. In this
case, RMs provide a bridge between the legal requirements and the market reality.
Although not explicitly mentioning the term 'RMs', the following articles relating to the Treaty on
Functioning of the European Union (TFEU)9 are a solid base for establishing a common European and
comparable measurement framework for the effective implementation and operation of the internal
market:
• Article 26: The Union shall adopt measures with the aim of establishing or ensuring the
functioning of the internal market.
• Article 114: […] adopt the measures for the approximation of the provisions laid down by
law […] which have as their object the establishment and functioning of the internal market.
• Article 179: […] the Union shall […] (enable) undertakings to exploit the internal market
potential to the full, […] (by) the definition of common standards […].
The importance of measurements in nuclear safety, security and safeguards was clearly recognised
and enshrined in Article 8 of the Euratom Treaty:
9 Consolidated version of the Treaty on the functioning of the European Union, OJ C326/47 (2012)
21
• […] It shall also ensure that a uniform nuclear terminology and a standard system of
measurements are established. It shall set up a central bureau for nuclear measurements10.
Moreover, Chapter VII of the Euratom Treaty tasks the European Commission with the control of all
civil fissile nuclear material in the European Union. The JRC-IRMM is responsible in fulfilling this legal
obligation in nuclear standards and measurements supporting Commission Regulation (Euratom)
302/2005 on the application of Euratom safeguards.
A strong regulatory push has been initiated by Regulation (EC) No 765/2008 setting out the
requirements for accreditation and market surveillance relating to the marketing of products:
• […] This Regulation provides a framework for the market surveillance of products to ensure
that those products fulfil requirements providing a high level of protection of public
interests, such as health and safety in general, health and safety at the workplace, the
protection of consumers, protection of the environment and security […]
• […] this Regulation on accreditation should apply to bodies carrying out conformity
assessments in both the regulated and the non-regulated areas. The issue at stake is the
quality of certificates and test reports […]
Therein, the need for using (C)RMs by control laboratories is mandated via their required
accreditation to international standards such as ISO/IEC 17025. Consequently, one of the JRC's key
competences listed in the Regulation establishing the EU Framework Programme for Research and
Innovation Horizon 202011 is RMs for supporting the implementation and monitoring of legal
requirements (see also Chapter 5).
4.2 Economic considerations
The basic economic logic behind public investment in R&D is market failure, especially on
infrastructure technologies. Private companies expect a certain return on investment which is
difficult to realise in a changing legal environment. Legislation is often technically complicated to
implement and changes sometimes relatively fast. For instance, environmental EU policy comprises
more than 500 legislative acts and includes pollution limits which are regularly updated.
Moreover, infrastructure technologies contribute to all three stages of economic activities (R&D,
production and commercialisation)12. As a result, they are broader in reach than market strategies of
companies. Consequently, there is a disincentive investing in them, as companies focus their efforts
on proprietary technologies (applied R&D).
10
As mentioned in Chapter 1, this led to the establishment of the CBNM now JRC-IRMM. 11
Annex II of Regulation (EU) No 1291/2013 establishing Horizon 2020 – the Framework Programme for
Research and Innovation, OJ C74E (2012) 12
Tassey, G., Modelling and Measuring the Economic Roles of Technology Infrastructure, NIST (2007)
22
A high technological risk and uncertainty is also closely linked to the development of new RMs which
hampers their marketing and commercialisation. Faced with long development time and lack of
significant cash flow during the process, private companies are reluctant to enter such a market. In
particular, the production of matrix RMs (representing real-life materials) requires substantial
interdisciplinary research and knowledge, from basic science and engineering to technologies. This
prevents making the production of specifically complex matrix based RMs a profitable business.
Furthermore, companies focus on the private rate of return (PRR) and infrastructure technologies
are best understood by social rate of return (SRR) – both rates being different in value and logic. In
general infrastructure technologies, supporting the economy, such as physical infrastructure (roads,
bridges, etc.), are seen as public goods which provide the framework for new and possibly disruptive
products, services and processes. They have the potential for a very high SRR and conversely, a low
PRR. A typical example are measurement standards (e.g., CRMs for calibration), which yield
significant benefits to society but are developed in a transparent process which cannot occur under
intellectual property (IP) protection. Therefore, a strong "free-rider" element occurs that
discourages private companies from investing adequately in developing infrastructure technology.
Consequently these technologies, and (C)RMs in particular, will predominantly be publicly funded.
4.3 Intervention logic for production of RMs by the JRC
The legal and economic constraints from the above clearly point to the need for public intervention
in the production of (C)RMs. The logical question then is why JRC-IRMM?
The JRC's RM activities draw on its competencies and infrastructure in analytical (measurement)
sciences applied in chemistry, biology and life sciences, material sciences and nuclear sciences.
Moreover, generic understanding of the international standardisation processes and quality
infrastructures is fundamental for translating policy and market needs into RM projects and RM
related deliverables with a high impact.
As outlined in Chapter 2, the JRC-IRMM steadily grew in its role of developing and producing RMs,
starting with nuclear RMs and covering to-date a broader range of materials. JRC's RM activities
respond to EU policy needs, covering wide areas such as environmental protection, industrial
competitiveness, food safety, consumer protection, citizen's health and nuclear security. These are
all shared competences between the EU and the Member States in which the subsidiarity principle
applies. It is hard to imagine a national body, maintaining a broad spectrum of knowledge and
infrastructure that addresses pan-European issues that mostly target the EU single market. The JRC-
IRMM, with its history of scientific excellence and second-to-none infrastructure, supports industrial
competitiveness, quality of life, safety and security in the EU by providing trustworthy measurement
standards and quality tools vital for technology development, innovation and market acceptance in
the frame of the EU single market.
23
The JRC demonstrated its ability to react efficiently to supranational crises (e.g. BSE) and to
effectively execute diverse CRM projects (e.g. a world leader in GMO CRMs, provider of crucial
healthcare biomarker CRMs, etc.). This enables the JRC to be a reliable partner of the European
Commission's policy DGs and international institutions and organisations. The considerations for
JRC's intervention in the area of RM development and production is visualised in Figure 8 and is
further outlined in Chapter 5.
Figure 8: JRC's reasoning for RM activities
24
5 Positioning of JRC's activities on reference materials
5.1 JRC’s priority setting for the RM activities
In positioning of the JRC as an internationally trusted and reliable provider of (C)RMs enabling and
supporting measurements required for the implementation and monitoring of EU policies, the
following aspects are (and should be further) applied:
• EU policy alignment - Alignment of JRC's RM activities with the tasks of the JRC, which are
derived from societal challenges and policy priorities of other Commission DGs.
• Legislation requiring RMs - Forecasting of required RM activities for the implementation and
monitoring of EU legislation. This takes into account the fact that demands for use of RMs
are often expressed in legislative documents in an indirect manner, e.g. via the prerequisite
for control laboratories or proficiency testing providers to be accredited according to ISO/IEC
17025 and ISO/IEC 17043, respectively, or to follow the principles of these standards.
• Avoiding duplication - Exploiting further the regular dialogues with other major RM
producers, in particular with institutes receiving public funding, to avoid duplication of
efforts as much as possible and to exchange best-practice information.
• Networking – Maintaining and strategically developing networks of external experts for
sharing knowledge on new developments, using complementary competences and
collaborating on RM projects.
Criteria for the selection and prioritisation of RM projects at JRC-IRMM are based on the needs,
requests, policy relevance and non-availability of an RM from other producers as outlined in Figure
9. The decision for a replacement of a highly demanded CRM is taken using the same selection and
prioritisation criteria as for other RM projects.
Figure 9: Criteria for selection and prioritisation of RMs to be developed by the JRC
25
Today, as a consequence of the EU policy needs and the worldwide RM supply activities, the JRC
focuses to a large extent on the design, development and provision of complex (so-called 'matrix')
RMs. This means that naturally occurring biological or environmental materials or man-made
products (e.g., foodstuff, advanced materials) of complex composition/structure are mainly used as
starting materials. They often demand the development and application of highly project-specific
metrological concepts for establishing traceability of certified values as well as advanced
technological capabilities for further material processing. The JRC’s projects for entirely new RMs
focus on scientifically cutting-edge materials with newly certified value/matrix combinations and
material properties closely and feasibly match real-world samples tested in routine control
laboratories. Priority is given to those scientific-technical developments which require
interdisciplinary competences and approaches as this has proven to allow exploiting synergies and
maximizing the JRC's impact as well as saving staff resources.
The other major drivers of JRC's RM activities are located within and outside the European
Commission. Several services in the policy DGs are cooperating with the JRC in the formulation
phase of new EU legislation, whereas most requests are derived from the technical implementation
stage or after detecting compliance problems with existing EU regulations.
More major drivers of RM activities are networks of official control laboratories in the Member
States, such as the National Reference Laboratories (NRLs) co-ordinated by a EU-Reference
Laboratory (EURL), Network Laboratories in nuclear safeguards and security, EU Agencies,
standardisation and accreditation bodies, and needs of EU market participants in complying with EU
regulations (e.g. inventors of Genetically Modified Organisms (GMO), In-Vitro-Diagnostics (IVD)
industry).
The JRC-IRMM aims to serve these bodies in situations where RMs are not available from other
reliable sources. Consequently, close information exchange and cooperation with European
standardisation, metrology and accreditation organisations, including their global counterparts as
well as application sector-specific organisations are crucial. To optimise its services and prioritise its
RM activities, JRC-IRMM explores the strategies of its customers and collaborators, engages in
regular pro-active dialogues with them, has discussions with international bodies and networks on
future needs, runs dedicated customer surveys, and implements the results thereof. During the last
years, about 30 newly produced CRMs were released annually by the JRC as shown in Figure 10:
26
Figure 10: Number of CRMs finalised and released in 2006- 2015 by the JRC
5.2 Food & feed reference materials
The intervention logic for the development and production of RMs for food and feed is summarised
in Figure 11.
Figure 11: Intervention logic for food and feed RMs
Food and feed legislation
Regulation (EC) No 882/2004 demands that official controls are carried out by the Member States to
check compliance of food and feed, following the provisions of the related EU laws. Furthermore, it
establishes European Union Reference Laboratories (EURLs), which shall provide (reference)
methods to the National Reference Laboratories (NRLs) and check the measurement capabilities of
the NRLs by organising proficiency tests on a regular basis. Official food and feed control laboratories
0
10
20
30
40
50
60
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Nu
mb
er
of
ne
w m
ate
ria
ls r
ele
ase
d
YearNon-nuclear materials Nuclear materials
Mandate (EC) No 882/2004 Official control, EURLs, NRLs (EC) No 1981/2006 Accreditation to ISO/IEC 17025 and ISO/IEC 17043: use of RMs e.g. (EC) No 1829/2003, (EC) No 619/2011: RM availability mandatory
Deliverables RMs for proficiency testing of laboratories RMs for method developments in CEN standardisation and EU projects (C)RMs for implementation of EU legislation
Impact Enabling implement-ation of EU legislation Setting up reliable measurement systems for operationally defined parameters Enabling & proving measurement capabilities of Member States' laboratories Enabling standardised methods (CEN, ISO) Ensuring food/feed quality and safety
Activities Development and production of (C)RMs Underpinning research Method development & validation for RM processing and characterisation Distribution of (C)RMs User guidance & training Standardisation
27
shall be accredited according to ISO/IEC 17025:2005, which demands the use of (certified) reference
materials for calibration and quality assurance.
EU legislation related to the methods of sampling and analysis of certain contaminants in food and
feed specifically requires the use of CRMs, where available. It concerns especially mycotoxins
(Regulation (EC) No 401/2006), dioxins and dioxin-like PCBs (Regulation (EC) No 1883/2006), and
lead, cadmium, mercury, inorganic tin, 3-monochlor-propanediol and polycyclic aromatic
hydrocarbons (Regulation (EC) No 333/2007).
Wines produced in the EU have an important market share in the global market and their quality is
of prime importance to maintain their reputation. To check whether sugar has been added to
fermenting must and/or wine has been watered, the International Organisation of Vine and Wine
(OIV) validated methods based on isotopic measurements of wine ethanol and wine water. The OIV
method for measuring the 13C/12C ratio of wine ethanol by isotope ratio mass spectrometry
mandates the use of CRMs (namely BCR-656 Wine alcohol, BCR-657 Glucose, CRM-660
Hydroalcoholic solution); the method for the determination of the deuterium distribution in ethanol
by nuclear magnetic resonance requires the use of the CRMs BCR-123 (Ethanol) and STA-003
(Tetramethylurea). The use of those OIV methods for the official control of wine in the EU is
obligatory (Regulation (EC) No 2676/90).
At the global level the Procedural Manual of the FAO/WHO Codex Alimentarius, which details the
rules on methods of analysis to be fulfilled for settling disputes, also requires the use of CRMs,
where available, for checking trueness of an analytical method.
GMO legislation
EU legislation regulates the placing on the market of food and feed which consists of, contains, or is
produced from genetically modified organisms (GMOs). These items are referred to as genetically
modified (GM) food and feed and require authorisation. According to Regulation (EC) No 1829/2003
food and feed products need to be labelled if they contain more than 0.9 % of GMOs. The EC
Recommendation (EC) No 787/2004/EC focussing on sampling and detection of GMOs in food and
feed had suggested to expressing measurements results in DNA copy number ratios. Since the
implementation of Regulation (EC) No 619/2011, a feed may contain 0.1 (m/m) % of a GMO for
which an authorisation process is pending, or for which authorisation in the EU has expired.
Furthermore, this regulation clarified in 2011 that measurement results should be expressed in GMO
mass fractions.
The authorisation of GM food and feed for the EU market requires explicitly the availability of GMO
RMs. They are needed for calibration and quality control of GMO measurements in the
implementation of the GMO labelling thresholds. JRC-IRMM developed and released the worldwide
first GMO CRMs based on gravimetrically prepared mixtures, certified for their GMO mass fraction.
As the EU Recommendation mentioned above had for some years suggested the need to express
GMO measurement results in DNA copy number ratios, JRC-IRMM developed a scientific concept for
implementing this different measurement unit in GMO quantification. For this purpose several GMO
CRMs were additionally characterised and certified for their DNA copy number ratio and specific
separate CRMs, based on designed DNA fragments, which were developed and released for the
28
calibration of the measurements. While the legal interpretation of GMO labelling thresholds
reverted to mass fractions, also the concept of suitable sets of GMO CRMs was also developed
further by JRC-IRMM and accepted internationally. Today, a pure GMO CRM is used by many
laboratories for calibration and different mixtures of GMO blank and GMO pure materials, certified
for their GMO mass fraction, primarily serve the implementation of (EC) No 619/2011 and (EC) No
1829/2003.
The biological species which are authorised in the EU as food and feed products increase constantly.
While the first GMOs were maize and soya, JRC-IRMM had to invest in the development of
processing techniques for other challenging species, such as sugar beet and potato (high sugar and
starch content, respectively) or cotton seed and rapeseed (high fat content). Besides these
challenges for the processing of GMO starting materials, the type of CRMs was in some cases
adjusted to the sampling and analysis techniques applied. For instance, the control of the correct
labelling of sugar is carried out on the sugar beets and not on the final food product. A similar
situation exists for potatoes. Therefore, instead of mixtures, a blank material and a pure GMO CRM
have been produced, thus focussing the characterisation and certification on the GMO identity.
During the period 2006-2015, JRC-IRMM has distributed on average about 7000 units of GMO CRMs
annually. The larger fraction of these CRMs is used in Europe (Figure 12), but a considerable amount
is also used in third countries to facilitate trade with the EU. So far JRC-IRMM developed and
released about half of the various GMO CRMs required for the EU market authorisation of a GMO
event as food or feed product.
Figure 12: Geographic distribution of customers ordering GMO CRMs from JRC-IRMM
An overview of all certified and non-certified food and feed reference materials which have been
released by JRC-IRMM in 2006-2015 is provided in Tables A1 and A2 in the Annex.
It should be noted that there are several unique RMs among the ones listed in the annexed Table A2.
For example the BSE RMs, which had been developed based on a concept created in co-operation
29
with Nobel Laureat S. Prusiner, were provided for the quality control of BSE testing by the
corresponding official control laboratories in the EU Member States.
5.3 Health related reference materials
The intervention logic for the development and production of RMs for health diagnostics is
summarised in Figure 13.
Figure 13: Intervention logic for health related RMs
The societal and economic challenges and consequences of citizen's health and healthcare are
tremendous. Improving the reliability of medical diagnostics has impacts on the efficiency of
diagnosis, therapy (improved medical guidelines, personalised medicine, pharmacokinetic/genetic
assessment of new and existing drugs) and the economy of healthcare systems. Moreover, it is
increasingly recognised that the majority of data from biomedical studies cannot be qualified as
'reproducible'. In fact, the quality of rapidly developing diagnostics techniques, particularly in
molecular biology, has so far not been sufficiently addressed. Reliable and thus comparable medical
measurement data are required for assessing the performance and limitations of current and new
diagnostic methods under realistic conditions. Corresponding standardisation efforts are of benefit
to patients, industry and society.
Therefore, EU Directive 98/79/EC on in-vitro diagnostic (IVD) medical devices demands that "[…] the
traceability of values assigned to calibrators and/or control materials must be assured through
Mandate
Directive 98/79/EC: Traceability to be established with CRMs EU Programme for Research and Innovation Horizon 2020
Deliverables
CRMs for implementation of EU legislation CRMs as globally recognised (JCTLM) calibrants of higher order Documentary standards as EU harmonised standards
Impact
Enabling implement-ation of EU legislation Setting up reliable measurement systems for health biomarkers Enabling IVD manufacturers to establish traceability for IVDs Enabling comparable health diagnostics data worldwide Saving healthcare costs and enabling medication developments
Activities
Development and production of CRMs Underpinning research Method development & validation for RM processing and characterisation Distribution of CRMs User guidance & training Standardisation
30
available reference measurement procedures and/or available reference materials of a higher order
[…]".
As already mentioned in Chapter 2, the JRC is closely co-operating with the International Federation
of Clinical Chemistry and Laboratory Medicine (IFCC) and is involved in international bodies aiming at
the establishment and maintenance of reliable and sustainable reference measurement systems for
health diagnostics. These are for IVDs in particular the International Organization for Standardization
(via ISO TC 212) and the Joint Committee on Traceability in Laboratory Medicine (JCTLM), which
operates under the umbrella of the IFCC, the International Laboratory Accreditation Corporation
(ILAC) and the International Bureau for Weights and Measures (BIPM). The health-related CRM
activities of the JRC are performed, thanks to its independence from commercial or specific national
interests and by an institution which can offer innovative and harmonised solutions for the EU single
market.
In 2006-2015, the development, production and distribution of CRMs for health diagnostics were
focused on ensuring the continuous availability of globally accepted and used biomarkers as well as
the realisation of new CRMs for the calibration and/or quality control of further biomarker
measurements. A prominent example of the first group is the CRM ERM-DA470k/IFCC, which is a
second-generation development of a CRM that has been successfully used by the major IVD
manufacturers worldwide as 'gold standard' for the calibration of their IVD kits and in measuring a
range of proteins in routine blood testing of patients since 1993. The newcomer group of CRM
includes world-first materials for human genetic testing of a prothrombin mutation (IRMM/IFCC-
490-492) and the first serum protein CRM (ERM-DA476/IFCC) for the calibration of measurements of
anti-myeloperoxidase immunoglobulin G antibodies, a marker for several autoimmune diseases.
Another highlight after solving some scientific-technical challenges was the release of a set of 6
calibrators (ERM-AD623a-f) allowing clinical laboratories to monitor precisely the efficacy of medical
therapies in patients suffering from a type of leukaemia representing about 15–20 % of all cases of
adult leukaemia in Western populations. This new CRM set is an essential tool to correctly assess the
human response to leukaemia treatment and to ensure the early detection of a relapse of individual
patients.
International acceptance of the new CRMs has been ensured, following compliance with the
principles of ISO Guide 34:2009, compliance with the EC mandated standards ISO 15194 and ISO
17511 and successful reviews and listing by the JCTLM.
An overview on all certified reference materials for health diagnostics which have been released by
JRC-IRMM in 2006-2015 is provided in Table A3 in the Annex.
The global character of IVD manufacturing and the influence of the EU IVD Directive on
corresponding CRM demands can be seen in Figure 14 below and by the more than 4000 CRM units
distributed annually on average during 2006-2015.
31
Figure 14: Geographic distribution of customers ordering health diagnostics CRMs from JRC-IRMM
5.4 Environmental reference materials
The intervention logic for the development and production of RMs for environmental analysis is
summarised in Figure 15.
Figure 15: Intervention logic environmental RMs
Environmental protection is an important cornerstone of sustainable growth, which is one of the
three priorities of Europe 2020. It includes the monitoring of the status of the environment as well
as of possible pollutions sources. Ensuring confidence in environmental information is one important
Mandate
Directives 2000/60/EC & 2008/105/EC & 2013/39/EC & 2009/90/EC Directive 2008/50/EC Regulation (EC) 765/2008 EU Programme for Research and Innovation Horizon 2020
Deliverables
CRMs for implementation of EU legislation RMs for proficiency testing of laboratories RMs for method developments in CEN standardisation and EU projects
Impact
Enabling implement-ation of EU legislation Enabling & proving measurement capabilities of MS laboratories Ensuring EU quality standards thereby supporting a common market in services Facilitating environmental monitoring efficacy
Enabling standardised methods (CEN)
Activities
Development and production of (C)RMs Underpinning research Method development & validation for RM processing and characterisation Distribution of (C)RMs User guidance & training Standardisation
32
objective defined in the Commission Communication on improving the delivery of benefits from EU
environment measures (COM (2012) 95 final). Environmental protection expenditure is estimated to
account for a 1.82 % of the gross domestic product in the EU or EUR 439 per capita (Environmental
statistics and accounts in Europe 2010 Edition, Eurostat 2010), while the costs of non-
implementation of current legislation are estimated at about EUR 50 billion. On the other hand, the
full implementation of the EU waste legislation alone is estimated to contain net costs, which are
EUR 72 billion lower than in the case of non-implementation (COM (2012) 95 final). Reliable
measurements help to decide how to spend money most efficiently in this field.
Directive 2000/60/EC (the Water Framework Directive, WFD) plus amending Directives 2008/105/EC
and 2013/39/EC stipulate the need to monitor priority hazardous substances in surface waters and
biota to ensure a good water status in the EU. Directive 2009/90/EC, which lays down technical
specifications for chemical analysis and monitoring of the water status, demands that "[…] technical
operations to ensure the quality and comparability of analytical results should adopt internationally
accepted quality management system practices. As a consequence, the practices set out in EN
ISO/IEC 17025 are appropriate. It is appropriate to ensure that laboratories performing chemical
analysis demonstrate their competence through their participation in internationally or nationally
recognised proficiency testing programmes, as well as their use of available reference materials […]".
Moreover this Directive requests that "[…] Member States shall ensure that laboratories or parties
contracted by laboratories demonstrate their competences in analysing relevant physico-chemical or
chemical measurands by […] analysis of available reference materials that are representative of
collected samples which contain appropriate levels of concentrations in relation to relevant
environmental quality standards […]".
Therefore, the JRC is regularly performing gap analyses regarding the availability of RMs for the
implementation of the Water Framework Directive and the other EU environmental legislation
covering the surface, ground and marine waters13. Based on that, JRC-IRMM participated in a project
of the European Metrology Research Programme (EMRP) and developed non-certified RMs (Table
A5) for investigating new analytical methods for selected priority pollutants in whole surface water.
Moreover, such RMs were also provided to CEN for establishing standardised methods for water
monitoring. Also a range of CRMs for the quality assurance of environmental water monitoring were
finalised and released in the reporting period.
For achieving an appropriate environmental status of air the Directive 2008/50/EC on ambient air
quality and cleaner air for Europe demands that "[…] to ensure accuracy of measurements and
compliance with the data quality objectives […], the appropriate competent authorities shall ensure
that the national laboratories […] are accredited according to EN/ISO 17025 […]". Consequently, DG
Environment requested JRC-IRMM to develop the missing CRMs to assess the performance of
analytical methods and control laboratories for particulate matter suspended in air (PM10). Two new
CRMs have been developed and produced to match the requirements of the Directive regarding the
type of matrix including the particle size and the nature and content of certified analytes. These
CRMs ERM-CZ100 and ERM-CZ120 have been made available for quality assurance of the analysis of
selected elements and polycyclic aromatic hydrocarbons (PAHs) in PM10 and for method validation
purposes including trueness estimation.
13
Ricci et al., Trends in Analytical Chemistry 76 (2016) 194-202
33
The EU-wide trend towards accreditation of laboratories involved in environmental monitoring has
been supported by the development and distribution of a range of environmental CRMs. They are
required to demonstrate the analytical competences of the control laboratories and the traceability
of their measurement results. Therefore, about 2000 corresponding CRMs were distributed annually
on average and the geographic origin of their customers is shown in Figure 16.
Figure 16: Geographic distribution of customers ordering environmental CRMs from JRC-IRMM
Tables A4 and A5 in the Annex provide an overview on all certified and non-certified environmental
reference materials which have been released by JRC-IRMM in 2006-2015.
34
5.5 Engineering reference materials
The intervention logic for the development and production of JRC's engineered RMs is summarised
in Figure 17.
Figure 17: Intervention logic for engineering RMs
The availability of (C)RMs as measurement standards and quality benchmarks for functional
properties of advanced materials, industrial products and fuels is important for supporting the
competitiveness of European industry and for the required compliance controls with EU legislation.
JRC's RM activities in the broad field of the so-called engineering materials have, in the period 2006-
2015 been focused on:
− the sustainable provision of CRMs for testing of impact resistance (in support of Regulation
(EU) 305/2011 and Directives 1997/23/EC and 2009/105/EC);
− the development and production of CRMs to support the implementation of Directive
2011/65/EU on the restriction of the use of certain hazardous substances in electrical and
electronic equipment ('RoHS Directive') and the Waste Electric and Electronic Equipment
Directive 2012/19/EU;
− the development and production of fuel & biofuel CRMs enabling the implementation of
Directive 2009/30/EC on fuel specifications and supporting Directive 2009/28/EC on the
promotion of renewable energy;
− the development of non-certified and certified RMs for reliable and comparable
measurements of the size of nanoparticles thus enabling the implementation of the
Commission Recommendation COM (2011)696 on the definition of the term 'nanomaterial'.
In 2005 JRC-IRMM started an activity on developing concepts for reference materials envisaged for
use in the field of nanotechnology. It was realised that this emerging field of technology was, and
still is, associated with some measurement challenges, to which JRC-IRMM could contribute by
Mandate
Directive 2009/30/EC on fuel specifications Directive 2011/65/EU on the restriction of hazardous substances Regulation (EU) 305/2011 and Directives 1997/23/EC & 2009/105/EC Regulation (EC) 765/2008 EU Programme for Research and Innovation Horizon 2020
Deliverables
CRMs for implementation of EU legislation RMs for method developments RMs for proficiency testing of laboratories RMs for internal quality control Documentary standards (ISO)
Impact
Enabling implement-ation of EU legislation Reducing non-fiscal barriers to trade Setting up reliable measurement systems for operationally defined parameters Enabling & proving
measurement capabilities of Member States' laboratories Enabling standardised methods (CEN, ISO)
Activities
Development and production of (C)RMs Underpinning research Method development & validation for RM processing and characterisation Distribution of (C)RMs User guidance & training Standardisation
35
transferring it experience with measurements, quality assurance of measurements and RM
development from other areas of expertise. In 2008 JRC-IRMM successfully finalised IRMM-304, a
non-certified RM for silica nanoparticles in solution. This was a first step that allowed JRC-IRMM, as
well as laboratories required for characterisation studies on candidate CRMs, to gain the necessary
experience with various size measurement methods and procedures. In 2010 JRC-IRMM could
release its first CRM for nanoparticle sizing, ERM-FD100. In the following year, IRMM-304 was
upgraded to a CRM (ERM-FD304) by using newly available measurement results. Moreover, the first
CRM with a bimodal size distribution of silica nanoparticles has been developed and produced (ERM-
FD102). These CRMs (see Table A6) are applied for quality control of particle size measurements. To
enable the development and performance assessment of new measurement methods for
nanoparticles in more complex materials such as foodstuff, a range of non-certified RMs have been
designed and produced for some EU projects (see Table A7).
The influence of EU legislation on manufacturing and product control activities of industry located
outside the EU but exporting a significant part of their goods into the EU can also be seen for specific
cases from RM customer demands. For instance, JRC's CRMs which enable the quality control of
measurements results required to demonstrate compliance of manufactured electrical and
electronic equipment with the 'RoHS Directive' 2011/65/EU have been ordered (about 700-800 units
per year) mainly by customers in Asia (see Figure 18) as their products have the largest share on the
EU market.
Figure 18: Geographic distribution of customers ordering CRMs supporting the implementation of
the RoHS Directive from JRC-IRMM
36
5.6 Nuclear reference materials
The intervention logic for the development and production of JRC's nuclear CRMs is summarised in
Figure 19.
Figure 19: Intervention logic for nuclear RMs
Chapter VII of the Euratom Treaty holds the European Commission (EC) responsible for the control
of all civil fissile nuclear material in the EU. Therefore, the production of nuclear RMs is embedded in
the Euratom Treaty and JRC-IRMM is responsible for fulfilling this legal obligation in nuclear
standards and measurements by developing and producing nuclear CRMs. Nuclear CRMs as provided
by the JRC are an indispensable metrological tool for nuclear industry and safeguard laboratories to
meet the requirements for accountancy measurements in compliance with The International Target
Values for Measurement Uncertainties in Safeguarding Nuclear Materials – ITVs-2010.
Nuclear safeguards conclusions are based to a large extent on comparison of measurement results
between operator and safeguards laboratories. In nuclear forensics, characteristic parameters (also
referred to as "signatures") are used for re-establishing the history of nuclear material found out of
regulatory control. Signatures can either be "predictive" (i.e. self-explaining) or "comparative" in
nature. The latter require external data of known nuclear material for supporting data
interpretation. In either case, accurate measurement results are required to be performed with a
validated method and expressed as a measured quantity value with uncertainty and traceability.
Today, the JRC is developing and producing its nuclear CRMs primarily on demand of DG Energy for
Euratom safeguards and for the safeguards authorities of the International Atomic Energy Agency
(IAEA). The work of the latter is performed in the framework of the EC Cooperative Support
Programme to IAEA (EC SP)14,15. Therefore, the JRC has invested enormous effort in the development
of new CRMs and the provision of other quality assurance tools (namely interlaboratory
14
http://publications.jrc.ec.europa.eu/repository/handle/JRC93746 15
https://www.iaea.org/safeguards/symposium/2014/home/eproceedings/sg2014-slides/000088.pdf
Mandate
Euratom Treaty (2012/C327/01)
Commission Regulation (Euratom) 302/2005 on the application of Euratom safeguards
EU CBRN Action Plan (2010/2114(INI))
Deliverables
CRMs for implementation of EU legislation Documentary standards CRMs for proficiency testing of laboratories for nuclear safeguards and security
Impact
Supporting European and international Safeguards authorities
with nuclear CRMs and quality assurance tools for the implementation of Chapter VII of the Euratom Treaty, the Non-proliferation Treaty, the Additional Protocol ((INFCIRC/153 corrected, INFCIRC/540), and the CBRN Action Plan
Activities Development of nuclear CRMs Standardisation Underpinning research Method development and evaluation Interlaboratory Comparisons REIMEP/NUSIMEP Distribution of CRMs User guidance and training courses (ESARDA, IAEA..)
37
comparisons), particularly for 'age-dating' of uranium and plutonium samples and for isotopic
fingerprinting. Moreover, JRC's nuclear CRMs are applied by users worldwide operating uranium-
enrichment facilities, fuel-fabrication, nuclear-power-generation and reprocessing plants. They are
also required by holders of small stocks of fissile materials for industrial, research or medical
purposes. JRC's nuclear CRMs are also used to assess the radioactivity measurement systems of EU
Member States.
Priority setting for the nuclear CRM development and production occurs at three levels:
• at JRC and partner DG level via the definition and assessment of the annual JRC Work
Programme, regularly monitored via respective task sheets;
• at the level of international/governmental organisations via mechanisms laid down in the
respective support programmes and/or cooperation agreements. Priorities for support to
the IAEA are set in line with the priorities as defined in the IAEA Department of Safeguards
Long-Term Research & Development Plan, 2012-2023 (STR–375). The Joint Steering
Committee meeting between the US Department of Energy (DOE) and Euratom represented
by the European Commission is held on an annual basis. During this meeting action items
are defined and their status reviewed and priorities set. It further ensures coordination
between JRC-IRMM and the US New Brunswick Laboratory (NBL) on nuclear reference
material development and provision of interlaboratory comparisons;
• at international level and with industry via regular technical meetings and dedicated
workshops using the existing platforms of exchange and cooperation between the
safeguards; security, operators; research; and metrology communities of the European
Safeguards Research and Development Association (ESARDA), the US Institute for Nuclear
Material Management (INMM) and the French Commission d'Etablissement des Methodes
d'Analyse (CETAMA).
38
6 Outlook into JRC's activities on reference materials
The JRC-IRMM has a proven track record in the field of RM development and production. It should
be stressed that new demands and challenges regarding new RMs constantly emerge, leading to the
legitimate question of, which directions the JRC should take in the future.
RMs are a very specific niche product whose benefits are fully understood by professionals such as
analytical chemists or laboratory technicians, though this may not be the case with policy makers
and ordinary citizens. Nevertheless, RMs have significant economic and social impacts, albeit most of
the times, indirectly. Two specific examples easily highlight the importance of the RMs:
• lives saved or prolonged (social impact) by improved medical treatment with the help of a
CRM for leukaemia monitoring (ERM-AD623) that helps determine when to exactly
administer a drug and when not;
• sound company management and control of competitive trading prices (economic impact)
by testing refined copper on the market with the help of copper CRMs (ERM-EB074 & 75), as
the price of copper, is established as a function of the impurity levels in the product.
Because of the nature of RMs, as an infrastructure technology, companies lack a strong incentive to
enter the market of RM production.
If development and production of RMs were to be suspended or downsized at the JRC, the void
might not be filled by the private sector or potentially by national RM producers. The former seeks
to maximise profits (hardly achievable for the vast majority of RMs) and the latter follow legitimate
specific national interests and priorities. Nevertheless, accurate measurement results, and thus the
need for (C)RMs, are in high demand in many fields and even projected to increase further. This is
elaborated in more detail in the following.
Health diagnostics
Health is a crucial and booming sphere in light of the ageing population and the spread of non-
communicable and rare diseases. A straightforward example is Alzheimer's disease, which global
cost is estimated at $604 billion – that means 1% of the world GDP (as a comparison: cancer costs
$895 billion annually and heart disease – $753 billion)16! Moreover, people affected by Alzheimer's
disease are projected to increase from 44 million in 2013 to 135 million in 2050, thus placing a heavy
burden on public finances and the social fabric. The JRC-IRMM is currently developing a CRM to
allow standardisation and to facilitate better treatment of Alzheimer disease – a daunting task with
considerable socio-economic impact.
Furthermore, personalised medical treatment and the subsequent spread of medical devices will
considerably increase the need for CRMs of higher order as already stipulated by the EU IVD
Directive17. The JRC's collaboration with the IFCC is an excellent forum to increase further pre-
normative research in the area and to address these standardisation challenges. Allergens, on the
16
M. Prince et al., Alzheimer's Disease International (ADI), London, UK 2013. 17
Directive 98/79/EC of the European Parliament and of the Council
39
other hand are also an emerging threat requiring accurate measurement results for decision-making
and are preferably to be standardised with CRMs (cross-cutting with the food area).
Food
Food is an important topic, not only for the European consumers who spent about 15% of their
household income on food and drinks in 2011, but also for the food industry, which is the largest
employer in Europe's manufacturing sector, accounting for 4.5 million people (14% of the
workforce)18. Due to the complexity of the global supply chain and differences in the food safety
requirements worldwide, foodborne illnesses may easily occur, thereby posing a significant
economic and public health burden. Among the consequences are; higher healthcare expenses,
product recalls, with its associated costs and complex epidemiological tracking studies. Food
matrices are especially challenging to be analysed in search of hazardous substances and possible
adulterants. Therefore, the use of control materials, such as (C)RMs, is essential and in line with the
EU's "farm-to-fork" principle. Besides food and feed safety, the prevention of food fraud is a priority
for EU policy makers. Therefore, food control authorities need to consistently develop new
methodologies, as well as adapt existing ones to detect fraud and to ensure the authenticity of food
products, which is important for protecting fundamental rights of consumers. The strong attitudes of
Europeans towards food and the economic importance of the sector are also an important aspect of
the current TTIP discussions. Maintaining high food standards require reliable measurements and
mutual trust in their results. If the JRC, with its extensive accumulated expertise, would step aside,
the consequences could be significant, given its goal of ensuring improved food control in protecting
consumers and businesses.
Environment
The environment is an area where the EU prides itself for setting up the global benchmark for quality
and sustainability. For instance, road dust is responsible for 33 % of air pollution. The JRC plays a
significant role by coordinating the European Air Quality Reference Laboratories network (AQUILA)
to which the JRC-IRMM contributes with RMs, thereby improving the quality assurance of the
measurements. JRC's CRMs on polycyclic aromatic hydrocarbons (PAHs) and selected heavy metals
in a PM10-like dust are pivotal for accurate air quality measurements. The importance is highlighted,
for instance, by the willingness of OECD citizens to pay $1.7 trillion19 to pre-empt possible deaths
from bad air quality. The EU is also a home to the most comprehensive piece of legislation
concerning water quality – the Water Framework Directive (WFD)20. The Directive and its Daughter
Directives call for the stringent monitoring of 45 priority pollutants and their uniform measurement
and quantification across the EU is best achieved with appropriate CRMs. However, many CRMs are
still missing which presents a great possibility for future research and developments resulting in
improved environmental protection.
18
FoodDrinkEurope – "2013-2014 Data & Trends of the European food and drink industry" 19
OECD, The Cost of Air Pollution, 2014 20
Directive 2000/60/EC of the European Parliament and of the Council establishing a framework for the
Community action in the field of water policy
40
Engineering
Engineering is a key driver of employment and economic growth and has a substantial demand for
accurate measurements supported by CRMs. Of particular interest is the emerging field of
nanotechnology and its numerous applications, ranging from computing to cosmetics and from
pharmaceuticals to construction materials. The nanotechnology market was valued at $26 billion in
2015 and is projected to increase to $76 billion in 202021. As a result, human exposure to
nanomaterials is becoming ubiquitous and logically raises the issue of better understanding their
properties, also related to safety and health. JRC-IRMM released the first silica nanoparticle CRM as
a benchmark for a widely used product, thus facilitating the comparability of measurement results
and promoting innovation. However, more building blocks are needed in a field with vast
opportunities and unknowns, which requires informed decisions on substantial investments in
infrastructure and human capital.
Nuclear safeguards
Safeguards authorities, nuclear industry, laboratories and research institutes worldwide use the JRC
nuclear CRMs, quality tools and services for accurate measurements of samples from all stages of
the nuclear fuel cycle and for environmental sample analysis. The Euratom Treaty endows the
European Commission with full responsibility for the implementation of safeguards in the EU. At the
international level, the IAEA is in charge of safeguards. Close interactions between the European
Union, its Member States and the IAEA, as well as the relevant authorities in the US, will define
future needs and guide related developments. There are, besides the JRC-IRMM, only two other
main nuclear RM providers. It is not expected that this number will increase in the future. Therefore,
the European Commission must ensure that the European and international safeguards community
can also count in the future on appropriate quality assurance tools. To this end, the JRC has to
guarantee that its role in the field of nuclear CRMs can be fulfilled. Obviously, the nuclear CRM
production should be as in the past, prioritised and duplication has to be avoided. This is pursued via
the close networking and transparent priority setting as outlined before.
Overall Summary
The examples above illustrate the need for (C)RMs in evidence-based policy making, in particular for
the implementation and monitoring of legislation in various sectors. Related RM activities require
significant investments in human capital, infrastructure and time as well as demonstrated
competence and reputation.
Although most of the above are already present at the JRC, further efforts are required to address
future needs in the health, food, environment and engineering sectors, but not only limited to them.
In the best case scenario, these challenges will be dealt with simultaneously. However, given the
current economic situation, precedence should be given to the most burning issues aligned with the
political priorities of the European Commission.
21
ReportLinker, Nanotechnology Market Outlook 2020.
41
Annex
42
Table A1: Food & feed CRMs released by JRC-IRMM in 2006-2015
Material code Matrix Certified property
IRMM-447 Genomic DNA of Listeria Monocytogenes
Identity
IRMM-449 Genomic DNA of Escherichia coli
Identity
ERM-BF423a Maize (GMO) MIR604 maize mass fraction
ERM-BF423b Maize (GMO) MIR604 maize mass fraction
ERM-BF423c Maize (GMO) MIR604 maize mass fraction
ERM-BF423d Maize (GMO) MIR604 maize mass fraction
ERM-BF421a Potato (GMO) EH92-527-1 potato mass fraction
ERM-BF421b Potato (GMO) EH92-527-1 potato mass fraction
ERM-BF419a Sugar beet (GMO) H7-1 sugar beet mass fraction
ERM-BF419b Cotton seed (GMO) H7-1 sugar beet mass fraction
ERM-BF422a Cotton seed (GMO) 281-24-236 x 3006-210-23 cotton seed mass fraction
ERM-BF422b Cotton seed (GMO) 281-24-236 x 3006-210-23 cotton seed mass fraction
ERM-BF422c Cotton seed (GMO) 281-24-236 x 3006-210-23 cotton mass seed fraction
ERM-BF422d Cotton seed (GMO) 281-24-236 x 3006-210-23 cotton seed mass fraction
ERM-BF424a Maize (GMO) 59122 maize mass fraction
ERM-BF424b Maize (GMO) 59122 maize mass fraction
ERM-BF424c Maize (GMO) 59122 maize mass fraction
ERM-BF424d Maize (GMO) 59122 maize mass fraction
IRMM-315 4-Deoxynivalenol in acetonitrile
4-Deoxynivalenol mass fraction
IRMM-316 Nivalenol in acetonitrile Nivalenol mass fraction
BCR-162R Soya-maize oil blend Fatty acid methyl ester (FAME) mass fractions
ERM-AC057 Aflatoxin B1 in acetonitrile Aflatoxin mass fraction
ERM-AC058 Aflatoxin B2 in acetonitrile Aflatoxin mass fraction
ERM-AC059 Aflatoxin G1 in acetonitrile Aflatoxin mass fraction
ERM-AC060 Aflatoxin G2 in acetonitrile Aflatoxin mass fraction
ERM-AD413 Plasmid DNA (GMO) MON 810 maize copy number ratio
ERM-BD273 Toasted bread Acrylamide mass fraction
ERM-BF413d Maize (GMO) MON 810 maize copy number ratio (addition of a certified value to an existing CRM)
ERM-BF420a Maize (GMO) 3272 maize mass fraction
ERM-BF420b Maize (GMO) 3272 maize mass fraction
ERM-BF420c Maize (GMO) 3272 maize mass fraction
ERM-BF425a Soya (GMO) 356043 GAT soya mass fraction
ERM-BF425b 356043 GAT soya (GMO) 356043 GAT soya mass fraction
ERM-BF425c 356043 GAT soya (GMO) 356043 GAT soya mass fraction
ERM-BF425d 356043 GAT soya (GMO) 356043 GAT soya mass fraction
ERM-BF426a Soya (GMO) 305423 OH soya mass fraction
ERM-BF426b Soya (GMO) 305423 OH soya mass fraction
ERM-BF426c Soya (GMO) 305423 OH soya mass fraction
ERM-BF426d Soya (GMO) 305423 OH soya mass fraction
IRMM-425 Tetramethylurea D/H ratio (Masterbatch)
43
Material code Matrix Certified property
IRMM-448 Genomic DNA of Campylobacter jejuni
Identity
IRMM/IFCC466 Glycated haemoglobin (HbA1c)
Purity
IRMM/IFCC467 Haemoglobin (HbA0) Purity
IRMM-804 Rice flour Trace element mass fraction
BCR-263R Peanut meal Aflatoxin mass fraction
BCR-380R Whole milk powder Crude protein, fat, lactose, ash mass fraction
BCR-385R Peanut butter Aflatoxin mass fraction
BCR-401R Peanut butter Aflatoxin mass fraction
BCR-685 Skim milk powder Crude protein, fat, lactose, ash mass fraction
ERM-BB124 Pork muscle Nitroimidazole mass fraction
ERM-BF410ak Soya (GMO) Roundup-ready soya
ERM-BF410bk Soya (GMO) Roundup-ready soya
ERM-BF410dk Soya (GMO) Roundup-ready soya
ERM-BF410gk Soya (GMO) Roundup-ready soya
IRMM-311 Genomic DNA of Bacillus licheniformis DSM 5749
Fragment length in the size interval 50 - 90 kb
IRMM-312 Genomic DNA of Bacillus subtilis DSM 5750
Fragment length in the size interval 15 - 97 kb
IRMM-351 Bioball Colony forming units of Escherichia Coli per sphere
IRMM-352 Bioball Colony forming units of Salmonella Enteriditis per sphere
STA-003k Tetramethylurea D/H ratio
ERM-BE376 Compound feedingstuff Aflatoxin mass fraction
ERM-BF413ak Maize (GMO) MON 810 maize mass fraction
ERM-BF413ck Maize (GMO) MON 810 maize mass fraction
ERM-BF413ek Maize (GMO) MON 810 maize mass fraction and copy number ratio
ERM-BF413gk Maize (GMO) MON 810 maize mass fraction
ERM-BF427a Maize (GMO) 98140 maize mass fraction
ERM-BF427b Maize (GMO) 98140 maize mass fraction
ERM-BF427c Maize (GMO) 98140 maize mass fraction
ERM-BF427d Maize (GMO) 98140 maize mass fraction
ERM-BF428a Cotton seed (GMO) GHB119 cotton seed mass fraction
ERM-BF428b Cotton seed (GMO) GHB119 cotton seed mass fraction
ERM-BF428c Cotton seed (GMO) GHB119 cotton seed mass fraction
IRMM-354 Bioball Colony forming units of Candida albicans per sphere
IRMM-355 Bioball Colony forming units of Enterococcus faecalis per sphere
ERM-BB130 Pork muscle Chloramphenicol (CAP) mass fraction
ERM-BB384 Pork muscle Proximate mass fraction
ERM-BC381 Rye flour Proximate mass fraction
ERM-BC382 Wheat flour Proximate mass fraction
ERM-BE375 Animal feed Aflatoxin mass fraction
ERM-BF429a Cotton seed (GMO) T30-40 cotton seed mass fraction
ERM-BF429b Cotton seed (GMO) T30-40 cotton seed mass fraction
ERM-BF429c Cotton seed (GMO) T30-40 cotton seed mass fraction
ERM-AD415 Plasmid DNA (GMO) NK603 maize copy number ratio
44
Material code Matrix Certified property
ERM-AD425 Plasmid DNA (GMO) 356043 soya copy number ratio
ERM-AD427 Plasmid DNA (GMO) 98140 maize copy number ratio
ERM-BB386 Bovine urine Stilbene mass fraction
ERM-BB389 Bovine urine Stilbene mass fraction
ERM-BB492 Milk powder Oxytetracycline (OTC) mass fraction
ERM-BB493 Milk powder Oxytetracycline (OTC) mass fraction
ERM-BD600 Milk Powder Vitamin mass fraction
ERM-BF415e Maize (GMO) NK603 maize copy number ratio (addition of a certified value to an existing CRM)
ERM-BF425c Soya (GMO) 356043 soya copy number ratio (addition of a certified value to an existing CRM)
ERM-BF427c Maize (GMO) 98140 maize copy number ratio (addition of a certified value to an existing CRM)
ERM-BF430a Potato (GMO) AM04-1020 potato mass fraction
ERM-BF430b Potato (GMO) AM04-1020 potato mass fraction
ERM-BF430c Potato (GMO) AM04-1020 potato mass fraction
ERM-BF430d Potato (GMO) AM04-1020 potato mass fraction
ERM-BF430e Potato (GMO) AM04-1020 potato mass fraction
ERM-BB184 Bovine muscle Trace elements mass fraction
ERM-BB186 Pig kidney Trace elements mass fraction
ERM-BF431a Potato (GMO) AV43-6-G7 potato mass fraction
ERM-BF431b Potato (GMO) AV43-6-G7 potato mass fraction
ERM-BF431c Potato (GMO) AV43-6-G7 potato mass fraction
ERM-BF431d Potato (GMO) AV43-6-G7 potato mass fraction
ERM-BF431e Potato (GMO) AV43-6-G7 potato mass fraction
ERM-BF432a Soya (GMO) DAS-68416-4 soya mass fraction
ERM-BF432b Soya (GMO) DAS-68416-4 soya mass fraction
ERM-BF432c Soya (GMO) DAS-68416-4 soya mass fraction
ERM-BF432d Soya (GMO) DAS-68416-4 soya mass fraction
ERM-BF433a Maize (GMO) DAS-40278-9 maize mass fraction
ERM-BF433b Maize (GMO) DAS-40278-9 maize mass fraction
ERM-BF433c Maize (GMO) DAS-40278-9 maize mass fraction
ERM-BF433d Maize (GMO) DAS-40278-9 maize mass fraction
ERM-BC211 Rice As species
ERM-BD150 Milk powder Trace and essential element mass fraction
ERM-BD151 Milk powder Trace and essential element mass fraction
ERM-BF434a Rapeseed (GMO) 73496 rapeseed mass fraction
ERM-BF434b Rapeseed (GMO) 73496 rapeseed mass fraction
ERM-BF434c Rapeseed (GMO) 73496 rapeseed mass fraction
ERM-BF434d Rapeseed (GMO) 73496 rapeseed mass fraction
ERM-BF434e Rapeseed (GMO) 73496 rapeseed mass fraction
ERM-BF436a Soya (GMO) DAS-44406-6 soya mass fraction
ERM-BF436b Soya (GMO) DAS-44406-6 soya mass fraction
ERM-BF436c Soya (GMO) DAS-44406-6 soya mass fraction
ERM-BF436d Soya (GMO) DAS-44406-6 soya mass fraction
ERM-BF436e Soya (GMO) DAS-44406-6 soya mass fraction
45
Material code Matrix Certified property
STA-003m Tetramethylurea D/H ratio
ERM-BF437a Soya (GMO) DAS-81419-2 soya mass fraction
ERM-BF437b Soya (GMO) DAS-81419-2 soya mass fraction
ERM-BF437c Soya (GMO) DAS-81419-2 soya mass fraction
ERM-BF437d Soya (GMO) DAS-81419-2 soya mass fraction
ERM-BC717 Maize two additional values for DON and NIV
ERM-BF435a Potato (GMO) PH05-026-0048 potato identity
ERM-BF435b Potato (GMO) PH05-026-0048 potato identity
ERM-AD442k DNA in buffer lambda DNA mass concentration
ERM-BF438a Maize (GMO) VCO-Ø18195 maize mass fraction
ERM-BF438b Maize (GMO) VCO-Ø18195 maize mass fraction
ERM-BF438c Maize (GMO) VCO-Ø18195 maize mass fraction
ERM-BF438d Maize (GMO) VCO-Ø18195 maize mass fraction
ERM-BF439a Maize (GMO) DP- ØØ1441-3 maize mass fraction
ERM-BF439b Maize (GMO) DP- ØØ1441-3 maize mass fraction
ERM-BF439c Maize (GMO) DP- ØØ1441-3 maize mass fraction
ERM-BF439d Maize (GMO) DP- ØØ1441-3 maize mass fraction
ERM-BF439e Maize (GMO) DP- ØØ1441-3 maize mass fraction
46
Table A2: Food & feed RMs (non-certified) released by JRC-IRMM in 2006-2015
Material code Matrix Property of interest Purpose of material
QCM-GHa500 BSE GENERIC HOMOGENATE (1:10 positive/negative dilution)
Mass fraction of BSE positive brain BSE testing – quality control
QCM-tgMB-147 BSE TRANSGENIC MOUSE BRAIN (147 days) Mass fraction of BSE positive brain BSE testing –
quality control
QCM-tgMB-220 BSE TRANSGENIC MOUSE BRAIN (220 days) Mass fraction of BSE positive brain BSE testing –
quality control
QCM-tgMB-98 BSE TRANSGENIC MOUSE BRAIN (98 days)
Mass fraction of BSE positive brain BSE testing – quality control
CRL-MYC_2007_04 Standard solution acetonitrile Aflatoxins Support EURL /
PT CRL-MYC_2007_05 Standard solution Ochratoxin Support EURL /
PT CRL-MYC_2008_06
Standard solution Deoxynivanenol Support EURL / PT
CRL-MYC_2008 Standard solution Fuominisin Support EURL / PT
CRL-MYC_2009 Standard solution T2 HT2 standard Support EURL / PT
EURL-MYC_2010_a
Standard solution HAc and ACN
Ochratoxin Support EURL / PT
EURL-MYC_2010_b
Standard solution HAc and ACN Ochratoxin Support EURL /
PT EURL-MYC_2010_c
Standard solution HAc and ACN Ochratoxin Support EURL /
PT EURL-MYC_2010_d
Standard solution HAc and ACN Ochratoxin Support EURL /
PT EURL-MYC_2010_e
Standard solution HAc and ACN Ochratoxin Support EURL /
PT
EURL-MYC_2011 Standard solution K2Cr2O7 Support EURL / PT
EURL-MYC_2011 Standard solution in toluene / ACN Aflatoxin B Support EURL /
PT
EURL-MYC_2011 Standard solution HAc and ACN Ochratoxin Support EURL /
PT
EURL-MYC_2012 Standard solution Ochratoxin Support EURL / PT
EURL-MYC_2013 Coconut Aflatoxins Support EURL / PT
EUR-MYC_2015a Nutmeg Ochrataoxin Support EURL / PT
EUR-MYC_2015b Nutmeg Ochrataoxin Support EURL / PT
CRL-PAH-2006_01 Acetonitrile standard Polycyclic aromatic hydrocarbons, PAH Support EURL /
PT CRL-PAH_2007_02a Acetonitrile standard Polycyclic aromatic hydrocarbons, PAH,
15+1 Support EURL / PT
CRL-PAH-2007_03 Edible oil
Polycyclic aromatic hydrocarbons, PAH, 15+1
Support EURL / PT
CRL-PAH_2008 Standard solution Polycyclic aromatic hydrocarbons, PAH, 15+1
Support EURL / PT
CRL-PAH_2009_05
Standard in toluene cyclohexane
Polycyclic aromatic hydrocarbons, PAH, 15+1
Support EURL / PT
CRL-PAH_2009_05
Mineral oil in solvent Polycyclic aromatic hydrocarbons, PAH, 15+1
Support EURL / PT
CRL-PAH_2009_06 Standard solution Polycyclic aromatic hydrocarbons, PAH,
15+1 Support EURL / PT
CRL-PAH_2009_07 Olive oil / ACN Polycyclic aromatic hydrocarbons, PAH,
15+1 Support EURL / PT
47
Material code Matrix Property of interest Purpose of material
CRL-PAH_2009_08 Olive oil Polycyclic aromatic hydrocarbons, PAH,
15+1 Support EURL / PT
EURL-PAH_2010_a
Standard solution PT infant formula
Polycyclic aromatic hydrocarbons, PAH, 15+1
Support EURL / PT
EURL-PAH_2010_b
Standard solution PT infant formula
Polycyclic aromatic hydrocarbons, PAH, 15+1
Support EURL / PT
EURL-PAH_2010_c
Standard solution PT infant formula
Polycyclic aromatic hydrocarbons, PAH, 15+1
Support EURL / PT
EURL-PAH_2010_d
Standard solution PT infant formula
Polycyclic aromatic hydrocarbons, PAH, 15+1
Support EURL / PT
EURL-PAH_2010_e
Standard solution PT infant formula
Polycyclic aromatic hydrocarbons, PAH, 15+1
Support EURL / PT
EURL-PAH_2010_f
Standard solution, PT olive oil
Polycyclic aromatic hydrocarbons, PAH, 15+1
Support EURL / PT
EURL-PAH_2010_g
Standard solution, PT olive oil
Polycyclic aromatic hydrocarbons, PAH, 15+1
Support EURL / PT
EURL-PAH_2010_h
Standard solution, PT olive oil
Polycyclic aromatic hydrocarbons, PAH, 15+1
Support EURL / PT
EURL-PAH_2010_i
Standard solution, PT olive oil
Polycyclic aromatic hydrocarbons, PAH, 15+1
Support EURL / PT
EURL-PAH_2010_j
Standard solution, PT olive oil
Polycyclic aromatic hydrocarbons, PAH, 15+1
Support EURL / PT
EURL-PAH_2011-07a
ACN solution food supplement
Polycyclic aromatic hydrocarbons, PAH, 15+1
Support EURL / PT
EURL-PAH_2011-07b
ACN solution food supplement
Polycyclic aromatic hydrocarbons, PAH, 15+1
Support EURL / PT
EURL-PAH_2011-07c
Toluene solution food supplement
Polycyclic aromatic hydrocarbons, PAH, 15+1
Support EURL / PT
EURL-PAH_2011-07d
Toluene solution food supplement
Polycyclic aromatic hydrocarbons, PAH, 15+1
Support EURL / PT
EURL-PAH_2011-08
Standard solution toluene / cyclohexane
Polycyclic aromatic hydrocarbons, PAH, 15+1
Support EURL / PT
EURL-PAH_2011-09a ACN / oil Polycyclic aromatic hydrocarbons, PAH,
15+1 Support EURL / PT
EURL-PAH_2011-09b Toluene / oil Polycyclic aromatic hydrocarbons, PAH,
15+1 Support EURL / PT
EURL-PAH_2011-09c Oil Polycyclic aromatic hydrocarbons, PAH,
15+1 Support EURL / PT
EURL-PAH_2012a Standard solution, ACN Polycyclic aromatic hydrocarbons, PAH,
15+1 Support EURL / PT
EURL-PAH_2012b Standard solution, toluene Polycyclic aromatic hydrocarbons, PAH,
15+1 Support EURL / PT
EURL-PAH_2012c Standard solution, toluene Polycyclic aromatic hydrocarbons, PAH,
15+1 Support EURL / PT
EURL-PAH_2012d Standard solution, toluene Polycyclic aromatic hydrocarbons, PAH,
15+1 Support EURL / PT
EURL-PAH_2013 Olive oil 4 PAHs EURL / PT
EURL-PAH_2013 Standard solution, ACN / toluene PAHs, (15+1) EURL / PT
EURL-PAH_2014_1 wine phtalates EURL / PT
EURL- wine phtalates EURL / PT
48
Material code Matrix Property of interest Purpose of material
PAH_2014_2
EURL-PAH_2014_3 wine phtalates EURL / PT
EURL-PAH_2014_4 wine phtalates EURL / PT
EURL-PAH_2014_5
Iso-octane phtalates EURL / PT
EURL-PAH_2014_6 Iso-octane phtalates EURL / PT
EURL-PAH_2014a Pork fat in solvent Boar taint EURL / PT
EURL-PAH_2014b
Pork fat in solvent Boar taint EURL / PT
EURL-PAH_2014c Pork fat in solvent Boar taint EURL / PT
EURL-PAH_2014d Pork fat in solvent Boar taint EURL / PT
EURL-PAH_2014e Pork fat in solvent Boar taint EURL / PT
EURL-PAH_2014f Pork fat in solvent Boar taint EURL / PT EURL-PAH_2014g
Pork fat in solvent Boar taint EURL / PT
EURL-PAH_2014h Pork fat in solvent Boar taint EURL / PT
EURL-PAH_2014i Pork fat in solvent Boar taint EURL / PT
EURL-PAH_2014 Fish oil PAHs, 15+1 EURL / PT
IMEP-102_2007 Acidified standard solutions Pb, Cd, Hg in mineral water EURL / PT
IMEP-103_2007 Fish feed Pb, Cd, Hg in fish feed EURL / PT
IMEP-104_2008 Lobster hepatopancreas Cd, Pb, Hg, methyl-Hg ,As EURL / PT
IMEP-105_2008 Mineral mix Cd, Pb, Hg and extractable Cd and Pb EURL / PT HM-EURL_IMEP-106_2009
Green tea Pb, Hg, Cd, As EURL / PT
HM-EURL_IMEP-107_2009 Rice Astot and inorganic As EURL / PT
HM-EURL_IMEP-109_2009 Dogfish liver tissue Pb, Hg, Cd, As EURL / PT
HM-EURL_IMEP-110_2010
Spinach leaves Pb, Hg, Cd, As EURL / PT
HM-EURL_IMEP-111_2010 Mineral feed Pb, Hg, Cd, As EURL / PT
HM-EURL_IMEP-112_2011 Wheat Astot and inorganic As EURL / PT
HM-EURL_IMEP-113_2011
Baby food ,soya milk Cd and Pb EURL / PT
IMEP-114_2012 Feed premix Pb, Hg, Cd, As and Sn EURL / PT HM-EURL_IMEP-115a_2012
Dogfish liver tissue Methyl mercury EURL / PT
HM-EURL_IMEP-115b_2012 Lobster hepatopancreas Methyl mercury EURL / PT
HM-EURL_IMEP-115c_2012 Oyster tissue Methyl mercury EURL / PT
HM-EURL_IMEP-115d_2012
Mussel tissue Methyl mercury EURL / PT
HM-EURL_IMEP-115e_2012 Tuna fish Methyl mercury EURL / PT
HM-EURL_IMEP-116_2013 Mushroom Cd, Pb, As, Hg and Sn EURL / PT
49
Material code Matrix Property of interest Purpose of material
HM-EURL_IMEP-117_2013 Feed premix Cd, Pb, As, Hg EURL / PT
HM-EURL_IMEP-118_2013
Canned vegetables (peas) Cd, As, Pb, Sn EURL / PT
HM-EURL_IMEP-119_2014 Alfalfa Cd, Pb, As EURL / PT
HM-EURL_HM-20_2015 Dark chocolate
Cd, Pb EURL / PT
HM-EURL_IMEP-121_2015 Kaolinitic clay Cd, Pb, As, Hg EURL / PT
IMEP-25_1_2009 Soft drinking water Bromate Support to CEN
IMEP-25_2_2009 Hard drinking water Bromate Support to CEN
IMEP-25_3_2009 Mineral water Bromate Support to CEN
IMEP-25_4_2009 Swimming pool water Bromate Support to CEN
IMEP-25_5_2009 Raw water Bromate Support to CEN
IMEP-25_6_2009 Blank Bromate Support to CEN
IMEP-25_7_2009 Standard solution Bromate Support to CEN
IMEP-32_1_2011 Fish feed blank Inorganic As Support to CEN
IMEP-32_2_2011 Fish feed spiked Inorganic As Support to CEN
IMEP-32_3_2011 Fish meal blank Inorganic As Support to CEN
IMEP-32_4_2011 Fish meal spiked Inorganic As Support to CEN
IMEP-32_5_2011 Fish fillets spiked Inorganic As Support to CEN
IMEP-32_6_2011 Fish meal spiked Inorganic As Support to CEN
IMEP-32_7_2011 Fish meal blank Inorganic As Support to CEN
IMEP-35_2012 Lipstick Pb EURL / PT
IMEP-41a_2014 Rice Inorganic As Support to CEN
IMEP-41b_2014 Wheat Inorganic As Support to CEN
IMEP-41c_2014 Mussel Inorganic As Support to CEN
IMEP-41d_2014 Cabbage Inorganic As Support to CEN
IMEP-41e_2014 Mushroom Inorganic As Support to CEN
IMEP-41f_2014 Seaweed Inorganic As Support to CEN
IMEP-41g_2014 Fish Inorganic As Support to CEN
IMEP-41h_2014 Rice Inorganic As Support to CEN
50
Material code Matrix Property of interest Purpose of material
IMEP-42_2015 Fish PFOA EURL / PT
REM_A_2012 Fresh water (mineral) Radionuclides PT / intercomparison
REM_B_2012 Fresh water (mineral) Radionuclides PT / intercomparison
REM_C_2012 Fresh water Radionuclides PT / intercomparison
SAFEED-PAP_A_2008 Animal feed Meat and bone meal (rests of PAP) EU project
SAFEED-PAP
SAFEED-PAP_B_2008 Animal feed Meat and bone meal (rests of PAP) EU project
SAFEED-PAP SAFEED-PAP_C_2008 Animal feed Meat and bone meal (rests of PAP) EU project
SAFEED-PAP SAFEED-PAP_D_2008 Animal feed Meat and bone meal (rests of PAP) EU project
SAFEED-PAP
IRMM-AD482 Plasmid DNA in buffer Ruminant DNA copy number concentration
Support to EURL / method validation
IRMM-AD483 Plasmid DNA in buffer Porcine DNA copy number concentration Support to EURL / method validation
CT-01/2010 GMO powder NK603 maize Support to EURL / PT
CT-02/2010 GMO powder MON 810 maize Support to EURL / PT
CT 01/2013 GMO powder 98140 maize Support to EURL / PT
CT 02/2013 GMO powder 356043 soybean Support to EURL / PT
CT 01/2014 GMO powder NK603 maize Support to EURL / PT
CT 02/2014 GMO powder DAS 40278-9 maize Support to EURL / PT
CT 01/2015 GMO powder 356043 soybean Support to EURL / PT
CT 02/2015 GMO powder DAS-81419-2 soybean and 68416-4 soybean
Support to EURL / PT
CT 01/2016 GMO powder DAS 40278-9 maize Support to EURL / PT
51
Table A3: Health diagnostic CRMs released by JRC-IRMM in 2006-2015
Material code Matrix Certified property
IRMM-468 Thyroxine (T4) Purity
IRMM-469 Triiodothyronine (T3) Purity
BCR-348R Human serum Progesteron mass fraction
IRMM/IFCC-490 Plasmid DNA preparation Identity for prothrombin wild type (homozygous)
IRMM/IFCC-491 Plasmid DNA preparation Identity for prothrombin mutation (homozygous)
IRMM/IFCC-492 Plasmid DNA preparation Identity for prothrombin mutation (heterozygous)
IRMM-435 Pharmaceutical glass Leachable alkali metal
ERM-DA470k/IFCC
Human serum Serum proteins
ERM-AD457/IFCC Enzyme preparation Aspartate transaminase activity
ERM-DA472/IFCC Human serum C-reactive protein (CRP) mass fraction
ERM-DA471/IFCC Human serum Cystatin C mass fraction
ERM-DA474 Human Serum C-reactive protein (CRP) mass fraction
ERM-AD623a Plasmid in buffer BCR-ABL copy number concentration
ERM-AD623b Plasmid in buffer BCR-ABL copy number concentration
ERM-AD623c Plasmid in buffer BCR-ABL copy number concentration
ERM-AD623d Plasmid in buffer BCR-ABL copy number concentration
ERM-AD623e Plasmid in buffer BCR-ABL copy number concentration
ERM-AD623f Plasmid in buffer BCR-ABL copy number concentration
ERM-DB001 Human hair Trace elements mass fraction
ERM-DA470k Human serum B2M mass fraction (addition of a certified value to an existing CRM)
ERM-DA476/IFCC Human serum anti-MPO IgG mass fraction
52
Table A4: Environmental CRMs released by JRC-IRMM in 2006-2015
Material code Matrix Certified property
ERM-CA615 Groundwater Trace element mass fraction
ERM-CA616 Groundwater Major element mass fraction
ERM-CA713 Waste water Trace elements mass fraction
IRMM-428 Water Polyfluorinated alkyl substances (PFAS) mass fraction
ERM-CA408 Simulated rainwater Major element mass fraction
ERM-AC213 Pure solution Polycyclic aromatic hydrocarbon (PAH) mass fraction
ERM-CZ100 PM10-like dust Polycyclic aromatic hydrocarbon (PAH) mass fraction
ERM-CZ120 PM10-like dust Trace element mass fraction
BCR-277R Estuarine sediment Trace element mass fraction
BCR-280R Lake sediment Trace element mass fraction
BCR-320R Channel sediment Trace element mass fraction
BCR-176R Fly ash Trace element mass fraction
IRMM-540R Oxide glass U mass fraction
IRMM-541 Oxide glass U mass fraction
IRMM-007/1-6 64Zn in 0.5 M HNO3 Isotope amount content
IRMM-3702 64Zn in 1 M HNO3 Isotope amount content
IRMM-643 32S in 2.8 M HNO3 Isotope amount content
IRMM-644 32S in 3.2 M HNO3 Isotope amount content
IRMM-645 32S in 2.8 M HNO3 Isotope amount content
IRMM-646 34S in 2.8 M HNO3 Isotope amount content
IRMM-651 64Zn in 0.5 M HNO3 Isotope amount content
IRMM-652 64Zn enriched in 0.5 M HNO3 Isotope amount content
IRMM-653 67Zn in 0.5 M HNO3 Isotope amount content
IRMM-654 68Zn in 0.5 M HNO3 Isotope amount content
ERM-BB350 Fish oil Polychlorinated biphenyl (PCB) mass fraction
ERM-CC141 Loam soil Trace element mass fraction
ERM-CD281 Rye grass Trace element mass fraction
ERM-BB422 Fish Trace elements mass fraction
ERM-CC141 Sediment Hg mass fraction (addition of a certified value to an existing CRM)
ERM-CE278k Mussel tissue Trace elements mass fraction
ERM-CD200 Bladderwrack Trace element mass fraction
ERM-EF001 Biodiesel Fuel parameters according to EN 14214:2012
IRMM-426 Wild berries Radionuclide activity concentration
IRMM-427 Pike-Perch Polyfluorinated alkyl substances (PFAS) mass fraction
53
Table A5: Environmental RMs (non-certified) released by JRC-IRMM in 2006-2015
Material code Matrix Property of interest Purpose of material
IMEP-40_2014 Seawater Cd, Co, Cr, Cu, Fe, Mn, Mo, Ni, Pb, Se, Zn EURL / PT
EMRP-ENV08_2014 Whole water Polybrominated biphenyl ethers, PBDE EMRP project
ENV08 EMRP-ENV08_2014 Whole water Polycyclic aromatic hydrocarbons, PAH
EMRP project ENV08
EMRP-ENV08_2014 Whole water Tributyl tin, PAH EMRP project
ENV08 EMRP-ENV08_2014
Model (suspended) Particulate matter, sediment PBDEs EMRP project
ENV08 EMRP-ENV08_2014
Model (suspended) Particulate matter, soil PAHs
EMRP project ENV08
EMRP-ENV08_2014
Model (suspended) Particulate matter, sediment TBT EMRP project
ENV08 EMRP-ENV08_2014 Humic acid solution, HA Technical grade HA solution EMRP project
ENV08 EMRP-ENV08_2014 Whole water PBDEs
CEN method standardisation
EMRP-ENV08_2014 Whole water PAHs CEN method
standardisation EMRP-ENV08_2014 Whole water TBT CEN method
standardisation
IAEA 375 Soil Radionuclides Material for intercomparison
54
Table A6: Engineering CRMs released by JRC-IRMM in 2006-2015
Material code Matrix Certified property
ERM-FD100 Silica in suspension Nanoparticle size
ERM-FD102 Silica in suspension Nanoparticle size
ERM-FD304 Silica in suspension Nanoparticle size
ERM-EC680k Polyethylene Trace element mass fraction
ERM-EC681k Polyethylene Trace element mass fraction
ERM-EC590 Polyethylene Brominated flame retardant mass fraction
ERM-EC591 Polypropylene Brominated flame retardant mass fraction
ERM-EF211 Petrol S mass fraction
IRMM-018a Silicon dioxide Si isotope ratios
BCR-261T Ta2O5 on Ta Areal density of oxygen atoms, oxide thickness ratio
ERM-FA013at Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA013ax Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA016at Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA016av Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA415k Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA415l Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA415m Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA415n Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA415o Steel Impact toughness according to ISO-148 (Charpy test)
IRMM-521R Ni foil Co mass fraction
BCR-724A Glass ceramic Thermal conductivity, thermal diffusivity
BCR-724B Glass ceramic Thermal conductivity, thermal diffusivity
BCR-724C Glass ceramic Thermal conductivity, thermal diffusivity
BCR-724D Glass ceramic Thermal conductivity, thermal diffusivity
ERM-FA013az Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA013bb Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA014p Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA015u Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA016aw Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA016az Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA013ba Steel Impact toughness according to ISO-148 (Charpy test) (master batch 30 J)
ERM-FA013bb Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA013bc Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA013bd Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA015v Steel Impact toughness according to ISO-148 (Charpy test) (Master batch 80 J)
ERM-FA016ax Steel Impact toughness according to ISO-148 (Charpy test) (Master batch 120 J)
ERM-FA016ay Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA016ba Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA415p Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA415r Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA013be Steel Impact toughness according to ISO-148 (Charpy test)
55
ERM-FA013bf Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA014q Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA015w Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA016bb Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA016bc Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA415t Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA013ay Steel Impact toughness according to ISO-148 (Charpy test) (master batch 30 J)
ERM-FA013bg Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA013bh Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA015x Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA015y Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA415u Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA013bi Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA013bj Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA016be Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA415s Steel Impact toughness according to ISO-148 (Charpy test) (master batch 150 J)
ERM-FA415v Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA415w Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FC395k Diesel Cold filter plugging point (CFPP), Cloud point (CP)
ERM-EF411 Hard coal Proximates and trace element mass fraction
ERM-EF412 Brown Coal Proximates and trace element mass fraction
ERM-EF413 Furnace coke Proximates and trace element mass fraction
ERM-FA013bk Steel Impact toughness at 0 °C according to ISO-148 (Charpy test)
ERM-FA013bl Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA013bs Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA013bt Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA016bf Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA016bg Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA415aa Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA415w Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA415z Steel Impact toughness according to ISO-148 (Charpy test)
IRMM-471 Cementite Carbon mass fraction
BCR-089 TiAl6V4 Trace element mass fraction (addition of certified values to an existing CRM)
ERM-EB530A Al Au mass fraction (calibrant for k0-INAA)
ERM-EB530B Al Au mass fraction (calibrant for k0-INAA)
ERM-EB530C Al Au mass fraction (calibrant for k0-INAA)
ERM-FA013bm Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA013bn Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA015ab Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA415ab Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA415ac Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA415ad Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA415ae Steel Impact toughness according to ISO-148 (Charpy test)
ERM-EB074A Electrolytic Cu Trace element mass fraction
56
ERM-EB074B Electrolytic Cu Trace element mass fraction
ERM-EB074C Electrolytic Cu Trace element mass fraction
ERM-EB075A Electrolytic Cu with added impurities
Trace element mass fraction
ERM-EB075B Electrolytic Cu with added impurities
Trace element mass fraction
ERM-EB075C Electrolytic Cu with added impurities
Trace element mass fraction
ERM-FA013bu Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA013bv Steel Impact toughness according to ISO-148 (Charpy test)
ERM-FA013bw Steel Impact toughness according to ISO-148 (Charpy test)
57
Table A7: Engineering RMs (non-certified) released by JRC-IRMM in 2006-2015
Material code Matrix Property of interest Purpose of material
IRMM-304 Silica in suspension Nanoparticle size Quality control, method developments
IRMM-310 Poly(ethyleneterephthalate) Brominated flame retardant mass fraction Quality control
IMEP-22 Petrol Sulfur Intercomparisons
Nanolyse_2011 Aqueous solution nano Ag low EU project Nanolyse
Nanolyse_2011 Aqueous solution nano Ag high EU project Nanolyse
Nanolyse_2011 Aqueous solution Silica low EU project Nanolyse
Nanolyse_2011 Aqueous solution Silica high EU project Nanolyse
Nanolyse_2011 Rapeseed oil Fullerenes, C60 (low) EU project Nanolyse
Nanolyse_2011 Rapeseed oil Fullerenes, C60 (high) EU project Nanolyse
Nanolyse_2011 Tomato soup Silica low EU project Nanolyse
Nanolyse_2011 Tomato soup Silica high EU project Nanolyse
Nanolyse_2012 Chicken paste nano Ag low EU project Nanolyse
Nanolyse_2012 Chicken paste nano Ag high EU project Nanolyse
Nanolyse_2012 Aquarius nano gelatine (low) EU project Nanolyse
Nanolyse_2012 Aquarius nano gelatine (high) EU project Nanolyse
Nanolyse_2012 Aquarius + ethanol nano gelatine (low) EU project Nanolyse
Nanolyse_2012 Aquarius + ethanol nano gelatine (high) EU project Nanolyse
Nanochop_01-2013 Aqueous solution Colloidal silica EU project Nanochop
Nanochop_02_2013 Aqueous solution Non-aminated silica EU project Nanochop
Nanochop_03_2013 Aqueous solution Quantum dots EU project Nanochop
IRMM-380_2014 Pigment Pigment yellow 83 EU project Nanochop
IRMM-381_2014 Fine chemical Barium sulfate EU project Nanodefine
IRMM-382_2014 Nanomaterial Carbon nanotubes EU project Nanodefine
IRMM-383_2014 Nanomaterial Nano steel EU project Nanodefine
IRMM-384_2014 Fine chemical (salt) Calcium carbonate EU project Nanodefine
IRMM-385_2014 Clay Kaolin EU project Nanodefine
IRMM-386_2014 Pigment Pigment yellow 83 opaque EU project Nanodefine
IRMM-387_2014 Fine chemical (salt) NM-220 Barium sulfate EU project Nanodefine
IRMM-388_2014 Fine chemical (oxide) TiO2 K2360 EU project Nanodefine
IRMM-389_2014 Polymer Amino methacrylate copolymer EU project Nanodefine
Nanodefine_2014 Polymer Nanopolymer mono-modal EU project Nanodefine
Nanodefine_2014 Polymer Nanopolymer tri-modal EU project Nanodefine
Nanodefine_2014 Polymer Silica tri-modal EU project Nanodefine
BIOREMA_1_2009 Biodiesel, B100 Numerous properties in fuel EU project Biorema
BIOREMA_2_2009 Biodiesel, B100 Numerous properties in fuel EU project Biorema
BIOREMA_3_2009 Biodiesel, B100 Numerous properties in fuel EU project Biorema
Quovadis_2006 Acid digest Heavy metals EU project Quovadis
58
Table A8: Nuclear CRMs released by JRC-IRMM in 2006-2015
Material code Matrix Certified property
IRMM-074 series 1 M HNO3 U-233/U-235 ratio,U-233/U-238 ratio, U-235/U-238 ratio
IRMM-1027i dried nitrate in CAB U-235, U-238 and Pu-239 amount content, U and Pu isotope amount ratios, mass
IRMM-075 series 1 M HNO3 U-236/U-238 ratio
IRMM-081a 5 M HNO3 Pu-239 amount content, Pu isotope amount ratios
IRMM-086 5 M HNO3 Pu-239 amount content, Pu isotope amount ratios
IRMM-1027j dried nitrate in CAB U-235, U-238 and Pu-239 amount content, U and Pu isotope amount ratios, mass
IRMM-3183 1 M HNO3 U isotope amount ratios
IRMM-3184 1 M HNO3 U isotope amount ratios
IRMM-3185 1 M HNO3 U isotope amount ratios
IRMM-3186 1 M HNO3 U isotope amount ratios
IRMM-3187 1 M HNO3 U isotope amount ratios
IRMM-1027k dried nitrate in CAB U-235, U-238 and Pu-239 amount content, U and Pu isotope amount ratios, mass
IRMM-3100 1 M HNO3 U isotope amount ratios
IRMM-3102 1 M HNO3 U isotope amount ratios
IRMM-3636 1 M HNO3 U-236, U-233 amount content, U isotope amount ratios
IRMM-3636a 1 M HNO3 U-236, U-233 amount content, U isotope amount ratios
IRMM-3636b 1 M HNO3 U-236, U-233 amount content, U isotope amount ratios
IRMM-3660 1 M HNO3 U-236 amount content, U isotope amunt ratios
IRMM-3660a 1 M HNO3 U-236 amount content, U isotope amunt ratios
IRMM-3660b 1 M HNO3 U-236 amount content, U isotope amunt ratios
IRMM-1027m dried nitrate in CAB U-235, U-238 and Pu-239 amount content, U and Pu isotope amount ratios, mass
IRMM-046b 5 M HNO3 U-233 and Pu-242 amount content, U and Pu isotope amount ratios
IRMM-1027n dried nitrate in CAB U-235, U-238 and Pu-239 amount content, U and Pu isotope amount ratios, mass
IRMM-3100a 1 M HNO3 U isotope amount ratios
IRMM-049d 5 M HNO3 Pu-242 amount content, Pu isotope amount ratios
IRMM-1027L dried nitrate in CAB U-235, U-238 and Pu-239 amount content, U and Pu isotope amount ratios, mass
IRMM-1027o dried nitrate in CAB U-235, U-238 and Pu-239 mass per vial, U and Pu isotope amount ratios
IRMM-019 UF6 U isotope amount ratios, U amount fractions, U mass fraction, U molar mass
IRMM-020 UF6 U isotope amount ratios, U amount fractions, U mass fraction, U molar mass
IRMM-021 UF6 U isotope amount ratios, U amount fractions, U mass fraction, U molar mass
IRMM-022 UF6 U isotope amount ratios, U amount fractions, U mass fraction, U molar mass
IRMM-023 UF6 U isotope amount ratios, U amount fractions, U mass fraction, U molar mass
IRMM-024 UF6 U isotope amount ratios, U amount fractions, U mass fraction, U molar mass
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Material code Matrix Certified property
IRMM-025 UF6 U isotope amount ratios, U amount fractions, U mass fraction, U molar mass
IRMM-026 UF6 U isotope amount ratios, U amount fractions, U mass fraction, U molar mass
IRMM-027 UF6 U isotope amount ratios, U amount fractions, U mass fraction, U molar mass
IRMM-028 UF6 U isotope amount ratios, U amount fractions, U mass fraction, U molar mass
IRMM-029 UF6 U isotope amount ratios, U amount fractions, U mass fraction, U molar mass
IRMM-046c 5 M HNO3 U-233 and Pu-242 amount content, U and Pu isotope amount ratios
IRMM-1027p dried nitrate in CAB U-235, U-238 and Pu-239 mass per vial, U and Pu isotope amount ratios
IRMM-1000a dried nitrate production date (via 234U/230Th chronometer)
IRMM-1000b dried nitrate production date (via 234U/230Th chronometer)
IRMM-1027q dried nitrate in CAB U-235, U-238 and Pu-239 mass per vial, U and Pu isotope amount ratios