Set of criteria with ranking system to steer the decision ... · NanoDefine Technical Report D7.4: Set of criteria with ranking system to steer the decision process for ma-terial

The research leading to these results has received funding from the European Community's Seventh FrameworkProgramme (FP7/2007-2013) under Grant Agreement n° 604347

The EU FP7 NanoDefine ProjectDevelopment of an integrated approach based on validated and standard-

ized methods to support the implementation of the EC recommendation

for a definition of nanomaterial

Set of criteria with ranking system tosteer the decision process for material

classification according to theEC nano-definition

NanoDefine Technical Report D7.4

Hans Marvin, Claire Gaillard, Hubert Rauscherand Agnieszka Mech

The NanoDefine Consortium 2014

NanoDefine Technical Report D7.4: Set of criteria with ranking system to steer the decision process for ma-terial classification according to the EC nano-definition

© 2014 The NanoDefine Consortium Page 2 of 31

NanoDefine in a nutshell

The EU FP7 NanoDefine project was launched in November 2013 and will run until October 2017. The pro-ject is dedicated to support the implementation of the EU Recommendation on the Definition of Nanomaterialby the provision of the required analytical tools and respective guidance. Main goal is to develop a noveltiered approach consisting of (i) rapid and cost-efficient screening methods and (ii) confirmatory measure-ment methods. The "NanoDefiner" eTool will guide potential end-users, such as concerned industries andregulatory bodies as well as enforcement and contract laboratories, to reliably classify if a material is nano ornot. To achieve this objective, a comprehensive inter-laboratory evaluation of the performance of currentcharacterisation techniques, instruments and software is performed. Instruments, software and methods arefurther developed. Their capacity to reliably measure the size of particulates in the size range 1-100 nm andabove (according to the EU definition) is validated. Technical reports on project results are published toreach out to relevant stakeholders, such as policy makers, regulators, industries and the wider scientificcommunity, to present and discuss our goals and results, to ensure a continuous exchange of views,needs and experiences obtained from different fields of expertise and application, and to finally integrate theresulting feedback into our ongoing work on the size-related classification of nanomaterials.

Bibliographic data

NanoDefine Technical Report D7.4

Report title: Set of criteria with ranking system to steer the decision process for material classifica-

tion according to the EC nano-definition

Authors: Marvin H.,1, Gaillard C.2, Rauscher H.2, Mech A.2

Contributors: Weigel S.1, Ghanem A.3, Mielke J.4, Wohlleben W.5, Larsen E. H.6 Tentschert J.7,

Jungnickel H.7, Stintz M.8, Friedrich C.9, van der Kammer F.10

Affiliations:1 Stichting Dienst Landbouwkundig Onderzoek (RIKILT)2 Institute for Health and Consumer Protection – Joint Research Centre (JRC-IHCP)3 Solvay SA (SOLVAY)4 Bundesanstalt fuer Materialforschung und Pruefung (BAM)5 BASF SE (BASF)6 Danmarks Tekniske Universitet (DTU)7 Bundesinstitut fuer Risikobewertung (BFR)8 Technische Universitaet Dresden (TUD)9 Fachhochschule Dortmund (FHDO)10 Universitaet Wien (UNIVIE)

Corresponding author: [email protected]



Publication date: 26/06/2014

Publisher: The NanoDefine Consortium

© Copyright 2014: The NanoDefine Consortium

Place of publication: Wageningen, the Netherlands

Citation: Marvin H.1, Gaillard. C., Rauscher H., Mech A.: Set of criteria with ranking system to steerthe decision process for material classification according to the EC nano-definition,NanoDefine Technical Report D7.4, NanoDefine Consortium, Wageningen, 2014

URL: http://www.nanodefine.eu

Contact: [email protected], www.nanodefine.eu



Table of Contents

1 Abbreviations and acronyms.......................................................................................62 Summary ....................................................................................................................83 Introduction .................................................................................................................94 Required and optional criteria ...................................................................................10

4.1 Purpose .................................................................................................................114.2 REACH registration ...............................................................................................164.3 Registration of cosmetics products ........................................................................184.4 French registration scheme ...................................................................................204.5 Danish registration scheme ...................................................................................22

5 Material Characteristics ............................................................................................246 Available equipment (optional information) ...............................................................257 Economic parameters (optional information) ............................................................258 Conclusions ..............................................................................................................269 References ...............................................................................................................27Annex 1 .............................................................................................................................28Annex 2 .............................................................................................................................30



Index of figures

Figure 1: Schematic presentation of the user interface components ..................................9Figure 2: Decision path. The criteria for the purposes of REACH are included as example

.....................................................................................................................................11Figure 3: Choice of purpose by the user of the NanoDefiner ............................................12Figure 4 : Decision path for a user registering a nanomaterial according to REACH........16Figure 5: Decision path for a user registering a nanomaterial in the CPNP......................18Figure 6: Pathway for a user registering a nanomaterial in the French register................20Figure 7: Pathway for a user registering a nanomaterial in the Danish registration scheme

.....................................................................................................................................23

Index of Tables

Table 1: Requirements for legal purposes: registration and enforcement .........................13Table 2 : Information required for REACH ........................................................................17Table 3: Required information for cosmetics products (as specified in the CPNP) ...........19Table 4: Required information for the French registration .................................................21Table 5 : Required information for the Danish registration according to the Danish

environmental protection agency. ................................................................................23



1 Abbreviations and acronyms

ANSES French Agency for Food, Environmental and Occupational Health andSafety

AFM Atomic Force MicroscopyAUC Analytical Disk- and Ultra-CentrifugationBET Brunauer–Emmett–Teller MethodBfR German Federal Institute for Risk AssessmentCAS Chemistry Abstract ServiceCE Capillary ElectrophoresisCLS Centrifugal Liquid SedimentationCPNP Cosmetics Products Notification PortalDLS Dynamic Light ScatteringDMA Differential Mobility AnalyserECHA European Chemicals AgencyEFSA European Food Safety AgencyEC European CommissionEU European UnionEM Electron MicroscopyEMA European Medicines AgencyFFF Field Flow FractionationFMPS Fast Mobility Particle SizerFTIR Fourier Transform Infrared SpectroscopyGC Gas ChromatographyGE Gel ElectrophoresisHDC Hydrodynamic ChromatographyHPLC High Performance Liquid ChromatographyICP-OES Inductively Coupled Plasma Atomic Emission SpectroscopyIUPAC International Union of Pure and Applied ChemistryLDE Laser Doppler ElectrophoresisNano SIMS Nano Secondary Ion Mass SpectrometryNMR Nuclear Magnetic Resonance



NVWA Netherlands Food and Consumer Product Safety AuthorityPCS Photon Correlation SpectroscopyREACH Regulation (EC) No 1907/2006 concerning the Registration, Evalua-

tion, Authorisation and Restriction of ChemicalsSAXS Small-angle X-Ray ScatteringSEM Scanning Electron MicroscopySERS Surface-enhanced Raman SpectroscopySMPS Scanning Mobility Particle SizerSPM Scanning Probe MicroscopyspICP-MS Single Particle Inductively Coupled Plasma Mass SpectrometryTAT Turn Around TimeTEM Transmission Electron MicroscopyVSSA Volume Specific Surface AreaXPS X-ray Photoelectron SpectroscopyXRD X-Ray Diffraction



2 Summary

This deliverable presents a decision criteria and ranking system for the NanoDefiner deci-sion support system in order to find out whether or not a material is a nanomaterial accord-ing to the EC Recommendation on a definition of nanomaterial and current legislation. Ittakes into account the purpose (legal, screening, quality check,…), required data quality(reference, quick screening,…) and cost (including instrument, cost, man-hours, …) of theanalysis. This decision criteria and ranking system defines, together with the materialsclassification system, the external parameters which the decision should take into account.These parameters will be applied to steer the decision process at each decision node ac-cording to clear priorities. The decision criteria presented here will be revised at the finalstage of the project to take into account the practical experience gained by executing thetest cases, as well as a possible evolution of the decision criteria and an amendment ofthe EC Definition.The first part consists of a brief introduction to the user interface. In the next section re-quired and optional criteria to steer the decision process are listed and explained. Thepurpose of the analysis is one of the priority criteria, and this is explained in detail in sec-tion 5, including the information required for legal (registration and enforcement) purposes.Section 6 deals with the material characteristics and some optional questions are alsolisted in order to help the user to fill this entry in the decision process. Finally, sections 7and 8 deal with the available equipment and information on economic parameters.



3 Introduction

The NanoDefiner e-tool provides the user with the best options of methods and proce-dures to determine whether a material of interest should be considered a nanomaterial ac-cording to the current legislation. To facilitate the communication between the NanoDefinere-tool and the user, a user interface will be developed (see figure 1). In this user interfacethe user will fill in some key criteria related to his/ her needs, which are (1) issues aboutthe purpose of the investigation, (2) material of interest (what should be analysed), (3)what equipment is available to the user, (4) and what costs are acceptable (how manysamples need to be measured, etc.).

Figure 1: Schematic presentation of the user interface components

It is obvious that each of these user requirements will influence the selection of the mostappropriate methods but they will also influence each other. It is therefore important also todetermine the relationships between these criteria. In this deliverable, a ranking system ispresented that will take into consideration the four main user requirements, including theirinterrelationships.Within the e-tool, the purpose will define the requirements and the minimum performancecharacteristics per parameter. It may be necessary to take into account also the propertiesof the material under investigation (NanoDefine Technical Report D7.3 material classifica-tion; item 2 below) to define the requirements. For example, minimum performance re-quirements may need to be less strict for nanoparticles in complex matrices as comparedto pure materials due to technical limitations.

In this interface proposed to the user, the purpose and the material are mandatory inputsto use the e–tool. On the other hand, available equipment or economic information are op-tional, and can be customised by the user in his individual NanoDefiner system.

USER INTERFACE

Purpose Material Availableequipment Economic



4 Required and optional criteria

A. PurposeIn the NanoDefine project two major purpose categories are distinguished, namely:

Legal, including (i) dossier preparation / registration and (ii) enforcement (invarious application sectors e.g. cosmetic products, biocide products, food ...)

Other purposes, including quality control, screening, research/ product devel-opment, risk assessment

The main purpose for which the decision process in NanoDefine will be developed isfor legal reasons, as explained above. A user might however wish to analyse a mate-rial in order to check whether it is a nanomaterial according to the EC definition or forother purposes as well. This could include product development, quality control, stud-ies in the context of risk assessment or basic research. The latter purposes are notwithin the basic scope of the NanoDefine project, and the associated requirementsand criteria might be rather different from those for legal purposes. On the other hand,it is advantageous if the decision processes for legal and other purposes are analo-gous, because this would allow the use of the NanoDefiner, with the same decisionflow scheme, in all these cases. Therefore, specific criteria for other than legal pur-poses will not be built into the NanoDefiner but the user will have the possibility to de-fine his/her own criteria, within the limits of the NanoDefiner.

Further performance characteristics, such as measurement uncertainty, trueness, pre-cision (reproducibility, repeatability) and selectivity/specificity, are desirable for a pre-cise and complete requirement specification. Currently such detailed general require-ments are not available and are not asked for regulatory purposes. It is therefore fore-seen that NanoDefine will develop recommendations for such requirements as addi-tional task, to be used in the decision flow.

B. Material under consideration

The material characteristics are the other mandatory parameters the user needs toprovide to the NanoDefiner. Part of the required information was developed in the ma-terial classification system in the NanoDefine Technical Report D7.3. Some optionalquestions to help the user are provided in section 7 of this document.

Two other sets of input parameters available in the user interface are optional:

C. Available Equipment

D. Economic parameters



The decision criteria system will be based on the requirements of the specific purpose andtranslated into a decision path, finally specifying which parameters have to be measured ina specific case (and with which data quality). The path is illustrated in figure 2.

Figure 2: Decision path. The criteria for the purposes of REACH are included as example

4.1 Purpose

For each specific legal purpose a Regulation may be in force which specifies the requiredparameters (including metrics) that have to be reported. These requirements can changein time when new or amended legislation or guidance applies. Certain requirements maynot be quantified and the regulator may instead ask that certain properties should be re-ported according to the technical state of the art.

Differently from the legal criteria, those corresponding to "Other purposes" (R&D, quality,screening) will be customisable by the user. He will have the possibility to choose his ownparameters within the limits of the NanoDefiner.

Purpose

Legal

Dossier filling/registration

REACH

Material type

Trade Form

ChemicalIdentification

Sizedistribution

Concentration

Surface area

Shape/morphology

CosmeticLegislation

Frenchregistration

DanishRegistration

BelgianRegistration

enforcement

Food Labelling

CosmeticLabelling

BiocideOther



Figure 3: Choice of purpose by the user of the NanoDefiner

To obtain information on the (technical) requirements of the various legal purposes (regis-tration and enforcement) and to fill in tables 1-3 below, a questionnaire was sent to organi-sations involved in these activities. The questionnaire can be found in annex 1 and wassent to organisations involved in

Registration, e.g.o ECHA for the purposes of REACHo ANSES for the French declaration scheme for nanomaterialso European Commission DG SANTE (formerly DG SANCO) for the

CPNPo Danish Environmental protection Agency for the Danish registration

scheme for nanomaterials Enforcement, e.g.

o Netherlands Food and Consumer Product Safety Authority (NVWA)o The German Federal Institute for Risk Assessment (BfR)

The enforcement organisations declared that, at the moment, they have no legal require-ments regarding the technical methods performances as mentioned in the table of thequestionnaire. Nevertheless, the table was completed as deemed relevant.

All organisations consulted are in charge of verifying the compliance with regulations andtheir specifications concerning nanomaterials, including EU specific product legislation andnational registers. They use the EC Recommendation for a definition of nanomaterial oranother sector-specific definition. All use the 50% threshold based on particle numbers inthe definition of nanomaterials except for the purposes of the CPNP as no threshold valuewas specified in the applicable Cosmetic Products Regulation (EC) No 1223/2009.

Further requirements, such as measurement uncertainty, trueness, precision (reproducibil-ity, repeatability) and selectivity/specificity, are desirable for a precise and complete re-quirement specification. Currently such detailed requirements are not available. It is there-fore foreseen that NanoDefine will develop such requirements as additional task, to beused in the decision flow.



Table 1: Requirements for legal purposes: registration and enforcement

Mainarea

Sub-area Specific pur-pose

Relevant regula-tion

Required parameters

Legal Registration Chemicals(European lev-el)

REACH (Regulationon Registration,Evaluation, Authori-sation and Re-striction of Chemi-cals; Regulation(EC) No1907/2006)1

Material type, tradeform, chemical identifi-cation, size distribution,concentration, surfacearea, shape/ morpholo-gy(from REACH form)

Registration Cosmetic prod-ucts(European lev-el)

EU Cosmetic Prod-ucts Regulation No1223/20092

Trade form, chemicalidentification, particlesize and average size,secondary particle size,agglomerates/ aggre-gates, surface area,crystalline shape, sur-face charge, surfacemodifications, coating,solubility catalytic activi-ty, chemical reactivesurface, photocalytic ac-tivity, quantity(from CPNP)

Registration Medical devic-es1

"Proposal for aRegulation of theEuropean Parlia-ment and of theCouncil on MedicalDevices, andamending Directive2001/83/EC, Regu-lation (EC) No178/2002 and Reg-ulation (EC) No

1 EMA specifications – if available – will be included in the revision at a later stage of the project



1223/2009"

Registration Biocides6 European legisla-tion

Biocide ProductsRegulation (No528/2012)

Registration under Bio-cidal Products Regula-tion and REACH. Mate-rials are nano accordingto the EC definition. Nospecific parameter re-quirements given. Samerequirements asREACH assumed.

Registration Food contactmaterials

Commission Regu-lation (EU) No10/2011 of 14 Jan-uary 2011 on plasticmaterials and arti-cles intended tocome into contactwith food

Currently no require-ments available. As-suming same require-ments as in food label-ling.

Registration French registra-tion(Nanomaterialand products)

Frenchlegislation3

Material type, chemicalidentification, particleand average size, sizedistribution, agglomer-ates/ aggregates, sur-face area, matrix, typeof substance con-cerned, impurities,shape, crystallite sizecoating, nature of coat-ing, surface charge,number dimensionslower than 100 nm,quantities (produced,distributed, importedetc.)

Registration Danish registra-tion(Nanomaterialand products)

Danish legislation 4 Chemical identification,particle size, size distri-bution, fraction in na-noscale, agglomerates/aggregates, surface ar-ea, matrix (products),form, surface chemistry,



nature of the coating,details about the coat-ing, surface charge

Registration Belgian regis-tration

Belgian legislation 5 Will be released by theauthorities.

Enforcement Cosmetic Prod-ucts labelling2

European legisla-tion

EU Cosmetic Prod-ucts Regulation No1223/20092

Implicitly the same re-quirement as for regis-tration in CPNP

Enforcement Biocides.6 European legisla-tion

Implicitly the same asfor registration. Sameregulation applies.

Enforcement Food labelling EU Regulation onthe provision offood information toconsumers; Regula-tion (EU) No1169/2011

According to the defini-tion included in the legaltext of the Regulation1169/2011



4.2 REACH registration

Figure 4 presents the decision path for a user and table 2 lists all the required informationfor REACH registration according to guidance released by ECHA. Characterisation meth-ods specifically listed and accepted in the REACH guidance are included in this table. Per-formance characteristics are currently not specified in the guidance.

Figure 4 : Decision path for a user registering a nanomaterial according to REACH

Purpose Legal Dossier filling/registration REACH

Material type

Trade Form

ChemicalIdentification

Sizedistribution

Concentration

Surface area

Shape/morphology



Table 2 : Information required for REACH

Parameter Units or Available Choices Specific method

Material type Mono constituent or multi-constituent

n/a

Trade form n/a

Chemical identification Identity of substance, EC in-ventory, CAS information,IUPAC name

n/a

Size distribution nm Ultrasonic (suspending me-dium), spectroscopy, TEM,SEM, SAXS, XRD, DLS,PCS, SMPS, FMPS

Concentration Mass or number n/a

Surface area m2/ g BET

Shape/ Morphology TEM, SEM, SPM



4.3 Registration of cosmetics products

Figure 5 presents the decision path for a user and table 3 lists all the required informationfor registration of cosmetics products according to CPNP guidance. Specific acceptedcharacterisation methods are included in this table. Performance characteristics are cur-rently not specified in the guidance.

Figure 5: Decision path for a user registering a nanomaterial in the CPNP



Table 3: Required information for cosmetics products (as specified in the CPNP)

Parameter Units or Available Choices Specific method

Trade form Solid/ powder/ solution/suspension/ dispersion/ oth-er

n/a

Chemical identification IUPAC/ CAS/ EC number n/a

Particle size and averagesize

nm FFF, HDC, HPLC, AUC,CLS disc centrifugation,TEM, SEM, AFM, DLS,DMA

Secondary Particle size nm

Agglomerates/ aggregates Dispersed free particles/agglomerates/ aggregates

n/a

Surface area (mandatory forpowders)

VSSA

m2/g,

m2/cm3

BET

Crystalline shape Spherical, hexagonal, py-ramidal, rod, plate, wire,whisker star-like, needlelike, fibre, tube, isometric,crystalline, irregular, amor-phous, other

AFM, TEM, SEM, NMR,XRD

Surface charge Zeta potential [mV] PALS

Surface modification Y/n LDE, SPM, XPS, FTIR,NMR, AUC, GE, SPM,LDE, NanoSIMS, SERS

coating y/n n/a

solubility mg/ml n/a

Catalytic activity y/n n/a



Chemically reactive surface y/n LDE, SPM, XPS, FTIR,NMR, AUC, GE, SPM,LDE, nanoSIMS, SERS

Photocatalytic activity y/n n/a

Quantity Kg n/a

4.4 French registration scheme

Figure 6 presents the decision path for a user and table 4 lists all the required informationfor the French registration scheme in according to guidance issued by ANSES. Specificaccepted characterisation methods are included in this table. Performance characteristicsare currently not specified in the guidance.

Figure 6: Pathway for a user registering a nanomaterial in the French register



Table 4: Required information for the French registration

Parameter Metric Specific method

Material type Pure substance, substancecontained in a mixture with-out being linked to it, sub-stance contained in a mate-rial intended to reject thesubstance under normal orreasonably foreseeablecondition of use

n/a

Chemical identification Chemical formula, name ofsubstance, CAS number

n/a

Particle and average size nm TEM, SEM, AFM, other

Size distribution nm DLS, laser diffraction, gravi-tational sedimentation, dif-ferential centrifugal sedi-mentation, Raman (NTC),other

Agglomerates/ aggregates nm n/a

Surface area m2/g, m2/cm3 BET using nitrogen,TEM/EM, SAXS

Matrix Solid, liquid, gas, powder n/a

Type of substance con-cerned

Carbon, noble metal, silica,non-magnetic oxides, car-bides, hydroxides and silico-aluminate, magnetic oxides,asbestos and amphibole,diesel particles, Cd and al-loys containing Cd, transi-tion metal and intermetallicalloys, inorganic semicon-ductors, polymers, lipids andliposomes, fluorophores,other

n/a

Impurities % XRF, ICP-OES, ICP-MS,HPLC, GC, CE, NMR, FT-



IR, other

Shape Spherical, pseudo spherical,rods, star, hollow fibre, fullfibre, film, capsule, other

TEM, SEM, AFM, other

Crystallite size Bravais lattice XRD

Nature of the coating Organic, inorganic, other n/a

Details about the coating Hydrophilic organic, hydro-phobic organic, hydrophilicinorganic, hydrophobic inor-ganic, other

n/a

Surface charge mV Zeta potential

Number of dimensions lowerthan 100 nm

1, 2, or 3 n/a

Quantity (produced, distrib-uted etc.)

Kg n/a

4.5 Danish registration scheme

Figure 7 presents the decision path for a user and table 4 lists all the required infor-mation for the Danish registration scheme according to the Danish Environment Pro-tection Agency guidance. Specific accepted characterisation methods are included inthis table. Performance characteristics are currently not specified in the guidance.Many materials and products are exempt from registration in the Danish registrationscheme. Therefore the user needs to know if the material to be analysed is not ex-empt (implying a legal purpose for entering the decision scheme). It may therefore behelpful to add a link to the Danish registration scheme to assist the user whether thepurpose is "legal" or "other".



Figure 7: Pathway for a user registering a nanomaterial in the Danish registration scheme

Table 5 : Required information for the Danish registration according to the Danish environmental pro-tection agency

Parameter Metric Specific method

Chemical identification Chemical formula, name ofsubstance, CAS number,

n/a

Particle size nm TEM, SEM, AFM, other

Size distribution nm DLS, laser diffraction, gravi-tational sedimentation, dif-ferential centrifugal sedi-mentation, Raman spec-troscopy, other

Fraction in the nanoscale % (wt) g n/a

Agglomerates/ aggregates Y/N n/a



Surface area m2/g BET using nitrogen,TEM/EM calculation, SAXS,other

Matrix How the nanomaterial is in-corporated in the product

n/a

Form (number of dimen-sions under 100 nm) andshape

1, 2, 3 TEM, SEM, AFM, other

Surface chemistry Is the surface treated/ coat-ed

n/a

Nature of coating Organic/ inorganic n/a

Details about coating Hydrophilic organic, hydro-phobic organic, hydrophilicinorganic, hydrophobic inor-ganic, other

n/a

Surface charge mV Zeta potential

5 Material Characteristics

Material characteristics refer to the material classification system developed in theNanoDefine Technical Report D7.3 as the major entry pathway into the decisionframework. Please refer to that document for detailed information.Additionally some other optional questions can be addressed to the user

Is it a known material (REACH or literature)?

If the answer is yes, the question is what the user should do or should have.

If it is it similar to a known nanomaterial, the user may have the possibility to fillin certain material characteristics. This will better specify the degree of similarityto known materials.

This question will be more addressed as a recommendation for sampling or sampledispersion.



Is it a new application of a known nanomaterial? If the material is known, butthe application is new, the user will receive recommendations on how to pre-pare the sample for measurements.

Is it prepared with a new preparation technique? Analysis data of the com-pound should be given (see material format), including possible impurities.

6 Available equipment (optional information)

This should be an optional requirement in the user interface. The user should have thepossibility to save and edit a list of the available equipment in his personalised installa-tion of the NanoDefiner e-tool in order to access it for repeated applications withoutthe need to insert it every time. The NanoDefiner will take into account this list in thedecision flow process, but will not limit the recommendations for specific techniques tothose immediately available for the user.Data treatment tools can also be included in this section. It is however foreseen thatthe e–tool will be able to work only with very limited and specific set of data formats,for example histograms of particle size measurements provided by the user.

7 Economic parameters (optional information)

This information will be optional in the user interface. The user should have the possi-bility to save and edit a list of the economic parameters in his personalised installationof the NanoDefiner e-tool in order to access it for repeated applications without theneed to insert it every time.

a. Number of samples to be analysedb. Time for sample preparation (time unit to be chosen)c. Measurement time (time unit to be chosen)d. Data reduction time (time unit to be chosen)e. Total time until result (time unit to be chosen)f. Required turnaround time (TAT) (time unit to be chosen)g. Instrument costs (in Euros)h. Analysis costs (in Euros)i. Limitations in cost per sample (in Euros)



8 Conclusions

The aim of this document is to present a set of criteria to steer the decision process in theNanoDefiner e-tool. In addition to the material classification system (see NanoDefineTechnical Report D7.3), the decision criteria and ranking system can be regarded as thesecond entry pathway in the e-tool user interface. This deliverable takes into account pur-poses, required data quality and costs.

The purpose for the analysis is the major entry criterion for the decision support flow sys-tem and it therefore is one of the mandatory criteria available for the user. If the analysis ismade for legal purposes certain parameters for the decision criteria will have to be prede-termined with fixed values or parameter limits. If the analysis is done for other purposes(e.g. R&D, screening, quality control) the parameters for the decision criteria will be cus-tomisable by the user.As this stage of the project (February 2015), guidance describing required or recommend-ed parameters are available for registration of nanomaterials for REACH, the CosmeticProducts Regulation and certain national regulations (French and Danish). Parametersapplicable to nanomaterials for the purposes of European food legislation and for medicaldevices and medicines were not available at this stage.

The required data quality is not specified for legal purposes but it is foreseen thatNanoDefine will develop recommendations for such requirements as additional task, to beused in the decision flow.

The cost and economic criteria are optional criteria that the user could fill according to hisequipment and other user specific conditions. These criteria are important but will not bedecisive for the e-tool to recommend appropriate method(s).

The decision criteria presented in this document will be revised at the final stage of theproject to take into account the practical experience gained during the project and by exe-cuting the test cases.



9 References

1. European Commission, Commission Recommendation of 18 October 2011 on the definition of na-nomaterial, Official Journal of the European Union. 2011/696/EU: 38-40, 2011

2. REGULATION (EC) No 1223/2009

3. Code de l’environnement – partie législative : articles L. 523-1 à L. 523-5

Code de l’environnement – partie réglementaire : articles R. 523-12 à D. 523-22

Décret n° 2012-232 du 17 février 2012 relatif à la déclaration annuelle des substances à l’état na-noparticulaire pris en application de l’article L. 523-4 du code de l’environnement

Arrêté du 6 août 2012 relatif au contenu et aux conditions de présentation de la déclaration an-nuelle des substances à l’état nanoparticulaire, pris en application des articles R. 523-12 et R. 523-13 du code de l’environnement

Avis au Journal Officiel de la République Française des 1er et 10 janvier 2013

Arrêté du 24 janvier 2013 définissant les conditions de présentation et d’instruction des demandesde dérogation relatives à la mise à la disposition du public de la déclaration annuelle des subs-tances à l’état nanoparticulaire, pris en application de l’article R. 523-20 du code del’environnement

4. http://eng.mst.dk/topics/chemicals/nanomaterials/ (Accessed 26/01/2015)

5. SERVICE PUBLIC FEDERAL SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ETENVIRONNEMENT [C − 2014/24329], 27 MAI 2014. — Arrêté royal relatif à la mise sur le marchédes substances manufacturées à l’état nanoparticulaire

6 http://echa.europa.eu/regulations/nanomaterials-under-bpr (Accessed 26/01/2015)



Annex 1; Questionnaire on the (technical) requirements of the various(legal) purposes

Is your organisation/agency in charge of handling declarations/registrations of nanomateri-al? Y/N

If yes, for which purpose? (e.g. REACH, specific register, national register or legislation…)

Is your organisation/agency in charge of verifying compliance with regula-tions/specifications concerning nanomaterials (e.g. enforcement, quality control, R&D)?Y/N

If yes, for which purpose/regulation? Please specify the purpose and provide the regula-tion or guidelines from which the need for verification/enforcement results.

Does your agency/organisation use a definition of nanomaterial? Y/N

If yes, is it the EC recommendation? Y/N

If your answer to the previous question is "no" please specify which definition of nano-material is used in your organisation and the differences to the EC recommendation.

What kind of information do you require for the registration/declaration?

Information Y/N Metric/units

(if applica-ble)

Specific methodobligatory? if yes,

which?

Requested information Specifications forperformance pa-

rameters (e.g. un-certainty, precision,

trueness etc.)

Material type (substance,mono-constituent subs-tance, multi-constituentsubstance, mixture, ar-

ticle)

Trade form (powder,paste, dispersion, ...)



Chemical Identification

Particle size

Average size

Size distribution

Other information relatedto the size

Fraction in the nanoscale

Agglomerates/aggregates

Concentration (mass,number)

Surface area, VSSA

Medium (pastes, disper-sions)

Matrix (products)

Other information

Does your organisation use a threshold in the nanomaterial definition? Y/N

If yes, please specify which one.



Annex 2: technical method performance requirements

The technical method performance requirements are copied from NanoDefine TechnicalReport D7.1 and may need some modifications to describe the needs

counting, separative or ensembletechniques

Single particle counting

Calculate number or concentrationfrom ensemble methods

Method combination (hyphenatedmethods)

Working range

Size range

Concentration range

Minimum needed sample

Linearity/proportionality

Limits of detection/quantification

Sensitivity (Counting efficiency) as afunction of size

Limits of detection/quantification What is the lower limit to detect

Trueness Indicate the trueness of this CM

Trueness in weighting the size frac-tions

Specify the trueness in weighting thesize fractions of this CM

Robustness Specify the robustness of this CM.

Precision Specify the precision of the CM

Resolution Specify the resolution of this CM

Size distribution Is it possible to measure size distribu-tion?

Selectivity

discrimination from non-nanoparticlesof the same composition

discrimination from non-nanoparticlesof another composition (matrix parti-

cles)



discrimination from nanoparticles ofanother composition

Impurities

Measures aggregationIs it possible to measure aggregation

or agglomeration of particles?

Measures individual particlesDoes these CM measure individual

particles?

Counting constituent particles in ag-gregations

Is the method able to count constitu-ent particles in aggregates?

Composition Does this CM analyse composition?

Specification of the type of size (di-ameter) Specify: for example hydrodynamic…

Destructive method or not Is it a destructive method?

Other Specificity

Documents

Set of criteria with ranking system to steer the decision ... · NanoDefine Technical Report D7.4: Set of criteria with ranking system to steer the decision process for ma-terial