An Integrated Analytical Approach to Implement the European Definition of a Nanomaterial

Transcription

1 An Integrated Analytical Approach to Implement the European Definition of a Nanomaterial Hans Marvin & Felice Simeone RIKILT Wageningen UR The European Materials Characterisation Council (EMCC)-Materials characterisation: a central pillar for the engineering and upscaling of the new generation of products for European industry, 24 June 2016, Amsterdam, the Netherlands

2 Innovative materials New materials in the nano- and micro range sizes. Intriguing properties, but: environmental, health & safety issues (EHS) unknown. legal aspects difficult to manage

3 EU Legal Definition A material is a nanomaterial if 50% or more by number of the constituent particles have one or more external dimensions in the size range nm. ( 2011/696/EU)

4 The official definition of Nanomaterials will be used in EU regulations Cosmetic Products EU Regulation No 1223/2009 Medical devices Proposal for a Regulation of the European Parliament and of the Council on Medical Devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 Biocides Biocidal Products Regulation (No 528/2012) Food contact materials Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food Food labelling EU Regulation on the provision of food information to consumers; Regulation (EU) No 1169/2011

5 Challenges How to define the size of a NP Which external dimension? Upper size limit? Average size, sum parameters? How to measure the size What techniques? How to make costs affordable (for reference: Electron Microscopy: ~1000 /sample)

6 Analytical challenges How to get number/size distribution Need of particles-counting techniques, or conversion (prone to errors) of intensities, volumes, masses into numbers. How to measure size down to 1 nm Need to measure simultaneously range 1-100nm and above 100 nm; only few techniques available for < 30 nm; uncertainty increases at the nano-scale. How to deal with agglomerates and aggregates

7 Through evaluation of a broad spectrum of techniques, materials, and matrices, NanoDefine develops an integrated approach based on validated and standardized methods of analysis.

8 The Project Collaborative EC FP7-Project Duration Nov Oct Budget 9.3 M (12.3 M US$) 28 partners Coordinator: RIKILT -Wageningen UR Focus on implementation of the EU definition (number based particle size distributions) The NanoDefiners

9 The Consortium 28 Partners

10 The Mission NanoDefine provides industries and regulatory agencies with the tools for the implementation of the EU definition of a nanomaterial. Materials real world, industrial, products Evaluation techniques, conversion Development Instruments, software, methods Guidance Manual, e-tool, standards Targeted dissemination

11 The Vision The NanoDefine approach will be: Easy to implement: it integrates with new developments the current practice/facilities/expertise of the end-users Cost efficient: it offers a tiered approach for the selection of the most adequate analytical route Flexible: it defines criteria for the inclusion of novel technologies. It can be adapted to new regulation; Sustainable: as the developed approach will be implemented in structures that persist beyond the duration of the project

12 Work packages and interdependencies WP1: Test and reference materials WP 2: Sample preparation, dispersion & sampling WP3: Evaluation and selection of techniques and methodologies WP4: Screening methods (tier 1) WP5: Confirmatory methods (tier 2) WP6: Validation and standardisation WP7: Implementation & case studies WP8: Dissemination, training & technology transfer WP 9,10 Management and Coordination (not shown)

13 The Concept Material properties Requirements/ Purpose Methods characterisation Existing data NanoDefiner Decision-tree for classification of a Nanomaterial. To be implemented as an e-tool. Sample preparation options Tier 1: Screening method options Tiered approach for classification Tier 1: robust, cost-efficient, widely available methods Tier 2: sophisticated, for complex samples Nano / non-nano? Plausibility check? Tier 2: Confirmatory method options, if required Nano / nonnano? Plausibility check? Non- Nano Nano

14 Scope of the Project 1. Sourcing and characterisation of real world test materials (industrial NM, products); 2. Comparative evaluation of techniques; 3. Development, validation, and standardisation of key methods; instrument + software improvements; 4. Integrative e-tool for selection of techniques, evaluation of results and classification according to the definition; 5. Dissemination to end-users.

15 Target Nano-Materials Inorganic CaCO 3, BaSO 4, TiO 2, nano-steel, kaolin, zeolites, Carbon Nano Tubes (CNT). Organic pigments, polymers Products Cosmetics (TiO 2, Al 2 O 3 ), food (SiO 2 ), plastic (Fe 2 O 3 )

16 Real world substances selected kaolin clay BaSO 4 CaCO 3

17 Target Techniques Particle Counting EM, spicp-ms, PTA, SMPS, ES-SMPS, TRPS Ensemble Parameters DLS, SLS, SAXS, USSp, VSSA Fractionating FFF, CLS, AUC

18 Products and Impact Recommendations on a revision of the EC definition of a nano-material Protocols for Dispersions of Nano Particles Instruments + data treatment suitable for the implementation of the definition (numbers output, or reliable conversions into numbers) The NanoDefine Manual of Methods: Technical guidance on the use of available methodologies Standard Operation Procedures (SOPs) for analysis of materials and products.

19 Products and Impact The NanoDefiner e-tool: Standardised automated procedure for method selection and NM classification (most economic implementation of the definition) CEN/ISO work items for key methods setting standards for i.a. regulatory purposes Identification of reference materials (potentially to be certified later) Technology and knowledge transfer to endusers.

20 For more information: Project secretary: