Introduction: How NanoDefine will contribute to the regulatory classification of nanomaterials Hans Marvin

Transcription

1 Introduction: How NanoDefine will contribute to the regulatory classification of nanomaterials Hans Marvin RIKILT Wageningen UR NanoDefine workshop: Analytical challenges and industry needs for the regulatory classification of nanomaterials, 8 February 2016, VCI building, Frankfurt/Main, Germany

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 Focus on implementation of the EU definition (number based particle size distributions)

9 The Consortium 28 Partners

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

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

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) 2 nd NanoDefine NSC Projects Synergy Workshop, 2 February 2016, Brussels

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

14 Scope of work plan 1. Sourcing and characterisation of real world test materials (industrial NM, products); 2. Comparative evaluation of existing techniques; 3. Development, validation and standardisation of key methods with instrument + software improvements; 4. Establishing integrative etool to select techniques, evaluate results and classify nanomaterials according to the definition; 5. Disseminate and transfer technology to endusers.

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

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

17 Expected outcome and impact Recommendations on a revision of the EC definition of a nano-material Protocols for dispersions of nanoparticles Standard Operation Procedures (SOPs) for analysis of materials and products. New instruments + data treatment/analysis, suitable to implement the definition (numbers output, or reliable conversions into numbers) The NanoDefine Manual of Methods: Technical guidance on the use of available methodologies

18 Expected outcome and impact The NanoDefiner e-tool: standardised automated procedure for method selection and material classification (most economic implementation of the definition) CEN/ISO new work item proposals for key methods setting standards for i.a. regulatory purposes Identification of reference materials possibly to be certified later Knowledge and technology transfer to endusers.

19 For more information: Project secretary: