Dr Steffi Friedrichs of AcumenIST SRL participated in the ‘Standardisation Workshop & Panel Discussion’ at Graphene Week 2023, held from the 4th – 8th September 2023 in Gothenburg. She contributed an introduction to the MACRAMÉ Project (Advanced Characterisation Methodologies to assess and predict the Health and Environmental Risks of Advanced Materials) and illustrated, how the nanotechnology community kicked off standardisation and harmonisation activities throughout 2005 to 2007, thereby laying the foundations for an extended, materials-specific approach to the collaborative development of standards (through ISO/TC 229, CEN/TC/352, ASTM/E56, and IEC/TC 113) and regulatory relevant guidelines (incl. OECD Test Guidelines and Guidance Documents). By now, this has led to the development of 215 standardisation and harmonisation documents, but many more still need to be developed; Dr Friedrichs listed 38 gaps in the standardisation and harmonisation landscape that have already been identified by TEMAS Solutions, partner of the MACRAMÉ Project (cf. Towards harmonisation of testing of nanomaterials for EU regulatory requirements on chemical safety).

1. The MACRAMÉ project has received funding from the European Union’s Horizon
Europe Research and Innovation programme under grant agreement No. 101092686.
Standardisation Workshop
& Panel Discussion
GRAPHENE WEEK 2023
4TH – 8TH SEPTEMBER 2023, GOTHENBURG, SWEDEN

2. Harmonisation & Standardisation of (Nano)Materials
– A brief History
Graphene Week 2023
4th – 8th September 2023, Gothenburg, Sweden
2
‘classic’ Standardisation of Nanotechnology & Nanomaterials
ISO/TC229 Nanotechnologies
(2005)
CEN/TC 352 Nanotechnologies
(2005)
ASTM International
Committee E56 on
Nanotechnology (2005)
IEC/TC 113 Nanotechnologies
for electrotechnical products
and systems (2006)
Regulatory relevance of Nanotoxicology
OECD’s Working Party on
Manufactured Nanomaterials
(2007)
NANoREG (2013 – 2017)
PROSAFE (2015 – 2017)
NANoREG II (2015 – 2019)
Safe & Sustainable by
Design (SSbD)
PARC (2022 – 2029)
SSbD Framework (by JRC)
(2022)
MACRAMÉ (2022 – 2025)
Graphene Flagship
§

3. NanoMaterials Standardisation Landscape
Graphene Week 2023
4th – 8th September 2023, Gothenburg, Sweden
3
Terminology
Achieved 18
On-going 7
Measurement
Achieved 8
On-going 6
Characterisation
Graphene
Achieved 13
On-going 8
ISO
Exposure and
Risk
Achieved 23
On-going 11
Characterisation
(Other)
Achieved 27
On-going 2
Performance
Evaluation
Achieved 3
Ongoing 3
Terminology
Achieved 7
On-going 5
Measurement
Achieved 5
On-going -
Exposure and
Risk
Achieved 19
On-going 11
Characterisation
(Other)
Achieved 1
On-going 3
Other
Achieved 4
CEN
Physico-chemical
Characterisation
Achieved 5
On-going 5
Human
Toxicology
Achieved 5
On-going 5
OECD
Environmental
Fate
Achieved 1
On-going 3
Environmetal
Toxicology
Achieved 1
On-going 4
End of Life
Achieved 1
Ongoing 1
215 Standards! But we still have gaps

4. (Nano)Materials Standardisation Gaps
Graphene Week 2023
4th – 8th September 2023, Gothenburg, Sweden
4
Ecotox
Phys-
Chem
Data
Environ-
mental
Fate
In vitro
In vivo
Dispersion in test samples
Detection in complex media
Guidelines for explosivity
Methods for oxidising properties
Reference materials for dustiness
Stability in relevant media
Dosimetry
Inflammation
Skin irritation/corrosion
Absorption Oral/dermal
In vitro Cell toxicity
Genotoxicity – comet assay
Reactivity
Reproductive toxicity
Skin sensitisation.
Phototoxicity
Toxicity by dermal route
Phototoxicity
Pre-natal toxicity
Reproductive toxicity
Immunotoxicity
Neurotoxicity
Endocrine disruption
Invertebrate toxicity
Plants and algae
Microbial toxicity
Toxicity in birds or mammals
(A)biotic degradation
Transport in air
Methods for ultrafine particles
Transport in water
Bioaccumulation
Biomagnification
Transport in soils
Data Description
Data Curation
Data Quality
FAIR Data
Publication
:

5. The MACRAMÉ R&I Approach
5
Illustration of the MACRAMÉ R&I
Approach (AdMa@CMs: Advanced
Materials in complex matrices; CF:
Characterisation Factor; GRM:
graphene-related material; IATA:
integrated approaches to testing and
assessment; LCA: Life-Cycle
Assessment; LCC: Life-Cycle-Costing;
MFA: Material-Flow Analysis; RA:
Risk-Assessment; SSbD: Safe-&-
Sustainable-by-Design).
Graphene Week 2023
4th – 8th September 2023, Gothenburg, Sweden

6. market-relevant industrial MACRAMÉ Use-Cases:
• Graphene oxide (GO) flakes in drinking-water filters;
• Few-layer graphene (FLG) in battery management systems (BMS);
• Graphene-related materials (GRM) in car polish consumer sprays;
• Carbon nanotubes (i.e. CNTs) in car-seats; and
• Poly lactic-co-glycolic acid (PLGA) for inhalable antibiotics.
… selected to conduct:
• SSbD: Safe-&-Sustainable-by-Design
• LCA: Life-Cycle Assessment
• LCC: Life-Cycle-Costing
• MFA: Material-Flow Analysis
• RA: Risk-Assessment
… building on real, market-relevant Products
6
5
Graphene Week 2023
4th – 8th September 2023, Gothenburg, Sweden

7. The MACRAMÉ’s Foundations
– Analyses, Assessments & Validations in industrial Value-Chains –
7
Graphene Week 2023
4th – 8th September 2023, Gothenburg, Sweden

8. The MACRAMÉ’s Foundations
– Analyses, Assessments & Validations in industrial Value-Chains –
8
‘Wimmelbild’ (engl. ‘teeming picture’)
Pieter Bruegel d. Ä . (source:
© KHM-Museumsverband)
Graphene Week 2023
4th – 8th September 2023, Gothenburg, Sweden

9. The MACRAMÉ’s Foundations
– Analyses, Assessments & Validations in industrial Value-Chains –
9
Graphene Week 2023
4th – 8th September 2023, Gothenburg, Sweden

10. The MACRAMÉ’s Foundations
– Analyses, Assessments & Validations in industrial Value-Chains –
10
Terminology:
• AdMa = Advanced Material
• CM = Complex Matrix
• EM = Environmental Matrix
• BM = Biological Matrix
• CPM = Complex Product Matrix
• EoL = End-of-Life
• AdMa@CMs
• AdMa@EM
• AdMa@BM
• AdMa@EoL(CPM)
• AdMa@EoL(CPM)@EM
Graphene Week 2023
4th – 8th September 2023, Gothenburg, Sweden

11. The MACRAMÉ project has received funding from the European Union’s Horizon
Europe Research and Innovation programme under grant agreement No. 101092686.
Thank you
www.macrame-project.eu
Steffi Friedrichs
Steffi@AcumenIST.com
+32 496 075 785

12. Meeting Announcements
12
1. Harmonisation & Standardisation Workshop:
22nd – 23rd November 2023, ONLINE
2. 1st MACRAMÉ Regulatory Risk Assessors’ Summit:
27th – 28th November 2023, Berlin
3. ‘Materials Week 2024’:
17th – 21st June 2024, Limassol, Cyprus
*** subscribe to the MACRAMÉ Newsletter***
Graphene Week 2023
4th – 8th September 2023, Gothenburg, Sweden

13. The MACRAMÉ Team
13
Graphene Week 2023
4th – 8th September 2023, Gothenburg, Sweden