NanoREG II · Project

Faster, Cheaper Regulatory Approval for Companies Using Nanomaterials

manufacturingTestedTRL 5

Imagine you make a new type of sunscreen ingredient using tiny particles. Before you can sell it, regulators need proof it's safe — but testing every single variation is like crash-testing every color of the same car model. NanoREG II built a system to group similar nanomaterials together so you only need to test representative ones, and it created a "safe-by-design" checklist so companies can build safety in from the start rather than discovering problems after millions in development. Think of it as a pre-flight safety checklist for nanomaterials that both companies and regulators agree on.

By the numbers

consortium partners validating the approach

countries represented in the consortium

industry partners involved in development

SMEs contributing to value chain studies

total deliverables produced

33%

industry ratio in the consortium

The business problem

What needed solving

Companies developing or using nanomaterials face a regulatory bottleneck: every new material variant requires expensive, time-consuming safety testing because regulators have no accepted way to group similar nanomaterials together. This means slower time-to-market, higher compliance costs, and uncertainty about whether products will pass regulatory review — especially as nanomaterial applications multiply faster than testing capacity can keep up.

The solution

What was built

The project produced grouping strategies that classify nanomaterials into categories sharing safety profiles, safe-by-design principles that embed regulatory compliance into early product development, and supporting guidance documents. Across 30 deliverables, the consortium delivered training workshops, validated methodologies through value chain implementation studies, and produced tools aligned with ECETOC and OECD categorization efforts.

Audience

Who needs this

Cosmetics companies using nano-scale UV filters or preservativesIndustrial coatings manufacturers adding nano-additives for performanceChemical companies producing manufactured nanomaterialsPharmaceutical companies exploring nano-delivery systemsRegulatory affairs consultants specializing in chemical safety

Business applications

Who can put this to work

Cosmetics & Personal Care

mid-size

Target: Cosmetics manufacturers using nano-ingredients (zinc oxide, titanium dioxide, nano-silver)

If you are a cosmetics manufacturer dealing with lengthy and expensive safety dossiers every time you reformulate a nano-ingredient — this project developed grouping strategies that let you classify similar nanomaterials together, potentially reducing redundant testing. With 43 partners including 14 industry players validating the approach, the methodology was built with real value chain input across 16 countries.

Coatings & Surface Treatment

SME

Target: Industrial coatings companies using nano-additives for scratch resistance or anti-corrosion

If you are a coatings company struggling to get regulatory clearance for each new nano-additive variant — this project created safe-by-design principles that help you engineer compliance into your product from day one. The consortium included 13 SMEs working on real value chain implementation studies, meaning the tools were tested against actual industry workflows.

Chemical Manufacturing

enterprise

Target: Chemical companies producing or incorporating manufactured nanomaterials

If you are a chemical manufacturer facing uncertainty about how regulators will classify your nanomaterials — this project developed grouping concepts recognized by both ECETOC and OECD working groups. With 20 research organizations contributing validated data and methodologies across 30 deliverables, the results feed directly into guidance documents that regulatory agencies reference.

Frequently asked

Quick answers

How much could this save us on regulatory testing costs?

The project does not publish specific cost savings figures. However, the core value proposition is that grouping similar nanomaterials reduces the need for individual testing of each variant. Based on available project data, the approach was validated through value chain implementation studies with 14 industry partners, suggesting practical cost reduction potential.

Can this work at industrial scale for our product lines?

The methodology was designed for industrial application — the consortium included 14 industry partners and 13 SMEs across 16 countries working on real value chain cases. The grouping concepts were developed specifically to support commercial launch of new nanomaterials at scale, though each company would need to apply the grouping criteria to their specific material portfolio.

What about IP and licensing — can we use these tools freely?

NanoREG II was a publicly funded Research and Innovation Action. Based on available project data, the grouping concepts and safe-by-design guidance documents are intended to support industries and regulatory agencies broadly. Specific licensing terms for any software tools developed should be confirmed with the coordinator INERIS.

Will regulators actually accept results based on this grouping approach?

The project was explicitly designed to couple safe-by-design principles to the regulatory process. The grouping concepts align with parallel efforts at ECETOC (which formed a dedicated task force) and the OECD Working Party on Manufactured Nanomaterials. This cross-institutional alignment significantly increases the likelihood of regulatory acceptance.

How long would it take to implement this in our product development process?

The project ran from 2015 to 2019 and produced 30 deliverables including training workshops. Based on available project data, implementation would depend on your existing regulatory workflow, but the safe-by-design approach is meant to be integrated into early-stage product development rather than added as a separate step.

Does this cover REACH and other EU chemical regulations?

The project specifically targeted the regulatory landscape for manufactured nanomaterials within EU regulatory processes. The grouping strategies were developed to support guidance documents that industries and regulatory agencies use under existing chemical safety regulations. Specific REACH applicability should be confirmed with the coordinator.

Consortium

Who built it

NanoREG II assembled one of the larger nanosafety consortia with 43 partners across 16 countries. For a business considering these results, the key signal is the 33% industry ratio — 14 industry partners and 13 SMEs were directly involved, meaning the tools and methodologies were shaped by companies that actually need to get nanomaterials through regulation. The 20 research organizations provided the scientific backbone, while the geographic spread across major European markets (DE, FR, NL, UK, IT, ES, and others) suggests the approach accounts for different national regulatory interpretations. The coordinator INERIS is France's national industrial environment and risk institute, giving the results institutional credibility with regulators.

INSTITUT NATIONAL DE L ENVIRONNEMENT INDUSTRIEL ET DES RISQUES - INERISCoordinator · FR
DSM MATERIALS SCIENCE CENTER BVparticipant · NL
BUNDESINSTITUT FUER RISIKOBEWERTUNGparticipant · DE
NANOMAKERSparticipant · FR
ROUMEN TSANEV INSTITUTE OF MOLECULAR BIOLOGY BULGARIAN ACADEMY OF SCIENCESparticipant · BG
NANOGAP SUB-NM-POWDER SAparticipant · ES
VENETO NANOTECH SOCIETA CONSORTILEPER AZIONIparticipant · IT
HIQ-NANO SRLparticipant · IT
AVANZARE INNOVACION TECNOLOGICA SLparticipant · ES
NEDERLANDSE ORGANISATIE VOOR TOEGEPAST NATUURWETENSCHAPPELIJK ONDERZOEK TNOparticipant · NL
UNIVERSITAT BASELparticipant · CH
IDEACONSULT LIMITED LIABILITY COMPANYparticipant · BG
ARISTOTELIO PANEPISTIMIO THESSALONIKISparticipant · EL
ASSOCIATION FRANCAISE DE NORMALISATIONparticipant · FR
COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVESparticipant · FR
TEMAS AG TECHNOLOGY AND MANAGEMENT SERVICESparticipant · CH
ISTITUTO SUPERIORE DI SANITAparticipant · IT
ECAMRICERT SRLparticipant · IT
IDRYMA TECHNOLOGIAS KAI EREVNASparticipant · EL
STIFTELSEN NILUparticipant · NO
INSTITUTE OF OCCUPATIONAL MEDICINEparticipant · UK
FUNDACION GAIKERparticipant · ES
AGENCIA ESTATAL CONSEJO SUPERIOR DE INVESTIGACIONES CIENTIFICASparticipant · ES
UNIWERSYTET GDANSKIparticipant · PL
INM - LEIBNIZ-INSTITUT FUER NEUE MATERIALIEN GEMEINNUETZIGE GMBHparticipant · DE
GRUPO ANTOLIN-INGENIERIA SAparticipant · ES
FONDAZIONE ISTITUTO ITALIANO DI TECNOLOGIAparticipant · IT
RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEUparticipant · NL
INSTITUTUL DE CHIMIE FIZICA - ILIE MURGULESCUparticipant · RO
KAROLINSKA INSTITUTETparticipant · SE
NANOTECHNOLOGY INDUSTRIES ASSOCIATIONparticipant · BE
UNIVERSITEIT UTRECHTparticipant · NL
HAUTE ECOLE SPECIALISEE DE SUISSE OCCIDENTALEparticipant · CH
STEINBEIS EU-VRI GMBHparticipant · DE
CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE CNRSparticipant · FR
DET NATIONALE FORSKNINGSCENTER FOR ARBEJDSMILJØparticipant · DK
EIDGENOSSISCHE MATERIALPRUFUNGS- UND FORSCHUNGSANSTALTparticipant · CH
JRC -JOINT RESEARCH CENTRE- EUROPEAN COMMISSIONparticipant · BE

How to reach the team

INERIS (Institut National de l'Environnement Industriel et des Risques), France — a public research institute, reachable through their institutional website

Order a report on this consortium See INSTITUT NATIONAL DE L ENVIRONNEMENT INDUSTRIEL ET DES RISQUES - INERIS profile →

Next steps

Talk to the team behind this work.

Want to know if NanoREG II's grouping tools apply to your nanomaterial portfolio? SciTransfer can arrange a direct conversation with the research team.

Order a report on this topic More in Manufacturing & Industry 4.0