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PROSAFE · Project

Regulatory Playbook for Getting Nanomaterials Safely to Market Across Europe

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Imagine you're a company making products with tiny engineered particles — coatings, cosmetics, packaging — but every EU country has slightly different safety rules, and nobody agrees on how to prove your material is safe. PROSAFE brought together regulators and researchers from 9 countries to create a shared rulebook for "Safe by Design," meaning you bake safety into your product from the very first sketch rather than scrambling to fix problems after launch. Think of it like building codes for construction — instead of every city inventing its own, you get one clear standard everyone trusts. The project also tackled the messy overlap between nanotechnology and biotechnology, where regulations hadn't caught up with what companies were already doing.

By the numbers
14
consortium partners coordinating nano-safety regulation
9
European countries aligned on Safe by Design principles
EUR 2,512,612
EU investment in regulatory coordination for nanomaterial safety
6
deliverables produced including regulatory guidance outputs
The business problem

What needed solving

Companies developing products with nanomaterials face a maze of inconsistent safety regulations across EU member states, with no agreed-upon method to prove a material is safe before it hits the market. This means costly delays, reformulations, and the risk of market withdrawal when rules change — problems that multiply for companies selling across borders.

The solution

What was built

PROSAFE produced coordinated regulatory guidance on Safe by Design for nanomaterials, harmonized approaches to toxicology testing and exposure monitoring, and a project website. With 6 deliverables total, the outputs focused on policy coordination, data management for regulatory testing, and promoting international acceptance of safety standards.

Audience

Who needs this

Specialty chemical companies producing nanomaterial-based productsCosmetics manufacturers using nano-ingredients in formulationsAdvanced coatings and materials companies with nano-enabled productsRegulatory affairs consultants advising on REACH and nano-specific rulesPackaging companies exploring nanomaterial barriers or antimicrobial coatings
Business applications

Who can put this to work

Chemical Manufacturing
mid-size
Target: Specialty chemical companies producing nanomaterial-based products (coatings, additives, catalysts)

If you are a specialty chemical manufacturer dealing with inconsistent safety requirements across EU member states — this project produced coordinated regulatory guidance and Safe by Design principles that can help you design products that meet safety standards from the start, reducing costly reformulation or market withdrawal. With input from 14 partners across 9 countries, the outputs reflect a broad European regulatory consensus.

Cosmetics & Personal Care
any
Target: Companies using nano-ingredients in sunscreens, skincare, or hair products

If you are a cosmetics company using nanomaterials like nano-titanium dioxide or nano-zinc oxide and struggling to navigate REACH registration and nano-specific reporting requirements — this project developed guidance on characterization and reporting of nanomaterial use that can streamline your compliance process. The Safe by Design approach means fewer surprises at the regulatory review stage.

Advanced Materials & Coatings
SME
Target: Companies producing nano-enabled coatings, textiles, or packaging materials

If you are a materials company developing nano-enabled products and worried about environmental fate and ecotoxicology liabilities — this project coordinated toxicology testing approaches and value chain assessments for environmental impact. The guidance from 9 research organizations can help you build a defensible safety case before your product reaches the market.

Frequently asked

Quick answers

What would it cost to implement Safe by Design in our product development?

PROSAFE itself was a coordination action funded at EUR 2,512,612 across 14 partners, focused on developing guidance rather than selling services. Implementing Safe by Design principles in your R&D process would require internal investment in safety assessment early in development, but no licensing fees apply — the regulatory guidance outputs are publicly available.

Can this scale to our full product line or is it limited to specific nanomaterials?

The project addressed nanomaterials broadly, not just specific types. The Safe by Design principles and regulatory coordination outputs were designed to apply across nanomaterial categories, including the convergence between nano and biotechnologies. However, case-specific differences were a stated priority, so application requires tailoring to your particular materials.

Is there intellectual property or licensing involved?

PROSAFE was a Coordination and Support Action (CSA), not a technology development project. Its outputs are regulatory guidance, coordination results, and policy recommendations — all publicly accessible. There are no patents or licenses to negotiate.

How does this affect our current regulatory compliance process?

The project aimed to streamline and harmonize how EU member states handle nanomaterial safety assessment, including toxicology testing, exposure monitoring, and waste treatment. If you operate across multiple EU countries, the coordinated approach reduces the patchwork of different national requirements you currently face.

Is this still relevant given it ended in 2017?

The regulatory principles and Safe by Design methodology developed by PROSAFE fed into ongoing EU regulatory processes for nanomaterials, including REACH updates. The 9-country coordination network and its outputs remain a reference point. However, specific regulatory requirements may have evolved since the project closed in April 2017.

Who was behind this project and can we trust the guidance?

The project was coordinated by the Dutch Ministry of Infrastructure and Water Management — a national government body, not a commercial entity. The consortium of 14 partners included 9 research organizations across 9 countries (BE, CH, DE, FR, IT, NL, PT, RO, UK), giving the outputs strong regulatory credibility.

Consortium

Who built it

This is a government-led consortium with strong regulatory credibility: coordinated by the Dutch Ministry of Infrastructure and Water Management, with 9 research organizations forming the backbone. The 14-partner group spans 9 countries (BE, CH, DE, FR, IT, NL, PT, RO, UK), giving it broad European coverage. However, with only 2 industry partners and a 14% industry ratio, the commercial perspective is limited. The 4 SMEs in the consortium suggest some private-sector engagement, but this is fundamentally a policy coordination effort rather than a market-driven initiative. For businesses, the value lies in the regulatory clarity these government and research partners can provide, not in commercial partnerships.

How to reach the team

Dutch Ministry of Infrastructure and Water Management (NL) — contact via CORDIS project page or ministry website

Order a report on this consortiumSee MINISTERIE VAN INFRASTRUCTUUR EN WATERSTAAT profile →
Next steps

Talk to the team behind this work.

Want to understand how Safe by Design guidelines affect your nanomaterial products? SciTransfer can brief you on the regulatory landscape and connect you with the right experts from this 9-country consortium.

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