Safe and Sustainable by Design (SSbD)

At AIMPLAS, we apply this framework by combining Life Cycle Sustainability Assessment (LCSA), laboratory hazard and exposure testing, and REACH and Occupational Health and Safety (OHS) compliance support, all delivered by a specialised technical team with expertise in plastics and the circular economy.

What is the SSbD approach and why does it affect your business?

SSbD is a voluntary framework developed by the European Commission that structures innovation into two phases: (re)design and assessment. Its objective is to guide the development of substances, materials and chemical products towards reducing substances of concern and minimising environmental, climate and health impacts throughout the entire product life cycle.

Companies operating in the plastics sector (packaging, construction, healthcare and medical devices, energy, electronics, transport, coatings and more) are directly affected, as SSbD is already influencing raw material selection and development strategies (including innovative advanced materials), REACH compliance and product viability in increasingly demanding European markets.

The SSbD assessment covers four sequential dimensions:

• Intrinsic hazard of the substance or material
• Worker exposure during production
• Exposure during use and end-of-life stages
• Overall impact through life cycle assessment

Unlike traditional approaches focused solely on regulatory compliance or environmental sustainability, SSbD incorporates early-stage safety assessment to identify potential risks to human health and the environment from the earliest development phases. This helps reduce future reformulation costs, minimise regulatory uncertainties and accelerate the market introduction of safer materials and products.

What capabilities does AIMPLAS offer within the SSbD framework?

Our SSbD approach integrates three coordinated areas of expertise:

LCSA – Life Cycle Sustainability Assessment

We address the three dimensions of sustainability using standardised methodologies:

• LCA (Life Cycle Assessment). Environmental assessment from raw material extraction to end of life, in accordance with ISO 14040/14044, including carbon footprint calculations.
• LCC (Life Cycle Costing). Cost assessment throughout the life cycle to evaluate economic feasibility.
• S-LCA (Social Life Cycle Assessment). Assessment of social impacts across the value chain.
• Ecodesign. Application of LCSA results to guide design decisions from the earliest development stages.

Risk and Safety Dimension – Laboratory Testing

We operate our own laboratory equipped with advanced techniques for physicochemical characterisation and biological effect assessment, following New Approach Methodologies (NAMs).

Physicochemical Characterisation

• DLS, SEM, µ-FTIR and Py-GC/MS for substance identification and quantification
• Analysis of PFAS, microplastics, nanoplastics and NIAS (Non-Intentionally Added Substances)
• Migration and release testing in complex matrices, including Q-TOF analysis

Biological Effects

• Cell viability testing (MTT, Neutral Red)
• Genotoxicity and mutagenicity (Micronucleus Assay, Ames Test, Comet Assay)
• Oxidative stress and inflammation
• Ecotoxicity testing (Vibrio fischeri and fish cell lines)

Our testing capabilities enable the assessment of key biological mechanisms associated with the main toxicological effects of regulatory and scientific interest, including cytotoxicity, genotoxicity, oxidative stress, inflammation, endocrine disruption and ecotoxicity.

This approach is particularly relevant for complex materials, recycled materials, UVCB substances, natural mixtures, NIAS and innovative advanced materials, where chemical characterisation alone may not be sufficient to identify all potential risks.

Occupational Safety

Exposure testing through pulmonary, dermal and gastrointestinal pathways (GUT–Lung–Skin). This enables the analysis of realistic manufacturing, processing and recycling scenarios to identify potential worker risks arising from emissions, particles, aerosols or substances released during industrial processes.

REACH and Occupational Health and Safety (OHS)

• Selection of raw materials according to SSbD criteria
• Monitoring of the SVHC Candidate List, Annex XIV (Authorisation), Annex XVII (Restrictions), CORAP and PACT
• Review and preparation of Safety Data Sheets (SDS) and CLP labelling
• Preventive measures and safety protocols to protect workers during manufacturing and processing activities

Which sectors and project types benefit from SSbD?

The SSbD service is particularly relevant for companies that:

• Develop or reformulate products and/or chemical substances subject to foreseeable regulatory restrictions
• Develop or work with innovative advanced materials
• Need to demonstrate product sustainability to access European markets or meet industrial customer requirements
• Participate in R&D&I projects funded by the EU where SSbD is a methodological requirement, or wish to strengthen their project proposals
• Seek to replace Candidate List SVHC substances or anticipate future REACH restrictions
• Participate in initiatives aligned with European One Health, Zero Pollution and Chemicals Strategy for Sustainability objectives

We work with companies in packaging, automotive, construction, medical devices, speciality chemicals, defence, coatings and many other sectors.

How is an SSbD project structured at AIMPLAS?

The assessment strategy is adapted to the technology readiness level (TRL) of the development, enabling progressive data generation from early R&D stages through to pre-industrial validation and regulatory support studies.

A typical SSbD project includes:

• Scope definition – identification of the material or substance, system boundaries and improvement objectives
• Hazard assessment phase – relevant physicochemical and biological testing according to the intended use profile
• Exposure assessment – workers (OHS) and end users
• LCSA – LCA, LCC and S-LCA using client process data
• Integrated SSbD report – results, identified gaps and (re)design recommendations
• Regulatory support – REACH review, SDS assessment and supply chain communication strategy

Where required, we conduct comparative studies between conventional materials and sustainable alternatives to demonstrate that environmental improvements do not compromise human or environmental safety, one of the fundamental principles of the SSbD framework. The assessment sequence can be adapted depending on the product status (new development or existing substance) and the project objective (redesign, regulatory compliance or market access).

Why choose AIMPLAS for SSbD support?

• Integrated multidisciplinary team covering circular economy, physicochemical characterisation, biological effects assessment, regulatory compliance and occupational safety under one roof, without the need for external coordination
• In-house laboratory accredited by ENAC according to UNE-EN ISO/IEC 17025 for physicochemical, biological and migration testing
• Extensive experience in European projects where SSbD is an evaluation requirement, including Horizon Europe, LIFE and PRIMA projects
• Up-to-date regulatory expertise through participation in standardisation committees and continuous monitoring of developments in REACH, CLP, the European Chemicals Strategy and Advanced Materials initiatives
• Specialisation in plastics and polymers, ensuring that only relevant assessments are performed and unnecessary testing is avoided
• Flexible and collaborative approach tailored to your needs, whether you require a partner to lead the entire SSbD study or to collaborate within a broader consortium
• Experience in safety assessment through NAMs and bioassays for complex materials, recycled materials, emerging substances, PFAS, NIAS and innovative advanced materials
• Ability to integrate safety, exposure, sustainability and regulatory compliance data into a single decision-making strategy, facilitating the development of products prepared for future European regulatory requirements

A sustainable material is not necessarily a safe material. The SSbD approach enables both dimensions to be assessed in an integrated manner, helping companies develop products ready for future markets and increasingly demanding regulatory and consumer expectations.

Would you like to know whether your material or product requires an SSbD assessment? Tell us about your project and we will be happy to advise you with no obligation.