We are writing to update you that the European Commission adopted on 6 March 2026 the revised recommendation on the Safe and Sustainable by Design (SSbD) framework.
For background:
- The initiative was first announced in the 2020 Chemicals Strategy for Sustainability. The framework builds on the 2022 Commission Recommendation, followed by a testing phase and stakeholder engagement involving Member States, industry, academic and research organisations, including a survey on draft updated SSbD Framework in 2025 to which MedTech Europe contributed (please see below copy of email). In the responses, MedTech Europe emphasised the recommendation for the framework to remain voluntary, thus we are pleased to inform you that it has remained so and therefore does not create new legal obligations for chemicals and materials.
Nevertheless, the Recommendation notes that the SSbD can guide anticipatory actions and decisions within the innovation process, including actions going beyond minimum legal compliance. Moreover, the European Chemicals Action Plan highlights the role of this revised recommendation to reinforce EU chemical industry competitiveness by making the innovation process towards safer and more sustainable alternatives more efficient.
- The revised framework maintains the level of ambition of the initial 2022 Framework and provides greater support for the innovation process by helping innovators efficiently identify the information needed to make safety and sustainability decisions, reducing inherent uncertainties in the process. The JRC has published Methodological Guidance providing practical recommendations on the most commonly encountered issues when applying the SSbD Framework. An updated version of the guidance is expected in April 2026.
- The details of the Framework, based on the JRC technical report, are set out in the Annex. Notably, criterion H1 flags the most harmful substances (according to CSS), including the substances of very high concern (SVHC) according to REACH Art. 57(a-f). Chemicals and materials that do not meet Criterion H1, are subjects or could become subjects to legislation that bans, restricts or discourages their use, expect for derogated uses, e.g. those considered essential for society, i.e., they are necessary for health, safety, or the critical functioning of society and no environmentally or health-safe alternatives are available, as outlined in Commission Communication C/2024/2849. Moreover, while safety and sustainability are essential, practical considerations, such as the functionality of the chemical or material and market considerations should also inform the evaluation of the innovation.
The Commission encourages the industry use the SSbD framework in their research and innovation when developing chemicals, materials and production processes. The industry is also encouraged to provide FAIR data and collaborate across value chain to facilitate comprehensive data collection and multidisciplinary approaches for the assessments, and share relevant information that helps identify safety and sustainability issues, while safeguarding confidentiality and competitiveness.
Finally, MedTech Europe will be represented at the EC conference on “Safe and Sustainable by Design: Accelerating the Industrial Transition” on 19 March 2026 to discuss how it can facilitate industrial transformation and what the opportunities and challenges are in supporting a wider uptake at national and regional level. Should there be specific points beyond our earlier remarks, please do not hesitate to flag them so that they can be brought up at the event.
