A THIRST FOR DATA EATS INNOVATION FOR BREAKFAST

Soon, innovation processes will likely become even more bureaucratic. Why? Let's talk about the EU Commission's "Safe-and-Sustainable-by-Design" (in short: SSbD) - approach and how this proclaimed "innovation boost" may even slow down innovation, after all. What sounds like a good idea, may have profound effects on innovation - due to additional burden like complex assessment procedures for chemicals.

SSbD stands for "Safe-and-Sustainable-by-Design". Doesn't sound bad at first. Everybody likes safe and sustainable materials and products. And indeed, with its "Safe-and-Sustainable-by-Design" concept, the EU Commission wants to make chemicals and materials safer and more sustainable, in the future. But is there such a thing as "absolute safety" or "absolute sustainability"? Shouldn't we also talk about trade-offs? And who decides whether something is safe or sustainable in the end, anyway? You see, we need a pragmatic solution. With the current approach, many stakeholders are somewhat skeptical about existing proposals how to get there, and here's why:

With the aim of creating a more sustainable Europe, the EU Commission presented the European Green Deal in 2019. An important component of this initiative is the EU Chemicals Strategy (CSS). It pays great attention to protecting people and the environment from the negative effects of hazardous chemicals, for example by promoting safer and more sustainable alternatives. One part of the CSS is the "Safe-and-Sustainable-by-Design" (SSbD) concept, which is intended to make the use of chemicals and materials safer and more sustainable right from the research stage and subsequently in production. It is not as if the chemical industry has no concern for this. In fact, the industry has always invested in the development of safe and sustainable materials. And the idea to stay on the safe and sustainable side is a good one. Nobody can't argue that. But the devil is in the detail.

Although SSbD is not legally binding for the time being, industry fears that it will make research processes even more bureaucratic and that the EU will create a second chemicals regulation, parallel to REACH. And this, in addition to a mere regulatory wave, which EU industry is facing curretly, that constricts production and business in an ongoing global race and in midsts of a huge transformation of the entire industrial sector. Above all, however, there is a risk that innovations will be slowed down, which will hinder rather than promote the path to sustainability (incl. EU Green Deal goals) as a whole. And here is the issue.

What has happened so far

SSbD was first announced as part of the publication of the CSS in October 2020. Commissioned by the EU Commission, the Joint Research Center (JRC) published a draft concept in 2022. This contains an assessment scheme, with intense data collection, consisting of five steps:

The first step is a hazard-based assessment of the chemical or material. This is followed by an assessment of health and safety aspects (step 2) in the production phase and health and environmental aspects (step 3) in the application phase. Finally, ecological sustainability is assessed in step 4 and social sustainability in step 5. The fact that a hazard-based approach was chosen is not expedient. The proven concept of risk assessment must be retained for all substances. In the long term, the hazard-based approach of the SSbD concept presented leads to an unnecessary stigmatization of proven substances that can be handled safely in research and production processes and professional applications.

The publication of the JRC report was followed by studies, consultations and workshops with the subsequent start of a two-year test phase. I am glad, that the initiative did not come right away, and that stakeholders have been invited to the design process of SSbD. The results and an initial interim assessment at the halfway point of the test phase were presented and discussed at a two-day stakeholder workshop in December 2023. The feedback was mixed. And the most important conclusions include:

• The system is far too complex and not workable as it includes enormous requirements for data collection (for the better?)
• The entire concept is based on a hazard-based approach, which prevents innovation per se. It simply limits the chemical tool-box and thus prevents breakthroughs in research and development of "new chemicals and materials". (Wasn't that the objective of this entire exercise?)
• Therefore, we need to ensure the practicability of the concept
• The EU Commission should investigate trade-offs between safety and sustainability,
• It shall standardize the criteria for the five assessment steps and take into account already established methods (e.g. Portfolio Sustainability Assessment (PSA)),
• Need to develop screening approaches to support small and medium-sized enterprises (SME) in particular with training and advisory services.

Above all, the current SSbD concept is not practicable yet. Meaning, we are not there yet! The SSbD concept still needs more refinement towards a shift to a more pragmatic solution, that sets quality standards to EU industry. So feedback by many different stakeholders is highly important for the ongoing dialogue with EU regulators.

What happens next?

The EU Commission is expected to publish its first "SSbD Guidance Report" in March 2024. There will then be an opportunity to comment as part of a consultation. Industry will also participate in the ongoing design and dialog process. The dialogue involves expertise from the areas of Public Affairs, Product Safety, Circular Economy, R&D, to name but a few, as this is a multidisciplinary topic.

I hope that comments and suggestions for revision that have already been submitted will be taken up and considered for the time ahead. Real life testing of a conceptual theory has highlighted strenghts and weaknesses. So we need to maintain the open dialogue along the design process of the SSbD approach. This is not a topic, that is purely reserved for the chemical industry. It needs collaboration along the entire value chain. So let's make SSbD workable!

SSbD will come. This is for sure. The concept is to be adapted so that it can be officially applied in research, by 2025. And this is not bad, but it needs to promote innovation and it needs to prove that it works under real-life conditions. Until then, I am looking forward to a fruitful dialogue between politics, academia, industry and civil society that gives valuable input into the ongoing design process. That dialogue is important - in order to ensure to have a workable solution and that a thirst for data is NOT eating innovation for breakfast.

Further read:

EU Commision info page: Safe and sustainable by design - European Commission

Cefic info page: Safe and sustainable-by-design - cefic.org

German VCI position on SSbD: Transformation braucht Freir?ume | VCI