This article is the first in a series, which we introduced in a previous Blog Post, exploring the “jargon” of the EU Commission’s Chemicals Strategy for Sustainability (CSS), an ambitious political action plan for chemicals regulation in the EU that was released in October 2020.
As part of this political initiative toward a profound reshape of the existing chemicals regulatory framework, the concept of “safe and sustainable by design” is fairly innovative and could well become one of the pillars of chemicals regulation in the EU. In a nutshell, the Commission calls in its CSS for a “transition” to chemicals that are safe and sustainable by design in order to reconcile the societal value of chemicals with human health and planetary boundaries. The Commission presents the “sustainable-by-design” concept as a holistic approach to achieve these objectives: it seeks to integrate “safety, circularity, energy efficiency and functionality of chemicals, materials, products, and processes throughout their life cycle and minimiz[e] the environmental footprint”. It is aimed at constituting an overarching concept, i.e., a guiding principle in the regulation of the chemicals sector.
This ambitious goal will have important concrete consequences for the industry. At the same time the safe and sustainable by design approach is advocated by the EU executive as an opportunity for the European industry to act as frontrunner in a stammering race for the production and use of safe and sustainable chemicals.
Continue reading for more information on the current state of play regarding “safe and sustainable by design”, the development of this important concept and next steps for related regulatory and political action.
The State of Play
As of today, the concept is still at an early stage of inception by EU institutions, with key actions scheduled from 2021-2023. A first step was achieved in April this year when the Commission unveiled a “Mapping study for the development of sustainable-by-design criteria” (the “Mapping Study“). The Mapping Study brings together existing initiatives and research and innovation activities related to sustainability that could be relevant for the development of sustainable-by-design criteria for chemicals, materials and products. The analysis and findings of the study launched by the Commission should serve as input in the development of sustainable-by-design criteria, which the Commission plans to develop over the course of this year.
In the Mapping Study, the Commission focuses on the chemicals sector where, according to the Commission, “the main aim is to prevent negative impacts on public health and the environment by addressing safety and sustainability considerations very early in the product development process”.
As of today, the very concept of sustainability lacks a shared understanding. Defining such a term is therefore a prerequisite for any successful development of a sustainable-by-design concept. The situation is similar to that of integrating the “precautionary principle” in EU legislation, i.e., a debate that has still not been fully resolved. Moreover, developing objective criteria to assess compliance with a sustainable-by-design concept will be the second enormous challenge for the Legislator, as can be learned from the Mapping Study.
The Mapping Study describes a “first sketch” of how to structure the criteria for sustainable-by-design in the form of a table. This first attempt to materialize the concept deserves the full attention of stakeholders.
The current political inception of this concept raises important questions, commensurate with the Commission’s ambition to create a paradigmatic shift in the regulation of chemicals. The Industry may likely have to learn to operate with the sustainable-by-design concept for the coming decade. This calls for the development of clear criteria and definitions at this early stage in the development of the Commission’s political proposal.
Putting Sustainability into Practice, a Breakthrough for Chemical Legislation
Until now, the “Registration, Evaluation, Authorisation and Restriction of Chemicals” (REACH) and “Classification, Labelling and Packaging” (CLP) regulations were mostly driven by a rationale of protecting human health and the environment, i.e., chemicals are addressed in terms of the level of hazard they (may) pose to human health or to the environment. However, there was no explicit preferential legal regime for chemicals that could be considered as “safe” or “sustainable”. The development of the sustainable-by-design approach would therefore lead to a paradigm shift. Indeed, in the future, new regulatory tools could “drive and reward” the production and use of safe and sustainable chemicals instead of regulating hazardous ones alone.
Furthermore, although the concept of “sustainability” has long existed in the framework of EU environmental policies, the Commission acknowledges that this important term currently lacks an appropriate definition. It is, rather, a catch-all term that is interchangeably used in various contexts. The Commission notes in the Mapping Study that the new policy proposals in the context of the CSS are intended to gradually bring some clarity to the concept. This would be very much welcomed and, in fact, should be a prerequisite to developing any meaningful regulatory provisions aimed at implementing the sustainable-by-design concept.
At this early stage of development, the sustainable-by-design approach is depicted as “a pre-market approach to chemicals that focuses on providing a function (or service), while avoiding volumes and chemical properties that may be harmful to human health or the environment, in particular groups of chemicals likely to be (eco) toxic, persistent, bio-accumulative or mobile” and where “[o]verall sustainability should be ensured by minimizing the environmental footprint of chemicals in particular on climate change, resource use, ecosystems and biodiversity from a lifecycle perspective.” It remains to be determined, however, how this very general program could fit into the constraints of a regulatory framework.
In particular, the concept of sustainability does not exists in REACH or CLP, the two main pieces of EU chemicals legislation. It is therefore unclear how the concept of sustainable-by-design could be used in the context of those existing, general regulatory tools. Will it serve as a standalone and overarching principle, as is currently the case of the “precautionary principle” which underpins all of the EU chemical regulatory framework? Would it rather be integrated into various pieces of general and/or sectorial legislations by means of specific provisions aiming to give a concrete meaning to the principle, which could be tailor-made for each legislative framework?
Interestingly, the two important roadmaps published by the Commission on May 4, 2021, which provided a glimpse at the intentions of the EU executive to revise REACH and CLP, have not clearly elaborated on the implementation of the sustainable-by-design approach. For example, we have not seen a proposal for integrating that guiding principle into REACH and the CLP (for more information on the release of the roadmaps, see our Blog Post available here).
The Development of Sustainable-by-Design Criteria
The identification and definition of criteria for the sustainable-by-design concept will also be key to its successful development. Notably, this process should seek to ensure that any adopted principle could be enforceable by the industry.
It is in this context that the Commission launched its Mapping Study, which aims to:
- map the plethora of current policies and initiatives in the EU (and more broadly) which implement sustainability criteria;
- analyze a sample of criteria under these policies and initiatives, with a focus on materials and chemicals; and
- analyze progress in research and innovation, with a specific focus on nanomaterials.
Unsurprisingly, the analysis of sustainability-related criteria in the context of existing relevant EU chemicals regulatory frameworks and initiatives shows that the main existing driving criteria relate to the “hazard” posed by substances used in products (i.e., to human health and the environment). The exact way hazards are handled may vary between legislations, but very few criteria cover other sustainability-related aspects.
Structuring its analysis around the different life stages of a chemical product, the Commission mapped the following criteria as related to sustainability:
|Environmental criteria||Safety criteria||Social criteria|
Emissions (to air, water and soil)
Resource consumption (energy, water, etc.)
Restricted substances related to environmental hazards
Sustainable sourcing of raw materials / natural resources
Recycled material content
Restricted substances related to worker health and safety
Functionality (fitness for use)
Restricted substances related to user health and safety
|Restricted substances related to health and safety for recyclers|
The Commission describes this table as a “first sketch” of how to structure the criteria for sustainable-by-design. This approach deserves the full attention of stakeholders as it constitutes the first attempt to materialize the concept of sustainable-by-design and confirms that the Commission has far-reaching ambitions. It is, however, rather difficult at this stage to foresee how the EU executive may reunify these elements under one overarching principle of “sustainable-by-design” and, in particular, how it could develop objective assessment criteria for some rather subjective concepts such as “social responsibility”, “functionality” or “durability”.
The complexity of this ambitious political action shows that there is still a long way to go in the inception and development of a sustainable-by-design concept.
The Commission announces in the Mapping Study that it will now seek to develop the methodology for the criteria, i.e., it will seek to identify which aspects of safety and sustainability are to be covered under that concept and to clarify the best methods to evaluate the criteria on safety and sustainability.
To shape the safe and sustainable by design methodology, the Commission launched a survey in April 2021 that seeks to collect input from stakeholders. Based on stakeholders’ feedback, the Commission will conduct key activities for the development of the methodology, namely i) the identification of the safety and sustainability dimensions to be covered by the approach, and ii) spotting priority sectors or applications. Both were announced to be carried out between 2021 and the first quarter of 2022.
The Commission would then apply the method and criteria to specific sectors or applications of chemicals, materials and products.
The criteria for safe and sustainable-by-design chemicals are expected for 2022, and in 2023 the Commission has planned to establish an EU-wide safe and sustainable-by-design support network. This calls for close monitoring by the industry. The authors will report on the relevant milestones of that ambitious political process as it develops.