Are ‘EU substitution centers’ in the cards for quicker substitution of toxic chemicals?

Regulatory context of the Commission’s initiative

• An integral part of the EU chemicals regulatory framework is ensuring the substitution of harmful chemicals with safer alternative substances or technologies for human health and the environment when available and technically and economically feasible. At the same time, chemicals substitution is significant for meeting the ambitions under the European Green Deal, including the objectives of the Commission’s Chemicals Strategy for Sustainability (CSS).
• Industry is required to seek out potential alternative chemicals, as well as create substitution plans where satisfactory alternatives are not yet available, in certain contexts (for example, when companies apply for authorization) under Regulation (EC) 1907/2006 on the registration, evaluation, authorization and restriction of chemicals (REACH). The process of restricting substances under REACH also involves alternatives assessment and substitution planning on the part of the authorities. Similarly, other EU chemicals legislation, such as Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS), stipulates related substitution and substitution planning provisions. [ Read this AgencyIQ analysis on substitution and substitution planning in the context of a study the Commission initiated last year that is expected to be completed by late 2024.]
• The Commission has pointed out that the “pace of addressing” risks of hazardous substances “through substitution is still slow and has addressed only a limited number of substances and uses to date.” The EU executive says this sluggishness can be attributed to the “lengthy procedural requirements” and the related “complexities” of the authorization application process and preparation of REACH restrictions. Such complexities include aggregating “heterogenous uses into a single use.” From start to finish, both procedures, on average, take around three years. By way of example, the Commission referred to applications made by companies for authorization of hexavalent chromium substances and the authorities’ preparation of the universal restriction of PFAS. “Both involve a wide range of uses and a high number of downstream users. The outcome of these challenges risk delaying actions to substitute the substance and missed opportunities for uses where earlier substitution may be possible,” according to the Commission.

Commission launches initiative to forge path for expedited chemicals substitution

• The EU Commission on July 23 put out a call on Tenders electronic daily (TED) for a contract estimated at 1.55 million euros to deliver a study “on EU Substitution Centre(s) – Providing support to businesses to substitute their use of hazardous chemicals through collaboration, innovation, research and direct assistance.” An undertaking slated to last 2.5 years, the study has as its primary objective to “ demonstrate the feasibility of a European Substitution Centre,” that would serve “to accelerate the substitution of toxic chemicals with safer alternatives.” Planned to be executed as a pilot project, the European Parliament included the study in the 2024 EU budget.

• The study will comprise four main deliverables, or “lots,” with the first dedicated to the pilot project, determining “how a network of substitution centres for hazardous chemicals could best be set up and identify if additional substitution centres should be created.” The other three lots are focused on supporting projects to promote substitution of specific chemicals, namely per- and polyfluoroalkyl substances (PFAS) in batteries, chromium(VI) substances in hard chrome plating, and substances or substance groups used in paints manufacturing.

Massachusetts experience serves as wellspring of inspiration

• The pilot project to be delivered in lot 1 is “inspired” by the Toxics Use Reduction Institute (TURI), an initiative that Massachusetts introduced through its 1989 Toxics Use Reduction Act (TURA), according to the tender specifications document. The Commission underscores TURI’s achievements, stating that the institute’s “staff have successfully helped companies, particularly SMEs [small and medium enterprises], to substitute hazardous chemicals with safer alternatives through collaboration and innovation, including research, direct technical and financial assistance, and a focus on finding alternatives that meet a user’s performance and fiscal constraints.” To back this up, the Commission cites several statistics from TURI, including that in 20 years (2000-2020), companies in Massachusetts cut toxic chemical use by 75%, toxic waste by 67%, and toxic releases by 91%. Likewise, from 1990 to 2020, the carcinogen trichloroethylene’s (TCE) use was diminished by 95% and its release by 97%.
• Under TURA, the Commission highlights, companies are required to report annually their use of substances included in a specified “list of toxic or hazardous substances” when certain quantities are reached. Likewise, they are obligated, every two years, to carry out a “Toxic Use Reduction (TUR) planning.”
• TURI offers “a wide range of services, including offering grants to businesses, researchers, and communities intending to reduce the use of toxic substances and conducting policy analysis about the potential applications of chemicals in the TURA list,” according to the specifications document.

Other sources of inspiration for enhancing substitution

• In addition to the experience from across the Atlantic, the project finds inspiration from substitution-related initiatives closer to home. Specifically, the Commission notes activities like the free Marketplace platform, developed and administered by Swedish NGO ChemSec, which seeks “to connect companies in the EU and to allow buyers and sellers of alternatives to hazardous chemicals to interact and forge partnerships.” Other initiatives highlighted include the Swedish Center for Chemical Substitution (RISE), a state-owned undertaking, as well as several other government-run entities that work to advance substitution efforts. In this context, the Commission mentions SUBSPORTplus! of the German Federal Institute for Occupational Safety and Health (BAuA), Ineris Portal of France’s National Institute for Industrial Environment and Risks, and the EU’s Innovation Centre for Industrial Transformation and Emissions (INCITE).
• Many industry associations have also been involved in efforts to substitute hazardous substances, the Commission notes, as well as “numerous partnerships with academia” and “research partnerships with the purpose of promoting safe and sustainable solutions.”
• The study also looks to the approach taken under the 2023 Transition Pathway for the chemical industry for guidance on how substitution planning should be developed. Namely, the tender specifications document says, “The purpose of substitution planning is to start discussions at expert level (authorities, current users of the substance, alternative providers and independent experts) on possibilities to substitute and the relative advantages and disadvantages of potential alternatives at an earlier stage.” What results from the discussions should be “an action road map” that has considered “all relevant challenges and opportunities” and lays out “substitution with clear but flexible and adaptable milestones, which can provide guidance for all involved actors on the way forward towards substitution of a substance, or a group of substances.” Comparable to the Transition Pathway, the Commission states, “substitution planning is based on the identification of challenges in a complex transition and a road map or pathway of action lines to achieve the transition.”

Analysis and next steps

• European regulators are looking at ways to improve hazardous chemicals substitution and substitution planning processes, given EU chemical legislation’s current shortcomings, including EU and member state authorities’ significant provision of time and resources, delays in regulatory decisions, and resulting uncertainties for business. The Commission has already started a project on strengthening the role of substitution planning, the results of which this study is intended to leverage. ( Refer to the AgencyIQ piece cited above under the “Regulatory context” section of this article.)
• This study is meant to test the waters of a new regulatory direction, setting up a pilot substitution center or network of centers that will aim to “provid[e] scientific, technical and practical advice to companies and authorities to identify safer alternatives and reduce chemical risks through the substitution of hazardous chemicals,” as well as to support “EU companies, in particular SMEs, in the context of innovation and investments into safer alternatives to targeted chemicals in the EU.”
• The study should “gain experience” with operating “an effective and efficient framework for substitution planning.” According to the Commission, the initiative should advance “collaboration of various actors towards identification of well performing, safer and cost-effective alternative solutions to uses of hazardous chemicals.” Focus should be on those cases where substitution is particularly complex or where regrettable substitution may play a key role. It should also provide support to stakeholders to identify the path, i.e., the action road map, and assist in realizing the concrete steps to take toward implementing alternatives to the hazardous chemicals they use.

• The Commission is prioritizing the substitution of PFAS in batteries, chromium(VI) in hard chrome plating, and certain, yet-to-be-decided substances used in paints manufacturing. Based on the specifications of the study, the deliverables of the three other lots (i.e., minus the first one, which specifies the pilot project) will entail completing the action road maps for substitution of these three substance-application combinations and implementing them.

• The Commission is presumably set to introduce significant modifications to how substitution (planning) of hazardous chemicals is handled in the EU. Considering the 1.5-million-euro price tag of this study, in addition to the resources the EU executive has already sunk to realize its other ongoing project addressing the role of substitution planning, these actions appear to signal serious plans for altering the approach to chemicals substitution. It’s still unclear whether such changes will entail new obligations under EU chemicals law or will be of a voluntary nature.
• Entities interested in submitting tenders to participate in the Commission’s call have until Thursday, September 12, at 4 p.m. CEST to do so.

To contact the author of this piece, email Scott Stephens. ( sstephens@agencyiq.com).
To contact the editor of this item, please email Jason Wermers ( jwermers@agencyiq.com).

Key Documents and Dates

• Tender specifications on Study on EU Substitution Centre(s) – Providing support to businesses to substitute their use of hazardous chemicals through collaboration, innovation, research and direct assistance (Call for tenders EC-GROW/2024/OP/0038)