Commission unveils “one substance, one assessment” reform package

The Periodic | By RAYAN BHARGAVA, MSC

Jan. 11, 2024

The Commission has long aspired to realize its one substance, one assessment concept in the EU’s chemical regulatory regime. With the publication of three proposed legal acts, this concept is one step closer to streamlining the way the bloc regulates chemicals.

Regulatory background

  • A 2019 fitness check of the most relevant chemical regulations found that protection afforded to human health and the environment was of a suitably high standard, although issues with consistency and efficiency were evident. Specifically, the report found inconsistent conduct of safety assessments and application of transparency rules. It identified clear inefficiencies in how “technical and scientific work” is conducted.
  • Perhaps the greatest source of inconsistency and inefficiency identified was simply the diverse sources of scientific and technical work from across European society. The science that informs various chemical regulations originates from scientific committees, expert groups, Commission departments or contractors, and, most often, from the four main EU agencies overseeing chemical regulation.
  • These agencies are the European Chemicals Agency (ECHA), the European Food Safety Authority (EFSA), the European Environment Agency (EEA), and the European Medicines Agency (EMA). These varied actors often also utilize different datasets, analyzed at different points in time, with differing levels of established science to draw from.
  • The European Green Deal built on the shortcomings identified by this fitness check, leveraging the Chemicals Strategy for Sustainability (CSS) as the vehicle to address them. The Green Deal made commitments “to review how to use better the EU’s agencies and scientific bodies to move towards a process of one substance, one assessment (1S1A) and to provide greater transparency when prioritizing action to deal with chemicals.” The ensuing Chemicals Strategy expounded upon the 1S1A concept further, presenting it as the definitive approach to heighten the efficiency, consistency, and transparency of European chemical regulation.
  • The 1S1A concept aims to ensure that substances and substance groups need only be definitively assessed once, with results being comprehensive and available to the point that they can serve all regulatory functions without need for retesting. This also has clear potential to reduce animal testing, another key commitment made by the Commission. The concept seeks to meet these goals through the creation of a data platform to ensure the requisite level of data availability, as well as greater coordination between EU agencies, which is intended to result in greater predictability and consistency in scientific and regulatory outcomes for industry stakeholders.
  • The European Commission last month unveiled a trio of legislative proposals aimed at initiating the 1S1A concept, and its underlying objectives, in earnest. These proposals are the subject of AgencyIQ’s summary and analysis below:

Reattribution of tasks

  • Two of the three proposals focus on reallocating tasks among four EU agencies. While it may, at first, seem confusing why one is a directive while the other is a regulation, a closer look at their contents clears up confusion. The newly proposed directive focuses solely on amending a fellow directive – the RoHS Directive (2011/65/EU) restricting the use of hazardous substances in electrical and electronic equipment. However, the newly proposed Regulation aimed at reattributing tasks, commonly called the Omnibus Regulation, seeks to accomplish this task with respect to four existing chemical regulations. These four are the Persistent Organic Pollutants Regulation (2019/1021/EU), the Medical Devices Regulation (2017/745/EU), the Regulation establishing the EEA (401/2009/EC), and the General Food Law Regulation establishing EFSA (178/2002/EC). Recall that, in the EU, regulations are binding uniformly throughout all member states upon entry into force, while directives outline outcomes that member states must achieve by transposing the spirit of EU law into their own domestic legislation.
  • Essentially, the newly proposed Directive reassigns the underlying scientific tasks servicing the RoHS Directive to ECHA. First, it takes the responsibility of identifying substances for potential RoHS restriction out of the hands of externally commissioned experts and into the purview of ECHA. The Directive also adds greater clarity for how to review the 10 substances and substance groups currently restricted by the RoHS Directive. Second, the proposal similarly places the task of adding, amending, or deleting exemptions from RoHS restrictions into the hands of ECHA, rather than external experts.
  • The Commission draws an analogy between the restriction and exemption process found in RoHS to the authorization and restriction processes (titles VII and VIII, respectively) found in the REACH Regulation (1907/2006/EC). REACH authorization can afford industry time-limited, application-specific exemptions from phase-out much like the exemption process under RoHS. Because ECHA and its scientific committees are already in charge of the REACH processes, the EU executive feels that adding the analogous RoHS processes to their plate would heighten predictability and consistency between the two regulations. Because stakeholders are already familiar with the decisions that ECHA makes with respect to REACH, and the methodology that underpins them, they could better anticipate the same sort of decisions made under RoHS.
  • The Omnibus Regulation has four main articles reattributing responsibilities across the four EU agencies primarily concerned with chemical regulation. Article 1 amends the General Food Law Regulation, inputting obligations for EFSA to cooperate with the other three agencies on matters of scientific opinion, exchange of data, alignment of assessment methodologies, and convergence of vocabulary. It also mandates that EFSA identify where its scientific opinion diverges from other bodies. If the divergence cannot be resolved, both agencies must draft a joint report for the Commission on why this is the case.
  • Article 2 adds near identical cooperation obligations to the EEA by amending its founding regulation. It also tasks the EEA with developing methodologies for assessing chemical safety.
  • Article 3 redirects tasks to ECHA regarding medical devices. Specifically, it amends the first annex of the Medical Devices Regulation, charging ECHA with updating guidelines on assessing risk from phthalates, carcinogens, mutagens, reprotoxic substances (CMRs), or endocrine disruptors in medical devices.
  • More tasks are potentially assigned to ECHA in article 4. It gives the Commission the power to charge ECHA with writing what is essentially an impact report on the addition or modification of concentration limit values for substances regulated by the POPs Regulation with 12 months’ notice. Additionally, ECHA’s committee for socio-economic analysis (SEAC) will have to produce an opinion on the ECHA report within 9 months of its submission to the Commission. The resulting Commission amendments to the POPs regulation substance list should be carried out through delegated acts. Finally, article 4 reaffirms the EEA’s role as the recordkeeper of POPs data, stating that all information on chemical exposure, toxicity, and occurrence data for the substance group should be provided to the agency.

Common data platform for chemicals

  • The establishment of a common data platform for chemicals (CDPC) is a cornerstone of the 1S1A concept’s functionality. It seeks to lessen the burden on industry stakeholders to repeatedly prove that the same substances are safe for use. Instead, a common data platform could allow for substance safety evaluations to be published just once for all relevant parties in a single online location.
  • AgencyIQ had previously seen glimpses of what this platform could entail through CARACAL expert group documents and the 2022 feasibility study, though the recent proposal for a regulation as part of the 1S1A reform package is the first time the Commission has unveiled concrete details on the platform’s final form. This proposal is long overdue, as it was initially slated for the first quarter of 2023. [For in-depth analysis of the CARACAL documents on the CDPC see AgencyIQ’s July 10, 2023 article.]
  • The proposed regulation is divided into 9 chapters. The first two outline the general scope of the data platform. It will involve the same four primary agencies mentioned above, along with the European Agency for Safety and Health at Work (EU-OSHA).
  • Chemical information stemming from Union legislation will be included. This is comprised of physico-chemical, hazard, exposure safety, occurrence, emissions, and environmental sustainability data. Data from pharmaceutical legislation is not included by default, though some specifically named pharma data relating to chemicals will be encompassed.
  • Chapter III obligates the Commission and EU agencies to specify what data formats and controlled vocabularies will be accepted on the CDPC. It sets out procedures for resolving divergences in opinion on these matters. If divergences are justified, the agencies will have to co-author a joint report explaining why.
  • Chapter IV defines both who will be allowed to access the platform and what rights authorities will have to use data within the platform. Authorities will have access to every piece of data in the platform, even data deemed confidential, while the public will only have access to data deemed acceptable for public consumption. Authorities may use the data in any regulatory endeavor but must refrain from publishing anything related to those endeavors that might release confidential data.
  • Chapter V is particularly consequential in that it sets up a monitoring framework for chemicals and their emerging risks. One component of this is the establishment of a dashboard of indicators to monitor chemical pollution impact and the effectiveness of existing chemical legislation. Another is an early warning and action system for emerging chemical risks. [For an in-depth analysis of the chemicals indicator framework, see AgencyIQ’s November 21, 2023 article.] An observatory will also be created that publicly compiles information on the properties, uses, and market presence of certain chemicals. This observatory will initially focus on nanomaterials.
  • Chapter VI grants data generation powers to ECHA that already exist for EFSA. This provision would provide ECHA with the mandate to commission studies supporting its overall mission. There is also consideration for the Commission to task ECHA with making these study requests. This is a competency already afforded EFSA through article 32 of the General Food Regulation.
  • Notification of studies is the subject of chapter VII. It obligates industry and the laboratories and testing facilities they employ to submit a notification to a database hosted by the CDPC when chemical safety assessments are commissioned. This provision is intended to prevent the duplication of studies among industry and keep the authorities abreast of what safety research is ongoing. ECHA will manage the notifications database. Notification is functionally the only new requirement directly affecting industry.
  • Chapter VIII serves an administrative purpose, empowering the Commission to update the Omnibus Regulation if any new EU chemical legislation comes into existence in the future.
  • Finally, enforcement is spelled out in chapter IX. Because the obligation to notify commissioned studies is the only new expectation of industry in this proposal, it is the primary subject of enforcement considerations. Agencies and member-state enforcement authorities will exchange information to make sure businesses and laboratories are complying with notification requirements. Member states are to draft penalties for non-compliance by June 30, 2025.

Analysis

  • One wonders what role the envisioned ECHA basic regulation will have in supporting this reform package. The Commission proposals involve quite a bit of centralization of responsibilities to ECHA. This comes at a time when the agency has repeatedly called attention to its ever-enlarging workload, despite relatively stagnant resources. Just last month an ECHA report indicated that the amount of hazardous chemicals imported into the EU has increased by a factor of over 20. This increase came almost entirely from the regulatory decision to include benzene as a constituent substance, a move that ECHA predicted would strain its capacities, with the agency asking for help in shouldering the burden of its workload. Surely, ECHA will require greater financial resources and personnel to take on its current workload, let alone the larger burden envisioned by this new reform package. [For in-depth analysis of ECHA’s recent report on hazardous chemical imports, see AgencyIQ’s January 4, 2024 article.]
  • The ECHA basic regulation and its provision of greater finances for ECHA were endorsed by the agency’s head in late November 2023. Sharon McGuinness explicitly lauded the standalone ECHA regulation’s potential to allow the agency to move beyond the REACH Regulation that currently provides the basis of its existence, without sacrificing quality, transparency, or efficiency. The newly proposed Omnibus Regulation also makes reference to the ECHA basic regulation, saying it is related in scope, but fails to provide any further indications on the planned law’s future. The ECHA basic regulation was slated for proposal by the second quarter of 2023, though it has yet to materialize. [For an in-depth analysis of Sharon McGuiness’ remarks, see AgencyIQ’s December 6, 2023 article.]
  • Notably, the Commission designed its reattribution of tasks proposals to minimize redundancy. It recognizes that the reallocation of duties can be achieved through the individual revisions of chemical regulation that will naturally occur or are even ongoing. The four regulations and the RoHS Directive are targeted by the two reattribution proposals specifically because they do not have reviews ongoing. In fact, the proposed Regulation even provides a list of EU chemical laws that were not included because reviews are ongoing or coming in the near future. It is significant that the Commission is exemplifying its commitment to reduce legislative redundancy.
  • The proposal for a CDPC contains a trend of applying existing legislative ideas and functions to the chemical regulation landscape. Granting ECHA the power to Commission studies, as chapter VI of the proposal does, is a simple copy and paste of the powers afforded to EFSA by article 32 of its establishing General Food Regulation. The contents of chapter VII can also be understood in this way. In fact, its obligation on business to submit notifications when studies are commissioned is an application of the Transparency Regulation (1381/2019/EU) to chemical safety studies. CARACAL documents have estimated that notifications would be a relatively small burden on business, taking only 30 minutes to complete per study.

Next steps

  • All three proposals are subject to ordinary legislative procedure and so will be evaluated by the European co-legislators, the European Parliament and the Council of the EU.
  • To learn more about the Commission’s recent push to reform chemical regulation in the image of its 1S1A concept, register to attend AgencyIQ’s January 17, 2024 webinar. AIQ’s EU experts will be delivering their thoughts on the three proposals live at 10 am EST.

To contact the author of this analysis, please email Rayan Bhargava.
To contact the editor of this analysis, please email Scott Stephens.

Key Documents and Dates

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