26 Oct 2023

Regulatory Review: September–October 2023

Trudy Watson-Leung, SETAC

Given increasingly busy schedules, we all benefit from digests that give us a quick way to review the news, hot research, upcoming due dates. We thought it would be beneficial to keep an eye on upcoming regulatory developments, forums, webinars, and other events pertaining to chemical regulation and then push these out to the SETAC audience. We hope that you will send along any pertinent and useful items that you have on your radar by sending them to [email protected].

United Nations Environment Programme (UNEP)

New Global Framework on Chemicals

Led by Germany, participating nations have agreed on a Global Framework on Chemicals – to support the vision of a world where chemicals and waste pose no harm, fostering a safe, healthy and sustainable future. The framework is based around 28 targets that aim to improve the sound management of chemicals and waste.

Come to the 14 November meeting on UNEP's Science-Policy Panel to Contribute Further to the Sound Management of Chemicals and Waste and to Prevent Pollution at 1:30 at the 44th SETAC North America meeting in Louisville, KY, and consider joining the SETAC CheM panel if you are interested in SETAC’s engagement as a Major Group within UNEP. 

Organisation for Economic Co-operation and Development (OECD)

Results of Workshop on Global Harmonization of Approaches to Occupational Exposure Limits (OELs)

While various organizations derive OELs, there is no globally harmonized approach. In 2022, Japan launched a new legal framework for establishing new OELs. The OECD report discusses case studies that highlight different approaches to setting OELs, how Japan’s guidance can be used by other countries and  the possibility of global harmonization.

Release of the (Q)SAR Assessment Framework Document

This new document establishes OECD principles for the assessment of (Q)SAR predictions and results based on multiple predictions and agreed on checklists to perform the assessment of models, predictions and results from multiple predictions in practice. A webinar on the new framework is scheduled for 9 November.

European Chemicals Agency (ECHA)

Comments on the Proposal to Restrict Per- and Polyfluoroalkyl Substances

Read the more than 5,600 comments from 4,400 organizations, companies and individuals on the proposal to restrict per- and polyfluoroalkyl substances (PFAS) in the European Economic Area. The comments will be checked by ECHA's scientific committees for risk assessment and socio-economic analysis, and those providing relevant evidence-based information will be considered in the opinion-making process.

ECHA to Prepare a Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Restriction Proposal on Certain Chromium (VI) Substances

ECHA will submit a report by 4 October 2024 on the possible restriction of chromium (V1) substances in Annex XIV of the REACH authorization list. A high number of applications to use these substances pose a challenge to the current and possible future workload of ECHA and the commission to evaluate and conclude opinions on them. ECHA may extend the deadline if a potential risk of regrettable substitution to other chromium (VI) substances is identified. Once the restriction is adopted, the substances in scope will be removed from the authorisation list. This would mark the first time in REACH’s history where such an action would be done.

European Food Safety Authority (EFSA) and European Union (EU)

New EFSA Dashboard Identifies New, Emerging or Recurring Pests in EU Territory

New, emerging or recurring pests of potential concern for EU territory are identified by systematic screening of scientific literature and media sources. This newly created dashboard provides online access to horizon scanning results. The tool has three sections: Emerging pests, priority pests and newsletter search engine. A newsletter is published monthly to bolster the EU’s ability to address emerging plant health risks. 

Call for Nanotechnology Experts Closes 30 October

EFSA has published a call for expressions of interest (Ref. EFSA/WG/NANO/2023/01) for working group experts in nanotechnologies. This opportunity is open to experienced, independent experts with relevant scientific expertise in nanomaterials or nanotechnologies and a motivation to contribute to the work of EFSA through participation in its working groups. If you have any questions, please contact [email protected].

Health Canada (HC)

Consultation On Canadian Drinking Water Guidelines for Iron Open Until 28 November

Health Canada has developed a technical document to provide regulatory authorities and decision makers with an objective for the level of iron substances in Canadian drinking water supplies. The review of the literature confirmed there is still no need for a health-based guideline and proposes an aesthetic objective (AO) ≤ 0.1 mg/L for total iron in drinking water. This is decreased from the 1978 AO of ≤ 0.3 mg/L.

Proposed Residential Indoor Air Quality (RAIQ) Guidelines for Benzene Open Until 29 November

Health Canada released a proposed RAIQ update that replaces the 2013 Guidance for Benzene in Residential Indoor Air: Science Assessment Document. The proposed long-term guideline value for benzene is 0.6 μg/m3. Levels of benzene in many homes in Canada may exceed the guideline value and may pose a health risk. Consultation on proposed Residential Indoor Air Quality (RAIQ) guidelines for benzene open until 29 November.

United States Environmental Protection Agency (EPA)

Toxic Substances Control Act (TSCA)

The EPA proposed a rule to strengthen its process for conducting risk evaluations on chemicals under TSCA that would ensure the processes acccout for all human health risks considering chemical mixtrues and exposure through multiple pathways. The rule advances the administration's ambitious environmental justice agenda, which includes enhancements to environmental protections in communities overburdened by pollution.

Sequence Alignment to Predict Across Species Susceptibility (SeqAPASS) Version 7.0

A tool to incorporate protein structural evaluations as another line of evidence has been added to SeqAPASS Version 7.0. SeqAPASS is an online screening tool that allows researchers to extrapolate toxicity information across species. The Iterative Threading Assembly Refinement (I-TASSER) tool allows users to generate protein structures. Users can then use those structures or incorporate additional structures from tools like the Research Collaboratory for Structural Bioinformatics Protein Data Bank (RCSB PDB) and AlphaFold to align them to their chosen species (typically a known sensitive species) then add evidence based on structural similarity in their chemical susceptibility predictions.


International Institute for Sustainable Development (IISD)

Public Engagement on Climate Change Adaptation

The IISD in co-operation with the National Adaptation Plan (NAP) Global Network and Climate Outreach released a report for decision-makers involved on developing country climate change NAP teams. The report includes case studies and presents key considerations for how to make public engagement inclusive and effective, including guidance on using impactful visuals. The report outlines why effective public engagement is critical to the long-term success of efforts to build climate resilience through NAP processes.

European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC)

Since 2010, ECETOC’s Targeted Risk Assessment (TRA) tool has been widely used to calculate the risk of exposure to chemicals for workers, consumers and the environment. The Technical Report (TR) No. 141 report outlines the ECETOC TRA task force comparison of modelled results from version 3.1 of the TRA tool with actual measured data. Results showed TRAv3.1 overestimates exposure in most exposure situations. A new version of the TRA Worker tool (v3.2) is set to be launched shortly, including a few targeted changes, described in TR No. 141, that further increase the conservatism of the tool.

Author's contact: [email protected]