Regulatory Review: End 2023–January 2024

This digest provides an overview of some of the latest regulatory news announcements of interest to the SETAC community. Please send your suggestions to [email protected].

United Nations Environment Programme (UNEP)

28th UN Climate Change Conference (COP28)

World leaders at COP28 recommitted to delivering the Paris Agreement goals and transition away from fossil fuels to reduce global emissions by 43% by 2030, trying to limit the global average temperature increase to 1.5 Celsius.

Organization for Economic Co-operation and Development (OECD)

Managing, Monitoring and Regulating Endocrine Disrupting Chemicals (EDCs) Report

The OECD released a report that presents new non-targeted analysis and bioassay water quality monitoring methods that supplement the traditional substance-by-substance chemical analysis approach to measuring EDCs in water. The report outlines policy instruments and proposes tools and regulations to manage the chemicals’ lifecycle from source to end-of-pipe.

(Q)SAR Assessment Framework Released

The OECD released “Guidance for the regulatory assessment of (Quantitative) Structure Activity Relationship models, predictions, and results based on multiple predictions.” The framework includes guidance and a checklist to help regulators bring clarity, consistency and transparency to the assessment of QSAR results.

European Commission (EC)

EC Published the Current Thinking on the Application of the Microplastics Restriction

The EC is working on a detailed Q&A document to help interpret the October 2023 Commission Regulation (EU) 2023/2055 on microplastics restriction to help with implementation of the new rules. In the meantime, they published the current thinking on the application of the microplastics restriction, including glitter on its own and in products. 

European Chemicals Agency (ECHA)

Key Areas of Regulatory Challenge Report

ECHA released its report on Key Areas of Regulatory Challenge (KARC) to support EU-wide research, identifying areas where research is needed to protect people and the environment from hazardous chemicals and highlighting where new animal-alternative methods are needed.

Investigation Reveals Regulatory Action Needed to Mitigate Risks from PVC Additives and Microparticle Releases

The human health and environmental impact of 63 PVC additives, including plasticizers, heat stabilizers and flame retardants, was investigated in the “Investigation Report on PVC and PVC Additives.”

European Food Safety Authority (EFSA)

Guidance on Protocol Development for EFSA Generic Scientific Assessments

EFSA has released “Guidance on protocol development for EFSA generic scientific assessments” to provide a harmonized and flexible framework for protocols for generic assessments. The guidance is accompanied by a standalone “template” that guides users step by step through the process of planning an EFSA scientific assessment. 

Environment and Climate Change Canada (ECCC) and Health Canada (HC)

Proposed Regulations for Controlling Coal Tars and Their Distillates

ECCC published the summary of public comments on the proposed risk management approach for coal tars and the proposed Certain Products Containing Toxic Substances Regulations. The 70-day comment period on the proposed regulation closes 27 January. 

Government of Canada Seeking Input on Development of Strategy to Guide the 3Rs of Vertebrate Animal Testing

ECCC and HC published a notice of intent to develop a strategy to guide the replacement, reduction or refinement (3Rs) of vertebrate animal testing under the Canadian Environmental Protection Act. They are seeking input on the strategy. The 60-day comment period closes 29 January.

Draft Assessment for the Titanium-Containing Substances Group Published for Comment

The draft assessment for the 13 titanium-containing substances group concluded that the substances entering the environment do not have the potential for immediate or long-term harmful effect and thus do not meet any of the criteria set out in section 64 of the Canadian Environmental Protection Act (CEPA).

Assessments of Siloxanes Group and Gas Oils and Kerosenes

Final assessments of these compounds were published. Down from 7 siloxanes initially identified, 5 siloxane substances were identified for action under the Chemicals Management Plan (CMP) and assessed in the published document.

United States Environmental Protection Agency (USEPA)

USEPA Proposed a Ban on All Uses of Trichloroethylene (TCE)

The USEPA has proposed to ban the manufacture, import, processing and distribution in commerce of TCE for all uses with a phase out goal of one year for most uses.

USEPA Enhanced PFAS Reporting to the Toxics Release Inventory

The USEPA finalized a rule that eliminates the exemption that allowed facilities to avoid reporting information on PFAS when those chemicals were used in small concentrations.

USEPA Prioritizes Five Chemicals Under the Toxic Substances Control Act (TSCA)

USEPA plans to prioritize the following chemicals for risk evaluation under TSCA: Acetaldehyde, Acrylonitrile, Benzenamine, 4,4’-Methylene bis(2-chloroaniline) (MBOCA) and Vinyl Chloride (CASRN 75-01-4).

USEPA Proposes to Strengthen Process for Conducting Risk Evaluations on Chemicals Under TSCA

The proposed rule includes changes to improve USEPA’s process for TSCA risk evaluations, such as commitment to consideration of the disproportionate harms facing overburdened communities, inclusion of all exposure pathways, and clarifications and assurances related to procedural requirements.

Ministry of Ecology and Environment (MEE), China

China MEE Published a Reference List of 363 Substances Related to PFOA

This list of the PFOA-related chemicals contains CAS numbers and identifiers to support the phase out of PFOA, its salts, and PFOA-related compounds. It is an update to the October 2023 inventory of severely restricted toxic chemicals.

National Institute for Public Health and the Environment (RIVM), the Netherlands

Methods and Guidance Released on the Characterization of Toxic Pressure of Chemical Pollutants in Vulnerable Areas

NIVM released a new report providing operational methodology that can be used in practice to characterize the ecological impacts of unintended mixtures in the terrestrial and aquatic ecosystems recognized as having specific societal value or being specifically vulnerable.

Brazil

Brazil’s published a standard that regulates the introduction of novel food products into the country. 

Mexico

Mexico published the New Official Mexico (NOM) list of the Hazardous Substances and Materials Most Frequently Transported (the “List”) to take effect 16 February. 

Australia

Australia's government is working to update its Strategy for Nature 2019–2030 to promote biodiversity in an inclusive manner.

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