Global Regulatory Update for September 2024

WEBINAR — “An Update on the EU Chemicals Strategy for Sustainability,” September 18, 2024, 11:30 a.m. – 12:30 p.m. (EDT): The Acta Group (Acta^®) is pleased to present “An Update on the EU Chemicals Strategy for Sustainability,” a complimentary webinar that will review and update how the Chemicals Strategy for Sustainability is fundamentally reshaping the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and the Classification, Labeling, and Packaging (CLP) regulations in ways that are resetting the global stage for the regulation of chemicals. During this webinar, Meglena Mihova, Managing Partner, EPPA; Jane S. Vergnes, Ph.D., DABT^®, Vice President, Scientific Affairs and Director of Toxicology, Acta; Tiina A. Lantto, Ph.D., Regulatory Consultant/Toxicologist, Acta; and Lynn L. Bergeson, President, Acta, will discuss the technical, regulatory science, political, and strategic implications of the introduction of new hazard classes under CLP, application of the generic approach to risk assessment, and development of the essential use concept, in terms of identifying new hazard classes, and New Approach Methodologies (NAM) for identifying them. Registration is open now.

AUSTRALIA

AICIS Will Publish Version 3 Of The AICIS Categorization Guidelines On September 24, 2024: The Australian Industrial Chemicals Introduction Scheme (AICIS) announced on August 27, 2024, that it will publish a new version of the Industrial Chemicals Categorization Guidelines on September 24, 2024. According to AICIS, the differences between the current guidelines and version 3 include:

• List of chemicals with high hazards for categorization: AICIS will add entries to the list of chemicals with high hazards for categorization (the list) that introducers may need to check during the AICIS categorization process. The changes include almost 600 unique entries added to the list, based on current sources and the European Commission (EC) Endocrine Disruptor List (List I) added as a source.

• Information to demonstrate absence of specific target organ toxicity after repeated exposure and bioaccumulation potential: AICIS will refine the requirements for introducers to show the absence of specific target organ toxicity after repeated exposure and bioaccumulation potential in version 3 of the guidelines.

• Changes to the regulation of vapes: AICIS notes that as it announced in July 2024, the use of chemicals in vaping goods is not an industrial use. This is due to the vaping reforms legislation. AICIS will remove all references to personal vaporizers (and chemicals used in personal vaporizers) in version 3 of the guidelines.

CANADA

Canada Publishes Notice Regarding Reporting Plastic Resins And Certain Plastic Products For The Federal Plastics Registry: On April 20, 2024, Canada published a Canada Gazette notice that will require companies (including resin manufacturers, service providers, and producers of plastic products) to report annually on the quantity and types of plastic they manufacture, import, and place on the market. The notice applies to all plastic resins and plastic products set out in Parts 1 through 4 of the Schedule that are manufactured in Canada, imported into Canada, or placed on the market in Canada. According to Canada’s web page on the Federal Plastics Registry, reporting will start in September 2025 with Phase 1, requiring reporting on plastic placed on the market in three categories for the 2024 calendar year. In 2026, Phase 2 adds reporting requirements for resin manufacturers and importers for the three categories that reported during Phase 1, as well as reporting on plastic placed on the market for remaining categories. Phase 2 will also see the introduction of reporting on plastic waste generated at industrial, commercial, and institutional (ICI) facilities and the introduction of reporting for plastic collected and sent for diversion and disposal for some categories. In 2027, Phase 3 adds additional reporting on plastics collected and sent for diversion and disposal for more categories. Canada notes that reporting requirements for Phase 4 will be covered in a future information gathering notice.

Comments On Canada’s Updated Draft State Of PFAS Report And Revised Risk Management Scope Due September 11, 2024: The July 13, 2024, Canada Gazette includes a notice announcing the availability of the Updated Draft State of Per- and Polyfluoroalkyl Substances (PFAS) Report (Updated Draft Report) and Revised Risk Management Scope for Per- and Polyfluoroalkyl Substances (PFAS) (Revised Risk Management Scope). The Updated Draft Report defines PFAS as “fluorinated substances that contain at least one fully fluorinated methyl or methylene carbon atom (without any [hydrogen, chlorine, bromine, or iodine atoms bonded] to it)” and states that the class of PFAS is composed of substances meeting this definition. The Updated Draft Report defines fluoropolymers as “fluorinated polymers made by polymerization or copolymerization of olefinic monomers (at least [one] of which contains fluorine bonded to [one] or both of the olefinic carbon atoms), to form a carbon-only polymer backbone with fluorine atoms directly bonded to it.” According to the notice, Canada proposes to conclude that the class of PFAS, excluding fluoropolymers, meets criteria set out in Section 64 of the Canadian Environmental Protection Act, 1999 (CEPA). The Minister of the Environment and the Minister of Health (the ministers) propose to recommend that the class of PFAS, excluding fluoropolymers, be added to Part 2 of Schedule 1 of CEPA.

According to the Revised Risk Management Scope, Canada is considering:

• As a first step, a regulatory instrument under CEPA to restrict PFAS not currently regulated in firefighting foams; and

• Additional regulatory instrument(s) under CEPA to prohibit other uses or sectors in relation to PFAS. Prioritization for prohibition may be based on factors such as socioeconomic considerations, the availability of feasible alternatives, and the potential for human and environmental exposure.

The Revised Risk Management Scope states that “[v]oluntary risk management actions are also being considered to achieve early results to reduce releases of PFAS, as a complement to the proposed regulatory instruments.” Comments were due September 11, 2024.

Canada’s Competition Bureau Begins Public Consultation On Competition Act’s New Greenwashing Provisions: On June 20, 2024, amendments to Canada’s Competition Act took effect, including provisions that address unsupported environmental claims by:

• Requiring that claims about the environmental benefits of a product be supported by adequate and proper testing; and

• Requiring that claims about the environmental benefits of a business or business activity be based on adequate and proper substantiation in accordance with an internationally recognized methodology.

The Competition Bureau launched a public consultation on July 22, 2024, to obtain input from stakeholders on the new greenwashing provisions. The comments will inform the Bureau’s future enforcement guidance on environmental claims. The Bureau seeks feedback about the new provision of the law relating to statements, warranties, or guarantees of a product or service’s environmental benefits and is “particularly interested” in responses to certain questions, including:

• Are there certain types of claims about environmental benefits of products or services that are less likely to be based on adequate and proper testing? Is there something about those types of claims that makes them harder to test?

• What challenges may businesses and advertisers face when complying with this provision?

The Bureau also seeks feedback about the new provision of the law relating to representations made about environmental benefits of businesses and business activities:

• Are there certain types of claims about the environmental benefits of businesses or business activities that are less likely to be based on “adequate and proper substantiation in accordance with internationally recognized methodology”? Is there something about those types of claims that makes them harder to substantiate?

• What internationally recognized methodologies should the Bureau consider when evaluating whether claims about the environmental benefits of the business or business activities have been “adequately and properly substantiated”? Are there limitations to these methodologies that the Bureau should be aware of?

• What challenges may businesses and advertisers face when complying with this new provision of the law?

Responses are due September 27, 2024.

Canada Requests Information On 312 PFAS; Responses Due January 29, 2025: On July 27, 2024, Canada’s Minister of the Environment published a Canada Gazette notice announcing a mandatory survey to obtain information on the manufacture, import, and use of 312 specific PFAS. Canada’s “Guidance manual for responding to the: Notice with respect to certain per- and polyfluoroalkyl substances (PFAS)” (Guidance Manual) states that the purpose of the notice is to collect information on certain PFAS substances, either alone, in mixtures, products, or manufactured items in Canadian commerce for the calendar year 2023. Canada will use this information to establish baseline commercial use data and support future activities related to the class of PFAS. The list of specific PFAS “is focused on those substances known, or anticipated to be in Canadian commerce that have not been recently surveyed.” Responses are due January 29, 2025.

While companies located outside of Canada are not subject to the notice, companies importing products must respond to the notice if the criteria are met. In the Guidance Manual, Canada “encourages” foreign suppliers to inform their Canadian customers that they import a reportable substance and may meet the reporting criteria of the notice. According to the Guidance Manual, a letter to help Canadian stakeholders obtain data from their foreign suppliers is available for download on the Request for information from foreign suppliers web page. The Guidance Manual notes that if confidential business information (CBI) cannot be shared with Canadian stakeholders to allow them to respond to the notice, foreign suppliers and Canadian importers can submit information together in the form of a blind submission. More information is available in our July 29, 2024, blog item.

On September 11, 2024, Environment and Climate Change Canada (ECCC) held an information session in English on the survey. Canada will hold a second session on the same content in November 2024.

Canada Begins 60-Day Comment Period On Computational Tool For Chemical Screening And Prioritization: As part of its implementation of the modernized CEPA, on August 17, 2024, Health Canada published a Canada Gazette notice announcing the availability of its Science Approach Document — Chemical Screening and Prioritization: Health Canada’s Automated Workflow for Prioritization (HAWPr). The science approach document (SciAD) describes the scientific approach that Canada applied to more than 25,000 chemicals on the Domestic Substances List (DSL) to prioritize their risk to human health based on their inherent hazard properties, current use in products, and quantities in commerce. Canada developed HAWPr to collect, organize, and process chemical data more efficiently to expand on the methods used to identify risk assessment priorities under CEPA. According to the Canada Gazette notice, the SciAD presents the key elements of the HAWPr, including:

• The information sources where data are collected;

• Predictive modeling approach for data-poor chemicals;

• The human health hazards considered and the criteria for determining if a substance has a hazard indicator;

• Substance use patterns and volume considerations used in a weight-of-evidence evaluation to determine exposure potential;

• The integration of hazard and exposure information for risk-based prioritization;

• Validation of the workflow by comparing prioritization decisions against known hazardous substances and those with known human exposure;

• Proposed outcomes for substances on the DSL; and

• Limitations and uncertainties of the tool.

The notice states that “SciAD demonstrates that the HAWPr is a robust tool that will improve how substances are prioritized for assessment work under CEPA in order to continue to protect the health of people living in Canada.” Preliminary results for the use of the HAWPr on the DSL substances are available as a supporting document to this approach. Canada is providing a public consultation on the SciAD in advance of using this information in prioritization activities to allow the public to comment and provide additional information on the approach and its application to the DSL. Comments are due October 16, 2024.

EUROPEAN UNION (EU)

Germany Posts Information On Dossier Submitter’s Ongoing Role In Proposed REACH Restriction For PFAS: On April 15, 2024, Germany’s Federal Institute for Occupational Safety and Health (BAuA) REACH-CLP-Biozid Helpdesk published an item entitled “Dossier Submitter’s ongoing role in the PFAS restriction proposal.” While the European Chemicals Agency’s (ECHA) Committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) evaluate the restriction proposal, the five national authorities that prepared the proposal (the Netherlands, Germany, Denmark, Sweden, and Norway) are updating the assessments supporting the proposal, taking into account the “unprecedented number of comments received” (5,642; >100,000 pages). According to the item, the comments contain extensive information on the uses of PFAS across the EU and the European Economic Area (EEA), as well as information on the suitability of alternatives and the socioeconomic impacts of the proposed restriction. For each of the sectors, the national authorities are:

• Identifying uses of PFAS that were not assessed in the initial report, incorporating these uses into existing sector assessments, or creating additional sectors, as necessary;

• Considering how changes to other relevant EU legislation since the submission of the proposal (e.g., the updated fluorinated gas (F-gas) regulation) affect/interact with the REACH restriction dossier;

• Assessing the information provided on alternatives to PFAS to review the appropriateness of the proposed derogations and transition periods (derogations may be added, revised, or removed while transition periods may be increased or reduced);

• Assessing the appropriateness of restriction options other than a ban to address the identified risks of PFAS (across their full life cycles) where relevant suggestions that were not previously considered are made in the consultation comments; and

• Updating the socioeconomic impact assessment to present clearly the trade-offs between the different restriction options considered to allow policy makers to make informed policy choices.

The item notes that in addition, the five authorities will also consider the information provided in the consultation on the hazard and risks of PFAS across their full life cycles. According to the item, this process will result in updates to the initial restriction proposal, which will be evaluated by RAC and SEAC. The item states that “[t]he five authorities are committed to deliver these updates in the shortest possible timeframe while ensuring the consistency and quality of their assessments. Their aim remains to support high quality science-based regulatory decision-making on the PFAS group.”

EC Communication Defines Principles On Limiting Most Harmful Chemicals To Essential Uses: On April 22, 2024, the EC announced that it adopted a “Communication from the Commission: Guiding criteria and principles for the essential use concept in EU legislation dealing with chemicals.” The press release states that “[t]he overall aim of this concept is to achieve higher regulatory efficiency and predictability for authorities, investors and industry for a faster phase-out of the most harmful substances in non-essential uses, while allowing more time for the phase-out of uses that are essential for society.” The EC intends the concept also to help industry to prioritize investments in innovative and sustainable chemicals in the EU. The Communication states that a use of a most harmful substance is essential for society if the following two criteria are met:

• That use is necessary for health or safety or is critical for the functioning of society; and

• There are no acceptable alternatives.

The Communication aims to provide clarity on these criteria and on how they can be implemented in legislation. The EC states that it “does not intend to change existing references to a technical and/or economic feasibility assessment if it proposes to introduce the essential use concept in any such legislative area.” The EC will weigh the appropriateness of such references to the legislative context when considering the introduction of the concept of essential use in any other areas. More information is available in our April 26, 2024, memorandum.

ECHA’s Enforcement Forum Agrees To EU-Wide Product To Check Classification And Labeling Of Mixtures In Products; Approves Pilot Project On ORs: ECHA announced on June 17, 2024, that its Enforcement Forum agreed to a new EU-wide project to check that hazardous mixtures present in products, such as air fresheners or electronic cigarettes, are classified, labeled, and packaged correctly to protect consumers and children from chemical hazards. According to ECHA, the checks will include consumer products that are widely available on the market and known to contain hazardous mixtures, “such as nicotine products with acutely toxic substances or air fresheners containing sensitising or irritant substances.” Inspectors will check if the suppliers of these products fulfilled their duties under the CLP regulation, including classification and labeling, as well as requirements for packaging and child resistant fastening. They will also check the notifications to the poison centers and the safety data sheets (SDS) of the mixtures. The project will be prepared in 2025 and inspections are expected in 2026.

The Enforcement Forum also agreed that its next pilot enforcement project will focus on Only Representatives (OR) who register imported substances, including those present in mixtures. According to ECHA, inspectors “will aim to identify free-riders and potentially fraudulent economic operators, which will contribute to a more level playing field for companies in different countries.” Inspectors will check that the tonnage of the substance is registered correctly and may also check that ORs keep records of importers covered and obligations regarding the SDSs.

ECHA Adds Chemical To Candidate List: ECHA announced on June 27, 2024, that it added bis(α,α-dimethylbenzyl) peroxide to the Candidate List because it is toxic for reproduction. According to ECHA, it is used as a processing aid (e.g., as a flame retardant). ECHA notes that under REACH, companies have legal obligations when their substance is included — either on its own, in mixtures, or in articles– on the Candidate List. If an article contains a Candidate List substance above a concentration of 0.1 percent (weight by weight), suppliers must provide their customers and consumers information on how to use it safely. Consumers have the right to ask suppliers if the products they buy contain substances of very high concern (SVHC). Importers and producers of articles have to notify ECHA if their article contains a Candidate List substance within six months from the date it has been included in the list (June 27, 2024). EU and EEA suppliers of substances on the Candidate List, supplied either on their own or in mixtures, have to update the SDS they provide to their customers.

ECHA Begins Public Consultation On Six Proposals To Identify New SVHCs: According to an item in the September 4, 2024, ECHA Weekly, ECHA has begun a public consultation on six proposals to identify new SVHCs. The substances and examples of their uses are:

• 6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid: Used in lubricants, greases, release products, and metal working fluids;

• O,O,O-triphenyl phosphorothioate: Used in lubricants and greases;

• Octamethyltrisiloxane: Used in manufacture and formulation. Used by professional workers or consumers in the following applications (including article service life): cosmetics, personal and health care products, pharmaceuticals, washing and cleaning products, coating and non-metal surface treatment, and in sealants and adhesives;

• Perfluamine: Used for the manufacture of electrical, electronic, and optical equipment, and machinery and vehicles;

• Reaction mass of: triphenylthiophosphate and tertiary butylated phenyl derivatives: This substance has no active registrations; and

• Tris(4-nonylphenyl, branched and linear) phosphite: Used in the following products: polymers, adhesives and sealants, and coatings.

Comments are due October 14. 2024.

PERU

Peru Begins Public Consultation On Draft Regulations Enacting Chemical Management Law: On July 24, 2024, Peru began a public consultation on draft regulations that would enact Decree No. 1570, the draft Supreme Decree approving it, and the draft statement of reasons. Decree No. 1570 establishes the legal framework for the comprehensive management of chemicals. It provides for the standardization of information on hazard classification, labeling, and SDSs; the traceability of information through the creation of the National Registry of Chemical Substances (RENASQ); and the adoption of risk management measures and the evaluation of their impact on health and the environment. The draft regulation contains provisions regarding:

• The classification of hazards, labeling of chemical substances, and SDSs;

• RENASQ;

• Reduction and management of health and/or environmental risks from chemical substances;

• Risk assessment of chemicals;

• Generation, use, and communication of information; and

• Supervision, inspection, and enforcement.

Comments on the draft regulations are due October 24, 2024.

UNITED KINGDOM (UK)

Defra Consults On Proposal To Amend UK REACH Use And Exposure Information Requirements: On May 16, 2024, the UK’s Department for Environment, Food and Rural Affairs (Defra) began a public consultation on the UK government’s proposals to amend the current transitional provisions under UK REACH for submitting registration information to the Health and Safety Executive (HSE). Defra, following an in-depth analysis of the current UK REACH requirements and working with the HSE and the Environment Agency (EA), has devised an Alternative Transitional Registration model (ATRm) for UK REACH. Defra states that the aim of this model “is to uphold existing human health and environmental protections (by gaining better information on the use and exposure of substances in Great Britain (England, Scotland and Wales)), while reducing costs to businesses transitioning from EU REACH to UK REACH.” The consultation includes several parts:

• Part One: Standard consultation questions;

• Part Two: The details and consultation questions on the ATRm;

• Part Three: As part of Defra’s ongoing project to improve UK REACH, it is also consulting on proposals for changes to the restriction and reporting process, as well as proposals to introduce further protections against unnecessary animal testing;

• Part Four: Seeks stakeholders’ views on impacts to trade;

• Part Five: Provides further detail on the UK REACH Article 1 consistency statement; and

• Part Six: Provides a list of all the consultation questions covered in the document. 

According to Defra, the consultation will provide it with the opportunity to consider stakeholder views before introducing legislative changes necessary to bring the proposed changes into effect. This will be followed by a second consultation that Defra plans to support with a Statutory Instrument and a final impact assessment. Defra notes that as required under the Environment Act 2021, it will publish, before or alongside the second consultation, an explanation of why the Secretary of State considers that the provision to be made by the regulations is consistent with Article 1 of UK REACH. Responses were due July 25, 2024.