Global Regulatory Update for March 2024

AUSTRALIA

Final Guidance On Environmental Claims Includes Principles To Guide Business: On December 12, 2023, the Australian Competition and Consumer Commission (ACCC), an independent Commonwealth statutory authority, announced eight principles intended to help businesses ensure their environmental marketing and advertising claims “are clear and accurate, and do not mislead consumers.” ACCC states that the principles comprise its final guidance on environmental claims, which sets out the ACCC’s view of good practice when making environmental claims, as well as making businesses aware of their obligations under the Australian Consumer Law. The eight key principles are:

• Make accurate and truthful claims;

• Have evidence to back up claims;

• Do not hide or omit important information;

• Explain any conditions or qualifications on claims;

• Avoid broad and unqualified claims;

• Use clear and easy-to-understand language;

• Visual elements should not give the wrong impression; and

• Be direct and open about sustainability transition.

ACCC states that in early 2024, it will release further guidance for businesses and consumers on emission and offset claims, as well as the use of trust marks. ACCC will also develop guidance to help consumers “confidently assess and rely on environmental claims.”

CANADA

Canada Announces Planned Public Consultation Opportunities To Support CEPA Reform, Begins Consultation On Discussion Document On Development Of A Right To A Healthy Environment Implementation Framework: As reported in our June 23, 2023, memorandum, Bill S-5, Strengthening Environmental Protection for a Healthier Canada Act, received Royal Assent on June 13, 2023. The bill modernizes the Canadian Environmental Protection Act, 1999 (CEPA) by recognizing the right to a healthy environment, strengthening Canada’s chemicals management regime, and increasing transparency in the way it is administered. Canada is working to implement the bill through several initiatives that include developing various instruments, such as frameworks, policies, strategies, regulations, and processes. Planned public consultation opportunities include:

• Discussion document on the implementation framework for a right to a healthy environment under CEPA;

• Proposed Watch List approach (spring 2024);

• Proposed plan of chemicals management priorities: Canada is developing a multi-year, integrated plan of chemicals management priorities. The plan will include risk assessment priorities and other priority initiatives that support chemicals management, such as information-gathering, research and monitoring, risk management, and risk communication (summer 2024);

• Draft strategy to replace, reduce, or refine vertebrate animal testing (summer/fall 2024);

• Draft implementation framework for a right to a healthy environment under CEPA (summer/fall 2024);

• Discussion document for toxic substances of highest risk regulations (winter 2025); and

• Discussion document on the restriction and authorization of certain toxic substances regulations (winter/spring 2025).

On February 8, 2024, Canada began a public consultation on a discussion document on the implementation framework for a right to a healthy environment under CEPA. Environment and Climate Change Canada (ECCC) and Health Canada (HC) have developed a discussion document on the right to a healthy environment under CEPA and the key elements being considered for the implementation framework. The discussion document includes a series of questions throughout. The framework will elaborate on:

• Principles to be considered in the administration of CEPA, including environmental justice, intergenerational equity, and non-regression;

• Research, studies, and monitoring in support of the right to a healthy environment;

• Relevant factors to be taken into account when interpreting and applying the right and in determining the reasonable limits to which it is subject, such as social, health, scientific, and economic factors; and

• Mechanisms to support protection of the right when making decisions under CEPA.

Comments are due April 8, 2024. Canada will consider comments when developing the draft implementation framework.

Canada Issues Code Of Practice For The Environmentally Sound Management Of Chemical Substances In The Chemicals, Plastics And Rubber Sectors: Canada announced on February 24, 2024, the availability of the Code of Practice for the Environmentally Sound Management of Chemical Substances in the Chemicals, Plastics and Rubber Sectors (Code). Issued under CEPA Section 54(4), the objective of the Code is to identify and promote best practices in the management and handling of chemical substances in the manufacturing and distribution of chemicals, plastics, and rubber products to prevent releases of these substances into the environment. The Code is intended to apply to manufacturers, formulators, and distributors in the chemicals, plastics, and rubber sectors that fall under, but are not limited to, the following North American Industrial Classification System (NAICS) codes:

• 3251 — Basic Chemical Manufacturing;

• 3252 — Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing;

• 325991 — Custom Compounding of Purchased Resins;

• 3261 — Plastics Product Manufacturing; and

• 3262 — Rubber Product Manufacturing.

According to the Code, the best practices identified should be applied based on the activities undertaken in relation to all chemical substances in use at individual facilities. The specific activities or operations within a facility will dictate which practices are relevant and applicable. The Code notes that it “does not have the force of law, and, therefore, it is not a substitute for existing regulatory requirements of the municipal, provincial/territorial, and federal authorities. Commitment by companies to conform to the Code recommendations does not remove obligations to comply with all applicable statutory and regulatory requirements.”

EUROPEAN UNION (EU)

Council Of The EU And EP Reach Provisional Agreement On Improving CLP: The Council of the EU announced on December 5, 2023, that it reached a provisional agreement with the European Parliament (EP) on the regulation for the classification, labeling, and packaging of chemicals (CLP regulation) that would update the 2008 legislation and aims to clarify the rules on labeling chemical substances and the required information for chemicals sold online. According to the Council, the provisional agreement adapts the CLP regulation to different forms of trade (such as online trade or trade in refill products), promotes the circularity of the chemical products, makes labels clearer and easier to understand (including digital labeling), and ensures a high level of protection against chemical hazards. The Council states that the proposed regulation includes the following measures:

• Better and faster processes for all actors to provide information on hazards of chemicals placed on the EU market;

• Communication of chemical hazards, including online, through simpler and clearer labeling and advertising requirements (i.e., a minimal font size for labels of chemicals);

• New powers for the European Commission (EC), in addition to EU member states and industry, to accelerate the procedure for identifying hazardous substances and make the necessary classification proposals; and

• Specific rules for refillable chemical products, so consumers can safely buy and use chemical products, such as home care chemicals, sold in bulk.

The Council and the EP must endorse and formally adopt the provisional agreement.

EC Proposes “One Substance, One Assessment” Chemicals Assessment Platform For Faster, Simplified, And Transparent Processes: The EC announced on December 7, 2023, the adoption of three legislative proposals intended to streamline assessments of chemicals across EU legislation; strengthen the knowledge base on chemicals; and ensure early detection and action on emerging chemical risks. The press release states that under this “one substance, one assessment” package, significant tasks will be reallocated between four EU agencies, “ensuring coherent and transparent safety assessments of chemicals used in products such as medical devices, toys, food, pesticides and biocides.” The proposals aim to:

• Strengthen cooperation and consolidate scientific and technical work on chemicals in the European Chemicals Agency (ECHA), the European Food Safety Authority (EFSA), the European Environment Agency (EEA), and the European Medicines Agency (EMA). The agencies will be better equipped to align priority setting, timelines, processes, and methodologies used for the assessment of chemicals. The press release states that “knowledge gained from assessments under one piece of legislation (for example on biocides) can be re-used for another one (for example in toys).”

• Establish a common data platform and introduce a “one-stop shop” access to data on chemicals held by the EU agencies and the EC, compiled under EU legislation. This includes data on hazards, physico-chemical properties, presence in the environment, emissions, uses, environmental sustainability of chemical substances, and on ongoing regulatory processes. According to the press release, the platform will subsume existing platforms such as the Information Platform on Chemical Monitoring (IPCHEM), the Public Activities Coordination Tool (PACT), and the EU chemicals legislation finder (EUCLEF). It will “expand their scope to almost all EU chemicals legislation and complement them with new tools and databases, for example with a repository of human- and environment-based reference values.”

• Establish systematic collection of human biomonitoring data generated in the EU to inform policy makers about the levels of chemicals found in people (e.g., in blood or breast milk). This will help to estimate better the level of exposure of EU citizens to chemicals.

• Set up a monitoring and outlook framework to enable early detection of chemical risks, such as from per- and polyfluoroalkyl substances (PFAS), early enough to prevent the pollution becoming widespread. It will also enable fast regulatory response and monitor the impact of regulatory actions taken on chemicals. The framework will consist of an early warning and action system and of a framework of indicators, among others.

• Empower the ECHA to generate data when needed.

• Ensure transparency of scientific studies on chemicals, including those commissioned by companies.

The EP and the Council of the EU will examine the three proposals under the ordinary legislative procedure.

Draft CoRAP Update Lists 28 Chemicals For Evaluation By EU Member States For 2024-2026: ECHA has released a draft Community Rolling Action Plan (CoRAP) update for 2024-2026. The draft CoRAP contains 28 substances, including 11 new substances compared to the current CoRAP for 2023-2025; ten substances are planned for evaluation in 2024, including evaluation of four substances as a group, and 18 are divided for evaluation in 2025 and 2026. ECHA submitted the draft update on November 30, 2023, to the Member State Competent Authorities and the ECHA Member State Committee. The Committee is expected to give its opinion on the draft update in February 2024. On the basis of the Committee’s opinion, ECHA aims to adopt and publish the CoRAP update for 2024-2026 in March 2024. ECHA encourages registrants to look at the draft list of substances planned for evaluation in 2024 and update their dossiers to include all relevant information before March 2024. More information is available in our December 29, 2023, blog item.

ECHA Calls For Evidence On Certain Chromium (VI) Substances: According to an item in the December 13, 2023, issue of the ECHA Weekly, ECHA is looking for information for a potential restriction of certain chromium (VI) substances under the Registration, Evaluation, Authorisation and Restriction of Chemicals regulation (REACH). ECHA has opened a call for evidence targeting companies using chromium (VI) substances. ECHA seeks information on:

• The costs and effectiveness of risk management measures to limit exposure to and emissions of chromium (VI); and

• Additional information relevant for the preparation of the Annex XV proposal for a restriction of certain chromium (VI) compounds.

Responses were due February 13, 2024. More information is available in our December 14, 2023, blog item.

EP Adopts Directive Banning Greenwashing And Misleading Product Information; EP Committees Approve “So-Called” Green Claims Directive: On January 17, 2024, the EP voted with 593 votes in favor, 21 against, and 14 abstentions to adopt a directive intended to improve product labeling and ban the use of misleading environmental claims. According to the EP’s January 17, 2024, press release, the new rules aim to make product labeling “clearer and more trustworthy” by banning the use of general environmental claims like “environmentally friendly,” “natural,” “biodegradable,” “climate neutral,” or “eco” without proof. The EC will regulate the use of sustainability labels, “given the confusion caused by their proliferation and failure to use comparative data.” Going forward, the EC will allow only sustainability labels based on official certification schemes or established by public authorities. Additionally, the directive will ban claims that a product has a neutral, reduced, or positive impact on the environment because of emissions offsetting schemes. After approval by the Council of the EU, the directive will be published in the Official Journal of the European Union. EU member states will then have 24 months to transpose it into national law.

The EP’s Internal Market and Environment Committees announced on February 14, 2024, their approval of the “so-called” green claims directive complementing the ban on greenwashing. The Committees adopted the draft report with 85 votes to 2 and 14 abstentions. It defines what kind of information companies must provide to support their environmental marketing claims. It also creates a framework and deadlines for checking evidence and approving claims, and specifies penalties for companies that break the law. According to the press release, the Committees agreed with the EC that companies should submit future environmental marketing claims for approval before making them. Accredited verifiers would assess the claims within 30 days. The Committees suggested that the EC create a list of less complex claims and products that could benefit from faster or simpler verification and that the EC decide whether green claims about products containing hazardous substances should remain possible. The EP will vote on the draft report at an upcoming plenary session, constituting EP’s position at first reading (most likely in March 2024). After elections on June 6-9, 2024, the new EP will consider the draft report.

ECHA Adds Five Chemicals To Candidate List Of SVHCs For Authorization: ECHA announced on January 23, 2024, that it added five chemicals to the Candidate List of substances of very high concern (SVHC) for authorization and updated the existing entry for dibutyl phthalate to include its endocrine-disrupting properties for the environment:

More information is available in our January 23, 2024, blog item.

ECHA’s Strategy Statement Sets Out Strategic Goals For Next Five Years: ECHA announced on January 30, 2024, the publication of the ECHA — Strategy Statement 2024-2028. The strategy details ECHA’s goals and priorities over the next five years to protect health and the environment through its work for chemical safety. ECHA’s goals and priorities include:

• Be a trusted chemicals agency:
  
  
  • Deliver transparent, independent, and high-quality scientific advice, opinions, and decisions as required under our legal mandate;
    
    
  • Enhance decision and policy making through optimal use of data, knowledge, and competence; and
    
    
  • Facilitate the prioritization and co-ordination of regulatory actions on substances and groups of substances with the EC, EU agencies, and Member State Authorities;
    
    
• Respond to emerging challenges and changes in our legal landscape:
  
  
  • Implement new legal requirements using existing and new synergies and experience as necessary;
    
    
  • Work with relevant EU agencies and bodies to deliver Chemical Strategy for Sustainability (CSS) actions and objectives; and
    
    
  • Provide scientific and technical advice on chemicals to EU policy makers;
    
    
• Communicate and engage:
  
  
  • Deepen our network of engagement with EU institutions and agencies and member states;
    
    
  • Collaborate and provide tools, advice, and support to industry; and
    
    
  • Promote awareness and understanding of ECHA’s work to stakeholders representing workers, the public, and the environment;
    
    
• Lead on chemical knowledge and expertise:
  
  
  • Contribute proactively to expanding scientific and technical competence and knowledge on chemical safety;
    
    
  • Promote the development and use of alternative methods for the assessment of hazards and risks of chemicals; and
    
    
  • Support the EC to enhance engagement and synergies at international level;
    
    
• Invest in people and organizational excellence:
  
  
  • Develop and empower people for success;
    
    
  • Create optimal ways of working for ECHA, its bodies, its people, and the environment; and
    
    
  • Adopt an IT delivery model that is cost-effective, streamlined, modular, interoperable, cloud-based, and centralized.

ECHA’s New Database For Chemicals Includes Information From All REACH Registrations: ECHA announced on January 30, 2024, the launch of ECHA CHEM, its “new solution for publishing information on chemicals.” According to ECHA, the first version of ECHA CHEM includes information from the more than 100,000 REACH registrations that companies have submitted to ECHA. On the support page for ECHA CHEM, ECHA notes that as it gradually transfers the data it makes publicly available from their current location (Search for chemicals) to ECHA CHEM, users may need to consult both ECHA CHEM and the former platform. ECHA will expand the database later in 2024 with the redesigned Classification and Labelling Inventory, followed by the first set of regulatory lists. More information is available in our February 9, 2024, blog item.

ECHA Begins Public Consultation On Recommending Authorization For Five SVHCs And Adding A New Hazard To DBP: ECHA announced on February 7, 2024, that it is considering recommending the following substances for the REACH Authorization List:

• Melamine;

• Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof (TBPH);

• S-(tricyclo[5.2.1.0 2,6]deca-3-en-8(or 9)-yl) O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate;

• Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide; and

• Barium diboron tetraoxide.

ECHA states that it is looking for further information on the uses of these substances in scope of authorization, their possible exemptions from the authorization requirement, and on the structure and complexity of the supply chains. ECHA encourages REACH registrants to update their use information alongside sending their comments. The public consultation will close May 7, 2024.

The EC has also requested ECHA to carry out an investigation on flame retardants that will cover TBPH, among other substances. According to ECHA, its report will support the EC in deciding whether to request that ECHA prepare a restriction dossier. A call for evidence for this investigation is open until April 5, 2024, and ECHA invites interested parties to provide information on TBPH via this call for evidence, as well. More information is available in our February 23, 2024, blog item.

ECHA Guidance Will Better Protect Bees From Biocides: ECHA announced on February 14, 2024, the availability of guidance to help companies and authorities assess the risks to bees from biocidal active substances and products. The guidance document presents an approach to assess the risks of biocides to honey bees, bumble bees, and solitary bees, and it addresses uses of products such as insecticides and acaricides (product-type 18). According to ECHA, the guidance will assist companies applying for active substance approvals or product authorizations under the EU’s Biocidal Products Regulation (BPR) to conduct the risk assessment for their applications. It also explains the guiding principles for authorities to evaluate applications and to conclude on a biocidal product’s compliance with the authorization conditions. ECHA will host a webinar on March 5, 2024, during which experts involved in preparing the guidance will provide an overview of its content and respond to questions from participants. ECHA states that the EC and EU member states will decide at a later stage when the guidance needs to be applied in the assessment of biocides.

INTERNATIONAL AGENCY FOR RESEARCH ON CANCER (IARC)

IARC Evaluates Carcinogenicity Of PFAS And PFOS: IARC announced on December 1, 2023, the results of its evaluation of the carcinogenicity of perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS). The IARC Monographs program convened a Working Group of 30 international experts from 11 countries for a meeting on November 7-14, 2023, in Lyon, France. After thoroughly reviewing the extensive published literature, the Working Group classified PFOA as carcinogenic to humans (Group 1) and PFOS as possibly carcinogenic to humans (Group 2B). IARC states:

PFOA is carcinogenic to humans (Group 1), on the basis of sufficient evidence for cancer in experimental animals and strong mechanistic evidence (for epigenetic alterations and immunosuppression) in exposed humans. There was also limited evidence for cancer in humans (renal cell carcinoma and testicular cancer) and strong mechanistic evidence in human primary cells and experimental systems (for epigenetic alterations and immunosuppression, as well as several other key characteristics of carcinogens).

PFOS is possibly carcinogenic to humans (Group 2B), on the basis of strong mechanistic evidence across test systems, including in exposed humans (for epigenetic alterations and immunosuppression, as well as several other key characteristics of carcinogens). There was also limited evidence for cancer in experimental animals and inadequate evidence regarding cancer in humans.

IARC states that PFOA and PFOS are “ubiquitously present in the environment, even in the most remote areas,” and they have also been found in products such as food packaging, carpets, building materials, cosmetics, cookware, waterproof clothing, and firefighting foams. According to IARC, exposures are expected to be highest among workers involved in producing PFOA or PFOS or using these chemicals directly in the manufacture of other products. Inhalation is thought to be the main route of exposure for workers, although dermal exposure is possible. The general population is exposed mainly via food and drinking water, and potentially via consumer products. At contaminated sites, drinking water is the main exposure source for the general population.

NEW ZEALAND

New Zealand Begins Public Consultation On Proposed Changes To Information Required From Hazardous Substance Importers And Manufacturers: The New Zealand Environmental Protection Authority (New Zealand EPA) announced on December 13, 2023, that it has begun a public consultation on proposed changes to the Hazardous Substances (Importers and Manufacturers) Notice 2015 that are aimed at improving how hazardous chemicals, including pesticides, fumigants, and antifouling paints, are managed. The proposed changes include requiring importers and manufacturers of certain chemicals to report on the quantities they have imported or manufactured. According to New Zealand EPA, other proposed changes include all importers and manufacturers being required to provide their New Zealand Business Number, Hazardous Substances and New Organisms (HSNO) approval number, and/or the name of the group standard approval for the chemicals they are importing or manufacturing. Comments are due 5:00 p.m. on March 28, 2024.

UNITED KINGDOM (UK)

HSE Recommends Adding DIHxP To UK REACH Authorization List: The UK’s Health and Safety Executive (HSE) announced in its January 17, 2024, UK REACH ebulletin that it recommended that diisohexyl phthalate (DIHxP) be added to the list of substances subject to authorization (Annex 14) for UK REACH. As reported in our October 13, 2023, blog item, ECHA prioritized DIHxP and included DIHxP in its April 12, 2023, recommendation for the inclusion of substances in Annex XIV of EU REACH. HSE used the results from ECHA’s prioritization exercise to inform its draft recommendation. HSE notes that this is its second recommendation (as the Agency for UK REACH) to the Appropriate Authorities (the Department for Environment, Food and Rural Affairs (Defra) Secretary of State and the Scottish and Welsh Ministers), who will make a decision on the addition to Annex 14. More information is available in our January 17, 2024, blog item.

HSE Publishes UK REACH Work Programme For 2023-24: In February 2024, HSE published the UK REACH Work Programme 2023/24, setting out how HSE, with the support of the Environment Agency, will deliver its regulatory activities to meet the objectives and timescales set out in UK REACH. The Work Programme outlines the operational activities that HSE will undertake in the work year 2023/24, including:

Defra Publishes Rationale For Prioritizing Substances In The UK REACH Work Programme For 2023-24: On February 15, 2024, Defra, the Scottish government, and the Welsh government published a policy paper setting out the rationale to identify priorities for regulatory action under the UK REACH Work Programme for 2023 to 2024. It provides:

• A rationale for each of the agreed priorities for regulatory action in 2023 to 2024; and

• The reasons why other proposals were not adopted as priorities for the 2023 to 2024 Programme.

The appropriate authorities have consulted with HSE, the Environment Agency, and other stakeholders to set the priorities for the annual UK REACH Work Programme.