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Global Regulatory Updates
April 1, 2023

Global Regulatory Update for April 2023

The ACTA Group

WEBINAR — PFAS Reporting, PBTs, And Other TSCA Hot Topics, May 17, 2023, 11:00 a.m. – 12:00 p.m. (EDT), Via Webinar: Panelists Richard E. Engler, Ph.D., Director of Chemistry, The Acta Group (Acta®), and Anna Lowit, Senior Science Advisor, Office of Pollution Prevention and Toxics (OPPT), will discuss expected per- and polyfluoroalkyl substances (PFAS) reporting rules, EPA actions on persistent, bioaccumulative, and toxic (PBT) chemicals, and other timely Toxic Substances Control Act (TSCA) issues. Register now.

RECORDED WEBINAR ON-DEMAND — “Extended Producer Responsibility (EPR) Regulations”: Panelists discuss the history and evolution of EPR legislation, expected developments that will affect the chemical and chemical product industry, and what companies need to know to prepare for these changes. Panelists included LeRoy (Lee) C. Paddock, Distinguished Professorial Lecturer of Environmental Law at the George Washington University Law School; Edith G. Nagy, Regulatory Consultant, Bergeson & Campbell, P.C. (B&C®) and Acta; and Lynn L. Bergeson, Managing Partner, B&C, and President, Acta. Watch now.

PODCAST — Product Stewardship, Supply Chain, And Downstream User Engagement — A Conversation With Catherine M. Croke, DBA: On this episode of All Things Chemical®, Lynn L. Bergeson and Catherine M. Croke, DBA, Director of Product Stewardship and Regulatory Affairs, B&C and Acta, discuss the expanding role and growing importance of product stewards in corporate America today, what product stewardship is, the value this role offers to companies, and where to begin if your company is without a product steward. Listen now or read the transcript.

PODCAST — Health Canada’s Update To Rev 7/8 Of GHS — A Conversation With Karin F. Baron: Lynn L. Bergeson and Karin F. Baron, MSPH, Director of Hazard Communication and International Registration Strategy, B&C and Acta, discuss the very important recently released amendments to the Canadian Hazardous Products Regulations (HPR). This episode focuses on what listeners need to know regarding the new HPR provisions, when they must be implemented, and how they will impact the classification and labeling of hazardous products in Canada and beyond. Listen now or read the transcript.

PUBLISHED BOOK — Lynn L. Bergeson And Bethami Auerbach Co-Edit Chemical Risk Governance Volume Of The Elgar Encyclopedia Of Environmental Law: Acta and B&C are pleased to announce the publication of Chemical Risk Governance, Volume XII of the Elgar Encyclopedia of Environmental Law. Lynn L. Bergeson and Bethami Auerbach, Of Counsel with B&C, edited the volume, along with Adam D.K. Abelkop, Associate Professor and Director of Legal Writing, University of San Francisco School of Law, and Lucas Bergkamp, Senior Policy Adviser, European Governance & Sustainability Center. This volume provides expert analysis of the foundations, main concepts, and substantive and procedural requirements of selected chemical law regimes as they pertain to the environment. Ms. Bergeson and Ms. Auerbach also co-authored, along with colleagues Lisa R. Burchi, and Carla N. Hutton, Chapter 13: Case Studies in Regulatory Concepts, a thorough review of types of chemicals, exposures, and the regulation of chemicals in products and manufacturing. Purchase online.

CANADA

Canada Considers Rules For Labeling Of Plastic Packing And Single-Use Plastics, Will Establish Federal Plastics Registry: Canada announced on February 17, 2023, the release of a report summarizing responses to two public consultations focused on developing rules for recyclability and compostability labeling and on establishing a federal plastics registry for the plastic products industry. According to the press release, Canada is developing new labeling rules to prohibit the use of the circular three-arrow symbol (often referred to as the chasing-arrows symbol) and other recyclability claims on plastic packaging and single-use plastics unless specific conditions are met. In addition, Canada is considering new rules to control the use of terms such as “compostable,” “degradable,” or “biodegradable” in the labeling of plastic packaging and single-use plastic items. The labeling rules would be part of new regulations that would also require minimum levels of recycled plastic in certain products. The press release states that the Canadian government “is committed to establishing a federal plastics registry that would require annual reporting of plastics in the Canadian economy and how these products are managed at the end of their lives. The registry would also collect and publish data for Canadians on the entire life cycle of plastics in Canada.”

Canada intends to publish a proposed framework for the recycled content and labeling regulations later in 2023, and it will be available for public consultation. Canada will use comments on the framework to inform the proposed regulations that are targeted for publication before the end of 2023.

Health Canada Will Hold Multi-Stakeholder Workshop In May 2023 For WHMIS Community: According to Health Canada’s March 2023 Workplace Hazardous Products Program newsletter, Health Canada will host a virtual multi-stakeholder workshop for all groups within the Workplace Hazardous Materials Information System (WHMIS) community on May 24 and 25, 2023, from 12:30 p.m. to 3:30 p.m. (EDT) each day. According to Health Canada, stakeholders and partners will lead discussions on various topics, with the intent of starting a dialogue and greater information sharing to improve worker safety and hazard communication of workplace chemical products. Topics to be discussed include:

  • Workplace Hazardous Products Program updates;
     
  • Amendments to the HPR;
     
  • Consumer product exclusion under the Hazardous Products Act (HPA);
     
  • Discussion on document retention requirements under the HPA (True Copy); and
     
  • Discussion on the use of quick response (QR) codes for safety data sheets (SDS).

Health Canada invites all interested stakeholders to join. More information is available by contacting it for details at whmis-simdut@hc-sc.gc.ca.

EUROPEAN UNION (EU)

ECHA Announces Updates To Monomer And Polymer Guidance Following Board Of Appeal Decision: On June 29, 2021, the European Chemicals Agency’s (ECHA) Board of Appeal (BoA) issued a decision on a compliance check case (A-001-2020) regarding registration obligations for polymer importers. ECHA announced on February 21, 2023, that it has revised its Guidance for monomers and polymers to align with BoA’s June 2021 decision and includes changes to the description of Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) registration obligations for those importing and manufacturing polymers and monomers. ECHA states that the key changes relate to:

  • The monomer that needs to be registered by the manufacturer or importer of a polymer;
     
  • The calculation of registration tonnages of monomers ending up in the final polymer as a reacted substance; and
     
  • The information that registrants of monomers must include in a registration chemical safety report.

More information is available in our February 21, 2023, blog item.

EC Proposes Digital Labeling For Fertilizing Products, Begins Public Consultation On Adopted Regulation: The European Commission (EC) announced on February 27, 2023, that it adopted a proposal on the voluntary digital labeling of EU fertilizing products. The EC notes that in the EU, digital labeling is already used for some products containing chemicals, such as batteries, and rules for digital labeling are under consideration for others, like for detergents, cosmetics, and chemicals. Suppliers of fertilizing products that meet EU-wide health, safety, and environmental standards (CE [European conformity]-marked) would be allowed to provide information on a digital label. The digital labeling would be voluntary, and products sold in packaging to farmers and other consumers would still be required to provide “the most important information on a physical label, such as on safety for human health and the environment, in addition to the digital label.” The European Parliament (EP) and the Council of the EU will now consider the proposal.

On April 3, 2023, the EC began a public consultation on its proposed regulation. Comments are due May 29, 2023. The EC will summarize all feedback received and present it to the EP and Council of the EU “with the aim of feeding into the legislative debate.”

ECHA Updates Recommendations To Improve REACH Registrations: On February 28, 2023, ECHA announced that it updated its recommendations to improve REACH registrations. According to ECHA, the recommendations are based on ECHA’s findings from registration dossier compliance checks and take recent changes to REACH information requirements into account. The recommendations focus on the rules for using adaptations to assess the safety of chemicals without animal testing. ECHA also released statistics on its progress evaluating registered substances. In 2022, ECHA conducted 330 compliance checks covering more than 2,300 registration dossiers and addressing 295 substances. According to ECHA, 302 checks were full compliance checks, addressing all relevant endpoints of substances of potential concern. They resulted in 277 draft decisions being sent to companies, requesting more data to clarify long-term effects on human health or the environment. More information is available in our March 1, 2023, blog item.

ECHA Enforcement Forum Project Finds Most Downstream Users Adhere To “Fundamental” Authorization Duties: ECHA announced on March 8, 2023, the results of the Enforcement Forum’s EU-wide project on inspections of REACH authorization duties. During the project, the enforcement authorities of 28 countries carried out 690 inspections at 516 companies. According to ECHA, the most commonly controlled substances of very high concern (SVHC) were chromium trioxide and strontium chromate. The inspections primarily focused on downstream users, specifically small and medium-sized enterprises (SME), that are the final users of the SVHCs. ECHA states that in one of four inspections (26 percent) of downstream users, inspectors found that the substance was not used in compliance with conditions set out in the EC’s authorization decision granted to their supplier. Consequently, in these companies, workers or the environment were not being adequately protected from possible adverse effects of the SVHCs. ECHA states that while there is “clear room for improvement in the levels of compliance” with specific authorization requirements, the results show that most downstream users adhere to the fundamental authorization duties.

The project report outlines recommendations for industry, the Enforcement Forum, national authorities, ECHA, and the EC. For example, suppliers of authorized substances should improve the quality of SDSs, while downstream users should ensure that the authorized substance is used in accordance with the conditions in the authorization decision. More information is available in our March 14, 2023, blog item.

EEA Publishes Briefing On Key Actions For Safer And More Sustainable Chemicals: The European Environment Agency (EEA) announced the release of a briefing on March 8, 2023, entitled “Managing the systemic use of chemicals in Europe.” According to EEA, the briefing highlights the importance of delivering on key actions, foreseen in the EC’s chemicals strategy for sustainability, to ensure safe products for citizens, keep ecosystems clean and healthy, and support the transition to a circular economy. These include:

  • Promoting chemicals that are safe and sustainable by design, harnessing the innovative capacity of the chemical industry to provide technologies, materials, and products that are non-toxic, low-carbon, and fit for circularity;
     
  • Phasing out uses of harmful substances that are not essential. According to EEA, harmful chemicals should be used only when they are necessary for health, safety, or if critical for the functioning of society and if there are no acceptable alternatives; and
     
  • Managing the risks of chemicals in groups, rather than one by one, to expedite protection of citizens and the environment.

ECHA Identifies Certain Brominated Flame Retardants As Candidates For Restriction: ECHA announced on March 15, 2023, that it released its Regulatory Strategy for Flame Retardants, identifying aromatic brominated flame retardants as candidates for an EU-wide restriction. ECHA states that aromatic brominated flame retardants, such as polybrominated diphenyl ethers, are generally persistent in the environment, and that many, like decabromodiphenylether, are also known or suspected of being toxic and accumulating in people and animals. ECHA notes that their release could be minimized through an EU-wide restriction. The restriction scope could cover all aromatic brominated flame retardants confirmed to be PBT or very persistent and very bioaccumulative (vPvB) through harmonized classification or identification as SVHCs. According to ECHA, for many aliphatic brominated and some organophosphorus-based flame retardants, more data are needed to determine if a restriction is necessary. ECHA states that it expects these data to be available from 2024 onward, and ECHA suggests reassessing the situation for those groups in 2025. More information is available in our March 21, 2023, blog item.

EEB And CHEM Trust Publish Report On Negative Impacts Of Delaying Reform Of EU Chemical Laws: On March 14, 2023, the European Environmental Bureau (EEB) and CHEM Trust announced the availability of a report entitled Waiting for REACH: The negative impacts of delaying reform of EU chemical laws. EEB and CHEM Trust analyzed the impact of the EC’s postponed proposal for a targeted revision of REACH by 2022. According to EEB and CHEM Trust, “the impact goes well beyond a mere delay: the current parliamentary term would have no chance to finish institutional negotiations before elections in 2024, significantly delaying the REACH revision even further, damaging the Green Deal legacy and creating huge uncertainties about the direction of the EU chemicals industry.” EEB states that this “would come at a time when clarity is needed regarding the regulatory framework and a clear signal sent to the market and investors regarding the phase-out of hazardous substances and the direction in which innovation will need to go.”

Regulation To Mitigate Risk Of Medical Device Shortages Enters Into Force: On March 20, 2023, the EC published a regulation extending the deadline for the certification of medical devices in the Official Journal of the European Union. Producers of medical devices will have until December 31, 2027, for higher risk devices and until December 31, 2028, for medium and lower risk devices to meet the legal requirements. The extension of the transition period will be granted under certain conditions to ensure that only devices that are safe and for which manufacturers have already started the certification procedure will benefit from the additional time. The regulation also reduces the risk of medical device shortages by removing the “sell-off” date rule. Only devices that comply with the previous EU law on medical devices will benefit from this rule.

EP Committee Supports Stricter Sanctions For Environmental Crimes: The EP’s Legal Affairs Committee announced on March 21, 2023, that it unanimously adopted its position on an update of EU rules on environmental crimes. The updated list of environmental crimes punishable at the EU level would now include the illegal timber trade; illegal depletion of water resources; pollution caused by ships; breaches of EU chemicals legislation; cultivation of genetically modified organisms; conduct causing forest fires; and infringements contributing to illegal, unreported, and unregulated fishing. According to the press release, the Committee wants offenses leading to death or harm to health and substantial environmental damage to be punishable by at least ten years imprisonment, with others incurring four or six years depending on their extent, seriousness, and duration. The Committee proposed toughened fines for environmental crimes committed by companies, with fines of at least ten percent of the average worldwide turnover of a business in the three previous business years, instead of the EC’s original proposal of five percent. The press release states that in line with the “polluter pays principle,” “offending businesses should work to restore the damaged environment, compensate victims and bear all the costs of court proceedings.” The proposal would adjust statute limitation periods for criminal offenses to start at the point of their discovery rather than when they took place. Once the mandate is confirmed by the EP as a whole, the report will become the EP’s position for negotiations with the EU member states on the final text of the legislation.

Public Consultation Begins On PFAS Restriction Proposal; ECHA Holds Information Session: ECHA announced on March 22, 2023, the beginning of a six-month consultation on the proposal to restrict more than 10,000 PFAS under REACH. As reported in our February 13, 2023, memorandum, the national authorities of Denmark, Germany, the Netherlands, Norway, and Sweden submitted the proposal after finding risks in the manufacture, placement on the market, and use of PFAS that are not, in their view, adequately controlled and need to be addressed throughout the EU and the EEA. The proposal suggests two restriction options — a full ban and a ban with use-specific derogations — to address the identified risks. According to ECHA, the public consultation is to give anyone with information on PFAS the opportunity to have their say. ECHA states that of particular interest is information relevant to the risks, socio-economic aspects, and alternative substances. Comments are due September 25, 2023.

ECHA’s scientific committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) will use the consultation input to evaluate the proposed restriction and to form an opinion on it. ECHA held an online information session on April 5, 2023. The speakers explained how the REACH restriction process works, provided details regarding the restriction proposal, and described how stakeholders and interested parties can participate in the consultation. More information on the information session is available in our April 7, 2023, memorandum.

EC Proposes Green Claims Directive Intended To Enable Sustainable Choices And End Greenwashing, Begins Public Consultation On Same: The EC announced on March 22, 2023, that is proposing common criteria against greenwashing and misleading environmental claims. The proposed Green Claims Directive targets explicit claims, such as “T-shirt made of recycled plastic bottles,” “CO2 compensated delivery,” “packaging made of 30% recycled plastic,” or “ocean friendly sunscreen.” It also aims to address the proliferation of labels, as well as new public and private environmental labels. The EC states that the proposed directive covers all voluntary claims about the environmental impacts, aspects, or performance of a product, service, or the trader itself. It excludes claims that are covered by existing EU rules, however, such as the EU Ecolabel or the organic food logo, because the current laws already ensure that these regulated claims are reliable. Claims that will be covered by upcoming EU regulatory rules will be excluded for the same reason.

The questions and answers on the proposed directive state that it would require EU member states to ensure that minimum requirements for substantiation and communication are respected by companies when they make voluntary green claims. Member states will be responsible for setting up verification and enforcement processes to be performed by independent and accredited verifiers, as follows:

  • Claims must be substantiated with scientific evidence that is widely recognized, identifying the relevant environmental impacts and any trade-offs between them;
     
  • If products or organizations are compared with other products and organizations, these comparisons must be fair and based on equivalent information and data;
     
  • Claims or labels that use aggregate scoring of the product’s overall environmental impact on, for example, biodiversity, climate, water consumption, or soil, shall not be permitted, unless set in EU rules;
     
  • Environmental labeling schemes should be solid and reliable, and their proliferation must be controlled. EU-level schemes should be encouraged, new public schemes, unless developed at the EU level, will not be allowed, and new private schemes are allowed only if they can show higher environmental ambition than existing ones and get a pre-approval; and
     
  • Environmental labels must be transparent, verified by a third party, and regularly reviewed.

Following the ordinary legislative procedure, the proposed Green Claims Directive will now be subject to the approval of the EP and the Council of the EU.

On March 23, 2023, the EC began a public consultation on its proposal. The EC is extending the eight-week comment period daily until the adopted proposal is available in all EU languages. Comments are currently due June 9, 2023. The EC will summarize all feedback received and present it to the EP and the Council of the EU “with the aim of feeding into the legislative debate.”

ECHA Enforcement Forum Pilot Project Will Target PFCAs And Related Substances: ECHA announced on March 23, 2023, that its Enforcement Forum has agreed to run a pilot project to check for the presence of restricted perfluorocarboxylic acids (PFCA) and related substances in consumer products such as cosmetics. Inspections in this pilot project will begin in 2023 and continue throughout 12 participating countries during 2024. According to ECHA, the objective is to protect consumers from being exposed to PFCAs and related substances, including perfluorooctanoic acid (PFOA), which have been identified as SVHCs due to their hazardous properties. ECHA states that the project was triggered by cases of PFOA, the use of which is restricted under the persistent organic pollutants (POP) regulations, found in cosmetics sold on the EU market. Inspectors may enforce restrictions under REACH or the POPs regulations, as applicable. Where breaches are detected, inspectors will take enforcement measures to ensure compliance with the applicable legislation. The project report should be published at the end of 2024.

RAC Supports Proposed PFAS Ban In FFF: ECHA announced on March 24, 2023, that RAC supports the proposed restriction on PFAS in firefighting foams (FFF). According to ECHA, RAC concluded that there is an EU-wide risk for people and the environment from their use in FFFs. The proposed restriction would effectively reduce emissions and the associated risks posed by these persistent substances. ECHA states that RAC’s concerns are based on the “very persistent” property combined with other properties, such as “mobility.”

ECHA notes that the draft opinion of SEAC also lends support to the proposed restriction. According to SEAC, the proposal is the most appropriate EU-wide measure for addressing identified risks, taking into account the availability of alternatives and the proportionality of its benefits and costs to society. SEAC suggests that a review of available and feasible alternatives be conducted before the end of the transition period, however, for sites that produce, treat, or store dangerous substances (covered by the Seveso Directive). ECHA states that “[t]his review is considered important to maintain safety where fires may have high impacts on the environment and human health.” SEAC’s draft opinion is open for consultation until May 15, 2023.

EC Amends CLP And Introduces New Hazard Classes For Endocrine Disruptors, PBTs, vPvBs, PMTs, And vPvMs: On March 31, 2023, the EC amended Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labeling, and packaging of substances and mixtures (CLP) to introduce new hazard classes and criteria for endocrine disruptors and substances that are PBT, vPvB, persistent, mobile, and toxic (PMT), and very persistent and very mobile (vPvM). The EC states:

  • The level of evidence as regards endocrine disrupting properties may be of different scientific strength. It is therefore appropriate to create two categories of endocrine disruptors: known or presumed endocrine disruptors (category 1) and suspected endocrine disruptors (category 2), both for human health and for the environment;
     
  • The intrinsic properties of PBT and vPvB substances and mixtures display similarities, but they differ substantially with regard to the toxicity criterion. It is therefore appropriate to create a new hazard class, with differentiation, while establishing common rules for the scientific assessment of the intrinsic properties related to persistency and bioaccumulation;
     
  • The intrinsic properties of PMT and vPvM substances and mixtures display similarities, but they differ substantially with regard to the toxicity criterion. It is therefore appropriate to create a new hazard class, with differentiation, while establishing common rules for the scientific assessment of the intrinsic properties related to persistency and mobility.

Substances must be classified in accordance with the new criteria beginning May 1, 2025, and mixtures must be classified in accordance with the new criteria beginning May 1, 2026. Substances placed on the market before May 1, 2025, are not required to be classified in accordance with the criteria until November 1, 2026, and mixtures placed on the market before May 1, 2026, are not required to be classified in accordance with the criteria until May 1, 2028.

EC Publishes Report On Developing The Essential Use Concept: The EC published a report entitled Supporting the Commission in Developing an Essential Use Concept. The report presents the outcome of a project to support the EC to define further the essential use concept and associated criteria to help phase out the most harmful chemicals. According to the abstract, the report investigates how the essential use concept could be implemented in EU legislation, including REACH, the Restriction of Hazardous Substances Directive, food contact materials legislation, the Cosmetic Products Regulation, the Taxonomy Regulation, and the End-of-life Vehicles Directive. For REACH, the report identifies “sub-options” for the essential use concept that could apply within options for the reform of authorization and restriction, as considered in the targeted revision of REACH. The report includes a qualitative assessment of expected impacts from the introduction of the essential use concept in REACH. The abstract states that the evidence base was built up through a review of legislation and literature; a targeted survey; interviews; and a workshop.

ECHA Recommends Eight Substances For REACH Authorization: ECHA announced on April 12, 2023, that it has recommended that the EC add the following substances to the REACH Authorisation List:

  • Ethylenediamine;
     
  • 2-(4-Tertbutylbenzyl)propionaldehyde and its individual stereoisomers;
     
  • Lead;
     
  • Glutaral;
     
  • 2-Methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one;
     
  • 2-Benzyl-2-dimethylamino-4′-morpholinobutyrophenone;
     
  • Diisohexyl phthalate; and
     
  • Orthoboric acid, sodium salt.

ECHA states that it prioritized these substances from the Candidate List of SVHCs for this recommendation “as they are of the highest priority, following the agreed approach of 2014.” The EC will determine which substances are added to the Authorisation List and what conditions apply for each substance. If a substance is included on the Authorisation List, it can only be placed on the EEA market or used after a given date, if an authorization is granted for a specific use.

ECHA Will Hold Webinar On Analysis Of Alternatives And Tools To Support Biocides Substitution: ECHA will hold a webinar on April 26, 2023, on “Analysis of alternatives and tools to support substitution of biocides.” According to ECHA, substitution and analysis of alternatives of the most hazardous biocidal active substances are topics of growing interest. The webinar will feature several tools and initiatives supporting stakeholders in the process of moving to safer alternatives. ECHA states that the webinar “should be of particular interest for applicants of biocidal active substances, downstream users, suppliers of alternatives, authorities and consultants.” Questions may be submitted from April 19, 2023, 12:00, until the end of the event.

INTERNATIONAL AGENCY FOR RESEARCH ON CANCER (IARC)

IARC Calls For Nominations Of Agents For Review In Future Monographs: IARC has called for the nomination of agents for review in future IARC Monographs. Nominations may include chemicals, mixtures, occupations, physical agents, biological agents, lifestyle factors, and any other agent suspected of causing cancer in humans. IARC states that agents will be selected for review based on: (a) evidence of human exposure; and (b) evidence or suspicion of carcinogenicity. According to IARC, for an agent evaluated in a previous monograph, it will give consideration to: (c) whether there is new evidence of cancer in humans or experimental animals, or mechanistic evidence to warrant re-evaluation and review of the current classification; and (d) if the agent was previously established to be carcinogenic to humans (Group 1), whether there is new evidence of cancer in humans that indicates a possible causal association with additional tumor sites. Nominations are due November 30, 2023.

IARC has also issued a call for scientists who wish to be considered for membership in the Advisory Group to Recommend Priorities for the IARC Monographs. IARC states that Advisory Group Members prepare and review preliminary pre-meeting materials and participate in a four-day meeting regarding the priorities for agents to be evaluated by the IARC Monographs. Members will be expected to make substantial contributions to the drafting of an Advisory Group report. The call for experts will close on July 31, 2023.

NEW ZEALAND

New Zealand EPA Releases Three-Year Reassessment Plan For Hazardous Substances: The New Zealand Environmental Protection Authority (New Zealand EPA) announced on February 17, 2023, that it released a work plan for all New Zealand EPA-initiated reassessments of hazardous substances over the next three years. The plan includes indicative start dates for each reassessment, reasons for reassessing a substance, and the existing hazardous substance approvals that may be affected. According to New Zealand EPA, all hazardous substances need its approval to be used in New Zealand, and it is “constantly reviewing the list of approved chemicals as new information becomes available.” New Zealand EPA reassesses approved hazardous substances if there is a risk to human health or the environment. It makes a decision at the end of the process on whether to change the rules for using a substance, further restrict its use, or ban a substance entirely. New Zealand EPA notes that there are 15 reassessments currently in progress or due to begin in the next three years, including for aquatic herbicides, synthetic pyrethroids used in insecticides, and domestic use of vertebrate toxic agents (used to kill or control pests such as rodents).

New Zealand Begins Public Consultation On Proposed Updates To The Cosmetic Group Standard: On March 2, 2023, New Zealand EPA announced a public consultation on proposed updates to the Cosmetic Products Group Standard. The proposed updates include:

  • Aligning the rules for ingredients with the EU: Schedules 4 to 8 of the group standard are lists of ingredients that are banned, restricted, or subject to other rules. The main aim of the updates is to align these lists with the EU requirements, which are “seen as a global high standard”;
     
  • Phasing out PFAS ingredients: New Zealand EPA proposes to ban PFAS from cosmetics, phasing them out by the end of 2025;
     
  • Extending the group standard to cover more products: According to New Zealand EPA, some cosmetic products currently contain hazardous substances in concentrations too small to classify the overall product as hazardous. It proposes to require these products to comply with the group standard; and

Other updates, include requiring clear recordkeeping for nanomaterials, updating requirements for fragrances, consolidating the main text and Schedules 4 to 8 into one document, and improving the presentation and usability of the group standard. Comments are due May 31, 2023.

New Zealand EPA Seeks Comment On Proposed Recognized International Regulators: New Zealand EPA announced on March 31, 2023, that it is requesting comment on which overseas regulators it will draw on for some hazardous substance assessments. According to New Zealand EPA, recognized international regulators must regulate hazardous substances in a similar way to New Zealand EPA. It proposes to recognize regulators from the EU and countries including the United States and Australia. New Zealand EPA will use information from the international regulators when assessing and reassessing hazardous substances through two new pathways aimed at streamlining the processes: approving a substance if the same use has been approved by a recognized international regulator, unless it will have significant cultural, environmental, and human health effects; or amending the hazard classifications or rules for use of an existing substance to align with recognized regulators. New Zealand EPA notes that it “will not automatically adopt decisions made by the international regulators.” Comments are due May 24, 2023.

ORGANIZATION FOR ECONOMIC COOPERATION AND DEVELOPMENT (OECD)

OECD Publishes Reports On Alternatives Assessment And Substitution Of Harmful Chemicals: OECD has recently posted the following publications on alternatives assessment and substitution of harmful chemicals:

UNITED KINGDOM (UK)

HSE Publishes RMOA For PFAS: On April 4, 2023, the Health and Safety Executive (HSE) published a regulatory management option analysis (RMOA) for PFAS. The RMOA is a preliminary step used within the UK REACH framework. The RMOA defines PFAS as “[f]luorinated substances that contain at least one fully fluorinated methyl carbon atom (without any hydrogen, chlorine, bromine or iodine atom attached to it), or two or more contiguous perfluorinated methylene groups (–CF2–).” The RMOA states that this “reduces the number of PFAS in scope to hundreds, maintaining focus on substances that are persistent degradation products of PFAS.” As reported in our February 13, 2023, memorandum, ECHA is accepting comments on a proposal to restrict more than 10,000 PFAS under REACH. The chemical scope of the restriction proposal is defined as “[a]ny substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it),” and this definition is aligned with OECD’s.

The RMOA states that based on initial considerations of likely effectiveness and efficiency of options — and considering the Precautionary Principle — HSE concludes that it would be appropriate to consider initiating some or all of the following risk management measures with regard to certain uses of PFAS:

  • Preparation of background dossiers to support potentially one or more UK REACH restrictions of PFAS, including:
    • The use and disposal of FFF where non-PFAS alternatives are available;
       
    • Other wide dispersive uses, such as the application of coatings or use of cleaning agents; and
       
    • The manufacture and placing on the market of consumer articles from which PFAS are likely to be released into air, water, or soil, or directly transferred to humans, including textiles, upholstery, leather, apparel, rugs and carpets, paints, varnishes, waxes and polishes, and cleaning products;
       
  • UK REACH authorization of PFAS used in processing aids in the manufacture and processing of fluorinated polymers;
     
  • Further evaluation and investigation of substances that have been highlighted to be of concern; and
     
  • Continued collaborative work across government and with external stakeholders to bring together work on PFAS strategically.

More information is available in our April 12, 2023, blog item.

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