Global Regulatory Update for September 2023
AICIS Extends Temporary Recordkeeping Provisions For NICNAS Introducers To April 1, 2024: On September 13, 2023, the Australian Industrial Chemicals Introduction Scheme (AICIS) announced that recordkeeping provisions for introducers that transitioned from the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) to AICIS will continue to be available until April 1, 2024. AICIS notes that these arrangements apply only to “eligible introducers who are still importing or manufacturing chemicals that were previously on the NICNAS Inventory.” These arrangements were originally set to end on November 30, 2023. Introducers must meet the following requirements to be eligible to use the temporary recordkeeping provisions:
- Introducer imported or manufactured (introduced) a chemical under NICNAS before July 1, 2020;
- The chemical introduced was listed on the NICNAS Inventory and the introducer continued to introduce the same chemical under AICIS after July 1, 2020; and
- The introducer does not know the chemical’s Chemical Abstracts Service (CAS) name or CAS Registry Number® (CAS RN®).
AICIS states that it has been exploring ways to resolve challenges that businesses have faced to comply with AICIS recordkeeping obligations under the Industrial Chemicals (General) Rules 2019 (the Rules). As a result, it has developed a suite of proposed changes to the Rules around recordkeeping requirements. AICIS “will soon announce a public consultation on these proposed changes, along with others relating to AICIS categorisation and reporting obligations.”
AICIS Announces Public Consultation On Suite Of Regulatory Proposals Related To Categorization, Reporting, And Recordkeeping: AICIS announced on September 15, 2023, a public consultation on a suite of regulatory proposals relating to categorization, reporting, and recordkeeping obligations. According to AICIS, it has explored possible solutions to address stakeholder advice that certain requirements of the General Rules “are challenging to comply with.” AICIS also identified aspects of the General Rules that it thinks should be strengthened to ensure protection of human health and the environment or to clarify the intent of certain requirements. AICIS notes that it developed the proposals “using an evidence- and risk-based approach to regulation that is appropriate to each circumstance.” AICIS lists the following key proposals:
- Replacing written undertakings with records that will make compliance easier;
- Greater acceptance of International Nomenclature of Cosmetic Ingredients (INCI) names for reporting and recordkeeping;
- Changes to the categorization criteria to benefit:
- Soap makers;
- Introducers of chemicals in flavor and fragrance blends; and
- Introducers of hazardous chemicals where introduction and use are controlled;
- Soap makers;
- Strengthening criteria and/or reporting requirements for health and environmental protection, for example, to prevent persistent organic pollutants (POP) from being categorized as exempted or reported Introductions.
AICIS notes that none of the proposals involve changes to the Industrial Chemicals Act 2019. Proposals that would benefit introducers are based on mechanisms that may lower regulatory burden while maintaining regulatory intent. Comments are due November 9, 2023. AICIS will hold a webinar on September 21, 2023, to provide an overview of the proposals, as well as two more webinars in October 2023.
Canada Issues Mandatory Information Request For 850 Chemical Substances: Canada published a notice in the Canada Gazette on June 24, 2023, announcing that it is collecting information on 850 substances for the purpose of prioritization, risk assessment, and risk management. Canada is gathering information from Canadian manufacturers, importers, and users on the commercial status, facility information (for example, releases), and uses of these substances in Canada, pursuant to Section 71 of the Canadian Environmental Protection Act, 1999 (CEPA). According to the notice, the Minister of the Environment requires the information to assess whether the listed substances are toxic or are capable of becoming toxic, or to assess whether to control, or the manner in which to control, the listed substances. The persons described in the notice must provide the specified information that may be in their possession, or to which they would reasonably be expected to have access. Responses are due January 17, 2024. More information is available in our August 2, 2023, memorandum.
HC Begins Consultation On Proposed New Requirements For Consumer Chemical Products Under The CCPSA: Health Canada (HC) has begun a consultation on a proposal to introduce new requirements for consumer chemical products under the Canada Consumer Product Safety Act (CCPSA). HC states that many substances found in consumer chemical products, like household cleaning products, have been linked to human health hazards of concern (HHHOC) such as carcinogens, mutagens, and reproductive toxicants. The proposed new requirements include the introduction of classification criteria for HHHOCs, information disclosure requirements, and additional protections for the health and safety of people in Canada. HC will use the public comments to inform next steps, which may include a cost-benefit analysis of the proposal and future consultations. HC notes that any future regulatory proposal would be pre-published in the Canada Gazette, Part I for further stakeholder consultation. Comments are due October 9, 2023.
The main objective of this proposal is to help protect the people of Canada from certain HHHOCs by introducing new requirements for consumer chemical products under the CCPSA. According to HC, it would achieve this objective by establishing a hazard classification and information disclosure framework for HHHOCs, complemented by additional protections such as prohibitions, restrictions, or child-resistant container requirements. HC states that “[i]n this way, users of consumer chemical products would be alerted to HHHOCs in consumer chemical products and would be provided with necessary precautionary statements, such as instructions for safe use and first aid, relevant to the applicable hazards.” More information is available in our August 17, 2023, memorandum.
Canada Holds Consultation On Pollution Prevention Planning Notice For Primary Food Plastic Packaging: In August 2023, Environment and Climate Change Canada (ECCC) published a Consultation document: Pollution prevention planning notice for primary food plastic packaging: Targets for reduction, reuse, redesign, and recycled content for a 30-day consultation period that ended August 30, 2023. Canada proposed the publication of a pollution prevention planning notice to address plastic primary food packaging as part of its comprehensive agenda to address plastic waste and prevent pollution. Canada notes that the public consultation was the first opportunity for stakeholders to provide input on how to reduce primary food plastic packaging waste and pollution. Canada will use comments to develop a proposed notice that it will publish in the Canada Gazette for public comment.
Canada Will Hold Information Sessions In October 2023 On Right To A Healthy Environment Amendments To CEPA: As reported in our June 23, 2023, memorandum, on June 13, 2023, Bill S-5, Strengthening Environmental Protection for a Healthier Canada Act, became law. The bill made a number of changes to CEPA, including recognizing that every individual in Canada has a right to a healthy environment as provided under CEPA. ECCC and HC will hold information sessions in October 2023 for those interested in learning more about the right to a healthy environment amendments to CEPA. The English session will be held October 3, 2023, from 11:00 a.m. to 12:00 p.m. (EST), and the French session will be held October 4, 2023, from 1:30 p.m. to 2:30 p.m. (EST). To participate in a session, contact Canada at email@example.com. More information is available on ECCC’s website.
COMMISSION FOR ENVIRONMENTAL COOPERATION (CEC)
CEC Holds Public Consultation On Advancing Supply Chain Transparency For Chemicals In Consumer Products: CEC is holding a public consultation on advancing supply chain transparency (SCT) for chemicals in consumer products. CEC “invites individuals, experts, business, and organizations involved in the use and communication of chemical information in consumer products to share their knowledge of current and emerging [SCT] practices, tools, and challenges.” According to CEC, information gaps and barriers affecting SCT include:
- Lack of information related to the chemical composition in recycled materials and the resultant lack of awareness of the risks they may pose;
- Insufficient information on alternative substances and emergent toxics (regrettable substitution);
- Scattered and/or outdated scientific information on chemical compounds;
- Restrictions associated with confidential business information (CBI) and boundaries of disclosure; and
- Lack of standardization and guidance for sharing data between companies, downstream users, and consumers.
CEC states that the goal of the project is to highlight industry best practices and shape region- and country-specific recommendations to foster SCT across Canada, Mexico, and the United States. Responses are due September 29, 2023.
EUROPEAN UNION (EU)
Proposed Toy Safety Regulation Would Increase Protection From “Harmful Chemicals”: On July 28, 2023, the European Commission (EC) announced a proposed Toy Safety Regulation that would revise the current rules to protect children from potential risks in toys. The proposal would update the safety requirements that toys must meet to be marketed in the EU, whether they are manufactured in the EU or elsewhere. According to the EC, the proposal will:
- Increase protection from harmful chemicals: The proposal would not only maintain the current prohibition of substances that are carcinogenic, mutagenic, or toxic for reproduction (CMR), but it would also prohibit the use of other harmful chemicals in toys. The proposal would target chemicals that are particularly harmful for children, such as endocrine disruptors and chemicals affecting the respiratory system or those that are toxic to a specific organ; and
- Strengthen enforcement: All toys would be required to have a digital product passport, which would include information on compliance with the proposed Regulation. Importers would have to submit digital product passports for all toys at the EU borders, including for those sold online. A new IT system would screen all digital product passports at the external borders and would identify the shipments that need detailed controls at customs.
ECHA Publishes Main Alternatives To Substances Subject To REACH Authorization: The European Chemicals Agency (ECHA) announced in the August 16, 2023, issue of ECHA Weekly that to support substitution toward safer chemicals, it has published information on the main alternatives to substances requiring authorization under Annex XIV of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. ECHA notes that companies applying for an authorization under REACH must provide information on potential alternatives to the Annex XIV substance(s) they use. This information is presented in the Analysis of Alternatives (AoA) submitted as part of their authorization application. ECHA publishes the public version of the AoA on its website. ECHA states that it extracted the main information on these alternatives from AoAs, and the information is available in the Shortlisted Alternatives Table. ECHA states that if a field is left blank, either the applicant has claimed the information as confidential or it has not identified corresponding information. The file contains data available as of June 30, 2023.
ECHA Will Assist In Developing Report On Substances Of Concern In Batteries Or Used In Their Manufacture: ECHA announced on August 17, 2023, that with the modernization of the EU’s regulatory framework for batteries, it has received new tasks to support the European Commission (EC), including assisting in the development of an EC report on substances of concern found in batteries or used in their manufacture that have negative impacts on human health, the environment, or recycling for safe and high-quality raw materials. The report, expected by December 31, 2027, will identify the substances and consider follow-up measures, such as possible EU-wide restrictions. ECHA states that it expects to begin its work toward this report in 2024. Additionally, according to ECHA, the EC may request ECHA to prepare restriction proposals on harmful substances in batteries and waste batteries. ECHA will also provide an opinion, through its Committee for Risk Assessment (RAC) and Committee for Socio-Economic Analysis (SEAC), on the restriction proposal’s effectiveness in managing the risk and its impact on society. According to ECHA, the goal is to make batteries on the European Economic Area (EEA) market more sustainable throughout their life cycle.
ECHA Begins Public Consultation On Draft Investigation Report On CMR Substances In Childcare Articles: On August 23, 2023, ECHA began a public consultation on its draft investigation report on the assessment of the presence of CMR substances in childcare articles. The EC requested ECHA to prepare an investigation report on substances classified as carcinogens, germ cell mutagens, or reproductive toxicant category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008 that may be present in childcare articles. ECHA states that the consultation is intended for interested parties, such as childcare article manufacturers, importers, or retailers; industry associations; consumer protection associations; testing laboratories; customs; and enforcement authorities. ECHA encourages both EU/EEA and non-EU stakeholders to participate. ECHA notes that information can be submitted confidentially and will be treated as such by ECHA. Comments are due September 29, 2023.
German Authorities Temporarily Withdraw Proposal To Restrict Bisphenols That Have Endocrine Disrupting Properties To The Environment: ECHA announced in its August 30, 2023, issue of ECHA Weekly that the German authorities have withdrawn their proposal to restrict bisphenols that have endocrine disrupting properties to the environment from the opinion-making process by ECHA’s scientific committees. According to ECHA, they intend to re-submit an updated proposal to ECHA once they have considered the information submitted by stakeholders during the six-month consultation and reworked the scope of the restriction. ECHA notes that once resubmitted, the proposal will be subject to a new consultation and scrutiny by ECHA’s scientific committees. ECHA will announce the timing of resubmission will be announced through its Registry of restriction intentions.
ECHA Reminds SME Registrants To Check Their Company Size: On August 30, 2023, ECHA reminded micro-, small-, or medium-sized (SME) companies to check that the correct company size was claimed when registering substances in REACH-IT. If the company size was declared incorrectly, ECHA must be informed at firstname.lastname@example.org by September 25, 2023. Documents supporting the claim must be uploaded in REACH-IT. ECHA states that it is “continually initiating new verifications on the size of companies who have declared they are an SME at the time of their REACH registration.” By declaring and correcting the company size before ECHA begins verifying it, companies will not have to pay the administrative charge, but only the difference to the correct registration fee.
ECHA Begins Public Consultation On Six Proposals To Identify New SVHCs: ECHA has begun a public consultation on six proposals to identify new substances of very high concern (SVHC). The substances and examples of their uses include:
- 2,4,6-tri-tert-butylphenol, used in the manufacture of another substance, formulation of mixtures, and in fuel products;
- 2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol, used in air care products, coating products, adhesives and sealants, lubricants and greases, polishes and waxes, washing and cleaning products;
- 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one, used in inks and toners, coating products;
- Bumetrizole, used in coating products, adhesives and sealants, washing and cleaning products;
- Dibutyl phthalate, used in metal working fluids, washing and cleaning products, laboratory chemicals and polymers; and
- Oligomerization and alkylation reaction products of 2-phenylpropene and phenol, used in adhesives and sealants, coating products, fillers, putties, plasters, modeling clay, inks, toners, and polymers.
Comments are due October 16, 2023. If a substance is identified as an SVHC, it will be added to the Candidate List for eventual inclusion in REACH Annex XIV (the authorization list).
OECD eChemPortal Updated With Latest Data From ECHA: ECHA announced on September 6, 2023, that data on over 1.3 million endpoints for 27,000 substances registered with ECHA under REACH are now available on the Organization for Economic Cooperation and Development’s (OECD) eChemPortal. According to ECHA, the update includes information on 186 new substances from ECHA’s database of REACH registrations, increasing the total number to 26,673 substance records. ECHA states that additionally, across all substances, 18,207 endpoint records were added, bringing their total amount to 1.35 million. ECHA notes that the eChemPortal allows users to run searches by chemical identifiers, properties of chemicals, and hazard classification. The eChemPortal also includes data from many other sources worldwide.
EP Adopts Position On Critical Raw Materials Act: The European Parliament (EP) announced on September 14, 2023, that it adopted its position on “boosting the supply of strategic raw materials, crucial to secure the EU’s transition to a sustainable, digital and sovereign future.” According to the EP, the Critical Raw Materials Act is intended to make the EU more competitive and autonomous. In their negotiating position ahead of talks with the Council of the EU, the EP highlighted the importance of securing strategic partnerships between the EU and third countries on critical raw materials to diversify the EU’s supply, on equal footing, with benefits for all sides. The EP states that it also wants to push for a stronger focus on research and innovation concerning substitute materials and production processes that could replace raw materials in strategic technologies. The EP adopted the draft legislation by a vote of 515 to 34, with 28 abstentions. The EP will now enter into negotiations with the Spanish presidency of the Council to reach a first reading agreement.
Responses To Proposed PFAS Restriction Proposal Due September 25, 2023: As reported in our February 13, 2023, memorandum, on February 7, 2023, ECHA announced the availability of a much anticipated detailed proposal to restrict more than 10,000 per- and polyfluoroalkyl substances (PFAS) under REACH. 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. Comments on the proposal are due September 25, 2023.
Acta and B&C have prepared a detailed memorandum that offers a high-level outline of issues, focusing on the most significant bans and restrictions, the most impactful potential legal developments regarding PFAS, and the most important steps chemical product manufacturers should be taking now to identify, diminish, and supplant, as appropriate, PFAS in their supply chains.
New Zealand EPA Confirms Overseas Regulators For Hazardous Substance Assessments: The New Zealand Environmental Protection Authority (New Zealand EPA) announced on August 16, 2023, that it has confirmed the international regulators it can draw on for information used in some hazardous substance assessments. The regulators are from Australia, Canada, the EU, the United Kingdom (UK), and the United States — “all of which regulate hazardous substances in a similar way to our own system,” according to New Zealand EPA. New Zealand EPA will use information from the recognized international regulators to assess and reassess hazardous substances through two new pathways aimed at streamlining the processes:
- Approving a substance via a rapid assessment if the same use has been approved by a recognized international regulator, unless it will have significant cultural, environmental, and/or human health effects; and
- Amending the hazard classifications or rules for use of an existing substance to align with recognized regulators.
The change will come into force on October 1, 2023. New Zealand EPA states that it will work with relevant industries to develop guidance for the new pathways, including the information that will be required.
July 2023 Meeting Of UK Chemicals Stakeholder Forum Includes Update On UK REACH: During the UK Chemicals Stakeholder Forum’s (UKCSF) July 20, 2023, meeting, UKCSF received updates from the Department for Environment, Food and Rural Affairs (Defra) and the Health and Safety Executive (HSE) on UK REACH. According to the UKCSF Chemicals policy and regulation update, Defra, along with Welsh and Scottish governments, worked with HSE, the Environment Agency, and a wide range of stakeholders, including non-governmental organizations (NGO) and trade associations, to identify priorities for the UK REACH Work Programme in 2023-2024. The update states that since UK REACH came into force, the Work Programme has prioritized the issues that are most effectively addressed through UK REACH and where action would have the greatest impact for human health and the environment. The UK REACH Work Programme 2023-2024 “will be published in due course and will be accompanied by an updated rationale setting how we identified priorities for this financial year.”
The update notes that substance evaluation under UK REACH aims to clarify concerns that the manufacture and/or use of the substances could pose a risk to human health or the environment. In line with its obligations under UK REACH Article 44 and as stated within the 2022-2023 Work Programme, HSE has published a rolling action plan (RAP) of substances that will be evaluated. In 2023 and 2024, HSE, working with the Environment Agency, will evaluate one substance, N-butylbenzenesulphonamide. More information is available in our August 15, 2023, blog item.
Defra Begins User Survey On The UK REACH Service: On September 19, 2023, Defra announced a user survey on the UK REACH service, such as using the online system, e-mails, guidance, and help line. Defra states that it wants to learn about:
- What works well;
- What needs improving; and
- What is missing.
Defra states that it will use feedback to understand how to improve the service. Defra estimates that the survey will take a minimum of 15 minutes to complete.
UNITED NATIONS (UN)
UN Publishes GHS Rev 10: On July 27, 2023, the United Nations (UN) published an electronic version of the tenth revision (Rev 10) of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) available for free for consultation purposes. The amendments to the ninth revision of the GHS (Rev 9) include the classification procedure for desensitized explosives (Chapter 2.17); the use of non-animal testing methods for classification of health hazards, in particular: skin corrosion/irritation (Chapter 3.2), serious eye damage/eye irritation (Chapter 3.3), and respiratory or skin sensitization (Chapter 3.4); further rationalization of precautionary statements to improve users’ comprehensibility while taking into account usability for labeling practitioners; and the review of Annexes 9 and 10 to ensure alignment of the classification strategy, guidance, and tools on metals and metal compounds with the provisions for long-term aquatic classification toxicity in Chapter 4.1.
The most significant changes are in Chapters 3.3 and 3.4. The changes focus heavily on guidance for the use of non-animal test methods and how to apply a weight of evidence assessment. These additions/revisions allow the user additional insight on how to utilize multiple data endpoints to determine if the criteria are met. More information is available in our August 24, 2023, memorandum.