Global Regulatory Update for June 2022


EVENTS

Register Now For “TSCA Reform -- Six Years Later” On June 29, 2022: Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health are pleased to present “TSCA Reform - Six Years Later.” This complimentary virtual conference marks the sixth Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Speakers will dive into a host of topics, including the interface of science and policy under TSCA, new chemicals, risk evaluation and management, the regulation of articles, and more. Register online.

Webinar Recording Available: “Domestic Chemical Regulation and Achieving Circularity”: B&C’s May 18, 2022, webinar “Domestic Chemical Regulation and Achieving Circularity” is now available for on-demand viewing at https://attendee.gotowebinar.com/recording/2013797750853340422. During this one-hour webinar, Lynn L. Bergeson, Managing Partner, B&C, moderated a timely and fascinating review of the state of sustainable chemical regulation in the United States with Kate Sellers, Technical Fellow, ERM; Mathy Stanislaus, Vice Provost, Executive Director, The Environmental Collaboratory, Drexel University; and Richard E. Engler, Ph.D., Director of Chemistry, B&C.

NEW PODCAST EPISODES

GHS Update — A Conversation With Karin Baron: Lynn L. Bergeson and Karin F. Baron, MSPH, sit down for this episode of All Things Chemical® to discuss the truly seismic changes underway in South and Central America, in the European Union (EU) and United Kingdom (UK), and in Asia with regard to adoption of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) and the Safety Data Sheet (SDS) implications of these actions. These initiatives have a profound impact on the movement of goods and materials internationally, and the unwary can find themselves in a world of trouble by not keeping up. Karin’s special talent in this space is directed at helping her clients avoid bad commercial things from happening. Listen now.

Trends In Product Sustainability And Circularity — A Conversation With Kate Sellers: On this episode of All Things Chemical, Lynn L. Bergeson and Kate Sellers, Technical Fellow at ERM, discuss an uptick in several product sustainability trends, including implementation of the Toxic Substances Control Act (TSCA), life-cycle assessment, circular economy programs, and sustainability initiatives. Listen now.

A Look Into The Household & Commercial Products Association — A Conversation With Steven Bennett, Ph.D.: During this episode of All Things Chemical, Lynn L. Bergeson and Steven Bennett, Ph.D.,, Executive Vice President, Scientific & Regulatory Affairs, Household & Commercial Products Association (HCPA), discuss a diverse and challenging range of scientific, regulatory, and science policy issues, from consumer exposures, to chemicals used in cleaning products, to the role HCPA members play in addressing COVID-19 and related public health issues. Listen now.

NEW ARTICLES

Lynn L. Bergeson And Richard E. Engler, Ph.D., Contribute To The Global Council For Science And The Environment’s “Compilation Memorandum Regarding The GCSE Plastics Reports: In February 2022, France and the United States announced their commitment to protect our shared environment for future generations against the harm resulting plastic pollution. Both nations stated their united recognition of the transboundary impacts of plastic pollution and the importance of mitigating plastic waste at its source. On March 2, 2022, as reported by the 5th UN Environment Assembly (UNAE-5.2) in Nairobi, both France and the United States, along with 173 other nations, adopted a Resolution to End Plastic Pollution with an international legally binding agreement by 2024, with discussions beginning in 2022. Significantly, the Resolution to End Plastic Pollution defines “plastic waste” to include “microplastic.” Building upon the historic collaboration between France and the United States regarding plastic waste and learning from the contrasts in their governmental structures and approaches to environmental regulation, this French and United States Comparative Law Analysis and Recommendations Regarding Plastic Waste is offered for use by policy makers in the upcoming negotiations regarding the global plastic waste treaty.

Lynn L. Bergeson Authors “Environmental Justice And Enforcement In America: What Investors Need To Know,” Financier Worldwide: By any standard, federal enforcement of environmental laws in the United States has been uneven, to say the least. The prevailing perception is that Democrats are “greener” than are Republicans when it comes to environmental enforcement. The data are quite scattered, however, and it would seem no party has cornered the environmental protection market. The Trump Administration may be the exception that proves the rule.

Most would agree civil and criminal enforcement case numbers were significantly below those of other Administrations, all by design. A raft of other actions taken by the Trump Administration crystallized that environmental enforcement was definitely not top of mind. Priorities today are decidedly different, and investors need to know the implications of the Biden Administration’s commitment to the twin goals of environmental protection and environmental justice. This article explores these topics.

Lynn L. Bergeson Authors “EPA Targets Asbestos,” Chemical Processing: On May 6, 2022, the U.S. Environmental Protection Agency (EPA) proposed reporting and recordkeeping requirements for asbestos under TSCA Section 8(a). Unsurprisingly, the proposed requirements are extensive and tough. This article provides a summary.

AUSTRALIA

AICIS Updates Recordkeeping Checklists For Exempted And Reported Introductions: The Australian Industrial Chemicals Introduction Scheme (AICIS) announced on April 29, 2022, that it updated some of its downloadable and printable record-keeping checklists. AICIS states that the checklists “are designed to help introducers understand their record-keeping obligations and provide certainty about the types of records needed to remain compliant.” Key changes include:

  • New guidance about what records AICIS will accept for chemical identity in circumstances where an introducer does not know the Chemical Abstracts Service Registry Number (CAS RN) of the chemical. This includes an explanation of the very limited circumstances when an International Nomenclature of Cosmetic Ingredient (INCI) name can be accepted;
     
  • Obligations to keep a record of the quantity of the chemical released to the environment for introductions that involve a “designated kind of release into the environment”;
     
  • Obligations to have a written undertaking from the chemical supplier or manufacturer if the chemical is a “specified class of introduction” and the introducer does not have the necessary information; and
     
  • More information on record-keeping requirements for the introduction of chemicals at the nanoscale.
     

AICIS Updates Rolling Action Plan Of Recently Completed Evaluations And Evaluations In Progress: On May 30, 2022, AICIS announced that it updated its Rolling Action Plan of recently completed evaluations and evaluations in progress. The updates include:

  • The addition of 28 evaluations initiated under Section 74 of the Industrial Chemicals Act 2019; and
     
  • Change to the status of evaluations from “in progress” to “completed” for evaluations that were recently completed and published. AICIS announced on May 30, 2022, that it completed nine evaluations of the human health and environmental risks associated with the use of certain chemicals on the Australian Inventory of Industrial Chemicals.
     

New Tool Provides Information About WHS Duties For Agriculture Industry: Safe Work Australia (SWA) announced on June 6, 2022, that it has developed an online tool to assist those working in the agriculture industry to understand and meet their duties under the model Work Health and Safety (WHS) laws. SWA suggests stakeholders use the interactive tool to find out how to meet their WHS duties as a person conducting a business or undertaking (PCBU) or worker in the agriculture industry. The tool also outlines common WHS hazards, including working in confined spaces, working with hazardous chemicals, outdoor work and working at heights, and information about how to eliminate and manage the risks of agricultural work.

CANADA

HC Proposes New Regulatory Scheme For Biocides: Health Canada (HC) published a Canada Gazette notice on May 7, 2022, “proposing to introduce modern regulations for biocides that would provide more flexibility in tailoring application and regulatory requirements specifically to these products to maintain a safe and effective supply of biocides for Canadians, and to facilitate future efforts in international alignment.” HC proposes to create new regulations under the Food and Drugs Act (FDA) specific to biocides that would see:

  • The transfer of disinfectants that are currently regulated under the Food and Drug Regulations (FDR) and surface sanitizers regulated under the Pest Control Products Act (PCPA) that meet the definition of a drug to the proposed Biocides Regulations (the Regulations);
     
  • The creation of a new, modern authorization and regulatory framework with safety, efficacy, and quality regulatory requirements better suited to biocides;
     
  • The maintenance of a life cycle approach to the regulation of biocides while supporting requirements and authorities for the continuous post-market monitoring of a biocide’s risks and benefits; and
     
  • The creation of a pathway for authorization based on decisions from foreign regulatory authorities.
     

Comments are due July 16, 2022.

Canada Proposes Prohibition Of Certain Toxic Substances Regulations, 2022: On May 14, 2022, Canada published in the Canada Gazette the proposed Prohibition of Certain Toxic Substances Regulations, 2022 that would repeal and replace the Prohibition of Certain Toxic Substances Regulations, 2012 and introduce restrictions on the manufacture, use, sale, and import of dechlorane plus (DP), decabromodiphenyl ethane (DBDPE), and products containing these substances. The proposed regulations would also further restrict the manufacture, use, sale, and import of the following chemicals and products containing them: perfluorooctane sulfonate, its salts, and its precursors (PFOS); perfluorooctanoic acid, its salts, and its precursors (PFOA); hexabromocyclododecane (HBCD); polybrominated diphenyl ethers (PBDE); and long-chain perfluorocarboxylic acids, their salts, and their precursors (LC-PFCA). The proposed regulations would allow for permits to be issued for up to three years that would allow the continued manufacture and import of DP, DBDPE, HBCD, and products containing these substances. The notice states that for a permit to be issued, there must be no technically or economically feasible alternatives available, the applicant must have taken measures to minimize any harmful effect of the substance on the environment and human health, and a plan must have been prepared identifying measures taken by the applicant to comply with the proposed regulations within three years. The proposed regulations set out that the conditions under which a permit is granted must be maintained throughout the duration of the permit. The proposed regulations would also clarify that the clauses allowing the continued use and sale of products found in Canadian inventory are only for those products that were imported or manufactured in Canada before the coming into force of the final regulations. Comments are due July 28, 2022.

Canada Publishes Draft Framework For The Risk Assessment Of Manufactured Nanomaterials Under CEPA: On June 17, 2022, Canada published its draft Framework for the Risk Assessment of Manufactured Nanomaterials under the Canadian Environmental Protection Act, 1999 (CEPA) for a 60-day public comment period. The plain language summary states that the framework describes how scientists at Environment and Climate Change Canada (ECCC) and HC conduct risk assessments on nanomaterials. The draft risk assessment framework outlines approaches and considerations for informing the risk assessment of nanomaterials under CEPA, including both existing nanomaterials on the Domestic Substances List (DSL) and new nanomaterials notified under the New Substances Notification Regulations (Chemicals and Polymers). A substance is assessed as a nanomaterial if it meets the criteria described in HC’s working definition for nanomaterial and particle size distribution threshold (number or mass-based), as stated in both the draft framework and the New Guidance Document for the notification and testing of new substances: chemicals and polymers. Comments are due August 16, 2022. More information is available in our June 21, 2022, blog item.

Canada Issues Single-Use Plastics Prohibition Regulations: On June 22, 2022, ECCC published the Single-use Plastics Prohibition Regulations in the Canada Gazette. The regulations will prohibit the manufacture, import, and sale (including for the purpose of export) of six categories of single-use plastics (checkout bags, cutlery, foodservice ware made from or containing problematic plastics, ring carriers, stir sticks, and straws), with a temporary exemption for export. These regulations also provide exemptions to accommodate people with disabilities. To assist stakeholders with the new regulations, ECCC published two guidance documents:

COLOMBIA

Registration Opens For National Registry Of Industrial Chemical Substances: On May 31, 2022, the Ministry of Commerce (MINCIT) issued Circular 18, announcing the launch of the online system to register chemicals for the new National Registry of Industrial Chemical Substances (Registro Nacional de Sustancias Químicas de Uso Industrial (RSQUI)). As reported in our January 19, 2022, Global Regulatory Update, on November 30, 2021, the Ministry of the Environment and Sustainable Development published Decree 1630/2021 regarding the comprehensive management of chemicals for industrial use, including risk management. The Decree established the RSQUI. Companies that manufacture or import industrial chemical substances categorized as hazardous in volumes exceeding 100 kilograms annually are required to report. Under the Decree, exemptions include substances of natural origin without chemical processing, chemical substances that are already regulated by other statutes, articles, byproducts that have not been imported or traded as such, polymers, and non-isolated intermediates. Manufacturers and importers have until May 30, 2025, to report the required information.

EU

REACHblog™: For access to a timely summary of key regulatory, policy, and business developments under the EU Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation and UK REACH, go to www.REACHblog.com.

EC Publishes Restrictions Roadmap, Prioritizing Group Restrictions For The Most Harmful Chemical Substances: On April 25, 2022, the European Commission (EC) published a Restrictions Roadmap under the Chemicals Strategy for Sustainability (Restrictions Roadmap) that provides detailed information on all ongoing work on future restrictions under the EU chemical legislation. The Restrictions Roadmap prioritizes group restrictions for the most harmful substances to human health and the environment, as set out in the Chemicals Strategy for Sustainability (Strategy). According to the EC’s press release, the Restrictions Roadmap includes a rolling list (Rolling List) of substances that will become the basis for the multiannual planning under REACH. The EC states that it will regularly review and update the Rolling List to ensure a balance between needed flexibility and commitment to ensure progress.

The Restrictions Roadmap provides detailed information to stakeholders on all ongoing work on future restrictions under EU chemical legislation. The Rolling List of substances will become the basis for future planning under REACH and is intended to allow companies and other stakeholders to be prepared better for potential upcoming restrictions. These restrictions will address a wider range of their uses -- industrial, professional, and in consumer products. The EC will review the Restrictions Roadmap regularly and update it as necessary to maintain flexibility and its commitment to ensure progress toward protecting human health and the environment from the most harmful chemical substances. More information is available in The Acta Group’s (Acta®) April 29, 2022, memorandum.

ORs Must Declare Their Non-EU Manufacturers: The European Chemicals Agency (ECHA) announced on April 25, 2022, that only representatives (OR) of non-EU manufacturers will be asked to identify the non-EU manufacturer represented, including their contact information in REACH-IT, from April 26, 2022. The OR must have a separate REACH-IT account for each non-EU manufacturer represented and have the necessary registrations for each of them. ECHA notes that ORs may need to reorganize their REACH-IT accounts to ensure that there are separate accounts for each non-EU manufacturer represented. Similarly, if an OR is also a manufacturer/importer under REACH, the OR will need separate REACH-IT accounts for the OR and for the manufacturer/importer roles. ECHA states that if ORs need to rearrange their REACH-IT accounts due to these new requirements, the fee for transferring registrations in REACH-IT accounts can be waived until October 14, 2022.

EC Surveys Industry On Potential REACH Amendments Concerning The Generic Risk Management Approach And Authorization And Restriction: The EC opened a survey focused only on potential reforms to the authorization and restriction provisions of REACH, as well as the extension of the Generic Risk management Approach (GRA). The EC is revising REACH to reflect the goals in its ambitious Chemicals Strategy for Sustainability (CSS). The survey supports the EC’s impact assessment for the REACH revision and is intended only for industry stakeholders. Responses were due June 1, 2022. More information is available in our May 11, 2022, memorandum.

EC Publishes 18th ATP To CLP: On May 3, 2022, the EC published in the Official Journal of the European Union the 18th adaptation to technical progress (ATP) to the Classification, Labeling, and Packaging (CLP) regulation. It amends the list of harmonized classification and labeling entries in CLP Annex VI, adding 39 new entries, revising 17 entries, and deleting one entry. It will apply beginning November 23, 2023. Substances and mixtures may be classified, labeled, and packaged in accordance with the 18th ATP before then.

ECHA In Early Phases Of Developing Scientific Reports On OELs, Calls For Comments And Evidence: ECHA called for comments and evidence related to the scientific evaluation of exposure limits at the workplace for the following chemicals:

Name

Deadline for Providing Input

1,2,3-trichloropropane

August 1, 2022

1,2-dichloropropane

August 1, 2022

2,3-epoxypropyl methacrylate (glycidyl methacrylate)

August 1, 2022

2-chloro-1,3-butadiene (chloroprene)

August 1, 2022

Nitrosamines

September 6, 2022

According to ECHA, calls for evidence allow parties to signal their interest and express their views and concerns in the early phases of developing a scientific report on occupational exposure limits (OEL) on a substance or chemical agent at the workplace. ECHA notes that a call for evidence is additional to and does not take the place of the consultation on the OEL scientific report in support of occupational exposure limits at the workplace.

ECHA Begins Consultation Identifying BPF, BPAF, And Eight BPAF Salts As Endocrine Disruptors: ECHA published an item in its May 11, 2022, ECHA Weekly announcing that it is launching consultations to support the Member State Committee (MSC) in adopting an opinion on whether 4,4’-methylenediphenol (BPF), 4,4’-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol (BPAF), and eight BPAF salts meet the criteria for endocrine disrupting substances for the environment, as defined by the World Health Organization (WHO)/International Program on Chemical Safety (IPCS) (2002). The substances have not been identified as substances of very high concern (SVHC). The German Competent Authority indicated through an entry on the Registry of Intentions that it intends to submit in October 2022 a proposal to restrict these substances. Comments are due June 20, 2022.

EFSA Calls For Data On Prioritized Phthalates And Other Plasticizers: The European Food Safety Agency (EFSA) announced on May 12, 2022, that feedback from two consultations helped its scientists prioritize reassessments of plasticizer substances used in food contact materials (FCM) and define a protocol for assessing consumer exposure. The EC asked EFSA to carry out preparatory work to re-evaluate the health risks from plasticizers such as phthalates, structurally similar substances, and substances used to replace phthalates in FCMs. EFSA’s scientific opinion focuses on plasticizers used in different types of FCMs (e.g., plastics, rubber, and inks) across the food chain (e.g., food processing equipment and packaging). EFSA prioritized only substances authorized for use in FCMs at the EU or national level, ranking them into three groups based on their most recent risk assessment as an FCM substance: high priority (assessed before 2001), medium priority (assessed between 2001 and 2011), and low priority (assessed since 2011). On June 1, 2022, EFSA launched a call for data on phthalates, structurally similar substances, and replacement substances migrating from or occurring in FCMs. According to EFSA, some examples of relevant groups of substances potentially used as plasticizers are phthalates, terephthalates, citrates, and benzoates. Responses are due November 1, 2022.

EC Begins Public Consultation On Evaluation Of The Environmental Liability Directive: The EC began a public consultation on May 12, 2022, on an evaluation of the Environmental Liability Directive (Directive 2004/35/EC). The Directive establishes a framework of environmental liability based on the “polluter pays” principle to prevent and remedy environmental damage. Article 18(2) of the Directive requires the EC to carry out an evaluation of the Directive before April 30, 2023. The EC states that the goal of the public consultation is to allow all citizens and stakeholders to provide their views on the experience gained in applying the Directive, notably as regards its effectiveness, efficiency, relevance, coherence, and EU added value, and thus inform the evaluation process. According to the EC, the consultation is likely to be of particular interest to the stakeholders specifically addressed by the Directive, notably operators (companies or others) subject to Directive obligations, business associations, insurance (and reinsurance) and other financial security providers and associations thereof, non-governmental organizations (NGO), in particular those active in the environmental domain, as well as competent authorities involved in the implementation of the Directive and academic and research institutions. Comments are due August 4, 2022.

High Level Roundtable On The CSS Holds Third Meeting In May 2022: On May 18, 2022, the High Level Roundtable on the Implementation of the CSS held its third meeting. During the meeting, the EC provided an update on the state of implementation of the CSS. According to the written report, main achievements since the last meeting of the High Level Roundtable include:

  • Promoting Safe and Sustainable-by-Design Chemicals;
     
  • Non-Toxic Material Cycles;
     
  • Tackling the Most Harmful Substances; and
     
  • Global Chemicals Management.
     

More information is available in our June 9, 2022, blog item.

ECHA Makes Improvements To Chemicals Database: ECHA has made some small improvements to its chemicals database, including:

  • Properties of concern on infocards now link to more information on the origins of each property of concern;
     
  • Standard unified date formats in regulatory lists; and
     
  • All lists feeding the public activities coordination tool (PACT) have a first publication date, allowing the entry date of a substance in the PACT list to be shown.
     

In the substances of concern in products (SCIP) database, users can now see when Candidate List SVHCs have been removed from products or components. Additionally, for nanomaterials on the EU market, the details page of the database now includes information on the nanomaterial form characterization.

EC Seeks Comments On Revision Of The Waste Framework Directive: On May 24, 2022, the EC announced that it began a public consultation on a targeted revision of the Waste Framework Directive, including setting EU food waste reduction targets. According to the EC, the revision aims to improve the overall environmental outcome of waste management in line with the waste hierarchy and the implementation of the polluter pays principle. The specific objectives are to reduce waste generation, increase re-use, and improve separate collection to promote preparing for re-use and quality recycling. The EC states that the revision will also address several review clauses in the Directive linked to waste prevention, including prevention of food waste and lubricant waste oils management. It will be based on an impact assessment of the feasibility and the economic, environmental, and social impacts of different policy options. Comments are due August 16, 2022.

RAC Proposes Not To Change Glyphosate Hazard Classification: ECHA announced on May 30, 2022, that the Committee for Risk Assessment (RAC) has concluded that the existing classifications for glyphosate as a substance that causes serious eye damage and is toxic to aquatic life with long lasting effects should be retained. According to ECHA, RAC found that the available scientific evidence did not meet the criteria to classify glyphosate for specific target organ toxicity, or as a carcinogenic, mutagenic, or reprotoxic (CMR) substance. ECHA will publish the adopted opinion on its website and send it to the EC and EFSA by mid-August 2022. EFSA states that it will carry out its risk assessment of glyphosate, which it expects to be ready in July 2023. The EC will analyze EFSA’s conclusions and the renewal assessment report that was prepared by Sweden, France, Hungary, and The Netherlands. The EC will then put forward a renewal report and a draft regulation to EU member states on whether the approval of glyphosate can be renewed.

ECHA Publishes Web Page For BPR Coordination Group: ECHA has published a web page for the Biocidal Products Regulation (BPR) Coordination Group, a body consisting of representatives of member state competent authorities and the EC. The BPR Coordination Group mainly solves disagreements on mutual recognition of national product authorizations and simplified notification procedures.

ECHA Adds Chemical To Candidate List: ECHA announced on June 10, 2022, that n-(hydroxymethyl)acrylamide has been added to the Candidate List as it may cause cancer or genetic defects. According to ECHA, it is mostly used in polymers and when manufacturing other chemicals, textiles, leather, or fur. ECHA notes that Candidate List substances may be placed on the Authorization List in the future. If a substance is on that list, its use will be prohibited unless companies apply for authorization and the EC authorizes them to continue its use. Under REACH, companies have legal obligations when their substance is included in the Candidate List. Suppliers of articles containing a Candidate List substance above a concentration of 0.1 percent (weight by weight) must give their customers and consumers enough information to be able to use them safely. Consumers have the right to ask suppliers whether the products they buy contain SVHCs. Importers and producers of articles must notify ECHA if their article contains n-(hydroxymethyl)acrylamide within six months from the date it has been included in the list, June 10, 2022. Suppliers of substances on the Candidate List, supplied either on their own or in mixtures, have to provide their customers with a SDS. Under the Waste Framework Directive, companies also have to notify ECHA if the articles they produce contain SVHCs in a concentration above 0.1 percent (weight by weight). This notification is published in ECHA’s SCIP database.

EC Revises Definition Of Nanomaterials: On June 10, 2022, the EC announced that it is clarifying the definition of nanomaterials in a new Recommendation that supports a coherent EU regulatory framework for nanomaterials, helping to align legislation across all sectors. The EC states that the new definition should be used in EU and national legislation, policy, and research programs. The Recommendation states:

‘Nanomaterial’ means a natural, incidental or manufactured material consisting of solid particles that are present, either on their own or as identifiable constituent particles in aggregates or agglomerates, and where 50% or more of these particles in the number-based size distribution fulfil at least one of the following conditions:

1. one or more external dimensions of the particle are in the size range 1 nm to 100 nm;

2. the particle has an elongated shape, such as a rod, fibre or tube, where two external dimensions are smaller than 1 nm and the other dimension is larger than 100 nm;

2. the particle has a plate-like shape, where one external dimension is smaller than 1 nm and the other dimensions are larger than 100 nm.

In the determination of the particle number-based size distribution, particles with at least two orthogonal external dimensions larger than 100 µm need not be considered.

However, a material with a specific surface area by volume of < 6 m2/cm3 shall not be considered a nanomaterial.

The new definition replaces the definition published in 2011. According to the EC, it developed the revisions following a comprehensive review, and the revisions “should allow easier and more efficient implementation, but will not significantly affect the scope of identified nanomaterials.”

ECHA’s Integrated Regulatory Strategy Annual Report Suggests Immediate Risk Management For 300 Chemicals: On June 17, 2022, ECHA announced the release of its fourth report under the Integrated Regulatory Strategy. In 2021, final assessments were completed for more than 1,900 substances, mostly grouped based on their structural similarity. ECHA states that for around 300 of these substances, risk management actions could begin immediately, while 800 do not currently require further action. The remaining 800 need more data, and around 350 of these are expected to move to risk management in the future. Around 25 percent of the assessed substances require further risk management. Some need to be restricted and have been included to the EC’s Restrictions Roadmap. For the other 75 percent of the assessed substances, no further regulatory action is currently needed because they are low hazard, the potential for exposure is limited, or there are already risk management measures in place. The regulatory needs of almost 1,300 high-volume substances (above 100 tonnes per year) remain to be assessed. Recommendations include:

  • EU member states dedicate resources to work on substances that need further regulatory action without delay, particularly for harmonized classification and labeling;
     
  • EU member states and ECHA should intensify collaboration so they can discuss and agree on which substances to prioritize. They should also use the EC’s Restrictions Roadmap to identify candidates for restriction; and
     
  • Companies should proactively review and update data in their registration dossiers, as the information they provide is the basis for the assessment of regulatory needs.
     

LATIN AMERICA

Report Summarizes Risk Management Approach For Industrial Chemical Substances And Products: The Virtual Working Group for the Rational Management of Industrial Chemical Substances in Latin America published an April 2022 report, Enfoque de Riesgo En la Gestión De Sustancias y Productos Químicos Industriales, that is intended to capture the key elements for the implementation of risk management system for industrial chemical substances and products, with a focus on compiling inventories, records, and other elements. The goal of the report is to promote discussion among government and industry representatives on the principles and technical concepts related to the development and implementation of regulations. The report notes that these should not be interpreted as mandatory regulatory requirements. Annex 4 of the report provides a list of worldwide existing chemical inventories and their main characteristics. The working group is an initiative of the Latin American Regulatory Cooperation Forum (LARCF) with the support of the International Council of Chemical Associations (ICCA).

ORGANIZATION FOR ECONOMIC COOPERATION AND DEVELOPMENT (OECD)

OECD Adds New Substance Records To eChemPortal Combined Exposures Database: OECD announced on April 14, 2022, that nine new studies, including 364 substance records, are now available in the eChemPortal Combined Exposures database. OECD states that governments, scientists, and industry can find information on a variety of studies where chemicals are grouped together for a risk assessment that is usually limited to one or a few human health or environmental endpoint(s).

SOUTH KOREA

MOE Intends To Tighten Regulations On Labeling And Advertising Of Consumer Products Under K-BPR: The Ministry of Environment (MOE) notified the World Trade Organization (WTO) on April 28, 2022, of a draft regulation regarding the labeling and advertising of products under the Consumer Chemical Products and Biocides Safety Act (K-BPR). According to MOE, the regulation would restrict phrases that could be misunderstood as non-toxic; phrases that may be misunderstood as having no negative impact on the environment or nature; phrases that may lead to excessive use of the product or induce incorrect use of the product by misleading consumers that there is no harm from the product; and phrases that may be misleading as indicating the product has no negative effects on humans or animals.

MOE Plans To Reduce Overlap In Chemical And Waste Regulations: MOE announced on June 10, 2022, that it would “swiftly resolve the chemical and waste regulatory overlaps by actively accepting the industries’ opinions.” MOE plans to reduce overlapping regulations in the Chemical Substances Control Act (CSCA) and the Wastes Control Act (WCA). Waste management companies are subject to the CSCA and WCA when they process hazardous chemical substances. According to MOE, typical wastes containing hazardous chemical substances include waste acids, waste alkalis, and waste toxic substances and are mostly categorized as designated wastes subject to compliance with the CSCA and WCA. MOE plans to revise the applicable statutes in 2022 to apply only the WCA when a waste management company stores, transports, and handles “waste containing hazardous chemical substances.” The CSCA will continue to apply in cases where a waste management company produces or supplies hazardous chemical substances through recycling or requires any action against a chemical accident.

UNITED KINGDOM (UK)

REACHblog™: For access to a timely summary of key regulatory, policy, and business developments under EU REACH and UK REACH go to www.REACHblog.com.

HSE Begins Public Consultations On First Restriction Dossiers Under UK REACH: The UK Health and Safety Executive (HSE) announced on May 6, 2022, the beginning of a six-month public consultation on restriction proposals on lead in ammunition and substances in tattoo inks and permanent make-up (PMU). According to its press release, HSE proposed the restriction on lead in ammunition after identifying there is an unacceptable risk to human health and the environment that is not adequately controlled. HSE proposed the restriction on hazardous substances present in tattoo inks and PMU as a precautionary measure to address potential risks to human health, as there is currently no legislation in Great Britain that addresses the risks presented by insertion into the skin of these substances. In forming opinions on whether to introduce the restrictions, HSE states that it will engage with independent experts on the REACH Independent Scientific Expert Pool (RISEP), who will form a Challenge Panel to provide knowledge, scrutiny, and challenge. Comments on the restriction proposals are due November 6, 2022.

National Audit Office Report On Regulating After Brexit Considers HSE’s Role In Chemicals Regulation: On May 18, 2022, the National Audit Office released a report on Regulating After EU Exit. The report examined:

  • HSE’s role in chemicals regulation, in particular the Chemicals Regulation Division;
     
  • The Food Standards Agency’s (FSA) role in regulating food safety and standards; and
     
  • The Competition and Markets Authority’s (CMA) roles in enforcing competition and consumer protection law; operating the Office for the Internal Market; and preparing to provide subsidy advice within the UK subsidy control regime.
     

According to the report, all three regulators took on significant new responsibilities and were allocated additional funding as a result of the UK leaving the EU. The regulators implemented measures aimed at ensuring continuity in their respective sectors on Day 1 after the transition period ended, in some cases this involved delaying new regulatory requirements, or extending deadlines. The report states that all three are building capability to match their increased responsibilities but are facing operational challenges that need to be addressed as they move away from interim arrangements. The challenges include recruiting people with the necessary skills, bridging information and data gaps, and planning for the future when there is uncertainty over long-term workloads in some key areas. The regulators and the respective policy departments are at an early stage with developing strategies for reaching their future state, while still having to manage the operational challenges that have already arisen following Brexit. The report concludes that “[u‌]ntil long-term strategies are fully developed, there is a risk that regulators’ current plans to meet operational challenges may be wasted effort and not align with longer-term ambitions.”


 
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