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January 1, 2022

Global Regulatory Update for January 2022

The ACTA Group

Forecast For U.S. Federal And International Chemical Regulatory Policy 2022: On January 3, 2022, Bergeson & Campbell, P.C. (B&C®), The Acta Group (Acta®), and B&C® Consortia Management, L.L.C. (BCCM) published our Forecast for U.S. Federal and International Chemical Regulatory Policy 2022. This extraordinarily detailed 108-page document offers our best informed judgment as to the trends and key developments we expect to see in 2022, including updates to the United Nations (UN) Globally Harmonized System of Classification and Labeling of Chemicals (GHS) model, amendments to the Hazard Communication Standard (HCS), changes to Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulations, and more.

What To Expect In Chemicals In 2022, January 26, 2022, 12:00 p.m. EST, Via Webinar: 2022 will bring competing priorities for the U.S. Environmental Protection Agency (EPA) for which companies should now prepare. Acta affiliate B&C is pleased to present “What to Expect in Chemicals in 2022,” a webinar offering insights for chemical industry stakeholders on what to watch for and how to prepare for developments in the year ahead. These include consequential policy shifts reflecting the Biden Administration’s “all of government” commitment to environmental justice and continuing evolution of EPA’s implementation of the Toxic Substances Control Act (TSCA) under Dr. Michal I. Freedhoff’s leadership. Lynn L. BergesonRichard E. Engler, Ph.D., and James V. Aidala will present this informative and forward-looking webinar. Register today.

A Conversation With Michal Freedhoff, Ph.D., Assistant Administrator, OCSPP: The All Things Chemical® podcast is pleased to present “A Conversation with Michal Freedhoff, Ph.D., Assistant Administrator, OSCPP.” In this episode, Lynn L. Bergeson, President, Acta, sits down with Dr. Michal I. Freedhoff, Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), EPA. They engage in a review of OCSPP’s priorities, including new chemical review, industrial chemical testing, EPA’s PFAS Action Plan for per- and polyfluoroalkyl substances (PFAS), and how OCSPP is dealing with a workload that is not matched by existing resources.

What Do “Reasonably Foreseen” And “Unreasonable Risk” Really Mean? — A Conversation With Richard Engler, Ph.D. And Todd Stedeford, Ph.D.: In this episode of All Things Chemical® Lynn L. BergesonRichard E. Engler, Ph.D., Director of Chemistry, Acta; and Todd J. Stedeford, Ph.D., DABT®, ERT, ATS, Senior Science and Regulatory Advisor, Acta, discuss a range of issues, including EPA new chemical reviews, when is something “reasonably foreseen,” and what is an “unreasonable risk,” among other topics. Listen now.

The Delicate Balance Between Food And Climate — A Conversation With Katherine Meighan Of IFAD: There is an inherent contradiction between greening the planet through decreasing emissions, and the need to feed people and support their livelihoods across a diverse range of populations. In this episode of All Things Chemical®Lynn L. Bergeson and Katherine Meighan, Associate Vice-President and General Counsel of the International Fund for Agricultural Development (IFAD), a UN agency headquartered in Rome, Italy, discuss the delicate balance between food and climate, and the essential role IFAD plays in addressing this challenge. Listen now.

Lynn L. Bergeson Authors “Straddling Digital And Environmental Goals: Tips For Investors,” For Financier Worldwide: The environmental impacts of the digital economy are increasingly the focus of attention and concern. There is no question the demand for electricity, water, and land have increased sharply in response to the growth in digital activity. Identifying, quantifying, and mitigating environmental and ecological impacts are core to value creation, and investors must be mindful of how a company is positioned to create value while avoiding public rebuke for neglecting to account for the environmental impacts of greatly increased digital activity.

This article explores the digital economy; the growing set of metrics used to assess environmental sustainability in a digital economy; the tools companies are using to improve efficiency, lessen environmental impacts, and increase supply chain transparency and traceability; and tips for investors in assessing a company’s environmental awareness of the impacts of greatly increased digital activity.

Lynn L. Bergeson Authors “Environmental Protection: Infrastructure Law Benefits Chemical Industry,” For Chemical Processing: On November 15, 2021, President Biden signed into law the Infrastructure Investment and Jobs Act (H.R. 3684). The House passed the bill on November 5, 2021, by a vote of 228 to 206, and the Senate passed the bill on August 10, 2021, by a vote of 69 to 30. The bill provides a $1.2 trillion infusion of cash into the economy and contains many provisions important to the chemical processing sector. This article covers some of the provisions in the 1,039-page bill that readers may find interesting.


AICIS Issues Infringement Notice To Chemical Supply Business Related To Alleged Unlawful Importation Of Industrial Chemicals: The Australian Industrial Chemicals Introduction Scheme (AICIS) announced on November 25, 2021, that AICIS Compliance issued an infringement notice of $13,320 to a chemical supply business operating in Sydney. AICIS Compliance alleged that the business unlawfully imported industrial chemicals without being registered with AICIS, in contravention of Section 13.1 of the Industrial Chemicals Act 2019 (IC Act). According to the announcement, AICIS Compliance believes the business intended to supply the chemicals to the mining industry. A consignment of these chemicals were also seized and are scheduled to be destroyed. The importer has since registered with AICIS. AICIS reminds all importers and manufacturers (introducers) of industrial chemicals to register with AICIS before introducing industrial chemicals into Australia.


Brazil Takes Significant Step Towards Passing EU REACH-Like Chemicals Regulation Framework: After Brazil’s draft Industrial Chemicals Regulation failed to make meaningful legislative progress for most of 2021, Brazil took an important step on December 6, 2021, toward enactment of a framework national chemical law. The head of the Environment Committee in the Chamber of Deputies analyzing the bill voted for its approval. The law is inspired by the European Union’s (EU) REACH and Canada’s Chemical Management Plan (CMP). Within three years of adoption, the law would establish a national inventory of industrial chemicals manufactured or imported in Brazil at more than one tonne/year.

The version of the draft approved in December 2021 is similar to the draft proposed in 2016 by Brazil’s National Chemical Safety Committee (CONASQ). That draft received wide approval, but was shelved by President Jair Bolsonaro when he took office in January 2019 and disbanded CONASQ. On October 19, 2020, federal Deputy Rodrigo Agostinho held a virtual meeting with members of the former CONASQ and Brazil’s Chemical Industry Association (ABIQUIM) to discuss adding a chemical regulation proposal to Congress’s agenda in late 2021. Representatives from industry, environmental non-governmental organizations (NGO), and labor authorities (comprised of former CONASQ members) all expressed support for the draft regulation.

The bill must pass a plenary vote in the Chamber of Deputies, and then pass the Senate before enactment. The Committee’s vote suggests that Brazil’s adoption of a comprehensive chemicals regulation framework is not off the legislative agenda.


Canada Publishes CMP Implementation Table For 2021-2024: On December 17, 2021, Canada published the CMP implementation table for 2021-2024. Canada plans to take the following actions under the listed statutes and regulations:

Canadian Environmental Protection Act, 1999 (CEPA)

  • Existing substances risk assessment: Complete assessments for remaining priorities from categorization;
  • Identification of risk assessment priorities (IRAP) priority substances;
  • Risk management of toxic substances: Continue to implement and administer risk management instruments developed through CMP and to develop regulations and other risk management instruments for CMP existing substances identified as toxic;
  • Performance measurement of risk management actions: Implement the CMP performance measurement evaluation strategy to provide information on the effectiveness of risk management actions in place for substances found to be toxic under CEPA;
  • Information gathering activities: Conduct information gathering activities to support risk assessment, risk management, and performance measurement;
  • Significant New Activity (SNAc) provisions: Apply and review the SNAc provisions on new and existing substances assessed under CMP;
  • New substances: Assess new substances and risk management when applicable;
  • Revised In Commerce List (R-ICL): Assess substances identified on the R-ICL, an administrative list of substances contained in products regulated under the Food and Drugs Act (F&DA) that were in Canadian commerce between 1987 and 2001;
  • Domestic Substances List (DSL) nanomaterials: Prioritize substances in commerce according to responses to the Section 71 survey and conduct screening assessment of high-priority nanomaterials on the DSL;
  • Monitoring: Monitor substances in humans and the environment;
  • Research: Research effects, exposure, methods, and tool development;
  • Compliance and enforcement; and
  • Drinking water: Guidelines for Canadian drinking water quality and recreational water quality.

F&DA and Food and Drug Regulations (FDR)

  • Environmental risk assessment and risk management of ingredients in drugs: Amend the F&DA to enable the management of environmental risks from drugs; and
  • Finish the development of an environmental risk assessment and risk management regulatory framework under the FDR.

Canada Consumer Product Safety Act (CCPSA) and Cosmetic Regulations under the F&DA

  • Consumer products and cosmetics: Continue surveillance of consumer products and cosmetics through analytical testing of levels of substances in these products.

Pest Control Products Act (PCPA)

  • Pesticides: Initiate re-evaluations;
  • Pesticides: Re-evaluate older chemicals;
  • Pesticides: Continue to monitor pesticide health and environmental incidents and take action as needed; and
  • Pesticides: Initiate special reviews.

Canada Publishes Proposed Single-Use Plastics Prohibition Regulations And Guidance For Selecting Alternatives: On December 25, 2021, Canada published in the Canada Gazette proposed Single-Use Plastics Prohibition Regulations that would prohibit the manufacture, import, and sale of six categories of single-use plastic manufactured items (SUP) (i.e., checkout bags, cutlery, foodservice ware made from or containing problematic plastics, ring carriers, stir sticks, and straws). Manufacture and import for the purposes of export would not be subject to the proposed prohibition. According to the notice, checkout bags, cutlery, and straws have reusable substitutes, so the proposed regulations would identify performance standards to differentiate between single-use and reusable items for these three product categories. The proposed regulations would also provide exemptions to accommodate people with disabilities. These exemptions are linked to the conditions upon which straws are sold. The prohibitions on the sale of straws would come into force one year after the proposed regulations are registered. The prohibition on the sale of all other single-use items would come into force two years after the proposed regulations are registered. The prohibitions on the manufacture and import of all six SUPs would come into force one year after registration of the proposed regulations. Comments are due March 5, 2022.

On December 25, 2021, Canada also published a draft of the Guidance for Selecting Alternatives to the Single-Use Plastics in the Proposed Single-Use Plastics Prohibition Regulations. Canada developed the draft guidance to help businesses transition away from SUPs. The draft guidance outlines “important considerations businesses can take into account when making decisions on alternative products or systems that prevent pollution and help Canada transition to a circular economy.” Comments are due March 5, 2022.


Colombia Publishes Decree Establishing Regulatory Framework For Industrial Chemicals: On November 30, 2021, the Colombian 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 establishes a National Inventory of Chemical Substances for Industrial Use. Companies that manufacture or import chemical substances for industrial use in volumes exceeding 100 kilograms annually will be required to report the following information:

  • Identity of the manufacturer/importer;
  • Annual production or import quantity of the chemical (the reporting instructions will address reporting mixtures);
  • Identification of the chemical substance, including its Chemical Abstracts Service Registry Number (CAS RN) (when applicable);
  • Hazard classification, according to the provisions of Decree 1496/2018, which adopted the sixth revision of the GHS; and
  • Identified uses.

The government must establish an online reporting portal within six months from entry into force of the Decree. Manufacturers and importers will have three years from the date the online portal becomes operational to report the required information. The information submitted must be updated annually. The government will use information from the National Inventory to identify priority chemicals. Additional information required for priority substances will be obtained through the online reporting portal. Manufacturers and importers of priority chemicals will be required to develop and implement risk reduction and management programs. The Decree does not apply to 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.


EC Begins Public Consultation On Simplification And Digitization Of Product Labels: On November 24, 2021, the European Commission (EC) began a public consultation on the simplification and digitalization of labeling of chemical products such as glues, laundry and dishwashing detergents, and fertilizing products. In its November 24, 2021, press release, the EC states that labels accompanying products are the primary means to communicate essential information to users, including hazard and safety information and product use instructions. According to the EC, the Fitness Check of the most relevant chemicals legislation (excluding REACH) and the evaluation of the Detergents Regulation showed that label comprehension and consequently consumer protection can be improved by avoiding overloading labels with information. The EC intends to gather feedback on experience and opinions from consumers, professional product users, industry, civil society organizations, national authorities, and any other interested parties. The results will feed into its considerations for proposals on a revision of the Classification, Labeling, and Packaging of Substances and Mixtures (CLP) and Detergents and Fertilizing Products Regulations, expected in 2022. Comments are due February 16, 2022.

EC Begins Comment Period On Draft Regulation On Recycled Plastic Materials And Articles Intended To Come Into Contact With Foods: The EC began a public consultation on December 6, 2021, on a draft regulation on recycled plastic materials and articles intended to come into contact with foods and repealing Regulation (EC) No 282/2008. The draft regulation would establish requirements for:

  • The placing on the market of plastic food contact materials (FCM) and articles containing plastic originating from plastic waste;
  • The development and operation of recycling processes to produce recycled plastic for use in those plastic materials and articles; and
  • The use in contact with food of recycled plastic materials and articles and of plastic materials and articles that are intended to be recycled.

The draft regulation would not apply to the use of plastic waste to manufacture substances included in the EU list of authorized substances in accordance with Article 5 of Regulation (EU) No 10/2011 when intended for subsequent use in accordance with that Regulation. Comments are due January 18, 2022.

ECHA Publishes First Assessments Of Regulatory Needs For Groups Of Chemicals: On December 7, 2021, the European Chemicals Agency (ECHA) announced its publication of the first assessment of regulatory needs covering more than 450 chemicals in 19 groups. ECHA states that for 18 of these groups, regulatory risk management measures or further data are needed. Among the first published assessments are four groups of phthalates and phthalate-like substances that were assessed as a group due to their potential reprotoxic, endocrine disrupting, or persistent, bioaccumulative, and toxic (PBT) properties. According to ECHA, for some of these phthalates, a restriction has been proposed to limit their potential releases from articles. In addition, some need harmonized classification and labeling, as well as identification as substances of very high concern (SVHC). For other substances in these groups, there is not currently enough information to confirm the potential hazard, and a few do not require any new regulatory actions at this time. ECHA encourages registrants of those substances for which new risk management is expected to begin preparing by updating their registration dossiers, verifying the use information, and anticipating the impact of the proposed measures.

ECHA Scientific Committees Support Further PFAS Restrictions: ECHA announced on December 9, 2021, that the Committee for Socio-Economic Analysis (SEAC) has adopted its final opinion on Germany’s proposal to restrict undecafluorohexanoic acid (PFHxA), its salts, and related substances. This follows an earlier opinion by the Committee for Risk Assessment (RAC) in June 2021 to restrict these substances that are very persistent and mobile in the environment and can damage the human reproductive system. ECHA states that RAC supported the proposed restriction for uses where it is not possible to minimize emissions through other means, especially for consumer uses in FCMs and textiles, as well as for fire-fighting foams used by municipal fire departments and at home. According to ECHA, SEAC considers that “a restriction of PFHxA is, in general, an appropriate measure to address the identified risks and to ensure a consistent level of protection for people and the environment across the EU.” ECHA notes that while SEAC concluded that a restriction on certain uses was likely to be proportionate (e.g., textiles in consumer apparel, paper and cardboard in FCMs, and cosmetic products), uncertainties in the available information prevented SEAC from concluding that the proposed restriction as a whole was the most appropriate means to address the identified risk.

EU-Wide Enforcement Project On Biocides Begins: ECHA announced on December 15, 2021, that enforcement authorities in EU member states will check that companies comply with obligations under the Biocidal Products Regulation (BPR) and national legislation on making biocidal products available on the EU market. According to the mandate, the focus is on biocidal products that contain approved and non-approved active substances. Inspectors will carry out onsite and desktop checks of companies during 2022. The project aims to enforce EU and member state rules for biocidal products and raise company awareness, with the goal of creating a safer biocidal products market and a level playing field for companies in the EU. ECHA also expects ad hoc activities on disinfectants and chemical analysis.

EC Proposes To Strengthen The Protection Of The Environment Through Revised Environmental Crime Directive: The EC announced on December 15, 2021, that it adopted a proposal to update the Environmental Crime Directive adopted in 2008. According to the EC, the proposal intends to make protection of the environment more effective by obliging EU member states to take criminal law measures. It defines new environmental crimes, sets a minimum level for sanctions, and strengthens the effectiveness of law enforcement cooperation. According to the EC’s Communication, new categories of offenses include “serious breaches of EU chemicals legislation causing substantial damage to the environment or human health.” The EC proposes to set a common minimum denominator for sanctions for environmental crimes. Where violations cause or are likely to cause death or serious injury to any person, EU member states would have to provide for imprisonment of up to ten years. The proposal also includes additional sanctions, including the restoration of nature, exclusion from access to public funding, and procurement procedures or the withdrawal of administrative permits. The legislative proposal was submitted to the European Parliament (EP) and the Council of the EU.

EC Adopts Recommendation To Help Companies Calculate Environmental Performance And Manufacture More Environmentally Friendly Products: The EC announced on December 16, 2021, that it adopted a revised Recommendation on the use of Environmental Footprint methods. According to the EC, the Recommendation will help companies calculate their environmental performance based on reliable, verifiable, and comparable information, and provide other actors (public administrations, NGOs, business partners) access to such information. The Environmental Footprint methods measure and communicate about the environmental performance of products (both goods and services) and organizations across their whole life cycle, relying on scientifically sound assessment methods agreed at the international level. They cover 16 environmental impacts, including climate change and impacts related to water, air, resources, land use, and toxicity. The general methods are complemented with product- or organization-specific calculation rules enabling comparison of environmental performances between similar products and companies active in similar sectors. The EC notes that the fundamental principles of the methods adopted in the revised Recommendation remain based on Life Cycle Assessment. According to the EC, most of the changes introduced are of a methodological nature in the following three main areas: modelling requirements, data and data quality requirements, and life cycle impact assessment. It also enshrines the development of category and sector rules, providing a sound basis for further policy development and implementation.

EP And Council Of The EU Reach Provisional Agreement On Fourth Update To Carcinogens And Mutagens Directive: The EP announced on December 16, 2021, that EP and Council of the EU negotiators reached an informal agreement on the fourth revision of the Carcinogens and Mutagens at Work Directive. Reprotoxic substances will be included, and the Directive will be renamed the Carcinogens, Mutagens, and Reprotoxic Substances Directive. Occupational exposure limits (OEL) will be set for acrylonitrile and nickel compounds, and the maximum limit will be lowered for benzene. According to the EP’s press release, the EP “has insisted that the Commission will present an action plan to achieve occupational exposure limit values for at least 25 substances or groups of substances before the end of 2022.” The informal agreement must be formally endorsed by the EP and Council to come into force. The Employment Committee will first vote on the deal in 2022.


Twelfth Malaysia Plan Addresses Management Of Chemical And Hazardous Substances: The Twelfth Malaysia Plan 2021-2025 aims to address current issues while restarting and rejuvenating Malaysia’s socioeconomic development for long-term sustainability and prosperity. The plan states that a dedicated task force will be established to coordinate and oversee the overall management of chemical and hazardous substances, from production to disposal stages. A detailed study will be undertaken to formulate a comprehensive regulatory framework and strengthen its governance to be on par with international best practices. According to the plan, Malaysia will introduce a new regulation requiring notification and reporting of production, import, export, use, and management of these substances. A mechanism to monitor the movement of chemical and hazardous substances and their waste will also be introduced. Malaysia will accelerate implementation of the Strategy and Action Plan for Chemical Management.


OECD Publishes Report On Sustainable Plastics Design: On December 7, 2021, OECD published a study entitled “A Chemicals Perspective on Designing with Sustainable Plastics: Goals, Considerations and Trade-offs.” The study builds on considerations from a similar OECD report from 2018 by analyzing four sector-specific case studies on insulation, flooring, biscuit wrappers, and detergent bottles. To produce this study, OECD conducted literature reviews, interviews, and workshops with chemists and suppliers, examining the chemicals perspective on the material selection process informing designers and engineering in finding sustainable plastics for their products. The study identifies limitations and recommends the following next steps:

  • Identify and address knowledge gaps within scientific insights on chemicals;
  • Continue to promote chemical innovation for improved outcomes for products and their operating environment;
  • Integrate sustainability design goals earlier in the design process;
  • Broaden the scope to include other materials families; and
  • Involve more stakeholders.

OECD Publishes Report On Surveys On Pesticide Product Label Data Elements To Support Sharing Pesticide Label Data: In December 2021, OECD published A Report on OECD Surveys on Pesticide Product Label Data Elements to Support the Sharing of Pesticide Label Data. Canada’s Pest Management Regulatory Agency (PMRA) designed two surveys with the goal of providing an overview of common label data elements, an overview of regulatory processes of reviewing and approving pest control product labels, a comparison of region specific label data element naming conventions, and identification of label data elements required for risk assessments in each member country. Responses were received to parts of one or both surveys from six member countries of the OECD Expert Group on the Electronic Exchange of Pesticide Data (Australia, Canada, Germany, Japan, New Zealand, and the United Kingdom (UK)), the European Food Safety Authority (EFSA), and an industry via Business at OECD. The report contains a collation of findings from the survey and recommendations to OECD member countries. OECD notes that the information in the report is a “snapshot” of information from respondents at the time of the survey and may not contain national, regional, or international initiatives that were ongoing at the time.


HSE Calls For Evidence On PFAS: On December 1, 2021, the Health and Safety Executive (HSE) opened a call for evidence on PFAS. HSE and the Environment Agency (EA) will prepare a regulatory management options analysis (RMOA) for PFAS. The RMOA will investigate the risks posed by PFAS and recommend the best approach to protect human health and the environment from any identified risks. The call for evidence is intended to gather information and evidence that will support HSE and EA with the preparation of the RMOA. HSE states that it is interested in all aspects of the manufacture, import, hazard profile, use, and exposure; these include environmental fate, waste and its disposal requirements, recycling opportunities for these substances and products that contain these substances, and any legislation and standards that apply, including product-specific legislation and standards. Responses are due January 30, 2022.

UK Proposes To Extend UK REACH Registration Deadline And Explore Alternative Information Requirements: On December 6, 2021, the UK’s Secretary of State for Environment, Food and Rural Affairs, George Eustice, sent a letter to the Chemical Industries Association (CIA). The letter confirms that the government is exploring a new model for transitional UK REACH registrations — the registrations under UK REACH of substances that were registered in the EU in accordance with EU REACH on or before December 31, 2020, the end of the Brexit transition period. In the same letter, the Department for Environment, Food and Rural Affairs (DEFRA) proposed extending the first UK REACH registration deadline from 2023 to 2025. This letter signals the first steps for the UK to chart its own course for the regulation of chemical substances since the end of the Brexit transition period. DEFRA is engaging with stakeholders to discuss the new proposals and will initiate a public consultation in 2022. More information is available in our January 11, 2022, memorandum.

DEFRA Publishes UK REACH Approach To Including SVHCs On The Candidate List: DEFRA published a policy paper on December 9, 2021, that sets out the UK REACH approach to including SVHCs on the UK REACH candidate list. The policy paper includes information on the interim principles for adding substances to the UK REACH candidate list; assessment of substances in the EU REACH candidate list pipeline; and inclusion of substances on the UK REACH candidate list. DEFRA and the Welsh and Scottish Governments have agreed on interim principles for including SVHCs on the candidate list in UK REACH:

  • Including SVHCs on the candidate list should be used to encourage the substitution of particularly hazardous substances;
  • A substance should not be proposed for inclusion on the candidate list unless it is a good candidate for the authorization list; and
  • RMOA, informed by calls for evidence, should be used to determine if inclusion on the candidate list is the correct route.

HSE, with EA, used these principles to assess the substances that have been added to the EU REACH candidate list since UK REACH came into force. HSE and EA identified the following four substance groups as priorities for further assessment via RMOA:

  • Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivatives, and any other stannane, dioctyl-, bis(fatty acyloxy) derivatives wherein C12 is the predominant carbon number of the fatty acyloxy moiety;
  • 1,4-Dioxane;
  • Small brominated alkylated alcohols (SBAA); and
  • Phenol, alkylation products (mainly in para position) with C12-rich branched or linear alkyl chains from oligomerization, covering any individual isomers and/or combinations thereof (PDDP).

The policy paper states that HSE will “soon” publish its initial assessment, including its reasons for prioritizing these four substance groups, on its website. HSE will continue to keep the substances that were not prioritized for further assessment at this time under review.