Global Regulatory Update for November 2021


The Acta Group and Bergeson & Campbell, P.C. extend our best wishes to our clients and many friends. We wish you and your family a safe and healthy New Year. As we have for many years, the firms have made a contribution to the House of Ruth, a shelter for battered women and their children, in lieu of gifts to our clients, and on our clients’ behalf.

B&C Launches FIFRA Tutor™ Online, On-Demand Regulatory Training: The Acta Group (Acta®) affiliate Bergeson & Campbell, P.C. (B&C®) is pleased to announce that FIFRA Tutor™ regulatory training courses are now available at www.FIFRAtutor.com. Professionals can preview and enroll in on-demand classes to complete at their own pace and timing. FIFRA Tutor joins B&C’s existing TSCA Tutor® training courses in offering efficient and essential training for chemical regulatory professionals, and a third training program, HazCom GHS Tutor, is planned for 2022. These courses are intended to provide on-demand knowledge to assist with the strategic planning that is critical to global product development. More information is available here.

Exploring The Environmental Footprint Of The Digital Economy -- A Conversation With David Rejeski: In the recent All Things Chemical® episode Exploring the Environmental Footprint of the Digital Economy — A Conversation with David Rejeski, Lynn L. Bergeson and David Rejeski, Visiting Scholar with the Environmental Law Institute (ELI), discuss David’s work with the Project on the Energy and Environmental Implications of the Digital Economy. With support from the Alfred P. Sloan Foundation, ELI, the Yale School of the Environment, and the Center for Law, Energy & the Environment at UC Berkeley, the Project is shedding much-needed light on the true environmental and energy implications of the digital economy, focusing on blockchain technologies, sharing platforms, artificial intelligence, and other technologies.

Higher Education, Management, And Climate Change -- A Conversation With Kurt Landgraf: Lynn L. Bergeson was recently joined by Kurt M. Landgraf, former Chairman and Chief Executive Officer (CEO) of DuPont Pharmaceuticals Company and most recently former President of Washington College located in Chestertown, Maryland, for an episode of All Things Chemical. Kurt’s extraordinarily diverse background includes a mix of pharmaceutical management issues, higher education, and observations on preparing students for careers in environmental disciplines, resulting in a fascinating conversation.

Richard E. Engler, Ph.D., Authors Chapter On “How to Commercialize Chemical Technologies for a Sustainable Future”: Richard E. Engler, Ph.D., Director of Chemistry, Acta, contributed Chapter 7: Pre-market Approval of Chemical Substances: How New Chemical Products Are Regulated to “How to Commercialize Chemical Technologies for a Sustainable Future,” edited by Timothy J. Clark and Andrew S. Pasternak. This book covers each step of the technology commercialization process, from market landscape analysis and financing to scale-up and strategic partnering, with Dr. Engler’s chapter focusing on legal regulatory requirements for bringing new chemicals to market in several key geographic regions, as well as the impact of public policy on commercialization.

2022 Forecast -- Hitting Inboxes The First Week Of January: Acta and B&C professionals are hard at work reporting and interpreting the many developments that will shape the agenda for chemicals and chemical products in the coming year. Our perennially anticipated Forecast document will be sent to clients and friends in the first week of January 2022.

AUSTRALIA

AICIS Publishes Draft Evaluations For Comment: On October 22, 2021, the Australian Industrial Chemicals Introduction Scheme (AICIS) published draft evaluations for the following chemicals that are in its Rolling Action Plan:

1H-Imidazole, 1-ethenyl- (N-vinyl imidazole) Isomers of octahydro tetramethyl naphthalenyl ethanone (OTNE)
1H-Imidazole, 1-methyl- Lactic acid isomers
2,5-Cyclohexadiene-1,4-dione (p-benzoquinone) Lead soaps
3-Cyclohexene-1-methanol, 2,4,6-trimethyl- (isocyclogeraniol) Linear alkylbenzene sulfonates
Acetylpropionyl and diacetyl Maleic acid
Benzenepropanol Maleic acid esters (medium to long chain)
Bronopol and bronidox Maleic acid salts
Butylated hydroxyanisole and related antioxidants Mercaptobenzimidazoles and their zinc salts
C7-C12 linear alpha-beta unsaturated aldehydes Phenol, 2,4-dichloro-
Chlorocresol and chloroxylenol Terpenes and terpenoids, sinpine
  Toluenesulfonamides

AICIS also seeks information about:

Comments are due December 17, 2021.

AICIS Amends Industrial Chemicals General And Transitional Rules: AICIS announced on November 22, 2021, rules amendments and regulatory changes beginning on November 23, 2021, and December 10, 2021, following amendments to the Industrial Chemicals (General Rules) 2019 and the Industrial Chemicals (Consequential Amendments and Transitional Provisions) Rules 2019. After considering stakeholder feedback, the Minister for Regional Health signed the Industrial Chemicals (General) Legislation Amendment (2021 Measures No. 1) Rules 2021 on October 30, 2021. AICIS states that it has revised the “Guide to categorising your chemical importation and manufacture” and other pages on its website to reflect amendments that were made to the General and Transitional Rules. Changes that began on November 23, 2021, include:

  • Requirements for chemicals introduced at the nanoscale (items 1-19 in Schedule 1 of the amending rules): Internet content changes to clarify the criteria for introductions of chemicals at the nanoscale, how the nanoscale criteria apply in practice, and the associated recordkeeping obligations;
     
  • Recordkeeping for listed introductions (item 24 in Schedule 1 of the amending rules): Introducers have a 40-working day timeframe to provide the Chemical Abstracts Service (CAS) name and Registry Number (CAS RN) for their chemical if requested and it is covered by a written undertaking. There is an extra option for the record that an introducer can keep if they do not know their chemical’s CAS name and CAS RN;
     
  • Recordkeeping for “specified classes of introduction” (items 25-32 in Schedule 1 of the amending rules): If an introducer does not have access to the information needed to meet recordkeeping obligations, the introducer has the option to hold a written undertaking from the person who knows the information;
     
  • Recordkeeping for internationally assessed (reported) introductions (items 36-39 in Schedule 1 of the amending rules): Changes to clarify that introducers must keep both records to prove that the volume introduced in a registration year did not exceed the volume stated in the pre-introduction report and records to prove that the volume introduced in a registration year did not exceed the assessed volume in the overseas assessment or evaluation;
     
  • Movement of industrial chemicals into or out of Australia (items 40-50 in Schedule 1 of the amending rules): Changes to align better the General Rules with the scope of the Rotterdam Convention and Stockholm Convention;
     
  • Air fresheners and “designated kind of release into the environment” (item 54 in Schedule 1 of the amending rules): The introduction of a chemical with an end use in air fresheners is no longer a “designated kind of release into the environment.” AICIS states that this change clarifies the original intent of this requirement;
     
  • Transitioned assessment certificates and chemicals (items 1-2 in Schedule 2 of the amending rules): A new rule was added so that when a chemical that is issued an assessment certificate under the transitional legislation is added to the Australian Inventory of Industrial Chemicals (Inventory), the conditions of that certificate will also be added to the chemical’s Inventory listing. Certain rows from the table showing chemicals with a National Industrial Chemicals Notification and Assessment Scheme (NICNAS) “conditions of use” that are transitioned to AICIS “defined scopes of assessment” have been removed; and
     
  • Other changes -- Corrections (items 51-56 in Schedule 1 of the amending rules): The name of the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) was corrected in section 6 of the General Rules. The table of industrial chemicals that are comparable to industrial chemicals listed on the Inventory was corrected by removing a chemical. An omission was corrected by adding circumstances for when an AICIS Approved Chemical Name or generalized end use must be used. An omission was corrected by allowing the consideration period for an application to be “paused.”
     

Changes that will begin on December 10, 2021, include:

  • Pre-introduction report requirement relating to nanoscale chemicals for research and development (R&D) (item 20 in Schedule 1 of the amending rules): An extra requirement will be added for pre-introduction reports that requires introducers to report whether their chemical is at the nanoscale. This applies to introductions of chemicals used only for R&D;
     
  • Permission to use international assessment report (items 21-23 in Schedule 1 of the amending rules): Introducers will need to declare that they have permission to use an international assessment report from the report’s owner; and
     
  • Recordkeeping for “designated kind of release into the environment” (items 33-35 in Schedule 1 of the amending rules): The type of records that must be kept for these introductions will be updated to include the words “if practicable” and add a new recordkeeping obligation about the quantity of the chemical released into the environment.
     

CANADA

Canada Begins Mandatory Survey On BPA and BPA Structural Analogues And Functional Alternatives: On November 13, 2021, Canada published a Canada Gazette notice pursuant to Section 71 of the Canadian Environmental Protection Act (CEPA) to collect information on the commercial status, industrial processes, and downstream use of bisphenol A (BPA) and BPA structural analogues and functional alternatives (BPA SAFA) in Canada from manufacturers, importers, and those who use these substances to produce goods. Canada will use the data collected to inform its prioritization decisions, risk assessment activities, and risk management. The notice applies to those who, during the 2019 calendar year, met any of the following criteria:

  • Manufactured more than ten kilograms (kg) of a substance;
     
  • Imported more than ten kg total of a substance whether the substance was:
    • Alone;
       
    • At a concentration equal to or above 0.02 percent by weight in a mixture or in a product; or
       
    • At a concentration equal to or above 0.02 percent by weight in a reportable manufactured item; or
       
  • Used more than ten kg of a substance, whether the substance was used alone or at a concentration equal to or above 0.02 percent by weight in a good, to produce a good.
     

Every person to whom the notice applies is required to report no later than March 16, 2022.

EUROPEAN UNION (EU)

European Court Of Justice Dismisses Appeal Of DEHP Authorization Decision: On October 6, 2021, the European Court of Justice published its judgment in an appeal of a General Court of the EU decision regarding the EC’s decision to reject a request from ClientEarth to review a decision granting an authorization for uses of bis(2-ethylhexyl) phthalate (DEHP). ClientEarth v. Commission, Case C-458/19 P. ClientEarth made several arguments in its appeal, including that the General Court erred in holding that only data relating to the intrinsic properties of a substance that were included in Annex XIV of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation are relevant for the risk assessment. According to ClientEarth, the EC should have considered information on the endocrine disrupting properties of DEHP that was included in the Candidate List but not referred to in Annex XIV.

The European Court of Justice held that details on the intrinsic properties of a substance that are included in the Candidate List but not included in Annex XIV should not be taken into account during that assessment. First, REACH provides for two different stages of the authorization procedure, and second, “the mere inclusion of certain intrinsic properties of a substance in the candidate list does not necessarily or automatically lead to the inclusion of those properties in Annex XIV to that regulation.” In its November 3, 2021, ECHA Weekly, the European Chemicals Agency (ECHA), which intervened in support of the EC, highlights this finding, stating that “[i‌]n particular, the Court clarified that the hazardous properties of a substance that should be assessed when applying for an authorisation are only those listed in Annex XIV to REACH. Even if additional properties have been identified, they should only be considered once included into Annex XIV.”

ECHA Posts New Set Of Q&As For Downstream Users Of Nanoforms: ECHA has posted a new set of questions and answers (Q&A) for downstream users of nanoforms. The new Q&As, posted under Section I, include:

  • What are my obligations as a downstream user purchasing, modifying or creating nanoforms?
     
  • How do I know when I have created a new nanoform from a supplied substance?
     
  • How do I know whether the nanoform I have created is covered by my supplier if I received [a safety data sheet (SDS)] with an exposure scenario attached?
     
  • How do I know whether the nanoform I have created is covered by my supplier if: i) I did not receive an SDS or ii) I received an SDS but it does not contain exposure scenarios?
     
  • How to check if my use and the conditions of use are covered by the exposure scenario received?
     
  • What do I need to do if my nanoform/uses are not covered by my supplier?
     
  • What should the downstream user chemical safety report contain?
     
  • How do I report to ECHA that I have performed a downstream user chemical safety report (or I am relying on an exemption)?
     

EC Standing Committee Approves EC Proposal To Ban Use Of Titanium Dioxide (E171) As A Food Additive: The EC announced on October 8, 2021, that the Standing Committee on Plants, Animals, Food and Feed approved the EC’s proposal to ban the use of titanium dioxide (E171) as a food additive. The EC states that its proposal “is based on a scientific opinion by the European Food Safety Authority, which concluded that E171 could no longer be considered as safe when used as a food additive, in particular due to the fact that concerns regarding genotoxicity cannot be ruled out.” According to the EC, unless an objection is adopted by the end of 2021 by either the Council or the European Parliament, the text will enter into force in early 2022. This will begin a six-month phasing out period after which a full ban will apply in food products. The EC has posted Q&As regarding its proposal.

EP Committee Calls For Future-Proof EU Pharmaceutical Policy: The European Parliament (EP) Committee on the Environment, Public Health and Food Safety adopted on October 12, 2021, a draft report on the implementation of the EU’s pharmaceutical strategy and upcoming revisions to the legislative framework. The Committee’s press release states that the Committee highlights the need for increasing the affordability and availability of medicines. The draft report also stresses the need for the work of the pharmaceutical industry to be environmentally friendly and climate-neutral throughout product life cycles, while still ensuring patients have access to safe and effective pharmaceutical treatments. Other recommendations include:

  • Introducing an EU therapeutic guide for antimicrobials and coordinated awareness campaigns on antimicrobial resistance;
     
  • Promoting “Made in Europe” pharmaceuticals by strengthening EU manufacturing and supply resilience;
     
  • Developing adequate capacity for the sustainable production of active substances, raw materials, and medicines that reduce dependence on external sources;
     
  • Facilitating the launch of large clinical trials coordinated at the European level; and
     
  • Setting up a wider political High Level Pharmaceutical Forum.
     

The EP was scheduled to vote on the report on November 24, 2021, the result of which will then feed into the EC’s proposals for the update of EU pharmaceutical legislation in 2022.

EC Adopts EU Ecolabel Criteria For Cosmetics And Animal Care Products: The EC published a notice in the October 26, 2021, Official Journal of the European Union that adopts revised Ecolabel criteria for cosmetic products and new criteria for animal care products. The EU Ecolabel is awarded to sustainably designed products, encouraging innovation and contributing to the EU goal of climate neutrality by 2050, and to a clean and circular economy with a zero-pollution ambition for a toxic-free environment. The EU Ecolabel criteria for cosmetic products has been expanded from applying only to rinse-off cosmetics like body wash or shampoo to cover all cosmetic products as defined under the Cosmetic Product Regulation, including leave-on cosmetics such as body lotion and sunscreen. More information is available in the EC’s fact sheets for cosmetic products and animal care products.

EC Adopts New Limits For Certain Chemicals In Waste: The EC announced on October 28, 2021, that it adopted a proposal to protect human health and the environment from “some of the most harmful chemicals in waste,” persistent organic pollutants (POP). The proposal tightens the limits for these chemicals in waste, preventing them from re-entering the economy. The EC states that its objective is to eliminate or minimize POP emissions from waste. Although POPs are generally no longer used in new products, the EC notes that they can still be found in waste from consumer products, such as waterproof textiles, furniture, plastics, and electronic equipment. The EC proposes to introduce stringent limits for the following three substances, or groups of substances, in waste:

  • Perfluorooctanoic acid (PFOA) and its salts and related compounds -- Found in waterproof textiles and fire-fighting foams;
     
  • Dicofol -- a pesticide previously used in agriculture; and
     
  • Pentachlorophenol, its salts and esters -- found in treated wood and textiles.
     

In addition, the EC is proposing to tighten the maximum limits in waste for another five substances or substance groups that are already regulated.

EC Bans More Hazardous Chemicals In Cosmetic Products: The EC announced on October 29, 2021, that it is prohibiting the use of 23 substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) in cosmetic products due to their long-term and serious effects on human health. The EC states that the ban will begin March 1, 2022, and will ensure that “cosmetic products used daily by Europeans are safer, no matter which EU country they shop in and whether the products are EU-made or imported.” The EC notes that this is the fourth regulation adopted restricting and/or prohibiting the use of CMRs in cosmetic products. The EC consulted SCCS and various interested parties before deciding on the ban. The EC published the regulation in the Official Journal for the European Union on November 3, 2021.

EFSA Begins Public Consultation On Draft Opinion Identifying And Prioritizing Plasticizers Used In FCMs: The European Food Safety Authority (EFSA) announced on November 5, 2021, that it has launched consultations on its draft opinion on the identification and prioritization for risk assessment of plasticizers used in food contact materials (FCM) and on its draft protocol for the exposure assessment of those substances that are prioritized. The two consultations respond to a request from the EC that EFSA conduct preparatory work for the re-evaluation of the risks to public health from the presence of plasticizers such as phthalates, structurally similar substances, and replacement substances in FCMs. According to EFSA, only substances authorized for FCMs at the EU or at the national level were prioritized. EFSA based prioritization on the date that substances most recently underwent risk assessment as an FCM, placing those assessed before 2001 in the high-priority group, those assessed between 2001 and 2011 in the medium-priority group, and those assessed after 2011 in the low-priority group. The second consultation on the draft protocol sets out the approach EFSA intends to use to retrieve and select data and to analyze and integrate evidence for the exposure assessment of the prioritized substances. Comments are due December 16, 2021.

ECHA Releases Report Concluding That REACH Requirements Need To Be Considered In Chemical Recycling: ECHA released on November 11, 2021, a report investigating the current knowledge on chemical recycling of polymeric materials such as plastics and rubber from waste. The report, commissioned by ECHA, introduces conclusions and recommendations that ECHA states should be considered to develop further chemical recycling and reduce plastic pollution, “particularly as the global production of plastics is expected to quadruple by 2050.” ECHA provides the following summary of the conclusions and the potential solutions:

  • Regulatory issues in chemical recycling are currently not discussed in scientific papers. The opportunities and challenges posed by REACH and other chemicals, waste, and product safety legislation are specific to each chemical recycling technology. As such, the report recommends that the regulatory issues be studied on a case-by-case basis, separately for each type of chemical recycling technology. It also summarizes the feedback from operators on the challenges for each recycling technology;
     
  • There is little knowledge about the abilities of different chemical recycling processes to eliminate substances of concern. To make sound conclusions, investigations at chemical recycling plants should be carried out;
     
  • Chemical recycling technologies differ in their potential to ensure the circularity of plastics. The potential of specific technologies should be evaluated case by case to avoid false generalizations on the pros and cons of one technology for the whole field of chemical recycling; and
     
  • Digital technologies contribute to improving the traceability of substances of concern in recycling. Their implementation requires substantial efforts between and inside organizations, however.
     

EC Holds Stakeholder Workshop On Reform Of Authorizations And Restrictions Under REACH: On November 12, 2021, as part of the revision of REACH, the EC hosted a stakeholder workshop on the reform of authorizations and restrictions under REACH. Workshop participants discussed the following questions:

  • Problem analysis and objectives;
     
  • Option 1: Elements for simplification under the current authorization and restriction system;
     
  • Option 2: Merging authorization and restriction;
     
  • Option 3: Removing the authorization title from REACH completely or partially; role of restrictions, role of the candidate list; notification obligations for uses after identification as a substance of very high concern (SVHC);
     
  • Level of ambition, advantages/disadvantages of options 1, 2, and 3;
     
  • National authorizations, international level playing field, and export bans;
     
  • Interface between REACH and other EU legislation; and
     
  • Innovation and how to support substitution; improving enforceability and impact on small- and medium-sized enterprises (SME).
     

The EC held a similar workshop with EU member states on November 9, 2021. According to the EC’s background paper, these workshops are part of wider consultations on the reform of the authorization and restrictions system and will continue at the Competent Authorities for REACH and Classification, Labeling, and Packaging (CLP) regulation (CARACAL) meetings in January and March 2022. The EC invites stakeholders to contribute to the Open Public Consultation (tentatively planned from December 2021 to March 2022), as well as to the targeted consultations in the form of questionnaires, possibly followed up by specific interviews. The EC states that stakeholders can express their interest to participate in the targeted consultations and are also invited to submit written contributions to GROW-ENV-REACHRevision@ec.europa.eu at any stage of the process.

ECHA Publishes Highlights From Enforcement Forum Meeting: On November 22, 2021, ECHA published highlights from the November 9-12, 2021, Enforcement Forum and November 16-17, 2021, Biocidal Products Regulation Subgroup (BPRS) meetings. According to ECHA, the Forum agreed to run a pilot project on controlling the placing on the market and use of dichloromethane (DCM) in paint strippers and N-methylpyrrolidone (NMP) in workplaces. ECHA states that while many REACH restrictions focus on the placing on the market and use in articles, these two restrictions define strict conditions under which DCM and NMP need to be used in workplaces. Inspectors will check whether these conditions are fulfilled and may cooperate in these controls with inspectors responsible for enforcement of occupational safety and health legislation. Timelines for the project are still to be confirmed.

The Forum also began preparations for two projects for which controls will start in 2022 and 2023. Work has begun on a project on classification of mixtures, focusing on the use of bridging principles in the classification of detergents and cleaning products. Controls in this pilot project may start as early as the second half of 2022. Preparations have also started for the 2023 EU-wide enforcement project (REF-11) that will look at the quality of information in safety data sheets (SDS).

The Forum also adopted the report for the eighth REACH-EN FORCE (REF-8) project, which focuses on enforcement of CLP, REACH, and Biocidal Products Regulation (BPR) duties related to substances, mixtures and articles sold online. According to ECHA, this will be published in December 2021.

BPRS also concluded the preparation for the EU-wide second BPR enforcement project (BEF-2), which will focus on checking the compliance of biocidal products and use of approved active substances while also emphasizing compliance checks of disinfectants that are widely in use during the COVID-19 pandemic. Inspections will start in January 2022.

During an active open session with representatives of 29 stakeholder organizations and four candidate countries, the Forum and BPRS discussed a broad range of topics, including controls of devices generating biocides in situ, consistency of enforcement between EU member states, enforceability of restrictions covering multiple substances, and limitations and opportunities for cooperation between inspectors and stakeholder organizations. ECHA states that depending on feedback from members, the Forum may further explore the potential for cooperating with national consumer organizations to identify non-compliant consumer products.

UNITED KINGDOM (UK)

Environment Act Becomes Law: The UK announced on November 10, 2021, the enactment of the Environment Act. It is intended to:

  • Transform UK environmental governance as the UK leaves the EU by putting environmental principles into law, introducing legally binding targets, and establishing a new Office for Environmental Protection;
     
  • Increase local powers to tackle sources of air pollution;
     
  • Protect nature and improve biodiversity by working with developers;
     
  • Extend producer responsibility, ensure a consistent approach to recycling, introduce deposit return schemes, and introduce charges for specified single-use plastic items; and
     
  • Secure long-term, resilient water and wastewater services, including through powers to direct water companies to work together to meet current and future demand.
     

HSE Publishes New GB Active Substance Open Invitations: The deadline for resubmitting pending active substance applications to the Health and Safety Executive (HSE) under the Great Britain Biocidal Products Regulation (GB BPR) has passed. According to HSE, several active substance/product type combinations that were being evaluated as part of the EU Review Program were not resubmitted to HSE. HSE has published open invitations to provide an opportunity for a person, company, or task force/consortium to notify an intention to take over the role of participant in the GB Review Program for these active substance/product type combinations. Product manufacturers should check the list to find out if the active substances used in their products are affected and to raise this with their active substance suppliers. Notifications to support one of the active substance/product type combinations on the list in GB must be submitted by November 12, 2022. If HSE does not receive a notification to take over the role of participant, those active substance/product type combinations will be subject to a GB non-approval decision. Biocidal products containing active substances with GB non-approval decisions for the relevant product types will be removed from the GB market.


 
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