Global Regulatory Update for October 2021
Available On Demand: “PFAS Reporting Rules — What Every Company Needs To Know” Webinar, Presented September 9: The Acta Group (Acta®) Affiliate Bergeson & Campbell, P.C. (B&C®) is pleased to offer the recording and slides from our “PFAS Reporting Rules — What Every Company Needs to Know” webinar focusing on the U.S. Environmental Protection Agency’s (EPA) proposed reporting rules for per- and polyfluoroalkyl substances (PFAS). Click the link to access the recording. For slides and other resources, send an e-mail to email@example.com.
Recording Of The First International Conference On Agricultural Law Available Now: The First International Conference on Agricultural Law was held jointly by the Agricultural Law Section of the International Bar Association (IBA), Project Pravo-Justice, and the Ukrainian Bar Association (UBA) on September, 23-24, 2021. A complimentary recording of this informative event is now available to stream. Acta President Lynn L. Bergeson is the Senior Vice Chair of the IBA’s Agricultural Law Section.
ABA Section Of Environment, Energy, And Resources 29th Fall Conference, October 13-15, 2021, Washington, D.C.: Lynn L. Bergeson will present during the “Moving Towards ‘Cradle-to-Cradle’: Regulatory Drivers and Barriers in Reducing Waste and Achieving Sustainable Lifecycle Management and a Circular Economy” session on October 14, 2021, at 1:45 p.m. (EDT), at the American Bar Association’s (ABA) Section of Environment, Energy, and Resources (SEER) 29th Fall Conference.
Are You A TSCA Newbie?: If you are among the recently minted class of “TSCA newbies,” help has arrived. The Toxic Substances Control Act (TSCA) has long been relegated to the unique province of industrial chemical manufacturers — those that make or import industrial chemicals. Not anymore. TSCA now applies to many businesses in the finished product community, perhaps including your company. B&C is pleased to offer you and your company the TSCA Starter Kit to help you understand TSCA and comply with it.
Lynn L. Bergeson Authors “Extended Producer Responsibility For Packaging: And So It Begins In The US” For Financier Worldwide: On July 13, 2021, Maine became the first state in the United States to enact extended producer responsibility (EPR) legislation for packaging. Quickly thereafter, on August 6, 2021, Oregon became the second state to enact a similar EPR law applicable to packaging. Other states are poised to enact similar legislation, following trends more mature in the European Union (EU) and elsewhere around the world. The full article is available to read online.
Australia Holds Public Consultation On Proposed Amendments To AICIS General Rules: According to Australia, after the first year of operation of the Australian Industrial Chemicals Introduction Scheme (AICIS), the regulated industry and staff within the Office of Chemical Safety identified “minor operational issues” that require amendments to the details set out in the Ministerial Rules. Australia has proposed targeted amendments to the Industrial Chemicals (General Rules) 2019 and the Industrial Chemicals (Consequential Amendments and Transitional Provisions) Rules 2019 that are intended to clarify the operation of the Ministerial Rules within existing policy. The proposed amendments address the following issues: clarifying criteria for industrial chemicals introduced at the nanoscale; declarations about data ownership; annual declarations; clarifying recordkeeping for listed introductions, specified classes, designated releases to the environment, and “internationally-assessed”; the authorization process for movement of industrial chemicals into or out of Australia that are subject to the Rotterdam Convention; and transitional provisions. Comments were due September 17, 2021.
Australia Recommends Beginning Categorization Process Now For Chemicals Being Introduced Under NICNAS Exemptions: AICIS issued updated guidance on September 9, 2021, on transitioning from the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) to AICIS. According to AICIS, companies can keep introducing chemicals under the following NICNAS exemptions until August 31, 2022:
- Research and development (R&D) — Less than 100 kilograms (kg);
- Cosmetic use (no unreasonable risk) — Less than 100 kg;
- Non-cosmetic use (no unreasonable risk) — Less than 100 kg; and
- Cosmetic use (non-hazardous) — Less than one percent.
Beginning September 1, 2022, companies will need to categorize their introductions. According to AICIS, it may take time to gather the necessary information. AICIS notes that the transition period is prescribed in the Industrial Chemicals (Consequential Amendments and Transitional Provisions) Rules 2019 and that there are no AICIS exemptions to replace the NICNAS exemptions.
AICIS Publishes Roadmap For Evaluating Industrial Chemicals: On September 17, 2021, AICIS published its evaluations roadmap, which outlines its strategic approach for evaluating the human health and environmental risks of introducing and using industrial chemicals in Australia. Under the Industrial Chemicals Act 2019, any chemical that meets the definition of an industrial chemical (or class of industrial chemicals) may be subject to evaluation. AICIS states that its main goal is to ensure that the introduction of chemicals to Australia is supported by contemporary information and recommendations about managing potential risks associated with their use. AICIS will do this by:
- Identifying and prioritizing industrial chemicals for evaluation;
- Producing targeted, risk-proportionate, transparent, and evidence-based evaluations and recommendations to risk managers; and
- Providing high-quality information and risk management advice for the safe use of industrial chemicals.
By the end of 2024, AICIS aims to evaluate at least 20 percent of the chemicals listed on the Australian Inventory of Industrial Chemicals for which a current risk assessment is not available. This includes inactive chemicals, chemicals unlikely to need further regulation to manage risks, and higher concern chemicals. AICIS states that it will focus on evaluating chemicals identified to be of concern. AICIS intends to evaluate the remaining unassessed higher concern industrial chemicals by the end of 2030. AICIS will review and reset its targets regularly. AICIS notes that stakeholders, government agencies, industry, and the public will continue to have their say on the outcomes of evaluations.
AICIS Publishes Rolling Action Plan Of Current And Recently Completed Evaluations: The Rolling Action Plan is AICIS’s work plan for prioritizing chemicals for evaluation. Chemicals are selected based on the outcomes of the Evaluation Selection Analysis (ESA) process. AICIS has published two lists:
- Evaluations that are in progress, currently open for public consultation, or recently completed. Each evaluation could be for a single chemical or a group of chemicals; and
- Chemicals that are covered by an evaluation that is in progress, currently open for public consultation, or recently completed. These chemicals can change during the course of the evaluation if new information becomes available.
Brazil Updates List Of Substances Prohibited In Personal Care Products, Cosmetics, And Perfumes: The Brazilian Health Regulatory Agency (ANVISA) has updated the list of substances prohibited in personal care products, cosmetics, and perfumes. The Ministry of Health published a resolution on August 4, 2021, prohibiting specific substances, as well as prohibiting the following substances with dangerous properties:
- Substances classified as Group 1 carcinogens by the International Agency for Research on Cancer (IARC); or
- Substances classified by the European Commission (EC) as carcinogenic, mutagenic, or toxic to reproduction (CMR) in categories 1A, 1B, or 2.
Chile Publishes First List Of Chemicals With Official GHS Classifications: As reported in our Global Regulatory Update for March 2021, on February 9, 2021, the Ministry of Health published a decree approving the regulations on the classification, labeling, and notification of chemical substances and mixtures. Under the regulations, the Ministry of Health has approved official Globally Harmonized System of Classification and Labeling of Chemicals (GHS) classifications that provide a minimum reference for companies to use in classifying and labeling chemicals. Chile published a notice on August 23, 2021, approving the official GHS classifications for the first list of substances. For chemicals not on the list, manufacturers and importers must use the classification criteria in the February 9, 2021, decree. Chile will implement the GHS requirements in phases. For substances and mixtures for industrial use, the requirements will take effect February 9, 2022, and February 9, 2025, respectively. For substances and mixtures for non-industrial use, the requirements will take effect February 9, 2023, and February 9, 2027, respectively.
EUROPEAN UNION (EU)
Compliance Checks and REACH — A Conversation with Karin Baron: In the recent All Things Chemical™ episode Compliance Checks and REACH — A Conversation with Karin Baron, Lynn L. Bergeson and Karin F. Baron, Senior Regulatory Consultant at B&C and Acta, discuss Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Article 41 “compliance checks,” an innocuous-sounding component of REACH that has the potential to cause considerable business anxiety, delay, and expense if a company’s REACH dossier is found to be deficient as a result of a compliance check. Karin explains what these checks are for, what could happen if you are caught up in one, and how best to respond if your dossier becomes ensnared in a compliance check.
EC Analyzing Responses To Targeted Stakeholder Consultation Concerning Review Of Recommendation On The Definition Of A Nanomaterial: The EC recently held a targeted stakeholder consultation to update, test, and verify the preliminary findings of its review of the Recommendation on the definition of a nanomaterial. The EC compiled the 136 non-duplicated replies in an XLS spreadsheet. The EC has posted an additional contribution by the French authorities, as well as supplemental information provided by the Industrial Minerals Association Europe (IMA-Europe) and the German Federal Institute for Risk Assessment (BfR). The EC is currently analyzing the responses in detail to help conclude its review. The EC states that it will publish the outcome of the review, including a summary of the feedback and statistical analysis of the responses, as an EC Staff Working document in 2021. At that time, the EC “will also indicate the plans for potential revision or replacement of the Recommendation 20122/696/EU.”
EC Will Phase Out Certain PFCAs: On August 5, 2021, the EC published a regulation in the Official Journal of the European Union that restricts certain perfluorocarboxylic acids (C9-C14 PFCA), a subgroup of per- and polyfluoroalkyl substances (PFAS). This decision follows the proposal of the German and Swedish authorities and the opinion of the European Chemical Agency’s (ECHA) scientific committees. PFCAs cannot be placed on the EU market or used in most applications beginning February 25, 2023, with the exception of some uses that have been granted longer transition periods.
EC Begins Targeted Consultation On Endocrine Disruptors, Will Hold Online Focus Groups In October: The EC is holding a targeted consultation on potential revisions to the REACH Annexes to introduce information requirements to improve the identification of substances with endocrine disrupting potential. The EC has developed two different options that would amend the Annexes to include new standard tests providing information on endocrine disrupting properties. The purpose of the targeted consultation is to obtain the views of key stakeholders on the costs and benefits of including in REACH standard information requirements for endocrine disruption. Responses to the targeted consultation are due October 8, 2021. More information is available in our September 1, 2021, memorandum.
ECHA Calls For Evidence On Cobalt And Inorganic Cobalt Compounds Related To OELs: On August 20, 2021, ECHA launched a call for evidence on cobalt and inorganic cobalt compounds related to scientific evaluation of exposure limits at the workplace. The EC asked ECHA to evaluate exposure to cobalt and inorganic cobalt compounds to assess the option of an airborne occupational exposure limit (OEL), other limit values, and notations. According to ECHA, cobalt and inorganic cobalt compounds are substances that range from 1A to 1B (carcinogenicity class) according to Annex VI to the Classification, Labeling and Packaging Regulation (CLP). The call is intended to gather any new scientific information on uses, exposure, health effects, toxicology, epidemiology, and modes of action of cobalt and inorganic cobalt compounds, as well as any other relevant information. ECHA will include the information gathered in the evaluation when preparing the scientific report. Responses are due November 19, 2021.
ECHA Publishes Database Containing Mammalian Elimination Half-Lives: According to ECHA, elimination half-lives in mammals, including humans, have been proposed as a potential complementary metric to expand the assessment of bioaccumulative properties to cover air-breathing organisms. To explore the possibilities of using such data in bioaccumulation assessment and predictions, the Norwegian Institute of Public Health (NIPH) and ECHA collected human and terrestrial mammalian elimination half-life data, along with physiochemical data and parameters. ECHA states that the Mammalian toxicokinetic database (MamTKDB) will facilitate looking up toxicokinetic data and finding respective studies. The first version of the database contains elimination half-life values for around 1,400 substances collected from publications and publicly available studies.
ECHA Announces Publication Of Substance Evaluation Conclusions: ECHA has announced that new documents are available for:
- Bis(4-hydroxy-N-methylanilinium) sulphate, added to the Community Rolling Action Plan (CoRAP) in 2020 and evaluated by Italy;
- Silicon dioxide, added to CoRAP in 2012 and evaluated by the Netherlands;
- Dichloromethane, added to CoRAP in 2016 and evaluated by Italy; and
- Bis(2-ethylhexyl) adipate, added to CoRAP in 2020 and evaluated by Finland.
ECHA Begins Public Consultation On Proposed SVHCs: On September 3, 2021, ECHA began a public consultation on four proposals to identify new substances of very high concern (SVHC):
|Name||Reason for Proposing||Uses|
|(±)-1,7,7-Trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one covering any of the individual isomers and/or combinations thereof (4-MBC)||Endocrine disrupting properties (Article 57(f) – human health)||Used as an ultraviolet (UV) filter in cosmetics and personal care products|
|6,6′-Di-tert-butyl-2,2′-methylenedi-p-cresol (DBMC)||Toxic for reproduction|
|Used as an antioxidant or stabilizer in the manufacture of polymers and as an additive in the rubber industry|
Also used by consumers and professional workers in lubricants, greases, adhesives, sealants, hydraulic fluids, and metal working fluids
|S-(tricyclo[22.214.171.124’2,6]deca-3-en-8(or 9)-yl) O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate||Persistent, bioaccumulative, and toxic (PBT) (Article 57(d))||Used to formulate lubricants (additives) and greases that are used by professional workers and at industrial sites|
|Tris(2-methoxyethoxy)vinylsilane||Toxic for reproduction|
|Used to manufacture rubber and plastic, to formulate non-metal surface treatment solutions or dispersions, and in sealants|
Comments are due October 18, 2021.
ECHA Publishes SCIP Data: ECHA announced on September 14, 2021, that approximately 6,000 companies successfully complied with their duty to notify ECHA about products containing SVHCs. According to ECHA, the Substances of Concern In articles as such or in complex objects (Products) (SCIP) database now displays more than four million article notifications. Based on the information submitted, the most commonly notified product categories in the database are:
- Machinery and its parts;
- Measuring instruments and their parts;
- Electronic equipment and its parts;
- Vehicles and their parts;
- Articles made of rubber; and
The most common SVHCs in notifications are:
- Lead (e.g., in ball bearings, batteries);
- Lead monoxide (e.g., in lamps, vehicle parts);
- Lead titanium trioxide (e.g., in electric cookers);
- Silicid acid, lead salt (e.g., in lead crystalware, vehicle coatings); and
- 1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[126.96.36.199,9.02,13.05,10]octadeca-7,15-diene, more commonly referred to as “Dechlorane PlusTM” (e.g., in paints, glues).
The SCIP database can be searched by article name or brand, product category, type of material, or the chemical name. According to ECHA, the data “will help consumers make informed choices by checking whether a product contains hazardous chemicals and reading its safe use instructions.” ECHA suggests that waste operators can use the data to increase the re-use of articles and further develop recycling processes. All companies placing articles containing SVHCs on the EU market must notify them to the database.
EC Seeks Comments On Initiative To Streamline And Update EU Rules On Detergents: On September 21, 2021, the EC began a public consultation on an initiative that will revise Regulation (EC) 648/2004 on detergents. The EC will review policy options in line with the following scenarios in terms of improving the coherence and simplifying the regulatory framework for detergents:
- Clarifications on the scope and definitions of the Regulation;
- Potential additional requirements for detergents, e.g., expansion of phosphorus limitations, or requirements for certain harmful substances currently not covered by the Regulation;
- Improvement of the coherence of the regulatory framework for detergents by addressing the overlaps and inconsistencies with REACH, CLP, and the Biocidal Products Regulations (BPR); and
- Options on the instrument itself, such as revising the Detergents Regulation, its repeal and incorporation of its provisions in other pieces of EU chemicals legislation, alignment with the New Legislative Framework (NLF), and non-legislative options.
Comments are due October 19, 2021.
EC Begins Public Consultation On Revision Of The EU’s Pharmaceutical Legislation: The EC began a public consultation on September 28, 2021, to support the evaluation of the existing general pharmaceutical legislation on medicines for human use and the impact assessment of its revision to ensure a future-proof and crisis-resistant medicine regulatory system. The public consultation addresses the performance of the EU’s pharmaceutical legislation; unmet medical needs; incentives for innovation; antimicrobial resistance; future-proofing the regulatory framework for novel products; improved access to medicines; competitiveness of the European markets to ensure affordable medicines; repurposing of medicines; security of supply of medicines; quality and manufacturing of medicines; and environmental challenges. The consultation will end December 21, 2021.
Parliament’s Environment Committee Calls For Public Submissions For HSNO Act Amendments: On August 12, 2021, the New Zealand Parliament’s Environment Committee began taking public submissions on the Hazardous Substances and New Organisms (Hazardous Substances Assessments) Amendment Bill. The bill would amend the Hazardous Substances and New Organisms (HSNO) Act 1996 to improve the assessment and reassessment processes for hazardous substances. The amendments would allow the New Zealand Environmental Protection Authority (New Zealand EPA) to make better use of data, assessments, and information from international regulators. The bill also aims to increase the efficiency and transparency of the reassessment process by:
- Allowing New Zealand EPA to engage in targeted consultation about a hazardous substance; and
- Requiring New Zealand EPA to develop a publicly available work plan for any reassessment process.
The bill also seeks to make three technical amendments to correct ambiguous language or omissions. Public submissions were due October 3, 2021.
UNITED KINGDOM (UK)
HSE Publishes Draft Recommendations To List Of Substances Subject To Authorization: On August 31, 2021, the Health and Safety Executive (HSE) published a draft recommendation for two substances to be included on the authorization list (Annex 14) of UK REACH:
HSE seeks general comments on the draft recommendation, as well as comments on the proposed dates for the transitional arrangements, information on uses that should be exempt, and information on the commenter’s position in the supply chain and use of the substance in Great Britain (England, Scotland, and Wales) (GB). Comments are due November 30, 2021.
DEFRA Publishes UK REACH: Grandfathered Registrations Notified Substances List: The Department for Environment, Food & Rural Affairs (DEFRA) has published a UK REACH: Grandfathered Registrations Notified Substances List. According to an item in HSE’s October 1, 2021, UK REACH eBulletin, the list contains the names and Chemical Abstracts Service (CAS)/European Community (EC) numbers for substances taken from notifications made under UK REACH Article 127B(4)(a). Article 127B(4)(a) required registrants of a former EU Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration grandfathered into UK REACH to notify HSE of basic information about their registration. These initial transitional data were submitted to HSE using the Comply with UK REACH service. The list covers data provided through July 1, 2021. HSE states that the substance information on the list has been taken from initial transitional data and that its accuracy is not guaranteed. That disclaimer aside, the notice is an important read for all stakeholders. More information is available in our October 1, 2021, memorandum.
DUINs Required By October 27, 2021: Downstream user import notifications (DUIN) are required by October 27, 2021. The DUIN process enables existing supply chains to continue and allows businesses time to determine how best to comply with the registration obligations under UK REACH. HSE notes that to keep the chemical substances in their supply chains on the UK market, businesses need to make sure that the relevant substances are eventually registered for UK REACH purposes. Companies can make use of the DUIN provision if they:
- Have acquired importer obligations under UK REACH as a previous downstream user or distributor of a substance covered by an EU-based registration; or
- Were previously covered by an Only Representative (OR) in the EU/European Economic Area (EEA).
Downstream users can notify HSE of their intention to continue importing substances from the EU or EEA by October 27, 2021, using a DUIN.
UNITED NATIONS (UN)
Ninth Revision Of GHS Is Available Online: On September 14, 2021, the UN published an electronic version of the ninth revision of the GHS available for free for consultation purposes. The amendments to the eighth revision of the GHS include:
- Revision of chapter 2.1 (explosives) to address better their explosion hazard when they are not in their transport configuration;
- The revision of decision logics;
- The revision of the classification and labeling summary tables in Annex 1;
- The revision and further rationalization of precautionary statements; and
- The updating of references to Organization for Economic Cooperation and Development (OECD) test guidelines for the testing of chemicals in Annexes 9 and 10.