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August 1, 2021

Global Regulatory Update for August 2021

The ACTA Group

WEBINAR — PFAS Reporting Rules – What Every Company Needs to Know, September 9, 2021, 11:00 a.m. – 12:00 p.m. (EDT): When it comes to per- and polyfluoroalkyl substances (PFAS), the U.S. Environmental Protection Agency (EPA) is not messing around. The Agency announced on June 10, 2021, three actions intended to protect communities from PFAS:

  • Proposing a rule designed to obtain comprehensive data on more than 1,000 PFAS manufactured in the United States,
  • Withdrawing guidance that EPA believes weakened its July 2020 significant new use rule (SNUR) restricting certain long-chain PFAS, and
  • Publishing a final rule that incorporates three additional PFAS into the Toxics Release Inventory (TRI) maintained under the Emergency Planning and Community Right-to-Know Act (EPCRA).

In light of this, Bergeson & Campbell, P.C. (B&C®) is pleased to announce a complimentary webinar focused on these issues. B&C Managing Partner Lynn L. Bergeson and Director of Chemistry Richard E. Engler, Ph.D. will discuss EPA’s proposed rules and what the regulated community must know and do to comply. Register now.

The Critical Role Of Product Stewardship In Business Continuity, August 19, 2021, 1:00 p.m. – 2:00 p.m. (EDT), via webinar: Join the Product Stewardship Society (PSS) and a panel of experts for a unique webinar on how your role as a product steward can make an impact. “The Critical Role of Product Stewardship in Business Continuity” includes a facilitated panel discussion with real-world examples provided of product stewardship management in the aftermath of disruptive events like the pandemic. Specific examples will be shared to illustrate how product stewards can help organizations successfully transition from incident management to recovery and resume operations in a “new normal.” B&C is pleased to sponsor this complimentary webinar.

Recording Of Mondaq/B&C Webinar “U.S. Chemical Regulation: What’s New, What’s Hot” Available On-Demand: On July 28, 2021, B&C Managing Partner Lynn L. Bergeson and B&C Director of Chemistry Richard E. Engler, Ph.D. presented “U.S. Chemical Regulation: What’s New, What’s Hot,” with legal information service Mondaq, discussing new topics in U.S. industrial chemical regulation, their implications for chemical stakeholders, and suggested actions for chemical producers, importers, processors, and manufacturers of finished goods containing chemicals. This complimentary webinar is now available on-demand.


Australia Publishes Draft Evaluations, Calls For Information On Chemicals: Australia has initiated evaluations under Section 74 of the Industrial Chemicals Act 2019 to assess the potential human health and environment risks associated with the use of a number of industrial chemicals. Australia selected the evaluations based on information collected when conducting its Evaluation Selection Analysis (ESA) process. Australia seeks information that has the potential to affect materially the outcome of the evaluation. This may be exposure, hazard, or other data. All claims must be supported by evidence and the relevance of submitted information should be highlighted. The public consultation includes calls for information on 188 chemicals with no known commercial use in Australialow concern chemicals that may not need further environmental risk management controls, and low concern chemicals that may not need further health risk management controls. Information is due August 20, 2021.

New Legislation Establishes IChEMS, Intends To Reduce Environmental Impact Of Industrial Chemicals: Australia announced on June 24, 2021, that new legislation has established the Industrial Chemicals Environmental Management Standard (IChEMS) to provide a national approach to how chemicals can be used, stored, handled, and disposed. IChEMS is intended to provide a more streamlined approach to managing environmental risks across the Commonwealth, states, and territories. Industrial chemicals will be scheduled on the IChEMS register according to their level of concern to the environment, with risk management measures also prescribed. Chemicals on the register will be managed to reduce the risks they pose to the environment:

  • Schedules 1-3 will be low concern chemicals with minimal controls;
  • Schedules 4-6 may require permits and increasingly stricter controls, up to severe restriction; and
  • Schedule 7 chemicals will be prohibited.

Australia will hold public consultations before chemicals are scheduled on the public register. The Department of Agriculture, Water and the Environment (DAWE) is working with states and territories on a plan for each jurisdiction to incorporate the IChEMS register into their laws. Scheduling on the IChEMS register is expected to begin in early 2022.


Performance Measurement Evaluation For DEHP Concludes Risk Management Tools Are Meeting Their Goals: In June 2021, Canada announced the results of its Performance Measurement Evaluation for Risk Management of Bis(2-ethylhexyl) phthalate (DEHP), Health Component. Canada first assessed DEHP in 1994, when it was found to be a possible carcinogenic risk to Canadians. Canada established the following risk management tools to help reduce DEHP exposures to the general population of Canada: Cosmetic Ingredient Hotlist (2009); the Phthalates Regulations (2011); reporting of DEHP content under the Medical Devices Regulations (2008); and provisions under the Food and Drugs Act (1985). The Performance Measurement Evaluation concluded that the risk management tools are meeting their intended goals. According to Canada, biomonitoring data collected from three cycles (2007 to 2017) of the Canadian Health Measures Survey (CHMS) shows that Canadians’ exposure to DEHP has progressively decreased since risk management tools were implemented. The Evaluation recommends ongoing measurement of DEHP in the CHMS, monitoring of the Phthalates Regulations, and ongoing reporting of DEHP concentrations in medical devices.

Canada Publishes Fact Sheets On Use Of MOEs And RQs In Risk Assessment And Exposure Factors Used In Human Health Risk Assessments: On June 25, 2021, Canada announced that it published two new risk assessment fact sheets: use of margins of exposure (MOE) and risk quotients (RQ) in risk assessment; and Canadian exposure factors used in human health risk assessments. Decision-making for ecological and human health screening assessments under the Canadian Environmental Protection Act, 1999 (CEPA) is based on a weight of evidence approach that considers various lines of evidence to characterize health and ecological risks caused by substances. MOEs and RQs are ratios of a substance’s toxicity relative to its exposure to humans or other organisms, and they suggest whether adverse effects may occur in humans or in the environment at current or predicted exposure levels in Canada. Canada states that to estimate human exposure to a substance, scientists use standard default values for receptor characteristics, such as body weight, body surface area, inhalation rates, ingestion of dust and soil, and drinking water consumption to ensure consistency of approach. Scientists use values that are representative of the Canadian general population. Exposure is estimated separately for different age groups because of physiological and psychological differences that may affect exposure.


Carla N. Hutton And Karin F. Baron, MSPH, Author “Expert Briefing: What could the European Commission’s plan to strengthen CLP mean for industry,” For Chemical Watch: To help achieve the ambitious goals of the European Green Deal, the European Commission (EC) adopted the chemicals strategy for sustainability in October 2020. The strategy suggests that the EC can address pressing human health and environmental concerns by reinforcing Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures — one of the EU’s cornerstones for regulating chemicals. Read the full article at (subscription required).

ECETOC Task Force Publishes Report On Persistent Chemicals And Water Resources Protection: On May 27, 2021, the European Center for Ecotoxicology and Toxicology of Chemicals (ECETOC) published a Technical Report prepared by a Task Force that evaluated the existing tools and theories for how and why contaminants may migrate into drinking water sources and examined the chemical monitoring data in the natural environment. According to ECETOC’s May 27, 2021, press release, the Task Force considered the scientific basis of the persistent, mobile, and toxic (PMT) and very persistent and very mobile (vPvM) criteria proposed by the German Environmental Agency (UBA) for use in the environmental assessment of chemicals under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The Task Force developed UBA’s proposal into a tiered approach for assessing potential chemical risks to humans from drinking water. ECETOC states that the tiered approach incorporates information on use and release of chemicals, as well as how they partition within the environment. The Task Force also identified research topics that would improve the reliability and applicability of the available tools.

ECHA Publishes Report On The Operation Of REACH And CLP: On June 1, 2021, the European Chemicals Agency (ECHA) announced publication of its third report on the operations of REACH and the Classification, Labeling, and Packaging (CLP) regulation. ECHA states that with its chemicals database a prime source of information, the legislation has improved transparency on substances, their hazards, and uses. This allows authorities, companies, workers, and consumers in the EU and beyond to make better informed decisions on chemical safety. According to ECHA, certain synergies among REACH, CLP, and other legislation, such as worker protection legislation, have often failed to materialize. This creates a lack of clarity on how substances are dealt with across different pieces of legislation. More needs to be done to make the regulations work more effectively and to make progress toward the “one substance, one assessment” ambition. ECHA notes that the report “provides facts to support further policy developments and to identify areas where the functioning of REACH and CLP can be improved.” ECHA describes the report as its “contribution” to the EC as it begins its third review of REACH and CLP in 2022.

EC Publishes Implementing Regulation Simplifying Authorization Procedure For Substances Used In Legacy Spare Parts: The EC published an implementing regulation in the June 1, 2021, Official Journal of the European Union allowing the submission of simplified applications for authorization or a review report for the following uses of substances on REACH Annex XIV:

  • To produce spare parts to repair articles or complex products that are no longer produced by the sunset date indicated in the Authorization List and for which the substance was used in their production; and
  • To repair articles or complex products that are no longer produced by the sunset date indicated in the Authorization List and for which the substance was used in their production.

According to information on ECHA’s website, the application fee will be 50% lower than usual. ECHA states that for 38 substances or substance groups, the EC has extended the latest application date to September 1, 2021, and the sunset date to March 1, 2023. ECHA notes that based on information from the automotive and aerospace industries, it expects “very few, if any,” applications for authorizations for these uses.

EC Publishes Report On BPR Implementation: The EC published a June 7, 2021, report to the European Parliament (EP) and the Council of the EU on the implementation of the Biocidal Products Regulation (BPR). According to the report, the main problems identified are the slow progress in evaluating active substances included in the Review Program and the “continuous substantial delays” in both active substance approval and product authorization processes. The report states that the main reason for the observed delays — and the difficulties for companies finding reference or evaluating EU member states accepting applications — “is a systemic lack of resources in the Member States.” If member states do not take the necessary measures to ensure that their authorities can execute the role of evaluating authority for applications for approvals, authorizations, and renewals, the report concludes that “the regulatory system set out in the BPR cannot function properly.”

EC Adopts EU Strategic Framework On Health And Safety At Work 2021-2027, Will Update Rules On Hazardous Chemicals: On June 28, 2021, the EC announced that it adopted the EU strategic framework on health and safety at work 2021-2027. The Strategic Framework focuses on three key objectives for the coming years:

  • Anticipating and managing change in the new world of work: To ensure safe and healthy workplaces during the digital, green, and demographic transitions, the EC will review the Workplaces Directive and the Display Screen Equipment Directive and update protective limits on asbestos and lead. It will prepare an EU-level initiative related to mental health at work that assesses emerging issues related to workers’ mental health and puts forward guidance for action;
  • Improving prevention of work-related diseases and accidents: The Strategic Framework will promote a “vision zero” approach to eliminate work-related deaths in the EU. The EC states that it will also update EU rules on hazardous chemicals to combat cancer, reproductive, and respiratory diseases; and
  • Increasing preparedness for possible future health threats: Drawing lessons from the current pandemic, the EC will develop emergency procedures and guidance for the rapid deployment, implementation, and monitoring of measures in potential future health crises, in close cooperation with public-health actors.

According to the EC, the actions in the Strategic Framework will be implemented through: strong social dialogue; a strengthened evidence-based policy-making; improved enforcement and monitoring of existing EU legislation; awareness-raising; and mobilizing funding to invest in occupational safety and health, including from EU funds.

Changes To REACH Information Requirements Will Apply In January 2022: On June 29, 2021, ECHA issued a press release concerning an update to the REACH Annexes that is intended to clarify the information companies need to submit in their registrations and makes ECHA’s evaluation practices more transparent and predictable. The update came into effect on July 8, 2021, and will apply beginning January 8, 2022. The main changes of concern include:

  • Requirements for surface tension and water solubility of metals and sparingly soluble metal compounds;
  • Requirements for in vitro testing for eye irritation and in vivo testing for skin or eye irritation;
  • Requirements and adaptations for 28-day and 90-day repeated dose toxicity studies;
  • Specific rules for adapting reproductive toxicity studies;
  • General rules for adaptation based on:
    • Use of existing data;
    • Weight of evidence;
    • Substance-tailored exposure-driven testing; and
    • Grouping of substances, in particular, those of unknown or variable composition, complex reaction products, and biological materials (UVCB);
  • New rules for adapting studies on fate and behavior in the environment based on a low octanol-water partition coefficient;
  • New specific rules for adapting for dissociation constant and viscosity; and
  • Additional requirements for human health and environmental testing to be performed at appropriately high dose levels.

ECHA states that it is updating its guidance materials and will publish more advice to registrants toward the end of 2021.

EU-Wide Enforcement Project Will Examine Quality Of SDSs: According to ECHA’s June 29, 2021, press release, the Enforcement Forum’s Eleventh Coordinated REACH Enforcement Project (REF-11) will examine the quality of information in safety data sheets (SDS). ECHA states that the “poor quality of information” in SDSs “is a long-standing issue detected also in many earlier enforcement projects — up to 52 % were found to be deficient in the Forum’s REF-2 project in 2013.” Experience from enforcement activities in member states confirms that the issue persists. REF-11 will check compliance with the revised requirements under REACH Annex II, which sets the content and format required for SDSs. With the revised requirements entering into force in 2023, ECHA states that “this is a timely opportunity to have a harmonised project to check that companies across the EU are fulfilling this duty.” The Enforcement Forum will prepare the project in 2022, run inspections in 2023, and report in 2024.

ChemSec Announces Release Of ChemCoach To Help Companies Identify And Replace Endocrine Disrupting Chemicals: On June 30, 2021, the International Chemical Secretariat (ChemSec) announced the release of ChemCoach, which provides a framework to identify, phase out, and replace chemicals with safer alternatives. ChemSec, in collaboration with Apple and other corporate members in the Business Group, developed the step-by-step approach to help companies advance chemical safety within their products and supply chains. ChemSec states that ChemCoach is a checklist and flowchart to help companies identify and move toward replacing endocrine-disrupting chemicals in their products and supply chains.

European Court Of Auditors Publishes Special Report On Polluter Pays Principle: The European Court of Auditors (ECA) announced on July 5, 2021, publication of a Special Report entitled The Polluter Pays Principle: Inconsistent application across EU environmental policies and actions. The report focuses on whether the principle was well applied in four EU environmental policy areas: industrial pollution, waste, water, and soil. ECA assessed whether the EC’s actions related to the Environmental Liability Directive for regulating environmental damage from economic activity brought results. Finally, ECA assessed whether the EC and member states protected the EU budget from being used to bear expenses that polluters should have paid. ECA found that the Polluter Pays Principle is reflected and applied to varying degrees in the different EU environmental policies. According to ECA, the EU budget is sometimes used to fund clean-up actions that should have been borne by polluters under the Polluter Pays Principle. ECA recommends that the EC:

  • Assess the scope for strengthening the integration of the Polluter Pays Principle into environmental legislation;
  • Consider reinforcing the application of the Environmental Liability Directive; and
  • Protect EU funds from being used to finance projects that should be funded by the polluter.

ECHA Begins Stakeholder Survey On Applications For Authorization: ECHA has begun a survey asking stakeholders for their feedback on the implementation of the application and opinion-making process for REACH authorizations. The survey is for all interested and involved parties. ECHA notes that applicants have already received separate surveys through REACH-IT, however. The general stakeholder survey aims to give all interested parties an opportunity to share their views and to help ECHA identify ways to improve the application and opinion-making processes, as well as the resulting opinions. ECHA asks for responses by August 23, 2021.

ECHA Offers Advice On Improving EOGRT Studies: Experts from ECHA and EU member states have found critical issues in the design and conduct of extended one-generation reproductive toxicity (EOGRT) studies. According to the July 7, 2021, ECHA Weekly, the issues can compromise data analysis and may raise questions over compliance or requests for further studies if there is a concern. ECHA states that it encourages registrants and test laboratories to consider the issues and improve ongoing and future EOGRT studies accordingly. ECHA has posted advice on improving EOGRT studies.

Eight Chemicals Added To Candidate List: ECHA announced on July 8, 2021, that eight chemicals were added to the Candidate List. According to ECHA, some of the newly added substances are used in consumer products such as cosmetics, scented articles, rubber, and textiles. Others are used as solvents, flame retardants, or to manufacture plastic products. The substances added include:

Substance NameReason for InclusionExamples of Use(s)
2-(4-Tert-butylbenzyl)propionaldehyde and its individual stereoisomersToxic for reproduction
(Article 57c)
Cleaning agents, cosmetics, in scented articles, polishes, and wax blends.
Orthoboric acid, sodium saltToxic for reproduction
(Article 57c)
Not registered under REACH.
May be used as solvent and corrosion inhibitor.
2,2-Bis(bromomethyl)propane1,3-diol (BMP);
2,2-Dimethylpropan-1-ol, tribromo derivative/3-bromo-2,2-bis(bromomethyl)-1-propanol (TBNPA);
2,3-Dibromo-1-propanol (2,3-DBPA)
(Article 57a)
BMP: Manufacture of polymer resins and in one-component foam (OCPF) application.
TBNPA: Polymer production manufacture of plastic products, including compounding and conversion and as an intermediate.
DBPA: Registered as an intermediate.
GlutaralRespiratory sensitizing properties (Article 57f — human health)Biocides, leather tanning, x-ray film processing, cosmetics.
Medium-chain chlorinated paraffins (MCCP) (UVCB substances consisting of ≥ 80% linear chloroalkanes with carbon chain lengths within the range from C14 to C17)PBT (Article 57d)
vPvB (Article 57e)
Flame retardants, plasticizing additives in plastics, sealants, rubber, and textiles.
Phenol, alkylation products (mainly in para position) with C12-rich branched alkyl chains from oligomerization, covering any individual isomers and/or combinations thereof (PDDP)Toxic for reproduction (Article 57c)
Endocrine disrupting properties (Article 57f — human health and environment)
Preparation of lubricant additive materials and of fuel system cleaners.
(Article 57a)
Equivalent level of concern having probable serious effects to the environment (Article 57f — environment)
Equivalent level of concern having probable serious effects to human health (Article 57f — human health)
4,4′-(1-Methylpropylidene)bisphenolEndocrine disrupting properties (Article 57f — human health and environment)Not registered under REACH.
May be used in manufacture of phenolic and polycarbonate resin.

RAC Publishes Opinions On Scientific Evaluations Of OELs For Asbestos And Cadmium And Its Inorganic Compounds: The ECHA Committee for Risk Assessment (RAC) has published opinions on the scientific evaluations of occupational exposure limits (OEL) for asbestos and cadmium and its inorganic compounds. For asbestos, the opinion describes how the level of excess cancer risk depends on the concentration of mixed asbestos fibers in air (the exposure response relationship). This will support the EC in its review of the current OEL. RAC noted that while the use of all asbestos fiber types is already banned in the EU and stringent control measures apply to asbestos removal work, occupational exposure may still occur, for example, during uncontrolled demolition or maintenance activities involving old asbestos products.

EC Begins Public Consultation On Initiative Considering Simplifying And Digitalization Of Labeling Requirements For Some Categories Of Chemicals And Chemical Products: On July 14, 2021, the EC began a public consultation on a roadmap for “Simplification and digitalisation of labels on chemicals (CLP, Detergents, Fertilising Products).” The initiative concerns the labeling requirements under CLP, the Detergents Regulation, and the Fertilizing Products Regulation. According to the roadmap, the main objective “is to increase the effectiveness of communicating essential information on chemicals, including safety and product use-instructions,” to reduce further the impact of harmful chemicals on health and the environment. The EC will explore the means of simplifying and streamlining information and introducing the use of digital tools for parts of the labels to fulfill this objective. The roadmap states that any policy option considered “will aim to facilitate compliance and increase cost-efficiency and competitiveness, and minimise regulatory burden for the EU chemicals industry.” The EC will consider technological and societal developments in information and communication technologies and the need to remain future-proof when addressing available policy options. Comments are due September 20, 2021.

Five EU Member States Announce Intention To Submit PFAS Restriction Proposal: On July 15, 2021, Germany, the Netherlands, Sweden, Denmark, and Norway formally announced their intention to submit a restriction proposal for PFAS to ECHA by July 19, 2022. The Dutch National Institute for Public Health and the Environment (RIVM) states in its press release that the five member states have published summaries of the information they have gathered about PFAS. In addition, they have created a questionnaire intended to gather further information to fill knowledge gaps. The survey is aimed at relevant industry and industry associations, as well as companies that produce or have knowledge of alternatives to PFAS. According to RIVM, the goal of the survey is to ensure that the information about PFAS and alternatives is accurate and representative of the market situation so that the member states have the best basis for a knowledge-based restriction proposal for 2022. RIVM notes that responses may form the basis for assessing any derogations or special conditions for certain applications of PFAS that are particularly important to society and where alternatives are not available. Responses to the questionnaire are due September 19, 2021.

EUON Publishes Nanopinion On ECHA Nanomaterials Expert Group: On July 15, 2021, the EU Observatory for Nanomaterials (EUON) published a Nanopinion entitled “The ECHA Nanomaterials Expert Group (NMEG)” by Frank Le Curieux, Scientific Area Leader for Genotoxicity at ECHA. Le Curieux provides a brief summary of the creation of NMEG and its history. NMEG’s current mandate is to provide informal and non-binding scientific and technical advice on questions related to nanomaterials or nanoforms of substances in the frame of the implementation of REACH, CLP, BPR, EUON, and other issues relevant to ECHA’s work. More information is available in our August 2, 2021, blog item.

EC Begins Public Consultation On Targeted Revision Of CLP: The EC announced on August 9, 2021, that it launched a public consultation on a targeted revision of CLP. The objective is to improve the safe use of chemicals and to simplify existing CLP rules. The consultation seeks to gather the views of citizens, institutions, and organizations from the public and private sectors on how best to revise CLP, taking into account scientific and technical progress. The questionnaire consists of two sections: one with more general questions, and the other with more expert questions. The questionnaire includes questions concerning:

  • New hazard classes, including for endocrine disruptors, PBTs, and PMTs;
  • Classification;
  • Testing on animals;
  • Labeling;
  • Online sales;
  • Scope of CLP; and
  • Notifications to poison centers.

Comments are due November 15, 2021.


EMB Updates Philippine Inventory Of Chemicals And Chemical Substances: On May 27, 2021, the Philippine Department of Environment and Natural Resources (DENR) Environmental Management Bureau (EMB) published EMB Memorandum Circular No. 2021-08 on the 2021 updated Philippine Inventory of Chemicals and Chemical Substances (PICCS). PICCS has been updated with the addition of 52 new chemicals, bringing the total to 22,277. PICCS lists all existing chemicals and chemical substances used, imported, distributed, processed, manufactured, stored, exported, treated, or transported in the Philippines. EMB updates PICCS annually to include all new chemicals that have been issued non-confidential Pre-Manufacture and Pre-Importation Notification (PMPIN) Clearance Certificates.


MOE Notifies WTO Of Draft Partial Amendments To K-REACH Enforcement Decree And Enforcement Rule: The Ministry of Environment (MOE) notified the World Trade Organization (WTO) on June 25, 2021, of a draft partial amendment to the Enforcement Decree of the Act on Registration, Evaluation, etc. of Chemicals (K-REACH) that would include the following provisions:

  • Additional chemical substances for which some registration data requirements can be waived (Article 13):
    • Polymers that are intended to be manufactured or imported in quantities less than 1,000 tons per year (ton/y); and
    • Chemical substances for which relevant data are already submitted to obtain an approval of a biocidal substance in accordance with the Act on Consumer Chemical Products and Biocides Safety (K-BPR).
  • Improved procedure for designation of authorization substances (Article 19):
    • When intending to designate authorization substance(s), MOE selects and announces the candidate substance(s) beforehand;
    • When it is necessary to perform a risk review of a candidate substance, MOE surveys the current status of its distribution on the market first, and then designates it as an authorization substance, if appropriate; and
    • When intending to designate an authorization substance or provide a grace period for authorization, MOE establishes and operates a consultative group consisting of manufacturers, importers, and users of the concerned chemical substance.
  • MOE can request information on the export and import of chemical substances (Article 29(3)):
    • When checking whether registration or notification is completed regarding the manufacture or import of chemical substances, MOE can request the Korea Customs Service to provide export, import, or return declarations under Article 245(2) of the Enforcement Decree of the Customs Act.
  • Improving the provisions related to delegated work (Article 19):
    • Regarding permission to use hazard data under K-REACH Article 19(2), MOE delegates relevant work (i.e., collection of the fees to use the data) to the Korea Environment Corporation (KECO); and
    • MOE delegates the following work to the Korea Chemicals Management Association (KCMA) that is established pursuant to Article 53 of the Chemicals Control Act: the works to support the communication of chemicals information under K-REACH Article 29(1); and the works for administrative, technical, and financial support that the industry has and uses existing vertebrate test data under K-REACH Article 42(2).

MOE also notified WTO of a draft partial amendment to the K-REACH Enforcement Rule that would include the following provisions:

  • Additional chemical substances for which some data requirements for registration can be waived (Article 5):
    • For polymers that are intended to be manufactured or imported in quantities less than 1,000 ton/y, MOE waives the risk data requirements under Article 5(1)2 of the K-REACH Enforcement Rule; and
    • MOE waives some data requirements for registration if such data are already submitted to obtain an approval of biocidal substance in accordance with K-BPR.
  • Submission of opinions about hazard review results (Article 24):
    • Those who received the results of the hazard review may submit opinions to the National Institute for Environmental Research (NIER) within 20 days from the date when he/she receives the review results.
  • Methods to prepare and provide chemical safety information (Article 36):
    • When an existing substance is still within the grace period of registration and not registered yet, or when a substance is registered without submission of risk data as its manufacture/import amount is less than ten ton/y, a person who provides a material safety data sheet (MSDS) within the supply chain shall include the registration or notification number of the chemical substance in the MSDS.
  • Additional data to be submitted to register nanomaterials (Attachment 1):
    • MOE requests the submission of data, including particle size, particle size distribution, particle shape, and length/diameter ratio, when applying to register nanomaterials.


HSE Publishes UK REACH Work Program: The Health and Safety Executive (HSE) has published the UK REACH Work Program, describing operational work planned for 2021-2022. According to the Work Program, the Environment Agency’s Chemical Assessment Unit will almost double its technical capacity in 2021 to support the HSE in the delivery of UK REACH. In the first year of UK REACH when upskilling delivery capability, HSE will ensure that the amount of work is proportionate to resources and allows flexibility within the areas of UK REACH. HSE worked closely with the Department for the Environment, Food and Rural Affairs (DEFRA), the Scottish and Welsh Governments, and the Environment Agency “to identify the most immediate priorities for proactive risk management in the first year of UK REACH operation.” The Work Plan states:

HSE has used a range of sources of information to identify substances and issues that warrant further investigation and will continue to do so. We will develop a Rolling Action Plan (RAP) of substances for evaluation. As well as this, further analysis, such as via Regulatory Management Options Analysis (RMOA), will be used to characterise risks and identify the most appropriate tools to manage any identified risk. Within UK REACH, these tools can include making a substance subject to authorisation (by adding it to the Candidate List and, eventually, the Annex 14 Authorisation List) or introducing a restriction.

HSE notes that stakeholders can get involved in UK REACH in several ways, including consultationsAccredited Stakeholder Organization (ASO) participation, and informal engagement.

HSE Updates Guidance On UK REACH: HSE has updated the following guidance relating to UK REACH in Great Britain (GB) only:

  • Downstream user import notification (DUIN): Companies that were a GB-based downstream user or distributor under EU REACH or were regarded as a downstream user by virtue of an Only Representative (OR) agreement should notify HSE within the first 300 days of the end of the transition period (October 27, 2021) to continue to import into GB. Once a company notifies HSE using the Comply with UK REACH service on GOV.UK, it will receive a UK REACH DUIN number. Companies should use this number when telling HSE about the substances that they wish to continue importing.
  • GB-based downstream users of a UK REACH authorization: If a company is a GB-based downstream user of a substance that is on the UK REACH Authorization List (Annex 14), it must be covered by a UK REACH authorization to continue to use the substance after its sunset date. If this authorization has been granted to an applicant up the company’s supply chain, the company must notify HSE that it is a downstream user of a UK REACH authorization.
  • List of UK REACH authorizations — granted and applications in progress: HSE has published a list of adopted opinions, granted UK REACH authorizations, and in-progress applications. The list contains information on in-progress applications for UK REACH authorizations, new UK REACH authorization applications, existing EU authorizations that have been grandfathered into UK REACH, and in-flight applications where a final opinion was adopted by ECHA but a decision has been made for UK REACH.
  • Lead registrants: UK REACH retains the “one substance, one registration” principle. If there is more than one registrant for a substance, co-registrants should agree between themselves who the lead registrant will be. HSE has updated the guidance on the main responsibilities of lead registrants.

HSE Publishes Guidance And Notification Form For The Official Controls (Plant Protection Products) Regulations 2020: The EU Official Controls Regulation (OCR) aims to improve feed and food safety, animal health and welfare, and plant health by applying official controls throughout the agri-food supply chain. The Official Controls (Plant Protection Products) Regulations 2020 apply the OCR to plant protection products (PPP) in GB (England, Scotland, and Wales). They introduce a new requirement for operators throughout the PPP supply chain to notify their competent authority. Operators must complete a notification if they import, manufacture, process, or distribute PPPs authorized for professional use, adjuvants, or PPP ingredients, including active substances, safeners, synergists, and co-formulants. There is a single notification process for GB operated by DEFRA, which will collect information on behalf of all three competent authorities. Other operators, including professional users of PPPs, will need to follow a similar process in future. HSE will provide more information over the coming months. HSE has published a simple form to be completed by operators, as well as guidance on how to notify that a business imports, manufactures, processes, distributes, or sells professional PPPs. The deadline for notification is September 22, 2021.


WHO Publishes New Data On Public Health Impact Of Chemicals: On July 6, 2021, WHO released new estimates on the public health impact of chemicals as part of the Ministerial Dialogue held on July 7, 2021, at the Berlin Forum on Chemicals and Sustainability: Ambition and Action towards 2030. The new estimates show a continuing increase compared to earlier years, with two million lives and 53 disability-adjusted-life-years lost in 2019 due to chemical exposures. The estimates in the 2021 data addendum are higher than the estimate of the previous data addendum of 1.6 million lives and 45 million disability-adjusted life-years lost in 2016. According to WHO, nearly half of the deaths attributable to chemical exposures in 2019 were due to lead exposure and resulting cardiovascular diseases. The other largest contributors were chronic obstructive pulmonary disease (COPD) from occupational exposure to particulates and cancers from occupational exposure to carcinogens. WHO acknowledges that data are only available for a small number of chemical exposures, however, “and people are exposed to many more chemicals every day.”