Global Regulatory Update for March 2021


Product Stewardship and the Pandemic: Surviving and Thriving in Disruptive Times, March 31, 2021, 1:30 p.m. - 3:00 p.m. EDT, via webinar: The COVID-19 global pandemic has had far-reaching impacts on business operations. To strengthen organizational resilience going forward, we must examine lessons learned and position product stewardship as a key player in business continuity and crisis management. This future-focused webinar hosted by the Product Stewardship Society® (PSS) will identify the broad range of complex, unresolved, and evolving issues product stewards have faced and continue to face because of the pandemic. Lynn L. Bergeson, President, The Acta Group (Acta®), and President of the PSS Board of Directors, will moderate this discussion. Acta affiliate Bergeson & Campbell, P.C. (B&C®) is a proud sponsor. Complimentary registration is available here.

All Things Chemical™ Podcast Celebrates Its 50th Fascinating Episode: B&C is pleased to announce the 50th episode of All Things Chemical, with the release of episodes 49 and 50, the two-part series “How will the Biden Administration Interpret Amended TSCA?” and “How will the New Administration affect the EPA?”. On this milestone, Lynn L. Bergeson stated "B&C is thrilled to offer the podcast platform to chemical stakeholders of diverse backgrounds. The complexity and ever-changing commercial, legal, scientific, and regulatory landscape of the global chemical community offer rich and seemingly endless content for listeners. We look forward to many more great conversations.” All episodes of All Things Chemical are available to stream online now.

GlobalChem 2021, March 31, 2021, via webinar: B&C is a proud sponsor of GlobalChem. Richard E. Engler, Ph.D., Director of Chemistry, Acta, presented "CBI Challenges and Opportunities," now available for registrants to stream on-demand, and will present "Plastics and UNEA" on March 31, 2021.

AUSTRALIA

SWA Announces Major Update To HCIS: Safe Work Australia (SWA) announced on March 8, 2021, that more than 1,200 chemicals have been added or updated on the Hazardous Chemical Information System (HCIS). HCIS is a free database of chemical classifications and workplace exposure standards for manufacturers, importers, suppliers, and end users. The update adds classifications for more than 700 new chemicals and updates over 500 existing entries. The total number of hazardous chemicals listed on HCIS is now over 6,300. SWA notes that the updated classification information is from tranches 21 to 26 of the Inventory Multi-tiered Assessment and Prioritization framework, run by the Australian Industrial Chemicals Introduction Scheme.

CANADA

Toxic Substances Warning Label Act Introduced In Parliament: The Toxic Substances Warning Label Act (C-266) was introduced and completed its first reading in the House of Commons on February 5, 2021. The bill would prohibit the sale, importation, and advertisement of any product that contains a toxic substance or produces a toxic substance when used, unless that product has a label warning of the potential exposure to the toxic substance affixed on one or more surfaces of its packaging. Similar bills have been introduced in previous sessions of Parliament. None has proceeded past the introduction and first reading in the House of Commons.

Canada Adjusts Fees For New Substance Notifications Effective April 1, 2021: Under Canada’s New Substances Fees Regulations, fees must be provided with each New Substance Notification (NSN) package submitted under the New Substance Notification Regulations (Chemicals and Polymers). The amount of the fee is dependent on the annual sales in Canada for the notifier, the specific Schedule being submitted, and other services being requested (e.g., confidential search on the Domestic Substances List (DSL) or Non-Domestic Substances List (NDSL) or masked name application). As of April 1, 2019, Environment and Climate Change Canada (ECCC) modifies NSN fees annually based on the country’s Consumer Price Index (CPI). Based on a decrease in Canada’s CPI over the past 12 months, fees for NSN submissions will decrease by 0.2% starting April 1, 2021. ECCC has posted a revised fees table, effective April 1, 2021, to March 31, 2022.

Canada Seeks Comment On Renewal Of Federal Agenda For VOCs In Consumer And Commercial Products: Canada began a public consultation on March 10, 2021, to obtain comments on the 2021 to 2028 agenda to reduce volatile organic compounds (VOC) in consumer and commercial products. The consultation paper is Canada’s first step in informing stakeholders of the federal government’s plans to develop specific measures to reduce VOC emissions further from consumer and commercial products over the 2021 to 2028 time frame. Canada’s approach will be to align, where possible, with requirements in place in key U.S. jurisdictions, which Canada states will contribute to a level playing field, provide regulatory certainty for business, and benefit human health and the environment. Canada seeks to engage with the paints and coatings industry; the automotive refinishing industry; portable fuel container manufacturers; the printing industry; the adhesives and sealants industry; stakeholders; and provincial and territorial governments. Comments are due April 8, 2021.

Natural Resources Canada Announces Critical Minerals List: On March 11, 2021, Natural Resources Canada announced the release of a list of 31 minerals considered critical for the sustainable economic success of Canada and its allies -- “minerals that can be produced in Canada, are essential to domestic industry and security and have the potential to support secure and resilient supply chains to meet global demand.” The press release states that the list “prioritizes building an industrial base for the low-carbon, digitized economy, and provides greater certainty and predictability to industry, trading partners and investors on what Canada has to offer.” The 31 critical minerals are:

Aluminum

Antimony

Bismuth

Cesium

Chromium

Cobalt

Copper

Fluorspar

Gallium

Germanium

Zinc
Graphite

Helium

Indium

Lithium

Magnesium

Manganese

Molybdenum

Nickel

Niobium

Platinum group metals
 
Potash

Rare earth elements

Scandium

Tantalum

Tellurium

Tin

Titanium

Tungsten

Uranium

Vanadium
 

Canada Posts Rolling Workplan For Performance Measurement Evaluations Of Toxic Substances: Canada conducts performance measurement evaluations to provide Canadians with information on the effectiveness of risk management actions for substances found to be toxic under the Canadian Environmental Protection Act, 1999 (CEPA). Canada systematically evaluates the risk management, human health, and environmental objectives using robust data and expert analysis. Canada has posted the following rolling workplan of performance measurement evaluations of risk management strategies for certain substances underway or to be initiated over the next four years. Canada states that it selected substances as set out in the Performance Measurement Evaluation Strategy for toxic substances. Canada notes that the substances listed and timeframes may be subject to change and that the rolling workplan is provided for information purposes only.

Timing Substances Targeted Component of the Evaluation
Evaluations in progress Bis(2-ethylhexyl) phthalate (DEHP) Health
Inorganic arsenic compounds Health
Benzene Health
Dichloromethane Health
Dioxins and furans Health
Polychlorinated biphenyls (PCB) Health
Upcoming evaluations (to be initiated in 2021/22 through 2022/23) Inorganic arsenic compounds Ecological
Inorganic cadmium compounds Health and Ecological
Ethylene oxide Health
Nonylphenol and its ethoxylates Ecological
Polycyclic aromatic hydrocarbons (PAH) Health and Ecological
Octamethylcyclotetrasiloxane (D4) Ecological
Dioxins and furans Ecological
Perfluorooctane sulfonate (PFOS), its salts, and its precursors Ecological

CHILE

Ministry Of Health Publishes Decree Approving Regulations On Classification, Labeling, And Notification Of Chemical Substances And Mixtures: 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. The regulations apply to manufacturers and importers of chemical substances and mixtures that are not already regulated by other regulations, exempting pharmaceutical products, food products for human or animal consumption, cosmetic products, pesticide residues in food, and hazardous waste. Under the regulations, the Ministry of Health will approve an official classification list of substances that will provide a minimum reference for classification. Containers containing substances and mixtures classified as dangerous must be labeled with hazard pictogram(s), signal words, hazard statements, appropriate precautionary statements, and supplementary information. The precautionary statements must be those in the regulations or in the latest edition of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Suppliers must provide safety data sheets (SDS), in Spanish, to their recipients. A single SDS may be provided to cover more than one substance or mixture as long as they meet the same classification criteria and contain the same components.

Every manufacturer or importer of a substance classified as dangerous, in quantities of one tonne or more per year, must submit a notification through the Substance Notification System. The notification must be made every two years, by August 30, for the previous two calendar years. The first notification must be made in the third year from the date of publication of the decree for substances for industrial use and in the fourth year for substances for non-industrial use. New substances must be notified prior to their commercialization, import, or manufacture, and certain data must be provided.

The Ministry of Health and the Ministry of Environment will select some substances of interest and will request a risk assessment from their manufacturers and importers. Within 18 months, the Ministries will specify the criteria for risk evaluation and for defining the substances of interest that will be subject to the risk assessment process. For substances and mixtures, the regulation will take effect February 9, 2022, and February 9, 2025, respectively. For substances and mixtures for non-industrial use, the regulation will take effect February 9, 2023, and February 9, 2027, respectively.

EURASIA

Discussions Resumed Regarding The Enactment Of The Two Implementing Sub-Regulations Of EAEU REACH: On February 18, 2021, the Eurasian Economic Commission (EEC) started a second round of public discussions on two implementing sub-regulations of the regional chemical framework on the safety of chemical products (Technical Regulation (TR) Eurasian Economic Union (EAEU) 041/2017), often referred to as EAEU REACH. The regulatory impact assessment was scheduled to conclude on March 19, 2021.

The two draft implementing sub-regulations, one proposing the procedure for creating and maintaining a register of substances and mixtures, and the second proposing the procedure to notify and register new substances, are available for public comment until April 1, 2021. The documents also provide a list in Russian and English of carcinogenic, mutagenic, and reprotoxic (CMR) substances, as well as substances that have chronic toxicity to the aquatic environment.

The latest version of the drafts contains a revised timeline for the adoption of the EAEU Register of substances. Most notably, applicants may submit information to the authorities without a notification procedure until November 1, 2024, if the applicant can confirm the circulation of the substance in the customs territory of the EAEU prior to the date TR EAEU 041/2017 entered into force.

Other notable deadlines include:

  • July 1, 2022 -- Conduct an inventory of substances, including those contained in mixtures, in circulation, and planned for circulation in the customs territory of EAEU, and submit relevant information to EEC;
     
  • September 1, 2022 -- Form the national parts of the register of substances and submit relevant information to EEC; and
     
  • October 1, 2022 -- Analyze the information obtained from the inventory and inform the competent authority about analysis results.
     

EUROPEAN UNION (EU)

REACH Enforcement Projects Will Focus On Authorization Obligations And Recovered Substances: The European Chemicals Agency (ECHA) announced on January 22, 2021, that the Enforcement Forum’s Ninth Coordinated Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Enforcement Project (REF-9) has begun. Inspectors in all 30 EU and European Economic Area (EEA) countries will check whether the substances of very high concern (SVHC) subject to authorization that have been placed on the market have been granted an authorization by the European Commission (EC). Inspectors will also check whether uses of the SVHCs comply with the conditions of the authorization decisions. According to ECHA, the inspections will be carried out in collaboration with national customs and authorities responsible for occupational safety and health legislation and for environmental protection. The enforcement activities for REF-9 will be carried out in 2021, and a report on their results will be available toward the end of 2022.

ECHA announced that inspections have also started in a pilot project on recovered substances. The project focuses on the exemption that the recycling sector has from registering substances that they have recovered from waste. The project targets recovered substances that fulfil the end-of-waste status. According to ECHA, the main aim is to check compliance with REACH registration for substances recovered from waste, as well as “to improve enforcement authorities’ knowledge about exemptions for the waste treatment industry and raise awareness among waste operators about REACH duties.” Inspectors will also collect information about the main labeling and packaging duties for recovered substances under the Classification, Labeling, and Packaging (CLP) Regulation. The pilot project inspections will be carried out in 2021, while the report with the results of the project is expected during summer 2022. More information is available in ECHA’s January 22, 2021, press release, “Authorisation obligations and recovered substances in the scope of two Forum enforcement projects.”

EC Screens Websites For Greenwashing Claims, Finds Half The Claims Lack Evidence: On January 28, 2021, the EC and national consumer authorities released the results of a sweep to identify breaches of EU consumer law in online markets. For the first time, the sweep focused on greenwashing, “the practice by which companies claim they are doing more for the environment than they actually are.” The sweep analyzed online claims from various business sectors such as garments, cosmetics, and household equipment. The EC states that in their overall assessments, taking various factors into account, in 42% of the cases, authorities “had reason to believe that the claim may be false or deceptive and could therefore potentially amount to an unfair commercial practice under the Unfair Commercial Practices Directive (UCPD).” National authorities will contact the companies concerned to point out the issues detected and to ensure that these are rectified where necessary. The findings of the sweep will feed into the impact assessment to be prepared for the new legislative proposal to empower consumers for the green transition, which was announced in the New Consumer Agenda.

ECHA Holds Public Consultation On Derogation To The Exclusion Criteria For Creosote: ECHA has begun a public consultation on a derogation to the exclusion criteria for creosote for product type 8 (PT 8; wood preservatives). Under the EU Biocidal Products Regulation (BPR), active substances that meet the exclusion criteria can be approved or renewed only if they meet one or more of the following derogation criteria: exposure is negligible; the active substance is essential to prevent a serious danger to human or animal health or the environment; or not approving the substance would have a disproportionate negative impact on society compared to the risks. Comments on whether the conditions for derogation are met for creosote for PT 8 are due March 30, 2021. More information is available in Acta’s March 1, 2021, memorandum, “ECHA Begins Public Consultation on Derogation to the Exclusion Criteria for Creosote.”

ECHA Highlights Achievements Of SVHC 2020 Roadmap: ECHA published on February 4, 2021, a brochure summarizing the achievements of the SVHC 2020 Roadmap, following its completion. ECHA states that the goal of the SVHC Roadmap was to identify all relevant, currently known SVHCs and include them on the Candidate List by 2020. The Candidate List now contains 211 substances. The roadmap also aimed to identify efficiently new chemicals of concern. According to ECHA, EU member states and ECHA have systematically screened information on registered substances. ECHA states that by the end of 2020, member states had carried out regulatory management option analysis (RMOA) on around 220 chemicals of potential concern and identified a need for further regulatory action for about 80 percent of them. More information is available in ECHA’s February 4, 2021, press release, “Roadmap to address substances of very high concern complete.”

EP Calls For Stronger EU Consumption And Recycling Rules: On February 10, 2021, the European Parliament (EP) adopted a report responding to the EC’s Circular Economy Action Plan. According to the EP’s February 10, 2021, press release, binding 2030 targets are needed for materials use and the EU’s consumption footprint, covering the entire lifecycle of each product category placed on the EU market. The EP also calls on the EC to propose product-specific and/or sector-specific binding targets for recycled content. The EP urges the EC to put forward new legislation in 2021, broadening the scope of the Ecodesign Directive to include non-energy-related products. This should set product-specific standards, so that products placed on the EU market perform well, are durable and reusable, can be easily repaired, are not toxic, can be upgraded and recycled, contain recycled content, and are resource- and energy-efficient.

During the plenary debate, the EP also emphasized that achieving the Green Deal objectives will only be possible if the EU switches to a circular economy model, and that this change will create new jobs and business opportunities. The EP added that existing legislation on waste must be implemented more thoroughly, and further measures are needed for key sectors and products, such as textiles, plastics, packaging, and electronics.

EC Calls For Applications For Expert Group On Chemicals Strategy For Sustainability: On February 23, 2021, the European Agency for Safety and Health at Work (EU-OSHA) announced that in association with other relevant EC Directorates-General (DG), DG Environment has opened a call for applications to select members for an expert group, the High-Level Roundtable on Implementation of the Chemicals Strategy for Sustainability. According to EU-OSHA, the expert group’s mission “is to set the Chemicals Strategy for Sustainability objectives and monitor its implementation in dialogue with the stakeholders concerned.” Specific tasks include contributing to identifying and addressing social, economic, and cultural barriers to the transition toward safe and sustainable chemicals. The expert group will act as a core group of ambassadors to facilitate discussions and promote this transition in the economy and society, developing a regular exchange of views, experiences, and good practices between the EC and stakeholders on the main objectives of the Strategy. Applications were due March 18, 2021.

EC Calls For Data On Ingredients With Potential Endocrine-Disrupting Properties Use In Cosmetic Products: To prepare requests for scientific opinions regarding the safety of certain ingredients with potential endocrine-disrupting properties used in cosmetic products, the EC invited interested parties to submit relevant scientific information for ten substances: butylparaben; methylparaben; ethylhexyl methoxycinnamate (EHMC)/octylmethoxycinnamate (OMC)/octinoxate; benzophenone-1 (BP-1); benzophenone-2 (BP-2); benzophenone-4 (BP-4); benzophenone-5 (BP-5); BHA/butylated hydroxyanisole/tert-butyl-4-hydroxyanisole; triphenyl phosphate; and salicylic acid. According to the EC, interested parties include academic and other research institutes, EU countries’ authorities, manufacturers of cosmetic products, producers of the substances concerned, and consumers associations. The EC seeks data regarding all physicochemical properties, toxicokinetics and toxicological endpoints, assessment of exposure through consumer products, and/or an indication of the suggested safe concentration limits. Upon receipt of sufficient data, the EC will mandate the Scientific Committee on Consumer Safety (SCCS) to evaluate the substances as soon as possible. If needed, the EC will then take action to prohibit or restrict the use of the different substances in cosmetics. Responses for butylparaben are due July 15, 2021. Responses on the other substances are due November 15, 2021.

ECHA Expands EUCLEF With 16 Additional Pieces Of Legislation: ECHA announced in March 2021 that it has expanded the scope of the EU Chemicals Legislation Finder (EUCLEF), which now provides an overview of 56 pieces of EU legislation on chemicals. The additions cover pesticides, end-of-life vehicles, food contact materials, medical devices, and health and safety at work. EUCLEF is fully integrated with the Search for chemicals on ECHA’s website. Users can send questions about the covered pieces of legislation to the EUCLEF Helpdesk.

EP Adopts Report Calling For “Urgent Adoption” Of Binding Law Ensuring Companies Address Human Rights And Environmental Standards Within Their Value Chains: On March 10, 2021, the EP adopted a legislative initiative report that “calls for the urgent adoption of a binding EU law that ensures companies are held accountable and liable when they harm -- or contribute to harming -- human rights, the environment and good governance.” The EP’s March 10, 2021, press release states that binding due diligence rules would oblige companies to identify, address, and remedy aspects of their value chain (all operations, direct or indirect business relations, investment chains) that could or do infringe on human rights (including social, trade union, and labor rights), the environment (contributing to climate change or deforestation, for example), and good governance (such as corruption and bribery). According to the press release, companies that want to access the EU internal market, including those established outside the EU, would have to prove their compliance with environmental and human rights due diligence obligations. The press release notes that to create a level playing field, “the future legislative framework on due diligence should be broad and apply to all large undertakings” governed by EU law or established in the EU, including those providing financial services. The rules should also apply to publicly-listed small- and medium-sized enterprises (SME) and high-risk SMEs, which should receive technical assistance to comply with the requirements. According to the EP’s press release, the EC announced that it will present its legislative proposal on the matter later in 2021.

ECHA Begins Public Consultation On Proposals To Identify New SVHCs: ECHA has begun a public consultation on proposals to identify the following chemical substances as SVHCs:

Chemical Name Reason for Proposing Examples of Use
1,4-dioxane Equivalent level of concern having probable serious effects on the environment (Article 57f) Equivalent level of concern having probable serious effects on human health (Article 57f) The substance is used in laboratory chemicals, pH regulators, water treatment products, and as a solvent for the manufacture of other chemicals.
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) Carcinogenic (Article 57a) The substances are used in the manufacture of plastic products and chemicals.
2-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers Toxic for reproduction (Article 57c) The substance is used in the manufacture of fragrance substances for use in cleaning and personal care products.
4,4'-(1-methylpropylidene)bisphenol; (bisphenol B) Endocrine disrupting properties (Article 57(f) -- environment and human health The substance is not registered under REACH.
Glutaral Respiratory sensitizing properties (Article 57(f) -- human health) The substance is used as a biocide, in leather tanning and in X-ray film processing. A call for evidence to support a potential restriction proposal will be launched in the coming weeks for this substance and will be announced separately at that time.
Medium-chain chlorinated paraffins (MCCP) Persistent, bioaccumulative, and toxic (PBT) (Article 57d) Very persistent and very bioaccumulative (vPvB) (Article 57e The substances are used in polymers/rubbers, adhesives and sealants, coating products, working fluids, and textile treatment products and dyes.
Orthoboric acid, sodium salt Toxic for reproduction (Article 57c) The substance is not registered under REACH.
Phenol, alkylation products (mainly in para position) with C12-rich branched or linear alkyl chains from oligomerization, covering any individual isomers and/ or combinations thereof (PDDP) Toxic for reproduction (Article 57c) Endocrine disrupting properties (Article 57(f) -- human health) Endocrine disrupting properties (Article 57(f) -- environment) The substances are used in the manufacture of chemicals, rubber products, and plastic products.

Comments are due April 23, 2021.

EFSA Begins Public Consultation On Draft Updated Guidance On Assessing The Exposure Of Operators, Workers, Residents, And Bystanders In Risk Assessment For Plant Protection Products: The European Food Safety Authority (EFSA) announced on March 15, 2021, that it has begun a public consultation on a draft updated Guidance on the assessment of exposure of operators, workers, residents, and bystanders in risk assessment for plant protection products (PPP). According to EFSA, the Guidance is designed to assist risk assessors and applicants when quantifying potential non-dietary, systemic exposures as part of the regulatory risk assessment for PPPs. The Guidance is based on the Scientific Opinion on “Preparation of a Guidance Document on Pesticide Exposure Assessment for Workers, Operators, Residents and Bystanders” developed by the EFSA Panel on Plant Protection Products and their Residues (PPR) in 2010. EFSA states that highlighting some inconsistencies between the approaches adopted by regulatory authorities, the PPR Panel proposed a number of changes to the practices in use (i.e., use of deterministic methods for individual PPPs; need to perform an acute risk assessment for PPPs that are acutely toxic; use of appropriate percentile for acute or longer term risk assessments). In the first version of the Guidance, issued in 2014, EFSA included several scenarios for outdoor uses, with an annexed calculator, as well as recommendations for further research. EFSA has updated the Guidance in 2021 to include additional scenarios and revise default values on the basis of the evaluation of additional evidence. To support users in performing the assessment of exposure and risk, EFSA further developed an online calculator that reflects the Guidance content. Comments on the draft updated Guidance are due May 9, 2021. EFSA will assess all comments submitted in line with the specified criteria. The relevant EFSA Panel will further consider the comments and take them into consideration if found to be relevant.

Council Of The EU Approves Conclusions On EU Chemicals Strategy For Sustainability: On March 15, 2021, the Council of the EU endorsed the EU Chemicals Strategy for Sustainability, “a new chemicals strategy setting a long-term vision for the EU chemicals policy.” The Council’s March 15, 2021, press release states that in its conclusions, the Council asks the EC to implement the actions laid down in the Strategy, including targeted amendments to streamline EU chemicals legislation, substituting and minimizing substances of concern, and phasing out the most harmful chemicals for non-essential societal uses. The Council also highlights the importance of limiting exposure to endocrine disruptors and of reducing the harmful effects of chemical mixtures. According to the press release, “[t]he Council endorses the EU taking a leading role at the global stage, by promoting its rules on chemicals as the golden standard, as well as ensuring that the EU has secured access to chemicals that are critical for health and the functioning of society.”

EC Begins Public Consultation On Sustainable Products Legislative Initiative: The EC began a public consultation on March 17, 2021, to gather opinions and evidence from the public and relevant stakeholders on the Sustainable Products legislative Initiative (SPI), including its possible scope, objectives, and the main policy options that should be considered for its implementation. According to the EC, as a legislative proposal, the SPI intends to widen the scope of the Ecodesign Directive beyond energy-related products so as to make it applicable to the broadest possible range of products (including services where appropriate) and make it deliver on sustainability, including circularity. The EC states that this may be complemented by other legislative proposals and other (non-legislative) actions if necessary. The SPI may also establish product sustainability principles and other ways to regulate sustainability-related aspects in a wide range of products. Comments are due June 9, 2021.

ECHA Publishes CoRAP Update Covering 2021, 2022, And 2023: The Community Rolling Action Plan (CoRAP) update for the years 2021, 2022, and 2023 lists 58 substances for evaluation by the member state competent authorities under the REACH substance evaluation process. CoRAP contains three newly allocated substances and 55 substances already published in the previous CoRAP update on March 18, 2020. The substances are distributed for evaluation in years 2021, 2022, and 2023 between 16 member states. In 2021, eight substances are to be evaluated by six member states. In 2022 and 2023, it is planned to evaluate 40 and 10 substances, respectively. Changes may be introduced for the substances listed for years 2022 and 2023 in the next CoRAP update in March 2022, however.

ECHA Updates List Of Mapped Substances: ECHA has updated the list of mapped substances available on its website. Since ECHA’s last update in August 2019, it has mapped an additional 1,900 REACH registered substances. Registered substances are divided into five pools based on the regulatory actions in place, initiated, or considered for them. According to ECHA, the mapping will contribute to the annual report on its Integrated Regulatory Strategy, which will be published in April 2021. ECHA’s aim is to have all registered substances screened and allocated to the pools by 2027.

EC Holds Workshop On Safe And Sustainable-By-Design Criteria For Chemicals, Materials, And Products: The EC held a safe and sustainable-by-design workshop in the framework of the Chemicals Strategy for Sustainability on March 19, 2021. The workshop was intended to inform stakeholders on the planned steps for developing the safe and sustainable-by-design criteria, to initiate a first exchange of views with all interested parties, and to obtain feedback from stakeholders on the presented steps and first developments on the safe and sustainable-by-design concept.

INDIA

India Posts Handbook On Chemicals And Hazardous Waste Management And Handling: On March 1, 2021, the Ministry of Environment, Forest and Climate Change (MOEFCC) posted a 2019 Handbook on Chemicals and Hazardous Waste Management and Handling in India. The Handbook provides a broad overview of the legislative and regulatory framework governing the chemical sector in India. The Handbook includes a detailed analysis of the following regulations on chemical and hazardous waste management:

  • The Manufacture, Storage and Import of Hazardous Chemical Rules, 1989 (as amended in 2000);
     
  • The Ozone Depleting Substances (Regulation and Control) Rules, 2000 (as amended in 2014);
     
  • The Hazardous and Other Waste (Management and Transboundary Movement) Rules, 2016 (as amended in 2019);
     
  • The E-Waste Management Rules, 2016, (as amended in 2018);
     
  • The Plastic Waste Management Rules, 2016 (as amended in 2018); and
     
  • The Batteries (Management and Handling) Rules, 2001 (as amended in 2010).
     

INTER-ORGANIZATION PROGRAM FOR THE SOUND MANAGEMENT OF CHEMICALS (IOMC)

IOMC Will Hold Webinar Series In Support Of SAICM And The Beyond 2020 Process: IOMC will hold a series of webinars on four key cross-sectoral issues and as a contribution to the on-going Beyond 2020 discussions:

The webinars are open to all interested stakeholders participating in the Strategic Approach to International Chemicals Management (SAICM)/Beyond 2020 process. According to IOMC, the aim of the webinars is to exchange information and share examples of good practices and policy options in a multi-sectoral context. Each webinar will feature presentations from lead IOMC organizations, as well as a panel discussion and interactive dialogue with participants.

LATIN AMERICA AND THE CARIBBEAN

Ministers Of Environment Of Latin America And The Caribbean Adopt Action Plan For Cooperation On Chemicals And Waste Management: The XXII Meeting of the Forum of Ministers of Environment of Latin America and the Caribbean was held February 1-2, 2021. According to the Decisions of the XXII Meeting, the Ministers agreed to adopt the Action plan for regional cooperation on chemicals and waste management 2021-2024 (Action Plan) within the framework of the Intergovernmental Network. The Action Plan includes the following priority topics and subtopics:

  • Governance and coordination mechanisms:
     
    • Strengthen capacities at national and local levels to apply and enforce legal frameworks;
       
    • Review and strengthen chemicals and waste regulatory and institutional frameworks; and
       
    • Strengthen linkages between science and policy to raise awareness of decision-makers on key aspects of chemicals and waste.
       
  • Knowledge, information, and monitoring:
     
    • Strengthen capacities in the elaboration of environmental risk assessments for chemicals and chemical products;
       
    • Disseminate methodologies to define a list of priority chemicals for control and monitoring; and
       
    • Promote collaboration and knowledge exchange among laboratories of the region and strengthen their capacities for sampling and testing priority hazardous chemicals.
       
  • Priority issues under the SAICM framework:
     
    • Promote GHS implementation, including building capacities in the public-private sector for its implementation;
       
    • Promote industrial development based on sustainable chemistry to prevent and reduce the use and generation of hazardous substances to reduce chemical risks and to find safer and sustainable alternatives;
       
    • Promote actions to eliminate exposure to lead (e.g., paints, lead-acid batteries);
       
    • Environmental sound management of plastic through their whole life cycle, including marine litter and microplastics; and
       
    • Building capacities for the prevention and effective response of chemical accidents and spills.
       
  • Basel, Rotterdam, and Stockholm Conventions: Implementation of the international conventions on chemicals and waste, building national capacities to comply with international obligations under these three conventions.
     
  • Mercury: Addressing chemicals of global concern, particularly mercury, in an integrated and coordinated manner, to reduce significantly their presence in the environment and their adverse effects on human health, as well as facilitating implementation of the Minamata Convention on Mercury.
     
  • Waste management: Integrated management of the different types of waste, at the national and the regional levels.
     

ORGANIZATION FOR ECONOMIC COOPERATION AND DEVELOPMENT (OECD)

OECD Publishes Guidance, Will Hold Webinar On Key Considerations For The Identification And Selection Of Safer Chemical Alternatives: OECD published a document entitled Guidance on Key Considerations for the Identification and Selection of Safer Chemical Alternatives. The Guidance is intended to advance a consistent understanding of the minimum requirements necessary to determine whether a chemical alternative is safer than the priority chemical, product, or technology for substitution. The Guidance focuses on minimum assessment criteria and recommended assessment practices for four core areas of alternatives assessments: determining the assessment’s scope; comparative hazard assessment; comparative exposure assessment; and the integration of hazard and exposure results to select a safer alternative. The Guidance notes that it is focused primarily on single chemical substitutions and not “functional substitution” where the alternative could include technology, product, or service changes. The Guidance states that “[a] functional substitution approach is recommended in any alternatives assessment not only to broaden the scope of possible alternatives, but also to identify safer alternatives when drop-in chemical substitutes are not significantly safer or more sustainable than the original substances of concern.” OECD will hold a webinar on the Guidance on April 12, 2021.

OECD Publishes New Chemical Legislation Indicator: OECD has published an interactive map that measures the progress countries have made in setting up management systems specifically dedicated to managing the risks of industrial and consumer chemicals. Industrial chemicals are defined as all chemicals not managed through legislation dedicated to specific uses, unlike pharmaceuticals or pesticides. The interactive map identifies legislation allowing countries to prioritize chemicals for risk management, perform a risk assessment on priority chemicals, and implement, if needed, risk reduction measures based on the outcome of the risk assessment.

OECD Publishes Guidance On Characterization, Validation, And Reporting Of PBK Models For Regulatory Purposes, Will Hold Webinar In May: OECD published guidance on the characterization, validation, and reporting of physiologically-based kinetic (PBK) models for regulatory purposes. OECD developed the guidance with the goal of increasing confidence in the use of these models parameterized with data derived from in vitro and in silico methods. According to OECD, the guidance provides insights into how the data generated by such methods can be applied to construct PBK models and how these models can be validated. OECD states that the use of scientifically valid PBK models will allow chemical assessment to rely on the use of these approaches for toxicity testing, rather than in vivo data derived from animal studies. The guidance includes case studies to illustrate the use of PBK models based on in vitro and in silico data, along with the application of the model assessment framework proposed. The EC’s Joint Research Center and the U.S. Environmental Protection Agency developed the guidance. OECD will hold a webinar on the guidance on May 10, 2021.

UNITED KINGDOM (UK)

Following Brexit, UK Establishes New Chemical Regulatory Regimes: The UK completed its withdrawal from the EU on December 31, 2020, and, as of January 1, 2021, is a “third country” from the EU perspective. Companies worldwide must be aware of the significant implications for compliance under the following newly established independent chemical regulatory regimes:

  • The Great Britain (England, Scotland, and Wales) (GB) Biocidal Products Regulation (GB BPR): According to UK Health and Safety Executive (HSE), the existing EU BPR has been copied into GB law and amended to enable it to operate effectively in GB;
     
  • The GB CLP: The classification of chemicals placed on the market in GB is regulated by the GB CLP;
     
  • The GB Prior Informed Consent (PIC) Regulation (GB PIC): GB PIC concerns the export and import of certain hazardous chemicals. Businesses exporting or importing PIC-listed chemicals from or to GB are required to comply with the new GB PIC and must notify their intention to export PIC-listed chemicals to countries outside GB by completing a PIC export notification form;
     
  • Regulation (EC) 1107/2009 concerning PPPs: All relevant EU law in relation to the regulation of PPPs has been retained in GB law and retains the same official titles, for example, Regulation (EC) 1107/2009. Northern Ireland will continue to be subject to existing EU law. The GB PPP regime makes independent decisions on active substances and maximum residue levels (MRL); and
     
  • The UK REACH Regulation: As of January 1, 2021, GB-based businesses procuring chemical substances directly from EU REACH-registered suppliers are considered importers under UK REACH. The GB-based company must obtain a UK REACH registration to continue importing from the EU REACH-registered suppliers, unless its supplier appoints a GB-based only representative (OR) to register under UK REACH on the importer’s behalf. To maintain supply chains and to ensure continued access to the GB market, GB importers must complete a notification to the HSE in the Comply with UK REACH information technology system. The substance must subsequently be registered within the applicable timeframe, which is 300 days plus two, four, or six years from the end of the transition period, depending on the tonnage and hazard profile of the imported substances. EU REACH Article 9 exemptions for substances imported or manufactured in GB for purposes of product(s) and process-oriented research and development will be grandfathered into UK REACH if basic information is provided to the HSE within 120 days (by April 30, 2021), and they will be subject to the same conditions imposed by ECHA.
     

More information, including links to additional resources, is available in The Acta Group®’s (Acta) February 9, 2021, memorandum.

UK HSE Announces March 31, 2021, And June 29, 2021, Deadlines For Businesses Under UK BPR: HSE published an HSE Biocides eBulletin on March 8, 2021, announcing upcoming deadlines for businesses under the GB BPR. As of January 1, 2021, HSE no longer has access to the EU’s information technology (IT) systems to access applications (including the data dossiers) previously submitted under those systems. Businesses must therefore resubmit applications for product authorizations and active substance approvals to HSE to be evaluated under GB BPR.

The following deadlines apply for resubmission of GB product authorizations (including renewals) and active substance approval (including renewals) to HSE:

  • March 31, 2021, for resubmission of any application where the UK was, at any time prior to January 1, 2021:
     
    • Evaluating the Union or National product authorization application (including renewal) as the reference Member State (rMS); or
       
    • The evaluating Competent Authority (eCA) for an active substance approval/renewal application.
       
  • June 29, 2021, for resubmission of any application where, prior to January 1, 2021, the UK was:
     
    • A concerned Member State (cMS) for the UK/EU product authorization application (including renewal, mutual recognition);
       
    • The rMS or cMS for the same biocidal product application (UK/EU) or any application to change an authorization; or
       
    • Not the evaluating eCA for an active substance approval/renewal application.
       

Businesses can consult HSE’s fact sheets to determine which deadline is relevant for their applications. Applicants must resubmit the full original application and any additional data gathered or generated since the original submission in IUCLID format. HSE will charge no fees for receiving and handling the resubmissions, but the regular fees will be charged for the evaluation of the resubmitted applications and data. The fee schedule is available on HSE’s website. More information is available in Acta’s March 9, 2021, memorandum, “UK HSE Announces March 31, 2021, and June 29, 2021, Deadlines for Businesses under UK BPR.”


 
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