Global Regulatory Update for August 2020


B&C To Present At PSX Virtual Conference September 15-17, 2020: PSX 2020, presented by the Product Stewardship Society (PSS), is designed to support professional growth by providing education relevant to current, emerging, and future issues in product stewardship. This year’s virtual event will feature comments from Lynn L. Bergeson, President, PSS, and Chair, Board of Directors, and Managing Partner, Bergeson & Campbell, P.C. (B&C®). B&C professionals Karin F. Baron, MSPH, Senior Regulatory Consultant, and Richard E. Engler, Ph.D., Director of Chemistry, will present “Evaluating New Chemicals and Disconnects in Hazard Communication.” Register now!

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AUSTRALIA

As AICIS Takes Effect, Australia Publishes Extra Guidance Documents: The Australian Industrial Chemicals Introduction Scheme (AICIS) took effect on July 1, 2020. Under AICIS, companies that import or manufacture (including introduce) industrial chemicals, or products that release industrial chemicals, into Australia for commercial purposes should first check whether the industrial chemical is listed on the Inventory. If the chemical is on the Inventory and the introduction meets the terms of Inventory listing, the introduction is automatically categorized as a “listed” introduction. If the chemical is not listed, it must be categorized into one of four categories: exempted introduction; reported introduction; assessed introduction; or commercial evaluation. Australia has published the following additional guidance documents for certain industrial chemicals or products that release industrial chemicals:

AICIS Registration Renewal Deadline Is August 31: Businesses that were registered under the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) were automatically registered with AICIS on July 1, 2020, with the same registration ID. These registrations will expire on August 31, 2020. All businesses (including sole traders and individuals) who introduce (import or manufacture) industrial chemicals, or certain products that release industrial chemicals, for commercial purposes that will continue introducing industrial chemicals after August 31, 2020, must renew their registrations online through AICIS Business Services by September 1, 2020.

BRAZIL

Brazil Extends Compliance Deadline For Plastic Food Contact Materials (FCM): On May 26, 2020, the Brazilian Health Regulatory Agency (ANVISA) published Resolution RDC No. 391, amending RDC No. 326, which was published on December 3, 2019. RDC No. 326 establishes a positive list of additives intended for use in plastic materials and polymeric coatings in contact with food. Because of the COVID-19 pandemic, ANVISA is extending the compliance deadline from June 4, 2020, to June 3, 2021.

CANADA

HC Posts Summary Of Comments Submitted On Integrated Strategy To Protect Canadians From Exposure To Chemicals: Health Canada (HC) has posted a summary of the comments it received on its integrated strategy for the protection of Canadian workers from exposure to chemicals. According to HC, many stakeholders welcomed its proposed efforts to enhance the protection of Canadian workers from exposure to chemicals through expanded activities and partnerships with other federal programs and Provincial and Territorial governments. HC was encouraged to:

  • Share a gap analysis that clearly articulates the issue(s) to address;
     
  • Conduct cost-benefit and impact analyses of the proposed actions;
     
  • Collaborate with federal, provincial, and territorial governments;
     
  • Leverage existing processes and experience (for example, national and international work, existing committees, and existing processes for prioritization); and
     
  • Involve all stakeholder groups, including other government departments, industry, workers, occupational health and safety professionals, and academia.
     

According to the summary, HC “will continue to consult and inform stakeholders as progress is made in determining the Government’s role in the possible development of an integrated strategy to protect Canadian workers from chemicals.”

CHINA

China Publishes Draft Guidance For Environmental Management Registration Of New Chemical Substances: The Chinese Ministry of Ecology and Environment (MEE), formerly the Ministry of Environmental Protection (MEP), issued the “Measures on the Environmental Management of New Chemical Substances” (MEE Order No. 12) on April 29, 2020, which will replace the current MEP Order No. 7 on January 1, 2021. To implement MEE Order No. 12, the MEE released the “Guidance for Environmental Management Registration of New Chemical Substances (Draft for Consultation)” (Draft Guidance) on August 17, 2020, to replace the current “Guidance for New Chemical Substances Notification and Registration” in effect under MEP Order No. 7 since October 15, 2010. As reported in our May 8, 2020, memorandum, “China Publishes Long-Awaited Revised MEP Order No. 7,” MEE Order No. 12 introduced some concepts similar to those under the U.S. TSCA and put emphasis on the management of new chemical substances with persistent (P), bioaccumulative (B), and toxic (T) potential. The Draft Guidance provides some details about the new chemical substance notification and registration under MEE Order No. 12. The deadline to submit comments to MEE regarding the Draft Guidance is September 6, 2020. More information is available in our August 20, 2020, memorandum.

COLOMBIA

Colombia Publishes Draft Decree Establishing Inventory Of Existing Industrial Chemicals: Colombia has published a July 13, 2020, draft decree on sound chemicals management that would establish an inventory of existing industrial chemicals. Under the draft decree, companies would be required to report basic information on all substances imported or produced in Colombia in quantities greater than 100 kilograms (kg) per year. The required information would also include the hazard classification according to the sixth edition of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Once an inventory is established, there would be a prioritization and registration stage, during which more detailed information would be collected on high-priority chemicals. The draft decree includes a one-year implementation period.

EUROPEAN UNION (EU)

European Focus On PMT And vPvM Substances Increases: On May 9, 2020, the European Commission (EC) began a public consultation on a roadmap for “Chemicals Strategy for Sustainability.” The roadmap states that the regulatory framework on chemicals needs to be strengthened to increase further the level of protection of human health and the environment -- in particular from exposure to endocrine disruptors; combinations of chemicals; hazardous chemicals in products, including in imports; and very persistent chemicals. The regulatory framework also needs “to rapidly reflect scientific evidence on the risk posed by endocrine disruptors, hazardous chemicals in products including imports, combination effects of different chemicals and very persistent chemicals.” Comments were due June 20, 2020, and the EC is working to adopt a communication on the “Chemicals Strategy for Sustainability” in the third quarter of 2020.

The European Chemicals Agency (ECHA) notes on its website that the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation pays specific attention to the management of persistent, bioaccumulative, and toxic (PBT) and very persistent and very bioaccumulative (vPvB) substances. According to ECHA, one aim of REACH is the substitution of PBT and vPvB substances where suitable technically and economically viable alternatives are available. REACH does not address persistent, mobile, and toxic (PMT) and very persistent and very mobile (vPvM) substances, however. To address this, in 2019 the German Federal Environment Agency (UBA) submitted to the EC a document on the criteria for identifying PMT and vPvM substances under REACH. The EC’s “Chemicals Strategy for Sustainability” communication could address the issue of PMT/vPvM substances by designating them as substances of very high concern (SVHC) under REACH. Even if the forthcoming communication does not address PMT/vPvM substances, companies should continue to monitor activity in the EU to regulate them. More information is available in Acta’s July 20, 2020, memorandum.

EC Publishes Notice Regarding Withdrawal Of UK And EU Rules In Field Of Biocidal Products: The EC published a June 17, 2020, notice to stakeholders regarding withdrawal of the United Kingdom (UK) and EU rules in the field of biocidal products. To address the consequences in the notice, the EC advises that:

  • UK-based suppliers included in the list established under Article 95 of Regulation (EU) No 528/2012 should appoint a representative established within the EU and communicate this to ECHA in due time, so that the information on the Article 95 list is updated before the end of the transition period;
     
  • Suppliers included in the Article 95 list and located in third countries with a representative in the UK should appoint a new representative established within the EU and communicate this to ECHA in due time, so that the information on the Article 95 list is updated before the end of the transition period; and
     
  • UK-based holders of authorizations should transfer the authorization to a new holder established within an EU Member State. UK-based authorization holders can trigger the amendment of their existing authorizations by means of an administrative change requiring prior notification before implementation. Such a change has to be submitted sufficiently in time before the end of the transition period.
     

Four Substances Added To Candidate List Of SVHCs: On June 25, 2020, ECHA announced that four chemicals were added to the Candidate List of SVHCs. One is an endocrine-disrupting substance used in consumer products, such as cosmetics. The three others are used in industrial processes to produce polymers, coating products, and plastics. The substances are:

Substance Name Reason for Inclusion Examples of Use(s)
1-Vinylimidazole Toxic for reproduction (Article 57 (c)) In formulations and as a monomer in the production of polymers
2-Methylimidazole Toxic for reproduction (Article 57 (c)) As a catalyst in the production of coating products
Dibutylbis(pentane-2,4-dionato-O,O')tin Toxic for reproduction (Article 57 (c)) As a catalyst and as an additive in the production of plastics
Butyl 4-hydroxybenzoate (Butylparaben) Endocrine-disrupting properties -- human health (Article 57(f) -- human health) Cosmetics, personal care products, and pharmaceuticals

ECHA urges companies to check their legal obligations relating to the safe use of their substances. Starting January 2021, companies will also have to notify products containing SVHCs to ECHA’s upcoming Substances of Concern In articles as such or in complex objects (Products) (SCIP) database on substances of concern in articles and products. The database aims to ensure transparent information on articles containing hazardous chemicals throughout their whole life cycle.

EC Amends REACH Annex II To Include SDS Requirements For Nanoforms: On June 26, 2020, the EC published a regulation in the Official Journal of the European Union that amends REACH Annex II. Annex II describes the requirements for compiling safety data sheets (SDS). The EC notes that specific requirements for nanoforms of substances took effect on January 1, 2020, and that information related to those requirements is to be provided in SDSs. The Annex II amendments include provisions regarding nanoforms. Other Annex II amendments include aligning the SDS requirements with the sixth and seventh editions of the GHS. The Annex II amendments will apply beginning January 1, 2021. SDSs not complying with the amended Annex II requirements may be used until December 31, 2022. More information is available in our July 1, 2020, blog item.

EU Inspectors Will Check Consumer Products For Hazardous Substances: ECHA announced on July 1, 2020, that under the REF-10, the Enforcement Forum’s major enforcement project planned for 2022, inspectors will check that the products comply with restrictions for selected hazardous substances under REACH. The inspectors will also check whether products comply with restrictions for the presence of persistent organic pollutants (POP). According to ECHA, specific substances to be covered by these checks will be decided in 2021 and could potentially include substances such as phthalates or perfluorooctane sulfonate (PFOS). Inspectors will also check REACH duties for substances in articles requiring that information on SVHCs in products is being communicated in the supply chain. This enforcement project will be prepared in 2021, with inspections conducted in 2022, and the report expected at the end of 2023. The Forum also set timelines for the pilot project on the classification of mixtures, which will focus on classification of detergents and cleaning products. The preparation for this project will start at the end of 2020, with inspections taking place in 2021 and 2022, and the report expected in 2023.

The Forum’s Biocidal Products Regulation Subgroup (BPRS) re-assessed Member States’ ongoing enforcement activities to address non-compliant (hand) disinfectants, which have appeared on the market during the ongoing COVID-19 pandemic. According to the press release, BPRS concluded that “current intensified enforcement actions at the national level are sufficient to address these cases.” BPRS also agreed to work with the EC to address any questions related to the borderline between the Biocidal Products Regulation (BPR) and the Cosmetics Regulation.

ECHA Reports Examine Direct And Indirect Effects Of REACH In Driving Replacement Of Harmful Chemicals: ECHA announced on July 8, 2020, publication of two reports that examine the direct and indirect effects of REACH in driving substitution. According to ECHA, based on a survey of industry associations and more than 80 companies, many of which were affected by authorization or restriction, around 19 percent indicated that restriction is their main reason for replacing hazardous chemicals with safer alternatives. Adding a substance to the Candidate List or Authorization List were the next most significant triggers for companies, with authorization selected by 15 percent of the companies responding. ECHA states that some companies have reportedly substituted when a regulatory management option analysis was still under development, and especially when the assessing Member State had, following the outcome of the analysis, proposed a further regulatory risk management activity, such as identification of SVHCs. ECHA notes that aside from regulation, companies also highlighted demands from their customers, enhancing their public image, and adopting their own corporate sustainability policies as their main drivers to substitute hazardous substances with safer alternatives.

EP Calls On EC To “Step Up” Action Against Dangerous Chemicals: As reported in our June 19, 2020, Global Regulatory Update, on May 9, 2020, the EC began a public consultation on a roadmap for “Chemicals Strategy for Sustainability.” On July 10, 2020, the European Parliament (EP) issued a press release announcing that it adopted a resolution calling on the EC to “step up” action against dangerous chemicals. According to the EP, the Chemicals Strategy “must fully reflect the precautionary principle and the polluter-pays principle, and ensure more transparent approval processes. It should also stimulate competition for developing safe and sustainable alternatives, e.g. by committing to securing funds for research.” The press release states that the EP believes in the “one substance -- one hazard assessment” principle: substances should be reviewed by only one EU agency to speed up the process and make chemicals regulation more consistent. The resolution calls for a comprehensive framework on endocrine disruptors to minimize the extent to which humans and the environment are exposed to endocrine disruptors. The resolution states that specific provisions on toys, food contact materials, and cosmetics should be inserted into legislation to treat endocrine disruptors in the same way as substances that are carcinogenic, mutagenic, and reprotoxic (CMR). The resolution also calls on the EC to heed the various calls of the EP to improve the EU’s authorization procedure for pesticides and accelerate the transition towards low-risk pesticides. The EP calls on the EC to develop EU criteria for sustainable chemicals to provide incentives for sustainable chemistry, materials, and technologies, especially non-chemical alternatives that are safe.

ECHA Publishes Results Of Survey On OSH-REACH Enforcement Interactions: ECHA has published the results from an Enforcement Forum survey on how national occupational safety and health (OSH) and REACH enforcement inspectors across 31 EU and European Economic Area (EEA) countries interact with each other. The survey examined the distribution of responsibilities and cooperation between inspectors to check compliance under their respective pieces of legislation. The report states that the findings from the survey show that there are many positive interactions between REACH and OSH inspectors already in existence, and there are established methods of cooperation in place, which allow both inspectorates to address safe use. According to the report, there are still some improvements to be made in certain areas such as increasing knowledge on derived no exposure limits (DNEL)/derived minimal effect levels (DMEL) and exposure scenario checks. There report states that there is also scope for more engagement between REACH and OSH inspectors in checking compliance requirements under authorization. The report notes that further developments, as outlined in the recommendations section, should help further strengthen interactions and collaboration between both inspectorates.

ECHA Board Of Appeal Publishes Decisions On Data And Cost-Sharing: On July 28, 2020, ECHA announced that the Board of Appeal published two decisions, covering nine appeals (A-013-2018 and Joined Cases A-014 to A-021-2018), concerning data and cost-sharing. According to ECHA, the nine appeals were filed by a potential registrant of nine substances. The appellant had applied to ECHA for permission to refer to vertebrate animal studies from registrations of the substances. ECHA states that it refused permission to refer on the grounds that the appellant’s behavior during the data and cost-sharing negotiations “did not show a real intention to find an agreement.” The appellant argued before the Board of Appeal that ECHA should have granted it permission to refer because the previous registrants for the nine substances proposed terms for data and cost-sharing that it claimed were not fair, transparent, and non-discriminatory. The Board of Appeal held that the previous registrants had failed to comply with the requirements of transparency (the itemization of data and costs) and the requirement for the terms to be non-discriminatory (the exemption of registrants’ affiliates from paying for data). The Board of Appeal therefore annulled ECHA’s nine decisions and granted the appellant permission to refer to the requested vertebrate animal studies.

ECHA Publishes Training Videos On Analysis Of Alternatives: ECHA announced in July 2020 that given the increasing interest in its online training on analysis of alternatives, it has posted the training videos for “easy and continuous access.” The training includes tools, guidance, and information for practitioners of analysis of alternatives. It consists of an introduction and five sessions: scoping an assessment; identifying and screening alternatives; hazard and exposure; cost and technical performance; and making and implementing decisions.

EC Publishes 15th ATP To The CLP: On August 11, 2020, the EC published the 15th adaptation to technical progress (ATP) to the Classification, Labeling and Packaging (CLP) Regulation. It amends CLP Annex VI, adding 37 new entries, revising 21 entries, and deleting two entries. The updated harmonized classifications will apply beginning March 1, 2022, to allow suppliers to adapt the labeling and packaging of substances and mixtures to the new or revised classifications and to sell existing stocks.

ECHA Begins Consultation On Applications For Authorization: ECHA has begun a public consultation on six applications for authorization covering 11 uses of:

  • Chromium trioxide used in etching as a pre-treatment step in the electroplating processes of plastic substrates; in functional chrome plating of different types of substrates (including functional chrome plating for decorative purposes); and as a coloring and hardening agent for stainless steel plates; and
     
  • Bis(2-methoxyethyl) ether (Diglyme) used as a carrier solvent in the formulation and subsequent application of sodium naphthalide etchant for fluoropolymer surface modification.
     

More information is available on ECHA’s website. Comments are due October 7, 2020.

ORGANIZATION FOR ECONOMIC COOPERATION AND DEVELOPMENT (OECD)

OECD Will Hold Green Talks LIVE Webinar On eChemPortal: On September 16, 2020, OECD will hold a webinar on “Green Talks LIVE -- eChemPortal: the Global Portal to Information on Chemical Substances.” OECD states that to meet public health and environmental objectives for the safe use of chemicals under proper conditions, increasing understanding of chemical hazards and risks is key. Increasing access to data and information allows governments and industry to work to reduce or eliminate adverse health effects from exposures to chemicals. The OECD eChemPortal provides direct access to scientific information on chemical substances of regulatory relevance with over 800,000 substance records from more than 34 databases. According to OECD, the portal allows countries and companies to share work, ensure resource efficiencies, and, subsequently, reduce animal testing. Gerlinde Knetch (Germany) and Jake Sanderson (Canada) will share their experience in improving chemical safety and how the eChemPortal supported this process.

PERU

Peru Begins Public Comment Period On Draft Regulation On Hazardous Chemical Products: Peru has begun a 90-day comment period on a new draft regulation on hazardous chemical products. The draft regulation would establish registration requirements for disinfectants, cleaners, and pesticides used in industrial or domestic settings. It would not address agricultural pesticides. The draft regulation also sets out import requirements under the Rotterdam Convention, lists of prohibited substances, and requirements for labeling and packaging.

SOUTH KOREA

South Korea Notifies WTO Of Draft Amendments To K-BPR Enforcement Decree And Rules: On July 31, 2020, the Ministry of Commerce, Industry, and Energy notified the World Trade Organization (WTO) of draft partial amendments to the enforcement decree and enforcement rules of the Consumer Chemical Products and Biocides Safety Act (K-BPR). According to the notification, the enforcement decree would be amended to add substances and products exempted from compliance check, notification, or approval; methods to apply for notification and approval changes in an already-notified or approved consumer chemical product subject to safety check; more elements of similarity criteria that are applied to imported treated articles; reasons to allow repeated vertebrate tests; the minimum period of work experience required for technicians of testing institutes to be designated; work that can be done by a representative assigned by overseas manufacturer; and information that the representative must provide importers. The notification states that the enforcement rules would be amended to provide the procedure to confirm whether a substance or product is exempt from compliance check, notification, or approval; changes to be notified or approved regarding an already-notified or approved consumer chemical product subject to safety check and relevant application forms; information on consumer chemical products subject to safety check that must be disclosed to the public; the joint submission procedure for approval and relevant data requirements; a method to allow temporary exemption from approval at a time of emergency; a ban on packaging and advertising claims different from those notified to or approved by the competent authorities; the qualification of a representative to be assigned by overseas manufacturer, and a procedure for notifying the competent authorities of the assignment or dismissal. The proposed date of adoption is November 1, 2020, and the proposed date of entry into force is January 1, 2021.

THAILAND

Thailand Launches Final Inventory Of Existing Chemicals: The Department of Industrial Works (DIW) has launched an inventory of existing chemicals. The inventory, which includes over 11,000 chemicals that are manufactured, processed, or imported in Thailand, can be searched by chemical name, molecular formula, hazardous substance category, chemical type, and CAS RN. As reported in Acta’s August 26, 2016, Global Regulatory Update, in summer 2016, DIW published a preliminary inventory of existing chemicals created by combining Thailand’s hazardous substance list; the most recent hazardous chemical notification list; chemicals listed in DIW's consultation database; and the national single window list from the Customs Department.

UNITED NATIONS (UN)

UNEP Announces Global Industry Standard On Tailings Management: The UN Environment Program (UNEP) announced on August 5, 2020, the launch of a Global Industry Standard on Tailings Management (the Standard), establishing “the first global standard on tailings management that can be applied to existing and future tailings facilities, wherever they are and whoever operates them.” The Standard covers the entire tailings facility lifecycle, from site selection, design, and construction, through management and monitoring, to closure and post-closure. UNEP states that the Standard “significantly raises the bar for the industry to achieve strong social, environmental and technical outcomes.” The Standard elevates accountability to the “highest organisational levels,” adds new requirements for independent oversight, and establishes clear expectations around global transparency and disclosure requirements.

The Standard was developed through the Global Tailings Review (GTR), an independent process co-convened in March 2019 by UNEP, the Principles for Responsible Investment (PRI), and the International Council on Mining and Metals (ICMM). The co-conveners have each endorsed it and call for its broad and effective implementation across the industry:

  • UNEP will support governments that wish to incorporate and build upon this Standard into their national or state legislation and policies;
     
  • PRI, representing $103.4 trillion (USD) in assets under management, will be developing investor expectations to support all mining companies in implementing the Standard; and
     
  • ICMM member companies will implement the Standard as a commitment of membership, which includes robust site-level validation and third-party assessments.
     

 
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