Global Regulatory Update for October 2020


Lynn L. Bergeson To Present During The Agricultural Law Section Of IBA 2020’s Virtual Conference: The International Bar Association’s (IBA) 2020 Virtually Together conference, occurring November 2-27, 2020, provides an exciting new way to bring the IBA and the world’s legal community together. Lynn L. Bergeson, Managing Partner at Bergeson & Campbell, P.C. (B&C®), and Vice Chair of the IBA’s Agricultural Law Section, will present during, “Opting out of climate unfriendly food? Consumer action or regulatory restrictions?,” on November 5, 2020.

CDR Cross-CheckTM: As you gather your company’s information for Chemical Data Reporting (CDR), let The Acta Group (Acta®) assist with the search of the TSCA Inventory and particular TSCA actions. CDR Cross-Check is a low-cost, straightforward way to have Acta search Chemical Abstracts Service (CAS) Registry Numbers (RN) and TSCA Accession Numbers and provide the output that you need to know whether a particular TSCA action changes a reporting exemption or the reporting threshold.

You do not have to be a current Acta client, simply go to https://cdr-cross-check.actagroup.com/, follow the instructions to upload your list of CAS RNs, and pay the search fee.

You have enough to worry about in CDR reporting. Let Acta help with the database searching!
 

AUSTRALIA

SWA Publishes Resources Intended To Support Transition To GHS 7: On August 31, 2020, Safe Work Australia (SWA) announced the availability of new guidance intended to help businesses transition to the seventh edition of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS 7). Australia will begin a two-year transition to the GHS 7 on January 1, 2021. To help businesses understand the changes required under GHS 7, SWA states that it has published a dedicated GHS 7 web page and suite of information sheets. The information sheets provide details about classification and labeling requirements for workplace hazardous chemicals and the duties of manufacturers, importers, suppliers, and end users. SWA notes that it delayed the transition to GHS from July 1, 2020, to January 1, 2021, due to the impact of COVID-19 on Australian businesses. To ensure that businesses that had started to implement GHS 7 are not disadvantaged, work health and safety regulators are allowing importers and manufacturers to classify and label chemicals in accordance with GHS 7 from July 1, 2020, to January 1, 2021, ahead of the official transitional period. Suppliers and end users can also supply and use GHS 3 or GHS 7 labeled chemicals during this period.

SWA Upgrades HCIS: SWA recently updated the Hazardous Chemical Information System (HCIS) with features intended to allow users to search chemicals more easily. Key changes include:

  • When searching for a hazardous chemical by its name, search results can be sorted by “most relevant.” This is the default search setting for hazardous chemicals;
     
  • The search criteria entered can be reviewed when searching for both hazardous chemicals and workplace exposure standards. To do this, click the “Search Criteria Entered” bar at the top of the search results page; and
     
  • Several bugs affecting the hazardous chemical and exposure standard history logs have been fixed:
     
    • When a chemical’s GHS hazard categories have been changed, this will be described using the correct hazard category names instead of numerical hazard category codes; and
       
    • A bug that sometimes caused history logs to display the wrong date has also been fixed.
       

CANADA

Canada Publishes Science Assessment Of Plastic Pollution, Proposes To Add Plastic Manufactured Items To CEPA Schedule 1: On October 7, 2020, Canada published a Science Assessment of Plastic Pollution, which provides a review of the available information on plastic pollution, including its sources, occurrence, and fate, as well as on the potential effects of plastics on the environment and human health. Canada notes that the Science Assessment is not intended to quantify the risks of plastic pollution on the environment or human health, but rather to survey the existing state of science to guide future scientific and regulatory or other activities. To advance the understanding of the impacts of plastic pollution on the environment and human health, the Science Assessment recommends research in the following areas to address the key knowledge gaps identified: developing standardized methods for sampling, quantifying, characterizing, and evaluating the effects of macroplastics and microplastics; furthering the understanding of human exposure to microplastics; furthering the understanding of the ecotoxicological effects of microplastics; furthering the understanding of the effects of microplastics on human health; and expanding and developing consistent monitoring efforts to include poorly characterized environmental media such as soil. According to the Science Assessment, in accordance with the precautionary principle, action is needed to reduce macroplastics and microplastics that end up in the environment.

On October 7, 2020, Canada published a discussion paper on a proposed integrated management approach to plastic products to prevent waste and pollution. The discussion paper seeks input on a proposed integrated management approach to plastics to take a number of actions, including regulations that would be developed under the provisions of the Canadian Environmental Protection Act, 1999 (CEPA). Canada invites businesses, civil society groups, jurisdictions, Indigenous Peoples, and all Canadians to provide their perspectives, expertise, and opinions. To help focus input, Canada asks stakeholders to consider questions regarding managing single-use plastics, establishing performance standards, and ensuring end-of-life responsibility. Comments are due December 9, 2020.

Canada proposed on October 10, 2020, to add “plastic manufactured items” to the List of Toxic Substances in CEPA Schedule 1, in accordance with the precautionary principle. The notice states that plastic manufactured items “are any items made of plastic formed into a specific physical shape or design during manufacture, and have, for their intended use, a function or functions dependent in whole or in part on their shape or design. They can include final products, as well as components of products.” The proposed Order would enable the ministers to propose risk management measures under CEPA on certain plastic manufactured items in order to manage the potential ecological risks associated with those items becoming plastic pollution. Comments on the proposal are due December 9, 2020.
 

CHINA

China Tariffs: Court Of International Trade Lawsuit Challenges Section 301 Tariffs: A recent legal challenge may be of interest to some of our clients. The challenge involves a case filed in the U.S. Court of International Trade (CIT) challenging President Trump’s authority to impose supplemental tariffs on goods from China identified on Lists 3 and 4A and seeking refunds. As our clients know well, some pesticides and cleaning products are listed on List 3 and thus subject to 25% China tariffs.

There are two prongs to the argument. One prong is that the List 3 and List 4A retaliations were not related to the original purpose for which retaliation was recommended by the U.S. Trade Representative (USTR), i.e., China’s Intellectual Property Rights practices. The second prong is that these retaliations were untimely because they occurred more than 12 months after the USTR issued its report.

We believe that the challenge has merit. It would be prudent for any importer who has paid the Section 301 tariffs on List 3 or List 4A goods to file a protective action in the CIT. We offer a memorandum prepared by our long-time customs and trade counsel, Michael K. Tomenga of Neville Peterson LLP, which provides additional information.

China Publishes Draft Law On Safety Of Hazardous Chemicals: The Chinese Ministry of Emergency Management (MEM) released the “Law on Safety of Hazardous Chemicals (Draft for Consultation)” (LSHC) on October 2, 2020, to replace the “Regulations on Safe Management of Hazardous Chemicals” (Decree No. 591). The draft LSHC was first introduced in 2017. This draft revision will replace the current Decree No. 591, introducing hazardous chemical registration exemptions for research and development (R&D), test marketing, low volume, low release and low exposure, and polymers. The draft LSHC proposes several changes that will be less burdensome for industry while allowing MEM to focus on the regulation of hazardous chemicals that pose the greatest potential risks to human health and the environment. Manufacturers in China that produce low-risk hazardous chemicals using simple processes that do not involve chemical reactions will not be required to obtain business licenses, but will be eligible for a record filing with a local authority once the LSHC becomes effective. The deadline to submit comments to MEM regarding the LSHC is November 1, 2020. Comments can be submitted to MEM via e-mail (yjbzfs@163.com). More information is available in Acta’s October 16, 2020, memorandum.
 

EUROPEAN UNION (EU)

EC Begins Public Consultation On Substantiating Claims About The Environmental Performance Of Products And Businesses: The European Commission (EC) began a public consultation on August 27, 2020 on substantiating claims about the environmental performance of products and businesses. The EC notes that with more 200 environmental labels active in the EU, and more than 450 active worldwide, as well as more than 80 widely used reporting initiatives and methods for carbon emissions only, it is difficult for consumers, companies, and other market actors “to make sense of the many environmental labels and initiatives on the environmental performance of products and companies.” According to the EC, greenwashing is another issue, with companies giving a false impression of their environmental impact or benefits. The EC states that it is important that claims on the environmental performance of companies and products are reliable, comparable, and verifiable across the EU. The EC launched the public consultation to gather stakeholders’ views on an initiative on green claims. The aims of the consultation are to give all citizens and organizations the opportunity to inform policy development and to gather opinions on policy options and their potential impacts. Responses to the questionnaire are due December 3, 2020.

ECHA Holds Public Consultation On Proposals To Identify Two Substances As SVHCs: The European Chemicals Agency (ECHA) held a public comment period on two proposals to identify the following substances as substances of very high concern (SVHC):

Comments were due October 16, 2020.

SCIP Database Ready For Use: Beginning January 5, 2021, companies supplying articles containing SVHCs on the Candidate List in a concentration above 0.1% weight by weight (w/w) on the EU market must submit information on these articles to ECHA. The Substances of Concern In articles as such or in complex objects (Products) (SCIP) database is intended to ensure that the information on articles containing Candidate List substances is available throughout the whole life cycle of products and materials, including at the waste stage. The information in the database is then made available to waste operators and consumers. On October 28, 2020, ECHA announced that the SCIP database is ready for use. ECHA has posted new and updated support materials intended to help companies prepare and submit notifications. ECHA will hold a webinar on November 19, 2020, that is intended to help companies prepare and submit SCIP notifications.

EC Announces Actions Intended To Make Europe’s Raw Materials Supply More Secure And Sustainable: The EC announced on September 3, 2020, an Action Plan on Critical Raw Materials, which includes the 2020 List of Critical Raw Materials, and a foresight study on critical raw materials for strategic technologies and sectors from the 2030 and 2050 perspectives. The EC intends the Action Plan to:

  • Develop resilient value chains for EU industrial ecosystems;
     
  • Reduce dependency on primary critical raw materials through circular use of resources, sustainable products, and innovation;
     
  • Strengthen the sustainable and responsible domestic sourcing and processing of raw materials in the EU; and
     
  • Diversify supply with sustainable and responsible sourcing from third countries, strengthening rules-based open trade in raw materials and removing distortions to international trade.
     

The concrete actions intended to achieve the objectives include the establishment of the European Raw Materials Alliance, which the EC launched on September 29, 2020. According to the announcement, the Alliance will identify barriers, opportunities, and investment cases to build capacity at all stages of the raw materials value chain. In its first phase, the Alliance will focus on increasing EU resilience in the rare earths and permanent magnets value chains. Later, it will expand to address other critical and strategic raw material and base metal needs, such as Materials for Energy Storage and Conversion.

EC Holds Public Consultation on Inception Impact Assessment for “Sustainable Products Initiative”: The EC began a public consultation on September 14, 2020, on the Inception Impact Assessment (Assessment) for a directive on the “Sustainable Products Initiative” (Initiative). According to the EC, this Initiative, which will revise the Ecodesign Directive and propose additional legislative measures as appropriate, intends to make products placed on the EU market more sustainable. The EC states that consumers, the environment, and the climate will benefit from products that are more durable, reusable, repairable, recyclable, and energy-efficient. The Initiative will also address the presence of harmful chemicals in products such as electronics and information and computer technology (ICT) equipment; textiles; furniture; and steel, cement, and chemicals. Comments on the Assessment are due November 16, 2020. According to the Assessment, the EC intends to launch a public consultation in the first quarter of 2021 to gather input from citizens and stakeholders. The EC will carry out further consultations to obtain input from and discuss policy options with a wide range of stakeholders, for example, through workshops, conferences, webinars, or other means. More information is available in Acta’s September 30, 2020, memorandum.

ECHA Begins Public Consultation On Proposed OELs For Cadmium And Inorganic Cadmium Compounds: On September 14, 2020, ECHA began a public consultation on proposed occupational exposure limits (OEL) for cadmium and inorganic cadmium compounds. The scientific report recommends the current OEL of 0.001 milligram (mg) per cubic meter (1 microgram (μg)/m3) (inhalable fraction) together with a biological limit value (BLV) of 0.002 mg per gram (g) creatinine (2 μg/g creatinine) for cadmium in urine. Comments are due November 12, 2020.

EP Calls For New Measures To Address Pharmaceutical Pollution: On September 17, 2020, the European Parliament (EP) passed a resolution calling for new measures to tackle pharmaceutical pollution, which “causes long-term damage to ecosystems, reduces drug efficiency and increases resistance to antibiotics.” According to the EP’s September 17, 2020, press release, the EP calls “for more careful use of medicines, the development of greener manufacturing and better waste management in the EU.” The press release states that the EP is “particularly concerned that the endocrine-disrupting properties of many medicines end up in the environment.” Measures to reduce the pollution should not only include end-of-pipe controls (e.g., improved wastewater treatment), but should also encompass the entire life cycle of drugs, from design and production to disposal.

EFSA Sets Tolerable Intake For PFAS In Food: On September 17, 2020, the European Food Safety Authority (EFSA) announced that it set a new safety threshold for the main perfluoroalkyl substances (PFAS) that accumulate in the body. EFSA notes that the threshold -- a group tolerable weekly intake (TWI) of 4.4 nanograms per kilogram of body weight per week -- is part of a scientific opinion on the risks to human health arising from the presence of these substances in food. According to EFSA, its assessment focused on perfluorooctanoic acid (PFOA), perfluorooctane sulfonate (PFOS), perfluorononanoic acid (PFNA), and perfluorohexane sulfonic acid (PFHxS). EFSA states that “[t]oddlers and other children are the most exposed population groups,” and “exposure during pregnancy and breastfeeding is the main contributor to PFAS levels in infants.”

EC Proposes To Update Carcinogens And Mutagens Directive: The EC announced on September 22, 2020, that it intends to add new or revised occupational exposure limits for the following chemicals to the Carcinogens and Mutagens Directive:

  • Acrylonitrile (new limit);
     
  • Nickel compounds (new limit); and
     
  • Benzene (limit revised downward).
     

The EC notes that it developed the initiative in close collaboration with scientists and representatives of workers, employers, and EU member states. Social partners (trade unions and employers’ organizations) were also involved through a two-phase consultation. The EC began a public consultation on its proposal. Comments are due November 20, 2020.

SEAC Final Opinion Supports Proposal To Restrict More Than 1,000 Skin Sensitizing Chemicals Used In Clothing And Other Articles: ECHA announced on September 22, 2020, that the Committee for Socio-Economic Analysis (SEAC) adopted its final opinion on France and Sweden’s proposal to restrict skin sensitizing substances in textile, leather, synthetic leather, hide, and fur articles that are placed on the market for the first time. According to ECHA, the proposed restriction covers substances that have a harmonized classification as skin sensitizers under the Classification, Labeling, and Packaging (CLP) Regulation such as chromium VI, nickel, and cobalt compounds. It also proposes to restrict some dyes that are considered to have skin sensitizing properties but that do not have a harmonized classification. ECHA notes that the proposal introduces a link with CLP, meaning that any substance that is classified as a skin sensitizer in the future under CLP would automatically be covered by the restriction. When substances are automatically added to the restriction, SEAC recommends a transition period of three years between classification and the conditions of the restriction taking effect to allow manufacturers to adapt. More information is available in ECHA’s press release, “ECHA’s committees back restricting over 1 000 skin sensitising chemicals used in clothing and other articles.”

EC Seeks Responses To Questionnaire On Review Of Rules To Reduce Packaging Waste: The EC began a public consultation on September 30, 2020, to gather views from citizens and stakeholders on possible measures to revise the Packaging and Packaging Waste Directive. The EC states that the initiative aims to improve packaging design to facilitate its cost-effective recycling and reuse and reduce the generation of packaging waste. According to the EC, despite an overall trend toward lightweighting (reducing the overall amount of material to create packaging) across a wider range of packaging formats in the last three decades, there has been an overall increase in packaging waste generated. In addition, the EC notes, packaging design does not sufficiently consider the difficulties and costs of treatment of packaging waste (including collection and sorting). The EC states that all citizens and the wider community of stakeholders are welcome to express their views, more specifically those affected by the rules on placing on the market of packaging and packaging waste prevention and management, namely: product designers, packaging producers and fillers, wholesalers and retailers, waste collectors, sorters and recyclers, extended producer responsibility organizations, material suppliers, public authorities, and consumers. The EC also invites non-governmental organizations (NGO), academia, and think thanks working on related matters to take part. Responses to the questionnaire are due January 6, 2021.

Regulation Clarifies Deadlines To Update REACH Registration Dossiers: The EC published a regulation on October 12, 2020, that clarifies the meaning of “without undue delay” related to registration updates under REACH. The regulation includes three-, six-, nine-, and 12-month deadlines for different scenarios that may trigger the need for registrants to update their dossiers:

  • A deadline of three months applies for administrative updates, such as a change in a registrant’s status or identity;
     
  • A deadline of six, nine, or 12 months applies for more complex updates, for example, when the classification and labeling of a substance without a harmonized classification changes, or there are changes in the chemical safety report or guidance on safe use;
     
  • When there are multiple reasons for updating a registration, only one submission is required and the longest deadline applies; and
     
  • A deadline of three months applies to inform that the manufacture or import of a substance has ceased.
     

More information is available in ECHA’s October 12, 2020, press release, “Deadlines for updating registration dossiers clarified.”

ECHA Calls For Evidence On BPA And Similar Bisphenols: On October 1, 2020, Germany submitted to ECHA an intention to restrict the placing on the market and use of bisphenol A (BPA) and structurally related bisphenols of similar concern for the environment. ECHA began a call for evidence on October 14, 2020. According to ECHA, the aim is to investigate the manufacture, import, use, and placing on the market of BPA and structurally related bisphenols of similar concern for the environment, as well as the possibility for substitution, potential alternatives, and the socioeconomic impacts of substitution. ECHA states that information on the life cycle, emissions to the environment, and the use in articles and occurrence in polymers is also of interest. Comments and evidence are due January 15, 2021.

EC Adopts EU Chemicals Strategy For Sustainability: The EC announced on October 14, 2020, that it adopted the Chemicals Strategy for Sustainability. The Strategy proposes a roadmap and timeline to transform industry with the goal of attracting investment into safe and sustainable products and production methods. The Strategy states that moving to safe and sustainable-by-design chemicals, including sustainable bio-based chemicals, and investing in finding alternatives to substances of concern are both critical for human health and the environment, as well as an important precondition for reaching a clean circular economy. According to the EC’s press release, flagship initiatives include:

  • Phasing out from consumer products the most harmful substances, including endocrine disruptors, chemicals that affect the immune and respiratory systems, and persistent substances such as PFAS, unless their use is proven essential for society;
     
  • Minimizing and substituting as far as possible the presence of substances of concern in all products;
     
  • Addressing the combination effect of chemicals by taking better account of the risk that is posed to human health and the environment by daily exposure to a wide mix of chemicals from different sources; and
     
  • Ensuring that producers and consumers have access to information on chemical content and safe use by introducing information requirements in the context of the Sustainable Product Policy Initiative.
     

The Strategy envisages the EU industry as a globally competitive player in the production and use of safe and sustainable chemicals. The Strategy announces the following actions that will support industrial innovation so that safe and sustainable chemicals “become the norm on the EU market and a benchmark worldwide”:

  • Developing safe and sustainable-by-design criteria and ensuring financial support for the commercialization and uptake of safe and sustainable chemicals;
     
  • Ensuring the development and uptake of safe and sustainable-by-design substances, materials, and products through EU funding and investment instruments and public-private partnerships;
     
  • Considerably stepping up enforcement of EU rules both at the borders and in the single market;
     
  • Putting in place an EU research and innovation agenda for chemicals to fill knowledge gaps on the impact of chemicals, promote innovation, and move away from animal testing; and
     
  • Simplifying and consolidating the EU legal framework, e.g., by introducing the “one substance one assessment” process, strengthening the principles of “no data, no market,” and introducing targeted amendments to REACH and sectorial legislation.
     

The EC has posted questions and answers (Q&A) and a factsheet on the Chemicals Strategy for Sustainability. According to the Q&A, the EC and member states are working on including the identification of endocrine disruptors under CLP, and in a second step, in GHS. The EC states that in parallel, it is also working on modifying the REACH annexes to allow the identification of substances as endocrine disruptors.

EC Begins Public Consultation On REACH Information Requirements: The EC began a public consultation on October 19, 2020, on a draft regulation that would amend certain aspects of REACH. According to the EC, the purpose is to clarify unclear or inconsistent wording and to update data requirements so that endocrine disruptors, which can have harmful effects on the body’s endocrine (hormone) system, can be more easily identified and assessed. Comments are due November 16, 2020.

Mandatory Naming Of Nanoforms For REACH Registration Will Begin November 2, 2020: Beginning November 2, 2020, following the next release of the International Uniform Chemical Information Database (IUCLID), companies will be required to provide a name for the nanoforms or sets of nanoforms of their substance when registering nanomaterials under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. According to an item in ECHA’s September 30, 2020, weekly news, companies that have already registered their nanoforms do not need to take any immediate action, but will be required to provide a name in the next update of their registration dossier.

Brexit Transition Period Will End December 31, 2020: The transition period for the UK’s withdrawal from the EU will end on December 31, 2020. ECHA recommends that companies check if they are affected by the withdrawal and states that UK-based registrations and authorizations should be transferred to an EU member state before the end of the transition period. Until then, EU laws including regulations managed by ECHA, still apply to the UK. Downstream users in the EU/European Economic Area (EEA) should check the list of substances registered only by UK companies to see if they will be affected and need to take action before the end of the transition period. ECHA has created a web page on “How will the UK withdrawal affect you?,” as well as Q&As for companies.
 

THAILAND

Thailand Joins OECD MAD Agreement: OECD announced on September 7, 2020, that Thailand has joined the OECD Mutual Acceptance of Data (MAD) system, “ensuring that its non-clinical safety data related to the protection of human health and the environment will be accepted by all 44 countries adhering to MAD.” OECD states that participation in the MAD system requires that testing be carried out using OECD standards for test methods and data quality. Governments verify laboratory compliance using OECD procedures. At present, all 37 OECD countries, as well as Argentina, Brazil, India, Malaysia, Singapore, South Africa, and Thailand, adhere to the system.
 

TURKEY

MoEU Holds Webinar On KKDIK: In September 2020, the Ministry of Environment and Urbanization’s (MoEU) Chemicals Management Department held a webinar on Registration (Kaydı), Evaluation (Değerlendirilmesi), Authorization (İzni) and Restriction (Kısıtlanması) of Chemicals (Kimyasalların) (Turkey REACH/KKDIK). During the webinar, the Department provided information on the upcoming registration process, permit and restriction applications, and the Chemical Registration System; they also answered questions from industry. Presentations on KKDIK and on the Chemical Registration System, Chemical Assessment Specialist, and planned studies are available online, in Turkish.
 

UNITED KINGDOM (UK)

DEFRA Guidance On How To Comply With EU REACH Includes Tonnage Band Deadlines: The transition period for the UK’s exit from the EU will end on December 31, 2020. At the end of the transition period, EU REACH will be brought into UK law under the European Union (Withdrawal) Act 2018 as amended by the European Union (Withdrawal) Agreement 2020. The UK intends to replicate EU REACH, and related legislation, with the necessary changes to make it operable in context. The independent chemical regulatory framework that will operate in the UK from January 1, 2021, will be known as UK REACH. On September 1, 2020, the Department for Environment, Food and Rural Affairs (DEFRA) published guidance for UK companies on how to comply with EU REACH when using, making, selling, or importing chemicals in the EU, and how to prepare for January 1, 2021. According to the guidance, the key principles of EU REACH will be retained. Under UK REACH, deadlines for the full submission of data to underpin registration dossiers will be staggered over a period of six years. These deadlines begin October 28, 2021, the end of the Downstream User Import Notification (DUIN) submission period. The guidance states that these bands have been set to ensure those chemicals manufactured or imported at high tonnage, and those substances with particularly hazardous properties, are registered first. The tonnage bands are:

Deadline Post October 28, 2021

Tonnage

Hazardous Property

Two years from October 28, 2021

1,000 tonnes or more per year

CMRs -- One tonne or more per year

Very toxic to aquatic organisms (acute or chronic) -- 100 tonnes or more per year

Candidate list substances (as of December 31, 2020)

Four years from October 28, 2021

100 tonnes or more per year

Candidate list substances (as of October 27, 2023)

Six years from October 28, 2021

One tonne or more per year

 

The guidance notes that as the UK will be operating an independent regulatory system, UK downstream users will no longer be able to rely on EU REACH authorization decisions addressed to companies in the EU/EEA starting January 1, 2021. All existing authorizations that have gone through the full authorization process (and have a review date) will be recognized by UK REACH. The guidance states that this means that chemicals can continue to be used by UK companies that rely on these authorizations. New authorization applications, and authorizations waiting for EU/ECHA approval, must be submitted to UK REACH.

OPSS Seeks Experts To Advise On Chemical Matters: The Office for Product Safety and Standards (OPSS) announced on October 8, 2020, that it seeks experts to apply to join the register of pre-approved experts from whom OPSS can commission short pieces of ad hoc scientific work to support its work in protecting the public. OPSS states that the experts will be selected based on their experience and ability to provide scientific evidence, analysis, or advice across OPSS’s remit in:

  • Chemical and toxicological risk assessment for cosmetic products, toys, childcare articles, and textile fibers (naming, labeling, and marking of textiles);
     
  • Ad hoc chemical advice on product safety issues that may impact human health;
     
  • Chemical research support that may include question design, proposal appraisal, rapid evidence reviews, report evaluation/peer review, quality assurance, and risk analysis; and
     
  • Guidance and technical support on the development and validation of analytical test methods for the determination of chemicals in consumer products.
     

UK REACH Statutory Instrument Laid Before Parliament: The UK Health and Safety Executive (HSE) announced on October 21, 2020, that The REACH etc. (Amendment etc.) (EU Exit) Regulations 2020 Statutory Instrument (SI) was laid before Parliament on October 19, 2020. HSE states that the SI will:

  • Help to ensure the UK meets its obligations under the Protocol on Ireland/Northern Ireland and provide for access by Northern Irish goods to the Great Britain (GB) market;
     
  • Extend transitional provisions for importers of substances from EU-based registrants by a further 120 days. These importers now have 300 days from January 1, 2021, to provide UK authorities with some initial information as part of a DUIN; and
     
  • Introduce a new phased approach to UK REACH data submission. Companies will now have two, four, or six years beginning after those 300 days for full registrations to be completed. These deadlines are dependent on tonnage bands and hazard profile, with the highest tonnage and most hazardous chemicals first.
     

Parliament will now consider the SI, with the intention that it will come into force at the end of the transition period on December 31, 2020. More information is available in Acta’s October 26, 2020, memorandum.

HSE Publishes Updated Pesticide Guidance, Pesticides (Amendment) (EU Exit) Regulations 2020: HSE has published updated guidance on regulating pesticides after the transition period ends on December 31, 2020. HSE states that beginning January 1, 2021, in GB (England, Scotland, and Wales) a new independent pesticides regulatory regime will operate. According to HSE, GB “will take responsibility for our own decisions using our own rules.” HSE notes that GB will have no formal role in EU decision-making processes, and new decisions made under the EU regime will not apply in GB. This includes active substance and maximum residue level (MRL) decisions and any new EU Plant Protection Product (PPP) legislation. HSE will remain the national regulator for the whole of the UK, on behalf of the UK government and the devolved administrations.

HSE announced on October 23, 2020, that the Pesticides (Amendment) (EU Exit) Regulations 2020 has been published to legislation.gov.uk. HSE notes that this SI is the latest in a series of pesticides EU Exit SI. According to HSE, the main SIs to ensure that the regulatory regime can continue to operate effectively in the UK are already in place. This SI instrument makes amendments to the retained direct EU legislation that forms the PPP and MRL regulatory regimes. It is due to come into force by January 1, 2021. HSE states that there will be a final PPP EU Exit Statutory Instrument in 2021 to address new EU regulations that come into force during the second half of 2020 and therefore too late to be addressed in the earlier EU Exit SIs.
 

VIETNAM

Companies Have Until April 15, 2021, To Propose Chemicals For Addition To Draft National Chemical Inventory: On October 16, 2020, Vietnam published a notice announcing that companies have until April 15, 2021, to propose chemicals that have been produced, used, or imported into Vietnam to be added to the Draft National Chemical Inventory. Submissions should include the chemical name, Chemical Abstracts Service Registry Number (CAS RN), safety data sheet (SDS), and documents proving that the chemical has been used in Vietnam (customs declaration, sales contract, or invoices).


 
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