Acta Group Launches CDR Cross-Check™ To Assist Companies In Identifying Chemical Data Reporting Requirements: The Acta Group (Acta®) announced on April 1, 2020, the launch of CDR Cross-Check™, an ingenious yet simple tool developed and offered by Acta to assist companies in preparing for the 2020 Chemical Data Reporting (CDR) required by the U.S. Environmental Protection Agency (EPA). CDR Cross-Check utilizes the most recent CDR listing information publicly available provided by EPA (currently, 2016 lists) to identify whether all or some of a company’s inventory of chemical substances are subject to CDR under the Toxic Substances Control Act (TSCA) and, if so, at what reporting threshold. CDR Cross-Check will make CDR reporting easier. Visit the CDR Cross-Check website, https://cdr-cross-check.actagroup.com/, for more information and to order a CDR Cross-Check report.
Navigating The Jurisdictional Tightrope Between Biopesticides, Biostimulants, And Related Emerging Technologies, April 29, 2020, 12:00 pm (EDT), Via Webinar: Register for the American Bar Association (ABA) webinar “Navigating the Jurisdictional Tightrope Between Biopesticides, Biostimulants, and Related Emerging Technologies” with Bergeson & Campbell, P.C. (B&C®) professionals deconstructing the jurisdictional boundaries distinguishing pesticides, biopesticides, plant regulators, biostimulants, and related technologies. The webinar will focus on draft EPA guidance intended to clarify the lines between and among those products that are subject to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration as plant regulators and those biostimulant products not subject to FIFRA registration. The webinar also will focus on new and evolving chemistry and technology issues that may blur some jurisdictional lines or potentially move products from one category to another. Lynn L. Bergeson, Managing Partner, B&C; Lisa R. Burchi, Of Counsel, B&C; and Sheryl Lindros Dolan, Senior Regulatory Consultant, B&C, will present.
Law, Climate Change, And Agriculture: Legal Tools In The Arsenal, April 22, 2020, 12:00 p.m. (EDT), Via Webinar: Register for the International Bar Association (IBA) webinar “Law, Climate Change, and Agriculture: Legal Tools in the Arsenal,” covering the role of innovative agriculture practices in combating climate change and highlighting the legal, policy, and institutional changes that will encourage innovation. Lynn L. Bergeson, President, Acta, is Vice Chair of the Agricultural Law Section of IBA.
Christopher R. Blunck, Former Special Assistant To The Director Of EPA’s Office Of Pollution Prevention And Toxics (OPPT), Joins B&C And Acta: B&C and Acta are pleased to announce that Christopher R. Blunck has joined our firms as Of Counsel with B&C and Senior Regulatory Specialist with Acta. Over his 30-year career at EPA, Mr. Blunck managed or participated in the development of hundreds of TSCA and Toxics Release Inventory (TRI) Program regulations, guidance documents, and policy papers, and his decades of involvement in the regulatory development process at EPA are an invaluable asset to clients seeking to anticipate, address, and resolve regulatory compliance matters.
SWA Pauses WES Review: In March 2020, Safe Work Australia (SWA) paused the release and public consultation for the workplace exposure standards (WES) review until further notice. During this period of pause, stakeholders can continue to submit comments for all current and previous releases via SWA’s dedicated inbox, [email protected]. SWA asks that stakeholders indicate the chemical(s) for which they are providing feedback. SWA states that it will communicate information about the revised time frames for completing the WES review as soon as possible.
NICNAS Posts List Of Chemicals With High Hazards For Categorization: Under the Australian Industrial Chemicals Introduction Scheme (AICIS), part of the categorization process involves working out the hazards to human health and the environment associated with a chemical’s introduction. To help companies with this process, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) has compiled a list of chemicals that are in the highest hazard bands for human health and the environment. If a chemical, its ester, or its salt is on the list, it is in the highest hazard band for the purposes of categorization (hazard band C for human health, hazard bands D or C for environment). If a company thinks that its chemical should not be in the highest hazard band, it will need to submit data to dispute the hazard identified in the high hazards list when it submits its pre-introduction report or exempted declaration. If a chemical, its ester, or its salt is not on the list, NICNAS notes that it could still be highly hazardous and that companies will need to determine its hazard in other ways. This process can include checking if there are hazard data already available for the chemical; whether the chemical has structural considerations that indicate its hazards; and if there is a similar chemical to use to fill gaps in hazard data.
NICNAS Will Post AICIS Educational Videos: NICNAS announced on March 29, 2020, that due to COVID-19, it has canceled all AICIS information sessions. NICNAS is “busily working” on a series of educational videos on key topics. NICNAS has posted videos on NICNAS to AICIS; NICNAS to AICIS — Transitions; AICIS Implementation: The Inventory; AICIS Implementation: Confidential Business Information (CBI); AICIS Evaluations; Overview of Categorization: What is your introduction category?; Step-by-Step Categorization: Steps 1-3; and Step-by-Step Categorization: Steps 4-6. NICNAS will post videos on assessed introductions; reporting and recordkeeping; compliance monitoring and enforcement; and use of animal test data.
Health Canada Publishes Summary Overview For The Application Of Human Factors To Consumer Products: On March 9, 2020, Health Canada announced the availability of a summary overview of a guidance document on Application of Human Factors to Consumer Products. According to the summary overview, the U.S. Consumer Product Safety Commission (CPSC) staff and Health Canada’s Consumer and Hazardous Products Safety Directorate developed the guidance document to help consumer product manufacturers integrate human factor principles into their product development process. According to the summary overview, many product-related injuries can be prevented by better design. The summary overview states that providing the consumer product industry with suggestions on how to apply human factor principles to their products can help lower the number of product-related adverse incidents and reduce costly compliance and enforcement actions. The guidance document is not a rule or regulation, and it is not meant to create legally enforceable responsibilities. A copy of the complete guidance document can be obtained by e-mailing [email protected].
Canada Extends Comment Period On Draft Science Assessment Of Plastic Pollution: As reported in our March 5, 2020, Global Regulatory Update, Canada published a Canada Gazette notice on February 1, 2020, announcing the availability of a draft science assessment of plastic pollution. The purpose of the report is to summarize the current state of the science regarding the potential impacts of plastic pollution on the environment and human health, as well as to guide future research and inform decision-making on plastic pollution in Canada. On March 27, 2020, Canada extended the comment period to May 1, 2020.
EUROPEAN UNION (EU)
ECHA Invites Comments On Proposal To Include Seven Substances In REACH Authorization List: On March 5, 2020, the European Chemicals Agency (ECHA) issued a press release entitled “Do you have further information on uses of seven substances proposed for authorisation?” In the press release and related Annex, ECHA provides that it is considering recommending the following substances for inclusion in the REACH Annex XIV Authorization List:
- Octamethylcyclotetrasiloxane (D4);
- Decamethylcyclopentasiloxane (D5);
- Dodecamethylcyclohexasiloxane (D6);
- Terphenyl, hydrogenated;
- Dicyclohexyl phthalate (DCHP);
- Disodium octaborate; and
- Benzene-1,2,4-tricarboxylic acid 1,2-anhydride (trimellitic anhydride; TMA).
ECHA is inviting comments and further information on uses of the substances, possible exemptions from the authorization requirement, and the structure and complexity of supply chains. Comments can be submitted until June 5, 2020. In parallel to ECHA’s consultation, the European Commission (EC) “is calling for information on the possible socio-economic consequences of including these seven substances in the Authorisation List.” ECHA states “[t]he information received will be passed on directly to the Commission and will not be considered by ECHA.”
The Member State Committee (MSC) will prepare an opinion on ECHA’s draft recommendation, taking into account the comments received during the consultation. Based on the MSC’s opinion and the consultation, ECHA will “provide its final recommendation to the [EC] in Spring 2021.” The EC will “decide on which of the substances to include in the Authorisation List and on the respective conditions applicable for each substance.”
Governments, Companies, And Organizations Sign European Plastics Pact: On March 6, 2020, 15 governments and 66 companies and organizations signed the European Plastics Pact. Initially led by France, the Netherlands, and Denmark, the European Plastic Pact is a public-private coalition forming a European network of companies, EU Member States, and other organizations such as non-governmental organizations (NGO) on mastering single-use plastic products and packaging. Participants of the European Plastics Pact commit to:
- Reusability and recyclability: Design all plastic packaging and single-use plastic products placed on the market to be reusable where possible and recyclable by 2025;
- Responsible use of plastics: Move toward a more responsible use of plastic packaging and single-use plastic products, aiming to reduce virgin plastic products and packaging by at least 20 percent (by weight) by 2025, with half of this reduction coming from an absolute reduction in plastics;
- Collection, sorting, and recycling: Increase the collection, sorting, and recycling capacity by at least 25 percent by 2025 and reach a level that corresponds to market demand for recycled plastics; and
- Use of recycled plastics: Increase the use of recycled plastics in new products and packaging by 2025, with plastic-using companies achieving an average of at least 30 percent recycled plastics (by weight) in their product and packaging.
Progress will be monitored and reported each year by all signatories, and a Secretariat will keep track of the results.
BPC Adopts Conclusions On Three Active Substances And Four Union Authorization Applications: On March 9, 2020, ECHA issued a press release entitled “Conclusions on three active substances and four applications for Union authorisation.” In its press release, ECHA provides that the Biocidal Products Committee (BPC) concluded on applications for the following active substance and product-type combinations:
- Chlorophene for product type 2 (disinfectants and algaecides not intended for direct application to humans or animals);
- Glyoxal for product types 2, 3 (veterinary hygiene), and 4 (food and feed area); and
- Reaction mass of peracetic acid and peroxyoctanoic acid for product types 2, 3, and 4.
The BPC’s opinion “is that chlorophene cannot be approved as a heavy-duty disinfectant as there are unacceptable risks that cannot be mitigated.” According to the BPC’s opinion, the other two active substances can be approved.
BPC also adopted opinions on four applications for Union Authorization of biocidal product families based on the following active substances:
- Propan-2-ol in product types 2 and 4;
- Methylchloroisothiazolinone/methylisothiazolinone (CMIT/MIT) in product type 6 (preservatives for products during storage);
- Peracetic acid in product type 2; and
- Hydrogen peroxide in product type 2.
The BPC’s opinion is that the biocidal product family based on hydrogen peroxide cannot be authorized “as it cannot be demonstrated that this product family is sufficiently effective to act as a disinfectant.” The EC, together with Member States, will make the final decision on the approval of the active substances and the Union Authorization of the biocidal product families. Further information is available in the Annex to ECHA’s press release.
EU Chemicals Legislation Finder Goes Live: ECHA announced on March 11, 2020, the release of the EU Chemicals Legislation Finder (EUCLEF), which provides companies access to an overview of 40 pieces of EU chemicals legislation with which they may need to comply. Integrated into ECHA’s chemicals database, ECHA states that companies “can use EUCLEF to navigate through the EU chemicals legislative framework and find relevant information on how their substances are regulated across the EU. This will give businesses a better understanding of the obligations they might have so they can ensure they are legally on the market.” The first version of EUCLEF covers legislation dealing with air and water quality, worker protection, pesticides, food contact materials, cosmetic products, toy safety, and many more issues. ECHA plans to add a further 16 pieces of legislation to EUCLEF in 2021. ECHA has posted a video tutorial.
EC Adopts New Circular Economy Action Plan: On March 11, 2020, the EC issued a press release entitled “Changing how we produce and consume: New Circular Economy Action Plan shows the way to a climate-neutral, competitive economy of empowered consumers.” In its press release, the EC states it has “adopted a new Circular Economy Action Plan — one of the main building blocks of the European Green Deal, Europe’s new agenda for sustainable growth.” The EC provides that “[w]ith measures along the entire life cycle of products, the new Action Plan aims to make our economy fit for a green future, strengthen our competitiveness while protecting the environment and [giving] new rights to consumers.”
The EC indicates that, building on the work done since 2015, the new Action Plan focuses on the “design and production” for a circular economy, with the aim to ensure that resources used are “kept in the EU economy for as long as possible.” The EC provides that the transition toward a circular economy “is already underway, with frontrunner businesses, consumers and public authorities in Europe embracing this sustainable model.” The EC states that it will “make sure that the circular economy transition delivers opportunities for all, leaving no one behind.” The Circular Economy Action Plan presents measures to:
- Make sustainable products the norm in the EU;
- Empower consumers;
- Focus on the sectors that use the most resources and where the potential for circularity is high (e.g., electronics, batteries and vehicles, packaging, plastics); and
- Ensure less waste.
ECHA’s Committees Conclude On Five Restrictions: On March 16, 2020, ECHA issued a press release entitled “ECHA’s committees conclude on five restrictions.” In the press release, ECHA provides that its Committee for Socio-Economic Analysis (SEAC) adopted its final opinion supporting ECHA’s proposal to restrict the placing on the market of D4, D5, and D6 as substances, constituents of other substances, or in mixtures in a concentration equal to or greater than 0.1 percent weight by weight of each substance. ECHA states “[t]his proposal covers both leave-on personal care products (D4, D5 and D6) and other consumer or professional products as well as wash-off personal care products (D6).”
SEAC also agreed in its draft opinion on ECHA’s proposal to restrict the placing on the market, manufacture, and use of five cobalt salts as substances on their own or in mixtures in a concentration equal to or above 0.01 percent by weight in industrial and professional applications. ECHA’s Committee for Risk Assessment (RAC) adopted its opinion on this restriction proposal by written procedure in February 2020. RAC adopted its opinion on “France and Sweden’s proposal to restrict skin sensitising substances in finished textile, leather, hide and fur articles, placed on the market for the first time.” ECHA states “[a]greement on the SEAC draft opinion is postponed until June 2020.”
RAC and SEAC supported Norway’s proposal to restrict the manufacture or placing on the market of “PFHxS (linear or branched), its salts or related substances and as a constituent of another substance,” in a mixture, or in articles. Additionally, SEAC supported ECHA’s proposal to restrict the placing on the market of articles releasing formaldehyde “at concentrations greater than 0.124 mg/m3 and that a formaldehyde concentration of 0.1 mg/m3 shall not be exceeded in the interiors of road vehicles and aircraft.” ECHA states “RAC’s opinion supported the proposal but included several proposed modifications to its scope and conditions.”
Consultations on the agreed SEAC opinions have begun, and comments are due May 25, 2020. The committees did not reach agreement on ECHA’s proposed restriction of intentionally added microplastics and will continue discussions in June 2020. Further information, including details regarding the opinions of RAC and SEAC on applications for authorization, is available in the Annex to ECHA’s press release.
ECHA Publishes CoRAP Update Covering 2020-2022: ECHA’s March 18, 2020, Community Rolling Action Plan (CoRAP) update for the years 2020-2022 lists 74 substances for evaluation by the Member State competent authorities under the REACH substance evaluation process. The updated CoRAP contains seven newly allocated substances and 67 substances as already published in the previous CoRAP on March 19, 2019. In 2020, 14 substances are to be evaluated by seven Member States. In 2021 and 2022, 32 and 28 substances will be evaluated, respectively. The updated CoRAP includes 52 changes made to the year of evaluation, postponing the evaluation year. According to ECHA, the main reason was “awaiting results from ongoing dossier evaluation processes on the same substance.” A secondary reason was aligning the timing for similar substances to achieve higher consistency between assessments, including awaiting results for similar substances, as well as limited resources of the evaluating Member State. Two of the existing entries were withdrawn upon requests of the evaluating Member State. In one case, the only registrant ceased manufacture of the substance, rendering an evaluation obsolete. In the second case, the designated Member State revised the initial ground of concern and considered that the evaluation of the substance was currently not needed. The withdrawn substances are isopropyl naphthalene and 3-methyl-1,5-pentanediyl diacrylate.
ECHA Supports Action Against COVID-19: On March 20, 2020, ECHA issued a press release entitled “ECHA to support EU-wide action against COVID-19.” In its press release, ECHA indicates it is “taking measures to support EU action to fight the pandemic caused by the coronavirus disease (COVID-19).” ECHA indicates that, together with the EC, it will support Member States and industry to address shortages with the supply of disinfectants, “which has become a critical issue in several EU Member States.”
ECHA states that deadlines for certain processes will be handled flexibly, including the payment of invoices. ECHA indicated that for certain deadlines “that fall between now and the end of May 2020, companies will receive an extension of two months.” This applies to cases where companies have initially failed to provide a complete registration for their chemicals and were granted a final deadline between March and May 2020, and also for requests for further information related to confidentiality claims. ECHA provides that an “extension of 30 days will also apply for companies to comment on ECHA’s draft decisions in cases where a registration has been considered incompliant with legal requirements.”
On March 24, 2020, ECHA issued an additional press release entitled “Speeding up the supply of disinfectants.” In this press release, ECHA states “[a]s the COVID-19 pandemic grows, it is essential for healthcare professionals and European citizens to have access to more disinfectants.” ECHA indicates that it is “supporting EU/[European Economic Area (EEA)] authorities to apply derogations from the normal authorisation requirement for biocidal products.” ECHA provides that companies looking to “quickly access” the market with disinfectants that contain an already approved active substance can apply for permission to the relevant national authority “by relying on Article 55(1) of the Biocidal Products Regulation (BPR).” ECHA states that this provision “allows national authorities to give time-limited derogations from the standard product authorisation requirements in situations where there is a threat to public health.”
ECHA indicated that several EU/EEA countries have already granted such permissions to companies that have the capacity to manufacture disinfectants. ECHA provides that it “is also recommending certain compositional requirements for the two approved active substances, propan-1-ol and propan-2-ol, for their use in disinfectants.” ECHA indicates that these recommendations will enable national authorities “to swiftly check the quality of the incoming applications before deciding on a derogation.” ECHA has also recommended certain compositional requirements for active chlorine released from sodium hypochlorite, hydrogen peroxide, and peracetic acid.
To “ease the work of authorities and for companies looking for information,” ECHA is making available three lists with information on: biocidal active substances approved or being reviewed for their use in disinfectant products; disinfectant products that are authorized under BPR; and disinfectant products authorized under national regimes in Spain, Netherlands, and Switzerland. Further information is available on ECHA’s COVID-19 webpage.
JRC Publishes Factual Summary Reports Of Public Consultations In Context Of Fitness Check Of EU Legislation With Regard To Endocrine Disruptors: The EC Joint Research Center (JRC) has published two factual summary reports regarding the public consultations in the context of a Fitness Check of the EU legislation with regarding to endocrine disruptors:
- Public Consultation in the context of a Fitness Check of the EU legislation with regard to Endocrine Disruptors: Factual Summary Report: This report provides a brief overview of the responses received to questions addressed to the general public. The aims of this public consultation were to collect views on the concerns of citizens related to endocrine disruptors, the extent to which the current EU legislation meets these concerns, and to identify possible opportunities for improvements.
- Targeted Stakeholder Consultation in the context of a Fitness Check of the EU legislation with regard to Endocrine Disruptors — Factual Summary Report: This report provides a brief overview of the responses received to more than 30 questions addressed to stakeholder organizations such as businesses, public authorities, academia, research organizations, and civil society organizations. The aims of the consultation were to collect views on the effectiveness, efficiencies, and possible legislative incoherencies of EU legislation with respect to endocrine disruptors and the possible impacts on stakeholders.
JRC will publish a factual summary report on a third consultation conducted under this Fitness Check that focused on small- and medium-sized enterprises (SME). According to JRC, the consultation responses will provide an essential input to its Fitness Check analysis. JRC states that it will publish a more detailed analysis of the responses from the three consultations in a synopsis report at the end of the process. More information on the public consultations is available in our December 18, 2019, memorandum, “EC Begins Public Consultations on Fitness Check of EU Legislation Regarding Endocrine Disruptors.”
ECHA Will Not Take Into Account Updates To Registration Dossiers During Substance Evaluation Decision Making: ECHA announced on March 31, 2020, that beginning April 14, 2020, it will apply a new policy regarding dossier updates during substance evaluation. After ECHA has sent registrants a draft decision for commenting, ECHA and evaluating Member States will no longer take dossier updates into account in their decision making. ECHA states that this is because registration dossiers “must reflect the best knowledge of the registrants at all times and contain the most up-to-date information, in particular on the exposure and use of the substance.” If registrants have new relevant information on their substance after receiving a draft decision, they will need to submit it through their comments to the draft decision. Authorities will consider the comments and amend the draft decision, if needed. ECHA notes that the same approach already applies to dossier evaluation. More information is available in ECHA’s press release, “Updates to registration dossiers not taken into account during substance evaluation decision making.”
ECHA Postpones Completeness Check Of CSRs To October 2020: As reported in our January 23, 2020, Global Regulatory Update, on December 11, 2019, ECHA issued a press release entitled “Revised completeness check to be launched in April 2020.” In its press release, ECHA states that completeness checks will be extended to Chemical Safety Reports (CSR), “to ensure they contain all the elements required under REACH.” On April 8, 2020, ECHA updated the press release to note that it amended the headline and content to reflect that the completeness checks of CSRs has been postponed to October 2020 to help companies facing difficulties due to the COVID-19 pandemic. ECHA states that the remaining changes to the completeness check will take effect on submissions as of May 1, 2020, as previously communicated.
ECHA Urges Registrants To Get Ready To Comment On Draft Substance Evaluation Decisions: ECHA intended to send out draft decisions to registrants between April 14 and 17, 2020, requesting more information on their substances. According to ECHA, the draft decisions address 12 substances that EU Member States evaluated in 2019. ECHA recommends that one representative send consolidated comments on behalf of all addressed registrants of a substance. ECHA notes that due to the coronavirus, the registrants have exceptionally 60 days to send their comments.
EP Adopts EC Proposal To Postpone New Requirements For Medical Devices: On April 17, 2020, the European Parliament (EP) adopted the EC’s proposal to allow the application of the Medical Devices Regulation to be postponed by one year, until May 26, 2021. The EP’s press release states that “[g]iven the current pressure on national health authorities and manufacturers of medical devices, there is a fear that there could be shortages or delays in getting the medical devices needed to fight COVID-19, were they to follow the new rules of the Medical Devices Regulation from May this year.” The EP states that it supports the EC’s proposal to postpone application of the regulation by one year to allow authorities and manufacturers alike to prioritize the fight against the coronavirus pandemic by continuing under current procedures. The proposal now has to be approved by the EU Member States and published in the Official Journal of the European Union before it will enter into force. According to the EP, this is expected by May 26, 2020, at the latest.
India Announces Fourth Draft Chemicals (Management And Safety) Rules: India released the fourth draft Chemicals (Management and Safety) Rules to select groups on March 16, 2020. This fourth draft is believed to be the final draft, despite assurances in February that the third draft was the final draft. The government accepted comments until March 31, 2020. The draft Rules include significant revisions to the list of priority substances that are subject to importation notifications, and hazard communication obligations (i.e., safety data sheets (SDS), labeling, and packaging). In addition, the draft Rules include 37 substances that are subject to registration.
India proposes in this latest version of draft Rules a notification, registration, and restriction approach. The draft Rules are meant to come into force on the date of their official publication. The “Rules apply to all Substances, Substances in Mixtures and Intermediates that are Manufactured, Imported, Placed or intended to be Placed in Indian Territory.” The draft Rules also include provisions for labeling and handling of hazardous chemicals.
India includes in the draft Rules the establishment of a Steering Committee that “shall oversee technical and administration matters arising out of these Rules, and carry out functions that may be assigned to it under these Rules.” A Scientific Committee and a Risk Assessment Committee would be developed, and a Chemical Regulatory Division (the Division) will be established and responsible for coordinating with the Committees and providing technical support to the committees. The Division, similar to ECHA, would be responsible for the evaluation of notification and registrations and provide recommendations to the Committees.
The initial notification would commence one year from the Rules coming into force and would terminate 180 days from the commencement. Notification is required for all existing substances imported or manufactured at or above one metric ton per year. All new substances must be notified at least 90 days prior to the date they are placed in Indian Territory. Schedule V provides the details required for the Notification. The information is similar to the requirements specified in the pre-registration phase of South Korea’s 2019 amended Act on Registration, Evaluation, etc. of Chemicals (K-REACH) and includes a significant demonstration of substance identity, use, and hazard classification detail.
More information is available in Acta’s March 27, 2020, memorandum, “India Announces Fourth Draft Chemicals (Management and Safety) Rules.”
Amended ICOP Includes Updated, New Chemical Classifications: On February 11, 2020, the Department of Occupational Safety and Health (DOSH) published the Industry Code of Practice on Chemicals Classification and Hazard Communication (Amendment) 2019 Part 1 (ICOP 2019) on its website. ICOP 2019 updates Part 1 of the Industry Code of Practice on Chemicals Classification and Hazard Communication 2014. ICOP 2019 contains a list of chemicals that have been classified under the Occupational Safety and Health (Classification, Labeling and Safety Data Sheet of Hazardous Chemicals) Regulations 2013 (CLASS Regulations). It provides the mandatory hazard classification and related labeling elements for listed chemicals. ICOP 2019 notes that the classifications specified are minimum classifications. If a principal supplier has data or other information that lead to classification of additional hazard classes or a more severe category compared to the minimum classification, the principal supplier may classify accordingly. If a company wants to exclude any of the hazard classes listed for a particular chemical, it must apply to DOSH and submit supporting documents. More than 400 chemical substances have been added to Part 1. Suppliers have until June 11, 2020, to update SDSs and labels to comply with the modified classifications. If a chemical is not listed, companies should classify it according to the rules in Part 2, which are based on the third revision of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).
SEMARNAT Working On Project To Improve Management Of Chemical Substances: The Ministry of Environment and Natural Resources (SEMARNAT) announced on March 19, 2020, that it presented to a group of experts its project to create the Chemical Substances Unit, which is intended to improve Mexico’s management of chemical substances and hazardous waste. Mexico will present its plan to the United Nations Environment Program (UNEP) for approval. Once UNEP approves the plan, the Chemical Substances Unit will be created and financing will be allocated. Implementation of the project complies with the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and Their Disposal; the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade; the Stockholm Convention on Persistent Organic Pollutants; the Minamata Convention on Mercury; and the Strategic Approach to International Chemicals Management (SAICM).
Russian Federation Accepting Nominations To New Inventory Of Existing Chemicals: The Russia Federation issued in final the Technical Regulation on the Safety of Chemical Products (TRSCP; Decree No. 1019) in October 2016 to establish a framework for regulation of chemical substances. Its implementation created a chemical inventory to include chemicals and mixtures in circulation and those intended for circulation in the territory of the Russian Federation. Inventory information is to be submitted online to the Russian Federation’s Governmental Industry Information Exchange Platform (GISP), which opened for submittal of substance information in November 2019. The initial submission deadline of January 1, 2020, is expected to be extended to July 1, 2020, on or about May 1, 2020. Information requirements include:
- Chemical identification information, including IUPAC name, synonyms, and molecular and structural formula;
- Use information;
- Volume as a three-year average or planned deliveries;
- Hazard classification according to Russian Gosudarstvennyy Standart (GOST) classification standards; and
- Company data.
Acta assists clients with Authorized Representative (AR) appointment and provides broad-based hands-on support in the Russian Federation to support its clients’ regulatory compliance and business success. More information is available in our April 2, 2020, memorandum, “Russian Federation Accepting Nominations to New Chemical Inventory.”
Parliament And Cabinet Approve Significant Amendments To K-BPR: South Korea’s Parliament and Cabinet have approved significant amendments to the Consumer Chemical Products and Biocide Safety Management Law (K-BPR). The amendments will enter into force on January 1, 2021. The changes to K-BPR include:
- The option for non-Korean manufacturers to appoint an Only Representative (OR) in South Korea to manage substance approvals;
- Revised authority of the Ministry of Environment (MoE) to disclose information on approvals for consumer chemical products subject to safety checks under K-BPR, including the product name, manufacturer or importer details, and the main ingredients of the product;
- A transition period for manufacturers and importers of biocidal products and treated articles to modify ingredients if prohibited active substances are included in the products or articles;
- Modified approval grace periods for certain products; and
- Measures to reduce vertebrate animal testing.
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