Global Regulatory Update for December 2019


AUSTRALIA

Australia Publishes Decision RIS For Workplace Exposure Standards Framework Under Model WHS Laws: Safe Work Australia (SWA) published on November 11, 2019, the Decision Regulation Impact Statement (RIS) about the framework for workplace exposure standards under the model Work Health and Safety (WHS) laws and how it should be kept up to date. The preferred option consists of:

  • Updating the workplace exposure standards for airborne contaminants;
     
  • No change to the requirement to ensure exposure standards for substances and mixtures are not exceeded (Regulation 49); and
     
  • Changing the name of workplace exposure standards to workplace exposure limits.
     

SWA states that a standard three-year transitional period was also preferred for implementing any changes to the workplace exposure standards for airborne contaminants. According to SWA, any changes to the workplace exposure standards will be supported by guidance materials and education to assist duty holders to meet their requirements.

NICNAS Announces Final Industrial Chemicals General Rules, Categorization Guidelines, And Transitional Rules: The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) announced on December 2, 2019, that the following key documents are now in final:

  • Industrial Chemicals (General) Rules 2019: The General Rules set out the details for the regulation of the importation and manufacture of industrial chemicals in Australia under the Australian Industrial Chemicals Introduction Scheme (AICIS), which will take effect from July 1, 2020;
     
  • Industrial Chemicals Categorization Guidelines (final draft): The final draft Categorization Guidelines set out technical details and requirements of the importation and manufacture of industrial chemicals in Australia. The AICIS Executive Director will sign off on the Guidelines so that they take effect from July 1, 2020; and
     
  • Industrial Chemicals (Consequential Amendments and Transitional Provisions) Rules 2019: The Transitional Rules cover matters relating to the changeover from NICNAS to AICIS. They will work together with the Industrial Chemicals (Consequential Amendments and Transitional Provisions) Act 2019. NICNAS provides the following transitional highlights:
     
    • NICNAS exemption categories will continue to be available until August 31, 2022, for introduction of chemicals not listed on the AICIS Inventory; and
       
    • NICNAS low volume and controlled use permits will remain in force until at least June 30, 2022.​

NICNAS states that the following documents are “coming soon”:

  • Stakeholder submissions following our public consultations on the General Rules and Categorization Guidelines; and
     
  • Summary of submissions and our responses to issues raised.
     

More information on AICIS is available in our August 28, 2019, memorandum, “Australia’s New Scheme for Introducing Industrial Chemicals Will Begin July 1, 2020.”

NICNAS Requests Information On Industrial Uses Of Certain Chemicals On The Current Inventory Of Chemical Substances: On December 3, 2019, NICNAS requested information on industrial uses of certain chemicals on the Australian Inventory of Chemical Substances. Under the Industrial Chemicals Act 2019 (IC Act), the Australian Inventory of Industrial Chemicals (the new Inventory) will replace the Australian Inventory of Chemical Substances (the current Inventory). IC Act Section 80 mandates that the new Inventory must contain only industrial chemicals. NICNAS states that it believes that the current Inventory lists more than 1,600 chemicals that are not industrial chemicals, and are (or have been) used solely as: an agricultural chemical; a veterinary chemical; a medicine or therapeutic; or a food or food additive. Chemicals used in these ways are not industrial chemicals and are regulated by other agencies. NICNAS intends to remove from the current Inventory all chemicals on the list that have no industrial use before AICIS begins on July 1, 2020. The new Inventory will then contain chemicals used only for industrial purposes. Information on the 1,600 chemicals is due March 31, 2020. NICNAS will then consider the information received, remove any chemical without an industrial use from the Inventory, and publish a list of these chemicals on its website. NICNAS will not remove any chemical that has an industrial use as well as an excluded use.

NICNAS Creates AICIS Guidance Hub: NICNAS announced on December 3, 2019, that it created a new section on its website dedicated to guidance about AICIS and NICNAS to AICIS transitional arrangements. The topics addressed include:

  • AICIS -- Annual declaration for all introducers (from July 1, 2020);
     
  • AICIS -- Exempted introduction declaration (from July 1, 2020);
     
  • AICIS -- How and why NICNAS assesses risk;
     
  • AICIS -- Using AICIS-approved chemical names for protecting confidentiality (from July 1, 2020);
     
  • NICNAS to AICIS -- Commercial evaluation permits;
     
  • NICNAS to AICIS -- Controlled use permits;
     
  • NICNAS to AICIS -- Early introduction permits;
     
  • NICNAS to AICIS -- Exemptions;
     
  • NICNAS to AICIS -- Low volume permits;
     
  • NICNAS to AICIS -- Registration;
     
  • NICNAS to AICIS -- Secondary notifications; and
     
  • NICNAS to AICIS -- The Inventory.
     

CANADA

Canada Intends To Amend DSL To Disclose The Identity Of Certain Masked Substances: Environment and Climate Change Canada (ECCC) published a Canada Gazette notice on November 30, 2019, announcing that it intends to amend the Domestic Substances List (DSL) to disclose the identity of the substances listed in Annex I by deleting them from the confidential portion of the DSL and adding them to the public portion of the DSL. The notice states that ECCC is conducting a pilot project to review 24 confidentiality claims for substance identity that are older than ten years. According to the notice, most of these substances are part of the third phase of the Chemicals Management Plan. ECCC requests that persons who have a commercial interest in any of the substances listed in Annex I and who wish for a substance identity to remain confidential provide a justification by completing the response template (one per substance). Publication of the Canada Gazette notice began a 30-day comment period.

Canada Publishes Summary Of Feedback From Consultation On Defining Vulnerable Populations: On December 5, 2019, Canada published a summary of feedback from a 2018 consultation on Canada’s proposed definition of vulnerable populations in the context of federal chemicals management activities. The online consultation provided stakeholders an opportunity to review the proposed definition and illustrative examples as a first step toward the development of a policy framework focused on enhancing the protection of vulnerable populations through the assessment and management of risks associated with certain chemicals. According to Canada, it received comments from 55 individual stakeholders and organizations. In general, stakeholders were supportive of the government’s intention to seek opportunities to strengthen its approach when considering vulnerable Canadians in chemicals management; they also supported the definition proposed in the consultation paper. Canada states that it also received suggestions on how the definition for vulnerable populations could be adjusted to highlight related issues, such as occupational exposure, and how a definition could be used in the implementation of a chemicals management program.

CHINA

China Consults On Three Draft National Standards On Consumer Product Safety: China’s National Consumer Product Safety Standardization Technical Commission (SAC/TC508) published three draft national standards on consumer product safety for public comments on November 27, 2019. The three draft voluntary national standards are:

  • Consumer Product Safety -- General Requirements on Physical Hazard Assessment;
     
  • Guidelines of Risk Assessment for Chemical Hazards in Consumer Products; and
     
  • Chemical Hazards in Consumer Products -- Hazard Characterization and Exposure Assessment.
     

The draft voluntary national standards refer to Guidelines for Exposure Assessment and Technical Guidance Document on Risk Assessment of the U.S. Environmental Protection Agency (EPA) and the European Chemicals Agency (ECHA) and will apply to all consumer products except for food, drugs, cosmetics, and products for military uses. The three draft voluntary national standards will provide the definitions and process guidelines for hazard identification, hazard characterization, exposure assessment, and risk assessment of physical hazards and chemical substances in consumer products. The Commission (SAC/TC 508) will accept comments submitted by e-mail to 15810962101@163.com or liuxia1010@163.com until January 30, 2020. The schedule for release of the three voluntary national standards in final is not provided but is expected in late 2020.

EUROPEAN UNION (EU)

EC Adopts 14th ATP To CLP, Council Of Ministers And EP Begin Their Review: On October 4, 2019, the European Commission (EC) adopted the 14th Adaptation to Technical Progress (ATP) to the Classification, Labeling, and Packaging (CLP) regulation. The delegated regulation would make the following changes in Table 3 of Annex VI:

  • Deletion of two entries;
     
  • Changes to 12 existing entries; and
     
  • Addition of 17 entries.
     

The substances newly added to Table 3 would include titanium dioxide, which has been classified as a suspected human carcinogen (i.e., carc. 2) in powder form containing one percent or more of particles with aerodynamic diameter ≤10 micrometers (μm). The 14th ATP would also amend Annexes II (Special Rules for Labeling and Packaging of Certain Substances and Mixtures) and III (List of Hazard Statements) to support new labeling obligations for mixtures containing titanium dioxide. The European Parliament (EP) and the Council of Ministers typically have two months from the date of adoption to object. While the EU Council of Ministers adopted an early “non-objection” decision, the EP extended the deadline to February 4, 2020, after the European Conservatives and Reformists tabled an objection to the proposal to classify titanium dioxide as a suspected carcinogen in powder form. On December 3, 2019, the EP’s Committee on Environment, Public Health and Food Safety failed to pass the resolution, however, meaning that it will not be considered by the EP at a plenary session.

ECHA Publishes Draft CoRAP For 2020-2022: ECHA announced the availability of the draft Community Rolling Action Plan (CoRAP) for 2020-2022 on October 23, 2019. Under the draft CoRAP, 14 substances would be evaluated in 2020, and 60 substances would be evaluated in 2021 and 2022. ECHA recommends that registrants of listed substances start coordinating their actions and contact the evaluating Member State authority. Downstream users of a listed substance should review the information they have available and share it with the registrants. ECHA states that it is important that information on the uses are up to date and exposure scenarios and related exposure estimations are clearly documented within the registrants’ chemical safety reports. For the substances to be evaluated in 2020, the relevant dossier updates should be made before March 2020. ECHA’s Member State Committee (MSC) will prepare an opinion on the draft plan in February 2020. Based on the opinion, ECHA will adopt and publish the CoRAP update for 2020-2022 in March 2020. From the date of publication onward, the Member States will have one year to prepare a draft decision requesting further information from the respective registrants to clarify potential concerns identified during evaluation. More information is available in ECHA’s press release, “Member States to evaluate 74 substances in 2020-2022.”

ECHA Plans Update To REACH Dossier Completeness Checks: ECHA is planning revision of Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration dossier completeness checks, focused “on the two following work streams”:

  • Ensuring that the standard information requirements under REACH Annexes VII-X have been met through implementing more explicit completeness check rules on the key end points; and
     
  • Strengthening the completeness check of the substance life cycle reporting and extending the completeness check to the Chemical Safety Report (CSR).
     

ECHA states that it reviewed the impact of the 2016 completeness check revision and observed positive results, “in particular related to the manual verification aspect.” ECHA indicates that, after the final registration phase, it has taken “a new look to the completeness check in view of the strategic priorities of its Multiannual programme.” ECHA provides that the “review suggests that the current completeness check implementation does not fully ensure that all the elements required are present in the dossier and that it could be improved to better support ECHA’s integrated regulatory strategy.”

ECHA provides that an analysis of the current completeness check implementation on the “key endpoints” revealed that the current rules do not “sufficiently well ensure that the registrants have addressed the specific information requirements in the relevant Annex.” ECHA identified “improvement needs” for REACH information requirements pertaining to mutagenicity, reproductive toxicity, and degradation, and will implement changes in this regard through modification of the computer-based completeness check rules.

ECHA plans to verify manually that CSRs contain required elements, and the verification “will contain the following items,” among others: (1) all substances classified as hazardous or with persistent, bioaccumulative, and toxic (PBT) properties must have a CSR with exposure assessment and risk characterization; and (2) all uses reported in the registration dossier must have corresponding exposure scenarios in the CSR. In addition to the manual checks on the CSR, “ECHA also foresees to strengthen the computerised check of the completeness of the substance life cycle.”

ECHA plans to implement the revised completeness checks in April 2020, and the checks will “apply equally to existing and new registrations.” ECHA has “prepared a plan” to raise awareness and support companies in adapting to the revised completeness checks. Further information is available in a document prepared for the 32nd Meeting of Competent Authorities for REACH and CLP.

ECHA Holds Biocides Day: ECHA held its annual Biocides Day on October 29, 2019, at its offices in Helsinki, Finland. The presentations and recordings available online include:

Session 1 -- Assessing Endocrine Disrupting Properties

Session 2 -- Revitalizing the Review Program

Session 3 -- Developments with Biocidal Product Families

SCCS Publishes Guidance On Safety Assessment Of Nanomaterials In Cosmetics: On November 4, 2019, the Scientific Committee on Consumer Safety (SCCS) published an updated Guidance on the Safety Assessment of Nanomaterials in Cosmetics. It covers the main elements of safety assessment -- general considerations (Section 2), material characterization (Section 3), exposure assessment (Section 4), hazard identification and dose-response characterization (Section 5), and risk assessment (Section 6). The Guidance includes key recommendations for the safety assessment of nanomaterials intended for use in cosmetics on the following topics: definition; material characterization; exposure assessment; hazard identification/dose-response characterization; and safety assessment. More information is available in our November 5, 2019, blog item.

Next Major Enforcement Project Will Focus On Authorization: On November 12, 2019, ECHA announced that the Enforcement Forum decided that its next major enforcement project, REF-9, will focus on provisions related to authorization under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation meant to protect the safety and health of workers and the environment. According to ECHA, inspectors will check that substances of very high concern (SVHC) that are subject to authorization are not placed on the market without a valid authorization and, where authorized, whether they are used in compliance with the conditions set in the authorization decision. ECHA states that the enforcement project will be prepared in 2020, inspections will be conducted in 2021, and the report is expected to be published at the end of 2022.

The Forum also began preparing the pilot project on substances recovered from waste, especially related to the exemption from the registration duty but possibly also addressing other duties related to chemicals in waste. The scope and timelines of the project will be refined in early 2020.

The Forum announced that its pilot project on the classification of mixtures will focus on the use of bridging principles in the classification of detergents and cleaning products. Preparation for this project will start near the end of 2020, and timelines for the project will be determined then.

The Forum adopted the report of the pilot project on duties applicable to substances in articles. According to ECHA, the results will be communicated shortly, together with the publication of the report.

Furthermore, the Forum reviewed the results of the REF-6 project on CLP mixtures. The report of this project will be published towards the end of 2019.

In its annual open session, the Forum also concluded its joint action with stakeholders on the quality of safety data sheets (SDS) where inspectors identified frequent non-compliances with SDSs and discussed with stakeholders how they could be addressed. The Forum offered to provide its feedback on standard phrases for the SDSs that industry uses when generating SDSs. ECHA states that its accredited stakeholders have committed to a number of actions, such as identifying examples of best practice SDSs, training companies on the quality of SDSs, or developing sector use maps and promoting their use. More information is available in ECHA’s press release, “Inspectors in the EU to target REACH authorisation duties.”

EC Publishes Updated Catalog Of Nanomaterials Used In Cosmetics: The EC announced on November 15, 2019, that it published an updated catalog of nanomaterials used in cosmetic products on the EU market. The catalog compiles information that responsible persons shared with the EC through the cosmetic products notification portal (CPNP) as of December 31, 2018. The catalog lists 27 nanomaterials used as ultraviolet (UV) filters, colorants, and preservatives. The catalog notes that “there may be a level of uncertainty regarding the status of some notified substances.” The EC states that “this catalogue is for information purposes only and is expressly not a list of authorised nanomaterials.” According to the press release, the EC will continue working with EU country authorities and industry stakeholders to improve the quality of the data submitted by the responsible persons.

ECHA States That Companies Need To Improve Communication Of Hazardous Substances In Products: ECHA announced on November 18, 2019, that an Enforcement Forum pilot enforcement project in 15 participating countries has found that 12 percent of inspected products contain SVHCs. According to ECHA, the majority (88 percent) of suppliers of these products are failing to communicate sufficient information to their customers about SVHCs in products they supply. ECHA states that the results of the pilot project show that companies need to improve their knowledge on the products they supply to their customers and to communicate information better so that products containing SVHCs can be used safely. The products checked by inspectors were selected especially as they were highly likely to contain targeted Candidate List substances. Such products included clothing, footwear and home textiles; wires, cables, and electronic accessories; plastic or textile floorings; wall coverings; and other plastic and rubber products. The ECHA Secretariat and the Forum will further analyze the results from the enforcement project and the recommendations included in the Forum’s final report and will consider further actions that could improve the situation.

EC Launches “Due Diligence Ready!”: The EC announced on November 19, 2019, the launch of “Due diligence ready!,” an online portal that contains information, tools, and training materials intended to guide companies in conducting due diligence on their minerals and metals supply chain. The EC states that “Due diligence ready!” will help businesses to:

  • Improve their due diligence capacity of minerals’ sourcing;
     
  • Facilitate compliance with the EU’s Regulation on Responsible Sourcing of Minerals; and
     
  • Respond to growing market demand for responsibly sourced minerals.
     

New SDS Requirements Under REACH Expected In January 2021: On November 19-20, 2019, members of the REACH Committee voted unanimously in favor of proposed amendments to REACH Annex II on SDSs. The proposed changes, which are expected to apply from January 1, 2021, include SDS requirements for nanoforms of substances and align REACH Annex II with the sixth and seventh revisions of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).

Further changes include alignment of REACH Annex II with Annex VIII of the CLP regulation. This measure will allow for a unique formula identifier to be indicated only in SDSs for hazardous mixtures that are supplied for use at industrial sites. It will also require for certain mixtures which are not packaged that the unique formula identifier be indicated in the SDS.

Under the proposal, companies will also be required to provide specific concentration limits, multiplying factors, and acute toxicity estimates in accordance with the CLP regulation if available. The proposal states “[a] number of specific requirements for [SDSs] have been identified as relevant for substances and mixtures with endocrine disrupting properties and Annex II of [REACH] should therefore be modified accordingly.”

The proposal indicates “[r]equiring economic operators who have already compiled [SDSs], to update them immediately in accordance with the provisions of this Regulation would impose a disproportionate burden on them.” Consequently, the proposal provides for a transition period from January 1, 2021, until December 31, 2022. During this time frame, SDSs may continue to be provided in accordance with current requirements. This is “without prejudice to the obligation to update [SDSs] in accordance with Article 31(9) of [REACH], and to the cases where the unique formula identifier is added to [SDSs] as provided for in section 5 of Part A of Annex VIII to [the CLP regulation].”

Further information is available in the Draft Commission Regulation and related Annex.

ECHA Publishes BPR Active Substances Action Plan: On November 21, 2019, ECHA published an “Active Substances Action Plan” for the Biocidal Products Regulation (BPR). In its Action Plan, ECHA highlights delays under the BPR Review Program, stating “[t]he focus is on the Review Programme because the evaluation and peer review is finalised for only 293 Active substance/Product type combination, out of a total of 727[,] possible unacceptable [risks] are not managed, thousands of biocidal products not being evaluated are still on the market. In essence, the expected high level of safety for [humans and the environment] is not achieved.”

ECHA’s Action Plan, proposed to Competent Authorities and the EC, comprises the following elements: (1) prioritizing dossiers; (2) supporting Competent Authorities to overcome resource or capacity issues; (3) streamlining the peer review phase; (4) reducing complexity in the assessment; and (5) facilitating and harmonizing the assessment of confidentiality claims. ECHA’s Action Plan includes details on each of these measures.

Regarding support to Competent Authorities, ECHA indicates it “will provide direct support to the [Competent Authorities] within the limits of its capacity,” assisting in technical/scientific, procedural, and/or regulatory issues. Regarding reduction of complexity, ECHA states that, in cooperation with groups of volunteers from Member States, it will prepare a proposal for a harmonized and efficient approach for performing a focused assessment for BPR approval.

ECHA is also preparing guidelines to support Competent Authorities in assessing confidentiality claims in applications for active substance approvals and biocidal product authorizations. The guidelines cover several key issues, including rules regarding confidentiality and the roles and responsibilities of Competent Authorities. “ECHA foresees to prepare the guidelines by the end of Q1 2020.” The EC and Competent Authorities have not yet agreed to adopt ECHA’s Action Plan. In conclusion to the Action Plan, ECHA states “[the Competent Authority] meeting members are requested to discuss and agree on the action plan.”

ECHA States Dossier Updates Are Not Considered During Evaluation Decision Making: On November 26, 2019, ECHA issued a press release entitled “ECHA does not consider dossier updates during evaluation decision making.” In its press release, ECHA indicates that once it has sent a draft decision to registrants, it does not consider dossier updates during evaluation decision making. ECHA states “[r]egistrants need to keep their registration dossiers up to date at all times.” In its press release, ECHA provides that REACH is based on the principle that registrants must ensure that substances used and placed on the market do not adversely affect human health or the environment. Therefore, ECHA indicates that registrants are legally obliged to submit a registration dossier that complies with the REACH information requirements -- and to keep “their dossiers up to date with the latest information to be validly on the market.”

Consequently, ECHA indicates that under dossier evaluation it takes into account only dossier updates submitted before it issues a draft decision. ECHA provides that, if new information becomes available following issuance of a draft decision, registrants must submit this information through their comments on the draft decision. ECHA states it “will consider the information in the comments and may amend the decision accordingly.”

ECHA indicates further that it does not take new information on tonnage, uses, and exposure into account after it has sent a draft decision to registrants for comments. ECHA states “[r]egistrants cannot retrospectively downgrade their tonnage band or remove certain uses from their registration to remove requests for information from ECHA’s decisions. This is because the registration dossier has to comply with the REACH information requirements for the registered tonnage band and uses at the time the dossier evaluation was opened.”

Further information is available in ECHA’s recommendations to registrants and its practical guide on dossier evaluation.

EC Grants Union Authorization, Approves Extensions, And Denies Approvals: The EC has published an Implementing Regulation granting Union Authorization under BPR for “BPF_Iodine_VET,” a biocidal product family. The Union Authorization application was submitted by Applied Biocide GmbH, and the active substance is iodine. The Union Authorization is valid from November 25, 2019, until October 31, 2029.

The EC also published Implementing Decisions postponing the approval expiry dates for the following active substances in product-type 8:

The Implementing Decisions provide that the expiry date for approval of tebuconazole is postponed to September 30, 2022, and that the expiry dates for K-HDO and IPBC approvals are postponed to December 31, 2022.

Additionally, the EC issued Implementing Decisions denying approval under BPR for the following active substances:

Roadmap On Carcinogens Is Renewed: Finland’s Presidency of the Council of the EU held a conference on November 27-28, 2019, on “Working together to eliminate occupational cancer.” Along with the European Agency for Safety and Health at Work (EU-OSHA), participants included experts from the EC, social partners, and national bodies responsible for occupational safety and health. On November 28, 2019, participants renewed the Roadmap on Carcinogens. The goal is to limit exposure to carcinogenic substances at work in the EU by setting binding limit values to be complied with at workplaces. According to the November 28, 2019, press release, the EC is in the process of amending the Carcinogens and Mutagens Directive (CMD) with four separate proposals. The EC has already published the first three proposals amending the Directive, and they are now being implemented by EU Member States. The press release states that the EC is currently preparing the fourth proposal for a directive and is expected to adopt it in early 2020.

ECHA Releases New, Updated Guidance Documents For Registering Nanoform Substances: ECHA announced on December 3, 2019, that it has developed a new Appendix for nanoforms applicable to the Guidance on Registration and Substance Identification. According to ECHA, it aligns ECHA’s guidance with the amended REACH annexes that will apply to nanomaterials and enter into force on January 1, 2020. The new guidance document explains the term nanoform, provides advice on how to build and justify sets of nanoforms, and explains what characterization information needs to be reported. ECHA updated the Appendix for nanoforms applicable to the Guidance on QSARs and Grouping of Chemicals to reflect the advice of the new guidance document. To support potential registrants in meeting the new information requirements, an updated overview of available test guidelines and other recognized methods and standards is available on the European Union Observatory for Nanomaterials (EUON) website.

ECHA Publishes List Of Registered Substances Mapped In Its Chemical Universe: ECHA published on December 4, 2019, a list of more than 21,000 REACH-registered substances mapped in its chemical universe. The mapping of registered substances, also called the chemical universe, is a planning and monitoring tool intended to help EU Member States and EU authorities “focus on substances of (potential) concern and identify appropriate regulatory actions, where needed.” According to ECHA, for companies and other stakeholders, publishing the mapping provides additional transparency on the work of authorities and the progress made in regulating chemicals. ECHA divided the registered substances into five categories based on the regulatory actions in place, initiated, or considered for them:

  • Regulatory risk management ongoing: Substances with confirmed hazards for human health and the environment;
     
  • Regulatory risk management under consideration: Substances that are currently being considered for regulatory risk management;
     
  • Data generation: Substances that require additional information to conclude whether further regulatory action is needed;
     
  • Currently no further actions proposed: Substances for which authorities have not proposed further regulatory action at the moment; and
     
  • Not yet assigned: Substances currently registered under REACH but not yet assigned to any of the other pools.
     

Jack de Bruijn, Director for Prioritization and Integration, states that ECHA is “currently focusing mostly on the substances registered for volumes greater than 100 tonnes per year, where we aim to assign each substance to one of the pools by the end of 2020. For all registered substances, the work should be concluded by 2027.” He notes that for many substances, “further hazard data will need to be generated as non-compliant registrations are hampering progress. To that end, we have a joint action plan with the Commission to improve compliance of registrations to ensure they contain the necessary information to establish safe use.”

ECHA notes that the chemical universe does not indicate whether a substance’s use is safe or not, stating that “it is mainly to help authorities focus their actions.” The assignment to a category is also not permanent -- “substances will move from one pool to another over time when new information becomes available or priorities change. Furthermore, the assignment is largely calculated by algorithms and is based on a snapshot of the data from August 2019.” ECHA encourages stakeholders to check the substances’ infocards for the latest information. ECHA expects to update the substance list in early 2021. More information is available in ECHA’s press release, “Mapping the chemical universe: List of substances by regulatory action published.”

INTERNATIONAL AGENCY FOR RESEARCH ON CANCER (IARC)

IARC Encourages Stakeholders To Nominate Agents For Review In Future IARC Monographs: IARC encourages the general public, the scientific community, national health agencies, and other organizations to nominate agents for review in future IARC Monographs. According to the IARC’s information on nominations, nominations may include chemicals, mixtures, occupations, physical agents, biological agents, lifestyle factors, and anything else suspected of causing cancer in humans. IARC will select agents for review based on: (a) evidence of human exposure; and (b) evidence or suspicion of carcinogenicity.

SOUTH KOREA

Public Consultation Begins On Draft K-BPR Rules: South Korea’s Ministry of Environment (MoE) has prepared draft updated safety standards for consumer chemical products subject to safety checks under the Consumer Chemical Products and Biocide Safety Management Law (K-BPR). The following changes have been proposed and are subject to public consultation until December 17, 2019:

  • Five biocidal substances will be prohibited for use in filter-type products (e.g., antibacterial filters) for air purifiers and air conditioning:
     
    • Polyhexamethylene guanidine (PHMG);
       
    • Oligo(2-(2-ethoxy)ethoxyethyl) guanidinium-chloride (PGH);
       
    • Polyhexamethylene biguanide (PHMB);
       
    • 2-methyl-4-isothiazolin-3-one (MIT); and
       
    • 5-chloro-2-methyl-4-isothiazolin-3-one (CMIT).
       
  • Manufacture or import of consumer chemical products for use in humidifiers and “similar electrical equipment” will be banned from January 1, 2021, unless a risk assessment has been completed for the product.
     
  • Effective January 1, 2021, K-BPR will cover three new product-types (i.e., ink pads, correction fluids and tapes, and fog machine liquids). Arsenic and cadmium will be prohibited in ink pads, and benzene and tetrachloroethylene will be prohibited in correction fluids and tapes. Ethylene glycol and diethylene glycol will be limited at ten percent or less in fog machine fluids.
     
  • From January 1, 2021, the manufacture or import of microbeads in certain cleaning and washing products (e.g., detergents, stain removers, fabric softeners) will be prohibited.

Further information is available, in Korean, in MoE’s notice. A final version of the notice is expected to enter into force in early 2020.

Requirements For South Korean Manufacturers And Importers Of Chemicals Continue To Change: Our December 9, 2019, memorandum, “Requirements for South Korean Manufacturers and Importers of Chemicals Continue to Change,” highlights recent developments under South Korea’s Act on Registration and Evaluation, etc. of Chemical Substances (K-REACH), Occupational Safety and Health Act (OSH Act), and K-BPR. As reported in our memorandum, industry is now focusing on K-REACH registration requirements that provide the following phase-in timelines:

  • Substances imported or manufactured > 1,000 tons/year and carcinogens, mutagens, and reproductive toxins (CMR) > one ton/year must be registered by December 31, 2021;
     
  • Substances imported or manufactured < 1,000 tons/year and ≥ 100 tons/year must be registered by December 31, 2024;
     
  • Substances imported or manufactured < 100 tons/year and ≥ ten tons/year must be registered by December 31, 2027;
     
  • Substances imported or manufactured < ten tons/year and ≥ one ton/year must be registered by December 31, 2030.
     

Implementing the regulation that was proposed in April, following revisions to South Korea’s OSH Act issued in final on January 15, 2019, includes making significant changes to material safety data sheet (MSDS) requirements. These changes are to enter into force January 16, 2021. The implementing regulation is expected to be issued in final in early 2020.

MoE published rules in September regarding data requirements for biocidal substance and product approvals under K-BPR. Entities must also provide information on exposure, uses, categories of users, and main routes of exposure. Test data for human health and environmental impacts are also required. Some exemptions for submission of hazard information are available if exposure levels are low or testing is technically impossible.

More information on recent and upcoming K-REACH, OSH Act, and K-BPR developments is available in our memorandum.

UNITED KINGDOM (UK)

UK Government Publishes Draft Post-Brexit POPs Legislation: The UK government has published a draft Statutory Instrument to develop a UK-specific version of the EU’s Persistent Organic Pollutants (POP) Regulation. The Explanatory Memorandum to the Statutory Instrument provides that the Statutory Instrument “makes the necessary corrections” to ensure that the EU’s POPs Regulation functions in the UK following Brexit. The Explanatory Memorandum states that this incudes transferring legislative and administrative functions, currently “conferred by EU legislation” upon the EC and ECHA, “to be exercisable instead by public authorities in the UK, so that they can be exercised at national level after the UK leaves the EU.”

The Explanatory Memorandum indicates that, following the UK’s withdrawal from the EU, the amendments made by the Statutory Instrument to the EU’s POPs Regulation will “enable the UK to implement the Stockholm Convention by regulating the production, placing on the market, and use of POPs.” The Explanatory Memorandum provides that the Statutory Instrument will also enable UK authorities to “regulate stockpiles and manage waste where POPs are present, and set out monitoring and reporting requirements.” Furthermore, the Memorandum indicates that the amendments made by the Statutory Instrument will “create a power which will enable UK to put in place the necessary measures to ensure the control and traceability of waste contaminated by relevant pollutants.”

As the EU’s POPs Regulation “would not be effective in UK law due to the deficiencies arising from the withdrawal of the UK from the EU,” the Statutory Instrument makes “minor and technical amendments” to EU law to “ensure the legislation is operable after EU Exit.” The changes include amending references to the EU, EU institutions, and EU administrative processes to UK equivalents, updating legal references to refer to relevant UK law, and placing an “obligation on the Secretary of State to publish reports previously sent to the Commission.”

House Of Commons Publishes Government’s Response To Report On Toxic Chemicals In Everyday Life: As reported in our September 2019 Global Regulatory Update, in July 2019, the House of Commons Environmental Audit Committee published its final report entitled Toxic Chemicals in Everyday Life, completing its inquiry into the impact of toxic chemicals in everyday life on human health and the environment. On October 29, 2019, the Committee published the government’s response to its report. The report states that after exiting the EU, the UK will continue to use evidence-based approaches to regulation and maintain high levels of protection for human health and the environment. The principles of high levels of protection for human health and the environment will be at the forefront of the Chemicals Strategy currently being developed in consultation with stakeholders. According to the government, the forthcoming Chemicals Strategy “will be a vehicle for exploring options to develop an early warning system for identifying emerging chemical issues, considering how to address the tracking of chemicals in products, and working internationally on the standardisation of methods that assess chemical safety.” The Strategy will address concerns related to endocrine disruptors and the use of potentially toxic substances in furniture and household goods. Regarding green chemistry, the government “is scoping the means to best support industry in developing new approaches in the field.” This is taking place as part of the development of the Chemicals Strategy and its program of stakeholder engagement. The UK intends to publish a discussion document in March 2020 that will also incorporate a call for evidence. The UK plans to publish the final Chemicals Strategy in 2021-2022.

CIA Issues Brexit-Related Memorandum On Key Issues For Chemicals Industry: The Chemical Industries Association (CIA) has issued a memorandum entitled “Britain at work.” CIA covers several important topics in its memorandum, including “Transformational Co-operation between Government and the UK Chemical Industry,” “The Chemical Industry and Brexit,” and “Policy and Regulation.” In its memorandum, CIA highlights the importance of the UK’s chemicals industry and suitable post-Brexit chemicals regulations.

CIA states that Brexit-related uncertainty is affecting businesses and that investment decisions are “at best paused and, worse, those that could have been secured for the UK go elsewhere.” CIA indicates an “early decision” for whoever is in government after the general election must be to “clarify what happens next and by when.” CIA states the chemicals industry in the UK and Europe needs a post-Brexit UK-EU relationship that delivers: (1) frictionless, free trade; (2) regulatory consistency and alignment; and (3) access to skilled people.

As the UK considers its future relationship with the EU and the rest of the world, CIA urges the UK government to:

  • Design policy solutions that strike the right balance between risk and hazard, through a reliance on sound scientific assessment and robust evidence.
     
  • Require that policy is coordinated across departments and, where possible, across the UK, to ensure environmental, health, social, and economic impacts are taken into consideration.
     
  • Embrace the “innovation principle” in mainstream policymaking, ensuring that the impact on innovation is fully assessed and addressed whenever policy or regulatory decisions are being taken.
     

CIA highlights the following as “specific policy areas” it wants to work on with the government and other stakeholders: (1) climate change; (2) innovation; (3) educations and skills; (4) energy costs and markets; (5) international trade; and (6) regional supply chains.


 
THE ACTA GROUP
Beijing, China | Brussels, Belgium | Manchester, U.K. | Washington, D.C.
Contact • Twitter
 
Privacy Policy | Terms of Use | Cookie Policy
©2020 The Acta Group All Rights Reserved.