Global Regulatory Update for February 2023
Forecast For U.S. Federal And International Chemical Regulatory Policy: On January 5, 2023, Bergeson & Campbell, P.C. (B&C®), The Acta Group (Acta®), and B&C® Consortia Management, L.L.C. (BCCM) published the “Forecast for U.S. Federal and International Chemical Regulatory Policy 2023.” This extraordinarily detailed document offers our seasoned team’s collective take on what to expect regarding global industrial, agricultural, and biocidal chemical initiatives in 2023, including a greater degree of oversight of U.S. Environmental Protection Agency (EPA) actions by the U.S. House of Representatives, a continued evolution of concepts core to the Toxic Substances Control Act (TSCA), the European Union’s (EU) bold commitment to net-zero global warming emissions by 2050, and more.
WEBINAR — Recording Available For “Two Years Later: How Has The Chemicals Strategy For Sustainability Changed REACH And CLP Regulations?”: Acta’s January 17, 2023, webinar, “Two Years Later: How Has the Chemicals Strategy for Sustainability Changed REACH and CLP Regulations?,” is now available for on-demand viewing. During this one-hour webinar, Meglena Mihova, Managing Partner, EPPA; Thomas Petry, Ph.D., Managing Director, ToxMinds; Jane S. Vergnes, Ph.D., DABT®, Vice President, Scientific Affairs, Director of Toxicology, Acta; and Lynn L. Bergeson, President, Acta, explore exactly how the Chemicals Strategy for Sustainability is fundamentally reshaping the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and the Classification, Labeling and Packaging (CLP) regulations in ways that are resetting the global stage in terms of identifying new hazard classes and New Approach Methodologies (NAM) for identifying them.
WEBINAR — “What To Expect In Chemicals Policy And Regulation And On Capitol Hill In 2023” Available On-Demand: Acta affiliate B&C’s January 31, 2023, webinar “What to Expect in Chemicals Policy and Regulation and on Capitol Hill in 2023” is now available for on-demand viewing. During this one-hour webinar, Lynn L. Bergeson, Managing Partner, B&C; James V. Aidala, Senior Government Affairs Consultant, B&C; Richard E. Engler, Ph.D., Director of Chemistry, B&C; and Dennis R. Deziel, Senior Government Affairs Advisor, B&C discussed EPA priorities, leadership, and operating environment in the new year. This includes a review of priorities and challenges that will shape updates that are expected to affect TSCA and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) implementation in 2023.
WEBINAR — Extended Producer Responsibility, March 22, 2023, 12:00 p.m. – 1:00 p.m. (EDT), Via Webinar: B&C is pleased to present “Extended Producer Responsibility,” a webinar featuring LeRoy Paddock, Associate Dean for Environmental Law Studies at George Washington University Law School; Edith G. Nagy, Regulatory Consultant, B&C; and Lynn L. Bergeson, Managing Partner, B&C as they discuss the Extended Producer Responsibility (EPR) policy approach of shifting responsibility for a product’s life cycle upstream and what that means for producers. Register now.
EVENT — Biocides North America 2023, February 28, 2023, Via Webinar: Chemical Watch’s sixth annual Biocides North America conference will focus on recent developments for antimicrobials in the United States, featuring the EPA Office of Pesticide Programs’ (OPP) priorities and challenges, updates on federal registration processes, a look at state level developments for per- and polyfluoroalkyl substance (PFAS) regulations, and an update on changes to the regulatory framework for biocides in Canada. Meibao Zhuang, Ph.D., Senior Scientist and Regulatory Consultant, Acta and Dennis R. Deziel, Senior Government Affairs Advisor, Acta will present “Emerging FIFRA legal and policy issues and the Congress: Implications for the pesticide community.”
AICIS Updates Decision Tool For Companies To Work Out If They Meet Reporting Category (Ten kg or Less) Criteria: On January 31, 2023, the Australian Industrial Chemicals Introduction Scheme (AICIS) announced that it updated its “Step 3” decision tool to include questions to help companies work out if their introduction meets the criteria for the reported category ten kilograms (kg) or less. AICIS states that it published these criteria last year in Step 3 of its “guide to categorising your chemical importation or manufacture” following last year’s changes to the Industrial Chemicals General Rules on introductions of ten kg or less.
Canada Amends Hazardous Products Regulations To Align With GHS Revs 7 And 8: On January 4, 2023, the Department of Health in Canada published in the Canada Gazette, Part II the revisions to the Hazardous Products Regulations (HPR). The HPR is the federal-level legislation that sets forth the classification, labeling, and Safety Data Sheet (SDS) requirements for hazardous products intended to be used, handled, or stored in workplaces in Canada. The current HPR is based on the fifth revised edition (Rev 5) of the United Nations (UN) Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The changes include updating the HPR to align with the seventh revised edition (Rev 7) of GHS, and they include elements from the eighth revised edition (Rev 8). The transition period is three years.
Highlights of the major changes include the following:
- Updates and amendments to terminology to align with Rev 7. This includes updates to several health and physical hazard class definitions;
- Revisions and amendments to the HPR Subpart that includes Flammable Gases. These changes include revised definitions and the incorporation of pyrophoric gases;
- Revisions and amendments to the HPR Subpart that address aerosols. These changes include adding non-flammable aerosols, revising the definitions, and renaming the Subpart from Flammable Aerosols to Aerosols;
- Clarifications on approaches to classification for Aerosols versus Gases Under Pressure;
- Adoption of Chemicals Under Pressure from Rev 8 to align with the U.S. proposed changes to the Occupational Safety and Health Administration (OSHA) updates to the current Hazard Communication Standard (HCS 2012);
- Expansion of the criteria and methods for the HPR Subpart for Oxidizing Solids;
- Revisions to Section 9 Physical and chemical properties content of the SDS;
- Changes to Section 14 Transport information on the SDS; and
- Amendments to allow for additional hazard statements for Combustible Dusts.
More information is available in our January 9, 2023, memorandum.
Canada Publishes Notice Of Intent On Promoting Reduced Reliance On Animal Testing In The New Substances Notification Regulations (Chemicals And Polymers): Canada published a notice of intent on January 14, 2023, to inform stakeholders that the government intends to consider possible amendments to the New Substances Notification Regulations (Chemicals and Polymers) (NSNR (Chemicals and Polymers)) to promote the reduced reliance on animal testing and the alignment of regulatory requirements with advancements in science. According to the notice, while animal testing provides important information for a number of regulatory programs — including Health Canada (HC) and Environment and Climate Change Canada (ECCC) programs administering the NSNR (Chemicals and Polymers) — that aim to protect the environment and Canadians’ health and safety, the government is committed to advancing efforts to replace, reduce, or refine the use of animals in testing where possible, including through proposed changes in legislation, such as the Canadian Environmental Protection Act (CEPA) and its regulations. In April 2022, HC and ECCC initiated a one-year review of the NSNR (Chemicals and Polymers) as part of the Regulatory Stock Review Plan in accordance with the Cabinet Directive on Regulation. The departments also committed to reviewing the requirements for animal testing in the NSNR (Chemicals and Polymers). Upon completion, the Regulatory Stock Review will result in a recommendation to maintain the current regulations, amend them, repeal them, or replace them with other instruments or regulations.
Canada Issues Proposed Code Of Practice For The Environmentally Sound Management Of Chemical Substances In The Chemicals, Plastics, And Rubber Sectors: Canada announced on February 4, 2023, that it issued the proposed Code of Practice for the Environmentally Sound Management of Chemical Substances in the Chemicals, Plastics and Rubber Sectors under CEPA Section 54(1). The objective of the code is to identify and promote best practices in the management and handling of chemical substances in the manufacturing and distribution of chemicals, plastics, and rubber products to prevent releases of these substances into the environment. In addition, the code has been developed for use as a supporting risk management instrument to address specific substances used in the chemicals, plastics, and rubber sectors. The code addresses environmental management systems, training, and recordkeeping; receiving and unloading of chemical substances; storage of chemical substances; transfer of chemical substances; production operations; packaging, loading, and shipping; container/tank and hopper car/truck cleaning; waste management; maintenance and housekeeping; and spills. To assess the degree of implementation of the code and to help identify areas of improvement, ECCC requests companies to submit an annual report (provided in Appendix 1) on their progress in implementing the code. Reports should be submitted by March 31 of each year. Comments are due April 5, 2023.
Canada Begins Public Consultation On Draft Objective For PFAS In Canadian Drinking Water: On February 11, 2023, Canada began a public consultation on a draft objective for PFAS in Canadian drinking water. Health Canada developed the technical document to provide regulatory authorities and decision makers with an objective for PFAS in Canadian drinking water supplies. To reduce exposure from drinking water, an objective of 30 nanograms per liter (ng/L) is proposed for the sum of total PFAS detected in drinking water. The purpose of the consultation is to solicit comments on the proposed objective, the approach used to develop it, and the potential impacts of implementing it. Canada seeks comments from regulatory authorities, decision makers, and the public. Comments are due April 12, 2023.
EC Adopts Proposal To Extend Transition Period Under The Medical Devices Regulation: The European Commission (EC) announced on January 6, 2023, that it adopted a proposal to provide more time to certify medical devices to mitigate the risk of shortages. The proposal would amend the transitional provisions to allow more time for manufacturers to transition from the previously applicable rules to the new requirements of the Medical Devices Regulation. The length of the extension of the transition periods would depend on the type of device: higher risk devices such as pacemakers and hip implants would benefit from a shorter transition period (until December 2027) than medium and lower risk ones, such as syringes or reusable surgical instruments (until December 2028). The proposal would also allow medical devices placed on the market in accordance with the current legal framework and that are still available to remain on the market (i.e., no “sell-off” date). The European Parliament (EP) and the Council of the EU must adopt the proposal though an accelerated co-decision procedure for the changes to take effect.
ECHA Receives “One Of The Broadest” Proposals To Restrict PFAS Under REACH: The European Chemicals Agency (ECHA) announced on January 13, 2023, that the national authorities of Denmark, Germany, the Netherlands, Norway, and Sweden have submitted a proposal to restrict more than 10,000 PFAS under REACH. ECHA published the detailed proposal, “one of the broadest in the EU’s history,” on February 7, 2023. The national authorities submitted the proposal after finding risks in the manufacture, placement on the market, and use of PFAS that are not, in their view, adequately controled and need to be addressed throughout the EU and the European Economic Area (EEA). The proposal suggests two restriction options — a full ban and a ban with use-specific derogations — to address the identified risks.
ECHA’s Scientific Committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) will check that the proposed restriction meets the legal requirements of REACH in their March 2023 meetings. If it does, RAC and SEAC will begin their scientific evaluation of the proposal. ECHA plans to begin a six-month consultation on March 22, 2023. ECHA states that it will hold an online information session on April 5, 2023, to explain the restriction process and help those interested in participating in the consultation.
ECHA notes that the opinions of RAC and SEAC are typically ready within 12 months of the start of the scientific evaluation, in accordance with REACH. In view of the complexity of the proposal and the extent of information that is expected from the consultation, however, RAC and SEAC “may need more time to finalise their opinions.” Once the opinions are adopted, they will be sent to the EC, who together with the EU member states will then decide on a potential restriction. More information is available in our February 13, 2023, memorandum.
ECHA Consulting On Harmonized Classification And Labeling For IPBC: ECHA is holding a public consultation on a harmonized classification and labeling (CLH) proposal for a biocidal active substance, 3-iodo-2-propynyl butylcarbamate; 3-iodoprop-2-yn-1-yl butylcarbamate (IPBC) (European Community Number (EC No.) 259-627-5, Chemical Abstracts Service Registry Number® (CAS RN®) 55406-53-6). ECHA used a combined format, including the competent authority (renewal) assessment report prepared according to Commission Delegated Regulation (EU 1062/2014) and the proposal for an updated CLH according to the Regulation (EC) No 1272/2008 on classification, labeling, and packaging of substances and mixtures. The hazard classes open for commenting are “acute toxicity — inhalation” and “hazardous to the aquatic environment (acute and chronic).” Comments are due February 17, 2023.
The Great Britain Mandatory Classification and Labelling (GB MCL) process includes the consideration of information gathered from public consultations, conducted by the United Kingdom (UK) Health and Safety Executive (HSE) or international bodies such as ECHA. HSE encourages UK-based businesses with an interest in the proposal to share any relevant information directly with ECHA. HSE suggests that if a business is affected by the Great Britain Classification, Labelling and Packaging (GB CLP) Regulation, it should consider whether it is likely to be affected by the classification and labeling proposal and let HSE know at an early stage if it anticipates any significant impacts or benefits. Information on wider policy and impact considerations can be submitted to HSE at GBCLP.GBMCL@hse.gov.uk. Under the GB CLP Regulation, HSE will consider all published opinions of ECHA’s RAC before publishing its own Agency Technical Reports and Agency Opinions, so any information provided will be important in any final GB MCL decision.
ECHA Adds Nine Hazardous Chemicals To Candidate List: ECHA announced on January 17, 2023, that it has added nine chemicals to the Candidate List because of their hazardous properties. According to ECHA, the chemicals are used in flame retardants, paints and coatings, inks and toners, coating products, and plasticizers, and in the manufacture of pulp and paper. The chemicals are:
|Reason for Inclusion
|Examples of Use(s)
|Very persistent and very bioaccumulative (vPvB) (REACH Article 57(e))
|While the substance itself is not registered under REACH, identification as a substance of very high concern (SVHC) can be seen as a measure to avoid future regrettable substitution.
|Carcinogenic (REACH Article 57(a))
|As a reactive flame retardant and as an additive flame retardant in the manufacture of polymer resins, in products such as epoxy-coated circuit boards, printed circuit boards, paper, and textiles.
|Toxic for reproduction (REACH Article 57(c));
Endocrine-disrupting properties (REACH Article 57(f) — environment);
Endocrine-disrupting properties (REACH Article 57(f) — human health)
|In the manufacture of pulp, paper and paper products, textile, leather or fur, and chemicals.
|Barium diboron tetraoxide
|Toxic for reproduction (REACH Article 57(c))
|In paints and coatings.
|Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof
|vPvB (REACH Article 57(e))
|As a flame retardant and as a plasticizer for flexible polyvinyl chloride (PVC) and for use in wire and cable insulation, film and sheeting, carpet backing, coated fabrics, wall coverings, and adhesives.
|Endocrine-disrupting properties (REACH Article 57(f) — human health)
|In the manufacture of substances and in the following products: coating products, fillers, putties, plasters, modeling clay, and inks and toners.
|Equivalent level of concern having probable serious effects to human health (REACH Article 57(f) — human health);
Equivalent level of concern having probable serious effects to the environment (REACH Article 57(f) — environment)
|In polymers and resins, coating products, adhesives and sealants, leather treatment products, and laboratory chemicals.
|Perfluoroheptanoic acid and its salts
|Toxic for reproduction (REACH Article 57(c));
Persistent, bioaccumulative, and toxic (PBT) (REACH Article 57(d));
vPvB (REACH Article 57(e));
Equivalent level of concern having probable serious effects to human health (REACH Article 57(f) — human health);
Equivalent level of concern having probable serious effects to the environment (REACH Article 57(f) — environment)
|While the substance itself is not registered under REACH, identification as an SVHC can be seen as a measure to avoid future regrettable substitution.
|Reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl)morpholine
|vPvB (REACH Article 57(e))
|Used in articles, by professional workers (widespread uses), in formulation or re-packing, at industrial sites, and in manufacturing.
More information is available in our January 31, 2023, blog item.
ECHA Announces Changes To Completeness Checks: ECHA carries out a completeness check on each incoming registration, as set out in REACH Article 20(2). In 2021 and 2022, the EC amended some of the information requirements for registering chemicals under REACH. In its January 23, 2023, press release, ECHA states that, beginning May 1, 2023, it will start checking both new registrations and updates to existing ones against the amended requirements, which will also take effect May 1, 2023, and will apply to both new registrations and updates of existing ones. ECHA states that registrants should prepare for the changes, as registrations submitted before may no longer pass the completeness check.
According to ECHA, in parallel, it has made limited revisions to the completeness check in other areas, such as use information. ECHA notes that the IUCLID validation assistant will also be updated with the amended completeness check rules when the new version of IUCLID is released at the end of April 2023. ECHA encourages registrants to use the validation assistant to check their registrations before submitting them to ECHA. More information is available in our February 8, 2023, blog item.
EC Publishes Transition Pathway For The Chemical Industry: In January 2023, the EC announced the availability of the Transition Pathway for the Chemical Industry (Pathway). The EC describes the Pathway as an actionable plan co-developed by the EC with EU countries, chemical industry stakeholders, non-governmental organizations (NGO), and other interested parties. The Pathway provides a group of topics and actions to be implemented by each of the involved actors. The most relevant ones are presented as a roadmap composed of:
- An action-oriented component grouping the topics under three cross-cutting themes: collaboration for innovation; clean energy supply; and feedstock diversification. These actions are expected to contribute toward the transition and are set against a timeline;
- A technology component identifying electrification, hydrogen, biomass, waste, carbon capture and utilization (CCU), and carbon capture and storage (CCS), as well as process efficiency as key technological contributors to the transition pathway; and
- A regulatory component that collects the existing legislation, including major research and innovation (R&I) initiatives, influencing digital and sustainable development of the chemical industry.
According to the Pathway, by implementing the actions identified under each topic, the chemical sector is expected to succeed in its green and digital (twin) transition and improve its own resilience, sustainability, and “circularity” (i.e., its functioning in line with the principles of the circular economy), in line with the European Green Deal. The Pathway states that the co-implementation of the transition pathway for the chemical industry will be the next step. This entails disseminating the pathway to all relevant stakeholders, who would then present their commitments specifying the actions and topics to which they will contribute. The proposals in the final chapter will be discussed and agreed on during the co-implementation process expected to start in spring 2023.
EC Begins Public Consultation On New Product Priorities For Ecodesign For Sustainable Products: On March 30, 2022, the EC adopted a proposal for a Regulation on Ecodesign for Sustainable Products (ESPR). The proposed ESPR is intended to reduce the environmental impacts of products across their life cycles and to improve the functioning of the EU’s internal market. It would extend the Ecodesign Directive to cover a very broad range of physical products and to strengthen its provisions, allowing the ESPR to set a range of far-reaching performance and information-related requirements for specific product groups and to improve product circularity, energy performance, and other environmental sustainability aspects. For groups of products that share a set of common characteristics, horizontal rules could be set. On January 31, 2023, the EC began a public consultation on new product priorities for the ESPR. In the call for evidence, the EC identified a number of new products (including 12 end-use and seven intermediary products) and horizontal measures as potentially suitable for first action under the ESPR:
- End-use products: Textiles and footwear; furniture; ceramic products; tires; detergents; bed mattresses; lubricants; paints and varnishes; cosmetic products; toys; fishing nets and gear; absorbent hygiene products;
- Intermediary products: Iron and steel; non-ferrous metals; aluminum; chemicals; plastic and polymers; paper, pulp paper, and boards; glass; and
- Horizontal measures: Durability; recyclability; post-consumer recycled content. (For each horizontal measure, potential provisions via which they could be applied are put forward.)
The EC notes that this is a preliminary analysis and is not binding. The assumptions and findings are subject to correction and further revision. Once adopted, the first working plan will serve as a key monitoring tool under the ESPR, as it will set out a list of products and horizontal measures against which regulatory progress can be benchmarked. Responses to the questionnaire are due April 25, 2023. Following the consultation, the EC will run targeted consultation exercises, planned for the second quarter of 2023.
ECHA Provides Updated Guidance On Testing Nanomaterials: ECHA announced in its February 1, 2023, ECHA Weekly that it has released an updated appendix for nanomaterials that provides guidance on how to obtain data under the new information requirements for nanoforms. According to ECHA, this includes information on how to perform environmental testing and advice on preparation methods and testing strategies for physico-chemical testing of nanoforms. ECHA notes that the Partner Expert Group (PEG) members “actively contributed to the update.” More information on the changes to Guidance on information requirements and chemical safety assessment: Appendix R7-1 for nanomaterials applicable to Chapter R7a Endpoint specific guidance are available in our February 1, 2023, blog item.
ECHA Calls For Evidence On PVC And PVC Additives: The EC requested that ECHA prepare an investigation report on PVC and PVC additives. ECHA has begun a call for evidence on alternative additives in PVC and other plastics. In consultation with targeted stakeholders, ECHA has compiled a list of additives currently used in PVC. From that list, ECHA selected a subset of additives currently used as heat stabilizers, plasticizers, and/or flame retardants in PVC (“additives in focus”). In the call for evidence, ECHA requests information on alternative substances to the currently used “additives in focus” in PVC and additives used in alternative plastics to PVC. The call for evidence is open until March 31, 2023.
EC Proposes New Exposure Limits For Lead And Diisocyanates: The EC announced on February 13, 2023, that it has taken action to improve the protection of workers from the health risks linked to exposure to lead and diisocyanates. The EC proposes to amend two Directives: for lead, the Directive on the protection of workers from the risks related to exposure to carcinogens, mutagens, and reprotoxic substances at work, and for lead and diisocyanates, the Directive on the protection of workers from the risks related to chemical agents at work. For lead, the EC proposes:
- To lower the occupational exposure limit (OEL) from 0.15 milligrams per cubic meter (0.15 mg/m3) to 0.03 mg/m3; and
- To lower the biological limit value from 70 micrograms per 100 milliliters of blood (70 µg/100 mL) to 15 µg/100 mL.
The EC proposes to introduce, for the first time, limit values to protect workers from exposure to diisocyanates at work. These limit values refer to the nitrogen, carbon, and oxygen (NCO) group of diisocyanates, responsible for their ill-health effects:
- An eight-hour OEL of 6 µg NCO/m3; and
- A short-term (15-minute) exposure limit of 12 µg NCO/m3.
The EP and the Council of the EU will now discuss the EC’s proposal. Once adopted, EU member states will have two years to transpose the Directives into national law.
France Appeals European General Court Decision Annulling The Harmonized Classification And Labeling Of Titanium Dioxide: According to a February 13, 2023, press release issued by France’s Ministry of Ecological Transition and Territorial Cohesion and Ministry of Energy Transition, France is appealing the November 23, 2022, decision of the European General Court that annuls the 2019 harmonized classification and labeling of titanium dioxide as a carcinogenic substance by inhalation in certain powder forms. As reported in our December 6, 2022, memorandum, the court concluded that the EC “made a manifest error in its assessment of the reliability and acceptability of the study on which the classification was based and, second, it infringed the criterion according to which that classification can relate only to a substance that has the intrinsic property to cause cancer.” France claims that the court exceeded the limits of its judicial review by conducting its own evaluation and interpretation of the scientific data. France notes that the appeal suspends the court’s decision and that the harmonized classification and labeling will continue to apply until the appeal is decided.
ChemSec Will Hold Webinar On Forthcoming PFAS Guide: On February 23, 2023, the International Chemical Secretariat (ChemSec) will hold a launch webinar for its PFAS Guide, “ChemSec’s new website and overall oracle when it comes to telling you if you have PFAS in your company product!” During the webinar, ChemSec will provide a “first exclusive look at the PFAS Guide.” Presenters will include:
- Dr. Anna Lennquist, Senior Toxicologist at ChemSec;
- Dr. Jonatan Kleimark, Senior Chemicals and Business Advisor at ChemSec; and
- Joséphine Källström, Business Developer at ChemSec.
REACHblog®: For access to a timely summary of key regulatory, policy, and business developments under the EU REACH regulation and UK REACH, go to www.REACHblog.com.
MOE Announces Major Policies For Environmental Health Bureau For 2023: On February 2, 2023, South Korea’s Ministry of Environment (MOE) published a press release regarding its annual work plans for environmental health and chemical safety for 2023. The major policies of the Environmental Health Bureau for 2023 include:
- Advanced Management of Environmental Risk Factors in People’s Daily Life: MOE will enhance indoor environmental quality by improving measurement, facilities, and management.
- Consumer-Centered Investigation and Management of Health Damage and Customized Support for Environmental Health: MOE will expand and strengthen the investigation and management of environmentally vulnerable areas.
- Reinforce Safety Management of Household Chemical Products: MOE plans to strengthen the safety management of household chemical products. MOE will expand the scope of consumer chemical products subject to safety verification. The press release states that MOE will only permit the distribution of biocidal substances and products with proven safety and effectiveness. MOE will prepare test and evaluation methods and guidelines for the approval process for biocidal products. According to the press release, MOE will assist companies in preparing their application for approval and will hold briefing sessions.
- Establish a Safe and Sustainable Chemical Management System: MOE plans to reduce hazards caused by chemicals by switching to low-toxic green chemical systems. According to the press release, MOE plans to reduce hazards caused by chemicals by switching to low-toxic green chemical systems. MOE will establish a “Comprehensive Plan for Green Chemistry” to reduce the use of toxic chemicals throughout their life cycle, beginning with their manufacture. MOE will prepare to amend the Act on Registration and Evaluation of Chemical Substances (K-REACH) and the Chemical Substances Control Act (CSCA) by August 2023. In addition, MOE plans to prepare a roadmap to manage chronic hazardous substances according to their risk characteristics “because chronic hazardous substances cause harm under long-term exposure at low concentrations.”
- Establish a Reliable System for Chemical Accident Prevention and Preparedness: The press release states that MOE “plans to strengthen functions to prevent chemical accidents by scientifically analyzing the cause of accidents and providing support for managing facilities.” MOE aims to prevent chemical accidents in advance by confirming whether workplaces with risks of similar accidents (400 cases) implement plans for chemical accident prevention and management.
Turkey Updates KKDIK Registration Requirements: On February 3, 2023, the Turkish Ministry of Environment, Urbanization and Climate Change (MoEUCC) released new guidance on the registration requirements under the KKDIK regulation (Kimyasalların Kaydı, Değerlendirilmesi, İzni ve Kısıtlanması). As a result of this new guidance, providing importer information for the registration of a substance is now optional instead of mandatory, the chemical safety report (CSR) may be submitted in English, and there is additional time after the registration deadline to submit the Turkish translation. Additionally, the “Registrant Identity” and the “Registration Number” may now be claimed as confidential business information (CBI).
The Ministry encourages registrants or their Only Representatives (OR) to include importer information where possible but no longer includes it as a mandatory field in KKS. The OR must keep an up-to-date list of the importers and the tonnage covered for each of these importers, as well as the information on obtaining the latest update of the SDS. All the relevant guidance documents will be updated to reflect these updates.
Industry also expressed concern about the requirement to submit a CSR translated into Turkish for every registration dossier at more than 10 mt per year. To many, this requirement would significantly delay the registration process. With the registration deadline rapidly approaching, the Ministry relented and announced that registrants now have the option of submitting the CSR in English. Registrants have up to an additional year after the December 31, 2023, deadline, to submit the Turkish translation. The Ministry does require that risk management measures be included in Turkish. The requirement to submit the information regarding robust study summaries in Turkish remains unchanged.
More information is available in our February 10, 2023, memorandum.
HSE Begins Public Consultation On Changes To GB BPR Data Requirements: On January 17, 2023, HSE began a public consultation on changes to the data requirements in the Great Britain (GB) Biocidal Products Regulation (GB BPR). GB BPR applies to the supply and use of biocidal products. Biocidal products are products that control harmful organisms, and include insecticides, rodenticides, wood preservatives, anti-fouling coatings on ships, disinfectants, and hand sanitizers. HSE is consulting on proposed revisions to Annexes II and III of GB BPR, which address the information requirements for biocidal active substances and the information requirements for biocidal products. Comments are due March 14, 2023.
HSE proposes to make technical updates to the Annexes that will:
- Introduce and place emphasis on in vitro studies rather than in vivo studies;
- Make new tests for endocrine disruptors part of the legal data requirements in GB BPR, rather than only being done on an ad hoc basis;
- Change mutagenicity requirements to reflect new information;
- Change requirements in relation to reproductive toxicity and generational studies;
- Change the requirements to include developmental neurotoxicity studies if certain triggers are met; and
- Change the requirements to include efficacy data to support the innate activity of the active substance for the intended use.
More information is available in our January 26, 2023, memorandum.
HSE Publishes Restriction Opinion On Tattoo And PMU Inks, Begins Public Consultation On Socio-Economic Analysis Opinion: HSE announced on February 14, 2023, that it published its final risk assessment opinion and draft socio-economic opinion on a restriction proposal for certain substances in tattoo and permanent make-up (PMU) inks. In its first risk assessment opinion issued under UK REACH, HSE offers two restriction options. The first option applies to the following substances and substances with the following hazard classes if they are present in tattoo or PMU ink:
- Substances classified in the GB MCL list as:
- Carcinogens (H350, H351) or mutagens (H340, H341);
- Toxic to reproduction (H360, H361);
- Skin sensitizers (H317);
- Skin corrosive or skin irritants (H314, H315); and
- Substances that cause serious eye damage/eye irritant substances (H318, H319);
- Carcinogens (H350, H351) or mutagens (H340, H341);
- Substances prohibited for use in cosmetic products under the Cosmetic Products Regulation; and
- Substances listed in the Council of Europe Resolution (CoE ResAP) (2008) that are not covered by one or more of the above categories.
The second option removes from its scope substances that are within the scope only because of their classification for skin corrosion, skin irritation, eye damage, or eye irritation. It is otherwise identical to the first option.
Both options aim to prevent inks for tattooing and PMU from being placed on the GB market or used for tattooing or PMU procedures if they contain any substance in scope of the restriction above the specified concentration limit. The restriction also introduces labeling requirements. HSE proposes a one-year transition period for ink formulators and suppliers. HSE proposes an additional year for tattoo artists and PMU practitioners to use up stocks of inks purchased before the end of the transition period.
Comments on the draft socio-economic opinion are due April 14, 2023.