Global Regulatory Update for April 2022


WEBINAR - Register Now For “FIFRA Hot Topics,” April 20, 2022, 12:00 p.m. EDT: Register now to join Lisa M. Campbell, Vice President, The Acta Group (Acta®); Edward Messina, Director, EPA OPP, and James V. Aidala, Vice President, Policy and Government Affairs, Acta, for "FIFRA Hot Topics," a complimentary webinar covering key U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) priorities in 2022, including renewed efforts to meet Endangered Species Act (ESA) consultation requirements with the release of the Balancing Wildlife Protection and Responsible Pesticide Use work plan, determining how best to meet core pesticide registration review obligations, and the development of the fifth Pesticide Registration Improvement Extension Act (PRIA).

WEBINAR - Register Now For “Domestic Chemical Regulation and Achieving Circularity,” May 18 2022, 12:00 p.m. EDT: A circular economy requires new thinking about what products we make, from which materials we make them, and where products go at the end of their useful life. An important but often overlooked aspect of new product development is an understanding of the consequences of the product’s chemical composition and the end-of-life implications of the decisions made at the front end of the process. Working within this framework plays a critical role in building a resilient, dependable, and sustainable system that fosters innovation to develop a circular economy. Register now to join Lynn L. Bergeson, President, Acta; Richard E. Engler, Ph.D., Director of Chemistry, Acta; Kate Sellers, Technical Fellow, ERM; and Mathy Stanislaus, Esquire, Vice Provost and Executive Director of Drexel University’s Environmental Collaboratory, for “Domestic Chemical Regulation and Achieving Circularity.”

Join Acta At Upcoming In-Person Events: Acta professionals are looking forward to seeing people in person again at live events this summer. We hope to see you at CHEMUK 2022 in Birmingham, UK, May 11-12, 2022, where Steven P. Brennan, Ph.D., Senior Manager, REACH, Acta, and Emma Louise Jackson, CBiol MSB, Regulatory Consultant, Acta, will be exhibiting.

AUSTRALIA

Public Consultation Begins On Draft IChEMS Decision-Making Principles: The Industrial Chemicals Environmental Management Standard (IChEMS) is a national approach to managing chemical use, storage, handling, and disposal. It is intended to deliver more consistent environmental regulation and make it easier for industry to choose less harmful chemicals. The government will categorize and schedule chemicals on the IChEMS Register based on their level of concern to the environment. The government has published the IChEMS roadmap, setting out key steps, roles, and responsibilities in delivering the new IChEMS framework. All Australian jurisdictions are working to adopt and implement IChEMS into their own regulatory frameworks from late 2022.

A public consultation has begun on the draft IChEMS decision-making principles, which will be established by legislative instrument under the Industrial Chemicals Environmental Management (Register) Act 2021. The draft principles set out technical criteria that define the level of environmental concern based on characteristics of the chemical and its use. This includes information such as whether a chemical is persistent in the environment, whether it is bioavailable, how toxic it is, and the predicted concentration in the environment. The criteria will be used to determine on which schedule of the IChEMS Register an industrial chemical and its proposed use should be listed, according to the level of environmental concern. The draft principles also provide broad guidance on risk management measures and other controls that can be included in the IChEMS Register to prevent or minimize environmental harm from industrial chemicals. Comments on the draft principles are due May 24, 2022.

BRAZIL

ANVISA Clarifies Cosmetics Regulations: The Brazilian Health Regulatory Agency (ANVISA) has reviewed the existing cosmetics regulations and made clarifying amendments. The amendments are intended to improve the wording and not make any substantive revisions. The published resolutions, separated by the effective date, include:

Effective Date: April 1, 2022

  • Resolution - RDC No. 628, of March 10, 2022: Provides for the list of permitted coloring substances for personal hygiene products, cosmetics, and perfumes and internalizes GMC MERCOSUR Resolution No. 16/2012. Repeals RDC No. 44 of 2012.
     
  • Resolution - RDC No. 629, of March 10, 2022: Provides for sunscreens and multifunctional products in cosmetics and internalizes GMC MERCOSUR Resolution No. 08/2011. Repeals RDC No. 30 of 2012.
     
  • Resolution RDC No. 630, of March 10, 2022: Establishes parameters for microbiological control of personal hygiene products, cosmetics, and perfumes and internalizes GMC MERCOSUR Resolution No. 51/1998. Repeals Resolution No. 481 of 1999.
     

Effective Date: May 2, 2022

  • Resolution - RDC No. 639, of March 24, 2022: Provides for the technical requirements for the regularization of personal hygiene products, cosmetics, and children's perfumes. Repeals RDC No. 15 of 2015. Revokes arts. 1 to 8 and 10 of RDC No. 237 of 2018.
     
  • Resolution - RDC No. 640, of March 24, 2022: Provides for the regularization of disposable personal hygiene products intended for personal hygiene, which include brushes and swabs for oral hygiene, dental threads and tapes, disposable sanitary pads, menstrual cups, and flexible swabs. Repeals RDC No. 142, of 2017. Repeals RDC No. 178 of 2017.
     
  • Resolution RDC No. 641, of March 24, 2022: Defines the extraordinary and temporary criteria and procedures for the manufacture and sale of antiseptic preparations or workshop sanitizers without prior authorization from ANVISA and other measures, due to the international public health emergency related to SARS-CoV-2. Repeals RDC No. 350 of 2020. Repeals RDC No. 422 of 2020.
     
  • Resolution RDC No. 642, of March 24, 2022: Provides for the criteria for inclusion, exclusion, and alteration of the concentration of substances used in personal hygiene products, cosmetics, and perfumes in lists and internalizes GMC MERCOSUR Resolution No. 133/96. Repeals Ordinance No. 295 of 1998.
     
  • Resolution RDC No. 643, of March 24, 2022: Establishes definitions and technical requirements of cosmetics related to skin tanning, as well as a labeling warning for tan activators/accelerators. Repeals RDC No. 126 of 2016.
     
  • Resolution RDC No. 644, of March 24, 2022: Establishes general rules for personal hygiene products, cosmetics, and perfumes manufactured in Brazil and destined exclusively for export. Repeals RDC No. 92 of 2008.
     
  • Resolution - RDC No. 645, of March 24, 2022: Provides for the conditions of use of lead acetate, formaldehyde, paraformaldehyde, and pyrogallol and internalizes GMC MERCOSUR Resolution No. 48/2010. Repeals RDC No. 521 of 2021.
     
  • Normative Instruction - IN No. 124, of March 24, 2022: Establishes the “List of actives allowed in cosmetic products to straighten or curl hair” with requirements for its use, pursuant to the Resolution of the Collegiate Board of Directors - RDC No. 409 of July 27, 2020. Repeals IN No. 64 of 2020. Repeals IN No. 98 of 2021.
     

Effective date: November 1, 2023

n Resolution RDC No. 646, of March 24, 2022: Provides for the obligation to describe the composition in Portuguese on the labeling of personal hygiene products, cosmetics, and perfumes. Repeals RDC No. 432 of 2020. Repeals RDC No. 499 of 2021.

CANADA

Canada Posts Updated Rolling Workplan Performance Measurement Evaluations Of Toxic Substances: Canada conducts performance measurement evaluations to provide Canadians with information on the effectiveness of risk management actions for substances found to be toxic under the Canadian Environmental Protection Act, 1999 (CEPA). Canada systematically evaluates the risk management, human health, and environmental objectives using robust data and expert analysis. In March 2022, Canada posted the following updated high-level rolling workplan of performance measurement evaluations of risk management strategies for certain substances underway or to be initiated over the next four years. Canada states that it selected substances as set out in the Performance Measurement Evaluation Strategy for toxic substances. Canada notes that the substances listed and timeframes may be subject to change and that the rolling workplan is provided for information purposes only.

Timing Substances Targeted Component of the Evaluation
Evaluations in progress Benzene Health
Dichloromethane Health
Dioxins and furans Health
Hexavalent chromium compounds Health
Inorganic arsenic compounds Health
Inorganic cadmium compounds Health and Ecological
Nonylphenol and its ethoxylates Ecological
Polychlorinated biphenyls (PCB) Health
Upcoming evaluations (to be initiated in 2021/22 through to 2022/23) Dioxins and furans Ecological
Ethylene oxide Health
Inorganic arsenic compounds Ecological
Octamethylcyclotetrasiloxane (D4) Ecological
Perfluorooctane sulfonate (PFOS), its salts, and its precursors Ecological
Polycyclic aromatic hydrocarbons (PAH) Health and Ecological
Trichloroethylene Health and Ecological

Canada Begins Public Comment Period On Targeted Review Of Pest Control Products Act: On March 21, 2022, Canada’s Pest Management Regulatory Agency (PMRA) began a public consultation on Discussion Document DIS2022-01, Further Strengthening Protection of Health and the Environment: Targeted Review of the Pest Control Products Act. PMRA states that it is currently advancing a Transformation Agenda that includes a number of program change initiatives intended to strengthen further human health and environmental protection through modernized business processes for the review of pesticides; to improve transparency and public access to information and data across the regulatory pesticide processes; and to increase the use of comprehensive, real-world data on water monitoring, crop production, and pesticide use, as well as independent scientific advice. The Discussion Document seeks input on specific questions to help inform the development of potential targeted legislative changes to the Pest Control Products Act. Comments are due May 20, 2022.

Canada Begins Public Consultation On Amendments To The Pest Control Products Regulations (Applications And Imports): On April 2, 2022, Canada published a Canada Gazette notice beginning a public consultation on elements of the Pest Control Products Regulations (PCPR) that could benefit from modernization:

  • Three aspects of the application process in the PCPR impose an unnecessary regulatory and administrative burden pertaining to manufacturing site information, formulant supplier information, and the maximum validity period of emergency registrations;
     
  • Five technical issues, including an issue raised by the Standing Joint Committee for the Scrutiny of Regulations (SJCSR) outside of the comprehensive review process, must be rectified; and
     
  • Five processes currently implemented by policy would be better codified in the PCPR, to provide industry with predictability.
     

Comments are due June 11, 2022.

EUROPEAN UNION (EU)

EC Begins Public Consultation On Revision Of The Detergents Regulation: The European Commission (EC) began a public consultation on March 2, 2022, on the revision of the Detergents Regulation. The EC states that it seeks the views and experiences of all relevant parties on how to improve the current legislation in order to achieve clear, simplified, and updated rules that allow for innovative products and sustainable new practices; burden reduction for manufacturers and clearer information to consumers; and an optimized protection of human health and the environment. According to the EC, the latest Evaluation of the Detergents Regulation and the Fitness Check of the most relevant chemicals legislation (excluding REACH) revealed “a number of weaknesses and areas for further improvement,” including overlaps with other pieces of EU chemical legislation, unclear information for consumers, an increasingly complex regulatory framework for detergents, and the need to update the legislation to adapt it to recent market developments and consumer practices. Comments are due May 25, 2022.

Trichloroethylene (TCE; EC 201-167-4, Chemical Abstracts Service Registry Number (CAS RN) 79-01-6) Use Reduces By 95 Percent Due To REACH Authorization Requirements: The European Chemicals Agency (ECHA) reports on the effectiveness of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) authorization process. TCE was added to the authorization list (Annex XIV) in 2013 because of its carcinogenic properties. The substance cannot be placed on the market, or used, unless an authorization is granted by the EC or an exemption applies.

REACH registration data show that 50,000 metric tons of TCE were on the market in 2010. As of January 2022, based on information contained within the authorizations granted by the EC, the estimated current use of TCE is around 1,200 metric tons -- this constitutes a 95 percent reduction in TCE. While there may be other drivers for this reduction in use, the report suggests that the primary cause is the REACH regulation.

According to the information available to ECHA, TCE is no longer being used in industrial metal parts cleaning. TCE has been substituted with other solvents (e.g., perchloroethylene, EC 204-825-9, CAS RN 127-18-4) or manufacturing processes (e.g., hot washing). The report recognizes that some alternatives may not be safer than TCE and recommends addressing the risks of structurally related substances via a group approach.

27 Percent Of Chemical Safety Reports Fail In First Year Of Manual Completeness Checks: ECHA implemented new checks on Chemical Safety Reports (CSR) submitted via REACH registration dossiers since March 1, 2021, so that it can “better fulfil” its obligation to ensure that registrations meet the information requirements.

ECHA’s CSR manual completeness check includes the following elements:

  • The CSR must contain an exposure assessment and risk characterization if the substance is (self)classified as hazardous or indicated as fulfilling the persistent, bioaccumulative, and toxic (PBT) or very persistent and very bioaccumulative (vPvB) criteria;
     
  • Each use reported in IUCLID Section 3.5 must have a corresponding exposure scenario in the CSR. As a general rule, there should be one exposure scenario per use. Deviations from this 1:1 principle should be limited to absolute exceptions and relevant reasoning must be provided;
     
  • Each exposure scenario must contain the contributing scenarios that cover each contributing activity reported for that use in IUCLID Section 3.5., where:
     
    • The worker contributing activities are normally labeled by at least one process category (PROC) and associated with at least one environmental contributing activity labeled by an environmental release category (ERC);
       
    • The consumer contributing activities are normally labeled by product categories (PC) or article categories (AC). These are associated with at least one environmental contributing activity, labeled by an ERC. Again, the general rule is that each contributing activity should be covered by one contributing scenario. Also here, the deviation from this 1:1 principle should be an exception and well justified in the CSR; and
       
  • If any of the required information is missing in the CSR, a substantiated justification must be provided within the relevant exposure scenario (at the place where the information is missing) or in the relevant subsection of Chapter 9.0 of the CSR, if the waiver systematically applies to many (all) exposure scenarios.
     

N-(Hydroxymethyl)acrylamide (EC 213-103-2, CAS RN 924-42-5) Proposed As A New Substance Of Very High Concern: The Swedish Member State Competent Authority (MSCA) proposed that N-(Hydroxymethyl)acrylamide is a substance of very high concern (SVHC) due to its carcinogenic and mutagenic properties. There are 14 active registrations of the substance and it is imported or manufactured in the European Economic Area (EEA) in volumes of 1,000 to 10,000 metric tons per year. N-(Hydroxymethyl)acrylamide is used as a monomer for polymerization, as a fluoroalkyl acrylate copolymer, and in paints or coatings. Stakeholders are invited to respond to the public consultation before April 19, 2022.

EP Committee Approves Corporate Sustainability Reporting Directive: The European Parliament (EP) Legal Affairs Committee announced on March 15, 2022, that it voted 22-1 in favor of the Corporate Sustainability Reporting Directive. According to the Committee, if agreed with EU governments, the bill would “make businesses more accountable for their impact on people and the planet, while giving investors and the public access to comparable, reliable and easily accessible information on sustainability.” The European Financial Reporting Advisory Group would be tasked with developing mandatory EU sustainability-reporting standards covering environmental matters, social affairs, including gender equality and diversity, and governance, including anti-corruption and bribery. The Committee agreed that the Directive should cover all large companies, as well as non-EU companies operating in the internal market. The EC would be asked to establish additional reporting criteria for companies with relevant activities in high-risk sectors (textile, agriculture, mining, and minerals). The Committee proposes to give companies an additional year to adapt to the new rules, with the first public reports due in 2025. Talks with EU member states can start once the EP as a whole approves its negotiating position.

27 Substances Added To The Community Rolling Action Plan: The Community Rolling Action Plan (CoRAP) update for the years 2022–2024 lists 27 substances suspected of posing a risk to human health or the environment. Two of the substances are new to the evaluation process and the other 25 are existing. The two new substances are:

Substance name EC No CAS RN Initial grounds of concern
1,3,4,6,7,8- hexahydro4,6,6,7,8,8- hexamethylindeno[5 ,6-c]pyran 214-946-9 1222-05-5 Potential endocrine disruptor, suspected PBT/vPvB, consumer use, exposure of environment
2-Pentanone oxime 484-470-6 623-40-5 Suspected carcinogenic, other hazard based concern, consumer use, exposure of workers, high (aggregated) tonnage, wide dispersive use

Companies that import, manufacture, use, or place these substances on the market should keep abreast of developments.

Consultation On Proposed REACH Restriction For Dechlorane PlusTM: ECHA’s Socio Economic Assessment Committee (SEAC) has reviewed Norway’s restriction proposal for 1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene (Dechlorane Plus) (EC 236-948-9, CAS RN 13560-89-9) and requests further information from stakeholders. Norway has identified several restriction options and each affects the manufacture, use, and placing the substance on the market in concentrations >0.1 percent, with possible derogations.

Dechlorane Plus™ is mainly used as a flame retardant in adhesives, sealants, and polymers, as well as an extreme pressure additive in greases. The main applications of Dechlorane Plus™ are reported to be in motor vehicles, electrical and electronic equipment (including consumer electronics), and in aerospace and defense. Additional uses in marine, garden, and forestry machinery and in medical devices were reported in the consultation on the Annex XV report.

SEAC requests:

  • Volumes used and function;
     
  • Potential alternatives that have been assessed;
     
  • A substitution timeline if alternatives are feasible; and
     
  • Socio-economic impacts in case a derogation to the restriction is not proposed.
     

The deadline for comments is May 16, 2022.

ECHA And Member States Conclude Assessment Of Regulatory Needs On Group Assessment Of Bisphenols: A group of 148 bisphenols has been assessed for risks to human health and the environment. Of these, more than 30 have been identified to have the potential for hormonal or reprotoxic effects.

Some uses of these bisphenols include:

  • Anti-oxidant for processing PVC;
     
  • Epoxy resin hardeners;
     
  • Textile, leather, paper and board;
     
  • (Intermediate in) the manufacture of polymers, polymer resins, epoxy resins;
     
  • Paints and coatings;
     
  • Adhesives and sealants;
     
  • Lubricant and greases/functional fluids;
     
  • Electrical/electronic engineering ceramic boards;
     
  • Washing and cleaning;
     
  • Perfume and fragrance;
     
  • Plant protection products;
     
  • Dental sealant;
     
  • Polycarbonate articles;
     
  • Rubber products;
     
  • Thermal paper;
     
  • Rigid foam; and
     
  • Fuel additive.
     

A group restriction of the hazardous bisphenols has been proposed as the best way to manage risks. German authorities are preparing a proposal to restrict the use of bisphenol A and other bisphenols with endocrine-disrupting properties for the environment. Once this proposal is published, ECHA and the EC will consider any further needs for regulatory action on bisphenols.

Information Requirements For REACH Registration Change: The EC updated REACH on March 25, 2022, to clarify the information required by registrants of substances.

Major changes include:

  • Requirements and specific rules for adaptation of:
     
    • In vitro and in vivo mutagenicity studies, specifying when further studies are needed based on mutagenicity concerns;
       
    • Reproductive toxicity studies, specifying the preferred animal species and administration routes, and clarifying the conditions triggering the need for further studies based on concerns;
       
    • Aquatic toxicity studies, clarifying when long-term studies must be performed instead of short-term studies or in addition to them;
       
    • Toxicity studies on terrestrial and sediment organisms, specifying when long-term studies are needed instead of short-term studies and clarifying that long-term testing must investigate both degradation and transformation products; and
       
    • Degradation and bioaccumulation studies, specifying when further testing is needed, including investigation of both degradation and transformation products.
       
  • The obligation for only representatives (OR) to provide details on the non-EU manufacturer they represent.
     
  • Substance identification information, including:
     
    • The requirement to describe the compositions, nanoform, or set of similar nanoforms related to information submitted to fulfill information requirements under REACH Annexes VII-X;
       
    • New requirements for reporting a crystal structure and for reporting compositions for substances with unknown or variable composition, complex reaction products or of biological materials (UVCB); and
       
    • Clarified requirements for reporting constituents, impurities, and additives, as well as for analytical information.
       

The changes will begin to apply from October 14, 2022. Registrants should review the updated legislation and prepare to update their dossiers.

EC Seeks Comment On EU Rules On Cosmetic Products: The EC announced on March 28, 2022, a public consultation on the upcoming targeted revision of the EU rules on cosmetic products. In line with the objectives of the Chemicals Strategy for Sustainability, the EC seeks feedback from stakeholders to improve further “existing provisions relevant to the safety of various hazardous substances and their exceptional and stringent use in cosmetics.” The public consultation also gauges views on other topics such as nanomaterials, simplified labeling, and how to set a more efficient process for the safety assessment of chemical substances by scientific committees. The EC will use the results to assess the relevance of new measures to improve the safety of cosmetic products and ensure free movement of cosmetic products within the single market. The consultation is open until June 20, 2022.

EC Proposes New Consumer Rights And Ban On Greenwashing: The EC announced on March 30, 2022, that it is proposing to amend the Consumer Rights Directive to ensure that consumers can make informed and environment-friendly choices when buying products. Consumers will have a right to know how long a product is designed to last and how, if at all, it can be repaired. In addition, the rules will strengthen consumer protection against untrustworthy or false environmental claims, banning “greenwashing” and practices misleading consumers about the durability of a product. Prohibited practices under the Unfair Commercial Practices Directive would include:

  • Making generic, vague environmental claims where the excellent environmental performance of the product or trader cannot be demonstrated. Examples of such generic environmental claims are “environmentally friendly,” “eco,” or “green,” which wrongly suggest or create the impression of excellent environmental performance;
     
  • Making an environmental claim about the entire product, when it really concerns only a certain aspect of the product; and
     
  • Displaying a voluntary sustainability label that is not based on a third-party verification scheme or established by public authorities.
     

The Council of the EU and the EP will discuss the EC’s proposals.

Five Substances Added To REACH Authorization List: The EC updated REACH on April 11, 2022, to add five new substances to Annex XIV (the authorization list). Companies cannot use or place these substances on the market after the Sunset Date unless an authorization has been granted by the EC or an exemption applies.

Substance name EC No CAS RN Latest application date Sunset date Intrinsic property
Tetraethyllead 201-075-4 78-00-2 November 1, 2023 May 1, 2025 Toxic for reproduction (Article 57c)
4,4'-bis(dimethylamino)-4''
-(methylamino)trityl alcohol
209-218-2 561-41-1 November 1, 2023 May 1, 2025 Carcinogenic (Article 57a)
Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP)
with =0.1% w/w 4-heptylphenol, branched and linear (4-HPbl)
- Formaldehyde, reaction products with phenol heptyl derivs. and 1,3,4-thiadiazolidine-2,5-dithione EC No.: 939-460-0 | CAS No.: 1471311-26-8
- Formaldehyde, reaction products with branched and linear heptylphenol, carbon disulfide and hydrazine EC No.: 300-298-5 | CAS No.: 93925-00-9
- - November 1, 2023 May 1, 2025 Endocrine-disrupting properties (Article 57(f) - environment)
2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate 239-622-4 15571-58-1 November 1, 2023 May 1, 2025 Toxic for reproduction (Article 57c)
Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE) - - November 1, 2023 May 1, 2025 Toxic for reproduction (Article 57c)

NEW ZEALAND

Parliamentary Committee Recommends Passage Of Bill Amending Hazardous Substances And New Organisms Act: The New Zealand Parliament’s Environment Committee issued a report in March 2022 on its review of the Hazardous Substances and New Organisms (Hazardous Substances Assessments) Amendment Bill. The bill would amend the Hazardous Substances and New Organisms Act 1996 to improve the assessment and reassessment of hazardous substances. It is intended to improve the processes and information available for the assessment and reassessment of hazardous substances by enabling the Authority to make better use of information from international regulators; making improvements to the reassessment process; and making some technical amendments. The Committee recommends that the bill be passed.

STRATEGIC APPROACH TO INTERNATIONAL CHEMICALS MANAGEMENT (SAICM)

Pilot Project Will Support African Countries In Implementing GHS: According to an item in the April 2022 SAICM Newsletter, Kenya, Ghana, Cote d’Ivoire, and Nigeria will benefit from a new four-year pilot project to support their national implementation of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). According to SAICM, the pilot project sets ambitious goals, such as legislation to implement GHS, activities that facilitate cost recovery mechanisms, and ensuring that the necessary capacity, guidance, and tools are in place to implement and enforce the legislation. The pilot project emphasizes long-term support and capacity-building for the recipient countries based on their respective national development plans and priorities.

UNITED KINGDOM (UK)

RECORDING AVAILABLE -- “UK REACH, What’s Happened and What’s Next?”: Acta’s March 23, 2022, webinar “UK REACH, What's Happened and What's Next?” is now available for on-demand viewing at https://attendee.gotowebinar.com/recording/815913916012295937. During this one-hour webinar, Lynn L. Bergeson, President, Acta; Steven P. Brennan, Ph.D., Senior Manager, REACH, Acta; and Jane S. Vergnes, Ph.D., DABT®, Vice President, Scientific Affairs and Director of Toxicology, Acta, discussed the significant implications for chemical regulatory compliance under the UK REACH regulation.

HSE Publishes The First Rolling Action Plan Under UK REACH: The Health and Safety Executive (HSE), the agency for UK REACH, has created a Rolling Action Plan (RAP) to increase understanding of the hazard and risk profile of two substances on the Great Britain (GB) market. HSE states that “we have sought to complement rather than replicate evaluation work that has been or will be performed by other regulatory regimes (such as via EU REACH).”

The two substances that have been added to the RAP are:

Year Substance EC No CAS RN Initial grounds for concern
2022 Paraffin waxes and hydrocarbon waxes, chloro 264-150-0 63449-39-8 Environment: suspected PBT/vPvB
Exposure: wide dispersive use, high (aggregated) tonnage
2022 2,2'-Diallyl-4,4'-sulfonyldiphenol 411-570-9 41481-66-7 Environment: potential endocrine disrupter
Human Health: suspected CMR
Exposure: wide dispersive use
2023 To be agreed in next update (by May 31, 2023) - - -
2024 To be agreed in update (by May 31, 2024) - - -

HSE may have limited information on these substances and will consider data from a number of sources:

  • The GB specific data within the UK database (Comply with UK REACH-IT);
     
  • UK REACH processes (such as dossier evaluation), which will also develop with the embedding of the UK REACH system past the first year of operation; and
     
  • Other intelligence -- such as horizon scanning of other regimes, both domestic (e.g., GB Classification, Labelling and Packaging regulation) and international (e.g., EU REACH and other regulatory systems from other countries).
     

Companies that import, manufacture, use, or place these substances on the market should keep abreast of developments.

HSE Produces A Final Opinion On The First New REACH Application For Authorization: HSE recommends that MeiraGTx UK II Limited receive a 12-year review period for its use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO). The applicant uses the substance as a manufacturing aid in the production of gene therapy products at its manufacturing facility in London, UK.

4-ter-OPnEO is known to have endocrine-disrupting properties in the environment. The use applied for may result in <100 g per year releases of the substance to the environment. HSE also recommends that the applicant identify and implement additional risk management measures.

The opinion is of significance to the applicant and to other companies that use or place substances on the market that are subject to the REACH authorization requirement. The Department for Environment, Food & Rural Affairs (Defra) Secretary of State will consider the HSE’s opinion before making a decision on the application.

UNITED NATIONS (UN)

UN Environment Assembly Will Negotiate Plastic Pollution Treaty And Science Body On Chemicals: During the fifth meeting of the UN Environment Assembly (UNEA) of the UN Environment Program (UNEP), held February 28-March 2, 2022, UN member states agreed to undertake negotiations on a legally binding instrument by 2024 to end plastic pollution and an agreement to establish a science-policy panel on chemicals. UN member states adopted a resolution entitled “End Plastic Pollution: Towards an internationally legally binding instrument” during the closing session. According to a March 10, 2022, SAICM news item, the agreement is expected to address the full lifecycle of plastics, including production, design, and disposal, as well as the design of reusable and recyclable products and materials. The UNEP Executive Director will convene a meeting in the first half of 2022 to prepare for the Intergovernmental Negotiating Committee’s (INC) work and determine its timetable. Governments must also decide on the rules for the negotiation, such as a definition of “plastic.” The subsequent process will include:

  • UNEP will convene a forum by the end of 2022 to share knowledge and best practices in different parts of the world. This forum will mark the first session of the INC; and
     
  • The INC will report to UNEA on progress during the next two years.
     

UNEP will convene a diplomatic conference to adopt the INC’s outcome and open the treaty for signature by national governments.

According to the news item, the UNEA agreement on creating a science-policy panel on chemicals and waste will aim to fill the gap between science and policy. The body is intended to ensure informed scientific input on all three aspects of the “triple planetary crisis,” complementing science-policy efforts on climate change and biodiversity. An Ad Hoc Open-ended Working Group will be charged with agreeing on the panel’s governance, scope, and mandate. Providing context for this agreement, the Ministerial Declaration notes that the threat of chemicals and waste pollution has been further aggravated by the COVID-19 pandemic through widespread use of single-use plastics and disinfectant chemicals.


 
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