On April 25, 2022, the European Commission (EC) published a Restrictions Roadmap under the Chemicals Strategy for Sustainability (Restrictions Roadmap) that provides detailed information on all ongoing work on future restrictions under the European Union (EU) chemical legislation. The Restrictions Roadmap prioritizes group restrictions for the most harmful substances to human health and the environment, as set out in the Chemicals Strategy for Sustainability (Strategy). According to the EC’s press release, the Restrictions Roadmap includes a rolling list (Rolling List) of substances that will become the basis for the multiannual planning under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. The EC states that it will regularly review and update the Rolling List to ensure a balance between needed flexibility and commitment to ensure progress.

The EC notes that the Restrictions Roadmap is a deliverable under the Strategy that calls for action toward a toxic-free environment and forms part of the European Green Deal. According to the EC, one of the actions foreseen by the Strategy is a revision of REACH and other relevant product legislation to ensure that consumer and professional products do not contain the most harmful substances. Until REACH is amended, the Strategy aims to “prioritise carcinogenic, mutagenic and reprotoxic substances (CMRs), endocrine disruptors, persistent, bioaccumulative and toxic (PBT[)] and very persistent and very bioaccumulative (vPvB) substances, immunotoxicants, neurotoxicants, substances toxic to specific organs and respiratory sensitisers for (group) restrictions” for all uses. To facilitate this action, the EC prepared the Restrictions Roadmap to prioritize these substances for (group) restrictions under REACH.

The Restrictions Roadmap provides detailed information to stakeholders on all ongoing work on future restrictions under EU chemical legislation. The Rolling List of substances will become the basis for future planning under REACH and is intended to allow companies and other stakeholders to be prepared better for potential upcoming restrictions. These restrictions will address a wider range of their uses — industrial, professional, and in consumer products. The EC will review the Restrictions Roadmap regularly and update it as necessary to maintain flexibility and its commitment to ensure progress toward protecting human health and the environment from the most harmful chemical substances. More information is available in The Acta Group’s April 29, 2022, memorandum.

By Lynn L. Bergeson

The EC updated the European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation 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.

By Lynn L. Bergeson

The European Chemicals Agency (ECHA) announced on April 6, 2022, that together with European Union (EU) member states, it has assessed a group of 148 bisphenols 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 polyvinyl chloride (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 European Commission (EC) will consider any further needs for regulatory action on bisphenols.

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 were invited to respond to the public consultation before April 19, 2022.

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 European Union (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 European Commission (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. More information on the EC’s proposal is available in our March 8, 2022, blog item.

The Acta Group’s (Acta®) 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 1-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 United Kingdom (UK) REACH regulation.

While the major regulations pertaining to chemicals were carried over into UK law mostly unchanged after the Brexit transition period, the UK now makes its own decisions. Divergence in areas big and small between the UK and European Union (EU) regulations will continue in 2022 and beyond. Regardless of one’s role, whether manufacturer, importer, non-Great Britain (GB) supplier, downstream user, or distributor, all companies doing business as or with a GB-based company are advised to follow the developments in GB closely. The first registration deadline of October 27, 2023, for 1,000 tonnes or more per year is approaching rapidly, and its extension is under consideration. Companies should act quickly to understand their rights and obligations under UK REACH to maintain continuity of their supply chains and market access. We encourage you to view the webinar and read and subscribe to our newly launched REACHblog™ to stay abreast of important updates in UK and EU REACH regulations.

The Health and Safety Executive (HSE), in conjunction with the Environment Agency, has assessed 11 substances and substance groups that were added to the EU REACH Candidate List. As a result, the agencies have identified the following four substances, or substance groups, that require regulatory management options analysis (RMOA):

Substance Name

Identified Uses

Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs. wherein C12 is the predominant carbon number of the fatty acyloxy moiety (DOTL)

[substance group, typically manufactured using dioctyltin oxide and coconut fatty acids or commercial “lauric acid” as starting materials in the ratio 1:2]

Catalyst in the manufacture of a variety of polyurethane applications, including rigid foams, varnish and powder coatings, and sealants. DOTL-based products also catalyze processes for manufacturing polyester polyols and other polyester products such as the cross-linked low-density polyethylene cable insulation that is used for communications applications and high-voltage power cables that may be used underground, overhead, across the oceans, or in buildings, tunnels, vehicles, ships, and trains.

1,4-dioxane

Solvent in the production of lacquers, varnishes, cleaning and detergent preparations, adhesives, cosmetics, deodorant fumigants, emulsions and polishing compositions, pulping of wood, extraction medium for animal and vegetable oils, laboratory chemical (eluent in chromatography), cassettes, plastic and rubber, and insecticides. May form as a contaminant in consumer products such as plastics, detergents, and cosmetics.

Small brominated alkylated alcohols (SBAA)

[substance group:

  • 2,2-Bis(bromomethyl)propane1,3-diol (BMP) (CAS RN 3296-90-0)
  • 2,2-Dimethylpropan-1-ol, tribromo derivative/3-bromo-2,2- bis(bromomethyl)-1-propanol (TBNPA) (CAS RNs 36483-57-5 and 1522-92-5). CAS 36483-57-5 contains three substructures, where one of them is CAS 1522-92-5.
  • 2,3-Dibromo-1-propanol (2,3-DBPA) (CAS RN 96-13-9)]

BMP — Reactive flame retardant in polymer resins.

TBNPA — Reactive intermediate for high molecular weight flame retardants, reactive flame retardant for polyurethanes, and may also be present in polymer preparations supplied to consumers.

2,3-DBPA — Intermediate in the preparation of flame retardants, insecticides, and pharmaceuticals.

Phenol, alkylation products (mainly in para position) with C12-rich branched or linear alkyl chains from oligomerization, covering any individual isomers and/or combinations thereof (PDPP)

[substance group, including but not limited to:

  • Phenol, 4-isododecyl- (CAS RN 27459-10-5)
  • Phenol, tetrapropylene- (CAS RN 57427-55-1)
  • Phenol, 4-dodecyl-, branched (CAS RN 210555-94-5)
  • Phenol, (tetrapropenyl) derivatives (CAS RN 74499-35-7)
  • Phenol, 4-isododecyl- (CAS RN 27147-75-7)
  • Tetrapropenyl phenol
  • 4-(3,4,5,6-Tetramethyloctan-2-yl)phenol
  • 4-(3,4,5-Trimethylheptyl)phenol
  • Phenol, alkyl branched (species comprising decyl, undecyl, dodecyl, tridecyl, tetradecyl, pentadecyl substituents)
  • Phenol, para-alkylation products with C12-rich branched olefins from propene oligomerization]

Chemical intermediate in the production of lubricant additives, hydraulic oils, and fuel system cleaners; synthetic rubbers, tires, and floor coatings; paints, printing inks, varnishes, epoxy, and phenolic resins.

 

The EC announced on February 23, 2022, that it adopted a proposal for a Directive on corporate sustainability due diligence. According to the EC, the proposal is intended to foster sustainable and responsible corporate behavior throughout global value chains. Companies would be required to identify and, where necessary, prevent, end, or mitigate adverse impacts of their activities on human rights, such as child labor and exploitation of workers, and on the environment, for example, pollution and biodiversity loss. The new due diligence rules would apply to the following companies and sectors:

  • EU companies:
  • Group 1: All EU limited liability companies of substantial size and economic power (with 500+ employees and more than €150 million EUR in net turnover worldwide); and
  • Group 2: Other limited liability companies operating in defined high-impact sectors that do not meet both Group 1 thresholds, but have more than 250 employees and a net turnover of more than €40 million EUR worldwide. For these companies, rules would start to apply two years later than for group 1.
  • Non-EU companies active in the EU with turnover threshold aligned with Group 1 and 2, generated in the EU.

The EC notes that small and medium enterprises (SME) would not be directly in the scope of the proposal.

This proposal would apply to the company’s own operations, their subsidiaries, and their value chains (direct and indirect established business relationships). According to the EC, to comply with the corporate due diligence duty, companies would need to:

  • Integrate due diligence into policies;
  • Identify actual or potential adverse human rights and environmental impacts;
  • Prevent or mitigate potential impacts;
  • Bring to an end or minimize actual impacts;
  • Establish and maintain a complaint procedure;
  • Monitor the effectiveness of the due diligence policy and measures; and 
  • Publicly communicate on due diligence.

The proposal would require group 1 companies to have a plan to ensure that their business strategy is compatible with limiting global warming to 1.5 °C, in line with the Paris Agreement. The proposal would also introduce directors’ duties to set up and oversee the implementation of due diligence and to integrate it into the corporate strategy. When fulfilling their duty to act in the best interest of the company, directors would have to consider the human rights, climate change, and environmental consequences of their decisions.

The EC will present the proposal to the EP and the Council for approval. Once adopted, EU member states will have two years to transpose the Directive into national law and communicate the relevant texts to the EC.

ECHA progresses a REACH restriction proposal on all PFAS in firefighting foams. Five different restriction options to protect human health and the environment from PFAS have been assessed. The preferred option would ban the placing on the market, use, and export of all PFAS in firefighting foams. This option would also provide transition periods to allow industry to develop and implement safer alternatives without compromising fire safety. If enacted into law, the restriction would prevent release of an estimated 13,000 metric tons of PFAS to the environment; it is estimated to cost society €7 billion EUR over 30 years. A six-month public consultation on the proposal will start on March 23, 2022. ECHA will also host an online webinar on April 5, 2022, to explain the restriction process and support stakeholders.

In addition, five member states of the EU are working on a restriction proposal for PFAS in all other uses. It is anticipated that this proposal will be brought to the EC in January 2023. PFAS importers, manufacturers, and users should keep abreast of the developments regarding firefighting foams as a blueprint for restriction of other uses.

The EC announced on February 22, 2022, the launch of a public consultation on how best to reduce the amount of unintentionally released microplastics into the environment. According to the EC, the public consultation will support its initiative on Microplastics pollution – measures to reduce impacts on the environment, “a key deliverable of the Circular Economy Action Plan and the Zero Pollution Action Plan.” According to the EC, the consultation focuses on plastic pellets, synthetic textiles, and tires, the sources that are known to release the largest quantity of microplastics. Additional sources, such as paints, geotextiles, and detergent capsules for laundry and dishwashers, are also being evaluated. Responses are due May 17, 2022.