The European Chemicals Agency (ECHA) implemented new checks on Chemical Safety Reports (CSR) submitted via European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (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.

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 European Commission (EC) or an exemption applies.

REACH registration data show that 50,000 metric tons of trichloroethylene (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) 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.

The European Chemical Agency’s (ECHA) 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[,9.02,13.05,10]octadeca-7,15-diene (Dechlorane Plus) 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.

The European Chemical Agency’s (ECHA) 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 Initial grounds of concern
1,3,4,6,7,8- hexahydro4,6,6,7,8,8- hexamethylindeno[5 ,6-c]pyran Potential endocrine disruptor, suspected persistent, bioaccumulative, and toxic (PBT)/very persistent and very bioaccumulative (vPvB), consumer use, exposure of environment
2-Pentanone oxime 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.

By Lynn L. Bergeson

The European Commission (EC) updated the European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation 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 Latest Application Date Sunset Date Intrinsic property
Tetraethyllead November 1, 2023 May 1, 2025 Toxic for reproduction (category 1A)
4,4′-bis(dimethylamino)-4”-(methylamino)trityl alcohol November 1, 2023 May 1, 2025 Carcinogenic (category 1B)
Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) 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 (DOTE) November 1, 2023 May 1, 2025 Toxic for reproduction (category 1B)
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 (category 1B)


The Health and Safety Executive (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 grams 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 Registration, Evaluation, Authorisation and Restriction of Chemicals (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.

The Health and Safety Executive (HSE), the agency for the United Kingdom (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 (g., GB Classification, Labelling and Packaging regulation) and international (e.g., European Union (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.

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.