On May 18, 2022, the High Level Roundtable on the Implementation of the Chemicals Strategy for Sustainability (CSS) held its third meeting. During the meeting, the European Commission (EC) provided an update on the state of implementation of the CSS. According to the written report, main achievements since the last meeting of the High Level Roundtable include:

  • Promoting Safe and Sustainable-by-Design Chemicals: The EC proposal for an update of the Industrial Emission Directive was adopted in April 2022. According to the report, the proposal includes provisions that will inter alia promote the use of safer chemicals and the elimination of substances of very high concern (SVHC) by industry. In addition, the EC is progressing with its work on the safe and sustainable-by-design criteria and is developing key performance indicators to measure the industrial transition to safe and sustainable chemicals. The High Level Roundtable was preparing its second report and recommendations on the topic of safe and sustainable by design, which was to be adopted on May 18, 2022.
  • Non-Toxic Material Cycles: The EC has made proposals to ensure that substances of concern in products are minimized and tracked through the Regulation on Ecodesign for Sustainable Products proposed in March 2022, as well as other initiatives on sustainable products (g., the European Union (EU) strategy for sustainable and circular textiles adopted also in March 2022) and sustainable finance (e.g., development of substantial contribution criteria for environmental objectives under the taxonomy regulation). Regulatory actions are going hand in hand with increased investments in innovative technologies to address the presence of legacy substances in waste streams.
  • Tackling the Most Harmful Substances: The report states that the CSS aims to ensure that consumers, vulnerable groups, and the natural environment are more consistently protected from the most harmful substances, including endocrine disruptors and persistent chemicals. To this end, the EC is revising the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation and sectoral product legislation on food contact materials (FCM), cosmetics, and toys to ensure that the most harmful substances are phased out in consumer products and for professional uses, unless their use is proven essential for society. While the approach to risk management is in place, the EC published a restriction roadmap in April 2022 to prioritize those substances for restrictions under REACH for all uses and through grouping, instead of regulating them one by one.Stricter maximum levels for lead and cadmium in certain foodstuffs were adopted in August 2021. The EC has also prepared a proposal for stricter levels of per- and polyfluoroalkyl substances (PFAS) in foodstuffs, which is planned to be voted on by member states in June 2022.

    According to the report, the EC has asked the European Chemicals Agency (ECHA) to prepare a restriction dossier on PFAS under REACH. ECHA performed the assessments and concluded in February 2022 that an EU-wide restriction is justified, as the risks posed by PFAS are currently not adequately controlled, and published an Annex XV restriction report proposing an EU-wide restriction on all PFAS in firefighting foams as the most appropriate means to prevent further groundwater and soil contamination and health risks for people and the environment. The Annex XV restriction report is now subject to public consultation and assessment by the relevant ECHA committees. The opinions are to be delivered in 2023, and the EC will decide then on possible restriction.

    The EU strategic framework on health and safety at work 2021-2027 was adopted in June 2021. The EC committed to propose protective limit values on asbestos, lead, and diisocynates in 2022 and cobalt in 2024 under the Chemical Agents and Carcinogens and Mutagens Directives. The EC further identified reprotoxic substances to be addressed as a priority under the Carcinogens and Mutagens Directive to expand the protection of workers.

  • Global Chemicals Management: The CSS aims to promote safety and sustainability standards outside the EU. The EU submitted in April 2021 a proposal for the listing of chlorpyrifos in the Stockholm Convention on Persistent Organic Pollutants. The report states that subject to the evaluation and recommendation of the review committee, this could lead to a global ban of the substance. In March 2022, the fifth session of the United Nations Environment Assembly reached a consensus to launch negotiations of an international, legally binding instrument on plastic pollution, including in the marine environment. It also agreed to establish a science-policy panel to contribute further to the sound management of chemicals and waste and to prevent pollution.

The European Chemicals Agency (ECHA) published an item in its May 11, 2022, ECHA Weekly announcing that it is launching consultations to support the Member State Committee (MSC) in adopting an opinion on whether 4,4’-methylenediphenol (BPF), 4,4’-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol (BPAF), and eight BPAF salts meet the criteria for endocrine disrupting substances for the environment, as defined by the World Health Organization (WHO)/International Program on Chemical Safety (IPCS) (2002). The substances have not been identified as substances of very high concern (SVHC). The German Competent Authority indicated through an entry on the Registry of Intentions that it intends to submit in October 2022 a proposal to restrict these substances. Comments are due June 20, 2022.

By Lynn L. Bergeson and Carla N. Hutton

The United Kingdom (UK) Health and Safety Executive (HSE) announced on May 6, 2022, the beginning of a six-month public consultation on restriction proposals on lead in ammunition and substances in tattoo inks and permanent make-up (PMU). According to its press release, HSE proposed the restriction on lead in ammunition after identifying there is an unacceptable risk to human health and the environment that is not adequately controlled. HSE proposed the restriction on hazardous substances present in tattoo inks and PMU as a precautionary measure to address potential risks to human health, as there is currently no legislation in Great Britain that addresses the risks presented by insertion into the skin of these substances. In forming opinions on whether to introduce the restrictions, HSE states that it will engage with independent experts on the REACH Independent Scientific Expert Pool (RISEP), who will form a Challenge Panel to provide knowledge, scrutiny, and challenge. Comments on the restriction proposals are due November 6, 2022.

HSE published the restriction dossiers following a request from the Department for Environment, Food and Rural Affairs (Defra) Secretary of State, with agreement from the Scottish and Welsh governments. HSE notes that restrictions are developed to limit, ban, or set conditions on the manufacture, placing on the market, or use of a substance (or group of substances) that are of concern due to risks posed to human health and/or the environment.

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[12.2.1.16,9.02,13.05,10]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.