The European Chemicals Agency (ECHA) has received restriction proposals for:

  • 4,4′-isopropylidenediphenol (bisphenol A) and other bisphenols and bisphenol derivatives with endocrine disrupting properties for the environment, prepared by the German authority. The proposal would restrict the use as an additive and the content in articles (0.02 percent by weight); restrict content of residues (unreacted monomer) in articles and for imported goods (0.02 percent by weight); restrict the use of mixtures with content of 0.02 percent by weight for non-automated processes; and introduce release rates for BPA from articles (products and subassemblies) during service life (weathering, leaching due to cleaning action) preventing release into the environment and/or (direct) migration to organisms.
  • Placing on the market, re-use, and secondary use of wood treated with creosote or related substances, prepared by the French authority.

ECHA’s Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) will now evaluate the proposals. After RAC and SEAC agree that the reports conform with the legal requirements for a Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) restriction proposal, ECHA will begin a public consultation.

On September 20, 2022, the European Commission (EC) began a public consultation on a draft delegated regulation that would amend Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) to add new hazard classes and their criteria. CLP would be amended to include hazard classes and criteria for:

  • Endocrine disruptors;
  • Substances and mixtures with persistent, bioaccumulative, and toxic (PBT) properties;
  • Substances and mixtures with very persistent, very bioaccumulative (vPvB) properties;
  • Substances and mixtures with persistent, mobile, and toxic (PMT) properties; and
  • Substances and mixtures with very persistent, very mobile (vPvM) properties.

The draft regulation states that the level of evidence regarding endocrine disrupting properties may be of different scientific strength. The draft regulation would create two categories of endocrine disruptors: known or presumed endocrine disruptors (category 1) and suspected endocrine disruptors (category 2). According to the draft regulation, the intrinsic properties of PBT and vPvB substances and mixtures display similarities, but they differ substantially with regard to the toxicity criterion. The draft regulation would create two separate hazard classes, each with its own criteria, while establishing common rules for the scientific assessment of the intrinsic properties related to persistency and bioaccumulation. While the intrinsic properties of PMT and vPvM substances and mixtures display similarities, they differ substantially with regard to the toxicity criterion. The draft regulation would create two separate hazard classes, each with its own criteria, while establishing common rules for the scientific assessment of the intrinsic properties related to persistency and mobility.

To ensure that suppliers of substances and mixtures have time to adapt to the new classification and labeling provisions, there would be a transition period. Substances and mixtures placed on the market before the end of the transition period would be allowed to remain on the market without being re-classified and re-labeled in accordance with the new requirements, to avoid additional burden on suppliers of substances and mixtures. Suppliers could apply the new classification and labeling requirements at an earlier stage on a voluntary basis.

The consultation will end on October 18, 2022. Our forthcoming memorandum will include a detailed summary of the proposed rule and an insightful commentary.

By Lynn L. Bergeson and Carla N. Hutton

The European Chemicals Agency (ECHA) recently reminded only representatives (OR) that they must identify the non-European Union (EU) manufacturers that they represent and provide their contact information in REACH-IT by October 14, 2022. According to an April 24, 2022, news item, ORs must have a separate REACH-IT account for each non-EU manufacturer they represent and have the necessary registrations for each. The contact information that must be provided includes:

  • Name, address, telephone number, and e-mail address;
  • Contact person;
  • Location of any production or formulation sites;
  • Company website; and
  • National company identification numbers.

ECHA states that ORs may need to reorganize their REACH-IT accounts to ensure that there are separate accounts for each non-EU manufacturer represented. Similarly, if an entity is an OR but also a manufacturer/importer under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), it will need separate REACH-IT accounts for the OR and for the manufacturer/importer roles. According to ECHA, if the REACH-IT accounts must be rearranged due to these new requirements, the fee for transferring registrations in REACH-IT accounts can be waived until October 14, 2022.

By Lynn L. Bergeson and Carla N. Hutton

The European Chemicals Agency (ECHA) has begun public consultations on nine proposals to identify new substances of very high concern (SVHC). The substances and examples of their uses are:

  • 4,4′-sulphonyldiphenol (bisphenol S; BPS): The substance is used for the manufacture of pulp, paper, and paper products; textile, leather, or fur; and chemicals.
  • Perfluoroheptanoic acid and its salts: The substances are not registered under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation.
  • Melamine: The substance is used in polymers and resins, coating products, adhesives and sealants, leather treatment products, and laboratory chemicals.
  • Isobutyl 4-hydroxybenzoate: The substance is used in the manufacture of substances and in coating products, fillers, putties, plasters, modeling clay, and inks and toners.
  • Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof: The substance is used as a flame retardant and as a plasticizer for flexible polyvinylchloride and for use in wire and cable insulation, film and sheeting, carpet backing, coated fabrics, wall coverings, and adhesives.
  • Barium diboron tetraoxide: The substance is used in paints and coatings.
  • 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 (FC-770): The substance is used in articles, by professional workers (widespread uses), in formulation or re-packing, at industrial sites, and in manufacturing.
  • 2,2′,6,6′-tetrabromo-4,4′-isopropylidenediphenol (tetrabromobisphenol-A; TBBPA): The substance is used 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, and paper and textiles.
  • 1,1′-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene]: The substance is not registered under REACH.

The deadline for comments is October 17, 2022.

According to an item in the August 10, 2022, ECHA Weekly, France, Ireland, and Germany are requesting interested parties to submit information related to skin sensitizing substances in consumer mixtures. The European Chemicals Agency (ECHA) website states that this is an opportunity for all sectors to provide information on the presence of skin sensitizing substances in mixtures with consumer uses, including information on known safe uses. The call for evidence is issued to assess whether there are risks that are adequately controlled under specific conditions and what impact additional regulatory risk management would have on society. The scope of the investigation comprises substances fulfilling the criteria for classification as skin sensitizers as defined by Regulation (EC) No 1272/2008 on the classification, labeling, and packaging of substances and mixtures (CLP Regulation) in mixtures marketed or available for consumers in the European Union (EU)/European Economic Area (EEA). Uses of substances in cosmetic products are outside the scope of the investigation. The deadline for comments is September 30, 2022.

The objective of the call for evidence is to obtain information on:

  • The sectors and types of uses/applications concerned;
  • Measures currently in place (g., changed formulation, reduction of concentration, specific packaging, conditions of use) to minimize consumer exposure;
  • Experience regarding substitution efforts, availability, and costs of alternatives or reasons for non-substitution;
  • The potency of the skin sensitizing substances and their technical functions in the mixtures;
  • Safe use of consumer products;
  • Epidemiology of allergic contact dermatitis and other health-related information, including health costs; and
  • Analytical methods to detect the presence of skin sensitizing substances in mixtures.

The target groups are:

  • Companies (g., manufacturers, formulators, suppliers, distributors, and importers) and their associations;
  • Trade associations;
  • Member state authorities; and
  • Any other stakeholder (including consumer associations and health insurance organizations) holding relevant information.

ECHA notes that calls for comments and evidence allow interested parties to signal their interest and express their views and concerns in the preparatory phase of the restriction proposal. They also let interested parties comment on the different documents under preparation in relation to restrictions, such as reports on substances in articles and guidelines on restriction entries. Calls for comments and evidence do not take the place of public consultations on restriction proposals developed by EU member states or ECHA, which form a standard part of the restriction process.

By Lynn L. Bergeson and Carla N. Hutton

The European Chemicals Agency (ECHA) recently reminded registrants of substances with a harmonized classification to update their dossiers. According to an item in the July 13, 2022, ECHA Weekly, ECHA will soon begin a second screening project to check that companies are keeping their registrations updated. The project will focus on substances with a harmonized classification and labeling and will examine registrations where this information is not used correctly. ECHA will pass cases where incompliance is suspected to national enforcement authorities. ECHA will publish the results of its first screening project, which focused on registrations of substances that are on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Authorization List, “next autumn.” ECHA states that these projects “remind registrants of their obligation to keep their registrations up to date.” ECHA provides information on keeping registration dossiers up to date.

The Department for Environment, Food and Rural Affairs (Defra) has published two calls for evidence on amending Annex 14 of UK REACH to include the following substances:

In December 2021, the Health and Safety Executive (HSE) recommended which substances of very high concern (SVHC) are a priority for inclusion in Annex 14. Following HSE’s recommendation, the appropriate authorities (Defra Secretary of State, Scottish and Welsh ministers) must decide whether those priority substances should be included in the list of substances subject to authorization (Annex 14 of UK REACH).

Defra will use the calls for evidence to inform the appropriate authorities’ consideration of HSE’s recommendation. Defra asks third parties with an interest in these substances to share any relevant information, including evidence about the use of the substance in Great Britain (GB), availability of alternatives, and impacts on the environment, public health, and society, as well as any general comments. Information is due August 12, 2022.

The Health and Safety Executive (HSE) recently published the UK REACH Work Programme 2022/23. The work programme sets out the activity that HSE, supported by the Environment Agency and other relevant agencies, will carry out to operate UK REACH. To complement the publication of the work programme, the Department for Environment, Food and Rural Affairs (Defra) has published the rationale used for identifying particular substances for potential regulatory action under UK REACH in 2022 to 2023. In preparation for the UK REACH Work Programme, Defra and the Welsh and Scottish governments worked closely with HSE and the Environment Agency to prioritize issues for regulatory action under UK REACH. Defra states that it used this exercise primarily to identify priorities for two types of activity in UK REACH:

  • Restriction: A mechanism that can lead to controls on the use of a substance or group of substances; and
  • Regulatory Management Options Analysis (RMOA): Analysis produced by HSE and/or the Environment Agency to understand the risks of using a substance, or group of substances, and make recommendations for managing them.

Defra states that it reviewed 17 proposals and identified the following five priorities for the 2022 to 2023 UK REACH work programme:

  • Per- and polyfluoroalkyl substances (PFAS): Acting on the recommendations of an ongoing RMOA, due for publication in summer 2022;
  • Intentionally added microplastics: An evidence project on identifying and managing the risks they pose;
  • Formaldehyde and formaldehyde releasers in articles: An RMOA to review the evidence base and evaluate a potential restriction;
  • Bisphenols in thermal paper: An RMOA to review the evidence base and evaluate a potential restriction; and
  • Hazardous flame retardants: Reviewing and updating the existing evidence on potential environmental risks, to feed into wider chemicals policy.

The document explains the rationale Defra used to identify these priorities. It also explains why some proposals were not adopted. Defra states that it intends to reconsider these proposals when identifying priorities for future annual work programmes. Defra notes that in addition, it may identify other activities to support the aims of UK REACH, such as commissioning projects to gather more evidence.

The European Chemicals Agency (ECHA) announced on June 10, 2022, that n-(hydroxymethyl)acrylamide has been added to the Candidate List as it may cause cancer or genetic defects. According to ECHA, it is mostly used in polymers and when manufacturing other chemicals, textiles, leather, or fur.

Candidate List substances may be placed on the Authorization List in the future. If a substance is on that list, its use will be prohibited unless companies apply for authorization and the European Commission (EC) authorizes them to continue its use. Under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation, companies have legal obligations when their substance is included in the Candidate List. Suppliers of articles containing a Candidate List substance above a concentration of 0.1 percent (weight by weight) must give their customers and consumers enough information to be able to use them safely. Consumers have the right to ask suppliers whether the products they buy contain substances of very high concern (SVHC).

Importers and producers of articles must notify ECHA if their article contains n-(hydroxymethyl)acrylamide within six months from the date it has been included in the list, June 10, 2022. Suppliers of substances on the Candidate List, supplied either on their own or in mixtures, have to provide their customers with a safety data sheet (SDS). Under the Waste Framework Directive, companies also have to notify ECHA if the articles they produce contain SVHCs in a concentration above 0.1 percent (weight by weight). This notification is published in ECHA’s substances of concern in products (SCIP) database.

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.