The European Chemicals Agency (ECHA) announced on November 16, 2022, that the Enforcement Forum agreed that the next Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) enforcement project will investigate how companies fulfill the registration, authorization, and restriction obligations for products and chemicals they import from outside the European Union (EU). According to ECHA, the project will be done in 2023-2025 and “will require close cooperation between REACH enforcement and national customs authorities in the Member States.” ECHA states that the project “was triggered by high levels of non-compliance in imported goods detected in previous Forum projects, including a recent pilot project” that found that 23 percent of inspected products were non-compliant with EU requirements and that further controls are necessary. ECHA notes that control of imports at the point of entry is the “most effective means” of checking that non-compliant substances, mixtures, and articles do not enter the EU market. The project will also work on further developing and strengthening existing cooperation between REACH inspectors and customs. By strengthening the control of imports, the project will also contribute to the goals of the EU’s Chemicals Strategy for Sustainability (CSS).

The Environmental Audit Committee of the United Kingdom (UK) Parliament announced on November 1, 2022, that it is planning an oral evidence session later in 2022 to examine progress in implementing UK REACH, which governs the registration, evaluation, and authorization of chemical products in England, Scotland, and Wales. The Committee plans to take evidence from representatives of the Department of Environment, Food and Rural Affairs (DEFRA) and the Health and Safety Executive (HSE).

In advance of that evidence session, the Committee states that it is interested in submissions from stakeholders in sectors affected by the implementation of UK REACH and the transitional provisions established to help industry with the move from the European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation to the domestic regime. Any stakeholder with observations on the implementation of UK REACH is invited to submit them to the Committee via the evidence portal, to be received not later than November 11, 2022.

The European Chemicals Agency (ECHA) has opened a call for evidence on polyvinyl chloride (PVC) and its additives related to:

  • Uses;
  • European Union (EU) volumes per use sector and end-use;
  • End-of-life information per use; and
  • Experimental/measured release and exposure information.

ECHA states that with this call, it seeks to obtain an understanding on the use volumes at the EU level per sector and for as many end-uses as feasible, but company-specific information is also welcome. To facilitate the data reporting, ECHA has compiled from various sources a list of end-uses and use sectors of PVC into a reporting format. ECHA has also generated a separate reporting format for collecting use and volume information on the additives for closer scrutiny. ECHA welcomes information submitted both using the reporting format and in another form. ECHA notes that it does not seek use and volume information on the industrial life-cycle stages nor exposures in this call. ECHA will use submitted information to prepare an investigation report on PVC and its additives that the European Commission (EC) has requested. The call for evidence will close January 6, 2023.

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.