European Chemicals Agency Releases Proposal Banning PFAS

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On February 7, The European Chemical Agency (ECHA) proposed a ban on per- and poly-fluoroalkyl substances (PFAS) as part of the European Union’s Registration, Evaluation, Authorization, and Restriction of Chemicals (“REACH”) regulation. The ban, which would include about 10,000 PFAS substances, could greatly impact US companies that export virtually any product to the European Union (“EU”). These companies will need to examine whether their products contain PFAS before exporting products to the EU.

The proposed ban is the EU’s largest-ever chemicals prohibition. It is intended to achieve the EU’s goal of a non-toxic environment by 2050. ECHA proposes banning chemicals, mixtures, and articles with 25 parts per billion (ppb) or more of a particular PFAS or 250 ppb of a combination of PFAS. ECHA defined PFAS as “Any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it).” According to ECHA, this definition encompasses more than 10,000 PFAS. The proposal explains that this definition is aligned with the definition of PFAS published in 2021 by the OECD. Excluded from the scope of the proposed ban are PFAS substances that are fully degradable as they do not fulfill the underlying concern of high persistence. The ban would begin 18 months following the finalization of the restriction, which is anticipated for some time in 2025.

The initial regulation will include a variety of exemptions with phase-out periods of five or 12 years. Pesticides (referred to as biocides in the EU), along with human and veterinary medicines, would also be exempted from the restriction. PFAS used in specialized fire-fighting suppressants, called aqueous film-forming foam (AFFF), are also exempt as they are being phased out through a separate restriction.

The proposed regulation would supersede existing regulations that allow PFAS in products such as food packaging, pesticides (referred to as biocides in the EU), and human and veterinary medicines. PFAS used in firefighting suppressants (aqueous film-forming foam) used largely by airports, fire departments, and military bases, are being phased out through a separate restriction.

Affected businesses may need to evaluate thousands of products for the presence of PFAS, ranging from camping gear to mobile phones. The ban is likely to have a significant impact on any US company selling products in the EU.

ECHA will accept public comments on the proposal until September 2023. EU companies, working through their trade associations, are already commenting on the proposed ban suggesting a longer phase-out period of 32 months instead of the proposed 18 months and additional exemptions where alternatives are not yet available. The final restriction is expected in 2025.

EU court rules on notification requirements for REACH articles.

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Under Europe’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation, notifications are required for components of complex products that meet the 0.1% threshold concentration for certain chemicals, the European Court of Justice (ECJ) has ruled. The court’s decision, issued last week, overturns guidance issued in 2011 by the European Commission and European Chemicals Agency (ECHA). Interpreting Articles 7(2) and 33 of REACH, which require disclosures when an article contains more than 0.1% by weight of Substances of Very High Concern (SVHC), the ECJ found that “there is no need to draw a distinction …between the situation of articles incorporated as a component of a complex product and that of articles present in an isolated manner.” Thus, notification duties apply based on the concentration of SVHCs in component articles that make up a complex product, rather than the complex product’s total weight.

According to the court, a “complex product” is “made up of a number of manufactured objects meeting the criteria laid down in Article 3(3),” which defines an “article” as “an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.” Further,

It is therefore only if the production of an object using a combination of more than one article gives that object a special shape, surface or design which is more decisive for its function than its chemical composition that that object may be classified as an article. Accordingly, unlike a simple assembly process, that production process must alter the shape, surface or design of the articles used as components.

Article 7(2) requires producers and importers of articles to notify ECHA if an SVHC is present at a level greater than 0.1% and totals over one tonne per year. Under Article 33, suppliers must inform recipients of articles containing SVHCs at this level, and provide similar information in response to consumer inquiries within 45 days.

The court ruled that a “producer’s duty to notify covers only those articles which the producer itself has made or assembled,” while third-party assemblers must make notifications for complex products it assembles. Importers are subject to notification duties for articles that comprise components of complex products. Suppliers’ notification duties, which include providing the name of the SVHC, apply “to all operators along the supply chain.”

The ECJ’s decision affirms the position of France, Belgium, Denmark, Germany, Austria, Sweden, and Norway, and is in line with the opinion published in February by an ECJ Advocate General, a legal advisor to the court. According to Chemical Watch, ECHA said it will begin the process of revising its guidance in light of the ECJ’s ruling.

European negotiating position on chemicals aims for regulatory cooperation in trade deal with U.S.

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Last week, the European Commission (EC) published papers describing its negotiating positions on five topics associated with the current EU-US talks on the Transatlantic Trade and Investment Partnership (TTIP). The position papers, released as part of the EC’s efforts at increasing transparency, propose improving the compatibility of rules governing chemicals, cosmetics, motor vehicles, pharmaceuticals, and textiles and clothing. Across all sectors, the EC proposes to end “unnecessary” or duplicative product testing and inspections; to recognize or better align existing regulations; and to harmonize procedures for registering and approving new products. The papers were published just before the latest round of trade talks begin this week in the U.S., and follows the late March release of a report by the U.S. International Trade Commission identifying REACH regulations as a main trade barrier for small and medium-sized businesses seeking to export chemicals to the EU.

With respect to chemicals [PDF], the EC’s position recognizes that the significant differences between existing regulations in the EU and US make harmonization and mutual recognition unattainable. Nevertheless, the position paper identifies four main objective areas in which “a higher degree of convergence” and cooperation in exchanging information would result in improved efficiency and reduced costs while maintaining the existing regulatory frameworks. These four areas are:

  • Prioritization of chemicals for assessment and agreed-upon testing procedures;
  • Classification and labeling;
  • Identifying and addressing new and emerging issues; and
  • More effective data-sharing and protection of confidential business information (CBI).

The position paper makes four concrete suggestions for achieving these objectives:

  • Establish a mechanism for mutual consultation on prioritizing chemicals for assessment or risk management as well as developing assessment methodologies. In addition, both sides would keep each other informed about related developments on the Member State/state level.
  • Determine a date by which the UN Globally Harmonized System (GHS) will be implemented for a broad range of chemicals in the U.S. A mechanism for mutual consultation on the process of classifying and labeling substances should also be established.
  • Establish a mechanism for regular consultation on new and emerging issues, focusing on those with regulatory relevance (e.g., endocrine disruptors, nanomaterials).
  • Identify and consider potential benefits and challenges to exchanging CBI, with the possibility of establishing a mechanism – including periodic reviews – to achieve such exchange if found to be appropriate.

Moreover, the position paper suggests that the TTIP’s “horizontal chapter” – a proposed section of the treaty that would set a framework for future regulatory convergence – should provide for an effective bilateral cooperation and consultation mechanism, as well as an improved way to provide feedback, so that both parties have sufficient time to comment on proposed regulations. In the chemical sector, this mechanism would apply to risk management proposals for substances at the federal/EU and Member State/U.S. state levels.

According to Chemical Watch, the proposals were well-received by the European Chemical Industry Council (Cefic). The industry group’s executive director, Lena Perenius, said the position papers applied the “same logic” as Cefic’s own.

EPA exploring data-sharing possibilities with European regulators.

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The EPA is considering ways to share chemical data with European regulators, including research on endocrine disrupting chemicals (EDCs) and information submitted for REACH compliance. Chemical Watch reports that Jim Jones, EPA Assistant Administrator of the Office of Chemical Safety and Pollution Prevention, will discuss sharing EDC data with regulators in Brussels in late June. Mr. Jones also commented that the U.S. and EU will likely take different approaches to regulating EDCs, but that data-sharing could improve the development of regulations for both sides.

Speaking this week at the Safer Consumer Products Summit in Santa Clara, California, Mr. Jones noted that EPA is considering how to access data submitted via Substance Information Exchange Fora (SIEFs) for the preparation of REACH dossiers. Under current rules and data-sharing agreements, this information is restricted, but EPA has previously stated that it is contemplating using its subpoena authority under the Toxic Substances Control Act (TSCA) to require U.S. companies to submit such information. Mr. Jones said that EPA has selected one chemical as a starting point to test whether European regulators would be open to sharing health and safety information with the agency.

Report: REACH a primary trade barrier for SMEs exporting to EU.

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Last week, the U.S. International Trade Commission (USITC) released a report identifying the high costs of complying with REACH as one of the primary trade barriers affecting American small and medium enterprises (SMEs) seeking to export to the EU. Although SMEs account for as much as 35 percent of U.S. chemicals exports to the EU, the complexities and costs of REACH disproportionately affect SMEs, meaning firms with less than 500 U.S.-based employees. SMEs reported that REACH compliance could add over 20 percent to the cost of the product.

REACH’s testing requirements and the need for a special representative in the EU are reportedly particularly burdensome for SMEs. Other problems with REACH cited by SMEs include what firms consider to be excessive disclosure requirements, especially of trade secrets; the prohibitive cost of registering chemical additives; the difficulty of communicating with the European Chemicals Agency (ECHA); and ECHA’s opaque rulemaking process. SMEs also reported that the Substance Information Exchange Forums (SIEFs) maintained under REACH “can hinder competition in that SMEs may have challenges accessing the necessary information and negotiating with the larger companies in the SIEF.” The report cited hearing testimony from the Society of Chemical Manufacturers and Affiliates (SOCMA) that the 2018 REACH deadline, applying the quantity threshold of just 1 metric ton per year, has already driven some companies to decide not to export to the EU market because of REACH’s costs and complexity.

In addition to REACH, the USITC report highlighted several other trade barriers facing U.S. SMEs exporting to the EU, including the Biocidal Products Regulation, the EU Cosmetics Directive, the Restriction of Hazardous Substances (RoHS) Directive, and the Waste Electrical and Electronic Equipment (WEEE) Directive. Challenges for SMEs dealing with these regulations reportedly include high compliance costs, increased product costs, expensive testing requirements, and lengthy certification processes.

The report, which was conducted at the request of the U.S. Trade Representative, was primarily based on information and statements collected from SMEs on a voluntary basis. The entire report is available for download here [PDF].

ECHA finalizes REACH CoRAP list.

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The European Chemicals Agency (ECHA) has adopted its final substance evaluation plan for 2014-2016. This updates the REACH Community Rolling Action Plan (CoRAP) list to contain 120 substances, 51 of which will be evaluated by member states this year. The plan provides that 48 more substances will be evaluated in 2015 and 21 in 2016, although it will be updated annually. The update includes 52 substances which are new entries to the plan, including 17 to be evaluated in 2014.

Common initial concerns for listing these substances include: persistent, bioaccumulative and toxic (PBT) effects; suspected endocrine disruption; and carcinogenic, mutagenic, and reproductive toxicity (CMR); combined with wide dispersive or consumer use. Substances of note on the list include a handful of phthalates, shale oil bitumen, and silver nanoparticles.

The adopted plan differs only slightly from the draft update circulated in the fall of 2013 and approved by ECHA’s Member State Committee last month. The final CoRAP list adds trixylyl phosphate and removes four substances:

  • 3,4,5,6,7,8,9,10,11,12,13,14-dodecahydro-2H-cyclododeca[b]pyran;
  • yellow pigment additive;
  • 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylindeno[5,6-c]pyran (HHCB); and
  • 1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one.

Aluminum chloride and aluminum chloride, basic were originally covered as one entry but are treated separately in the final list. In addition, several other substances were evaluated under the last CoRAP – including shale oil bitumen and naphthalene – and were found to qualify for re-evaluation.

ECHA encourages registrants to follow its new best practices recommendations for interactions during substance evaluation, which we have previously discussed.

The complete CoRAP list is available online.

ECHA committee takes step towards reclassifying BPA as 1B reprotoxicant.

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The Risk Assessment Committee of the European Chemicals Agency (ECHA) has adopted an opinion to strengthen the harmonized classification and labeling (CLH) of bisphenol A (BPA), in line with a proposal by France regarding the substance’s adverse effects on sexual function and fertility. BPA is currently classified as a category 2 reproductive toxicant and would be reclassified as a category 1B reproductive toxicant.

The committee’s consensus-made action was based on “‘rock-solid’ multigenerational rodent studies” and tees up a final decision to be made by the European Commission. France’s reclassification proposal has received mixed responses [PDF] from member states and industry. If approved, the reclassification of BPA as category 1B would trigger Substance of Very High Concern (SVHC) criteria under REACH.

BPA is a monomer widely used in the production of polycarbonate plastics and epoxy resins and as a developer in thermal paper. In late 2013, ECHA followed up a German substance evaluation of BPA by issuing a request for further data on skin absorption and environmental exposure. The European Found Safety Authority (EFSA) also recently closed a public consultation period on a draft assessment of the human health risks of BPA via food exposure. A recent rodent study conducted by U.S. researchers at the National Center for Toxicology Research, however, concluded that orally-ingested BPA did not affect body weight, reproductive organs, or hormones at levels comparable to the amount Americans typically ingest.

RoHS working group will consider restricting five substances.

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The European Commission will present proposals to restrict five additional substances under the EU’s Restriction of Hazardous Substances Directive (RoHS), which applies to electrical and electronic equipment. Four of the substances – hexabromocyclododecane (HBCDD) and the phthalates DEHP, BBP and DBP – have already been assessed by the Austrian Environment Agency (UBA). These assessments are part of the RoHS 2 Annex II report, which UBA released on February 5. The consultancy Öko Institut is currently reviewing the fifth substance, the phthalate DIBP, and is expected to release results by the end of April.

The UBA’s assessments found that HBCDD, DEHP, BBP, and DBP pose unacceptable risks to workers’ health or the environment and thus should be added to Annex II of RoHS2. The report noted that the proposed bans would not be cost prohibitive, and safer alternatives are technical and economically feasible.

Under RoHS2 – a recast of RoHS adopted in 2011 – a first review of the list of restricted substances is required by July 2014. The Commission will establish a working group to review the priority list of substances, which was developed by UBA. Chemical Week reports that, according to the RoHS policy officer at the Commission’s Environment Directorate-General (DG Environment), the working group will include representatives from approximately three member states, various industries, DG Environment, and the Directorate-General for Enterprise and Industry.

In addition, the working group will consider the procedure for reviewing substances. The Directive does not require updating the review process, but the Annex II report examines issues associated with the methodology used for the substance assessments and makes recommendations for a four-year review cycle going forward. The report also discusses lessons learned from the substance review process, such as the scarcity of relevant information, the lack of integration of exposure estimates from waste treatment facilities, and overlaps with other legislation, like REACH. The Commission plans to release non-binding guidance on the review process near the end of the year.

UK REACH survey: high costs and supply chain communications problems.

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According to a survey conducted by the UK’s Department for Environment, Food and Rural Affairs (Defra), REACH registration has forced some firms to withdraw products from the market. Defra’s REACH Business Impacts Survey collected information from over 150 respondents on the effects of REACH on UK businesses following the first and second registration deadlines, with the intent of developing a “better understanding of how the implementation of [REACH] might be improved.”

The UK Chemicals Stakeholder Forum – an advisory group to the UK government composed of industry, NGOs, trade unions, and academia – reviewed initial results of the survey at a January 28 meeting. Registrants or downstream users comprised the bulk of survey respondents, although some distributors, importers, and trade groups were also included. The survey posed questions specific to the various stages in the supply chain (registrants, distributors, downstream users) and about the quality of support provided by various entities (the Health and Safety Executive, ECHA, trade associations).

On the topic of Substance Information Exchange For a (SIEFs), registrants reported mixed experiences. Costs, time commitment, and workload were some of the major problems associated with SIEFs. However, SIEFs did appear to be effective in data-sharing among businesses to assemble the required data. In addition, participation in SIEFs was found to be easier in 2013 than in 2010.

Twenty-five registrants reported withdrawing substances because of REACH; in 17 cases, the withdrawal was due to the high cost of registration rather than supply chain pressure. The survey also found that most respondents were dissatisfied with the quality of information provided in supply chain communication. Businesses experienced particular difficulties with supply chain communications and confidentiality; customers were reportedly “generally very reluctant to give information about their specific uses.” Of 37 businesses that registered or attempted to register substances imported from outside the EU, nine “experienced difficulty with obtaining information from non-EU suppliers,” due to a lack of understanding of the REACH process and, e.g., the lack of test information from China.

The preliminary survey results did not identify any clear trends on whether registrants would adopt a different approach for the next REACH registration deadline, on June 1, 2018. Changes proposed by some respondents including more planning and spreading of costs, starting the process earlier, and taking a phased approach. With regard to specific concerns to be addressed in advance of the 2018 deadline, the comments revealed two areas of needed improvement: (1) more time; and (2) more guidance from the European Chemicals Agency (ECHA).

Analysis of the survey results are still at an early stage, but the validated findings will be shared with the European Commission and ECHA. Defra plans to commission follow-up interviews in summer 2014 to address issues highlighted in the survey in greater detail.

Member states, ECHA agree to improve substance evaluation interactions.

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Member states, the European Commission, and the European Chemicals Agency (ECHA) have agreed on recommendations for improving communications under the REACH Community Rolling Action Plan (Corap). Last month, we reported on the presentation and endorsement of a working group paper recommending the improvement of interactions during the REACH substance evaluation process. Earlier this week, ECHA released the paper [PDF], which is aimed at evaluating member states and intended to “give guidance for a common approach and create a level playing field.”

The nonbinding recommendations encourage evaluating member states to contact the lead registrant in the first instance. Registrants should be proactive, “speak with one voice” in communications, and send consolidated comments on draft decisions on behalf of all registrants.

The recommendations are not meant to be exhaustive, since interactions will vary by evaluation, and instead focus on the “informal interaction” between evaluators and registrants during the current evaluation year. The experience gained from first year of evaluations informed the recommendations, which will be revised as necessary based on further experiences. The paper is intended to complement the previously published leaflet, “Substance evaluation under REACH – Tips for registrants and downstream users” [PDF].