ECHA proposes adding 11 substances to REACH Authorization List.

Last week, the European Chemicals Agency (ECHA) announced that it is considering adding 11 substances to the Authorization List, also known as Annex XIV of REACH. The agency is soliciting comments on its draft recommendation, including “comments on the priority of the substances, their uses, possible exemptions from the authorisation requirement and on the proposed transitional arrangements.” In addition, the European Commission is separately accepting comments on the socioeconomic impact of the inclusion of these substances on the Authorization List.

The substances and their common uses, according to ECHA, are:

  • Dihexyl phthalate and 1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear (plasticiser in PVC);
  • HHPA and MHHPA (hardener for epoxy resins);
  • Trixylyl phosphate (in lubricants, hydraulic fluids and plastics production);
  • Two boron compounds: sodium perborate; perboric acid, sodium salt and sodium peroxometaborate (in detergents and bleaching products);
  • Four lead compounds: orange lead (lead tetroxide); lead monoxide (lead oxide); tetralead trioxide sulphate and pentalead tetraoxide sulphate (batteries and rubber production, in adsorbents)

Comments will be accepted through February 17, 2016.

Under REACH, substances on the Authorization List are assigned a “sunset date,” after which the substance can only be placed on the market or used if a company has applied for and received an authorization for a specific use. ECHA regularly prioritizes substances from the “Candidate List” and makes recommendations for additions to the Authorization List, including use conditions, application deadlines, and sunset dates. The 11 substances are all proposed to have application deadlines of between 18 and 24 months, with recommended sunset dates 18 months after.

Last week’s recommendations are the agency’s seventh round of recommendations, and include four lead substances that were included in ECHA’s 2014 draft recommendations, but which were not part of the final recommendation submitted to the Commission in July 2015.

After considering public comments, the Member State Committee will prepare an opinion on the agency’s draft recommendation. ECHA will then develop its final recommendation and submit it to the European Commission, which will decide whether to include the substances on the Authorization List and on the conditions applicable for each substance.

EU court rules on notification requirements for REACH articles.

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.

REACH Candidate List updated with four new Substances of Very High Concern.

The European Chemicals Agency (ECHA) has announced the addition of four new Substances of Very High Concern (SVHCs) to the Candidate List: cadmium chloride, a phthalate (1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear), and two boron substances (sodium peroxometaborate and sodium perborate; perboric acid, sodium salt). This addition brings the Candidate List to a current total of 155 substances.

ECHA identified cadmium chloride as a carcinogenic, mutagenic, and toxic for reproduction (CMR) substance, as well as “being of an equivalent concern based on probable serious effects to human health,” with specific focus on effects to the kidneys and bones. The other three substances are identified as toxic for reproduction.

One of the boron substances was added directly to the Candidate List by ECHA because no relevant comments regarding its identification as an SVHC were submitted during public consultation. The Member State Committee (MSC) added the other three substances via unanimous agreement in written procedure regarding their identification as SVHCs. The addition of cadmium chloride and the borate substances to the Candidate List were proposed in March by Sweden and Denmark, respectively.

The addition of these substances to the Candidate List marks a first step towards the substances possibly becoming subject to authorization under REACH. Inclusion in the Candidate List triggers certain notification obligations for manufacturers or importers of the substances, including when they are present in mixtures or articles.

EPA exploring data-sharing possibilities with European regulators.

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.

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.

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.

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

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.

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].

ECHA finds that 70 percent of REACH registration dossiers are noncompliant.

After evaluating over 1,000 substance registration dossiers in the over-100 tonne per year band, the European Chemicals Agency (ECHA) found that almost 70 percent of the dossiers were noncompliant. Yesterday, ECHA announced the results of its compliance checks of 1,130 dossiers, comprising 5.7 percent of the registration dossiers over 100 tonnes submitted for the first REACH registration deadline in 2010. REACH requires the agency to check compliance for at least 5 percent of each tonnage band.

The agency identified two main causes for noncompliance: information deficiencies regarding the substance’s identification and composition; and missing data in chemical safety reports or insufficient justification for not submitting required studies.

ECHA’s Executive Director, Geert Dancet, described the completion of the compliance check as an “important milestone which helps all registrants to better understand their legal requirements.” Dancet also pointed out that the high noncompliance rate was not surprising since ECHA had targeted the compliance check on dossiers that had been electronically pre-screened for having “apparent shortcomings.”

ECHA has issued decisions as a result of the compliance check to registrants, who are required to submit the requested information. EU member states are responsible for enforcement of these decisions. ChemicalWatch notes that ECHA has declined to reveal either the companies or substances associated with the noncompliant dossiers, to the chagrin of certain NGO critics.

European Commission orders study of polymers for possible REACH registration requirements.

Polymers are currently exempt from REACH registration requirements, but recent actions taken by the European Commission (EC or the Commission) suggest that polymers might face a heavier regulatory burden in the future. Today, ChemicalWatch reported that the Commission has awarded a contract to study whether and how polymers should be subject to REACH registration requirements. The contract was awarded to Bio-Intelligence, a consultancy, in December 2013, and the study is expected to be completed by October 2014.

Article 138(2) of REACH empowers the Commission to present legislative proposals for selecting polymers for registration after finding a practicable solution and publishing a report on the matter. This report must cover risks posed by polymers in comparison with other substances; and the need, if any, to register certain types of polymers, taking into account factors including competitiveness and innovation as well as human health and the environment.

Last year’s REACH Review concluded that there was insufficient information to conclude whether certain types of polymers should be registered. In 2012, the consultancy RPA conducted another study for the EC on registration requirements for polymers. Taken together, the studies may for the basis for a new proposal on registering certain polymers.