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].

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

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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.

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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.

REACH substance evaluation interactions to be improved.

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At a recent meeting of the Competent Authorities for REACH and CLP (Caracal), member states, the European Chemicals Agency (ECHA), and industry agreed on steps to improve interactions between registrants and member state competent authorities (MSCAs) during the REACH substance evaluation process. Chemical Watch reported last week that a working group presented a paper making a series of recommendations on how to improve communication under the REACH Community Rolling Action Plan (Corap). The working group was established at a May meeting of ECHA and industry representatives and was led by Ireland and the European Chemical Industry Council (Cefic), among others.

According to Chemical Watch, the paper – which has not yet been released – makes various recommendations for substances listed on Corap year one, generally specifying which communications should occur at certain points throughout the evaluation process; e.g., evaluators should contact registrants shortly after publication of the Corap, and a mechanism should be developed to ensure that all registrants are informed of an impending evaluation. For substances listed on Corap years two and three, the paper recommends that evaluating authorities communicate clarifications on the substance evaluation process, while registrants should provide status updates on ongoing tests or planned dossier changes which might affect the evaluation.

The purpose of the recommendations, according to ECHA representative Claudio Carlon, is to “to increase clarity on the Corap process and explain what registrants need to do before it starts and post draft decisions, and encourage informal interaction between member states and registrants.” The recommendations were reportedly supported by attendees of the Caracal meeting. Industry groups including Cefic are planning to publish “a comparable initiative,” focusing on how industry can prepare for interactions with MSCAs during the evaluation process. This initiative will also address “interactions with downstream users.”

ECHA is expected to publish the working group’s paper with “minor amendments” by the end of the year or early 2014.

Scientists agree on EDC thresholds.

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Scientists representing both sides of the Endocrine Disrupting Chemicals (EDCs) debate have agreed that thresholds for activity of EDCs may not exist. The conclusion is one of several reached during a recent meeting hosted by European Union (EU) chief scientific advisor Anne Glover in an attempt to identify areas of consensus and disagreement on the subject.

In the published minutes [PDF] of the meeting, the scientists say uncertainty about the existence of EDC activity thresholds—the exposure level or dose of a chemical above which toxicity or adverse health effects can occur—is due to experimental constraints and limited understanding of biological systems. They also agreed that defining EDC thresholds by in vivo experiments alone  is not possible. Rather, establishing whether thresholds exist must be defined by better understanding “the mechanisms of action in a quantitative systems approach.”

The scientists also agreed with the World Health Organization’s 2002 definition of EDCs and that criteria for identifying endocrine disruptors need to consider the disturbance of homeostasis at different stages of development. In addition, they agreed that non-monotonic dose response effects exist for some EDCs, both in in vitro and in vivo tests. However, although reliable study designs to find non-monotonic effects are available, the scientists say that more dedicated methods are needed to evaluate possible effects of EDCs on humans. Furthermore, they noted that validated OECD guidelines for testing do not cover all adverse effects or modes of action of EDCs.

Meanwhile, the German Chemical Industry Association (VCI), which recently published its opinion on EDCs, believes that EDC thresholds do exist, despite uncertainty, and any discussion about setting regulatory limits on EDCs should be viewed in that context. Furthermore, the association argued that while in vitro tests can be used in order to inform the mode of action for EDCs, they should not be used to derive regulatory thresholds. In vivo testing should be used to test for endocrine disruption since it allows scientists to more meaningfully investigate the complex interactions in the hormone system.

VCI also criticized the group’s conclusions on testing as overly pessimistic, since OECD guidelines cover the most relevant endpoints for EDCs and provide a solid foundation to test chemicals for their estrogenic, androgenic and thyroid-endocrine properties.

EU, U.S. TTIP negotiators discuss reducing chemical costs, regulating cosmetics.

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Last week, U.S. and European Union (EU) negotiators held a second round of Transatlantic Trade and Investment Partnership (TTIP) discussions. During the week-long talks, negotiators examined how to reduce regulatory and industry costs for chemicals.

According to U.S. TTIP chief negotiator Dan Mullaney, a range of tools are available to reduce costs for chemicals and other sectors.  Ignacio Garcia Bercero, the EU’s chief negotiator, said specific ideas for cost reduction include harmonization of labeling requirements and better cooperation between the EPA and ECHA in performing risk assessment and exchanging data to avoid unnecessary testing. Bercero said the European and U.S. negotiating teams also discussed regulatory compatibility for cosmetics. Negotiators considered the feasibility of achieving “greater convergence” between the positive and negative lists of cosmetic ingredients in the EU and the U.S., which may be difficult since the U.S. allows certain cosmetic ingredients that are prohibited in the EU, said Bercero.

Meanwhile, NGOs have continued to express concerns over the lack of transparency in TTIP negotiations. Spokespeople from the European Consumer Organization (BEUC) and Friends of the Earth Europe said that open negotiations are necessary to ensure that the trade deal does not undermine or eliminate existing consumer legislation in the EU, as well as U.S. states like California with stricter chemical legislation. Both groups want access to the negotiating texts and regular consultations before and after each negotiating round. In response to NGO concerns, both Mullaney and Bercero said that talks on regulatory convergence in the chemical sector will not affect the level of protection or legislation under REACH or TSCA. The EPA has also stated that it does not believe TTIP negotiations will influence the agency’s “risk-based approach to chemicals management.”

The next round of TTIP negotiations will take place in Washington, D.C., between December 16 and 20.

Dutch survey finds SMEs struggling with awareness, cost of REACH.

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A recent Dutch survey found that the costs of implementing REACH are much higher for Small to Medium Enterprises (SMEs) than previously thought and awareness among SMEs is lower than expected. The survey findings highlight just some of the major issues facing SMEs subject to REACH.

The Dutch survey, which is believed to be the largest national assessment yet of impacts of the Regulation on SMEs, interviewed 1,143 Dutch SMEs by telephone. The companies were selected on the basis of research that indicated they would be affected by REACH. The survey produced the following results:

  • Less than 30% of the companies had knowledge that REACH existed.
  • The cost of complying with the Regulation for SMEs was estimated to be €425m in 2012.  Jan Wijmenga, of the Dutch Ministry of Infrasture and Environment, said that the costs are much higher than originally expected, considering the estimate by the European Commission (“the Commission”) that REACH would cost companies €10 billion to implement in total, until 2018.
  • The cost of access to data is cited as the highest contribution to REACH expenses; however, this element is largely outside the remit of national member states and ECHA.

Although the survey was conducted for the Dutch Ministry of Infrastructure and the Environment, Mr. Wijmenga said that the survey would also be of interest to the Commission and ECHA. The survey highlighted certain priorities for REACH, such as developing simpler, easy-to-read guidance to the Regulation, clear information on how Substance Information Exchange Fora (SIEF) work, digitalization of safety data sheets, and greater consistency between REACH and other EU legislation. These priorities can be added to the list of the issues that have received attention since the end of the REACH registration deadline for tier two pre-registered, phase-in substances (100-1,000 tonnes) on May 31, 2013. Some of the major issues include:

  • The high cost of submitting dossiers, even for low tonnage bands. Much of the cost is due to laboratory studies (although some of this cost can be reduced by participating in SIEFs).
  • The practical problems SMEs face when participating in SIEFs, including the cost of letters of access, transparency, and the powers of lead registrants.
  • The number of companies falsely declaring themselves to be SMEs (which allows them to pay lower registration fees). In 2012, 62% of companies who had registered as SME were unable to demonstrate eligibility; 56% were considered not to be SMEs.
  • The time frame in which SMEs must respond to public consultations on EU chemicals legislation, particularly SMEs’ need for more time to process the information, given their often limited resources.

In particular, the survey findings will help supplement the Commission’s ongoing investigation of the impact of REACH on SMEs. A REACH review addressed the subject in February 2013, and this summer, the Commission’s Directorate-General for Enterprise and Industry (DG ENTR) put out a tender for technical assistance to further assess SMEs “in the context of socio-economic analysis under REACH.” The Commission also plans to hold a workshop on December 10-11, 2013, in Brussels, to further discuss the challenges faced by SMEs under REACH.

Efsa revises draft guidelines for food contact materials, calls for proposals to study implications.

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The European Food Safety Authority’s (Efsa) Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) recently drafted revisions to its guidelines [PDF] for food contact materials (FCMs), incorporating new data requirements that could lead to substance re-evaluations. In response, Efsa’s Food Ingredients Packaging (FIP) unit has launched a call [PDF] for proposals to study the implications of the revisions.

The guidelines specify the data that must be submitted with applications for safety assessments of substances to be used in FCMs prior to authorization by the European Commission. CEF revisited the guidelines in light of recent scientific developments, opinions issued by Efsa, and experience gained from safety evaluations of many different substances. In the revisions, CEF proposes carrying out “an exposure assessment using a harmonised methodology” established by Efsa. The assessment would take into account specific consumption by subgroups of the population, such as infants and toddlers, in contrast to the current approach, which uses a single value. The CEF panel also suggests setting standardized consumption data for a number of food categories.

The exposure-based approach proposed by CEF could result in different requirements for submission of toxicological information and use restrictions for certain substances. Therefore, Efsa “considers it necessary” to assess the implications of the draft revised guidelines and the differences from the current guidelines, as specified in the call for proposals.

The draft revised guidelines are not yet publically available. The CEF panel plans to adopt the revisions at its plenary meeting next week, after which the guidelines will be released for public consultation.