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.

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.

Nearly 3,000 Substances Registered by REACH Deadline.

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REACH passed its second registration deadline on May 31, with over 9,000 dossiers for almost 3,000 “phase-in” substances submitted to the European Chemicals Agency (“ECHA”). The deadline applies to those substances which have long been on the European market and which are manufactured or imported in the EU at a rate ranging from 100 to 1,000 tons per year. 2,344 of the substances have already been successfully registered, while pending cases are mostly awaiting collection of registration fees. Substances were registered by 3,215 companies, with 82% of substances registered as joint submissions.

Chemical Watch (sub. req’d) quotes Christel Musset, director of registration at ECHA, as noting discrepancies between the final number of registrations and the projected number as reported in a 2011 survey. The survey found that industry intended to register 3,103 substances in 2013, but 984 registrations were not pursued and a different set of 804 substances were registered. Musset said ECHA would investigate and determine “the reason for non-registration of those [984] substances.”

ECHA’s next steps will be to evaluate all testing proposals as well as 5% of dossiers in each tonnage band by June 2016.

More detailed statistics and other non-confidential information on the registration submissions will be available on ECHA’s website after all the dossiers are processed, which the agency projects will be in September. The final REACH deadline, for substances made or imported in the EU at a minimum of 1 ton per year, is scheduled for May 31, 2018.

Chemical Watch reports the chemical industry’s reaction to the deadline as “mixed” (sub. req’d). Industry representatives voiced general support for the REACH program, while also describing it as particularly burdensome for the growing portion of registrants that are small- and medium-sized businesses.

Verdant Proudly Sponsors Prop.65 Clearinghouse's Green Chemistry Conference

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Green Chemistry:

Verdant is pleased to announce its sponsorship of the Prop.65 Clearinghouse Green Chemistry Annual Conference.  This year’s conference will be held on Tuesday, April 9, 2013, at the The City Club of San Francisco, 155 Sansome Street.

  • Verdant attorney, Philip Moffat, will present on “REACH 2013.”
  • Verdant attorney, Catherine Lin, will present on “Supply Chain Management.”

More information about the conference is available here and an agenda is available here.   A copy of Mr. Moffat’s presentation is available here [PDF].

EU Commission Releases Roadmap on Substances of Very High Concern

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EU REACH Substances of Very High Concern:

Last week, the EU Commission released its Roadmap on Substances of Very High Concern (SVHC). The Roadmap outlines a process for identifying and assessing potential SVHCs within the following categories: substances that are carcinogenic, mutagenic or toxic for reproduction (CMRs); substances that are persistent, bioaccumulative or toxic for the environment (PBTs); substances that are very persistent and very bioaccumulative (vPvBs); and substances of equivalent concern, such as endocrine disruptors. The Roadmap estimates that the process will evaluate up to 440 substances, a far lower number than the 1,900 substances originally anticipated, with an initial goal of completing 80 assessments by the end of 2014.

The Roadmap follows the Commission’s commitment to compile a comprehensive REACH candidate list of SVHCs and is designed to help meet the Commission’s plan to include all currently known SVHCs on the candidate list by 2020.

The SVHC Roadmap proposes first screening substances with REACH registration dossiers by applying a minimum quantity threshold and generally exempting substances registered only for intermediate uses. The second step entails conducting a “Risk Management Options” (RMO) analysis. Under this approach, the best regulatory option to manage a particular risk is chosen after considering actions available within REACH (like imposing authorization, restriction or substance evaluation requirements) or under other legislative schemes, such as RoHS. For example, the Roadmap suggests that substances with demonstrated risk should be restricted under REACH.

The roadmap is downloadable as a PDF from the EU website.

The European Commission Reviews REACH.

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The European Commission published its long-anticipated REACH Review on February 5, concluding that chemical use in Europe was much safer since REACH entered into force in 2007. The Review declined to propose any major changes to the regulatory scheme.

The Commission published a 13-page report and 148-page Staff Working Document which covers topics including the law’s operation, scope, and application; achieving REACH objectives like human health and market competitiveness; and enforcement.

The Review focused on ways to reduce the costs of REACH compliance for small and medium-sized enterprises (SMEs). The Commission anticipates further action to help SMEs comply with the law, including revising the REACH Fee Regulation and publishing guidance on transparency, non-discrimination and cost-sharing in preparing registration dossiers.

Other areas of improvement highlighted by the Commission include encouraging registrants to improve the quality of registration dossiers and enhancing the coordination of REACH enforcement in EU member states, especially with regard to “substances of very high concern” (SVHCs).

The Review concluded that there was insufficient information available to propose changes to registration requirements for substances produced in small quantities (1 to 10 tons) or for polymers. The Commission will continue to study these issues and, if appropriate, will release a new proposal by January 1, 2015.

The Review also did not propose any changes to the EU’s regulation of nanomaterials. The Commission will make an “impact assessment of relevant regulatory options” on the issue and may develop a draft implementing act by the end of the year.

The EU Executive is expected to organize a conference on REACH Review in the coming months.

The full report and Staff Working Document are available on the European Commission’s website.

EU Member State Committee Identifies 5 More SVHCs

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REACH/SVHCs/Authorization

During meetings held from June 6 – 8, 2012, the EU’s Member State Committee (MSC) unanimously agreed on the identification of five substances of very high concern (SVHCs).  SVHCs are thought to have serious and often irreversible effects on human health and the environment.  The five substances identified by the MSC are diborontrioxide and the following four dyes:  C.I. Basic Violet 3; C.I.Basic Blue 26; C.I. Solvent Blue 4; and 4,4′-bis(dimethylamino)-4”-(methylamino)trityl alcohol.  The listing for the four dyes will clarify that the substances will only be identified as SVHCs when the concentration of the impurities Michler’s ketone or Michler’s base is equal to or higher than 0.1%.

SVHCs include substances that have one or more of the following hazard characteristics: Carcinogenic, Mutagenic or Toxic for Reproduction (CMR 1,2); Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB); or cause probable serious effects to human health or the environment (e.g. Endocrine Disruptors).  REACH, the primary regulation for industrial chemicals, aims at ensuring that the risks resulting from the use of SVHCs are controlled and that the substances are replaced where possible.

The five substances will be added to the Candidate List and may subsequently become subject to authorization under REACH Title VII.  When an SVHC becomes subject to authorization, persons using or making it available on the EU market must apply for authorization within a prescribed deadline (i.e., the “sunset date”), seeking approval of nonexempt uses while also including an analysis of possible substitutes.  If they can show that the risks from their uses are adequately controlled (except non-threshold CMRs and PBTs/vPvBs), or that the socio-economic benefits outweigh the risks and no suitable alternatives exist, then their uses of the SVHC are “authorized” to continue.

Even without being selected for authorization, inclusion of substances on the Candidate List immediately triggers certain regulatory obligations. 

  • EU or EEA suppliers of articles which contain substances on the Candidate List in a concentration above 0.1% (w/w) have to provide sufficient information to allow safe use of the article to their customers or upon request, to a consumer within 45 days of the receipt of the request. This information must contain as a minimum the name of the substance.
  • EU and EEA producers or importers of articles have to notify ECHA if their article contains a substance on the Candidate List. This obligation applies if the substance is present in those articles in quantities totalling over one tonne per producer or importer per year and if the substance is present in those articles above a concentration of 0.1% (w/w).
  • EU and EEA suppliers of substances on the Candidate List have to provide their customers with a safety data sheet.
  • EU and EEA suppliers of mixtures not classified as dangerous according to Directive 1999/45/EC have to provide the recipients, at their request, with a safety data sheet if the mixture contains at least one substance on the Candidate List and the individual concentration of this substance in the mixture is ≥ 0.1% (w/w) for non-gaseous mixtures if the substance is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB).

More information about the MSC is available here, and information about the process for identifying SVHCs is available here.

European Chemical Industry Debuts Chemical Combination Screening Tool – Concludes Regulating Individual Chemicals is Usually Adequate

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Chemical Mixture Risk Assessment:

May 31, the European Chemical Industry Council (Cefic) unveiled a tool for assessing the risks posed by chemical combinations: the Maximum Cumulative Ratio (MCR) (see e.g., news release, combination effects tools).  MCR compares the toxicity of individual chemicals to the cumulative toxicity of all chemicals in an exposure scenario.  Cefic argues that in most exposure scenarios the risk of one or two chemicals contribute nearly all risk of harm.  The organization notes that prioritization of chemical combinations is necessary to identify combinations of concern that warrant full risk assessment. 

Cefic references Maximum Cumulative Ratio (MCR) as a Tool for Assessing the Value of Performing a Cumulative Risk Assessment (in International Journal of Environmental Research and Public Health) for full discussion of the application of MCR.  The article comprises an investigation of the magnitude of toxicity from multiple chemical exposure that is missed in scenarios where no cumulative risk assessment is conducted.  U.S. Geological Survey water quality data were used for the evaluation. From 5 to 81 chemicals were present in the 3,000 samples analyzed.  The authors estimate that approximately 20 percent of cumulative toxicity –compared to component chemical toxicity– is missed where cumulative risk assessments are not conducted.  However, mixture toxicities were dominated by only a fraction of chemical compounds present.

Because risk is usually driven by one or two chemicals in a combination, Cefic believes that controlling individual substances through the current regulatory schemes will often control the risk from combination exposures.

Cefic notes that MCR is based on the WHO risk assessment framework (see e.g., Combined Exposure Risk Assessment Workshop Report) and relies on cumulative risk assessment theories from the European Scientific Committees (see e.g., Environmental Risk Assessment of Mixtures Symposium).

ECHA Publishes the 2011- 2013 Work Program of the REACH and CLP Enforcement Forum

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REACH/CLP Enforcement:

On July 6, 2011, the European Chemicals Agency (ECHA) published the 2011 -2013 work program for the Forum on Exchange of Information on Enforcement of the REACH and CLP Regulations.  The program lists the Forum’s current and upcoming activities, a description of the activities, the expected time frame for each, and its priority.  Readers less familar with the REACH and CLP Regulations should know that the Forum coordinates a network of authorities responsible for enforcement of the regulations in each country or “Member State.”

Very high priority activities for the work period include the follwing: 

  • EU-wide coordinated REACH Enforcement Projects (REFs) such as the coordinated project concerning downstream user obligations of formulators of mixtures;
  • clarification of the links between ECHA, Member State competent authorities and Member State enforcement authorities;
  • access to REACH-IT by Member State enforcement authorities;
  • cooperation with customs authorities, including execution of a coordinated enforcement initiative; and
  • preparation of advice concerning the enforceability of REACH restriction proposals.

In addition, new rules of procedure for the Forum adopted at the recent ECHA Management Board meeting are published, along with minutes of the Forum meeting held in March of this year. 

Copies of the documents are avaialble here.

Downstream User Reports-ECHA Webinar Tue May 31

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Readers interested in learning more about downstream user reporting may login to the webinar Tuesday May 31 or download a recorded version of the program from the ECHA website.

The webinar will be addressed to all downstream users of registered substances interested in learning more about downstream user reports and how to submit them to ECHA successfully.

Webinar
Date: 31 May 2011
Time: 11:00 AM Eastern European Time
(4:00 AM Eastern U.S. Time)
Register at: https://echa-events.webex.com/echa-events/onstage/g.php?t=a&d=701184789

Participants will receive practical information on how to complete a downstream user report using IUCLID5 and successfully submit it to ECHA via REACH-IT. Participants wishing to benefit from this training should have elementary knowledge of IUCLID5.

Downstream users may need to report their uses if these are not covered by the exposure scenarios provided by their suppliers. Exposure scenarios are part of the extended safety data sheets under REACH.

Producers, formulators, industrial users, other professional users, re-importers, and other downstream users can learn more about obligations under REACH from ECHA. Downstream user obligations include informing customers of hazards, providing risk management advice to formulators and suppliers, and, for chemicals of very high concern, warning customers and users about the parameters of and protocols for