EU Commission Publishes REACH Review

The EU Commission has fulfilled its obligation to review the REACH program. It published its REACH review on February 5, 2013. The 15-page document concluded:

"that REACH functions well and delivers on all objectives that at present can be assessed. Some needs for adjustments have been identified, but balanced against the interest of ensuring legislative stability and predictability, the Commission will not propose any changes to the enacting terms of REACH."

They did, however, determine that there is a need to reassess the impact of REACH on small and medium sized entities (SMEs), which because of their relative low benefit compared to the high costs of compliance the Commission felt have still been unduly impacted despite reduced fees and testing obligations.

A summary of the report can be read here.

The prepublication version of the report can be downloaded here as a PDF.

ECHA Lists 54 Substances of Very High Concern

The European Chemicals Agency (ECHA) plans to add another set of substances of very high concern (SVHC) to the candidate list under the REACH Regulation. The 54 new substances brings the total on the candidate list to 138. Most of the substances listed are CMRs, i.e., carcinogenic, mutagenic or reproductive toxicants, or PBTs, i.e., persistent, bioaccumulative and toxic. Three of the new substances are listed because they exhibit "equivalent concern," a more nebulous characteristic that covers any toxicity or other concern that does not fit neatly into one of the other categories, e.g., endocrine disruption, or in this case, strong respiratory sensitizers.

All of the substances on the candidate list are evaluated for inclusion on the Annex XIV Authorization list.

The full list of candidate list substances can be found in the table here.

ECHA Cancels REACH Registrations Because Companies Misrepresented Themselves

The European Chemicals Agency (ECHA) in Helsinki, Finland has revoked "a number of" REACH registrations because the registrants misrepresented their size. Size is important because the registration fee is dependent on the size of the entity submitting the registration. Small and Medium Sized Enterprises (SMEs) are allowed a significant discount to avoid disproportionate costs of registration compared to market value. According to ECHA, this "ensures equal and fair treatment of registrants." Companies declare their size when registering the fee is assigned automatically when the registrant makes their electronic dossier submission. Once submitted registration dossiers pass a completeness check, which includes payment of the fee, the registrant is given a registration. This generally occurs within three weeks of submission.

In their more comprehensive review since the November 2010 submission deadline, ECHA has determined that some companies inappropriately claimed they were SMEs when they did not, in fact, qualify for that designation or the reduced fee. Those companies that cannot document their SME status or pay the full size entity fee are considered to have failed the completeness check. In those cases ECHA has chosen to revoke the registration, which means the companies can no longer legally manufacture or import the chemical substance in question.

More details on the revocation can be found on the ECHA website.

ECHA Strengthens Compliance Check Strategy

From the European Chemicals Agency (ECHA):

"To ensure increased compliance of REACH registration dossiers, ECHA carries out both full compliance checks of the dossiers and now more effectively also targets its evaluation to specific parts of them.

In a full compliance check, ECHA addresses the full dossier content in a single evaluation exercise, especially for randomly selected registration dossiers. This means that ECHA performs a systematic evaluation of all information requirements in the technical dossier (e.g. physico-chemical, environmental and human health endpoints), including the corresponding elements and conclusions provided in the chemical safety report (i.e. PBT/vPvB assessment, classification and labelling, exposure assessment and risk characterisation). Where a dossier is non-compliant with an information requirement, ECHA will request the information in a single decision. The decision is taken in cooperation with the Member States.

In a targeted compliance check, ECHA evaluates only a specific part of the registration dossier based on specified concerns. Selected (groups of) endpoints or criteria, called areas of concern, have been identified that are in particular relevant for the safe use of substances.  The ultimate goal is to focus on those endpoints that matter for human health and the environment. Emphasis will be given to Persistent, Bioaccumulative and Toxic (PBT);  Carcinogenic, Mutagenic or Toxic to reproduction (CMR); or sensitising (S) properties of a substance. IT-assisted targeting combined with expert judgement will help to achieve the necessary increased compliance of the registration dossiers. The chances of non-compliant dossiers being picked up for compliance check are now higher. Dossiers submitted individually outside an existing joint submission and dossiers with obviously incomplete essential elements will be automatically selected for compliance check."

The full press release can be read here.

ECHA Publishes Practical Guide for Reporting Toxicity Data for REACH

ECHA has announced that it has made available a new "practical guide" to assist REACH registrants in "How to prepare toxicological summaries in IUCLID and how to derive DNELs." The guide "supports registrants in correctly summarising the toxicological information for substances in section 7 of IUCLID 5.4."

The most critical part of the guide explains how to undertake the take of "Derivation of No Effect Levels" (DNELs), which are used to compare toxicity to exposure in the assessment of risk. DNELs must be derived for all relevant toxicological endpoints (e.g., oral and dermal exposures) and represent the effects side of the equation for human health concerns. For environmental concerns there is a similar derivation of "Predicted No Effect Levels" (PNECs) for aquatic and terrestrial organisms. PNEC derivation is not discussed in the new practical guide.

More information on the Practical Guide can be found on the ECHA web site.

The Practical Guide in PDF format can be downloaded directly here.

ECHA to make more data on chemicals available

According to an ECHA news release:

"Beginning in November, ECHA will make more information from registration dossiers available on its website. This will implement a decision taken by ECHA in 2011 and is in line with Article 119(2)d of REACH. With these new elements, information made available will include the name of the registrant, the registration number of the substance as well as other items normally contained in a Safety Data Sheet (SDS). Companies wishing to request confidentiality on these items need to update their dossiers and justify their requests for confidential treatment."

 More information can be found on the ECHA web site.

ECHA Adds Thirteen Substances to Candidate List

The European Chemicals Agency (ECHA) has added thirteen new substances of very high concern (SVHCs) to the REACH candidate list.  This list serves as a staging area for substances to be added to Annex XIV of REACH, which puts them on a track to be banned pending authorization for limited uses for limited time periods.

According to ECHA:

"Four have been identified as SVHCs under the precondition that they contain certain carcinogenic constituents above the concentration limit for classifying these substances as carcinogenic. Five of the new SVHCs have been included in the Candidate List following a scrutiny of the comments received during the public consultation and the unanimous agreement of the Member State Committee (MSC). The further eight substances, which did not receive comments challenging the identification as SVHCs during public consultation, were directly added to the Candidate List."

More information and the full candidate list of substances can be found on the ECHA site.

REACH-IT update scheduled for 11 July 2012

The European Chemicals Agency (ECHA) has announced that it will upgrade REACH-IT, the user interface needed to submit chemical dossiers for the REACH registration program.  The upgrade will occur on July 11, 2012. To prepare for the changeover, REACH-IT will be inaccessible from Friday 6 July 2012 at 14.00 hrs (Eastern European Time) until 11 July 2012 at 9.00 hrs, in order for ECHA to install the new version of the software and to migrate the data from the present to the new version of REACH-IT.

In addition to REACH-IT, ECHA has also recently released an updated IUCLID, now version 5.4.  IUCLID 5.4 must be used for all dossiers submitted beginning July 11th.  And not to be left out, ECHA has also released a new version of Chesar, the exposure and risk assessment tool needed to complete the analysis of risk. Various plug-ins to the IUCLID software, e.g., Technical Completeness Check, Fee Calculation, Dissemination, and CSR, have also all been upgraded and will be available as the release of the new REACH-IT.

More information can be found on the ECHA site.

Chesar 2.0 released and strongly recommended by ECHA for REACH

Announced by the European Chemicals Agency (ECHA):

ECHA launches a new generation of its Chemical Safety Assessment and Reporting Tool to further harmonise and improve information on the safe use of chemicals.

Helsinki, 20 June 2012 – Version 2.0 of Chesar is now available and can be downloaded from the revised Chesar website. ECHA has invested in the redesign of the IT technology of Chesar in order to enhance its stability and make it a better platform for further developments as part of the long term strategy for Chesar. Other improvements include: a redesigned user interface, more transparency in determining the scope of the required exposure assessment, a simplified risk characterisation and an updated version of the Targeted Risk Assessment (TRA) developed by ECETOC. The possibilities to import and export complete chemical safety assessments (CSAs) or CSA building blocks have also been extended.

With Chesar industry organisations can make available generic exposure assessments for the conditions of use in their sector. Single registrants may then import and use this information as a starting point for their own substance specific assessment. Using Chesar will contribute to efficiency and harmonisation in carrying out CSAs. Thus, ECHA strongly recommends (potential) registrants to systematically use Chesar for making chemical safety reports and exposure scenarios.

Today's release of Chesar 2.0 includes the functionalities for carrying out CSAs based on a IUCLID 5.4 dataset and to generate chapters 9 and 10 of the chemical safety report (CSR), with one exception: exposure estimations for consumer uses is not yet included in the current release, but will be included in version 2.1.

The full press release and more information are available here.

ECHA Calls for Comment on 10 Chemicals to be Banned

ECHA, the European Chemicals Agency based in Helsinki, issued a request for comment yesterday on proposals to ban ten additional chemicals under the Authorization phase of REACH.  All of the chemicals have been on the "candidate list" of Substances of Very High Concern (SVHC).  Currently there are 84 substances on the candidate list, of which 14 have already been placed in Annex XIV for eventual removal from the marketplace.  The first sunset date is in early 2013, pending applications for authorization from manufacturers who want to keep the chemical on the market while they develop alternatives.

The ten chemicals out for public comment are:

• Pentazinc chromate octahydroxide 
• Arsenic acid
• Formaldehyde, oligometric reaction products with aniline (technical MDA)
• Potassium hyroxyoctaoxodizincated dichromate
• Strontium chromate
• 1,2-Dichloroethane (EDC)
• Dichromium tris(chromate)
• 2,2'-dichloro-4,4'-methylenedianiline (MOCA)
• N,N-Dimethylacetamide (DMAC)
• Bis(2-methoxyethyl) ether (Diglyme)

According to ECHA, interested parties may submit comments on the draft recommendation by September 19, 2012.


More information can be found on the ECHA site.

ECHA Drops Proposal to Restrict Four Phthalates

The European Chemicals Agency (ECHA) has dropped its plan to restrict the use of four phthalate chemicals. The proposal had been put forth last year on the chemicals commonly called DIBP, DBP, BBP, DEHP.  However, after review an expert committee determined that the proposed restrictions could not be justified, ECHA last week retracted the proposal.


Denmark had asserted in 2011 that the four phthalates could affect sexual development.  The expert committee disagreed - they noted that the "available data does not indicate that there is currently a risk from combined exposure to the four phthalates." The committee also concluded that regulatory actions already being put into place would result in significant reduction of exposures, thus making the proposed restrictions somewhat redundant, yet overly punitive.


The decision is the first time the expert committee has refuted a proposed restriction from ECHA.  


A summary of the Danish report can be read here.

The full proposal can be downloaded here.

ECHA launches public consultations on two proposals for harmonised classification and labelling

ECHA, the European Chemicals Agency responsible for the evaluation of chemicals under the REACH program, has opened a public consultation on proposals to harmonize classification of two substances.  According to their news release:

ECHA  invites the parties concerned to comment on two new proposals for harmonised classification and labelling (CLH): Fenoxaprop-P-ethyl and 8:2 Fluorotelomer alcohol (8:2 FTOH). The public consultation will be open for 45 days and will end on 1 June 2012. The CLH reports and the dedicated webform to post the comments are available on the ECHA website.

ECHA's Committee for Risk Assessment (RAC) will consider the comments received during the public consultation when developing its opinion on the CLH proposal. The Commission takes into account the RAC opinion when it decides whether the proposal for harmonised classification and labelling is accepted and if so, the substance is added to the list of hazardous substances for which harmonised classification and labelling has been established (Annex VI, part 3 of the CLP Regulation).

More information can be found on the ECHA site.

ECHA to Update REACH-IT and IUCLID 5 Software for REACH Chemical Assessments

According to an ECHA press release:

The European Chemicals Agency (ECHA) is going to release a new version of IUCLID 5 in late May 2012 and subsequently a new release of REACH-IT. Later this year, ECHA will start publishing more information on chemical substances.

Helsinki, 11 April 2012 - The new IUCLID 5.4 release will bring about changes mainly on how certain substance information included in the Chemical Safety Report (CSR) is reported. In addition, certain information included in the Safety Data Sheet (SDS) will be made publicly available. As a continuation of the IUCLID 5 update, a new version of REACH-IT will be released later in the summer. The new REACH-IT release will accept only IUCLID 5.4 dossiers. ECHA publishes a Question and Answer (Q&A) document to inform stakeholders in advance about the impact on the upcoming submissions of registration and other dossiers.

More information

ECHA Updates REACH Guidance on Data Sharing for Chemical Regulation

The European Chemicals Agency (ECHA) has updated its guidance on data sharing.  The update takes into consideration information and experience obtained during the REACH registration process and since the original publication of the guidance in 2007.

According to ECHA,"the text has been throroughly revised amending both content and structure." Changes to content include improvement of the "overall coherence" and to create a more focused document that helps companies avoid "unnecessary testing." Duplicative material covered in other guidance has been removed and/or made more consistent.  Two new sections have been added to make the document clearer, including more comprehensive discussions of the data sharing process for phase-in and non-phase-in substances. Additional new sections cover the "data sharing dispute processes" and "post-registration data sharing obligations."

More information can be found on the ECHA site.

ECHA QSAR Toolbox version 2.3 now available for REACH

ECHA has announced the release of the newest version (Version 2.3) of the OECD QSAR Toolbox for use in REACH and other regulatory actions.  According to their press release, "the software helps registrants and authorities to use Quantitative Structure-Activity Relationship ((Q)SAR) methodologies to group chemicals into categories and to fill data gaps by read-across, trend analysis and to assess the (eco)toxicity hazards of chemicals under REACH. This helps to reduce costs and unnecessary testing on vertebrate animals."

While many chemicals do have existing or new data to meet many endpoints, they often have data gaps.  QSARs can be used both to meet some data requirements and provide an estimate of certain properties that allows decision-making on whether new testing is needed.

For more information see here.

The QSAR Toolbox and guidance documents can be downloaded here.

REACH Won't Work for TSCA Reform, Says Industry Based on Indiana Report

The US chemical industry is pointing to a new academic report as proof that the European REACH chemical management system is not a good fit for implementing in the US.  The report from Indiana University comes while Congress has effectively punted on pursuing reform of the 35 year old Toxic Substances Control Act (TSCA). 

The full report, for preparation of which the authors acknowledge receiving "unrestricted financial support from the American Chemistry Council, Dow, and DuPont," presents information about REACH and offers the following five findings:


FINDING #1: U.S. Policymakers Should Consider Simplifications of the REACH program.

FINDING #2: If a REACH-like system is adopted in the United States, more public disclosure of safety-related information and opportunities for public participation should be provided.

FINDING #3: In considering how to streamline REACH for application in the United States, more focus should be on priority-setting based on risk and the opportunity to reduce risks to human health and the environment.

FINDING #4: Since some of the frustration and burden in the early years of REACH implementation has been linked to ambiguity in program design, a REACH-like system in the United States should provide clarification about critical standards, processes, and tools.

FINDING #5: If the United States chooses to adopt a REACH-like system of registration, unnecessary burdens on industry can be lessened by allowing for mutual, cross-Atlantic recognition of registration dossiers.

The full report can be downloaded as a PDF file here.

ECHA Proposes to List 13 Chemicals as Substances of Very High Concern Under REACH

The European Chemicals Agency (ECHA) has proposed to add 13 additional chemicals to their candidate list of Substances of Very High Concern (SVHC).  Each of the chemicals "is classified as carcinogenic, mutagenic or toxic for reproduction."  Stakeholders and other interested parties are urged to comment on the proposed listings.  Besides toxicity, "information on the uses of the substances is invited."

The public consultation "will be open for 45 days and will end on 12 April 2012."  After the consultation period, ECHA will consider all comments and then make final decisions on including the substances on the candidate list.  Eventually these substances could be included on the REACH Annex XIV Authorisation List. If that happens then companies will have to apply for authorisation, that is, apply to have their substance remain on the market, usually only for specific controllable uses, limited volumes, and for a limited period of time while substitutes are developed.


More information and the list of chemicals can be found on the ECHA web site.

ECHA Identifies 2300 Chemical Substances for REACH Registration by 2013

A survey of potential registrants by the European Chemicals Agency (ECHA) has resulted in a list of 2,300 chemical substances that are intended to be registered by the 2013 deadline under REACH.  Substances that are manufactured or imported into Europe at levels above 100 tonnes per year must be registered by May 31, 2013.  This is in addition to the previous deadline of November 30, 2010 for registration of chemicals at volumes greater than 1000 tonnes per year or were substances of very high concern (SVHC).

ECHA will update the list monthly and invites those potential registrants who have not informed ECHA of their intent to do so as soon as possible.

Registrants must prepare an IUCLID dossier containing data requirements as specified in the REACH regulation.  The dossier is filed electronically through ECHA's REACH-IT system and must be done prior to the deadline in order to continue to manufacture or import those substances.  New substances not on the preregistered phase-in list must submit completed dossiers prior to manufacture or import.

More information can be found in the ECHA press release.

ECHA Says "Only Representatives" Can Apply for Chemical Authorization

According to the European Chemicals Agency (ECHA):

"In December 2011, the European Commission services informed ECHA that, in their view, an Only Representative (OR) of a non-EU manufacturer can also apply for authorisation. Following this, ECHA updated the webforms to allow ORs to send their applications while developing long term functionalities in REACH-IT. The relevant Data Submission Manual Part 22 - How to Prepare and Submit an Application for Authorisation using IUCLID 5 is also being updated and will be published once the new version of IUCLID is released, which is currently expected to be during summer 2012."

Previously it was assumed that only a European registrant could apply for authorization under REACH.  Authorization is the process by which companies can apply to keep certain uses of their Substances of Very High Concern (SVHC) that have been targeted for banning on the market for a limited period of time while alternatives are developed.

More information on applying for authorization can be found on the ECHA site.

ECHA Recommends 13 Substances of Very High Concern be Banned

According to the European Chemicals Agency (ECHA):

"The European Chemicals Agency has submitted to the European Commission a recommendation that thirteen Substances of Very High Concern should in future not be used without authorisation. These substances are all classified because of their carcinogenic, mutagenic or toxic to reproduction (or a combination thereof) properties. They are used in applications where there is potential for worker exposure.

The thirteen substances and their main uses within the scope of authorisation are:

• Trichloroethylene (carcinogen). A substance mainly used in surface cleaning, in textile scouring, in adhesives and as a heat transfer fluid.
• Chromium trioxide (carcinogen, mutagen). A substance mainly used for metal finishing and as a catalyst.
• Acids generated from chromium trioxide and their oligomers (group containing: chromic acid, dichromic acid, oligomers of chromic acid and dichromic acid) (carcinogen). A substance that could be used to replace chromium trioxide in many of its uses.
• Sodium dichromate (carcinogen, mutagen, toxic for reproduction). A substance mainly used in metal surface treatment.
• Potassium dichromate (carcinogen, mutagen, toxic for reproduction). A substance mainly used in metal surface treatment and as a processing aid.
• Ammonium dichromate (carcinogen, mutagen, toxic for reproduction). A substance with currently no uses in the scope of authorisation. It could however be used to replace other chromium(VI) substances.
• Potassium chromate (carcinogen, mutagen). A substance mainly used in metal surface treatment.
• Sodium chromate (carcinogen, mutagen, toxic for reproduction). A substance mainly used in metal surface treatment.
• Cobalt(II) sulphate (carcinogen, toxic for reproduction). A substance mainly used in surface treatment processes and as a water treatment chemical, oxygen scavenger and corrosion inhibitor.
• Cobalt dichloride (carcinogen, toxic for reproduction). A substance mainly used in surface treatment processes and as a water treatment chemical, oxygen scavenger and corrosion inhibitor.
• Cobalt(II) dinitrate (carcinogen, toxic for reproduction). A substance mainly used in surface treatment processes and as a water treatment chemical, oxygen scavenger and corrosion inhibitor.
• Cobalt(II) carbonate (carcinogen, toxic for reproduction). A substance mainly used in fertilisers and in surface treatment processes.
• Cobalt(II) diacetate  (carcinogen, toxic for reproduction). A substance mainly used as a catalyst and in surface treatment processes."

More information can be found on the ECHA site.