This news page contains items and observations from the past 4 months likely to be of particular interest to past and prospective registrants who may need to take action as a result. Other key statistics are also included. The ECHA website contains a more detailed list of press releases and new items of interest but not necessarily requiring action. Any views expressed are solely those of Chemsage Ltd and Davison Consultants Ltd and should not be taken as official advice or representative of the views of other third parties.
6/7/2012 REACH IT upgrade
This weekend REACH-IT is being upgraded. This will make it compatible with the new version of IUCLID (v5.4). After the upgrade, REACH-IT will only accept dossiers prepared As yet, none of the plugins are available for IUCLID 5.4 which will make checking dossier completeness and preparing CSRs impossible until they are ready. As a short term fix, it would appear necessary, to continue to use v5.3 and to import/export them into a v5.4 installation before creating the dossier for submission.
28/6/2012 ECHA issues practical guide for downstream users to assess exposure scenarios
ECHA has published a guide to assist recipients of exposure scenarios assess their applicability to their circumstances. The new guide provides tips for checking whether the uses and use conditions of a chemical substance are covered by exposure scenarios provided by suppliers with the Safety Data Sheet. It includes advice on the action to take based on the outcome of this check. The guide can be found at http://echa.europa.eu/view-article/-/journal_content/41581066-2a03-4298-8b85-1b4b0b66556d. Readers are reminded that Reachsupport.eu has its own tool available for downstream users to carry out such assessments. Our tool compliments the guidance since the latter provides an overview of the assessment process whilst the tool allows the detailed assessment to be undertaken and documented.
28/6/2012 Chesar 2 launched
The new version of Chesar has been launched. This is a major upgrade and now Chesar works as a free standing installation rather than being a plugin to IUCLID. There still remains heavy integration with IUCLID however. Whilst much of the ECETOC TRA v3 (itself launched in April this year) is incorporated into the internal modelling, it still remains a very conservative tier 1 model in the first instance, especially for consumer exposure.
20/6/2012 New substances added to authorisation list
ECHA launches a public consultation on its draft recommendation of ten new priority substances to be included in the Authorisation List. The deadline for interested parties to submit comments is 19 September 2012. The substances are:
1. formaldehyde, oligomeric reaction products with aniline (technical MDA)
2. arsenic acid
3. dichromium tris(chromate)
4. strontium chromate
5. potassium hydroxyoctaoxodizincatedichromate
6. pentazinc chromate octahydroxide
7. bis(2-methoxyethyl) ether (diglyme)
8. N,N-dimethylacetamide (DMAC)
9. 1,2-dichloroethane (EDC)
10. 2,2'-dichloro-4,4'-methylenedianiline (MOCA)
6/6/2012 CEFIC publishes guidance on dossier evaluation process
CEFIC has published a basic overview of the dossier evaluation and tips for registrations on how to plan for and get through the process. This can be found at http://www.cefic.org/Documents/IndustrySupport/REACH%20Implementation/Cefic%20guidance%20on%20Dossier%20Evaluation.pdf.
5/6/2012 IUCLID 5.4 launched.
Version 5.4 of IUCLID is now available. This new version includes additional fields for reporting exposure, PBT (Persistent, Bioaccumulative and Toxic chemicals) and human hazard assessment data as well as major changes to section 3.7 for reporting the uses. The section on waste has also been dropped. The new section 3.7 will require transcribing of much of the information in the exposure scenarios from the CSR into a structured form within IUCLID. It does raise fears that ECHA will be able to data trawl for any registrant who has not followed the exact stringent and ultra-conservative requirements of the guidance. It is not immediately apparent yet how alternative approaches such as using measured data or SCOEL IOELVs instead of DNELS can be incorporated. At present none of the required plugins are available (eg CSR, TCC) so users with a single installation are advised not to upgrade just yet, not least because REACH-IT will not yet accept dossiers prepared using IUCLID 5.4. ECHA have indicated that none of the new data fields will become compulsory to complete before the June 2013 deadline but have indicated that this is likely to happen soon after. (ECHA are releasing two versions of the TCC tool, one of which, TCC+ will indicated what they want to see completed and, presumably will insist is completed in the future.)Bearing in mind experiences with version 5.2, it is also probably best to wait a few weeks to check for problems not unearthed during the beta testing. Another problem is the helptext has not yet been updated, so there is no way of finding out how to use new features such as the folder structure or, indeed, what ECHA expect to see in some of the new fields! One known danger of this in IT circles is that if you add data fields and don’t clearly indicated what is intended, users will put in ‘junk’ just to get the dossier accepted. The one good thing is that, in our experience, the upgrade and data migration process is quite straightforward and we have not run into the same problems we experienced in moving from 5.2 to 5.3.
31/5/2012 New and updated guidance from ECHA.
ECHA have published updated guidance on registration and have also published annexes to chapters R.8, R.10 and R.14 of the Guidance on Information Requirements and Chemical Safety Assessment (IR & CSA) to specifically cover the requirements for nanomaterials. These can be found at http://echa.europa.eu/web/guest/guidance-documents/guidance-on-reach. New guidance on dealing with monomers and polymers has also been published, which can be found at http://echa.europa.eu/documents/10162/13632/polymers_en.pdf.
31/5/2012 Late pre-registration for 2013 closes
Anyone who now wishes to manufacturer or import any existing substance for the first time at a level >100tpa will need to submit an enquiry followed by a full registration and can no longer take advantage of phase in status.
10/5/2012 Changes on who can submit classification and labelling notifications
The European Commission has instructed ECHA that is should broadened the scope of who can submit CLP notifications to include Only Representatives and third parties who represent groups of manufacturers and importers. In the case of the latter, the third party will need to have documentary evidence to demonstrate their mandate. Allowing the former will bring CLP into line with REACH and address a glaring anomaly between the two regulations.
3/5/2012 ECETOC launch version 3 of their Tier one Targetted Risk Assessment tool
ECETOC have launched version 3 of their widely used exposure prediction tool. The tool was extensively used to predict environmental and worker exposure during the first round of REACH registrations for the 2010 deadline. Version 3 extensively improves the consumer part of the tool, which was widely regarded as being too conservative to be of general use. ECETOC have worked with ECHA to refine the approach, although it still remains inherently very conservative, more so than tools such as those developed by ESIG and much more so that tier 2 tools such as Consexpo. The worker part of the tool has been refined with some changes to base exposures and more options to reduce exposure through the use of extra risk management measures have been introduce. The environmental modelling has also been refined and tweaked, but still remains based on the TGD implementation of EUSES. It can be downloaded from the ECETOC site at http://www.ecetoc.org/.
2/5/2012 Three update guidance documents published
The European Commission has instructed ECHA that is should broadened the scope of who can ECHA has clearly been busy this spring in that three new versions of the guidance documents have been published covering guidance on registration, guidance on dealing with monomers and polymers and guidance on applying the CLP criteria. In addition, guidance on dealing with nano materials has also been published. These can be found here:
25/4/2012 Study reviewing ECHA published
A study contracted by the European Commission and conducted by PricewaterhouseCoopers has found that ECHA has made a good start as an organisation, showing flexibility and performing well and that ECHA's stakeholders are generally satisfied with the achievements and the work the Agency has done. The authors of the report recommend that ECHA should be more transparent in some of its work, to develop scenarios to better face uncertainties, and that it should broaden stakeholder involvement and share even more of the data collected. More details can be found here.
21/4/2012 – Chesar 2.0 to be released soon
An ECHA webinar demonstrating the new version of Chesar will be held on 21/5/2012 (see ECHA website for details). Chesar 2.0 is due for release during the summer. This becomes a standalone program, rather than a IUCLID plugin) that runs via a web browser interface. Both standalone and server based versions will be available. The new version is strongly linked to the latest versions of the ECETOC TRA tool and includes an improved, although still very conservative, consumer assessment module. The new version is more intuitive to use but will still produce very conservative tier 1 assessments. Version 2.0 will still only produce chapter 7 and 8 of the CSR. A version that produces the whole CSR is not expected until early 2013. ECHA would ideally prefer all users to use Chesar. It remains to be seen if it is in time for the 2013 registrations and if it is realistic enough in the exposure assessments produced to be widely usable.
18/4/2012 – IUCLID and REACH IT upgrade latest
The latest version of IUCLID (v5.4) is expected to be released at the end of May. This will be a significant upgrade and introduce a number of new features, the key ones of which are:
- Inclusion of the PBT assessment within IUCLID (currently only part of the CSR)
- Major expansion of the information in section 3 on uses, bringing in much of the exposure assessment from the CSR
- Significant additional information on the end point summaries for toxicity and ecotoxicity, which will require addition of information on how assessment factors are derived and selection of key studies.
These new features will significantly increase the amount of time to prepare a dossier. The workload to update existing dossiers should not be underestimated. The benefit for ECHA are that it greatly improves the amount of structured information available to them that is currently ‘hidden’ in the CSR and will greatly improve the ability to data mine dossiers. For registrants the changes appear to be all negative. It will significantly decrease the ability to be flexible and use scientific judgement in assessing hazard and risk and force registrants towards a box ticking approach (and boxes that ECHA thinks must be completed!). ECHA have promised that none of the new fields will be mandatory and part of the technical completeness check before the June 2013 registration deadline but it can be expected that they will become mandatory at some point in the future.18/4/2012 ECHA to disseminate information on individual registrants
In addition to the new IUCLID version, a new version of REACH-IT will follow along soon after sometime later this summer. This new version will be able to use the new information available in IUCLID 5.4. The new version of REACH-IT will only accept dossiers prepared using IUCLID 5.4, so anyone expecting to update a dossier soon is advised to do so before the new version of REACH-IT becomes live.
Readers are strongly recommended to read the ECHA FAQ on the new software tools, which is available here.
As part of a policy change announced in May last year, the change to IUCLID 5.4 and REACH-IT above will allow ECHA to publish more information on those who have registered substances, including registrants names and numbers. ECHA believes that they can do this based on their interpretation of REACH article 119(2)(d) on the dissemination of “information” contained in safety data sheets, other than that listed in paragraph 1 [of article 119]. Only substances classified as hazardous will meet this fate (since non hazardous substances do not have to have safety data sheets). This could be of particular concern to Only Representatives, who may wish to start checking with the companies they represent that this will not cause commercial problems.
18/4/2012 ECHA commits to published notified tonnage bands of chemicals
ECHA has published the method and level of detail it will disclose publicly on its website regarding the total tonnage of each notified substance. This information will be made available sometime in June. There will be three levels of disclosure. Where there are >4 registrants or no confidentiality claims are made, the tonnage band (eg 1-10, 10-100, 10000-100000 etc) will be disclosed. If there are any confidentiality claims and <4 registrants, only the lower end of the band will be disclosed (eg >1, >10, >10000 etc). (It is not clear what happens if there are exactly 4 registrants!) If uses are only for intermediate production, only this fact will be disclosed. If all registrants claim confidentiality, there will be no disclosure of any information. Full details can be found here. 4/4/2012 – Updated guidance on data sharing
ECHA has updated its guidance on data sharing. This is available by clicking here.
29/3/2012 Classification and labelling inventory updates
ECHA have update the classification and labelling inventory to fix a number of bugs. However, the key flaws of the inventory (see news item 13/2/12 below) have not been addressed. There is also no likelihood in the foreseeable future of a facility being created to aid industry to harmonise divergent classifications.
28/3/2012 – Updated guidance on naming of substances
ECHA has published a corrigendum to its guidance for the identification and naming of substances under REACH and CLP. The update to v1.2, published in all 22 official EU languages, merely updates the definition of “phase-in substance” to the definition of Regulation (EC) No 1907/2006 introduced by Council Regulation (EC) No 1354/2007 and by Corrigendum, OJ L 36, 5.2.2009, p.84 (1907/2006).
14/3/2012. QSAR toolbox v2.3 published.
Version 2.3 of the OECD QSAR toolbox is now available for download. The toolbox can be used to help identify and justify read across from other chemicals to aid in filling datagaps and avoid the need for new tests to be carried out.
13/3/2012 – Four new harmonised classifications agreed
The Committee for Risk Assessment (RAC) has adopted opinions on proposals for the harmonised classification and labelling of four chemicals: Proquinazid, Amidosulfuron, Tebufenpyrad and 1,2’,1’’-nitrolotripropan-2-ol. Further information can be found here .
13/3/2012 – CEFIC issues fact sheet on communication of uses along the supply chain
CEFIC has published a template letter than can be used by prospective 2013 registrants for them to use with their downstream customers on the topic of identifying and covering appropriate uses during the registration process. The letter can be found here .
7/3/2012 – Information on SVHC substances made available for the first time.
According to the REACH regulation, manufacturers and importers must notify ECHA if they are manufacturing or importing articles containing substances identified as SVHC substances and listed on the candidate list if they are present above certain concentrations in the article. ECHA has now published the results of the notifications received so far. The list can be found here.
The majority of notifications received so far relate to four phthalates. These can typically be found in plastic articles, such as cables, bags, packaging material, waterproof garments and PVC flooring. The second most common notification is for the brominated flame retardant (HBCDD). This is found in articles used by the construction and building sectors such as plastic panels for the thermal insulation of buildings. It has also been notified in polystyrene foam used for packaging and in the plastic housing of electronic appliances.
ECHA has so far received only 203 notifications and suspects many producers and importers may yet be unaware of their responsibility to notify. Consequently, this information almost certainly does not provide a full picture of substances of very high concern in articles on the EU market. The deadline for producers and importers of articles to notify ECHA of the presence in articles of the 20 SVHCs that were included in the Candidate List in December 2011 is in June 2012.