Final advice for companies registering by 31 May 2013
ECHA has given some final advice to registrants ahead of the 31 May 2013 deadline. Lead Registrants are encouraged to submit their dossier as soon as possible to allow member registrants to submit their own dossiers in time. The LR's dossier must pass the 'business rules' before members submit their dossier. Member registrants must also confirm their membership of the joint submission using the token provided by the LR before they submit their member dossier.
The advice also encourages companies who are still having difficulties in meeting their registration obligations to contact the ECHA Helpdesk who will provide a response to registrants having an 'exceptional' situation.
The guidance includes key advice for successful dossier submission, such as ensuring company information is correct, verifying company size, taking care that substance identity is clear, and use of IUCLID tools to ensure dossier quality and completeness.
Eight substances added to the Authorisation List (19 April 2013)
Annex XIV of REACH has been amended by Regulation (EU) No 348/2013, with a further eight substances being subject to Authorisation:
- Chromium trioxide
- Sodium dichromate
- Potassium dichromate
- Ammonium dichromate
- Potassium chromate
- Sodium chromate
- Acids generated from chromium trioxide and their oligomers. Group containing:
- Chromic acid and,
- Dichromic acid
- Oligomers of chromic acid
The sunset date, after which the substance cannot be used or manufactured in the EEA unless exemption applies or without authorisation for a specific use, is 21 April 2016 for trichloroethylene and 21 September 2017 for the chromium compounds. Companies that wish to use an Annex XIV substance after the sunset date need to apply for authorisation (unless their use is exempt); applicants who submit an application before the "latest application date" may continue to use the substance after the sunset date while they wait for a decision from the European Commission.
The Authorisation List now contains 22 substances.
ECHA offers DCG support in 'exceptional' cases for 2013 registration
The Directors' Contact Group (DCG) was set up in January 2010, with objectives to monitor the overall preparedness of companies for registration and to resolve priority issues of concern relevant to registration. After the first registration deadline, the work of the DCG was framed by a new mandate with emphasis on monitoring progress towards the 2013 deadline.
Potential registrants concerned they are in an exceptional situation preventing their substance registration by 31 May 2013 are advised to contact ECHA before they submit their dossier. There are eight scenarios from the "Summary Paper on 28 issues and solutions" for which potential registrants may contact ECHA:
- Completeness of dossier
- Difficulties for importers to obtain data on substances in mixtures, for example determining to which substance an impurity belongs (Issue 10.2)
- Results of testing required in Annexes VII and VIII not available by the registration deadline despite the tests being ordered in a timely manner (Issue 10.3)
- Legal entity change
- Company split in which a resultant legal entity(s) does not have a pre-registration and is not eligible for late pre-registration (Issue 15.1)
- Transfer of assets where legitimate late pre-registration is not possible for the company without a pre-registration (Issue 15.2)
- Transfer of production from one entity to another where legitimate late pre-registration is not possible for the company without a pre-registration (Issue 15.3)
- Dependency on Lead Registrant
- Lead Registrant has submitted a registration but fails to complete the dossier within the Technical Completeness Check deadline (Issue 20.1)
- Lead Registrant fails to submit his registration dossier before the registration deadline (Issue 20.2)
- SIEF without an EU manufacturer
- If a substance is manufactured only outside EU, it is often difficult for an Only Representative or importer to take up the Lead Registrant role. Should a Downstream User take up the role of Importer if their supplier fails to register late pre-registration may not be possible (Issue 21).
Companies are requested to provide detailed justification of their situation and an explanation of the measures taken to comply with REACH to benefit from the ECHA support.
Please note: if you are not required to register your substance by 31 May 2013 then DCG issues do not apply to you.
Follow the 2013 registration progress online (22 March 2013)
In a new initiative, ECHA is publishing specific information on registration progress towards the 2013 deadline. This information is updated weekly and is available on the REACH 2013 web page.
The new information relates to the number of substances registered for the deadline, and provides a breakdown by type, role in the joint submission, company size and the role of the registrant (manufacturer, importer, or OR). Additionally, the number of registration dossiers submitted in each of the Member States and the number of dossiers being processed is presented.
The REACH 2013 web page will continue to provide an overview of the substances intended to be registered by 31 May, together with detailed lists on registration intentions and lead registrant nominations. The web page also provides support on IT tools for the registration process and tips and guidance for their role in the joint submission.
ECHA anticipates the registration of approximately 4000 substances by the 31 May deadline. Of these, 900 were already registered for the 2010 deadline and 3100 are additional substances for the 2013 deadline.
Ten potential SVHCs added to the Registry of Intentions for inclusion on the Candidate List (4 March 2013)
Member States Competent Authorities (MSCAs) from Germany, Poland and Sweden have recommended 10 substances for addition to the REACH candidate list. For the first time this includes substances based on their specific target organ toxicity after repeated exposure. Four of the substances are phenolic benzotriazoles and other proposals are for ammonium pentadecafluorootanoate (APFO) and pentadecafluorooctanoic acid (PFOA), 4-nonlyphenol, branched and linear, ethoxylated, cadmium and cadmium oxide and di-n-pentyl phthalate. The consultation will be open for 45 days and will end on 18 April 2013.
Annual CoRAP update published (20 March 2013)
The Community rolling action plan (CoRAP) for 2013-2015 covers 115 substances that are suspected of posing risk to human health or the environment. Of these substances, 62 are newly allocated and 53 come from the first CoRAP adopted in 2012. The updated CoRAP list has been prepared in cooperation with the Member States, taking into account the agreed risk-based criteria for the selection of substances.
From the publication of the CoRAP update, the respective Member States have one year to evaluate substances specified for 2013 and, where justified, to prepare a draft decision requesting the registrants to submit further information to clarify any possible risk. The decision will be taken by ECHA after consultation of the Member State Competent Authorities and the MSC, or by the European Commission if there is no unanimity at the MSC. Registrants are encouraged to communicate with Member States in order to clarify any concerns related to the substances, in particular those under evaluation in 2013.
REACH Review published (5 February 2013)
The European Commission has published the REACH Review which reports on the regulation's effect and the recommendations to reinforce ECHA's long term strategic objectives. The European Commission notes in its REACH review report that the REACH Regulation functions well and delivers on all the objectives as demonstrated by the valuable studies it summarised in the Staff Working Document. It does state that within the current framework, however, there is a need to reduce the impact of REACH on SMEs. The annex to the general report sets out measures that will contribute to this goal. Some key findings and recommendations are:
- The report makes recommendations to improve REACH implementation. These include improving the quality of registration dossiers, enhancing the use of safety data sheets as a central risk management tool, and addressing issues related to cost sharing within Substance Information Exchange Forums (SIEFs).
- The report recommends reducing the financial and administrative burden on SMEs in order to ensure the proportionality of legislation and to assist them to fulfil all their REACH obligations.
- There are no major overlaps with other EU legislation.
- Considerable efforts to develop alternative methods to animal testing have been made and will continue: since 2007, the Commission has made available € 330 million to fund research in this area.
- Enforcement could be improved. As this is the responsibility of the Member States, the report recommends that Member States reinforce coordination amongst them.
- Although the report identifies a need for some adjustments to the legislation, the Commission wants to ensure legislative stability and predictability for European businesses. No changes to REACH's main terms are proposed at present.
As one of the "next steps" The Commission will also follow up on the registration requirements for substances in tonnages between 1 and 10 tonnes and the impact of REACH on innovation and report back by January 2015.
ECHA recommends 10 SVHCs for authorisation (17 January 2013)
ECHA has recommended that ten substances of very high concern are included to the authorisation list. The substances are classified as carcinogenic or toxic to reproduction and are used in applications where there is potential for worker exposure. They have been prioritised based on their hazard properties, volumes used, and use related potential for exposure to humans. In its recommendation the Agency took into account the comments received during the public consultation last summer and a recent opinion of the Member State Committee, which supports ECHA's recommendation. For each substance recommended for inclusion in Annex XIV, a proposed sunset date is suggested. After this deadline companies will only be able to use it within the EU if an authorisation has been granted.
The final decision on the inclusion of the substances in Annex XIV and their sunset dates will be taken by the European Commission according to Comitology procedure.
ECHA updates Candidate List to 138 Substances (19 December 2012)
Twenty substances have been added to the Candidate List of substances of very high concern (SVHCs), taking the total to one hundred and thirty eight. According to ECHA's News Alert twenty three of the substances were added following the unanimous agreement of the Member State Committee; a further thirty one substances received no comments challenging the identification as SVHC during public consultation and were directly added to the Candidate List.
Five substances are identified as PBT substances (persistent, bioaccumulative and toxic) and/or vPvB substances (very persistent and very bioaccumulative). Five further substances are identified as giving rise to an equivalent level of concern. The remaining 44 SVHCs added to the Candidate List are identified as having carcinogenic, mutagenic and/or toxic for reproduction properties, thereby fulfilling the criteria outlined in Art. 57 (a, b and/or c) of REACH.
Companies may have legal obligations resulting from the inclusion of these substances in the Candidate List which may apply to the listed substances on their own, in mixtures or in articles. Producers and importers of articles have until 19 June 2013 to notify ECHA where the SVHC is present in those articles above 0.1% by weight and totals 1 tonne or more per year, unless the substance is already registered for that use or exposure can be excluded.
First wave of proposals to test substances examined
ECHA has announced it has examined all testing proposals submitted by registrants for the first registration deadline. ECHA prepared draft or final decisions for all proposals by 1 December 2012. A total of 571 dossiers (with altogether 1,184 individual testing proposals) have been examined. Nearly 130 cases were terminated due to the withdrawal of the proposals, testing already being initiated or for other reasons. Draft decisions were issued in 436 cases, of which 146 have already resulted in a final decision. In the other 290 cases the decision making procedure will continue in 2013. In 24 of these cases, the proposals for reproduction toxicity tests have been referred to the Commission because the Member State Committee did not reach agreement on them.
New release of REACH-IT due 30 November
In advance of the 2013 deadline there will be an update to REACH-IT at the end of November. The system will be taken down on 28 November 2012 at 12:00 (EET) for the update and is due to go live on 30 November at 12:00 (EET). The upgrade will include the new Co-Registrants page, which gives potential and existing registrants direct access to each other's contact details. This enhancement should benefit those going through the Inquiry process. The new release also contains other minor improvements aimed at supporting the use of the system, for example an update of the login screen with links to other dossier submission processes that are not yet covered by REACH-IT.
For more information see the ECHA website.
Registrants advised to submit dossier updates by 16 November
The new version of REACH-IT is scheduled for release on 30 November. It will include a Co-Registrants page allowing registrants direct access to each other's contact details. ECHA has advised registrants to review its instructions on updating contact information and submit any dossier updates by 16 November. Companies using Third Party Representatives (TPR) should ensure they have reported the TPR consistently in their registration to ensure the correct information is published on the Co-Registrants page. Where a registrant needs to update their dossier with revised TPR information ECHA advises no other updates should be included, in order to facilitate prompt processing of the update prior to 30 November.
For more information please see the ECHA website.
Registrants advised to check company information in REACH-IT
In advance of the changes to REACH-IT due in November, ECHA have advised registrants to check the company information provided in submitted dossiers to ensure that company details are not unexpectedly disclosed. This applies to both existing and potential registrants. Those who have made notifications under NONS (whether under REACH or not) are also advised to consider if their identity needs to be protected.
Click here for more information.
C&L inventory updated
ECHA has updated the public C&L inventory to contain all information on hazardous substances on the EU market. The inventory now shows all notifications for substances for which there is at least one notification classifying it as hazardous, including those notifications indicating the substance as not classified. The inventory also contains all notifications for EINECS substances.
ECHA is currently developing a web-based discussion platform, which will be released during 2013. The aim of this platform is to encourage industry to make efforts to agree on classification where possible.
The current version of the inventory contains approximately 5.3 million notifications relating to 120,000 substances.
Click here for more information.
Registrants of intermediates advised to check REACH-IT account
ECHA has undertaken an IT-based screening exercise of all REACH intermediate registration dossiers. The screening exercise has raised serious quality and compliance concerns for the agency. ECHA has stated that some 5,500 registrations for intermediates have been screened out of which 2,388 dossiers included uses that do not, or are very unlikely to, fulfil the definition of intermediates and/or are used under strictly controlled conditions. The dossiers with deficiencies and a potential for incompliance represent 760 substances. As a consequence ECHA has now sent letters to 574 registrants, asking them to review carefully and update registration dossiers within three months. At the end of the three month period, ECHA will undertake a new screening of dossiers and identify those that require regulatory action.
Companies are strongly advised to check their REACH-IT account to find out if ECHA has requested an updated registration dossier for their substances.
Fifteen potential SVHCs added to the Registry of Intentions for inclusion on Candidate List
Member States Competent Authorities (MSCAs) from Germany, Austria, Netherlands, UK, Sweden and Slovakia, on request by the Commission have recommended 15 substances for addition to the REACH candidate list at the end of the year. The dossiers on the substances were submitted by 6 August, allowing ECHA to begin consulting on whether to include them in September. The recommended substances include flame retardants, perfluorinated acids and phthalates.
Click here for more information
Practical Guide 14: reporting toxicological summaries and deriving DNELs
To support registrants as they prepare for the 2013 registration deadline, ECHA has published a new Practical Guide which describes how to report toxicological summaries in IUCLID and how to derive DNELs. Based on Chapter R.8 (DNEL derivation) of the Guidance on Information Requirements and CSA, Practical Guide 14 should provide a consistent starting point for exposure assessment and risk characterisation, where required. It should also help registrants improve the quality of the information in the CSR of existing dossiers.
Click here for more information.
Presentations from the Regulatory Issues Corner can now be downloaded by our silver and gold subscribers. The presentations include several talks on REACH as well as chemical regulations in Korea and Turkey. If you are a silver or gold subscriber, log in to the website now and the link can be found on the "Welcome" page. If you aren't already one of our subscribers you can join as a (FREE) silver subscriber to access the files - join for free.
IUCLID 5.4 is now available
Released on 5 June 2012, IUCLID 5.4 includes additional fields for reporting exposure, PBT (Persistent, Bioaccumulative and Toxic chemicals) and human hazard assessment data as well as other new functionalities. In a significant change to previous versions, section 3 has been redesigned to increase the possibility to document information on uses.
As with previous releases, all IUCLID documents created with previous versions of IUCLID 5 can be uploaded to the latest version.
The upgrade to IUCLID 5.4 includes a migration step which starts when launching the new IUCLID 5.4 application for the first time. However, it is strongly recommended to back-up the IUCLID database before upgrading to the new version.
New versions of all IUCLID plugins which are compatible with IUCLID 5.4 are anticipated for July. A new version of REACH-IT which will accept dossiers created in IUCLID 5.4 is also expected in July. Please note that until REACH-IT is updated companies wishing to submit new dossiers or updates must still use IUCLID 5.3.
Click here for further information.
Illustrative Chemical Safety Report published by ECHA
ECHA has published an illustrative CSR providing tips and advice to registrants on how to improve the quality of submitted information and avoid common deficiencies. The illustrative CSR demonstrates the assessment of a hypothetical monoconstituent organic substance used principally in coatings applications. The publication includes hints and tips to facilitate companies in complying with their CSR obligations. Notes and other inserts are used at key points in the CSR to explain when critical factors need to be considered and how they can be resolved.
Increased support for Downstream Users
ECHA has introduced new measures to support downstream users in fulfilling their duties under REACH. This includes a Question and Answer document on downstream user reports and a template for reporting conditions of use, in case reporting to ECHA according to Article 38 of REACH is required.
ECHA has also published information on all downstream user reports received in 2011. A total of 62 downstream user reports were received from 27 companies. The most common reason for producing a report was related to downstream users having to prepare the chemical safety report (CSR) for a use which was not covered by the supplier.
The Q&A document is available from ECHA's website.
ECHA webinar for Downstream Users announced
As part of their commitment to support downstream users, ECHA will host a webinar on 23 April 2012 to clarify downstream user obligations and to describe the support available.
Downstream users may need to report to ECHA where their use was not included in their supplier's registration. ECHA has published a set of Q&A on such reporting, together with an overview of facts and figures on downstream user reports received in 2011. A template for reporting conditions of use has also been made available; such a document should be attached to section 13 of the downstream user's IUCLID dossier prior to submission via REACH-IT.
For more information please see the ECHA website.
First CoRAP published (29 February 2012)
The first Community Rolling Action Plan (CoRAP) has been published by ECHA. The list contains 90 substances selected using risk-based criteria for substance evaluation, and each has a designated Member State responsible for the evaluation. In 2012, 36 substances are being evaluated by 17 Member States.
The designated Member States have 12 months to evaluate the substances specified for 2012 starting from 29 February 2012, the date of publication of the first CoRAP list. Where necessary they will prepare a draft decision for requesting further information from registrants to clarify the suspected risks. The information requested may go beyond the standard requirements in Annexes VII to X to REACH and may consider the substance exposure or its intrinsic properties.
Following evaluation of a substance the designated Member State may propose further controls such as restriction, EU-wide occupational exposure limits, or Candidate List inclusion.
For more information please see the ECHA Press Release.
ECHA updates Candidate List to 73 Substances (19 December 2011)
Twenty substances have been added to the Candidate List of substances of very high concern (SVHCs), taking the total to seventy-three. According to ECHA's News Alert twelve of the substances were added following the unanimous agreement of the Member State Committee; the other eight substances received no comments challenging the identification as SVHC during public consultation and were directly added to the Candidate List.
Companies may have legal obligations resulting from the inclusion of these substances in the Candidate List which may apply to the listed substances on their own, in mixtures or in articles. Producers and importers of articles have until 19 June 2012 to notify ECHA where the SVHC is present in those articles above 0.1% by weight and totals 1 tonne or more per year, unless the substance is already registered for that use or exposure can be excluded.
First six substances added to Annex XIV of REACH (17 February 2011)
The European Commission has included the first six substances of very high concern (SVHCs) subject to Authorisation in Annex XIV of REACH. In addition, ECHA has published new web pages on Authorisation; the Authorisation list is found at http://echa.europa.eu/reach/authorisation_under_reach/authorisation_list_en.asp.
For each listed SVHC a "sunset date" applies, after which time the substance cannot be used without authorisation unless the use is specifically exempt. Note that there was an error in the dates in the Annex XIV as published in the Official Journal of the European Union on 18/02/2011 (O.J. L 44/2); a corrigendum is available here.
ECHA has published guidance to help companies applying for an Authorisation. The Agency also plans to host a seminar for potential applicants in Helsinki, Finland, on 12 April 2011.
ECHA adds eight substances to the Candidate List (18 June 2010)
The European Chemicals Agency has added eight chemical substances to the Candidate List of Substances of Very High Concern (SVHC) for authorisation. REACHReady reiterates the advice of ECHA and recommends companies check their potential legal obligations that result from this listing.
The official Candidate List is available at http://echa.europa.eu/web/guest/candidate-list-table
For further information, see http://echa.europa.eu/documents/10162/17095/pr_10_12_candidate_list_20100618_en.pdf.
Practical Guides from ECHA (09 April 2010)
ECHA has published six Practical Guides to help registrants meet their information requirements for REACH registration. The Practical Guides provide registrants with comprehensive and in-depth advice on preparing their registration dossiers using IUCLID 5. They also cover the options for the adaptation of information requirements and include the reporting practice for alternative (e.g. non-animal) testing methods.
For more information see http://echa.europa.eu/documents/10162/17095/na_10_16_practical_guides_20100409_en.pdf
Acrylamide added to Candidate List (30 March 2010)
Acrylamide (EC number 201-173-7) has now been included in the Candidate List of Substances of Very High Concern for Authorisation. On 26 March, the President of the General Court of the European Union dismissed the application for interim measures in Case T-1/10 R, lifting the temporary suspension of the inclusion of the substance.
For more information see http://echa.europa.eu/documents/10162/17096/pr_10_05_acrylamide_20100330_en.pdf
Candidate List extended with 14 additional SVHCs (13 January 2010)
Today ECHA added 14 chemical substances to the Candidate List of Substances of Very High Concern (SVHC) for authorisation (http://echa.europa.eu/web/guest/candidate-list-table). Acrylamide (EC No 201-173-7 and CAS No 79-06-1) was also identified as a Substance of Very High Concern by ECHA’s Member State Committee. However, the inclusion of acrylamide in the Candidate List of substances for eventual inclusion in Annex XIV of REACH is suspended until the General Court of the European Union makes a ruling (Case T-1/10 R). Companies manufacturing or importing these substances on their own as well as in mixtures and in articles need to check their potential obligations that result from the update to the Candidate List:
UK REACH enforcement (August 2009)
HSE, the UK's Competent Authority for REACH, has revealed on its website that in March and April 2009 it issued a series of REACH Improvement Notices in relation to alleged failures to register the manufacture or import of substances. In what seems to be a coordinated campaign directed mainly at the lime products industry, notices were issued to named businesses and individuals across the UK, giving a limited time to comply or face court proceedings. This step is very significant and shows that HSE are prepared to take action at the highest level. HSE's public register of enforcement notices is found at http://www.hse.gov.uk/notices/default.asp
First Candidate List published by ECHA (28 October 2008)
On 28 October 2008, ECHA included 15 substances in the Candidate List of Substances of Very High Concern (SVHC) for authorisation. This list was published on the ECHA website at: http://echa.europa.eu/chem_data/candidate_list_table_en.asp
The publication of the list instigates immediate legal obligations for EU and EEA companies supplying such SVHC, either in articles, in preparations or as substances. Companies are strongly advised to confirm their obligations under REACH resulting from the publication of the Candidate List. The Candidate List will be updated periodically with additional SVHC; companies are advised to check the ECHA website periodically for changes. REACHReady's Gold members will also receive updates via Technical Alerts.
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