Introduction The Regulation (EC) No 1907/2006 of the European Parliament and of the Council of December 18, 2006 (EU-REGULATION) on the Registration, Evaluation and Authorization  of Chemicals (REACH) requires manufacturers and/or importers of chemicals and/or materials containing such chemicals to pre-register and register those at the European Chemicals Agency/Helsinki (ECHA) within the deadlines and according to a procedure prescribed in the EU-REGULATION. © SASFORREACH Consortium GbR 2012 News 2021-09-02 / Substance Evaluation for Synthetic Amorphous Silica concluded On August 26, 2021 the European Chemicals Agency (ECHA) published on its website the substance evaluation conclusion and evaluation report by the evaluating member state The Netherlands. With this report the procedure that started in 2012 is finally completed. REACH foresees several potential follow up measures, of which the Netherlands proposed the following: Harmonised Classification and Labelling Other EU-wide measures The Dutch competent authority intends to propose a harmonized classification as STOT RE 1 for either all SAS production routes or for pyrogenic SAS only (this is currently unclear due to inconsistencies in the conclusion) and to potentially follow this up with an Occupational Exposure Limit proposal. The SASFORREACH consortium will evaluate the conclusion in the upcoming weeks in detail and - if applicable - will communicate relevant measures via its website and/or via REACH-IT. Please make sure that your contact details in REACHT-IT are always up to date. 2021-04-13 / Information from the Lead Registrant about the recently performed dossier update was sent to all registrants via their REACH IT contact details 2021-01-31 / Update on dossier update for SAS in relation to information on nanomaterials: On December 21, 2020, the Lead registrant Evonik updated the joint registration dossier for SAS with the additional information on nanomaterials after ECHA has rejected two previous updates because of format errors in the IUCLID dossier. ECHA confirmed the completeness of the latest update on December 22, 2020.   Action is required for the registrants of:   SAS (nano) = update needed (see email to all registrants from Dec 2019)   SAS non nano = opt out needed (see FAQ 3.5)   SAS Bulk form = opt out  needed (see FAQ 3.5)   If any action is required the registrants will be always contacted directly via their REACH IT contact! 2020-09-21 / BREXIT - OR CHANGE: any OR change must be notified to the Consortium because due to the legal entity change a new contract must be signed with the new OR. The contract covers the OR change and includes a Letter of Access (LoA) for the new OR; the agreement has to be signed by all parties, i.e., the old and the new OR and the Consortium; after payment of an administration fee the new LoA will be issued. Please note that if the OR change is not documented properly the new OR has no valid Letter of Access from the SASFORREACH Consortium with all consequences (no support, no right to refer to the studies in the joint submission, no legal documentation for checks by competent authorities)! 2020-03-10 / Submission of data for lead dossier: The lead registrant submitted the updated lead dossier in due time. The dossier was in compliance with the technical rules of ECHA and passed the technical completeness check. However, ECHA in addition added a second level of surveillance to all nano dossiers, i.e., the so-called manual completeness check for which the rules were unknown at the time of submission. Meanwhile ECHA provides additional information on their expectations through different channels which are, however, not easy to understand and intensive work is required to meet these extended requests. ECHA has set the deadline to complete the update for May 16, 2020. Furthermore, ECHA informed in a webinar that co-registrants may update their dossier at any time before the lead registrant has done so, however, they need to be aware that the boundary composition of their update may interfere with the one presented by the lead registrant later on, if there has been no proper communication from the co-registrants to the lead registrant via the consortium manager prior to any submission. In such a case the co-registrant has either to correct its update or to file a full opt-out registration since, according to ECHA, partial opt-outs are legally not feasible for sets of nanoforms.   2020-02-24 / ECHA Webinar "Registering nanoforms: practical advice We would like to draw your attention to the upcoming ECHA Webinar "Registering nanoforms: practical advice". The webinar will take place on 24th February at 12:00 pm Northern Europe Time. All information as well as the registration form can be found on the ECHA homepage  The registration of nanoforms is mandatory since 1st January 2020. However, updating the registration dossiers with the new IUCLID version 6.4 turned out more complicated and many dossier updates were rejected by the technical or manual completeness check. Therefore, this webinar is a welcome opportunity to directly address your specific problems to the ECHA experts. 2020-01-30 Update on dossier update for SAS in relation to information on nanomaterials: On December 17, 2019, the Lead Registrant Evonik updated the joint registration dossier for SAS with the additional information on nanomaterials which is required to be submitted by January 1, 2020 („Nano Information“) pursuant to Commission Regulation (EU) 2018/1881. On January 17, 2020, ECHA informed the Lead Registrant that the Nano Information submitted by the Lead Registrant for SAS did not pass a manual completeness check. ECHA has therefore invited the Lead Registrant to discuss the way forward with regard to the submission of the Nano Information. The Consortium will inform Co-Registrants about the outcome of the discussions with ECHA on Nano Information in due course. In this context, it is important to note that even if the Nano Information provided in the joint registration dossier passes the completeness check, this does not mean that ECHA may not require additional information (regardless of whether such information is Nano-Information or other information) in connection with a compliance check pursuant to Art. 41 REACH or a substance evaluation pursuant to Art. 43 et seq. REACH. 2020-01-15 / Dossier update SAS-nano / additional cost: The lead registrant has updated the SAS dossier for the first time in December 2019 to include the information requirements of Commission Regulation (EU) 2018/1881 of 3 December 2018 amending regulation (EC) 1907/2006 (REACH) Annexes I, III, VI, VII, VIII, IX, X, XI, XII to address nanoforms of SAS. Co-Registrants have received the joint CSR and an i6z-file including Section 1.2 with all relevant information regarding boundary compositions. Please check your REACH-IT account to which this information was sent by e-mail. Additional updates to include further sets of nanoforms into the boundary composition are planned for 2020 and 2021. All information on nanoforms received from co-registrants is currently being evaluated by the trustee of the SASFORREACH Consortium GbR to ensure compliance with applicable antitrust law and will be integrated into the SAS dossier in due course. The updated guidance for registering substances in nanoform has been published by ECHA on December 3, 2019, however, it is currently still unclear what additional information requirements will ultimately result from the REACH Annex amendments. Therefore, the Consortium is currently not in a position to make any estimations on the additional costs to be shared among co-registrants of SAS resulting from such update(s). Please bear in mind that the update of the nanoform-related information in the SAS dossier has only just begun and that this work also has to be combined and coordinated with the ongoing substance evaluation process. Please note  that the costs incurred by the SASFORREACH Consortium GbR for both processes will be included in the recalculation of the LoA costs. 2019-07-15 / Dossier update SAS: The lead registrant Evonik Degussa GmbH has updated the SAS dossier as required by the Board of Appeal decision. This update does not include the requirements of Commission Regulation (EU) 2018/1881 of 3 December 2018 amending Regulation (EC) No 1907/2006 (REACH) Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances. Therefore, also the substance identity profile remains unchanged. The SASFORREACH Consortium GbR has however, included assessment entities and boundary compositions for bulk (non- nano) silicon dioxide, non-surface treated, and for SAS silanized. The latter includes all materials used in (eco-) toxicological and physico-chemical studies that have been used for this update. For the time being this specific assessment entity for surface treated silicon dioxide does NOT exclude other surface treatments because this will only be covered by Regulation (EU) 2018/1881 which applies from January 2020. The update is also not complete regarding the requested study because final data and reporting from the toxicological institute are not available yet. The lead registrant has communicated this to ECHA as well as to the evaluating member state. A second update including all study data will be made by October 31, 2019. Both ECHA and the evaluating member state have confirmed not to take any enforcement actions until then. For co-registrants no specific actions arise from this update of the joint part of the registration. The lead registrant will inform you directly via your REACH-IT contact regarding the next steps. Please keep in mind, however, to keep your company specific part up to date. 2019-01-08 / Dossier update SAS: The SASFORREACH Consortium GbR is in the process of preparing two updates of the SAS dossier as required by (i) the Board of Appeal decision (which will be implemented by July 2019) and (ii) by the  Commission Regulation (EU) 2018/1881 of 3 December 2018 amending Regulation (EC) No 1907/2006 (REACH) Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances [so called new REACH Annexes] (which will be implemented by January 2020). After finalization of the update the members of the joint submission will be informed via the consortium webpage or by e-mail. In the meantime, should your substance meet the substance identification profile ("SIP") criteria as described on the webpage / in the SIEF Information letter, please follow the short guidance for new registrations. Changes in the SIP and/or the registration procedure, if any, will be published after finalization of the evaluation process. Furthermore, please note that neither particle size (i.e., neither the size of the aggregates nor the size of the constituent particles) nor any BET values are currently part of the SIP and, therefore, currently are not used for inclusion or exclusion from the dossier. ECHA is currently working with several stakeholders to develop guidance documents related to the REACH annexes requirements on nanoforms of substances. As soon as these updates are available, the SASFORREACH Consortium GbR will start implementing those requirements and contact co-registrants where necessary and relevant. 2018-08-21/ Revision of LoA cost: The Consortium is currently still in the process of recalculating the LoA costs on the basis of the figures as of July 31st, 2018. Once this process is completed, the Consortium will inform all joint submission members directly and publish the relevant information for new registrants on its webpage However, it is important to note that due to the ongoing substance evaluation  and significant upcoming changes in the REACH regulation which will be coming into force in 2020, a final recalculation of the LoA price can only be prepared once the current substance evaluation process has been finalized and the impact of the new REACH provisions on the data to be provided in the joint registration has been fully assessed and the additional information required has been generated. According to the information currently available to the Consortium, this process will not be finalized before 2020 at the earliest. Therefore, it is likely that the final recalculation will only be available in 2021 or later. For further details, please refer to the news item dated 2017-10-10 below. Please also bear in mind that ECHA may also start another substance or dossier evaluation process at any time and that such new process may lead to additional costs which need to be shared under REACH. 2017-10-10 / Revision of LoA cost: Due to (i) the currently ongoing substance evaluation process with regard to SAS and the costs of complying with the additional information requirements resulting therefrom; (ii) the appeals filed against the final decision issued by ECHA as a result of such evaluation, (iii) the new implementation regulation and the new version of the guidance on data sharing ("Guidance") the Consortium is the process of reviewing the current cost sharing model applied in the calculation of the price for a letter of access for SAS (”LoA”). This includes a recalculation of the LoA prices. Such recalculation may result in a different price for the LoA (i.e, either higher or lower). Such a recalculation which needs to take into account a lot of different factors as provided in the Implementing Regulation and the Guidance (e.g., dossier updates and administrative costs incurred since 2009), is a rather complex exercise which cannot be completed at short notice. Because the Consortium need the total number of co-registrants the new LoA price calculation will be completed not before the REACH deadline May 2018. Any change of the LoA cost / reimbursement / additional payments will be communicated on the webpage and if necessary directly with the co- registrants. The LoA cost published in the SIEF Information Letter 4 are still valid until recalculation! 2017-07-05 / Substance Evaluation SAS: The Board of Appeal (BoA) has issued decisions on two appeals for substance evaluation decisions issued by ECHA on synthetic amorphous silica EC 231-545-4 (A-014-2015 and A-015-2015), published on 2016-12-06 / Substance Evaluation SAS: The board of appeal closed the proceedings on the appeal 2016-10-12 / Dossier Evaluation NAS: The Board of Appeal (BoA) has issued decisions on appeals for four compliance check decisions issued by ECHA on silicic acid, aluminium sodium salt (NAS) EC 215-475-1 (A-008-2015, published on 2016-08-10 / Substance Evaluation SAS: In April, the interveners PISC (PETA International Science Consortium Ltd.) and ClientEarth/CIEL (Center for International Environmental Law) lodged their observation on the appeals. The appellants made their observations on the interveners’ observations in May 2016. The written procedure has been closed in August. The hearing date was proposed by ECHA for October 2016. 2016-06-16 / Dossier Evaluation NAS: Four companies appealed their respective final decision on dossier evaluation in March 2015. The executive director of ECHA partly rectified some decisions. In March 2016 the written proceedings were closed in all appeals and a joint oral hearing took place in Helsinki in June 2016. The Board of Appeal has 90 working days from the date of the hearing for issuing a decision (i.e., September/October 2016). 2015-11-05 / Evaluation SAS: The Board of Appeal decided to extend the deadline for lodging the observations on the Defence to 15 January 2016. 2015-10-28 / Evaluation SAS: The appellants asked the Board of Appeal for a time extension to submit observations on the Defence. 2015-10-19 / Evaluation SAS: The Board of Appeal informed the appellants about the Defence submitted by the Agency on 21 September 2015. The Board of appeal invited the appellants to provide comments on the Defence until 19 November 2015. 2015-06-10 / Evaluation SAS: On June 10, 2015, the Lead Registrant Evonik and 20 other companies have filed a joint appeal  against the substance evaluation decision on SAS with the Board of Appeal of ECHA.  2015-03-11 / Evaluation SAS: ECHA sent the final decision on the substance evaluation to the Lead Registrant and all co-registrants via REACH-IT. The Lead Registrant Evonik will inform the joint submission members directly via email about the next steps. 2014-11-27 / Evaluation SAS: ECHA invited a representative of the Lead Registrant of  synthetic amorphous Silicon dioxide and 2 experts  (toxicology, physico-chemistry) to the next Member State Committee meeting (MSC-39, 8-11 December).  After receiving the final decision the Consortium will inform the SIEF with a new SIEF INFORMATION LETTER. 2014-11-13 / Evaluation SAS: The Lead Registrant Evonik submitted the documents commenting ECHA´S and MSCA´s proposed amendments to the Draft Evaluation Decision to the agency within the given deadline. 2014-10-10 / Evaluation SAS: ECHA informed the registrants about the receipt of proposals for amendments to the final Draft Decision from member states and ECHA. 2014-10-09 / Evaluation SAS: MSC meeting with a representative of the Lead Registrant of  synthetic amorphous Silicon  dioxide and 2 experts  (toxicology, physico-chemistry).  2014-09-04 / Evaluation SAS: Evaluation SAS: Dutch eMSCA forwarded final Draft Decision to ECHA. 2014-08-27 / Evaluation SAS: Conference call between representatives of the Lead Registrant EVONIK Industries and the SASFORREACH Consortium GbR & the Dutch eMSCA. 2014-05-12 / Evaluation SAS: Meeting between representatives of the Lead Registrant EVONIK Industries and the SASFORREACH Consortium GbR & the Dutch eMSCA. 2013-12 -17 / Evaluation SAS: LR Evonik shared data with the Dutch eMSCA requested during the last meeting (Reuzel study, morbidity study, proposal of grouping grades, information on surface treated SAS). 2013-08-29 / Evaluation SAS: Meeting between representatives of the Lead Registrant EVONIK Industries and the SASFORREACH Consortium GbR & the Dutch eMSCA. The draft decision of the CA and the comments from the LR were outlined and discussed. It was decided to further exchange information and to continue the communication process in an effort to revise the draft decision. 2013-05-06 / Evaluation SAS: LR Evonik sent comments on the draft decision (DD) to the Dutch evaluating Member State competent authority (eMSCA). 2013-04-29 / Evaluation SAS: The Lead Registrant Evonik discussed the DD and the comments during a conference call with interested co- registrants. 2013-04-13 / Evaluation SAS: The Dutch evaluating Member State competent authority eMSCA prepared the draft decision (DD) on SAS and informed the Lead Registrant Evonik and all co-registrants. Imprint Notice to all (potential) Co-Registrants of SAS and Silicates covered by the SASFORREACH Consortium GbR The SASFORREACH Consortium GbR ("Consortium") cannot assist with general questions regarding REACH (Dossier updates, nanoform-related information, etc.); therefore please check the ECHA webpage / related guidance text etc. and inform yourself about your responsibility as a registrant under REACH. If you have problems with the dossier preparation or general questions regarding, e.g., substance identification or the registration process please contact ECHA or your national helpdesk. EU-REGULATION. The Consortium will answer questions on SAS/NAS/CS/AS1/AS2 only by referring to the webpage, where all relevant information for a joint submission is published. The Consortium will continue to communicate information which is relevant for the registration of SAS (EC 231-545-4) and the silicates directly and/or via the webpage only. The Consortium will of course continue to support each co-registrant in the LoA purchase process as necessary. Also, the Consortium confirms that the lead registrant will act in full compliance with the REACH regulation and up-date the dossiers as required. This, however, will not release any co- registrant from its obligation to up-date the company-specific information or any information in connection with opt-outs made by any co-registrant. IMPORTANT: For communication with the joint submission members and the co-registrants, only the contact data from REACH -IT will be used, thus it is important that the email address of each joint submission member is valid.  It is in the responsibility of every joint submission member to update his contact data in  REACH-IT when necessary. The conclusion in the BoA decision are relevant for all registrants and thus it is the obligation of each registrants to contribute/to comply to/with any future activities to up-date the dossier.