© Industry Consortium SAS FOR REACH  2012 Imprint Frequently Asked Questions on REACH by Industry Synthetic amorphous Silica and Silicates (Silica/Calcium Silicate CS/Sodium Aluminium Silicate NAS) 1. Joint submission & Dossier Content General questions The Consortium can not and will not act as a consultant for any third party. Thus, please, contact your national helpdesk for general questions beside the registration of SAS. Contact data are available on the ECHA webpage. o What is the base of the joint submission proposal from the SAS For REACH Consortium? o What data are specifically included in the dossier? o Does the LoA include access to the data or is it supplemented by summaries of the studies in order to cover uses not covered by the chemical safety report? o What supplementary data do we have to provide on our own for completion of the full dossier (joint dossier and “personal” submission)? o Do I have to register chemically surface treated substances? o Is Silica classified? o Does one LoA for SAS includes all SAS products from various processes listed in the SIEF Information Letter 1? o In December 2018 the European Commission amended some Annexes of the REACH regulation to include specific requirements for nanoforms of substances. Where can I find official information on it? 2. Joint submission: Dossier & Costs o What would be the final cost of the Letter of Access to the dossier? o Are the dossier and the CSR separately available? o On which basis were these charges calculated? How were they estimated and shared between the registrants? o When the entire package (Dossier & CSR) is not necessary, can individual studies be purchased? o Is the LoA granted per legal entity or per company? o Does the SASFORREACH Consortium offer a rebate for purchasers of a letter of access if more letters of access are sold than anticipated? o If a company buys the LoA for a 100-1000 tpa dossier and increases its tonnage band to > 1000 t/a, would it have to pay the difference? 3. SIEF, Consortium & Dossier o Has the amorphous, pyrogenic, crystalline-free Silica dossier already been submitted to the ECHA? o Can other SIEF members join the joint submission later? o Given that the SIEF is formed and that a Silica registration dossier is already filed at the ECHA, is it possible that some SIEF members submit a different dossier jointly? In other words, are two joint submissions acceptable within a same SIEF? o Does the submitted Silica dossier specifically include nanoforms and/or non-nanoforms of Synthetic Amorphous Silica (SAS)? o If you want to register a non-nanoform of SAS o On the ECHA webpage SAS is registered as silicon dioxide and as synthetic amorphous silicon dioxide (nano); does the dossier still covers non nano forms? o In December 2018 Commission Regulation (EU)2018/1881 was published amending the REACH regulation with specific requirements for nanomaterials. Are any actions required from co-registrants for keeping their registration dossier up-to-date? 4. VAT / Payment o VAT o Payments o International Payments 5. Are Read-Across Data available? o In light of recent developments in the regulatory environment the SASFORREACH Consortium has decided that it will no longer offer Letters of Access for Read- Across purposes. In this context, it should be noted that unlike for data sharing within a SIEF, there is no statutory obligation to share data for read-across purposes. Any requests for obtaining data for Read-Across purposes should be addressed to the respective data owner. The manager of the SASFORREACH Consortium will identify the respective data owner upon request. Requests identifying the studies and/or data for which read-across access is requested may be addressed to: sasforreach@sasforreach.eu 6. Miscellaneous o Contact for questions about SAS, cosmetic products & nano labeling  o AMORPHOUS SILICA, CAS 112945-52-5, EC 601-216-3 o Does the SASFORREACH Consortium also sell Letters of Access for registrations or other regulatory purposes outside the EU? o Brexit / Transfer of registration o Fee for additional administrative work Version 2.5 Release 7 Published on 1st March 2014 o What is the base of the joint submission proposal from the SAS For REACH Consortium? The Letter of Access (LoA) agreement offered by the SAS for REACH Consortium (the "Consortium") will enable any registrant to refer to the joint registration submitted to ECHA by the Consortium. The Consortium will update the information contained in its registration as and when requested by ECHA. If a registrant decides to purchase a LoA from the Consortium, it will be allowed to reference both the registration dossier and the chemical safety report (CSR) for Silica which were submitted by the lead registrant, Evonik Degussa GmbH, in their respective form (the "Documents"). The pricing of a letter of access is based on the tonnage bands provided in REACH and assumes that all information which is required for the registration of amorphous, pyrogenic, crystalline-free Silica as identified by the CAS and EINECS numbers for which the registration has been submitted by the Consortium is already included in the Documents. Should, however, ECHA require any further studies or additional information during the evaluation phase which leads to additional costs for the Consortium, the Consortium will reserve the right to claim an adequate participation in such additional costs also from any registrant who has bought a letter of access from the Consortium in accordance with the principles on cost sharing set forth in the guidance documents issued by ECHA. In any case, it is important to note that the Consortium will not warrant the sufficiency, accuracy and/or completeness of the information in the Documents. Furthermore, any registrant will have to carefully review the information in the Documents to ensure that his silica/silicate is identical to the substance registered by the Consortium, and provide any additional information required under REACH with regard to his respective substance and uses at his own cost. o What data are specifically included in the dossier? The dossier is a full package available for each of the four tonnage bands. This includes all necessary data for the registration dossier (LoA to the technical dossier; copy of the CSR; pre-filled template of IUCLID 5 chapters 0 -3). This means that after filling out the specific company related parts (e.g. address, contact, production/import volume, etc.) you can send in your dossier, based on the already approved Joint Submission dossier. o Does the LoA include access to the data or is it supplemented by summaries of the studies in order to cover uses not covered by the chemical safety report? No, you have no access to the study reports and the LoA is not supplemented by study summaries. However, the CSR contains summaries of the key studies in the IUCLID 5 dossier and the list of uses is exhaustive. o What supplementary data do we have to provide on our own for completion of the full dossier (joint dossier and “personal” submission)? Depending on the tonnage, e.g. for a >1000 t substance: 1. General Information: Identification (composition, purity, constituents…), analytical information (analytical methods and spectral data) 2. Manufacture, use and exposure: technological process ( methods), estimated quantities, sites, form in the supply chain, identified uses and exposure scenarios, uses advised against, waste from production and use. Please check the ECHA website for the actual version of ‘Manual 5’. o Do I have to register chemically surface treated substances? The surface treatment of a substance is a “two dimensional” modification of macroscopic particles. A “two dimensional” modification means a chemical reaction between the functional groups only on the surface of a macroscopic particle with a substance which is called a surface treating substance. By this definition it becomes clear that this kind of modification means a reaction of only a minor part (surface) of a macroscopic particle with the surface treating substance, i.e. most of the macroscopic particle is unmodified. Therefore a chemically surface treated substance cannot be regarded as a preparation nor be defined by the criteria of the "Guidance for identification and naming of substances under REACH". With the same reasoning, a chemically surface treated substance could not be reported for EINECS nor be notified according to Directive 67/548/EEC because it was covered by the separate EINECS entries of both the basis substance (macroscopic particle) and the surface treating substance. Taking this decision up under REACH means a consequent continuation of former decisions. Using the same line of arguments, chemically surface treated substances should not be registered as such under REACH, but the following requirements should be fulfilled: 1. Registration of the basis substance (macroscopic particle) 2. Registration of the surface treating substance 3. Description of the use “surface treatment” in the registration dossier of the surface treating substance and in the registration dossier of the basis substance 4. Any specific hazards or risks of the surface treated substance should be appropriately covered by the classification and labelling and by the chemicals safety assessment and resulting exposure scenarios. o Is Silica classified? Silica - as registered by the Lead registrant and described in the SIEF Information letters - has an amorphous structure. It is important to distinguish between the synthetic amorphous and crystalline forms which are different in their inhalation toxicity behaviour. Based on the data of the Lead Registrant the synthetic amorphous form is a non hazardous substance and therefore does not trigger any CLP classification. o Does one LoA for SAS includes all SAS products from various processes listed in the SIEF Information Letter 1? Yes, after the payment for the LoA for SAS it is possible to register all silicas covered by the registration of the Lead Registrant and described in the Silica (SAS) - SIEF Information Letter 1: ...... Substance For this registration, the definition of SAS covers products from various processes: i. Silica, amorphous, pyrogenic, crystalline-free (CAS#:7631-86-9, 112945-52-5), ii. Silica gel and precipitated silica, crystalline-free (CAS#: 7631-86-9, 112926-00-8), iii. Colloidal Silica (CAS#: 7631-86-9, 112926-00-8) ...... The cost of the LoA depends on the tonnage band in total off all SAS types! o What would be the final cost of the Letter of Access to the dossier? The final LoA cost (Dossier & CSR) is tonnage band dependent. For details published see SIEF INFO LETTER 4 o If a company buys the LoA for a 100-1000 tpa dossier and increases its tonnage band to > 1000 t/a, would it have to pay the difference? Yes, in this case the difference would have to be paid. o Are the dossier and the CSR separately available? No, the dossier and CSR are not available separately. o On which basis were these charges calculated? How were they estimated and shared between the registrants? These charges were calculated based on the actual costs incurred by the Consortium and its members for the relevant studies and projects. The data ownership and cost sharing processes were developed following strictly the ECHA Guidance Document RIP 3.4 on Data Sharing. o When the entire package (Dossier & CSR) is not necessary, can individual studies be purchased? Yes, by payment of 20% of the original study costs. o Is the LoA granted per legal entity or per company? The LoA is granted per company, including affiliates. Individual tokens will be provided as per the definition of an affiliate, which means any undertaking 1. in which a company holds, directly or indirectly, at least 50% of the shares or voting rights, or 2. which is a party to a profit and loss absorption agreement with a company (either upstream or downstream), or 3. which is otherwise controlled by a company, or 4.  which controls a Member directly or indirectly, or 5. which is controlled directly or indirectly by an undertaking which is a direct or indirect controlling shareholder of the company, and 6. which is either a manufacturer of the Substance or (vii) an importer of the Substance in the EU.1 1This means that a production facility owned directly or indirectly by a company or a parent of a company outside the EU (e.g., in China or India) that exports synthetic  amorphous Silica to the EU is an Affiliate. Furthermore, this definition also includes sister companies of companies. Individual tokens will be provided per Legal Entity. NOTE of JUNE 2016: This cost sharing model applied by the SASFORREACH Consortium is subject of an internal evaluation as a result of (i)  the new ECHA Draft Guidance on data sharing which was published in April 2016, and (ii) the current substance evaluation of SAS conducted by ECHA. Following the finalization of the aforementioned guidance document and the substance evaluation of SAS, the Consortium will prepare a new calculation of the cost contribution of each co-registrant. As part of this review, the Consortium may decide to alter the current cost sharing model. Until such time, the current pricing model for the LoA remains in full force and effect. The Consortium will contact the co-registrants directly and inform the SIEF members via the webpage. o Does the SASFORREACH Consortium offer a rebate for purchasers of a letter of access if more letters of access are sold than anticipated? 1. The sale of letters of access to the REACH dossier for synthetic amorphous silica (SAS) is fully at the financial risk of the Consortium. It is impossible to predict exactly how many letters of access (“LoA”)’s will actually be sold for each tonnage band. 2. In calculating the price of the LoA, the Consortium has made certain assumptions regarding the likely number of purchasers to be expected for each tonnage band. These assumptions are supported by the evidence available to date. 3. If the number of LoA's sold is lower than expected, purchasers of a LoA will not receive a supplemental invoice. 4. Thus, to be fair, if the number of LoA's sold should be higher than expected, no rebate will be paid either. 5. In this context, it is important to note that, as is the case with regard to many other substances, the number of pre-registrations for SAS (3,805) is in no way indicative of the number of LoA’s which will be sold as many companies have pre-registered SAS only as a precautionary measure. 6. Of course, the Consortium will act in accordance with REACH REGULATION (EC) No 1907/2006 and with applicable antitrust law at all times. 7. Please note that if as a result of a substance and/or dossier evaluation under REACH additional studies need to be prepared, the costs for such studies (which are not included in the calculation of the LoA price) will have to be shared among all registrants of SAS in the tonnage bands for which such additional studies must be provided on a fair, transparent and non-discriminatory basis. SAS is currently undergoing a substance evaluation under REACH and the draft decision issued by the evaluating competent member state authority in the Netherlands contains a request for additional studies. The Consortium and its members (including the lead registrant) are currently in discussions with the competent authority with regard to the contents of the draft decision. Once a final decision has been adopted by ECHA, you will be informed thereof. o Has the amorphous, pyrogenic, crystalline-free Silica dossier already been submitted to the ECHA? Yes, the full dossier has already been submitted to the ECHA by the lead registrant, Evonik Degussa GmbH. It has been approved by the ECHA and the registration number for amorphous, pyrogenic, crystalline-free Silica has been issued to Evonik Degussa GmbH in its capacity as lead registrant o Can other SIEF members join the joint submission later? Yes, other SIEF members or late-pre registrants can register later depending upon their tonnage band. Useful information about the 'joint submission' is available on the ECHA & CEFIC web pages. o Given that the SIEF is formed and that a Silica registration dossier is already filed at the ECHA, is it possible that some SIEF members submit a different dossier jointly? In other words, are two joint submissions acceptable within a same SIEF? In principle, yes, however the “OSOR” principle (one substance, one registration) has to be considered. Also see ECHA homepage (http://echa.europa.eu). o Does the submitted Silica dossier specifically include nanoforms and/or non-nanoforms of Synthetic Amorphous Silica (SAS)? The registration dossier for SAS covers both, nanoform(s) and non-nanoform(s) of SAS. Members of the SASFORREACH consortium, however, have only knowledge about nanostructured SAS. That means that SAS  is a “nano-structured material” according to ISO TC 229 (Draft CS 27687, draft TS800004-5), consisting of aggregates and agglomerates. The consortium does not cover any non-nanoform of SAS. o If you want to register a non-nanoform of SAS The SASFORREACH Consortium covers only nano-structured SAS. If you or your client needs a registration of a non-nano SAS (EC 231-545-4), in consideration of the one substance one registration rule, the SASFORREACH Consortium proposes the following procedure: The SIP conditions must be fulfilled (see webpage http://www.reach-sas.org/silica.htm) You either have to provide a full dossier containing all 13 chapters with an opt-out justification for each end-point (total opt out) the individual part of your dossier must contain the specific analytic details of your non-nanoform o VAT The Consortium is established as a taxable entity in Germany with a VAT-number of (DE-xxxxx). Services between the Consortium and LoA purchasers normally qualify as business to business (B2B) supply of services. Invoices are issued by the Consortium's accounting firm CRB in the name and on behalf of the Consortium. If the purchaser's place of establishment is Germany the supply of service is taxable in Germany. The purchaser will receive an invoice with 19% VAT added to the net total amount. Since the purchaser is acting as a taxable entity, paid tax can be deducted (Vorsteuerabzug). If the purchaser's place of establishment is not in Germany but is within the EU, the supply of service is taxable at the purchaser's place of establishment. The VAT Identification Number of the customer is required to issue an invoice. The purchaser will receive a net invoice showing no VAT charge. The purchaser will account for VAT at the purchaser's establishment under the reverse charge mechanism. o Payments Payments of invoices can be made from any bank account to the escrow bank account of the Consortium: Account holder: Chemie Revisions- und Beratungsgesellschaft mbH Bank account no: 721551005 Bank sort code: 76070024 Bank name: Deutsche Bank AG SWIFT / BIC: DEUT DE DB 760 IBAN: DE97 76070024 0721 5510 05 We kindly ask to transmit payments by regular bank transfer rather than by SEPA. If SEPA transfer is used please add the additional expenses to your payment that are charged to the recipient. o International Payments Invoices will be issued only to our contract partner in the European Union. Payments can be made from any entity worldwide. We kindly ask to ensure that i. the full invoice amount is credited to the account of the Consortium without any deduction (e.g., handling fees, etc.), and ii. the payment contains a full reference to the contract the payment is made for (e.g.: "LoA SAS for X Ltd. as OR for Y, Inc."). The access token and the LoA will only be provided once payment has been received in full. If payment is not made by the invoice recipient, an internal reimbursement might be required between purchaser and payer. Such reimbursement will not affect the consortium and should be negotiated between purchaser and the alternative payer. Tax implications of any such arrangement should be considered o Contact for questions about SAS, cosmetic products & nano labeling For questions about SAS, cosmetic products & nano labeling please contact the Association of Synthetic Amorphous Silica Producers (ASASP) via the webpage: http://www.asasp.eu/ o AMORPHOUS SILICA, CAS 112945-52-5, EC 601-216-3 The substances covered by the SASFORREACH Consortium are published on the webpage and described in the SIEF Information letters; other silicates with different EC numbers are NOT covered and must be registered separately. o Does the SASFORREACH Consortium also sell Letters of Access for registrations or other regulatory purposes outside the EU? No, the sole purpose of the SASFORREACH Consortium is to enable registrants to comply with their registration obligations under EU law. In order to obtain access rights to data and information for use in other jurisdictions (including the UK post-Brexit), please contact the respective data owners and/or the competent authorities in the respective jurisdictions directly. The SASFORREACH Consortium is not in a position to provide any advice or assistance in this regard. Irrespective hereof, the data owners are currently evaluating possible solutions for the joint handling of mandatory data sharing in jurisdictions other than the EU. o Brexit / Transfer of registration ECHA recommended to transfer registrations before the UK’s withdrawal; the SASFORREACH Consortium will support existing co-registrants with the transfer and prepare the new documents after receiving the updated business information (form, see ‘How to register’ Step 3) and payment of the administrative cost. o Fee for additional administrative work The Consortium will invoice a lump sum fee of € 1,000 plus VAT, where applicable, for additional administrative work incurred in connection with the preparation of a new agreement  due to a change of the contract partner (e.g., OR change, merger, reorganization, etc.); no additional costs will be charged for the inclusion of additional affiliates in existing LoA agreement and the issuance of the corresponding letter of access. o On the ECHA webpage SAS is registered as silicon dioxide and as synthetic amorphous silicon dioxide (nano); does the dossier still covers non nano forms? The SASFORREACH consortium is aware of the changes ECHA made on the Brief Profile for Synthetic Amorphous Silica (SAS). The new identifier “silicon dioxide; synthetic amorphous silicon dioxide (nano)” was not introduced by the lead registrant or the consortium and is, therefore, not part of the joint dossier. The additional name was initiated by ECHA without further communication to the lead and/or joint registrants and, thus, is not been reflected in the current dossier and its title, which still reads as originally submitted. Note that the brief profile is an automatically generated summary and that not all available data may be displayed. The content is subject to change without prior notice. The information has not been reviewed or verified by ECHA or any other authority. The Agency thus does not guarantee the correctness of the information displayed. Due to the revised REACH annexes dated December 2018, the consortium will contact each co-registrant in 2019 to define a revised boundary composition for SAS valid from January 2020. This will be done via your REACH-IT account and the SASFORREACH website. Therefore, we ask you to maintain a valid e-mail address in REACH IT and have a regular look at our website. o In December 2018 Commission Regulation (EU)2018/1881 was published amending the REACH regulation with specific requirements for nanomaterials. Are any actions required from co-registrants for keeping their registration dossier up-to-date? The amended REACH regulation adds significant requirements to individual registrants, especially considering Substance Identification. Parameters for the newly introduced concept of nanoforms like particle size (distribution), surface treatment and others will be identifiers, so that the lead registrant will update the boundary composition and co-registrants need to update their legal entity compositions. The guidance for identifying nanoforms is still under development, but an up-dated draft version is publicly available on the ECHA web-page. SASFORREACH has started the preparation work for an up-date in compliance with the legal requirements. SASFORREACH will contact co-registrants via REACH-IT and its webpage several times throughout 2018 to define appropriate  nanoforms and sets of nanoforms. o In December 2018 the European Commission amended some Annexes of the REACH regulation to include specific requirements for nanoforms of substances. Where can I find official information on it? The European Commission has dedicated a website to nanomaterials and more specific to nanomaterials in REACH and CLP. Please refer to https://ec.europa.eu/environment/chemicals/nanotech/reach-clp/index_en.htm to find the official text of  Commission Regulation (EU) 2018/1881 to modify REACH Annexes I, III and VI-XII, introducing nano-specific clarifications and new provisions in the chemical safety assessment (Annex I), registration information requirements (Annex III and VI-XI) and downstream user obligations (Annex XII). The European Chemicals Agency (ECHA) also has its own website on nanomaterials. There you find among others the definition recommendation of the European Commission and related guidances and several further links explaining nanomaterials in European regulations REACH and CLP. Finally a draft guidance “Appendix on recommendations for nanomaterials applicable to the Guidance on Registration and Guidance on Substance ID” is available on ECHAs website on on-going guidance consultations. It is expected that the finalized guidance will be available in late 2019. Please note that all links are subject to change and will not be verified by SASFORREACH again. If you experience any problems, please contact the owner of the webpages.