- Joint submission & Dossier Content
- Joint submission: Dossier & Costs
- SIEF, Consortium & Dossier
- Sameness & Impurities
- Uses & Chemical Safety Report (CSR)
- Payment & VAT
- Classification and Labelling Inventory
- OR Change
- Fee for additional administrative work
When was the lead dossier filed? When was the last update?
The lead dossier was first filed on January 26, 2009 by the then acting lead registrant for the carbon black joint submission, Evonik Degussa GmbH. It was confirmed to be technically complete by ECHA on May 6, 2009.
On March 15, 2018, ECHA accepted an update of the lead dossier. The Carbon Black REACH Consortium “Consortium”) including the current lead registrant (Orion Engineered Carbons GmbH) had decided to update the lead dossier due to the upgrade of the IUCLID tool from IUCLID 5 to IUCLID 6 and the REACH-IT associated upgrades as well as due to the listing of carbon black on the Community Rolling Action Plan (“CoRAP”) for evaluation in 2019 by the French Competent Authority (French Agency for Food, Environmental and Occupational Health & Safety, Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail “ANSES”).
What data are specifically included in the lead dossier? Which data are covered by the letter of access?
The lead dossier is a full package available for each of the four tonnage bands. The letter of access (“LoA”) grants a right to refer to all data contained in the technical part of the lead dossier.
Buyers will be provided with
- an LoA to the technical dossier
- an electronic token for becoming a member of the joint submission via IUCLID
and - only for tonnages >=10 t/a -
- an electronic copy of the chemical safety report (CSR) in pdf format.
This means that after filling out the specific company-related parts (e.g. address, contact, production/import volume, etc.) you can submit your member dossier, based on the lead dossier.
Does the LoA include access to the data? Will buyers of a LoA be provided with access to full study reports or summaries of the studies, for example in order to cover uses not covered by the chemical safety report?
The LoA grants a right to refer to the data but not does not grant access to the data itself. You will have no access to the full study reports and the LoA is not supplemented by study summaries. However, the robust study summaries of the studies in the dossier are available via the ECHA webpage. Furthermore, the CSR contains summaries of the key studies in the IUCLID 6 dossier and the list of uses is, to the best knowledge of the members of the Consortium, exhaustive.
What supplementary data do we have to provide on our own for completion of our member dossier?
Depending on the tonnage band, e.g. for a >1,000 t/a registration:
- General information: identity of manufacturer/importer of the substance
- General information: Identity of the substance (composition, purity, constituents…), analytical information (analytical methods and spectral data)
- Information on the 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 see for more details Art. 10 REACH and check the ECHA website for the current version of ECHA´s Guidance on registration and ECHA´s Guidance on data-sharing.
Who is responsible for determining whether my substance is carbon black as defined in the lead dossier?
Every registrant is solely responsible for self-identifying his substance as CAS# 1333-86-4 or EINECS 215-609-9, i.e., the substance defined in the lead dossier which has been submitted by the lead registrant and Registrants shall also provide any additional information required under REACH with regard to his respective substance and uses, if any, at his own cost. The Consortium will not be liable for any costs or damages caused by the failure of the registrant to properly identify his substance. If you are in doubt regarding the exact composition of the carbon black you are importing, please refer to your supplier for more information.
Is the lead dossier currently subject to a dossier compliance check/dossier evalua-tion or substance evaluation? Will the results be included in updates of the lead dossier?
ECHA opened a dossier evaluation for carbon black in January 2015. After a period of silence on this matter, on March 12, 2018, the lead registrant received a letter from ECHA announcing that ECHA terminated the compliance check procedure. ECHA explained that its decision is predicated on recent decisions issued by ECHA’s Board of Appeal that have resulted in the annulment of several of ECHA’s decisions addressed to registrants of nanomaterials. In light thereof, ECHA terminated the compliance check procedure related to the draft decision. ECHA, however, reserved its right to reopen further compliance checks on the present dossier at a later stage.
Carbon black is listed on the Community Rolling Action Plan (CoRAP) for evaluation in 2019 by the French Competent Authority (French Agency for Food, Environmental and Occupational Health & Safety, Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail “ANSES”).
It is possible that additional tests will be requested as a result of the substance evaluation process. The results of any tests mandated through the substance evaluation process will be included in the technical part of the dossier as a robust study summary and any costs resulting from such additional information requirements will need to be shared by all co-registrants of carbon black pursuant to the cost sharing provisions in the REACH Regulation and in the Implementing Regulation 2016/09.
Do I have to register chemically surface treated substances?
Please refer to ECHA guidance on this issue, in particular Source: ECHA
Does the CB4REACH Consortium offer a reimbursement for purchasers of a letter of access if more letters of access are sold than anticipated?
Yes, the cost calculation scheme makes allocations for reimbursements in accordance with REACH and the Implementing Regulation 2016/09 (“IR”).
Is access to the dossier and the CSR available separately?
An electronic copy of the CSR in pdf format is provided to buyers of LoA for tonnage bands above 10 t/a.
No CSR is included and provided for registrants of the tonnage band 1-10 t/a.
Access to the dossier is available separately if the buyer of an LoA intends to submit its own CSR separately.
Will the jointly submitted lead dossier enable buyers of a LoA to successfully register carbon black?
The LoA offered by the Carbon Black REACH Consortium ("Consortium") will enable any registrant to refer to the jointly submitted information which is currently contained in the technical part of the lead dossier submitted by the Lead registrant to ECHA.
If a registrant purchases a LoA from the Consortium, the registrant will be allowed to reference data currently contained in the technical part of the lead dossier and - for registrations >10t/a - the current CSR for carbon black which has been submitted by the lead registrant (together, the "Documents").
The pricing of the LoA is based on the tonnage bands provided in REACH. Please note that each registrant still has to bear its own registration fee which is charged separately by ECHA.
Do we have to pay additional compensation in case of updates to the lead dossier, for example during substance evaluation? Can the substance evaluation process trigger additional costs for LoA buyers?
The tonnage band for which a LoA is purchased must be calculated on the basis of the tonnage band applicable to the legal entity with the highest production and/or import volume, as calculated according to REACH.
The Consortium and the lead registrant will update the information contained in the lead dossier if necessary, for example due to changes in the regulatory framework or when requested by ECHA or other competent authorities, for example following a a substance evaluation process.
Should any update (e.g. further studies or additional information) trigger additional costs (including administration costs) for the Consortium, the Consortium reserves the right to claim an adequate participation in such additional costs also from any registrant who has bought an LoA from the Consortium in accordance with the principles on cost sharing set forth in the REACH-Regulation and the IR.
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 as this is subject to change over time, taking into account additional information requirements imposed by ECHA or the European Commission.
Is the LoA granted per legal entity or per company?
As in many other REACH consortia, the LoA is currently granted per legal group, including affiliates. Individual tokens will be provided per legal entity.
Definition of an ‘Affiliate’:
Affiliate shall mean any undertaking (i) in which a company holds, directly or indirectly, at least 50% of the shares or voting rights, or (ii) which is a party to a profit and loss absorption agreement with a company (either upstream or downstream), or (iii) which is otherwise con-trolled by a company, or (iv) which controls a Member directly or indirectly, or (v) which is controlled directly or indirectly by an undertaking which is a direct or indirect controlling shareholder of the company, and (vi) which is either a manufacturer of the Substance or (vii) an importer of the Substance in the EU.
This 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 carbon black to the EU is an Affiliate. Furthermore, this definition also includes sister companies of companies. Individual tokens will be provided per Legal Entity.
If a company needs a co-registration also for its affiliates, on which basis must the tonnage band be calculated?
The tonnage band must be calculated on the basis of the tonnage band applicable to the legal entity with the highest production and/or import volume, as calculated according to REACH.
When the entire package (Lead Dossier & CSR) is not necessary, can the right to reference individual studies be purchased?
Yes, by payment of a fair, transparent and non-discriminatory contribution to the costs of the studies.
If a company buys the LoA for a 1-10 tpa dossier and increases its tonnage band to e.g. 100 t/a, would it have to pay the difference?
Yes, in this case the difference would have to be paid. If you bought an LoA before the recalculation of the LoA cost you have to pay the difference between the old and the new LoA cost.
LoA 1-10t paid: 20.000€
Update to 10-100t, new LoA cost: 59.000€
Difference to pay: 39.000€
How were the original LOA prices calculated?
In 2009 the CB4REACH Consortium (“Consortium”) calculated the costs for the letter of access (“LOA”) to the carbon black dossier (“Dossier”) on the basis of the then available version of the Guidance on data-sharing by the European Chemicals Agency (“ECHA”) (Version 1, September 2007).
A defined amount of costs (EUR 6.2 million) was used to calculate the price of a LOA. An audit which was conducted by Chemie-Revisions- und Beratungsgesellschaft Wirtschaftsprüfungsgesellschaft mbH, Fürth, Germany dated October 25, 2010 confirms that indeed a total amount of EUR 6.2 million were incurred. This includes study costs from 1996 to 2009 as well as administrative costs for the preparation of the Dossier until 2008.
The Consortium estimated the number of co-registrants who were likely to need an LOA for carbon black for the four tonnage bands on the basis of market information available at that time. Already in 2009, the Consortium did not seek to make a profit from data sharing, but intended to only recover a part of the incurred costs as provided in REACH.
Why does the recalculation of the costs incurred until June 1, 2018 lead to a cost share which is lower than the amount originally anticipated for some co-registrants?
Since the first submission of the Dossier in 2009, additional studies were added to the Dossier and further administrative costs have been incurred. In spite of these additional administrative and study costs, the current recalculation which has been prepared by the Consortium has shown that the costs which were incurred until the expiration of the last registration deadline (June 1, 2018) per buyer are lower than originally estimated in some tonnage bands because the number of buyers of LOAs is substantially higher than the number of registrants originally anticipated by the Consortium. Therefore, all costs which have been and which will be incurred henceforth are shared among more parties than originally estimated.
Moreover, ECHA´s original “Guidance on data-sharing” (Version 1, September 2007) which was available when the LOA prices were established has been revised several times since (cf. current Version 3.1, January 2017). In addition, cost sharing principles have been clarified by the Implementing Regulation (EU) 2016/9 (“IR”) since the original calculation of the LOA prices. The updated cost-sharing model reflects these changes and is in compliance with ECHA´s current Guidance on data-sharing and the IR.
Is the new cost sharing mechanism compliant with REACH, the Implementing Regulation 2016/9 and the guidance documents issued by ECHA?
The new cost sharing mechanism distributes the costs for all buyers of LOAs in a fair, transparent and non-discriminatory way and is therefore in the Consortium’s view in compliance with Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (“REACH”), the IR and the EU guidance issued by ECHA.
Do I have to pay for studies which I do not need for my tonnage band?
In accordance with REACH and the IR every buyer of a LOA only has to pay for the studies which it needs to fulfill the information requirements for his respective tonnage band. In other words, buyers for LOAs in lower tonnage bands are not charged for studies which are only necessary for higher tonnage bands.
How did the Consortium spread the costs across the different tonnage bands?
In the original cost calculation, the Consortium made a differentiation between the tonnage bands in accordance with the tonnage bands defined in REACH. In the current updated cost calculation, this differentiation is even more refined. In the new cost calculation mechanism, data costs are spread across the different tonnage bands defined in REACH by using a coefficient for each tonnage band which takes into consideration the present value of the studies (PVS) as well as the number of registrants associated with the respective tonnage band. The same factor is applied for spreading the administrative costs across the different tonnage bands.
Is there a discount for SMEs?
No, there is no discount for small and medium-sized enterprises (“SME”). REACH and the IR do not require rebates for SME in data and cost sharing agreements between co-registrants.
Is there a discount for members of CB4REACH Consortium?
No, there is no discount for members of the CB4REACH Consortium. The members of the Consortium pay the same share of data and administrative costs in their respective tonnage bands as non-Consortium members do.
Why is there a reimbursement mechanism?
The IR demands that each cost sharing agreement must contain a reimbursement mechanism which includes a method of redistribution to each LOA buyer if additional companies subsequently also buy a LOA.
When will cash reimbursements/additional invoices be paid or issued by the CB4REACH Consortium, respectively?
There is no legal requirement for the timing of the reimbursement. In order to minimize administrative costs, the Consortium has decided that
- a first recalculation of the LOA prices was completed in 2020 and
- a second recalculation will be carried out after update of the Dossier in connection with the new nano-specific information requirements under the amended REACH-Annexes as well as the completion of the dossier evaluation proceedings which are likely to restart in 2020 and the substance evaluation proceedings which are currently scheduled to start in 2021.
As a result of the first recalculation which was completed in 2020, co-registrants will receive a credit/debit note only, but no cash payment. For reasons of practicality, fairness and equal treatment of all co-registrants, any cash payments, be it in the form of a reimbursement or an additional payment to the Consortium, will only be effected after the second recalculation which is to be carried out after the end of the dossier and substance evaluation process and the implementation of any additional information requirements resulting from such evaluation processes.
If I receive a credit note in 2020, does that mean the end of my cost sharing obligations?
No, depending on the outcome of the dossier and substance evaluation and the costs incurred in providing the new nano-related information, registrants who have received a credit note in 2020 may indeed receive a further invoice in the future, e.g., after the end of the second recalculation.
Why do co-registrants not receive a cash payment in 2020?
As a result of the first recalculation completed in 2020, co-registrants will receive a credit/debit note only, but no cash payment/invoice.
The Consortium has decided to establish contingency funds which are designed to cover expected costs for studies in the pending dossier and substance evaluation and for the update due to new nano-related information requirements.
Depending on the costs to be incurred in the future – in particular resulting from the dossier and substance evaluation processes and the update due to new nano-related information requirements – and the future development of the number of registrants, the Consortium will either reimburse or re-invoice registrants after the second recalculation. Until the completion of the second recalculation, registrants will be informed about the results of the first recalculation by way of a credit note where the current calculation mechanism would result in a reimbursement for the respective co-registrant, or by way of a debit note, as applicable. However, re-invoicing of additional cost contributions or actual pay-outs, if any, of reimbursement amounts will only be made after the end of the second recalculation.
Why are contingency funds necessary?
Contingency funds are necessary to cover the imminent study and administrative costs which will be incurred in connection with the upcoming dossier and substance evaluation of carbon black and for updating the Dossier with regard to the new nano-related information requirements in the updated Annexes of REACH which may likewise cause the need for additional data and studies to be performed, including administrative expenses associated therewith.
Who determines the amount of the contingency funds and how and when the contingency funds can be used?
The Consortium has calculated the amount of the contingency funds based on estimated costs for the upcoming dossier and substance evaluation and in the light of the new nano-specific information requirements based on its knowledge and reasonable best estimates at the time of making the first recalculation. The Consortium will also determine how and when to use the contingency funds. The Consortium will not use the contingency funds for internal Consortium management (as opposed to general administrative costs related to the management of the joint submission and registration dossier). The Consortium will use the contingency funds for costs incurred in connection with dossier and substance evaluation and for the new nano-specific information requirements. This includes costs for proactively engaging with European authorities with the goal to have carbon black properly evaluated, e.g., by partial funding of workshops and conferences which promote interaction among experts. This is essential to bring the science to the regulators who will be making a decision on the potential classification of carbon black as a carcinogen or otherwise as a hazardous chemical in the evaluation process of REACH. Please note that the amounts reserved for each contingency fund are necessarily based on estimated figures only as these costs have not yet been incurred. In light hereof, the Consortium expressly reserves the right to increase or decrease the amounts allocated to each contingency fund as well as to shift funds among the contingency funds.
Why does the Consortium use three separate contingency funds?
First, a contingency fund for costs expected in connection with the upcoming dossier evaluation proceedings has been set up.
So far, most of ECHA´s additional information requests directly affect only the tonnage bands of 100-1000 t/a and of >1000 t/a. However, ECHA´s information request for the genotoxicity endpoint affects endpoints in the lower tonnage bands as well. Therefore, registrants in these tonnage bands will also have to contribute to some extent to contingency fund 1.
A second contingency fund has been set up for costs which are expected in connection with the new nano-specific information requirements in the revised REACH-Annexes.
A third contingency fund has been established for the upcoming substance evaluation of carbon black beginning in 2022 as part of the CoRAP process.
Please note that the amounts reserved for each contingency fund are necessarily based on estimated figures only as these costs have not yet been incurred. In light hereof, the Consortium expressly reserves the right to increase or decrease the amounts allocated to each contingency fund as well as to shift funds among the contingency funds.
Who has to bear the costs for the contingency funds?
The contributions to the contingency funds are spread proportionally across the different tonnage bands in the same manner as the costs for existing data and studies, with the registrants in the highest tonnage band bearing the largest share.
If necessary, the Consortium will take into account tonnage-band specific costs, adjust the current factor for spreading the costs across the different tonnage bands and may reimburse/ re-invoice registrants of specific tonnage bands when it calculates the second reimbursement, for example if the outcome of the pending substance evaluation only affects specific higher tonnage bands, but not lower tonnage bands. However, please note that ECHA may demand additional information in a substance evaluation which may not be requested in a dossier evaluation and can demand such information from all registrants.
Which agency will identify the requirement for additional studies?
Different European and national authorities may identify a requirement for additional studies.
ECHA issued a draft dossier evaluation decision dated December 19, 2018. ECHA concluded in this draft decision that four additional studies shall be conducted: a comet assay in rats treated with Printex 90 via the inhalation route of exposure; a 90 day subchronic study in rats treated with Printex 90 via the inhalation route, and two prenatal developmental toxicity studies (PNDT), one in the rat and the other in the rabbit, both species treated to Printex 90 via the inhalation route. Moreover, ECHA indicated in the draft decision dated December 19, 2018 that the absence of an extended one-generation reproductive toxicity (“EOGRT”) study in the dossier constitutes a data gap and encouraged the lead registrant to commence with steps to bring the dossier into compliance.
ECHA terminated this dossier evaluation procedure on December 20, 2019 due to an ongoing toxicokinetic study for carbon black which will influence the design of the requested toxicological studies. ECHA has already indicated that it will restart a new dossier evaluation of carbon black after January 7, 2020 which will take into account the results of the toxicokinetic study and, at the same time, verify whether the Dossier complies with the new nano-specific information requirements. It is, therefore, likely the dossier evaluation will restart in 2020. The final decision for dossier evaluation will be issued by ECHA or the European Commission.
The substance evaluation of carbon black is currently scheduled to be carried out by the competent French authority (French Agency for Food, Environmental and Occupational Health & Safety, Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail “ANSES”) beginning in 2021. ANSES will thereafter prepare a draft substance evaluation decision which will formally be issued by the European Chemicals Agency (“ECHA”) or the European Commission.
The competent authorities of all European member states participate in the dossier and substance evaluation decisions. If they agree on a draft decision, ECHA will issue the final decision. If they do not reach unanimous agreement on a draft decision, the Commission will issue the final decision.
Who will arrange and manage future required studies?
The Consortium will arrange and manage future required studies in cooperation with the International Carbon Black Association (“ICBA”). The ICBA is a scientific, non-profit corporation whose purpose is to sponsor, conduct and participate in investigations, research, and analyses relating to the health, safety, and environmental aspects of the production and use of carbon black. The Consortium will be granted access rights to studies which are owned by the ICBA. If any co-registrants of carbon black should be in possession of any relevant studies, they are welcome to bring such studies to the attention of the Consortium for possible inclusion in the Dossier. The costs for any such studies shall be considered in the second recalculation of the costs to be shared.
Who will pay for future studies? How will these costs be shared?
The costs for future studies and administrative costs will be spread proportionally across the different tonnage bands for all buyers of LOAs in the same manner as the costs for existing data and studies, with the co-registrants in the highest tonnage band bearing the largest share.
If necessary, the Consortium will adjust the current factor for spreading the costs across the different tonnage bands and will reimburse/re-invoice registrants of specific tonnage bands when it calculates future reimbursements or additional payments, as the case may be.
When will my data and cost sharing obligations end for carbon black?
Data and cost sharing obligations under REACH are a dynamic and continuous process. ECHA or the European Commission can impose further information requests in dossier and substance evaluation decisions at any time. In this case, the costs for generating additional information for the Dossier must be shared in a fair, transparent and non-discriminatory way. As long as substances are manufactured or imported into the European Union, the data and cost sharing obligations of REACH-registrants do not end.
Can I use the LOA which the Consortium has granted for other purposes and in other countries?
The use of the LOA is strictly confined to use for registration of the import or manufacture of carbon black in the EU as required by REACH. The LOA does not grant any reference rights to studies contained in the Dossier which may be needed in other legislations outside the EU, e.g., under the applicable chemicals legislation in Korea (“K-REACH”).
Can other SIEF members join the joint submission later?
New SIEF members, such as new importers or manufacturers, can join the joint submission later. However, after the expiry of the last registration deadline, the Consortium does not expect a significant increase of members of the SIEF. However, the consequences of BREXIT may result in new members to the SIEF who may join the joint submission later.
Given that the SIEF is formed and that a carbon black registration lead dossier has already been filed with 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?
No, ECHA accepts only one registration and one registration dossier due to the OSOR-principle (one substance, one registration; please refer to ECHA guidance for details on possi-ble separate registrations of intermediates); a (partial or complete) opt out and separate submission of information is still possible, however, even (full) opt-out registrants must become a member of the joint submission.
Does knoell Germany GmbH take the position as Lead Registrant for the SIEF?
No, knoell Germany GmbH is the Consortium manager; the current Lead registrant is Orion Engi-neered Carbons GmbH, a member of the Consortium.
To ensure the validity of a joint registration for carbon black, how do I establish the sameness of my product (substance identity information, compositional specification)?
The sameness criteria for carbon black have been published in the SIEF Information Letter 2 which is available here.
Are there any restrictions on the manufacturing process and/or the impurities (if applicable)?
The process is not restricted to the manufacturing processes described on the webpage of the Consortium (www.cb4reach.eu). The impurity levels have been posted in the SIEF In-formation Letter 2 (updated 2016) which is available here.
Does carbon black contain SVHC as per the candidate list?
Carbon black as registered in the lead dossier does not contain any of the currently listed SVHC above 0.1%.
Beyond the list of uses given on the CB4REACH website, which other uses are addressed in your CSR? This information is necessary to cover all exposure scenarios relevant to carbon black.
Carbon black is not classified as a hazardous material; therefore, no exposure scenario is necessary.
Should further information be required, the potential registrant should disclose his use to the consortium manager on a confidential basis for him to check whether such use is covered by the lead dossier or not.
Will the Chemical Safety Report be a generic one onto which specific exposure scenarios can be added?
The CSR is complete. No exposure scenarios are required because carbon black is not classi-fied as a hazardous material.
Uses contained in the lead dossier
The “Uses” contained in the lead dossier and described in the “CB4REACH SIEF Information Letter 3” were determined using the “Guidance on information requirements and chemical safety assessment Chapter R.12: Use descriptor system.” This document was published by ECHA in May 2008 and updated, the latest version of the R.12 guidance (Version 3.0) is dated December 2015. The “Use Descriptors” incorporated in the carbon black joint registration dossier that was submitted and accepted by ECHA include the IU (Identified use), SU (Sector of use), PC (Chemical product category) and Process category (PROC) as defined in this document.
The Consortium is established as a taxable entity in Germany with a German VAT-number (DE-xxxxx). Services between the Consortium and LoA purchasers normally qualify as busi-ness 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 in 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 normally be deducted as input tax (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.
Invoices will be issued only to the name of the purchaser and to an EU address. We kindly ask to transmit payments by regular bank transfer rather than by SEPA. If a SEPA transfer is used, the additional expenses that are charged to the recipient need to be borne by the payor so that the full amount of the consideration is received by the Consortium.
The C&L Inventory includes several notifications for carbon black classified in different hazard classes. Does the joint submission dossier include a self-classification of carbon black?
Carbon black as registered in the lead dossier and as described on the webpage of the Consortium in the Sief Information Letters 1 - 3 is not classified according to Regulation (EU) No. 1272/2008.
Please be aware that the entries in the C&L inventory for carbon black do not reflect the legal position in the EU on the classification and labelling of carbon black, but rather they reflect the situation on the market because they are the self – classifications made by the respective notifiers/registrants. No verification of the content of the C&L Inventory is performed by ECHA.
ECHA recommended to transfer registrations before the UK’s withdrawal; the CB4REACH 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 (1,000€)
For a change of an OR, the Consortium has prepared an agreement which must be signed by all contracting parties (old OR, new OR, customer of OR, Consortium). The new OR must follow the guidance (see webpage CB) and send the corresponding information (NDA/form) to the manager of the Consortium (@). After the finalisation and payment of the handling fee, the new Letter of Access will be issued. Please note that without this contract, the new OR has no right to refer to the joint registration / lead dossier!
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.