Frequently Asked Questions on REACH by Industry
1. Joint submission & Dossier Content
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 and a copy of the CSR (for tonnages >10 per annum; electronic token for Registration on ECHA Website).
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.
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 full 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, to the best knowledge of the members of the Carbon Black REACH Consortium, exhaustive.
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:
- General Information: Identification (composition, purity, constituents…), analytical information (analytical methods and spectral data)
- 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 current version of the registration guidance.
Will the proposed joint submission of the consortium enable to successfully register Carbon Black with no further action or cost?
The letter of access agreement offered by the Carbon Black 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 letter of access from the Consortium, it will be allowed to reference both the registration dossier and (for registrations >10t/a) the chemical safety report for carbon black which were submitted by the lead registrant, Evonik Degussa GmbH (now: Orion Engineered Carbons GmbH), in their respective form as updated from time to time by the lead registrant (together, 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 carbon black as identified by the CAS and EINECS numbers for which the joint 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 (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 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.
ECHA opened a dossier evaluation for carbon black in January 2015. The dossier evaluation process is still underway. Furthermore, carbon black has been listed on the CORAP (see webpage –> Registration/Evaluation / start 2018). Given these developments, it is anticipated that additional tests will be requested by ECHA as a result of such evaluation process, which of course will mean additional costs for the co-registrants. As a result hereof, the CB4REACH Consortium has decided to postpone recalculations for possible additional cost contributions/reimbursements until such time when the dossier and substance evaluations have been completed and the costs for additional information requested by ECHA as a result of such evaluations are known.
Furthermore, any 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 joint registration dossier which has been prepared by the Consortium, and 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.
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:
- Registration of the basis substance (macroscopic particle)
- Registration of the surface treating substance
- Description of the use “surface treatment” in the registration dossier of the surface treating substance and in the registration dossier of the basis substance
- 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.”
Source: ECHA (https://echa.europa.eu/support/qas-support/qas/)
2. Joint submission: Dossier & Costs
Does the CB4REACH Consortium offer a rebate for purchasers of a letter of access if more letters of access are sold than anticipated?
The sale of letters of access to the REACH dossier for carbon black 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. 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. Thus, the Consortium has estimated that the number of LoA’s for, e.g., the > 1,000t/a tonnage band will be less than twenty (20). These assumptions are supported by the evidence available to date. If the number of LoA's sold is lower than expected, purchasers of a LoA will not receive a supplemental invoice. Thus, to be fair, if the number of LoA's sold should be higher than expected, no rebate will be paid either. 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 carbon black (> 2,500) is in no way indicative of the number of LoA’s which will be sold as many companies have pre-registered carbon black only as a precautionary measure. Of course, the Consortium will act in accordance with REACH REGULATION (EC) No 1907/2006 and the Implementing Regulation (EU) 2016/9 at all times.
ECHA opened a dossier evaluation for carbon black in January 2015. The dossier evaluation process is still underway. Furthermore, carbon black has been listed on the CoRAP for substance evaluation beginning in 2018 (see webpage –> Registration/Evaluation / start 2018). Given these developments, it is anticipated that additional tests will be requested by ECHA as a result of such evaluation process, which of course will mean additional costs for the co-registrants., As a result hereof, the CB4REACH Consortium has decided to postpone recalculations for possible additional cost contributions/reimbursements until such time when the dossier and substance evaluations have been completed and the costs for additional information requested by ECHA as a result of such evaluations are known.
Are access to the dossier and the CSR available separately?
No, access to the dossier and to the CSR is not available separately.
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.
Is the LoA granted per legal entity or per company?
The LoA is granted per company, 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 controlled 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.1
1 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.
! N.B.: This cost model is currently under evaluation due to the draft Guidance on Data Sharing published by ECHA in April 2016; it is not excluded that the current cost model will have to be revised and that as a result of such revision every affiliate of a company group will need to buy a separate LoA!
When the entire package (Dossier & CSR) is not necessary, can the right to reference individual studies be purchased?
Yes, by payment of 50% of the costs required to repeat the respective study or studies today.
3. SIEF, Consortium & Dossier
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.
Given that the SIEF is formed and that a carbon black 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?
No, ECHA accepted only one registration and one dossier; an opt out is still possible (see Implementation Regulation (EU) 2015/864), however, even opt-out registrations are technically treated as part of the joint registration dossier (see Implementing Regulation (EU) 9/2016).
Does Dr. Knoell Consult GmbH take the position as Lead Registrant for the SIEF?
No, Dr. Knoell Consult is the Consortium manager; the Lead registrant is Orion Engineered Carbons GmbH, a member of the Consortium.
4. Sameness & Impurities
To ensure the validity of a joint registration for carbon black, what are the sameness criteria listed in the submitted registration dossier (substance identity information, compositional specification)?
4. Sameness & Impurities
The sameness criteria for carbon black have been posted in the SIEF Information Letter 2.
Are there any restrictions on the manufacturing process and/or the impurities (if applicable)?
The process is not restricted to the processes described on the webpage.(http://www.cb4reach.eu). The impurity levels have been posted in the SIEF Information Letter (updated 2016).
Does the submitted Carbon Black dossier specifically include nano-forms of carbon black?
Carbon Black is a so-called “nano-structured material” (ISO TC 229, Draft TS 12921), i.e., consisting of primary particles formed in the carbon black process that combine within milliseconds after formation in the reactor to aggregates and agglomerates. Therefore a differentiation for Carbon Black between nano-material and bulk/conventional material is not necessary.
Does Carbon Black contain SVHC as per the candidate list?
Carbon Black as registered does not contain any of the currently listed SVHC above 0.1%.
5. Uses & Chemical Safety Report (CSR)
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 it is covered 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 classified as a hazardous material.
We use carbon black as a raw material, by mixing with other raw materials and heat treating, in the manufacture of electrical and mechanical carbon components. Can you confirm that this type of use is included in the submitted dossier?
Yes, because the use descriptions in the CSR are exhaustive. This particular case would be covered under “Other carbon preparations” as shown on the Consortium website at http://www.cb4reach.eu/index.php?id=informationfordownstreamusers. In case of any doubts, please, contact your Carbon Black supplier.
Uses Contained in the Carbon black Dossier
The “Uses” contained in the Carbon Black Consortium’s REACH dossier and written in “CB4REACH SIEF Information Letter 3” were determined using version 1.2 of 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 remains the latest version of the R.12 guidance to date. 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.
Section R.12.6 of the above ECHA document states "For dangerous substances processed into articles, the manufacturer or importer of the substances may find it necessary to specify which types of articles are covered in the CSA and ESs." Since Carbon Black is not considered as a dangerous product the AC (Article Category) is not included in the Carbon Black dossier.
Currently the “Use descriptor system R.12” guidance document is in the process of being updated by ECHA. The update is at the “Draft to Committees” stage (see http://guidance.echa.europa.eu/guidance4_en.htm). When the new version of the R.12 guidance is approved, the Carbon Black Consortium will review the dossier and the necessary changes will be made to comply with the final guidance document.
6. Payment & VAT
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 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 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 (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 and EU address. 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.
7. Classification and Labelling Inventory
The C&L Inventory includes several notifications for Carbon Black classified in different hazard classes. Regulation (EC) No. 1272/2008, Article 41 urges registrants to come to an agreement on differing entries. Is the consortium about to take any actions in the scope of this Article 41?
CB as registered in the CB4REACH Consortium’s joint registration dossier and as described on the CB4REACH webpage in the SIL 1 - 3 is not classified according to Regulation (EU) No. 1272/2008 or Directive 67/548 EEC.
- Please be aware that the entries in the C&L inventory for CB do not reflect the legal position in the EU on the classification and labelling of CB, 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.
- As required by article 41 of the CLP Regulation, the members of the Consortium plan to take part in discussions with the other notifiers/registrants so that a consistent classification can be made for CB. ECHA plans to develop and provide a communication tool which will aid industry in this harmonisation process. The Consortium does not plan to start the discussion of this issue with the SIEF members until ECHA has published this tool.