Q: What is your strategy for REACh?

A: Dow Corning supports the aims of REACh to protect the environment and human health. REACh is a complex regulation that has significant business implications for manufacturing supply chains. As a chemical supplier, we intend to ensure that REACh causes a minimum of business disruption to our customers and that we actively capitalize on the opportunities that REACh presents. As a company with an established track record in Product Stewardship, we believe that REACh provides reinforcement of our ongoing programs. Additional insight can be obtained from our position statement.

Q: How have you been preparing for REACh?

A: Dow Corning is well underway in its preparation efforts for REACh. In 2006, we established a dedicated multi-functional REACh business team and have systematically reviewed our entire product portfolio. We have already pre-registered those substances for which we have the responsibility and obligation to do so including a number of substances in our non-EU vendor supplied raw materials and Dow Corning products manufactured outside the EU, and are preparing for Registration through active participation in many SIEFs.

Q: What is the implementation timeline?

A: There are several phases of implementation. A REACh timeline is available on the Dow Corning REACH Resource Center.

Q: How will the supply contracts change to account for the requirements of REACh?

A: REACh is a regulatory requirement in the European Union (EU). Materials supplied – either directly or indirectly – to the European Union Market will need to fully meet the requirements of REACh. How this is reflected in supply contracts will depend on company to company expectations and agreements.

Q: Did Dow Corning pre-register its substances?

A: Dow Corning pre-registered all substances for which it has the responsibility or the obligation to do so under REACh including a number of substances in our non- EU vendor supplied raw materials and Dow Corning products manufactured outside the EU.

Q: How do I know if Dow Corning pre-registered?

A: We have a web portal available for customers of our legal entities based in the European Union to obtain supporting information concerning the (pre)registration status of the products they purchase from Dow Corning. Where Dow Corning procures raw material substances from its suppliers, we will ensure that we provide – to the best of our abilities – the latest information available to us.

Q: Will you provide pre-registration numbers as evidence of pre-registration?

A: Dow Corning products are composed of varying numbers of substances. Some of these substances are pre-registered by our vendors or their suppliers who are not obliged to provide the pre-registration numbers to us or our customers. In any event, it is not possible to determine the pre-registrant or substance merely from receipt of the pre-registration number. Therefore, even to the extent it would be able to, Dow Corning has decided not to provide pre-registration numbers to customers.

Q: Why can’t you simply tell me if the Dow Corning product contained in my exports to the EU are registered for REACh?

A: REACh is different from other regulations in that Registration is by supply chain as well as substance. Imported products can be covered by the substance registration(s) of an “Only Representative” appointed by the non-EU manufacturer or formulator if the name of the importers and their individual importer volumes is referenced in the “OR” registration dossier. Importer volumes must also be traceable in supply chain. Dow Corning has multiple complex supply chains and so we must trace the product back to our point of shipment to know if we have registrations that can potentially cover your product. Our solution is to use a Trustee to trace the supply chain and be referenced in Registration dossiers as storing sensitive importer names and their individual volumes. To obtain coverage, if you are a direct customer of Dow Corning, please complete the ORT Request form. If you purchase your material from another source, please refer to the ORT workflow chart to understand how the request should be passed up the supply chain to obtain coverage.

Q: Will I need to specify an improved grade of raw material to comply with REACh?

A: Typically, no. However, in some cases REACh will drive changes in the grade or specifications of certain materials, especially those where Substances of Very High Concern (SVHC) are components or potential contaminants.

Q: Can you say which products are REACh compliant?

A: Dow Corning feels the terms “REACh compliant” and “REACh Ready” are imprecise and open to potential misinterpretation. We can advise you which products contain only substances that have been (pre)registered under REACh within the given supply chain and for the intended uses.

Q: What reassurances can you give me that the products you supply me will still be available under REACh?

A: Dow Corning is taking all commercially reasonable actions to ensure the continuity of supply of its products. In the majority of cases REACh will have only limited impacts. Where it is possible to re-supply/reformulate an affected product to meet or exceed existing technical performance requirements we will use reasonable commercial endeavors to do this. Where this proves to be not possible or is not economically feasible, we will inform customers of our intended actions. Currently Dow Corning does not intend to apply for authorization of any substances contained in its products

Q: Are there any SVHCs in the products that Dow Corning sells me? What products and what concentrations?

A: We have identified a very limited number of cases where SVHCs listed currently in the REACh Regulation occur (EC/1907/2006; Appendices 1 to 6); these occurrences are reported – as required by the applicable laws – in the European Union Safety Data Sheet for concerned products. As ECHA publishes new Candidate lists, we continue to review our products. Please refer to the current list of Dow Corning products containing substances on the candidate list through the link Products Impacted by REACH Candidate List.

Q: When will new “REACh format” Safety Data Sheets be available for Dow Corning products?

A: We are progressively changing the format of our Safety Data Sheets (“SDS”) to that required by the REACh regulations [Article 31, Annex II]. It is our understanding that the European Commission and the Member States’ Competent Authorities have agreed a period of transition to the new format [EChA Guidance on Registration, V1.4, pp. 62-63]. We believe that the same authorities have suggested that the format of the SDS be updated as soon as a pertinent change in the safety information is required (e.g., modification of the product classification and labeling) or as additional information becomes available as part of the REACh registration process (e.g., exposure scenarios).
SDS will be updated following this proposed approach and provided via the usual channels to downstream users and others as required [Article 31 (8)].

Q: Will you provide compositional information to support my REACh pre/registrations?

A: Dow Corning believes its product compositions are very valuable assets. Although limited protection can be provided with non-disclosure agreements, we are keen to keep compositional information as secure as possible, and so endeavour to support customer compliance needs through other means whenever possible. To date, we have been able to meet all customer compliance needs in relation to REACh without divulging composition information (besides SVHCs). We therefore encourage you to visit the REACh Resource Center to learn about our “My Premiere” web portal (for customers of EU legal entities) and Only Representative Trustee service (for customers of non-EU legal entities).

Q: According to the Classification, Labeling & Packaging (CLP) regulation, ECHA must be notified of active substances imported into the EEA/EU for the purpose of updating the Classification and Labelling (C&L) inventory. Is Dow Corning taking care of this for me?

A: All active substances contained in Dow Corning products which are manufactured in or imported into the EEA/EU by Dow Corning, or for which we have provided cover to customers under our Only Representation pre/registrations are being notified to the ECHA C&L inventory. Therefore, you can be assured that your responsibilities regarding the C&L inventory have been or will be taken care of for all products for which you either have a certificate issued under our Only Representative Trustee model, or have procured from a Dow Corning EU Legal Entity.

Q: Will Dow Corning register the product xyz for REACh?

A: REACh requires the registration of substances. Many of the products that we sell are preparations/mixtures of substances – each of which may require registration under REACh whether by Dow Corning or one of its suppliers.

We have already pre-registered those substances for which we have the responsibility and obligation to do so including a number of substances in our non–EU vendor supplied raw materials and Dow Corning products manufactured outside the EU. Where this was not possible, we are proactively communicating our planned actions with customers to assist in minimising business disruption.

Q: Are there any substances that will be restricted under REACh present in the materials that Dow Corning sells me? What are Dow Corning’s future plans and actions on this?

A: Wherever commercially feasible we will seek to reformulate materials containing restricted substances or those requiring Authorisation under REACh. We shall proactively communicate with customers as information regarding potential Authorisations becomes available. Currently we are not aware of any substances in our products that will be restricted.

Q: Which party will register your substance for REACh?

A: That depends on the substance, the commercial structure involved in the manufacture and sales of that substance and the applicable legal requirements. REACh requires the registrant to be the EU manufacturer or importer, or an EU entity acting as the Only Representative of the non-EU manufacturer/formulator. Dow Corning has several legal entities incorporated in the EU that could perform importer or only representative registrations.

Q: Will I need to change my supply chain if Dow Corning does not list my use in the Safety Data Sheet (SDS)?

A: If Dow Corning does not list your use in the extended SDS of the purchased product we would need to evaluate such use to determine if it can be supported. If your use is supported by Dow Corning, we may be able to amend the existing dossier submission to include your use. In such circumstances, please contact us to review your specific situation, including use and exposure information.

If Dow Corning cannot support your use, we shall not register such use under REACh. Therefore, you will be legally obliged to either perform your own assessment or cease such use/application of the Dow Corning product.
Dow Corning will also be happy to assist you in assessing alternate products to meet your needs.

Q: What is the approach that you are taking for developing and communicating exposure scenarios?

A: Most of our products are specified for uses that are described in the REACh catalogue of use descriptions. Where required, we are developing exposure scenario templates with the assistance of key downstream users and will make these available to all users of our products. The basis of this will be where our records show that the use of the product would be similar to that/those covered in the exposure scenario. New uses or uses not already supported by
Dow Corning will be assessed on a case- by-case basis.

Q: If I buy and use a Dow Corning material outside of the EU (European Union), and then export a preparation or article with intended release containing that Dow Corning material to the EU, can I rely on your substance registration to cover my imports? Will you take care of this for me?

A: Dow Corning has submitted Only Representative pre-registrations for many substances in our vendor supplied raw materials and Dow Corning products manufactured outside the EU. If your volume and use of the Dow Corning material imported to the EU is covered by these pre-registrations, we should be able to cover your imports. Please contact us to start the dialogue needed for such cover.

Q: What is OR? Why is it needed?

A: All substances contained in imports into the EU need to be covered by a pre/registration. This pre/registration can either be done by the importer or the Only Representative (OR) of a non-EU manufacturer/formulator in the supply chain. Subject to certain terms, Dow Corning has chosen to offer cover to importers for selected products under our Only Representative pre/registrations. This enables our customers to continue business reliant upon export to Europe without paying the large costs involved in registration of the substances in our products.

Q: What is an ORT?

A: EU importer information must be linked with Only Representative Registrations. As Dow Corning Europe SA is acting as Only Representative for our non-EU legal entities, this would require Dow Corning to know the names of the importers and their volumes. Importers are typically customers of our customers and so this information is potentially commercially sensitive, making disclosure prejudicial and possibly infringing antitrust law. Our solution is to list on our registrations Chemservice as a trustee holding such importer information and to assist us with any investigations/enquiries from the REACh competent authorities. Using the Trustee means that Dow Corning will not need to see this commercially sensitive information and the model used will assist with effective tracking of volumes in accordance with REACh requirements.

Q: Why should I pay to use the ORT?

A: This is a very cost effective method of meeting compliance requirements for exports to the EU. The alternative method of supporting your business reliant upon exports to the EU of Dow Corning products is to pay the extensive costs linked to registration of the individual substances in the Dow Corning product. Compared to the potential loss of business, we believe our ORT model is a very cost effective option. The payment needs to be made by the supply chain member to allow a contract between the supply chain member and Chemservice that ensures confidentiality.

Q: What are the costs incurred to utilize the ORT service offered by Dow Corning?

A: Currently each member of the supply chain will need to pay to Chemservice a fee of €100 per certificate. This fee will buy a certificate that covers your product volume to the amount stated on the certificate for the stated period. Import certificates are valid for a single calendar year, while Code certificates requested by members further up the supply chain may be valid to the end of the calendar year following the year of issuance.

Q: Do I need to pay for the trustee even if I am comfortable to reveal the importer details to Dow Corning?

A: Yes. The role of the trustee is two-fold. Firstly, it is to protect sensitive data such as importer names. Even if you are comfortable with Dow Corning seeing this data, it may still be sensitive as this data may need to be referenced in registrations submitted by our suppliers as well as ourselves. Secondly, to ensure compliance, we need to use the same system to provide OR coverage for all customers - the trustee helps us with compliance assisting with enquiries from competent authorities and tracking and reporting to us summarized volumes. In addition to these needs, we believe additional benefit can be gained from shipping goods with an "Import Certificate of REACH Compliance Coverage".

Q: Are the ORT fees paid by the distributor, by the distributor’s customer, customer or by Dow Corning?

A: All members in the supply chain with the exception of the importer pay fees for every certificate that they request. For example, if you purchase from a distributor and then export your formulated product to a customer in France (or another country), the following steps would need to occur:

1. You request OR coverage from the distributor.
2. The distributor then requests a code certificate from Dow Corning.
3. Dow Corning purchases a code certificate from Chemservice and sends a copy to the distributor.
4. The distributor purchases a code certificate from Chemservice quoting the code on the certificate from Dow Corning, and sends a copy to yourself.
5. You then purchase an import certificate from Chemservice quoting the code on the certificate from the distributor, and send a copy of the Import certificate to your customer.
6. Your customer receives the Import certificate from yourselves with no additional fee payable to Chemservice.

Q: How does the distributor’s customer or customer’s customer obtain cover under this model?

A: Please refer to Dow Corning REACh Resource Centre for an overview of the workflow explaining how the request should be passed up the supply chain to obtain coverage.

Q: Is customers' information provided to the ORT confidential?

A: This information is stored securely by the ORT under a confidential agreement between the ORT and the customer. This will only be divulged to national competent authorities such as customs agents if required as part of an investigation/enquiry to prove compliance.

Q: What is the process that the ORT follows to ensure that the customer information is confidential?

A: The ORT has a limited number of employees authorized to access the secure database that stores this information.

Q: If the non-EU customer’s end product has ingredients other than that of Dow Corning, maybe silicone or non silicone substances, does this model help cover only Dow Corning substances or does the non EU customer have to look at multiple OR’s?

A: Dow Corning will only provide OR cover for the proportion of the end product that is made from the Dow Corning product. The other supplier may choose to also appoint Chemservice or may offer the services of another OR.

Q: Is the Trustee model only for products imported in the EU/EEA in volumes of 1 metric tonne or more?

A: REACh pre/registration is required for substances and monomers imported into the EU/EEA in quantities of 1 tonne or more per annum per importer. It is therefore logical that imports of less than 1 tonne of a finished product per annum per importer would not require pre/registration. However, if several products are being imported by one company, the importer must aggregate the volumes of the same substance contained in all imported products. If an importer is in doubt whether such aggregated amounts would not exceed the 1 tonne threshold across multiple products, they could consider seeking OR cover for the substance(s) in one or more of the products imported.

 

Disclaimer

The content of this document is for general information only and represents Dow Corning’s interpretation of, and comments on, the REACh regulation (and any other legislation referred to herein). No guarantees, undertakings or warranties concerning the accuracy, completeness or up-to-date nature of the information contained herein are provided. Dow Corning Corporation (including its affiliated companies and subsidiaries) does not invite reliance upon nor accepts responsibility and has no liability for the information provided herein (or any reliance placed thereupon). This document does not constitute legal or professional advice and must not be relied upon as such.