General REACh questions
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
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
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
Chemical Substances in Products (including SVHCs)
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
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?
: 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
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
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
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
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
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
Q: Will I need to change my supply chain if
Dow Corning does not list my use in the Safety Data Sheet
: 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
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
Dow Corning will be assessed on a case- by-case basis.
Importation by customers
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?
: 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
: 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
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
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
Q: Are the ORT fees paid by the distributor,
by the distributor’s customer, customer or by Dow Corning?
: 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:
- You request OR coverage from the distributor.
- The distributor then requests a code certificate from
- Dow Corning purchases a code certificate from Chemservice and sends a
copy to the distributor.
- The distributor purchases a code certificate from Chemservice quoting the
code on the certificate from Dow Corning, and sends a copy to
- 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.
- 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?
: 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
Q: Is customers' information provided to the
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
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
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