August 2008
We are receiving a number of questions from our customers and suppliers, asking for information relating to the implementation of the new European Union (EU) Regulation 1907/2006/EC on chemicals (REACH).
The attached document is a compilation of the most frequently asked questions we have received so far and summarizes the position we are currently developing to prepare for the implementation of REACH for products which are imported / manufactured at Darlington and other EU powder coating sites.
A very few products which are currently sourced from outside the EU are dependent on the REACH implementation strategy of non-EU suppliers. We will keep you informed as to their decision when it becomes known.
We hope that this document will provide you with all the information that you will need from us at this stage in order to prepare for REACH. Should you require further clarification please do not hesitate to contact us.
Yours faithfully,
This information is based on our current level of knowledge. This information may be subject to revision as new knowledge and experience becomes available, and DuPont makes no warranties and assumes no liability in connection with any use of this information. Since DuPont cannot be aware of all aspects of your business and the impact the REACH Regulation has for your company, DuPont strongly encourages you to get familiar with the REACH Regulation in order to comply with its requirements and timelines.
General questions concerning REACH
1. Do you have a working group for the new REACH regulation?
DuPont has assigned a global lead function with European and US work teams on corporate and business level for all functions.
Work teams for supplier interface, internal product assessment and customer interface have been installed as well as corporate substance evaluation and (pre-) registration and authority interface groups.
2.
Do you plan to engage your customers in your strategy?
We do plan to work together with our customers and down stream users, as promoted under the REACH Regulation; we shall ensure involvement at the appropriate time to meet applicable deadlines, on a case by case basis and through established business contacts.
3. Do you have in place the infrastructure to enable you to comply with REACH?
DuPont has assigned a global lead function and put in place various working groups to enable us to comply with the REACH Regulation. This team gathers resources from the central functions and from the businesses, both in Europe and in other regions of the world, in order to anticipate and react to the variety of issues that the REACH Regulation is raising.
4. Do you participate in the different working groups and activities related to the implementation of REACH? i.e. RIPs, Industry association
DuPont remains fully engaged in the debate relating to the implementation of the REACH Regulation, to ensure that the final application of the Regulation fulfils the objective and needs of all stakeholders in a balanced way. DuPont is active in several REACH Implementation Projects (RIPs) as well as in some of the industry initiatives.
5.
What is the role of your company in the Supply Chain?
Dependent on the products we manufacture or import we can have all the roles within the supply chain.
(Registrant – Manufacturer – Importer – Downstream user Distributor – Actor in the supply chain – Supplier of a substance or preparation – Customer of a substance or preparation)
6.
What is the type of products you supply?
(Substance – Preparation – Polymer – Article)
DuPont's products portfolio includes all of the above.
Please refer to the Material Safety Data Sheet for the product you are supplied with, to have its identification.
NOTE: be aware that only the Polymers as such are exempted from registration under REACH; on the contrary, additives in polymer compounds must be broken down and considered as substances falling under the REACH Regulation.
Questions concerning communication
7. Have you developed a communication strategy with your suppliers?
We are setting up our internal tools for an ongoing exchange with our suppliers and have already initiated programs to identify the appropriate contact for REACH and collect first information. In-depth collaboration will be set up once the common protocols for communication and information exchange are finalized.
8.
Have you developed a communication strategy with your competitors?
We intend to work with other chemical companies and with other entities that may be involved in the data sharing, within the legal frame in industry groups and associations.
At this point in time, more specific information exchange is ahead of the official time line (defined by the formation of SIEFs). Consequently, we are not yet actively involved in official ‘Reach Industry Groups’ on specific chemicals.
DuPont will be ready in time to participate in the relevant work groups.
(SIEF= Substance Information Exchange Forum)
9.
Have you developed a communication strategy with downstream users?
We are setting up our internal tools for an ongoing exchange with our customers and down stream users. In-depth collaboration will be set up once the common protocols for communication and information exchange are finalised.
However, we have already started a generic campaign of information and are collecting information to establish communication lines for future exchange.
Questions concerning Registration / Authorisation
10. Do you have plans to pre-register and register the substances or components of your products?
DuPont plans to assure the pre-registration of the substances for which DuPont is the manufacturer or the importer. The objective is the final registration of these substances. Final decision as to registration will however depend on a number of factors beyond DuPont’s control and/or on Safety, Health and Environment or business related considerations.
11.
What will be the timing when you plan to register your substances / products?
For those substances which we will be able to support, we plan to register within the time frame set out by REACH according to the related volume band.
Concerning the deadline for registration, we currently anticipate that we use the available time frame, so that we may collect and process all the necessary information on substances from downstream users and suppliers.
12.
Do you have in place plans to notify the agency before 2010 of the classification and labelling of substances you produce or import into the European market?
We have plans in place to notify the agency of the classification and labelling of substances we place onto the European market before 2010.
At this stage, we plan to implement the new global classification and labelling system (GHS) for substances in 2010.
13.
Did you already perform a data gap analysis on those substances that you intend to pre-register?
We have put together a multi discipline group of experts to define the data gaps we have for those substances we intend to pre-register.
We are currently working on extending this work with some of our suppliers for whom we will have to act as a registrant, as we are the importer of their products.
14.
Will DuPont performance Coatings and/or DuPont’s suppliers ensure pre-registration of the chemical substances and polymers contained in DuPont products?
DuPont Performance Coatings (DPC) is in the process of pre-registering all the substances and polymers which DPC manufactures or imports into the EU, by November 30, 2008 at the latest. With respect to the products DPC purchases on the European chemical market, DPC is in an intensive dialogue with the relevant suppliers and almost all suppliers have already declared their intent to pre-register.
15.
Does any substance or product you supply contain any impurity or component at >0.1% which is part of the “Authorisation” scope?
Please refer to the Safety Data Sheets which contain already today information concerning some substances that may be expected to become part of the candidate list for authorisation*. Please note however that the candidate list has not yet been defined. DuPont will continue to provide relevant information to its customers via Material Safety Data Sheets and other appropriate information tools. Substances which might become candidates for authorisation will get DuPont’s special attention.
* (CMR cat. 1 and 2 as per Annex I of European Directive 67/548/EEC)
16.
Does any starting raw material used by your company to manufacture substances and products supplied to the European market belong to the “Authorisation” scope?
On the basis of the information mentioned above, we are currently evaluating which of the substances that we are using may be included into the candidate list for authorisation; considering however that the candidate list has not yet been defined, we are unable, at this point in time, to come to final conclusions on that matter.
17.
If you are not the manufacturer of the substances you supply into the European market have you already discussed with your own suppliers to define whether they use any starting raw material(s) which belongs to the “Authorisation” scope?
In the frame of the review of all chemicals which go into our products, we already have conducted an assessment of the majority of those substances which could become subject to authorisation under REACH.
This information is currently refined and is integral part of the work programs with our suppliers.
18.
Are your products used in exempted uses from REACH?
DuPont provides products for a large range of industrial and consumer uses.
Some quantities of one given product may go into exempted applications.
Please refer to the specific product information for further details.
19.
Which uses and exposures will be supported or excluded for your products?
As required by REACH, the supported or excluded uses for a given product are based on the information received from the downstream users. This information has to be processed through a risk assessment and take into account use and exposure information, as reported by downstream users.
DuPont cannot be knowledgeable about all such possible scenarios at downstream level; therefore we will only be able to provide more detailed information later on in the REACH process, which may go up to the end of the registration period in 2018.
20.
Is DuPont ready to disclose the composition of its products in order to allow the tracking of substances by its customers whether registered by the supplier prior to the applicable registration deadline?
In general, DuPont considers the compositions of its products as proprietary and confidential information, pertaining to business secret. Disclosing composition of the products to downstream users is not required under REACH. As manufacturer or importer, we are in charge of (pre-) registration of the substances we import and / or manufacture and, if applicable, to provide for the necessary follow up with our own suppliers regarding the registration of their own substances.
REACH does not foresee that downstream users need to track the (pre-) registration activities of their suppliers. Downstream users will be able to ensure that applicable registrations have been made via the communication of the revised Material Safety Data Sheets, which will show the related registration number(s).
Compositional disclosure of a preparation in no case allows a downstream user to monitor post pre-registration activities of the supplier.
21.
Is DuPont ready to act for its customers as “Only Representative“?
We are currently evaluating different import scenarios and their implications.
These scenarios include cases where customers, located outside the EU, want to export their products into the EU.
Due to significant business implication, we will handle this question on a case-by-case basis at a later stage.
22.
When will DuPont implement the new SDS format as required by REACH?
The REACH Regulation requires that a new Material Safety Data Sheet (SDS) format be used as of the date REACH comes into force (1st June 2007). The required changes are: the order of information provided in section 2 and 3, and the addition of an e-mail address of the supplier.
DuPont has made the necessary preparations and will issue all new SDS after the 1st June 2007 in the new format. The old and the new SDS in terms of Safety, Health and Environmental information are equivalent.
23.
I am operating outside the European Union and purchase DuPont materials locally, which I convert into finished or semi-finished articles. I intend to sell these finished or semi-finished articles into the European Union. Can I obtain from DuPont a certification of REACH compliance for the materials I purchase from DuPont?
REACH is a regulation, which concerns the registration of chemical substances for manufacturing in or import into the European Union. Any substance purchased and used outside the European Union is in principle not subject to REACH. Finished or semi-finished products (technical term ‘article’) which are (i) manufactured with materials purchased outside the EU and (ii) imported into the EU are not subject to registration under REACH with the following two exceptions: they contain ‘Substances of very high concern’ (SVHC) or they contain substances which are intended for release.
SVHC and / or substances intended for release may bear obligations in terms of notification, information and registration; the content of these obligations is related to the importer and his operation.
As appears from the above, the REACH regulation is not only linked to chemical substances but also to certain conditions of manufacture, use and import. Therefore, a generic ‘REACH compliance certification’ from the producer for a given substance cannot be provided.
The list of SVHC is currently being defined by the European Authorities. Once it is set and published, DuPont will communicate the presence of any SVHC above the regulated threshold limit to its customers, including those located outside the European Union and selling their finished or semi-finished articles into the European Union. The publication of SVHC is expected to happen earliest as of mid of 2008 under the form of a so-called ‘Candidate list for Authorisation’.
24.
I am operating outside the European Union and purchase DuPont materials locally, which I mix, blend or compound with other materials into a raw material for further use.
I intend to sell these products into the European Union. Can I obtain from DuPont a certification of REACH compliance for the materials I purchase from DuPont?
REACH is a regulation, which concerns the registration of chemical substances for manufacturing in or import into the European Union. A substance purchased outside the European Union will be subject to the REACH Regulation if it is imported into the EU. The REACH Regulation will apply in such a case, whether the substance is imported as such, or whether it is mixed, blended or compounded with other substances to form another raw material (technical term ‘preparation’). Regarding “preparations” specifically, the rule is that the importer has the duty to register all chemical substances contained in the preparation as of 1 ton /year of import.
As appears from the above, the REACH regulation is not only linked to chemical substances but also to certain conditions of manufacture, use and import. Therefore, a generic ‘REACH compliance certification’ from the producer for a given substance cannot be provided.
25.
Do your preparations or your articles contain substances of very high concern (SVHC)?
The list of SVHC will be defined by the European Authorities only as of mid of 2008 earliest.
Only once the SVHC have been defined by the authorities and the candidate list for authorisation published, will DuPont be in a position to officially communicate the presence of any SVHC above the regulated threshold limit.
This communication shall then be made to those of its customers which are concerned by these DuPont products, including the customers located outside the European Union and selling their finished or semi-finished articles into the EU.
However, we have already conducted a first evaluation of which of the substances we are using MAY be included into the candidate list for authorisation.
This current analysis and assessment of all the substances contained in our products will enable us to either ensure the continuous supply of the products we intend to support in the European market or to develop proposals for modified or alternative products.
Questions concerning Downstream Users
26. Do you plan to engage your customers in your strategy development or to communicate your decisions?
Have you developed standard operating procedures for working with your downstream users?
We are factoring in REACH relevant questions into product strategies; this partly involves customers and downstream users at an early stage.
On a broader basis, our customers and downstream users will, at the appropriate time, become involved, on a case by case basis, through established business contacts.
27.
How can we ease the interface between you as supplier and our downstream users?
At this point in time, please prepare use and exposure information for YOUR OWN OPERATION (locate and collect available exposure and use relevant data and process descriptions). You also may want to warn your downstream users to do the same for THEIR OWN OPERATION.
Once common information exchange protocols are available (RIP 3.2 / 3.5), all actors shall use these throughout the supply chain.
28.
When do you plan to develop a communication strategy and communicate it to your downstream users?
We already have developed a global communication strategy and have started to implement it through information letters to our customers.
The same approach is taken towards our suppliers.
Concerning more concrete data exchange we have to wait for standardised communication formats (RIP 3.2 / 3.5), which will not only allow efficiently developing and collecting information, but also to process them.
29.
Do you plan to provide to the downstream users toxicological and environmental data available on substances to allow them to prepare their exposure scenario?
Exposure scenarios are not prepared by downstream users, but by the suppliers. The downstream user will have to supply exposure information to the supplier. Neither toxicity nor environmental data from the supplier are needed for that purpose.
The substance manufacturer will combine both hazard and exposure data to develop his risk evaluation and define the resulting risk management measures.
Prior to the completed registration of substances, REACH does not foresee to share hazard data with downstream users going beyond the current information on Safety Data Sheets.
Questions concerning Toxicological Data
30. By when do you plan to provide toxicological and environmental data available on substances to us?
We will provide the appropriate information into the defined information process, which will mainly rely on revised Material Safety Data Sheets (SDS).
The industry will pool all the information available and, if needed, develop new data. This process will start in 2009 and continue until 2018.
31.
How do you plan to share both toxicological and environmental data with your customers?
Information will be provided via the communication channels that will be set up by authorities and / or the industry. This includes at a global level, SDS, IUCLID 5, as well as Industry information via CEFIC and DuPont corporate and business specific information.
32.
Some downstream users may want to do their own registration (‘post card registration’): how do you plan to share both toxicological and environmental data with those downstream users?
DuPont expects that registrations made by downstream users on their own will only occur in exceptional cases; requests for information from such downstream users will be handled on a case by case basis.
33.
When do you expect to contact downstream users to collect the “identified use(s)” from their own downstream users and also their exposure information?
We are currently mailing out information to our customers to inform them about REACH and alert them to the need to prepare use and exposure information FOR THEIR OWN OPERATIONS (locate and collect available exposure and use relevant data and process descriptions) and to warn their downstream users to do the same FOR THEIR OWN OPERATIONS
We strongly suggest you to wait for standardised communication formats, which will allow to efficiently collect those information.
34.
How do you intend to get information on exposure categories from your customers and the downstream users?
We will prepare appropriate questionnaires or other standardised documents aligned with industry standards to allow our customers to efficiently communicate with DuPont up and down the supply chain. We strongly suggest to wait for this standardised communication process.