FAQ - Frequently Asked Questions
Here you can find questions and answers regarding IMDS content and usage in several categories. To see the content of each category and to read the answer to a question, please click on the category/question to expand the content.
You find OEM-specific IMDS documentation for suppliers in the Help category "OEM Specific Information" (no longer under FAQ).
When is a Material eligible for Biocidal Product Regulation (BPR) and which Product Types (PT) can be used? *** NEW ***
Initially, the End-of-Life Vehicle (ELV) directive was the only legislation that IMDS was designed to address, and it was simple to select the application codes for a specific substance. Other regulations have since been introduced and supported in IMDS:
- Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulations has its permissible uses, permissible regions and different REACH versions in different areas.
- Biocidal Product Regulation (BPR) substances have product categories and substances that are permitted for some product categories but not others.There is also an additional consideration of why a specific chemical was added to a material (for example: if the usage is biocidal, BPR regulation applies, otherwise the usage is permitted).
The new IMDS Chemistry Manager functionality allows companies to provide REACH Annex XIV Regulatory information and Biocide Product Regulation (BPR) information which becomes instantaneously visible to all levels of the supply chain. This should reduce the work needed through the supply chain to manage regulatory information, and reduce response time compared to MDS revision and cascading. A link is maintained between the added regulatory information and the related MDSs. IMDS Chemistry Manager also provides a framework for support of new regulations in the future.
When the user is granted access to IMDS Chemistry Manager, they can see the IMDS Chemistry Manager screens and the regulatory information that has been entered for their related MDSs. A user without IMDS Chemistry Manager access will not see any IMDS Chemistry Manager screens, or fields on existing screens such as MDS Search and the IMDS Ingredients tab, which are related to IMDS Chemistry Manager. All users with IMDS Chemistry Manager access granted will receive weekly emails regarding IMDS Chemistry Manager requests if there are any open requests within the company. If no one in the company (including Company Administrators) has IMDS Chemistry Manager access, then all Company Administrators will receive the email notifications.
The core function of the IMDS Chemistry Manager is the Regulation Wizard. Using the wizard the user can search for MDSs that contain regulation-relevant data (BPR and REACH) and directly modify the regulation relevant responses without loading the MDSs themselves. Users will be able to display multiple MDSs at once to modify the regulatory information for all contained relevant references.
This wizard is a new screen, which will be available for users with IMDS Chemistry Manager access in the "Functions" menu, and offering a search screen similar to the general Module/MDS search. The user will be able to search for specific MDSs he wants to enter regulatory information for or request an update of regulatory information. The search results only contain the latest released and active versions of MDSs for which the regulatory information can be entered. If regulatory information can be entered for child nodes, the parent MDS is also available in this list.
Users may request regulatory information updates for specific MDSs. These requests can be sent directly from the ingredients tab of the MDS details, while the user is viewing the details of a reference in the tree, even if the reference is located deep inside the tree. Requests can be managed using the Regulation Wizard.
Unlike MDS update requests that must travel down and then back up the supply chain, regulatory requests submitted via IMDS are transmitted quickly (usually within an hour) to the pertinent material producers. When the material producers update the regulatory information, the information is made available quickly and automatically to the requester and all other consumers of the material MDS simultaneously. This discourages regulatory requests to suppliers made external to IMDS, as such requests prevent IMDS from tracking the request, delay the material manufacturer receipt of the request, and slow the regulatory response process.
The user must be able to use the MDS that contains the reference. If the reference is contained within a received MDS that has not been accepted, the user cannot request an update of its regulatory information. Substances marked confidential should not pertain to the regulation wizard, yet it is possible for this to occur if a substance had recently become Declarable and/or Prohibited. If regulatory information relates to a substance marked confidential in an owned MDS, and the user does not have permission to view owned confidential substances, the user will not be able to respond for regulatory information.
Requests are issued anonymously, and requests are sent to the originator of the material. The company owning the material MDS will be able to see how many companies requested new regulatory information for a certain MDS. The date of the earliest request will also be shown. This information will help them to prioritize their data entry.
If a user selects a reference to a foreign MDS or some node/reference within such a reference, they can view all regulatory information entered. In each regulatory information box (BPR, REACH) there is a "Request update of regulatory information" button, which is only visible if the regulatory information has not been provided or is not complete (red clause sign or yellow clause sign in the tree).
Regulatory information is provided on the lowest appropriate tree level. However, there are REACH questions that pertain to (semi)components containing a specific regulated substance, and other questions that pertain to materials that contain a specific regulated substance, so it is common for both the material provider and the component manufacturer to receive requests for information on the same MDS. In general, all regulatory information can be entered for Modules, MDSs and child nodes. The regulatory information will be stored for a Module ID or MDS ID. In case of child nodes the parent Module's or MDS's ID will be used.
If a substance requires regulatory data concerning BPR, this information is provided on the Material, which directly references the substance. If sub-materials to a parent material have regulatory information attached, no regulatory information for the parent material is required.
The same is true for REACH information provided for Semi/Components: It is entered for the lowest Semi-/Component that includes the reference to the REACH relevant Material, even if this Material is referenced inside another Material.
All regulatory information will be stored by MDS ID. This means that all different versions of the same MDS will always have the same regulatory information assigned to them. If a user looks at an older version of an MDS, which does not contain the same set of regulation-relevant references as the current version, he will be notified about these discrepancies and the reason why they are present.
Regulatory information can only be entered by the company that created the affected MDS.
Regulatory information has a history function, but does not have true versioning the way an MDS does. Also, regulatory information applies not to a specific version of an MDS, but to the MDS in general. This can create confusion at times. For each MDS there can be infinitely many history records of prior regulatory responses for each different regulation (REACH, BPR), but there can be, at most, only one editable version. When the regulatory information is released there is no editable version, and the regulatory information must be made editable before new information may be entered.
When creating a new MDS, by default, no regulatory information version is created. The MDS has to be released before regulatory information can be entered. After creating and choosing to release the regulatory information, a check is executed to verify all entered or missing data. If there are no errors, the user may proceed and the regulatory information is released. Once released, the new regulatory information will become active throughout the whole supply chain immediately. There is no accept or reject process, because of the vast amount of potential stakeholders (similar to published MDSs which also cannot be rejected, and because they are available to everyone).
Since released regulatory information always refers to the latest active released version of the MDS, regulatory information can only be released if there is at least one active released version of the MDS.
To see regulatory information, you must first have IMDS Chemistry Manager access granted to you user ID. In addition, the checkbox “show regulatory information” above the MDS ingredients should be checked to see the regulatory information. Finally, if the regulation information pertains to an owned MDS substance marked confidential, you must have rights to view own confidential substances.
If substances were added to the MDS after regulatory information was provided, the regulatory information will not be shown for the added substances. An update to the regulatory information will need to be requested.
Often, a downstream or end customer will not know where a specific material or component is produced. If a product contains regulatory relevant substances, these clients are likely to request regulatory information in IMDS Chemistry Manager. If your company receives a request for regulatory information even though its product is not produced or, to your knowledge imported, into the EU, material supplier will need to use the IMDS Chemistry Manager function and answer No to the EEA produced and EU imported question. If your company manufactures a product outside the EU and is not aware it gets imported into the EU, regulatory information will still need to be provided. The importer would need to complete the component regulatory information in the regulation wizard and report that the item is imported. This will inform the material manufacturer that the component is imported into the EU and that material regulatory information is needed.
There are many scenarios that would require a component manufacturer to provide product information in the regulation wizard. Two examples are as follows:
A material or component may be manufactured in or imported into the EU by a component manufacturer, making the component manufacturer responsible for certain reporting pertaining to the item.
If there is no exemption at the material level, or if the exemption is due to expire, then downstream customers need to determine if a REACH authorization to use the substance for a specific purpose at the component level exists or is in progress. (REACH authorizations are similar to acceptable ELV applications for substances, yet must be obtained by each company seeking to use the substance for the specific authorization.)
For Biocides, there are two similar questions: "Added for biocidal property?" and "Biocidal property desired in finished article/product?" The difference between these can be confusing.
- Added for biocidal property?" seeks to determine whether a substance was added specifically as a biocide, or whether another use was intended. A common example is zinc oxide, which may be added as a biocide, as an UV protectant, as a vulcanization agent, for other purposes, or for a combination of these purposes.
"Biocidal property desired in finished article/product?" seeks to determine whether the biocidal substance continues to operate as a biocide after production is complete. Leather a good example to illustrate this point. Biocides are added to leather hides during manufacturing to prevent bacterial growth (from the animal residue left on them).In this case you would answer “Yes” to Added for biocidal property? When the hides are tanned, cured and processed into seating surfaces, this biocidal function in the final property is no longer required, and so the leather in the seats does not fall under the treated article definition.In this case you would answer “No” to Biocidal property desired in finished article/product?
When is a Material eligible for Biocidal Product Regulation (BPR)
and which Product Types (PT) can be used?
The following file shows which Product Types can be selected for a BPR substance depending on the classification of the Material containing the substance:
Since IMDS Release 12 (11.05.2019) Product Types not referenced in this file can no longer be selected.
If a classification does not allow any Product Types to be selected according to this file, the classification is considered not eligible for BPR. All materials created after IMDS Release 12 that use one off these classifications will not receive BPR regulatory information, even in case they contained a BPR substance.
As is always true in IMDS, a company referencing a regulated substance in a standard material or semi-component must provide the regulatory information for that item. Companies with references to REACH in standard materials inside owned MDSs will need to provide the regulatory information. Currently, we believe it will not be necessary to enter regulatory information for biocides in Standard MDSs, yet this may change later.
The importance of regulation wizard information will vary depending on the product, its market, the substances involved, the amount the customer imports, etc. In some cases the OEM may not be able to import or sell their vehicle without some of the information in IMDS Chemistry Manager, so in those cases, it will be very important. If information is missing, it will enable the OEM to concentrate on this supply chain to establish the status of the supplied components.
The responsibility for material regulatory compliance reporting varies from company to company. This is similar to ELV and existing REACH reporting for the substances in the product. Until specific individuals are assigned the responsibility and IMDS Chemistry Manager access, Company Administrators are notified of IMDS Chemistry Manager requests. Once the Company Administrators identify the correct people to manage the IMDS Chemistry Manager information and grant those users access to IMDS Chemistry Manager, these individuals will receive the email notifications of IMDS Chemistry Manager requests and have access and responsibility to complete the responses in the Regulation Wizard.
The Biocidal Product Directive has a milestone of March 2017 for biocidal product reporting. Other due dates may be assigned by customers to meet specific program requirements and production milestones.
Companies at every level of the supply chain will use the information in IMDS Chemistry Manager to meet their regulatory reporting requirements. In some cases, REACH and BPR information is required for import or sale of products into the EEA. IMDS Chemistry Manager information is not accepted and rejected as are MDS entries, yet companies are likely to escalate issues if accurate information is not provided via IMDS Chemistry Manager when it impacts their ability to comply with the relevant regulations.
There are no changes to the IMDS Recommendations associated with the implementation of IMDS Chemistry Manager.
Chapter 7 of the IMDS Release 13 User Manual is devoted to details about the IMDS Chemistry Manager.
High Level training for Chemistry Manager is available in the "What's new in IMDS Release 11", these FAQs, and other resources in the IMDS Information Pages. Many of our training partners are offering formal training on IMDS Chemistry Manager separate from their standard IMDS offerings. Consult the IMDS Advanced Solutions Registration Training pages.
IMDS Chemistry Manager will continue to be optimized as we learn more about how it is actually used and we seek to find the best balance between responsiveness and functionality. Minor changes to appearance and functionality should be expected, especially in the first several months of operation.
The Regulation Wizard is limited to 500 MDSs, including referenced children MDSs and modules which are regulatory relevant. This means that if your top-level MDS references sub-level MDSs and substances, one MDS will count as multiple MDSs towards the 500 limit. The Regulatory Information tab of the Regulation Wizard will display the first 50 rows that meet your search criteria. Use the Next and Previous buttons to display the next and previous group of 50 rows if available.
Yes, all IMDS Chemistry Manager functionality is accessible and supported via the IMDS Advanced Interface. Most of the established IMDS-AI solution providers are in the process of adding IMDS Chemistry Manager support to their solutions.
Changes are in process for the IMDS-a2 to support the new IMDS Chemistry Manager functionality. The expected release of the IMDS-a2 with IMDS Chemistry Manager is targeted for May 2017.
FAQ(よくあるご質問集) - その他
ELV and Annex
Where can I find the European ELV Directive and the latest version of Annex II?
Here you can download the EU ELV Directive 2000/53/EC (including the latest version of the Annex II, Version: 2023).
Here you can additionally find an IMDS Steering Committee document on the application changes for your support (Version: June 2016).