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Harmonized EU poison center submission requirements (2019)

Hello All,

wanted to know if SAP is planning any solution in place to deal with the harmonized EU poison center submission requirements starting to come into force in 2019?

maybe:

  1. Somewhere to maintain the Unique Formula Identifier – so that it can be displayed on the labels / SDS
  2. Whether there will be a way integrated within SAP to produce the XML format required for submission under Annex VIII of CLP.

SAP's initial POV was that it is a consulting solution. let me know your thoughts.

Read the Regulation Here

5.2. The submitter shall print or affix the UFI on the label of a hazardous mixture. The UFI shall be preceded by the acronym “UFI” in capital letters and it shall be clearly visible, legible and indelibly marked.

5.3. By derogation from Section 5.2, the UFI may in the case of hazardous mixtures for industrial use and for mixtures which are not packaged alternatively be indicated in the Safety Data Sheet.

Regards,

Gaurish

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6 Answers

  • Best Answer
    Jun 05, 2017 at 08:36 PM

    Dear Gaurish

    1.) I am not aware of any plans of SAP to support "harmonized EU poison center submission requirements".

    2.) Somewhere to maintain the Unique Formula Identifier – so that it can be displayed on the labels / SDS ==> if needed you can easily implement own identifier (or use a new property)

    3.) I am not aware of any plans of SAP to support the XML format required for submission under Annex VIII of CLP.

    In any case: if there will be a support. Then only by using an EnhPack (as in the past). But there is no high chance to get new EnhPack with new EHS functionality now (as SAP is investing in S/4 HANA)

    Only if enough companies come together add add the some requirement then I have the feeling that SAP will prepare sa solution in next 5 years

    Coming back to requirement:

    5.2. The submitter shall print or affix the UFI on the label of a hazardous mixture. The UFI shall be preceded by the acronym “UFI” in capital letters and it shall be clearly visible, legible and indelibly marked.

    ==> e.g. use new identifier to solve the topic

    5.3. By derogation from Section 5.2, the UFI may in the case of hazardous mixtures for industrial use and for mixtures which are not packaged alternatively be indicated in the Safety Data Sheet.

    ==> e.g. use new identifier to solve the topic

    if you are buying SAP content: then I would assume that for some part of the requirement you will get a solution "out ofthe box"

    (e.g. new phrases, new identfiers, new layouts ,new data etc.)

    PS: Please check: https://www.opesus.com/en/next-step-in-european-harmonization-of-product-notification/

    So you will get a solution

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    • Thanks C.B. Yes, We are using SERC content. So my expectation was that SAP would consider these Changes in the future updates. yes, we can always solve them using a new Identifier.

      Do update the group if you get more info. on the topic.

      Regards,

      Gaurish

  • Jun 06, 2017 at 05:07 AM

    Hello Gaurish

    To add to Christoph's response if you go through the document it has following broad requirements

    - Need for classification based on composition ranges

    - Requirement to capture UFI information

    - Ability to export as XML format to easily import to the system

    - Creation of document in a specified content for internal validation

    - Modification / Inclusion of content in MSDS or labels

    As far as the item 1 is concerned you an create a expert rule to read the composition ranges and provide you emergency health response ranges i.e.,, hazardous component categorization based on section 3.2., 3.3. and 3.4.

    Item 2 is property tree extension to hold the registration information which should hold data of multiple sort sequences based on date of expiry information.

    Item 3 generation of xml format of substance data based on the format provided in "Part B" by the agency. Please note agency is yet to publish the xml format and it will be published in due course free of cost.

    Item 4 can be a property tree to hold the required information and a exportable node option, it is based on xml format or if you want to have a report to validate internally you can have different substance export formats created for excel output or any other report format like WWI for your internal validation.

    Item 5 can be managed based on the data maintenance option used in above items.

    Finally the need for holding the information pertaining to group submission or similar information is more of process required data which can also be stored in the system.

    So conclusion is the regulation will come into effect in about 3+ years from now and it would be a moving target now to comment anything concrete system direction, which might change in due course.

    Thanks and Regards

    Jayakumar

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    • Thanks Jayakumar for a detailed response.

      1. I was expecting SAP might consider it as new Expert Rule under SERC which we can use. hopefully!

      3. Yes, but still to fill the XML, we would need so tool right?

      4. Could you explain this point further please? what do you infer by Exportable node?

      Thanks in Advance!

      Regards,

      Gaurish

  • Jun 08, 2017 at 07:35 AM

    Hello Gaurish,

    As Christoph has pointed out opesus is developing software that will enable companies who use SAP EH&S to submit data to the poison centers / appointed bodies via XML in order to comply with Annex VIII of CLP.
    We (opesus) are part of the EU Posion Centern Notfication IT Group and are currently working together with EACH and the industry on the details.

    The functionality will be be part of the opesus EHS Product Notification Tool that today already supports the submission of the same kind of data via XML to the German (BfR) and Swiss(BAG) poison centers / appointed bodies.
    You can find more details about the solution here: opesus EPN.

    Let me know if you need more information!

    Mark

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  • Jun 07, 2017 at 04:56 AM

    Hi Gaurish

    Regarding the item 3 - XML is the format for submission either you can generate the document and upload to the agency site, if you also require to send the XML versions along with your MSDS document to your customers, you will have additional exercise of doing changes similar to Exposure Scenario XML shipment.

    Regarding the item 4 Exportable node means in the property tree you need to define all the value assignments which needs to exported as xml segment for that you need to have a mechanism of identification, usually by means of a separate property tree, when you use the same property tree for both MSDS and XML generation you need to differentiate them based on a indicator in the value assignment level..

    Thanks and Regards

    Jayakumar

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  • Jun 09, 2017 at 10:32 AM

    Thanks C.B, Jayakumar and Mark for your inputs! Clear Now :)

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  • Jun 20 at 10:32 AM

    I am also interested, if SAP will create a solution for this topic!

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