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  • 1.  PHT DINP labelling MDR REACH

    Posted 19-Apr-2021 03:12
    Dear all,

    I just changed company and I encountered an issue with documents at my new company where I am way out of my depth. So I hope you clever people can help me :-)

    We have some accessoiries for an urometric device. These are filled with liquid (NaCl) which can be delivered into the bladder (as far as I understand it). They are sterile and class IIa (rule 2, first bullet point).

    The GSPR state the accessoiries are free of phtalates. Labelling shows a symbol "contains PHT DINP", IFU says "DHEP-free fluid path". Supplier says  "The component is DINP, the tubing is non-phathalate but not free." They provided some documentation which states both substances (and other funny acronyms ending on "P") are below 1000ppm.

    I am neither chemist nor toxicologist. I do not have a clue regarding REACH. I just look at the documents with my RA/QM eye and find it off. My company does not have this knowledge either. The devices were OEM under MDD and now the company changes to true legal manufacturer.

    Any thoughts are very much apprechiated.

    Thank you!


    ------------------------------
    Britta Cyron
    Quality Manager

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  • 2.  RE: PHT DINP labelling MDR REACH

    Posted 22-Apr-2021 06:38
    Isn't there anybody out there who can help me?

    ------------------------------
    Britta Cyron
    Quality Manager
    phenox GmbH
    Dorsten
    Germany
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    Original Message


  • 3.  RE: PHT DINP labelling MDR REACH

    Posted 22-Apr-2021 08:17

     

     

    Hi Britta,

     

    Sounds like you have some conflicting, or at least inconsistent, product information.

     

    As you probably gathered by now, DINP is indeed a phthalate (i.e., diisononyl phthalate).  So the "DHEP-free" language may be technically correct, but it doesn't sound as if it would be correct to claim the accessory is phthalate free.

     

    The statement "the tubing is non-phathalate but not free" has unclear meaning to me.  The term "non-phathalate" suggests the absence of phthalates which would be inconsistent with the balance of the phrase.  Perhaps this term is a poor translation into English of something like "low phthalate levels"?

     

    The 1000 ppm level is the same as 0.1%, so this claim may be meant to address the EU-MDR requirement for endocrine disrupting substances (such as phthalates) to be less than that level.  Frankly, I'm a bit skeptical because plastics that need plasticizers usually have them at levels considerably higher than 0.1%.  If you could get more information from the supplier on the specific material composition, it would be prudent.

     

    Finally, be careful with the spelling.  I noticed DHEP and phathalate as spelled incorrectly.  Happy to help decipher the other phthalate abbreviations if you want to provide them.

     

    Hope that is some help!

     

    Best regards,

     

    Ted

     

    --

    Theodore (Ted) Heise, PHD, RAC

    Vice President Regulatory and Clinical Services

     

    MED Institute Inc.

    1330 Win Hentschel Blvd.

    West Lafayette, IN  47906-4149 USA

    765.463.1633 ext. 4444

    http://medinstitute.com

    theise@medinstitute.com

     

     

     

     

     




    Original Message


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