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  • EU responsbile person

    Posted by healthorganic on March 21, 2018 at 8:37 am

    Hi all! 

    I have a question about regulations. As owner of my own brand, I understand that I can be the ‘responsible person’ under EU regulations as long as  the products have the following before distribution; 

    • safety evaluation and safety report
    • Product information file (PIF)
    • appropriate labelling
    • production is made according to the guidance of ISO 22716, appropriate to the good manufacturing practise (GMP).

    Is my understanding correct?

    Thanking you in advance!

    healthorganic replied 5 years, 2 months ago 3 Members · 4 Replies
  • 4 Replies
  • paulasbrito

    March 21, 2018 at 8:24 pm

    I am also in the EU and for what I understand the responsible person has to have a degree in chemistry or related, to sign the papers and so on. If you dont have a degree maybe you know someone who has it and ask him/her to sign the papers.

  • Bill_Toge

    Professional Chemist / Formulator
    March 22, 2018 at 12:23 am

    if your name, or your company’s name, is on the pack, that makes you the Responsible Person by default - as the Responsible Person, you are legally obliged to have this information to hand in case someone comes to harm from using your product, and the Competent Authorities (Trading Standards Agency in the UK, and equivalent agencies in other countries) need to investigate

    @paulasbrito the only person who has to have any particular qualification is the safety assessor; they need to have a background in toxicology, and preferably have professional accreditation as well as an academic qualification

  • healthorganic

    March 22, 2018 at 11:03 am

    @paulasbrito thanks for your comment. Greatly appreciate it :smiley:

  • healthorganic

    March 22, 2018 at 11:09 am

    @Bill_Toge Thank you for your comment. That’s really helpful because I am getting all the necessary tests done by experts and was wondering why the responsible person should be other than my company name. Many thanks for your input!