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Saatja: Carolina Campana <[email protected]> Saaja: Natali Promet Teema: Re: Estonian company: Free sales certificate information (Arcana 23) Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Natali, hope you are doing well. Attached you will find the CPNP notification for our Eyelash Boosting Serum. Which are the next steps to request the FSC? Thank you for your time and assistance Looking forward to hearing from you Kind regards Carolina Il giorno mer 3 mag 2023 alle ore 17:24 Carolina Campana <[email protected] <mailto:[email protected]> > ha scritto: Dear Natali, thank you for all the information provided. Indeed, we are not yet registered in the CPNP. We just opened the company in February 2023 so we are doing all the necessary documents to sell correctly. We are going to operate as Responsible Person for this serum for eyelash growth. Once the product is registered in the cosmetics portal, I shall come back to you to know how to request the FSC? It has been requested by a new customer in Mexico. Thank you for your time and assistance Looking forward to hearing from you Kind regards Carolina Il giorno mar 2 mag 2023 alle ore 09:27 Natali Promet <[email protected] <mailto:[email protected]> > ha scritto: Dear Carolina To have FSC You have to notify the product in the CPNP (Cosmetic product notification portal) You can find all the needed information in English at the European Commission vebpage https://single-market-economy.ec.europa.eu/sectors/cosmetics_en And as a producer you have to comply with all the requirements for responsible person, which is given in art 5 p.1 of the cosmetic regulation https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009R1223-20221217 <https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009R1223-20221217> : „Responsible persons shall ensure compliance with Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1),(2) and (5), as well as Articles 20, 21, 23 and 24.“ After that You have to send me an official application to get the document. By now You are not in CPNP: Also You have to be very careful with the composition and clains of your product – it may not be a cosmetic. In the borderline manual https://ec.europa.eu/docsroom/documents/42850 as it is a case-by-case basis approach for this kind of product. 3.3.5. Products that make eyelashes grow 96.Question: Are products that influence the growth of eyelashes cosmetic products? 97.Answer: The question of whether such products significantly restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action has to be assessed on a case-by-case basis. 98.In assessing the proper classification of these eyelash products, one has to consider all characteristics of the product, including, for example, the presentation of the product, any promotional literature, the composition, the product's specific pharmacological, immunological or metabolic properties47, the mode of application under normal and reasonably foreseeable conditions of use, the frequency of application, the application site, the degree of penetration, and the risk which its use may entail48 . 99.The fact that a substance is used in medicinal products49 as an active ingredient is not decisive. However, this may be an indicator for a pharmacological, immunological or metabolic action of the product. 100.On the other hand, other substances with an influence on eyelash growth may exist (or be designed), which are not used as active drug ingredients, but the product containing them could still restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action (e.g. some specially designed peptides). 101.The presentation of the product may give useful indications to the competent authorities, without, however, replacing a careful assessment of the mode of action and all the elements indicated above. For example, the claim to the effect of "eyelash growth" would indicate an intention to modify a physiological function. The absence of such claims, however, does not necessarily mean that the product does not influence eyelash growth. Kind regards Natali Promet Chief specialist Chemicals Safety Department +372 794 3533 Health Board +372 794 3500 [email protected] <mailto:[email protected]> www.terviseamet.ee <http://www.terviseamet.ee/> Paldiski mnt 81, 10614 Tallinn This e-mail is confidential and meant for use by the person named in the letterhead. Any use in any way or copying of it by a person not marked as the addressee thereof is prohibited. If you have got this e-mail by mistake, please notify of it the sender without delay and delete the received e-mail together with all its attachments. Saatja: Carolina Campana <[email protected] <mailto:[email protected]> > Saatmisaeg: neljapäev, 20. aprill 2023 13:51 Adressaat: TA Info <[email protected] <mailto:[email protected]> > Teema: Estonian company: Free sales certificate information (Arcana 23) Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Estonian Health Board team; I am Carolina, and I'm contacting you on behalf of Arcana 23, a newborn cosmetic Estonian company. I want to request information about getting the ¨Free sales certificate¨ for our cosmetic (an eyelash growth serum). How is the procedure? Many thanks for your help. If you need any more information, feel free to let me know. Kind regards -- Carolina Campana CEO M: +39 348 242 9030 E: [email protected] <mailto:[email protected]> www.arcana23.com <https://arcana23.com/> Book a call with me: click here! <https://meetings-eu1.hubspot.com/meetings/carol1> -- Carolina Campana CEO M: +39 348 242 9030 E: [email protected] <mailto:[email protected]> www.arcana23.com <https://arcana23.com/> Book a call with me: click here! <https://meetings-eu1.hubspot.com/meetings/carol1> -- Carolina Campana CEO M: +39 348 242 9030 E: [email protected] <mailto:[email protected]> www.arcana23.com <https://arcana23.com/> Book a call with me: click here! <https://meetings-eu1.hubspot.com/meetings/carol1> <https://t.sidekickopen02-eu1.com/Cto/5G+23284/d37Fq604/R5R8b46LwN866HYN2fJpLW3DMjxs3GLCrnW3z8mPJ1W-tzfW1Gc_4k3BKm5BW20WxrK1_khDsW25cxsy1N4hm3n20Z1s64W1>