https://ceway.eu/component---src-pages-cosmetics-regulatory-servic…-person-index-en-js-ae204b6c6c8bd3799c4a.js

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(EU Regulation 1223/2009, Article 4.1)"))))),l.createElement("div",{className:"section-two"},l.createElement(o.W2,{mobileColumn:!0,alignItems:"center"},l.createElement("div",{className:"content"},l.createElement(s.Ir,{className:"title text-start"},"Who can be an EU Responsible Person?"),l.createElement(s.Sl,{className:"text"},"Any EU-based legal or natural person, including:"),l.createElement(s.Sl,{className:"list-item"},"Manufacturer (if EU-based)"),l.createElement(s.Sl,{className:"list-item"},"Importer"),l.createElement(s.Sl,{className:"list-item"},"Distributor"),l.createElement(s.Sl,{className:"list-item"},"A third party/company accepting the role in writing"),l.createElement(s.Sl,{className:"text margin-bottom"},"There must be ",l.createElement("b",null,"one RP per product for the entire EU market"),"."),l.createElement(o.bK,{className:"text"},l.createElement(s.Sl,null,"In order to establish clear responsibilities, each cosmetic product should be linked to a responsible person established within the Community. (EU Regulation 1223/2009, Article 11)")),l.createElement(o.bK,{className:"text margin-bottom"},l.createElement(s.Sl,null,"For the purpose of effective market surveillance, a product information file should be made readily accessible, at one single address within the Community, to the competent authority of the Member State where the file is located. (EU Regulation 1223/2009, Article 17)")),l.createElement(s.q9,{className:"text",weight:700},"Key requirements"),l.createElement(s.Sl,{className:"list-item"},"RP must be ",l.createElement("b",null,"established in the EU")),l.createElement(s.Sl,{className:"list-item"},"Must be ",l.createElement("b",null,"formally designated in writing")," and accept the role"),l.createElement(s.Sl,{className:"list-item"},"RP can be the manufacturer (if established in the EU), a distributor, an importer, or a professional (designated) Responsible person"),l.createElement(s.Sl,{className:"list-item"},"Each product must be clearly linked to one RP")),l.createElement("div",{className:"image"},l.createElement("img",{src:n.Z,alt:"Cosmetics regulatory services",className:"img-main"}),l.createElement("img",{src:i.Z,alt:"Cosmetics regulatory services",className:"img-rec"})))),l.createElement("div",{className:"section-three"},l.createElement(o.W2,{maxWidth:"53%",mobileMaxWidth:"100%",column:!0,mobileColumn:!0},l.createElement(s.Ir,{className:"title text-start"},"Core obligations"),l.createElement(s.Sl,{className:"text"},"The RP ensures compliance with multiple regulatory articles (notably Article 5), including safety, labelling, and notification."),l.createElement(o.bK,{className:"text"},l.createElement(s.Sl,null,"For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations set out in this Regulation. (EU Regulation 1223/2009, Article 4.2)")),l.createElement(o.bK,{className:"text"},l.createElement(s.Sl,null,"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. (EU Regulation 1223/2009, Article 5.1.)")),l.createElement(s.Sl,{className:"text"},"They must ensure:"),l.createElement(s.Sl,{className:"list-item"},"A ",l.createElement("b",null,"Product Information File (PIF)")," is available at a single EU address"),l.createElement(s.Sl,{className:"list-item"},"PIF is accessible to authorities ",l.createElement("b",null,"for 10 years after the last batch")),l.createElement(s.Sl,{className:"list-item"},"Compliance with Safety (Article 3), Good Manufacturing Practice (Article 8), Safety assessment (Article 10), Notification via CPNP (Article 13), Labelling, claims, nanomaterials, CMR substances, etc."))),l.createElement("div",{className:"section-four"},l.createElement(o.W2,{mobileColumn:!0,justifyContent:"space-between"},l.createElement(d.o,{maxWidth:"49%",mobileMaxWidth:"100%",className:"m-bottom"},l.createElement("thead",null,l.createElement("tr",null,l.createElement("th",

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1null,"Article"),l.createElement("th",null,"Referring to"))),l.createElement("tbody",null,l.createElement("tr",null,l.createElement("td",null,"16"),l.createElement("td",null,"Nanomaterials")),l.createElement("tr",null,l.createElement("td",null,"17"),l.createElement("td",null,"Traces of prohibited substances")),l.createElement("tr",null,l.createElement("td",null,"18"),l.createElement("td",null,"Animal testing")),l.createElement("tr",null,l.createElement("td",null,"19"),l.createElement("td",null,"Labelling")),l.createElement("tr",null,l.createElement("td",null,"20"),l.createElement("td",null,"Product claims")),l.createElement("tr",null,l.createElement("td",null,"21"),l.createElement("td",null,"Access to information for the public")),l.createElement("tr",null,l.createElement("td",null,"22"),l.createElement("td",null,"Communication of serious undesirable effects")),l.createElement("tr",null,l.createElement("td",null,"23"),l.createElement("td",null,"Information on substances")))))),l.createElement("div",{className:"section-five"},l.createElement(o.W2,{column:!0,mobileColumn:!0},l.createElement(s.Ir,{className:"title text-start !mb-4"},"Responsibilities in practice"),l.createElement(s.q9,{className:"text !mb-8"},"The RP must:"),l.createElement(o.W2,{mobileColumn:!0,justifyContent:"space-between"},l.createElement("div",{className:"list"},l.createElement(s.Sl,{className:"list-item"},"Ensure ",l.createElement("b",null,"product safety and regulatory compliance")," before and during market placement"),l.createElement(s.Sl,{className:"list-item"},"Maintain and update the"," ",l.createElement(u.q,{to:"/cosmetics-regulatory-services/cosmetics-product-information-file"},"Product Information File (PIF)")),l.createElement(s.Sl,{className:"list-item"},"Ensure"," ",l.createElement(u.j,{href:"https://news.ceway.eu/eu-cosmetics-gmp-requirements-iso-22716"},"GMP compliance")," ","and safety assessment"),l.createElement(s.Sl,{className:"list-item"},"Substantiate 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