{"id":49053,"date":"2021-11-04T00:00:00","date_gmt":"2021-11-03T23:00:00","guid":{"rendered":"https:\/\/biorius.com\/cosmetic-news\/fip-que-es-un-fichero-de-informacion-de-producto\/"},"modified":"2024-05-08T11:31:07","modified_gmt":"2024-05-08T09:31:07","slug":"fip-que-es-un-fichero-de-informacion-de-producto","status":"publish","type":"post","link":"https:\/\/biorius.com\/es\/cosmetic-news\/fip-que-es-un-fichero-de-informacion-de-producto\/","title":{"rendered":"FIP: \u00bfQu\u00e9 es un Fichero de Informaci\u00f3n de Producto?"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\">FIP Cosm\u00e9tico (Fichero de Informaci\u00f3n del Producto) Definici\u00f3n<\/h2>\n\n<div class=\"wp-block-coblocks-row coblocks-row-104121527483\" data-columns=\"2\" data-layout=\"33-66\"><div class=\"wp-block-coblocks-row__inner has-background has-padding has-medium-padding has-margin has-huge-margin is-stacked-on-mobile has-medium-gutter\" style=\"background-color:#e8edef\">\n<div class=\"wp-block-coblocks-column coblocks-column-104121529228\" style=\"width:33%\"><div class=\"wp-block-coblocks-column__inner has-no-padding has-no-margin\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><img decoding=\"async\" src=\"https:\/\/biorius.com\/wp-content\/uploads\/2023\/10\/icone-dossier.png\" alt=\"\" class=\"wp-image-15921\" style=\"width:176px;height:173px\"\/><\/figure>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-coblocks-column has-text-align-left is-vertically-aligned-center coblocks-column-104121529232\" style=\"width:66%\"><div class=\"wp-block-coblocks-column__inner has-no-padding has-no-margin\">\n<p class=\"has-text-align-left\"><strong>Un FIP (Expediente de Informaci\u00f3n sobre el Producto<\/strong>) es <strong>un expediente amplio y muy estructurado que contiene toda la informaci\u00f3n relacionada con un producto cosm\u00e9tico determinado<\/strong>.<\/p>\n<\/div><\/div>\n<\/div><\/div>\n\n<h2 class=\"wp-block-heading has-text-align-left\">  \u00bfC\u00f3mo crear un Fichero de Informaci\u00f3n de Producto?<\/h2>\n\n<p><\/p>\n\n<h3 class=\"wp-block-heading has-text-align-left\"> <span class=\"has-inline-color has-primary-color\">\u00bfD\u00f3nde encuentro los datos adecuados?<\/span><\/h3>\n\n<div class=\"wp-block-coblocks-row coblocks-row-104131144845\" data-columns=\"2\" data-layout=\"66-33\"><div class=\"wp-block-coblocks-row__inner has-no-padding has-no-margin is-stacked-on-mobile are-vertically-aligned-center has-medium-gutter\">\n<div class=\"wp-block-coblocks-column is-vertically-aligned-center coblocks-column-104131147239\" style=\"width:66%\"><div class=\"wp-block-coblocks-column__inner has-no-padding has-no-margin\">\n<p><strong>Algunos de los datos proceden de:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Fabricantes de productos<\/li>\n<\/ul>\n\n\n\n<p><strong>Otros datos proceden de :<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Un laboratorio independiente,<\/li>\n\n\n\n<li>Un evaluador de seguridad debidamente cualificado con titulaci\u00f3n reconocida por el art\u00edculo \u00a72.<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-coblocks-column is-vertically-aligned-center coblocks-column-104131147241\" style=\"width:33%\"><div class=\"wp-block-coblocks-column__inner has-no-padding has-no-margin\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><img decoding=\"async\" src=\"https:\/\/biorius.com\/wp-content\/uploads\/2023\/10\/icone-conformite.png\" alt=\"\" class=\"wp-image-15915\" style=\"width:209px;height:204px\"\/><\/figure>\n<\/div><\/div><\/div>\n<\/div><\/div>\n\n<div style=\"height:54px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"wp-block-heading\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-primary-color\">\u00bfQu\u00e9 documentos e informaci\u00f3n deben formar parte del PIF cosm\u00e9tico?<\/mark><\/h3>\n\n<div class=\"wp-block-getwid-table has-table-layout-auto\"><table><tbody><tr><td>1. Una descripci\u00f3n del producto cosm\u00e9tico que permita atribuir claramente el expediente de informaci\u00f3n sobre el producto al producto cosm\u00e9tico<\/td><\/tr><tr><td>2. El CPSR parte A y B<\/td><\/tr><tr><td>3. Los anexos del CPSR<\/td><\/tr><tr><td>4. F\u00f3rmula en materias primas<\/td><\/tr><tr><td>5. Ficha t\u00e9cnica y\/o certificado de an\u00e1lisis del producto acabado<\/td><\/tr><tr><td>6. Documentaci\u00f3n sobre cada materia prima (FDS, CofA, IFRA e informe sobre al\u00e9rgenos, si procede)<\/td><\/tr><tr><td>7. Estudio de estabilidad<\/td><\/tr><tr><td>8. Informaci\u00f3n microbiol\u00f3gica (pruebas de provocaci\u00f3n &#8211; an\u00e1lisis microbiol\u00f3gico)<\/td><\/tr><tr><td>9. Informaci\u00f3n sobre el material de envasado (descripci\u00f3n del material, declaraci\u00f3n de impurezas, declaraci\u00f3n de contacto con alimentos,)<\/td><\/tr><tr><td>10. Evaluaci\u00f3n toxicol\u00f3gica con el uso normal y razonablemente previsible, datos de exposici\u00f3n, c\u00e1lculo de MoS, perfil toxicol\u00f3gico de cada sustancia.<\/td><\/tr><tr><td>11. Declaraci\u00f3n de efectos indeseables<\/td><\/tr><tr><td>12. Otras pruebas, si las hubiera<\/td><\/tr><tr><td>13. El diploma del evaluador de seguridad<\/td><\/tr><tr><td>14. Descripci\u00f3n del m\u00e9todo de fabricaci\u00f3n<\/td><\/tr><tr><td>15. Una declaraci\u00f3n sobre el cumplimiento de las buenas pr\u00e1cticas de fabricaci\u00f3n<\/td><\/tr><tr><td>16. Cuando est\u00e9 justificado por la naturaleza o el efecto del producto cosm\u00e9tico, la prueba del efecto reivindicado para el producto cosm\u00e9tico<\/td><\/tr><tr><td>17. Datos sobre cualquier ensayo con animales en el producto acabado y en cada materia prima<\/td><\/tr><tr><td>18. Las etiquetas<\/td><\/tr><tr><td>19. Los PIF deben estar en ingl\u00e9s (en caso de que Biorius tome el RP para el Reino Unido, se acepta el franc\u00e9s si es para la UE)<\/td><\/tr><\/tbody><\/table><\/div>\n\n<h3 class=\"wp-block-heading has-text-align-left\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-primary-color\">\u00bfNecesitas ayuda para crear tu Fichero de Informaci\u00f3n sobre Productos Cosm\u00e9ticos (FIP)?<\/mark><\/h3>\n\n<p>Biorius, Tu Experto en Reglamentaci\u00f3n puede ayudarte de muchas maneras en relaci\u00f3n con tu Fichero de Informaci\u00f3n del Producto (FIP) :<\/p>\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/biorius.com\/cosmetic-regulations\/europe\/#product-information-file-pif-and-cpnp-notification\" target=\"_blank\" rel=\"noreferrer noopener\">BIORIUS puede hacer el PIF por ti y convertirse en tu Persona Responsable<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/biorius.com\/es\/reglamento-cosmeticos-2\/cambio-de-responsable-de-cosmeticos\/\" target=\"_blank\" rel=\"noreferrer noopener\">BIORIUS puede auditar tus PIF cosm\u00e9ticos actuales para ver si est\u00e1n alineados con la legislaci\u00f3n vigente<\/a><\/li>\n\n\n\n<li>BIORIUS proporciona muchos consejos o servicios que pueden ayudarte a obtener informaci\u00f3n obligatoria <a href=\"https:\/\/biorius.com\/es\/reglamento-cosmeticos-2\/pruebas-de-laboratorio-para-productos-cosmeticos\/\" target=\"_blank\" rel=\"noreferrer noopener\">como pruebas toxicol\u00f3gicas<\/a><\/li>\n\n\n\n<li>BIORIUS adapta su oferta a tus necesidades espec\u00edficas para ayudarte en este proceso<\/li>\n<\/ul>\n<script type=\"text\/javascript\">\n\/* <![CDATA[ *\/\nvar 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gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible gfield--text gfield--large\"  data-field-class=\"gfield--text gfield--large\" ><label class='gfield_label gform-field-label' for='input_1_17'>Nombre<span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_text'><input name='input_17' id='input_1_17' type='text' value='' class='large'     aria-required=\"true\" aria-invalid=\"false\"   \/><\/div><\/div><div id=\"field_1_18\" class=\"gfield gfield--type-text gfield--input-type-text gfield--width-half gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible gfield--text gfield--large\"  data-field-class=\"gfield--text gfield--large\" ><label class='gfield_label gform-field-label' for='input_1_18'>Apellidos<span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_text'><input name='input_18' id='input_1_18' type='text' value='' class='large'     aria-required=\"true\" aria-invalid=\"false\"   \/><\/div><\/div><div id=\"field_1_6\" class=\"gfield gfield--type-email gfield--input-type-email gfield--width-half gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible gfield--email gfield--large\"  data-field-class=\"gfield--email gfield--large\" ><label class='gfield_label gform-field-label' for='input_1_6'>Env\u00eda un correo electr\u00f3nico a<span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_email'>\n                            <input name='input_6' id='input_1_6' type='email' value='' class='large'    aria-required=\"true\" aria-invalid=\"false\"  \/>\n                        <\/div><\/div><div id=\"field_1_7\" class=\"gfield gfield--type-phone gfield--input-type-phone gfield--width-half field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible gfield--phone gfield--large\"  data-field-class=\"gfield--phone gfield--large\" ><label class='gfield_label gform-field-label' for='input_1_7'>N\u00famero de tel\u00e9fono<\/label><div class='ginput_container ginput_container_phone'><input name='input_7' id='input_1_7' type='tel' value='' class='large'    aria-invalid=\"false\"   \/><\/div><\/div><div id=\"field_1_8\" class=\"gfield gfield--type-textarea gfield--input-type-textarea gfield--width-full gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible gfield--textarea gfield--small\"  data-field-class=\"gfield--textarea gfield--small\" ><label class='gfield_label gform-field-label' for='input_1_8'>Preguntas o comentarios<span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_textarea'><textarea name='input_8' id='input_1_8' class='textarea small'     aria-required=\"true\" aria-invalid=\"false\"   rows='10' cols='50'><\/textarea><\/div><\/div><fieldset id=\"field_1_13\" class=\"gfield gfield--type-checkbox gfield--type-choice gfield--input-type-checkbox gfield--width-half gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible gfield--checkbox gfield--large\"  data-field-class=\"gfield--checkbox gfield--large\" ><legend class='gfield_label gform-field-label gfield_label_before_complex' >Deseas vender:<span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/legend><div class='ginput_container ginput_container_checkbox'><div class='gfield_checkbox ' id='input_1_13'><div class='gchoice gchoice_1_13_1'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_13.1' type='checkbox'  value='europa'  id='choice_1_13_1'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_1_13_1' id='label_1_13_1' class='gform-field-label gform-field-label--type-inline'>Europa<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_1_13_2'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_13.2' type='checkbox'  value='uk'  id='choice_1_13_2'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_1_13_2' id='label_1_13_2' class='gform-field-label gform-field-label--type-inline'>REINO UNIDO<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_1_13_3'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_13.3' type='checkbox'  value='usa'  id='choice_1_13_3'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_1_13_3' id='label_1_13_3' class='gform-field-label gform-field-label--type-inline'>EE.UU.<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_1_13_4'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_13.4' type='checkbox'  value='a\/nz'  id='choice_1_13_4'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_1_13_4' id='label_1_13_4' class='gform-field-label gform-field-label--type-inline'>Australia<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_1_13_5'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_13.5' type='checkbox'  value='Canad\u00e1'  id='choice_1_13_5'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_1_13_5' id='label_1_13_5' class='gform-field-label gform-field-label--type-inline'>Canad\u00e1<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_1_13_6'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_13.6' type='checkbox'  value='oriente medio'  id='choice_1_13_6'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_1_13_6' id='label_1_13_6' class='gform-field-label 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