{"id":4769,"date":"2019-10-21T13:44:08","date_gmt":"2019-10-21T05:44:08","guid":{"rendered":"http:\/\/kaseybeauty.com\/?p=4769"},"modified":"2019-11-11T11:46:11","modified_gmt":"2019-11-11T04:46:11","slug":"what-are-the-documents-required-before-placing-the-product-on-the-eu-market","status":"publish","type":"post","link":"https:\/\/www.kaseybeauty.com\/es\/what-are-the-documents-required-before-placing-the-product-on-the-eu-market\/","title":{"rendered":"\u00bfCu\u00e1les son los documentos necesarios antes de colocar el producto en el mercado de la UE?"},"content":{"rendered":"

One of the major requirements specified in EC No. 1223\/2009 is that the company should be responsible in keeping a product information file (PIF) for each product placed on the EU market at a single address within the EU that is indicated on the label. As a whole, the PIF is a compilation of the following information:<\/p>\n

\u2022 Description of the product which enables the PIF to be clearly attributed to the cosmetic product such as the exact product name consistent with the product name used when notifying the product or an internal reference that uniquely identifies the product and formulation
\nMethod of manufacture and a certificate or a statement on compliance with good manufacturing practice (GMP) standard ISO 22716
\n\u2022 Claims substantiation, if applicable
\n\u2022 Labeling and photograph of the corresponding packaging
\n\u2022 The cosmetic product safety report (CPSR)
\nThe CPSR is the most important part of the PIF and is composed of two parts: cosmetic product safety information and cosmetic product safety assessment. The main documents to be included in the cosmetic product safety information are:
\n\u2022 Qualitative and quantitative composition of the product with INCI ingredient names, CAS and EINECS\/ELINCS numbers, ingredient functions and concentrations of each raw material
\n\u2022 Physical, chemical and microbiological specifications of the raw materials and their toxicological profiles
\n\u2022 Physical, chemical and microbiological specifications of the finished product and test reports (e.g., stability test, challenge test, etc.)
\n\u2022 Packaging specifications
\n\u2022 Exposure to the product and the substances
\n\u2022 Intended use of the product
\nAny data on undesirable effects from using the cosmetic product<\/p>\n

This product dossier shall be readily accessible and available in a Language easily understood by the competent regulatory authority of the Member State where the responsible person for this product is based. It shall be kept for a period of ten (10) years following the date on which the last batch of the cosmetic product was placed on the market.<\/p>\n

\"What<\/p>\n

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    \n
  1. Tenemos m\u00e1s de 10 a\u00f1os de experiencia en cosm\u00e9ticos personalizados, por lo que es f\u00e1cil para nosotros ayudar a que su visi\u00f3n se convierta en realidad.<\/li>\n
  2. Nos comprometemos a proporcionar productos, servicios y soporte de la m\u00e1s alta calidad para nuestros clientes que cumplan con las expectativas de los mismos.<\/li>\n
  3. La Calidad Es Nuestra Cultura, trabaje con nosotros su dinero a salvo y su negocio a salvo<\/li>\n<\/ol>\n<\/div>\n\n
    \n

    <\/p>