Registrations and Guarantees

Products registered in the EU

500Cosmetics products comply with the required regulations of the main member countries of the European Union and are in the following Spanish and European registries:

  • EFSA (Food Safety and Nutrition Agency). The ingredients of the food supplements sold in 500Cosmetics are included in the database of ingredients analyzed and approved by EFSA, the European Food Safety Authority.
  • Ministry of Political Health and Equality.
  • Compliance with the provisions of article 9 of Royal Decree 1487/2009 of September 26 on food supplements. According to article 1. Purpose and scope of application "regulates those food products consisting of concentrated sources of nutrients and that are presented in order to complement the intake of such nutrients in the normal diet."
  • Spanish Agency for Medicines and Health Products.
  • GMP (Good Manufacturing Practice).
  • Certificate of good manufacturing. They are included within the concept of Quality Assurance, they constitute the factor that ensures that the products are manufactured in a uniform and controlled manner, in accordance with the quality standards appropriate to the use that the products are intended to give and in accordance with the required conditions. for marketing. The regulations governing GMP are primarily intended to reduce the risks inherent in all pharmaceutical production.
  • Prior sanitary license to operate the installation of sanitary products.

Article 5.1 of Royal Decree 414/1996, of March 1, which regulates medical devices, at the proposal of the general subdirectorate of health products and having seen the favorable report from the health area of ​​the Madrid government delegation.

  • Office for Harmonization of the Internal Market (OHIM).
  • Possession of the Registration Certificate for the Gnetics Extender Community Trademark.
  • CE declaration of conformity
  • Registry in which the manufacturer in the European Union declares that the products marketed satisfy the essential requirements of the various application Directives. This allows the free movement of products within the European market. By adding the CE marking to these products, the manufacturer declares under his sole responsibility, the conformity of said product with the legal requirements required to ensure the validity of the product.

The 500Cosmetics management system is based on a Quality management system based on:

  • UNE EN ISO 13485: 2004 Sanitary Products - Quality Management Systems - Requirements for regulatory purposes.
  • UNE EN ISO 9001: 2000 Quality Management Systems. Requirements
  • UNE EN ISO 9004: 2000 Quality Management Systems. Fundamentals and vocabulary
  • MDD 93/42 / CEE Medical Devices Directive
  • Royal Decree 414/1996 Royal Decree on Sanitary Products
  • UNE EN ISO 14971: 2007 Application of risk management to medical devices
  • UNE EN ISO 10993 Biocompatibility Test

Other references that have been used in the conception of the Quality Management System have been:

  • ISO 14969 Guide to ISO 13485
  • ISO 9001 for small business.
  • Geneva 2002
  • AEMPS circulars
  • MEDDEV guides
  • NBMED Recommendations
  • ZLG, EK.MED guides
  • EUCOMED guides

The acceptance and commercialization of the products is made by principle of mutual recognition and by virtue of the provisions of articles 32 and 36 of the treaty on the operation of the European Union and based solely on the administrative file notified by the applicant.

If you have questions about the registries in your country, we will answer your questions by contacting us here. aqui.