ECU/502
WTO/TBT
EC Ecuador
  • 11 - Medizintechnik
  • 13 - Umwelt, Gesundheitsschutz, Sicherheit
  • 71 - Chemische Verfahrenstechnik
2021-06-07
2021-04-15

The notified Sanitary Technical Regulation establishes the internal procedure for the application of the Andean Decisions on obtaining the mandatory sanitary notification (NSO). It also establishes the procedure for recognition and renewal requests and requests to change information and to use an existing NSO code (parallel importer, only applicable to cosmetics); for obtaining authorization for samples with no commercial purpose; for voluntarily obtaining a certificate of good manufacturing practices; for obtaining a certificate of free sale or export certificate; for obtaining an operating permit; and for donating cosmetics, domestic hygiene products and absorbent personal hygiene products in emergency situations. The provisions contained in this Technical Regulation apply to all national or foreign natural or legal persons located in national territory that manufacture, store, package, pack, arrange, assemble, sell, import, export, distribute or market cosmetics, domestic hygiene products and absorbent personal hygiene products.

Proyecto de Reforma a la Resolución ARCSA-DE-006-2017-CFMR Normativa Técnica Sanitaria para productos cosméticos, productos de higiene doméstica, productos absorbentes de higiene personal (Draft Amendment to Resolution ARCSA-DE-006-2017-CFMR: Sanitary Technical Regulation on cosmetics, domestic hygiene products and absorbent personal hygiene products) (34 pages, in Spanish)

The notified Sanitary Technical Regulation establishes the internal procedure for the application of the Andean Decisions on obtaining the mandatory sanitary notification (NSO). It also establishes the procedure for recognition and renewal requests and requests to change information and to use an existing NSO code (parallel importer, only applicable to cosmetics); for obtaining authorization for samples with no commercial purpose; for voluntarily obtaining a certificate of good manufacturing practices; for obtaining a certificate of free sale or export certificate; for obtaining an operating permit; and for donating cosmetics, domestic hygiene products and absorbent personal hygiene products in emergency situations. The provisions contained in this Technical Regulation apply to all national or foreign natural or legal persons located in national territory that manufacture, store, package, pack, arrange, assemble, sell, import, export, distribute or market cosmetics, domestic hygiene products and absorbent personal hygiene products.