{"id":12267,"date":"2022-10-29T06:09:37","date_gmt":"2022-10-29T06:09:37","guid":{"rendered":"https:\/\/swaritadvisors.com\/blog\/?p=12267"},"modified":"2022-10-29T06:20:11","modified_gmt":"2022-10-29T06:20:11","slug":"what-are-exemptions-of-cosmetics-under-cosmetics-rules-2020","status":"publish","type":"post","link":"https:\/\/swaritadvisors.com\/blog\/what-are-exemptions-of-cosmetics-under-cosmetics-rules-2020\/","title":{"rendered":"What are the Exemptions of Cosmetics under Cosmetics Rules, 2020?"},"content":{"rendered":"\n<p>As\nper the Drugs &amp; Cosmetics Act, 1940 and Cosmetics Rules, 2020, enacted\nthereunder, the State Drug Control Department inspects &amp; grants Cosmetic\nLicense approval for manufacturers &amp; importers in India. Furthermore, the\nimport of cosmetics is governed or controlled by a Registration system\nadministered by the CDSCO, which is responsible for regulating cosmetics\nactivities &amp; propagating corresponding regulations. Cosmetics, as may be\nspecified in <strong><em>the 12<sup>th<\/sup><\/em><\/strong> <strong><em>Schedule<\/em><\/strong>, shall be exempted from <strong><em>the\nprovisions of Chapter III &amp; Chapter IV of the Act &amp; Rules<\/em><\/strong> made\nthereunder to the extent &amp; subject to the conditions specified in that\nSchedule. Exemptions of Cosmetics products are not manufactured for consumption\nor sale in India. In this write-up, we will discuss exemptions of Cosmetics\nunder Cosmetics Rules, 2020.<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_65 counter-hierarchy ez-toc-counter ez-toc-light-blue ez-toc-container-direction\">\n<p class=\"ez-toc-title\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a3aa0722fbd4\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a3aa0722fbd4\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/swaritadvisors.com\/blog\/what-are-exemptions-of-cosmetics-under-cosmetics-rules-2020\/#Primary_Functions_of_CDSCO_for_Cosmetic_Regulation\" title=\"Primary\nFunctions of CDSCO for Cosmetic Regulation\">Primary\nFunctions of CDSCO for Cosmetic Regulation<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/swaritadvisors.com\/blog\/what-are-exemptions-of-cosmetics-under-cosmetics-rules-2020\/#Exemptions_of_Cosmetics_as_per_the_12th_Schedule_of_Cosmetics_Rules\" title=\"Exemptions of\nCosmetics as per the 12th Schedule of Cosmetics Rules\">Exemptions of\nCosmetics as per the 12th Schedule of Cosmetics Rules<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/swaritadvisors.com\/blog\/what-are-exemptions-of-cosmetics-under-cosmetics-rules-2020\/#Conclusion\" title=\"Conclusion\">Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Primary_Functions_of_CDSCO_for_Cosmetic_Regulation\"><\/span>Primary\nFunctions of CDSCO for Cosmetic Regulation<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following\nare some primary functions of Cosmetic Regulation include:<\/p>\n\n\n\n<ol><li>Amending the <strong>Drugs and Cosmetics Rules, 1945<\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Drugs_and_Cosmetics_Rules,_1945\" class=\"text-primary\"><strong>[1]<\/strong><\/a><\/sup> &amp; and Cosmetics Rules 2020 and concerning Import Registration for Cosmetic Products;<\/li><li>Responding to Government correspondences &amp; BIS requests as required;<\/li><li>Examining &amp; reading applications for Cosmetic Registration as per Rules circulated by the Drugs &amp; Cosmetics Act 1940 and, Rules 1945 &amp; New Cosmetics Rules 2020. Thereunder;<\/li><li>Helping the public with hearings or inquiries regarding Import Registration of Cosmetics &amp; providing guidance thereon;<\/li><li><a href=\"https:\/\/swaritadvisors.com\/cdsco-cosmetic-import-registration\" class=\"text-primary\"><strong>Cosmetic Import Registration<\/strong><\/a> received from the applicant is pre-screened;<\/li><li>The pre-screening checklist &amp; standard operating procedures for evaluating cosmetic import &amp; registration applications have been changed to show the current working procedures;<\/li><li>Deal with complaints from NGOs, business associations, the general public, and consumer forums regarding Cosmetic Standards;<\/li><li>Evaluating &amp; reviewing various applications for NOCs or Clarifications related to the import of cosmetics.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Exemptions_of_Cosmetics_as_per_the_12th_Schedule_of_Cosmetics_Rules\"><\/span>Exemptions of\nCosmetics as per the 12<sup>th<\/sup> Schedule of Cosmetics Rules<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following are exemptions of cosmetics as per the 12<sup>th<\/sup> Schedule of Cosmetics Rules:<\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Class\n  of Cosmetics<\/strong>\n  <\/td><td>\n  <strong>Extent\n  &amp; Conditions of Exemptions of Cosmetics<\/strong>\n  <\/td><\/tr><tr><td>\n  Cosmetics\n  <\/td><td>\n  The provisions of Chapter IV\n  of the Act &amp; Rules made thereunder should be covered by a License for\n  sale, provided that the Cosmetics sold, if of Indian origin, are manufactured\n  by certified manufacturers.\n  <\/td><\/tr><tr><td>\n  Cosmetics imported in a Kit\n  form are to be marketed in India as such, wherein all products of the kit are\n  already registered for import into India under Cosmetic Rules, 2020.\n  <\/td><td>\n  The provision of Chapter III\n  of the Act &amp; Rules required them to be covered by the Registration\n  Certificate.\n  <\/td><\/tr><tr><td>\n  <strong><em>Following are the categories\n  of cosmetics:<\/em><\/strong>\n  Cosmetic for R&amp;D purposes\n  such as customer studies, transport studies, packaging trials &amp; shelf\n  life studies.Cosmetics imported for use in\n  hotels exclusively for their captive consumption &amp; after providing a\n  notarized undertaking to this effect.Cosmetics for sale to foreign\n  passengers in duty-free shops in international airports.Cosmetics in bulk for\n  repackaging for 100% export to other nations.Cosmetics in amenity kits for\n  the exclusive use of overseas passengers on a complimentary basis if not used\n  for domestic sales.\n  \n  \n  \n  \n  <\/td><td>\n  The provision of Chapter III\n  required them to be covered by a Registration Certificate subject to a\n  condition, i.e., the Cosmetics shall not be used for domestic sale.\n  <\/td><\/tr><tr><td>\n  Hairs Fixers, namely\n  mucilaginous preparations, contain gums used by men to fix their beards.\n  <\/td><td>\n  The provisions of Chapter IV\n  of the Act &amp; Rules thereunder.\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<ul><li>It is prohibited to import or manufacture cosmetics containing colours, dyes &amp; pigments that do not meet the specifications of BIS. Colours &amp; pigments used in cosmetic products or items shall be those listed by the BIS &amp; Schedule Q. Cosmetics products may contain no more than the following synthetic &amp; natural organic colours:<\/li><\/ul>\n\n\n\n<ol><li>20 parts per million concentration of lead are calculated as the lead;<\/li><li>100 parts\/million concentration of heavy metals other than the lead is calculated as the total of the respective metals;<\/li><li>2 parts\/million concentration of arsenic calculated as arsenic trioxide.<\/li><\/ol>\n\n\n\n<ul><li>Cosmetics imported into India\/manufactured domestically shall be predominately mercury-based. The percentage of mercury proportion should be:<\/li><\/ul>\n\n\n\n<ol><li>As far as finished cosmetics are concerned, unintentional mercury levels must not exceed one part\/million (1 ppm);<\/li><li>The mercury level, calculated as the metal, shouldn&#8217;t exceed 70 parts\/million in cosmetics products intended for use only in the eye area.<\/li><\/ol>\n\n\n\n<ul><li>Importation of cosmetics products that have been tested or examined on animals is prohibited;<\/li><li>Cosmetics, including hexachlorophene are prohibited from being manufactured\/imported;<\/li><li>Cosmetics containing arsenic or lead for the purpose of colouring cosmetics are prohibited or banned from manufacturing or being imported.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The provisions of Chapter IV of the Act &amp; Rules made thereunder should be covered by a License for sale, provided that the Cosmetics sold, if of Indian origin, are manufactured by certified manufacturers. Exemptions of Cosmetics products are not manufactured for consumption or sale in India.<\/p>\n\n\n\n<p class=\"text-left\"><b>Read our Article<\/b>:<mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/swaritadvisors.com\/blog\/grant-of-test-license-for-import-under-mdr-2017\/\">An Overview of Grant of Test License for Import under MDR, 2017\n<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>As per the Drugs &amp; Cosmetics Act, 1940 and Cosmetics Rules, 2020, enacted thereunder, the State Drug Control Department inspects &amp; grants Cosmetic License approval for manufacturers &amp; importers in India. Furthermore, the import of cosmetics is governed or controlled by a Registration system administered by the CDSCO, which is responsible for regulating cosmetics activities [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":12294,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1016],"tags":[1068],"acf":[],"_links":{"self":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/12267"}],"collection":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/comments?post=12267"}],"version-history":[{"count":30,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/12267\/revisions"}],"predecessor-version":[{"id":12298,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/12267\/revisions\/12298"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media\/12294"}],"wp:attachment":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media?parent=12267"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/categories?post=12267"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/tags?post=12267"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}