{"id":41655,"date":"2022-03-31T14:13:10","date_gmt":"2022-03-31T08:43:10","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=41655"},"modified":"2022-09-10T14:40:58","modified_gmt":"2022-09-10T09:10:58","slug":"cosmetic-rules-2020","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cosmetic-rules-2020\/","title":{"rendered":"An Overview of Cosmetic Rules 2020"},"content":{"rendered":"\n<p class=\"has-drop-cap\">The Ministry of Health &amp; Family Welfare, India, notified the Cosmetic Rules 2020 in continuation to the powers conferred upon it under the pertinent provisions of the Drugs &amp; Cosmetics Act, 1940, to separate organise rules for effective compliance. It&#8217;s also important that all the licenses granted before the notification under the <strong>Drugs &amp; Cosmetics Act, 1940<\/strong> (old rules) will continue to be valid until the expiration date or time period of no later than 18 months from the notification date of these Rules.<\/p>\n\n\n\n<p>The Cosmetic Rules, 2020 introduced the concept of a new cosmetic for the 1<sup>st<\/sup> time, which has been specified to mean a cosmetic that contains a unique ingredient that has not been exploited anywhere in the world or is not recognised for use in cosmetics in any domestic or international literature. These new Cosmetic Rules highlight the process of Import Registration of Cosmetics. Along with the rules of the <a href=\"https:\/\/corpbiz.io\/learning\/an-interplay-between-cdsco-guidelines-and-public-health-safety\/\"><strong>CDSCO<\/strong><\/a>, the apex regulatory authority has issued FAQs and guidance documents for the issuance of a Registration Certificate or license for import or manufacture of cosmetics in the nation. These new rules mandate manufacturers or importers of new cosmetics to make an application &amp; get approval from the <strong><em>CLA or Central Licensing Authority<\/em><\/strong> before such new cosmetics could be manufactured or imported in India. <\/p>\n\n\n\n<p>The application for the registration of a cosmetic product or item intended to be imported into India shall be made either by its authorised agent or by the manufacturer itself or importer in India\/by a subsidiary in India certified by the manufacturer via the official portal of the Central Government in a prescribed <strong><em>Form COS-1. <\/em><\/strong>Once fulfilled, the Central Licensing Authority can issue an Import Registration Certificate in the prescribed form, i.e., <strong><em>Form COS-2<\/em><\/strong>or may reject any application for reasons to be documented in writing within 6 months of the application date and remain valid in endlessness, subject to payment of the retention fee for the Certificate of Registration before the completion of the 5 years from the issuance date, unless, it&#8217;s cancelled by the pertinent authority of the Indian Government. Scroll down to check the new <strong>Cosmetic Rules 2020<\/strong><sup><a href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/en\/Notifications\/Gazette-Notifications\/\"><strong>[1]<\/strong><\/a><\/sup>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">New Cosmetic\nRules 2020<\/h2>\n\n\n\n<ul><li><strong>Cosmetics\nQuality<\/strong>: The Cosmetic Rules 2020 don\u2019t allow the\nmanufacturer and\/or import of cosmetics that don\u2019t satisfy the vital guidelines\nconcerning the standard of quality &amp; safety. Specified raw materials (<strong><em>as\nmentioned under Annex A of the Indian Standard IS 4707 Part 2<\/em><\/strong>) have\nalso been prohibited.<\/li><li><strong>Registration\n&amp; Import of Cosmetics<\/strong>:&nbsp; The process of import and registration of\ncosmetics remain mostly unchanged, though certain noteworthy changes have been\nbrought forth concerning forms or applications for the same. The Rules pave the\nway for importers who want to make a single license application &amp; seek a\nsingle Registration Certificate to import one\/more cosmetics produced by the\nsame manufacturer into a single production facility, which also involves\nvarious factories working jointly. The Cosmetic Rules 2020 call upon for\nprohibition of cosmetics import in the following instances:<\/li><li>The sale, manufacture, or\ndistribution of the cosmetic in question is prohibited in the country of\norigin;<\/li><li>The cosmetic which includes\n\u201chexachlorophene\u201d (deemed to have harmful effects on humans);<\/li><li>The <strong><em>Use by Date or Use Before<\/em><\/strong>\nis less than the 6 months from the date of import;<\/li><li>The cosmetic which has been\nexamined on animals after Nov 12, 2014.<\/li><li><strong><em>Voluntary Recall Mechanism<\/em><\/strong>:\nThe Rules lay an extra obligation on the manufacturer\/his authorised agent\nconcerned to withdraw cosmetics from the market if the manufacturer\/their\nauthorised agent considers or has reason to consider that such cosmetics are\nlikely to affect the customer&#8217;s health or have any negative impact &amp; may\ntherefore be unsafe. In such an event, the concerned manufacturer\/certified\nagent must immediately withdraw such cosmetics from the market by obeying the\nprocedure and state reasons for such withdrawal and inform the SLA (State\nLicensing Authority)\/the Central Licensing Authority as the situation may be.<\/li><li><strong><em>Manufacture of Cosmetics for\nDistribution or Sale<\/em><\/strong>: The process of getting a\nlicense for sale, manufacturing &amp; distribution is highly identical to that\ncited under the Act. Moreover, the Cosmetic Rules 2020 mandate the applicant to\nfacilitate a self-declaration affirming compliance with good manufacturing\npractices &amp; other sets of guidelines. It also visualises the necessity of\nobtaining separate licenses for each premise in situations that involve\nmanufacturing at more than a single premise. Moreover, parallel to import the\nRegistration Certificate, license for manufacture\/loan must essentially remain\nvalid in perpetuity &amp; the same shall be subject to payment of retention fee\nbefore a time of 5 years from the issuance date of the license.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Conclusion<\/h2>\n\n\n\n<p>The notified Rules have united and enhanced the regulatory requirements surrounding the cosmetic industry. The clarifications to regulatory necessities and standards regarding import manufacture &amp; distribution of cosmetics in India introduced a secure degree of regulatory certainty which was absent under the Drugs &amp; Cosmetics Act, 1940. The Cosmetic Rules set up an accountability fortress engaging the liability of importers &amp; manufacturers regarding their cosmetic products&#8217; quality. It also imposes an obligation on the inspectors to examine the premises licensed to manufacturers of cosmetics at least once every 3 years to make sure they comply with the provisions of the Act &amp; Rules.<\/p>\n\n\n\n<p><strong>Read our Article<\/strong>:<a href=\"https:\/\/corpbiz.io\/learning\/penalties-under-drugs-and-cosmetics-act-1940\/\">\nPenalties Under Drugs and Cosmetics Act 1940 \u2013 An Overview\n<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Ministry of Health &amp; Family Welfare, India, notified the Cosmetic Rules 2020 in continuation to the powers conferred upon it under the pertinent provisions of the Drugs &amp; Cosmetics Act, 1940, to separate organise rules for effective compliance. It&#8217;s also important that all the licenses granted before the notification under the Drugs &amp; Cosmetics [&hellip;]<\/p>\n","protected":false},"author":35,"featured_media":41575,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2219],"acf":{"service_id":"508"},"authorName":"Karan Singh","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/01\/processed-1-150x150.jpeg","authorDescription":"A legal writing enthusiast, a wanderer, and a zealous reader. After gaining a lot of knowledge about the diverse legal topics and developing research skills, Karan joined the league of legal content writers to deliver quality-rich blogs.","postViews":6572,"readingTime":3,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/41655"}],"collection":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/users\/35"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=41655"}],"version-history":[{"count":19,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/41655\/revisions"}],"predecessor-version":[{"id":48598,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/41655\/revisions\/48598"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/41575"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=41655"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=41655"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=41655"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}