Proposed Amendments to Cosmetics Rules 2020: Strengthening Regulations

On 15th May 2023 the Ministry of Health and Family Welfare has published a draft Rules proposing certain amendments to the Cosmetics Rules of 2020. These amendments are intended to further strengthen the regulatory framework surrounding cosmetics products. The draft rules, formulated under the powers conferred by the Drugs and Cosmetics Act of 1940, have been released for public consultation and are open for objections, suggestions, and feedback. The Ministry of Health and Family Welfare invites all stakeholders likely to be affected by these proposed changes to participate in the consultation process.

This blog post explores the key amendments brought about by the Cosmetics Rules 2020 and their implications for the cosmetics industry.

  1. Enhancing Labeling Clarity: An explanation was inserted in Rule 3 Clause (w) to address the usage of “use before” and “date of expiry” terms on cosmetic labels. The explanation stated that “use before” indicates the product should be used before the first day of the stated month, while “date of expiry” signifies that the cosmetic will expire on the last day of the mentioned month. This clarification will help consumers understand the timeframe in which a cosmetic product remains safe and effective for use.
  2. Streamlining Regulatory Authorities: To ensure effective implementation and oversight, the Cosmetics Rules 2020 introduced changes to the terminology used. Rule 6 replaced the term “Controlling officer” with “Controlling Authority” throughout the regulations. This modification aligns the language used in the rules with the updated terminology, enhancing clarity and consistency in regulatory communication.
  3. Strengthening Testing and Analysis: The amended Cosmetics Rules emphasized the importance of accurate testing and analysis of cosmetic products. Rule 11 introduced the concept of the Central Cosmetics Laboratory, designating the Central Drugs laboratory as the central hub for analyzing and testing cosmetic samples. This laboratory, acting under the provisions of Section 20 of the Act, assumes responsibility for assessing product safety and compliance.
  4. Furthermore, the Central Government is proposed to be empowered to designate other laboratories under its control as Central Cosmetics Laboratories. However, these designated laboratories must meet specific criteria, such as being certified as GLP (Good Laboratory Practice) compliant or duly accredited by the National Accreditation Body for Testing and Calibration Laboratories. This change will ensure that testing facilities maintain high standards and expertise in evaluating cosmetics, bolstering consumer confidence in product safety.
  5. Strengthening Record-Keeping Obligations: Under Rule 26, several amendments are proposed to enhance record-keeping practices by cosmetic manufacturers. Licensees will be required to keep detailed records of each batch of cosmetics manufactured, including information on the raw materials used. These records must be maintained in accordance with the particulars specified in the Eighth Schedule of the rules.
  6. Furthermore, the proposed rules stipulate that these records should be retained for a minimum of three years or six months after the expiry of the batch, whichever is later. This provision ensures that manufacturers have accurate and accessible information about their products, facilitating traceability and enabling prompt action in the event of any safety concerns.
  7. In Rule 31, Clause (2), the term “officer” is being substituted with the word “Authority.” This amendment aims to streamline the inspection process and empower inspectors appointed by the Central Government to carry out special inspections of identified manufacturing facilities. These inspections are conducted to ensure strict adherence to the provisions of the Act and rules governing the cosmetics industry.
  8. By replacing “officer” with “Authority,” the language used in the rules aligns with the hierarchical structure of regulatory bodies, reinforcing the authority and decision-making powers of those responsible for overseeing compliance. This change strengthens the role of the Central Licensing Authority in overseeing inspections and promoting adherence to regulatory standards.
  9. On Cancellation and Suspension of Licenses: To maintain strict compliance with the Cosmetics Rules, a new rule, 31A, has been proposed. This rule empowers the State Licensing Authority to cancel or suspend licenses in cases where licensees fail to comply with the conditions of the license or provisions of the Act and rules made thereunder.
  10. The Cosmetics Rules 2020 also address labeling requirements for cosmetics meant for export. In Rule 34, Sub-Rule 10, specific provisions have been proposed to meet the labeling requirements of the country to which the cosmetics are exported. The revised rule states that if a cosmetic is intended for export, the labels on packages or containers must meet the specific requirements of the destination country’s laws. These particulars ensure that crucial information, such as the name and address of the manufacturer. In cases where the consignee requests that the name and address of the manufacturer not be displayed, the packages or containers must bear an approved code number assigned by the State Licensing Authority. This provision allows for flexibility in export labeling while still maintaining essential information and traceability.
  11. Rule 53 of the Cosmetics Rules 2020 introduces provisions for the confiscation of cosmetics, implements, machinery, and other materials involved in the manufacturing of spurious cosmetics. This provision operates under Section 17D of the Drugs and Cosmetics Act.

Conclusion: The Cosmetics Rules 2020 have brought about significant changes to enhance safety measures, labeling standards, and regulatory compliance in the cosmetics industry. The amendments address labeling clarity, streamline regulatory authorities, strengthen testing and analysis procedures, and enforce rigorous record-keeping obligations. By embracing these changes, the cosmetics industry can reinforce consumer trust, prioritize safety, and maintain the integrity of cosmetic products.