In December 2023, HSA’s Complementary Health Products Branch publishes guidance on “Procedures for Reporting of Adverse Effects, Product Defects and Product Recalls for Cosmetic Products”. The document provides guidance on company’s obligations to report safety related information to the HSA under the Health Products Act 2007 and the Health Products (Cosmetic Products–ASEAN Cosmetic Directive) Regulations 2007.
REPORTING OF ADVERSE EFFECTS AND PRODUCT DEFECTS FOR COSMETIC PRODUCTS
Under the Health Products (Cosmetic Products – ASEAN Cosmetic Directive) Regulations, the person responsible for placing a cosmetic product in the market must report serious adverse effects and product defects to HSA within the stipulated timelines stated in the guideline.
REPORTING OF PRODUCT RECALLS FOR COSMETIC PRODUCTS
Under the Health Products Act, a manufacturer, importer or supplier must inform HSA of the product recall of a cosmetic product. The company should notify HSA of the recall, and the reasons for the recall, no later than 24 hours (excluding Sundays and public holidays) before the start of the intended product recall. This allows HSA to review and comment on the company’s recall strategy and offer guidance in the recall process.
Companies are reminded to report serious adverse effects or product defects and product recalls relating to cosmetic products to HSA in a timely manner. A person who fails to comply with the reporting requirements is liable to a fine of up to $20,000 and/or imprisonment up to 12 months.
For more details on the reporting procedure and timelines, please view HSA’s guidance at the following link: https://www.hsa.gov.sg/docs/default-source/hprg-cosmetics/guidance_ae-defect-reporting-and-product-recall_cp_1dec2023f3789679278c40f3806db3d167333724.pdf