PIF Phase Two Implementation in Taiwan: Detailed Information on Infant, Lip, Eye, and Non-Medicated Toothpaste and Mouthwash Cosmetics

· Regulations

The second phase of the Product Information File (PIF) implementation in Taiwan has imposed stricter regulations on the safety and quality of cosmetics specifically designed for infants, lips, eyes, and oral hygiene. Here's a detailed breakdown of the regulations and their implications for these product categories:

Scope of Applicable Products

  • Infant Cosmetics: Including baby wipes, baby oil, baby lotion, and baby bath products, which come into direct contact with the delicate skin of infants.
  • Lip Cosmetics: Including lipsticks, lip glosses, and lip balms, which come into direct contact with the lip mucosa.
  • Eye Cosmetics: Including eyeshadow, eyeliner, mascara, and eye cream, which come into direct contact with the sensitive skin around the eyes.
  • Non-Medicated Toothpaste and Mouthwash: Including general toothpaste and mouthwash used for oral hygiene.

Key Points of PIF Phase Two

  • Increased Transparency of Ingredient Information: Manufacturers must provide more detailed ingredient information, including ingredient names, content, and functions.
  • Stricter Safety Assessments: Safety assessments for products intended for infants, lips, and eyes will be subject to more stringent standards.
  • Enhanced Traceability of Manufacturing Processes: Manufacturers must establish comprehensive production records to ensure product quality and safety.
  • Higher Qualifications for Safety Signatories: Safety signatories must possess more specialized knowledge and experience to assess product safety.

Impact on Consumers

  • Safer Products: The implementation of PIF Phase Two will help ensure the safety of infant, lip, eye, and oral hygiene products on the market, reducing consumer risks.
  • Greater Transparency of Product Information: Consumers can learn about product ingredients and safety through PIF, enabling them to make more informed purchasing decisions.

Impact on the Industry

  • Increased Costs: Manufacturers will need to invest more resources in product testing, document preparation, and other tasks, leading to increased costs.
  • Increased Demand for Talent: Manufacturers will need to hire safety signatories with relevant expertise, increasing the demand for talent.
  • Adjustment of Product Formulas: To comply with PIF requirements, some manufacturers may need to adjust their product formulas.

Notes

  • Transition Period: Although PIF Phase Two has been officially implemented since July 1, 2025, manufacturers may need some time to complete PIFs for all their products.
  • Inspections: Health authorities will intensify inspections of products on the market to ensure that manufacturers comply with PIF regulations.
  • Penalties: Manufacturers who fail to comply with PIF regulations will face fines and other administrative penalties.
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