Criteria for Whitening Agents and Concentrations
- Whitening agents must be effective at the minimum concentration and safe up to the maximum concentration identified.
- Concentration levels are based on clinical trials and product information from various sources.
- The list includes both natural extracts and chemical compounds.
List of Accepted Whitening Agents and Recommended Concentrations
- GIGAWHITE: 0.2% to 5%
- DERMWHITE: 0.5% to 2%
- PAPAYA EXTRACT: 1% to 5%
- PAPAIN EXTRACT: 0.2% to 0.5%
- MULBERRY EXTRACT (powder): 0.10% to 1%, (liquid): 1% to 5%
- LACTIC ACID (Exfoliant): 1% to 10%
- MELAWHITE: 2% to 4%
- VITAMIN C variants:
- Rovisome C: 1% to 5%
- Glycosphere Vitamin C: 0.2% to 5%
- Vitaceton: 1% to 5%
- MAGNESIUM ASCORBYL PHOSPHATE (MAP): 0.01% to 18.5%
- SODIUM LACTATE: 10% to 12%
- BEARBERRY EXTRACT (MELFADE): 3% to 10%
- LICORICE EXTRACT: 0.0003% to 1%
- KOJIC ACID: 2.0%
- UNINONTAN U-34 (Sodium Citrate Lemon Extract and Cucumber Extract): 5.0%
Safety and Regulatory Compliance
- Products must be formulated within the specified concentration range to guarantee safety and efficacy.
- The BFAD retains authority to revise, update, or delist any whitening agents based on new safety evidence or introduction of more effective substances.
- Manufacturers and distributors are required to comply with the standards established by the circular.
Authority and Enforcement
- Enacted and signed by the BFAD Director, Prof. Leticia Barbara B. Gutierrez, MS, on April 3, 2004.
- The circular serves as a regulative instrument for BFAD in evaluating cosmetic products containing whitening agents.
Important Legal Concepts
- Ensuring consumer safety through regulated concentration limits.
- Continuous monitoring and possible revision of accepted whitening agents.
- Balance between product effectiveness and minimal adverse reactions.
- BFAD’s mandate to safeguard public health in cosmetic use.