Philippine Cosmetics Notification

Definition of Cosmetics in the Philippines

Cosmetics in the Philippines are defined by the Food and Drug Administration (FDA) as any substance or preparation intended to be applied to external parts of the human body—such as the skin, hair, nails, lips, external genitalia, teeth, or oral mucosa—for the purposes of cleaning, perfuming, altering appearance, controlling body odor, protecting, or maintaining good condition. This includes products such as skincare creams, shampoos, perfumes, lipsticks, makeup, mouthwash, toothpaste, oral sprays, and feminine washes.

Regulatory Background

The Philippine FDA, operating under the Department of Health, regulates cosmetics to ensure their safety, purity, and quality. As an ASEAN member, the Philippines adopted the ASEAN Harmonized Cosmetic Regulatory Scheme (ACRS) and the ASEAN Common Technical Dossier (ACTD) in April 2005, with full implementation beginning January 1, 2008. Since then, the country has operated under a cosmetic product notification system.

All cosmetics companies must obtain a License to Operate (LTO) before engaging in production, importation, distribution, or sale. The LTO is also required for submitting product notifications through the FDA E-Portal using a CCRR user account. Companies must ensure their products comply with the ASEAN Cosmetic Directive (ACD) and related annexes.

Market Entry Process

Required Documentation for Notification

Basic Product Information

• Brand and product name

• Variants, packaging sizes, and container types

• Net content

• Formula table (INCI names, functions, concentrations)

Notifying Entity Information (must match LTO details)

• Company name and address

• LTO number

• Entity type: distributor, manufacturer, or trader

• Manufacturer’s name and address

• Company representative contact details

Supporting Documents (as applicable)

• Product label samples

• Usage instructions

• Mechanism of action

• Certificate of origin for ingredients

• Material Safety Data Sheet (MSDS)

• Certificate of Analysis (COA)

Notification Timeline

• Product notification processing: 3–4 months

• Notification validity: 1, 2, or 3 years (depending on QPIRA qualification)

Product Information File (PIF)

The PIF consists of four main sections:

1. Administrative documents

2. Quality and safety data of cosmetic ingredients

3. Product quality and safety information

4. Safety and efficacy reports (e.g., assessments, test results)

Other supporting documents as needed