Philippines Cosmetic Registration (FDA Philippines – Center for Cosmetics Regulation and Research, CCHRR)

1. Regulatory Authority & Framework

Cosmetics in the Philippines are regulated under:

• Republic Act No. 9711 (FDA Act of 2009)
• AO No. 2016-0003 – Guidelines on Cosmetic Notification
• ASEAN Cosmetic Directive (ACD) — fully implemented
• FDA Philippines – Center for Cosmetics Regulation and Research (CCRR)

The Philippines uses a pre-market notification system, not approval.
Approved products receive a Notification Certificate.

2. Definition of Cosmetic (ACD-Aligned)

Cosmetic = externally applied product for:

• Cleansing
• Beautifying
• Perfuming
• Correcting odours
• Altering appearance
• Protecting or maintaining condition of body/hair/skin

Products with medicinal or therapeutic claims fall under drug/OTC/medical device categories.

3. Registration Type – Cosmetic Notification (CN)

All cosmetic products require a Cosmetic Notification Certificate.

Output:

• Notification Number (e.g., NN-##########)
• Validity: 2 years
• Renewal required before expiry

Notification is submitted via FDA e-portal.

4. Local Responsible Person (LRP) Requirement

Foreign manufacturers cannot file directly.
A Philippine-based company must act as the Responsible Person (RP).

RP responsibilities:

• Submit notification via e-portal
• Maintain Product Information File (PIF)
• Ensure compliance with ACD
• Labeling (English or Filipino)
• Adverse event reporting
• Recalls and corrective actions
• Cooperate with FDA during PMS inspections

5. Cosmetic Notification Dossier (e-Portal System)

Required Documents

1. Cosmetic Notification Form
2. Complete Ingredient List (INCI)
3. Label Artwork including:
   • Product name & function
   • Net content
   • Manufacturer & RP details
   • Batch/lot number
   • Manufacturing date/expiry (if applicable)
   • Warnings/precautions
4. Product Information File (PIF) containing:
   • Part I: Administrative
   • Part II: Quality & specifications
   • Part III: Safety assessment
   • Part IV: GMP documentation
5. GMP Certificate / ISO 22716
6. Authorization Letter / Power of Attorney from the foreign manufacturer
7. Certificate of Free Sale (CFS) from the originating country
   • Must be authenticated/consularized (depending on origin country)

6. Ingredient Control (ASEAN Cosmetic Directive)

The Philippines fully adopts ACD Annexes:

• Annex II – Prohibited ingredients
• Annex III – Restricted ingredients
• Annex IV – Colorants
• Annex VI – UV filters
• Annex VII – Preservatives

Strict prohibitions:

• Hydroquinone, steroids, tretinoin, mercury
• Hair dyes with unapproved amines
• AHA/pH limits enforced
• Sensitive ingredients require warning statements

FDA Philippines actively tests cosmetics for heavy metals & banned ingredients.

7. Labeling Requirements (ACD-Compliant)

Label must include:

• Product name & function
• Full INCI ingredient list
• Batch/lot number
• Net content
• Manufacturing & expiry date (for <30 months)
• Manufacturer name and address
• Country of origin
• Philippines Responsible Person name & address
• Warnings (for restricted ingredients – AHA, SA, hair dyes)
• Directions for use

Languages:

• English or Filipino (both accepted)

Sticker labeling allowed for imported items, but must be accurate.

8. Fees & Timelines

Government Fees

• PHP 500 per product (approx. $10 USD)

Timeline

• Dossier preparation: 1–2 weeks
• FDA review time: 3–10 working days (typically very fast)
• Validity: 2 years
• Renewal: Required before expiry

The Philippines is one of the fastest notification systems in ASEAN.

9. Post-Market Surveillance (PMS)

FDA Philippines conducts:

• Market sampling
• Laboratory testing (heavy metals, microbiology)
• Border control checks
• Advertising monitoring (online & physical stores)
• GMP compliance checks
• Enforcement actions (suspensions, revocations, public advisories)

RP obligations:

• Maintain PIF for at least 3 years after last batch is marketed
• Report adverse events
• Conduct recalls if required
• Monitor online sellers & distributors

10. Borderline Product Rules (Important)

Cannot be classified as cosmetics:

• Acne treatment (“treat acne”, benzoyl peroxide, high-level SA)
• Hair loss / hair growth products
• Whitening creams claiming melasma treatment
• Scar removal or wound healing products
• Antiseptic solutions
• Medicated shampoo (antidandruff with ketoconazole, etc.)
• Products with pharmaceutical actives
• Sunscreens with therapeutic claims

Such products must follow Drug / OTC or Medical Device registration pathways.

11. Consulting Notes for Your Portfolio

12. Advantages of the Philippines Cosmetic Market

• Fastest notification among ASEAN (3–10 days)
• Low fee (PHP 500)
• ACD harmonization → easier multi-country registration (MY/SG/VN/ID/TH)
• English labeling accepted
• High cosmetic consumption, rapid beauty e-commerce growth