Definition and Scope of Cosmetics
- Cosmetics are defined as articles under Section 10(h) of RA 3720, amended by Article 4(u) of RA 7394.
- Only applicants with valid BFAD permits to manufacture, import, sell, or distribute cosmetics may apply for listing.
Pre-Market Approval and Listing Requirement
- Cosmetics without pre-market approval must be officially listed with BFAD before distribution or sale.
Application Requirements for Local and Foreign Cosmetics
- Local cosmetics listing application must include:
- Application letter from manufacturer/importer/distributor.
- Complete product formulation.
- Technical specifications.
- Label specimen showing ingredients.
- One commercial product presentation.
- Brand name clearance.
- Certificate of agreement between manufacturer and distributor.
- Foreign cosmetics require the above plus:
- Certificate of Registration or Free Sale from the country of origin.
- Certificate of agreement with the foreign firm.
Evaluation of Listing Application
- BFAD evaluates applications for:
- Completeness of documents.
- Absence of prohibited substances.
- Compliance with standards and labeling per M.C. 19-A, s. 1992.
Effect of Compliance and Issuance of Certificate
- Cosmetic complying with requirements is deemed listed.
- BFAD issues Certificate of Product Listing (CPL) within 30 working days.
- CPL is valid for one year and allows market sale.
- Listed products receive a Cosmetic Listing Number to appear on labels within three months.
Changes in Formulation and Pre-clearance
- Any formulation or packaging changes require BFAD pre-clearance with:
- Manufacturer’s letter detailing changes.
- Updated formulation or label design.
- Commercial sample bearing the change.
Renewal of Listing
- Renewal requires:
- Application letter.
- Copy of current CPL.
- Label specimen.
- Commercial sample.
Cosmetic Specialty Listing
- Initial list of cosmetics allowed without pre-market approval is annexed as Annex "A".
- Inclusion or modification of products done by BFAD per scientific data and industry recommendation.
Applicant Obligations and Sanctions
- Applicants must fully and truthfully disclose all pertinent information.
- Failure or misrepresentation grounds for cancellation of CPL and sanctions.
- Misbranded or adulterated cosmetics found upon monitoring subject to recall and CPL cancellation.
Separability Clause
- Invalid provisions do not affect the remainder of the administrative order’s enforcement.
Repealing Clause
- Previous conflicting orders or regulations are repealed or modified.
Effectivity
- The regulations take effect 15 days after publication in a newspaper of general circulation.
Annex "A" - Cosmetic Specialties Eligible for Listing Without Pre-Market Approval
- Includes various cosmetic products such as aftershave lotions, baby lotions, shampoos, colognes, face powders, lipsticks, nail polishes, perfumes, shaving creams, and hair grooming aids, among others.