Definitions and product characterization
- A cosmetic is an article within the meaning of Section 10(h) of Republic Act No. 3720, as amended by Article 4(u) of Republic Act No. 7394.
- The term cosmetic specialty refers to the cosmetic products that are subject to BFAD listing before they may be sold without pre-market approval.
Core prohibition on distribution and sale
- A cosmetic product without pre-market approval must be officially listed with BFAD before it is distributed and sold.
- No cosmetic specialty may be accepted for listing from an applicant unless the applicant holds a current BFAD permit to engage in the manufacture, importation, sale, or distribution of that cosmetic specialty.
Listing application requirements
- Applications for listing of locally manufactured cosmetic specialties must be accompanied by the following:
- (a) an application letter from the manufacturer, importer, or distributor;
- (b) the complete formulation of the finished product;
- (c) the technical specifications of the finished product;
- (d) one unattached label or specimen of the proposed label reflecting the ingredients used and other labelling materials;
- (e) one commercial presentation of the finished product;
- (f) Brand Name Clearance; and
- (g) a Certificate of Agreement between manufacturer and distributor.
- Applications for listing of foreign-manufactured cosmetic specialties must be accompanied by all requirements in Section D-5.1.4, plus:
- (a) an Approved Certificate of Registration or Free Sale Certificate from the country of origin, or its duly authenticated copy; and
- (b) a Certificate of Agreement with the foreign firm.
- Applicants for listing must fully and truthfully disclose all pertinent information and documentation regarding the product.
BFAD evaluation standards and listing effect
- BFAD evaluates applications for listing of cosmetic specialties in terms of:
- (a) completeness of documentary requirements;
- (b) absence of non-permissible substances; and
- (c) compliance with the specific standards and labelling requirements for cosmetic products under M.C. 19-A, s. 1992.
- When the submitted application shows compliance with all requirements, the cosmetic is deemed listed with BFAD.
Certificate of Product Listing timeline and labeling
- BFAD issues a Certificate of Product Listing (CPL) within thirty (30) working days from the date of filing.
- The CPL is valid for one (1) year.
- Once listed, the product is entitled to be freely sold in the market thereafter.
- Listed cosmetics must be assigned a Cosmetic Listing Number (CL #), which must appear on the packaging label, within three (3) months from the issuance of the CPL.
Changes to listed cosmetics and pre-clearance
- Any changes in the formulation of a listed cosmetic product must be pre-cleared with BFAD.
- Pre-clearance must be accompanied by:
- (a) a letter from the manufacturer stating the changes in formulation, packaging design, and label text;
- (b) a list of the new formulation of the product or a copy of the packaging design or label text; and
- (c) one commercial presentation of the sample bearing the change.
Renewal of listing requirements
- Renewal of listing of special cosmetics requires:
- (a) an application letter from the manufacturer, importer, or distributor;
- (b) a xerox copy of the current CPL;
- (c) one unattached label or specimen of the final label; and
- (d) one commercial presentation of the sample.
Initial list and changes to it
- The regulation includes an Annex “A” titled Cosmetic Specialty Qualified for Listing (Without Pre Market Approval), with categories that include items such as After Shave Lotions, Baby Lotions, Oils, Powders and Creams, Baby Shampoos, Bath Oils, Tablets and Salts, Beard Softeners, Blushers, Bubble Baths, Colognes and Toilet Waters, Dusting and Talcum Powders, Face Powders, Foundations, Fragrance Products (Perfume), Hair Conditioners, Lipsticks, Makeup Bases, Men’s Talcum, Moisturizing Creams and Lotions, Nail Creams and Lotions, Nail Extenders, Nail Polish and Enamel Removers, Nail Polish and Enamels, Perfumes, Preshave Lotions, Rinses, Non-coloring, Rouges, Shampoos, Non-coloring, Shaving Creams, Skin Fresheners, and Tonic, Dressings and Other Hair Grooming Aids.
- Inclusion of other products and modification of the initial list may be done by BFAD through an appropriate Memorandum Circular, upon recommendation by the BFAD Cosmetic Industry Group based on the latest pertinent scientific data.
Consequences of false disclosure and misbranding/adulteration
- Failure to fully disclose material information about the product or misrepresentation of product information is a ground for cancellation of BFAD Certificate of Product Listing and/or the imposition of other sanctions under existing law and regulations.
- Cosmetic products found to be misbranded or adulterated during monitoring are a ground for:
- recall of the product from the market; and
- cancellation of the Certificate of Product Listing.
Separability, repealing, and effectivity
- If any provision of the administrative order is declared invalid, the remainder continues in effect under the separability clause.
- All administrative orders, rules, regulations, and other administrative issuances, or parts thereof, inconsistent with these regulations are repealed or modified under the repealing clause.
- The regulation takes effect fifteen (15) days after its publication in a newspaper of general circulation.
- The administrative order was adopted on 18 May 1994 and signed by Juan M. Flavier, M.D., M.P.H., Secretary of Health.