QuestionsQuestions (BFAD ADMINISTRATIVE ORDER NO. 29-A)
R.A. 3720 (Food, Drug and Cosmetic Act), as amended by R.A. 7394, provides the State policy to ensure safe and good quality cosmetic supply and authorizes BFAD to regulate production, sale, and distribution to protect public health. Under Section 26(a) of R.A. 3720, BFAD may promulgate regulations such as requiring pre-market approval and, where applicable, listing with BFAD before distribution and sale.
A cosmetic product without pre-market approval shall be distributed and sold only after it has been officially listed with BFAD.
It states that a cosmetic is an article within the meaning of Section 10(h) of R.A. 3720, as amended by Article 4(u) of R.A. 7394.
No cosmetic specialty shall be accepted for listing unless the applicant is a holder of a current permit issued by BFAD to engage in the manufacture, importation, sale, or distribution of that cosmetic specialty.
The application must include: (a) application letter from manufacturer/importer/distributor; (b) complete formulation of the finished product; (c) technical specifications of the finished product; (d) one unattached label or specimen reflecting ingredients and other labeling materials; (e) one commercial presentation; (f) Brand Name Clearance; and (g) Certificate of Agreement between manufacturer and distributor.
In addition to the locally manufactured requirements, the applicant must submit: (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.
BFAD evaluates based on: (a) completeness of documentary requirements; (b) absence of non-permissible substances; and (c) compliance with specific standards and labeling requirements for cosmetic products under M.C. 19-A, s. 1992.
If compliance is shown, the cosmetic shall be deemed listed with BFAD.
BFAD will issue the Certificate of Product Listing (CPL) within thirty (30) working days from the date of filing, and the CPL is valid for one (1) year.
The CPL entitles the product to be freely sold in the market thereafter. Listed cosmetics must be given a Cosmetic Listing Number (CL #) reflected on the packaging label within three (3) months from issuance of the CPL.
Any changes in formulation of a listed cosmetic product must be pre-cleared with BFAD before implementation.
Pre-clearance must include: (a) a letter from the manufacturer stating the changes in formulation, packaging design, label text, etc.; (b) the list of the new formulation or copy of the packaging design or label text; and (c) one commercial presentation of the sample bearing the change.
Renewal requires: (a) application letter from manufacturer/importer/distributor; (b) xerox copy of the current CPL; (c) one unattached label or specimen of the final label; and (d) one commercial presentation of the sample.
Applicants must fully and truthfully disclose all pertinent information and documentation. Failure to fully disclose material information or misrepresentation is a ground for cancellation of BFAD’s CPL and/or imposition of other sanctions under existing law and regulations.
Misbranded or adulterated cosmetics during monitoring are grounds for recall of the product from the market and cancellation of the CPL.
If any provision is declared invalid, the remainder of the Administrative Order continues to be enforced and remains in effect.
It takes effect fifteen (15) days after its publication in a newspaper of general circulation.