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(NAR) VOL. III NO. 3 / JULY - SEPTEMBER 1992
[ BFAD MEMORANDUM CIRCULAR NO. 16, July 17, 1992 ]
DECLARATION OF AMNESTY FOR UNREGISTERED COSMETICS IN THE MARKET
Whereas, Administrative Order No. 150 s. 1971 requires that cosmetic specialties may be distributed or sold only after they are duly registered with the Bureau of Food and Drugs (BFAD);
Whereas, Administrative Order No. 72 s. 1983 authorizes the BFAD to seize and confiscate unregistered cosmetics, among others;
Whereas, a significant number of unregistered cosmetic products is in the market;
Whereas, cosmetic establishments, (manufacturers and importers) request for a grace period to allow these unregistered cosmetics to be sold and stay in the market;
Whereas, Section 29-A of R.A. 3720 as amended, provides that an administrative fine in the amount of not less one thousand pesos (P1,000.00) nor more than five thousand pesos (P5,000.00) may be imposed for any violation of the said Act or its implementing rules and regulations;
Whereas, the distribution and sale of unregistered cosmetics is a violation of A.O. 150 s. 1971 issued pursuant to R.A. 3720 as amended;
Whereas, in the consultation meeting with the cosmetic establishments on June 25, 1992, the said establishments manifested their willingness to declare their unregistered cosmetic products and pay the imposable fines for the act of selling/distributing unregistered cosmetic products;
THEREFORE, by virtue of the authority granted under Administrative Order 118 s. 1992 in relation with A.O. 72 s. 1983, the BFAD hereby declares an amnesty to all unregistered cosmetic products already in the market subject to the following conditions, to wit:
1. the cosmetic product does not contain non-permissible substances;
2. the manufacturer, distributor, or importer declares the existence of the unregistered cosmetics in the market in the application to BFAD for listing these products, NOT LATER THAN OCTOBER 31, 1992;
3. the manufacturer, distributor, or importer pays for the administrative fine for the sale or distribution of unregistered cosmetic products in violation of A.O. 150 s. 1971, hereunder specified to wit:
Fine for each commercial presentation of unregistered cosmetic product
1. Sale of unregistered products by local manufacturer or importer without license to operate from BFAD — P4,000.00
2. Sale of unregistered product by establishments with pending application for a license to operate — P3,000.00
3. Sale of unregistered product by establishments with a license to operate — P2,000.00
4. Sale of unregistered product with pending application for registration by licensed cosmetic establishment — P1,000.00
The declaration/application to BFAD listing the unregistered products shall be accompanied by three copies of the labels of the cosmetic product, a statement that the product does not contain non-permissible substances and that the manufacturer, distributor/importer is willing to pay the administrative fine.
This amnesty shall allow the listed cosmetic products to remain in the market until December 31, 1993, unless the listed product is registered with BFAD before that date, in which case, the product may be allowed in the market during the validity period of the product’s registration.
The BFAD will issue a certificate that the unregistered cosmetic product is covered by the amnesty and is allowed to remain in the market up to Dec. 31, 1993. Any unregistered product not covered by such certificate shall be subject to confiscation by a duly authorized Food and Drug Regulation Officer. To avoid confiscation, the manufacturer, distributor/importer should provide its retail outlets with the BFAD listing certificate.
Unregistered products with BFAD listing certificate may be advertised provided the advertisement is consistent with the label submitted to BFAD; and provided further that the advertising claims are within the cosmetic benefits/effects/use of the product.
To facilitate the listing of unregistered cosmetic products, the BFAD will provide for the application and the certificate forms to be accomplished by the manufacturer, distributor/importer, copy of which is attached for the information of all concerned.
Adopted: 17 July 1992
Whereas, Administrative Order No. 72 s. 1983 authorizes the BFAD to seize and confiscate unregistered cosmetics, among others;
Whereas, a significant number of unregistered cosmetic products is in the market;
Whereas, cosmetic establishments, (manufacturers and importers) request for a grace period to allow these unregistered cosmetics to be sold and stay in the market;
Whereas, Section 29-A of R.A. 3720 as amended, provides that an administrative fine in the amount of not less one thousand pesos (P1,000.00) nor more than five thousand pesos (P5,000.00) may be imposed for any violation of the said Act or its implementing rules and regulations;
Whereas, the distribution and sale of unregistered cosmetics is a violation of A.O. 150 s. 1971 issued pursuant to R.A. 3720 as amended;
Whereas, in the consultation meeting with the cosmetic establishments on June 25, 1992, the said establishments manifested their willingness to declare their unregistered cosmetic products and pay the imposable fines for the act of selling/distributing unregistered cosmetic products;
THEREFORE, by virtue of the authority granted under Administrative Order 118 s. 1992 in relation with A.O. 72 s. 1983, the BFAD hereby declares an amnesty to all unregistered cosmetic products already in the market subject to the following conditions, to wit:
1. the cosmetic product does not contain non-permissible substances;
2. the manufacturer, distributor, or importer declares the existence of the unregistered cosmetics in the market in the application to BFAD for listing these products, NOT LATER THAN OCTOBER 31, 1992;
3. the manufacturer, distributor, or importer pays for the administrative fine for the sale or distribution of unregistered cosmetic products in violation of A.O. 150 s. 1971, hereunder specified to wit:
Fine for each commercial presentation of unregistered cosmetic product
1. Sale of unregistered products by local manufacturer or importer without license to operate from BFAD — P4,000.00
2. Sale of unregistered product by establishments with pending application for a license to operate — P3,000.00
3. Sale of unregistered product by establishments with a license to operate — P2,000.00
4. Sale of unregistered product with pending application for registration by licensed cosmetic establishment — P1,000.00
The declaration/application to BFAD listing the unregistered products shall be accompanied by three copies of the labels of the cosmetic product, a statement that the product does not contain non-permissible substances and that the manufacturer, distributor/importer is willing to pay the administrative fine.
This amnesty shall allow the listed cosmetic products to remain in the market until December 31, 1993, unless the listed product is registered with BFAD before that date, in which case, the product may be allowed in the market during the validity period of the product’s registration.
The BFAD will issue a certificate that the unregistered cosmetic product is covered by the amnesty and is allowed to remain in the market up to Dec. 31, 1993. Any unregistered product not covered by such certificate shall be subject to confiscation by a duly authorized Food and Drug Regulation Officer. To avoid confiscation, the manufacturer, distributor/importer should provide its retail outlets with the BFAD listing certificate.
Unregistered products with BFAD listing certificate may be advertised provided the advertisement is consistent with the label submitted to BFAD; and provided further that the advertising claims are within the cosmetic benefits/effects/use of the product.
To facilitate the listing of unregistered cosmetic products, the BFAD will provide for the application and the certificate forms to be accomplished by the manufacturer, distributor/importer, copy of which is attached for the information of all concerned.
Adopted: 17 July 1992
(SGD.) QUINTIN L. KINTANAR, M.D., PH.D.
Director — CESO I
Director — CESO I