QuestionsQuestions (BFAD MEMORANDUM CIRCULAR NO. 19-A S. 1992)
The Circular cites Administrative Order No. 150 (s. 1971), which provides that a cosmetic specialty shall be distributed only after it has been officially registered with the Bureau of Food and Drugs, and to ensure uniform registration standards.
It refers to (1) articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance, and (2) articles intended for use as components of such articles, except that the term does not include soap.
The label must bear: (1) name of the product; (2) name and address of manufacturer/importer/distributor/repacker presented conspicuously as one phrase on the principal display panel of both inner and outer labels (with “Manufactured by” or equivalent, and “Imported by” for imported products); (3) net content in standard metric sizes; (4) registration number; (5) ingredients known or suspected to cause untoward reaction to some individuals; and (6) directions for use and/or warnings, if any.
All required words and statements must be in English or Filipino. If distributed solely in a territory where the predominant language is neither, the predominant language may be used.
It may be printed on the outer label only, when there are justifiable reasons why it cannot be printed on the inner label.
They must include: “Avoid spraying towards eyes or towards an open flame. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 48°C. Keep out of reach of children.”
The phrase “except under adult supervision” may be added at the end of the last sentence of the warning.
“Use only as directed, intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.”
Exempt are: (1) foam or cream products with less than 10% propellant; (2) products in containers with a physical barrier preventing propellant escape at time of use; (3) products under 30 g that release a measured amount per valve actuation; and (4) products under 8 g.
Required warning: “This product contains ingredients which may cause skin irritation to some individuals. Preliminary tests according to the accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.” If space on the principal display panel of the immediate container is limited, the warning may be placed on the carton/outer label.
Shampoos designated as “egg shampoo” should contain one egg (or equivalent amount of dried whole egg or 2% egg lecithin) in the quantity of product used in one shampooing of the hair.
Shampoos with less than one egg per shampoo should not be referred to as an “egg shampoo,” and the word “egg” should not be used as part of the name of the article.
The use of the word “hygiene” or “hygienic” or words suggesting medical usefulness renders it misbranded.
They must contain: “For external use only. Do not apply to broken or raw skin, or large area of the body.” However, if rinsed off immediately after use, the warning need not be included.
Labeling is deemed misleading if it does not conform to, is inconsistent with, or exceeds the guidelines—e.g., it cannot imply effects beyond cosmetic properties, cannot falsely suggest foreign manufacture, cannot use false/inaccurate safety or effect descriptions, and superlatives/semi-superlatives require adequate substantiation (contextual evaluation).
Cosmetics must be packed, appropriately labeled, marked, and sold in standard metric sizes using grams (g) for solids and milliliters (mL) for liquids, conforming to the metrication standards of the Bureau of Product Standards (BPS).
If no specific standard exists or there is conflict, the U.S. Code of Federal Regulations shall be applied; and BFAD may amend/revise standards or establish new ones via appropriate circular upon written petition and consultation with relevant specialists/experts with concurrence of petitioner.