Coverage and cosmetic product definition
- For purposes of registration and compliance, cosmetics (or cosmetic specialty) are articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance.
- For the same purposes, cosmetics (or cosmetic specialty) also include an article intended for use as a component of such an article.
- “Soap” is excluded from the definition of cosmetics for purposes of registration and application of these standards.
- The Circular governs registration-related standards and labeling, ingredient, color, sunscreen, and formulation rules for cosmetic products distributed in the Philippines.
Labeling standards for cosmetic products
- All label information required by the Circular must be in the English or Filipino language.
- If a product is distributed solely in a territory where the predominant language is one other than English or Filipino, the predominant language may be used.
- Cosmetic product labels must include the following information:
- Name of the product
- Name and address of the manufacturer, importer, distributor or repacker, presented conspicuously as one phrase on the principal display panel of the inner and outer label, qualified by “Manufactured by” or words expressing the fact (e.g., “Made by,” “Produced by”).
- If imported, the importer’s name must likewise appear qualified by the words “Imported By.”
- If the information cannot be printed on the inner label for justifiable reason(s), the information may be printed on the outer label only.
- Net content expressed in standard metric sizes
- Registration number
- Ingredients known or suspected to cause untoward reaction to some individuals
- Directions for use and/or warnings, if any
- The Circular defines labeling terms as follows:
- “Label” means written, printed, or graphic matter on the article, its containers/wrappers, or attached to or accompanying it.
- “Principal display panel” is the label portion most likely to be displayed under retail conditions; it must be large enough to place mandatory information clearly and without obscuring designs/vignettes/crowding.
- “Immediate container” means packaging enclosing the article.
- “Labelling” means all labels and written/printed/graphic matter upon or accompanying the article and its containers.
- “Inner label” means the label on or affixed to an immediate container.
- “Outer label” means the label on or affixed to the outside package (often the carton label).
- “Packaging material” means items used or attached to bind/enclose/contain the preparation for market presentation.
Special labeling rules and product categories
- Self-pressurized containers expelled under pressure must bear:
- Directions for use
- Warning: “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.”
- For children’s products expelled under pressure, the phrase “except under adult supervision” may be added at the end of the last sentence of the warning.
- For products in glass containers, “break” may substitute for “puncture” in the warning.
- For products not expelled as a spray, “avoid spraying towards eyes” may be deleted from the warning.
- For self-pressurized products, an additional warning must be included:
- “Use only as directed, intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.”
- The additional warning is not required for these categories:
- Products expelled as foam or cream containing less than 10% propellant in the container.
- Products in a container with a physical barrier preventing propellant escape at the time of use.
- Products with net quantity of contents less than 30 g designed to release a measured amount with each valve actuation.
- Products with net quantity of contents less than 8 g.
- Hair dyes must bear:
- Direction for skin patch test
- Direction for use
- 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 the principal display panel of the immediate container is limited, the hair dye warning may be placed on the carton/outer label; skin patch test and direction for use may be in a package insert.
- Feminine deodorant spray intended for the female genital area must bear:
- Direction for use
- Warning: “For external use only. Spray at least 20 cm. away from skin. Do not apply to broken, irritated or itching skin. Persistent, unusual odor or discharge may indicate conditions for which a physician should be consulted. Discontinue use immediately if rash, irritation, or discomfort develops.”
- If the expelled contents do not contain a liquefied gas propellant such as hydrocarbon propellant, the “Spray at least 20 cm. away from skin” sentence need not be included.
- Use of the words “hygiene” or “hygienic” (or equivalents indicating medical usefulness) renders the product misbranded for this category.
- Bubble bath products that foam and contain detergent/foaming surface active agents must bear:
- Direction for use
- Warning: “Use only as directed. Excessive use or prolonged exposure may cause irritation to skin and urinary tract. Discontinue use if rash, redness, or itching occur. Consult your physician if irritation persists. Keep out of reach of children.”
- For bubble bath products intended for children, the phrase “except under adult supervision” may be added at the end of the last sentence of the warning.
- Shampoos, conditioners, and rinses must bear directions for use.
- Shampoos containing egg are governed by these labeling rules:
- Shampoos with less than one egg per shampoo must not be referred to as an “egg shampoo” and the word “egg” must not be used as part of the name.
- “plus egg” may be used if it appears in subordinate position on the label.
- Shampoos with less than 2% egg need not declare the presence of egg.
- Products designated “egg shampoo” must contain one egg (or the equivalent amount of dried whole egg or 2% egg lecithin) in the quantity used in one shampooing of the hair.
- Cosmetics containing borax or boric acid must bear:
- “For external use only. Do not apply to broken or raw skin, or large area of the body.”
- If the borax/boric acid cosmetic is rinsed off immediately after its use, it may be without that warning.
- Eyebrow pencils, eyeliners, and other pencil-form cosmetics that do not have a bottom label need not print the cosmetic registration number on the product itself, provided the registration number is printed on the carton/outer label.
- Hair straighteners, depilatories, perming lotion, and neutralizers must bear:
- Direction for use
- Warning: “Improper use of this product may cause serious skin irritation.”
- Cosmetics in small containers must comply with these labeling guides:
- If the inner label is too small for required information, a box/carton/outer label or package insert/outsert must contain the labeling requirements.
- For small containers with bottom labels whose diameter does not exceed 20 mm and where other parts have no graphics, the registration number need not be printed on the immediate-container label, provided it is printed on the carton/outer label.
- Cosmetics containing flammable ingredients (e.g., nail polish, nail enamel) must bear:
- Warning: “Flammable. Keep away from flame, keep out of reach of children.”
- Cosmetics intended for children must bear:
- Direction for use
- Warning: “Use only under adult supervision.”
- Cosmetics controlling dandruff must bear:
- Warning: “For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water. If condition worsens or does not improve after regular use of this product as directed, consult a doctor.”
- Cosmetics containing anti-perspirant ingredients must bear:
- Direction for use: Apply to underarm. Do not use generally over the body.
- Warning: “Do not apply to broken skin. Some users will experience skin irritation. If irritation develops, discontinue use. Consult physician if necessary.”
- Active ingredient/s must be declared.
- Beauty masks and similar products must bear:
- Direction for use
- Warning: “Do not apply around the area of the eye.”
- Suntan products must bear:
- Direction for use
- Maximum safe sun exposure period under conditions of prescribed use
- Necessary warning statements to prevent health hazards
- Nail hardeners containing no more than 5% formaldehyde must bear:
- Direction for use
- Warning: “Improper use of this product may cause allergic reactions in certain individuals.”
Misleading claims and product misbranding
- A cosmetic label is misleading if labelling claims, declarations, or representations do not conform to labeling guidelines or are inconsistent with them.
- Names of places may be used only as part of a product name if the product is produced/manufactured in the place cited.
- Cosmetic labeling must not give the impression that the cosmetic has indications or effects exceeding the properties of cosmetics.
- Cosmetic labeling for products manufactured in the Philippines must not falsely suggest that the cosmetic is manufactured in a foreign country.
- False or inaccurate descriptions must not be used to indicate the effects or safety of a cosmetic product.
- Superlative or semi-superlative expressions describing effects or the product itself may be allowed only if accompanied by adequate substantiation, and evaluation must be contextual rather than literal word-for-word.
- Claims that a cosmetic is designated, approved, recommended, instructed or exclusively used by medical, pharmaceutical professionals or other reputable persons or organizations may be allowed only with adequate clinical testing and/or appropriate testimonies supporting the claims.
- Comparisons of a company’s product with others regarding method of preparation, quality, indications, effects, and safety must not slander products of other companies.
- Vitamin-ingredient declarations may be allowed if they do not convey misleading impressions.
- Vitamin-containing products may claim cosmetic benefits only if supported by clinical evidence.
- Labels that violate or are inconsistent with the Circular’s labeling guidelines render the cosmetic product misbranded.
Metrication and ingredient/color restrictions
- Cosmetic products must be packed, appropriately labeled, marked, and sold locally in standard metric sizes, using gram (g) for solids and milliliters (mL) for liquids.
- Cosmetic specialties must conform with metrication standards promulgated by the Bureau of Product Standards (BPS) of the Department of Trade and Industry.
- Restricted ingredients for cosmetics are classified into five (5) categories, namely:
- Substances which cosmetic products must not contain except under restrictions and conditions in Table I
- Preservatives which cosmetic products may contain subject to restrictions and conditions in Table II
- Preservatives which are provisionally allowed in Table III, and are subject to review after a period and/or upon a condition specified in Section hereof
- Non-permissible colors in cosmetics are listed in Table IV; their presence in a cosmetic product is a ground to:
- deny registration, and/or
- render the cosmetic product adulterated under Article 35(e) of the Consumers Act of the Philippines.
- Permissible color additives are allowed only under the restrictions and conditions in Table V.
- Sunscreen agents allowed in cosmetics are grouped into two categories:
- Sunscreen agents that cosmetics may contain as listed in Table VI
- Sunscreen agents that cosmetics may provisionally contain subject to review after a period and/or upon conditions specified in Section hereof, as listed in Table VII.
Hypoallergenic and special cosmetic rules
- Hypoallergenic cosmetics are non-medicated cosmetic products that are not meant to treat skin problems.
- Hypoallergenic cosmetics must not contain commonly known allergens and must eliminate ingredients liable to cause allergic reactions.
- Hypoallergenic cosmetics must use ingredients that are the least allergenic to skin, with emphasis on perfumes, lanolins, preservatives, and dyes.
- Hypoallergenic cosmetics must be produced in the most hygienic manner, packaged to support hypoallergenicity, and properly tested under controlled conditions.
- Hypoallergenic cosmetics must not contain:
- Sensitizer preservatives such as formaldehyde and phenl mercuric acetate
- Coal-tar dyes (with safer insoluble pigments used)
- Ordinary lanolins (well processed lanolins used)
- Highly comedogenic agents such as acetal, acetulan, isopropyl myristyl myristate, 5% sodium lauryl sulfate, isopropyl isostearate hexadecyl alcohol, etc.
- Hypoallergenic cosmetic testing requirements include:
- Eye irritation test when applicable
- Closed or open patch test on animal and human skin
- Insult patch test on human subjects known to have sensitiveness to certain cosmetic ingredients
- All tests must be conducted under supervision of an appropriate medical specialist
- Tests conducted abroad are acceptable if no local tests are done and the tests are applicable to local conditions
- Hypoallergenic cosmetics must bear on labels:
- List of ingredients
- Lot/Batch numbers
- Hypoallergenic cosmetics must comply with formulation and processing requirements:
- Water must be distilled
- Bottles must be made of glass or non-porous plastics
- Aluminum tubes must be varnished on the inside
- Perfumes must be certified as hypoallergenic, with the certificate issued by the supplier stating conformity with requirements of the Research Institute of Fragrance Materials (RIFM) and the International Fragrance Association (IFRA)
- Well tolerated stearates and vegetable oils must be used
- Well purified ingredients must be used
- Special cosmetic products are articles (other than medical device) whose action on the human body is mild and not intended for therapeutic use, characterized by prophylactic effect.
- Special cosmetic products must achieve cosmetic effects through a process that affects the structure or function of the human body at least to a limited degree.
- Labelling and promotions of special cosmetic products must:
- Present labelling claims that are less drug-oriented, truthful, and informative
- Avoid therapeutic indications and avoid therapeutic-use framing even when claims about improved skin chemistry or function approach drug claims or drug ingredients
- Base promotion primarily on cosmetic benefits
- Ensure each claim or representation is examined in the context of the remaining promotional material(s)
- Special cosmetic products must have their safety adequately verified.
- Special cosmetic products include:
- Anti-dandruff shampoos
- Dentifrices
- Deodorants and anti-perspirants
- Other cosmetic preparations with anti-microbial agents other than those used as preservatives.
Provisionally allowed substances and continuing review
- Substances or ingredients provisionally allowed are automatically treated as extended until BFAD either:
- delists/deletes them as permissible substances, or
- lists them in the non-permissible or restricted substances in cosmetics.
- Provisionally allowed substances are subject to review:
- during renewal registration of a cosmetic product containing such substances, or
- when information is received raising safety issues about the substances.
Amendment, conflicts, supersession, and standards
- Standards and requirements may be amended or revised, and additional specific standards for cosmetic preparations not covered by the Circular may be formally established by an appropriate circular upon written petition by an interested party and consultation with appropriate specialists or experts identified by BFAD, with concurrence of the petitioner.
- In the absence of a specific standard or requirement covering an ingredient/substance, or in case of conflict between standards in this Circular and other requirements, the U.S. Code of Federal Regulations is applied.
- All circulars or issuances inconsistent with this Circular are superseded or modified accordingly.