TABLE OF CONTENTS
MEMORANDUM CIRCULAR
No. 19-A s. 1992
To : All Cosmetic Establishments And Parties Concerned
Subject : Specific Standards And Requirements
Section I. Labeling Requirements For Cosmetic Products .............. 1
1. Definition of Terms ......................................... 1
a. Label ................................................... 1
b. Principal display panel ........................ 2
c. Immediate container ........................... 2
d. Labeling .............................................. 2
e. Inner label ........................................... 2
f. Outer label ........................................... 2
g. Packaging material ............................. 2
2. All words, statements and other information required to appear on the label shall be presented in the English or Filipino language. ........................................ 2
3. General Labeling Requirements for Cosmetic Products. ......... 2
a. Name of the product. .................................... 2
b. Name and address of the manufacturer, importer, distributor or repacker... - .........................….. 2
c. Net content expressed in standard metric sizes. ......... 3
d. Registration number. .................................... 3
e. Ingredients known or suspected to cause untoward reaction to some individuals.....…………….. 3
f. Directions for use and/or warnings, if any. ............. 3
4. Labeling Requirements for Specific Products. ................. 3
A. Cosmetic products packaged in a self-pressurized container.................................. 3
a. Directions for use. ................................ 3
b. Warning. ........................................... 3
b.1 For products intended to be used by children... - .................................. 3
b.2 For products packaged in glass containers... ... 3
b.3 For products not expelled as a spray... - ...... 4
b.4 For products packaged in a self-pressurized container... - ................................. 4
1. Products expelled in the form of a foam or cream... - ................................ 4
2. Products in a container with a physical barrier... - ............................…... 4
3. Products with a net quantity of contents less than 30 g. ... - .......................... 4
4. Products with a net quantity of contents less than 8 g. ... - .........................… 4
B. Hair dyes shall bear the following : .................... 4
a. Direction for skin patch test. ..................... 4
b. Direction for use. ................................. 4
c. Warning . .......................................... 4
C. Definition of Feminine Deodorant Spray. ................. 5
a. Direction for use. ................................. 5
b. Warning. ........................................... 5
D. Bubble bath products. ................................... 5
a. Direction for use. .................................. 5
b. Warning. ........................................... 5
E. Shampoos, Conditioners and Rinses shall bear the direction for use....................................... 6
F. Shampoos containing eggs - guidelines labeling. ......... 6
a. Shampoos with less than one egg per shampoo... - .... 6
b. Shampoos containing less than 2% egg... - ........... 6
c. Shampoos designated as "egg shampoo"... - ........... 6
I. Hair straighteners, depilatories, perming lotion, and neutralizers shall bear the ff :
a. Direction for use. ................................. 6
b. Warning. .........................................…. 7
J. Cosmetics contained in small containers - specific guidelines in labeling... - ....................... 7
K. Cosmetics containing flammable ingredients... - .......... 7
L. Cosmetics intended for use by children shall bear the following ................................................ 7
a. Direction for use ................................. 7
b. Warning ............................................ 7
N. Cosmetics containing anti-perspirant ingredients shall bear the following ................................. 7
a. Direction for use. ................................. 8
b. Warning. ........................................... 8
c. Active ingredient/s. ............................... 8
O. Beauty masks and similar products shall bear the following: ......................................... 8
a. Direction for use. ............................... 8
b. Warning. ........................................... 8
P. Suntan products shall bear the following : ............. 8
a. Direction for use. ................................ 8
b. Maximum safe sun exposure period under conditions of prescribed use. ............................... 8
c. Necessary warning statements to prevent health hazards. .......................................... 8
Q. Nail hardeners which contains no more than 5% formaldehyde shall bear the following :............ 8
a. Direction for use. ................................ 8
b. Warning. .......................................... 8
5. Misleading Declaration / Representation. ..................... 8
A. Names and places may only be used as part of a product name... -........................................ 9
B. Labeling of a cosmetic product... - ...................... 9
C. Labeling of a cosmetic product manufactured in the Philippines shall not give a false
impression to the consumers that t he cosmetic is manufactured in a
foreign country. ................................................ 9
D. False or inaccurate description shall not be used to indicate the effects or safety of a cosmetic product. .……………………………….. 9
E. Labeling which claims that a cosmetic is designated, approved, recommended, instructed... ..................9
Section II. Standard Metric Sizes For Cosmetic Products ............ 10
Section III. Restricted Ingredients For Use In Cosmetics ............ 10
Restricted ingredients for use in cosmetics are classified into five (5) categories.................................. 10
C. Preservatives which are provisionally allowed in Table III... - ..................................................... 10
Section IV. Non-permissible Colors in Cosmetics .................... 11
Section V. Permissible Color Additives ............................ 12
Section VI. Sunscreen Agents ....................................... 13
Definition of Sunscreen Agents. ................................. 13
A. Sunscreen agents which cosmetic products may contain listed in Table...................................... 13
B. Sunscreen agents which cosmetic products may provisionally contain subject to review after a period and/or upon the conditions specified in Section hereof and listed in Table VII hereunder................................................ 13
Section VII. Hypoallergenic Cosmetics
Definition of Hypoallergenic Cosmetics ........................... 14
A. Hypoallergenic cosmetics shall not contain the following ingredients: .......................................... 14
a. Sensitizer preservatives such as formaldehyde and phenyl mercuric acetate .......................... 14
b. Coal-tar dyes (safer insoluble pigments must be used) .…………. 14
c. Ordinary lanolins (use well processed lanolins) ......... 14
d. Highly comedogenic agents... - .......................... 14
C. Testing Requirements
1. Eye irritation test when applicable .................... 14
2. Closed or open patch test on animal and human skin ..... 14
3. Insult patch test on human subjects who are known to have sensitivities to certain cosmetic ingredients .......... 15
D. Hypoallergenic cosmetic product shall bear the following information on its labels :
1. List of ingredients ................................... 15
2. Lot/Batch numbers ..................................... 15
E. Other Requirements
1. Water shall be distilled. ............................. 15
2. Bottles shall be made of glass or non-porous plastics.……………… 15
3. Tubes made aluminum shall be varnished on the inside .………….. 15
4. Perfumes shall be certified as hypoallergenic. ......…………………. 15
5. Well tolerated stearates and vegetable oils shall be used. ................................................ 15
6. Well purified ingredients shall be used. ............... 15
Section VIII. Special Cosmetic Products
Definition of Special Cosmetic Products ........................ 16
A. Labeling claims and promotions ... - ......................... 16
a. Labeling claims shall be less drug-oriented, truthful and informative. ..................................... 16
b. While claims for improved skin chemistry or function as a result of specific ingredients.......... 16
B. Safety of these special cosmetic products shall be adequately verified ......................................... 17
C. The following may be classified as special cosmetic products: .................................................. 17
a. Anti-dandruff shampoos
b. Dentifrices
c. Deodorants and anti-perspirants
d. Other cosmetic preparations with anti-microbial agents other than those used as preservatives
Section IX. Validity Period of Provisionally Allowed Substances ..... 17
Section X. The standards and requirements herein established may be amended or revised................. 17
Section XI. In the absence of any specific standard or requirement covering a particular ingredient/substance... - ......... 18
Section XII. All circulars or issuances issued inconsistent with this are hereby superseded or modified accordingly. ............. 18
REPUBLIC OF THE PHILIPPINES
DEPARTMENT OF HEALTH
BUREAU OF FOOD & DRUGS
DOH Compound
Alabang, Muntinlupa M. M.
1992 July 30
MEMORANDUM CIRCULAR
No. 19-A s. 1992
To : All Cosmetic Establishments And Parties Concerned
Subject : Specific Standards And Requirements
Pursuant to Admin. Order 150 s. 1971, which provides that a cosmetic specialty shall be distributed only after having been officially registered with the Bureau of Food and Drugs, and to facilitate registration as well as to ensure a uniform application of the standards and requirements for registration, the following specific standards and requirements for the registration of cosmetic product are hereby established and/or confirmed, for the information of all parties concerned.
For purposes of registration and this circular, cosmetics (or cosmetic specialty) means (1) 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, and (2) article intended for use as a component of such article except that such term shall not include soap.
Section I. Labeling Requirements For Cosmetic Products
1. Definition Of Terms
a) Label - means a display of written, printed or graphic matter upon any article or any of its containers or wrappers or attached to or accompanying such articles.
b) Principal display panel - means the part of the label that is most likely to be displayed,presented, shown, or examined under customary conditions of display for retail sale. This shall be large enough to accommodate all the mandatory label information required to be placed thereon with clarity and conspicuousness and without obscuring designs, vignettes, or crowding.
c) Immediate container - means any form of packaging materials which enclose the article.
d) Labeling - means all labels and other written, printed or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such articles.
e) Inner label - means the label on or affixed to an immediate container.
f) Outer label - means the label on or affixed to the outside package of an article. This is often described as the carton label.
g) Packaging material - means all items used or attached to bind, enclose or contain the preparation in the final form for market presentation of the product.
2. All words, statements and other information required to appear on the label shall be presented in the English or Filipino language. In case of articles distributed solely in a territory where the predominant language is one other than English or Filipino, the predominant language may be used.
3. General Labeling Requirements for Cosmetic Products - The label of all cosmetic products shall bear or contain the following information:
a) Name of the product
b) Name and address of the manufacturer, importer, distributor or repacker presentedconspicuously as one phrase on the principal display panel of the inner and outer label and qualified by the phrase "Manufactured by" or words that expresses the fact, e.g. "Made by", "Produced by", etc.; provided that when the product is imported, the name of the importer must likewise be printed qualified by the words "Imported By". When these informations can not be printed on the inner label because of justifiable reason(s), the same may be printed on the outer label only.
c) Net content expressed in standard metric sizes.
d) Registration number
e) Ingredients known or suspected to cause untoward reaction to some individuals.
f) Directions for use and/or warnings, if any.
4. Labeling Requirements for Specific Products - In addition to the information generally required for all cosmetic products, the following specific products shall comply with the corresponding specific labeling guidelines or requirements provided hereunder.
A) Cosmetic products packaged in a self-pressurized container and intended to be expelled from the package under pressure shall bear the following:
a) Directions for use
b) Warning : "Avoid spraying towards eyes or towards an open flame. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 48oC. Keep out of reach of children.
b.1 For products intended to be used by children, the phrase "except under adult supervision" may be added at the end of the last sentence of the warning.
b.2 For products packaged in glass containers the word "break" may be substituted for the word "puncture" in the warning.
b.3 For products not expelled as a spray the words "avoid spraying towards eyes" may be deleted from the warning.
b.4 For products packaged in a self-pressurized container, the label shall bear the following additional warning :
"Use only as directed, intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
The additional warning statements above are not required for the following products:
1. Products expelled in the form of a foam or cream, which contains less than 10% propellant in the container.
2. Products in a container with a physical barrier that prevents escape of the propellant at the time of use
3. Products with a net quantity of contents less than 30 g. that are designed to release a measured amount of product with each valve actuation.
4. Products with a net quantity of contents less than 8 g.
B. Hair dyes shall bear the following:
a. Direction for skin patch test
b. Direction for use
Direction for skin patch tests and direction for use may be contained in a package insert.
C. Feminine deodorant spray which is defined as spray deodorant product whose labeling represents or suggests that the product is for use in the female genital area, shall bear the following:
b. Warning: "For external use only. Spray at least 20 cm. away from the 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.
Products whose expelled contents do not contain a liquefied gas propellant such as hydrocarbon propellant need not include the sentence "Spray at least 20 cm. away from the skin" in the warning.
The use of the word "hygiene" or "hygienic" or words, which may represent or suggest that this product has medical usefulness, will render this same product misbranded.
D. Bubble bath products which are added to a bath for foaming effects and which contain surface active agents serving as detergent or foaming ingredients, shall bear the following:
b. 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 products intended for use by children, the phrase "except under adult supervision" may be added at the last sentence of the warning.
E. Shampoos, Conditioners and Rinses shall bear the direction for use.
F. Shampoos containing eggs shall comply with the following guidelines in their labeling:
b. Shampoos containing less than 2% egg need not declare the presence of egg in the preparation.
c. Shampoos designated as "egg shampoo" should contain one egg (or the equivalent amount of dried whole egg or 2% egg lecithin) in that quantity of product, which would be used in one shampooing of the hair.
G. Cosmetics containing borax or boric acid should contain the warning: "For external use only. Do not apply to broken or raw skin, or large area of the body." However, if this cosmetic preparation is rinsed off immediately after its use, the same cosmetic may not contain the said warning.
H. Eyebrow pencils, eyeliners and other cosmetic preparations in pencil form which do not have bottom label need not print the cosmetic registration number on the product itself, provided, however that the same registration number is printed on the carton or outer label.
I. Hair straighteners, depilatories, perming lotion, and neutralizers shall bear the following:
b. Warning: "Improper use of this product may cause serious skin irritation."
J. Cosmetics contained in small containers shall comply with the following specific guidelines in labeling:
b. Cosmetics contained in small containers with bottom labels whose diameter does not exceed 20 mm. and where the other parts of the container are without graphics need not print the cosmetic registration number on the label of the immediate container, provided however, that the said number is printed on the carton/outer label.
K. Cosmetics containing flammable ingredients, e.g. nail polish, nail enamel, shall contain the warning: "Flammable. Keep away from flame, keep out of reach of children."
L. Cosmetics intended for use by children shall bear the following:
a. Direction for use.
b. Warning: "Use only under adult supervision.
M. Cosmetics used for controlling dandruff shall contain the 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.
N. Cosmetics containing anti-perspirant ingredients shall bear the following:
a. Direction for use: Apply to underarm. Do not use generally over the body.
b. Warning: "Do not apply to broken skin. Some users will experience skin irritation. If irritation develops, discontinue use. Consult physician if necessary."
c. Active ingredient/s
O. Beauty masks and similar products shall bear the following:
a. Direction for use
b. Warning: Do not apply around the area of the eye.
P. Suntan products shall bear the following:
a. Direction for use.
b. Maximum safe sun exposure period under conditions of prescribed use.
c. Necessary warning statements to prevent health hazards.
Q. Nail hardeners which contains no more than 5% formaldehyde shall bear the following:
a. Direction for use.
b. Warning : Improper use of this product may cause allergic reactions in certain individuals.
5. Misleading Declaration/Representation - Labeling claims declaration and/or representation shall be deemed misleading if they do not conform or if they are inconsistent with the guidelines provided hereunder.
A. Names of places may only be used as part of a product name if the product is produced/manufactured in the place cited.
B. Labeling of a cosmetic product shall not give an impression that the cosmetic has indications or effects exceeding the properties of cosmetics.
C. Labeling of a cosmetic product manufactured in the Philippines shall not give a false impression to the consumers that the cosmetic is manufactured in a foreign country.
D. False or inaccurate description shall not be used to indicate the effects or safety of a cosmetic product. The use of superlative or semi-superlative expressions in describing the effects of or the cosmetic product itself, may only be allowed if accompanied by adequate substantiation; and in evaluating superlative or semi-superlative expressions, the same shall be taken on a contextual basis and not on a literal word for word basis.
E. Labeling which 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 provided there are adequate clinical testings and/or appropriate testimonies in support of such claims.
F. Labeling which compares the company's own product with that of the other companies with respect to the method of preparation, quality, indications, effects and safety and that which slanders products of other companies shall not be allowed.
G. Cosmetic products declaring ingredients as vitamins may be allowed provided that they do not convey any misleading impression. However, vitamin-containing products can make a claim of cosmetic benefit provided it is supported by clinical evidence.
6. Labels which are in violation of, inconsistent with or not conforming with the labeling guidelines provided for under this circular will render the cosmetic product misbranded.
Section II - Standard Metric Sizes For Cosmetic Products
Cosmetics or cosmetic specialties shall be packed, appropriately labeled, marked and sold locally in standard metric sizes using gram (g) as the unit for solids and milliliters (ml) for liquids. For this purpose, the cosmetic specialties shall conform with the metrication standards promulgated by the Bureau of Product Standards (BPS) of the Department of Trade and Industry.
Section III - Restricted Ingredients For Use In Cosmetics
Restricted ingredients for use in cosmetics are classified into five (5) categories, namely:
A. Substances which cosmetic products must not contain except under the restrictions and conditions laid down in Table I.
B. Preservatives which cosmetic products may contain subject to the restrictions and conditions laid down in Table II.
C. Preservatives which are provisionally allowed in Table III and therefore, subject to review after a period and/or upon a condition specified in Section hereof.
Section IV - Non-permissible Colors in Cosmetics
The non-permissible colors in cosmetics are listed in Table IV and their presence in a cosmetic product will be a ground to deny registration and/or will render the cosmetic product adulterated in accordance with Article 35 (e) of the Consumers Act of the Philippines.
Section V - Permissible Color Additives
Permissible color additives refer to color additives which are allowed under the restrictions and conditions laid down in Table V hereunder.
Section VI - Sunscreen Agents
Sunscreen agents are substances which are specifically intended to filter certain UV rays in order to protect the skin from certain harmful effects of these rays. The sunscreen agents which cosmetic products may contain are classified into two categories, namely:
A. Sunscreen agents which cosmetic products may contain listed in Table VI.
B. Sunscreen agents which cosmetic products may provisionally contain subject to review after a period and/or upon the conditions specified in Section hereof and listed in Table VII hereunder.
Section VII - Hypoallergenic Cosmetics
Hypoallergenic cosmetics are non-medicated cosmetic products and are not meant to treat skin problems. The products shall not contain commonly known allergens in the formula or shall eliminate from the formulation ingredients liable to cause allergic reactions. These products shall be made of ingredients that are the least allergenic to the skin, specially with regards to perfumes, lanolins, preservatives and dyes. They must be produced in the most hygienic manner, packaged to support the hypoallergeneity of the product and properly tested under controlled conditions.
A. Hypoallergenic cosmetics shall not contain the following ingredients:
a) Sensitizer preservatives such as formaldehyde and phenyl mercuric acetate
b) Coal-tar dyes (safer insoluble pigments must be used)
c) Ordinary lanolins (use well processed lanolins)
d) Highly comedogenic agents such as acetal, acetulan, isopropyl myristyl myristate, 5% sodium lauryl sulfate, isopropyl isostearate hexadecyl alcohol, etc.
C. Testing Requirements
1. Eye irritation test when applicable
2. Closed or open patch test on animal and human skin
3. Insult patch test on human subjects who are known to have sensitivities to certain cosmetic ingredients
All tests conducted must be under the supervision of an appropriate medical specialist.
If no tests are done locally, tests conducted abroad may be acceptable provided the same may be applicable to local conditions.
D. Hypoallergenic cosmetic product shall bear the following information on its labels:
1. List of ingredients
2. Lot/Batch numbers
E. Other Requirements
1. Water shall be distilled.
2. Bottles shall be made of glass or non-porous plastics.
3. Tubes made of aluminum shall be varnished on the inside.
4. Perfumes shall be certified as hypoallergenic. The certificate as hypoallergenic. The certificate of hypoallergenecity shall be issued by the supplier stating that the perfume conforms with the requirements of the Research Institute of Fragrance Materials (RIFM) and International Fragrance Association (IFRA).
5. Well tolerated stearates and vegetable oils shall be used.
6. Well purified ingredients shall be used.
Section VIII - Special Cosmetic Products
Special cosmetic products refer to articles (other than medical device) whose action on the human body is mild and are not intended for therapeutic use. They are mainly characterized by propylactic effect.
The cosmetic effects of cleansing, beautifying, promoting attractiveness, or altering the appearance of these products are accomplished through a process which at least to a limited degree, affects the structure or function of the human body.
A. Labeling claims and promotions of these special cosmetic products are the factors that shall distinguish them from products that are classified or defined by regulations as drugs or drug product. The following guidelines in their labeling and promotion shall be complied:
a. Labeling claims shall be less drug-oriented, truthful and informative.
b. While claims for improved skin chemistry or function as a result of specific ingredients or the formula itself are coming very close to drug claims and/or drug ingredients, labeling should not contain therapeutic indications or use.
c. Promotion of these products shall be based primarily on their cosmetic benefit.
d. Each claim or representation shall be carefully examined, not only by itself but also in the context with the remaining language of the promotional material(s).
B. The safety of these special cosmetic products shall be adequately verified.
C. The following may be classified as special cosmetic products:
a) Anti-dandruff shampoos
b) Dentifrices
c) Deodorants and anti-perspirants
d) Other cosmetic preparations with anti-microbial agents other than those used as preservatives.
Section IX - Validity Period of Provisionally Allowed Substances
The validity period of substances or ingredients provisionally allowed will automatically be considered extended until the same is either delisted/deleted as having been considered by BFAD as a permissible substance, or listed in the non-permissible or restricted substances in cosmetics.
The substances or ingredients provisionally allowed will be subject to review either during the process of renewal registration of a cosmetic product containing such substances, or when an information is received raising the issue of safety of the said substances.
Section X. The standards and requirements herein established may be amended or revised, and specific standards or requirements of cosmetic preparations not covered by this circular may be formally established by an appropriate circular, upon a written petition of an interested party and consultation with the appropriate specialist/s or expert/s identified by BFAD with the concurrence of the petitioner.
Section XI. In the absence of any specific standard or requirement covering a particular ingredient/substance or in case of conflict between the standards and requirements herein established the U.S. Code of Federal Regulations shall be applied.
Section XII. All circulars or issuances issued inconsistent with this are hereby superseded or modified accordingly.
QUINTIN L. KINTANAR, M.D. Ph. D. Director - CESO I