and safe, efficacious and good quality drugs
COSMETIC PRODUCT and devices in the country
DEVELOPMENT
LECTURE 2: REGULATORY REQUIREMENTS OF
COSMETIC PRODUCTS
OUTLINE
I. Introduction
II. RA 3720 – Food, Drugs, and Cosmetics
Act
III. RA 9711 – Food and Drug
Administration Act of 2009
IV. RA 7439 – Consumer Act of the
Philippines
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V. ASEAN Harmonized Cosmetic
Regulatory Scheme
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VI. Product Information File
Introduction m
Regulatory Requirements
● RA 3720 – Food, Drugs, and Cosmetics Act
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● RA 9711 – Food and Drug Administration Act of
2009
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● RA 7439 – Consumer Act of the Philippines
RA 3720 – Food, Drugs, and Cosmetics Act
● An Act to ensure the safety and purity of Foods,
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Drugs, and Cosmetics being made available to
the public by creating the Food and Drug
Administration which shall administer and
enforce the laws pertaining thereto
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● Food, Drug, Devices, and Cosmetics Act
Section 2. It is hereby declared the policy of the
State to insure safe and good quality of food, drug,
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and cosmetic, and to regulate the production, sale,
and traffic of the same to protect the health of the
people.
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Section 3. In the implementation of the foregoing
policy, the foregoing policy, the Government shall
in accordance with the provisions of this Act:
● Establish standards and quality measures for
foods, drugs, devices, and cosmetics.
● Adopt measures to insure pure and safe supply
of foods and cosmetics in the country, and pure
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Chapter X, Sections 23 and 24, is about adulterated
and misbranded cosmetics
Adulterated Cosmetics
Section 23. A cosmetic shall be deemed to be
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adulterated:
a. If it bears or contains any poisonous or
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deleterious substances which may render it
injurious to users under the conditions of use
prescribed in the labeling thereof, or under the
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conditions of use as are customary or usual:
Provided, That this provision shall not apply to
coal-tar hair dye, the label of which bears the
following legend conspicuous displayed
thereon: "Caution: This product contains
ingredients which may cause skin irritation on
certain individuals and a preliminary test
according to accompanying directions should
first be made. This product must not be used for
dyeing the eyelashes or eyebrows; to do so
may cause blindness", and the labeling of
which bears adequate directions for such
preliminary testing. For the purposes of this
paragraph and paragraph
b. the term "hair dye" shall not include eyelash
dyes or eyebrow dyes.
Misbranded Cosmetics
Section 24. A cosmetic shall be deemed to be
misbranded:
● If its labeling is false or misleading in any
particular way.
● If in package form unless it bears a label
containing
○ (1) the name and place of business of the
manufacturer, packer, or distributor; and
○ (2) an accurate statement of the quantity of
the contents in terms of weight, measure, or
numerical count: Provided, That under
reasonable variations shall be permitted
and exemptions as to small packages shall
be established by regulations prescribed by
the Secretary.
○ If any word, statement, or other information
required by or under authority of this Act, to
appear on the label or labeling is not
prominently placed thereon with such
 conspicuousness (as compared with other
words, statements, designs, or devices, in
the labeling) and in such terms as to render
it likely to be read and understood by the
ordinary individual under customary
conditions of purchase and use.
○ If its container is so made, formed, or filled as
to be misleading.
RA 9711 – Food and Drug Administration Act
of 2009
● An Act strengthening and rationalizing the
regulatory capacity of the Bureau of Food and
Drugs (BFAD) by establishing adequate testing
laboratories and field offices, upgrading its
equipment, augmenting its human resource
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complement, giving authority to retain its
income, renaming it the Food and Drug
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Administration (FDA), amending certain sections
of Republic Act 3720, as amended, and
appropriating funds thereof
○ Renamed to Food and Drug Administration
m According to RA 3720
Act of 2009
SEC. 3. It is hereby declared a policy of the State to
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adopt, support, establish, institutionalize, improve
and maintain structures, processes, mechanisms
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and initiatives that are aimed, directed and
designed to:
a. protect and promote the right to health of
the Filipino people; and
b. help establish and maintain an effective
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health products regulatory system and
undertake appropriate health manpower
development and research, responsive to
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the country’s health needs and problems.
Pursuant to this policy, the State must enhance its
regulatory capacity and strengthen its capability
with regard to the inspection, licensing and
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monitoring of establishments, and the registration
and monitoring of health products.
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SEC. 6. Section 5 of Republic Act No. 3720, as
amended, is hereby further amended and new
subsections are added to read as follows:
“SEC. 5. The FDA shall have the following centers
and offices:
● The Centers shall be established per major
product category that is regulated, namely:
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○ Center for Drug Regulation and Research
(to include veterinary medicine, vaccines
and biologicals)
○ Center for Food Regulation and Research;
○ Center for Cosmetics Regulation and
Research (to include household
hazardous/urban substances); and
○ Center for Device Regulation, Radiation
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Health, and Research.
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Section 10 of RA 3720 was amended
● ‘Cosmetics’ means any substance or
preparation intended to be placed in contact
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with the various external parts of the human
body or with the teeth and the mucous
membranes of the oral cavity, with a view
exclusively or mainly to cleaning them,
perfuming them, changing their appearance
and/or correcting body odor, and/or protecting
the body or keeping them in good condition.
● "Cosmetic" 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. articles intended for use as a component of
any such articles.
Chapter XIV, a new chapter added, is the chapter
establishing the testing laboratories and field offices
● The FDA is hereby mandated to improve,
upgrade and increase the capability of the
agency, to test, calibrate, assay and examine
samples of health products.
● The FDA shall establish field offices in all regions
of the country to effectively implement its
regulatory functions. The current regional food
and drug regulatory officers and regional health
physicists in every regional office of the DOH
shall now be put under the FDA’s sole control
and supervision. The regional field office shall
also assume primary jurisdiction in the collection
of samples of food, drugs, devices and
cosmetics being imported or offered for import
at a port of entry other than Manila
Cosmetic Product Notification
The following information shall be declared in the
Cosmetic Product Notification:
● Brand Name/Product Name/Product Variants
● Product Types, or the type/s of the cosmetic
product that you are applying for notification.
● Particulars of the Product
● Intended Use
● Product Presentations
● Local Company Responsible for Placing the
Cosmetic Product in the Market.
● Establishment Information
● Person Representing the Local Company
● Product Ingredient List
RA 7394 – Consumer Act of the Philippines
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● It is the policy of the State to protect the
interests of the consumer, promote his general
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welfare and to establish standards of conduct
for business and industry.
● Towards this end, the State shall implement
measures to achieve the following objectives:
m Good Manufacturing Practice appearing as
○ Protection against hazards to health and
safety
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ASEAN Harmonized Cosmetic Regulatory
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Scheme
● Signed September 2, 2003 by ASEAN Ministers
● The agreement covers:
○ ASEAN Mutual Recognition Arrangement of
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Product Registration Approvals for
Cosmetics
○ ASEAN Cosmetic Directive
● Administrative Order No. 2005-0015 (Adoption
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of the ASEAN Harmonized Cosmetic Regulatory
Scheme and the ASEAN Common Technical
Documents) was issued in order to formally align
the national standards with, and adopt, the
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ASEAN Harmonized Cosmetic Regulatory
Scheme.
● The FDA allowed the Cosmetic Industry a
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transitory period of until December 31, 2007 to
comply with the ASEAN Labeling Requirements.
● Scope
○ Registration requirements
○ Labeling of cosmetic product
○ ASEAN Cosmetic Claim Guidelines
○ ASEAN Cosmetic Ingredient Listings from Part
I to V and ASEAN Handbook of Cosmetic
Ingredients
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○ Implementation of ASEAN Guidelines for
Cosmetic Good Manufacturing Practice
(CGMP) and Post Market Surveillance
System
ASEAN Cosmetic Directive
Requires persons or companies placing a product
on the market to keep a product information file
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(PIF) readily accessible to the regulatory authority
of the Member State.
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Product Information File
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● Article 8 of the ACD states the list of information
required in the Product Information File
○ the qualitative and quantitative composition
of the product
○ specifications of the raw materials and
finished product;
○ the method of manufacture complying with
the good manufacturing practice as laid
down in the ASEAN Guidelines For Cosmetic
Appendix VI;
○ assessment of the safety for human health
of the finished product, its ingredients, its
chemical structure and its level of exposure;
○ existing data on undesirable effects on
human health resulting from use of the
cosmetic product; and
○ supporting data for claimed benefits of
cosmetic products should be made
available; to justify the nature of its effect.
Method of Analysis
● Article 9 of the ACD requires the company to
provide information on the method of analysis
to the regulatory authority
● the available methods used by the
manufacturer to check the ingredients of
cosmetic products corresponding with the
Certificate of Analysis
● the criteria used for microbiological control of
cosmetic products and chemical purity of
ingredients of cosmetic products and/or
methods for checking compliance with those
criteria
Recommended Parts of the PIF
● Part I: Administrative Documents and Product
Summary
● Part II: Quality Data of Raw Material
● Part III: Quality Data of Finished Product
● Part IV: Safety and Efficacy Data
Administrative Documents and Product Summary
● Administrative documentation
● Qualitative and Quantitative formula of the
product (INCI or other ACD approved
reference names and corresponding
concentrations of the ingredients)
● Product presentation and label, including: -
Outer and inner labels (photographs and/or
drawings will be useful)
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● Manufacturing Statement
● Safety Assessment (summary) as per the ASEAN
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Guidelines for the Safety Assessment of a
Cosmetic Product
● Confirmed undesirable effects on human health
(summary) m
● On-pack product claim support (summary)
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Quality Data of Raw Material
The second part of the PIF should include full
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technical information on the quality of the raw
materials/ ingredients:
● Specifications and test methods of raw
material/ ingredients:
● Data on the safety of the raw materials based
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on data from the supplier, on published data or
on reports from Scientific Committees like the
ASEAN Cosmetic Scientific Body (ACSB), the EU
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Scientific Committee on Consumer Products
(SCCP) or the US Cosmetic Ingredient Review
Board (CIR);
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Quality Data of Finished Product
● Qualitative and Quantitative formula of the
product (INCI or other approved ACD
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reference names and corresponding
concentrations of the ingredients)
● Manufacturing → contact details, summary of
the manufacturing process, QC documents
● Specifications and test methods of the finished
product
● Product Stability Summary Report, if the product
durability is below 30 months
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Safety and Efficacy Data
● Safety Assessment
● The latest compiled report on confirmed or
recorded adverse events or undesirable effects
on human health resulting from use of the
cosmetic product
● On-pack product claim support
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Annexes of the ACD
● Annex I : Illustrative list by category of cosmetic
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products
● Annex II: Prohibited ingredients list
● Annex III: Restricted ingredients list
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● Annex IV: Colorants positive list
● Annex V: List of excluded from the scope of the
Directive
● Annex VI: Preservatives positive list
● Annex VII: UV Filters positive list
Cosmetics Good Manufacturing Practices
The objective of the Cosmetic Good Manufacturing
Practice (GMP) guidelines is to ensure that products
are consistently manufactured and controlled to
the specified quality. It is concerned with all aspects
of production and quality control.
General Considerations
● In the manufacture of cosmetic products,
overall control and monitoring is essential to
ensure that the consumer receives products of
specified quality.
● The quality of a product depends on the starting
materials, production and quality control
processes, building, equipment and personnel
involved
Quality Control
● Quality control is an essential part of GMP. It
provides assurance that cosmetic products will
be of consistent quality appropriate to their
intended use.
● A quality control system should be established
to ensure that
○ products contain the correct materials of
specified quality and
○ quantity and are manufactured under
proper conditions according to standard
operating procedures.
● Quality control involves sampling, inspecting
and testing of starting materials, in process,
intermediate, bulk, and finished products.
○ It also includes, where applicable,
environmental monitoring programs, review
of batch documentation, sample retention
program, stability studies and maintaining
correct specifications of materials and
Microbiological Tests
● Buying guaranteed 'clean' raw materials, stored
in sealed containers in clean warehouses.
● Adopting good hygiene in manufacture, filling
and storage.
● Carrying out routine testing on all raw materials
including water for processing and cleaning.
● Routine testing periodically at all stages of

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products. manufacture and storage of product,
equipment and environment and in all factory

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Testing of Cosmetic Products areas
● Chemical and Physicochemical Tests ○ including applying the concept of Hazard
● Microbiological Tests Analysis Critical Control Point (HACCP)

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● Stability Testing ■ determining which points in the
● Efficacy Testing manufacture is critical to the quality of
● Safety tests the product (detrimental to the product)

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● Skin Irritation Tests ● Accumulating knowledge of the product's
● Skin Sensitivity Tests behaviour under repeated contamination in

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● Skin Hydration Tests storage and during consumer use to assess the
● Skin Protection / Barrier Effect Tests activity of the preservative system.
● Anti-Itch Testing ○ what species
m ○ how they micromicrobials are being
Physicochemical Tests introduced
Active ingredients, preservatives, UV filters, ○ how does this affect in compare with the
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water-soluble and fat-soluble vitamins, dyes and customers uses
surfactants are subjected to be tested by the ● Commonly test for Bacteria, yeast and molds
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following: and pathogenic microorganisms

● Presence of contaminants: heavy metals,
allergens, CMR substances (carcinogenic, Challenge Test: determination of the effectiveness
mutagenic or toxic for reproduction like of the preservatives system
nitrosamines), impurities
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Product for Other products

● Physical Properties: Rheology, density, particle children under 3
size, pH, viscosity, etc years, eye area
○ pure compound will have a definite physical and mucous
membranes
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properties that is used to check if they are in

standard value Total aerobic ≤ 500 cfu/g or ≤1000 cfu/g or
● Organoleptic properties and other: Sensory mesophilic cfu/mL cfu/mL
microorganism
analysis (organoleptic attributes), gravimetric,
(bacteria, Yeast,
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volumetric, instrumental methods (HTLC, UV Vis., and Mold)

etc)
● Tests depend on the nature of raw materials and P. aeruginosa
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cosmetic vehicle. Absent in 0.1 g at .1 mL test sample

S. aureus
○ Ex: Soaps - test for ester value,
saponification value, presence of glycerol C. albicans
○ Toothpaste - test for pyrophosphate,
fluoride and monofluorophosphate Stability Studies
contempt ● prototype (to determine the shelf life) , Raw
● Ester value, acid value, saponification value, Material, procedure, and packaging
presence of glycerol or sorbitol ● Assumption: increasing storage temperature
speeds up aging reactions
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● Rule of thumb: sample stored at 45oC for 8
weeks is equivalent to one that is stored at room
temperature for one year (accelerated stability
testing)
○ Not an exact predictor, but is good enough
for cosmetic products
○ make a batch of samples and add 30-40%
as allowance which will be left for QC and
Efficacy Test
● Efficacy tests are designed to show that a
product performs the function for which it is
intended
● In order to establish a frame of reference for the
evaluation of product efficacy it is usual to
include both positive and negative controls in a
study

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stability test and make initial readings ○ The positive control is often a leading
■ put different samples (2 samples) at marketed product with an established

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different conditions (room temp., 50oC , history of effective performance.
45oC, 37oC, 25oC and 4oC) → 24 hours ○ The negative control, in the simplest case,
soy to freeze testing would be the placebo

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■ Evaluations done in 2, 4, 8, 12, and 52,
weeks and more than a year for room Safety Test
temp. 37oC and 4oC → real time stability ● Essential to evaluate the product based on skin

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testing tolerance, ensuring consumer protection
■ For 50oCand light box tested at 2,4 and 8 ○ In vivo studies to investigate the

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weeks, and determine at 8 weeks toxicological potential of a cosmetic
ingredient when applied to human skin
Stability Changes ■ determination of the none-observed
Contents m adverse level (no adverse effect - safe)
● Physical or no effect level
● Viscosity ● Sensitivity/Irritation Tests
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● Texture ○ Uses the HRIPT: Human repeat insult Patch
● Color Test (48 hours patch test)
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● Odor ● Compatibility Tests

● pH ○ confirm no harmful effects is found when
● loss of volatile constituents applying the product to the human skin or
● uptake of water, oxygen or carbon dioxide mucous membrane
○ support claim that they are ‘tear free’, ‘for
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Chemical sensitive skin’ and ‘non comedogenic’

● Degradation of (active) constituents ● Use Tests/Consumer Acceptability Tests
○ if degraded to by products ○ Self perception of the consumer to confirm
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● Interaction between constituents the fulfillment of the expectation of the

○ to form a new compound product used under normal conditions
● loss of constituents by sorption by container ● Solar protection studies
○ Broad spectrum test for SPF determination
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Microbiological
● loss of antimicrobial preservative efficacy Skin Irritation Tests
● microbial spoilage ● to support the risk management associated with
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the handling and transport of chemicals and

Container also possible exposure to acutely irritant
● Leakage substances contained in various products
● Corrosion ● Irritation: non-immunological mediated
● Stress cracking: container is damaged by inflammation of the skin; erythema, dryness,
internal pressure, frozen, etc scaling, itching, burning, and/or tingling
○ Accumulated irritant: responses after
repeated exposure on the same skin area

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 ○ Acute irritant: one time exposure only and
can see the manifestation

Skin Sensitivity Tests

● Sensitivity: hyper-reactivity to external factors
○ manifest into itching, burning, stinging,
sensation of tightness
● Skin patch test: 24 hours

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○ check for redness, itching, blistering or
soreness

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Skin Hydration Tests
● Level of moisture

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● adhesive test area removes dead skin flakes
○ the more skin flakes removed, the drier the
skin is

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● Electronic capacitance analyzer

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— NOTHING FOLLOWS—

⭐ GOOD LUCK GUYS! YOU GOT THIS !

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