Guide Manual For The HUHS Industry

Guide Manual for the HUHS Industry – Initial Product Registration
DISCLAIMER
The Guide Manual for the HUHS Industry – Initial Product Registration has been prepared
by the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and
Research (CCHUHSRR) as a guidance document supplementary to its administrative
issuances to support its Household/Urban Hazardous Substances (HUHS) stakeholders as
they comply with the Food and Drug Administration’s (FDA’s) regulatory requirements and
secure initial Certificates of Product Registration for their HUHS products. It is the first in a
series of guidance documents that will revolve around the Agency’s current policies, rules and
regulations on HUHS establishments and the products they place in the market. The Guide
Manual for the HUHS Industry – Initial Product Registration is not a legal text of the rules and
regulations promulgated and implemented by the FDA which remains to be the administrative
issuances signed by the FDA Director-General.
The information contained in this guidance document is up-to-date as of the date of its
publication; however, readers, particularly the HUHS industry, are also advised to regularly
check the FDA website at www.fda.gov.ph for any new information or update to the current
HUHS regulations.
Lastly, the use of this document remains the sole responsibility of the readers; the FDA does
not accept any liability with regard to the use that may be made of the information contained
in this document.
2
REVISION HISTORY
VERSION CHANGES DATE OF REVISION
2023 Edition First Edition 20 October 2023
3
DEFINITIONS AND ABBREVIATIONS

Administrative Order (AO)
ASEAN Cosmetic Directive (ACD)
Certificate of Analysis (COA)
Certificate of Product Registration (CPR) refers to the marketing authorization issued by

the Food and Drug Administration for a Category III and IV Household/Urban Hazardous
Substance product after evaluation of its safety, efficacy, and quality that permits its
manufacture, importation, exportation, sale, offer for sale, distribution, transfer, and where
applicable, its use, testing, promotion, advertisement, and/or sponsorship.
CAS number refers to a unique numeric identifier assigned to a specific substance by the
Chemical Abstracts Service.
Carcinogenic, Mutagenic and Reprotoxic (CMR)
Center for Cosmetics and Household/Urban Hazardous Substances Regulation and

Research (CCHUHSRR) refers to the Center under the Food and Drug Administration that
regulates cosmetics and Household/Urban Hazardous Substance products
Department of Trade and Industry (DTI)
ECHA Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Expiration or Expiry Date refers to the date within which an HUHS product is expected to
remain within established specifications if stored correctly. It is established for a specific
batch/lot of an HUHS product by adding the product shelf-life to the date of manufacture or
manufacturing date.
FDA Circular (FC)
FDA Electronic Portal V2.0 System (e-Portal 2)
Food and Drug Administration (FDA) refers to the National Regulatory Authority for health
products
Globally Harmonized System of Classification and Labeling of Chemicals (GHS)
Hazard Category refers to the division of criteria within each hazard class, i.e., oral acute
toxicity includes five hazard categories and flammable liquids include four hazard categories.
Hazard Class refers to the nature of the physical, health or environmental hazard of a
chemical, i.e., flammable solid, carcinogen, acute oral toxicity.
Hazard Statement refers to a statement assigned to a hazard class and category that
describes the nature of the hazards of a hazardous product, including, where appropriate, the
degree of hazard.
4
Household/Urban Hazardous Substance (HUHS) refers to
(1) any substance or mixture of substances intended for individual or limited purposes and
which is toxic, corrosive, an irritant, a strong sensitizer, is flammable or combustible, or
generates pressure through decomposition, heat or other means, if such substance or
mixture of substances may cause substantial injury or substantial illness during or as a
proximate result of any customary or reasonably foreseeable ingestion by children, but
shall not include agricultural fertilizers, agricultural pesticides, and agricultural insecticides,
and other economic poisons, radioactive substance, or substances intended for use as
fuels, coolants, refrigerants and the like;
(2) any substance which the FDA finds to be under the categories enumerated in clause
(1); and
(3) any toy or other articles intended for use by children which the FDA may determine to
pose an electrical, chemical, physical, or thermal hazard. For this purpose, “toys and other
articles intended for use by children” refers to toys and articles specified to be for children
less than fourteen (14) years of age.
(4) This term shall not apply to food, drugs, cosmetics, devices, or to substances intended
for use as fuel when stored in containers and used in the heating, cooking or refrigeration
system of a house, but such term shall apply to any article which is not in itself an
agricultural pesticide but which is a hazardous substance, as construed in clause (1), by
reason of bearing or containing such harmful substances described therein.
HUHS Product Registration refers to the process whereby the FDA approves the sale and
use of an HUHS product following the evaluation of scientific data demonstrating that the
product is effective for its intended purposes and does not pose an unacceptable risk to human
or animal health as well as the environment.
International Agency for Research on Cancer (IARC)
Industrial Use refers to product use in manufacturing and/or production facilities, aviation
industry, utilities and electric power companies including nuclear power plants.
Label refers to a display of written, printed, or graphic matter on the immediate container, or
other materials affixed thereto, of any article. The label of an HUHS product shall include other
informative materials such as but not limited to inserts, hangtags, etc.
Label Element refers to one type of information that has been harmonized (under GHS) for
use in labels. The GHS label elements are the signal words, pictograms and hazard
statements.
Letter of Disapproval (LOD)
Manufacturing Date refers to the date when a specific batch/lot of an HUHS product has
been manufactured.
Marketing Authorization (MA) refers to the approval granted by the FDA to market a specific
HUHS product in the Philippines. For Categories III and IV HUHS products, the marketing
authorization is the CPR.
Marketing Authorization Holder (MAH) refers to the HUHS establishment reflected/named

in the issued Marketing Authorization. For HUHS products, the MAH is the owner of the CPR
issued by the FDA.
5
Mixture refers to a mixture or a solution composed of two or more substances in which they
do not react.
Overlabeling or relabeling refers to the act of placing a new label over an old label
Pictogram refers to a graphical composition that may include a symbol plus other graphic
elements such as a border, background pattern or colour that is intended to convey specific
information.
Precautionary Statement refers to a phrase (and/or pictogram) that describes recommended

measures that should be taken to minimize or prevent adverse effects resulting from exposure
to a hazardous product, or improper storage or handling of a hazardous product.
Professional Use HUHS products refer to HUHS products that are highly concentrated
requiring further dilution and are restricted only to be applied by trained personnel.
Ready-to-Use HUHS products refers to HUHS products that are ready to be used outright of
the packaging and for general purposes, which require no further dilution prior to application.
This term also refers to HUHS products that are diluted before use whose application are NOT
restricted to trained personnel or professionals.
Safety Data Sheet (SDS)
Shelf-life refers to the period of time during which an HUHS product, if stored correctly, is
expected to comply with its established specifications.
Signal Word refers to a word used to indicate the relative level of severity of hazard and alert
the reader to a potential hazard on the label. The GHS uses “Danger” and “Warning” as signal
words.
Stability Studies refer to scientific studies performed to show data, demonstrate, or

substantiate a claimed shelf-life of HUHS products. These tests are performed to determine
the acceptable period of storage at a specified condition within which the HUHS product still
meets its established specifications or claimed efficacy. Stability studies may either be real-
time or accelerated.
Substance refers to chemical elements and their compounds in the natural state or obtained
by any production process, including any additive necessary to preserve the stability of the
product and any impurities deriving from the process used, but excluding any solvent which
may be separated without affecting the stability of the substance or changing its composition.
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LIST OF TABLES
Table Title Page
2.1 Illustrative List of Category III HUHS Products (Cleaners, Fresheners
15
and Deodorizers)
2.2 Illustrative List of Category IV HUHS Products (Do-It-Yourself and
16
Hobby Items)
2.3 Schedule of Fees for Initial HUHS Product Registration Depending on
19
the Number of Years of CPR Validity Applied For
2.4 List of Adopted Standards for HUHS Products 21
2.5 Classification of Carcinogens Under IARC and their Equivalents in GHS 22
2.6 Different Hazard Classes Under Physical, Health and Environmental
Hazard According to the Globally Harmonized System of Classification 24
and Labeling of Chemicals
2.7 Hazard Criteria for GHS Acute Toxicity (Oral/Dermal/Inhalation) and Its
Five (5) Hazard Categories (Adapted from Table 3.1.1 of the 8th Revised 25
Edition of the GHS)
2.8 Hazard Criteria for GHS Skin Corrosion/Irritation Category 1 and Its
25
Subcategories (Table 3.2.1 of the 8th Revised Edition of the GHS)
2.9 GHS Pictograms and Their Corresponding Codes and Names (Table
28
A3.4.1 from the 8th Revised Edition of the GHS)
2.10 Minimum Information for Safety Data Sheets (SDS) (Adapted from Table
30
1.5.2 of the 8th Revised Edition of GHS)
2.11 Examples of HUHS Product Claims and the Documents Acceptable to
35
Support Said Claims
2.12 List of the National and Regional Poison Centers in the Philippines and
Their Contact Information as Listed in Department of Health Department 40
Circular No. 2020-0081
2.13 Variants of ABC Disinfectant Spray 66
2.14 Different Ways to Register the Two (2) Variants of ABC Disinfectant
67
Spray
2.15 Sample HUHS Product for Registration and Its GHS Hazard
71
Classifications with the Corresponding Assigned GHS Label Elements
2.16 Hazard Information for non-GHS Compliant HUHS Products (Adapted
73
from Administrative Order No. 311 s. 1977)
2.17 Sample Formulation of a HUHS Product Containing an Ingredient in the
Form of a Mixture and its Declaration in the Ingredient List Section of the 77
Initial HUHS Product Registration Application Form
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LIST OF FIGURES
Figure Title Page
2.1 Decision Matrix to Identify Categories III and IV HUHS Products Regulated
17
Under FDA Circular No. 2020-025
2.2 Application of the Globally Harmonized System of Classification and
24
Labeling of Chemicals (GHS)
2.3 Decision Logic for GHS Flammable Liquid (Decision Logic 2.6 from the 8th
26
Revised Edition of the GHS)
2.4 A Sample of an Acceptable Certificate of Analysis (COA) 33
2.5 Sample Labeling Material for HUHS Products Not Intended for Children’s
Use Containing the Mandatory Label Information Prescribed in FDA 41
Circular No. 2020-025
2.6 Sample Labeling Material for HUHS Products Intended for Children’s Use
Containing the Mandatory Label Information Prescribed in FDA Circular 46
No. 2020-025
2.7 User’s Registration Form 51
2.8 Log-in Interface of FDA Electronic Portal V2.0 System 53
2.9 FDA Electronic Portal V2.0 Homepage 54
2.10 “Summary” Dialogue Box 55
2.11 On Process Folder Displaying the Relevant Information of a Case
55
Application
2.12 Business Process Flow for the Initial Registration of HUHS Products 56
2.13 Steps to Create a New Case Application for Initial HUHS Product
57
Registration
2.14 Sample of the Order of Payment Sent to the HUHS Establishment for Initial
59
HUHS Product Registration That Passed Pre-Assessment
2.15 Agreement of the HUHS Establishment to the Declaration of Undertaking 62
2.16 Dropdown Menu Showing the License to Operate Number/s Issued to the
63
Applicant
2.17 Required Information on Product Source for Applicants with License to
64
Operate as HUHS Manufacturer
2.18 Required Information on Product Source for Applicants with License to
64
Operate as HUHS Trader
2.19 Procurement Process for Directly-Sourced HUHS Products 65
2.20 Procurement Process for Indirectly-Sourced HUHS Products 65
2.21 Dropdown Menu for Product Line / Type 66
2.22 Net Content Declaration for a HUHS Product Available in 10mL Sachet
69
and 50mL/100mL Tube
2.23 Net Content Declaration for the Varying Pack Sizes of the Two (2) Variants
69
of ABC Air Freshener
2.24 Declaration of Hazard Information for a GHS-Compliant HUHS Product
72
with Multiple Hazard Classifications
2.25 Declaration of Hazard Information for Non-GHS Compliant HUHS Product 73
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TABLE OF
CONTENTS
Disclaimer 2
Revision History 3
Definitions and Abbreviations 4
List of Tables 7
List of Figures 8
I. Introduction, Scope and Applications 10
II. Initial Registration of HUHS Products 12
General Guidelines on Securing an Initial Certificate of Product Registration for 13
HUHS Products
Information on the Technical Requirements 22
A. Product Formulation 22
B. Globally Harmonized System of Classification and Labeling of Chemicals 23
C. Certificate of Analysis 32
D. Claim Substantiation 34
E. HUHS Product Labeling and Packaging 38
FDA Electronic Portal V2.0 System 51
A. Introduction to FDA Electronic Portal V2.0 51
B. Navigating FDA Electronic Portal V2.0 53
Initial HUHS Product Registration in FDA Electronic Portal V2.0 System 56
A. Initial HUHS Product Registration Process 56
B. Initial HUHS Product Registration Application Form 61
III. Annexes 80
Annex A Self-Assessment Checklist for Initial HUHS Product Registration 81
References 93
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I. INTRODUCTION, SCOPE
AND APPLICATIONS
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Introduction
In 2019, the Secretary of Health signed Administrative Order (AO) No. 2019-0019, effectively
repealing AO No. 2015-0038 and instructing the Food and Drug Administration (FDA) to issue
the rules and regulations that would implement the reinstated licensing and registration
requirements for Household/Urban Hazardous Substances (HUHS) establishments and
products, respectively. A year later, in 2020, the FDA released the guidelines for the licensing
and inspection of HUHS establishments as well as the guidelines for the registration of HUHS
products through FDA Circular (FC) No. 2020-025.
With the new regulatory framework in effect for HUHS, the Center for Cosmetics and
Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) has seen
it fit to prepare a series of guidance documents discussing the FDA’s regulatory requirements
for HUHS. This particular guidance document, Guide Manual for the HUHS Industry – Initial
Product Registration, focuses on the FDA’s technical and documentary requirements for
initial registration of HUHS products as well as the procedural guidelines to secure said
marketing authorization.
Scope
The Guide Manual for the HUHS Industry – Initial Product Registration covers information
related to the initial registration of Categories III and IV HUHS products for consumer and
institutional use as defined and categorized in Republic Act No. 9711 and FC No. 2020-025,
respectively. It does not apply to other HUHS product categories (e.g., Categories I, II or V)
and products for industrial use nor does it discuss the licensing of HUHS establishments as
well as FDA’s post-registration requirements for HUHS.
Applications
The Guide Manual for the HUHS Industry – Initial Product Registration contains detailed
information on HUHS product registration that is aimed to provide the HUHS industry with the
necessary support as they fulfill their regulatory obligations to register their HUHS products.
The instructions provided in this document have been simplified as much as possible and have
been designed to be clear, comprehensible and easy to follow, ensuring that the readers can
make full use of the guidance document as they prepare their initial HUHS product registration
applications in accordance with the FDA’s requirements and standards.
The Guide Manual is a working document based on FDA’s existing laws, rules and regulations
on HUHS and is subject to revisions, as necessary, following future updates and amendments
to these laws, rules and regulations.
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II. INITIAL REGISTRATION

OF HUHS PRODUCTS
12
General Guidelines on Securing an Initial Certificate of

Product Registration for HUHS Products
(1) HUHS products intended to be manufactured, imported, exported, distributed, sold,
offered for sale, transferred, promoted, advertised and/or sponsored must be duly
registered with the FDA pursuant to AO No. 2019-0019 and FC No. 2020-025.
However, note that by virtue of FC No. 2021-011-A, a transitory period on the mandatory
HUHS product registration is in effect until 31 December 2023. During this time, HUHS
establishments are allowed to continue distributing their HUHS products not yet
registered with the FDA nor fully compliant with its standards and requirements. Starting
01 January 2024, a CPR shall be mandatory for all HUHS products.
For initial HUHS product registration purposes, notations discussing the special
considerations given to the HUHS industry during the transitory period are found in
certain parts of this guide manual for the industry’s reference.
(2) Item 6, Section IV (General Guidelines) of FC No. 2020-025 states that only FDA-
licensed HUHS establishments shall be allowed to apply for a CPR. More particularly,
only FDA-licensed HUHS establishments who own the product and product
formulation in the local setting are allowed to submit initial HUHS product registration
applications. These include the:
(a) FDA-licensed HUHS Manufacturers,
(b) FDA-licensed HUHS Traders, and
(c) FDA-licensed HUHS Distributor-Importers.
(3) The registration guidelines provided in FC No. 2020-025 only applies to Categories III
(Cleaners, Fresheners and Deodorizers) and IV (Do-It-Yourself and Hobby Items)
HUHS products intended for consumer and institutional use.
HUHS products intended for consumer and institutional use are those that are used in
places of human habitation, work and recreation. Examples of such products are those
used in homes including pools, dormitories, office, restaurants, cars, schools, malls,
condominiums, hospitals, among others.
It shall NOT apply to Categories II (Yard and Home Products) and V (Toys and Childcare
Article Products) HUHS products, the licensing and registration/notification of which are
covered by existing FDA guidelines and procedures specific for such HUHS product
categories, nor will it apply to Category I (Novel HUHS Products) HUHS products whose
product list includes the Vapor Products and Heated Tobacco Products currently
regulated by the Department of Trade and Industry (DTI) pursuant to Republic Act No.
11900.
The registration requirements contained in FC No. 2020-025 shall also NOT apply to the
following:
(a) HUHS products intended for donation;
(b) HUHS products imported for personal use;
(c) HUHS products intended for exhibit purposes;
(d) products intended exclusively for industrial use;
(e) products intended exclusively for use in agricultural setting;
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(f) products intended for other health-related/medical-related use covered by the other
Centers of the FDA (e.g. disinfectant products under the jurisdiction of Center for
Device Regulation, Radiation Health and Research);
(g) products directly applied on animals or pets; and
(h) raw materials used in the manufacture of HUHS products.
An illustrative list of Categories III and IV HUHS products subject to FDA’s regulatory
requirements under FC No. 2020-025 are provided in Tables 2.1 and 2.2, respectively.
Readers may also access the illustrative list of HUHS products by category from this link:
https://www.fda.gov.ph/wp-content/uploads/2021/04/HUHS-Product-Listing-2.pdf.
Note that these illustrative HUHS product lists are non-exhaustive. Other products not
included in the lists may still be subject to FDA’s registration requirements under FC No.
2020-025. HUHS establishments are referred to the decision matrix provided in Figure
2.1 to assist in identifying Categories III and IV HUHS products regulated under FC No.
2020-025.
In cases wherein the illustrative HUHS product lists found in Tables 2.1 and 2.2, and the
decision matrix in Figure 2.1 are not sufficient to determine whether a product is regulated
under FC No. 2020-025, HUHS establishment may inquire with the CCHUHSRR via
landline (+63 2 8 857 1900 local 8113/8107) or email (cchuhsrr.lrd.huhs@fda.gov.ph).
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Table 2.1 Illustrative List of Category III HUHS Product (Cleaners, Fresheners and
Deodorizers)
Chlorine Bleach
Oxygen Bleach
Bleaching Powder
Bleaches
Solid Bleach
Bleaching Textiles and Fur
Household Laundering and Sanitizing
Abrasive Cleaners (liquids and powders)

Non-Abrasive Cleaners (liquid, powder, spray)
Cleaners (i.e. corrosive,
Specialty Cleaners (kitchen, bathroom, glass and metal
multi-purpose, surface,
cleaners, floor and furniture cleaners)
etc.)
All-Purpose Cleaners
Corrosive Cleaners
Deodorizers Room Deodorizers
Dishwashing and Laundry Dishwashing Products (liquids, solid and powders)

Detergents/Soaps Detergents (liquid, powders, soaps)
Disinfectants (for surfaces) Surface Disinfectants (aerosols, liquids, powders)
Fabric Fabric Conditioner

Conditioners/Softeners and Fabric Softeners
Ironing Aids Ironing Aids
Fresheners (i.e. room, car, Fresheners (solid, liquids, and aerosols)

etc), Aromatics, Diffusers Scented Candles (candles)
Moisture Absorbing Agents

Silica Gels
(i.e. desiccant)
Wax (furniture and floor waxes)

Metal Polishes
Polishes
Leather and Shoe Polish
Oil, Water and Spirit-based Polishes
Sanitizers (TriChlor, DiChlor, bromine, cyanuric acid)

Oxidizers (chlorine, calcium hypochlorite, chlorine free
shock)
Water Balancers
pH Increaser (soda ash)
pH Reducers (sodium bisulfate)
Pool Chemicals Alkalinity Increases
Calcium Hardness Increaser (calcium chloride)
Chlorine Neutralizer (sodium thiosulfate)
Chemical Combo Packs
Specialty Chemicals (algaecides, clarifiers, enzymes, filter
cleaners, metal magnets, phosphate removers, stain
removers, tile and vinyl cleaner)
15
Table 2.2 Illustrative List of Category IV HUHS Products (Do-It-Yourself and Hobby
Items)
Contact Cement
Adhesives, Glues and Sealants
Sealants General Purpose Adhesives (households, floor, tiles,
surfaces)
Cleaners
Automotive, Furniture
Shampoo
and Jewelry Care, and
Waxes
Restoring Products
Jewelry Restoring Products
Button Batteries Button Cells
Crayons
Coloring Materials
Watercolors
Fabric Dyes
Fabric Dyes, Tattoo Dyes
Synthetic Fabric and Tattoo Dyes
Paints for Household and Facilities for Coating Purposes,

such as Waterproof Coating
Paints, Varnishes, and Varnishes
Thinners Paint Thinners
Lacquers
Furniture Maintenance Products
Paint Stripper
Paint Stripper
Paint Remover
Chemical Removers
Rust
Rust Converters
Remover/Degreasers
Chelating Agents
16
Figure 2.1 Decision Matrix to Identify Categories III and IV HUHS Products Regulated
Under FDA Circular No. 2020-025
17
(4) Categories III and IV HUHS products are further classified as either:
(a) Ready-to-Use, which refers to HUHS products that are ready to be used outright of
the packaging and for general purposes, which require no further dilution prior to
application. This term also refers to HUHS products that are diluted before use whose
application are NOT restricted to trained personnel or professionals.
(b) For Professional Use, which refers to HUHS products that are highly concentrated
requiring further dilution and are restricted only to be applied by trained personnel.
(5) HUHS products bearing brand and product names that are identical to those already
registered with FDA as HUHS, and/or which are offensive, obscene, scandalous or
otherwise contrary to public morals and policy are NOT allowed in accordance with AO
No. 2005-0016.
Hence, no two (2) HUHS products bearing the same brand and product name but
having different formulations are allowed to be registered at the same time nor is
an HUHS product allowed to be registered by two (2) different HUHS
establishments.
(6) The hazards of the HUHS product must be classified based on the Globally Harmonized
System of Classification and Labeling of Chemicals (GHS).
Because of the highly hazardous nature of chemicals classified as GHS Category 1 in any
physical, health or environmental hazard class, HUHS products classified as such require
proof of product safety under normal conditions of use during their initial product
registration. For more information on the documents that may be submitted to substantiate
product safety under normal conditions of use, proceed to the Claim Substantiation
section of this guide manual.
(7) Products having multiple uses regulated by FDA and other National Regulatory Agency
(i.e. Fertilizer and Pesticide Authority) must be registered with both regulatory authorities.
An example of such multiple-use product having other non-HUHS uses regulated by
another National Regulatory Agency are surface disinfectants also intended to be used in
agricultural setting.
(8) HUHS products must only have claims that are within the definition, scope and
intended use of HUHS. Non-HUHS claims and intended use including but not limited to
cosmetic, agricultural and industrial use are not allowed.
For HUHS products bearing additional household pesticide claims, these shall be
registered following the guidelines set forth in AO No. 2019-0008 and its future
amendments.
(9) HUHS products must be registered on a per formulation basis. HUHS products intended
to be marketed in multiple pack sizes and/or packaging materials (i.e. 10mL Sachet as
well as 150mL, 500mL and 1000mL HDPE Bottle) may be registered together in a single
initial HUHS product registration application, provided that all pack sizes and/or packaging
materials are declared in the application.
(10) HUHS products which have the same base formulation but differ in the fragrance and/or
colorant/s used are considered as variants and may be registered together in a single
18
initial HUHS product registration application, provided that all variants of the HUHS
products and their formulations are declared in the application. The initial HUHS product
registration application platform in FDA Electronic Portal V2.0 system (e-Portal 2)
accommodates up to a maximum of five (5) variants per application.
(11) HUHS products that have been banned or withdrawn in the country of
origin/source/manufacture are NOT allowed to be registered with FDA nor are they
allowed to enter the Philippine border.
(12) Applications for HUHS product registration are submitted through e-Portal 2 accessible at
https://eportal2.fda.gov.ph following the registration procedure provided in FC No. 2023-
006 and detailed in the Initial HUHS Product Registration in FDA Electronic Portal V2.0
System section of this guide manual.
(13) Applications for initial HUHS product registration must be accompanied by the following
documentary requirements as provided in Annex E of FC No. 2020-025:
(a) Declaration and Oath of Undertaking (embedded in the online application platform)
(b) Accomplished Application Form (embedded in the online application platform)
(c) Safety Data Sheet (SDS) of the HUHS Product (in GHS format)
(d) Certificate of Analysis (COA) of the Finished Product
(e) Documentation to substantiate product claims that are within the scope of HUHS, if
applicable
(f) Clear and complete loose labels or artworks of all packaging sizes, as applicable, in
Filipino or English language (in .png format)
(g) Pictures of the product in all angles and in different packaging sizes, allowing visual
recognition of a product similar to the one being registered
(h) Payment of fees
The current schedule of fees for HUHS product registration is based on AO No. 50 s.
2001, subject to a Legal Research Fund (LRF) of 1% of the computed fee or Php 10.00
whichever is higher, and is listed in Table 2.3.
Table 2.3 Schedule of Fees for Initial HUHS Product Registration Depending on the
Number of Years of CPR Validity Applied For
Years of CPR Validity Fees and Charges LRF
Php 1,000.00 1% of the total fees and

2 years
+ 200 per additional variant charges
Php 1,500.00 1% of the total fees and

3 years
+ 300 per additional variant charges
(14) Depending on the evaluation of the submitted application, the final result of an initial HUHS
product registration application may either be approved or disapproved.
A marketing authorization in the form of a CPR is issued to initial HUHS product

registration applications that satisfactorily complied with all applicable FDA requirements
and standards. The back of the CPR contains the list of post-approval conditions that must
be complied with by the HUHS establishment at the end of the transitory period or during
CPR renewal.
19
For initial HUHS product registration applications that have NOT satisfactorily complied
with all applicable FDA requirements and standards, a Letter of Disapproval (LOD) is
issued. Pursuant to FC No. 2020-025, the following instances are grounds for the
disapproval of an initial HUHS product registration application:
(a) The application requirements show that the establishment does not meet the required
technical requirements or appropriate standards;
(b) The applicant made misrepresentations, false entries, or withheld any relevant data
contrary to the provisions of the law, existing FDA rules and regulations, or appropriate
standards;
(c) The holder or owner has violated any of the terms and conditions of its license,
registration or authorization;
(d) The label of the health product is false and misleading or does not conform with current
labeling requirements;
(e) Such other analogous grounds or causes as determined by the FDA.
(15) Variation in the circumstances of a registered HUHS product involving changes in the
address of the manufacturer and/or product formulation requires an initial HUHS product
registration application.
(16) FDA regulations on HUHS extend beyond securing the appropriate marketing
authorization for HUHS products intended to be placed in the market. Marketing
Authorization Holders (MAH) are responsible for the continued compliance of their
registered HUHS products with existing FDA laws, rules, regulations and applicable
adopted standards as well as in ensuring the safety, efficacy and quality of their HUHS
products. The list of adopted standards for HUHS products are found in Table 2.4 and
Annex G of FC 2020-025. For more information on the post-registration
obligations/responsibilities of MAH, readers are referred to FC No. 2020-025.
20
Table 2.4 List of Adopted Standards for HUHS Products

Philippine National Standards (PNS)
PNS 461:1991 PNS 2044:2005
PNS 562:1992 PNS ASTM D 2022-2007
PNS 48:1994 PNS ASTM C 1311:2011
PNS 10:2002 PNS 1994:2012
Issuances and Standards Emanating from Laws Governing Other National
Government Agencies
PD 442 RA 9165
RA 6969 RA 9514
RA 7394 RA 8970
Joint DTI-DENR-DA-DOF-DILG-DOLE-
DOTC Administrative Order No. 01 series
of 2009
International Conventions, Treaties and Protocols
Montreal Protocol on Substances That Deplete the Ozone Layer
Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and
Their Disposal
Chemical Weapons Convention
Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous
Chemicals and Pesticides in International Trade
Stockholm Convention on Persistent Organic Pollutants
Minamata Convention on Mercury
Internationally-Acceptable Standards Based on:
Association of Southeast Asian Nations
European Union
Food and Agriculture Organization of the United Nations
International Agency for Research on Cancer
International Organization for Standardization
Organization for Economic Co-operation and Development
U.S. Consumer Product Safety Commission
U.S. Environmental Protection Agency
World Health Organization
21
Information on the Technical Requirements

A. Product Formulation
(1) HUHS products must NOT contain substances banned or prohibited in accordance with
the following international standards:
(a) Stockholm Convention
(b) ASEAN Cosmetic Directive (ACD) Annex II (applicable only for HUHS products with
skin exposure under normal conditions of use)
(c) FDA Advisory No. 2021-0879 (Ban of Silver Jewelry Cleaners Containing Cyanide)
(2) HUHS products are generally not allowed to contain any carcinogenic, mutagenic,
reprotoxic (CMR) ingredients. However, since CMRs, according to the GHS, are classified
into multiple hazard categories depending on the strength of available evidence and
application of weight of evidence approach, and in consideration of the fact that there are
instances wherein the use of a CMR ingredient in a HUHS product is sufficiently proven
to be safe and without undue health risks, HUHS products containing CMR ingredient/s
may be allowed to be registered without additional documentary requirements, provided
that the:
(a) CMR ingredient/s does not exceed the cut-off value/concentration limit specified in
their respective GHS hazard class chapters that would trigger the classification of the
HUHS product as GHS CMR Category 1, and
(b) HUHS product is not classified as GHS CMR Category 1A/B.
Should the HUHS product be classified as GHS CMR Category 1A/B based on available
test data on the product itself or based on the presence of GHS CMR 1A/B ingredients in
concentrations exceeding the specific cut-off value/concentration limit, proof of product
safety under normal conditions of use (i.e. risk assessment) must be submitted as part of
the initial HUHS product registration application. Particularly for HUHS products classified
as GHS Carcinogenic Category 1A/B based on available test data on the product itself or
based on the presence of GHS Carcinogenic Category 1A/B ingredients in concentrations
beyond the GHS cut-off value/concentration limit, proof of product safety must show
negligible carcinogenic risk to exposed population (i.e. Excess Lifetime Cancer Risk = 10-
6
).
HUHS industry may use the following international databases as sources of information
as to a chemical’s GHS hazard classification:
(a) European Chemicals Agency C&L Inventory
(b) ECHA Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
(c) Japan National Institute of Technology and Evaluation
(d) International Agency for Research on Cancer (IARC) Monographs for carcinogens
Because the classification of carcinogenic chemicals under IARC is different from the
one used in GHS, Table 2.5 contains the IARC and GHS equivalency table for
carcinogens.
Table 2.5 Classification of Carcinogens Under IARC and their Equivalents in GHS
IARC GHS
Group 1 – Carcinogenic to Humans Category 1A
Group 2A – Probably Carcinogenic to Humans Category 1B
Group 2B – Possibly Carcinogenic to Humans Category 2
22
(3) The use of restricted ingredients in HUHS products must comply with the set restrictions
or conditions of use. Restricted ingredients are found in the following:
(a) Annex XVII to REACH Regulation
(b) ACD Annex III and VI (applicable only for HUHS products with skin exposure under
normal conditions of use)
(4) HUHS products containing GHS Category 1 chemicals/ingredients in any health hazard
class other than those listed in Item (2) or in any environmental hazard class in
concentrations that would trigger the classification of the finished product as GHS
Category 1 are not allowed to be registered, unless proof of product safety under normal
conditions of use can be provided. For documents that may be submitted to substantiate
product safety under normal conditions of use, proceed to the Claim Substantiation section
of this guide manual.
B. Globally Harmonized System of Classification and Labeling of

Chemicals
Consistent with the adoption of the Globally Harmonized System of Classification and Labelling
of Chemicals (GHS) for the following sectors: agriculture, industrial chemicals,
workplace/production, transport and consumer products through the issuance of Joint DTI-
DENR-DA-DOF-DOH-DILG-DOLE-DOTC AO No. 01, series of 2009, items 14.3.6.2 and
14.3.6.3 under Section V of FC No. 2020-025 require the hazards of the HUHS products to be
classified according to GHS and in cases where the HUHS product meets the GHS hazard
criteria, to include in the labels the appropriate GHS label elements (pictogram, signal word
and hazard statement).
GHS is an international system that harmonizes hazard classification and the communication
of such hazards. As seen in Figure 2.2, it is a logical and comprehensive approach to:
(1) defining the physical, health and environmental hazards of chemicals;
(2) applying agreed hazard criteria to classify chemicals based on their hazardous effects;
and
(3) communicating hazard information on labels and SDS.
GHS has been developed in order to improve chemical safety and health through the provision
of consistent and comprehensive information on the hazards of chemicals based on a
harmonized classification criteria and appropriate protective measures through hazard
communication tools such as labels and SDS.
At present, the Center, together with other GHS-implementing regulatory agencies, is adopting
the 8th revised edition of the GHS Purple Book for implementation. Readers may access a copy
of the 8th revised edition of the GHS Purple Book through the following links:
 https://unece.org/fileadmin/DAM/trans/danger/publi/ghs/ghs_rev08/ST-SG-AC10-30-
Rev8e.pdf
 https://www.fda.gov.ph/wp-content/uploads/2022/04/Globally-Harmonized-System-of-
Classification-and-Labelling-of-Chemicals-GHS-8th-rev.-ed..pdf
The GHS Purple Book is divided into the following four (4) parts:
(1) Part 1: Introduction - outlines the purpose, scope and application of GHS as well as
provides the definition of terms and general information on hazard classification and
communication including labeling and SDS
(2) Part 2: Physical Hazards – chapters containing the different physical hazard classes
(3) Part 3: Health Hazards – chapters containing the different health hazard classes
23
(4) Part 4: Environmental Hazards – chapters containing the different environmental hazard
classes
Hazard Hazard Hazard

Indentification Classification Communication
Figure 2.2 Application of the Globally Harmonized System of Classification and

Labeling of Chemicals (GHS). The GHS is a logical approach to the identification and
assessment of the intrinsic physical, health and environmental hazards of a chemical
using available relevant data, classifying said chemical based on these intrinsic hazards
by applying the GHS hazard criteria and then conveying this information on chemical
hazards to end-users through hazard communication tools.
General Information on Hazard Classification
Under the GHS, there are three (3) main group of hazards - Physical, Health and
Environmental hazards. Within each hazard group, there are a number of hazard classes.
Hazard class is the nature of the physical, health or environmental hazard. Table 2.6 lists the
twenty-nine (29) hazard classes in GHS.
Table 2.6 Different Hazard Classes Under Physical, Health and Environmental Hazard
According to the Globally Harmonized System of Classification and Labeling of
Chemicals
Hazard Classes Under Hazard Classes Under Hazard Classes Under
Physical Hazard (17) Health Hazard (10) Environmental Hazard (2)
 Explosives  Acute Toxicity  Hazardous to the
 Flammable Gases (Oral/Dermal Aquatic Environment
 Aerosols and Chemicals /Inhalation) (Acute/Chronic)
Under Pressure  Skin  Hazardous to the
 Oxidizing Gases Corrosion/Irritation Ozone Layer
 Gases Under Pressure  Serious Eye
 Flammable Liquids Damage/Eye Irritation
 Flammable Solids  Respiratory or Skin
 Self-Reactive Substances Sensitization
and Mixtures  Germ Cell
 Pyrophoric Liquids Mutagenicity
 Pyrophoric Solids  Carcinogenicity
 Self-Heating Substances  Reproductive Toxicity
and Mixtures  Specific Target Organ
 Substances which, in Toxicity - Single
contact with water, emit Exposure
flammable gases  Specific Target Organ
 Oxidizing Liquids Toxicity - Repeated
 Oxidizing Solids Exposure
 Organic Peroxides  Aspiration Hazard
 Corrosive to Metals
 Desensitized explosives
24
Hazard classes are then divided into hazard categories. A hazard category is the division of
the criteria within a hazard class meant to be an indication of the degree of severity. As an
illustration, Table 2.7 presents the five (5) hazard categories of Acute Toxicity
(Oral/Dermal/Inhalation) based on the division of the hazard criteria which is the Acute Toxicity
Estimate (ATE).
Table 2.7 Hazard Criteria for GHS Acute Toxicity (Oral/Dermal/Inhalation) and Its Five (5)
Hazard Categories (Adapted from Table 3.1.1 of the 8th Revised Edition of the GHS)
Exposure Route Category 1 Category 2 Category 3 Category 4 Category 5
Oral (mg/kg
ATE ≤ 5 5 < ATE ≤ 50 50 < ATE ≤ 300 300 < ATE ≤ 2000
bodyweight) 2000 < ATE
≤ 5000
Dermal (mg/kg
ATE ≤ 50 50 < ATE ≤ 200 200 < ATE ≤ 1000 1000 < ATE ≤ 2000
bodyweight)
Gases (ppmV) ATE ≤ 100 100 < ATE ≤ 500 500 < ATE ≤ 2500 2500 < ATE ≤ 20000
Vapours (mg/l) ATE ≤ 0.5 0.5 < ATE ≤ 2.0 2.0 < ATE ≤ 10.0 10.0 < ATE ≤ 20.0
Dusts and Mists

ATE ≤ 0.05 0.05 < ATE ≤ 0.5 0.5 < ATE ≤ 1.0 1.0 < ATE ≤ 5.0
(mg/l)
In a number of hazard classes, a hazard category is subdivided into subcategories to

differentiate based on potency. To illustrate, Table 2.8 presents Category 1 of GHS Skin
Corrosion/Irritation which is divided into three (3) subcategories based on the rapidity of
corrosive response after exposure.
Table 2.8 Hazard Criteria for GHS Skin Corrosion/Irritation Category 1 and Its
Subcategories (Table 3.2.1 of the 8th Revised Edition of the GHS)
Criteria
Destruction of skin tissue, namely, visible necrosis through the
Category 1 epidermis and into the dermis, in at least one tested animal after
exposure ≤ 4 h
Corrosive responses in at least one animal following exposure ≤ 3
Sub-category 1A
min during an observation period ≤ 1h
Corrosive responses in at least one animal following exposure > 3
Sub-category 1B
min and ≤ 1 h and observations ≤ 14 days
Corrosive responses in at least one animal after exposures > 1 h and
Sub-category 1C
≤ 4 h and observations ≤ 14 days
However, it should be noted that not all GHS hazard classes are divided into hazard categories.
In some physical hazard classes, instead of hazard categories, terms such as groups (i.e.
Gases under Pressure) and types (i.e. Self-reactive Substances and Mixtures) are used to
differentiate within a hazard class.
To aid the HUHS establishment in the classification of their HUHS products according to GHS,
a decision logic is incorporated into each of the hazard class chapter in the GHS Purple Book.
A decision logic is a graphical display of the classification process for a particular hazard
class that aims to assist in hazard classification by ensuring that all steps of the classification
process are followed. Hence, the HUHS establishment, in the classification of their HUHS
products, are advised to refer to these decision logics.
25
Figure 2.3 presents GHS Decision Logic 2.6 for flammable liquids. After determining the flash
point and initial boiling point of a chemical, the chemical can be classified for GHS Flammable
Liquid using Decision Logic 2.6.
Figure 2.3 Decision Logic for GHS Flammable Liquid (Decision Logic
2.6 from the 8th Revised Edition of the GHS). The first step in the
classification process is to determine whether a chemical is a liquid. If the
answer is yes, proceed to the 2nd step - determining whether the chemical
has a flash point of ≤ 93°C. If the answer is no, the chemical is not classified
as GHS Flammable Liquid. If the answer is yes, proceed to the 3rd step –
determining whether the chemical has a flash point > 60°C. If the answer is
yes, the chemical is classified as GHS Flammable Liquid Category 4. If the
answer is no, proceed to the next step. The classifier goes through all the
steps in the decision logic until a final GHS classification for Flammable
Liquid is reached.
In the classification of chemical mixtures, where test data is available for the mixture itself,
classification will always be based on such test data. For physical hazard classes, chemical
mixtures are classified the same way a chemical substance is classified – through testing. GHS
has identified appropriate test methods that should be used to obtain relevant data needed for
classification. For health and environmental hazard classes, on the other hand, the GHS is test
method neutral, provided that tests are conducted according to internationally recognized
scientific principles.
26
Where test data on the chemical mixture is not available, the GHS classification process allows
the use of available information on a similar tested mixture for certain hazard classes. This is
called bridging principle. GHS bridging principles includes dilution, batching, concentration
of highly toxic mixtures, interpolation within one toxic category, substantially similar mixtures
and aerosols. Hazard classes that allow the use of bridging principles to classify a chemical
mixture will have a section in their respective chapters in the GHS Purple Book dedicated to
bridging principles.
Where test data on the chemical mixture itself or a similar mixture are not available, the GHS
classification process allows the use of available information on the individual ingredients to
classify a chemical mixture for certain hazard classes. This is based on the general premise
that the less amount of a hazardous substance present in a chemical mixture, the less likely
the chemical mixture is going to pose a particular hazardous effect. Under the GHS, there are
three (3) types of calculations whereby a chemical mixture can be classified based on known
ingredient information:
(1) Cut-off value or concentration limit, where a chemical mixture is classified or meets the
hazard criteria for classification if the concentration of at least one ingredient having a
certain hazard category exceeds a set cut-off value or concentration limit (i.e.
Carcinogenicity)
(2) Summation method (based on the theory of additivity), where a mixture is classified
or meets the hazard criteria for classification if the total sum concentration of the
ingredients having a certain hazard category exceeds a threshold classification cut-off
value (i.e. Skin Corrosion/Irritation)
(3) Proportional calculation, where the toxicity of the mixture is calculated using the toxicity
of each ingredient and their respective concentration in the mixture
When classifying chemical mixtures based on known information of its individual ingredients
using summation or proportional calculation, care must be taken in determining the relevant
ingredients. Applicants are advised to refer to the respective hazard class chapters in the
GHS Purple Book for a detailed discussion on the relevant ingredients that must be taken into
consideration when classifying a chemical mixture using known information on its individual
ingredients.
General Information on Hazard Communication
The GHS hazard communication aims to provide consistent and comprehensive hazard
information and appropriate protective measures to end-users. The hazard communication
tools in GHS include the label and SDS.
Label
Annex J of FC No. 2020-025 incorporates the three (3) GHS label elements into the minimum
mandatory information that must be printed on the label of HUHS products not intended for the
use of children – signal word, pictogram/s and hazard statement/s. These GHS label elements
must be located together in the label consistent with the provisions of the GHS.
The term GHS label elements refer to the following:

(1) pictograms, which are graphical composition that may include a symbol plus other graphic
elements such as border, background pattern or color that is intended to convey specific
information. Pictograms prescribed by the GHS should have a black symbol on a white
background with a red frame in the shape of a square set at a point sufficiently wide to be
clearly visible. Table 2.9 presents the nine (9) GHS pictograms their codes and name.
27
(2) signal word, which is a word used to indicate the relative level of severity of a hazard and
alert the end-users to a potential hazard. GHS uses Danger and Warning as signal words.
(3) hazard statement, which are statements assigned to a particular hazard class and
category that describe the nature of the chemical hazard, including, where appropriate, the
degree of hazard. Section 1 of GHS Annex 3 lists the different hazard statements, their codes
and the hazard class and category where they are assigned.
Table 2.9 GHS Pictograms and Their Corresponding Codes and Names (Table A3.4.1
from the 8th Revised Edition of the GHS)
CODE HAZARD PICTOGRAM SYMBOL
GHS01 Exploding bomb
GHS02 Flame
GHS03 Flame over circle
GHS04 Gas cylinder
GHS05 Corrosion
GHS06 Skull and crossbones
GHS07 Exclamation mark
GHS08 Health hazard
GHS09 Environment
Once a chemical has been classified into a specific hazard category, the appropriate GHS
label elements can be determined as each hazard category is assigned its own signal word,
pictogram and hazard statement.
28
However, classification in multiple hazard classes can occur for chemicals particularly for
mixtures due to the presence of different chemical substances having their own intrinsic
hazardous properties. To determine the appropriate GHS label elements in such cases, the
GHS has set out rules of precedence in the allocation of hazard information. The following
arrangements shall apply, as applicable, in chemicals classified in multiple hazard classes:
(1) Precedence for the allocation of pictograms for health hazards

(a) If the skull and crossbones symbol applies, the exclamation mark should not appear
(b) If the corrosive symbol applies, the exclamation mark should not appear where it is used
for skin or eye irritation
(c) If the health hazard symbol appears for respiratory sensitization, the exclamation mark
should not appear where it is used for skin sensitization or for skin or eye irritation
(2) Precedence for the allocation of signal words

(a) If the signal word “DANGER applies, the signal word “Warning” should not appear
(3) Precedence for allocation of hazard statements

(a) If the statement H410 "Very toxic to aquatic life with long lasting effects” is assigned, the
statement H400 “Very toxic to aquatic life” may be omitted;
(b) If the statement H411 “Toxic to aquatic life with long lasting effects” is assigned, the
statement H401 “Toxic to aquatic life” may be omitted;
(c) If the statement H412 “Harmful to aquatic life with long lasting effects” is assigned, the
statement H402 “Harmful to aquatic life” may be omitted;
(d) If the statement H314 “Causes severe skin burns and eye damage” is assigned, the
statement H318 “Causes serious eye damage” may be omitted.
In addition to the above rules of precedence in the allocation of hazard statements, Table
A3.1.2 in Annex 3 of the 8th revised edition of GHS includes specific combinations of hazard
statements that may be used.
Safety Data Sheet (SDS) of the HUHS Product
SDS is a document compiled by the chemical supplier that provides detailed information on
the chemical including its identity, chemical composition, physical characteristics, hazard
classification, (eco) toxicological information and measures for safe handling, storage and
disposal as well as accidental release and personal protection measures, among others.
Under the current regulatory guidelines of the FDA, an SDS is required for all HUHS products.
For HUHS products with multiple variants, applicants may opt to prepare only one (1) SDS,
provided that all the variants covered by said SDS are clearly identified and that the information
contained within the document applies to all the variants.
In the preparation of the SDS, the minimum information required by GHS must be presented
under the relevant heading/section (n=16), where applicable and available, in the order
provided in Table 2.10. The SDS should not contain any blank space; where information is not
available or lacking, this should be clearly stated. For a detailed guide on SDS preparation,
readers are advised to refer to Chapter 1.5 and Annex 4 of the 8th revised edition of the GHS.
29
Table 2.10. Minimum Information for Safety Data Sheets (SDS) (Adapted from Table 1.5.2
of the 8th Revised Edition of GHS
SECTION CONTENT
1 Identification of
the a. GHS product identifier
Substances or b. Other means of identification
Mixture and of c. Recommended use of the chemical and restrictions on use
the Supplier d. Supplier’s details (including name, address, phone number, etc.)
e. Emergency phone number
Note: The supplier identified in this section may be the product

manufacturer or any of the suppliers declared in the application form
including the applicant. Should this not be the case, a
clarification/justification letter may be submitted.
2 Hazard(s)
Identification a. GHS classification of the substance/mixture and any national or
regional information
b. GHS label elements, including precautionary statements. (Hazard
symbols may be provided as a graphical reproduction of the
symbols in black and white or the name of the symbol, e.g.
“flame”, “skull and crossbones”)
c. Other hazards which do not result in classification (e.g. “dust
explosion hazard”) or are not covered by the GHS.
Note: For HUHS products whose hazards have been classified

according to GHS, all the GHS precautionary statements appropriate
for the product based on its hazard classification/s must be included
(refer to Annex 3 Section 3 of the 8th revised edition of the GHS for
the precautionary statements assigned to each GHS hazard
(sub)category). Should this not be the case, submit either:
a. justification for the omission consistent with A3.2.5.1.1 of the
8th revised edition of the GHS, or
b. letter of commitment to update the submitted SDS during CPR
renewal (note that this is only accepted until such time the
CCHUHSRR issues its GHS implementing guidelines).
3 Composition / Mixture
Information on The chemical identity and concentration ranges of all ingredients
Ingredients which are hazardous within the meaning of the GHS and are present
above their cut-off levels.
In case the HUHS product is a substance:
a. Chemical identity
b. Common name, synonyms, etc.
c. CAS number and other unique identifiers
d. Impurities and stabilizing additives which are themselves
classified and which contribute to the classification of the
substance
30
4 First-Aid a. Description of necessary measures, subdivided according to the

Measures different routes of exposure (i.e. inhalation, skin and eye contact
and ingestion)
b. Most important symptoms/effects, acute and delayed
c. Indication of immediate medical attention and special treatment
needed, if necessary
5 Fire-Fighting a. Suitable (and unsuitable) extinguishing media
Measures b. Specific hazards arising from the chemical (e.g. nature of any
hazardous combustion products)
c. Special protective equipment and precautions for fire-fighters
6 Accidental a. Personal precautions, protective equipment and emergency
Release procedures
Measures b. Environmental precautions
c. Methods and materials for containment and cleaning up
7 Handling and a. Precautions for safe handling
Storage b. Conditions for safe storage, including any incompatibilities
8 Exposure a. Control parameters (e.g. occupational exposure limit values or
Controls / biological limit values)
Personal b. Appropriate engineering controls
Protection c. Individual protection measures, such as personal protective
equipment
9 Physical and a. Physical state
Chemical b. Colour
Properties c. Odour
d. Melting point / freezing point
e. Boiling point or initial boiling point and boiling range
f. Flammability
g. Lower and upper explosion limit / flammability limit
h. Flash point
i. Auto-ignition temperature
j. Decomposition temperature
k. pH
l. Kinematic viscosity
m. Solubility
n. Partition coefficient: n-octanol/water (log value)
o. Vapour pressure
p. Density and/or relative density
q. Relative vapour density
r. Particle characteristics
10 Stability and a. Reactivity
Reactivity b. Chemical stability
c. Possibility of hazardous reactions
d. Conditions to avoid (e.g. static discharge, shock or vibration)
e. Incompatible materials
f. Hazardous decomposition products
31
11 Toxicological Concise but complete and comprehensible description of the various

Information toxicological (health) effects and the available data used to identify
those effects, including:
a. Information on the likely routes of exposure (inhalation, ingestion,
skin and eye contact)
b. Symptoms related to the physical, chemical and toxicological
characteristics
c. Delayed and immediate effects and also chronic effects from
short- and long-term exposure
d. Numerical measures of toxicity (such as acute toxicity estimates)
12 Ecological a. Ecotoxicity (aquatic and terrestrial, where available)
Information b. Persistence and degradability
c. Bioaccumulative potential
d. Mobility in soil
e. Other adverse effects
13 Disposal Description of waste residues and information on their safe handling
Considerations and methods of disposal, including the disposal of any contaminated
packaging
14 Transport a. UN Number
Information b. UN proper shipping name
c. Transport hazard class(es)
d. Packing group, if applicable
e. Environmental hazards (e.g. Marine pollutant (Yes/No))
f. Transport in bulk according to IMO instruments
g. Special precautions which a user needs to be aware of or needs
to comply with in connection with transport either within or outside
their premises
15 Regulatory Safety, health and environmental regulations specific for the product
Information in question
16 Other
Information a. Information relevant to the preparation (and revision) of the SDS
(e.g. date of preparation/latest revision, changes that have been
made to the previous version in case of SDS revision)
b. Key/legends to abbreviations and acronyms used in the SDS
c. Key literature references and sources of data used to compile the
SDS (optional)
C. Certificate of Analysis (COA)

The COA is a document a manufacturer prepares each time it produces a specific batch/lot
that verifies the conformance of the manufactured products with set product technical
specifications. As such, results of the tests conducted on the manufactured product batch/lot
must show that the manufactured products are within the established acceptance criteria or
specifications. Note that for HUHS products with multiple components (i.e. crayons) in a single
packaging, each component (i.e. color) must undergo testing as part of quality assurance.
For initial registration purposes, applicants may submit one (1) COA for HUHS products with
multiple packaging presentation and/or size. However, for HUHS products with multiple
variants, one (1) COA for each declared variant shall be submitted. All COAs must reflect the
following minimum information:
32
(1) Brand and product name including the variant name, if any
(2) Batch/lot/SKU/Item no., manufacturing date, expiration date or date of analysis
(3) Name and/or logo of the company that conducted the tests (may be the product
manufacturer or a third-party laboratory)
(4) Name and signature of the laboratory analyst
(5) Name and signature of the laboratory manager or quality assurance (QA)
(6) Technical specifications of the HUHS product
(7) Actual Test Results, which must be in numerical values for quantitative tests
An example of an acceptable COA is presented in Figure 2.4. However, note that special
considerations are given to the following COAs and are accepted for initial registration
purposes:
(1) electronically-generated COA without the signatures of the laboratory analyst and manager,
provided that the document has been proven to be valid without the signatures, and
(2) COAs without the name and signature of the laboratory analyst, provided that a document
showing proof of adherence to written procedure has been submitted.
CERTIFICATE OF ANALYSIS
Product Name: ABC Multi-purpose Cleaner

Lot No.: 20220705HUHSA
Manufacturing Date: July 05, 2022
Expiration Date: July 05, 2024
Date of Analysis: July 05, 2022
Parameter Standard Result Test Method

Appearance Clear Liquid Clear Liquid Organoleptic
Color Colorless Colorless Organoleptic
Odor Cucumber Scent Cucumber Scent Organoleptic
pH @25°C 1.50 +/- 0.5 1.65 Mettler Toledo pH/Ion
S220
Specific Gravity 1.05 +/- 0.5 1.07 25mL Pycnometer
Remarks: PASSED
Analyzed by:
Precious Pearl D. Ramos, RChE

QA Analyst
Checked by:
Ma. Christina D. Ledesma, RPh

QA/QC Supervisor
Figure 2.4 A Sample of an Acceptable Certificate of Analysis (COA)
33
D. Claim Substantiation
Annex E of FC No. 2020-025 lists the documentary requirements that must be part of an initial
HUHS product registration application, one of which is the documentation to substantiate
product claims that are within the scope of HUHS. Hence, HUHS products for registration are
not allowed to have claims that are beyond the definition, scope and intended use of HUHS
and which are not adequately substantiated.
Documents submitted to support HUHS claims must be based on scientifically-sound evidence

and/or come from reliable and competent authorities. Depending on the specific claim,
substantiation documents may be:
(1) Peer-reviewed journals on the properties of the active ingredient;

(2) Peer-reviewed journals on the properties of similarly formulated HUHS products;
(3) Certifications from competent/qualified authorities or groups (i.e. professional
associations, accredited certifying bodies, regulatory agencies);
(4) Reports of laboratory tests/analyses conducted on the HUHS product for registration in
accordance with internationally accepted standards or validated test methods; or
(5) Reports of surveys or well-controlled studies (preferably conducted by 3rd party entities to
avoid conflict of interest).
It should be noted that the HUHS establishment or applicant is responsible for ensuring that
the submitted substantiation documents are relevant, appropriate and sufficient to support the
HUHS product claim.
Table 2.11 lists a number of HUHS product claims and the corresponding supporting
documents deemed acceptable to substantiate said claim.
34
Table 2.11 Examples of HUHS Product Claims and the Documents Acceptable to Support Said Claims
HUHS Claim Acceptable Substantiation Document
(1) Claims against bacteria, Qualitative claim except viricidal claims (i.e. kills bacteria and fungi):
fungi and virus (a) Peer-reviewed journals on the properties of the active ingredient/s or a similarly formulated HUHS product,
taking into consideration the percent (%) concentration of the active ingredient/s, target organisms and the
exposure time.
(b) Reports of laboratory tests conducted on the HUHS product or a similarly formulated HUHS product (i.e.
variants of the HUHS product) in accordance with internationally accepted standard references or validated test
method, taking into consideration the recommended dilution rate, if any, target organisms and exposure time.
Quantitative claims (i.e. kills 99.99% bacteria) and qualitative claims of viricidal activity (i.e. antiviral
activity against SARS-CoV-2):
(a) Reports of laboratory tests conducted on the HUHS product or a similarly formulated HUHS product (i.e.
variants of the HUHS product) in accordance with internationally accepted standards or validated test method,
taking into consideration the recommended dilution rate, if any, target organisms and exposure time. If available
test data of a similarly formulated HUHS product is used to substantiate a quantitative claim, justification for the
bridging of data must be submitted.
An example of an internationally accepted standard is the US EPA Product Performance Test Guidelines OCSPP
810.2200 Disinfectants for Use on Environmental Surfaces Guidance for Efficacy Testing. According to the
standard, the following microorganisms are used during efficacy testing depending on the HUHS product claim:
Bacteria Representative Gram Positive (Staphylococcus aureus)
Representative Gram Negative (Salmonella enterica or Pseudomonas aeruginosa)
For institutional/hospital use:

Representative Gram Positive (Staphylococcus aureus)
Representative Gram Negative (Pseudomonas aeruginosa)
In case of claims against specific bacteria, the product shall be tested against the identified
bacteria.
Tuberculoidal Mycobacterium bovis
Fungus Trichophyton interdigitale
Virus Virus claimed on the label
Note: HUHS product claiming viricidal activity must identify on its label the specific virus
against which the product has been tested and proven to be effective.
For sporicidal claims, tests organisms that can be used in efficacy testing are Bacillus subtilis and Clostridium
sporogenes.
35
(2) Product shelf-life (in Report of stability study conducted on the HUHS product. For HUHS products with multiple declared packaging
cases where there is an presentation / material and/or variants, one (1) stability study report must be submitted per packaging presentation
indication of an expiry / material and/or per variant. The submitted reports must indicate the following information:
date in any of the (a) Product Information (brand/product/variant name, batch/lot number, manufacturing date, packaging
submitted document or presentation / material, in case there are multiple packaging presentation / material)
on the HUHS product (b) test duration, environmental conditions under which the product has been stored and testing interval
itself) (c) technical specifications of the HUHS product
(d) test results (results for quantitative tests must be in numerical values)
(e) conclusion
(f) name and signature of the laboratory analyst and manager
To substantiate a claimed product shelf-life, the HUHS establishment may conduct an accelerated or a real-time
stability study. For real-time stability studies, these must be conducted locally or in an environment with similar
climatic conditions as the Philippines.
In selecting which type of study to conduct, the HUHS establishment must take into consideration their knowledge
of the HUHS product including but not limited to its physico-chemical properties, and determine whether the
extreme environmental conditions used in an accelerated stability study would be appropriate (i.e. will it negatively
affect the stability of the HUHS product) or would a real-time stability study be more suitable.
For accelerated stability study, the US EPA and FAO/WHO have used the following testing conditions which are
equivalent to 2-year shelf-life:
(a) 54 ± 2°C for 14 days
(b) 50 ± 2°C for 4 weeks
(c) 45 ± 2°C for 6 weeks
Note that during the transitory period provided in FC No. 2021-011-A, for initial product registration, HUHS
establishments are allowed to submit either a stability study report to substantiate the claimed product shelf-life or
a self-declaration of product shelf-life with a commitment to provide the complete stability data during CPR
renewal.
36
(3) Product Safety Under GHS Category 1 in any physical hazard class as well as Skin Corrosion/Irritation and Serious Eye Damage/Eye Irritation
Normal Conditions of (a) Presence of appropriate GHS precautionary statements and sufficient instructions for safe handling, storage and
Use (for HUHS products disposal on the HUHS product label
classified as GHS (b) Use of child-resistant packaging
Category 1 in any (c) less severe GHS classification of diluted solution (in cases where dilution is required prior to use)
hazard class)
GHS Category 1 in any environmental hazard class
(a) Presence of appropriate GHS precautionary statements and sufficient instructions for safe handling, storage and
disposal on the HUHS product label
GHS Category 1 in any health hazard class other than Skin Corrosion/Irritation and Serious Eye Damage/Eye Irritation
(a) Risk Assessment prepared in accordance with internationally accepted references/guidelines (i.e. WHO Human
Health Risk Assessment Toolkit: Chemical Hazards)
(b) Exposure studies showing negligible direct/indirect human exposure to the HUHS product under normal conditions
of use.
(c) COA of the Raw Material of Concern, if the GHS Category 1 classification of the HUHS product is triggered by the
presence of GHS Category 1 contaminant in the raw material (i.e. 1,3-butadiene contaminant in Butane/Isobutane)
(d) IFRA certificate, if the fragrance material triggered the classification of the HUHS product as GHS Category 1
(4) Market-based claims or Reports of market surveys conducted including the methodology used; preferably conducted by 3rd party entities to
those related to the eliminate bias
popularity of the HUHS
product (i.e. No. 1
Brand)
(5) Comparative claims (i.e. Reports of comparative studies conducted including the methodology used; preferably conducted by 3 rd party entities to
cleans 2x more than the eliminate bias
old formula)
(6) Halal Certifications from accredited halal-certifying bodies
(7) Biodegradability Report of biodegradability tests conducted in accordance with internationally accepted standards (i.e. OECD Test
Guidelines 301 or 306)
(8) Plant-based, nature- Claims on the ingredient:
based, organic and such Certifications from the supplier of the raw material that the chemicals used in the production of the raw material is plant-
other similar claims based, organic and such other similar claim used.
Claims on the HUHS product:

Certification from accredited organic-certifying bodies
(9) Age Grading Report of age grading test conducted in accordance with internationally-accepted standards (i.e. CPSC Age
Determination Guidelines: Relating Consumer Product Characteristics to the Skills, Plays Behaviors, and Interests of
Children, 2020)
37
E. HUHS Product Labeling and Packaging

(1) Labels of HUHS products must reflect the mandatory label information prescribed in Annex
J of FC No. 2020-025 including the GHS label elements (i.e. pictograms, signal word and
hazard statement/s) appropriate for the HUHS product based on its GHS hazard
classification/s.
More particularly, HUHS products NOT intended for children’s use must bear labels that
contain the following information:
(a) Product Information
 Brand and Product Name including the Variant Name, if any
 Full Ingredient List (in chemical name)
Fragrance Materials – may be declared using its chemical name or as
“Fragrance”
Colorants – may be declared using its chemical name, CI number or FD&C
number
Botanical Ingredients – in its binomial nomenclature
 Net Content
 Batch/Lot/Item/SKU Number
 Manufacturing Date / Expiry Date
 Product Category (Indicate if “For Institutional Use” or “For Professional Use”)
(b) Directions for Use
(c) Handling, Storage and Disposal (include requirement for personal protective equipment
or PPE, if any)
(d) Particulars of the Company or MAH (Company Name, Complete Address and Contact
Information)
(e) Country of Manufacture
(f) Contact Information of the National/Regional Poison Center (Refer to Table 2.12 for the
contact information of the different poison centers in the Philippines)
(g) Hazard and Safety Information
 Hazard Information (GHS Label Elements: Signal Word, Pictogram/s, Hazard
Statement/s)
 GHS Precautionary Statements including the statement “Keep out of reach of
children”
 Signs/Symptoms of Poisoning (if applicable)
 First Aid Treatment / Medical Advice
For HUHS products intended for children’s use, on the other hand, the product labels
must reflect the following mandatory information:
(a) Product Information
 Brand and Product Name including the Variant Name, if any
 Full Ingredient List (in chemical name)
Fragrance Materials – may be declared using its chemical name or as
“Fragrance”
Colorants – may be declared using its chemical name, CI number or FD&C
number
Botanical Ingredients – in its binomial nomenclature
 Net Content
 Batch/Lot/Item/SKU Number
38
 Manufacturing Date / Expiry Date

(b) Directions for Use
(c) Handling, Storage and Disposal
(d) Particulars of the Company or MAH (Company Name, Complete Address and Contact
Information)
(e) Country of Manufacture
(f) Contact Information of the National/Regional Poison Center (Refer to Table 2.12 for the
contact information of the different poison centers in the Philippines)
(g) Hazard and Safety Information
 Age Grading
 Precautionary Statement or warning including a statement indicating that the use
of the product requires adult supervision
39
Table 2.12 List of the National and Regional Poison Centers in the Philippines and Their
Contact Information as Listed in Department of Health Department Circular No. 2020-0081
National Poison Control Center Contact Information
National Poison Management and Control Center,
Hotline: (02) 85241078
University of the Philippines - Philippine General
Globe: 09667189904
Hospital
Regional Poison Control Center
Baguio General Hospital and Medical Center (074) 6617910 loc 396
Poison Control Unit
(02) 89211212
East Avenue Medical Center
(02) 89280611 loc 707
Toxicology Referral and Training Center
09232711183
Rizal Medical Center (02) 88658400 loc 113
Poison Control Unit 09661783773
(045) 9632279
Jose B. Lingad Memorial General Hospital
09338746600
Poison Control Unit
09234117107
Batangas Medical Center 09218832633
Poison Control Center (043) 7408307 loc 1104
Bicol Medical Center 09165354692
Poison Control Unit 09480161575
Corazon Locsin Montelibano Memorial Regional
Hospital 09178694510
Biomarine and Toxicology Unit
Western Visayas Sanitarium 09194980443
Poison Control Unit
Vicente Sotto Memorial Medical Center 09228496542
Poison Control Center
Eastern Visayas Regional Medical Center (053) 8320308
Poison Control Center
Zamboanga City Medical Center (062) 9912934
Poison Control Center (062) 9920052
Northern Mindanao Medical Center (088) 7226263
Poison Control Center 09058855645
Southern Philippines Medical Center 09992250208
Poison Control and Treatment Institute (082) 2272731 loc 5065
For better illustration of HUHS product labels that are compliant with Annex J of FC No. 2020-
025, sample labeling materials are provided for HUHS product not intended for children’s use and
HUHS product intended for children’s use in Figures 2.5 and 2.6, respectively.
40
(a)
41
(b)
42
(c)
43
(d)
44
(e)
Figure 2.5 Sample Labeling Material for HUHS Products Not Intended for Children’s Use
Containing the Mandatory Label Information Prescribed in FDA Circular No. 2020-025
45
(a)
46
(b)
47
(c)
48
(d)
Figure 2.6 Sample Labeling Material for HUHS Products Intended for Children’s Use
Containing the Mandatory Label Information Prescribed in FDA Circular No. 2020-025
49
(2) The HUHS establishment must not use FDA in the promotion, advertisement, sponsorship,
marketing or commercial materials of its HUHS product. Hence, labels of HUHS products are
not allowed to bear the FDA logo, the words/initial “Food and Drug Administration”, “FDA”,
“Philippine FDA” or any imitation of such logo, words and initials in accordance with FDA
Memorandum Circular No. 2013-030.
(3) Labels of HUHS products and other information materials must not bear unsubstantiated
claims, misinformation or misleading information including those contained in brand names
or trademarks.
(4) Labels of HUHS products must not bear the words “safe”, “non-toxic”, “non-hazardous” or
other equivalent descriptive words or phrases or modifiers. Descriptive words, phrases or
modifiers considered equivalent to those expressly mentioned above include but are not
limited to “banayad sa kamay”, “hypoallergenic”, “gentle on skin/hand”, “mild”, “for sensitive
skin”, “recommended by pediatricians” and the unqualified use of the word “baby”.
(5) Labels of HUHS products must not be presented in a way that is attractive to children.
(6) HUHS products must be placed in suitable packaging, preferably in child-resistant packaging
material or containers, that will ensure protection of children from undue exposure, or their
labels must contain sufficient storage instructions so as not to be easily accessed by children.
For more information on the mandatory label information for HUHS products not intended for
children’s use, refer to Item (1) of this section.
(7) Labels of HUHS products must be in English or Filipino language and the information must
be legible, indelible and comprehensible.
(8) For imported HUHS products with labels not compliant with FC No. 2020-025, stickering and
overlabeling is allowed.
Stickering is allowed when the lacking information are only the particulars of the MAH
(company name, complete address, contact number) and the contact information of the
national/regional poison center. Stickering may be done by either the HUHS Distributor-
Importer that brought the product into the country or an FDA-licensed HUHS Repacker.
If information beyond those allowed to be stickered are missing from the label of the imported
HUHS product, overlabeling is allowed provided that the following conditions are met:
(a) the entirety of the old label is covered;
(b) written authorization from the product/formulation owner (i.e. foreign manufacturer) has
been secured; and
(c) an FDA-licensed HUHS Repacker conducts the overlabeling.
50
FDA Electronic Portal V2.0 System

A. Introduction to FDA Electronic Portal V2.0
The FDA Electronic Portal V2.0 system or “e-Portal 2” is an online application platform operated
by the FDA, through the CCHUHSRR, for the licensing and registration of HUHS establishments
and products, respectively. It is accessible through a secure site which ensures the protection of
company information within the FDA information and communication technologies (ICT)
infrastructure.
In order for HUHS establishments to access and use the system, a request for user account
must be submitted to the CCHUHSRR. Here are the step-by-step instructions on how to secure
an e-Portal 2 user account:
(1) Go to bit.ly/ePortal2
(2) Accomplish the user’s registration form by providing all the required information as marked in
Figure 2.7.
Provide all the required information in the

user’s registration form
Figure 2.7 User’s Registration Form. The mandatory information that

must be provided by the HUHS establishment to secure a user account in
FDA Electronic Portal V2.0 System are marked with a red asterisk (*).
(3) Attach proof of ownership which must be in PDF file format. Documents that may be submitted
as proof of ownership include:
(a) Certificate of Business Registration issued by the DTI
(b) Certificate of Registration issued by the Securities and Exchange Commission and
Articles of Incorporation
(c) Certificate of Registration issued by the Cooperative Development Authority and Articles
of Cooperation
(d) LTO issued by FDA for other product types
(e) Certificate of Registration issued by the Bureau of Internal Revenue
(4) After accomplishing the user’s registration form and attaching the required proof of ownership,
click “Submit”.
51
Submitted requests for user accounts are processed by the CCHUHSRR within three (3) working
days upon receipt of request. User accounts are only created for HUHS establishments that have
submitted a complete and compliant user’s registration application. The user credentials
(username and password) are sent to the email address of the HUHS establishment provided in
the user’s registration form which is now the registered email address of the company. Initial
user accounts are only valid for one (1) year; requests for user account renewal must be made
via bit.ly/UserRenewal a month before the expiration of the account.
For user’s registration application that are found to be incomplete and/or non-compliant, a
notification email containing the deficiency/ies found in the request is sent to the registered email
address.
In case the HUHS establishment wishes to change its registered email address, an email request
must be sent to cchuhsrr.lrd.huhs@fda.gov.ph with the following information (Items 1 to 7) and
attachments (Items 8 to 9):
(1) New email address for registration

(2) Registered email address
(3) Issued Username
(4) Company Name
(5) Company Address
(6) Name of the Owner
(7) Contact Number
(8) Letter of intent signed by the owner stating the reason for the change in the registered email
address
(9) Valid ID of the owner (for verification of request)
To aid HUHS establishments in securing their e-Portal 2 user accounts, walkthrough video
tutorials in English and Filipino have been prepared and can be accessed via the following links:
i. Tutorials for User Account Application (Filipino version):

https://www.youtube.com/watch?v=OL1aS7cnE7E
ii. Tutorials for User Account Application (English version):
https://www.youtube.com/watch?v=iyEHb_GEPvk
As holders of e-Portal 2 user accounts, HUHS establishments and their owners must always keep
in mind the following reminders:
(1) The responsibility for the security and integrity of its e-Portal 2 account rests solely with the
HUHS establishment and its owner. They must ensure that only authorized personnel have
access to the account given to the HUHS establishment.
(2) The e-Portal 2 account must always be used in accordance with existing laws, and FDA rules
and regulations. The FDA, at all times, reserves the right to suspend and cancel any e-Portal
2 user account found to be in violation of said laws, and FDA rules and regulations. The FDA
does not accept liability for any loss, damage or expenses resulting from negligence,
dereliction of duty/responsibility or violations of existing laws and FDA rules and regulations
that may be committed by the HUHS establishment in connection with the use of its e-Portal
2 user account.
(3) Only true, correct, up-to-date and complete information and documents must be uploaded to
the system and submitted to the CCHUHSRR.
(4) Documents uploaded to the system must meet the following specifications:
52
(a) Free from bugs, viruses, and the like that may compromise the FDA ICT infrastructure and
system;
(b) Scanned and saved in PDF file format at 100-150 dots-per-inch (dpi) with the exception of
required photos and loose label artwork of the HUHS product during registration, both of
which must be in PNG format;
(c) Must have a file size of 4 megabytes (mb) or less per document and a total file size of 20
mb per application; and
(d) With a filename that is composed of less than 40 characters in length and does not contain
the following characters: \ ? / : * “ > < I . ”
B. Navigating FDA Electronic Portal V2.0

In this section, general information on how to navigate e-Portal 2 have been provided to introduce
the system to HUHS establishments who will be submitting their HUHS applications using said
online application platform.
(1) Log-in
To access e-Portal 2, go to https://eportal2.fda.gov.ph and log in using the user credentials
(username and password) issued to the HUHS establishment.
a
b
Figure 2.8 Log-in Interface of FDA Electronic Portal V2.0 System. Log in by
entering the username (a) and password (b) issued by the CCHUHSRR to the
HUHS establishment.
(2) Homepage
Upon successful log-in, the e-Portal 2 homepage, as shown in Figure 2.9, automatically
appears, displaying the following features:
(a) Navigation Pane (proceed to the next item for more detailed information)
(b) Account Information, which displays the personal information of the account owner
when clicked
(c) Search and Filter Tools, which include:
 Search Tab, which allows users to search for a specific application by typing in the
case number assigned to the application, establishment name or brand/product name
 Filter Tools, which allows users to narrow the search parameter by category (i.e.
Licensing of Establishment, Product Registration, etc.) or type of process (i.e. e-
License to Operate, Household Urban Hazardous Substances Registration).
53
(3) Navigation Pane

As shown in Figure 2.9, the left-hand side of the e-Portal 2 homepage displays the navigation
pane which contains the following:
(a) New Application button, which allows users to create new case applications. For
HUHS, the different processes under which a new application may be created includes
e-License to Operate, both initial and variation application, and Household Urban
Hazardous Substances Registration (Initial Application)
(b) On Process folder, which serves as the account “inbox” for incoming applications
assigned to the user (i.e. applications routed to the HUHS establishment for compliance
as well as viewing of pre-assessment and evaluation results)
(c) Draft folder, which allows users to view all unfinished applications that have not yet been
submitted to the CCHUHSRR
(d) Processed folder, which serves as the “repository” of all applications created by the user
including drafts as well as ongoing and closed applications; this folder allows users to
view and check the status of their applications
Account Information
Search and
Filter Tools
Navigation Pane
Figure 2.9 FDA Electronic Portal V2.0 Homepage
(4) Content of folders

The different folders under the navigation pane, when opened (clicked), shows the following
information relative to the case applications contained in the folder:
(a) #, which is the case number assigned to the application
(b) Summary ( ), as shown in Figure 2.10, which when clicked, shows a pop-up dialogue
box where users can access the following:
 General Information, which contains information relative to the application including
the process under which the case application has been created (Process), the
establishment or brand/product name (Application Title), case number (Application
Number) and status of the application (Application Status)
 More Information, which contains the application summary
 Uploaded Documents, which contains all the documentary requirements uploaded
into the e-Portal 2 system as part of the application
 Generated Documents, which contains all the documents generated by the e-Portal
2 system relative to the application; this includes the result of the pre-assessment,
order of payment and, depending on the final decision rendered, the issued
authorization (i.e. License to Operate, CPR) or Letter of Disapproval.
54
Figure 2.10 “Summary” Dialogue Box
(c) Application, which contains information on the type of application (i.e. Initial Application,
Variation) and the name of the product (for CPR application) or establishment (for License
to Operate application)
(d) Process, which contains information on the process under which the case application has
been created. For HUHS, the different processes under which a case application may be
created includes e-License to Operate, both initial and variation application, and
Household Urban Hazardous Substances Registration (Initial Application)
(e) Task, which contains information on the current status of the application (i.e. Initial
Application, Pre-Assessment Result, Payment Verification, Application Evaluation,
Application Checking, Final Decision, Download Result)
(f) Last Modified, which reflects the date when the application has been last opened
(g) Sent by (only found in the On Process folder), which contains information on the user who
delegated the case application to the current user
(h) Due Date (only found in the On Process and Draft folders), which reflects the estimated
“deadline” of the current task; this serves as a guide to all e-Portal 2 users as to the
application timeline
(i) Current User, (only found in the Processed folder), which reflects the user account where
the case application is currently assigned
Figure 2.11 shows the On Process folder displaying the different relevant information of a
case application.
Figure 2.11 On Process Folder Displaying the Relevant Information of a Case

Application (From Left to Right: #, Summary, Application, Process, Task, Sent By, Due Date,
Last Modified)
55
Initial HUHS Product Registration in FDA Electronic Portal

V2.0 System
A. Initial HUHS Product Registration Process
Initial registration of HUHS products are submitted through e-Portal 2. Once the License to
Operate (LTO) as HUHS establishment has been secured, the duly licensed HUHS establishment
may now prepare its initial HUHS product registration application. Figure 2.12 presents a simple
illustration of the business process for initial HUHS product registration.
Figure 2.12 Business Process Flow for the Initial Registration of HUHS Products. HUHS
establishment prepares the initial HUHS product registration application and submits it for pre-
assessment. Once the application passed the pre-assessment, the HUHS establishment and
FDA Cashier pays and posts the payment in the system, respectively, after which the application
undergoes evaluation. A final decision on the application is then rendered and the result of the
application is sent to the HUHS establishment. Not shown in this figure is the Notice of Deficiency
step during the transitory period pursuant to FDA Advisory No. 2021-3501.
(1) Initial Application

During this step, the HUHS establishment prepares its initial HUHS product registration
application in e-Portal 2. To do this, HUHS establishments must:
(a) Log-in to e-Portal 2 (https://eportal2.fda.gov.ph) using the user credentials (username

and password) issued by the CCHUHSRR
(b) Start a new case application by sequentially clicking the “New Application” button in the
navigation pane, “Household Urban Hazardous Substances Registration (Initial
Application)” under Product Registration and the “Start Application” button on the right-
hand side of the screen as shown in Figure 2.13.
Another way to create a new case application is to simply double-click on “Household

Urban Hazardous Substances Registration (Initial Application)” under Product
Registration.
56
a c
Figure 2.13 Steps to Create a New Case Application for Initial HUHS Product
Registration. Create a new initial HUHS product registration application by sequentially
clicking (a) New Application, (b) Household Urban Hazardous Substances Registration (Initial
Application) and (c) Start Application, or simply double-click on (b) Household Urban
Hazardous Substances Registration (Initial Application).
(c) Prepare the initial HUHS product registration application. This step includes:
 Reading through and consenting to the terms and conditions listed in the
Declaration of Undertaking.
 Accomplishing the application form embedded in e-Portal 2 with the assistance of
the Application Wizard that will sequentially provide the different parts of the
application form to be filled-up. For a detailed discussion on how to correctly
accomplish the application form, proceed to the next section, Initial HUHS Product
Registration Application Form.
 Upload all the documents required to support the initial HUHS product registration
application.
(d) Review the final draft of the initial HUHS product registration application before submitting
it to the CCHUHSRR. The Application Summary allows the applicant to review and
recheck the draft application including the uploaded documents. HUHS establishments
must ensure that all the declared information in the application form and in the uploaded
documents are complete, consistent and correct and that the application satisfactorily
complies with set FDA standards and requirements.
In case there is an error in the draft application form or the documents uploaded are
incomplete/incorrect, go back to the particular section of the application form where the
error occurred by clicking “Previous Steps” in the upper-left corner of the window and
then make the necessary changes/corrections.
A self-assessment checklist for initial HUHS product registration is appended as Annex

A to this guide manual to aid the applicants in reviewing their applications for
completeness, consistency and correctness.
(e) Submit the initial HUHS product registration application to the CCHUHSRR for pre-
assessment by clicking the “Next” button and then “Continue” once the draft application
has been deemed acceptable.
(2) Pre-Assessment
Pre-assessment filters out unacceptable applications by checking the submitted initial HUHS
product registration application for:
(a) Completeness of the required information and documentary requirements;
(b) Consistency of information in the application; and
(c) Correctness of information provided.
57
Though the pre-assessment step has been incorporated into the initial product registration
process to filter out applications that do not meet the standards for consistency, correctness
and completeness, this merely intends to facilitate the evaluation of applications that have
been successfully lodged with the CCHUHSRR (i.e. applications with posted payment). It
remains to be the HUHS establishment’s sole responsibility to ensure that the applications
they submit meet the aforementioned standards.
Once the initial HUHS product registration application has been pre-assessed, the results are
automatically sent by the system to the registered email address of the HUHS establishment
(email notification). Results of pre-assessment may either be:
(a) Pre-Assessment Disapproval (tagged as INCOMPLETE)
Applications that are found to be incomplete or to contain incorrect and/or inconsistent

information are tagged as incomplete and disapproved during pre-assessment. For these
applications, the email notification will contain the reason/s for the pre-assessment
disapproval.
A copy of the pre-assessment result may also be accessed in e-Portal 2. Go to the “On
Process” folder and double-click on the specific initial HUHS product registration
application. The system will then show the result of the pre-assessment containing the
reasons for the disapproval. Click “Next” to access the application summary and verify
the result of the pre-assessment. Once done, click “Next” and then “Finish” to end the
process.
Note that the disapproval of an initial HUHS product registration application during the
pre-assessment step does not preclude the HUHS establishment from submitting a new
application, provided that the deficiencies cited in the pre-assessment result have been
addressed prior to re-submission.
(b) Pre-Assessment Approval (tagged as COMPLETE)

Applications that have met the standards for completeness, consistency and correctness
are tagged as complete. Once tagged as complete, an email
notification containing the Order of Payment, as shown in Figure 2.14, is sent to the
HUHS establishment while the application is automatically forwarded to the FDA Cashier
for posting of payment.
A copy of the Order of Payment may also be accessed in e-Portal 2. Go to the

“Processed” folder and search for the specific initial HUHS product registration
application. Right-click on the application and select “Summary” or click the “Summary”
button ( ), then go to “Generated Documents” where a copy of the Order of Payment
may be downloaded.
Note that approval of application in pre-assessment is NOT an indication that it will no

longer be issued an LOD should evaluation find that the initial HUHS product registration
application does not satisfactorily comply with applicable FDA requirements and
standards.
58
Figure 2.14 Sample of the Order of Payment Sent to the HUHS

Establishment for Initial HUHS Product Registration That Passed Pre-
Assessment
(3) Payment
The Payment step involves actions from both the HUHS establishment and FDA Cashier.
The HUHS establishment pays the prescribed fees and charges indicated in the order of
payment via any of the following payment channels:
(a) BancNet
For more information on making payments through BancNet, refer to FDA Advisory No.
2015-021 accessible at https://www.fda.gov.ph/wp-content/uploads/2021/03/FDA-
Advisory-No.-2015-021.pdf.
(b) Over-the-counter in any branch of the Land Bank of the Philippines
For more information on how to pay over-the-counter in any branch of the Land Bank of
the Philippines, refer to Item B.6. (Payment Collection), Section IV (Guidelines) of FDA
Memorandum Circular No. 2013-038 available at https://www.fda.gov.ph/wp-
content/uploads/2021/08/FDA-Memorandum-Circular-No.2013-038.pdf.
For easy reference, the clearing account number for the Center for Cosmetics and
Household/Urban Hazardous Substances Regulation and Research is 0392-2220-06.
(c) Link.BizPortal e-payment facility of the Land Bank of the Philippines
For more information on how to use Link.BizPortal to make payments, proceed to
https://www.landbank.com/e-banking/other-e-banking-services/linkbizportal.
59
The FDA Cashier then verifies the payment by posting the payment details in e-Portal 2. This
automatically advances the initial HUHS product registration application to the next step -
evaluation.
(4) Evaluation
This step involves the verification of the quality, safety and efficacy of the HUHS product
by evaluating the application’s satisfactory compliance with all applicable requirements and
standards in accordance with FC No. 2020-025. For initial HUHS product registration in e-
Portal 2, the evaluation step covers three (3) tasks – Application Evaluation, Application
Checking and Final Decision.
HUHS product registration applications that have satisfactorily complied with all applicable
requirements and standards are recommended for approval and issuance of CPR whereas
those that do not are recommended for disapproval and issuance of LOD.
Note that during the transitory period provided in FC No. 2021-011-A, a Notice of Deficiency
(NOD) may be issued once for initial HUHS product registration applications found to contain
minor deficiencies instead of outright disapproval pursuant to FDA Advisory No. 2021-3501
(proceed to Item 6).
Minor deficiencies are those that can be corrected or complied with through the submission
of additional supporting documents and does NOT require revision of the submitted
application form. These include but are not limited to:
(a) findings that require further clarifications from the HUHS establishment,
(b) insufficiently substantiated product claims,
(c) presence of unsubstantiated and/or safety claims on the existing product label
(d) minor errors in the submitted documents that will not affect the declared information in
the application form, and
(e) proposed label that is not compliant with Annex J of FC No. 2020-025.
Deficiencies that affect the declared information in the application form are not considered
as minor deficiencies. Instead, these are treated as major deficiencies based on the HUHS
establishment’s declaration and agreement at the start of the application process that all data
and information provided in the attached application are true, correct and based on existing
records, legal documents and available information.
(5) Result
Once a final decision has been rendered, an email notification is automatically sent to the
registered email address of the HUHS establishment containing an instruction on how to
access the result of the initial HUHS product registration application.
To access the result of the application in e-Portal 2, go to the “On Process” folder and
double-click on the specific application. The system will then show the application summary.
Click “Next Step” to view and download the issued document which may either be a CPR for
approved applications or LOD for disapproved ones. Once done, click “Next” and then
“Finish” to end the process.
To access the generated result again, go to the “Processed” folder and search for the
specific initial HUHS product registration application. Right-click on the application and select
“Summary” or click the “Summary” button ( ), then go to “Generated Documents” where a
copy of the CPR or LOD may be downloaded.
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Note that disapproval of initial HUHS product registration applications does not preclude the
HUHS establishment from submitting a new application, provided that the deficiencies noted
in the disapproved applications are addressed prior to re-submission.
(6) NOD
For initial HUHS product registration applications with minor deficiencies, the email
notification sent to the registered email address of the HUHS establishment serves as the
NOD which contains the list of deficiency/ies that must be addressed within fourteen (14)
calendar days. Failure to address all noted deficiencies within this timeline shall result to the
disapproval of the application.
To comply with the issued NOD, access the initial HUHS product registration application in
e-Portal 2. Go to the “On Process” folder and double-click on the specific application issued
with a NOD. Go through the application summary and evaluation notes by clicking “Next”
and then proceed to the part of the application process where documents are uploaded.
Upload the compliance documents and click “Next” and then “Submit” to return the
application to the CCHUHSRR for evaluation.
Submitted compliance documents are evaluated relative to the original initial HUHS product
registration application. Depending on whether these documents sufficiently address the
minor deficiencies noted in the application, an initial HUHS product registration application
may either be recommended for approval or disapproval (refer to Item 5).
HUHS establishments should note that regardless of whether compliance documents have
been uploaded into the e-Portal 2 system to address the minor deficiencies, initial HUHS
product registration applications are automatically reverted back to the CCHUHSRR once
the compliance period has lapsed.
B. Initial HUHS Product Registration Application Form

This section provides detailed instructions on how to accomplish the initial HUHS product
registration application form embedded in e-Portal 2. As a general rule, in filling-up the application
form, HUHS establishments are advised to:
(1) Ensure that the information declared are correct, complete and consistent with the
information contained in the submitted documentary requirements to minimize pre-
assessment disapproval. Keep in mind that information contained within a document must
also be correct, complete and consistent.
(2) Make use of the information bubbles available near each section of the application form to
serve as guide.
(3) Ensure that all fields marked with a red asterisk (*) are filled-up and not left blank as these
fields are mandatory information. In case the field does not apply to the HUHS product for
registration, put “Not Applicable” or “N/A”.
(4) Make sure to carefully read and understand the Declaration of Undertaking from start to
end. The itemized terms and conditions are automatically undertaken by the HUHS
establishment as the prospective MAH as part of the initial HUHS product registration
application after confirmation of agreement, and are considered conditions for the issuance
of the CPR. Hence, findings of non-compliance to any of the listed terms and conditions can
be grounds for the suspension, cancellation or revocation of the issued marketing
authorization.
Note that the applicant will not be able to access the initial HUHS product registration
application form unless it confirms its agreement to the Declaration of Undertaking by
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selecting “Yes, I Agree” as shown in Figure 2.15. Selecting “No, I Disagree” automatically
ends the application process.
Figure 2.15 Agreement of the HUHS Establishment to the Declaration of

Undertaking. Select “Yes, I Agree” to confirm agreement of the HUHS
establishment to the terms and conditions laid out in the Declaration of Undertaking.
Once agreement to the Declaration of Undertaking has been confirmed, the application
automatically proceeds to the initial HUHS product registration application form as provided by
the application wizard:
(1) Local Company Responsible for Placing the Product in the Market
As the HUHS establishment securing the marketing authorization for the HUHS product, the
applicant is recognized by the FDA as the local company responsible for placing the product
in the market and the MAH once the CPR has been issued.
In the 1st part of the application form, the applicant must provide relevant company
information including its owner, LTO number and validity, company name and address as
well as primary and secondary activities. As e-Portal 2 houses both the licensing and
registration processes of HUHS, applicants are only required to select from the dropdown
menu its valid LTO number as HUHS establishment (manufacturer, trader or distributor-
importer), after which the system automatically provides all other relevant information. Figure
2.16 shows the dropdown menu from which the appropriate valid LTO as HUHS
establishment of the applicant is selected.
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Figure 2.16 Dropdown Menu Showing the License to Operate Number/s Issued to
the Applicant. For the purpose of initial HUHS product registration, select the
appropriate License to Operate number of the HUHS establishment that corresponds
to the activity of the applicant relative to the HUHS product for registration.
If the applicant is not confident of its LTO number, the information may be verified against
the LTO issued by the FDA. Keep in mind that the declared type of establishment must
correspond to the intended activities of the applicant relative to the HUHS product for
registration. More particularly, indicate the establishment LTO as:
(a) HUHS Manufacturer, if the formulation of the HUHS product for registration is owned by
the applicant and it manufactures the HUHS product for registration;
(b) HUHS Trader, if the formulation of the HUHS product for registration is owned by the
applicant but the product is manufactured in the Philippines by an FDA-licensed HUHS
toll manufacturer; or
(c) HUHS Distributor-Importer, if the HUHS product for registration is imported by the
applicant from a foreign supplier/source.
(2) Product Source

In the 2nd part of the application form, the applicant must provide relevant information
regarding the source of the HUHS product for registration. The required relevant information
depends on the declared HUHS LTO of the applicant, to wit:
(a) LTO as HUHS Manufacturer

For applicants with LTO as HUHS Manufacturer, the system automatically fills-up the
application form with the recorded information of the HUHS establishment as shown in Figure
2.17.
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Figure 2.17 Required Information on Product Source for Applicants with License to
Operate as HUHS Manufacturer. The information on product source is automatically
provided by the FDA electronic portal V2.0 system for the HUHS manufacturer.
(b) LTO as HUHS Trader

For applicants with LTO as HUHS Trader, provide the valid LTO number of the toll
manufacturer hired to produce the HUHS product for registration as shown in Figure 2.18.
The other required information of the toll manufacturer is automatically provided by the e-
portal 2 system based on the indicated LTO number.
Figure 2.18 Required Information on Product Source for Applicants with License to
Operate as HUHS Trader. The valid license to operate number of the HUHS toll
manufacturer is the only information that must be provided; the rest of the required fields
are automatically filled-up by the system once the License to Operate number has been
provided.
(c) LTO as HUHS Distributor-Importer

For applicants with LTO as HUHS Distributor-Importer, provide information on whether the
HUHS product for registration is directly- or indirectly sourced. Declare the HUHS product
for registration as:
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- Directly sourced, if the HUHS product for registration has been procured directly from
its (foreign) manufacturer as shown in Figure 2.19.
Foreign
Manufacturer Applicant
(Product Origin)
Figure 2.19 Procurement Process for Directly-

Sourced HUHS Products. Directly-sourced HUHS
products are those that have been procured by the
applicant directly from the foreign manufacturer.
For directly-sourced HUHS product for registration, the following information must be
provided:
 Country of Origin
 Information on the (Foreign) Manufacturer (manufacturer’s name and
address)
- Indirectly sourced, if the HUHS product for registration has been procured from a
foreign supplier who is not the foreign manufacturer as show in Figure 2.20.
Foreign Foreign
Manufacturer Applicant
(Product Origin) Supplier
Figure 2.20 Procurement Process for Indirectly-Sourced HUHS

Products. Indirectly-sourced HUHS products are those that have been
procured by the applicant from a foreign supplier who is not the foreign
manufacturer.
For indirectly sourced HUHS product for registration, the following information must
be provided:
 Country of Origin
 Information on the (Foreign) Manufacturer (manufacturer’s name and
address)
 Information on the (Foreign) Supplier (supplier’s name and address)
Note that applicants may only declare one (1) product source per initial HUHS product
registration application. Thus, for an HUHS product with multiple product sources, an initial
HUHS product registration application must be submitted by the applicant for each product
source.
(3) Product Information

In the 3rd part of the application form, the applicant must provide the following information
relative to the HUHS product for registration:
(a) Product Line / Type

From the dropdown menu, select the product line / type that best describe the primary
function of the HUHS product for registration as shown in Figure 2.21.
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For applicants that are licensed HUHS manufacturers, the dropdown menu will only
contain the product lines / types that have been declared during the LTO application. In
case the HUHS product for registration does not fall within any of the product lines / types
found in the dropdown menu, the HUHS manufacturer must first amend its LTO via an
application for LTO variation to include the specific product line / type in its license.
Figure 2.21 Dropdown Menu for Product Line / Type. Select the product line / type
that corresponds to the HUHS product for registration based on its primary function.
(b) Particulars of the Products

- Product Name
Indicate the complete brand and product name of the HUHS product for
registration.
The applicant must ensure that the brand and product name declared in the
application form is consistent with all the submitted documents. In case the brand
and product names reflected in the submitted documents are not consistent with the
one declared in the application form, the applicant must submit a
declaration/certification listing all the different brand and product names used and
certifying that all the names refer to the HUHS product for registration.
- List of Variants
Variants of a HUHS product refer to products with identical base formulation but
contain different colorant/s and/or fragrance. To better illustrate, Table 2.13 is an
example of a HUHS product with multiple variants.
Table 2.13. Variants of ABC Disinfectant Spray

Variant 0 / 1 Variant 2 Variant 3
Base Formulation Chemical A Chemical A Chemical A
Chemical B Chemical B Chemical B
Chemical C Chemical C Chemical C
Chemical D Chemical D Chemical D
Colorant CI 12490 CI 18965 CI 42053
Fragrance Fragrance 1 Fragrance 2 Fragrance 3
If the applicant is uncertain that its HUHS products for registration are considered
as variants, here are some additional reminders to keep in mind:
 The base formulation of the variants of the HUHS product with the exception of
the active ingredient/s may either be quantitatively and qualitatively identical, or
66
they may contain minor differences in concentration due to adjustments made

for the different colorants and/or fragrances used.
 The concentrations of the colorants and/or fragrance used in the variants of the
HUHS product may vary/differ.
 A change in the concentration of the active ingredient/s is not allowed in variants
of an HUHS product. In such cases, the HUHS products with different
concentrations of active ingredient/s must be registered separately.
 Botanical ingredients (i.e. botanical extracts) are not considered as fragrance
material despite their use to impart a desired smell. Hence, HUHS products with
identical formulation except for the botanical ingredients used are not
considered as variants and must be registered separately.
In case the HUHS products for registration are considered as variants, the applicant
may either register the variants under a single application or opt to register them
individually as shown in Table 2.14. Note that a single initial HUHS product
registration application can only accommodate up to five (5) variants.
To register more than one (1) variant in a single application, declare the brand and
product name of the HUHS product under “Product Name” and list the names of
the variants under the “List of Variants” as shown in Table 2.14 (A). Remember to
only declare one (1) variant per row. Add or delete rows by clicking the “+ New”
button on the upper left corner of the field and the “ ” button at the end of the
row, respectively.
To register the variants of the HUHS product individually, the applicant may either:
 Declare the variant name together with the brand and product name of the
HUHS product under “Product Name” and indicate “Not Applicable” or “N/A” in
the “List of Variants” as shown in Table 2.14 (B), OR
 Declare the brand and product name of the HUHS product under “Product
Name” and declare the variant name in the “List of Variants” as shown in Table
2.14 (C).
Table 2.14 Different Ways to Register the Two (2) Variants of ABC Disinfectant
Spray
More than One
1 Variant per 1 Variant per
Application (1) Variant in a
Application Application
Form Single
(B) (C)
Application (A)
Product ABC Disinfectant Application #1 Application #1
Name Spray ABC Disinfectant ABC Disinfectant
Spray – Lavender Spray
Application #2 Application #2
ABC Disinfectant ABC Disinfectant
Spray - Lemon Spray
List of Lavender N/A Application #1
Variants Lemon Lavender
Application #2
Lemon
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For coloring materials with multiple variants/colors within a single product packaging,
indicate in this section the available packaging sizes of the product based on the
number of colors in a pack (i.e. Crayons 8 Colors; Crayons 16 Colors).
In case the HUHS product for registration does not have any variants, indicate “Not
Applicable” or “N/A”.
- Product Presentation (Primary Packaging)

From the dropdown menu, select the product presentation that best describe the
primary packaging of the HUHS product for registration (i.e. Bottle, Canister, Tub,
Tube, Blister Pack, Sachet, etc).
In case the product presentation of the HUHS product is not found in the dropdown
menu, select “Others” and indicate the most appropriate description of the primary
packaging.
In case the HUHS product for registration has multiple pack sizes with different
product presentations, select “Others” and indicate all available primary packaging
of the product. To illustrate, for a HUHS product available in 10mL Sachet and
50mL/100mL Tube, select “Others” and indicate “(a) Sachet (b) Tube”.
- Product Presentation (Secondary Packaging)

From the dropdown menu, select the product presentation that best describe the
secondary packaging of the HUHS product for registration (i.e. Box, Pouch, Blister
Pack, etc).
In case the secondary packaging presentation of the HUHS product is not found in
the dropdown menu, select “Others” and indicate the most appropriate description
of the secondary packaging.
secondary packaging, select “Others” and indicate all available secondary
packaging of the product. To illustrate, continuing with the example from above, for
a HUHS product available in 10mL Sachet with no secondary packaging and
50mL/100mL Tube in a Box, select “Others” and indicate “(a) N/A (b) Box”.
In case the HUHS product does not have a secondary packaging, select “Not
Applicable”.
- Net Content
Indicate all available pack size/s of the HUHS product for registration consistent
with those printed on the product label. Remember to use the metric unit in declaring
the net content and to declare one (1) pack size per row. Add or delete rows by
clicking the “+ New” button on the upper left corner of the field and the “ s ” button
at the end of the row, respectively.
In cases where the metric unit is not the most appropriate measure of the product
content, the net content may be indicated using other means. To illustrate, for
surface disinfectant wipes, the declared net content may be the number of wipes
contained in a single pack (i.e. 80 wipes, 30 wipes) while for coloring materials, the
net content may be the number of colors available in the product packaging (i.e. 8
colors, 16 colors).
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primary packaging, declare the net content together with the product presentation.
To illustrate, using the example from above, for a HUHS product available in 10mL
Sachet and 50mL/100mL Tube, declare the net content as 10mL Sachet, 50mL
Tube and 100mL Tube, one pack size per row, as shown in Figure 2.22.
Figure 2.22 Net Content Declaration for an HUHS Product Available in 10mL
Sachet and 50mL/100mL Tube
In case the HUHS product for registration has more than one (1) variant which are
available in differing pack sizes, declare the net content together with the variant
name. To illustrate, Figure 2.23 shows how to declare the varying pack sizes of the
two (2) variants of ABC Air Freshener in the application form.
Figure 2.23 Net Content Declaration for the Varying Pack Sizes of the Two (2)
Variants of ABC Air Freshener
- Product Category
From the dropdown menu, select the appropriate category of the HUHS product for
registration. Select
 Ready-to-Use, if the HUHS product for registration is ready to be used outright
of the packaging and for general purposes, which require no further dilution prior
to application. Also select this product category for HUHS products diluted
before use but whose application are NOT restricted to trained personnel or
professionals.
 For Professional Use, if the HUHS product for registration is highly
concentrated, requiring further dilution and is restricted to be applied only by
trained personnel
- Product Description
Indicate the technical specifications of the HUHS product for registration as
reflected in the COA. Applicants may also opt to indicate the results of the tests
69
conducted on the HUHS product as reflected in the COA together with the product
specifications.
Note that applicants must ensure that the technical specifications of the HUHS
product found in the COA and declared in the application form are consistent with
those reflected in Section 9 of the SDS, if indicated.
- Directions for Use

Indicate the instructions for the proper use of the HUHS product for registration
as reflected on the submitted product label
- Number of Years Applied For

Indicate the CPR validity applied for. For initial HUHS product registration,
applicants may either apply for a 2-year or 3-year CPR validity.
(c) Safety Information

- GHS Compliant
Based on the hazard information found in Section 2 of the SDS, declare the HUHS
product for registration to be either:
 GHS-Compliant by selecting “Yes”, if its hazards have already been
classified according to GHS.
For GHS-compliant HUHS products, applicants must then declare the GHS
hazard classification/s of the HUHS product and the appropriate GHS label
elements as listed in Section 2 of the SDS.
o GHS Hazard Classification

Indicate the hazard classification/s of the HUHS product under the
appropriate hazard group – Physical Hazard, Health Hazard and
Environmental Hazard.
In case the HUHS product for registration does not meet the hazard criteria
for classification in any of the GHS hazard classes under a particular hazard
group, indicate “Not Classified”.
o GHS Hazard Communication

Indicate the following GHS label elements assigned to the HUHS product
for registration based on its hazard classification:
 Signal Word (i.e. Danger, Warning);
 Pictogram/s (i.e. Flame, Gas Cylinder, Skull and Crossbones,
Corrosion); and
 Hazard Statement/s (i.e. Flammable liquid and vapour, Harmful if
swallowed).
Note that for HUHS products classified in multiple GHS hazard classes, the
GHS has set out rules of precedence for the allocation of hazard information.
To illustrate, Figure 2.24 shows how hazard information of a GHS-compliant

HUHS product having multiple GHS hazard classifications as listed in Table
2.15 must be declared in the application form.
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Table 2.15 Sample HUHS Product for Registration and Its GHS Hazard
Classifications with the Corresponding Assigned GHS Label Elements
GHS Label Elements
GHS Hazard
Classification Hazard
Signal Word Pictogram
Statement
Flame
Highly flammable
Flammable Liquid
DANGER liquid and vapour
Category 2
Skull and
Crossbones
Acute Oral Toxicity Toxic if swallowed
DANGER
Category 3
Corrosion
Causes severe
Skin
skin burns and
Corrosion/Irritation DANGER
eye damage
Category 1
Environment
Hazardous to the
Aquatic
WARNING Very toxic to
Environment,
aquatic life
Acute
Category 1
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1 Danger Flame, Skull and Highly flammable liquid and vapour,

Crossbones, Corrosion, Toxic if swallowed,
Environment Causes severe skin burns and eye
damage,
Very toxic to aquatic life
Figure 2.24 Declaration of Hazard Information for a GHS-Compliant HUHS

Product with Multiple Hazard Classifications
For more information on GHS and allocation of hazard information, refer to the
Information on the Technical Requirements section of this guide manual or the
8th revised edition of the GHS (Chapter 1.4 and Annex 3).
Note that during the transitory period provided in FC No. 2021-011-A, special
considerations are given to GHS-compliant HUHS products whose existing
labels do not yet reflect the appropriate GHS label elements and thus, are
inconsistent with the hazard information declared in the application form and
SDS, as companies are allowed to submit existing product labels regardless of
compliance to Annex J of FC No. 2020-025 for registration purposes, provided
that all claims are substantiated. However, should an artwork of proposed
product label be submitted together with the existing product label, full
evaluation of the proposed label shall be conducted to verify compliance to
Annex J of FC No. 2020-025 and the consistency of label information with those
declared in the application form and SDS.
 Non-GHS Compliant by selecting “No” if its hazards have NOT been

classified according to GHS.
For non-GHS compliant HUHS product, applicants must then declare the
hazard information of the product consistent with Item 14.3.6.3, Section V
(Specific Guidelines) of FC No. 2020-025. Table 2.16 provides a tabulation of
the hazard information that may be declared for non-GHS compliant HUHS
product based on its hazardous nature.
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Table 2.16 Hazard Information for non-GHS Compliant HUHS Products

(Adapted from Administrative Order No. 311 s. 1977)
Affirmative Statement of
Hazard Signal Word Pictogram
the Hazard/s
Highly Toxic POISON Skull and Vapor Fatal, Fatal if
Chemical Crossbones swallowed, Fatal in contact
Substance or with skin or similar wording
Mixture to describe the highly toxic
nature of the chemical
substance or mixture
Corrosive or DANGER Not Applicable Causing burns or similar
Extremely wording to describe the
Flammable corrosive nature of the
Chemical chemical substance or
Substance or mixture
Mixture
Extremely or highly
flammable or similar wording
to describe the flammable
nature of the chemical
All other CAUTION or Not Applicable Any affirmative statement
hazards WARNING describing the principal
hazard/s of the chemical
To illustrate, a sample declaration of the hazard information of a non-GHS

compliant HUHS product determined to be corrosive, extremely flammable,
harmful when ingested and toxic to the environment is shown in Figure 2.25.
Figure 2.25. Declaration of Hazard Information for Non-GHS Compliant

HUHS Product
Note that the non-GHS compliant hazard information declared in the application
form must be consistent with Section 2 of the SDS. Applicants should further note
that non-GHS compliant HUHS products are only allowed during the transitory
period provided in FC No. 2021-011-A, after which no non-GHS compliant HUHS
products shall be allowed to be registered with FDA and to be made available in
the market.
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During the transitory period provided in FC No. 2021-011-A, special considerations

are given to submitted existing product labels which do not reflect the declared
signs and symptoms of poisoning as companies are allowed to submit existing
product labels regardless of compliance to Annex J of FC No. 2020-025, provided
that all claims are substantiated. However, should an artwork of proposed product
label be submitted together with the existing product label, full evaluation of the
proposed label shall be conducted to verify compliance to Annex J of FC No. 2020-
025 and consistency of label information with those declared in the application form
and SDS.
- Precautionary Statements and Warnings

Indicate the precautionary statements and warnings applicable to the HUHS
product. For GHS-compliant HUHS products, this refers to the GHS precautionary
statements appropriate for the product based on its hazard classifications.
For HUHS products NOT intended for the use of children, the statement “Keep out
of reach of children” or its equivalent must be included.
For HUHS products intended for the use of children, the statement indicating that
the use of the product requires adult supervision must be included.
Note that the information declared in the application form on precautionary

statements and warnings must be consistent with those found in Section 2 of the
SDS and on the product label.

precautionary statements and warnings as companies are allowed to submit existing
proposed label shall be conducted to verify compliance to Annex J of FC No. 2020-
and SDS.
- Signs and Symptoms of Poisoning

Indicate the signs and symptoms of poisoning that manifest after accidental or
undue exposure to the HUHS product.
Note that the information declared in the application form on signs and symptoms of
poisoning must be consistent with those found in Sections 4 and/or 11 of the SDS
and on the product label, if indicated.

are given to submitted existing product labels which do not reflect the declared signs
and symptoms of poisoning as companies are allowed to submit existing product
labels regardless of compliance to Annex J of FC No. 2020-025, provided that all
claims are substantiated. However, should an artwork of proposed product label be
submitted together with the existing product label, full evaluation of the proposed
label shall be conducted to verify compliance to Annex J of FC No. 2020-025 and
consistency of label information with those declared in the application form and SDS.
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- First Aid Instructions / Medical Advice

Indicate the information on initial aid or care that should be given in case of
accidental or undue exposure to the HUHS product.
Note that the information declared in the application form on first-aid instructions /
medical advice must be consistent with those found in Section 4 of the SDS and on
the product label.

are given to submitted existing product labels which do not reflect the declared first
aid instructions / medical advice as companies are allowed to submit existing
proposed label shall be conducted to verify compliance with Annex J of FC No. 2020-
and SDS.
- Handling, Storage and Disposal Information

Indicate the information on the proper handling, storage and disposal of the
HUHS product.
Note that the information declared in the application form on proper handling,
storage and disposal must be consistent with those found in Sections 7 and 13 of
the SDS and on the product label.

handling, storage and disposal information as companies are allowed to submit
existing product labels regardless of compliance to Annex J of FC No. 2020-025,
provided that all claims are substantiated. However, should an artwork of proposed
product label be submitted together with the existing product label, full evaluation of
the proposed label shall be conducted to verify compliance to Annex J of FC No.
2020-025 and consistency of label information with those declared in the application
form and SDS.
(d) Ingredient List

Declare the qualitative and quantitative formulation of the HUHS product for
registration by providing the required ingredient information. For applications with more
than one (1) variant, declare the base formulation first followed by the fragrance materials
and/or colorants that make up the different variants. For coloring materials, declare the
ingredient list on a per color/hue basis.
Note that the ingredient list provided in the application form must be consistent with
Section 3 of the SDS and the full ingredient list on the product label. In case the
formulation declared in the application form is inconsistent with Section 3 of the SDS,
submit a clarification letter explaining the inconsistency.
During the transitory period provided in FC No. 2021-011-A, special considerations are
given to submitted existing product labels which do not reflect the full ingredient list as
companies are allowed to submit existing product labels regardless of compliance to
Annex J of FC No. 2020-025, provided that all claims are substantiated. However, should
an artwork of proposed product label be submitted together with the existing product
label, full evaluation of the proposed label shall be conducted to verify compliance to
75
Annex J of FC No. 2020-025 and consistency of label information with those declared in
the application form and SDS.
To start, applicants must first declare whether the initial registration application covers
multiple variants of a HUHS product. Select “Yes” from the dropdown menu if more than
one (1) variant have been declared in the application. Otherwise, select “No”. Once done,
provide the following ingredient information:
- Column 1 - Variant Name (only applicable if there are multiple variants in the
application) Declare the name of the variant/s where the declared ingredient
has/have been used.
Note that the variant names declared in Column 1 must be consistent with those
provided in the first part of the application form (Particulars of the Product).
- Column 2 - Ingredient Name

Declare the common, chemical or IUPAC name of the ingredient used in the
formulation of the HUHS product for registration, one (1) ingredient per row. Add or
delete rows by clicking “+ New” on the upper left corner of the field and the “ ”
button at the end of the row, respectively. Note that trade names of raw materials
are NOT allowed.
In case the ingredient is a mixture, declare the individual components of the mixture
in a single row/entry with their corresponding percent concentration relative to the
overall formulation of the raw material alongside them.
For fragrance materials, these may be declared using the chemical name of the
fragrance or the word “fragrance. Botanical ingredients are not considered as
fragrance material and must be declared using its assigned binomial nomenclature
(scientific name). For colorants, these may be declared using the chemical name
of the colorant, its Food Drug and Cosmetic (FD&C) number or color index (CI)
number. For dye mixtures considered as Confidential Business Information,
applicants are advised to contact the HUHS Section of the CCHUHSRR – Licensing
and Registration Division via email (cchuhsrr.lrd.huhs@fda.gov.ph).
- Column 3 - CAS Number

Provide the Chemical Abstracts Service (CAS) number assigned to the declared
ingredient.
In case the ingredient is a mixture whose individual components have assigned CAS
numbers, indicate said CAS numbers in Column 3 as shown in Table 2.17.
76
Table 2.17 Sample Formulation of a HUHS Product Containing an Ingredient

in the Form of a Mixture and its Declaration in the Ingredient List Section of
the Initial HUHS Product Registration Application Form
FORMULATION OF THE HUHS PRODUCT
Raw Material CAS No. % in the HUHS Product
RM Mixture 1 60%
Component A – 50% 010101-02
Component B – 25% 020202-03
Component C – 25% 030303-04
RM 2 040404-05 20%
RM 3 050505-06 20%
INGREDIENT LIST DECLARATION IN THE APPLICATION FORM
Ingredient Name CAS No. % in the HUHS Product
Chemical Name of 010101-02 60%
Component A (50%) 020202-03
Chemical Name of 030303-04
Component B (25%)
Chemical Name of
Component C (25%)
Chemical Name of RM 2 040404-05 20%
Chemical Name of RM 3 050505-06 20%
In case the components of the mixture have no assigned CAS numbers, indicate
“Mixture”. For fragrance materials, known allergens, if present, may be declared
using their corresponding CAS numbers under Column 3 alongside their percent
concentration in the HUHS product formulation.
For more information on how to declare the Ingredient Name (Column 2) and CAS
Number (Column 3) of fragrance materials and colorants in the application form,
refer to the Frequently Asked Questions on Fragrance and Colorants available at:
https://www.fda.gov.ph/wp-content/uploads/2021/04/FAQS-Fragrants-and-
Colorants.pdf.
- Column 4 – Function
Provide the function of the declared ingredient relative to the HUHS product
formulation.
- Column 5 - Percentage (%)

Provide the percent (%) concentration of the declared ingredient relative to the
HUHS product formulation.
Note that the sum total concentration of the declared ingredients must be:
 100%, for HUHS products with up to one (1) declared variant in the application
 100% per variant, for HUHS products with more than one (1) declared variants
in the application
77
- Column 6 – Formulation
For HUHS products with more than one (1) declared variants in the application,
select “BASE” from the dropdown menu for declared ingredients that are part of the
base formulation (i.e. ingredients that are present in all declared variants) or
“VARIANT” if it is a colorant and/or fragrance material that differs between variants.
For HUHS products with up to one (1) declared variant in the application, all
ingredients including the fragrance material/s and colorant/s must be declared as
“BASE”.
- Column 7 - Active Ingredient/s

Select “Yes” from the dropdown menu if the declared ingredient functions as the
“active ingredient” in the HUHS product formulation. Otherwise, select “No”.
The active ingredient is the chemical that gives the HUHS product the ability to
deliver its claimed benefit (i.e. quaternary ammonium chloride as the active
ingredient in surface disinfectants). Note that ingredient/s declared as active
ingredients are reflected in the marketing authorization issued by the FDA.
(4) Document and Label Requirements

Upload the documents required to support the initial HUHS product registration application.
For a detailed discussion on the different documents required to support an initial HUHS
product registration application, read Part II (Initial Registration of HUHS Products) of this
guide manual.
Note that uploaded documents must be in the correct format - PDF file format (100-150 dpi)
for documents and PNG format for the required loose label artwork and pictures of the HUHS
product. To upload documents, click “Choose Files” and select the files intended to be
submitted as part of the application. Applicants may upload documents individually or as a
set of multiple files.
During the transitory period provided in FC No. 2021-011-A, for the purpose of initial
registration, FDA accepts loose label artwork of HUHS products regardless of their
compliance to Annex J of FC No. 2020-025, provided that all product claims reflected on the
label are substantiated. However, should the existing label reflect an unsubstantiated claim,
a proposed label that is already compliant with Annex J of FC No. 2020-025 (placeholders
are allowed) with the unsubstantiated claim deleted must be submitted.
In case of unallowable safety claims in the existing product label, the applicant must submit
either of the following:
(a) a proposed label that is already compliant with Annex J of FC No. 2020-025
(placeholders are allowed) with the safety claim deleted, or
(b) a letter with the commitment that the new HUHS product label will no longer contain the
prohibited safety claim
(5) Application Summary

In the last part of the application form, a summary of the finished draft is shown. This gives
the applicant a last opportunity to review and recheck the draft application for any errors that
may lead to disapproval before submission. Applicants must ensure that the information
contained in the initial HUHS product registration application are CORRECT, CONSISTENT
and COMPLETE, and that the application satisfactorily complies with the set FDA standards
and requirements. A Self-Assessment Checklist is appended as Annex A to this guide
manual which the applicants may use to check their draft initial registration applications.
78
In case the applicant made an error in the application form, click the “Previous Step” button
in the upper left corner of the application window to revisit the page where the error is and
make the necessary correction. For the attached documents, these may be viewed and
checked by clicking its file name.
Once the applicant is satisfied that the draft initial HUHS product registration application is
acceptable and complies with FDA standards and requirements:
(a) indicate the name of the uploaded documents (i.e. SDS, COA, Documentation to
Substantiate Product Claims, Other Documents) and the side of the HUHS product
shown in the uploaded pictures (i.e. Front, Back, Right, Left, Top, Bottom, Commercial
Loose); and
(b) click “Next” and then “Continue” to submit the initial HUHS product registration
application to FDA for pre-assessment.
79
III. ANNEXES
80
Annex A
SELF-ASSESSMENT CHECKLIST FOR
INITIAL HUHS PRODUCT REGISTRATION
81
SELF-ASSESSMENT CHECKLIST FOR INITIAL HUHS PRODUCT REGISTRATION
Brand and Product Name :
Variant Name, if any : Case No. :
• Declaration and Oath of Undertaking (Select “YES, I AGREE” only if you have read and agree with the Terms and
conditions laid down).
DOCUMENTARY REQUIREMENTS Y/N NOTES FROM FDA

Part I. Administrative Documents Information bubbles are available near each section of the
(Application Form) application form to serve as guide in filling up the form.
1. Local Company Responsible for Placing the Provide a valid LTO number as:
Product in the Market • HUHS Manufacturer (see 2.a)
• HUHS Trader (see 2.b)
• HUHS Distributor-Importer (see 2.c)
Note that the type of establishment declared (i.e.

manufacturer, trader or distributor-importer) must be
consistent with the applicant’s activity relative to the
HUHS product for registration.
2. Product Source
a. In case the applicant is the HUHS The product source information are automatically
Manufacturer generated.
b. In case the applicant is a HUHS Trader Indicate the valid LTO number of the HUHS Toll
Manufacturer. The system automatically provides all
other relevant information once a valid LTO number has
been provided.
c. In case the applicant is a Distributor- Indicate whether the HUHS product for registration is
Importer directly or indirectly-sourced.
Directly-sourced products refer to products procured

directly from the manufacturer whereas indirectly-
sources products are those that are procured from a
foreign supplier that is not the product manufacturer.
For directly-sourced products, indicate the:

• Country of origin
• Foreign manufacturer’s name and address.
For indirectly-sourced products, indicate the:

• Country of origin
• Foreign manufacturer’s name and address
• Foreign supplier’s name and address
3. Product Information
(a) Product Line/Type Select the product line/type that best describe the HUHS
product for registration based on its primary function.
(b) Particulars of the Products
- Product Name Indicate the brand and product name of the HUHS product
for registration.
Note that there are restrictions to brand/product name

pursuant to Administrative Order No. 2005-0016 and Item
14.3.6.8 of FDA Circular No. 2020-025 Section V
(Specific Guidelines).
- List of Variants Indicate the variant name/s of the HUHS product included
in the application, if any. A maximum of 5 variants is
allowed per application.
Variants of a HUHS product refers to HUHS products

with identical base formulation but contains different
colorant/s and/or fragrance/s.
Note that a change in the concentration of the active

ingredient/s is NOT allowed in variants of a HUHS
product nor are differences in botanical ingredient/s.
For coloring materials with multiple colors within a

product packaging, indicate in this section the available
packaging size/s of the product based on the number of
colors in a pack (i.e. Crayons 8 Colors; Crayons 16
Colors).
If there are no variants, indicate “Not Applicable” or

“N/A”.
- Product Presentation (Primary Select the product presentation that best describe the
Packaging) primary packaging of the HUHS product.
In case the primary packaging of the HUHS product is not

found in the dropdown menu, select “OTHERS” and
indicate the product’s primary packaging.
In case the HUHS product for registration has multiple

pack sizes with different primary product presentations,
select “OTHERS” and indicate all available primary
packaging of the product.
- Product Presentation (Secondary Select the product presentation that best describes the
Packaging, if applicable) secondary packaging of the HUHS product.
In case the secondary packaging is not found in the

dropdown menu, select “OTHERS” and indicate the
product’s secondary packaging.

pack sizes with different secondary product presentations,
select “OTHERS” and indicate all available secondary
packaging of the product.
In case the HUHS product has no secondary packaging,

select “NOT APPLICABLE”
- Net Content Indicate the net content in metric unit consistent with those
printed on the product label.
One (1) pack size per row.
For surface wipes, the net content may be indicated using

the number of wipes contained in the pack. For coloring
materials, the net content may be indicated using the
number of colors in a pack.

pack sizes with different primary packaging, declare the
net content together with the product presentation
- Product Category Indicate the appropriate product category.
Select for professional use if the product is restricted for

use by trained personnel or professional; otherwise, select
ready-to-use.
- Product Description Indicate the technical specifications of the product as

reflected in the Certificate of Analysis (COA)
- Direction for Use Indicate the directions for use as reflected on the product
label.
- Number of Years Applied For Select the number of CPR validity applied for. Fees will
vary depending on the year of CPR validity selected.
(c) Safety Information
- GHS Compliant (Hazard Based on the hazard information found in the Safety Data
Information) Sheet (SDS), declare the HUHS product for registration to
either be:
• GHS-compliant (product is classified according to
GHS)
• Non-GHS-compliant (product is not classified
according to GHS)
Select “YES” if the product is GHS- compliant and “NO”

if not.
GHS Compliant
▪ GHS Hazard Classification
Physical Hazard Based on Section 2 of the SDS, indicate the GHS hazard
Health Hazard classification of the product under the appropriate hazard
Environmental Hazard group.
Refer to the 8th revised edition of the GHS:

Part 2 – Physical Hazards
Part 3 – Health Hazards
Part 4 – Environmental Hazards
▪ GHS Hazard Communication Indicate the harmonized GHS label elements appropriate
(Pictograms, Signal Word and to the HUHS product for registration based on its GHS
Hazard Statements) hazard classifications.
The declared information must be consistent with those

found in Sec 2 of the SDS and product label.
During the transitory period, special considerations are

given to existing product labels that do not reflect the GHS
label elements.
Non-GHS Compliant Non-GHS compliant HUHS products are only allowed

during the transitory period (TP).
▪ Hazard Information Indicate the appropriate hazard information of the product

in accordance with Item 14.3.6.3 of FDA Circular No.
2020-025 Section V (Specific Guidelines).
The declared information must be consistent with those

found in Sec 2 of the SDS.

given to existing product labels that do not reflect the non-
GHS compliant hazard information.
- Precautionary Statement and Indicate the precautionary statement and warnings

Warnings applicable to the HUHS product consistent with Sec 2 of
the SDS and product label.
For GHS-compliant HUHS products not intended for

children, the statement “Keep out of reach of children”
or its equivalent must be included along with the other
GHS precautionary statements appropriate for the product
based on its GHS hazard classifications.
For HUHS products intended for children, a statement

indicating that the use of the product requires adult
supervision must be included.

given to existing product labels that do not reflect the
declared precautionary statement and warnings.
- Signs and Symptoms of Poisoning Indicate the signs and symptoms of poisoning applicable
to the HUHS product consistent with Secs 4 and/or 11 of
the SDS and the product label, if indicated.

declared signs and symptoms of poisoning.
- First Aid Instructions/Medical Indicate the first-aid instructions / medical advice
Advice applicable to the HUHS product consistent with Sec 4 of
the SDS and product label.

declared first aid instructions / medical advice.
- Handling, Storage and Disposal Indicate the handling, storage and disposal instructions
Information applicable to the HUHS product consistent with Secs 7 and
13 of the SDS and product label.

declared handling, storage and disposal information.
(d) Full Ingredient List Under the “With Variant” section, select “YES” if more
than one (1) variant of the HUHS product have been
declared in the application. Otherwise, declare “NO”
Declare the qualitative and quantitative formulation of the

HUHS product by providing all required ingredient
information.
In case the formulation declared in the application form is

inconsistent with Sec 3 of the SDS, provide sufficient
justification / clarification for the inconsistency.
- Variant Name For applications with more than one (1) declared variants,
indicate the variant names where the declared ingredient
has been used.
- Ingredient Name Declare the ingredients used in the formulation of the
product using their common, chemical or IUPAC names.
Trade names are NOT allowed.
One (1) raw material per row. In case the raw material is a
mixture, declare all its components in a single row with
their corresponding % concentration relative to the raw
material formulation alongside them.
For fragrance materials, indicate either the chemical name

of the fragrance or the word “Fragrance”. Note that
botanical ingredients are not considered as fragrance
materials and must be declared using its assigned
binomial nomenclature (scientific name).
For colorants, indicate either the chemical name of the

colorant, its FD&C number or color index (CI)
number.
For dye mixtures considered as Confidential Business

Information (CBI), contact the HUHS Team.
- CAS Number Indicate the CAS number assigned to the declared
ingredient.
For mixtures whose components have assigned CAS

numbers, indicate said CAS numbers. Otherwise, indicate
“Mixture”.
- Function Indicate the function of the declared ingredient relative to

the product formulation.
- Percentage Indicate the % concentration of the declared ingredient

relative to the product formulation.
The sum total concentration of the ingredients must be

100% per product or per product variant, if there are
multiple declared variants.
- Formulation For products with up to one (1) declared variant, select

“BASE” for all ingredients including the
colorants/fragrance.
For products with more than one (1) declared variants,

select “BASE” for the base formulation (ingredients
present in ALL variants) and “VARIANT” for the
colorants and/or fragrance that differs between variants.
- Active Ingredient/s Select “YES” if the declared ingredient is the active

ingredient in the product formulation. Otherwise, select
“NO”.
Part II. Technical Documents Documents must be in the correct format - PDF file format
(100-150 dpi) for documents and PNG format for the
required loose label artwork and pictures of the HUHS
product.
1. Safety Data Sheet (SDS) of the Formulated Refer to the Guide Manual for the HUHS Industry – Initial
Product Product Registration and 8th revised edition of the GHS for
the format and minimum information that must be found
in an SDS.
In case a single SDS covers several variants of a HUHS

product, all variant names must be listed in the SDS and
all information on the SDS must apply to all covered
variants.
Supplier reflected in the SDS may be the product

manufacturer or any of the suppliers declared in the
application form including the MAH. If this is not the case,
submit a justification/clarification letter.
2. Certificate of Analysis (COA) of the The COA must reflect the following information:
Finished Product (1) Brand and product name including the variant name, if any
(2) Batch/lot/SKU/Item no., manufacturing date, expiration
date or date of analysis
(3) Name and/or logo of the company that conducted the tests
(may be the product manufacturer or a third-party
laboratory)
(4) Name and signature of the laboratory analyst
(5) Name and signature of the laboratory manager or quality
assurance (QA)
(6) Technical specifications of the HUHS product
(7) Actual Test Results, which must be in numerical values for
quantitative tests
One (1) COA may be submitted for HUHS products with

multiple packaging presentations.
One (1) COA must be submitted per variant of a HUHS

product.
Electronically-generated COA without signature are

accepted, provided that the document is proven to be valid
without it.
The name and signature of the laboratory analyst may be

omitted, provided that a document showing proof of
adherence to written procedure (i.e. QWP) is provided
3. Claim Substantiation
Acceptable Substantiation for Qualitative
Claims
a. Report of tests conducted on the Based on internationally-accepted standards or validated
HUHS product test method.
b. Published literature on the active
ingredients
c. Published literature on similarly
formulated product
d. Others (reports of surveys and
studies, certifications, etc)
Acceptable Substantiation for Quantitative
Claims
a. Report of tests conducted on the Based on internationally-accepted standards or validated
HUHS product test method.
b. Stability study (for claimed shelf- Stability data may be from accelerated or real-time
life) stability studies conducted.
Stability study reports are submitted on a per packaging

presentation basis (i.e. HDPE bottle vs sachet) and on a per
variant basis (i.e. Lemon vs Lavender).
During the TP, self-declaration of shelf-life is allowed

under the condition that a commitment is made that a
stability study report will be submitted during CPR
renewal.
c. Report of age grading test conducted
(for age grading claims)
d. Others (reports of surveys and
studies, certifications, etc.)
In case the HUHS product for registration is
classified as GHS Category 1 in any hazard
class, submit any of the following, as
appropriate, to substantiate product safety under
normal conditions of use
a. Exposure Studies
b. Risk Assessment
c. Other documents to substantiate
product safety under normal
conditions of use (i.e. proof of child-
resistant packaging, sufficient
precautionary statements on the
label, COA of the raw material of
concern, etc)
4. Clear and Complete Loose Labels or During the TP, existing product labels are accepted
Artworks of All Packaging Sizes, as regardless of their compliance with Annex J of FDA
applicable, in Filipino or English Language Circular No. 2020-025 provided that product claims are
(in .png format) sufficiently substantiated.
In case the existing label contains unsubstantiated claims

and/or safety claims which are not allowed, an artwork of
proposed label without the unsubstantiated claim and/or
safety claim must be submitted. In lieu of a proposed label,
for unallowable safety claims, a letter may be submitted
containing a commitment to delete/remove the safety
claim from the new HUHS product label.
Submitted proposed labels must be compliant with Annex

J of FDA Circular No. 2020-025. Note that placeholders
are allowed. Note further that labels of HUHS product are
not allowed to have claims that are beyond the definition,
scope and intended use of HUHS.
a. Brand and Product Name
b. Full Ingredient List Must be consistent with the application form.
c. Net Content
d. Batch/Lot/Item/SKU Number
e. Manufacturing / Expiry Date
f. Directions for Use
g. Handling, Storage and Disposal Must be consistent with Secs 7 and 13 of the SDS
h. Name, Complete Address and Must be consistent with the declared Local Company
Contact Information of the MAH Responsible for Placing the Product in the Market in the
application form
i. Country of Manufacture Must be consistent with the product source information in
the application form
j. Contact Information of the
National/Regional Poison Center
Additional requirements for HUHS
products not intended for children
k. Product Category
l. Appropriate Hazard Information Must be consistent with Sec 2 of the SDS
m. Precautionary Statements or Must be consistent with Sec 2 of the SDS

Warnings
Must include:
(a) Keep out of reach of children
(b) Other GHS precautionary statements appropriate
for the HUHS product based on its GHS hazard
classification
n. Signs / Symptoms of Poisoning Must be consistent with Secs 4 and/or 11 of the SDS
o. First-Aid Treatment / Medical Must be consistent with Sec 4 of the SDS

Advice
Additional requirements for HUHS
products intended for children:
a. Age grading Indicated age grading must be supported by sufficient
substantiation (i.e. report of age grading test)
b. Precautionary statement Include a statement indicating that the use of the product
requires adult supervision
5. Pictures of the product in all angles and in Submit photos of the HUHS product from all angles for all
different packaging sizes declared packaging size/s.
a. Front
b. Back
c. Top
d. Bottom
e. Left
f. Right
CONSISTENCY TABLE
All information found in the application including those declared in the application form and those contained in the submitted
documents MUST be consistent. Applications found to contain inconsistent information SHALL be disapproved during pre-
assessment, unless sufficient justification/clarification have been provided.
Put “✓” if the information declared in the application form is consistent with that found in the submitted documents (per
column), and “X” if it is not consistent, and “N/A” if the information is not found in the submitted document.
Application Form SDS COA Label Claim Other

Substantiation Documents
1. Local Company Responsible
for Placing the Product in the
Market
2. Product Source
3. Product Line/Type
4. Product Name
5. List of Variants
6. Product Presentation (Primary

Packaging)
7. Product Presentation
(Secondary Packaging)
8. Net Content
9. Product Category
10. Product Description
11. Directions for Use
12. Safety Information

a. Non-GHS Compliant
Hazard Information
b. GHS-Compliant Hazard
Information (GHS Hazard
Classification and
Communication
Elements)
13. Other Safety Information
a. Precautionary Statement
and Warnings
b. Signs and Symptoms of
Poisoning
c. First-aid Instructions /
Medical Advice
d. Handling, Storage and
Disposal Information
14. Full Ingredient list
INGREDIENTS’ GHS HAZARD CLASSIFICATION TABLE
(Determining the GHS classification of the HUHS product based on available data on its individual ingredients using the summation method,
proportional calculation or cut-off value/concentration limit)
Skin Eye Skin/ Repro

Acute Acute Acute Germ STOT Asp.
Ingredient % Corrosion Damage / Resp Carc. STOT SE and Dev’t
Oral Dermal Inh. Cell Mut. RE Hazard
/Irritation Irritation Sens. Toxicity
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
Finished HUHS Product

REFERENCES
Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”
Joint DTI-DENR-DA-DOF-DOH-DILG-DOLE-DOTC Administrative Order No. 01, s. 2009, The

Adoption and Implementation of the Globally Harmonized System of Classification and Labeling
of Chemicals (GHS) GHS Purple Book, 8th Revised Edition
Administrative Order No. 2019-0019, Reinstatement of Requirements of Licensing as

Importers, Exporters, Manufacturers, Toll Manufacturers, Wholesalers, Distributors, Retailers, or
Re-Packers of Those Engaged in Certain Household/Urban Hazardous Substances, and from the
Requirement of Prior Registration and/or Notification of Said Products
Administrative Order No. 2005-0016, General Policies and Guidelines Governing Brand Names
of Products for Registration with the Bureau of Food and Drugs
FDA Circular No. 2023-006, Updated Guidelines on the Filing and Submission of Applications
for the Licensing and Registration of Household/Urban Hazardous Substances (HUHS)
Establishments and Products, Respectively, Through the FDA E-Portal V.2 System
FDA Circular No. 2021-011-A, Extension of Transitory Period and Provision of Interim Guidelines
for Product Registration, including the Labeling Requirements, for Household/Urban Hazardous
Substances
FDA Circular No. 2020-032, Renaming of the Center for Cosmetics Regulation and Research to
Include Jurisdiction Over Household/Urban Hazardous Substances in its Title Pursuant to
Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”
FDA Circular No. 2020-025, Implementing Guidelines for Administrative Order No. 2019-0019,
“Reinstatement of Requirements of Licensing as Importers, Exporters, Manufacturers, Toll
Manufacturers, Wholesalers, Distributors, Retailers, or Re-Packers of Those Engaged in Certain
Household/Urban Hazardous Substances, and from the Requirement of Prior Registration and/or
Notification of Said Products”
FDA Memorandum Circular No. 2013-030, Guidelines on the Use of the FDA Logo and Name
in Promotional, Advertisement, Sponsorship, Marketing or Commercial Materials
FDA Memorandum Circular No. 2013-038, Filing and Receiving of Registration and Licensing
Applications
FDA Advisory 2021-3501, Inclusion of Notice of Deficiencies (NOD) Step in the

Household/Urban Hazardous Substances (HUHS) Product Registration Process
FDA Advisory No. 2021-0879, Ban of Silver Jewelry Cleaners Containing Cyanide
FDA Advisory No. 2015-021, The Food and Drug Administration (FDA) is Now Online Through
the BancNet for Clients Online Payment Gateway System
93
Published by the
Food and Drug Administration
Civic Drive Filinvest Corporate City
Alabang, Muntinlupa City
2023
Trunk Line +63 2 8 857 1900

Email info@fda.gov.ph
Website www.fda.gov.ph
94

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Guide Manual for the HUHS Industry – Initial Product Registration

Guide Manual for the HUHS Industry – Initial Product Registration

DEFINITIONS AND ABBREVIATIONS

ASEAN Cosmetic Directive (ACD)

Certificate of Analysis (COA)

Certificate of Product Registration (CPR) refers to the marketing authorization issued by

Carcinogenic, Mutagenic and Reprotoxic (CMR)

Center for Cosmetics and Household/Urban Hazardous Substances Regulation and

Department of Trade and Industry (DTI)

ECHA Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

FDA Circular (FC)

FDA Electronic Portal V2.0 System (e-Portal 2)

Globally Harmonized System of Classification and Labeling of Chemicals (GHS)

Household/Urban Hazardous Substance (HUHS) refers to

International Agency for Research on Cancer (IARC)

Letter of Disapproval (LOD)

Marketing Authorization Holder (MAH) refers to the HUHS establishment reflected/named

Precautionary Statement refers to a phrase (and/or pictogram) that describes recommended

Safety Data Sheet (SDS)

Stability Studies refer to scientific studies performed to show data, demonstrate, or

II. INITIAL REGISTRATION

General Guidelines on Securing an Initial Certificate of

Abrasive Cleaners (liquids and powders)

Deodorizers Room Deodorizers

Dishwashing and Laundry Dishwashing Products (liquids, solid and powders)

Disinfectants (for surfaces) Surface Disinfectants (aerosols, liquids, powders)

Fabric Fabric Conditioner

Fresheners (i.e. room, car, Fresheners (solid, liquids, and aerosols)

Moisture Absorbing Agents

Wax (furniture and floor waxes)

Sanitizers (TriChlor, DiChlor, bromine, cyanuric acid)

Button Batteries Button Cells

Paints for Household and Facilities for Coating Purposes,

Php 1,000.00 1% of the total fees and

Php 1,500.00 1% of the total fees and

A marketing authorization in the form of a CPR is issued to initial HUHS product

Table 2.4 List of Adopted Standards for HUHS Products

Information on the Technical Requirements

B. Globally Harmonized System of Classification and Labeling of

Hazard Hazard Hazard

Figure 2.2 Application of the Globally Harmonized System of Classification and

General Information on Hazard Classification

Dusts and Mists

In a number of hazard classes, a hazard category is subdivided into subcategories to

General Information on Hazard Communication

The term GHS label elements refer to the following:

CODE HAZARD PICTOGRAM SYMBOL

GHS01 Exploding bomb

GHS03 Flame over circle

GHS04 Gas cylinder

GHS06 Skull and crossbones

GHS07 Exclamation mark

GHS08 Health hazard

(1) Precedence for the allocation of pictograms for health hazards

(2) Precedence for the allocation of signal words

(3) Precedence for allocation of hazard statements

Safety Data Sheet (SDS) of the HUHS Product

Note: The supplier identified in this section may be the product

Note: For HUHS products whose hazards have been classified

4 First-Aid a. Description of necessary measures, subdivided according to the

11 Toxicological Concise but complete and comprehensible description of the various

C. Certificate of Analysis (COA)