Republic of the Philippines  
Department of Health  
OFFICE OF THE SECRETARY  
 
 
 
Building I, San Lazaro  Compound , R izal Av·enue, Sta .Cruz, 1003 Mani  la • Trunk  Line  651-7800 local 1113, 1108, 1135  
Direct Line: 711 -9502; 711 -9503 Fa x: 743-1829 • URL: http://www.doh.gov.ph ; e-mail: officeofsoh@doh.gov.ph  
 
 
 
 
ADMINISTRATIVE ORDER  
No.__________________ _________  
 
 
SUBJECT:  New Rules and Regulations in the Regi stration of Household 
Pesticide Products and Their Active Ingredients  
 
 
I. RATIONALE  
 
 The evaluation of the safety and efficacy of household/urban hazardo us 
substances (HUHS), such as household pesticide  products , is essential to ensure that 
potential health  risks to the general public and its applicators are kept at a minimum 
or to prescribed acceptable levels . 
 
Pursuant to Republic Act (RA) 9711, otherwis e known as the “Food and Drug 
Administration (FDA) Act of 2009”, and its Implementing Rules and Regulations 
(IRR), the FDA is granted the authority to regulate health products, including 
household pesticide products, among others.  
 
Consistent with this Act , Administrative Order (AO) No. 2014 -0038 entitled 
“Rules and Regulations Governing Household/Urban Pesticides Licensing of 
Establishments and Operators, Registration of Their Products and for Other Purposes”  
was issued on 27 October 2014 . As there is a ne ed to provide updated guidelines and 
requirements consistent with international commitments such as but not limited to 
Montreal Protocol, Rotterdam Convention, and/or Stockholm Convention, and related 
local pesticide regulations and standards, this AO shal l replace AO 2014 -0038 to (1) 
better protect public health and the environment from the risks associated with 
pesticide use; and (2) to ensure safety, efficacy and quality of pesticide products.  
 
 
II. OBJECTIVES  
 
This Order aims to:  
 
1. Provide guidelines on the registration of household pesticide products ; and  
2. Establish guidelines for product stewardship , as applicable , in the market of 
household pesticide products.  
 
 
III. SCOPE  
 
These guidelines shall cover household  pesticide p roducts and their active 
ingredient/s  and the establishments that are engaged in the manufacture, importation, 
exportation, sale,  offer for sale, distribution, donation, transfer, and where applicable,  
 
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 the use, testing, promotion, advertising, or sponsorship of such household pesticide  
products  and/or active ingredient/s . 
  
 This AO , however, shall not cover guidelines on genet ically -
modified/engineered household pesticide products , and issuance of permits for 
experimental use to generate efficacy data for label expansion.  
 
 
IV. DEFINITION OF TERMS  
 
1. Acute Toxicity – refers to those adverse effects occurring following oral or dermal 
administration of a single dose of a substance, or multiple doses given within twenty -
four (24) hours, or an inhalation exposure of four (4) hours . 
 
2. Banned Pesticide – refers to a pesticide , all uses of which have been prohibited by 
final regulatory action to protect human health or the environment.  
 
3. Bio-efficacy Test – refers to a scientific study conducted to show, demonstrate or 
substantiate a claim of efficacy against p est/s as indicated in the label or as claimed by 
the applicant. The data or information generated from bio -efficacy studies shall be 
based on actual experiment with hypothese s consistent with the mechanism of action.  
 
4. Certificate of Product Registration (C PR) – refers to  the authorization issued by FDA 
for a household pesticide 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 . 
 
5. Chronic Toxicity – refers to adverse effects following chronic exposure. The term 
also refers to effects which persist over long period of time whether or not they occur 
immediately upon ex posure or are delayed.  
 
6. Emergency condition – means an urgent, non -routine situation that requires the use of 
a household pesticide product and shall be deemed to exist when:  
 
a. No effective household pesticide products are available that have labelled uses  
registered for control of the pest under the conditions of the emergency; and/or  
 
b. No economically or environmentally feasible alternative practices which provide 
adequate control are available; and/or  
 
c. The situation:  
 
i. Involves the introduction or dissemina tion of an invasive species or a 
pesticide new to or not theretofore known to be widely prevalent or 
distributed within or throughout the Philippines; or  
 
ii. Will present significant risks to human health; or  
 
iii. Will present significant risks to threatened or e ndangered species, 
beneficial organisms, to the environment; or  
  
 
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 iv. Will cause significant economic loss due to an outbreak of a pest.  
 
7. FPA – refers to the Fertilizer and Pesticide Authority  
 
8. Globally Harmonized System of Classification and Labelling of Chemi cals ( GHS ) – 
refers to a system for standardizing and harmonizing the classification and labelling of 
chemicals. It is a logical and comprehensive approach to:  (a) d efining health, physical 
and environmental hazards of chemicals ; (b) c reating classificatio n processes that use 
available data on chemicals for comparison with the defined hazard criteria; and  (c) 
communicating hazard information, as well as protective measures, on labels and 
Safety Data Sheets (SDS).  
 
9. Household Pesticide – also known as “househ old/urban pesticide”, refer s to non-
agricultural pesticide s used for the control of pests in homes, yards and gardens, 
domestic and/or commercial establishments such as schools, malls, condominiums, 
hospitals, buildings, manufacturing sites, warehouses, go lf courses, etc. but shall 
exclude chemicals used in commercial agricultural production. The term also refers to 
a product  used for the co ntrol of insect pests, rodents , and weeds that are found in 
places of human habitation, work and recreation. Examples of insect pests are flies, 
mosquitoes, cockroaches, ants, termites, bedbugs, and others.  
 
Household pesticides shall include products such as, but not limited to, insecticides, 
rodenticides, herbicides, larvicides, termiticides, wood preservative, baits, and 
repelle nts. 
 
For the purpose of this AO, the term household pesticide shall not include 
disinfectants.  
 
Household pesticides can be classified as follows:  
 
a. For Professional Use – refer to household pesticide products used in the control of 
pests of pub lic health significance and intended to be used or applied by a trained 
FDA -certified pesticide handler under the supervision of a FDA -licensed Pest 
Control Operator  to institutions such as but not limited to schools, malls, 
condominiums, hospitals, buildi ngs, manufacturing sites, warehouses, golf 
courses, etc. because of its higher risk/probability to cause unreasonable adverse 
effects to man.  
 
b. For General Use – refer to household pesticide products intended to control pests 
in the household and its surrou ndings which when applied in accordance with its 
direction for use, will generally not cause unreasonable adverse effects to man.  
 
10. Household Pesticide Establishment – refers to sole proprietorship, partnership, 
corporation, institution, association or orga nization engaged in the manufacture, 
importation, exporation, distribution, transfer, promotion, advertising or 
sponsorship of household pesticide products. Household Pesticide Establishments 
shall be classified as follow:  
a. Manufacturer  
b. Trader  
c. Distributor  
d. Distributor (Active Ingredient ) 
  
 
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 11. Household Pesticide Expert Panel – refers to the recommendatory body created by 
FDA to provide technical expertise in the review and development of strategic policy 
direction and guidance on household pesticide products . 
 
12. Household/Urban Hazardous Substances means:  
 
a. 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, generates pressure through decomposi tion, 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 agricul tural 
fertilizers, agricultural pesticides, and agricultural insecticides and other economic 
poisons, radioactive substances, or substances intended for use as fuels, coolants, 
refrigerants and the like;  
 
b. Any substance which the FDA finds to be under the c ategories enumerated in 
clause ( a) of this paragraph;  
 
c. Any toy or other articles intended for use by children which the FDA may 
determine to pose an electrical, chemical, physical, or thermal hazard; and  
 
d. This term shall not apply to food, drugs, cosmetics , devices or to substances 
intended for use as fuels 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 haz ardous substance, 
as construed in paragraph ( a), by reason of bearing or containing such harmful 
substances described therein.  
 
13. Label – means a display of written, printed, or graphic matter upon the immediate 
container, or other materials affixed thereto,  of any article. The label of the 
product shall include other informative materials such as, but not limited to, 
pamphlets, leaflets, insets, hangtags, etc.  
 
14. License to Operate  (LTO)  – refers to an authorization issued by FDA to 
establishment(s) authorizin g the manufacture, importation, exportation, sale, offer for 
sale, distribution, transfer, and where applicable, the use, testing, promotion, 
advertisement, and/or sponsorship of pesticide products.  
 
15. Marketing Authorization (MA) – is the approval granted b y the National Regulatory 
Authority (NRA) to market a specific product in a particular country. The NRA in the 
Philippines is the FDA. A CPR is a MA issued by the FDA.  
 
16. Marketing Authorization Holder (MAH) – means the establishment or company 
named on the Marketing Authorization for a specific product in a particular country. 
The owner of the CPR issued by the FDA is the MAH.  
 
 
 
 
  
 
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 17. Pesticide Registration – means the process whereby the FDA approves the sale and 
use of a household pesticide product following the evaluation of comprehensive 
scientific data demonstrating that the product is effective for its intended purposes and 
does not pose an unacceptable risk to human or animal health or the environment.  
 
18. Safety Data Sheet (SDS) – is a document that provide s important physical 
characteristics, ecological, safety and toxicological information on chemical 
substances or mixtures of ingredients used at the workplace, transported or maybe 
utilized by the consumer.  
 
19. Stability Study – refers to a scientific study p erformed to show data, demonstrate or 
substantiate a claimed shelf -life of a product. Stability tests are carried out to 
determine the acceptable period of storage at a specified condition within which the 
household pesticide product still meets its establ ished specifications or claim of 
efficacy.  
 
20. Toxicity – refers to the ability of a substance to cause injury to biologic material.  
 
21. Toxicity Study – refers to a study performed in vivo  or on animals that is initiated by 
exposure to a chemical, physical or b iological agent, and to determine the toxicity 
level, adverse effects and to show a series of events.  The toxicity reports contain  sets 
of data or information from an experiment for the purpose of risk assessment and risk 
analysis of the product.  
 
 
V. GENERAL  GUIDELINES  
 
1. The applicant  for registration of household pesticide product and the active 
ingredient/s for use in the formulation of a household pesticide product shall be a 
holder of a valid LTO as Household Pesticide Establishment issued by the FDA.  
 
2. All household pesticide  product s  intended to be manufactured, imported, export ed, 
sold, offered for sale, distributed, transferred, and where applicable, used, promoted, 
advertised, and/or sponsored  shall be registered with the FDA  in a per formulation 
and per packaging material type basis.  
 
3. Household pesticide product shall contain a maximum of three (3) active ingredients.  
 
4. For a household pesticide product with dual use as agricultural pesticide, the applicant 
shall register such dual -use pesticide product  with both the FDA and FPA.  
 
5. All active ingredients for use in the formulation of household pesticide products shall 
be register ed with the FDA. If such active ingredient/s has current and valid 
registration with the FPA, the FDA shall recognize the FPA re gistration of such active 
ingredient/s.  
 
6. The applicant for registration of household pesticide product shall submit stewardship 
program in protecting consumer health and the environment. The FPA guidelines on 
product stewardship and responsible care are he reby adopted for compliance by 
applicants of household pesticides for registration.  
  
 
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 7. Household pesticide product labe ls shall have the mandatory label elements of the 
Globally Harmonized System of Classification and Labeling of Chemicals.  
 
8. The FDA shall ad here and promote the agreements such as the Montreal Protocol, 
Rotterdam Convention, Stockholm Convention, and other international convention/s 
wherein the Philippine government is one of the signatories, in the ban or restriction 
of ingredients used in th e manufacture of household pesticide products.  
 
9. All household pesticide products containing any banned ingredient as declared by the 
FDA, and/or FPA shall be prevented from entering the Philippine market.  
 
10. Hazard Classification of the household pesticide p roduct shall be based on GHS.  
 
11. Only household pesticide products with GHS Acute Toxicity  Categories 3, 4, and 5 
shall be allowed for registration for household use.  Household Pesticide products 
classified as GHS Acute Toxicity Category 1 and 2 shall be pro hibited in household 
use. 
 
12. Only household pesticide products with GHS Acute Toxicity Categories 2, 3, 4, and 5 
shall be allowed for r egistration for professional use. Household pesticide products 
classified as GHS Acute Toxicity  Category 2 shall be subject  to the review and 
recommendatory action of the Household Pesticide Expert Panel . 
 
13. FDA -registered  household pesticide p roducts for professional use shall  not be allowed 
for over -the-counter selling.  
 
14. FDA -registered products shall  be subject to post-marketi ng surveillance activities 
including but not limited to product verification, laboratory analysis and product 
recall.  
 
15. MAH shall be responsible for the continuous monitoring and evaluation  of their 
household pesticide products , such as but not limited to  periodic review of scientific 
evidence and market reports  pertaining to the product’s safety and efficacy , to ensure 
continuous compliance with the latest standards.  
 
16. Variations involving changes  in the product’s  indications of use  GHS health hazard 
categor y (acute toxicity, skin corrosion/irritation, serious eye damage/ eye irritation 
and skin sensitization),  composition, manufacturer, address of manufacturer, and/or 
supplier, s hall warrant a new product registration.  Any other changes shall only 
require CP R amendment.  
 
17. MAH  shall immediately notify FDA in cases of serious adverse effects associated 
with the use of household pesticide products.  It shall be the responsibility of the MAH 
to ensure availability and adequate supply of antidote for their household  pesticide 
products.  
 
18. The FDA shall work closely with local partners and international organizations to 
develop and strengthen FDA regulatory standards or approaches to the sound 
management of household pesticide products.  
 
 
  
 
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 19. MAH  shall conform to the exist ing guidelines of Republic Act (RA) 6969, otherwise 
known as the “Toxic Substances and Hazardous and Nuclear Wastes Control Act of 
1990” and its Implementing Rules and Regulations (IRR)  for the  storage, transport 
and final disposal of expired, banned, obso lete, rejected, recalled and/or out of 
specification formulated household pesticide products . 
 
 
VI. SPECIFIC GUIDELINES  
 
All applicants for registration of active ingredients and household pesticide products 
shall submit the registration requirements as specif ied by the FDA.  
 
1. Application Process  
 
a. Filing  
 
 An application for Certificate of Product Registration (CPR), whether new, 
renewal, or variation, is considered valid and final  upon submission of complete 
requirements including payment of required fees and c harges.  
 
b. Evaluation  
 
The evaluation of all applications for CPR shall be based on the completeness 
and accuracy  of the submitted documents, compliance with appropriate standards  and 
acceptability of the product safety and efficacy . 
 
i. Submission of Bio -efficacy Study  
 
a. Product claims shall  be based on the pests/insects tested, spectrum of 
activity, mode of a pplication and dose rate that sha ll be used in the bio -
efficacy study/ies to be conducted.  
 
b. The study shall  be conducted locally by an independent research er. 
Foreign generated data (laboratory and field trials) shall be acceptable 
provided the trials were conducted under s imilar environmental 
conditions and test animals or insects used are proven to be the same 
with the local species . 
 
c. The submitted bio -efficacy study shall comply with the requirements 
specified by the FDA in accordance with accepted protocols , if available,  
including but not limited to:  
 
Product  Protocol  
Insecticidal Net  WHO Guidelines for Laboratory and 
Field Testing of Long -Lasting 
Insecticidal Nets  
Human Mosquito Repellent  WHO Guidelines for Efficacy Testing 
of Mosquito Repellents for Human 
Skin 
Mosquito Coils, Vaporizer Mats, 
Liquid Vaporizersm Ambient 
Emanators and Aerosols  WHO Guidelines for Efficacy Testing 
of Household Insectici de Products   
 
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 Mosquito Larvicide  WHO Guidelines for Laboratory and 
Field Testing of Mosquito Larvicides  
 
d. Test insects which will be used shall be the local strain. Any other 
deviation from the standard protocol shall be justified.  
 
e. The study shall be accep ted if it has been conducted for not more than 
ten (10) years or upon proof of continued efficacy against the claimed 
target pest/s, unless there are reports of development of resistance, 
adverse effects, etc., prior to registration.  
 
f. The treatments shall  be composed of the positive control, negative 
control and the product being registered.  In case of novel products, the 
positive control is allowed to be omitted from the bio -efficacy study.  
 
g. The FDA -registered positive control and t he product being registe red 
shall  have the same active ingredient/s or active ingredients from the 
same family of chemicals at the very least , formulated into similar 
product type (i.e. aerosol, repellent lotion) . 
 
h. The negative control shall simulate the concentration of the solv ent used 
in the formulation.  
 
i. Product efficacy of the product being registered shall be deemed 
acceptable if proven to be equivalent with or bether than the positive 
control, unless the standard protocol set a minimum limit for efficacy 
(≥80% mortality aft er 24 hours or ≥95% knock -down 60 minutes after 
exposure for insecticidal net).  
 
ii. Submission of Toxicity Study  
 
a. Toxicity study/ies shall  be conducted using the household pesticide 
product being registered.  
 
b. The submitted toxicity study/ies shall comply with  the requirements 
specified by the FDA in accordance with accepted protocols such as the 
Organization for Economic Cooperation and Development ( OECD ) 
guidelines or any international counterpart.  
 
In case the applicant made misrepresentations, false entries , or withheld any 
relevant data to the provisions the law or appropriate standards , the application shall 
be disapproved. In such cases, the applicant shall  be investigated, and appropriate 
charges may be filed  and penalties  be imposed , if the circumstance s so warrant . 
 
2. Issuance of CPR  
 
A CPR shall be issued to household pesticide products that comply with the  
documentary requirements and standards of safety, efficacy and quality based on 
existing FDA rules and regulations.  
  
 
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 A registration number shall be assigned to a household pesticide product 
whose product registration a pplication has passed the product registration process of 
the FDA.  
 
The validity of the CPR shall be for a minimum of two (2) years or maximum 
of five (5) years unless recalled or banned  by the FDA.  
 
3. Cancellation of CPR  
 
a. Automatic Cancellation  
 
The registration of a household pesticide  product that is not renewed within  one 
hundred twenty  (120) days from the date of expiration shall be automatically 
cancelled and deleted from the list of  registered household pesticide  products 
without prejudice to their re -application. The product shall be re -applied for 
registration and shall follow the new registration process and requirements  and 
pay the corresponding fees . 
 
b. Voluntary Cancellation  
 
The MAH may apply for voluntary cancellation of its existing CPR by filing a 
formal notification with the FDA  citing the reasons thereof . 
 
c. Cancellation  and/or Revocation  as a Penalty  
 
The FDA shall  impose the penalty of cancellation and/or revocation of CPR  as per 
Book II, Article I, Sec. 4. Grounds for Disapproval of Application and Suspension 
or Cancellation of License, Registration or Authorization of the IRR of RA 9711.  
 
The MAH shall remain to be accountable/liable for any violations committed, and 
are sub ject to the penalties levied and administrative sanctions imposed by FDA.  
 
4. Accessibility  
 
The relevant forms, requirements for application, and the submission process 
shall  be made accessible at the FDA w ebsite.  
 
5. Responsibility of the Marketing Authorizati on Holder (MAH)  
 
In case the household pesticide product has been withdrawn for health and 
safety reasons due to violations, the MAH shall immediately undertake the necessary 
measures, as well as shoulder incidental costs, in banning its sale, distribution  or 
donation, or its immediate recall, withdrawal or seizure from the market, and its 
disposal in accordance with existing rules and regulations  and product stewardship 
comitments . 
 
 
 
 
 
 
  
 
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 6. Issuance of Off -Label Use / Emergency Exemption Permit  
 
In emergency  conditions as declared by the DOH or the respective Local 
Government Unit ( LGU ) such as pest outbreaks or disease/epidemic, an off -label 
permit may be applied for use by an unregistered household pesticide product or by a 
registered household pesticide pr oduct with use different from what has been 
approved by the FDA . 
 
Application for an off -label use permit shall be evaluated on its merit based on 
the information submitted and shall  be granted permission only for the duration of the 
emergency period and u pon the recommendation of the Household Pesticide Expert 
Panel.  
 
 
VII. FEES AND CHARGES  
 
The FDA shall charge a fee for all CPR applications whether new , renewal or 
variation/s based on existing guidelines being implemented by the FDA.  
 
 
VIII.  PENALTY CLAUSE  
 
Establi shments engaged in the manufacture, importation, exportation, sale, 
offer for sale, distribution, donation, transfer, and where applicable, the use, testing, 
promotion, advertising, or sponsorship of household pesticide  products  including the 
facilities an d installations needed for its activities who are found to be operating 
outside th e rules and regulations of FDA sha ll be subjected to sanctions and penalties 
as prescribed by RA 9711.  
 
 
IX. REPEALING CLAUSE  
 
This Order effectively repeals AO 2014 -0038 entitle d “Rules and Regulations 
Governing Household/Urban Pesticides Licensing of Establishments and Operators, 
Registration of Their Products and for Other Purposes” . All other a dministrative 
issuances, bureau circulars and memoranda and other regulations incons istent with 
this Order are hereby withdrawn, repealed and/or revoked accordingly.  
 
 
X. SEPARABILITY CLAUSE  
 
If any part or term of provision of this Order shall be declared invalid or 
unenforceable, the validity or enforceability of the remaining portions or provisions 
shall not be affected and this Order shall be construed as if it did not contain the 
particular invalid or unenforceable part, term or provision.  
 
 
 
 
 
 
  
 
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 XI. EFFECTIVITY  
 
This Order  shall take effect fifteen (15) days following the completion of its 
publication i n two (2) newspapers of general circulation and submission of a copy 
hereof to the  University of the Philippines  Office of the National Registry              
(UP-ONAR) . 
 
 
 
 
 
         FRANCISCO T. DUQUE III, MD, MSc.  
                                                                                           Secretary of Health  
 
 
Office  FDA  HRT  HPDPB  OSEC  
 
 
 
Initial   
 
 
NELA CHARADE G. 
PUNO, RPh.  
Director General   
 
 
ROLANDO ENRIQUE D. 
DOMINGO, MD, DPBO  
Undersecretary   
 
 
MAYLENE M. BELTRAN, 
MPA, CE SO III  
Director IV   
 
 
ATTY. FATIMA P. 
LAPERAL  
Head Executive Assistant  
Date      
 
 
Keywords  Household pesticides, GHS, CPR  
Related Issuances, Laws, Directives  RA 9711, A.O. 2014 -0038 , AO 2016 -0003