Note:  This draft is only intended as a copy for comments during the stakeholder consultation 
period of the proposed guidelines. The content of this draft may change and does not prejudge 
any policy nor decision of the FDA. Citation of any text in this draft, for purposes other than 
the submission of com ments as indicated in the issued announcement, is not recommended.  
 
  1 
ADMINISTRATIVE ORDER  2 
 3 
No. ____________________  4 
 5 
SUBJECT  : Rules and Regulations Governing the Issuance of 
Authorizations for Toys and Childcare Articles  
 6 
 7 
 8 
I. RATIONALE  9 
 10 
Through previous  policies implementing Republic Act (RA) No. 7394, otherwise 11 
known as the “Consumer Act of the Philippines”, the Department of Health (DOH) 12 
initially established the regulatory framework governing health products, particularly 13 
toys for children, through th e then -Bureau of Health Devices and Technology. With the 14 
enactment of RA 9711  or the “Food and Drug Administration Act of 2009” , the Food 15 
and Drug Administration (FDA) was strengthened , and the law  align ed regulatory 16 
functions o ver health products of the D epartment to the  created  Health Product Centers 17 
of the FDA. Thereafter,  through  the Center for Cosmetics and Household/Urban 18 
Hazardous Substances Regulation and Research (CCHUHSRR) , the FDA implemented 19 
regulatory processes ensuring the safety, efficacy and quality of household/urban 20 
hazardous substances, including toys and articles intended for children.  21 
 22 
In 2015, the FDA promulgated guidelines to streamline the authorization processes f or 23 
toys and childcare articles through a product notification procedure, which also placed 24 
emphasis on the responsibility of market authorization holders  (MAH)  to ensure 25 
compliance with FDA -instituted standards. Updates to toy safety regulation were 26 
furthe r introduced in 2019 by way of  the Implementing Rules and Regulations (IRR) 27 
of RA 10620, otherwise known as the “Toy and Game Safety Labelling Act of 2013” 28 
which introduced special labeling requirements for toys and  games.  29 
 30 
A review of the existing regulatory framework for toys and articles intended for 31 
children revealed gaps in  the policies and guidelines, including the need to update 32 
labeling requirements  to be  consistent with the IRR of RA 10620, the need to address 33 
the in congruency of the requirement s for the  issuance of certifications  for exempted 34 
toys,  and the need to update standards to ensure the safety of to ys and childcare articles.  35 
Hence, this Order is hereby issued to provide the updated rules and regulations 36 
governing the issuance of authorizations for toys and childcare articles.  37 
 38 
 39 
II. OBJECTIVES  40 
 41 
This Order aims to establish the rules and regulations governing the issuance of 42 
authorizations for toys and childcare articles  (TCCA) . Specifically, it aims to:  43 
 44  
 
Page 2 of 10 
 A. Update and align TCCA  regulations with appropriate laws , locally -established  1 
standards, and  internationally -accepted standards;  2 
B. Institutionalize the Product Notification procedure for toys and childcare articles ; 3 
C. Rationalize the issuance of Certificates of  Exemption for exempted toys , games , 4 
and childcare article s; and, 5 
D. Provide the roles and responsibilities of market ing authorization holders in ensuring 6 
the safety, efficacy , and quality of toys and childcare articles throughout the product 7 
life cycle.  8 
 9 
 10 
III. SCOPE  11 
 12 
This Order covers all establishments engaged in the manufacture, packing, repack ing, 13 
importation, exportation, sale, offer for sale, distribution, transfer, use, testing, 14 
promotion, advertising, and sponsorship of toys and articles intended for use by 15 
children less than fourteen (14) years of age.  16 
  17 
 18 
IV. DEFINITION OF TERMS  19 
 20 
For the purposes of  implementing  this Order, the following terms are defined as 21 
follows. Other terms used shall have the same meaning as defined in RA 9711 and its 22 
IRR.  23 
 24 
A. Certificate of Product Notification - an authorization secured  by a  TCCA 25 
establishment from  the FDA  for its intention to place  a particular TCCA product  in 26 
the local market  27 
 28 
B. Certificate of Exemption  – an authorization issued by  the FDA  to an entity  29 
importing  TCCA products  for the  limited purpose s of display , exhibit  or donation , 30 
without any intention  to be sold in the Philippine market  31 
 32 
C. Foreseeable  use- play modes that conform to the instructions that accompany the 33 
toy, that have been established by tradition or custom, or that are evident from an 34 
examination of the toy . This term shall also refer to as apparent use.  35 
 36 
D. License to Operate - authorization issued by FDA to  an establishment to grant 37 
permission to undertake a trade or carry out a business activity, such as the 38 
manufacture, distribution , importation, exportation , sale, offering for sale, or 39 
transfer of toys and childcare articles  40 
 41 
E. Market Authorization Holder - is the owner  on the marketing authorization  issued 42 
by FDA  for a specific  health  product  43 
 44 
F. Re-export - the act of sending imported goods to another country .  45 
  46 
G. Toys  and childcare articles  – articles intended for use by children less than 47 
fourteen (14) years of age that the FDA may determine to pose an electrical, 48 
chemical , physical, or thermal hazard.  49 
 50  
 
Page 3 of 10 
 H. TCCA product s for personal use – refer to TCCA products whether new or used 1 
in non -commercial quantities for purposes of personal use or consumption and not 2 
for commercial  purposes . Commercial quantities shall refer to the quantity for a 3 
given kind or class of articles that are in excess of what is compatible with and 4 
commensurate to the person’s normal requirements for personal use.  5 
 6 
 7 
V. GENERAL GUIDELINES  8 
 9 
A. Establishments engaged in the manufacture,  packing, repack ing, importation, 10 
exportation and distribution of toys and articles intended for use by children less 11 
than fourteen (14) years of age shall secure a License to Operate (LTO) from the 12 
FDA before the commencement of  such activities.  A Certificate of Product 13 
Notification (CPN) for the TCCA product shall likewise be secured  from the FDA 14 
by the licensed establishment  prior importation and/or being placed in the market.  15 
 16 
B. The label ing and packaging of TCCA products shall be in adherence with the 17 
labeling requirements adopted by the FDA, consistent with RA 739 4, RA 10620 , 18 
and their IRR and future amendments . 19 
 20 
C. TCCA products, including the chemicals they contain, must not jeopardize the 21 
safety and health of children and users  when used as intended or in a foreseeable 22 
way, bearing in mind the behavior of children . Further, TCCA products shall be in 23 
compliance with applicable product standards adopted by the  DOH and the  FDA , 24 
including but not limited to safety standards in relation to their physical, 25 
mechanical, electrical, chemical, or thermal properties . Further more , TCCA 26 
products must be free from substances banned by the  DOH and the  FDA  and/or 27 
must not contain ingredients restricted by the DOH and the FDA in concentratio ns 28 
exceeding allowable limits.  Further, lastly, no claim shall be made in labeling, 29 
advertisements, marketing and promotional materials that implies that a TCCA 30 
product has characteristics it does not have . 31 
 32 
D. The primary responsibility of ensuring the safety, efficacy , and quality of TCCA 33 
products covered by this Order shall rest upon the market authorization holder  34 
(MAH) . Establishments engaged in the sale of TCCAs declared by the FDA to be 35 
injurious, unsafe, or dangerous shall be required to immediate ly recall, withdraw, 36 
seize, or ban the sale, distribution, or donation to the public.  Any TCCA product, 37 
the sale or use of which has been banned or withdrawn in the country of 38 
manufacture, shall not be imported into the country.  The FDA shall not be preclu ded 39 
from  issuing the necessary notices and/or warnings in order to prevent the purchase 40 
and use of injurious, unsafe, dangerous, or mislabeled TCCA products.  41 
 42 
E. Any untoward i ncident involving TCCA products resulting in the death, serious 43 
illness or injury, medical treatment of a child shall be  reported by  the manufacturers, 44 
traders, distributors, importers, and/or the MAH s to the FDA  immediately and 45 
within prescribed timeframes . Non-serious untoward incidents  and safety concerns  46 
involving TCCA products shall  likewise  be reported to the FDA . 47 
F. The FDA shall conduct postmarket ing surveillance (PMS) activities on TCCA 48 
establishments and products to monitor compliance with this Order, and other 49  
 
Page 4 of 10 
 applicable FDA rules, regulations and standards. Further, the FDA sh all not be 1 
precluded to undertake any regulatory action, following due process, upon entities 2 
found to be in violation of RA 9711, RA 7394, RA 10620, and other applicable 3 
laws, rules and regulations, in order to ensure consumer protection and public health  4 
and safety.  5 
 6 
VI. SPECIFIC GUIDELINES  7 
 8 
A. Definition and Classificati on of TCCAs  9 
 10 
1. TCCA  products  shall  be classified accord ing to age group and use , as follows : 11 
a. Toys  intended for children below 14 years  of age  12 
b. Swings, slides, and similar activity toys for indoor and outdoor family 13 
domestic use   14 
c. Childcare articles  designed or intended by the manufacturer to facilitate 15 
sleep, feeding, and hygiene  that comes directly in contact with the 16 
mouth, or to help children with sucking  or teething  17 
 18 
2. Products shall be classified consistent with the definitions provided in this 19 
Order. The product presentation, including the age category of users, intended 20 
and apparent use, design, claims, of the TCCA product shall be considered  in 21 
this determination.  22 
 23 
3. Annex A  provides a n illustrative list  of currently identified TCCA products. 24 
Currently unimagined product forms and types sh all be considered against the 25 
definition of a TCCA product.  26 
 27 
4. The FDA shall have the authority to create additional classes, classify  or 28 
reclassify  products  that will be considered as TCCA Products , consistent with 29 
this Order , and in pursuit of public health and safety . 30 
 31 
B. Licensing of TCCA E stablishments  32 
 33 
1. Establishments shall be classified according to their licensed activity(ies), 34 
namely:  35 
a. Manufacturers , Manufacturer/Packers, Manufacturer/Repackers;  36 
b. Trader s; and,  37 
c. Distributor/Importers, Distributor/Exporters, Distributor/Wholesalers, 38 
or a combination thereof . 39 
 40 
2. The requirements and the  procedure for filing an LTO application  shall be in 41 
accordance with  DOH Administrative Order (AO) No. 2020 -0017 and its 42 
amendments . 43 
 44 
3. Establishments shall comply with applicable standards, including but not 45 
limited to Good Manufacturing Practices (GMP), Good Distribution and 46  
 
Page 5 of 10 
 Storage Practices (GDSP), and other standards  promulgated and/or  adopted by 1 
the FDA,  in the conduct of their licensed activity /ies. 2 
 3 
4. The FDA shall have the authority to enter any covered establishments engaged 4 
in FDA -regulated activities involving TCCA pro ducts during operating hours 5 
to conduct routine or spot check inspections.  6 
 7 
C. Market Authorization  of TCCA products  8 
 9 
1. FDA -licensed manufacturers , traders, packers, repackers and distributors  shall 10 
signify their intent to introduce  a toy and/or childcare articl e in the Philippine 11 
market through the filing of an application for CPN. Only TCCA with valid 12 
CPNs by the FDA may be imported and/or placed in the Philippine market.  13 
 14 
2. The procedure for filing an application for a CPN for TCCAs  shall be in 15 
accordance with the latest guidelines issued by the FDA . 16 
 17 
a. The requirements which shall be submitted in support of the application  18 
are listed in Annex B. 19 
b. The product standards  applicable for TCCA products  are listed in Annex 20 
C. 21 
c. The labeling and packaging requirements for TCCA products are listed 22 
in Annex D. 23 
 24 
A CPN shall be issued upon an application that has satisfactorily complied with 25 
all applicable requirements and standards.  The validity of  TCCA authorization  26 
shall vary depending on the  length applied , i.e., 1, 2, or 3 years .   Any c hanges  27 
to the product information submitted in support of a CPN application shall 28 
constitute a new application.  29 
 30 
3. Any of the following or similar instances shall be a ground for the disappro val 31 
of an application, suspension, revocation or cancellation of the authorization , 32 
following Book II, Article I, Section 4.B of the IRR of RA 9711 : 33 
 34 
a. The application requirements submitted show that the establishment 35 
does not meet the required technical requirements or appropriate 36 
standards;  37 
b. The applicant made misrepresentations, false entries, or withheld any 38 
relevant data contrary to the provisions o f the law or existing FDA rules 39 
and regulations or appropriate standards;  40 
c. The holder or owner has violated any of the terms and conditions of its 41 
authorization;  42 
d. The label of the health product is false and misleading or does not 43 
conform with current label ing requirements;  44 
e. The holder or owner of the CPR/authorization, without legitimate reason 45 
fails to sell the health product or fails to cause it to be marketed during 46  
 
Page 6 of 10 
 an uninterrupted period of at least three (3) years from date of issuance 1 
or renewal of th e registration, or the last date of operation or marketing;  2 
f. Such analogous grounds or causes as determined by the FDA.  3 
 4 
Nothing in this section shall restrict the FDA from imposing the penalty of 5 
suspension, revocation, or cancellation of registration or authorization for 6 
administrative violations of any other relevant laws or their implementing rules 7 
and regulations.  8 
 9 
D. Postmarketing surveillance of TCCA products  10 
 11 
1. The primary responsibility of ensuring the safety, efficacy and quality of TCCA  12 
products  covered by this Order shall rest upon the MAH . Notified TCCA 13 
products shall continuously comply with the product standards instituted by  and 14 
as updated by  the FDA. The MAH shall ensure that no claim shall be made in 15 
labeling, advertisements, marketing and  promotional materials that implies that 16 
a TCCA product has characteristics it does not have.  17 
 18 
2. Establishments engaged in the sale of TCCAs  declared by the FDA to be 19 
injurious, unsafe, or dangerous shall be required to immediately recall, 20 
withdraw, seize, o r ban the sale, distribution, or donation to the public.  Any 21 
TCCA product, the sale or use of which has been banned or withdrawn in the 22 
country of manufacture, shall not be imported into the country. For this purpose, 23 
a product recall procedure shall be de veloped and maintained by the MAH , as 24 
part of its overall Risk Management Plan.  Further, the MAH shall observe and 25 
comply with the guidelines on the conduct of product recall under FDA Circular 26 
No. 2016 -012 and its amendments.  27 
 28 
3. Any untoward incident involving TCCA products resulting in the death, serious 29 
illness or injury, medical treatment of a child shall be reported to the FDA. The 30 
MAH shall report to the FDA such untoward incidents within two (2) working  31 
days upon first k nowledge . 32 
 33 
Non-serious untoward incidents involving TCCA products shall likewise be 34 
reported to the FDA by the MAH within fifteen  (15) days upon first knowledge.  35 
 36 
4. The FDA shall develop  a reporting platform  to receive complaints, including 37 
safety  concern s from the public .  38 
 39 
5. The FDA shall conduct postmarket ing surveillance (PMS) activities , including 40 
but not limited to the sampling, collection, verification  of products in the 41 
market, inspection of  TCCA establishments , recall effectiveness audits.  and 42 
testing of  products , to monitor compliance with this Order, and other applicable 43 
FDA rules, regulations and standards.  Further, t he FDA shall not be precluded 44 
to undertake any regulatory action, following due process, upon entities found 45 
to be in violatio n of RA 9711, RA 7394, RA 10620, and other applicable laws, 46 
rules and regulations, in order to ensure consumer protection and public health 47 
and safety.  48  
 
Page 7 of 10 
  1 
E. Rules for TCCA products intended for specific purposes  2 
The following rules shall apply to TCCA products  which are not intended to be 3 
placed in the Philippine market:  4 
 5 
1. Imported TCCA products intended for donation, charity and missionary work 6 
shall comply with the guidelines provided under DOH Administrative Order 7 
No. 2020 -0001  and its amendments . 8 
 9 
2. TCCA products  which  are intended solely for the purpose of display/exhibition 10 
may be imported; Provided, that the imported product shall not be offered for 11 
sale; Provided, further, that the imported product shall be re -exported or 12 
disposed after display/exhibit ion; Provided, lastly, that the importing entity 13 
secures a Certificate of Exemption from the FDA.   Individuals and entities 14 
importing such toys and games shall adhere to the conditions granted under the 15 
issued certification.  16 
 17 
3. Manufacturers and distributor/exporters of TCCA products intended  solely  for 18 
export  and re -export shall secure an LTO from the FDA. However, a CPN for 19 
such TCCA products shall no longer be required.  20 
 21 
Further, establishments exporting and/or re -exporting such TCCA product s 22 
shall bear the overall responsibility for the safety, efficacy and quality of their 23 
products. Furthermore, such establishments shall be responsible for any 24 
necessary compliance with the standards and regulations of the receiving 25 
country or state.  26 
 27 
4. Indivi duals importing TCCA products for personal use shall be exempted from 28 
securing prior clearance from the FDA ; Provided, that such products are 29 
imported in quantities not exceeding the limits set and following conditions 30 
specified in DOH -FDA -Bureau of Custom s (BOC) Joint Circular No. 1 -2015  31 
and its subsequent amendments . 32 
 33 
Further, i ndividuals shall assume full responsibility over the use  of such 34 
imported TCCA products . Any  untoward incidents arising  from the use of such 35 
imported TCCA products shall be immediately reported to the FDA  the 36 
described timeframes consistent with Item no. 3 of Section VI. D; wherein,  such 37 
individuals shall fully cooperate with the FDA  and other relevant authorities  on 38 
corrective actions which will be required.  39 
 40 
 41 
VII. ROLES AND RESPONSIBILITIES  42 
 43 
A. TCCA Manufacturers , Traders,  Packers,   Repackers  and Distributors  44 
 45 
1. The MAH  shall ensure continuous compliance with  these Guidelines, including  46 
the established product standard s, technical, labeling , and packaging 47 
requirements  set by the DOH and the FDA,  to guarantee the safety and quality 48 
of the notified TCCA products.  49  
 
Page 8 of 10 
 2. Manufacturers , Packers,  and Repackers  shall observe Good Manufacturing 1 
Practices in the manufacture of  TCCA products.  2 
3. Manufacturers, Packers, Repackers, and Distributors shall observe Good 3 
Distribution and Storage Practices in the distribution of TCCA products across 4 
the supply chain.  5 
4. The MAH shall be responsible for conducting  the proper monitoring and 6 
investigation of reported untoward incidents related to t he usage of TCCA  7 
products . 8 
5. The MAH shall be responsible for reporting to the FDA any untoward incidents 9 
within the prescribed timeframes  provided  in this Order  and in accordance with 10 
further implementing guidelines issued by the FDA . 11 
6. The MAH shall initiate necessary measures for the immediate recall and 12 
discontin uation of the sale and/or distribution of TCCA products deemed to be 13 
injurious, unsafe, dangerous, or grossly deceptive. Incidental costs emanating 14 
from the aforementioned safe ty measures shall be borne by the MAH.  Recalls 15 
conducted by the MAH shall be in compliance with product recall guidelines 16 
under FDA Circular No. 2016 -012 and its future amendments . 17 
7. The MAH shall fully cooperate with the FDA  in the conduct of PMS activities , 18 
and shall be responsible for  timely  carrying out corrective and preventive action 19 
plans for identified non-conformities  and deficiencies  against standards . 20 
 21 
B. TCCA Retailers  22 
 23 
1. Retailers shall ensure that TCCA products sold or offered on sale in their 24 
establishments or platforms , including physical and online,  are supplied through 25 
licensed TCCA Manufacturers and/or Distributors.  26 
2. Retailers shall take measures to verify that TCCA products sold or offered on 27 
sale in their establishments or platforms  are duly -notified with the FDA  and 28 
bear the appropriate labeling and packaging requirements.  29 
3. TCCA Retailers shall cooperate with the FDA in the conduct of PMS activities, 30 
including the recall, return, and/or quarantine of TCCA products deemed to be 31 
injuri ous, unsafe, dangerous, or grossly deceptive.  Retailers shall remove 32 
violative products from their shelves and take down products from their 33 
platforms in accordance with issued advisories, warnings and/or orders by the 34 
FDA.  35 
 36 
C. FDA  37 
 38 
1. The FDA shall issue the ne cessary guidelines , including transitory 39 
arrangements,  to effectively  implement this Order.  40 
2. In addition to the requirements  and standards in the Annexes , the FDA may 41 
require additional technical and administrative requirements  and introduce 42 
updates to the standards , including those not covered by this Order, provided 43 
that these shall be issued in the form of FDA Circulars, in order to ensure the 44 
effective implementation of this Order.  45 
3. The FDA shall keep a record of licensed est ablishments and notified TCCA 46 
products pursuant to this Order on its FDA website, which shall be accessible 47 
to consumers and other concerned stakeholders.  48  
 
Page 9 of 10 
 4. The FDA shall develop and implement a PMS plan , which shall allow the 1 
monitoring  of the continuous co mpliance of TCCA establishments and products 2 
with this Order.  3 
5. The FDA shall issue the necessary  appropriate  public health warnings and/or 4 
advisories for sta keholders and the public, pursuant to its conducted PMS 5 
activities wherein violations o f existing rules and regulations and/or risks to 6 
public health and safety are found.   7 
 8 
 9 
VIII.  TRANSITORY PROVISIONS  10 
 11 
A. The FDA shall issue implementing rules or guidelines for the provisions stated 12 
herein  within six (6) months  of the effectivity of this Order .  13 
  14 
B. Affected stakeholders shall be provided a transitory period of not more than six (6) 15 
months from the date of effectivity of the implementing rules or guidelines of this 16 
Order to allow covered establishments to comply with the new guidelines.  17 
 18 
 19 
IX. PENALTY CLAU SE 20 
 21 
Any person and/or establishment found in violation of this Order shall be deemed a 22 
violation of Republic Act No. 3720 as amended by Republic Act No. 9711 and shall be 23 
penalized accordingly following the Uniform Rules of Procedures laid down under 24 
Book III of the Implementing Rules and Regulations of Republic Act No. 9711.  25 
 26 
 27 
X. REPEALING CLAUSE  28 
 29 
Administrative Order No. 2009 -0005 and its amendments, FDA Circular No. 2015 -002 30 
are hereby repealed . Other related issuances inconsistent or contrary to the provisions 31 
of this Administrative Order are hereby amended or modified accordingly.  32 
 33 
 34 
XI. SEPARABILITY CLAUSE  35 
 36 
If any part, term of provision of this Order shall be declared invalid or unenforceable, 37 
the validity or enforceability of the remaining portions or provisions shall not be 38 
affected and this Order shall be construed as if it did not contain the particular invalid 39 
or unenforceable or unconstitutional part, term, or provision.  40 
 41 
 42 
XII. EFFECTIVITY  43 
 44 
This Administrative Order shall take effect fifteen (15) days following the publication 45 
in the Official Gazette or in a newspaper of general circulation and filing with the  46 
University of Philippine s Office of the National Administrative Register.  47 
 48 
 49  
 
Page 10 of 10 
  1 
TEODORO J. HERBOSA, MD   2 
                                  Secretary of Health   3 
 4 
 5 
 6 
Office    FDA   COS  
Initials      
   
DR. SAMUEL A. ZACATE   
Director General    
 
GLORIA J. BALBOA, MD, MPH, MHA, CEO VI, CESO III   
OIC- Undersecretary of Health and Chief of Staff  
Date       
   7 
Keywords   Toys, Childcare Articles, Licensing, Authorization, FDA   
Related issuances, laws, directives 
from other government agencies   AO No. 2020 -0017, AO No. 2009 -0005, AO No. 2009 -0005 -A, AO No. 
2009 -0005 -B, FDA Circular No. 2015 -002, DOH -FDA -BOC Joint 
Circular No. 1 -2015, DOH Administrative Order No. 2020 -0001, RA 
9711, RA 7394, RA 10620  
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