DRAFT FOR COMMENTS  
FDA CIRCULAR  
No. 2022 -_____  
  
SUBJECT:      Guidelines on the Voluntary Certification of Food Contact Articles    
                         Used  for Prepackaged Processed Food Products  
___________________________________________________________________________  
 
I. RATIONALE  
            Pursuant to Section 2 Article II Book I of the Implementing  Rules  and Regulation (IRR) 
of the Republic Act 9711 otherwise known as “The Food and Drug Administration Act 
of 2009”, mandates the Food and Drug Administration (FDA) to develop and issue 
policies, standards, regulations, and guidelines that would cover establishments, 
facilities, and health products . Health products as defined in the said Act refer to the 
products that may have an effect on health which requires regulation as determined by 
the FDA.  
 
            Furthermore, in Section 9 of Republic Act 10611 or the Food Safety Act of 2 013 also 
known as “An Act to Strengthen the Food Safety Regulatory System in the Country to 
Protect Consumer Health and Facilitate Market Access of Local Foods and Food 
Products, and for Other Purposes, the setting of food safety standards “(a) xxx shall b e 
established based on science, risk analysis, scientific advice from expert body/ bodies, 
standards of other countries, xxx” as its guiding principle.  
 
 The safety of Food Contact Articles must be  evaluated as chemicals can migrate from 
the materials into food, wherefore, to ensure that the quality and safety of the food 
available to the consuming public are free from  contaminants that may alter the 
characteristics of the food unacceptably or have adverse effects on the taste and/or odor 
of foods, and no migration of unsafe levels of chemical substances from the materials to 
the food that might result to toxicological risk because of contamination (Linssen, 1992) 
thus posing a potential public health problem , the determination of the suitability of the 
Food Contact Articles for use in the packing, packaging, transporting, or holding of food 
was perceived to be imperative by the FDA. The materials must be manufactured in 
compliance with Good Manufacturing Practices such that any potential transfer to foods 
does not raise safety concerns . 
 
 
II. OBJECTIVES  
 
General Objective  
 
To provide guidelines  on the procedure for the voluntary certification of Food Contact 
Articles.   
 
 
  Page 2 of 7 
 
 
 Objectives  
  
1. To establish the guidelines on the conduct of voluntary certification of food contact    
       articles used for prepackaged processed food products.  
 
2. To provide information on the process of application for the voluntary certification    
       to the stakeholders involved.  
 
 
III. SCOPE  
 
A. This Circular shall cover both locally manufactured and imported food contact 
articles,  in finished or final from, with or without applied adhesives and/or printing inks,  
limited only to: 
  
1. Direct Food Contact Articles  which include all primary packaging materials of 
pre-packaged processed food products having the following materials:  
a. Metal  
b. Glass  
c. Ceramic  
d. Enameled  
e. Synthetic Resin  
f. Phenolic Resin  
g. Melamine Resin  
h. Urea Resin  
i. Synthetic Resin made from Formaldehyde  
j. Polyvinyl Chloride  
k. Polyethylene  
l. Polypropylene  
m. Polystyrene  
n. Polyvinylidene Chloride  
o. Polyethylene Terephthalate  
p. Polymethyl Methacrylate  
q. Nylon  
r. Polymethyl Pentene  
s. Polycarbonate  
t. Polyvinyl Alcohol  
u. Rubber  
v. Paper and paperboard  
 
2.  Articles with incidental contact  to processed food products  having the materials 
listed under Direct Food Contact Articles.  
  Page 3 of 7 
 
 
 3.  Polyethylene and polypropylene resins used as raw  materials for processing of 
articles intended  for packaging of food ; and; 
  
4.  Filter paper for filtration for use in (e.g., milk, coffee, tea, sugar).  
 
 
IV. DEFINITION OF TERMS  
 
For the purpose of this Circular, the following terms shall mean:  
 
A. Adhesives  – refer to the naturally derived materials such as paste, glue etc. used 
for sealing of folding cartons, laminating paper to paperboard and labeling of food 
containers. This may also include starch and casein -based adhesives, natural rubber 
latex , polyvinyl alcohol emulsion, petroleum wax in combination with polymers 
and tackifying resin. Glued -on, self -adhesive (pressure sensitive), in -mold and 
sleeve labels are most commonly used for any type of food container including 
bottles and metal cans.  
 
B. Certification  - refers to the authorization issued by the FDA for food contact 
articles upon recommendation of the Common Services Laboratory (CSL) after 
thorough evaluation/ review of application documents.  
 
C. Establishment  - means a sole proprietorship, a partnership, a corporation, an 
institution, an association, or an organization involved in the manufacture, 
importation, and distribution of food contact articles.  
 
D. Food Contact Substance /Materials – any substance that is intended for use as a 
component of materials used in packing, packaging, transporting, or holding food 
if such use of the substance is not intended to have any technical effect in such 
food.  
  
E. Food Contact Articles - is the finishe d or final form made up of one or multiple 
different food contact substances/materials and food contact chemicals such as 
adhesives and printing inks.  
 
F. Migration  - is defined as the partitioning of chemical compounds by diffusion or 
absorption from the packaging into the food.  
 
G. Prepackaged  - means packaged or made up in advance in a container, ready for 
sale to the consumer, or for catering purposes.  
 
H. Primary Packaging  – the term used to designate the layer of packaging in 
immediate contact with the prod uct, thus, it is the first packaging layer in which  Page 4 of 7 
 
 
 the product is contained. It is constructed considering the product itself and any 
existing secondary layers of packaging.  
 
I. Printing Inks  - in this context also called packaging inks, including varnishes,  
means any product manufactured from colourants, binders, solvents and additives. 
There are solvent -based, waterborne, oleo -resinous or energy -curing (UV or 
electron beam) systems. They are applied by printing or varnishing processes, such 
as flexography, offset, gravure printing and roller varnishing. The term packaging 
ink is used in order to differentiate the products used on packages from prints for 
other purposes.  
 
J. Processed Food  - refer s to food that has been subjected to some degree of 
processing like milling, drying, concentrating, canning, or addition of some 
ingredients which changes partially or completely the physico -chemical and/or 
sensory characteristics of the food’s raw  material .  
 
 
V. GENERAL GUIDELINES  
 
 
A. Evaluation of the suitability of the food contact articles is conducted by the CSL 
to serve the needs of establishments that voluntarily secure a “food grade 
certification” to substantiate the suitability of their product as requi red by their 
clients for the intended application of use.   
 
B. The evaluation of the FCA shall be performed by the CSL of the FDA for the 
applicant seeking assistance in attesting the suitability of their product for the 
intended application of use.  
 
C. The determination of the suitability of FCA for use in the packing, packaging, 
transporting, or holding of food shall be based on the requirements established 
by the CSL  to ensure the suitability of the food contact materials for their 
intended use and its saf ety. 
 
D. Establishment involved in the manufacture, importation, exportation, sale, 
offering for sale, distribution, transfer of FCA  may secure voluntary certification 
prior to utilization, selling, and commercial distribution.  
  
E. For the standards, methods of analysis, limits, and guides, the following shall be 
adopted:  
  
1. Latest edition of the “Specifications and Standards for Foods, Food 
Additives, etc. Under the Food Sanitation Act (Abstracts)” of the Japan 
External Trade Organization (JETRO)  
   Page 5 of 7 
 
 
 2. Latest edition of  “Specifications, Standards and Testing Methods for 
Foodstuffs, Implements, Containers and Packaging, Toys, Detergents” of  
JETRO .  
  
3. Code of Federal Regulation Title 21 Part 170 to 199 of the US Food and 
Drug Administration.  
 
4. Regulatory requirements of the importing country for products intended fo r 
export, if necessary.  
 
F. The documentary requirements are listed in Annex A. Incomplete s ubmission 
of these documents shall be a ground for disapproval of the application.  
 
G. Complete documentary requirements must be submitted  through online or 
manual application onsite (under section VI Specific Guidelines).  
  
H. Test parameters to be conducted by an FDA -accredited/recognized laboratory 
will depend on the type and conditions of use where the food contact article shall 
be utilized. Samples for analysis must be in the finished or final form of the 
product.  
 
I. Monitoring of the FCA may be conducted as directed by the Center for Food 
Regulation and Research in coordination with the  CSL and the Field Regulatory 
Operations Office (FROO).  
 
J. Pre-application queries from applicants shall be entertained thru Online or 
manual. The process is ind icated in Annex B.  
 
K. Application Fee shall be based on Administrative Order No. 50 s 2001 or current 
FDA Fees and Charges.  
 
 
VI. SPECIFIC GUIDELINES  
 
A.   Application for Certification of Food Contact Articles (FCA)  
 
1. Online filing of application for Certification of FCA  
 
a. The applicant shall submit the scanned copy of the requirements 
(ANNEX A) to csl@fda.gov.ph  with “Email Subject: Voluntary 
Application for Food Suitability Evaluation of FCA …” FDA 
shall only accept application once the testing of FCA by the 
accredited laboratory is completed.   Page 6 of 7 
 
 
 b. The Receiving and Releasing Unit (RRU)  shall review the 
application fo r completeness of requirements.  
 
*If incomplete: application is returned stating the reason for    
  rejection . 
*If complete: assigns a Reference Number and forwards the   
         application to the Toxicology Section.  
2. Manual filing of application for Certification  
a. The applicant shall submit the scanned  copy of the requirements  
       (ANNEX A) at the  Food and Drug Action Center (FDAC). FDA   
        shall only accept  application once the testing of FCA by the   
        accredited laboratory is completed.  
b. The RRU of the CSL at FDAC shall review the application for   
        completeness of Requirements.  
      * If incomplete: application is returned stating the reason for   
         rejection . 
                     * If complete: assigns a Reference Number and forwards       
                        the application to the Toxicology Section . 
c. The Lab Tech of the CSL/RRU at the FDAC FDA Records   
            shall release the Evaluation Report to th e client . 
 
B. Evaluation and Issuance of Certification  
 
1. The Toxicology Section will conduct evaluation based on the submitted 
documents and samples.  
2. The evaluation shall be based on the type of FCA and its intended use 
as indicated in the request letter.  
3. The test results and other provided information shall be evaluated in 
accordance with the adopted standards and other regulations as deemed 
appropriate.  
4. After thorough evaluation and subsequent approval, a certification will 
be issued if the FCA is  determined to be suitable for its intended use. 
Otherwise, a letter of disapproval will be issued.  
5. Certification or letter of disapproval will be issued within 12 working 
days upon acceptance by the RRU.  
6. Certification shall be valid for a period of one (1 ) year from the date of 
issuance.  
7. Reapplication may be done once the observations on the initial 
application have been addressed. Reapplication entails the payment of 
the required application fee.  
 
 
VII. SEPARABILITY CLAUSE   Page 7 of 7 
 
 
  
If any provision of this Circular be declared invalid or unconstitutional, the remaining 
portions shall remain legal and in full force.  
 
 
VIII.  EFFECTIVITY  
 
This Circular shall take effect fifteen (15) days following its publication in one (1) 
newspaper of general circulation and filing  of three (3) certified true copies to the Office 
of the National Administrative Register (ONAR) University of the Philippines . 
 
 
 
                          FRANCISCO T. DUQUE III, MD, MSc  
                                           Secretary of Health  
  
DTN: 201601281036 Page 1 of 8 
 
 
 
  
ANNEX A  
Requirements For Application Of  
Certification of Food Contact Articles  
  
A. Checklist of Requirements for Online Application:  
1. Request Letter stating the intended use of the food contact article(s) (FCA).  
2. FCA  Information must include the following information;  
- Technical Specification  
- Intended use of the product (i.e., primary or s econdary packaging/ direct 
or indirect contact with food)  
- Overview of the production process  
*For products wherein part of its component is recycled material, the    
 following should be submitted:  
  a. Recycling process  
              b. Source of starting  material or major material that will be recycled  
3. Certificate of Analysis/Quality Control Inspection Report, wherein the batch or 
lot number  and production date  of the concerned product should be indicated;  
4. Health and Safety Information/Safety Data Sheet (SDS) of the concerned 
product, (Finished product and raw materials)  
5. Formulation/ Composition of the concerned FCA;  
- Specific chemical name  and corresponding percentage composition  
- Chemical Abstract Service Registry Number (CAS No .)  
- Percentage  of all raw materials used (include the colorants and additives, 
if any).  
*For  food contact articles FCA made from metals and its alloy, the      
  specific alloy should be indicated along with its elemental composition.  
  *For food contact articles FCA in which part of its component  
              are recycled  materials, all the chemicals used in the recycling process  
              must be reflected.  
6.  Report of Analysis from  an FDA Accredited / Recognized Laboratory as 
listed in the  FDA website  (Batch/Lot No. must be indicated in the Test Report)   
7. Clear Photo of the FCA (Al l parts – i.e., inner and outer parts)  
*For consideration: Submission of FCA samples via courier  
8. Proof of payment (e.g., Official Receipt, Landbank Oncoll Machine -Validated 
Payment, verified and posted payment by the FDA Cashier).  
 
B. Checklist of Requirement s for Manual Application  
 
1. Request Letter (State the intended use of the product).   Page 2 of 8 
 
 
 
 2. Food Contact Article ( FCA ) Information must include the following 
information;  
- Technical Specification  
- Intended use of the product (i.e., primary or secondary 
packaging/ direct or indirect contact with food)  
- Overview of the production process  
    *For products wherein part of its component is recycled material, the    
      following should  be submitted:  
      a. Recycling process  
      b. Source of starting mat erial or major material that will be recycled  
3. Certificate of  Analysis /Quality Control Inspection Report, wherein the batch or 
lot number of the concerned product should be indicated;  
4. Health and Safety Information/Safety Data Sheet (SDS) of the concerned 
product (Finished product and raw materials)  
5.  Formulation/ Composition of the concerned Food Contact Article FCA;  
- Specific chemical name,  
- Chemical Abstract Service Registry Number (CAS No.)  
- Numbers of all raw materials used (include the colorants and 
additives, if any).  
 * For food contact materials (FCM ) made from metals and its alloy, the specific    
    alloy should be indicated along with its elemental composition.  
 * For products wherein part of its component is recycled materials, all the  
    chemicals used in the recycling process must be reflected.  
6. Report of Analysis from an FDA Accredited / Recognized Laboratory as listed 
in the  FDA website  (Batch/Lot No. must be indicated in the Test Report)  
7. Representative sample  
8. Proof of payment (e.g., Official Receipt, Landbank Oncoll Machine -Validated 
Payment, verified and posted payment by the FDA Cashier).  
 
C. Checklist of Requirements for Online Pre -Application Query  
1. Email Inquiry which contains at least the following information about the 
FCA to be applied for evaluation:  
a. formulation/composition;  
b. intended use and the specific food that will be contained  
 
D. Checklist of Requirements for Onsite -Pre-Application Query  
1. Letter of Inquiry which contains at least the following information about the 
FCA to be applied for evaluation:  
a. formulation/composition;  
b. intended use and the specific food that will be contained.  
 
  Page 3 of 8 
 
 
 
 ANNEX B  
Process for Pre application Query  
 
A. Pre-Application Query  
1. Online Pre -Application Query  
 
a. The establishment/applicant shall send an email inquiry to 
the            csl@fda.gov.ph  with “ Email Subject: Pre-Application  
Query on FCA Evaluation —” 
b. The CSL/Receiving and Releasing Unit (RRU) personnel receives 
and acknowledges receipt of the email inquir y, and generates DTN.  
c. The CSL/RRU personnel forwards the email inquiry to the CSL -
Toxicology Section.  
d. Once response is already available , The CSL/RRU personnel 
forwards the Reply Letter (Original Hard Copy) to the FDA – 
Records , and sends the scanned copy to the applicant.  
e. FDA Records Releases reply letter (Original Hard Copy) to client.  
 
2. Manual  Pre-Application Query  
 
a. Establishment/Applicant shall submit letter of inquiry at the Food 
and Drug Action Center (FDAC).  
b. The CSL/ Receiving and Releasing Unit (RRU)  personnel  at the 
FDAC receives and forwards the letter of inquiry to the Common 
Services Laboratory Receiving and R eleasing Unit (CSL RRU).  
c. The CSL/RRU personnel forwards the letter of inquiry to the CSL -
Toxicology Section.  
d. Once response is already available,  CSL/RRU personnel forwards 
the Reply Letter to the FDAC.  
e. CSL/RRU personnel assigned at FDAC releases the Reply Letter to 
the client.  
 
 
 
 
 
 
 
 
 
 
 
 
  Page 4 of 8 
 
 
 
 ANNEX C  
Process Flow  
Responsible  Process  Notes  
A. Pre-application Query on Tests to be conducted (for applicants who have not had any 
previous evaluation report/ certification from FDA)  
   
                        
  
CSL/RRU    
Letter of inquiry to CSL with the 
following minimum details on 
the food contact articles:  
1. Formulation/composition  
2. Intended use  
3. The specific food that 
will be contained  
May also inquire through  
csl@fda.gov.ph  
with subject “Email Subject: 
Pre-Application Query on 
FCA Evaluation  —” with the 
same minimum details on the 
food contact articles  
 
CSL/RRU  
   
Only those queries with 
complete details as specified will 
be referred to CSL -Toxicology 
Section  
 
CSL-
TOXICOL
OGY 
SECTION    
Review al and recommend ation 
of specific analysis to be 
conducted by FDA accredited/ 
recognized laboratory  
 
CSL-
TOXICOL
OGY 
SECTION    
The assigned FDRO shall 
prepare and send reply letter 
with the recommended specific 
analysis and documentary 
requirements  STAR T 
Client inquiry to CSL  
Online  Manual  
Referral to 
Cosmetics/Toxicology 
Section  
Conduct review and give 
recommendation  
 
Preparation of Reply 
Letter   Page 5 of 8 
 
 
 
 CSL/RRU    
 
  Total: 7 working days  
 
  
  
B. Filing of application for Certification of Food Contact Articles  
  
 
  
CSL/RRU 
at FDAC  
 
 
 
 
 
 
 
 
 
 
  Once the testing of the food 
contact article by the accredited 
laboratory is completed, the 
applicant shall submit the 
requirements at the Food and 
Drug Action Center (FDAC).  
The applicant may also apply 
online by submitting the  
scanned copy o f the 
requirements to csl@fda.gov.ph 
with “Email Subject: Voluntary 
Application for Food 
Suitability Evaluation of 
FCA ___” 
CSL/RRU 
at FDAC  
   
 
Reviews application for 
completeness of requirements  
 
CSL/RRU   
 
 
 
 
 
 
 
  
 
If incomplete: application is 
rejected stating the reason of 
rejection. If complete: assigns a 
Reference Number and forwards 
the application to the Toxicology 
Section  Forward to FDAC  
 
END  
STAR T 
Filing of application  Payment of Fee thru 
Landbank  
Review of submitted 
documents  
Compliant?   Page 6 of 8 
 
 
 
 Voluntary Certification of Food Contact Articles  
 
 
 
 
 
         
              YES                                             NO  
 
 
 
 
 
 
CSL/RRU   
 
 
 
  
CSL-
Toxicology 
Section   
 
  Evaluation shall be conducted by 
the CSL -Toxicology Section  
CSL/RRU             
 
 
                                                                                                                 
                    
                                                                    
 
 
         Hard copy shall be forwarded to 
FDA Records  
 
FDA 
RECORDS   
 
 Releases the Evaluation Report 
shall to the client  
 
 
  Total: 12 working days  Issuance of 
Letter of  
Disapproval  Forwards the 
application to 
the Toxicology 
Section  
 
Forward the application 
for Evaluation  
Food Suitability Evaluation 
and preparation of Report   
Forward the Evaluation 
Report to the FDA Records   
Releasing of Evaluation 
Report  
END   Page 7 of 8 
 
 
 
 ANNEX D  
References  
 
 
J. P. H. Linssen,J. C. E. Reitsma,J. P. Roozen, July 1992. Polystyrene sheet composition and 
temperature as parameters for migration of styrene monomer into corn oil . 
https://doi.org/10.1002/pts.2770050408  
 
ASEAN Guidelines for Good Manufacturing Practice for Food Contact Materials . chrome 
extension://efaidnbmnnnibpcajpcglclefindmkaj/viewer.html?pdfurl=https%3A%2F%2Fasean
.org%2Fwp -content%2Fuploads%2FASEAN -GMP -Guideline -for-Food -Contact -Materials -
endorsed -29PFPWG.pdf&clen=1045435&chunk=true  
 
Deshwal, G. K., Panjagar i, N. R., & Alam, T. (2019). An overview of paper and paper -based  
food packaging materials: health safety and environmental concerns. Journal of food science 
and technology, 56(10), 4391 –4403. https://doi.org/10.1007/s13197 -019-03950 -z 
 
USFDA Food Ingredient & Packaging Terms . https://www.fda.gov/food/food -ingredients -
packaging/food -ingredient -packaging -terms  
 
Arvanitoyannis, I.S., Kotsanopoulos, K.V. Migration Phenomenon in Food Packaging. Food –
Package Interactions, Mechanisms, Types of Migrants, Testing and Relative Legislatio n—A 
Review. Food Bioprocess Technol 7, 21 –36 (2014). https://doi.org/10.1007/s11947 -013-1106 -
8 
 
B. Aurela, L. Söderhjelm,  2007 . in Chemical Migration and Food Contact Materials . 
https://www.sciencedirect.com/topics/agricultural -and-biological -sciences/printing -inks 
 
Administrative Order No. 2014 -0030, Revised Rules and Regulation Governing the Labelling 
of Prepackaged Food Product s Further Amending Certain Provisions of Administrative Order 
No. 88 -B s. 1984 or the “Rules and Regulations Governing the Labelling of Prepackaged Food 
Products Distributed in the Philippines ,” and for Other Purposes.  
https://www.fda.gov.ph/archives/  
 
Department Of Health Food and Drug Administration Citizen’s Charter Common Services 
Laboratory 2022 (3rd Edition) Effectivity Date: 31 March 2022 . 
https://www.fda.gov.ph/citizens -charter/  
 
Administrative Order No. 50 s. 2001  Revised 2001 Schedule of Fees and Charges for the 
Corresponding Services Rendered by the Bureau of Food and Drugs  
https://www.fda.gov.ph/archives/  
  Page 8 of 8 
 
 
 
 Republic Act 11032 An Act Promoting Ease of Doing Business and Efficient Delivery of 
Government Services , amending  for the purpose Republic Act No. 9485, Otherwise known as 
the Anti -Red Tape Act  of 2007, and for Other Purposes . chrome -
extension://efaidnbmnnnibpcajpcglclefindmkaj/viewer.html?pdfurl=https%3A%2F%2Farta.g
ov.ph%2Fwp -
content%2Fuploads%2F2020%2F07%2FRA.11032 _Certified_True_Copy.pdf&clen=170619
9&chunk=true