I. RATIONALE
Pursuant to Section 2 Article II Book I of the Implementing Rules and Regulation (IRR) of Republic Act 9711 otherwise known as “The Food and Drug Administration Act of 2009”, the Food and Drug Administration (FDA) is mandated 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 that requires regulation as determined by the FDA. Food Contact Articles (FCA) are health products constituting chemicals that can migrate from the materials into food. As these chemicals migrate, they may alter the characteristics of the food unacceptably or have adverse effects on the taste and/or odor of foods (Linssen, 1992).
Regulation of FCA is specified in R.A. 10611 also known as the Food Safety Act of 2013 which states that food is adulterated if it is in a container having in whole or in part any poisonous or deleterious substance. Moreover, any food packaging material which results or may reasonably be expected to result, or indirectly in it becoming a component or otherwise affecting the characteristics of any food is considered a food additive according to the Bureau Circular 2006-016 or the Updated List of Food Additives.
Hence, the determination of the suitability of the Food Contact Articles for use in the packing, packaging, transporting, or holding of food shall be conducted by the FDA Common Services Laboratory (CSL) to carry out the foregoing laws.
II. OBJECTIVES
To provide guidelines on the procedure for the voluntary certification of Food Contact Articles. Specific Objectives of this are as follows:
- To establish the guidelines on the conduct of voluntary certification of food contact articles used for prepackaged processed food products.
- To provide information on the process of application for the voluntary certification to the stakeholders involved.
III. SCOPE
This Circular shall cover both locally manufactured and imported food contact articles, in finished or final form, with or without applied adhesives and/or printing inks, limited to:
A. Direct Food Contact Articles which include all primary packaging materials of pre-packaged processed food products having the following materials:
-
- Metal
- Glass
- Ceramic
- Enameled
- Synthetic Resin
- Phenolic Resin
- Melamine Resin
- Urea Resin
- Synthetic Resin made from Formaldehyde
- Polyvinyl Chloride
- Polyethylene
- Polypropylene
- Polystyrene
- Polyvinylidene Chloride
- Polyethylene Terephthalate
- Polymethyl Methacrylate
- Nylon
- Polymethyl Pentene
- Polycarbonate
- Polyvinyl Alcohol
- Rubber
- Paper and paperboard
B. Articles with incidental contact to processed food products having the materials listed under Direct Food Contact Articles.
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. 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.
C. 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.
D. Food Contact Articles – are the finished or final form made up of one or multiple different food contact substances/materials and food contact chemicals such as adhesives and printing inks.
E. Migration – is defined as the partitioning of chemical compounds by diffusion or absorption from the packaging into the food.
F. Prepackaged – means packaged or made up in advance in a container, ready for sale to the consumer, or for catering purposes.
G. Primary Packaging – the term used to designate the layer of packaging in immediate contact with the product, thus, it is the first packaging layer in which the product is contained. It is constructed considering the product itself and any existing secondary layers of packaging.
H. Printing Inks – Mixtures of colourants with other substances which are applied on materials to form a graphic or decorative design together with or without other coloured or uncoloured overprint varnishes/ coatings or primers which are normally applied in combination with a) in order to enable the printed design to achieve specific functions such as ink adhesion, rub resistance, gloss, slip/friction, durability, etc.
I. Processed Food – refers 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.
II. Voluntary Certification – an official document attesting the suitability and safety of the Food Contact Articles issued by the FDA upon recommendation of the Common Services Laboratory (CSL) after thorough evaluation/ review of application documents submitted by the client’s own choice and consent.
V. GENERAL GUIDELINES
A. The evaluation of the suitability of the food contact articles shall be 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 required 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 safety. See Annex A.
D. The establishment involved in the manufacture, importation, exportation, sale, offering for sale, distribution, and transfer of FCA may secure voluntary certification prior to utilization, selling, and commercial distribution.
E. Any or a combination of the following references shall be adopted and be used in the evaluation:
- 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)
- Latest edition of “Specifications, Standards and Testing Methods for Foodstuffs, Implements, Containers, and Packaging, Toys, Detergents” of JETRO.
- Code of Federal Regulation Title 21 Part 170 to 199 of the US Food and Drug Administration.
- Other references for Food Contact Articles recognized by ASEAN member states.
- Regulatory requirements of the importing country for products intended for export, if necessary.
F. The documentary requirements are listed in Annex A. Incomplete submission of these documents shall be a ground for disapproval of the application.
G. Complete documentary requirements shall be submitted through online or onsite application onsite (under section VI Specific Guidelines).
H. Test parameters to be conducted by an FDA-accredited/recognized laboratory shall depend on the type and conditions of use where the food contact article shall be utilized. Samples for analysis shall be in the finished or final form of the product.
I. Pre-application queries from applicants shall be entertained thru Online or face-to-face. The process is indicated in Annex B.
J. Application Fee shall be based on Administrative Order No. 50 s 2001 or current FDA Fees and Charges.
VI. SPECIFIC GUIDELINES
A. Pre-Application Query
The client may inquire thru the following options:
- Online Pre-Application Query
a. The establishment/applicant shall send an email inquiry to the [email protected] with “Email Subject: Pre-Application Query on FCA Evaluation”
b. The CSL/Receiving and Releasing Unit (RRU) personnel shall receive and acknowledge receipt of the email inquiry, and generates the Document Tracking Number (DTN).
c. The CSL/RRU personnel shall forward the email inquiry to the assigned unit
d. Once response is already available, the CSL/RRU personnel shall forward the Reply Letter (Original Hard Copy) to the FDA – Records, and shall send the scanned copy to the applicant.
e. The FDA Records Section shall release reply letter (Original Hard Copy) to client.
- Onsite Pre-Application Query
a. Establishment/Applicant shall submit letter of inquiry at the Food and Drug Action Center (FDAC).
b. The CSL/RRU personnel at the FDAC shall receive and forward the letter of inquiry to the Common Services Laboratory Receiving and Releasing Unit (CSL-RRU).
c. The CSL/RRU personnel shall forward the letter of inquiry to the assigned unit.
d. Once response is already available, CSL/RRU personnel shall forward the Reply Letter to the FDAC.
e. CSL/RRU personnel assigned at FDAC shall release the Reply Letter to the client.
B. Application for Certification of Food Contact Articles (FCA)
The client may apply for the certification through the following options:
- Online filing of application for Certification of FCA
a. The applicant shall submit the scanned copy of the requirements (ANNEX A) to [email protected] with “Email Subject: Voluntary Application for Food Suitability Evaluation of FCA” FDA shall only accept applications once the testing of FCA by the accredited laboratory is completed. (To access the List of FDA-accredited laboratories see Annex D)
b. The Receiving and Releasing Unit (RRU) 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 assigned unit.
2. Onsite filing of application for Certification
a. The applicant shall submit the hard 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 assigned unit.
c. FDAC FDA Records shall release the Evaluation Report to the client.
C. Evaluation and Issuance of Certification
- The CSL shall conduct the evaluation based on the submitted documents and samples.
- The evaluation shall be based on the type of FCA and its intended use as indicated in the request letter.
- The test results and other provided information shall be evaluated in accordance with the adopted standards and other regulations as deemed appropriate.
- After a thorough evaluation and subsequent approval, a certification shall be issued if the FCA is determined to be suitable for its intended use. Otherwise, a letter of disapproval shall be issued.
- A certification or a letter of disapproval shall be issued within 12 working days upon acceptance by the RRU.
- 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
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 after its publication in the Official Gazette or in any newspaper of general circulation and upon filing with the University of the Philippines Law Center Office of the National Administrative Register.