All concerned stakeholders may submit comments in MSWord format on or before 30 April 2022 via email to [email protected] using the format below:
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 2013 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 be 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.
To provide guidelines on the procedure for the voluntary certification of Food Contact Articles.
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.
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:
e. Synthetic Resin
f. Phenolic Resin
g. Melamine Resin
h. Urea Resin
i. Synthetic Resin made from Formaldehyde
j. Polyvinyl Chloride
n. Polyvinylidene Chloride
o. Polyethylene Terephthalate
p. Polymethyl Methacrylate
r. Polymethyl Pentene
t. Polyvinyl Alcohol
v. Paper and paperboard
2. 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. 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 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.
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 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.
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 – 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.
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 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.
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)
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 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 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 indicated 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 [email protected] 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.
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 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 the 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
If any provision of this Circular be declared invalid or unconstitutional, the remaining portions shall remain legal and in full force.
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.