Packaging Requirements for FCM
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Packaging Requirements for FCM
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Food Contact Materials (FCM)
Philippines
The below version control table serves to document all updates made to the report. The purpose is to ensure the information is always accurate and up-to-date.
| Version Number | Content Creation Date | Publishing Date | Section(s) Updated & Reason(s) for Update |
|---|---|---|---|
| V0 | 18 Feb 2025 | 19 Feb 2025 | N/A (new report) |
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1. Overview of Relevant Regulatory Standards for Food Contact Materials
Food Contact Articles (FCA) 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 [1].
Excerpt from FDA Circular No.2022-0011: Guidelines on the Application and Issuance of Voluntary Certification of Food Contact Articles (FCA) Used for Prepackaged Processed Food Products [1]
Food Contact Substances/ Materials are 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 effect on such food [1].
Regulation of FCA is specified in 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 [2]. Furthermore, any food packaging material that 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 [3].
Under FDA Circular No. 2022-0011 entitled “Guidelines on the Application and Issuance of Voluntary Certification of Food Contact Articles (FCA) Used for Prepackaged Processed Food Products”, the FDA Common Services Laboratory (CSL) is assigned to determine the suitability of FCAs for use in the packing, packaging, transporting, or holding of food. [1]
2. General Standards for Food Contact Materials
In reference to FDA Circular No. 2022-0011, any combination of the following references shall be adopted and used in the evaluation of FCA applications [1]:
Excerpt from FDA Circular No.2022-0011: Guidelines on the Application and Issuance of Voluntary Certification of Food Contact Articles (FCA) Used for Prepackaged Processed Food Products [1]
Below are the general guidelines according to the ASEAN General Guideline on Food Contact Materials [4]:
All FCM shall be manufactured in compliance with good manufacturing practice (GMP) so that under normal or foreseeable conditions of use, the FCM does not transfer their constituents to food in quantities that could:
- endanger human health;
- bring about an unacceptable change in the food;
- bring about an unacceptable change in the organoleptic characteristics thereof.
The safety of FCM should be determined by risk assessment of substances. For FCM authorized by a national/regional authority may be considered to be safe upon review of relevant risk assessment results and/or of approvals granted by the relevant national/regional authority.
The release of constituents from FCM into food shall be as low as reasonably practicable in accordance with GMP to avoid contamination of food and to preserve the characteristics thereof. Overall migration limits and specific migration limits, when appropriate, shall be established. The release of constituents from FCM into food shall not change the organoleptic characteristics of food so as to render the food unfit for human consumption.
3. Specific Requirements per Type of Food Contact Materials
Requirements per type of food contact materials can be found in the Specifications, Standards, and Testing Method for Foodstuffs, Implements, Containers and Packaging, Toys, and Detergents 2008 of the Japan External Trade Organization (JETRO) [5].
3.1 Glass Bottles
3.2 Metal Can
3.3 Caps/stoppers (Plastics, Metal)
There are no specific requirements for caps/stoppers made of plastic/metal. Regulatory requirements of the exporting country can be applied.
4. Other Rules
In reference to FDA Circular No. 2022-0011 [1], below is the process flow for applying for FCA:
5. Summary Table
Food contact materials | General legislation applicable | Specific legislation applicable |
Glass bottle | FDA Circular No.2022-0011: Guidelines on the Application and Issuance of Voluntary Certification of Food Contact Articles (FCA) Used for Prepackaged Processed Food Products [1] | Specifications, Standards and Testing Method for Foodstuffs, Implements, Containers and Packaging, Toys, Detergents 2008 of the Japan External Trade Organization (JETRO) [5] |
Metal can | ||
Caps/stoppers (Plastics, Metal) | None | None |
6. References
1. FDA Circular No.2022-0011: Guidelines on the Application and Issuance of Voluntary Certification of Food Contact Articles (FCA) Used for Prepackaged Processed Food Products
https://www.fda.gov.ph/wp-content/uploads/2022/12/FDA-Circular-No.-2022-011.pdf
2. Republic Act 10611 also known as the Food Safety Act of 2013
3. FDA Bureau Circular 2006-016: Updated List of Food Additives
https://www.fda.gov.ph/wp-content/uploads/2021/05/Bureau-Circular-No.-2006-016.pdf
4. ASEAN General Guideline on Food Contact Materials
https://asean.org/book/asean-general-guidelines-on-food-contact-materials/
5. Specifications, Standards and Testing Method for Foodstuffs, Implements, Containers and Packaging, Toys, Detergents 2008 of the Japan External Trade Organization (JETRO), Page 113 – 116, Page 127-129
https://www.jetro.go.jp/ext_images/en/reports/regulations/pdf/testing2009dec-ep.pdf
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