What FDA regulates and what it does not
In the United States, materials that touch food are regulated as food contact substances. The rules sit in Title 21 of the Code of Federal Regulations, parts 174 to 178, which list the polymers, additives, adjuvants and conditions under which they may be used in contact with food. FDA sets these rules and enforces them, but it does not inspect and approve individual finished containers before they are sold. There is no FDA registration number for a takeout box and no FDA certificate a plant can hang on the wall for a product line.
This matters for wording. A listing or a carton that says a container is approved or certified by FDA makes a claim that cannot be true. The accurate statement is that the item is made from materials that comply with the relevant sections of 21 CFR, per supplier declaration or per test report, for the stated conditions of use. That is the wording the desk uses on specifications, and the wording we suggest for listings. For the legal reading of a specific product, confirm with your test lab or counsel.
21 CFR 177.1520: the section for PP and PE
Most food containers in this range are polypropylene, resin code 5. PP and polyethylene are olefin polymers, covered by 21 CFR 177.1520. That section defines which olefin polymers qualify and sets specifications for them, such as the melting point range for PP, given as 160 to 180 degrees C, and limits on extractables measured with solvents such as n-hexane. A resin producer's grade that meets 177.1520 is the starting point for a compliant container; the converting plant then needs to show that its additives, colorants and processing do not take the finished item outside the rules.
Other materials sit in other sections. PET has its own section, paper and board are covered in part 176, and colorants and additives have their own listings. For a mixed set, such as a PP base with a PET lid for cold display, each part needs its own line in the declaration.
Conditions of use: the detail that decides hot food
A declaration that only says FDA compliant is incomplete. Food contact rules depend on the food type and the temperature. 21 CFR 176.170(c) Table 1 sets out conditions of use from A to H, ranging from high temperature heat sterilized uses down to frozen storage and room temperature filling. Many declarations refer to these conditions, so a buyer can see whether a box was assessed for hot fill, for refrigerated storage only or for reheating.
| Item | Example for a PP takeout box | Why it matters |
|---|---|---|
| Product and part | 750 ml rectangular box, base and lid, 170x115x51 mm | Ties the document to one item |
| Material of each part | PP base, PP lid, resin code 5 | Each material has its own section |
| Regulation | 21 CFR 177.1520 for olefin polymers | Names the rule, not a vague label |
| Conditions of use | Condition letter per 21 CFR 176.170(c) Table 1 | Shows hot, cold or frozen use |
| Food types | Aqueous, acidic, fatty, as assessed | Fatty and hot foods are the hardest case |
| Supporting evidence | Resin statement, extraction test report where needed | Backs the declaration with data |
| Issuer and date | Partner plant or brand, per project | Makes the file traceable |
Supplier statements versus tested facts
Partner plant literature often carries strong statements. One partner plant describes the PP of its injection molded cups as tolerating -10 to 120 degrees C and suitable for boiling water. Export soup cups from a thermoforming plant in the same cluster carry the PP code 5 and a microwave symbol molded into the base. These are the supplier's statements. They are useful, and they are what end users see, but the desk treats them as claims to be checked: a heating test on the sample, a hot water test where boiling water use is claimed, and a lab test where the buyer's market or retailer asks for one.
What the desk asks for
For each plastic part in a US program, the desk requests a supplier declaration from the partner plant naming the item, the material, the 21 CFR section and the conditions of use, together with the resin producer's statement for the grade used. Where a retailer, a marketplace or the brand's own policy requires it, a third-party lab runs extraction tests on the finished item. Documents are issued to the partner plant or to your brand per project, verified by the desk and filed with the lot number. The food contact safety page explains the tests, and the compliance guide sets out the document file for each market.
Paper parts and state rules
Federal rules are not the whole picture. Paper boxes, molded fibre and bagasse items fall under state rules on PFAS in food packaging. California AB 1200 has banned intentionally added PFAS in plant fibre food packaging since 1 January 2023, using a total organic fluorine screening line of 100 ppm, and at least 13 states restrict PFAS in food packaging in some form. A program that combines PP boxes with kraft bakery boxes needs both files. See PFAS in paper food packaging.
Common gaps in US files
- A declaration for the resin grade only, with nothing from the plant that makes the container.
- A declaration for the base that is silent on the lid, the insert or a colored masterbatch.
- No conditions of use, so a box assessed for room temperature filling is sold for hot soup.
- A document issued years ago for a different model, reused without checking the item name.
- Listing wording that goes further than the evidence, such as approval language.
Each of these is easy to fix before the order and expensive to fix after a retailer or marketplace asks for the file.
Timing and ordering
Declarations for stock items can often be issued within the sample stage. Extraction tests at a lab add time, so they are scheduled with the samples rather than after the order. Typical sample times are 3-7 working days from stock and 7-15 working days for printed items, confirmed in writing per program; see MOQ and lead time. Send the item list, the foods and the temperatures through the quote form, and the desk will return the matched models with the document plan for the US market.