Under federal law, anything that can move from a jar, lid, bag or jug into food counts as a food additive unless it's generally recognized as safe or was approved before 1958. So the materials that touch food have to be cleared one of four ways: an FDA regulation, mostly in 21 CFR parts 175 to 178; a food contact notification a supplier filed for its own substance; the threshold of regulation for substances that migrate at trace levels; or GRAS or prior approval. A food maker doesn't file any of this. The packaging supplier does, and your job is to ask for it in writing. "Food grade" on a catalog page isn't enough: what you want is a letter naming the clearance and the conditions of use it covers, FDA's letters A to H, from heat-sterilized and hot filled down to frozen. A container cleared only for room temperature filling isn't cleared for a sauce poured in at 190°F. The other paper worth having is a guaranty, the supplier's signed statement that what it ships isn't adulterated or misbranded. And the food safety rules ask you to make sure packaging is safe and suitable, which is what the file shows. In the example below, a Louisville ketchup maker finds a cheaper jug that isn't cleared for hot filling.
The short version
- Packaging that can migrate into food is a food additive unless it's cleared.
- Cleared means an FDA regulation, a food contact notification, the threshold of regulation, or GRAS.
- The supplier holds the clearance; you get it in writing.
- Ask for a letter naming the clearance and the conditions of use, A to H.
- Hot filling above 150°F is condition C; a room-temperature-only container isn't cleared for it.
- Keep a guaranty from each packaging supplier, per shipment or continuing.
- TaroStack keeps packaging as items received by supplier and lot. More below.
Conditions of use
| Letter | Condition |
|---|---|
| A | High temperature heat-sterilized, over 212°F |
| B | Boiling water sterilized |
| C | Hot filled or pasteurized above 150°F |
| D | Hot filled or pasteurized below 150°F |
| E | Room temperature filled and stored |
| F | Refrigerated storage |
| G | Frozen storage |
| H | Frozen or refrigerated ready meals reheated in the container |
How suppliers get approved in general is in supplier approval program template, and what packaging costs in packaging cost per unit.
The rules
| Rule | Where |
|---|---|
| Packaging as a food additive | Any substance that may become a component of food, including from packaging, unless GRAS or sanctioned before 1958 (21 U.S.C. 321(s)) |
| Food contact notifications | Filed by the manufacturer or supplier, effective after 120 days, covering only its own substance (21 U.S.C. 348(h)) |
| Good manufacturing practice | No more than needed, of a purity suitable for the use; no odor or taste passed to the food (21 CFR 174.5) |
| Conditions of use | Letters A to H (21 CFR 176.170(c)) |
| Threshold of regulation | Substances that migrate at trace levels can be exempted (21 CFR 170.39) |
| Your plant | Food-packaging materials safe and suitable (21 CFR 117.80(a)(2)) |
| Guaranty | Signed by the U.S. supplier, per shipment or continuing (21 U.S.C. 333(c)(2), 21 CFR 7.13) |
This is general information, not legal advice.
An example: a cheaper gallon jug
Butchertown Ketchup Co., the made-up ketchup maker in a Louisville shared kitchen I use in these examples, hot fills its ketchup at about 190°F into 12 oz glass bottles and restaurant gallon jugs. A jug supplier offered a cheaper jug, and before switching, the owner pulled every packaging letter into one file:
| Item | Clearance on the letter | Conditions | Fill | Covered? |
|---|---|---|---|---|
| 12 oz glass bottle | Supplier's letter: suitable for food contact | A-H | C | Yes |
| Lug cap with gasket | 21 CFR 177.1210 and 175.300 | B-H | C | Yes |
| Gallon jug, new supplier | 21 CFR 177.1520 | E-G | C | No |
| Gallon jug, current supplier | 21 CFR 177.1520 | C-G | C | Yes |
Both jugs are polyethylene under the same regulation, but the new supplier's letter cleared its jug only for room temperature, refrigerated and frozen use, not hot filling, and it had sent no guaranty. Butchertown stayed with its current jug. The ketchup's costs are in ketchup business plan.
Get the workbook
Download the packaging letter file. Two sheets. Packaging file: each item that touches food, its supplier, material and how you fill it; the clearance and conditions on the letter, its date and the guaranty; whether the letter covers how you fill it and how old the letter is fill in. Conditions of use: FDA's letters A to H. It's an ordinary Excel file with no macros, and it works in Google Sheets, LibreOffice and Numbers.
Where this stops working
The letter is for one supplier's jug. When a case of jugs from someone else turns up because the usual ones were out, the letter on file no longer describes what's on the line, unless each delivery is recorded by supplier.
How TaroStack does it
TaroStack keeps packaging as items received by supplier and lot.
Packaging as items. Bottles, caps and jugs are items like ingredients, received with their supplier and lot.
Batches by lot. Each batch records which jug and cap lots it used, so the packaging behind a gallon is on record.
Recalls. If a packaging lot turns out to be wrong, one report shows every customer who got food packed in it.
| The job | Notebook | In TaroStack |
|---|---|---|
| Which supplier's jugs came in | The packing slip | Receiving by supplier and lot |
| Which jugs a batch used | Not recorded | Batches by lot |
| Who got food in a bad lot | Invoices | One recall report |
Receiving, batches and recalls are on every plan, from $49 a month. The first 30 days are free, with no credit card. If you'd like a hand setting up, ask, and we'll do it with you.