Drinkware Component Approval Record
Record the body, the lid, and each food-contact substance on its own row before a drinkware sample loop is closed for production.
Buyer type: Readers closing a drinkware sample loop
Category: Custom drinkware
Services used: Not applicable: editorial worksheet
Closing a drinkware sample loop on the body while the lid is still open leaves the production reference wrong. Record the body, the lid, and each food-contact substance on its own row before anyone approves the complete unit.
A drinkware sample loop closes when the body, the lid, and every food-contact substance each have a row that names the substance, the authorization that covers it, and the approver. FDA states that a food-contact article follows each substance, and that a food-contact notification covers the manufacturer, the substance, and the conditions of use named in it (FDA page, accessed October 18, 2026). 21 CFR 174.5 requires a purity suitable for the intended use. On a repeated-use container, 21 CFR 175.300(c)(3) limits a resinous or polymeric food-contact coating to 18 milligrams per square inch and to 0.005 percent of the water capacity in milligrams divided by the food-contact area in square inches (eCFR, October 1, 2026). A lid gasket uses 21 CFR 177.1210. Earlier sample-count, defect-rate, and timeline claims on this URL are withdrawn.
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| Input or item | Value on the public page | Why the file needs it |
|---|---|---|
| Substance status | FDA: the article follows each substance | An unnamed substance has no row to accept |
| Authorization parts | Identity, specifications (purity or physical properties), and conditions of use | The row carries all three |
| Food-contact notification | The manufacturer, the substance, and the conditions of use named in that notification | Resin from a different manufacturer stays off that notification |
| Purity | 21 CFR 174.5: a purity suitable for the intended use | The row names the substance |
| Repeated-use coating | 18 mg per square inch, and 0.005 percent of water capacity in mg divided by area in square inches | Both ceilings apply together |
| One-time coating, capacity at most 1 gallon | 0.5 mg per square inch, the same 0.005 percent ceiling, and 50 ppm of water capacity on a fabricated container | A reusable cup uses the repeated-use row |
| Gasket water column, types 1 to 4 | 50 ppm of the container water capacity | The lid row stays open without this result |
| Type II, room temperature, no heat treatment in the article | Water extractant at 120 °F for 24 hours | Only where table 2 condition E names type II |
| Earlier claims on this URL | Sample counts, defect rates, and timelines: withdrawn | Those lines are not inputs |
What each component row records
Copy one row per component. Blank cells wait for the purchase order and the person who accepts the revision. The case-study index holds the same kind of recording sheet for other files. The supplier cell stays blank until the contract names the company. When the authorization is a food-contact notification, the manufacturer on that notification has to be the company supplying the substance. How to match that company is in how to verify a Chinese supplier.
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| Field | What you copy |
|---|---|
| Component | Body, lid, coating, or gasket |
| Substance identity | The name the authorization uses |
| Authorization | Regulation, GRAS, prior sanction, threshold-of-regulation exemption, or food-contact notification, plus the manufacturer when the notice names one |
| Specifications | Purity or physical properties the authorization states |
| Conditions of use | The conditions written in that authorization |
| Reference | Color, artwork, or fit reference for this component, with the viewing setup you agreed |
| Result and evidence ID | Open, accept, or further checks, plus the report or photo ID |
| Approver and date | The person authorized to accept this component |
Accepting the body does not accept the lid. The complete unit stays open until every row says accept.
Where the sample loop breaks
The dominant failure mode is a component that moves into production while its row is still open. Prevention is the same sheet: no complete-unit acceptance until every row says accept.
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| Handoff | Dominant failure mode | Prevention |
|---|---|---|
| Complete unit | The body is accepted and the lid or gasket row is still open | Keep the unit open until every component row says accept |
| Food-contact notification | A substance from a second manufacturer is treated as covered by the first manufacturer’s notification | Copy the manufacturer named in the notification onto that substance row |
| Coating extractives | Chloroform-soluble extractives, corrected for zinc extractives as zinc oleate, exceed 18 mg per square inch or the 0.005 percent capacity ceiling | Hold the coating. On the coating test, divide a heptane result by five before comparing it with the food ceiling |
| Lid gasket | The lid is accepted with no extractive calculated on the water capacity of the article the closure will close | Hold the gasket until the table 2 tolerance for that gasket type is on the row |
| Color reference | The body reference is copied onto the lid | Leave the lid reference blank until its own reference is accepted |
This page does not set a color-difference number. Write the reference and the viewing setup on the row that uses them.
Coating ceilings on a repeated-use cup
21 CFR 175.300 allows a resinous or polymeric coating as the food-contact surface when the coating is a continuous film or enamel over a metal substrate, or when it is applied to any suitable substrate as a continuous film or enamel that is a functional barrier between the food and the substrate and is intended for repeated food contact. Paragraph (c)(3) then applies to a coating used as a component of a container for repeated use.
Rule of thumb: If chloroform-soluble extractives from that repeated-use coating exceed 18 milligrams per square inch, or exceed 0.005 percent of the water capacity in milligrams divided by the food-contact area in square inches, hold the coating. Both ceilings are in 21 CFR 175.300(c)(3). The extractives are corrected for zinc extractives as zinc oleate. A heptane result on this coating test is divided by five before it is compared with the ceiling for a food product.
Formula: Capacity ceiling (mg/in²) = (0.005 percent of the water capacity in milligrams) / food-contact area in square inches.
Worked example. 0.005 percent equals 0.005 / 100, which is 0.00005. The two ceilings meet when 0.00005 × water capacity in milligrams / area in square inches = 18. Then water capacity / area = 18 / 0.00005 = 360,000. The 0.005 percent ceiling is the tighter one when water capacity in milligrams is below 360,000 times the food-contact area in square inches. This page has no measured capacity and no measured area.
Gasket extractives stay on the lid row
21 CFR 177.1210 covers closures with sealing gaskets for food containers. The closure assembly, including the sealing gasket, is extracted with the solvent and the time and temperature that characterize the food and the use. Net chloroform-soluble extractives, corrected for zinc as zinc oleate, stay at or under the table 2 tolerance, calculated on the water capacity of the container the closure is used on.
Table 2 prints 50 ppm in the water column for gasket types 1, 2, 3, and 4. Type 5 is dry foods only, and the extractability tests are marked not applicable. A drinkware lid that seals a beverage is not that dry-food row.
Formula: Water-extractive ceiling (mg) = 50 / 1,000,000 × water capacity (mg).
Worked example. 50 ppm of 1,000,000 milligrams of water capacity is 50 milligrams. 50 / 1,000,000 = 0.00005, the same ratio as 0.005 percent in the coating ceiling. This page has no measured water capacity, so it stops at that ratio.
For an acidic aqueous food (table 1 type II, pH 5.0 or below) filled and stored at room temperature with no thermal treatment in the article, table 2 condition E names a water extractant at 120 °F for 24 hours. Condition E does not name type I. A nonacid aqueous food (type I, pH above 5.0) that is refrigerated, with no thermal treatment in the article, is on condition F: water at 70 °F for 48 hours. Use the row that names both the food type and the condition of use.
When these ceilings do not apply
Paragraph (c)(3) is the repeated-use coating. A one-time container of not more than 1 gallon is paragraph (c)(1): 0.5 milligram per square inch, the same 0.005 percent capacity ceiling, and, for a fabricated container, 50 ppm of the water capacity. A one-time container above 1 gallon is paragraph (c)(2): 1.8 milligrams per square inch and the same 0.005 percent ceiling.
An uncoated metal wall, or a lid that is the polymer itself, sits outside the coating paragraph. 21 CFR 174.5 still requires a purity suitable for the intended use, and the substance still needs an authorization: GRAS, a prior sanction, a regulation in parts 174, 175, 176, 177, 178, or § 179.45, or an effective food-contact notification. A lid with no sealing gasket sits outside 21 CFR 177.1210.
Carry the closed revision into the order
Freeze the accepted rows as the specification the factory packs. The sequence for that handoff is in how to source products from China. A repeat extractive test, a replacement component, or storage of an accepted body while another row stays open is a charge on the order. How those charges sit on a landed-cost sheet is in how to calculate landed cost. This file states no fee, no unit price, and no duty.
After the rows are accepted, check the bulk lot against that revision with the quality-control checklist. Arrival at a warehouse is a receipt. It becomes acceptance only when the checklist is tied to this revision and the approver’s row says accept.
Method and sources
Updated October 2026. Wholesale Sourced is an independent publisher. This worksheet is a recording method. It is not a customer order and not a laboratory report.
Public pages read on October 18, 2026:
- FDA, “Determining the Regulatory Status of Components of a Food Contact Material.” Used for the rule that the article follows each substance, for the three parts of an authorization, and for the limit of a food-contact notification to the named manufacturer and the named conditions of use.
- eCFR, 21 CFR 174.5, enhanced text for October 1, 2026. Used for purity suitable for the intended use, and for the list of authorizations that can cover a food-contact component.
- eCFR, 21 CFR 175.300, enhanced text for October 1, 2026. Used for the coating scope, the 18, 0.5, and 1.8 milligram-per-square-inch ceilings, the 0.005 percent capacity ceiling, the 50 ppm fabricated-container wording, the heptane factor of five, and table 2 conditions E and F.
- eCFR, 21 CFR 177.1210, enhanced text for October 1, 2026. Used for closure-sealing gaskets, table 2 water-column tolerances of 50 ppm for types 1 through 4, and the dry-food row where extractability tests do not apply.
Library search on drinkware, food contact, and color returned trade and packaging pages. Those pages are not the CFR text used above. Cached search for this topic had no stored result, so no new search-result set was purchased.