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Selling kitchenware and food contact articles in the US

In the US, the FDA regulates substances in cookware, tableware and containers that may migrate into food. Each must be listed in 21 CFR 174 to 186, GRAS, prior-sanctioned, exempt under the threshold of regulation, or under an effective food contact notification. Ceramicware has FDA action levels for extractable lead; decorative pieces are marked 'Not for Food Use'.

Updated · Each section links to the official source it comes from

Regulator
The FDA, for materials that contact food
Main rules
21 CFR Parts 170 to 186
New substances
Food contact notification (FCN), or a petition
Ceramics
FDA lead guidance; decorative ware marked under 21 CFR 109.16
Children's feeding items
CPSC phthalate and lead rules also apply

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Which materials in the article touch food: plastics, coatings, paper, rubber, ceramic, metal? Read more
  2. 2Is each substance listed in 21 CFR 174 to 186, GRAS, prior-sanctioned, exempt, or under an effective FCN? Read more
  3. 3Is the substance used within its limits and conditions, at suitable purity? Read more
  4. 4If it is ceramicware, has it been tested for extractable lead? Read more
  5. 5If it is decorative ceramicware, is it marked 'Not for Food Use'? Read more
  6. 6Is it a children's feeding item, subject to CPSC rules? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

Food contact substances

How the FDA authorises materials that touch food.

  • A food contact substance is any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting or holding food, if it is not intended to have a technical effect in the food.
  • Substances that may be used in articles that contact food include those GRAS in or on food or for use in packaging, those used under a prior sanction, those permitted by 21 CFR 174 to 178 and 179.45, and food contact substances under an effective food contact notification.
  • Parts 175 to 178 cover adhesives and components of coatings, paper and paperboard, polymers, and adjuvants, production aids and sanitisers; Part 186 lists indirect food substances affirmed as GRAS.
  • Under good manufacturing practice, a substance is used in no more than the amount reasonably needed for its technical effect in the article, within any limits set, and at a purity suitable for its use.
  • A listing does not relieve the article from the rest of the FD&C Act: for example, a material that imparts odour or taste making food unfit is still a problem.

How we help: Compliant Always reads your suppliers' declarations of compliance against the 21 CFR section or FCN each one cites, and keeps them with the article, dated. Ask about this

Food contact notifications and threshold of regulation

The routes for a substance that is not yet listed.

  • A food contact notification (FCN) is effective only for the substance made by the manufacturer or supplier named in it; another supplier of the same substance for the same use submits its own.
  • A petition, rather than an FCN, is needed where the use raises dietary concentration to 1 ppm or more (200 ppb for a biocide), or where an unreviewed bioassay is not clearly negative for cancer, unless the FDA agrees to accept an FCN.
  • Substances that migrate into food at negligible levels may be exempted from regulation as food additives under the threshold of regulation process in 21 CFR 170.39.
  • The FDA publishes an inventory of effective food contact notifications and of threshold of regulation exemptions.

How we help: Compliant Always checks that the FCN a supplier relies on names that supplier, and shows when a declaration no longer matches the inventory. Ask about this

Ceramicware and lead

Lead in glazes and decorations.

  • Some ceramic foodware has been found to leach significant amounts of lead from food contact surfaces. The FDA uses criteria in Compliance Policy Guide 545.450 when deciding on legal action or detaining imports.
  • Ceramicware that contains lead and is properly made can be sold in the US; the FDA has action levels for extractable lead in ceramic tableware.
  • Ornamental or decorative ceramicware that appears suitable for food use is considered for food use unless it carries a stick-on label and a permanent statement on the base, such as 'Not for Food Use. May Poison Food', in letters at least 3.2 mm high, or has a hole bored through the food contact surface.
  • Traditional pottery labelled 'lead free' has been found with extractable lead; the FDA has guidance on the use of the term.

How we help: Compliant Always keeps extractable lead results with each ceramic line and batch, and checks decorative pieces for the 21 CFR 109.16 marking. Ask about this

Children's feeding items

Where CPSC rules apply as well as the FDA's.

  • A child care article includes a product designed or intended to help with the feeding of children 3 and under; such articles may not contain more than 0.1 percent of any of eight listed phthalates.
  • Products designed or intended primarily for children 12 and under are subject to the CPSIA lead content limits.
  • Feeding products such as drinking glasses, dishes and eating utensils are exempt from the small parts ban for children under 3.
  • Children's products are certified in a Children's Product Certificate on the basis of third party testing.

How we help: Compliant Always works out which FDA and CPSC rules apply to a children's feeding item and keeps both sets of evidence together. Ask about this

Consumer product safety

Kitchen products as consumer products.

  • A firm reports to the CPSC within 24 hours of obtaining information reasonably supporting the conclusion that a consumer product it distributed has a defect that could create a substantial product hazard, or creates an unreasonable risk of serious injury or death.
  • Severe burns are among the injuries that, where a defect has caused or could cause them, are reported unless the firm has investigated and found them not reportable.

How we help: Compliant Always keeps complaints and test reports with the product and lot, so the facts behind a reporting decision are in one place. Ask about this

Who answers for what

WhoWhat they answer forHow we help
Substance or material supplierThe regulatory status of the substance, including its own FCN where it relies on one.Declarations read against the regulation each one cites.
Article manufacturerUsing permitted substances within their limits, and lead control in ceramics.Material specifications and migration results kept by article.
ImporterBringing in articles that meet US rules; the FDA may detain ceramicware.Overseas factories' declarations and lead results read before the goods ship.
Brand or retailerClaims such as 'lead free', and the marking of decorative ware.Claims and markings checked against the evidence behind them.

Federal and state

Federal agencies set the national rules. States can add their own: California's Proposition 65, for example, can call for a warning on a product sold there.

Retailers and marketplaces often ask for more than the law does, such as test reports by lot or third party certificates.

Questions businesses ask

Does the FDA regulate kitchenware?
The FDA regulates substances in articles that contact food, such as cookware, tableware and containers, as food contact substances or indirect food additives under 21 CFR 170 to 186.
What must a food contact material meet in the US?
Each substance in it that may migrate into food must be GRAS, prior-sanctioned, listed in 21 CFR 174 to 178, exempt under the threshold of regulation, or covered by an effective food contact notification.
What is a food contact notification?
A premarket notification under section 409(h) of the FD&C Act. It is effective only for the substance from the manufacturer or supplier named in it.
What is the threshold of regulation?
A process under 21 CFR 170.39 by which the FDA exempts substances that migrate into food at negligible levels from regulation as food additives.
Which CFR parts cover plastics and coatings?
Part 177 covers polymers; Part 175 adhesives and components of coatings; Part 176 paper and paperboard; Part 178 adjuvants, production aids and sanitisers.
Can ceramic dishes with lead be sold in the US?
If the ceramicware is properly made, yes. The FDA has action levels for extractable lead in ceramic tableware and can detain imports that exceed them.
How is decorative ceramicware marked?
With a stick-on label and a permanent statement on the base such as 'Not for Food Use. May Poison Food', in letters at least 3.2 mm high, or a hole through the food contact surface.
Do baby bottles and children's tableware have extra rules?
Yes. Child care articles for feeding children 3 and under may not contain more than 0.1 percent of eight listed phthalates, and children's products are subject to lead limits and third party testing.
Does a listing in 21 CFR cover everything about a material?
No. The article must still meet the rest of the FD&C Act; a material that makes food unfit, for example by imparting odour or taste, is not covered by its listing.
How does Compliant Always help with selling in the US?
Our team reads the rules for the markets you sell in. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches federal sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

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