Updated: 2005-11-29
BACKGROUND:
Some ceramic foodwares have been found to leach significant quantities of lead from potential food contact surfaces. The metal is extractable by foods and can cause a wide variety of adverse health effects including the traditional effects of chronic lead poisoning under continued food use.
REGULATORY ACTION GUIDANCE:
The following represents the criteria that should be considered in deciding whether to recommend legal action or to detain imports to the CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605):
The article:
Category | Criteria | Guidelines micrograms/mL |
---|---|---|
Flatware | average of 6 units | 3.0 |
Small Hollowware other than cups and mugs | any one of 6 units | 2.0 |
Cups/mugs | any one of 6 units | 0.5 |
Large Hollowware other than pitchers | any one of 6 units | 1.0 |
Pitchers | any one of 6 units | 0.5 |
The categories of ceramic articles used in the preparation, serving or storage of food, are defined as follows:
Flatware: ceramic articles which have an internal depth as measured from the lowest point to the horizontal plane passing through the upper rim, that does not exceed 25 mm.
Hollowware: ceramic articles which have an internal depth measured from the lowest point to the horizontal plane passing through the upper rim, greater than 25 mm.
Small hollowware: a capacity of less than 1.1 liter.
Large hollowware: a capacity of 1.1 liter or more.
Cups and mugs: small ceramic hollowware vessels commonly used for consumption of beverages, for example, coffee or tea at above room temperature. Cups and mugs normally, but not exclusively, have a capacity of about 240 mL or 8 fl. oz. and are manufactured with a handle. Cups normally have a base and curved sides while a mug has cylindrical sides.
Pitchers: large ceramic hollowware vessels (sometimes known as jugs) commonly used for the storage and dispensing of fruit and vegetable juices or other acidic beverages at or below room temperature which are normally manufactured without a lid but with a handle and lip spout. For the purpose of this guideline, creamers, coffeepots, and teapots are not considered to be pitchers. Depending on capacity, creamers, coffeepots and teapots will be considered small or large hollowware.
NOTE: In accordance with 21 CFR 109.16(b), the article will be considered unsuitable for food use if:
SPECIMEN CHARGE:
Article (Flatware) (Hollowware) (Cups and Mugs) (Pitchers) adulterated (when introduced into and while in interstate commerce)(while held for sale after shipment in interstate commerce), within meaning of Section 402(a)(2)(C) of the Federal Food, Drug and Cosmetic Act, in that it contains a food additive, namely lead, which is unsafe within the meaning of Section 409(a), because its use and intended use are not in conformity with a regulation or exemption established pursuant to Section 409.
REMARKS:
If all lots in an entry were sampled using an invoice on a line by line basis, detain only those lots meeting the above criteria. If only one lot (line item) was sampled and meets the above criteria, the entire entry may be detained without further analysis.
RELEASE OF IMPORT DETENTIONS:
Upon analysis or other examination by the importer to demonstrate suitability
for release, the articles may be released on a lot by lot basis with checks
by the District laboratory to determine compliance.
Release may be based on labeling the article for other than food use in compliance
with 21 CFR 109.16(b).
Release based on any other labeling conditions must have prior clearance of
the CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605).
EXEMPTION:
Non-food service plates will not be required to meet the guidelines for dinnerware. These include, but are not necessarily limited to, the following types of articles manufactured solely for ornamental display purposes: commemorative plates, souvenir plates, hand-painted plates, and other highly decorated plates, provided the article is in compliance with 21 CFR 109.16(b).
*Material between asterisks is new or revised *
Issued: 10/1/80
Revised: 4/16/92, 12/12/95 (60 FR 63721), 5/2005