FDA Registration for Egg and Egg Product Manufacturers: What the Full Product Range Covers

When foreign manufacturers think about FDA registration requirements for egg products, they typically think about shell eggs — fresh eggs in the carton. The registration obligation is broader than that. Under 21 CFR Part 1, Subpart H, any foreign food facility that manufactures, processes, packs, or holds food for human consumption in the United States must register with FDA. The egg product category under this rule covers shell eggs, liquid eggs, frozen eggs, dried eggs, and a wide range of products made with eggs as a primary ingredient. The list of products that trigger the registration requirement is longer than most manufacturers expect.

What counts as an egg product under FDA rules

The egg product category includes shell eggs of any poultry species — chicken, duck, quail — in any packaging format. It also includes processed egg forms: liquid whole egg, liquid egg white, liquid egg yolk, frozen whole egg, frozen egg white, frozen egg yolk, dried whole egg, dried egg white, and dried egg yolk. Products manufactured with eggs as a primary ingredient — egg noodles, egg pasta (fettuccine, linguine, vermicelli), egg rolls, egg salad, egg foo young, egg soup, scrambled egg mix, egg nog, and pickled eggs — all require the manufacturing facility to hold an FDA food facility registration. Grade designations (Grade A, organic) and packaging size (carton, bulk) do not change the registration requirement.

The shell egg registration rule under 21 CFR Part 118

Beyond the general food facility registration, processors and packers of shell eggs for the US market are subject to 21 CFR Part 118, the Egg Safety Rule. This rule — separate from the food facility registration — imposes specific Salmonella Enteritidis prevention requirements: environmental testing, refrigeration requirements during transport and storage, and diversion of eggs from flocks that test positive for SE. Foreign egg producers shipping shell eggs to the US must both hold an active FDA food facility registration and comply with the Part 118 requirements applicable to their operations. The shell egg registration that FDABridge manages is the Part 118 producer registration combined with the FURLS food facility registration.

Dried egg products and the allergen disclosure requirement

Egg is one of the nine major food allergens recognized by FDA under the Food Allergen Labeling and Consumer Protection Act (FALCPA). Any food product that contains egg — including dried egg products used as ingredients in other foods — must declare egg as an allergen on the US label. This applies to dried egg ingredients sold in bulk to US food manufacturers as well as to finished consumer products. A foreign manufacturer that produces dried egg white or dried egg yolk for sale to US buyers must register the facility and must ensure that any labeling on the product accurately declares egg allergen presence.

Quail eggs, duck eggs, and specialty egg products

The registration obligation applies to eggs from all poultry species, not only chickens. Quail egg manufacturers exporting to the US — whether as fresh shell eggs, pickled quail eggs, or canned quail eggs — must register their facility. Duck egg producers face the same obligation. Specialty formats like salted preserved eggs (century eggs, salted duck eggs) are processed egg products and require facility registration. These products are subject to the same labeling requirements as any other imported food, including allergen disclosure and country of origin.

What to register and how

A foreign facility that manufactures any of the products described above must register through FDA's FURLS system before first exporting to the US. The registration requires a US Agent — a person or company with a US physical address who will receive FDA communications on the facility's behalf. FDABridge provides both the shell egg registration service (including the Part 118 registration component) and the US Agent service for Year 1. Visit fdabridge.com/shell-egg-registration for details on egg product registrations or fdabridge.com/food-facility-registration for the standard food facility registration.