FDA Registration for Frozen Dairy
Ice cream, frozen custard, sherbet, gelato, frozen yogurt, mellorine — what you can call it, and how you keep it safe, are both spelled out.
Key Takeaways
- Frozen desserts are heavily standardized — ice cream, custard, sherbet, mellorine (Part 135).
- Ice cream = ≥10% milkfat, ≥20% milk solids, ≥4.5 lb/gallon, from a pasteurized mix.
- Weight per gallon caps overrun — you can't whip in unlimited air.
- Vegetable fat → "mellorine," not "ice cream."
- Listeria is the defining pathogen — RTE zero tolerance, environmental monitoring.
- Milk (and egg in custard) are allergens; the mix must be pasteurized.
The Name Is a Legal Recipe
Frozen desserts are among the most tightly standardized foods FDA regulates. Each name carries minimum composition:
| Product | Key requirements | Cite |
|---|---|---|
| Ice cream | Pasteurized mix; ≥10% milkfat, ≥20% total milk solids; ≥4.5 lb/gal, ≥1.6 lb solids/gal; no other food fats | 135.110 |
| Frozen custard (French ice cream) | Meets ice cream + ≥1.4% egg yolk solids | 135.110 |
| Sherbet | 1–2% milkfat; 2–5% total milk solids; ≥6 lb/gal; fruit type: titratable acidity ≥0.35% | 135.140 |
| Mellorine | Nonmilk (vegetable) fat substituted; ≥6% fat, ≥2.7% protein — cannot be called "ice cream" | 135.130 |
Pasteurized, Ready-to-Eat — and Listeria
The mix must be pasteurized
Pasteurization is written into the ice cream standard itself. Dairy ingredients tie into the Grade A system and the Pasteurized Milk Ordinance (PMO), and many states also license and inspect frozen-dessert plants directly — on top of FDA facility registration.
Listeria is the pathogen
Frozen dairy is ready-to-eat, and Listeria monocytogenes survives freezing and grows cold. FDA treats RTE food containing Listeria as adulterated — effectively zero tolerance — so sanitation and environmental monitoring for Listeria are central to the plan.
Allergens, Registration & Cold Chain
Bringing a Frozen Dairy Product to Market
Match the product to a standard
Meet the standard for ice cream/custard/sherbet/mellorine, or use an accurate alternative name.
Pasteurize the mix
Source Grade A dairy; meet PMO and state frozen-dessert requirements.
Register the facility
The maker/packer/holder registers; foreign facilities add a U.S. Agent.
Control Listeria
Part 117 preventive controls with environmental monitoring for Listeria.
Get labeling right
Declare milk, egg (custard), and add-in allergens; use the correct standardized name.
Handle imports & cold chain
Prior notice + FSVP; maintain the frozen cold chain; keep registration current.
Get Your Frozen Dairy to Market
FDA Registration Assistance registers frozen dairy facilities, serves as U.S. Agent, reviews standardized names and allergen labeling, supports Listeria-focused preventive controls, and handles FSVP and prior notice for imports. Food Facility Registration is available as a service starting at $858.
Contact us at info@fdaregistrationassistance.com or call +1 (928) 275-8333. Trusted by companies across 135+ countries, with 15+ years of experience.
Frequently Asked Questions
1. Do frozen dairy products need FDA registration?
The facility that makes, packs, or holds them registers as a food facility, and foreign facilities need a U.S. Agent. Frozen dairy is conventional food but carries two extra layers — detailed standards of identity and Listeria control. Registration isn't approval.
2. What is the standard of identity for ice cream?
Under 21 CFR 135.110, "ice cream" is made by freezing a pasteurized mix and must contain at least 10% milkfat and 20% total milk solids, weigh at least 4.5 lb per gallon, and contain at least 1.6 lb total solids per gallon — with no other food fats. A product that doesn't meet this can't be called "ice cream."
3. Why is there a minimum weight per gallon?
Because ice cream is whipped with air (overrun), and the weight-per-gallon minimum effectively caps how much air can be added. Too much air makes it underweight and out of standard — a form of economic adulteration. The 4.5 lb/gal and 1.6 lb-solids/gal floors keep it honest.
4. What's the difference between ice cream and frozen custard?
Frozen custard (French ice cream) is ice cream with at least 1.4% egg yolk solids (21 CFR 135.110). It meets the ice cream standard plus the egg-yolk minimum — which also makes egg a declared allergen.
5. What is mellorine?
Mellorine (21 CFR 135.130) looks like ice cream but substitutes nonmilk fat (such as vegetable fat) for milkfat — so it can't be labeled "ice cream." It must be called "mellorine," with at least 6% fat and 2.7% protein. Using vegetable oil in a product labeled "ice cream" is a common error.
6. How is sherbet different?
Sherbet (21 CFR 135.140) has much less dairy — 1–2% milkfat and 2–5% total milk solids — and weighs at least 6 lb per gallon. Fruit sherbet must also have a titratable acidity of at least 0.35%. It sits between ice cream and a non-dairy water ice.
7. Is frozen yogurt federally standardized?
No — unlike ice cream, sherbet, and mellorine, there's no federal FDA standard of identity for frozen yogurt; it's largely state-regulated. It's still subject to allergen labeling, pasteurization, and Listeria controls.
8. Does the mix have to be pasteurized?
Yes — pasteurization is built into the ice cream standard, and dairy ingredients tie into the Grade A system and the Pasteurized Milk Ordinance. Many states also license and inspect frozen-dessert plants directly, on top of FDA facility registration.
9. Why is Listeria such a focus for frozen dairy?
It's a ready-to-eat product, and Listeria monocytogenes survives freezing and grows at refrigeration temperatures. FDA treats RTE food with Listeria as adulterated — effectively zero tolerance — so sanitation and environmental monitoring are central to the plan.
10. What allergens apply to frozen dairy?
Milk is inherent and must be declared; frozen custard adds egg; and mix-ins — nuts, peanuts, soy, wheat (cookie dough, brownie, cones) — bring their own. Every major allergen present must be declared and cross-contact controlled.
11. Do frozen dairy facilities need preventive controls?
Generally yes — under 21 CFR Part 117, the hazard analysis for frozen dairy centers on Listeria (with environmental monitoring) and allergens. Where a hazard needs a control, the plan documents it. Small/qualified facilities have modified requirements.
12. Do importers need FSVP and prior notice?
Yes — a registered foreign facility with a U.S. Agent, prior notice per shipment, and an importer FSVP. Because it's frozen RTE dairy, both FSVP and cold-chain (transit temperature) controls matter.
13. Is "FDA registered" the same as "FDA approved"?
No — registration tells FDA a facility exists and what it does; it isn't approval of the product. "FDA approved" based on registration is inaccurate.
14. How does FDA Registration Assistance help?
It registers frozen dairy facilities, serves as U.S. Agent, reviews standardized names and allergen labeling, supports Listeria-focused preventive controls, and handles FSVP and prior notice — starting at $858, for companies across 135+ countries. Contact info@fdaregistrationassistance.com or +1 (928) 275-8333.
