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Baby Food Co-Packer: Lead Limits, Processing and Quotes

Finding a baby food co-packer: FDA's lead action levels, testing every lot, low-acid purees, frozen or shelf-stable, three quotes compared, and a calculator.

By Koa Sterling. Product specialist at TaroStack and small business owner. Yes, I am a real human, and I actually sit in front of a computer and write these articles. Reviewed October 16, 2026 · 6 min read

A baby food co-packer cooks, purées, portions and packs your recipes into pouches, jars, frozen cubes or puffs. It's one of the most watched categories in food: FDA has set action levels for lead in processed food for babies and young children, so every ingredient lot and finished lot needs testing, and many vegetable purées are low-acid foods, which decides whether they're sold frozen, refrigerated or made shelf-stable in a plant set up for low-acid canning. In the example below, a frozen baby food maker selling 4,000 trays a month to grocers pays $3.37 a tray making it itself, $2.69 with a small frozen co-packer, and $2.20 with a larger plant whose minimum is two and a half months of sales. Below is the lead limits, processing, what the co-packer needs, three quotes, and a free calculator.

The short version

  • FDA's action levels for lead in food for babies under two: 10 ppb, or 20 ppb for single-ingredient root vegetables and dry infant cereals.
  • Test ingredients and finished lots for lead and other heavy metals, and keep the results with each lot.
  • Many vegetable purées are low-acid foods; shelf-stable pouches need a plant set up for low-acid canning.
  • Frozen and refrigerated purées avoid that, and need a cold chain all the way.
  • Root vegetables and rice tend to carry more heavy metals; source and test with care.
  • Compare quotes on the cost of a good unit, testing included.
  • TaroStack keeps each lot's test results with it, from ingredient to tray. More below.

FDA's lead action levels

In January 2025 FDA set action levels for lead in processed food intended for babies and young children under two, packaged in jars, pouches, tubs or boxes: 10 parts per billion for fruits, vegetables other than single-ingredient root vegetables, mixtures, yogurts, custards and single-ingredient meats; 20 ppb for single-ingredient root vegetables; and 20 ppb for dry infant cereals. FDA may regard food above those levels as adulterated, and expects industry to keep reducing lead over time (FDA). For a brand, that means a testing plan for ingredients and finished lots, agreed with the co-packer, with results kept by lot. This is general information, not legal advice. How a baby food business is planned, testing included, is in baby food business plan.

Frozen, refrigerated or shelf-stable

Low-acid foods have a finished equilibrium pH above 4.6 and a water activity above 0.85 (21 CFR 113.3); many vegetable and meat purées are. Sold shelf-stable in sealed pouches or jars, they need a validated thermal process in a plant set up and registered for low-acid canned foods. Fruit purées are often acidic enough to be simpler. Frozen purées and refrigerated ones sidestep the canning rules and rely on the cold, with a cold chain to the grocer's freezer. The format decides which co-packers can make it.

What a baby food co-packer will ask you for

  • The recipe by weight, with each ingredient's source and specs, and your heavy metals testing plan.
  • The format: pouch, jar, frozen cube tray or puffs, and the process each needs.
  • Specs: texture by age stage, fill weight, pH for purées.
  • Packaging and labels, checked for the rules on foods for young children.
  • A forecast and a deposit, and who pays for each lot's tests.

What a spec sheet holds is in product specification sheet.

Three quotes compared

Thimble Islands Kitchen, a made-up frozen baby food maker near Branford, Connecticut, I use in these examples, sells about 4,000 trays of purée cubes a month to grocers:

Make it yourself Small frozen co-packer Larger baby food plant
Run you'd order 600 4,000 10,000
Minimum run none 2,000 10,000
Good trays, after the loss 582 3,920 9,900
Setup, with each lot's heavy metals test $250 $600 $1,200
Fee, or your own labor, a tray $1.10 $0.70 $0.40
Organic produce, a tray $1.20 $1.15 $1.05
Tray and sleeve $0.55 $0.50 $0.42
Freight a run, frozen $0 $350 $800
Run cost $1,960 $10,350 $20,700
Months to sell the run 0.1 1.0 2.5
Freezer storage while it sells $0 $176 $1,114
Cost a good tray $3.37 $2.69 $2.20

Making it itself, Thimble Islands cooks and portions 600 trays a day, seven days a month, and tests every batch. The small co-packer saves 68 cents a tray, about $2,700 a month, and runs bigger lots, so each lot's test is spread over more trays. The larger plant saves another 48 cents, with two and a half months of trays in its freezer and $20,700 out. How co-packer quotes compare more generally is in co-packer vs commercial kitchen.

Get the calculator

Download the baby food co-packer quote calculator. One column for each quote and one for making it yourself: type the run you'd order, the minimum, the loss, the setup, the fee or your labor, ingredients, packaging, freight and storage, and the run's cost, the months it takes to sell at your sales a month, the storage while it sells, the cost of each good tray and the cash out before it sells fill in. It's an ordinary Excel file with no macros, and it works in Google Sheets, LibreOffice and Numbers.

Where this stops working

Organic carrots, sweet potatoes and apples from four farms, each lot tested, runs at a co-packer and finger foods in your kitchen, and trays in three freezers. A spreadsheet can't keep each carrot lot's lead result with the trays it went into, or show which grocers got a lot if a test comes back late.

How TaroStack does it

TaroStack keeps each lot's test results with it, from ingredient to tray.

Tests on the lot. Each lot of produce is received with fields of your own, such as the lead and arsenic results and the lab report number, and each finished lot carries its own results, so the test behind every tray is on record.

Runs that record their lots. Each run is a batch that records the produce lots it used, so a carrot lot with a high result leads straight to the trays it went into. A lot waiting on its test can be held, kept out of what can be sold.

The co-packer and recalls. The co-packer's freezer can be a site, with transfers in and out (more than one site is on Standard at $99 a month), and a recall report shows which grocers got each lot. How lot tracking works is in what is lot tracking.

The job Spreadsheet In TaroStack
A carrot lot's lead result A lab PDF A field on the lot
Which trays used that lot Unknown Lots recorded on the run
A lot waiting on its test Set aside, maybe Held from sale
Which grocers got lot 1009 Search the invoices One recall report

Lots, holds, batches and recalls are on every plan, from $49 a month; more than one site is on Standard at $99. The first 30 days are free, with no credit card. If you'd like a hand setting up, ask, and we'll do it with you.

Questions people also ask

What are FDA's lead limits for baby food?

Action levels of 10 ppb for most processed foods for babies under two, and 20 ppb for single-ingredient root vegetables and dry infant cereals, set in January 2025.

Does a baby food co-packer test for heavy metals?

Ask: agree a testing plan for ingredients and finished lots before the first run, and who pays for it.

Can baby food pouches be made shelf-stable?

Yes, with a validated thermal process; many vegetable purées are low-acid foods, so they need a plant set up for low-acid canning.

What is the minimum order for a baby food co-packer?

In the example, 2,000 trays at a small frozen co-packer and 10,000 at a larger plant.

Sources

  1. FDA, Guidance for Industry: Action Levels for Lead in Processed Food Intended for Babies and Young Children (January 2025): 10 ppb, 20 ppb for single-ingredient root vegetables and dry infant cereals · read October 16, 2026
  2. 21 CFR 113.3, Low-acid foods: a finished equilibrium pH above 4.6 and water activity above 0.85 · read October 16, 2026

We use AI to help with the research for these articles. Every one is read, checked against its sources and edited by Koa before it's published. Spot a mistake? Tell us and we'll fix it and say so. How we write these.

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