# The compliance engine. Every rule quoted from 21 CFR.

The compliance engine is fixed FDA rules from 21 CFR 101.9 and 101.12, versioned, with no AI in it. Same recipe, same answer.

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[Read 21 CFR 101.9](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-101/subpart-A/section-101.9)

Figure: One rule card: the calorie rounding value on top, and the 21 CFR 101.9(c)⁠(1) paragraph it comes from under it Value: Calories. Up to and including 50, nearest 5 (47 becomes 45). Above 50, nearest 10 (52 becomes 50). Under 5, may show 0 (3 becomes 0). Source, quoted word for word in part: 21 CFR 101.9(c)⁠(1), "…expressed to the nearest 5-calorie increment up to and including 50 calories, and 10-calorie increment above 50 calories…"

One rule card: the value and its CFR paragraph

## How are the numbers on a label rounded?

By the increments 21 CFR 101.9(c) sets for each nutrient. Here is sodium, as Formulate stores it.

1. Under 5 mg Shown as 0
  - 4.9 mg is shown as 0 mg
2. 5 to 140 mg Nearest 5 mg
  - 7.5 mg is shown as 10 mg
3. Over 140 mg Nearest 10 mg
  - 142 mg is shown as 140 mg
  - 145 mg is shown as 150 mg

> “to the nearest 5-milligram increment when the serving contains 5 to 140 milligrams of sodium …”

[21 CFR 101.9(c)⁠(4)](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-101/subpart-A/section-101.9#p-101.9(c)(4))

Free to start. No card needed.

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## Where does the serving size come from?

From the FDA reference amounts (RACC) in 21 CFR 101.12, by food category. You set the serving in a household measure.

Figure: A serving of 2 pieces, 28 g, set against the 30 g reference amount for cookies Category: Bakery products, cookies, with a reference amount (RACC) of 30 g. One piece weighs 14 g. On a scale from 0 to 45 g, two pieces reach 28 g, the closest whole count to 30 g. A third piece, drawn dashed, would reach 42 g. The serving size is 2 pieces (28g).

A cookie’s category and its RACC

- [Look up a reference amount, free](https://bettermenu.live/tools/racc/)
- [21 CFR 101.12(b), the RACC table(opens in a new tab)](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-101/subpart-A/section-101.12#p-101.12(b))

## Which Daily Values does the label use?

FDA’s Daily Values, from 21 CFR 101.9(c). %DV is the amount per serving ÷ its Daily Value. Here it is worked for the sample granola’s 60 g serving.

[How %DV is worked out](https://bettermenu.live/platform/how-we-calculate/#dv-before-rounding)

Sample granola, one 60 g serving

| Nutrient | Per serving | Daily Value | %DV on the label |
| --- | --- | --- | --- |
| Total Fat | 8.78 g | 78 g | 11% |
| Saturated Fat | 0.88 g | 20 g | 4% |
| Sodium | 168.0 mg | 2,300 mg | 7% |
| Total Carbohydrate | 36.0 g | 275 g | 13% |
| Dietary Fiber | 5.15 g | 28 g | 18% |
| Added Sugars | 9.80 g | 50 g | 20% |

Every Daily Value, adults and children 4+. [21 CFR 101.9(c)⁠(9) (opens in a new tab)](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-101/subpart-A/section-101.9#p-101.9(c)(9)). [See every Daily Value in the free tool](https://bettermenu.live/tools/rda/).

Questions

## More questions

### What is the compliance engine?

Fixed FDA rules that do every calculation, rounding and %DV. AI suggests the matches, any missing weight and, in Studio, the added sugars. You review them, change any and confirm, and the engine calculates. We send recipe lines only to AI providers that do not train on them and keep none of them after answering. Labels are not reviewed by FDA.

### How do I know a rule was copied right?

Each value keeps its citation and the eCFR’s own words, checked automatically against a saved copy. A value changes only with a written correction.

## Read next

- [Check FDA rounding applied. In Studio, added sugars suggested for you to review and confirm.](https://bettermenu.live/formulate/check/)
- [Build Paste a recipe, match USDA data, set servings.](https://bettermenu.live/formulate/build/)
- [How we calculate From ingredient grams to the rounded number.](https://bettermenu.live/platform/how-we-calculate/)

## Make your first label today.

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Source: https://bettermenu.live/platform/regulation-engine/