Automated Regulatory Compliance for Packaging

FDA, EU, GHS, and pharmaceutical label requirements — validated automatically against your artwork before it reaches production. Catch compliance failures at preflight, not at recall.

AI Compliance — Invite-Only Alpha

FDA Nutrition Facts

21 CFR 101.9

United States Food and Drug Administration requirements for nutrition labeling on food packaging.

What LintPDF Checks

Check	Severity	Description
Nutrition Facts header font size	Error	Header must be in 13pt or larger Franklin Gothic Heavy or equivalent.
Serving size declaration	Error	Serving size and servings per container must be present and correctly formatted.
Nutrient ordering	Error	Nutrients must appear in the FDA-mandated order (calories, total fat, saturated fat, trans fat, etc.).
Daily value percentages	Warning	Percent Daily Value column must be present and right-aligned.
Font size minimums	Error	Body text minimum 8pt. Packages with < 40 sq in PDP may use 6pt minimum.
Hairline rules	Info	Horizontal rules between nutrient groups must meet minimum weight specifications.
Footnote presence	Warning	The '% Daily Value' footnote must be present on standard format labels.

Example Finding

{
  "inspection_id": "ai.fda.nutrient_order",
  "severity": "error",
  "message": "Nutrient 'Trans Fat' appears after 'Cholesterol' — FDA requires Trans Fat immediately after Saturated Fat",
  "page": 1,
  "source": "ai"
}

EU Food Information

Regulation (EU) No 1169/2011

European Union requirements for food information provided to consumers, including nutritional declarations and allergen labeling.

What LintPDF Checks

Check	Severity	Description
x-height minimum	Error	Mandatory information must have an x-height of at least 1.2mm (0.9mm for packages < 80 cm²).
Allergen emphasis	Error	Allergens in ingredients list must be typographically distinguished (bold, underline, or CAPS).
Nutritional declaration order	Error	Must follow: energy, fat, saturates, carbohydrate, sugars, protein, salt.
Mandatory fields present	Error	Product name, ingredients, allergens, net quantity, date marking, storage conditions, origin (where required).
Energy units	Warning	Energy must be expressed in both kJ and kcal.
Per 100g/100ml declaration	Error	Nutritional values must be declared per 100g or per 100ml.

Example Finding

{
  "inspection_id": "ai.eu_fir.allergen_emphasis",
  "severity": "error",
  "message": "Allergen 'milk' in ingredients list is not typographically distinguished — EU 1169/2011 Article 21 requires emphasis",
  "page": 1,
  "source": "ai"
}

GHS/CLP Chemical Labels

Regulation (EC) No 1272/2008

Globally Harmonized System of Classification and Labelling of Chemicals, implemented in the EU as the CLP Regulation.

What LintPDF Checks

Check	Severity	Description
Hazard pictogram presence	Error	All required GHS pictograms must be present based on product classification.
Pictogram minimum size	Error	Each pictogram must be at least 1/15th of the label area, minimum 1 cm².
Signal word	Error	'Danger' or 'Warning' must be present and match the highest hazard classification.
H-statement validation	Error	All required Hazard statements must be present with correct codes and text.
P-statement validation	Warning	Precautionary statements must be present and appropriate for the classification.
Supplier identification	Warning	Name, address, and telephone number of the supplier must be present.
Product identifier	Error	Product name and chemical identifiers must be present on the label.

Example Finding

{
  "inspection_id": "ai.ghs.pictogram_size",
  "severity": "error",
  "message": "GHS07 (exclamation mark) pictogram area is 0.8 cm² — minimum required is 1 cm² per CLP Regulation",
  "page": 1,
  "source": "ai"
}

Pharmaceutical Packaging

EU FMD (2011/62/EU) & National Requirements

Pharmaceutical packaging requirements including serialization, Braille, patient information leaflets, and font compliance.

What LintPDF Checks

Check	Severity	Description
Serialization area	Error	EU Falsified Medicines Directive requires 2D DataMatrix code area with adequate quiet zones.
Braille placeholder	Warning	Outer packaging must include Braille rendering of the medicine name (or placeholder area).
Font size compliance	Error	Patient information must meet minimum font size requirements per national guidelines.
Leaflet structure	Info	Patient information leaflet should follow the standard QRD template section ordering.
Tamper evidence indicator	Warning	Anti-tampering device area must be identifiable on the packaging artwork.
Batch and expiry placement	Error	Batch number and expiry date must be present and positioned per requirements.

Example Finding

{
  "inspection_id": "ai.pharma.serialization_area",
  "severity": "error",
  "message": "2D DataMatrix serialization area not detected — EU FMD requires serialization on outer packaging",
  "page": 1,
  "source": "ai"
}

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