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Regulation Guide

🇪🇺 Mandatory Warning Statements in EU

European Union requires specific warning statements on labels for products containing certain ingredients including sweeteners, alcohol, caffeine, and allergens.

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What the Rule Is

Certain ingredients and product characteristics trigger mandatory warning statements in European Union. Unlike general label information, these warnings must appear in a prescribed format and location. Failing to include them is a compliance violation enforceable by EFSA & European Commission. Annex III of Regulation 1169/2011 prescribes exact warning wording: "with sweetener(s)", the aspartame/phenylalanine warning, the high-caffeine warning "Not recommended for children or pregnant women" with the mg/100ml content, liquorice statements, and added-phytosterol warnings.

What You Must Include
  • Phenylalanine/PKU warning for products containing aspartame
  • "With sweetener(s)" for products containing intense sweeteners (EU/UK)
  • High caffeine warning for beverages with >150mg/L caffeine
  • Alcohol content warning for beverages above 1.2% ABV
  • Laxative warning for products with excessive polyols
  • Sulphite allergen warning above 10mg/kg threshold
Common Violations
  • Missing PKU warning on aspartame-containing products
  • Omitting "With sweetener(s)" front-of-pack statement
  • No caffeine level declared on energy drinks
  • Missing laxative effect warning on sugar-free confectionery with sorbitol/mannitol
Examples: Compliant vs Non-Compliant

Compliant Examples

"Contains a source of phenylalanine" near aspartame in ingredients
"With sweetener(s)" near product name
"High caffeine content. Not recommended for children or pregnant women (32mg/100mL)"

Non-Compliant Examples

Aspartame listed in ingredients with no phenylalanine warning
Sweetener-containing product with no front-of-pack "With sweetener(s)" statement
Energy drink with no caffeine content declaration
How LabelGuard Checks This

LabelGuard scans your entire label for ingredients that trigger mandatory warnings in EU and flags any missing statements.

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Frequently Asked Questions

Which regulation governs mandatory warning statements in EU?

Annex III of Regulation 1169/2011 prescribes exact warning wording: "with sweetener(s)", the aspartame/phenylalanine warning, the high-caffeine warning "Not recommended for children or pregnant women" with the mg/100ml content, liquorice statements, and added-phytosterol warnings.

Which ingredients trigger mandatory warning statements in EU?

Aspartame (PKU), intense sweeteners, high caffeine (>150mg/L in beverages), polyols above threshold, sulphites above 10mg/kg, and alcohol above 1.2% ABV.

Where must warning statements appear on the label?

The phenylalanine warning should be in close proximity to the ingredient list. "With sweetener(s)" must appear near the product name. Caffeine warnings must state the level per 100mL.

Regulation Sources

Last updated: 2026-07-20

Disclaimer: This information is for guidance only and does not constitute legal advice. Always consult official regulations and seek professional legal advice for specific compliance questions.

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