Label requirements · European Union (other member states)

European Union (other member states) label requirements — check your label

What a label sold in European Union (other member states) must carry for food and drinks, other consumer goods, medical devices, item by item, each with the law it comes from. Paste your label below: Drict shows what it found, on which line, and what is missing.

Your points to check appear here.

Drict looks for the items each label law names, by key words. It is not legal advice and does not say a label is compliant: read the official text, and ask the authority or a specialist before you print.

Food and drinks — what a European Union (other member states) label must show

6 mandatory · 4 only if it applies

Mandatory

  • Net quantity (net wt / net weight) — Regulation (EU) 1169/2011
  • List of ingredients (ingredients / ingredientes) — Regulation (EU) 1169/2011
  • Expiry date (best before / use by) — Regulation (EU) 1169/2011
  • Name and address of the manufacturer / packer / distributor (manufactured by / manufactured for) — Regulation (EU) 1169/2011
  • Batch number (lot / batch) — Regulation (EU) 1169/2011
  • Nutrition information (nutrition / energy) — Regulation (EU) 1169/2011

Only if it applies

  • Allergens (contains / allergen) — Regulation (EU) 1169/2011
  • Storage conditions (store in / store at) — Regulation (EU) 1169/2011
  • Origin (made in / product of) — Regulation (EU) 1169/2011
  • Directions for use (directions / how to use) — Regulation (EU) 1169/2011

Check by eye: Language: check it yourself — the label must be in a language easily understood by buyers in the country of sale, usually its official language (FIC Article 15). Allergens emphasised in the ingredients.

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Other consumer goods — what a European Union (other member states) label must show

1 mandatory · 5 only if it applies

Mandatory

  • Name and address of the manufacturer / packer / distributor (manufactured by / manufactured for) — Regulation (EU) 1169/2011

Only if it applies

  • Net quantity (net wt / net weight) — Regulation (EU) 1169/2011
  • Origin (made in / product of) — Regulation (EU) 1169/2011
  • Directions for use (directions / how to use) — Regulation (EU) 1169/2011
  • Warnings (warning / caution) — Regulation (EU) 1169/2011
  • Name and address of the importer (imported by / importer) — Regulation (EU) 1169/2011

Check by eye: Product name: check it yourself — in the languages the law requires. Safety symbols, logos and certification marks are images — they cannot be found as text.

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Medical devices — what a European Union (other member states) label must show

5 mandatory · 6 only if it applies

Mandatory

  • Manufacturer’s name and registered address — MDR Annex I 23.2(c)
  • Lot number (LOT) or serial number (SN) — MDR Annex I 23.2(g)
  • UDI carrier — MDR Annex I 23.2(h), Art. 27
  • Use-by date, or the date of manufacture when there is none — MDR Annex I 23.2(i)(j)
  • The indication that it is a medical device (“MD”) — MDR Annex I 23.2(q)

Only if it applies

  • Authorised representative in the EU (“EC REP”), if the manufacturer is outside the Union — MDR Annex I 23.2(d)
  • Importer’s name and address, for an imported device — MDR Art. 13(3)
  • Sterile state and method of sterilisation — MDR Annex I 23.2(l)
  • Special storage or handling conditions — MDR Annex I 23.2(k)
  • Warnings and precautions to bring to the user’s attention — MDR Annex I 23.2(m)
  • Single use (“Do not re-use”) — MDR Annex I 23.2(n)

Check by eye: The device’s name and what it is for (23.2(a)(b)); the CE marking, with the notified body’s four-digit number where one was involved (Art. 20); ISO 15223-1 symbols (factory, LOT, SN, hourglass, MD, EC REP, STERILE, do not re-use) are pictures — Drict reads only words, so a symbol used alone shows as not found.

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Official sources

Other countries