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Annel – expert guide on adapting product labels for EU compliance and market entry

How to Adapt Product Labels for Sale in the European Union

A Comprehensive Guide for Non-EU Manufacturers with Annel as Your Trusted EU Partner

Entering the European Union (EU) market requires more than appealing design and marketing. It demands strict regulatory compliance, especially in product labelling. For exporters from the United States, China, Japan, Korea, or other non-EU countries, navigating the EU’s rules can be challenging. This guide explains what you need to know, and how Annel helps you succeed in Europe quickly, safely and legally.

1. Why Labelling Matters: Your Legal Passport to the EU

In the EU, a label is not just a marketing detail; it is a legal document. Every symbol and statement has meaning. Labelling ensures traceability, consumer safety and regulatory compliance. Incorrect labelling can lead to border seizures, market withdrawals, or financial penalties. By working with Annel’s compliance experts, you gain the assurance that your documentation, labelling and claims align with EU law from the outset.

2. Cosmetic Products: Transparency and Safety First

All cosmetic products sold within the EU must comply with Regulation (EC) No 1223/2009. It ensures that every cosmetic on the market is safe, traceable and correctly labelled.

  • Name and address of the Responsible Person (RP) within the EU. The RP is legally accountable for compliance. Annel’s Responsible Person Service (EU, UK & USA) helps your brand meet this requirement seamlessly.
  • Country of origin, if manufactured outside the EU.
  • List of ingredients using INCI nomenclature, arranged by descending concentration.
  • Batch number or product reference, for traceability.
  • Date of minimum durability or Period After Opening (PAO) symbol.
  • Safety warnings or precautions, where relevant.

All labelling must be legible, indelible and durable, and must not mislead consumers (for instance, by implying medicinal benefits). For cosmetic brands entering Europe, Annel’s Cosmetics Regulatory Compliance – EU, UK & USA service covers label reviews, PIF preparation, ingredient assessment and safety compliance.

3. Chemical Mixtures: CLP Regulation in Practice

If your products contain hazardous substances such as scented candles, essential oils or cleaning agents, they fall under the CLP Regulation (EC No 1272/2008) on Classification, Labelling and Packaging.

  • Product identifier (trade name and hazardous components).
  • Signal word: Warning or Danger.
  • Hazard pictograms (red diamonds, at least 1 cm²).
  • Hazard (H) and Precautionary (P) statements, limited to six most relevant.
  • Supplementary EUH phrases, e.g. EUH208 for allergens ≥ 0.1 %.
  • Supplier information, including name, address and EU phone number.

Real case: a missing pictogram costs thousands. A candle manufacturer shipping from South Korea was fined in Spain after omitting a single CLP hazard pictogram on the outer box. Although the product was safe, the authorities classified it as incorrectly labelled. The result was €8,000 in re-labelling costs and delayed shipments. Annel’s compliance team helps manufacturers avoid these pitfalls with detailed label checks before export. For reference, verify classification data via the European Chemicals Agency (ECHA).

4. Roles and Responsibilities: Understanding the EU Supply Chain

The EU defines specific responsibilities for each economic operator in the supply chain.

Manufacturer (outside the EU)

  • Ensures the product complies with EU legislation.
  • Provides technical documentation and draft labelling.
  • Authorises an EU partner, such as Annel, to act as Responsible Person or importer.

Importer / Responsible Person (in the EU)

  • Displays their name, address or trademark on the packaging.
  • Verifies labelling and documentation before placing products on the market.
  • Retains required files (such as the Declaration of Conformity) for ten years.

Distributor

  • Confirms that labels and languages meet local market requirements prior to sale.

Why it matters: EU enforcement authorities do not just check paperwork, they test accountability. If an imported product has no clear EU contact or Responsible Person, it is treated as an “orphan product” and can be detained or destroyed at customs. Partnering with Annel provides a recognised EU presence, giving both regulators and distributors confidence that your brand is compliant.

5. Language and Localisation: Beyond Translation

The EU’s 27 Member States and 24 official languages make localisation essential. Each country determines which languages are mandatory for safety and consumer-facing information.

  • France: French
  • Germany: German
  • Belgium: French, Dutch and sometimes German
  • Finland: Finnish and Swedish

What happens if your labels are not translated? In 2023, a US skincare brand launched online sales in France and Germany with packaging available only in English. Within weeks, products were removed from marketplaces for non-compliant labelling. The issue was not product quality, but missing translations of safety phrases. It is a simple mistake with costly consequences: fines, product withdrawal and loss of consumer trust. Working with Annel ensures your packaging, inserts and online listings meet every linguistic and legal requirement before launch. Annel supports clients with verified translations and localisation strategies to ensure full compliance.

6. CE Marking: When It Applies

For regulated product categories such as machinery, toys, electrical goods or PPE, the CE marking demonstrates conformity with EU safety standards.

  • The manufacturer or authorised representative affixes the CE mark under their own responsibility.
  • It must be visible, legible and permanent.
  • If a notified body participated in assessment, its identification number must follow the mark.
  • For online sales, CE marks and safety warnings must be visible on the product webpage before purchase.

To simplify the process, see Annel’s CE & UKCA Marking Service, tailored for non-EU manufacturers needing certification support.

7. Maintaining Compliance: Staying Ahead of Regulation

Example: The substance TPO (trimethylbenzoyl diphenylphosphine oxide) will be banned in cosmetics from 1 September 2025 as a CMR substance. Products containing TPO must be withdrawn or reformulated before that date.

Lesson learned: One Asian nail-gel supplier failed to notice the upcoming TPO ban. By the time enforcement began, 20,000 units were already stocked in European warehouses, unsellable overnight. Regulatory change is constant in the EU. Annel’s regulatory monitoring service tracks upcoming amendments so your business stays ahead, not one step behind.

8. Best Practice Tips for Exporters from the US and Asia

  1. Appoint an EU Responsible Person early. Annel’s RP Service covers both EU and UK markets.
  2. Translate all safety and usage instructions into the required EU languages.
  3. Verify ingredients and substances against the CosIng database and ECHA.
  4. Maintain technical documentation for at least ten years.
  5. Audit your labels regularly to reflect evolving laws.
  6. Ensure your online listings match your physical packaging.
  7. Access additional guidance via Annel’s Free Regulatory Guides.
  8. Stay informed through Annel’s Cosmetic Regulatory Blog.

Ready to Start Your EU Journey?

Let’s make your EU expansion effortless. Contact the Annel Team today for a free consultation on labelling, compliance and documentation. Your EU market entry starts here. With Annel, you’re ready.