Translating Cosmetic Product Documentation for CPNP Notification

A company placing a cosmetic product on the EU market must notify it through the CPNP (Cosmetic Products Notification Portal) before it reaches shelves. That process depends on the Cosmetic Product Safety Report (CPSR), the technical file, the labelling and supporting documents being correct and, in most cases, translated into the language of the country where the product will be sold. A terminology error in any of these documents can delay notification or, worse, trigger a market surveillance issue once the product is already in circulation.

What Regulation (EC) No 1223/2009 requires

Regulation 1223/2009 requires every cosmetic product placed on the EU market to have a CPSR prepared by a qualified safety assessor (typically a pharmacist, physician or toxicologist), a Responsible Person established in the EU, and consumer-facing information in the official language of the Member State where the product is sold.

This has direct consequences for translation:

• Labelling (the INCI ingredient list, warnings, directions for use) must follow the national language requirements of each market.
• The CPSR does not need to be translated for CPNP submission, but the Responsible Person and market surveillance authorities may request it in the local language in case of inspection or complaint.
• The Product Information File (PIF), which includes the CPSR, must be available in the language of the Member State where the product is marketed, or in English where the competent authority of that country accepts it.

The notification itself, submitted through the CPNP portal, is completed directly in the platform's fields, in English. What demands careful translation is the supporting documentation held by the Responsible Person and made available to market surveillance authorities.

Where translation goes wrong most often

INCI terminology (International Nomenclature of Cosmetic Ingredients) is never translated. Ingredient names always follow the international nomenclature, regardless of the labelling language. A translator unfamiliar with the sector tends to render chemical names into the target language, producing an ingredient list that is invalid for legal purposes.

Claims are another common failure point. Terms like "hypoallergenic", "dermatologically tested" or "paraben-free" carry different regulatory weight in different markets, and some are outright restricted in certain Member States. A literal translation of a claim approved in one country can become non-compliant in another.

Safety warnings, particularly for products containing retinol, acids or UV filters, follow standardised wording set by European cosmetics legislation. Rewording those sentences for style, even with good intentions, can strip them of the legal weight the original wording carried.

This terminology discipline mirrors what applies to other regulated products, covered in more detail in the article on drug labelling translation: the same principle of nomenclature fidelity and regulatory compliance applies.

Which documents need translation, and how carefully

For a complete CPNP notification and a well-prepared PIF, the documents that typically require translation include:

• Label and packaging (INCI ingredients, directions for use, warnings, symbols)
• Safety data sheet, where applicable
• Technical dossier supporting the CPSR (stability studies, skin compatibility tests, toxicological data)
• Promotional material accompanying the product, when subject to the same claims rules
• Correspondence with the market surveillance authority, in case of a clarification request

Each of these documents carries a different level of risk. An error in the safety data sheet can have clinical consequences; an error in promotional material can trigger enforcement action for misleading advertising. The level of review applied to each document should reflect that risk, rather than treating the whole dossier the same way.

Companies already working with medical devices will recognise this risk-based classification logic, explained further in the article on medical device documentation translation under the MDR.

How M21Global supports CPNP dossiers

M21Global has worked with pharmaceutical and regulated product translation for more than 20 years, holding ISO 17100:2015 certification audited by Bureau Veritas and ISO 18587 certification for machine translation post-editing. For CPNP dossiers, the right level of review depends on the document. The Estratégica tier, with review by a second linguist (translation, editing, proofreading) and an ISO 17100 audited workflow, is the right fit for the CPSR, safety data sheets and labelling carrying regulatory claims, where an error has direct legal consequences. For high-volume technical files and internal reference material, the IAH+ or Standard tiers may be more appropriate.

If a company needs to prepare a CPNP dossier for a new product notification or an update, M21Global reviews the documents and returns a quote within three business hours, with a clear recommendation on which tier applies to each file in the dossier. Request a quote through the pharmaceutical translation service page.

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