EU Cosmetic Language Requirements
Biorius has observed that many of its clients face confusion regarding language requirements in the EU. While ensuring compliance with these requirements is ultimately the responsibility of distributors (as stated in Article 6 of the EU Cosmetics Regulation), it is crucial for brands to be aware of the applicable rules. Given that designing and updating labels and packaging can be a significant investment, a clear understanding of these regulations can help prevent costly errors and streamline compliance.
Here’s a brief reminder of the current language requirements in the EU to support your brand in meeting regulatory expectations efficiently.
Table of Content
Minimal legal requirements imposed by the European Cosmetics Regulation
According to Article 19 §5 of the EU Cosmetics Regulation, distributors have to ensure that a certain number of labeling requirements are properly translated in the national language(s) of the countries where the products are intended to be sold.
These labeling requirements are:
-
The nominal content (imperial units in the UK, metric units in all the other EU countries) -
The date of minimum durability and the Period After Opening (PAO) -
The warnings, precautionary use statements -
The function of the cosmetic product (not mandatory if obvious but to be translated if reported on the product label) -
The enclosed or attached leaflet, label, tape, tag or card if there is one -
The notice in immediate proximity to the container in which the cosmetic product is exposed for sale if any
The distributors are fully entitled to refuse products that would not comply with these language requirements and such a rejection cannot be regarded as the responsibility of Biorius or any other EU Responsible Persons.
The labeling of the product function is not mandatory if this one is clear from the product presentation. However, if you have to (or decide to) label it, then it has to be in the appropriate language(s).
Having the product function in English and the translationsin a leaflet is not acceptable unless the product is only sold in Cyprus, Ireland, Malta and, United Kingdom.
Likewise, the warnings and precautionary use statements can be reported on the leaflet if there is no space enough on the container (primary packaging) or the packaging (secondary packaging). However, if you have to label them, then it has to be in the appropriate language(s). Again, having the warnings and precautionary use statements reported in English on the container or packaging and the translations in a leaflet is not acceptable unless the product is only sold in Cyprus, Ireland, Malta and, United Kingdom.
See ‘National provisions’ below for more information.
Legal requirements imposed by the European Cosmetic Claims Regulation
Biorius recommends that the product claims be translated as well. Translating the claims is not a formal requirement of the European legislation (see ‘National provisions’ for exceptions) but more an interpretation of the legislation by the National Authorities. Indeed, Regulation EU No 655/2013 on the justification of cosmetic claims mentions that:
“The acceptability of a claim shall be based on the perception of the average end user of a cosmetic product, who is reasonably well-informed and reasonably observant and circumspect, taking into account social, cultural and linguistic factors in the market in question.”
On this basis, it is usually considered as safer to translate the claims in the language(s) of the countries where the product is sold. It may be argued that most of the people living in some countries have a good understanding of English but this remains a matter of interpretation and the outcome is therefore uncertain.
Based on its experience, Biorius confirms that not translating the claims should not be a problem in northern European countries such as The Netherlands, Finland, Denmark, Sweden or Iceland for instance. To the opposite, not translating the claims is likely to be a problem (at least from a marketing standpoint) in southern European countries.
On this basis, brand owners basically have three options:
-
Develop a specific label and packaging for every country (or for a couple of countries) – best option according to BIORIUS -
Create a unique label and packaging complying with all the language requirements (all the translations are labeled on the container or packaging) – impossible unless you only target a few countries of the EU -
Develop a unique label and packaging and apply a sticker where needed – practical optionbut questionable from a marketing standpoint
National languages to consider:
Country | Language |
---|---|
Austria | German |
Belgium | Dutch, French and German |
Bulgaria | Bulgarian |
Czech Republic | Czech |
Cyprus | Greek or English |
Denmark | Danish |
Estonia | Estonian |
Finland | Finnish and Swedish |
France (Caution) | French (see below) |
Germany | German |
Greece | Greek |
Hungary | Hungarian |
Ireland | English |
Italy (Caution) | Italian |
Latvia | Latvian |
Lithuania | Lithuanian |
Luxemburg | French, German or Luxemburgish |
Malta | Maltese or English |
The Netherlands | Dutch |
Norway | Norwegian |
Poland | Polish |
Portugal | Portuguese |
Romania | Romanian |
Slovakia | Slovak |
Slovenia | Slovenian |
Spain | Spanish |
Sweden | Swedish |
United Kingdom | English |
National Provisions
Two countries passed national laws to ensure that everything on the label is translated in their national language: France and Italy. Not translating the labels in French and Italian if the products are placed on these markets may lead to compliance issues.
In France, Toubon’s law (n°94-665 of August 4th, 1994) obliges you to use the French language for labeling purposes. The only labeling element that is exempted from translation is the “Made in” statement. This exemption does not extend to similar statements such as “Country of origin”.
Regarding the warnings and use instructions or marketing claims that may be indicated on a leaflet rather than on the product label: it is recommended that the French, Italian and English translations remain on the product labels while it is acceptable to have the other translations on the leaflet.
Author
Christophe Brault-Chevalier
Related Posts
Get in Touch
Need a piece of advice, a quotation or answers to your questions?
Fill in this form or contact us directly: info@biorius.com – We will answer as soon as possible!
As specialists in cosmetic Regulations for more than 15 years, Biorius offers a reliable turnkey solution for placing cosmeticproducts in various markets:
-
First Class specialists in cosmetic regulations in Europe, the United Kingdom, the United States, and in more than 60 countries -
50 regulatory experts, toxicologists, pharmacists, and chemists to serve you. -
A unique model that guarantees you both the fastest turnaround possible and high-quality services. Curious? Ask us to know more! -
A best-in-class IT tool, free of charge, and saving a lot of your time. -
More than 1,500 international clients have already chosen Biorius! -
We evaluated more than 100,000 products and have always successfully managed compliance over 15 years of existence
Get in Touch
"*" indicates required fields