Endocrine Disruptors in Europe

EU Cosmetic Language Requirements

BIORIUS realized that many of its clients are confused by the language requirements in the EU. Although this aspect falls under the responsibility of your distributors (according to Article 6 of the EU Cosmetics Regulation), it is important to make a reminder of the rules currently in application as the design and edition of labels and packaging is a costly exercise for cosmetic brand owners.

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

For memory, the national languages to consider are the following:

Country Language
Austria German
Belgium Dutch and 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 (see below)
Latvia Latvian
Lithuania Lithuanian
Luxemburg French or 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 isrecommended that the French, Italian and English translations remain on the product labels while it is acceptable to have the other translations on the leaflet.

Any questions?

Author

  • Frédéric Lebreux

    Dr. Frédéric Lebreux is Biorius's Chief Executive Officer and has worked in the cosmetic industry for more than 13 years. He is regularly invited as a speaker or Professor to cosmetic events.

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