NEWS LETTER

KOREAN
EU Cosmetics Regulations: 5 Things You Must Know
2026,05.29
By
OTCM
May
2026, NO.20
OTCM 뉴스레터
Q1.
When exporting cosmetics to the EU,
do we need to include the languages of
all 27 member states on the label?


캐릭터

This is a common point of confusion, but the answer is No.

According to Article 19 of Regulation (EC) No 1223/2009, mandatory information must be labeled in "a language which can be easily understood by the final consumer" as determined by the Member State where the product is made available. Therefore, you do not need to list the languages of all 27 member states. You only need to meet the language requirements of the specific countries where your product is actually being sold.

However, please note that not all text on a label is subject to the same level of translation requirements. While legally mandatory information (e.g., function, instructions for use, precautions) must be provided in the local language, certain details—such as the ingredients list, which uses common international nomenclature (INCI), or other general information—may not require translation.

Ultimately, the key to EU labeling is not the "number of languages, "but accurately identifying and applying the specific scope of mandatory information required by each country of sale.


Q2.
If exporting to multiple EU countries,
must the PIF be translated into each local language?


캐릭터

This is a common point of confusion, but the answer is No.

This is a common point of confusion, but the answer is No. The PIF does not need to be written in the language of every country where the product is sold. Instead, it must be prepared in a language that the Competent Authority of the member state where the PIF is kept can easily understand. In practice, most EU member states accept English as the language that is "easily understood by the authorities."


Q3.
My formula is perfect.
Could my sales still be blocked because of the packaging?


캐릭터

Absolutely. In the EU, packaging is just as strictly regulated as the formula itself.

The EU regulations govern the entire lifecycle of packaging—from manufacturing and composition principles to recyclability requirements and recovery/recycling responsibilities. In other words, packaging structure, recyclability, sorting instructions, and EPR (Extended Producer Responsibility) registration are mandatory legal requirements within the EU.

The EU market does not look at the formula in isolation. Only when your packaging compliance is fully prepared can you successfully launch your product.


Q4.
Can we use the same marketing claims in the EU
that we used in Korea without any issues?


캐릭터

This is where most compliance failures occur.
Under the EU Claim Regulation (655/2013), every claim must be supported by objective and verifiable evidence.
For instance, terms like "Whitening" or "Wrinkle Improvement," which are permitted in Korea through functional cosmetic reporting, are not automatically recognized in the EU. To use these claims, you must provide clinical data and scientific evidence that meet specific EU standards.

In practice, sanctions due to misleading claims are more frequent than those due to ingredient issues. In the EU, "what you say" can be even more critical than "what you put" into the product.


Q5.
What is the most frequently overlooked risk
in the EU market?


캐릭터

‘It is not "pre-launch" preparation, but "post-launch" maintenance.

Even seemingly minor changes—such as formula tweaks, raw material specification updates, changes in manufacturing sites, or packaging renewals—must be reflected in the CPNP and PIF. Since the EU is not an approval-based market, any failure to keep your records in their "latest state" will be immediately exposed during post-market surveillance.

Establishing a system for continuous management is far more critical than simply getting it right the first time.

EU export is not a process of obtaining a single approval.
A product can only be placed on the market when all of the requirements mentioned earlier are fulfilled simultaneously.

Rather than being simply a “difficult” market, the EU is a market that requires a clear responsibility structure and a high level of preparation.

Ultimately, the key to entering the EU market is not merely passing procedures, but having all regulatory requirements systematically prepared before launch. When properly prepared, EU regulations become not a barrier, but a standard.

It is not the companies that know the regulations, but the companies that are fully prepared, that enter the market first.

For a successful cosmetic export to the EU, understanding the latest regulations and practicing hands-on compliance are more critical than ever.

Partner with OTCM—your reliable guide to entering the European market.



Latest Newsletter
OTCM
https://otcmfg-us.com/eng/main/
OTCM, 8th Floor, Gasan Digital 2ro 43-14, Gumcheon-gu, Seoul, Korea
(+82) 02-853-3201
 
아이콘
Clinical Research
Location
Inquiry