The questions brands preparing to export to EU ask most often — answered by OTC experts.
Cosmetics in the EU are regulated under Regulation (EC) No 1223/2009.
The EU does not operate a separate pre-approval system, but before a product is placed on the market it must meet requirements including a safety assessment, appointment of a Responsible Person (RP), preparation of a Product Information File (PIF) and CPNP notification.
Ingredient restrictions, labeling, advertising claims, packaging and recycling obligations must also be reviewed.
In other words, the EU is not a market where you obtain an approval — it is a market where the company itself must demonstrate the safety and regulatory compliance of its products.
Regulation (EC) No 1223/2009 is the core legislation setting out safety, ingredients, labeling, appointment of a Responsible Person and market placement requirements for cosmetics in the EU.
All 27 EU member states apply the same cosmetics regulation, so once the requirements are met a product can be sold throughout the EU.
To place a cosmetic on the EU market you must appoint a Responsible Person (RP) established in the EU.
The RP verifies that the product complies with the EU Cosmetics Regulation (EC) No 1223/2009 and bears responsibility for the product, including keeping the PIF, making the CPNP notification, dealing with authorities, managing undesirable effects and handling recalls.
Every cosmetic sold in the EU must therefore be managed through an RP in the EU.
The PIF is the product information dossier used to demonstrate the safety and regulatory compliance of an EU cosmetic.
The PIF must be kept at the RP's address and be available for submission at the request of market surveillance authorities.
The CPSR (Cosmetic Product Safety Report) is the cosmetic safety assessment report.
Before a product is placed on the EU market, a qualified safety assessor must comprehensively review its ingredients, conditions of use, consumer exposure and toxicological information, and assess whether the product can be used safely.
Article 10 of Regulation (EC) No 1223/2009 also sets out the qualification requirements for safety assessors. The assessment must be carried out by an expert holding a degree or equivalent formal qualification following a university course in pharmacy, toxicology, medicine or a similar discipline recognized as equivalent.
The CPSR is therefore not merely paperwork — it is a core safety document in which a qualified expert scientifically assesses the safety of the product.
The CPNP (Cosmetic Products Notification Portal) is the online cosmetic notification system operated by the European Commission.
Before placing a cosmetic on the EU market you must register product information, ingredient information, Responsible Person (RP) details and label images. This is known as CPNP notification.
CPNP is a notification system, not an approval system. Completing a notification does not mean the safety or compliance of the product has been reviewed or approved. Responsibility for regulatory compliance rests with the RP and the company.
The EU manages cosmetic ingredients through the Annex system of Regulation (EC) No 1223/2009.
Colorants, preservatives and UV filters in particular may in principle only be used if listed in the relevant Annex, and the prescribed conditions on concentration, product type and warnings must be observed.
EU ingredient rules are also revised continuously in line with scientific assessment, so it is important to check the latest provisions before launching a product.
Even a product lawfully sold in Korea can only be placed on the EU market once it satisfies the EU Cosmetics Regulation.
Requirements differ between Korea and the EU in areas such as ingredient restrictions, fragrance allergen labeling, preparation of the CPSR and PIF, and labeling and advertising standards. Separately regulated ingredients such as UV filters, preservatives and colorants may also have different conditions of use or permitted ranges.
A separate regulatory review is therefore required before exporting to the EU.
Missing or inaccurate labeling can attract market surveillance action, so it is important to review label compliance thoroughly before launch.
Under Regulation (EU) No 655/2013 all claims in the EU must be supported by objective and verifiable evidence.
Expressions such as "Anti-Wrinkle", "Brightening" or "Clinically Proven", for example, may only be used where appropriate test data and scientific substantiation exist.
The EU applies Recommendation 2006/647/EC for sunscreen labeling, and the PA system used in Korea is not an official EU labeling system. The EU uses the UVA circle logo to indicate the level of UVA protection.
The UVA Protection Factor (UVAPF) must be at least one third of the SPF
The EU also discourages expressions that may mislead consumers, such as "sunblock" or "total protection", and recommends indicating an appropriate protection level according to the SPF value. Even a sunscreen that has been through functional cosmetic review in Korea therefore requires a separate review of SPF/UVA test results and labeling standards for EU sale.
Many companies assume that because the EU is a single market one English label is enough.
In practice, the language requirements of each country of sale must be met.
A product sold in Germany, for example, must provide directions for use and precautions in a language German consumers can understand, and France and Italy in particular apply relatively strict language requirements.
When entering the EU it is therefore important to review not only ingredient regulation but also a labeling strategy for each country of sale.
The EU in principle prohibits animal testing of finished cosmetic products and cosmetic ingredients, and prohibits marketing cosmetics that rely on animal test data.
There may nevertheless be cases requiring practical review in relation to data required under legislation other than the cosmetics regulation, such as REACH. It is therefore important to check animal testing documentation and supply chain information from the raw material selection stage onward.
The EU is not a market where you register once and finish — it is a market that must be managed continuously.
Where a formulation, raw material, manufacturing site or label changes, the PIF and CPNP information must also be kept up to date.
Because current information must be available for immediate submission at the request of market surveillance authorities, continuous document management is necessary after launch.
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