European owns the world's most prominent cosmetic market. Despite the coronavirus effect, this area still remains a market of over one hundred billion dollars, attractive to cosmetic enterprises worldwide. Cosmetic safety control in the EU has a long history of over 40 years, providing references for many other countries in cosmetic legislation. REGULATION (EC) No 1223/2009, a robust, internationally recognized regime, is the main regulatory framework for finished cosmetic products sold in the EU market, which reinforces product safety while taking into consideration the latest technological developments. Product compliance is essential for every company intending to sell cosmetics to the EU market. Based on this context, ChemLinked compiles five main steps to export cosmetics to the EU:
Step 1. Designation of Responsible Person (RP)
According to REGULATION (EC) No 1223/2009, to establish clear responsibilities, each cosmetic product should be linked to a Responsible Person. Therefore, before placing cosmetics on the EU market, the cosmetic enterprise should designate a Responsible Person in the EU. The Responsible Person can be either an EU manufacturer, importer, or a third party, who is responsible for ensuring product compliance, taking corrective measures on unqualified products, and providing the product compliance documentation to the authority.
Step 2. Formula Review
The Responsible Person shall check if the cosmetics contain any prohibited substances or forbidden CMR substances, and if the stakeholders/manufacturers/enterprises use the restricted substances, colorants, preservatives, UV-filters, or Nanomaterials properly.
Step 3. Label Review
Information on the cosmetic label shall include the following items and be translated into the exporting country’s language:
Name and address of the Responsible Person
Date of minimum durability or quality guarantee period after opening
Step 4. Product Information File (PIF) Preparing
The Responsible Person shall keep the product information file (PIF) for ten years after placing the cosmetics on the EU market. Therefore, preparing the PIF is another essential element for selling cosmetics to the EU.
The product information file shall contain the following information and data, which shall be updated as necessary:
A description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product;
The cosmetic product safety report (CPSR);
A description of the manufacturing method and a compliance statement with GMP;
Proof of the claimed effect of the cosmetic product
Data on any animal testing performed by manufacturers, their agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries.
Step 5. Notification via CPNP
Before placing the cosmetic product on the market, the Responsible Person shall submit the product information to the European Commission via the Cosmetic product notification portal (CPNP).
Information to be notified on the portal are specified as below:
The category of cosmetic product and its name or names;
The name and address of the Responsible Person;
The country of origin;
The Member State in which the cosmetic product is to be placed on the market;
The contact details of a physical person;
The presence of substances in the form of nanomaterials and
Their identification, including the chemical name (IUPAC) and other descriptors;
The reasonably foreseeable exposure conditions;
The name and the Chemicals Abstracts Service (CAS) or EC number of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), of category 1A or 1B, under Part 3 of Annex VI to Regulation (EC) No 1272/2008;
The frame formulation allowing for prompt and appropriate medical treatment in the event of difficulties.
After finishing the CPNP notification, enterprises can place the cosmetics on the EU market.
*Note that for the cosmetic ingredient whose annual import/manufacture amount , the ingredient needs to be registered under REACH regulation (EU regulation (EC) No 1907/2006 concerning the Registration, Evaluation and Authorization of Chemicals).