Ekotox Centers offer preparation of all documents required for registration of a cosmetic products and their placing on the EU market according to the requirements of Regulation (EC) No. 1223/2009. We also offer services regarding to CPNP (Cosmetic Products Notification Portal) such as registration of the products and company account registration in CPNP.
Cosmetic Products (CP)
The placing of cosmetic products on the market in the European Union is governed by Regulation (EC) No 1223/2009 of the European Parliament and of the Council. This regulation entered into force on 11 July 2013.
The main objective of the regulation is to ensure a high level of public health protection by harmonising requirements across the EU. This includes provisions related to the composition, labelling, and packaging of cosmetic products marketed in EU Member States.
According to Article 2 of Regulation 1223/2009, a “cosmetic product” means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips, and external genital organs) or with the teeth and the mucous membranes of the oral cavity, the exclusive or main purpose of which is to clean them, perfume them, change their appearance, protect them, maintain them in good condition, or correct body odor.
Regulation 1223/2009 introduces a robust, internationally recognized system that strengthens product safety while taking into account the latest technological advances, including the potential use of nanomaterials.
Key principles introduced by the regulation:
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Introduction of the concept of “responsible person”
Only cosmetic products for which a natural or legal person has been designated as the “Responsible Person” within the EU may be placed on the market. The regulation clearly outlines who can act as the Responsible Person and their obligations.
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Enhanced product safety requirements
The regulation increases coordination for market surveillance and places more responsibility throughout the supply chain. It also defines the structure and content of the product safety assessment and Product Information File (PIF).
Once a product is placed on the market, the Responsible Person must maintain the PIF for 10 years from the date the last batch was placed on the market. This file must be easily accessible in a language understood by the competent authorities of each Member State and must include:
- Description of the cosmetic product
- Cosmetic product safety report
- Manufacturing method and compliance with Good Manufacturing Practice (GMP)
- Proof of the claimed effects (if applicable)
- Data on animal testing
The Responsible Person must ensure a safety assessment is performed by a qualified professional before placing the product on the market. This person must hold a diploma or certification in pharmacy, toxicology, medicine, or a related field.
The safety report must include:
- Quantitative and qualitative composition of the product
- Physical/chemical characteristics and stability
- Information about the cosmetic product
- Microbiological quality
- Impurities, traces of prohibited substances, packaging materials
- Reasonably foreseeable exposure conditions
- Exposure to substances
- Toxicological profile of substances
- Undesirable effects and serious undesirable effects
- Assessment conclusions
- Warnings and instructions for use
- Expert credentials
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Centralised notification system via CPNP
Manufacturers must submit product notifications through the Cosmetic Products Notification Portal (CPNP). While this notification only needs to be made once, any changes—such as to the label or countries of sale—must be updated accordingly.
All data submitted via CPNP is electronically shared with the competent national market surveillance authorities, consumer safety authorities, and poison centres for proper treatment guidance in case of adverse effects.
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Obligation to report serious undesirable effects (SUE)
The Responsible Person must report any SUE to the competent national authority. These authorities collect additional information from users and health professionals and share it across all EU Member States.
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Specific requirements for nanomaterials
Colorants, preservatives, and UV filters—including those containing nanomaterials—must be specifically authorised. Other nanomaterials not prohibited under the regulation must undergo full safety assessment if the Commission expresses concern. These materials must be clearly labelled in the ingredients list with the word “nano” in brackets (e.g., titanium dioxide (nano)).
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Good Manufacturing Practice (GMP) compliance according to ISO 22716
All cosmetic products sold in the EU must be manufactured in accordance with GMP. This applies both to products produced within the EU and those imported from outside.