Regulation (EC) No. 1223/2009, known as the Cosmetics Regulation, has been developed as one of the key provisions of the European Union in regard to the cosmetics industry. It entered into force on July 11, 2013, in terms of replacing the novel Directive 76/768/EEC. Focused on enhancing a high degree of health and safety of humans, this regulation simultaneously allows the movement of cosmetic products across the EU markets without restrictions.
Objectives
Safety: All cosmetic products made available to the end user shall be safe for human health when applied under normal or reasonably foreseeable circumstances.
Transparency & Consumer Protection: It requires clear and accurate labelling of cosmetic products, allowing consumers to make informed choices about the products they use.
Harmonization for the Single Market: By creating uniform standards in all EU member states in order to enable the free circulation of cosmetic products.
Key Aspects
Responsible Person:The “Responsible Person” is defined in Article 4 as the natural or legal person to ensure that a cosmetic product meets regulatory requirements throughout its lifecycle. For a cosmetic product manufactured within the EU, and not subsequently exported and imported back into the Community, the manufacturer can be the responsible person. The manufacturer can also appoint, by a written mandate, a person established within the Community as the responsible person.
Product Information File (PIF): The Product Information File (PIF) is a documented collection of information required by Article 11, which provides comprehensive details on the cosmetic product. The PIF must be readily accessible to the authorities and contains essential information. The PIF is fundamental in demonstrating compliance with safety and regulatory standards, ensuring that all necessary data is available for review in the event of inquiries or safety assessments.
Safety Assessment: A Safety Assessment is defined in Article 10. It refers to the process of evaluating a cosmetic product’s safety, conducted by a qualified safety assessor. Prior to marketing, every cosmetic product must undergo a thorough safety assessment to evaluate potential risks associated with its ingredients and formulations. This assessment includes an evaluation of the toxicological profile of the ingredients and the overall risk to human health when used as intended. The findings of this assessment are documented within the PIF and are critical for ensuring consumer safety.
Labelling: Labelling requirements are outlined in Article 19, specifying how a cosmetic product must be labelled before it is sold. The regulation mandates specific label information, including the product’s name, the name and address of the Responsible Person, a list of ingredients, and any necessary precautionary statements or instructions for safe use. Labels must be clear, legible, and understandable to consumers, ensuring they have all the necessary information to make informed choices about the products they use.
Notification: Notification is described in Article 13, which requires cosmetic products to be submitted to the Cosmetic Product Notification Portal (CPNP) before being placed on the market. Before any cosmetic product is sold in the EU, the Responsible Person must notify the European Commission through the CPNP.
Understanding the 1223/2009 EC Cosmetic Regulation is essential for anyone involved in the cosmetics industry from manufacturers, distributors to consumers. By ensuring the safety and efficacy of cosmetic products, the regulation not only protects public health but also supports fair competition in the market.
