Cosmetics Regulation 1223/2009/EC

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Cosmetics Regulation 1223/2009/EC

Cosmetics on the European market are regulated by the Cosmetics Regulation 1223/2009/EC. This regulation took effect in July 2013 and replaced the old Cosmetics Directive (76/768/EC). The core of the Cosmetics Regulation is that cosmetics have to be safe. The use of cosmetic products may not harm the health of human beings. Stringent requirements regarding the safety and documentation of a cosmetic product are stipulated in the Cosmetics Regulation. Each product on the European Market has to comply with these requirements. As the manufacturer, you bear the responsibility for ensuring that your products comply with the legislation.

A brief explanation of the most important components of the Cosmetics Regulation 1223/2009/EC is provided below.

Safety Assessment

An important requirement of the Cosmetics Regulation is conducting a safety assessment. This has to be done for every cosmetic product before it is brought onto the market. Products that were already on the market prior to the new Cosmetics Regulation taking effect in July 2013 should be tested again in accordance with the new directives.

A qualified safety assessor should conduct the safety assessment. This is someone with training or demonstrable experience in pharmacology, toxicology, medicine or a comparable discipline.

Product Information File

An important requirement of the Cosmetics Regulation is conducting a safety assessment. This has to be done for every cosmetic product before it is brought onto the market. Products that were already on the market prior to the new Cosmetics Regulation taking effect in July 2013 should be tested again in accordance with the new directives.

Notification of the product

One of the requirements of the Cosmetics regulation is the notification of cosmetic products to the Cosmetic Product Notification Portal. This is an online portal of the European Commission. Every cosmetic product on the European market has to be registered with the CPNP.

The notification should contain specific data on the product, the person responsible for the product and information about the composition. The European Commission communicates this information to the competent authorities of all Member States. The Member States use the information to control their own markets. Toxicology Centers and hospitals also have insight into the information in cases where a hazardous situation occurs with a product.

Reporting nanomaterials

Cosmetic products that contain new nanomaterials have to be specially notified. A nanomaterial is new if it has never been used previously in a cosmetic product. Various nanomaterials have already been assessed by the European Commission and are described in the appendices to the Cosmetics Regulation.
When giving notification of cosmetic products with new nanomaterials, information about the safety of this nanomaterial should be provided. The European Commission may request that this information be subjected to scientific assessment.

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