Cosmetic Regulation & Compliance


Cosmetic products placed in the European Union have requirements established by Regulation (EC) No. 1223/2009. According to the definiton of the European Union Regulation, cosmetics are substances or products that are intended to be applied on external parts of the body, that inlcudes skin, nail, lips, teeth and oral cavity, and has the purpose of cleaning or changing form or appearance in order to beautify or maintain good conditions of these parts.

Regulation (EC) No. 1223/2009 draws specific guidelines for the manufacturing process, content and labelling requirements, as well as registration and traceability in order to ensure safety and quality of cosmetic products.

According to Regulation (EC) No. 1223/2009 of the European Parliament on cosmetic products, for every cosmetic product on the market a Product Information File must be drafted and held available for the competent authorities, when asked for, at the premises of the responsible person, as well as Registration on the Cosmetic Product Notification Portal.

The information held in these files is confidential, and is available only to Competent Authorities  of Romania. The product information file includes all information imposed by Regulation (EC) No. 1223/2009, a description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product and the cosmetic product safety report  referred to in Article 10(1) of Regulation (EC) No. 1223/2009. These files and data are updated as necessary.

The product information file contains the following information:

  • 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 referred to in Article 10(1) of Regulation EC 1223/2009
  • The intended use of the cosmetic product ant the anticipated systemic exposure to individual ingredients in a final formulation;
  • The cosmetic product safety report, that is kept up to date in view of additional information generated, subsequent to placing the product on the market
  • A description of the method of manufacturing and a statement on compliance with good manufacturing practice referred to in Article 8.

We Lila Rossa certify that our products are in compliance with Regulation EC No. 1223/2009, and the complete information concerning all the product we deliver is up to date and. Our work is defined by Good Manufacturing Practice, and we comply with the standards imposed by ISO 22176, thus creating an advantage and promoting safe personal care products.