Compliance with Cosmetic Product Regulation 

As of July 11, 2013, the new European Regulation 1223/2009/EC for Cosmetic Products came into full effect. This Regulation establishes rules to be complied with by any cosmetic product made available on the market, in order to ensure the functioning of the internal market and a high level of protection of human health.

According to article 8 of European Regulation 1223/2009, the manufacture of cosmetic products must comply with Good Manufacturing Practice (GMP), as determined by the relevant harmonized international standard EN ISO 22716:2007. Compliance with GMP must be declared and described in the Product Information File (PIF).

When a cosmetic product is placed on the market, the responsible person shall keep a product information file (PIF) for it as required by article 11 of the European regulation. The Product Information file includes a description of the cosmetic product, a cosmetic product safety report (CPSR), a manufacturing method description and declaration of compliance with the Good Manufacturing Practices (GMP), proof of the product’s claimed effect(s) and Information on any animal testing done in connection to the development or safety assessment of the product or its ingredients.

Regulation 1223/2009 also requires that the responsible persons and, under certain circumstances, the distributors of cosmetic products to submit some information about the products they place or make available on the European market through the so-called Cosmetic Product Notification Portal (CPNP). When a product has been notified in the CPNP, there is no need for any further notification at national level within the EU.

As per article 19 of the European cosmetics regulation, cosmetic products must include information explaining to the consumer what they are used for, how to use them safely and how to get the best result. The information is usually marked on the packaging labels of the products.

Support Services

YNB provides support services to companies that want to place their cosmetic product in the EU market, always in compliance with the European cosmetics regulation.

  • Design and implementation of GMPs in accordance with the widely used international standard, ISO 22716:2007.
  • We assist companies to obtain a Cosmetic Product Manufacturing License.
  • Preparation and review of Product Information Files for cosmetic products in accordance with the requirements of the European Regulation 1223/2009.
  • Notification of cosmetic products and their ingredients in the CPNP (Cosmetic Product Notification Portal).
  • We review cosmetic product claims to avoid false and misleading information that may lead to disciplinary action from the Regulatory Authorities.
  • Preparation of packaging labels for cosmetic products in accordance with the requirements of European regulation 1223/2009.