Safety of cosmetic products available in the market has been the primary focus of the cosmetic regulation. In accordance with the same, the European Union (EU) regulation EC1223/2009 has been in place to govern manufacture, labeling, and supply of personal care products and cosmetics in the European Economic Area (EEA).

However, this regulation was replaced with EU Cosmetics Directive 76/768/EEC on 11th July, 2013 which further simplifies the process consistently across the EU. The purpose of the protection has been further accentuated with the applicability of new regulation, under which a PIF (Product Information File) needs to be maintained for the product intended to be marketed in the EEA.

The respective health authority should be notified and the information pertaining to the safety, manufacturing, labeling and other supporting information must be documented. Subsequently, the cosmetic products have to undergo Safety assessment, resulting in the preparation of a Cosmetic Product Safety Report (CPSR), with specifically defined scenarios for Infants up to 3 years of age, and other special scenarios as required.

It also emphasizes label and package information, including the INCIs and warnings. The claims and the supporting documentation also form a part of the assessment. CPSR can broadly be segregated under Part A (cosmetic product safety information) and Part B (Full Safety Assessment). The term CPSR, is a relatively new term used in EC1223/2009.

Freyr Value Add

  • With a fine understanding of the increased importance of the new regulation, Freyr has successfully enabled major cosmetic players to meet the deadline for the regulation.
  • The assessments provided by Freyr’s duly qualified professionals include several hundreds of products, ranging from simple formulations to complex aerosols and moisturizers, and are in themselves a certification of the safety of the products, within the intended application and its compliance to the various annexes of the cosmetics regulation.
  • After completing the highly complicated retrospective assessments for the existing products, Freyr’s experts provide cosmetics companies with end-to-end scientific and regulatory support to ensure compliance with the with Regulation (EC) no. 1223/2009.

Freyr Expertise

Freyr’s end-to-end Cosmetic Regulation Compliance Services encompass the following:

Cosmetic Safety Assessments

  • Cosmetics Ingredient Profiles
  • Product Information Files (PIFs)
  • Cosmetic Product Safety Reports (CPSR)
  • Part A Cosmetic Product Safety Information
  • Part B Full Safety Assessment
  • General Toxicological reports for ingredients