Cosmetics Toxicology Regulations

A Cosmetic Product Safety Report ("CPSR") is a document that provides information on the safety of a cosmetic product.

In the European Union ("EU"), cosmetics must be safe for human health when used under normal or reasonably foreseeable conditions of use.

As such, all cosmetic products sold in the EU must have a CPSR.


In order to sell a cosmetic product in the EU, you must have a CPSR for the product and provide it to the relevant national regulatory authority upon request. 

It is important to work with a qualified safety assessor to ensure that your CPSR is thorough and meets all regulatory requirements.


Cosmetics Regulations

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 governs the manufacture of cosmetic products in the European Union (EU).

It is applicable to all 27 EU countries.

This Regulation comprehensively harmonises the rules in the Community in order to achieve an internal market for cosmetic products while ensuring a high level of protection of human health.

It is subject to amendments and the current effective amendment is Regulation (EU) 2022/1531 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetic products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction and correcting that Regulation.


A Consolidated text was published on 17.12.2022: Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (Text with EEA relevance)

  • Strengthened safety requirements for cosmetic products
  • Specific requirements for manufacturers in the preparation of a Product Safety Report prior to placing a product on the market


SCCS (Scientific Committee on Consumer Safety) Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation - 12th revision published on May 16th 2023.

The document contains relevant information on the different aspects of testing and safety evaluation of cosmetic substances in Europe. 

It is designed to provide guidance to public authorities and to the cosmetic industry in order to improve harmonised compliance with the current cosmetic EU legislation. 



For Cosmetics PDEs, we develop our toxicological risk assessments while taking into consideration Annexes V and VI


Last updated on January 10th, 2023.

In general, the substances are of chemical nature, except several APIs such as Salicylic acid and its salts, Benzoic acid and its salts, Chlorobutanol…

It contains the maximum concentration limits as well as other restrictions concerning the 174 substances included. 


All of them are chemical substances

It contains the concentration limits as well as other restrictions concerning the 47 substances included.

Last updated on January 6th, 2023. 


Next Generation Risk Assessment (NGRA) for Cosmetic Safety Assessment

Under the guidance of the International Cooperation on Cosmetics Regulation ("ICCR"), integrated strategies for risk assessment of cosmetics ingredients (or ‘Next Generation Risk Assessment’) were put into place in order to conduct safety assessment without the use of animal data.

As animal testing for cosmetics is banned in

  • Europe (complete implementation of the EU animal testing ban for cosmetics since 11 March 2013: marketing ban) and
  • Norway, Iceland, Switzerland, India, Israel Australia, Colombia, Ecuador, Guatemala, New Zealand, South Korea, Taiwan, Turkey, Mexico and several states in Brazil
  • 10 states in the United States of American as of December 2022

 we use a new approach to consumer safety. 


Next Generation Risk Assessment’ ("NGRA"), defined as an

exposure-led, hypothesis driven risk assessment approach

that integrates in silico, in chemico and in vitro approaches.


You can check Tox by Design methodology for Cosmetics Risk Assessments, signed by an European Registered Toxicologist expert here.

In the event you are performing this exercise for innovative compounds GMP scale up manufacturing, please be noted Tox by Design is duly accredited for the French Research Tax Credit CIR.

Feel free to contact us using this email link to receive a quotation for Tox Cosmetics Risk Assessment procedure used on your manufacturing line.