Regulatory context

A sustainable development of in vitro alternative methods has been done within an ethical and regulatory framework which comprises the following topics:


Process aimed to confirm that procedures employed for a specific test are suitable for its intended use. It Guaranties that a method developed for a specific purpose will gave the same result whatever the place and the user. It is not only linked to alternatives, but concerns all domains.


The frame

Alternative methods should provide the same (or higher) level of information than animals” (European commission).


The decision-makers

  • ECVAM (European Centre for the Validation of Alternative Methods) coordinates alternatives methods in Europe
  • ESAC (Ecvam Scientific Advisory Committee) delivers Scientific peer review and approval


REACh is the acronym for Registration, Evaluation and Authorisation of CHemicals (June 2007). The REACh proposal requires industry to register all existing and future new substances with a new European Chemicals Agency. 

 The three main goals are:

  • to protect human health and environment  
  • to provide detailed information about chemicals and to secure their handling  
  • to improve business competitiveness

Around 30,000 substances have to be registered by 2018. The Commission prioritizes the registration of these substances depending on their produced or imported annual volume. 

(for more information please go visit



EPISKIN answers consumer’s demand for ethical testing and development of alternative methods to follow the 3R policy of animal use (Replace, Reduce, Refine).

After graduating the suffering of animals used in experiments in English laboratories, W.M.S. Russell and R.L. Burch developed a program for setting up and developing "humane" guidelines, called the "3 R's rule" including the following points: 

  • Reduce the number of animals being tested
  • Refine the methodology used, 
  • Replace the animal models

It is now part of several official documents.

(for more information about the 3R please visit



This directive/regulation is applicable in Europe for all ingredients and finished products for safety assessment.

This amendment, among other provisions, forbids animal testings on:

  • finished products as well as the sales of finished products tested on animals (applicable from 11 September 2004)
  • cosmetic ingredients as well as the sales of cosmetic ingredients tested on animals (applicable from 11 March 2009)

The marketing ban applies since 11 March 2009 for all human health effects with the exception of repeated-dose toxicity, reproductive toxicity, and toxicokinetics. For these specific health effects, the marketing ban applies since 11 March 2013, irrespective of the availability of alternative non-animal tests.

(For more information please visit