SkinEthic Labotories

Regulatory context


A sustainable development of in vitro alternative methods within an ethical and regulatory framework

I. The 3R


SkinEthic Laboratories answer 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, this implies the notion of end-points)

  Replace the animal models

(for more information about the 3R please read the FAQ section)


II. REACh



Registration Evaluation & Authorization of Chemicals
(REACh – June 2007)

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


Existing substances (about 30,000) have to be registered within the first 11 years, the so-called phase-in period. The Commission's proposal basically prioritises these substances based on produced or imported annual volume.
(for more information about REACh please read the FAQ section)



III. The 7th amendment of cosmetic european directive



7th Amendment of cosmetic european directive applicable for all ingredients and finished products for safety assessment: a complete ban of animal use (March 2009).

The Directive provides for a ban on animal testing of finished products (applicable from 11 September 2004), and a complete ban on animal testing of cosmetic ingredients as soon as alternative methods are validated and adopted by EU legislation. The final deadline of 11 March 2009 applies even if alternative tests are not available then.
A marketing ban on animal-tested products also applies, from 11 September 2004 or as soon as alternative methods are validated and adopted and again by 11 March 2009 at the latest, with the exception of three study areas where development of alternatives will unavoidably take longer – alternative tests for repeated dose toxicity, reproductive toxicity and toxicokinetics need not be introduced until 11 March 2013 (and perhaps later if technical problems arise).


(for more information about the 7th Amendment please read the FAQ section)




IV. Validations


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 resultwhatever the place and the user

Not linked only to alternatives: 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)
     - coordination of alternatives methods in Europe
     - EU joint research center 1992
  • ESAC (Ecvam Scientific Advisory Committee)
     - Scientific peer review and approval