The EEC Directive 93/35 establish three main requirements for cosmetics:
- no ingredients or combination of ingredients which have been tested
on animals shall be used in cosmetics (effective from June 30th, 2002); -
an assessment of the safety must be included in the cosmetic dossier; -
proof of the ascribed cosmetic effects shall complete the dossier.
Innocuity test on the finished product may be needed in order to perform
the safety assessment, beside the general toxicological profile of
ingredients, their chemical structure and the exposure level. As animal
tests are being banned, the remaining possibilities are in-vitro and/or
in-vivo test, such as the HET-CAM method and patch-test on volunteers.
Efficacy evaluations, are considered necessary when not clearly or
logically understandable from the formulation and in particular when
scientific literature is not supporting significantly the label claim.
Various instrumental techniques can be applied: pHmetry, sebometry,
corneometry, elasticity, skin barrier (TEWL), etc. Moreover, sensory
analysis may be necessary, as it is the only method to measure how a
product is perceived by the consumers.