ECARF Label Criteria

This defines reasonable criteria for the so called ECARF label, as guidance for consumer to cosmetic products which underwent state-of-the art safety assessments and which shall be suitable for consumers which claim to have "sensitive skin".

a) Quantitative Risk Assessment
(QRA, also called Exposure Based Risk Assessment) to be shared and reviewed by experienced toxicologist(s) to be assigned by the ECARF label owner. Ideally, the IFRA (International Fragrance Association) guidance shall be applied.

QRA shall encompass following parts:

1. Definition of NESILs (No Expected Sensitization Levels, formerly called NOEL) of all potential skin sensitizers in the product or formulation. The NESILs must base on reliable and reproducible animal or human test data (e.g. Local Lymph Node Assay or Human Repeat Insult Patch Test) giving a dose per unit area (µg/cm²) which is judged to not induce a skin sensitization.
2. Definition of Sensitization Assessment Factors (SAF) for the respective product application. This shall address:
   - Inter-individual variability (usually factor 10x as default)
   - Formulation effects
   - Skin site/application effects
3. Definition of the Acceptable Exposure Level (AEL) by dividing NESIL by the overall SAF
4. Accurate definition and calculation of Consumer Exposure Level (CEL, ie. exposure of the skin sensitizer(s) on skin resulting from product use). The CEL must be either based on commonly agreed and accessible default numbers (like IFRA standards) or needs to be verified via appropriate data to be disclosed to the ECARF label owner.
5. Verification of AEL ≥ CEL.

b) Human skin patch test and Product In Use Test

Success criteria: No or low number of incompatibilities, in line with product which has proven to be well-tolerated in market

• e.g. 21 Day Cumulative Irritation Patch Test with 30 patients

          Or:

• Human Repeat Insult Patch Test (HRIPT) with at least 100 persons among them 50% self-perceived sensitive skin.
  (Atopics can be included in both)
• Product in use test with 20 patients with atopic dermatitis

 

c) Good health related consumer complaint follow-up system in place.

This shall enclose:

• Easy to identify contact details of manufacturer (e.g. phone number or email-access printed on pack).
• Personal follow-up of health related consumer by trained/experienced personnel directly with concerned consumer. 
• Efficient system of recording health related consumer complaints.
• Efficient system to support of dermatologists with patch test solutions to identify allergens.