Safety & Efficacy

of Cosmetics
New rules of the
European Commission
Nicola Lionetti
ISPE srl L. Rigano Industrial Consulting & Research
ISPE – Institute of Skin Product Evaluation
 Regulation (EC) 1223/2009 of the 
European Parliament
and of the Council
of the 30 November 2009
on cosmetic products
(recast)

http://eur‐lex.europa.eu/LexUriServ/LexUriServ.do?
uri=OJ:L:2009:342:0059:0209:en:PDF
Entry into force & date of application
11 January 2010 (20 d publication Official  
Journal)

Only for CMR ⇒ 1 December 2010

New Notification  ⇒ 11 January 2012

Nanomaterial ⇒ 11 January 2012

11 July 2013
 Regulation 1223/2009
Mainly a RECAST
Clarification/Explication on:
Responsible Person (RP)
Good Manufacturing Practice (GMP)
Supply Chain & Market Surveillance
Safety of the Cosmetics
Proof of the effect claimed
 Regulation 1223/2009
New rules on:
Cosmetic Notification (CPNP)
Nanomaterials (def. & Notification)
CMR
Label Indications

Underline the Titanium Dioxide (nano)
PIF address
 Regulation 1223/2009
Improves

FREE CIRCULATION
SAFETY
CLAIM

of COSMETICS
Safety Assessment
Little Digression
 Clarification/Explication ?
Safety of the Cosmetics
Article 7a, paragraph d (Directive 76/768)
Assessment of the safety for human health of the finished product. To that 
end the manufacturer shall take into consideration the general toxicological 
profile of the ingredients, their chemical structure and their level of exposure. 
It shall take particular account of the specific exposure characteristics of the 
areas on which the product will be applied or of the population for which it is 
intended. There shall be inter alia a specific assessment for cosmetic products 
intended for use on children under the age of three and for cosmetic products 
intended exclusively for use in external intimate hygiene

SCCNFP/0690/03, Final : Notes of Guidance for the testing of cosmetic 
ingredients and their safety evaluation, 5th revision, adopted by the SCCNFP 
during the 25th plenary meeting of 20 October 2003
 Safety Report
Art. 11 – Product Information File shall contain:
‐ ……..
‐ cosmetic product safety report (CSR)

Art. 10 – CSR:
‐ guaranteed by RP
‐ kept up to date
‐ carried out by qualified person
(pharmacy, toxicology, medicine or a similar discipline, or a 
course recognised as equivalent by Member State)
 Safety Report
Art. 10 – CSR:

‐ The Commission, in close cooperation with all 
stakeholders, shall adopt appropriate 
guidelines to enable undertakings, in 
particular small and medium‐sized enterprises, 
to comply with the requirements laid down in 
Annex I.
 Annex I
COSMETIC PRODUCT SAFETY REPORT
The cosmetic product safety report shall, as a 
minimum, contain the following

PART A – Cosmetic product safety information

PART B – Cosmetic product safety assessment

RISK ASSESSMENT
 Annex I
PART A – Cosmetic product safety information

1. Quantitative & qualitative composition cosmetic 
product
2. Physical/chemical characteristics & stability
3. Microbiological quality
4. Impurities, traces, information on packaging 
material
5. Normal & reasonably foreseeable use
 Annex I
PART A – Cosmetic product safety information

6. Exposure to the cosmetic product
7. Exposure to the substances
8. Toxicological profile of the substances
9. Undesirable effects & serious undesirable effects
10. Information on the cosmetic product
 Annex I
PART B – Cosmetic product safety assessment

1. Assessment conclusion
2. Labelled warnings and instructions of use
3. Reasoning
4. Assessor’s credentials and approval of part B
 Annex I
PART A – Cosmetic product safety information

1. Quantitative & qualitative composition cosmetic 
product
2. Physical/chemical characteristics & stability
3. Microbiological quality
4. Impurities, traces, information on packaging 
material
5. Normal & reasonably foreseeable use
 Annex I
4. Impurities, traces, information about the 
packaging material

4.1 The purity of the substances and mixtures

4.2 In the case of traces of prohibited substances, 
evidence for their technical unavoidability

4.3 The relevant characteristics of packaging 
material, in particular purity and stability
 Guidelines on Annex I

COMMISSION IMPLEMENTING DECISION 
of XXX 
on Guidelines on Annex I to Regulation (EC) No 
1223/2009 on cosmetic products

http://ec.europa.eu/enterprise/tbt/tbt_reposito
ry/EEC186_EN_2_1.pdf
 Guidelines on Annex I
4.3 The relevant characteristics of packaging 
material, in particular purity and stability

• Direct contact with the formulation
• Reference to Regulation on Food Contact Materials 
(migration)
• Experience with similar formulation/packaging
• Interaction between product and packaging material
• Barrier properties of packaging material
• Composition of the packaging material (+ additives)
• Technically unavoidable impurities
 Example
Eyeshadow powder pressed in pan tin plate 
containing in plastic container

Safety/Technical Sheets Plastic container:
Acrylonitrile Butadiene Styrene (ABS) polymers > 98%
Styrene < 0,1% (Flam. Liq. 3, Acute Tox. 4, Eye Irrit. 2, Skin Irrit. 2)
NOT RELEVANT
Safety/Technical Sheets Tin Plate:
Nichel = 800 ppm
Arsenic = 200 ppm
RELEVANT
 Annex I
PART A – Cosmetic product safety information

6. Exposure to the cosmetic product
7. Exposure to the substances
8. Toxicological profile of the substances
9. Undesirable effects & serious undesirable effects
10. Information on the cosmetic product
RISK ASSESSMENT
INGREDIENTS
RISK ASSESSMENT PROCESS
 RISK ASSESSMENT PROCESS

1) HAZARD 2) DOSE- RESPONSE 3) EXPOSURE

IDENTIFICATION ASSESSMENT

RISK
CARACTERISATION

RISK
MANAGEMENT

RISK COMMUNICATION
Little Digression
 HAZARD ≠ RISK
HAZARD: - POTENTIAL TO CAUSE INJURY
- INTRINSIC PROPERTIES
- NO RELATION WITH DOSE OR
EXPOSURE

RISK: - PROBABILITY OF HARM

- RELATION WITH EXPOSURE
- EXTENSION TOWARDS SEVERITY
AND NATURE OF HARM
POTENTIAL RISK OF A HAZARDOUS SUBSTANCE
(CYANIDE)
Hazard
Risk

Cyanide Cyanide Cyanide in Cyanide

Locked away Accessible kitchen cupboard In your tea
Labelled Labelled unlabelled
POTENTIAL RISK OF A NON-HAZARDOUS SUBSTANCE
(WATER)
Hazard
Risk

0L 1L 3L 12 L
Water/day Water/day Water/day Water/day
 RISK ASSESSMENT PROCESS
2) DOSE‐ RESPONSE
1) HAZARD        3) EXPOSURE 
IDENTIFICATION  ASSESSMENT

RISK CARACTERISATION

RISK MANAGEMENT

RISK COMMUNICATION
 RISK ASSESSMENT PROCESS
1) HAZARD       
IDENTIFICATION 

• CAN X CAUSE ADVERSE HEALTH EFFECT?
• BASED ON
‐ EPIDERMIOLOGICAL STUDIES
‐ CLINICAL STUDIES INTRINSIC
‐ IN VIVO STUDIES
‐ IN VITRO STUDIES PROPERTIES
‐ QSAR
 RISK ASSESSMENT PROCESS
2) DOSE‐ RESPONSE

• WHAT IS RELATIONSHIP BETWEEN DOSE &  
INCIDENCE/SEVERITY of ADVERSE HEALTH EFFECT?
• WHAT IS DOSE NECESSARY to CAUSE HARM?

• NOAEL (No Observed
NOAEL ( Adverse Effect Level)
 RISK ASSESSMENT PROCESS
NOAEL (No Observed Adverse Effect Level)
NOAEL (
The  highest  administered  dose  of  a  substance  for 
which  no  visible  change  in  the  morphology, 
functional capacity, growth of the organism

• The outcome of long term toxicity (28 – 90 days)

The NOAEL should be expressed as mg/kg bw/day 
 RISK ASSESSMENT PROCESS

3) EXPOSURE 
ASSESSMENT

WHAT IS AMOUNT & TIME of EXPOSURE
Dose exposure
Skin exposure
Percutaneous absorption

SED
Systemic Exposure Dosage of a cosmetic ingredient
 CALCULATION OF EXPOSURE DOSE
Amount applied on skin or mucous membrane, expressed:
‐ weight
‐ weight per body weight (ex: mg/kg bw)
‐ weight per unit of surface (ex: mg/cm2 of skin)

a case by case approach considering:

™ Class of cosmetic product
™ Method of application
™ Frequency of application
™ Consumer target group
™ Site of contact
™ Duration of contact
™ Concentration of ingredients in the product
™ Forseeable misuse
Estimation of consumers’ exposure to the 
finished product

™ Data provided by Cosmetics Europe (ex Colipa)

™ 4 main types:

¾ Oral hygene and care products

¾ Eye products
¾ Leave on products
¾ Rinse off products
Partition coefficient:
takes into account rinsing off and
diluition of finished products by
application on wet skin
Ex: Toothpaste

Retention coefficient:
takes into account the residual part of
finished products in direct contact with
skin
Ex: Shampoo
 ORAL HYGENE PRODUCTS

Product Total  Frequency of  Partition Exposure

type amount per  application (%) per day
application per day  (g)
(g)
Toothpaste 1.40 2 17 0.48

Mouthwash 10.00 3 10 3.00

Lipstick 0.01 4 100 0.04

Total 3.52
 EYE PRODUCTS
Product type Total amount Frequency of  Partition Exposure
per application application (%) per day
(g) per day  (g)
Eye make‐up 0.010 2 100 0.020
Mascara 0.025 1 100 0.025
Liner 0.005 1 100 0.005
Total 0.050
 LEAVE ON PRODUCTS
Product type Total amount Frequency of  Partition Exposure
per application application (%) per day
(g) per day  (g)
Face cream 0.8 2 100 1.60
General cream 1.2 2 100 2.40
Body lotion 8.0 1 100 8.00
Deodorant 0.5 1 100 0.50
(roll on)
Hair styling 5 2 10 1
Total 13.50
 RINSE OFF PRODUCTS
Product type Total amount Frequency of  Partition Exposure
per application application (%) per day
(g) per day  (g)
Make up  0.010 2 100 0.020
remover
Shower gel 0.025 1 100 0.025
Shampoo 8.0 1 1 0.08
Hair conditioner 14.0 0.28 1 0.04
Total 0.72
 Maximalized global daily exposure

™Total oral hygene products 3.52 g

™Total eye products 0.05 g
™Total leave on products 13.50 g
™Total rinse off products 0.72 g
Maximum Daily Exposure 17.79 g
 CALCULATION DAILY EXPOSURE DOSE OF 
SUBSTANCE APPLIED TO THE SKIN (I)

I (mg/day) =
= A (g/application) x 103 (mg/g) x C (%) x 10-2 x F (day-1)

Where:
A (g) = Amount of finished product applied/application

C (%) = Concentration of ingredient

F (day-1) = Frequency of application of the substance

 SKIN ABSORPTION
Skin exposure:  amount of  substance in  contact 
with an unit area of  skin for a  defined period of 
time

Percutaneous absorption:  passage of 

substance across the  skin without indication of  its
fate
™Penetration
™Permeation
™Resorption
 PERCUTANEOUS ABSORPTION

™Reported ad absolute amount of 

substance penetrating the skin after a 
certain period (μg/cm2)

™Reported as a percentage of subtance

penetrating the skin
 SED
Amount expected to enter the blood stream

SED = mg/kg bw/day

Mean body weight = 60 kg (commonly accepted)

 CALCULATION (SED)

SED = I (mg/day) x DAp(%) x 10‐2
(mg/kg bw/day) 60 kg bw

Where I (µg/ day)  = Daily exposure to the substance

DAp (%) = Dermal absorbtion of substance in percentage
 CALCULATION (SED)

DAa (µg/ cm2) x 10‐3 (mg/ µg) x SSA (cm‐2) x F (day‐1)
SED =
(mg/kg bw/day) 60 kg bw

DAa (µg/ cm2) = Dermal absorption of substance as amount (µg/ cm2)

SSA (cm2) = Surface skin area expected to be in contact with cosmetic

product

60 kg bw = Default human body weight

F (day‐1) = Frequency of application of the substance

 RISK ASSESSMENT PROCESS
2) DOSE‐ RESPONSE
1) HAZARD        3) EXPOSURE 
IDENTIFICATION  ASSESSMENT

RISK CARACTERISATION

RISK MANAGEMENT

RISK COMMUNICATION
 RISK ASSESSMENT PROCESS
RISK CHARACTERISATION

• Data on INGREDIENT
Irritation Sensibilization, etc

MoS calculation
• WHAT IS THE NATURE OF IT?
• IMPORTANCE OF VARIABILITY, UNCERTAINITY
 CALCULATION OF THE MARGIN OF SAFETY 
(MoS)

NOAEL (mg/ Kg bw/ day)
Margin of safety =
SED (mg/ kg bw/ day)

MoS never below 100

Risk characterisation usually involves an expert …….  followed by
calculation of  an uncertainty factor or  ‘margin of  safety’ (MoS).  This
calculation depends on the systemic exposure to the substance and its
toxicological parameters.
The omission of these steps must be duly justified.
4.0 2.5 3.2 3.2
 RISK ASSESSMENT PROCESS
2) DOSE‐ RESPONSE
1) HAZARD        3) EXPOSURE 
IDENTIFICATION  ASSESSMENT

RISK CARACTERISATION

RISK MANAGEMENT

RISK COMMUNICATION
 RISK ASSESSMENT PROCESS
RISK MANAGEMENT
• Restriction:
concentration of one ingredient
Frequency or applied amount

• Full authorisation without limits and restrictions

• Not to go/Withdrawal from the market
 RISK ASSESSMENT PROCESS
2) DOSE‐ RESPONSE
1) HAZARD        3) EXPOSURE 
IDENTIFICATION  ASSESSMENT

RISK CARACTERISATION

RISK MANAGEMENT

RISK COMMUNICATION
 RISK ASSESSMENT PROCESS
RISK COMMUNICATION

• Warning on the label
‐ avoid eye contact
‐ do not apply on irritated skin
‐ etc
 COSMETIC SAFETY REPORT
Include
- Hazard data/information related to ingredients,
manufacture process, packgaging, chemical &
microbiological contaminations….
- Quantify SED for product & ingredients
- Quantify & evaluate RISK related to use

Combination of all these parametrs

 SAFETY TESTS
9 Stability (accelerated, centrifuge, etc)
9 Microbiological (Count, Challenge)
9 Tollerability
* Patch-test, HRIPT
* Repeated Arm-Wash Test
* Het-cam Tests
* In-use test
ISPE srl
UVA & SPF ???
 PATCH‐TEST
ISPE srl Irritation potential
9 Open, Occlusive
9 Single/Multi-application (24/48 h, 4 d, 21 d)
9 Product diluted or not
9 Normal / Sensitive skin ⇒ Baby

Clinical Evaluation/Parameters
Erythema, Edema, Desquamation, Burning
Sensation, Itchimg
 HUMAN REPEATED INSULT 
ISPE srl PATCH‐TEST
Sensitization Potential
9 Occlusive
9 Multi-application
Induction phase (48/72 h, 2 weeks)
Challenge phase (after 2 wks, 72 h)
9 25 volunteers
9 Maximization Grading (n° positive)
9 UV-exposure ⇒ photo-sensitization
 REPEATED ARM‐WASH TEST
Cleansing product

9 4-5 wash/day
9 Product vs SLES vs Tape water
9 pH, TEWL, Skin colour;
9 Influenced by Temp. & Hardness water

ISPE srl
 HET‐CAM TEST
ISPE srl
Eye‐Mucous Product

9 chorioallantoic membrane of
fertilised chicken eggs

9 Control solution (SLES, Sodium Laureth 8-Sulfate, Magnesium

Laureth Sulfate, Magnesium Laureth 8-Sulfate, Sodium Oleth Sulfate, Magnesium
Oleth Sulfate at 5% active substance)

9 Q-value (irritation time for adverse reaction)

 UVA ‐ SPF

SAFETY
or
EFFICACY / CLAIM
 EFFICACY
&
CLAIM SUBSTANTIATION
 CLAIM = SAFETY

9 UVA & SPF

9 SENSITIVE SKIN
9 Baby product
 CLAIM
Article 20
Product claims
1. In the labelling, making available on the market 
and advertising of cosmetic products, text, names, 
trade marks, pictures and figurative or other signs 
shall  not  be  used  to  imply  that  these  products 
have characteristics or functions which they do not 
have.
Little Digression
 Clarification/Explication ?
Article 7a, paragraph g (Directive 76/768)
proof of the effect claimed for the cosmetic product, 
where  justified  by  the  nature  of  the  effect  or 
product;

Directive 87/357/EEC on the  approximation of the 

laws of  the  Member States concerning products
which,  appearing to be other than they are, 
endanger the health or safety of consumers
NOT ONLY COSMETICS
 Clarification/Explication ?
Directive 2005/29/EC concerning unfair business‐
to‐consumer commercial practices
NOT ONLY COSMETICS

Directive 2006/114/EC concerning misleading and 
comparative advertising
NOT ONLY COSMETICS

Manual on the scope of application of the Directive 
76/768/EEC ‐ VERSION 8.0 (JUNE 2011)
 Example
Manual for application 76/768/EEC
Question: Are products that plump up the lips cosmetic 
products?

Answer: … make  lips  more  voluminous  may  … fulfill  the 

definition of cosmetic products  … placed in contact with the 
lips  “with  a  view  to  exclusively  or  mainly  changing  their 
appearance”

However,  … may  also  meet  the  definition  of  medicinal 

products  “by virtue of function”,  … to  “restoring, correcting 
or  modifying  physiological  functions  by  exerting  a 
pharmacological,  immunological  or  metabolic  action,  or  to 
making a medical diagnosis”
 Example
Manual for application 76/768/EEC

… if  these  products  act  through  inflammation

and/or  irritation (e.g.  products  containing 
capsaicin),  the  deliberate  induction  of  a  swelling 
effect  could  be  perceived  as  a  significant 
modification  of  one  or  more  physiological 
functions  in  the  lips,  thus  bringing  the  products 
under the definition of medicinal products.
 Clarification/Explication ?
EU Recommendation 22 September 2006 on the 
efficacy of sunscreen product and their labelling

EU Recommendation 7 June 2006 ⇒ claim on 

animal testing

…… manufacturer and his suppliers have not carried out or 
commissioned any animal tests on the finished product, or its 
prototype or any of the ingredients contained in it, or used any
ingredients that have been tested on animals by others for the 
purpose of developing new cosmetic products.
Criteria & Guidelines
 EU Commission Timing
Adoption of the guidelines for criteria ⇒ 2012

Market surveillance/monitoring ⇒ 2012‐2015

Report to EU Parliament ⇒ 2016
 Regulation for claims
COMMISSION REGULATION (EU) No 655/2013
of 10 July 2013
laying down common criteria for the justification of 
claims used in relation to cosmetic products

+
Guidelines to Commission Regulation (EU) No 655/2013

Annex I Annex II
Further description of criteria Best Practice
 Criteria
1. Legal compliance
2. Truthfulness
3. Evidential support
4. Honesty
5. Fairness
6. Informed decision‐making
 1. Legal Compliance
Regulation:
(1)  Claims  that  indicate  that  the  product  has  been 
authorised or  approved  by  a  competent  authority 
within the Union shall not be allowed

Guidelines – Annex I:
… since  a  cosmetic  product  is  allowed  on  the  Union 
market  without  any  governmental  approval.  Equally,  a 
CE‐mark  shall  not  be  applied  on  cosmetic  products  as 
this  would  make  the  consumer  think  that  they  are 
under a regulatory  regime  different from  the  Cosmetic 
Product Regulation
 Annex II
Best practice for claim substantiation evidence
9 Best practices applying to experimental studies (in 
silico, in vitro, ex‐vivo, etc)
⇒ Similar to “Colipa guidelines ‐ Efficacy Evaluation 
of Cosmetic Products”

9 Best practice applying to consumer perception 
tests
9 Best practice applying to the use of published 
information
 EXAMPLE
9 DOES NOT CONTAIN…
9 FREE- OF…
A) ‘contrary to product X, this product does not contain 
ingredient Y which is known to be irritating’
B) ‘Well tolerated as it does not contain mineral oils’
C) ‘Low in allergens because without preservatives’

Lacking of FAIRNESS
SILICON FREE ? PROPYLEN GLYCOL FREE ?

PARABEN FREE ?
ETHOXYLATED FREE ?
EFFICACY TESTS

ISPE srl
 OUR CRITERIA
9 Certified ISO 9001:2008
9 Member of Order of  Research Laboratories of the 
Ministry of University & Scientific Research
9 IN‐VIVO, IN‐VITRO, SENSORIAL TESTS
9 ETHICAL REQUIREMENTS
9 Inclusion Criteria: age, sex, race, skin type, etc)
9 Non‐Inclusion Criteria (e.g. pregnancy,skin
diseases, etc)
 Ethical aspects
‐ Good Clinical Practice
‐ Declaration of Helsinki (adverse effects, medical 
control, etc)
‐ Subject informed
‐ Written informed consent (sign)
‐ Respect of privacy
‐ Unwanted effects monitored by competent 
technicians
‐ Payment
 PROTOCOL
Clinical trials should be
scientifically sound and
described in a clear and
detailed protocol.
 PROTOCOL
EEMCO Guidelines
European group of Efficacy
Measurement of Cosmetics 
and Other topical products

COLIPA
THE EUROPEAN COSMETIC, TOILETRY 
AND PERFUMERY ASSOCIATION
Guidelines for the evaluation of the 
Efficacy of Cosmetic products
 IN‐VIVO 
EFFICACY TESTS 
&
CLAIM SUBSTANTATION
Instrumental evaluation of 
cosmetic efficacy
Biophysical methods
Non invasive technique
Information about skin structure and 
function
Objective evidence of 
the cosmetic efficacy
 pH
Hydration
Roughness

Sebum Elasticity

specific evaluation
for each claim 86
 CLAIM SUBSTANTATION
 

LENITIVE RESTORING
   EVAPORIMETRY, COLORIMETRY 
REPAIRING PROTECTIVE
   CORNEOMETRY, FLOWMETRY 
SOOTHING 
   PROFILOMETRY, ECOGRAPHY 
   EXPERIMENTAL MODELS 
LIGHTENING  COLORIMETRY 
ANTI‐DARK SPOTS  IMAGE ANALYSIS 
ANTI‐AGE SPOTS  DIGITAL IMAGES 
MOISTURIZING  CORNEOMETRY
HYDRATANT  PROFILOMETRY 
EMOLLIENT  EVAPORIMETRY, CUTOMETRY 
SOOTHING  D‐SQUAME + COLORIMETRY 
FIRMING 
CORNEOMETRY 
TONIFYING 
CUTOMETRY 
NOURISHING  ECOGRAPHY 
PLUMPING 
 
 CLAIM SUBSTANTATION
ANTI‐AGE    

ANTI‐WRINKLE  CORNEOMETRY 
REPLENISHING  CUTOMETRY 
FILLER EFFECT SMOOTHING,  COLORIMETRY 
PLUMPING  FLOWMETRY 
RESTRUCTURING  PROFILOMETRY 
REDEFINING, REFINISHER  ECOGRAPHY 
           REDENSIFYNG  IMAGE ANALYSIS 
REMODELLING  DIGITAL IMAGES 
REJUVENATION  CLINICAL ASSESSMENT 
DECONTRACTING 
 
  IMAGE ANALYSIS
  ANTI DARK CIRCLES  COLORIMETRY FLOWMETRY 
 
ECOGRAPHY 
       ANTI EYEBAGS  CLINICAL ASSESSMENT 
 
 CLAIM SUBSTANTATION
 

  CORNEOMETRY 
  CUTOMETRY 
ANTI‐CELLULITE  FLOWMETRY 
  PROFILOMETRY 
ECOGRAPHY 
IMAGE ANALYSIS 
CLINICAL ASSESSMENT 
 
 
 
IMAGE ANALYSIS 
 
  COLORIMETRY 
ANTI‐  ECOGRAPHY 
STRETCH MARK  CUTOMETRY 
 
PROFILOMETRY 
IMAGE ANALYSIS 
     CLINICAL ASSESSMENT 
  
 APPLICATIONS

ISPE
HAIR CARE
PHOTOTRICHOGRAM: TrichoScan
 SKIN  CARE
SKIN CARE
 CLAIMS
ANTI‐DARK SPOTS
LIGHTENING
WHITENING
AUTO‐TANNING
ANTI‐COUPEROSE
ISPE srl LENITIVE
94
 SKIN COLOUR:
CHROMA METER CR‐300

Xenon light source
Colour rating system L* a* b* CIELAB
CIE (Commission Internationale de l’Eclairage)

L* = luminosity, brightness, radiance, shining  
(from 0 = black to 100 = white)
a*= red‐ green axis (‐60  +60)
b*= blue‐ yellow axis (‐60  +60) 
Anti‐wrinkle/Anti‐ageing tests:

Skin hydration
Skin elasticity
skin roughness
Skin density 
Skin colour
Macrotopography
Clinical assessment
Skin roughness: Skin replica and 
Image analysis
Skin surface analysis
and quantification of wrinkles
Negative imprints of skin surface: 
fast hardening synthetic polymer 
and adhesive disks
 SKIN REPLICA
of crow’s feet
T0
T0

T30

T60
 Silicone replica is illuminated and  skin 
furrows are translated into shadows. 
Image Processing Software (Quantilines, 
Monaderm)
 Skin roughness: 
PRIMOS PICO Optical 3 D system
three‐dimensional images of the skin surface using 
a digital stripe projection
skin density/echogenicity through
ultrasounds echography
DERMASCAN C® Ver. 3, Cortex Tech

25 year old                        51 year old
20 MHz 

Claims
plumping, densifying, nourishing
 Skin hydration
CORNEOMETER CM 825
Gradient in the horny layer
Physical principle: condenser
Electrode + upper skin = capacitor
Epidermal capacitance
Reliable ‐ reproducible measurements
under standard conditions (T°, rh)
Arbitrary units
 Skin elasticity
Cutometer C&K
measures the 
viscoelastic
properties of the skin
Vertical deformation
of the skin into the 
probe
Claims
Firming, tonifying, nourishing
BODY CARE

BODY CARE
 Cellulite
DERMASCAN C® Ver. 3, Cortex Tech

Before                         After
Cellulite = excess subcutaneous fat bulges into the dermis 
‘herniation of the dermo hypodermal junction’ (in red in the 
images). 
Product application = decrease in the length of 
dermo‐hypodermal junction (linearization).
 Periflux PF4001

Blood micro‐flow measured by 
computerized 
Laser Doppler device
 DIGITAL IMAGES

BEFORE APPLICATION 60 DAYS AFTER APPLICATION
 Skin surface: stretch‐marks: 
PRIMOS PICO Optical 3 D system
three‐dimensional images of the skin surface using 
a digital stripe projection
Volume evaluation: Scars and Keloids
PRIMOS PICO Optical 3 D system

BEFORE  AFTER 
DEODORANT EFFICACY
SNIFF TEST
MAKE UP
 MASCARA: LENGTHENING EFFECT

WITHOUT MASCARA WITH MASCARA 
3.55 mm 4.08 mm

distance between rima palpebrarum (eyelash insertion on the upper 

eyelid) and point of maximum length of the eyelashes. 
 MASCARA: CURLING EFFECT

WITHOUT MASCARA WITH MASCARA 
The length of the radius is inversely correlated to the eyelashes 
curvature: the higher the curvature, the smaller the radius.
The curling effect is proved by an increase in the values of the
curvature.
 MASCARA: VOLUMIZING EFFECT

WITHOUT MASCARA WITH MASCARA 

The volumizing effect is proved by an increase in the values 
of the surface occupied by the eyelashes.
 SUNSCREENS
SUN PRODUCTS
 UVB PROTECTION FACTOR
IN‐VIVO ‐ SPF 

INTERNATIONAL STANDARD ISO 
24444:2010
 WATER RESISTANT TEST

Colipa Guidelines for evaluating Sun

Product Water Resistance 2005

Colipa n° 16
Water Resistance labelling, 2006

ISPE srl
 IN‐VITRO
BOOTS STAR RATING 2011

SUN PROTECTION FACTOR EVALUATION  
DIFFEY and ROBSON + DIN 67502

IN‐VITRO UVA PROTECTION EVALUATION 
UVAPF and Critical Wavelength METHOD ISO 
24443 2012 
 Consumer’s  Evaluation

It evaluates the consumer’s perception 
of product efficacy 

Realistic in‐use tests useful for analysing concepts, 
colours, packaging, acceptance, texture, fragrance
and expectations.

ISPE
 Consumer’s  Evaluation
Intensity level n° answers score %
Very efficient 1 5%
Fairly efficent 9 45%
Not very efficient 9 45%
Not at all efficient 1 5%
NOT AT ALL VERY
5% 5%

NOT VERY FAIRLY

45% 45%
 SENSORY ANALYSIS
MEASURE OF

PLEASANTNESS
ACCEPTABILITY 
SENSORY PERCEPTIONS
 DEFINITION
Scientific discipline used to measure 
and analyse the human responses to 
properties of materials as they are 
perceived by the senses
 Sensory Panel

group of people trained to
detect and quantify 
sensory perceptions 

ISPE
 Sensory profile

Consistency
10
8
6
4
2
0

Absorption Spreadability

A B C

ISPE
 According to our experience
best result is obtained
by employing a combination
of techniques:  
instrumental test,  
clinical assessments, sensory and 
subjective tests.
ISPE srl
 Final report
¾ Product & sponsor 
identifications 
¾ Study design
¾ Method & devices
¾ Statistical analysis
¾ Results: tables and 
graphs 
¾ Signs
ISPE srl ¾ Bibliography
“A fool with a tool is always a 
fool”
A. Kligman

Thank you!