INIZIATIVE DELL’INDUSTRIA COSMETICA EUROPEA NELL’AREA ... · PDF fileINIZIATIVE...

7 Aprile 2006 Cosmoprof Bologna 1

INIZIATIVE DELL’INDUSTRIA COSMETICA EUROPEA NELL’AREA

DELLA PROTEZIONE SOLAREEuropean Cosmetic Industry Initiatives in the Area of Sunprotection

Dr Romano E. Mascotto

Presidente del Gruppo Solare Colipa


Introduction


Overall Colipa Objectives

Advice and support to consumers

Overall Colipa Approach

Agreed industry practices for the substantiationof efficacy claims (Testing)

Harmonised consumer information on how to use sunscreens correctly (Labelling)


Colipa approach : Agreed industrypractices for the substantition of

efficacy claims (Testing)

• Test / measurement protocols

• Calculation / interpretation of results

• Quality / compliance criteria


Status of Colipa initiatives : Testing

Guideline on SPF test method (1994 European; 2003 International)including Guideline on monitoring of light sources

Guidelines on water resistance testingGuidelines on UVA protection testing (underdevelopment)Guidelines on photostability testing of UV filters in sunscreen formulations


Colipa approach : Harmonised consumerinformation on how to use sunscreens

products correctly (Labelling)

Colipa recommendations to industry on usageinstructions on sun products as well as clearlabelling of key parameters of sun protection

Company initiatives on consumer education, including joint initiatives with authorities, dermatologists, ...


Status of Colipa initiatives : Labelling

Recommendation on SPF labellingRecommendation on UVA protection labelling (under development)Recommendation on usage instructions


Testing


UVB Protection test method(SPF Testing)


Development of standardised SPF testing

From DIN to European/International

DIN 67501 (1984)

Colipa SPF Guideline (1994)

International SPF Guideline (2003)

Improvement of science/method and growing acceptance


Variables in SPF Determination

• Selection of volunteers (number, phototype)• Test area, number and size of test sites • Products

- Quantity of applied product- Application procedure

• Solar Simulator- Lamp type- Light quantity- Light quality

• Reading of MEDu and MEDp• Calculation of SPF and statistics


SPF Testing : Achievements of current industry

method (2003)• Improved SPF determination

– Standardised test protocol – Video demonstration of product application technique – Specification and guidelines for monitoring of light

sources

• Adopted in 2003 by cosmetic industries in EU, Japan and South Africa.

• Interest in harmonisation expressed by Australia, China and USA


Water resistance test method


Water resistance : Principle of the method

• Compare SPF for a sunscreen product after a defined period of immersion in water with the original (static) SPF determined according to the International SPF Test Method.

• Defined immersion equipment and conditions :

– Spa pool, Jacuzzi or bath tub– Water quality and temperature– Immersion wet-dry sequence standardised


Water resistance : Definitions for labelling

• Water Resistant : 2 baths of 20 minutesremaining SPF efficacy ≥ 50%

• Very Water Resistant : 4 baths of 20 minutesremaining SPF efficacy ≥ 50%


UVA Protection test method(ongoing work)


UVA protection : Ongoing work

Development of an in vitro UVA protection determination (validated against the in-vivo PPD method)

Ring studies with preliminary protocol

Data analysis ongoing

Final protocol expected in the course of 2006


Photostability Test Method for

UV Filters in Sunscreen Formulations


Photostability : Principle of the method

• In vitro procedure for determining thephotostability of UV filters alone and in sunscreen formulations.

• Simple and reliable in vitro model to determine analytically the concentration of UV filters before and after exposure to controlled doses of UV radiation from a standard source.


Photostability :

Results and Status

• Agreement on final test protocols

• Reproducibility and accuracy demonstrated by

ring studies

• Publication of results

• 1999 Int. J. Cos. Scien. (UV filters)

• in preparation (UV filters in sunscreen formulations)


Labelling


SPF Labelling

SPF should be the primary consideration for sunscreen potency

(Consensus position by American Academy of Dermatology, 2001)


SPF labelling

SPF 35sunblock

SPF 36sunblock

What is the difference ?


SPF Labelling : Colipa Objective

To simplify the existing sun protection labelling system in order to avoid confusion and to giveconsumers clear and meaningful information.


SPF labelling : Colipa Recommendation

Ultra50+

Very High30 - 40 - 50

High15 - 20 – 25

Medium8 - 10 -12

Low2 - 4 - 6

Class(optional)

SPF

Abolish the use of the word « sunblock »


UVA Protection Labelling(ongoing work)


UVA protection labelling : Objective

Provide additional relevant information toconsumers in a harmonised manner whichdoes not lead to confusion with existing SPFlabelling


UVA labelling : Status

Key principles :

• The SPF is (and should remain) the key efficacy parameter for the consumer

• UVA protection of a product should be in relation to the SPF (i.e. UVB protection) to ensure a consistent protection over the whole UV spectrum

• Thus, the possibility of making UVA related claims should be linked to a minimum ratio SPF / UVA protection = 3


Usage Instructions


Usage instructions : Colipa Objective

Improve consumer awareness of the necessityand means to protect themselves against the sun.


Usage instructions : Colipa Recommendation

All sun protection products to carry clear advice to consumers :

• Avoid intensive midday sun• Apply before sun exposure• Reapply frequently


Usage instructions : Colipa Recommendation (contd.)

Children products to carry additional advice :

• Keep babies and young children out of direct sunlight

• Wear protecting clothing and very high SPF sunscreens (higher than 25)


Individual Company Initiatives


Co-operation with Government Agencieseg The Health Education Authority

The Health Education Authority (HEA) is now The Department of Health (DoH)


Conclusions


Conclusions (1)• Sun protection is a main area of activity for

Colipa.• Harmonisation of testing and labelling of

sun protection was not included in the scope of the EU Cosmetics Directive.

• Therefore, Colipa has recognised the need for the development and active promotion of industry standards on testing, labelling and consumer education.


Conclusions (2)

• Today standardized test protocols are available for:

– SPF measurement– Water resistance measurement– (UVA protection measurement)– Photostability measurement


Conclusions (3)

• Harmonised labelling has been developed for :

– UVB Protection - SPF– (UVA protection)– Water resistance


Conclusions (4)Consumer education regarding

responsible behaviour towards sun protection is carried out at Colipa level (harmonised usage instructions on products) and at individual company level.

EU continues to be the motor in international harmonisation of sun protection measurements.


GRAZIE PER LA VOSTRA ATTENZIONE

INIZIATIVE DELL’INDUSTRIA COSMETICA EUROPEA NELL’AREA ... · PDF fileINIZIATIVE...

Documents

Transcript of INIZIATIVE DELL’INDUSTRIA COSMETICA EUROPEA NELL’AREA ... · PDF fileINIZIATIVE...