1. CONTRIBUTION OF THE SCCNFP TO
DG SANCO
CONTRIBUTION OF THE SCCNFP TO
THE THREE Rs
VERA ROGIERS
DEPARTMENT OF TOXICOLOGY
VRIJE UNIVERSITEIT BRUSSEL
BELGIUM

2. CONTENTS What is the SCCNFP ? SCCNFP and its role in 3R-methodology
implementation in safety assessment of cosmetic ingredients
some practical examples

3. CONTENTS What is the SCCNFP ? SCCNFP and its role in 3R-methodology
implementation in safety assessment of cosmetic ingredients
some practical examples

4. SCCNFP What is the SCCNFP ? = Scientific Committee on
Cosmetic Products and Non-Food
Products intended for Consumers
• historical
• composition
• tasks, domains of competence

5. Historical What is the SCCNFP ?  Commission Decision 78/45/EEC: SCC
 Commission Communication 30/4/1997
on Consumer Health and Food Safety
« … in matters relating to the health of the consumer, scientific
advice is of the utmost importance at all stages of the drawing up
of new legislation and for the execution and management of
existing legislation. The Commission will use this advice for the
benefit of the consumer in order to ensure a high level of
protection of health. »
 Council Directive 97/579/EC establishment of SCCNFP

6. Composition What is the SCCNFP ?
independent & highly qualified scientists in medicine, pharma-
cology, toxicology, dermatology, chemistry, microbiology,...
secretary: Directorate-General for Consumer Policy and
Consumer Health Protection
actually: 18 members of 11 Member States
appointed by Commission after call for expression of interest
3 yrs ( x2 )
1 chairperson, 2 vice-chairpersons
declaration of interest / independence / confidentiality
external experts on invitation

7. Tasks What is the SCCNFP ?  assist & advice
 scientific & technical matters
composition, manufacture,
packaging, labelling
COSMETICS
COMPULSORY
76/768/EEC
SCCNFP
COMMISSION
mandates
scientific
opinions
NON-FOOD
PRODUCTS
NOT COMPULSORY

8. Tasks safety matters What is the SCCNFP ? alternative methods clinical
test procedures
safety
matters
cosmetic
ingredients
annexes
COSMETICS
COMPULSORY
76/768/EEC
alternative
methods
development
& validation
clinical
testing
ethical &
safety issues

9. NOTES OF GUIDANCE FOR TESTING OF
What is the SCCNFP ?
Tasks
cosmetic
ingredients
annexes
safety
matters
test procedures
COSMETICS
COMPULSORY
76/768/EEC
alternative
methods
development
& validation
ethical &
safety issues
clinical
testing
NOTES OF GUIDANCE FOR TESTING OF
COSMETIC INGREDIENTS FOR THEIR SAFETY EVALUATION

10. CONTENTS What is the SCCNFP ? SCCNFP and its role in 3R-methodology
implementation in safety assessment of cosmetic ingredients
some practical examples

11. safety matters SCCNFP and 3Rs alternative methods clinical testing
cosmetic
ingredients
annexes
safety
matters
test procedures
COSMETICS
COMPULSORY
76/768/EEC
alternative
methods
development
& validation
ethical &
safety issues
clinical
testing
NOTES OF GUIDANCE FOR TESTING OF COSMETIC INGREDIENTS
FOR THEIR SAFETY EVALUATION

12. safety matters SCCNFP and 3Rs alternative methods clinical testing
cosmetic
ingredients
annexes
safety
matters
test procedures
COSMETICS
COMPULSORY
76/768/EEC
alternative
methods
development
& validation
ethical &
safety issues
clinical
testing
NOTES OF GUIDANCE FOR TESTING OF COSMETIC INGREDIENTS
FOR THEIR SAFETY EVALUATION

13. MANDATE BY COMMISSION (DG XXIV/1890/98)
SCCNFP and 3Rs
MANDATE BY COMMISSION (DG XXIV/1890/98)
under 1.1. « … The SCCNFP shall act as a resource of scientific
expertise to the European Commission with regards to the
development of alternative methods. … »

14. ON ALTERNATIVE METHODS
SCCNFP and 3Rs
MANDATE BY COMMISSION (DG XXIV/1890/98)
SCCNFP WORKING GROUP
ON ALTERNATIVE METHODS
follow-up of validation studies by ECVAM or
other centres  status report
study applicability in safety assessment of cosmetic ingredients
encourage use in dossiers

15. ON ALTERNATIVE METHODS
SCCNFP and 3Rs
MANDATE BY COMMISSION (DG XXIV/1890/98)
SCCNFP WORKING GROUP
ON ALTERNATIVE METHODS
follow-up of validation studies by ECVAM or
other centres  status report
study applicability in safety assessment of cosmetic ingredients
encourage use in dossiers

16. (COSMETIC INGREDIENTS)
SCCNFP and 3Rs: follow-up & status report
alternative
methods
3 Rs CONCEPT
VALIDATED
ALTERNATIVE METHODS
(COSMETIC INGREDIENTS)
skin corrosivity : TER (OECD 430), EPISKIN®,EPIDERM® (OECD 431)
(CORROSITEX®)
- skin sensitisation : LLNA (OECD 429)
- phototoxicity : 3T3 NRU-PT (OECD 432)
- percutaneous absorption with human/pig skin (OECD 428)
- mutagenicity, photomutagenicity
- (embryotoxicity: WEC, MM, EST)
(SCCNFP/0546/02)

17. SCCNFP and 3Rs: follow-up & status report
alternative
methods
3 Rs CONCEPT
“VALID” ALTERNATIVE METHODS
AS USED BY MAJOR COSMETIC
COMPANIES
(FINISHED PRODUCTS)
skin irritation
HUMAN SKIN MODELS AND CYTOTOXICITY, PIG EAR TEST,
SIFT
eye irritation : HET-CAM,
ISOLATED EYE TEST, BCOP
CYTOTOXICITY TEST
SCCNFP list:

18. PROSPECTS FOR NEAR FUTURE
SCCNFP and 3Rs: follow-up & status report
PROSPECTS FOR NEAR FUTURE
- SUBACUTE TOXICITY
SKIN IRRITATION
- OCULAR IRRITATION
- SKIN SENSITISATION
- EMBRYOTOXICITY
ACUTE TOXICITY
- CHRONIC TOXICITY
- REPRODUCTIVE TOXICITY
TARGET ORGAN & SYSTEMIC
TOXICITY
CARCINOGENICITY
(non-genotoxic compounds)
(SCCNFP/0546/02)
 NEED FOR BASIC RESEARCH !

19. ON ALTERNATIVE METHODS
SCCNFP and 3Rs
MANDATE BY COMMISSION (DG XXIV/1890/98)
SCCNFP WORKING GROUP
ON ALTERNATIVE METHODS
follow-up of validation studies by ECVAM or
other centres  status report
study applicability in safety assessment of
cosmetic ingredients
encourage use in dossiers

20. SCCNFP and 3Rs: applicability
EXAMPLES
3T3 NRU PT: Nov  extra study on
UV-filters (SCCNFP/0069/98 Final)
IN VITRO PERCUTANEOUS ABSORPTION TEST: June 1999  basic criteria (SCCNFP/0167/99, rev 3)
LLNA: May 2000  suitability for cosmetic
ingredients (SCCNFP/0255/99 Final)

21. SCCNFP and 3Rs: applicability
EXAMPLES
3T3 NRU PT: Nov  extra study on
UV-filters (SCCNFP/0069/98 Final)
IN VITRO PERCUTANEOUS ABSORPTION TEST: June 1999  basic criteria (SCCNFP/0167/99, rev 3)
LLNA: May 2000  suitability for cosmetic
ingredients (SCCNFP/0255/99 Final)

22. SCCNFP and 3Rs: applicability
EXAMPLES
3T3 NRU PT: Nov  extra study on
UV-filters (SCCNFP/0069/98 Final)
IN VITRO PERCUTANEOUS ABSORPTION TEST: June 1999  basic criteria (SCCNFP/0167/99, rev 3)
LLNA: May 2000  suitability for cosmetic
ingredients (SCCNFP/0255/99 Final)

23. SCCNFP and 3Rs: applicability
EXAMPLES
3T3 NRU PT: Nov  extra study on
UV-filters (SCCNFP/0069/98 Final)
IN VITRO PERCUTANEOUS ABSORPTION TEST: June 1999  basic criteria (SCCNFP/0167/99, rev 3)
LLNA: May 2000  suitability for cosmetic
ingredients (SCCNFP/0255/99 Final)

24. ON ALTERNATIVE METHODS
SCCNFP and 3Rs
MANDATE BY COMMISSION (DG XXIV/1890/98)
SCCNFP WORKING GROUP
ON ALTERNATIVE METHODS
follow-up of validation studies by ECVAM or
other centres  status report
study applicability in safety assessment of
cosmetic ingredients
encourage use in dossiers

25. SCCNFP and 3Rs: encourage use
EXAMPLES
SCCNFP Plenary Meeting Febr. 2000: « …All new cosmetic
ingredients, whose dossier are submitted to SCCNFPs approval …
must contain studies for their in vitro assessment of percutaneous
absorption, following the basic criteria indicated in
Annex 10 of Notes … »

26. SCCNFP and 3Rs: encourage use
EXAMPLES
MUTAGENICITY / GENOTOXICITY: Notes of Guidance
ALL INGREDIENTS ON ANNEXES (SCCNFP/0321/00 Final)
« …the combination of 2 in vitro tests (bacterial reverse
mutation test, in vitro mammalian cell chromosome aberration
test) provides in general sufficient evidence of… »
FOR HAIR DYES
Strategy for testing hair dye cosmetic ingredients
(SCCNFP/0566/02 Final)
 2 test stages
 4 in vitro tests and positive results
before any in vivo test

27. SCCNFP and 3Rs: encourage use
EXAMPLES
TOXICOLOGICAL PROFILE OF INGREDIENTS:
Notes of Guidance (SCCNFP/0321/00 Final)
« …Often scientifically developed alternative methods are
used to obtain in vitro supportive results. This is acceptable
on the condition that these methods have a good history of
being used in the safety assessment of a particular class of
compounds and are supported by results of appropriate
positive and negative controls … »

28.   SCCNFP contributes significantly to the 3Rs
CONCLUSION 
SCCNFP contributes significantly to the 3Rs
implementation in cosmetic testing by:
- follow-up and studying the applicability of validated studies
for the safety assessment process of cosmetic ingredients
- pro-active measures
- active encouragement of 3Rs methodology in submission
dossiers of cosmetic ingredients
SCCNFP contribution could be substantially increased
towards other fields of legislation of non-food products ! 