CONTRIBUTION OF THE SCCNFP TO

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DG SANCO
CONTRIBUTION OF THE SCCNFP TO THE THREE Rs
VERA ROGIERS DEPARTMENT OF TOXICOLOGY VRIJE
UNIVERSITEIT BRUSSEL BELGIUM
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CONTENTS
some practical examples
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CONTENTS
What is the SCCNFP ?
some practical examples
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SCCNFP
Scientific Committee on Cosmetic Products
and Non-Food Products intended for Consumers
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Historical
? 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
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Composition

• 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

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Tasks
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Tasks
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Tasks
safety matters
alternative methods
clinical testing
NOTES OF GUIDANCE FOR TESTING OF COSMETIC
INGREDIENTS FOR THEIR SAFETY EVALUATION
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CONTENTS
What is the SCCNFP ?
SCCNFP and its role in 3R-methodology
implementation in safety assessment of cosmetic
ingredients
some practical examples
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safety matters
alternative methods
clinical testing
NOTES OF GUIDANCE FOR TESTING OF COSMETIC
INGREDIENTS FOR THEIR SAFETY EVALUATION
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safety matters
clinical testing
NOTES OF GUIDANCE FOR TESTING OF COSMETIC
INGREDIENTS FOR THEIR SAFETY EVALUATION
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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.  
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MANDATE BY COMMISSION (DG XXIV/1890/98)
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MANDATE BY COMMISSION (DG XXIV/1890/98)
SCCNFP WORKING GROUP ON ALTERNATIVE METHODS
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SCCNFP and 3Rs follow-up status report
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)
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SCCNFP and 3Rs follow-up status report
3 Rs CONCEPT
SCCNFP list http//www.europa.eu.int/comm/dg24/h
ealth/SC/ncomm6/index_en.htm
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SCCNFP and 3Rs follow-up status report
PROSPECTS FOR NEAR FUTURE
- SUBACUTE TOXICITY
- CHRONIC TOXICITY
- REPRODUCTIVE TOXICITY

• TARGET ORGAN SYSTEMIC
• TOXICITY

• CARCINOGENICITY
• (non-genotoxic compounds)

(SCCNFP/0546/02)
? NEED FOR BASIC RESEARCH !
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MANDATE BY COMMISSION (DG XXIV/1890/98)
SCCNFP WORKING GROUP ON ALTERNATIVE METHODS
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SCCNFP and 3Rs applicability
EXAMPLES
3T3 NRU PT Nov. 1998 ? 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)
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SCCNFP and 3Rs applicability
EXAMPLES
3T3 NRU PT Nov. 1998 ? 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)
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SCCNFP and 3Rs applicability
EXAMPLES
3T3 NRU PT Nov. 1998 ? 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)
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SCCNFP and 3Rs applicability
EXAMPLES
3T3 NRU PT Nov. 1998 ? 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)
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MANDATE BY COMMISSION (DG XXIV/1890/98)
SCCNFP WORKING GROUP ON ALTERNATIVE METHODS
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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  
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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

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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  

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CONCLUSION