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

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

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

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

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

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

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

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

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

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

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

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

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. … »

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

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

(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)

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: http://www.europa.eu.int/comm/dg24/health/SC/ncomm6/index_en.htm

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 !

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

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)

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)

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)

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)

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

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 … »

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

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 … »

  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 ! 