CONTRIBUTION OF THE SCCNFP TO THE THREE Rs VERA ROGIERS DEPARTMENT OF TOXICOLOGY VRIJE UNIVERSITEIT...

CONTRIBUTION OF THE SCCNFP TO

THE THREE Rs

VERA ROGIERSDEPARTMENT OF TOXICOLOGYVRIJE UNIVERSITEIT BRUSSEL

BELGIUM

DG SANCO

What is the SCCNFP ?

CONTENTS

SCCNFP and its role in 3R-methodology implementation in safety assessment of cosmetic ingredients

some practical examples

CONTENTS





SCCNFPSCCNFP = Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers

• historical

• composition

• tasks, domains of competence

Historical


Commission Decision 78/45/EEC: SCC

Commission Communication 30/4/1997on 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 ofexisting 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


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


SCCNFP

COMMISSION

mandates scientificopinions

COSMETICSCOMPULSORY

76/768/EEC

NON-FOOD

PRODUCTSNOT COMPULSORY

assist & advice

scientific & technical matters

composition, manufacture, packaging, labelling


Tasks

COSMETICSCOMPULSORY

76/768/EEC

alternativemethods development

& validation

clinicaltesting

ethical & safety issues

test procedures

safetymatters

cosmeticingredients

annexes


alternativemethods

clinicaltesting

cosmeticingredients

annexes

test procedures

development& validation


NOTES OF GUIDANCENOTES OF GUIDANCE FOR TESTING OF COSMETIC INGREDIENTS FOR THEIR SAFETY EVALUATION

COSMETICSCOMPULSORY

76/768/EEC

safetymatters

Tasks

CONTENTS




SCCNFP and 3Rs

NOTES OF GUIDANCE FOR TESTING OF COSMETIC INGREDIENTS FOR THEIR SAFETY EVALUATION

alternativemethods

clinicaltesting

cosmeticingredients

annexes

test procedures

development& validation


COSMETICSCOMPULSORY

76/768/EEC

safetymatters

SCCNFP and 3Rs

MANDATE BY COMMISSION (DG XXIV/1890/98)

under 1.1. « … The SCCNFP shall act as a resource of scientificexpertise to the European Commission with regards to the

development of alternative methods. … »

SCCNFP and 3Rs

SCCNFP WORKING GROUPON 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: follow-up & status report

- percutaneous absorption with human/pig skin (OECD 428)

- skin corrosivity : TER (OECD 430), EPISKIN®,EPIDERM® (OECD 431) (CORROSITEX®)

VALIDATEDALTERNATIVE METHODS

(COSMETIC INGREDIENTS)

- skin sensitisation : LLNA (OECD 429)

- phototoxicity : 3T3 NRU-PT (OECD 432)

- mutagenicity, photomutagenicity

3 Rs CONCEPTalternativemethods

- (embryotoxicity: WEC, MM, EST)

(SCCNFP/0546/02)

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

3 Rs CONCEPTalternativemethods


“VALID” ALTERNATIVE METHODS AS USED BY MAJOR COSMETIC

COMPANIES(FINISHED PRODUCTS)

- skin irritationHUMAN SKIN MODELS AND CYTOTOXICITY, PIG EAR TEST,SIFT

- eye irritation : HET-CAM,ISOLATED EYE TEST, BCOPCYTOTOXICITY TEST

PROSPECTS FOR NEAR FUTURE

- SUBACUTE TOXICITY- CHRONIC TOXICITY- REPRODUCTIVE TOXICITY

- SKIN IRRITATION- OCULAR IRRITATION- SKIN SENSITISATION- EMBRYOTOXICITY

- ACUTE TOXICITY

- TARGET ORGAN & SYSTEMIC TOXICITY- CARCINOGENICITY (non-genotoxic compounds)


(SCCNFP/0546/02)

NEED FOR BASIC RESEARCH !NEED FOR BASIC RESEARCH !

SCCNFP and 3Rs






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






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 … »


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 DYESStrategy 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


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 … »

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 !

CONTRIBUTION OF THE SCCNFP TO THE THREE Rs VERA ROGIERS DEPARTMENT OF TOXICOLOGY VRIJE UNIVERSITEIT...

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