IFRA & Safety Assessment of Fragrance Materials

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1 IFRA & Safety Assessment of Fragrance Materials An Overview Bhashkar Mukerji, PhD, Head, Regulatory & Product Safety, Givaudan

2 DISCLAIMER The views expressed in this presentation belong to the presenter and not that of Givaudan 3/20/2017 2

3 This Presentation... What is a Fragrance? What is IFRA? What are IFRA Code of Conduct? What is RIFM? What are IFRA standards? IFRA 48th amendment Safety Assessment of fragrances Quantitative Risk Assessment for Dermal Sensitization Conclusions 3/20/2017 3

4 WHAT IS A FRAGRANCE? A Fragrance is most often a mixture of more than one chemical entity It is used to impart certain cosmetic benefits ; mostly used at relatively low concentrations, except in fine fragrances It could be composed of fully synthetic components or natural or a mix of both, etc. Safety assessment follows the principles of hazard evaluation and risk assessment 3/20/2017 4

5 Three Evaporation Stages Top Note (Extremely Volatile) Light, Fresh citrus, fruity, green Mid Note (Intermediate Volatility) Round, Warm floral, spicy, aldehydic Base Note (Extremely Low Volatility) Heavy, Rich woody, powdery, musky

6 RESPONSIBILITY 3/20/2017 6

7 INTERNATIONAL FRAGRANCE ASSOCIATION FOUNDED IN 1973 ; HQ IN BRUSSELS VOICE OF THE FRAGRANCE INDUSTRY PROMOTES THE SAFETY AND BENEFITS OF THE FRAGRANCE INDUSTRY S PRODUCTS ITS MEMBERS ACCOUNT FOR 90% OF THE GLOBAL PRODUCTION VOLUME OF FRAGRANCE COMPOUNDS 3/20/2017 7

8 ESTABLISHED THE IFRA CODE OF PRACTICE FRAGRANCE INGREDIENTS AND FRAGRANCE COMPOUNDS ARE SUBJECT TO INTERNATIONAL REGULATORY REGIMES WORLDWIDE ISSUES AN IFRA STANDARD. IFRA STANDARDS CAN EITHER PROHIBIT, RESTRICT OR SET PURITY REQUIREMENTS FOR SPECIFIC INGREDIENTS FINAL RESPONSIBILITY OF SAFETY OF INGREDIENTS AND FINISHED FRAGRANCES RESTS WITH IFRA MEMBERS 3/20/2017 8

9 IFRA STANDARDS PUBLISHED EVERY 2 YEARS PREPARED BY THE IFRA SCIENTIFIC COMMITTEE ON THE BASIS OF THE DECISIONS MADE BY REXPAN (THE RIFM EXPERT PANEL) STANDARDS SUBJECT TO REGULAR CHANGES AS NEW INFORMATION RELEVANT TO THE SAFETY OF FRAGRANCE INGREDIENTS BECOME AVAILABLE MEMBERS MUST COMPLY WITH IFRA STANDARDS NOT FOLLOWING STANDARDS IS DEEMED AS VIOLATION OF THE IFRA CODE OF CONDUCT 3/20/2017 9

10 3/20/

11 RESEARCH INSTITUTE FOR FRAGRANCE MATERIALS (RIFM) OBTAINS AND EVALUATES SAFETY DATA ON FRAGRANCE INGREDIENTS WORKS THROUGH INDEPENDENT, INTERNATIONAL PANEL OF EXPERTS WITH NO TIES TO THE FRAGRANCE INDUSTRY 3/20/

12 IFRA RIFM COLLABORATION International Fragrance Association Code of Practice Standards Regional Associations EFFA (EU) Regulation proposals National Associations JFFMA (Japan) FMA (USA) SFFIA (Switzerland) DRH (Germany) Full Member Companies Givaudan Firmenich IFF etc. Self Regulation Research Institute for Fragrance Materials Scientific Database Testing of Fragrance Materials Industry Standards External Laboratories & Scientific Experts ACA PROPERTY. NOT TO BE REPRODUCED WITHOUT PERMISSION OF ACA 3/20/

13 Industry Coordination Board RIFM REXPAN Ingredient safety assessments RIFM STEERING COMMITTEE Approves animal testing where needed. Approves high level decisions IFRA Standard (if necessary) Research RIFM CORE TEAMS Genotoxicity Sensitization Repeat Dose Reproductive 3/20/

14 Example of an IFRA Standard - 1 3/20/

15 Example of an IFRA Standard - 2 3/20/

16 Example of an IFRA Standard - 3 3/20/

17 Example of an IFRA Standard - 4 3/20/

18 Example of an IFRA Certificate 3/20/

19 Standards Page - 3/20/

20 IFRA 48 TH AMENDMENT 3/20/

21 IFRA 48 implementation timeline forecast 3/20/ bans 3 new Standards for restrictions 1 correction & 7 revised standards policy on photoxic ingredients

22 2 new banned materials Bans due to insufficient data for safety assessment on : Sorbic alcohol (Hexadienol) 2,4-Dodecadien-1-ol, 3/20/

23 Deadlines summary for existing compounds The timelines refer to the fragrances compound, not to the end product Regulation Constraint IFRA 47 IFRA 47 IFRA 48 IFRA 48 Bans & restrictions New elements of specification Bans and restrictions (including new CAS # added & combined phototoxicity removal except on FCs) Updated specifications August 10 January 10 August 10 January 10 3/20/

24 Safety Asessment of Fragrances 3/20/

25 Risk vs. Hazard RISK = HAZARD X EXPOSURE 3/20/

26 Safety Assessment of Fragrances Fragrance ingredients Fragrance compounds Fragranced end-products Toxicology studies Hazard assessment Ingredients Risk assessment IFRA Use limits Specification/ Prohibitions Fragrances End-product manufacturers Safety review Risk assessment 3/20/

27 Safety Assessment of New Fragrance Ingredients Predict Compare with existing structurally similar ingredients In silico evaluation using QSAR tools Characterize In vitro skin sensitization assays (e.g., KeratinoSens) Ex vivo skin sensitization assay (e.g., LLNA) Bacterial reverse mutation test In vitro metabolism Register Acute oral/dermal/inhalation toxicity In vitro skin/eye irritation In vivo acute skin/eye irritation In vitro chromosomal aberration test Repeated dose oral toxicity study (28-day) Follow up studies (e.g., in vivo micronucleus test) Risk assessment for endpoints (e.g., sensitization) and/or uses of concern (cosmetics) 3/20/

28 QRA for Skin Sensitization Dermal sensitization: human / guinea pig / LLNA Weight of evidence approach no expected sensitizing induction level (NESIL) Converted to dose/unit area for NESIL determination NOEL from HRIPT (>100 human subjects) used to set NESIL LOEL human test takes precedence over NOEL from HRIPT NOEL from human test can be used if confirmed by LLNA (if no HRIPT) Guinea pig results not to be used alone to set NESIL Results from LLNA confirmed by HRIPT 3/20/

29 Risk Assessment for Dermal Sensitization Extrapolation from controlled experimental situation to real life exposure scenarios Inter-individual susceptibility (10) Matrix effects (product category specific) Consumer products are much more complex than common vehicles in experiments Use considerations (product category specific) Product used vs. experimental conditions Site Barrier integrity Occlusion Api et.al., Regul Toxicol Pharmacol, 52: 3,

30 Risk Assessment for Dermal Sensitization Exposure Assessment Careful and conservative determination of data to use Exposed populations, magnitude of exposure under various conditions, duration, frequency, etc. Calculated as dose/unit area/per diem to allow direct comparison When multiple sources of exposure exist, select the highest to be conservative For surface area measurements for same area of the body, select smallest surface area to be conservative Exposure assessment for shampoos: Calculated exposure = 23,630 mg/day (CTFA) Area = 1430 cm 2 (EPA, 1997; area hands + ½ head) Retention Factor = 1% or 0.01 (SCCNFP, 2003) Exposure = 23,630 mg/day * cm 2 = 0.17 mg/cm 2 /day 3/20/

31 Example: Risk Assessment for Dermal Sensitization Risk Characterization Acceptable Exposure Level (AEL) = WoE NESIL / SAF Comparison of Acceptable Exposure Level (AEL) to calculated Consumer Exposure Level (CEL): AEL > CEL to be acceptable Api et.al., Regul Toxicol Pharmacol, 52: 3, /20/

32 IFRA Product Categories 3/20/

33 CONCLUSIONS 1. Fragrance materials are rigorously assessed for safety 2. Safety assessment of fragrance materials is subject to scrutiny by regulatory authorities and end-product manufacturers 3. Large amount of toxicity data are available for fragrance materials 4. Advanced risk assessment methodology for critical endpoint 5. Fragrance compounds are complex mixtures and adequately assessed 3/20/

34 CONCLUSIONS 6. IFRA RIFM collaboration helpful in managing fragrance safety assessment 7. Fragrance industry is at the forefront of developing novel animal alternatives 8. NO NEED FOR ADDITIONAL SAFETY ASSESSMENT 9. IFRA ASSESSMENT COMPREHENSIVE, ALLOWS SIGNIFICANT MARGIN OF SAFETY 10. CONSTANTLY MONITORED, PEER REVIEWED AND UPDATED 11. LINKED TO GLOBAL REGULATORY AND SCIENTIFIC SCRUTINY 3/20/

35 Terimah Kasih! Contact Bhashkar Mukerji Mobile: Confidential business and proprietary information of Givaudan, may not be copied or distributed to anyone without the express written permission of Givaudan

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