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Dr. Prof. Shu Jun Cheng

Promote Animal-free Testing in China Through Bottom-up Way. Dr. Prof. Shu Jun Cheng Toxicology Dept. of Guangdong Inspection & Quarantine Technology Center, Guangzhou, China. 2015.11.20. 1. Content. Introduction of AQSIQ Bottom-up way retrospect of Alternatives in China

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Dr. Prof. Shu Jun Cheng

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  1. Promote Animal-free Testing in China Through Bottom-up Way Dr. Prof. Shu Jun Cheng Toxicology Dept. of Guangdong Inspection & Quarantine Technology Center, Guangzhou, China 2015.11.20 1

  2. Content • Introduction of AQSIQ • Bottom-up way retrospect of Alternatives in China • Activities of standardization and validation • Administration accept alternative methods • Promote the application in Industries • Continuous Education and Training • Difficulties and challenges

  3. Introduction of AQSIQ AQSIQ General Administration of Quality Supervision, Inspection and Quarantine of People’s Republic of China (AQSIQ) , as the ministry organization directly led by State Department to exert administration and execute laws, AQSIQ supervise national quality, measurement, entry-exit commodity inspection, entry-exit sanitation quarantine, entry-exit animals and plants quarantine, import and exportfood/cosmetics safety, certification and accreditation and standardization work, etc.. 35 Inspection and Quarantine bureaus directly under AQSIQ.

  4. Consumer safety AQSIQ Bottom-up way of Alternatives in China Motivation Regulations of global trade Cosmetics ban of animal testing， Chemicals/REACH advocate non-animaltesting and animal only as last resort， Food additive, packaging material, pesticides risk assessment Biology product/medicine pre-clinical testing Environment safety assessment Science and technology development ”Omics” Computer and predicity Stem cells and engineering tissue Cell engineering and culture High throughput/content screening Society development Animal protection movement Awakening of animal welfare consciousness ---2010/63/EU --- Guideline on Humane Treatment to LaboratoryAnimals（Ministry of Science and Technology ） Competition of testing service new testing field new technology/ standards service import-export enterprise customization testing service

  5. Bottom-up support of alternatives in China Exchange and Consultations of Regulations/Directive of Main Trade Countries Cosmetics: 2003/15/EC,1223/2009/EC Chemical: REACH(1907/2006) Food: EFSA,SCCP Labanimal and welfare: 2007/526/EC, 2010/63/EU New Methods R & D Government project Cooperation Consensus platform AQSIQ Validation and Administration Acceptance multi-center validation bi-center validation accepted by AQISQ Standardization GLP of in vitro lab GCCP guideline Alternative methods transfer Lab certification by CNAS Training and Education Standards training In vitro testing training Animal welfare and 3Rs education Technology service Industries Enterprise The third part institutes

  6. Standardization and administration acceptance AQSIQ as administration responsible for exit-entry inspection which support the alternatives through set up SN testing standards/guidelines for AQSIQ system. Also provide the in vitro CRO service and third-part entrusted testing. The Ministry of Health(MOH) and CFDA as authority of the domestic cosmetics responsible for issue and implement Cosmetics Health Standards(2007 version), new Cosmetics Safety Technical Specification(draft revision) still insist on animal testing and will not abolition old or add new test methods including alternative methods.

  7. AQSIQ SN standards/guidelines acceptance •Good Laboratory Practice for Cosmetics Alternative Testing In vitro. SN/T2285-2009 •Cosmetics Acute Toxicity of Keratinocyte Cytotoxicity Test. SN/T 2328—2009. •Cosmetics Ocular Corrosive and Irritant HET-CAM Test Method.SN/T2329-2009 •Embryrotoxicity and Developmental Toxicity of Mice Embryonic Stem Cell Test. SN/T2330-2009 Cell line NRU test for eye irritation Local lymph node assay (LLNA) for skin sensitization • Cosmetics guideline for risk assessment strategy and decision-tree.No.2010B072 • cosmetics phototoxicity test for combined RBC methods.No. 2010B074 • cosmetics testing in vitro for good cell culture practices and sample preparation principles.No. 2010B075 • cosmetics guideline for alternative methods validation and acceptance.No. 2010B076 • cosmetics skin irritation test for isolated skin. No. 2010B079 • cosmetics developmental toxicity test for whole embryo culture.No. 2010B269k … … …

  8. Scientific validation activities • 2010, AQSIQ set up validation criterion and procedure with reference to the EURL-ECVAM, OECD, ICCVAM related validation guideline. • 2011-2013,multi-center validation for skin irritation by equivalent skin model Episkin(made in China) Milestone event for alternative methods validation in China

  9. CAIQ lab Guangdong Lab Beijing Lab Shanghai Lab L`oreal R&I organization Management team Auditor National new drug safety assessment center China National Accreditation Service for Conformity Assessment(CNAS) Independent statistics: the statistical society members Chemical distribution: professional third-party outsourcing company The professional transport

  10. New Alternative Methods Development • Short Time Exposure (STE) test for Cosmetics, an Alternative to Draize Eye Irritation Test • A Modified Short-Time Exposure (mSTE) Test for Cosmetics: an Alternative to the Draize Eye Irritation Test • Screening of skin irritation using monolayer cells • A Combined Test Skin Irritation Evaluation: Monolayer cell, 3-dimensional Skin Model tests and Human Patch test • The alternatives in oral mucous membrane irritation • The integrated testing for eye irritation to personal and household care products • Combination of CAMVA and BCOP to predictive the eye irritation of cosmetics. • Establishing an in vitro screening test for developmental neurotoxicity • Personal care products in vitro test based on the clinical characteristics of children's skin • The role of TRP channels family at infant skin development and mechanism of mediated skin sensitization • Anti-irritation study by 3D reconstructed skin model in vitro test • Integrated screening methods study for personal care product skin sensitization

  11. Promote the integrated test strategy for cosmetics safety and efficacy Efficacy test safety/toxicity test Whitening Nutrition Anti-oxidant Anti-ageing Anti-inflammation Angiogenesis Hair growing Anti adipose Basic cytomics Repair in vitro Patch test Anti-UV lesion （Photo） patch test SPF test in vitro Non-animal testign: QSAR、TTC、Read-across Eye irritation ： HET-AM+BCOP+RBC+Epiocular Skin irritation：3D skin phototoxicity：3T3 NRU,3D skin Skin Sensitization：DPRA, H-CALT, co-culture Genotoxicity testing：3D model Acute oral toxicity predictive：cytotoxicity: embryotoxicity：EST Endocrine disruptor screening ……. Integrated Test Strategy Human testing Adaptability and Efficacy test

  12. Support and Help Industries Application of Alternative Methods Recent years, Chinese brands gradually accept alternative methods for safety assessment and /or functional evaluation. We through various ways to promote the application of these methods, including training, testing services and other customization mode. For toxicology assessment: covered acute toxicity prediction(3T3 NRU,KC NRU, target tissue cytotoxicity), eye irritation(CAMVA+BCOP,HET-CAM+BCOP,MDCK-FL+BCOP), skin irritation (keratinocyte, EpiSkin), phototoxicity(3T3 NRU-PT+RBC-PT) and skin sensitization(DPRA,H-CALT ). For in vitro efficacy ingredients screening, for example antioxidant(ring-CAM, fibroblast ROS), sunscreen(keratinocyte P53, inhibition ET-1) and whitening (anti-tyrosinase activity, inhibition keratinocyte uptake). It is also helpful for the safety evaluation and efficacy claims of products. 

  13. Third part animal free testing service in China • The number of testing increased every year • OECD or valided methods Toxicity testing • Market size forecasting only 2 million Test methods covered

  14. Continuous Education and Training 1.Education and Scientific public Alternatives Laboratory Animal Methods principle and Application, Science Press,2010 The Three Rs and the Humanity Criterion( Chinese version) ,Science Press,2014 Predictive toxicology and guideline of alternative methods, Science Press,2016 2. Academic seminar

  15. Continuous Education and Training From 2013, the formal alternative training meeting were hold 1-2 times every year host by Guangdong Inspection and Quarantine Technology Center (GDCIQ). The first workshop hold in March of 2013 at Guangzhou which the theme is Humane Cosmetics Testing: a new starting point for China The 2nd hold in Aril of 2014 at Guangzhou which the theme is the 3Rs Road from ideas to practice. The 3rd hold in Nov. of 2014 at Chengdu which the theme is the Alternatives standardization and new technology application . The 4th hold in April of 2015 at Guangzhou which the theme is the Modernization of animal testing and alternatives progress.

  16. The 5thWorkshop of Alternative Methods The 4th will be held 2nd-5th in Dec of 2015 at Shanghai which the theme is the Animal free testing in chemical and cosmetics assessment. GDCIQ`s workshop has become China's most influential alternatives meeting. Continuous education and trainings promotes the no animal testing alternative methods development in China.

  17. Consensus Platform for Alternatives Chinese Center for Alternatives Research & Evaluation (CCARE) http://www.vitrotox.com CCARE Purpose • Promote the knowledge and acceptance of the 3Rs alternatives at public • Establish and maintain a sharing database on alternative resource • Promote the standardization and application of alternatives • Provide the communication platform between scientists, administrations and public

  18. Difficulties and challenge Promote animal free testing regulations approved in Chinese need: • Reconstructed animal welfare concept • Filling the gap between animal welfare/3Rs concept and scientific realized way • Support and help industries application alternative methods • Reach a consensus between local industries and regulators • Outspread application of alternative methods in the country, set up a laboratory network • Need(policy and time) to set up corresponding related industry support • National validation center and Data sharing ……… Bottom-up support ----may be slowly ----enterprise actively support gradually ----obeying market rules ----alternatives acceptance is the scientific practice rather than movement

  19. Obstacle: Segmentation of management mode complex network to promote animal free testing- Good Outcome Pathway Third part Co. Hi-tech service outsourcing cosmetics Chemicals household medicines Standardization Administration of China (SAC) --cosmetics -labanimal -dangerous chemicals -pesticide Pharmacopoeia  industries service standards Commercial Supplier Cell culture consumables 3D skin model Instrument in vitro commerical Regulation accept Policy plan government validation education MOH MEP MOA AQSIQ MOST • National • Local government • National department • International cooperation • Industrial policy School education Higher education Continue education Vocational education Public education National CaVAM? Industries prevalidation CNAS

  20. Good Outcome Pathway (GOP) for Animal Free Testing External motivation Organ Response Cellular Response Organism Response Initiating Event Cellular Response Valided accepted and Standard methods Application Animal free testing universal Regulatory accept Local industries laboratories Outspread 3Rs conception Toxicology Moderization New methods innovation validation Cosmetics animal testing ban 1990`s 2008 2014 2020 ? 2008 2020 ?

  21. Many thanks for your attention Dr.Prof. Shujun Cheng Guangdong Entry-Exit Inspection & Quarantine Bureau Technology Center Website：Chinese Center for Alternative Research and Evaluation(CCARE) http://www.vitrotox.com Email：chengsj@126.com Tel：8620-38290670；13602811627 Add: #1211 B tower, No.66 Huacheng Avenue, Guangzhou, China

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