Quality Assurance & Control Systems Cosmetics Testing Laboratory

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1 Quality Assurance & Control Systems Cosmetics Testing Laboratory

2 QACS Services Complete range of micro physicochemical tests Challenge Test The challenge test laboratory Safety Assessment (PIF) Patch Test-HRIPT Stability Efficacy One Stop Shop on Cosmetics Testing

3 QACS Time Line 2002 Laboratory creation, GLP, Micro, Challenge 2004 ISO accreditation 2006 New premises 2008 Safety Assessment, Marketability 2009 GLP on Pharmaceuticals 2010 Central Europe, Middle East, Asia, QACS Istanbul 2011 ISO 9001, Dermatological testing 2012 ERPA member, Efficacy tests 2014 Pharmaceuticals 2015 In Vitro testing 2016 Expand Efficacy tests

4 QACS in figures Laboratory creation : 2002 Manpower Annual production : 40 persons : samples Site Athens : 1000 m 2

5 Cosmetics testing

6 EC Regulation 1223/2009 Cosmetic Product Safety Report

7 Annex I- Cosmetic Product Safety Report Part A. Gathering all the necessary data to prove that the product is safe Part B. The actual assessment of the safety of the product by the assessor

8 Part A 1. Quantitative and qualitative composition of the cosmetic product 2. Physical/chemical characteristics and stability of the cosmetic product 3. Microbiological quality 4. Impurities, traces, information about the packaging material 5. Normal and reasonably foreseeable use 6. Exposure to the cosmetic product 7. Exposure to the substances 8. Toxicological profile of the substances 9. Undesirable effects and serious undesirable effects 10. Information on the cosmetic product

9 Part B 1. Assessment conclusion 2. Labeled warnings and instructions of use 3. Reasoning 4. Assessor s credentials and approval of part B

10 Preservation Efficacy

11 Protocols EP or USP 35 protocol Challenge ISO Mixed culture test Re-inoculation protocol Wipe protocol

12 Patch Test

13 Protocols Protocol 48hrs Patch Test Claim Non- irritant Human Repeated Insult Patch Test (HRIPT) Hypo-allergenic

14 EC Regulation 655/2013 Efficacy In Vivo and In Vitro

15 Claims to support Anti Wrinkle Moisturizing Elasticity Sebum control Ophthalmologically Tested Very well tolerated to skin Very well tolerated to eyes

16 Stability

17 Shelf life & PAO Shelf life The period of time during which a product remains in compliance with its specification when stored under the conditions of the market Expiry date (EC date of minimum durability) The date on which the product becomes no longer acceptable The date by which it is best to use the product The date until which the cosmetic product will continue to fulfill its initial function and remain safe PAO (Period After Opening) Where the minimum durability is more than 30 months, the consumer should be informed of the period of time after opening that the cosmetic product may be used without any harm to the consumer

18 Traces - Impurities Heavy Metals-Allergens- Others

19 EC/1223/2009, ANNEX II Substances Prohibited in Cosmetics No Chemical name CAS EC 97 Chromium; chromic acid and its salts Lead and its compounds Arsenic and its compounds Mercury and its compounds, except those special cases included in Annex V (preservative 0,007 % (of Hg) Cadmium and its compounds Antimony and its compounds Selenium and its compounds with the exception of selenium disulphide under the conditions set out under reference No 49 in Annex III (antidandruff 1%) No limits

20 EC/1223/2009, ANNEX III Substances which cosmetics must not contain except subject to restrictions laid down Reference number Allergens INCI name CAS number Amyl cinnamal alpha-amylcinnamyl alcohol Anise alcohol Benzyl alcohol Benzyl benzoate Benzyl cinnamate Benzyl salicylate Butyl phenyl methyl propional Cinnamal Cinnamyl alcohol Citral Citronellol Coumarin Eugenol Farnesol Geraniol Hexyl Cinnamal Hydroxycitronellal Hydroxyisohexyl-3- cyclohexene carboxyaldehyde Isoeugenol Alpha-isomethyl ionone d-limonene Linalool Methyl-2-octynoate Evernia prunastri/oak moss Evernia furfuracea/tree moss

21 Need to test examples 1,4-Dioxane byproduct during the manufacturing process of certain cosmetic ingredients (detergents, foaming agents, emulsifiers and solvents) Nitrosamines Hair dyes Benzopyrenes Wood Tars and Wood Tar preparations Acrylamides Polyquaterniums, polyacrylamides Benzene Petrolatum

22 QACS Competitive Advantages One stop shop on cosmetics testing A variety of protocols in competitive prices ISO accredited ISO 9001 certified GLP compliant Real time information on intermediate results 24hr sample collection service (EU)

23 QACS Accreditation ISO accreditation by ESYD (Hellenic Accreditation System) GLP accreditation by NDO (National Drug Organization)

24 QACS Certification Safety Assessment of Cosmetic Products Skin Tolerance Assessment (patch test) Efficacy Studies (in vitro and use tests) Determination of Allergens Stability Testing Evaluation of Disinfectants and Antiseptics

25 QACS GMP/GLP Medicinal Products Pharmaceutical Starting Materials Cosmetic Products Microbiological Quality Control Testing of Water Disinfectants Food Supplements Medical Devices

26 international fairs 2008 Amsterdam 2009 Munich, Istanbul 2010 Paris, Istanbul 2011 Milan, Istanbul 2012 Barcelona, Paris, Istanbul 2013 Paris, Istanbul 2014 Paris, Istanbul, Hamburg 2015 Barcelona, Istanbul, Paris 2016 Paris, Amsterdam, Istanbul, Barcelona

27 Thank you for your attention!

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