Quality Assurance & Control Systems Cosmetics Testing Laboratory
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
QACS Time Line 2002 Laboratory creation, GLP, Micro, Challenge 2004 ISO 17025 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
QACS in figures Laboratory creation : 2002 Manpower Annual production : 40 persons : 40000 samples Site Athens : 1000 m 2
Cosmetics testing
EC Regulation 1223/2009 Cosmetic Product Safety Report
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
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
Part B 1. Assessment conclusion 2. Labeled warnings and instructions of use 3. Reasoning 4. Assessor s credentials and approval of part B
Preservation Efficacy
Protocols EP or USP 35 protocol Challenge ISO 11930 Mixed culture test Re-inoculation protocol Wipe protocol
Patch Test
Protocols Protocol 48hrs Patch Test Claim Non- irritant Human Repeated Insult Patch Test (HRIPT) Hypo-allergenic
EC Regulation 655/2013 Efficacy In Vivo and In Vitro
Claims to support Anti Wrinkle Moisturizing Elasticity Sebum control Ophthalmologically Tested Very well tolerated to skin Very well tolerated to eyes
Stability
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
Traces - Impurities Heavy Metals-Allergens- Others
EC/1223/2009, ANNEX II Substances Prohibited in Cosmetics No Chemical name CAS EC 97 Chromium; chromic acid and its salts 7440-47-3 231-157-5 89 Lead and its compounds 7439-92-1 231-100-4 43 Arsenic and its compounds 7440-38-2 231-148-6 221 Mercury and its compounds, except those special cases included in Annex V (preservative 0,007 % (of Hg) 7439-97-6 231-106-7 68 Cadmium and its compounds 7440-43-9 231-152-8 40 Antimony and its compounds 7440-36-0 231-146-5 297 Selenium and its compounds with the exception of selenium disulphide under the conditions set out under reference No 49 in Annex III (antidandruff 1%) 7782-49-2 231-957-4 No limits
EC/1223/2009, ANNEX III Substances which cosmetics must not contain except subject to restrictions laid down Reference number 67 92 Allergens INCI name CAS number Amyl cinnamal 122-40-7 alpha-amylcinnamyl alcohol 101-85-9 Anise alcohol 105-13-5 Benzyl alcohol 100-51-6 Benzyl benzoate 120-51-4 Benzyl cinnamate 103-41-3 Benzyl salicylate 118-58-1 Butyl phenyl methyl propional 80-54-6 Cinnamal 104-55-2 Cinnamyl alcohol 104-54-1 Citral 5392-40-5 Citronellol 106-22-9 Coumarin 91-64-5 Eugenol 97-53-0 Farnesol 4602-84-0 Geraniol 106-24-1 Hexyl Cinnamal 101-86-0 Hydroxycitronellal 107-75-5 Hydroxyisohexyl-3- cyclohexene carboxyaldehyde 31906-04-4 Isoeugenol 97-54-1 Alpha-isomethyl ionone 127-51-5 d-limonene 5989-27-5 Linalool 78-70-6 Methyl-2-octynoate 111-12-6 Evernia prunastri/oak moss 90028-68-5 Evernia furfuracea/tree moss 90028-67-4
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
QACS Competitive Advantages One stop shop on cosmetics testing A variety of protocols in competitive prices ISO 17025 accredited ISO 9001 certified GLP compliant Real time information on intermediate results 24hr sample collection service (EU)
QACS Accreditation ISO 17025 accreditation by ESYD (Hellenic Accreditation System) GLP accreditation by NDO (National Drug Organization)
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
QACS GMP/GLP Medicinal Products Pharmaceutical Starting Materials Cosmetic Products Microbiological Quality Control Testing of Water Disinfectants Food Supplements Medical Devices
QACS @ 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
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