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Quality Assurance & Control Systems Cosmetics Testing Laboratory

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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 : 40 persons

Annual production : 40000 samples

Site Athens : 1000 m2

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

48hrs Patch Test Non- irritant

Human Repeated Insult Patch Test(HRIPT)

Hypo-allergenic

Protocol Claim

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 IISubstances 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

297Selenium 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

GLP accreditation by NDO

(National Drug Organization)

ISO 17025 accreditation by ESYD

(Hellenic Accreditation System)

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

Thank you for your

attention!