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Diamond FX Eye Liner.pdf - Face Paints Direct

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<strong>Diamond</strong> <strong>FX</strong>/ Pretty <strong>Face</strong> B.V. P/O 9354 1800GJ Alkmaar The Netherlands.<br />

<strong>Diamond</strong> <strong>FX</strong>/ COSMETIC REGISTRATION INFORMATION (ONLY FOR INTERNAL USE)<br />

YOUR PRODUCT BRAND NAME: <strong>Diamond</strong> <strong>FX</strong> <strong>Eye</strong>liner Pen / EY00, EY10, EY20, EY60, EY66, EY68.<br />

ARTICEL NR.: <strong>Diamond</strong> <strong>FX</strong> <strong>Eye</strong>liner Pen Carbon<br />

FORMULA REFERENCE: UBM formula for EYELINER / Formula-Nr.: 060917.109-P / 060917.108-P<br />

060917.106-P, 060917.34-P, 060917.34-P<br />

SECTION 01:<br />

BSE FREE / CMR CERTIFICATE / Free of ANIMAL TESTING<br />

We herewith confirm that following products listed here<br />

PRODUCTS: SEMI PERMANENT INK EYELINER PEN * <strong>Diamond</strong> <strong>FX</strong> <strong>Eye</strong>liner Pen / shades with COLORINGS<br />

FORMULAS: Formula-Nr.: 060917.109-P, 060917.108-P, 060917.106-P, 060917.34-P, 060917.33-P<br />

are<br />

A. FREE OF ANY ANIMAL ORIGIN INGREDIENTS and BSE FREE B. NOT TESTED ON ANIMAL<br />

C. DOES NOT CONTAIN ANY INGREDIENTS LISTED in the CMR category 1, 2 or 3<br />

Article 4b of the Cosmetics <strong>Direct</strong>ive, prohibits the use in cosmetic products of substances CMR<br />

Category 1, 2 and 3 classified in the Annex I of the Council <strong>Direct</strong>ive 67/548/EEC.<br />

SECTION 02:<br />

MATERIAL SPECIFICATION CERTIFICATE<br />

We herewith confirm that following products listed here<br />

PRODUCTS: SEMI PERMANENT INK EYELINER PEN * <strong>Diamond</strong> <strong>FX</strong> <strong>Eye</strong>liner Pen / shades with COLORINGS<br />

FORMULAS: Formula-Nr.: 060917.109-P, 060917.108-P, 060917.106-P, 060917.34-P, 060917.33-P<br />

are made out of following materials:<br />

A. MATERIAL SPECIFICATION: CAPS PP<br />

B. MATERIAL SPECIFICATION: BODY PP<br />

C. MATERIAL SPECIFICATION: END CAPS * PP<br />

TOTAL WEIGHT: 6,33 gr filled pen<br />

TOTAL WEIGHT: 5,15 gr empty pen<br />

PP = Polypropylen / CAS - number: 9003-07-0<br />

/ RECYCLING CODE PP RAW MATERIAL SPECIFICATION: The raw material PP is free of nitrite.<br />

MOLECULAR FORMULA: The molecular formula (C3H6) MELTING POINT PP: 130–171 C (266–340 F)<br />

DECLARATION OF INK VOLUME: 1,0 ml declared (minimum fill volume) / 1,2 ml real fill volume<br />

www.Dfx<strong>Face</strong>art.eu info@dfxfaceart.nl


<strong>Diamond</strong> <strong>FX</strong>/ Pretty <strong>Face</strong> B.V. P/O 9354 1800GJ Alkmaar The Netherlands.<br />

Section3:<br />

ANALYZEN ZERTIFIKAT / CERTIFICATE of ANALYSIS<br />

Art.-Nr. / PRD NR.: 060917.109-P, 060917.108-P, 060917.106-P, 060917.34-P, 060917.33-P<br />

Name / NAME : SEMI PERMANENT INK LINER PEN<br />

Status / STATUS : approved<br />

Revision: A<br />

Version: 00001<br />

Seite / PAGE:1 von 1<br />

Freigabe Nr / APPROVAL NR. : 0323/12 Lieferant / Herkunft / ORIGIN : intern<br />

Eingangsdatum / ENTRY DATE: 23.03.2012<br />

FORMULA INK LINER<br />

PRODUCT / PRODUKT: INK LINER BLACK<br />

BRAND NAME / MARKE: all / different<br />

PRODUCTION DATE / HERSTELLUNGSDATUM: open EXPIRATION DATE / HALTBAR BIS: 36 months<br />

Microbiological Analysis<br />

L.Z<br />

NR.<br />

Prüfparameter :<br />

TEST PARAMETERS :<br />

Spezifikation<br />

SPECIFICATION<br />

Methode<br />

METHOD<br />

Ergebnis<br />

RESULT<br />

PK / Datum<br />

PROD. CONT. DATE<br />

Aussehen<br />

VISUAL IMPRESSION<br />

trübe Flüssigkeit<br />

cloudy liquid UBM CH/02a<br />

Entspricht<br />

corresponding PPA / 23.03.12<br />

Farbe<br />

COLOUR RAL 7035 UBM CH/02b<br />

Entspricht<br />

corresponding PPA / 23.03.12<br />

Geruch<br />

ODOR Standard UBM CH/03<br />

Entspricht<br />

corresponding PPA / 23.03.12<br />

Dichte / Biegeschw.<br />

Meth. DMA48<br />

1,00- 1,02 g/cm³ DGF C-IV2d 1,0091 PPA / 23.03.12<br />

DENSITY<br />

pH-Wert<br />

pH LEVEL 6,8 – 7,0 DGF H-III 1 6,86 PPA / 23.03.12<br />

Gesamtkeimzahl<br />

CONC. OF BACTERIA


<strong>Diamond</strong> <strong>FX</strong>/ Pretty <strong>Face</strong> B.V. P/O 9354 1800GJ Alkmaar The Netherlands.<br />

Section 4:<br />

CERTIFICATE of FREE SALE / HEALTH CERTIFICATE<br />

We herewith confirm that following products listed her are ..<br />

A. All products listed here<br />

PRODUCTS: SEMI PERMANENT INK EYELINER PEN * <strong>Diamond</strong> <strong>FX</strong> <strong>Eye</strong>liner Pen / shades with COLORINGS<br />

FORMULAS: Formula-Nr.: 060917.109-P, 060917.108-P, 060917.106-P, 060917.34-P, 060917.33-P<br />

All listed products are free to be sold in all countries and conform to the European Standards i.e.<br />

European Council <strong>Direct</strong>ive 76/768/EEC - January 11, 2010 and Council <strong>Direct</strong>ive 2011/84/EU of<br />

September 20, 2011 amending the <strong>Direct</strong>ive 76/768/EEC - in accordance with the German Public Health<br />

Regulations and that they are freely sold in Germany and in all EXPORT COUNTRIES listed below for<br />

cosmetic purposes.<br />

B. This document is destined for the export to following EXPORT COUNTRIES: ALL STATES in EUROPE /<br />

USA / JAPAN / MIDDLE EAST & LATIN AMERICA<br />

SECTION 05:<br />

E.U CONFORMITY DOCUMENT FOR UBM INK LINER FORMULA<br />

PRODUCTS: SEMI PERMANENT INK EYELINER PEN * <strong>Diamond</strong> <strong>FX</strong> <strong>Eye</strong>liner Pen / shades with COLORINGS<br />

FORMULAS: Formula-Nr.: 060917.109-P, 060917.108-P, 060917.106-P, 060917.34-P, 060917.33-P<br />

We herewith confirm that all the COLORINGS and INGREDIENTS used in the product range LIQUID SEMI<br />

PERMANENT EYELINER & EYEBROW & TATTOO & LIPLINER & LIPSTICK & LIP STAIN and REMOVER PEN<br />

STANDARD & REMOVER PEN R-IBF FORMULA are conform to the applicable European Standards i.e.<br />

European Council <strong>Direct</strong>ive 76/768/EEC - January 11, 2010 and Council <strong>Direct</strong>ive 2011/84/EU of<br />

September 20, 2011 amending the <strong>Direct</strong>ive 76/768/EEC.<br />

We also confirm that NONE of the Raw Materials and Colorants used in our LIQUID SEMI PERMANENT<br />

EYELINER & EYEBROW<br />

& TATTOO & LIPLINER & LIPSTICK & LIP STAIN and REMOVER PEN STANDARD & REMOVER PEN R-IBF<br />

formulas are animal or<br />

human derived.<br />

www.Dfx<strong>Face</strong>art.eu info@dfxfaceart.nl


<strong>Diamond</strong> <strong>FX</strong>/ Pretty <strong>Face</strong> B.V. P/O 9354 1800GJ Alkmaar The Netherlands.<br />

SECTION 06:<br />

GMO CERTIFICATE (Genetically Modified Organisms)<br />

We herewith confirm that following products listed here<br />

PRODUCTS: SEMI PERMANENT INK EYELINER PEN * <strong>Diamond</strong> <strong>FX</strong> <strong>Eye</strong>liner Pen / shades with COLORINGS<br />

FORMULAS: Formula-Nr.: 060917.109-P, 060917.108-P, 060917.106-P, 060917.34-P, 060917.33-P<br />

are ..<br />

A. FREE OF ANY genetically modified animal based INGREDIENTS B. FREE OF ANY genetically modified<br />

plant based INGREDIENTS<br />

SECTION 07:<br />

MANUFACTURING PROCESS MANAGEMENT / METHOD of MANUFACTURING<br />

QC SYSTEM * PRODUCT STABILITY 12 m “BEST USE BEFORE” RECOMMENDATION<br />

PRODUCTS: SEMI PERMANENT INK EYELINER PEN * <strong>Diamond</strong> <strong>FX</strong> <strong>Eye</strong>liner Pen / shades with COLORINGS<br />

FORMULAS: Formula-Nr.: 060917.109-P, 060917.108-P, 060917.106-P, 060917.34-P, 060917.33-P<br />

THE INDUSTRY TEST STANDARDS : QUALITY CONTROL & MANUFACTURING PROCESS<br />

Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing<br />

Practice') is a term that is recognized worldwide for the control and management of manufacturing and<br />

quality control testing of foods and pharmaceutical products.<br />

UBM manufactures all the <strong>Liner</strong> Pen products according to the GMP norms.<br />

Since sampling products will statistically only ensure that the samples themselves (and perhaps the<br />

areas adjacent to where the samples were taken) are suitable for use, and end-point testing relies on<br />

sampling, GMP takes the holistic approach of regulating the manufacturing and laboratory testing<br />

environment itself. An extremely important part of GMP is documentation of every aspect of the<br />

process, activities, and operations involved with drug and medical device manufacture. If the<br />

documentation showing how the product was made and tested (which enables traceability and, in the<br />

event of future problems, recall from the market) is not correct and in order, then the product does not<br />

meet the required specification and is considered contaminated (adulterated in the US). Additionally,<br />

GMP requires that all manufacturing and testing equipment has been qualified as suitable for use, and<br />

that all operational methodologies and procedures (such as manufacturing, cleaning, and analytical<br />

testing) utilized in the drug manufacturing process have been validated (according to predetermined<br />

specifications), to demonstrate that they can perform their purported function.<br />

www.Dfx<strong>Face</strong>art.eu info@dfxfaceart.nl


<strong>Diamond</strong> <strong>FX</strong>/ Pretty <strong>Face</strong> B.V. P/O 9354 1800GJ Alkmaar The Netherlands.<br />

THE COSMETIC INDUSTRY STANDARDS:<br />

A. DOCUMENTATION: All manufacturing process must be documented.<br />

B. QUALITY CONTROL INCOMING RAW MATERIALS: All raw materials are visually controlled and UBM<br />

microbiology<br />

tested before any process and production.<br />

C. QUALITY CONTROL FINISHED PRODUCTS: All finished products must be microbiology tested after<br />

filling and production before shipped to clients.<br />

D. ANALITICAL TESTING: All purchased ingredients and colorings must be received with a Certificate of<br />

Analysis.<br />

E. BACK UP SAMPLES: The manufacturer of the finished product should keep from all manufactured<br />

products in each color and specification 12 BACK UP SAMPLES for the following 7 years.<br />

F. BATCH CODE / LOT NR.: Every single product must have a BATCH CODE on the packaging.<br />

UBM MANUFACTURING PROCESS MANAGEMENT<br />

1. All incoming ingredients have a certificate of analysis from the former suppliers.<br />

2. All incoming ingredients are controlled by UBM QC with the backup samples we have in our lab.<br />

Any difference can be found out before the UBM manufacturing process begins.<br />

3. The fluid ready mixed base of the ink formula is colored in the UBM factory with corresponding<br />

colorings.<br />

4. The colorings are purchased always from the same source and with a certificate of analysis, so<br />

that we cannot have any differences in quality.<br />

5. After filling and finishing of the pen, the UBM QC Manager takes from different cartons from all<br />

colors 12 samples<br />

which are microbiology tested in an external lab.<br />

6. If there are no unexpected negative results, the goods can leave the factory.<br />

7. All the products have an automatically embossed batch code on the end plugs of the liner pens.<br />

8. The identification of a problem is guaranteed through the back up samples in our factory.<br />

9. The products can be used without any problems within 12 months after first use PAO 12m.<br />

DESINFECTION & CLEANING OF THE MANUFACTURING FACILITY<br />

1. All rooms, warehouses and every room of the UBM factory is covered from floor to the ceiling with<br />

tiles.<br />

2. All equipment and all surfaces of the UBM factory are stainless steel.<br />

3. All rooms are cleaned daily with antibacterial cleaners.<br />

4. All walls are disinfected every week from floor to ceiling.<br />

DOCUMENTATION OF THE UBM PRODUCTION PROCESS<br />

1. All steps of the UBM manufacturing process are documented for each and every order we produce.<br />

2. All external purchased ingredients and parts are documented for each and every order we produce.<br />

3. The documents are available for the following 7 years.<br />

PRODUCT SAFETY / DANGEROUS INGREDIENTS / FLAMMABLE INGREDIENTS<br />

1. The formula is free of alcohol or any other flammable or explosive ingredients. There are no<br />

dangerous<br />

www.Dfx<strong>Face</strong>art.eu info@dfxfaceart.nl


<strong>Diamond</strong> <strong>FX</strong>/ Pretty <strong>Face</strong> B.V. P/O 9354 1800GJ Alkmaar The Netherlands.<br />

ingredients in the formula of the ink.<br />

2. The formula is 100% water based solution.<br />

3. The incoming ready mixed fluid base of the formula comes with a microbiology test certification.<br />

4. All plastic parts used in this item are Polypropylen / PP and are not dangerous for human health.<br />

R E S U L T: FOR ALL FINISHED LINER PENS / PAO 12 MONTHS / WAREHOUSING 36 MONTHS<br />

1. The formula is safe and the preservative system of the base and coloured ink works according to the<br />

standards. The products can be used without any problems within 12 months after first use.<br />

2. The liner pen is an air tight product which can be warehoused 36 months after delivery safely.<br />

3. The microbiology test for the finished product can guarantee a clean and safe product for the<br />

consumer.<br />

SECTION 08:<br />

PAO CERTIFICATE<br />

of BEST USE BEFORE / WAREHOUSING TIME / PAO<br />

We herewith confirm that following products listed here<br />

PRODUCTS: SEMI PERMANENT INK EYELINER PEN * <strong>Diamond</strong> <strong>FX</strong> <strong>Eye</strong>liner Pen / shades with COLORINGS<br />

FORMULAS: Formula-Nr.: 060917.109-P, 060917.108-P, 060917.106-P, 060917.34-P, 060917.33-P<br />

are ..<br />

A. WAREHOUSE TIME / UNOPENED PRODUCTS : 36 months after production<br />

B. WAREHOUSE TIME / OPENED PRODUCTS : 12 months after first use<br />

C. PAO : 12 m<br />

SECTION 09:<br />

PAO 12m / SHELF LIFE 36m : TEST CERTIFICATE<br />

SEMI PERMANENT INK LINER PENS<br />

We herewith confirm that following products listed here<br />

PRODUCTS: SEMI PERMANENT INK EYELINER PEN * <strong>Diamond</strong> <strong>FX</strong> <strong>Eye</strong>liner Pen / shades with COLORINGS<br />

FORMULAS: Formula-Nr.: 060917.109-P, 060917.108-P, 060917.106-P, 060917.34-P, 060917.33-P<br />

are tested as follows:<br />

TESTING METHOD:<br />

A. SHELF LIFE: The products are in original transport cartons / packed on pallets / warehoused.<br />

B. PAO: The products are during one week used 7 x times and / warehoused in our lab.<br />

www.Dfx<strong>Face</strong>art.eu info@dfxfaceart.nl


<strong>Diamond</strong> <strong>FX</strong>/ Pretty <strong>Face</strong> B.V. P/O 9354 1800GJ Alkmaar The Netherlands.<br />

MATERIAL OF THE PACKAGING: The packaging of the liner pens are made of PP.<br />

WAREHOUSING CONDITIONS: Closed carton boxes WAREHOUSE TEMPERATURE: 6 – 48 C<br />

UNOPENED PRODUCTS / RESULT AFTER TIME PERIOD<br />

MONTHS 6 9 12 24 36 48<br />

RESULT 99,89% 99,84% 99,83% 99,81% 99,81% 99,81%<br />

INK wet wet wet wet wet wet<br />

WET: functional & 100% equal color like the master sample ..<br />

ONCE OPENED & USED PRODUCTS / RESULT AFTER TIME PERIOD<br />

MONTHS 3 6 9 12 18 24<br />

RESULT 99,87% 99,83% 99,82% 99,79% 99,79% 99,79%<br />

INK wet wet wet wet wet wet<br />

WET: functional & 100% equal color like the master sample ..<br />

SECTION 10:<br />

STABILITY TEST CERTIFICATE / REPORT<br />

We herewith confirm the stability if the following products listed here<br />

PRODUCTS: SEMI PERMANENT INK EYELINER PEN * <strong>Diamond</strong> <strong>FX</strong> <strong>Eye</strong>liner Pen / shades with COLORINGS<br />

FORMULAS: Formula-Nr.: 060917.109-P, 060917.108-P, 060917.106-P, 060917.34-P, 060917.33-P SEMI<br />

PERMANENT INK LINER PEN – SLIM STD „PP“ PACKAGING<br />

PRODUCT FILL VOL. AFTER 21 DAYS AFTER 45 DAYS AFTER 90 DAYS<br />

EYELINER black 109 1,155 gr 1,155 gr 1,143 gr 1,132 gr<br />

EYELINER S. PERM. 1,155 gr 1,155 gr 1,138 gr 1,128 gr<br />

EYEBROW S. PERM. 1,155 gr 1,155 gr 1,138 gr 1,128 gr<br />

LIPLINER S. PERM. 1,155 gr 1,155 gr 1,138 gr 1,128 gr<br />

LIPSTICK S. PERM. 1,155 gr 1,155 gr 1,138 gr 1,128 gr<br />

TATTOO S. PERM. 1,155 gr 1,155 gr 1,138 gr 1,128 gr<br />

REMOVER PEN 1,155 gr 1,153 gr 1,136 gr 1,126 gr<br />

REMOVER PEN R-IBF 1,155 gr 1,153 gr 1,136 gr 1,126 gr<br />

• SAME DAY MANUFACTURED PRODUCTS HAS BEEN STORED IN AN OWEN OF : 52 C<br />

• DECLARED VOLUME : 1,0 gr e / filled between 1,15 and 1,20 gr<br />

• CHANGE OF VISCOSTY / COLOR : not existent<br />

• CHANGE OF VISUAL IMPRESSION & ODOR : not existent<br />

• PP MATERIAL SHRINKS AFTER PRODUCTION WITHIN 4 to 6 WEEKS: MAX. 2% to 3%<br />

www.Dfx<strong>Face</strong>art.eu info@dfxfaceart.nl


<strong>Diamond</strong> <strong>FX</strong>/ Pretty <strong>Face</strong> B.V. P/O 9354 1800GJ Alkmaar The Netherlands.<br />

SECTION 11:<br />

SAFETY DATA SHEET / MSDS FINISHED PRODUCT<br />

1. PRODUCT AND COMPANY IDENTIFICATION<br />

PRODUCTS: SEMI PERMANENT INK EYELINER PEN * <strong>Diamond</strong> <strong>FX</strong> <strong>Eye</strong>liner Pen / shades with COLORINGS<br />

FORMULAS: Formula-Nr.: 060917.109-P, 060917.108-P, 060917.106-P, 060917.34-P, 060917.33-P<br />

Company: <strong>Diamond</strong> <strong>FX</strong>. Pretty <strong>Face</strong> B.V. P/O 9354 1800GJ Alkmaar The Netherlands<br />

Emergency telephone number: +31-620385188<br />

Email: Info@dfxfaceart.nl<br />

2. COMPOSITION / INFORMATION ON INGREDIENTS<br />

Mixture of non hazardous materials according to the ingredients list<br />

3. HAZARDS IDENTIFICATION<br />

Cosmetic product for external use, not considered as dangerous by the EEC. This product is not dangerous for the<br />

health if used in a normal condition.<br />

4. FIRST AID MEASURES<br />

No special measures required.<br />

This product is not dangerous for the health if used in a normal condition<br />

Skin and <strong>Eye</strong>s: In case of irritation immediately flush eyes or skin with plenty of water for at least 15 minutes and<br />

get medical attention if irritation persists.<br />

Ingestion: Rinse mouth with water several times and get medical attention. Inhalation: No risk known<br />

5. FIRE FIGHTING MEASURES<br />

Extinguishing media: All standard fire fighting media.<br />

Special fire fighting procedures: No special procedure necessary. Inflammation risk: The product itself is not<br />

flammable or burns hardly.<br />

6. ACCIDENT RELEASE MEASURES<br />

Wipe, scrap or soak up in an inert material and put in a container for disposal. Do not pour into the public.<br />

7. STORAGE AND HANDLING<br />

Special handling procedures: No special handling required. Product to be stored in a cool and dry place. The shelf<br />

life of this product is 3 years after the production date.<br />

8. EXPOSURE CONTROLS AND PERSONAL PROTECTION No special measures required.<br />

Use close gloves and an apron or other light clothing for protection.<br />

9. PHYSICAL AND CHEMICAL PROPERTIES Appearance: liquid<br />

Odor: odorless<br />

Density: 1,01 +/- 0,01<br />

Viscosity: 9 +/- 3 mps<br />

Miscibility in water: yes pH: 10 +/- 0,40-7.00<br />

10. STABILITY AND REACTIVITY: Stable under normal conditions<br />

11. TOXICOLOGICAL INFORMATION: No hazardous product for eye and skin based on dermatological tests<br />

12. ECOLOGICAL INFORMATION: No risk for environment – Water endangering class: 0<br />

13. DISPOSAL INFORMATION: Waste disposal method incinerate according local regulations<br />

14. TRANSPORT INFORMATION: Not classified<br />

15. REGULATORY INFORMATION: No classification and special labeling according to EU regulations<br />

16. OTHER INFORMATION: None<br />

www.Dfx<strong>Face</strong>art.eu info@dfxfaceart.nl


<strong>Diamond</strong> <strong>FX</strong>/ Pretty <strong>Face</strong> B.V. P/O 9354 1800GJ Alkmaar The Netherlands.<br />

Section 12:<br />

BATCH CODE SYSTEM (embossed on colored end caps/ not removable)<br />

We herewith confirm that following products listed here<br />

PRODUCTS: SEMI PERMANENT INK EYELINER PEN * <strong>Diamond</strong> <strong>FX</strong> <strong>Eye</strong>liner Pen / shades with COLORINGS<br />

FORMULAS: Formula-Nr.: 060917.109-P, 060917.108-P, 060917.106-P, 060917.34-P, 060917.33-P<br />

are batch coded / cold embossed ON THE COLORED END CAPS as follows ..<br />

A. UBM BATCH CODE system / with 4 digits / year and week<br />

SECTION 13:<br />

PRESERVATIVE CHALLENGE TEST<br />

PRODUCTS: SEMI PERMANENT INK EYELINER PEN * <strong>Diamond</strong> <strong>FX</strong> <strong>Eye</strong>liner Pen / shades with COLORINGS<br />

FORMULAS: Formula-Nr.: 060917.109-P, 060917.108-P, 060917.106-P, 060917.34-P, 060917.33-P<br />

THE INDUSTRY TEST STANDARDS:PRESERVATIVE CHALLENGE TEST<br />

The challenge test is a 28-day test used to verify the effectiveness of a preservative system in a finished<br />

cosmetic formulation. Selected formulations were inoculated with microorganisms at the onset of<br />

testing (0 hours), then sampled for one month in seven day intervals. At 21 days the formulations were<br />

re-inoculated with the same microorganisms. Pass/fail criteria were based on modified CTFA* protocol.<br />

Inoculum Concentration (CFU/g)<br />

Test Organisms 0 hours 21 days<br />

A. niger 16404 2.5x10 5 3.0x10 5<br />

B. cepacia 25416 5.3x10 6 3.1x10 6<br />

C. albicans 10231 4.3x10 6 1.4x10 6<br />

E. coli 8739 4.0x10 6 7.5x10 6<br />

P. aeruginosa 9027 4.5x10 6 5.2x10 6<br />

Staph. aureus 6538 8.7x10 6 2.7x10 6<br />

www.Dfx<strong>Face</strong>art.eu info@dfxfaceart.nl


<strong>Diamond</strong> <strong>FX</strong>/ Pretty <strong>Face</strong> B.V. P/O 9354 1800GJ Alkmaar The Netherlands.<br />

Preservative Efficacy Test Results (CFU/g)<br />

Test Organisms 48 hours 7 days 14 days 21 days 28 days<br />

Aspergillus niger


<strong>Diamond</strong> <strong>FX</strong>/ Pretty <strong>Face</strong> B.V. P/O 9354 1800GJ Alkmaar The Netherlands.<br />

TEST STANDARDS: SMUDGE PROOF APPLICATION EFFECT<br />

NUMBER OF THE TEST PERSONS: 30 women<br />

NUMBER OF TEST DAYS:<br />

14 days<br />

PRODUKT: UBM EYELINER / colour black 10<br />

APPLICATION:<br />

on dry and clean skin / both eyes<br />

RESULTS: UBM EYELINER / colour black 10<br />

A. The application shows a bleeding effect in the wrinkles: YES: 0% NO: 100%<br />

B. The application is removable with dry finger: YES: > 6% NO: < 94%<br />

TEST STANDARDS: WATERPROOF / WATER RESISTENT EFFECT<br />

NUMBER OF THE TEST PERSONS: 30 women<br />

NUMBER OF TEST DAYS:<br />

14 days<br />

PRODUKT: UBM EYELINER / colour black 10<br />

APPLICATION:<br />

on dry and clean skin / both eyes<br />

RESULTS: UBM EYELINER INK FORMULA / colour black 10<br />

A. The application is easy to remove with normal cold water: YES: 0% NO: 100%<br />

B. The application is removable with warm / shower water: YES: >6% NO: < 94%<br />

TEST STANDARDS: PRODUCT COMFORT FOR SENSITIVE SKIN & EYES EFFECT<br />

NUMBER OF THE TEST PERSONS: 30 women<br />

NUMBER OF TEST DAYS:<br />

14 days<br />

PRODUKT: UBM EYELINER / colour black 10<br />

APPLICATION:<br />

on dry and clean skin / both eyes<br />

RESULTS: UBM EYELINER / colour black 10<br />

A. The application feels comfortable on skin / eyes: YES: 100% NO: 0%<br />

B. The application shows an itching feeling:<br />

YES: 0% NO: 100%<br />

C. The application is drying the / eyes:<br />

YES: 0% NO: 100%<br />

R E S U L T<br />

These results are showing that following marketing specs can be published without any legal problems:<br />

Easy to use<br />

For sensitive eyes & skin<br />

24 h formula<br />

Long lasting formula<br />

12 h formula<br />

Smudge proof formula water resistant formula<br />

www.Dfx<strong>Face</strong>art.eu info@dfxfaceart.nl


<strong>Diamond</strong> <strong>FX</strong>/ Pretty <strong>Face</strong> B.V. P/O 9354 1800GJ Alkmaar The Netherlands.<br />

SECTION 15:<br />

ASSESSMENT SAFETY TEST / HRIPT (= Human Repeat Insult Patch Test)<br />

for SKIN ALLERGY - PERMANENT INK LINER<br />

PRODUCTS: SEMI PERMANENT INK EYELINER PEN * <strong>Diamond</strong> <strong>FX</strong> <strong>Eye</strong>liner Pen / shades with COLORINGS<br />

FORMULAS: Formula-Nr.: 060917.109-P, 060917.108-P, 060917.106-P, 060917.34-P, 060917.33-P<br />

THE INDUSTRY TEST STANDARDS<br />

1. The standard guidelines recognized in the industry for Repeat Insult Patch Test involves placing<br />

an occlusive patch, which is sealed on all four sides, on a one inch area of skin.<br />

2. The clinical study should be conducted using the production 50 consenting women panellists.<br />

The patches must be left on for 24 hours.<br />

3. The following day the panellist come back to the lab for an evaluation and another patch is<br />

placed on the same<br />

area. This process must be repeated for nine applications, after which a 10-14 day rest period is given.<br />

4. Each panellist then comes back for a "challenge test" which is done on an adjacent unexposed<br />

area of skin. They return to the lab 24 hours later when the patch is removed and evaluated. This is<br />

again repeated.<br />

5. The product should not produce any reaction or sensitivity during the entire trial period on any<br />

of the 50 women<br />

tested.<br />

6. These clinical trials gives the product the highest hypoallergenic and "safe use" rating.<br />

UBM TEST PROCEDURE<br />

1. In the HRIPT, a small patch of the test material (smaller than the pad of a standard plaster) is<br />

applied for 24 hours to the upper arm of each of 50 panellists.<br />

2. The material is reapplied three times a week for three weeks at the same site on the upper arm.<br />

3. After a two week rest period, the test material is applied again at the same site.<br />

4. If the test material causes a contact allergy, the test site will appear red, and may be slightly<br />

swollen or itchy.<br />

RESULT:<br />

There was no indication that the basic formulation or any of the coloured variations caused contact<br />

allergies or any negative<br />

side effects. This was the expected result for the finished product formulation since none of the<br />

individual ingredients have been shown to cause skin allergies at the levels used in the UBM<br />

PERMANENT INK LINER & REMOVER PEN formulas.<br />

www.Dfx<strong>Face</strong>art.eu info@dfxfaceart.nl


<strong>Diamond</strong> <strong>FX</strong>/ Pretty <strong>Face</strong> B.V. P/O 9354 1800GJ Alkmaar The Netherlands.<br />

SECTION 16:<br />

SAFETY ASSESSMENT<br />

PRODUCTS: SEMI PERMANENT INK EYELINER PEN * <strong>Diamond</strong> <strong>FX</strong> <strong>Eye</strong>liner Pen / shades with COLORINGS<br />

FORMULAS: Formula-Nr.: 060917.109-P, 060917.108-P, 060917.106-P, 060917.34-P, 060917.33-P<br />

Safety Assessment / Sicherheitsbewertung nach KVO - SCCNFP 0690/03<br />

Regarding the general toxicological profile of the ingredients, their chemical structure and the level of<br />

exposure, in accordance with the principle of good laboratory practice (GLP), the above mentioned<br />

product can be considered as safe in the intended composition as documented in the annexed formula,<br />

when applied to the human skin as intended in compliance with the instructions for use and the<br />

cautionary notices.<br />

This assessment is supported by the following:<br />

1. Toxicological profile of the ingredients:<br />

Available toxico-dermatological documentation of the raw materials, and finished product tests<br />

Incl. dermatological compatibility tests and microbiological stability tests, information for poison control<br />

centers, safety data sheets, legal regulations, generally binding international assessments,<br />

recommendations of authorities and associations and marketing experience.<br />

2. Chemical structure:<br />

The manufactured formula based on specified raw materials, specifications of the finished goods and<br />

physicchemical<br />

tests.<br />

3. Level of exposure:<br />

Depending on the conditions of use established in the instructions for use. For averting dangers,<br />

reference is to make to voluntary and statutory warnings and other information representing part of the<br />

products presentation. The composition and specification of the finished product has to be assured by<br />

suitable quality assurance measurements such as God Manufacturing Practices (GMP).<br />

ELEMENTS TOTAL CONTENT mg/kg (according to Test Report N° FUHL0923333)<br />

Cadmium:


<strong>Diamond</strong> <strong>FX</strong>/ Pretty <strong>Face</strong> B.V. P/O 9354 1800GJ Alkmaar The Netherlands.<br />

SECTION 17:<br />

FILLING VOLUME / SLIM LINER PEN<br />

PRODUCTS: SEMI PERMANENT INK EYELINER PEN * <strong>Diamond</strong> <strong>FX</strong> <strong>Eye</strong>liner Pen / shades with COLORINGS<br />

FORMULAS: Formula-Nr.: 060917.109-P, 060917.108-P, 060917.106-P, 060917.34-P, 060917.33-P<br />

We herewith confirm following physical research results:<br />

WEIGHT OF INK / SLIM PENS: declared * printed 1,0 ml (g) / in fact filled 1,2 ml (g)<br />

• Product life by daily use twice is: 14 months<br />

SECTION 18: for Islamic countries<br />

** PORK FREE - QUALITY CERTIFICATE **<br />

The involved products are:<br />

PRODUCTS: SEMI PERMANENT INK EYELINER PEN * <strong>Diamond</strong> <strong>FX</strong> <strong>Eye</strong>liner Pen / shades with COLORINGS<br />

FORMULAS: Formula-Nr.: 060917.109-P, 060917.108-P, 060917.106-P, 060917.34-P, 060917.33-P<br />

We certify that these products are in conformity with the EU Commission <strong>Direct</strong>ive 76/768/EEC. They<br />

are considered safe in all normal conditions of use by consumers. They do not contain any biological<br />

bovine, ovine or caprine derived ingredients able to present a risk of B.S.E./T.S.E. contamination. None<br />

of these products contain pork, pork fat or pork derivatives.<br />

SECTION 19: FDA / USA conformity<br />

** FDA conform **<br />

PRODUCTS: SEMI PERMANENT INK EYELINER PEN * <strong>Diamond</strong> <strong>FX</strong> <strong>Eye</strong>liner Pen / shades with COLORINGS<br />

FORMULAS: Formula-Nr.: 060917.109-P, 060917.108-P, 060917.106-P, 060917.34-P, 060917.33-P<br />

are manufactured according to the COSMETIC GMP EU - NORMS:<br />

The involved products are:<br />

PRODUCTS: SEMI PERMANENT INK EYELINER PEN * <strong>Diamond</strong> <strong>FX</strong> <strong>Eye</strong>liner Pen / shades with COLORINGS<br />

FORMULAS: Formula-Nr.: 060917.109-P, 060917.108-P, 060917.106-P, 060917.34-P, 060917.33-P<br />

We certify that these products are in conformity with the FDA regulations and restrictions.<br />

www.Dfx<strong>Face</strong>art.eu info@dfxfaceart.nl


<strong>Diamond</strong> <strong>FX</strong>/ Pretty <strong>Face</strong> B.V. P/O 9354 1800GJ Alkmaar The Netherlands.<br />

FINAL SECTION 01:<br />

GMP CERTIFICATE<br />

PRODUCTS: SEMI PERMANENT INK EYELINER PEN * <strong>Diamond</strong> <strong>FX</strong> <strong>Eye</strong>liner Pen / shades with<br />

COLORINGS<br />

FORMULAS: Formula-Nr.: 060917.109-P, 060917.108-P, 060917.106-P, 060917.34-P,<br />

060917.33-P<br />

GMP – ZERTIFIKAT GMP –<br />

CERTIFICATE Bestätigung der Guten Herstellungs-<br />

Confirmation of Good<br />

Manufacturing Praxis bei der Herstellung kosmetischer<br />

Practice when<br />

manufacturing cosmetics Mittel (Kosmetik – GMP)<br />

(Cosmetics – GMP)<br />

Wir bestätigen, dass die Herstellung kosmetischer<br />

We confirm that the production<br />

of cosmetics Mittel in unserem Werk die Leitlinien zur Guten<br />

in our factory complies with the<br />

guidelines Herstellungspraxis Kosmetischer Mittel erfüllt.<br />

of Good Manufacturing Practice<br />

for<br />

Das umfasst:<br />

P e r s o n a l<br />

R ä u m l i c h k e i t e n<br />

T e c h n i s c h e A u s r ü s t u n g<br />

B e t r i e b s h y g i e n e<br />

A u s g a n g s m a t e r i a l i e n<br />

Z w i s c h e n p r o d u k t e u n d<br />

B u l k w a r e<br />

H e r s t e l l u n g<br />

Q u a l i t ä t s p r ü f u n g<br />

D o k u m e n t a t i o n<br />

cosmetics, which include:<br />

S t a f f<br />

L o c a l i t i e s<br />

T e c h n i c a l E q u i p m e n t<br />

M a n u f a c t u r i n g h y g i e n e<br />

I n i t i a l m a t e r i a l s<br />

I n t e r m e d i a t e p r o d u c t s a n d<br />

b u l k a r t i c l e s<br />

M a n u f a c t u r i n g<br />

Q u a l i t y t e s t<br />

D o c u m e n t a t i o n<br />

Our factory is regularly under unannounced control of the German VETERINÄR & GESUNDHEITSAMT (German<br />

Health<br />

Authority) which is responsible for food and cosmetics regulations and certifications.<br />

Further our company makes for each and every manufactured ink an external micro biological test in an<br />

independent external lab with result certificate under the name / brand name of Pretty <strong>Face</strong> B.V.<br />

www.Dfx<strong>Face</strong>art.eu info@dfxfaceart.nl

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