Diamond FX Eye Liner.pdf - Face Paints Direct
Diamond FX Eye Liner.pdf - Face Paints Direct
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