dossier paraffina lavanda 500ml - danagroup.it · PARAFFINA LAVANDA 500 ml BRAND NAME DEPILIA C.I....

QUALITATIVE AND QUANTITATIVE COMPOSITION

PRODUCT BARCODE

8024116003412

FUNCTIONINGREDIENTS(INCI)

CAS NR. EINECS NR. INGREDIENTS(CTFA)

%

Emollient,Viscosity controlling

Paraf�n 8002-74-2;64742-51-4

232-315-6;265-154-5

Paraf�n75,00000

Antistatic,Emollient,Skin protecting,Solvent

Paraf�num liquidum 8012-95-1;8042-47-5

232-384-2;232-455-8

Mineral oil24,00000

PRODUCT NAME

PARAFFINA LAVANDA 500 ml

BRAND NAME

DEPILIA

Cosmetic colorantC.I. 60725 81-48-1 201-353-5 Violet 20,65000

Deodorant,Masking,Perfuming

Parfum Fragrance0,25554

Deodorant,Perfuming

Linalool 78-70-6 201-134-4 Linalool0,05369

PerfumingCoumarin 91-64-5 Coumarin0,02110202-086-7

Dott. Alberto Allegretti

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www.danagroup.it

Intesa Sanpaolo S.p.A.: Agenzia di Teverola (CE) - IBAN: IT 61 X 03069 75084 100000004532 - SWIFT: BCITITMMCariparma S.p.A.: Agenzia di Giugliano in Campania (NA) - IBAN: IT 13 F 06230 39900 000056894484 - SWIFT: CRPPIT2P519Pec: [email protected] - P.IVA/C.F.: IT 02604291217 - C.C.I.A.A. 501897Iscr. Trib. Napoli 5190/92 - M. Export NA032824 - Camera Commercio Italo-Arabo Cod. 94

Dana Italia s.r.l.Sede Legale: Via Roma, 157 - 80029 Sant’Antimo (NA) ItaliaStabilimento: Zona Industriale A.S.I. - 81032 Carinaro (CE) ItaliaTel.: +39 081 5016019 - Fax: +39 081 8911459 - [email protected]

PUROD G ®ANA PositionCosmetic Product Safety Evaluator (according to European Rules 1223/2009)

For Dana Italia s.r.l.

100,0000

European Association of Poison Centers and Clinical Toxilogists (EAPCCT) & European Cosmetic Toiletry and Perfumery Association (COLIPA), European Commission database with information on cosmetic substances and Ingredient (COSING).

QUALITATIVE AND QUANTITATIVE COMPOSITION

PRODUCT BARCODE

8024116003412

FUNCTIONINGREDIENTS(INCI)

CAS NR. EINECS NR. INGREDIENTS(CTFA)

%

PRODUCT NAME


BRAND NAME

DEPILIA

Denaturant,Perfuming,Solvent

Limonene Limonene0,00304

PerfumingCitronellol 106-22-9;26489-01-0;7540-51-4;1117-61-9

203-375-0;247-737-6;231-415-7;214-250-5

Citronellol0,00124

Perfuming,Tonic

Geraniol 106-24-1 203-377-1 Geraniol0,01538

138-86-3 205-341-0

Flavouring,Perfuming

Citral Citral0,000025392-40-5 226-394-6


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DECLARATION

CONFORMITY CERTIFICATE

Released by Dana Italia S.r.l. Via Roma, 157 - 80029 Sant’Antimo (NA) Italy

Manufacturer of depilatory waxes intended for professional use on the basis of checks carried out during the of productionand business management.

DECLARES

For more information, please refer to the technical documentation for Dana Italia S.r.l.

That our products are in accordance with current regulations of the 1223/2009 and in accordance with the New EuropeanCosmetic Regulations.

PRODUCT BARCODE

8024116003412

PRODUCT NAME


BRAND NAME

DEPILIA


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CHEMICAL PROPERTIES

pH

Boiling point

Density (20°C)

Flammability limits

Solubility in water

Solubility in hydrocarbons solvens

Total viable count

Pathogenic microorganisms

Not-determined (not water-based product)

>120°C

0,8---0,98 g/cm3

Not-�ammable

Insoluble

Very soluble

Not determined because product is totally waterlessand microbial growthis not possibleAbsence

PHYSICAL AND CHEMICAL PROPERTIES

GENERAL INFORMATION

PHYSICO-CHEMICAL SPECIFICATIONSOF THE FINISHED PRODUCT

SPECIFICATION RESULT RANGE

Chemical identi�cation Mixture composed by naturaland synthetic ingredients

Aspect Highly thick �uid Visual examination

METHOD

Color Violet

Smell Floral Olfactory

Visual examination

PHYSICAL PROPERTIES

Viscosity 3.00-5.00 Brook�eld RVDV-I Prime,cPs, (spindle 03 - RPM 5 a 65.0°C)

PRODUCT BARCODE

8024116003412

PRODUCT NAME


BRAND NAME

DEPILIA


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CERTIFICATE OF ANALYSIS

METHODPARAMETER RESULTS MEASURE UNIT ACCPTED RANGE

BROOKFIELDRVDV-I PRIME65°C

VISCOSITY 3.5 CPS 3.00 - 5.00

COMPARISING WITHINTERNAL STANDARD

COLOR OK COMPARISING WITHINTERNAL STANDARD

XXXXXXXX

COMPARISING WITHINTERNAL STANDARD

SMELL TYPICAL COMPARISING WITHINTERNAL STANDARD

XXXXXXXX

METTLER TOLEDODP 70ASTM D6090

SOFTENING POINT 51.1 °C 55° ± 1°C

PRODUCT BARCODE

8024116003412

PRODUCT NAME


BRAND NAME

DEPILIA


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SPECIFICATIONS OF PACKAGING MATERIALS

MATERIAL USED SPECIFICATION OF MATERIAL USED

Polypropylene containerPackage

PrintLabel

Folding 12 piecesCarton

This package protects formulation against oxygen and light, and allow a good application of wax on the skin.

PRODUCT BARCODE

8024116003412

PRODUCT NAME


BRAND NAME

DEPILIA


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PHASE A

MANUFACTURING PROCESS

OPERATIVE PROCESS

Clean the kettle and all other mixer or �ask that wil l be used for production, according to clearing procedure. Weight off raw materials. Proceed with methodic as described in approved batch card.

Manufacturer of depilatory waxes intended for professional use on the basis of checks carried out during the of production and business management.

LOT #

PHASE A

% QUANTITY KG CHECK

PARAFFINUM LIQUIDUM

INGREDIENTS

PARAFFIN

Weigh out all ingredients of phase A and put them into the kettle. Heat until temperature has reached 110° - 115 °C. Start to mix. If the product is competely clear, and you’ll start �lling the cassettes, make sure the product is between 85° - 90°C.

PARFUM

C.I. 60725

All cosmetic products manufactured by Dana Italia s.r.l. comply with the Good Manufacturing Practice (GMP)conformity with EU regulation 1223/2009 of the European Parliament and of the Council of 30 November 2009 on Cosmetic Products. As an example of manufacturing process, we report a part of Batch card, with instruction for operators.

BRAND NAME

DEPILIA

PRODUCT NAME



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For a good testing procedure, is important that the mix reach a good equilibrium of chemical, physical and viscosity features; for this reason , wait 3 hours before testing product, during this period , hold product at a temperature around 85°C under stirring. After this period, start with test on bulk, following the QC protocol, approved from company. If the batch pass all tests, proceed with packaging.

CHEMICAL AND PHYSICAL TEST ON PRODUCT

PRODUCT BARCODE

8024116003412

PRODUCT NAME


BRAND NAME

DEPILIA


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Microbial attack (Challenge Test) Not-determined (not water-based product)

Preservative system The product does not need preservatives

Conclusion: product CONFIRMS on the level of its microbiological quality.

SPECIFICATION

Not-determined (not water-based product)Bacterial count

Not-determined (not water-based product)Fungus count

Not-determined (not water-based product)Escherichia coli

Not-determined (not water-based product)Salmonella

Not-determined (not water-based product)Stapphylococcus aurens

Not-determined (not water-based product)Pseudomonas aeruginosa

INFORMATION ON RESISTENCE TO MICROBIAL CONTAMINATION

MICROBIOLOGICAL SPECIFICATIONSOF THE FINISHED PRODUCT

PRODUCT BARCODE

8024116003412

PRODUCT NAME


BRAND NAME

DEPILIA


9

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QUALITY ASSURANCE DEPARTMENT STABILITY STUDY PROTOCOL

STABILITY

STABILITY REPORT

HEAT-SHOCK TEST

This product doesn’t contain water, so is highly not probable the microbiological contamination; other substances used asingredients have all a very high chemical stability and are resistant to oxidation by oxygen contained in atmospheric air;hygroscopic ingredients are not present, for this reason is not possible the presence of water coming from atmosphere. This product can be de�ned stable and without modi�cation, for three years if stored under appropriate condition and in the original packaging, without opening. This product can be de�ned stable and without modi�cation, for three years if stored underappropriate condition and in the original packaging, without opening.

STABILITY TEST

This product passed all stability tests, performed in the factory, according to internal test protocol . during tests, the products is put under conditions that can accelerate all phenomena of not stability. At the end of stability tests the product is evacuate for the potential interactions between product and the packaging that might occur during Thermo-Shock Test. This product can be de�ned stable and without modi�cation , for three years if stored under appropriate condition and in the original packaging, without opening.

Conclusion: this product, under all stabilitysimulations, doesn’t showed any change that induced to change formulation or packaging or labeling or production cycle. It is stable when stored and handled under appropriate conditions. PAO IS 12 MONTHS.

COMPATIBILITY CONTENT / BOX

The aim of this test is to accelerate, the most is possible, the phenomena of “aging” of cosmetic product, for discovering any not stability in a short time.Product, in his �nal packaging, has been stored at room temperature for 24 hours, after, it has been stored at -10°C for 24 hours, after, put in professional heater for cartridges of depilatory waxes for 24 hours; at the end, stored at room temperature after this Heat-Shock Cycle, all eventual modi�cations have been evaluate and compared with a sample, stored always at room temperature andconsidered as the referring sample. The Heat-shock Test is repeated on the same sample for three cycles.

After Heat Shock Cycle have been evaluated all phenomena on packaging such as:

increased weakness brocken areasdeformationschange of color and transparencechange of permeabilityloss of productproblems with product exit label deformation or lowering of colorationblockage of opening systemcolor transfer from product to packaging

• ••• • • • • • •

The objective of this stability report is to ensure that product maintains is intended physical, chemical and microbiological quality, as well as functionally and aesthetics when stored under appropriate conditions. The features and the results of study protocol are specified in document relative to “Physical,Chemical and Microbiological Specifics”.

PRODUCT NAME



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REAL TIME STABILITY DATA

RESULTSTEST RELEASE CRITERIA TECHNIQUE

Complies

Complies

Complies

Complies

Complies

Complies

Appearance

Color

Odour

pH

Water bath

Viscometer

Higly dense liquid

Violet

Floral

Not-determined(not water-based product)

Water bath complies with standard

Viscometer complies with standard

Visual inspection

Visual inspection

Olfactory

pH meter

Water bath machine

Viscometer machine

060191 04-02-2019

STORAGE CONDITIONS AND PACKINGRoom Temperature: 10°C > 35°CPackaging: POLYPROPYLENE

FREQUENCY TESTEach production is analyzed and subjected to accelerated aging tests (Incubator and Thermal Shock).

MANUFACTURING DATEBATCH NO. EXPIRED DATE

IDENTIFICATION, MANUFACTURING DATE, EXPIRED DATE

04-02-2022

PRODUCT BARCODE

8024116003412

PRODUCT NAME


BRAND NAME

DEPILIA


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RESULT OF TEST DURING STORAGE AT 40°C (± 2°C)AND THERMIC SHOCK ON THE PRODUCT

REAL TIME STABILITY DATA

Conclusion: stability data still under study, according to our observations, we certify the shelf life ofPARAFFINA LAVANDA 500 ml WILL BE STABLE FOR 36 MONTHS.

TIME APPEARANCE COLOR ODOUR pHWATERBATH VISCOSITY

MICROBIALLIMIT

Limit

Initial

3 Months

6 Months

Wax

Complies

Complies

Complies

Violet

Complies

Complies

Complies

Floral

Complies

Complies

Complies

Not-determined

Complies

Complies

Complies

Complies

Complies

Complies

Complies

Compliesto standard

Complies

Complies

Complies

Complies tomanufacturespeci�cation

Complies

Complies

Complies

Result of test during, storage at 40°C (± 2°C) and thermic shock on the product.

PRODUCT NAME


SHELF LIFE

36 MONTHS


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ACCELERATED STABILITY DATA

TIME APPEARANCE COLOR ODOUR pHWATERBATH VISCOSITY

MICROBIALLIMIT

Limit

Initial

3 Months

6 Months

Wax

Complies

Complies

Complies

Violet

Complies

Complies

Complies

Floral

Complies

Complies

Complies

Not-determined

Complies

Complies

Complies

Complies

Complies

Complies

Complies

Compliesto standard

Complies

Complies

Complies

Complies tomanufacturespeci�cation

Complies

Complies

Complies

Result of test during, storage at 40°C (± 2°C) and thermic shock on the product.

Conclusion: stability data still under study, according to our observations, we certify the shelf life ofPARAFFINA LAVANDA 500 ml WILL BE STABLE FOR 36 MONTHS.

PRODUCT NAME


SHELF LIFE

36 MONTHS


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GIFTBOX PRINT ARTWORK

This is electronically documentand therefore has no signature.

Para�na/Lavanda

Para�na/LavandaPara�n/LavanderPara�na/Lavanda

Para�na/LavandaPara�n/Lavander

CÓMO UTILIZAR:1) Se calienta la parafina en el calentador de parafina o microondas.2) Sumergir lentamente la mano hasta la muñeca (o el pie hasta que el tobillo) en parafina fusa.3) Tire de la mano (o pie) lentamente y esperar a que el endurecimiento de la parafina en pelle.4) Repetir la inmersión durante 3-5 veces.5) Use guantes en las manos o los pies (calcetines) y dejar actuar durante 15-20 minutos.6) Quítese los guantes o (calcetines) junto con parafina, siguiendo la dirección de dita.7) Masaje con una crema idratante.

MODO D’USO:1) Riscaldare la paraffina nello scalda paraffina o nel microonde.2) Immergere lentamente la mano fino al polso (o il piede fino alla caviglia) nella paraffina fusa.3) Tirare fuori la mano (o il piede) lentamente e attendere l’indurimento della paraffina sulla pelle.4) Ripetere l’immersione per 3-5 volte.5) Indossare i guanti sulle mani (o le calze sui piedi) e lasciare in posa per 15-20 minuti.6) Togliere i guanti (o calze) insieme alla paraffina, seguendo la direzione delle dita.7) Massaggiare con una crema idratante.

Prodotto cosmetico, solo uso esterno, tenere lontano dalla portata dei bambini.

Para�na/Lavanda Para�na/LavandaINSTRUCTION FOR USE:1) Warm the paraffin in the heater or in the microwave.2) Immerse smoothly the hand to the wrist (foot to the ankle) in melted paraffin.3) Take out slowly the hand (foot) and wait for paraffin solidifies on the skin.4) Repeat procedure 3-5 times.5) Wear gloves on the hands (or socks on the feet) and leave on for 15-20 minutes.6) Remove gloves (or socks) together with paraffin, following the fingers direction.7) Massage with moisturizing cream.

Para�n/Lavander

Cosmetic product, external use only, keepaway from children.

Producto cosmético, uso externo, mantener alejado de los niños.

Prodotto da / Produced by / Fabricado por:Dana Italia s.r.l. Zona Industriale A.S.I. 81032 Carinaro (CE) Italia www.danagroup.it

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USO PROFESSIONALEPROFESSIONAL USEUSO PROFESIONAL

MADE IN ITALY

LOT 060191500 ml fl.oz 16,91

INGREDIENTSINCI (CTFA): Paraffin, Paraffinum liquidum (Mineral oil), Parfum (Fragrance), C.I. 60725 (Violet 2), Linalool, Cou-marin, Geraniol.


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dossier paraffina lavanda 500ml - danagroup.it · PARAFFINA LAVANDA 500 ml BRAND NAME DEPILIA C.I....

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