QUALITATIVE AND QUANTITATIVE COMPOSITION

Transcription

1 QUALITATIVE AND QUANTITATIVE COMPOSITION INGREDIENTS (INCI) CAS NR. EINECS NR. % FUNCTION INGREDIENTS (CTFA) Aqua ,58933 Solvent Water Cetyl alcohol Cetrimonium chloride , ,00000 Emollient, Emulsifying, Emulsion stabilising, Foam boosting, Masking, Opacifying, Surfactant, Viscosity controlling Antimicrobial, Antistatic, Emulsifying, Preservative, Surfactant Cetyl alcohol Cetrimonium chloride Cetearyl alcohol ; ,50000 Emollient, Emulsifying, Emulsion stabilising, Foam boosting, Opacifying, Surfactant, Viscosity controlling Cetearyl alcohol Myristyl alcohol ,50000 Emollient, Emulsion stabilising, Foam boosting, Skin conditioning, Viscosity controlling Myristyl alcohol Parfum ,30809 Deodorant, Masking, Perfuming Fragrance Guar hydroxypropyltrimonium chloride ,30000 Antistatic, Film forming, Skin conditioning, Viscosity controlling Guar hydroxypropyltrimonium chloride Glycerin ,25000 Denaturant, Humectant, Perfuming, Solvent Glycerin Panthenol ; ,25000 Antistatic, Hair conditioning, Skin conditioning Panthenol 1

2 QUALITATIVE AND QUANTITATIVE COMPOSITION INGREDIENTS (INCI) CAS NR. EINECS NR. % FUNCTION INGREDIENTS (CTFA) DMDM hydantoin ,20000 Preservative DMDM Hydantoin Dimethicone ; ; ,10000 Antifoaming, Emollient, Skin conditioning, Skin protecting Dimethicone Disodium EDTA ,10000 Chelating, Viscosity controlling Disodium EDTA Menthol ; ; ; ,09000 Denaturant, Masking, Refreshing, Soothing Menthol Eugenol ,03468 Denaturant, Perfuming, Tonic Eugenol Limonene ,02877 Denaturant, Perfuming, Solvent Limonene Citric acid ; ,02000 Buffering, Chelating, Masking Citric acid Linalool ,01318 Deodorant, Perfuming Linalool Benzyl benzoate ,01157 Antimicrobial, Perfuming, Solvent Benzyl benzoate 2

3 QUALITATIVE AND QUANTITATIVE COMPOSITION INGREDIENTS (INCI) CAS NR. EINECS NR. % FUNCTION INGREDIENTS (CTFA) Coumarin ,00165 Perfuming Coumarin Cinnamal ,00131 Denaturant, Flavouring, Perfuming Cinnamal Methylchloroisothiazolinone ,00056 Preservative Methylchloroisothiazolinone Citral ,00050 Flavouring, Perfuming Citral Cinnamyl alcohol ,00017 Flavouring, Perfuming Cinnamyl alcohol Methylisothiazolinone ,00011 Preservative Methylisothiazolinone Geraniol ,00006 Perfuming, Tonic Geraniol Isoeugenol ,00001 Flavouring, Perfuming Isoeugenol 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). 100,0000 3

4 DECLARATION CONFORMITY CERTIFICATE Released by Via Roma, Sant Antimo (NA) Italy Manufacturer of mask products intended for professional use on the basis of checks carried out during the of production and business management. DECLARES That our products are in accordance with current regulations of the 1223/2009 and in accordance with the New European Cosmetic Regulations. For more information, please refer to the technical documentation for 4

5 PHYSICO-CHEMICAL SPECIFICATIONS OF THE FINISHED PRODUCT SPECIFICATION RESULT RANGE METHOD PHYSICAL AND CHEMICAL PROPERTIES GENERAL INFORMATION Chemical identification O/W emulsion composed of natural and synthetic ingredients Aspect Viscous fluid Visual examination Color White Visual examination Smell Citrus, Floral Olfactory PHYSICAL PROPERTIES Viscosity Brookfield LVDV-I Prime 50/60 Hz, cps, (spindle S64 - RPM C) CHEMICAL PROPERTIES ph 4.41 ± 0.5 Flammability limits Solubility in water Solubility in hydrocarbons solvens Total bacterial count Pathogenic microorganisms Not-flammable Soluble Insoluble < 1000 ufc/g Absence 5

6 CERTIFICATE OF ANALYSIS PARAMETER RESULTS MEASURE UNIT METHOD ACCPTED RANGE VISCOSITY CPS BROOKFIELD LVDV-I PRIME 25 C COLOR OK COMPARISING WITH INTERNAL STANDARD COMPARISING WITH INTERNAL STANDARD XXXXXXXX SMELL TYPICAL COMPARISING WITH INTERNAL STANDARD COMPARISING WITH INTERNAL STANDARD XXXXXXXX SOFTENING POINT 50 C METTLER TOLEDO 50 ± 1 C DP 70 ASTM D6090 6

7 SPECIFICATIONS OF PACKAGING MATERIALS MATERIAL USED SPECIFICATION OF MATERIAL USED Package PP JAR CAP PP CAP Label Print Carton Folding 24 pieces This package protects formulation against oxygen and light, and allow a good application on the hair. 7

8 MANUFACTURING PROCESS All cosmetic products manufactured by 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. OPERATIVE PROCESS Clean the kettle and all other mixer or flask that will be used for production, according to clearing procedure. Weight off raw materials. Proceed with methodic as described in approved batch card. Manufacturer of mask intended for professional use on the basis of checks carried out during the of production and business management. PHASE A INGREDIENTS % QUANTITY KG LOT # CHECK AQUA GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE DISODIUM EDTA DMDM HYDANTOIN GLYCERIN PANTHENOL CETRIMONIUM CHLORIDE METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE PHASE A Combine ingredients of A. Combine ingredients B. Heat A 80 C; Heat B 70 C; Separately. Mixing for 30 minute. Cool down to 30 C, under slow stirring. 8

9 MANUFACTURING PROCESS All cosmetic products manufactured by 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. OPERATIVE PROCESS Clean the kettle and all other mixer or flask that will be used for production, according to clearing procedure. Weight off raw materials. Proceed with methodic as described in approved batch card. Manufacturer of mask intended for professional use on the basis of checks carried out during the of production and business management. PHASE B INGREDIENTS % QUANTITY KG LOT # CHECK CETYL ALCOHOL CETEARYL ALCOHOL MYRISTYL ALCOHOL PARFUM MENTHOL DIMETHICONE CITRIC ACID PHASE B Combine ingredients of A. Combine ingredients B. Heat A 80 C; Heat B 70 C; Separately. Mixing for 30 minute. Cool down to 30 C, under slow stirring. 9

10 CHEMICAL AND PHYSICAL TEST ON PRODUCT 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 25 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. 10

11 MICROBIOLOGICAL SPECIFICATIONS OF THE FINISHED PRODUCT SPECIFICATION Total bacterial count < 1000 ufc/g Gram + Gram - Absent Yeasts and moulds < 10 ufc/g INFORMATION ON RESISTENCE TO MICROBIAL CONTAMINATION Microbial attack (Challenge Test) Preservative system STAPPHYLOCOCCUS AURENS; ESCHERICHIA COLI; CANDIDA ALBICANS; ASPERGILLUS NIGER JUDGMENT ACCORDING TO CTFA: ACCEPTABLE Conclusion: product CONFIRMS on the level of its microbiological quality. 11

12 STABILITY REPORT QUALITY ASSURANCE DEPARTMENT STABILITY STUDY PROTOCOL 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. STABILITY The product contains water. They were used preservatives to warranty the storage for 30 months from the date of the production batch. The added ingredients were carefully evaluated to ensure the efficiency when stored under appropriate conditions and in 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. HEAT-SHOCK TEST 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 final 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 creams, emulsions, shampoos, lotions, styling waxes for 24 hours; at the end, stored at room temperature after this Heat-Shock Cycle, all eventual modifications have been evaluate and compared with a sample, stored always at room temperature and considered 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 areas deformations change of color and transparence change of permeability loss of product problems with product exit label deformation or lowering of coloration blockage of opening system color transfer from product to packaging Conclusion: this product, under all stability simulations, 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. 12

13 REAL TIME STABILITY DATA TEST RELEASE CRITERIA RESULTS TECHNIQUE Appearance Viscous cream Visual inspection Color White Visual inspection Odour Citrus, Floral Olfactory ph 4.41 ± 0.5 ph meter Incubator Incubator complies with standard Incubator machine Viscometer Viscometer complies with standard Viscometer machine IDENTIFICATION, MANUFACTURING DATE, EXPIRED DATE BATCH NO. MANUFACTURING DATE EXPIRED DATE STORAGE CONDITIONS AND PACKING Room Temperature: 10 C > 35 C Packaging: PP FREQUENCY TEST Each production is analyzed and subjected to accelerated aging tests (Incubator and Thermal Shock). 13

14 REAL TIME STABILITY DATA RESULT OF TEST DURING STORAGE AT 37.5 C AND THERMIC SHOCK ON THE PRODUCT SHELF LIFE 30 MONTHS Result of test during, storage at 37.5 C and thermic shock on the product. TIME APPEARANCE COLOR ODOUR ph INCUBATOR VISCOSITY MICROBIAL LIMIT Limit Viscous cream White Citrus; Floral 4.41 ± 0.5 to standard to manufacture specification Initial 3 Months 6 Months Conclusion: stability data still under study, according to our observations, we certify the shelf life of MASK M2 ANTISTATICA 500 ml WILL BE STA- BLE FOR 30 MONTHS. 14

15 ACCELERATED STABILITY DATA SHELF LIFE 30 MONTHS Result of test during, storage at 37.5 C and thermic shock on the product. TIME APPEARANCE COLOR ODOUR ph INCUBATOR VISCOSITY MICROBIAL LIMIT Limit Viscous cream White Citrus; Floral 4.41 ± 0.5 to standard to manufacture specification Initial 3 Months 6 Months Conclusion: stability data still under study, according to our observations, we certify the shelf life of MASK M2 ANTISTATICA 500 ml WILL BE STA- BLE FOR 30 MONTHS. 15

16 GIFTBOX PRINT ARTWORK MASKM2 MASCHERA ANTISTATICA ANTISTATIC MASK PANTENOLO PANTHENOL EFFETTO RINFRESCANTE COOLING EFFECT 500 ml 16,91 fl.oz. DESCRIZIONE: MASCHERA al PAN- TENOLO ad azione rinfrescante, districante ed antistatica, indicata per tutti i tipi di capelli. Rinforza le fibre donando vigore, lucentezza ed una piacevole sensazione di freschezza. DESCRIPTION: PANTHENOL MASK with refreshing, detangling and antistatic action, suitable for all hair types. Reinforces the fibers giving force, shine and a pleasant sensation of freshness. MADE IN ITALY MODO D USO: Applicare sui capelli lavati e tamponati, dalla radice alle punte massaggiando delicatamente. Lasciare agire 5 minuti e aiutarsi con un pettine per migliorare la distribuzione del prodotto. Risciacquare accuratamente. HOW TO USE: Apply on washed hair and towel dried, from the root to the tips massaging gently. Leave on 5 minutes and help with a comb to improve the distribution of the product. Rinse thoroughly. USO PROFESSIONALE PROFESSIONAL USE INGREDIENTS INCI (CTFA) AQUA (WATER), CETRIMONIUM CHLORIDE, CE- TEARYL ALCOHOL, MYRISTYL ALCOHOL, CE- TYL ALCOHOL, GLYCERIN, PANTHENOL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, PAR- FUM (FRAGRANCE), DMDM HYDANTOIN, MEN- THOL, DIMETHICONE, DISODIUM EDTA, EU- GENOL, LIMONENE, CITRIC ACID, LINALOOL, BENZYL BENZOATE, METHYLCHLOROISO- THIAZOLINONE, METHYLISOTHIAZOLINONE. Prodotto da: Zona Industriale A.S.I Carinaro (CE) Italia 12 m LOT This is electronically documentand therefore has no signature. 16