QUALITATIVE AND QUANTITATIVE COMPOSITION INGREDIENTS (INCI) CAS NR. EINECS NR. % FUNCTION INGREDIENTS (CTFA) Aqua 7732-18-5 231-791-2 84,02272 Solvent Water Sodium laureth sulfate 3088-31-1; 9004-82-4; 68891-38-3; 1335-72-4; 68585-34-2; 91648-56-5 221-416-0 500-234-8 500-223-8 293-918-8 7,29000 Cleansing, Emulsifying, Foaming, Surfactant Sodium laureth sulfate Cocamidopropyl betaine 61789-40-0 263-058-8 931-296-8 2,70000 Antistatic, Cleansing, Foam boosting, Hair conditioning, Surfactant, Viscosity controlling Cocamidopropyl betaine Cocamide DEA 68603-42-9 271-657-0 931-329-6 1,57500 Emulsifying, Emulsion stabilising, Foam boosting, Surfactant, Viscosity controlling Cocamide DEA Propylene glycol 57-55-6 200-338-0 1,30000 Humectant, Skin conditioning, Solvent, Viscosity controlling Propylene glycol Sodium chloride 7647-14-5 231-598-3 1,30000 Bulking, Masking, Oral care, Viscosity controlling Sodium chloride Parfum ------------ 0,58063 Deodorant, Masking, Perfuming Fragrance DMDM hydantoin 6440-58-0 200-289-5 0,20000 Preservative DMDM Hydantoin Citrus medica limonum peel extract 92346-89-9; 84929-31-7 296-174-2 284-515-8 285-359-3 0,17500 Emollient, Skin conditioning, Skin protecting, Tonic Citrus medica limonum (Lemon) peel extract For 1
QUALITATIVE AND QUANTITATIVE COMPOSITION INGREDIENTS (INCI) CAS NR. EINECS NR. % FUNCTION INGREDIENTS (CTFA) Glycerin 56-81-5 200-289-5 0,17500 Denaturant, Humectant, Perfuming, Solvent Glycerin Urtica dioica leaf extract 84012-40-8 281-685-5 0,17500 Skin conditioning Urtica dioica (Nettle) leaf extract Polyquaternium-7 26590-05-6 ------------ 0,15000 Antistatic, Film forming Polyquaternium-7 Disodium EDTA 139-33-3 205-358-3 0,10000 Chelating, Viscosity controlling Disodium EDTA Guar hydroxypropyltrimonium chloride 65497-29-2 65497-29-2 0,10000 Antistatic, Film forming, Skin conditioning, Viscosity controlling Guar hydroxypropyltrimonium chloride PEG-18 glyceryl oleate/cocoate ------------ 0,10000 Emulsifying PEG-18 glyceryl oleate/cocoate Citric acid 77-92-9; 5949-29-1 201-069-1 0,03500 Buffering, Chelating, Masking Citric acid Hexyl cinnamal 101-86-0 202-983-3 639-566-4 0,01800 Perfuming Hexyl cinnamal C.I. 15985 2783-94-0 220-491-7 0,00150 Cosmetic Yellow 6 colorant For 2
QUALITATIVE AND QUANTITATIVE COMPOSITION INGREDIENTS (INCI) CAS NR. EINECS NR. % FUNCTION INGREDIENTS (CTFA) Citral 5392-40-5 226-394-6 0,00120 Flavouring, Perfuming Citral Methylchloroisothiazolinone 26172-55-4 247-500-7 0,00056 Preservative Methylchloroisothiazolinone Coumarin 91-64-5 202-086-7 0,00017 Perfuming Coumarin Methylisothiazolinone 2682-20-4 220-239-6 0,00011 Preservative Methylisothiazolinone C.I. 19140 1934-21-0; 217-699-5 0,00005 Cosmetic Yellow 5 12225-21-7; colorant 74920-66-4; 84681-80-1 C.I. 42051 3536-49-0 222-573-8 0,00005 Cosmetic colorant Food blue five 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). For 3
DECLARATION CONFORMITY CERTIFICATE Released by Via Roma, 157-80029 Sant Antimo (NA) Italy Manufacturer of shampoo 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 For 4
PHYSICO-CHEMICAL SPECIFICATIONS OF THE FINISHED PRODUCT SPECIFICATION RESULT RANGE METHOD PHYSICAL AND CHEMICAL PROPERTIES GENERAL INFORMATION Chemical identification Mixture composed of natural and synthetic ingredients Aspect Viscous fluid Visual examination Color Yellow/Brown Visual examination Smell Citrus, Floral Olfactory PHYSICAL PROPERTIES Viscosity 4.000-6.000 Brookfield LVDV-I Prime 50/60 Hz, cps, (spindle S62 - RPM 2.5-25 C) CHEMICAL PROPERTIES ph 5.0 ± 0.5 Flammability limits Solubility in water Solubility in hydrocarbons solvens Total bacterial count Pathogenic microorganisms Not-flammable Soluble Insoluble < 1000 ufc/g Absence For 5
CERTIFICATE OF ANALYSIS PARAMETER RESULTS MEASURE UNIT METHOD ACCPTED RANGE VISCOSITY 5.500 CPS BROOKFIELD 4.000-6.000 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 For 6
SPECIFICATIONS OF PACKAGING MATERIALS MATERIAL USED SPECIFICATION OF MATERIAL USED Package Plastic bottle in PP CAP PP CAP Label Print Carton Folding 6 pieces This package protects formulation against oxygen and light, and allow a good application on the hair. For 7
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 shampoo 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 C.I. 15985, C.I. 19140, C.I. 42051 PROPYLENE GLYCOL CITRUS MEDICA LIMONUM PEEL EXTRACT URTICA DIOICA LEAF EXTRACT GLYCERIN POLYQUATERNIUM-7 METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE PHASE A Combine ingredients of A. Combine ingredients B. For 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 shampoo 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 SODIUM LAURETH SULFATE SODIUM CHLORIDE COCAMIDOPROPYL BETAINE COCAMIDE DEA PARFUM CITRIC ACID PEG-18 GLYCERYL OLEATE/COCOATE PHASE B Combine ingredients of A. Combine ingredients B. For 9
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. After this period, start with test on bulk, following the QC protocol, approved from company. If the batch pass all tests, proceed with packaging. For 10
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. For 11
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. For 12
REAL TIME STABILITY DATA TEST RELEASE CRITERIA RESULTS TECHNIQUE Appearance Viscous fluid Visual inspection Color Yellow/Brown Visual inspection Odour Citrus, Floral Olfactory ph 5.0 ± 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 177171 26-04-2017 26-10-2020 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). For 13
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 fluid Yello/Brown Citrus; Floral 5.0 ± 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 SHAM- POO S3 RIEQUILIBRANTE 1000 ml WILL BE STA- BLE FOR 30 MONTHS. For 14
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 fluid Yello/Brown Citrus; Floral 5.0 ± 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 SHAM- POO S3 RIEQUILIBRANTE 1000 ml WILL BE STA- BLE FOR 30 MONTHS. For 15
GIFTBOX PRINT ARTWORK SHAMPOOS3 SHAMPOO RIEQUILIBRANTE REBALANCING SHAMPOO LIMONE & ORTICA LEMON & NETTLE TRATTAMENTO COADIUVANTE CAPELLI GRASSI ADJUVANT TREATMENT HAIR FAT DESCRIZIONE: SHAMPOO RIEQUILIBRANTE azione dermopurificante. Deterge i capelli senza appesantirli e purifica il cuoio capelluto. Gli estratti di Limone e Ortica permettono di eliminare con efficacia il sebo in eccesso, hanno proprietà astringenti ed aiutano ad equilibrare la produzione di sebo normalizzando il ph del cuoio capelluto. DESCRIPTION: REBALANCING SHAMPOO with dermopurifying action. Cleanses the hair without weighing it down and purifies the scalp. The Nettle and Lemon extracts allow to effectively eliminate excess sebum, have astringent properties and help to balance sebum production by normalizing the ph of the scalp. MODO D'USO: Applicare sui capelli bagnati e frizionare dolcemente lasciando agire il prodotto per qualche istante. Risciacquare accuratamente. Ripetere l operazione se necessario. HOW TO USE: Apply to wet hair and rub gently letting it soak for a while. Rinse thoroughly. Repeat if necessary. INGREDIENTS INCI (CTFA) AQUA (WATER), SODIUM LAURETH SULFATE, CO- CAMIDOPROPYL BETAINE, COCAMIDE DEA, SO- DIUM CHLORIDE, PROPYLENE GLYCOL, CITRUS MEDICA LIMONUM PEEL EXTRACT [CITRUS MEDICA LIMONUM (LEMON) PEEL EXTRACT], URTICA DIOICA LEAF EXTRACT [URTICA DIOICA (NETTLE) LEAF EXTRACT], PARFUM (FRAGRAN- CE), DMDM HYDANTOIN, POLYQUATERNIUM-7, PEG-18 GLYCERYL OLEATE/COCOATE, GUAR HY- DROXYPROPYLTRIMONIUM CHLORIDE, DISODIUM EDTA, CITRIC ACID, HEXYL CINNAMAL, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, C.I. 19140 (YELLOW 5). Prodotto da: Zona Industriale A.S.I. 81032 Carinaro (CE) Italia www.kedanprofessional.it 12 m 1000 ml 33,81 fl.oz. USO PROFESSIONALE PROFESSIONAL USE MADE IN ITALY LOT 177171 This is electronically documentand therefore has no signature. For 16