SWEET ALMOND MILK - NAT

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1 G SWEET ALMOND MILK - NAT Version: 25-08/FEB/ PRODUCT IDENTIFICATION Trade Name: SWEET ALMOND MILK - NAT Manufacturer: PROVITAL Responsible for the Safety Assessment: Lourdes Mayordomo Tf./Fax: / l.mayordomo@provitalgroup.com Kind of Raw Material: Active Ingredient Function of the Ingredient (PCPC Inventory): Hair Conditioning Agent, Fragrance Ingredient, Skin- Conditioning Agent - Miscellaneous, Skin-Conditioning Agent - Occlusive Function of the Ingredient (UE Inventory): Hair Conditioning, Skin Conditioning 2. PRODUCT COMPOSITION Components Breakdown (INCI). Including actives, solvents, preservatives, antioxidants and other additives: [EU] CAS EINECS Aqua % Prunus Amygdalus Dulcis Fruit Extract 3-5 % Zea Mays Starch 1,5-3,5 % Glycerin 5-10 % Prunus Amygdalus Dulcis Oil 2-4 % Polyglyceryl-4 Caprate 0,3-0,7 % Xanthan Gum 0,2-0,4 % Antioxidants Tocopherol 0,2-0,4 % Preservatives Sodium Benzoate 0,2-0,3 % Potassium Sorbate 0,2-0,3 % Additives Gluconolactone 0,7-0,8 % Calcium Gluconate 0,008-0,012 % PCPC [CTFA] CAS EINECS Water % Prunus Amygdalus Dulcis (Sweet Almond) Fruit 3-5 % Zea Mays (Corn) Starch 1,5-3,5 % Glycerin 5-10 % Prunus Amygdalus Dulcis (Sweet Almond) Oil 2-4 % Polyglyceryl-4 Caprate 0,3-0,7 %

2 Xanthan Gum 0,2-0,4 % Antioxidants Tocopherol 0,2-0,4 % Preservatives Sodium Benzoate 0,2-0,3 % Potassium Sorbate 0,2-0,3 % Additives Gluconolactone 0,7-0,8 % Calcium Gluconate 0,008-0,012 % TOXICOLOGICAL INFORMATION Data obtained in our own toxicological tests and/or bibliographical research Animal testing: This product has not been the subject of animal testing or retesting for cosmetic purposes by or on behalf of this company. General information: The following substances have the GRAS status ('Generally Recognized As Safe'): Glycerin (21CFR ), Corn starch (21CFR and 21CFR182.90) The following substances are used as Food Additives permitted for human consume by FDA: Corn starch (21CFR , 21CFR ) Direct food substances affirmed as generally recognized as safe: Gluconolactone (21CFR ), Calcium gluconate (21CFR ) Gluconolactone is a permitted food additive in Europe (E575) and in the USA it is considered a safe substance (GRAS) which can be used directly in the food (21CFR ). The CIR panel concluded that the Tocopherol is safe in the present practices of use and concentration in cosmetics when formulated to be non-irritating (CIR Final Amended Report March, 2014) The CIR Final Report on Safety Assessment of Sodium Benzoate (IJT, 20(S3):23-50, 2001, reopened 06/10) exists and includes all the toxicological data. The CIR Expert Panel reported a Safety Assessment of Polyglyceryl Fatty Acid Esters and concluded that Polyglyceryl-4 Caprate is safe in the present practice of use and concentration in cosmetic products. (CIR Expert Panel Meeting, September 26-27, 2016) The CIR Final Report on Safety Assessment of Potassium Sorbate (JACT 7 (6): , 1988, confirmed 04/06) exists and includes all the toxicological data. The CIR expert panel concluded that the Prunus amygdalus dulcis (Sweet Almond) Oil is safe in the present practices of use and concentration described in the safety assessment (CIR Final Report, 03/04/2011) The Cosmetic Ingredient Review (CIR) Expert Panel concluded that the Zea Mays (Corn) Starch is safe as used as described in this report (Int J Toxicol 2011; 30 (3 Suppl):17S-39S) The CIR Expert Panel concluded that glycerin is safe in the practices of use and concentration described in the Safety Assessment of Glycerin as Used in Cosmetics, Final Report, December 2014, which include the toxicological data. The Cosmetic Ingredient Review (CIR) Expert Panel concluded that the ingredient Xanthan Gum is safe in the cosmetic practices of use and concentrations as described in the safety assessment. (CIR Final Report, October 5, 2012) Classification according to Council of Europe (*): Non-classified. *(1)- Non-recommended ingredients (2)-Ingredients which could not be assessed (3) Recommended ingredients Cytotoxicity: Test performed with other products of Provital: Sweet Almond Milk (Cod. 4760): NRU Test on 3T3 fibroblasts, 2

3 IC50 = µg/ml. Skin Irritation: Corn starch: Study of chronic irritation on the skin of rats and rabbits, the results were little or no reaction. (J. Pharm. Soc. Jap., vol 102, 1982, 89:98) Glycerin (RTECS no. MA ): Draize Test in the skin of rabbit, 500 mg, 24h, mild. Polyglyceryl-4 Caprate: No irritant in the skin of rabbits. Method OCDE 404 (Supplier data) Xanthan Gum. Daily application of 1% solution for 15 days to rat skin and 6 weeks to rabbit produced no irritation, indicating that it is very well tolerated (WHO Food Additives Series 21,1987) Undiluted Prunus Amygdalus Dulcis (Sweet Almond) Oil, was tested for skin irritancy in rabbits using occlusive patches, resulting product as non-irritating. (CIR Final Report, 03/04/2011) In a 60-day cumulative irritation test, 10 and 100% Prunus Amygdalus Dulcis (Sweet Almond) Oil was applied to rabbits. Results indicated that, when applied to the skin over a long period of time, Prunus Amygdalus Dulcis (Sweet Almond) Oil is slightly irritating; whereas, at 10% it is practically non-irritating. (CIR Final Report, 03/04/2011) Undiluted Prunus Amygdalus Dulcis (Sweet Almond) Oil was non-irritating in a single insult patch test with 101 subjects. (CIR Final Report, 03/04/2011) Corn starch (RTECS no: GM ): Draize Test in human skin, 300 ug/3d-i,mild Glycerin (50% in water) was not irritating to subjects with dermatitis (n=420) when administered for 20-24h under occlusion. (Safety Assessment of Glycerin as Used in Cosmetics, Final Report, December 2014) Skin Sensitization: Polyglyceryl-4 Caprate: No sensitizant. Method OCDE 406 (Supplier data) Xanthan Gum. Intradermal challenge tests in guinea-pigs did not produce evidence of sensitization (WHO Food Additives Series 21, 1987) A maximization assay was used to determine the sensitizing potential of Prunus Amygdalus Dulcis (Sweet Almond) Oil. using guinea pigs, at concentrations of 5, 10 and 100% determined to be non-sensitizing. (CIR Final Report, 03/04/2011) HRIPT in a facial oil with 45.25% of Prunus Amygdalus Dulcis (Sweet Almond) Oil, was not dermal irritant or sensitizer. (CIR Final Report, 03/04/2011) A HRIPT was done on 99 participants using a powder containing 97% corn starch. Four cases of faint, minimal erythema were observed during the induction phase, and there was no observed irritation during the challenge phase. This same methodology was repeated with 109 participants and there was no observed irritation. (Int J Toxicol 2011; 30 (3 Suppl):17S-39S) In a sensitization study, natural and synthetic glycerin were not sensitizing to white male guinea pigs (n=12). A moisturizer containing glycerin (65.9%) was not sensitizing in a modified Draize test (n=48). There were no reaction during either the induction or challenge phase. (Safety Assessment of Glycerin as Used in Cosmetics, Final Report, December 2014) Eye Irritation: Test performed with other products of Provital: Sweet Almond Milk (Cod. 4760): In-vitro Irritation Index: HET- CAM (con. 100%): Glycerin (RTECS no. MA ): Draize Test eye rabbit = 500 mg/24h, mild. Polyglyceryl-4 Caprate: No irritant in the eye of rabbits. Method OCDE 405 (Supplier data) Xanthan Gum. Daily application of a 1% solution for 5 days to rabbit conjunctiva produced no signs of irritation (WHO Food Additives Series 21, 1987) Undiluted Prunus Amygdalus Dulcis (Sweet Almond) Oil, was tested for eye irritancy in rabbits, resulting product as nonirritating to minimally irritating. (CIR Final Report, 03/04/2011) Mutagenicity: Polyglyceryl-4 Caprate: No mutagenic substance (Ames Test). (Supplier data) Glycerin was not genotoxic in multiple Ames tests using multiple strains of Salmonella typhimurium up to 50mg/plate. It was not genotoxic in a cytogenetic assay, in a HGPRT assay, sister chromatid exchange assay using CHO cells, unscheduled DNA synthesis assay using rat hepatocytes, or a in vitro chromosome aberration test using CHO cells, up to 1.0mg/mL was tested in these studies. (Safety Assessment of Glycerin as Used in Cosmetics, Final Report, December 2014) Moreover in two in vivo chromosome aberration assays, glycerin was not genotoxic when administered orally to rats at 1mg/kg or by injection into the abdomen at 1000/mg/kg. (Safety Assessment of Glycerin as Used in Cosmetics, Final Report, December 2014) 3

4 Acute toxicity: Corn starch (RTECS no.gm ): LD50 i.p. mouse = 6600 mg/kg Glycerin (RTECS no. MA ): TDLo oral in human = 1428 mg/kg. Glycerin (RTECS no. MA ): LD50 in rat: p.o. = mg/kg, i.p. = 4420 mg/kg, s.c. = 100 mg/kg, i.v. = 5566 mg/kg. LDLo in rat i.m. = 10 mg/kg, TDLo in rat i.m. = 5 g/kg. Glycerin (RTECS no. MA ): LD50 oral mouse = 4090 mg/kg, LD50 i.p. mouse = 8700 mg/kg, LD50 s.c. mouse = 91 mg/kg, LD50 i.v. mouse = 4250 mg/kg, LD50 oral rabbit = 27 g/kg, LD50 i.v. rabbit = 53 g/kg, TDLo i.m. rat = 4 ml/kg, TDLo i.m. rat = 4000 mg/kg. Almond Oil (RTECS RJ ): LD50 oral, rat > 5 g/kg; LD50 skin, rabbit > 5 g/kg. Polyglyceryl-4 Caprate: Acute oral toxicity, LD50 rat > 2000 mg/kg. Method OCDE 401 (Supplier data) Xanthan Gum: LD50 mouse: p.o.>1 g/kg, i.p. >50 mg/kg, i.v mg/kg. LD50 rat p.o.> 45 g/kg. LD50 dog p.o. >20 g/kg (WHO Food Additives Series 21, 1987) Xanthan Gum. Five rats received by inhalation route a single dose of 21 mg/l, No signs of toxicity were seen after a period of 14 days (WHO Food Additives Series 21, 1987) Corn starch (RTECS no: GM ): LD50 i.p. mouse = 6600 mg/kg Subchronic and chronic toxicity: Corn starch (RTECS no.gm ): TDLo p.o. rat = 420 g/kg/4w-c Glycerin (RTECS no. MA ): TDLo oral rat = 96 g/kg/30d-i, TDLo oral mouse = 560 g/kg/8w-c, TDLo oral mouse = 2800 mg/kg/25w-c. The NOAEL of glycerin in rats was between 115 and 2300 mg/kg when orally administered in water for 44days.The NOEL in dogs was 950 when orally administered for 3 days. (Safety Assessment of Glycerin as Used in Cosmetics, Final Report, December 2014) In repeated dose toxicity studies with humans there were no signs of toxicity or effects on blood or urine production when subjects (n=14) were orally administered glycerin ( g/kg/day) for 50 days.(safety Assessment of Glycerin as Used in Cosmetics, Final Report, December 2014) There were no treatment effects when glycerin (100%; 0.5-4mL) was administered to 30% of the body surfaces of rabbits for 45 weeks.(safety Assessment of Glycerin as Used in Cosmetics, Final Report, December 2014) The inhalation NOAEL was for glycerin administered nose only for 5h/day, 5day/week for 13 weeks in rats. (Safety Assessment of Glycerin as Used in Cosmetics, Final Report, December 2014) Xanthan Gum. Study in rats fed with diets containing 7.5 o 10% of xanthan gum for days. No adverse effects were observed (WHO Food Additives Series 21, 1987) Xanthan Gurm: the administration in mice at a dose of 5 mg in 0.5 ml of water by i.p. route over 2 weeks, caused no toxicity. Also its administration in diet in dog for 12 weeks gives a NOAEL of 0.25 g/kg/día. (CIR Final Report, October 5, 2012) Xanthan Gum: Five subjects consumed 150 mg/kg/day xanthan gum for 23 days; the ingestion had no significant adverse effects. The industrial exposure in employees of a manufacture plant of xanthan gum, caused no significant acute or chronic effects in pulmonary function. (CIR Final Report, October 5, 2012) Corn starch (RTECS no: GM ): TDLo p.o. mouse = 420 g/kg/4w-c Reproductive effects: Glycerin (RTECS no. MA ): rat, i.t. TDL0 = 280 mg/kg, 2 days, male; rat oral TDL0 = 100 mg/kg, 1 day, male; rat, i.t., TDL0 = 862 mg/kg, 1 day, male. Xanthan Gum : A three-generation reproduction study in rats, Dose: 0, 0.25 and 0.5 g/kg/day in the diet. No adverse effects. (WHO Food Additives Series 21, 1987) In a two-generation reproductive study in rats (n=10/sex), the administration of glycerin (0,20%; 2000mg/kg/day in drinking water) for 8 weeks before mating until weaning of pups produced no adverse effects on the reproductive efficiency of the parents (F0) or the development of the offspring (F1). (Safety Assessment of Glycerin as Used in Cosmetics, Final Report, December 2014) When glycerin was administered orally to rats and mice on days 6 through 15 of gestation, there were no adverse effects observed in the dams. The NOAEL for maternal toxicity and teratogenicity was 1310 mg/kg/d for rats and 1280 mg/kg/d for mice. (Safety Assessment of Glycerin as Used in Cosmetics, Final Report, December 2014) When glycerin was administered orally to rabbits (n=25) on days 6 through 18 of gestation, there were no adverse effects found in the dams. The NOAEL for maternal toxicity and teratogenicity was 1180 mg/kg/d. (Safety Assessment of Glycerin as Used in Cosmetics, Final Report, December 2014) Other data: 4

5 Corn starch: 2-year bioassay in rats fed with corn, the absence of significant toxic effects were registered. The substance is Not Classifiable as Human Carcinogen. (ACGIH. Documentation of the threshold limit values and biological exposure indices Vol:7th Ed (2001) 2p) Corn starch: It is considered a substance of low toxicity by all routes and does not produce significant systemic toxicity in occupational exposures. TLV-TWA = 10 mg/m3. (ACGIH. Documentation of the threshold limit values and biological exposure indices Vol:7th Ed (2001) 2p) Corn starch diets have a protective role against DMH-colon carcinogenesis in the rat. (Basic Life Sci. 1993;61:437-45) Xanthan Gum. Several studies in humans indicated no adverse effects at levels up to g daily (WHO Food Additives Series 21,1987) Formulations containing 0.1% - 2.0% Prunus Amygdalus Dulcis (Sweet Almond) Oil, tested for photosensitization in a total of 764 subjects, did not manifest photosensitivity in any of the test subjects. (CIR Final Report, 03/04/2011) 4. ECOLOGICAL DATA Biodegradability: Glycerin (HSDB no. 492, revision: ): Activated sludge test: 220 mg/l resulted in a COD of 97%; Test in a 5 days: BOD = 82%. Glycerin is considered an easily degradable substance. Aquatic Toxicity: Glycerin: Multiplication inhibition test in algae (Microcystis aeruginosa) and protozoa (Entosiphon sulcatum): Toxicity threshold = 2900 mg/l and 3200 mg/l (HSDB no. 492, revision: ). Glycerin (HSDB no. 492, revision: ): LC50 goldfish > 5000 mg/l/24h. Other data: No data available. 5. CONCLUSION The European cosmetics legislation (Regulation (EC) No 1223/2009) establishes the need to assess the safety of cosmetic products, taking into account the toxicological profile of the ingredients. To do this, in the case of possible systemic effects, it is necessary to obtain the NOAEL (no observed adverse effects level) for the calculation of MoS (margin of safety). The absence of these considerations shall be duly justified. The NOAEL value, or else other data used for the same purpose (LOAEL, LD50, etc.), can only be calculated experimentally from toxicological studies that require the use of animals. Since Provital does not perform any animal testing, it has established a system to ensure the safety of its products without the need of NOAEL and the subsequent calculation of MoS. This systematic, in the case of natural complex substances (NCS) has been endorsed by international organisms and renowned toxicologists. The safety of this ingredient is then established based on the following information: known uses of the active in different fields (medicine, food, cosmetics, etc.), profile of the chemical compounds of the ingredient and bibliographic toxicological information available for the active and its components. The integration and study of all these data allows for a conclusion on the safety of the ingredient. The components of this product have registered adverse effects neither in its described uses nor in the historical marketing of this company. These data and the available toxicological information lead to the conclusion that the use of this product, under the normal conditions of cosmetic use, involves no risk for consumers. This information is based on Provital's current knowledge and experience and Provital has no legal obligation or liability in relation to any damage, loss or offense, including in regard to patent rights. Risks and liabilities arising from the use of this information, the product or its applications are accepted by the user according to current 5

6 local laws. Provital does not guarantee efficacy experimental results under conditions other than those specified. Provital also reserves the right to make changes to this document due to technical progress or further developments. 6