G PRONALEN FRUIT ACIDS AHA-20 * Version: 24-23/FEB/2016

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1 G PRONALEN FRUIT ACIDS AHA-20 * Version: 24-23/FEB/ PRODUCT IDENTIFICATION Trade Name: PRONALEN FRUIT ACIDS AHA-20 * 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): Skin-Conditioning Agents-Miscellaneous; Antioxidants Function of the Ingredient (UE Inventory): Skin Conditioning; INCI approved in: Registered in EU, USA, Japan Japanese Name: JCLS: Glycollic Acid, Lactic Acid, Citric Acid, Tartaric Acid Japanese translation available in PCPC. 2. PRODUCT COMPOSITION Components Breakdown (INCI). Including actives, solvents, preservatives, antioxidants and other additives: [EU] CAS EINECS Aqua % Alcohol denat % Passiflora Edulis Fruit Extract 3-4 % Ananas Sativus Fruit Extract % Vitis Vinifera Fruit Extract % Antioxidants Sodium Bisulfite 0,002-0,003 % Preservatives Potassium Sorbate 0,08-0,1 % Additives Disodium EDTA 0,008-0,011 % PCPC [CTFA] CAS EINECS Water % Alcohol denat % Passiflora Edulis Fruit Extract 3-4 % Ananas Sativus (Pineapple) Fruit Extract % Vitis Vinifera (Grape) Fruit Extract % Antioxidants Sodium Bisulfite 0,002-0,003 % Preservatives Potassium Sorbate 0,08-0,1 % Additives Disodium EDTA 0,008-0,011 %

2 Impurities: Heavy Metals (as Pb) Pesticides No data available. Not expected to be found. No data available. Not expected to be found. 3. 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 fruit of Passiflora edulis is considered safe. The fruit can be grown to eat or for its juice, which is often added to other fruit juices to enhance aroma. The fruits of the pineapple constitute an important edible resource and are registered in all the Codex Alimentarious. (Tratado de Fitofármacos y Nutracéuticos; Dr. Jorge Alonso, pag 153) The Cosmetic Ingredient Review (CIR) Expert Panel concluded that the cosmetic ingredient Vitis vinifera (Grape) Fruit Extract is safe in the present practices of use and concentration described in this safety assessment. (Safety Assessment of Vitis vinifera (Grape)-Derived Ingredients as Used in Cosmetics, CIR Expert Panel Meeting, September 10-11, 2012) In the Food and Drug Administration (FDA) Food Labelling regulations (21CFR101) subpart C, which addresses Specific Nutrition Labelling Requirements and Guidelines, grapes are listed as one of the 20 most frequently consumed raw fruits. (Safety Assessment of Vitis vinifera (Grape)-Derived Ingredients as Used in Cosmetics, CIR Expert Panel Meeting, September 10-11, 2012) Grape skin extract (enocianina), prepared by an aqueous extraction of the fresh deseeded marc remaining after grapes have been pressed to produce grape juice or wine, is a FDA-approved food color additive (21CFR73.170). Based on the available information included in the Final Report, the CIR (Cosmetic Ingredient Review) concludes that Glycolic and Lactic Acid, their common salts and their simple esters, are safe for use in cosmetic products at concentrations =10%, at final formulation ph =3.5, when formulated to avoid increasing sun sensitivity or when directions for use include the daily use of sun protection. These ingredients are safe for use in salon products at concentrations =30%, at final formulation ph =3.0, in products designed for brief, discontinuous use followed by thorough rinsing from the skin, when applied by trained professionals, and when application is accompanied by directions for the daily use of sun protection. (IJT 17(S1):1-242, 1998) Alcohol Denat. denatured with t-butyl Alcohol, Denatonium Benzoate, Diethyl Phthalate or Methyl Alcohol is considered safe as cosmetic ingredient by the Cosmetic Ingredient Review (CIR) (IJT 27(S1):1-43, 2008) It exists a CIR Final Report on Safety Assessment of Sodium bisulfite including all the toxicological data: IJT 22(S2):63-88, The CIR Final Report on Safety Assessment of Potassium Sorbate (JACT 7 (6): , 1988, confirmed 04/06) exists and includes all the toxicological data. It exists a CIR Final Report on Safety Assessment of Disodium EDTA including all the toxicological data: IJT 21 (2) Classification according to Council of Europe (*): Vitis: 3 *(1)- Non-recommended ingredients (2)-Ingredients which could not be assessed (3) Recommended ingredients Cytotoxicity: No data available. Skin Irritation: PRONALEN FRUIT ACIDS AHA-20: In-vitro Skin Corrosivity Index (CORROSITEX 100% solution) =Group III. Mild corrosive PRONALEN FRUIT ACIDS AHA-20: SKINTEX (HSA) score >1.2 : Slightly irritant or higher.. Lactic acid (RTECS nº OD ): Draize test skin: rabbit 5 mg/24h = Severe; Human 10%/48H. Citric acid (RTECS no. GE ): Draize test skin: rabbit 500 mg/24h = mild; rabbit 0.5 ml = moderate. Glycolic acid (RTECS nºmc ): Test the Draize in skin of rabbit, 0.5ml, Reaction: severe. 2

3 Alcohol Denat. Skin Irritation: No irritant (OECD Guideline 404). (Supplier Data) In in vitro testing, a product containing 3% Vitis Vinifera (Grape) Fruit Extract was predicted to be a non-irritant in a dermal irritection test in human skin and a product containing 10% Vitis Vinifera (Grape) Fruit Extract was predicted to be non-irritating/ minimal in an Epiderm MTT viability assay. (Safety Assessment of Vitis vinifera (Grape)-Derived Ingredients as Used in Cosmetics, CIR Expert Panel Meeting, September 10-11, 2012) Skin Sensitization: Bromelain: (HSDB no.7202) As contact allergens the enzymes play a minor role In clinical testing, products containing up to 10% Vitis Vinifera (Grape) Fruit Extract, a formulation containing 0.1% Vitis Vinifera (Grape) Juice, cosmetic formulations containing 0.5% Vitis Vinifera (Grape) Juice Extract, and Vitis Vinifera (Grape) Seed Extract tested at a maximum concentration of 1% in a raw material were not irritant or sensitizers in human repeated insult patch testing (HRIPTs). (Safety Assessment of Vitis vinifera (Grape)- Derived Ingredients as Used in Cosmetics, CIR Expert Panel Meeting, September 10-11, 2012) Alcohol denat: Not considered a skin sensitizer (equivalent or similar to OECD Guideline 429). (Supplier data) Eye Irritation: PRONALEN FRUIT ACIDS AHA-20: In-vitro Irritation Index (HET-CAM, 100% solution) =9.2. Irritant severe PRONALEN FRUIT ACIDS AHA-20: EYTEX (UMA) score 50.8 : Irritant. Two products containing 3 and 10% Vitis Vinifera (Grape) Fruit Extract were predicted to be a minimal ocular irritant using the ocular irritection test method. (Safety Assessment of Vitis vinifera (Grape)-Derived Ingredients as Used in Cosmetics, CIR Expert Panel Meeting, September 10-11, 2012) Alcohol denat: According to the Harmonised classification from the ECHA (European Chemicals Agency) and the Annex VI of CLP Regulation 1272/2008/ EC, ethanol is not classified as ocular irritant substance. Lactic acid (RTECS nº OD ): Draize test eye: rabbit 750 ug = severe. Citric Acid (RTECS no. GE ): Standard Draize test, rabbit eye = 750 µg/24h, severe irritation. Glycolic Acid (RTECS nºmc ): Standard Draize test in eye rabbit, 2mg, Reaction: severe Mutagenicity: There is a history of positive Ames tests with some foods, including grape. Although positive results for mutagenicity occur in bacterial assays, it is known that constituents of foods such as grapes, e.g. flavonoids, do not appear to be genotoxic to mammals in vivo. Additionally, Vitis vinifera-derived extracts have demonstrated an inhibition of tumor promotion. Therefore, the mutagenic effects in bacterial systems were not considered relevant to the safety of these cosmetic ingredients. (Safety Assessment of Vitis vinifera (Grape)-Derived Ingredients as Used in Cosmetics, CIR Expert Panel Meeting, September 10-11, 2012) Alcohol denat: There is not significant evidence that ethanol present a genotoxic risk according to the criteria normally applied for classification and labeling. (Supplier data) Lactic Acid(RTECS no. OD ):Test in E. coli 210 ppm/3h, cytogenetic analysis in hamster ovary 10 mmol/l Acute toxicity: Bromelain: (RTECS no. EF ) LD50 p.o. rat > 10gm/kg; LD50 i.p. rat = 85200ug/kg; LD50 p.o. mouse >10gm/kg; LD50 i.p. mouse = 36700ug/kg; LD50 i.v. mouse = 30mg/kg; LD50 i.v. rabbit = 20mg/kg Bromelain: (HSDB no.7202) LD50 parenteral rat = 85.2mg/kg; LD50 parenteral mouse = 30-35mg/kg; LD50 parenteral rabbit >20mg/kg Fruit juice of Passiflora edulis: LD50 mouse p.o. = mg/kg (An Fac Med Lima 2006; 67(3)). Alcohol denat. AcuteToxicity, Oral : LD50: mg/kg, dermal: LD50: mg/kg, inhalation: LC50: mg/m3 air. All the values are above the threshold of the classification of the acute toxicity, so this product is considered no-toxic. (Supplier Data) Lactic Acid (RTECS no. OD ): LD50: p.o rat.3.5 g/kg, p.o. mouse 4.9 g/kg, skin rabbit > 2 g/kg, p.o. guinea pig 1.8 g/kg. LDLo: p.o. rabbit 5g/kg Glycolic Acid (RTECS nºmc ): LD50 p.o. rat 1950 mg/kg, i.v.cat 1 gm/kg, p.o. guinea pig 1920 mg/kg Citric acid (RTECS no. GE ): LD50 p.o. rat = 3 g/kg; LD50 i.p. rat = 290 mg/kg; LD50 s.c. rat = 5500 mg/kg; LD50 p.o. mouse = 5040 mg/kg; LD50 i.p. mouse = 903 mg/kg; LD50 s.c. mouse = 2700 mg/kg; LD50 i.v. mouse = 42 mg/kg; LD50 i.v. rabbit = 330 mg/kg; LD16 i.p. rat = 197 mg/kg; LD16 p.o. rat = 5 g/kg; LD16 p.o. mouse = 5440 mg/kg; LD i.p. rat = 382 mg/kg; LD p.o rat = 83 g/kg; LD p.o mouse = 9080 mg/kg; LDLo p.o. rabbit =7 g/kg; TDLo intratraqueal guinea pig = 118 g/kg; TDLo i.v. dog = 64 mg/kg/30m; TDLo i.v. dog = 256 mg/kg/1h; TCLo inhalation guinea pig = 20 pph/10m; TCLo inhalation monkey = 2.5 pph/5m; TCLo inhalation guinea pig = g/m3/3m; TCLo inhalation rat = 180 mg/m3; TCLo inhalation guinea pig = g/m3/10m; TCLo inhalation human = g/m3/0.0083m. 3

4 Tartaric Acid (RTECS nº WW ): LDLo p.o rat 7500 mg/kg; LD50 i.v. mouse 485 mg/kg; LDLo p.o. dog 5 gm/kg; LDLo p.o. rabbit 5 gm/kg Subchronic and chronic toxicity: Bromelain: (RTECS no. EF ): TDLo p.o. mouse = 33600mg/kg/24W-I; TDLo p.o. mouse = mg/kg/129D-I; TDLo p.o. mouse = 1500mg/kg/6D-I; TCLo mouse skin = 50pph/24W-I. Grape juice, purple (RTECS nº MD ): TDLo p.o. human = 100 ml/kg/14d-i; TDLo p.o. rat = 500 mg/kg/5d- I. Alcohol Denat: NOAEL: 1730 mg/kg/day (Supplier data) Lactic Acid (RTECS no. OD ):TDLo skin rat 57590mg/kg/13W-I Citric Acid (RTECS no. GE ): TDLo p.o. rat = 9.3 g/kg/15d-i; TDLo p.o. rat = 18.6 g/kg/30d-i; TDLo p.o. rat = 12.6 g/kg/21d-i. Glycolic Acid (RTECS nºmc ): TDLo p.o. rat 2480 g/kg/35 W-C, TDLo p.o. rat mg/kg/3 W-C, TDLo p.o. cat 970 mg/kg/7d-i Glycolic Acid (RTECS nºmc ): TCLo inhalatiion rat 2 gm/m3/6h/2w-i; LC50 inhalation rat 7100 ug/m3/4h Glycolic acid (RTECS nºmc ): TDLo oral rat gm/kg/90d-i; Reproductive effects: Unripe ananas fruit extract (RTECS no. BV ): TDLo p.o rat (300 mg/kg), female days after conception. A two-generation reproductive study in which 7.5 or 15% grape colour extract (aqueous solution of anthocyanin grape pigments) was fed in the diet was performed using rats. The only statistically significant effects observed were decreases in the body weights of F1 and F2 pups of both test groups and in body weights and liver, adrenal gland, and thyroid gland weights in F1 animals fed the test article for 30 days prior to mating. (Safety Assessment of Vitis vinifera (Grape)-Derived Ingredients as Used in Cosmetics, CIR Expert Panel Meeting, September 10-11, 2012) Alcohol denat: Adverse effects on reproduction have only been observed at very high doses, only relevant in deliberate and repeated ethanol consumption by ingestion. The most important studies are the two-generation study showing a NOAEL of 13.8 g/kg and inhalation studies showing a NOAEC of ppm. (Supplier data) Lactic Acid (RTECS no. OD ):TDLo p.o. rat 5700 mg/kg female 6-15 days after conception Glycolic Acid (RTECS nºmc ): TDLo p.o. rat 9 g/kg female 7-12 days after conception Other data: The administration of berry and leaf juice of Vitis vinifera to mice significantly reduced the hepatic and renal damage caused by ingestion of the mycotoxin ochratoxin A. None of the animals receiving V. vinifera showed the formation of hepatorenal carcinoma whereas 25% of animals receiving only ochratoxin A developed such lesions (Cytobios. 1998; 93 (373):123-8). The inhibition of tumor promotion by Vitis vinifera has been assessed in many studies. Seed polyphenols and extracts in particular were shown to inhibit DMBA-initiated and TPA-promoted tumors in mouse skin; dermal application and dietary administration both had significant inhibitory activity. Dietary grape seed extract also inhibited UV-initiated, UV-promoted, or UV-initiated and promoted skin tumors in hairless mice, and it inhibited the formation of AOM-induced aberrant crypt foci in the intestines of rats. Some of the studies examined the effect of applying DMBA to mice and then later either treating the animals topically or in the diet with grape seed extract without TPA. Mice did not develop tumors when dosed dermally or orally with grape seed extract after initiation with DMBA. (Safety Assessment of Vitis vinifera (Grape)-Derived Ingredients as Used in Cosmetics, CIR Expert Panel Meeting, September 10-11, 2012) Cardioprotective action of red wine was studied by preperfusing isolated rat hearts with ethanol-free red wine extract. The results indicate that red wines are cardioprotective by their ability to function as an in vivo antioxidant. (Journal of Cardiovascular Pharmacology, 2000, 35(2): ) A study investigated whether a polyphenolic extract from red wine affect azoxymethane-induced intestinal carcinogenesis. Male rats received the wine extract mixed in the diet at a dose of 50 mg/kg for 16 weeks. Significantly fewer rats in the wine extract group had adenomas and colorectal tumours than in controls. The tumours from the wine group had a significantly greater apoptotic index than controls. In contrast, the apoptotic index of the normal mucosa did not vary among groups. (Carcinogenesis 2000, 21(11), ) Pineapple and its extracts are usually very well tolerated (Tratado de Fitofármacos y Nutracéuticos; Dr. Jorge Alonso, pag 153) 4

5 4. ECOLOGICAL DATA Biodegradability: Denat Alcohol: Ethanol has a low log Kow and is a readily biodegradable substance. Ethanol is not classified as dangerous for the environment. (Supplier data) Aquatic Toxicity: Alcohol denat: LC50 for freshwater fish: mg/l, EC50 (48h) for freshwater invertebrates: 5012 mg/l, CE50/CL50 for freshwater algae: 275 mg/l. (Supplier data) 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. This product at 100% is classified as Corrosive for the Skin and causing of serious damage to eyes.nevertheless the bibliographical information of traditional use, the historical marketing in this company and the toxicological available information allow to conclude that the employment of this product, inside the normal conditions of cosmetic use and to the maximum recommended concentration, does not present any risk for the consumer. This product at 100 % presents effects of skin irritation and / or ocular irritation. Nevertheless the bibliographical information of traditional use, the historical marketing in this company and the toxicological available information allow to conclude that the employment of this product, inside the normal conditions of cosmetic use and to the maximum recommended concentration, does not present any risk for the consumer. 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 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. 5