G POLYPLANT OILY SKIN GNBN Version: 20-26/MAR/2014

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1 1. PRODUCT IDENTIFICATION Trade Name: POLYPLANT OILY SKIN GNBN Manufacturer: PROVITAL Responsible for the Safety Assessment: Lourdes Mayordomo Tf./Fax: / Kind of Raw Material: Active Ingredient Function of the Ingredient (CTFA Handbook): Fragrance Ingredients; Skin-Conditioning Agents - Miscellaneous; Oral Care Agents; Skin Protectants; Skin-Conditioning Agents - Emollient Function of the Ingredient (UE Inventory): Perfuming, Antidandruff, Cleansing, Oral care, Tonic, Emollient, Anticaking, Antimicrobial, Astringent, Skin conditioning, Skin protecting, Soothing, Smoothing. INCI approved in: Registered in EU, USA, Japan Japanese Name: JCLS: Watercress Extract, Burdock root Extract, Sage Extract, Ivy Extract, Saponaria Extract, Algae Extract Japanese translation available in PCPC. 2. PRODUCT COMPOSITION Components Breakdown (INCI). Including actives, solvents, s, preservatives, antioxidants and other additive dditives: [EU] CAS EINECS Glycerin % Aqua % Nasturtium Officinale Extract 0,15-0,43 % Arctium Majus Root Extract 0,15-0,43 % Salvia Officinalis Leaf Extract 0,15-0,43 % Citrus Limon Peel Extract 0,15-0,43 % Hedera Helix Leaf Extract 0,15-0,43 % Saponaria Officinalis Leaf/Root Extract 0,15-0,43 % Fucus Vesiculosus Extract 0,15-0,43 % Preservatives Sodium Benzoate 0,2-0,3 % Potassium Sorbate 0,2-0,3 % PCPC [CTFA] CAS EINECS Glycerin % Water % Nasturtium Officinale Extract 0,15-0,43 % Arctium Majus Root Extract 0,15-0,43 % Salvia Officinalis (Sage) Leaf Extract 0,15-0,43 % Citrus Limon (Lemon) Peel Extract 0,15-0,43 %

2 Hedera Helix (Ivy) Leaf Extract 0,15-0,43 % Saponaria Officinalis Leaf/Root Extract 0,15-0,43 % Fucus Vesiculosus Extract 0,15-0,43 % Preservatives Sodium Benzoate 0,2-0,3 % Potassium Sorbate 0,2-0,3 % Impurities: Heavy Metals (as Pb) Pesticides Less than 20 ppm. 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 following herbs have been approved by the German Commission E Monographs: Watercress (Published 1990); ; Salvia leaf ( Published May 15, 1985; Revised March 13, 1990 ); Hedera helix (Published July 6, 1988).; Soapwort root (Published April, 1989) The following substances have the GRAS status ('Generally Recognized As Safe'): Salvia officinalis(21cfr182.20); Lemon Peel (21CFR182.20)., Glycerin (21CFR ) The following substances are used as Food Additives permitted for human consume by FDA: Salvia officinalis (21CFR ) American Herbal Products Association: Arctium majus root - Herb that can be safely consumed when used appropriately (Class 1). American Herbal Products Association: Lemon peel is classified as herb that can be safely consumed when used appropriately (Class 1). 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 Final Report on Safety Assessment of Potassium Sorbate (JACT 7 (6): , 1988, confirmed 04/06) exists and includes all the toxicological data. Classification according to Council of Europe (*): Nasturtium 3, Arctium 3, Salvia 3, Citrus 3 (fruit), Hedera 3, Saponaria 2, Fucus 3. *(1)- Non-recommended ingredients (2)-Ingredients which could not be assessed (3) Recommended ingredients Cytotoxicity: No data available. Skin Irritation: Test done with other Provital products: Cod : Patch Test (30 min), IIP =0%, Patch Test (48 h), IP =15% Glycerin (RTECS no. MA ): Draize Test in the skin of rabbit, 500 mg, 24h, mild. Skin Sensitization: Topical administration of an aqueous extract of Arctium majus (5 mg/animal) on the ear of mice, 4 hours before challenge with whey in the ear, inhibited acute ear swelling by 50% in an vivo cow's milk allergic model. Arctium majus has an important potential of use in anti-allergic treatments (Exp Biol Med 2008 Nov; 233(11): ). Eye Irritation: Test done with other Provital products: Great Burdock Extract H.G. (Cod. 4220): In-vitro Irritation 2

3 Index: HET-CAM (con.100%): 2.37.; Sage Extract HG (4440): In-vitro Irritation Index (HET-CAM, 5% solution) = 2.2 +/- 1.6.; Lemon Peel Extract HG (Cod. 4340): In-vitro Irritation Index: HET-CAM (con. 100%): 3.90.; Ivy Extract HG (4310): In-vitro Irritation Index (HET-CAM, 5% solution) = 7.3 +/- 0.8.; Fucus Extract H.G. (Cod. 4200): In-vitro Irritation Index: HET-CAM (con. 100%): Hedera saponin : irritant in rabbit eye at a concentration of 1:10000 (ARZNAD 12,815,62) Glycerin (RTECS no. MA ): Draize Test eye rabbit = 500 mg/24h, mild. Mutagenicity: Arctium majus root: Presents antimutagenic activity (ADEFHEDRU, 2, 144, 93). Sage Extract: DNA Inhibition (human lymphocytes) : 2500 ppm (CNREA8 39, 4802, 79) Sage leaf tincture (ESCOP, 2ªEd. 2003):No mutagenic activity in Ames Test at 200 ul/plate using strains TA98 and TA100, with and without metabolic activation Salvia officinalis, in the form of tea infusion, showed antimutagenic potential in the somatic mutation and recombination test (SMART) on Drosophila melanogaster.(food Chem Toxicol (1):180-3) Salvia officinalis administered to mice at 25 microl/kg caused no increment in the frequency of chromosome aberrations respect to the control. (Acta Vet Hung 2004;52(4):439-43) Neohesperidin (RTECS no. DJ ): EPA GENETOX PROGRAM Negative in BFU Test in Salmonella typhimurium. Hesperidin: Ames Test on Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA1538 and in E. coli WP2, with and without S-9; dose: mg/plate; result: no mutagenic (CCRIS-Chemical Carcinogenesis Research Information System, number 3940, last revision date: ). Hesperidin (RTECS no. MK ): TDLo p.o. rat = mg/kg/6w-c. a-hederin: not mutagenic in the Ames Test (TA98, +/- S9) (MUTA 5,327,90) An aqueous extract of Fucus vesiculosus was found to be non genotoxic using the chromosome aberration and Comet assays in human lymphocyte cultures at 0.25, 0.5 and 1.0 mg/ml doses. Furthermore, when the extract was added to the lymphocyte cultures before a genotoxic agent (doxorubicin), showed a protective effect against DNA damage (Genetics and Molecular Biology, 30, 1, , 2007). Glycerin: DNA inhibition in human lymphocyte, 200 mmol/l (PNASA, 6, 79, 1171, 1982); Cytogenic Analysis rat p.o., 1 g/kg (TGANAK 19, 436, 1985). Acute toxicity: Watercress Extract : LD50 i.p. rat = 1 g/kg (IJEBA 6 16, 228, 78) Arctium Lappa Linn., root extract (RTECS no. CE ): LD50 i.p. in rat = 700 mg/kg. Arctium Lappa Linn. extract (RTECS no. CE ): LD50 i.p. in mouse = 681 mg/kg. Salvia extract (RTECS nº: VP ): LD50 i.p. in mouse: >1 g/kg. Rosmarinic Acid (RTECS no. GD ): LD50 i.v. mouse = 561mg/kg; TDLo i.p. mouse = 2mg/kg and 0.5 mg/kg; TDLo p.o. rat = 100 mg/kg. Citrus limon (L.) Burm.f., extract: Acute toxicity study on mouse, intraperitoneal, LD50 > 250 mg/kg (RTECS - Registry of Toxic Effects of Chemical Substances, number: GE , last update: ). Neohesperidin (RTECS no. DJ ): TDLo i.p. mouse = 30 mg/kg. Hesperidin (RTECS no. MK ): LD50 i.p. mouse = 1 g/kg; TDLo i.p. mouse = 5 mg/kg; TDLo i.p. mouse = 25 mg/kg. Naringin (RTECS no. QN ): LD50 i.p. rat = 2 g/kg; guinea pig = 2 g/kg; TDLo p.o. rat = 100 mg/kg; i.p. mouse = 30 mg/kg. Ivy Leaf Extract: LD50 p.o. mice > 3 g/kg, LD 50 p.o. rat > 4.1 g/kg. Ivy Saponine mixture:ld50 p.o. mice > 4 g/kg, LD50 i.p. mice 2.3 g/kg (ESCOP 2ªEd. 2003) Hedera helix saponin:: (RTECSno.MH ): LD50 p.o. rat> 100 mg/kg LD50 i.v. rat = 13 mg/kg Hederagenin:(RTECS no.rk ): LD50 i.p. mouse=600mg/kg Hederagenin: LD 50 i.p. mouse > 2 g/kg (YAHOA3,39,137,95) a-hederin: LD50 p.o. mouse > 4g/Kg, LD50 i.p. mouse 1.8 mg/kg (ANPHAFR,38,545,80) Saponin: LD50 i.p. mouse = 75 mg/kg (HPBIA 9, 22, 154, 76) Gypsogenin: LD50 o. rat > 50 mg/kg LD50 i.v. rat = 1.9 mg/kg (ARZNAD 12, 815, 62) 3

4 Gypsogenin: LDLo p.o. mouse= 2g/kg, LDLo s.c. mouse = 100 mg/kg, LDLo i.v. mouse = 15 mg/kg (HBAMAK 4,1289,35) Fucoidan, Fucus vesiculosus (RTECS no. LS ): TDLo i.v rat = 5 mg/kg. Alginic Acid, calcium salt (RTECS no. AZ ): LD50 i.p. rat = 1407 mg/kg, LD50 i.v. rat = 64 mg/kg. Alginic acid, sodium salt (RTECS no. AZ ): LD50 p.o. rat > 5 g/kg, LD i.p. rat > 1 g/kg, LD50 i.v. rat = 1 g/kg, LDLo i.p. mouse = 500 mg/kg, LD50 i.p. cat = 250 mg/kg, LD50 i.v. rabbit = 100 mg/kg, TDLo p.o. rat = 100 mg/kg, TDLo p.o. rat = 22 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. Subchronic and chronic toxicity: Nasturtium officinale, 70% ethanol extract (RTECS nº QN ): TDLo p.o. rat = 5000 mg/kg/10d-i; TDLo p.o. rat = mg/kg/30d-i. Salvia officinalis, extract (RTECS nº: VP ):TDLo mouse = 9800 mg/kg/14d-c A water infusion of Salvia officinalis administered to mice and rats for 14 days in the diet did not affect the body weight and food consumption and did not induce liver toxicity.(j Ethnopharmacol 2005; 97(2):383-9) Rosmarinic Acid (RTECS no. GD ): TDLo p.o. rat = 41.4 g/kg/2w. Hesperidin (RTECS no. MK ): TDLo p.o. rat = 2750 mg/kg/22w-i. Naringin (RTECS no. QN ): TDLo p.o. rat = 560 mg/kg/56d-i. Ivy leaf extract: rat p.o. 1.5 g/kg/day for 100 days caused no toxic effects (ESCOP 2ª Ed. 2003) Saponin Hedera Helix: (RTECSnºMH ): TDLo p.o. rat = 200 mg/kg/4d-i. Two extracts from the Fucus vesiculosus containing 28.8% of polyphenols or 18% of polyphenols, plus % of fucoxanthin have been studied to determine their toxicity. Both extracts were shown to lack any relevant toxic effects in a toxicity test following a 4 week daily treatment on rats (J Agric Food Chem (17): ). 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. Reproductive effects: Arctium majus extract: Does not affect fertility of female mice when injected subcutaneously twice a day for five days (ADEFHEDRU, 2, 144, 93). 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. Other data: Hepatoprotective effect of Great Burdock: Study in rats - Great Burdock at dose of 300 mg/kg shows a protective effect on the hepatotoxicity induced by ethanol and CCI4 (J Biomed Sci 2002; 9(5): 401-9). Study in mice - Great Burdock shows a protective effect on CCI4 and acetaminophen-induced liver damage ( Am J Chin Med 2000; 28(2):163-73). Arctium majus rhizomes: Carcinogenicity test, rats treated with a diet containing 33% of rhizomes for 120 days, without detecting tumors in any animal (ADEFHEDRU, 2, 144, 93). A clinic study was realized in 286 patients with acute viral pharyngitis. Patients were treated for 3 days with a spray containing 140 microl Salvia officinalis extract per dose; the product showed very good tolerability and was considered safe.(eur J Med Res 2006;11(1):20-6) A clinical prospective assay with patients with bronchitis concluded that the safety of the therapy with ivy leaf extract was very good with an overall incidence of adverse events of 2.1% (mainly gastrointestinal disorders with 1.5%). (Phytomedicine; 2006 Jul 20). A fucoidan-rich nutrient complex obtained from a blend of brown algae extracts (85% of Fucus vesiculosus, 10% of Macrocystis pyrifera and 5% of Laminaria japonica) was administered at a doses of 4

5 100 mg and 1000 mg for 4 weeks at a group of 10 patients. The preparation was considered safe; no adverse effects related to the treatment were registered. (Biologics Targets & Therapy 2011: ) The ability of Fucus vesiculosus extracts to protect against H(2)O(2) and tert-butyl hydroperoxide (tert- BOOH) induced stress in Caco-2 cells was investigated. The DNA protective effects of the extracts significantly protected (P<0.05) against H(2)O(2) (50 µm) induced DNA damage. (Food Chem. 2012;134(2): ) 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. 5

SWEET ALMOND MILK - NAT

4254100G SWEET ALMOND MILK - NAT Version: 25-08/FEB/2018 1. PRODUCT IDENTIFICATION Trade Name: SWEET ALMOND MILK - NAT Manufacturer: PROVITAL Responsible for the Safety Assessment: Lourdes Mayordomo Tf./Fax: