<<

Name of the CAS Cosing / SCCS Scientific Committee on Consumer Products Rating Function CIR Cosmetic Ingredient Review (opinions) STUDIES ingredient Number Restriction (opinions)

4- 99-96-7 Fragance and v/12. 0,4% (as acid) When incorporated into cosmetic formulations for non-preservative Report reopened on segurity of parabens including 4- (1) SCCNFP opinions 1997-2004. OPINION OF CONCERNING RESTRICTIONS ON hydroxybenzoi preservative for single ester functions, should be subjected to the same restrictions in usage levels hydroxybenzoic acid. The CIR Expert Panel concluded that the MATERIALS LISTED IN ANNEX VI OF DIRECTIVE 76/768/EEC ON COSMETIC c acid. 0,8% (as acid) for and warnings as when used for preservative effect (1 ). following 20 of 21 parabens are safe in in the present PRODUCTS ADOPTED BY THE PLENARY SESSION OF THE SCCNFP OF 17 mixtures of esters There is no evidence of demonstrable risk for the development of practices of use and concentration described in the safety FEBRUARY 1999. breast cancer caused by the use of paraben-containing underarm assessment.All animal sensitization tests indicated that the parabens (2) SCCP/0874/05 Extended Opinion on Parabens, underarm cosmetics and breast cancer. cosmetics. Conflicting results have been reported for p- are non-sensitizing, in the latest report of 2018, now (4). (3) SCCP/1183/08. OPINION ON Parabens COLIPA n° P82. hydroxybenzoic acid tested in vivo (2). (4) Amended Safety Assessment of Parabens as Used in Cosmetics Tentative Amended Safety data need to be provided for all authorised parabens, including Report for Public Comment January 23, 2019. April 8-9, 2019 iso-alkyl and pheny. Based upon the currently available in vitro data and in vivo rodent test results, the SCCS agrees that the estrogenic properties displayed by parabens appear to increase with increasing chain length parabens(3). 4- 36861-47- UV filter, UV less than 4%. VI/18 Safe for use in finished cosmetics no data (1) OPINION ON 4-Methylbenzylidene (4-MBC) SCCS 1184/08. Methylbenzyly 9/38102-62-4 absorber Products (applied to the whole body) in a concentration upto 4%. This (2) OPINION ON THE EVALUATION OF POTENTIALLY ESTROGENIC EFFECTS dene camphor report doesn't evaluate inhalation method (1). OF UV-FILTERS ADOPTED BY THE SCCNFP DURING THE 17TH PLENARY (4-MBC), Based on the actual scientific knowledge, the SCCNFP is of the MEETING OF 12 JUNE 200. SCCNFP 0483/01. Enzacamene opinion that the organic UV-filters used in cosmetic (3) Developmental toxicity of UV filters and environmental exposure: a review.Schlumpf products, allowed in the EU market today, have no estrogenic effects M, Int J Androl 2008 Apr;31(2):144-51). that could potentially affect human health (2) . (4) Included in UN list: United Nations Environment programme Overview Report II: An overview of current scientific knowledge on the life cycles, environmental exposures, and environmental effects of select endocrine disrupting chemicals (EDCs) and potential EDCs July 2017 Prepared by: The International Panel on Chemical Pollution (IPCP)7. (5) Maerkel K1, Lichtensteiger W, Durrer S, Conscience M, Schlumpf M. Sex- and region- specific alterations of receptor mRNA levels and sensitivity in rat brain following developmental exposure to the estrogenic UV filter 4-methylbenzylidene camphor. Environ Toxicol Pharmacol. 2005 May;19(3):761-5. Disponible en: doi:10.1016/j.etap.2004.12.055. (6) Schlumpf M et al. In vitro and in vivo estrogenicity of UV screens. Environ Health Perspect. 2001 Mar;109(3): 239–244. (7) Carvalhi UM.Official publication of the Brazilian Society of Dermatology. An Bras Dermatol.2014;89(6s1):01-74. (8) Sánchez Saldaña L, Lanchipa P, Pancorbo J, Regis A, Sánchez E. Topical photoprotectors. Peruvian dermatological review. 2002;12(2). Alcohol denat no tiene cas Antifoming, none none safe in the present prctices of use and concentration, up to 99% (1) (1) Final Report of the Safety Assessment of Alcohol Denat., antimicrobial, Including SD Alcohol 3-A, SD Alcohol 30, SD Alcohol 39, astringent, SD Alcohol 39-B, SD Alcohol 39-C, SD Alcohol 40, SD masking, Alcohol 40-B, and SD Alcohol 40-C, and the Denaturants, solvent, Quassin, Brucine Sulfate/Brucine, and Denatonium viscosity Benzoat. International Journal of Toxicology, 27(Suppl. l):1—43, 2008. (2) Masters in Life controlling Quality and Aesthtical Medical Care II edition.

Alginato de 9005-38-3 binding, none none The CIR Expert Panel concluded that the following 105 ingredients (1) Safety Assessment of Polysaccharide Gums as Used in Cosmetics. Final Report. calcio (Algin) masking, are safe in the present practices of use Release Date: October 22, 2015 Panel Date: September 21-22, 2015. viscosity and concentration in cosmetics, as described in this safety (2) Interpenetrating network hydrogel membranes of sodium alginate and poly(vinyl conytolling assessment, and that the available data are insufficient for alcohol) for controlled release of prazosin hydrochloride through skin. Raghavendra V. determining the safety of hydrolyzed carrageenan in cosmetic Kulkarnia,∗, V. Sreedhara, Srinivas Mutalikb, C. Mallikarjun Settyc, Biswanath Sad. products. The Panel expressed concern about pesticide residues International Journal of Biological Macromolecules 47 (2010) 520–527. and heavy metals that may be present in ingredients (3) Nacre-mimic Reinforced Ag@reduced Graphene Oxide-Sodium Alginate Composite that are derived from plants. They stressed that the cosmetics Film for Wound Healing Xu Yan,#1,2 Fei Li,#3 Kang-Di Hu,#3 Jingzhe industry should continue to use current good Xue,corresponding author4,5 Xiao-Feng Pan,3 Tao He,3 Liang Dong,5 Xiang-Ying manufacturing practices (cGMPs) to limit impurities. The Panel also Wang,3 Ya-Dong Wu,3 Yong-Hong Song,3 Wei-Ping Xu,corresponding author1,2 and agreed that the same suggestion is applicable Yang Lucorresponding author3. Sci Rep. 2017; 7: 13851. Published online 2017 Oct 23. to alkylating and other agents (e.g., haloethylaminopropionic acid; 3- doi: 10.1038/s41598-017-14191-5 (dodecenyl)-2,5-furandione; and 2,3- epoxypropyltrimethylammonium chloride) that are used to modify polysaccharide gums (1). Allantoin 97-59-6 skin none none The safety test data in this safety assessment and in previous safety (1) Final Report of the Safety Assessment of Allantoin ans its Related Complexes. Llilian conditioning, assessments were considered sufficient to support the safety of C. Becker. IJT 29(Suppl. 2):84-97, 2010 skin allantoin and the allantoin complexes in product categories and at protecting, concentrations reviewed in this safety assessment (1). smoothing Almond oil 12046-50-0 emollient, none none Safe for use in cosmetics when formulated to be non-irritating (1) (1) Safety Sssessment of PEGylated oils as used in cosmetics. Christina, L. Burnett IJT peg-6-Esters emulsificant 33(Suppl 4):13-39, 2014 Aloe 85507-69-3 emolinent, none none Safe as cosmetic ingredients in the practices of use and (1) International Journal Toxicology 26(suppl-2):1-50. 2007. Final Report on the Safety Barbadensis, humectant, concentrations as described in this safety assessment, if Assessment of Aloe. leaf extract. oral care, skin anthraquinone levels in the ingredients do not exceed 50 ppm. (1) (2) An Aloe Vera-Based Cosmeceutical Cream Delays and Mitigates Ionizing Radiation- conditioning Induced Dermatitis in Head and Neck Cancer Patients Undergoing Curative Radiotherapy: A Clinical Study Suresh Rao 1, Sanath Kumar Hegde 1, Manjeshwar Poonam Baliga-Rao 2, Princy Louis Palatty 3, Thomas George 3 and Manjeshwar Shrinath Baliga 1,*. Academic Editors: Sivarama Vinjamury and Elizabeth Sommers Received: 9 May 2017; Accepted: 19 June 2017; Published: 24 June 2017. (3 )A phase III trial comparing an anionic phospholipid-based cream and aloe vera-based gel in the prevention of radiation dermatitis in pediatric patients Thomas E Merchant*1, Christina Bosley1, Julie Smith1, Pam Baratti1, David Pritchard1, Tina Davis1, Chenghong Li2 and Xiaoping Xiong2. Radiation Oncology 2007, 2:45 doi:10.1186/1748-717X-2-45 (4) Aloe vera for prevention of radiation-induced dermatitis: a self-controlled clinical trial P. Haddad md,*† F. Amouzgar–Hashemi md,† S. Samsami md,† S. Chinichian,‡ and M.A. Oghabian phd. Curr Oncol, Vol. 20, pp. e345-348; doi: http://dx.doi.org/10.3747/co.20.1356. (5) Clear Evidence of Carcinogenic Activity by a Whole-Leaf Extract of Aloe barbadensis Miller (Aloe vera) in F344/N Rats Mary D. Boudreau,*,1 Paul W. Mellick,† Greg R. Olson,† Robert P. Felton,‡ Brett T. Thorn,‡ and Frederick A. Beland*. toxicological sciences 131(1), 26–39 (2013) doi:10.1093/toxsci/kfs275 Advance Access publication September 11, 2012 (6) Masters in Life Quality and Aesthtical Medical Care I edition. (2017).

Alpha They reduce DEM and increase the rad UV damage, concerns about Glycolic and Lactic Acid, their common salts and their simple esters, (1) SCCS 0799/04 UPDATED POSITION PAPER CONCERNING Hydroxy maintaing the integrity of the dermal barrier and long term security. are safe for use in cosmetic products at concentrations ≤10%, at final CONSUMER SAFETY OF ALPHA-HYDROXY ACIDS. Acids Improve the absorption of other substances (1). formulation pH ≥3.5, when formulated to avoid increasing sun (2) SCCS/03070/00. UPDATED POSITION PAPER CONCERNING CONSUMER (alfahidroxiáci Their should be appropriate warnings to the consumer of : avoiding sensitivity or when directions for use include the daily use of sun SAFETY OF ALPHA-HYDROXY ACIDS. dos) contact with the eyes, avoiding / or affording protecting from UV protection. These ingredients are safe for use in salon products at (3) IJT 17(S1):1-242, 1998 whilst using products containing AHAs because of the suggestion of concentrations ≤30%, at final formulation pH ≥3.0, in products susceptibility to increased damage from UV whilst cosmetic products designed for brief, discontin-uous use followed by thorough rinsing containing them are being used (2) . from the skin, when applied by trained professionals, and when application is accompanied by directions for the daily use of sun protection (3). aluminium, 7429-90-5 colouring IV/117 none none Included in the EU list of endocrine disruption substances with concern CI77000 (http://ec.europa.eu/environment/chemicals/endocrine/strategy/substances_en.htm) with category 3C Aluminum 7446-70-0 antitranspirant, none none (1) M. Streker ꞏ T. Reuther ꞏ S. Verst ꞏ M. Kerscher chloride astringen, Studiengang Kosmetikwissenschaft (FB 13), Universität Hamburg deodorant. Hyperhidrosis axillaris – Effektivität und Verträglichkeit eines aluminiumchloridhal- tigen Antiperspirants Prospektive Evaluation an 20 Patienten mit idiopathischer Hyperhidrosis axillaris. Hautarzt 2010 ꞏ 61:139–144 DOI 10.1007/s00105-009-1841-y Online publiziert: 3. Dezember 2009 © Springer-Verlag 2009. (2) The Effect and Persistency of 1% Aluminum Chloride Hexahydrate Iontophoresis in the Treatment of Primary Palmar Hyperhidrosis Khosro Khademi Kalantaria*, Afsane Zeinalzadea, Farzad Kobarfardb and Salman Nazary moghadamc. Iranian Journal of Pharmaceutical Research (2011), 10 (3): 641-645. Aluminum 54182-58-0 skin none none none (1) Ferreira EB, Vasques CI, Gadia R, Chan RJ, Guerra EN, et al. Topical interventions to sucrose conditioning prevent acute radiation dermatitis in head and neck cancer patients: a systematic review. octasulfate Support Care Cancer. 2017 Mar;25(3):1001-1011 (sucralfato) Release Date: March 9, 2018. (2) Feight D, Baney T, Bruce S, McQuestion M. Putting Evidence Into Practice. Clin J Oncol Nurs. 2011 Oct;15(5):481-92 Ascorbic 50-81-7 / Antioxidant, none none L Ascorbic acid is safe as used in cosmetic products. up to 10%. (1) (1) Final Report of the Safety Assessment of L- Ascorbic Acid as used in Cosmetics. Acid, vitamin 62624-30-0 buffering, International Journal of Toxicology 2005. C masking, ski (2) P. González-Muñoz L. Conde-Salazar,b S. Vaño-Galvána Actas Dermosifiliogr. conditioning 2014;105(9):822-832. (3) Espinal-Perez LE, Moncada B, Castanedo-Cazares JP. A double blind randomized trial of 5% ascorbic acid vs 4% hydroquinone in melasma. Int J Dermatol 2004;43:604-7 Ascorbyl 137-66-6 Antioxidant, none none Safe in cosmetics in the present practices of use and concentration (1) Safety Assessment of Ethers and Esters of Ascorbic Acid as Used in Cosmetics Status: Palmitate masking described in this safety assessment. (2)up to 0.2% (1). Final Report Release Date: October 6, 2017 Panel Date: June 12-13, 2017. (2) IJT 18(S3):1- 26, 1999 Astaxanthin 472-61-7 skin none none (1) Intracellular Signaling Mechanisms Involved in the Biological Effects of the contitioning Xanthophyll Carotenoid Astaxanthin to Prevent the Photo-aging of the Skin in a Reactive Oxygen Species Depletion-independent Manner: The Key Role of Mitogen and Stress- activated Protein Kinase 1 10.1111/php.13034. (2) Fungi J (Basilea) . 2017 sep 3 (3) 44. PMCID: PMC5715937 Published online 30 July 2017 doi: 10.3390 / jof3030044 PMID: 29371561 Biosíntesis de astaxantina como un carotenoide principal en la levadura heterobasidiomycetous Xanthophyllomyces dendrorhous Jose L. Barredo , 1 Carlos García- Estrada , 2, 3 Katarina Kosalkova , 2 y Carlos Barreiro 2, 4, *(3) Seki T. Effects of astaxanthin on human skin. Fragrance J 2001;12:98-103. Avena sativa, 84012-26-0 Astringent none none Safe in cosmetics in the present practices of use (1) Safety Assessment of Avena sativa (Oat)-Derived Ingredients as Used in Cosmetics flower//steam and concentration described in this safety assessment when Status: Final Report Release Date: January 15, 2015 Panel Meeting Date: December 8-9, leaf formulated to be non-sensitizing (1). 2014

Behenyl 661-19-8 binding,emollie none none (1) Safe as cosmetic ingredients in the present practices of use. Non- (1) Journal of the american college of toxicology Volume 7, Number 3, 1988 Mary Ann alcohol nt, emulsion sensitising, irritant nor fotosensitising. Liebert, Inc., Publishers5Final Report on the SafetyAssessment of Cetearyl Alcohol, Cetyl stabilising, (2) Reconsidered in 2005/2006, and determined not to reopen. Alcohol, lsostearyl Alcohol,MyristylAlcohol, and Behenyl Alcohol viscosity (2) Annual Review of Cosmetic Ingredient Safety Assessments: 2005/2006 )IJT 27(Suppl. controlling 1):77-142, 2008. (3) Regulatory Toxicology and Pharmacology 36, 80–85 (2002) doi:10.1006/rtph.2002.1566 The Toxicity of Behenyl Alcohol II. Reproduction Studies in Rats and Rabbits Guadalupe Iglesias, Jason J. Hlywka,,1 James E. Berg,† M. H. Khalil,† Laura E. Pope,† and Dov Tamarkin Based on these findings, there is no evidence to suggest that behenyl Benzoic acid 65-85-0/532- Bulking v/I a) Rinse-off The SCCNFP does not find the submission appropriate for a safety Safe as cosmetic ingredients in the present practices of use 0.000002 (1) SCCNFP/0532/01, final, opinion OF THE SCIENTIFIC COMMITTEE ON and its 32-1 masking, products, except evaluation of benzoic acid and sodium benzoate for the applied “other to 5% (3). COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR sodium salt preservative oral care products uses” in cosmetic products (1). CONSUMERS CONCERNING BENZOIC ACID AND SODIUM BENZOATE, of 4 June b) Oral care Suitable only for benzoic acid or sodium benzoate, but not for other 2002. products salts or esters, these need data about irritation and senstising if they are (2) 0891/05 - Opinion on Benzoic Acid and Sodium Benzoate. c) Leave-on to be used in cosmetics (2). (3) Safety Assessment of Benzyl Alcohol, Benzoic Acid and its salts and Benzyl benzoate,. products a) 2.5% Wilbur Johnson,Jr, Wilma F. Bergfeld. International Journal os Toxicology 2017 Vol (acid) 36/suplement3)SS-305. DOI:10.117/10915817728996 Final amended report 10/11; b) 1.7% (acid) original IJT 20(S3):23-50, 2001 c) 0.5% (acid) (4) Preservatives in hygiene and cosmetic products, topical medicines and household cleaning products in Spain. María Antonia Pastor-Nieto et al. Actas Dermosifiliogr. 2017;108(8):758-770 Benzophenone 131-57-7 UV filter, UV 6% maximum There isn't sufficient data to calculate the Securitty Margin of Reconsidered in (1) Opinion on BenzophenoneSCIENTIFIC COMMITTEE ON CONSUMER -3, absorber concentration, no benzophenone-3 in suggested condiciones of use upto 10%) (1). 2005/2006, and determined not to reopen(3). On the basis of the PRODUCTS. SCCP 1069/06. more than 0,5% as a The SCCP is of the opinion that the use of benzophenone-3 as a UV- available animal data and clinical human experience, it is concluded (2) OPINIONSCIENTIFIC COMMITTEE ON CONSUMER PRODUCTS SCCP OF formulation filter up to 6% in cosmetic sunscreen products and up to 0.5% in all that Benzophenone-1, -3, -4, -5, -9, and -11. are safe for topical BENZOPHENONE-3 SCCP 1201/08 protector types of cosmetic products to protect the formulation does not pose a application to humans in the present practices of use and (3) Annual Review odf Cosmetic Ingredient SAfety Assessments- 2002-2003. IJT risk to the health of the consumer, apart from its contact allergenic and concentration in cosmetics (4) 24(Suppl. 1):1-102, 2005. (4) Final Report on the Safety Assessment of Benzophenones-1 I photoallergenic potential (2). -3, -4, -5, -9, and -11. JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY Volume 2, Number 5, 1983 Mary Ann Liebert, Inc., Publishers. (5) Gaspar LR, Tharman J, Maia Campos PM, Liebsch M. Skin phototoxicity of cosmetic formulations containing photounstable and photostable UV-filtersand vitamin A palmitate. Toxicol In Vitro. 2013Feb;27(1):418-25. Available at: doi: 10.1016/j.tiv.2012.08.006. . (6) Stiefel C,Schwack W in changing times – UV filter efficacy and safety, sensitization processes and regulatory aspects. Int J cosmet Sci.2015;37(1):2–30. Disponible en: doi: 10.1111/ics.12165 Review Article. (7) Gilaberte Y, Carrascosa JM. Realities and challengegs of photoprotection in infants. Actas Dermosifiliogr.2014 4;105(3):253-262. (9) Lim HW, et al. Current challenges in photoprotection. J Am Acad Dermatol.2017;76(3S1):S91-9.. (8) (Alergic contact deramatitis by anatomical regions.Diagnostic Keys. E. Rozas-Muñoz, Actas Dermosifiliografica. 2018;109(6):485-507). (9) Included in the UN list: United Nations Environment programme Overview Report II: An overview of current scientific knowledge on the life cycles, environmental exposures, and environmental effects of select endocrine disrupting chemicals (EDCs) and potential EDCs July 2017 Prepared by: The International Panel on Chemical Pollution (IPCP). (10) Steinemann A. Fragranced consumer products: exposures and effects from emissions. Air Quality, Atmosphere & Health. 9 (8):Oct 2016

Benzyl alcohol 100-51-6 Solvent III/45, III/45 and Fragrance chemicals, which according to existing knowledge, are most Save in the present practises and concentration. 0,000005 to 10% (2). (1) Scientific Committee on Consumer Safety SCCS Fragrance/ V/34 (maximum frequently reported and well-recognised consumer allergens (1) Benzyl alcohol, Sodium benzoate and Benzoic Acid are safe for OPINIONon Fragrance allergens in cosmetic productsSCCS /1459/11. (2) Assesssment f aromatic concentration 1,0% cosmticas formulations at contration up 5%. The available data are Benzyl Alcohol, Benzoic Acid and its Saltas, and Bnezyl Bnezoate. Wilbour Johnson IJT compositions/ insufficient to support the safety in which a primary route expsoure is 36(Suppl. 3):5-30, 2017 their raw inhalation. Benyzl Alcohol is safe for use in hair dyes al (3) Assesssment f Benzyl Alcohol, Benzoic Acid and its Saltas, and Bnezyl Bnezoate. IJT materials. onceentration up to 10% (3). 20(suppl 3):23-50, 2001. Preservative, (4) Nair B. Final report on the safety assessment of Benzyl Alcohol, Benzoic Acid, and perfuming, Sodium Benzoate. International journal of toxicology. 2000 Dec;20:23-50. (5) Included in solvent, List of 26 Fragances That Must be Included on Label of Cosmetic Products, according to viscosity the Seventh Amendment of the European Cosmetics Directive. (6) Amerian Contact controlled Dermatitis Society Core. Dermatitis. Vol 24-No 1- JAnuary/February 2013. Benzyl 118-58-1 perfume, UV III/75 There is no demonstration in the peer reviewed scientific literature that none (1) Opinion concerning Essential oils Scientific Committee on Consumer Products. salicylate absorber fragrances compounds of natural origin are ‘safer’ than synthetics (1). 0673/03. (2) Memorandum on the SSCCNFP opinion concerning Fragance Allergy. It is noted that there is a proposal that for leave-on products this should 0450/01 be 10 ppm in the finished cosmetic product. Regarding rinse-off (3) 0017/98 - Opinion concerning Fragrance Allergy in Consumers - A Review of the products, the SCCNFP would consider a working level ten times Problem - Analysis of the need for appropriate Consumer Information and Identification of higher than that recommended for leave-on products to be reasonable Consumer Allergens. (4) Included in List of 26 Fragances That Must be Included on Label (2). of Cosmetic Products, according to the Seventh Amendment of the European Cosmetics Fragrance chemicals, which according to existing knowledge, are most Directive. frequently reported and well-recognised consumer allergens (3). BHA 25013-16-5 Antioxidant, none none A safety assessment of Butylated Hidroxyanisole was published in (1) Annuual Review of Cosmetic Ingredient Safety Assessments-2004/2005 !IJT 25 (Supl. (butylated masking 1984 with the conclusion that this indredient is safe as a comsetic 2): 1-89,2006. hydroxyanisol ingredientre in the practices of use (Elder 1984). New studies,along (2) Included in the UN list: United Nations Environment programme Overview Report II: e ) with update informtion regarding types ando concentrations of use, An overview of current scientific knowledge on the life cycles, environmental exposures, were considered by the CIR Experte Panel . The Panel dtermidedd to and environmental effects of select endocrine disrupting chemicals (EDCs) and potential nor reopen this safety assessment.Safe as cosmetic ingredients in the EDCs July 2017 Prepared by: The International Panel on Chemical Pollution (IPCP). present practices of use.noup to 0,2% (1). (3) Included in the EU list of endocrine disruption substances with concern (http://ec.europa.eu/environment/chemicals/endocrine/strategy/substances_en.htm) without category. (4) Allergic Contact Dermatitis Caused by Cosmetic Products P. González-Munñoz, L. Conde-Salazar,b S. Vaño-Galvána Actas Dermosifiliogr.2014;105(9):822-832.

BHT 128-37-0 Antioxidant, none none Safe as cosmetic ingredients in the present practices of use.no UP TO (1) Final report on the safety assessment of BHT (International Journal of Toxicology) (butylated masking 0,5% favourable report, topically applied it isn't sensitisng, irritant or 2002.Final Report of the Amended Safety Assessment of Myristic Acid and Its Salts and hydroxytoluen photocarcinogenic, its percutaneous absorbtion doesn't seem to have Esters as Used in Cosmetics (Int. Jour. Of Toxicology 2010).FDA Food Additive Status e) systematic reprecusions (1). American Conference of Governmental Industrial Hygienists (ACGIH).Vorhees, CShearn,Colin T ikism, Haris G. (2) Included in the UN list: United Nations Environment programme Overview Report II: An overview of current scientific knowledge on the life cycles, environmental exposures, and environmental effects of select endocrine disrupting chemicals (EDCs) and potential EDCs July 2017 Prepared by: The International Panel on Chemical Pollution (IPCP). (3) Allergic Contact Dermatitis Caused by Cosmetic Products P. González-Munñoz, L. Conde-Salazar,b S. Vaño-Galvána Actas Dermosifiliogr.2014;105(9):822-832.

Bis- 187393-00-6 UV filter, UV VI/25 Photostable and not estrogenic (1). none (1) OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND ethylhexyloxy absorbent, skin NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING phenol conditioner 2,4-BIS-{[4-(2-ETHYL-HEXYLOXY)-2-HYDROXY]-PHENYL}-6-(4- methoxyoheny METHOXYPHENYL)-(1,3,5)-TRIAZINESCCNFP/0082/98. l triazine.Bis- OTER STUDIES ethylhexyloxy (2) Skotarczak K, Osmola-Mankowska A, Lodyga M, Polanska A, Mazur M, Admski Z. phenol Photoprotection: facts and controversies. Eur Rev Med Pharmacol Sci. 2015 Jan;19(1):98- methoxyoheny 112.. l triazine. (3) Carrascosa JM. The future becomes the present in solar photoprotection. Elsevier Piel. 2011;26(7):311–314. Bisabolol 23089-26-1 masking, skin none none The expert Panel decided no reopen (1). Formulators should be alert (1) $0th Anniversary Overview and Rereview Summaries From 2011 to 2015. Monice conditioner, to the possibility that use of Bisabolol may increase the penetration of Fiume and Heldreth. IJT 36(Suppl 2):14-58, 2017. (2) Final Report on The safety smoothing the other componenets of a cosmetic formulation. Based on the Assessment of Bisabolol. IJT 18(S3):33-40, 1999 available data it concluded tahr the Bisabolol is safe as used in cosmteic formulation (2). Boric acid 10043-35-3 antimicrobial, III/1a, at 5% it is SCCS considers that these compounds have chemical, biological and Iin concentrations less than or equal to 5% are safe in cosmetics (1) Scientific Committee on Consumer Safety. SCCS OPINION ON the safety of boron buffer, prohibited in toxicological properties similar to boric acid. Therefore the general fortmulations containing free sodium borate or boric acid in this compounds in cosmetic products. SCCS/1523/1 3. denaturant, children under 3yo restrictions applicable to boric acid should apply to the whole group of concentration. Should not be used on infant skin or injured skin. (2) Scientific Committee on Consumer Safety SCCS OPINION ON Boron CMR1B. and on damaged skin borates (1). There have been signs of toxicity (3). compounds.SCCS/1249/09. Revision of 28 September 2010. The SCCS considers that a reproductive toxicity threshold can be Decided no to reopen (4). (3) Final Report on the safety assesssment os sodium borate and boric acid. JACT 2 (7): 87- established for boric compounds. From this base, boric acids, borates 125, 1983. and tetraborates are safe when used in the conditions set out in the first (4) Annual Review of Cosmetic Ingredientes Safety Assesssment 2004-2005. IJT 25 (Supl. entry in annex III (2). 2): 1-89,2006 Butyl 70356-09-1 Chemical. UV VI/1,8 none none (1) Damiani, E Stitt WZD, Scott GA, Martin RE, Gaspari AA. methoxydiben Filter/Absorber C (> 5%) (2) Stiefel C,Schwack W Photoprotection in changing times – UV filter efficacy and safety, zoylmethane ( sensitization processes and regulatory aspects. Int J cosmet Sci.2015;37(1):2–30. Available Avobenzona) in: doi: 10.1111/ics.12165 Review Article . (3) Sánchez Saldaña L, Lanchipa P, Pancorbo J, Regis A, Sánchez E. Topical photoprotectors. Peruvian dermatological review. 2002;12(2).. (4) Gaspar LR, Tharman J, Maia Campos PM, Liebsch M. Skin phototoxicity of cosmetic formulations containing photounstable and photostable UV-filtersand vitamin A palmitate. Toxicol In Vitro. 2013Feb;27(1):418-25. Available at: doi: 10.1016/j.tiv.2012.08.006. (5) Carvalhi UM.Official publication of the Brazilian Society of Dermatology. An Bras Dermatol.2014;89(6s1):01-74.

Butyl octyl 190085-41-7 hair none none They must be produced so as to not irritate. Salicylic acid and the 18 (1) Int J Toxicol. 200Amended Safety Assessment of salicylate conditioner, ingredients of salicylates are safe in cosmetics with current use Salicylic Acid and Salicylates as Used in Cosmetics,CIR, 2018. "Amended Safety (Benzoic acid, skin practices and concentrations described when it is produced so as to Assessment of Salicylic Acid and Salicylates as Used in Cosmetics.Status: Tentative 2-hydroxy-, 2- conditioner, not irritate." (1). Amended Report for Public Comment Release Date: July 3, 2018. Panel Date: September butyloctyl solvent 24-25, 2018. International Journal of Toxicology,22(suppl.3):1-108,20033; 22 Suppl 3: 1- ester) 108., Butylparaben 94-26-8 preservative, V/!12.For leave-on the SCCS reiterates its previous conclusions and requests regarding an The CIR Expert Panel concluded that the following 20 of 21 parabens (1) SCCS 1514/13 OPINION ON Parabens Updated request for a scientific opinion on masking products designed improvement of the data, in particular: a) on the exposure of humans are safe in cosmetics in the present practices of use and concentration propyl- and butylparaben. for children under including children to propyl- and butylparaben in cosmetic products described in the safety. Also concluded that the available data are (2) Amended Safety Assessment of Parabens as Used in Cosmetics Tentative Amended three years of age: and the toxicokinetics of propyl- and butylparaben in humans (1) insufficient to make a determination that Benzylparaben is safe under Report for Public Comment January 23, 2019. April 8-9, 2019. "Do not use on the the intended conditions of use in cosmetic formulations. This OTHER STUDIES nappy area" ingredient is not reported to be in current use (2) (3) Included in the UN list: United Nations Environment programme Overview Report II: An overview of current scientific knowledge on the life cycles, environmental exposures, and environmental effects of select endocrine disrupting chemicals (EDCs) and potential EDCs July 2017 Prepared by: The International Panel on Chemical Pollution (IPCP). Butyrospermu 91080-23-8 emolient, skin none none The panel concluded that the 244 palnt-derived fatty oils included in (1) Safety assessment of Plant-Derivated Fatty Acid Oils. Christina L. Burnett. m Parkii Oil conditioner this report are safe in the present practices of usesand concentration International Journal of Toxicology 2017, Vol.36(suplement 3) 515-1295. DOI: (Aceite de described in this assessment Since many of these oils ares edible, and 10.1177/091581817740569. (2) Safety Assessment of Butyrospermum parkii (Shea)- manteca de their systemic toxicity potential is low, the review focused on dermal Derived Ingredients as Used in CosmeticsStatus: Final Report. Release Date: October 5, Karite) effects (1). 2017. Panel Meeting Date: September 11-12, 2017 The Panel concluded that these ingredients are safe in the present practices of use and concentration when formulated to be non- sensitizing (2). Calendula 84776-23-8 masking, none none Are safe for use in cosmetics in the practices of use and concentration (1) Final Report of the Cosmetic IngredientNReview Expert Panel Amended Safety Officinalis perfuming, given in this amended safety assessment, up to 6% (1). Assessment of Calendula officinalis–Derived Cosmetic Ingredients F. Alan Andersen, Flower skin PhD1 , Wilma F. Bergfeld, MD, FACP1, Donald V. Belsito, MD1,Ronald A. Hill, PhD1, Extract conditioner Curtis D. Klaassen, PhD1, Daniel C. Liebler, PhD1, James G. Marks Jr, MD1, Ronald C.Shank, PhD1, Thomas J. Slaga, PhD1, andPaul W. Snyder, DVM, PhD1. International Journal of Toxicology 29(Supplement 4) 221S-243S Camellia 84082-60-0 antimicrobial, none none The Panel concluded that the C. sinensis leaf-derived ingredients are (1) Safety Assessment of Plant – Derived Fatty Acid Oils. Cosmetic Ingridient Review sinensis leaf antioxidant, safe as used when formulated to be non-sensitizing. The available (International Journal of Toxicology 2017. extract astringent, data are insufficient to determine whether the non-leaf-derived (2) Safety Assessment of Camellia sinensis dariced Ingredients as Used in Cosmetics. 2014 emolient, ingredients are safe for use in cosmeticsindustry should use good . Cosmetics Ingredients Review. moistening, manufacturing practices to limit impurities that could be present in masking, oral botanical ingredients (1). Ingredients derived from sinesis leaves are care, skin safe when used in cosmetics with limited concentration (2). conditioner, skin protector, tonic, UV absorbent Carbomer 9007-20-9/ gel forming, - none Impurities reported for Carmomer resins include water, benzene, (1) Amended Safety Assessment of Acrylates Copolymers as Used in Cosmetics (2018) 37625 emulsion propionic acid, acetic acid, acrylic acid, heavy metals, iron, arsenic International Journal of Toxicology.Environment Canada Domestic Substance List stabilsing, and lead. The Panel calls attention to the presence of benzene as an viscosity impurity in Carbomer and recommends that everything be done to controlling reduce it to the lowest value possible. Also, the formulas that have upto 0.25% Carbomer demonstrated a low irritation potential on human skin, sensibilization, phototoxicity and photocontact allergicity. Manufacturers should continue using best production methods to guarantee that the quantity of residual monomer be kept as low as possible. The Panel stipulates that these ingredients should't be polymerised in benzene. (1) Centella 84696-21-9 skin none none Are safe in the present practices of use and concentration in (1) Safety Assessment of Centella asiatica-derived Ingredients as Used in Cosmetics. asiatica Leaf conditioning cosmetics, as described in this safety assessment, Status: Final Report.Release Date: July 10, 2015.Panel Date: June15-16, 2015 Water when formulated to be non-sensitizing (1) Ceramide 100403-19-8 Hair none none Ingredients derived from nervous system tissues are not permited for (1) Safety Assessment of Ceramides as Used in Cosmetics Status: Final Report. AP,AS,EOP,E 100403-19-8 conditioning use in cosmetic products. And ceramides 1,2,3,4,5,1A and 6II are ReleaseDate: April 6, 2015.Panel Meeting Date: March 16-17, 2015.Cosmetics Ingredients OS,NG,NP, skin removed.(1) Review. conditioning (2) Tessema, E.N.; Gebre-Mariam, T.; Neubert, R.H.H.; Wohlrab, J. Potential applications of phyto-derived ceramides in improving epidermal barrier function. Skin Pharmacol. Physiol. 2017, 30, 115–138. (3) Park, J.W.; Park, W.J.; Futerman, A.H. Ceramide synthases as potential targets for therapeutic intervention in human disease. Biochim. Biophys. Acta 2014, 1841, 671–681 cetearyl 67762-27-0 / emollient, none none Although there are gaps in knowledge about product use, the overall (1) Final Report on the safety assessment of Cetararyl alcohol, cetyl alcohol, myristyl alcohol 8005-44-5 emulsificant, information available on the types of products in which these alcohol, isostearyl alcohol and behenyl alcoholJACT 7(3):359-413, 1988. emulsion ingredients are used and at what concentration indicate a pattern of us (2) Annuual Review of cosmetics ingredients safety assessment 2005/2006. IJT 27(Suppl. stablising, (1). 1):77-142, 2008. foam boosting, Decided no to reopen (2). opacifying, surfactant, controlled viscosity

Cetyl alcohol 36653-82-4 emollient, none none safe up 50% (1). (1) International journal of Toxicology, JT 27(Suppl. 1):77-142, 2008 JACT 7(3):359- emulsificant, 413, 1988. emulsion (2) P. González-Muñoz L. Conde-Salazar,b S. Vaño-Galvána Actas Dermosifilio stablishing, gr.2014;105(9):822-832. foam boosting, (3) Committee for Medicinal Products for Veterinary Use 16 March 2017 opacifying, EMA/CVMP/519714/2009–Rev.35. surfactant, controlled viscosity, masking

Chamomilla 84082-60-0 masking, skin none none Safe (1). (1) Amended Safety Assessment of Chamomilla Recutita-Derived Ingredients as Used in Recutita conditioner Safe when formulated to not be irritating (2). Cosmetics Status: Final Amended Report Release Date: June 29, 2016 Panel Date: June 6- Flower 7, 2016. Extract (2) Amended Sfety Assessment of Chamomilla Recutia -Derived Ingredientes as used in cosmetics. Wilbourd Jhonsn.IJT 37(Suppl 3):51-79, 2018 Ciclopentasilo 541-02-6 emollient, hair none Cyclopentasiloxane (D5) can contain traces of cyclotetrasiloxane (D4) Safe upto 93% (2). (1) SCCS/1549/15 Final version of 29 July 2016El . xane (D5) conditioner, which the EU classifies as toxic for reproduction. As such, the impurity (2) IJT 30 (Suppl. 3): 149-227, 2011 skin level of cyclotetrasiloxane (D4) as an impurity of cyclopentasiloxane conditioner, (D5) must be kept as low as possible. Also, it is not safe in aerosols (1). solvent Citric acid 77-92-9 / 5949- buffering, none Should be appropriate warnings to the consumer of : Safe in the present practices of use and concentration (3). (1) POSITION PAPER CONCERNING THE SAFETY OF ALPHA-HYDROXY ACIDS 29-1 chelating, * avoiding contact with the eyes SCCNFP/0370/00, final. masking * avoiding / or affording protecting from UV whilst using products (2) UPDATED POSITION PAPER CONCERNING CONSUMER SAFETY OF ALPHA- containing AHAs HYDROXY ACIDS.SCCNFP/0799/04. because of the suggestion of susceptibility to increased damage from (3) SafetyAssessment of Citric Acdo, InorganicSalts, and Añkyl Citrate Esters Used in UV whilst cosmetic products containing them are being used (1). cosmeticas. Monice. M. Fiume. IJT 33(Suppl.2):16-46, 2014. The SCCNFP maintains its previous opinion (2).

Cocamidopro 61789-40-0 antistatic, none none This cosmetic ingredient is similar DMAPA and amidoamine, which (1) Final Report of the Cosmetic Ingredient Review Expert Panel on the Safety pyl Betaine cleaner, foam are known as sensitizers. The Cir Panel concluded that beacuse these Assessment of Cocamidopropyl betaine (CAPB). Christina L. Burnett. IJT 31(Suppl. 1):77- CAPB control, skin ingredients ares no signifficant toxicity , when formulated as 111, 2012 conditioner, nosensizitier (which may be based on quantitative risk assessment), surfactant, these ingredeintes are safe for use as cosmetic ingredeintes in the (2) (Alergic contact dermatitis by anatomical regions. Diagnostic keys. E. Rozas-Muñoz, viscosity practices of use and concentratio of this safety assessment (1). Actas Dermosifiliografica. 2018;109(6):485-507). control Curcumin 458-37-7 cosmetic IV/114 none none (1) Palatty PL, Azmidah A, Rao S, Jayachander D, Thilakchand KR, et al. Topical colourant and application of a sandal wood oil and turmeric based cream prevents radiodermatitis in head antioxidant and neck cancer patients undergoing external beam radiotherapy: a pilot study, . Br J Radiol. 2014 Jun;87(1038):20130490 Cyclomethico 69430-24-6 / Hair Cyclomethicone is a The SCCS claims that cyclometicone (D4, D5) doesn't represent a The panel concludes that cyclomethicone, cyclotetrasiloxane, (1) Scientific Committee on Consumer Safety SCCS OPINION ON Cyclomethicone ne (D4, 556-67-2 / 541- conditioner, mixture of low health risk when used in cosmetic products. cyclopentasiloxane, cychohexasiloxane and cyclohpetasiloxane are Octamethylcyclotetrasiloxane (Cyclotetrasiloxane, D4) and +D5+D6) 02-6 / 540-97- skin molecular weight It should be noted that D4 is classified as a reprotoxic substance, safe as cosmetic ingredients for practice and use in the given Decamethylcyclopentasiloxane (Cyclopentasiloxane, D5). SCCP/0893/05, SCCS/1241/10 6 conditioner, volatile cyclic category 3 (1). concentrations (2). (2) Safety Assessment of Cyclomethicone, Cyclotetrasiloxane, Cyclopentasiloxane, emollient, siloxanes, the Cyclohexasiloxane, and Cycloheptasiloxane. Wilbyr Johnson. IJT 30 (Suppl. 3): 149-227, solvent, principal ingredients 20. viscosity of which are (3) D4,D5 and D6 included in VHCs REACH list control octamethylcyclotetra siloxane (D4), decamethylcyclopent asiloxane (D5) and dodecamethylcycloh exasiloxane (D6), in varying proportions

diazolidinyl 78491-02-8 preservative, V/46. 0,5% the total content of formaldehyde in the finished cosmetic product must is safe up to a maximum concentration of 0.5%.is safe up to a (1) THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD urea fragance not exceed 0.2% (1). maximum concentration of 0.5%.The Expert Panel recognized that PRODUCTS INTENDED FOR CONSUMERS OPINION CONCERNING while earlier studies (Elder 1990) indicated that Diazolidinyl Urea THE DETERMINATION OF CERTAIN FORMALDEHYDE RELEASERS IN was not genotoxic in bacterial or mammalian systems, but COSMETIC PRODUCT. SCNNFP/586/02. acknowledged that more recent genotoxicity data (Pfuhler and Wolf (2) Internationalfournal of Toxicology, 27(Suppl. 1):77—142, 2008 2002) in which the authors concluded that this preservative is a weak Copyright © American College of Toxicology mutagen. The Panel’s review ofthe experimental procedure ISSN: 1091-5818 print I 1092-874X online determined that the assay included a preincubation step that allowed DOT: lO.1080/109T58T080203236 the generation of additional free formaldehyde; this was likely the Annual Review of Cosmetic Ingredient Safety Assessments: 2005/20061 reason for the weak mutagenic effect. (2). (3) Final report on yhe Safety Assessment of Diazolidyl Urea. JACT 9(2):229-245, 1990. Free frm formaldehyde. May be safe used in cosmetic products at the (4) Included ( Diazolidinil urea 2% pet) in the Spanish standard series of the GEIDAC minumum effective concentration, not exceed 0,5%. (3). 2016( Grupo Español de Inestigación en Dermatitis de Contacto y Alergia Cutánea). (5) P. González-Muñoz L. Conde-Salazar,b S. Vaño-Galvána Actas Dermosifiliogr.2014;105(9):822-832. (6) Preservatives in hygiene and cosmetic products, topical medicines and household cleaning products in Spain. María Antonia Pastor-Nieto et al. Actas Dermosifiliogr. 2017;108(8):758-770 . diethyl 84-66-2 hair none Despite there being a lack of adequate toxicological data for some of In 1985 safety assessment of Dibutyl, Dimethyl, and Diethyl (1) Scientific Committee on Consumer Products SccP Opinion of diethyl phthalate n phthalate conditioner, this group of phthalates, and in view of the low concentrations found in Phthalate, The CIR stated that these ingredients ares safe for use in cosmetics. SCCP/1016/06. (2) Opinion of diethylphthalate. SCCNFP/0767/03. (DEP) masking, the samples of perfume analysed, there would be no quantifiable risk the presetn practise of use and concentration. In 1992,butyl benzyl (3) Opinion Diethyl phthalate. SCCNFP/0411/01). plasticizer, for the consumer. No need to update its phthalate was found safe and in 2007 confirmed that conclusion. In (4) 40Th Anniversary Overview and rereview Summaries Frem 2011 to 2015. IJT denaturant, opinion on the safe use of diethyl phthalate (DEP) (doc. n° 2012 confirmed Dibutyl, Dimethyl, and Diethyl Phthalate and Butyl 36(Suppl 2):14-58, 2017. (5) Incluido en lista ONU: United Nations Environment solvent SCCNFP/0441/01) in cosmetics on the basis of the new scientific data Benzyl Phthalate. The Panel decided no repone the safety programme Overview Report II: An overview of current scientific knowledge on the life provide (1). asssessment (4). cycles, environmental exposures, and environmental effects of select endocrine disrupting Stated in its opinion on diethyl phthalate of4 June 2002 (doc. n° chemicals (EDCs) and potential EDCs July 2017 Prepared by: The International Panel on SCCNFP/0411/01) (2). Chemical Pollution (IPCP) The SCCNFP states that the security profile of Diethyl Phthalate supports its use in cosmetic products at current levels (3). Diethylhexhyl 103-23-1 emollient, none Safe when formulated to not be irritating (1). (1) Opinion of diethylphthalate. SCCNFP/0767/03. adipate plasticizer, skin conditioner, film former diethylhexyl 154702-15-5 UV filter VI / 17 Maximum Favourable studies and max. concentration for use in UV at 10 % (1). none (1) OPINION ON BENZOIC ACID, 4,4‐{[6‐[[[(1,1‐DIMETHYL)AMINO]CARBONYL]PHENYL] butamido concentration 10% AMINO]‐1,3,5‐TRIAZINE‐2,4‐DIYL)DIIMINO}BIS‐, BIS(2‐ETHYLHEXYL)ESTER. SCCNFP triazone opinions 1997‐2004. () Dimethicone 63148-62-9 / Emollient, No restrictions none Safe up up to 80% in hair preparations; up to 24% in makeup. Its use (1) IJT 22(Suppl. 2):11-35, 2003. Final report on the safety assessment of Dimethicone, 9006-65-9 / skin protection is safe, as long as the concentrations are followed. According to cir it Methicone, (International Journal of Toxicology) 9016-00-6 isn't sensitisng, its absorption by molecular weight isn't probable, but take care with inhalation (1) . Drometrizole 155633-54-8 UV chemical < 15% none Its use is safe, in appropriate concentrations, up to 0,07% (1). (1) IJT 27(Suppl. 1):63-75, 2008. JACT 5(5):455-470, 1986, favourable studies 2008, trisiloxane absorbing photostable with some restrictions (65), Maximum absorbance in 243,298 and 340 nm. Amended final report of the safety assessment of cromiotrizol as used in Cosmetics. (International Journal of Toxicology)

EDTA 60-00-4 chelating none none none (1) Final Report on the Safety Assessment of EDTA, Calcium Disodium EDTA, Diammonium EDTA, Dipotassium EDTA, Disodium EDTA, TEA-EDTA. Tetrasodium EDTA , Tripotassium Edta, Trisodium EDTA, HEDTA, and Trisodium HEDTA 1. IJT 21(S2):95-142, 2002 Ethylhexhyl 118-60-5 UV filter VI/20. 5% Favourable (1). Review of estrogenicity as non binding. Mild irrritation, no (1) 1860/95 - Opinion on 2-Ethylhexyl salicylate. OPINION OF THE SCIENTIFIC Salicylate, photosensitivity, no ocular irritant, no canrinogenicity. Safe when is COMMITTEE ON COSMETIC AND NON-FOOD PRODUCTS INTENDED FOR Octisalate formulated as no irritant (2) CONSUMERS CONCERNING 2-ETHYLHEXYL SALICYLATE ADOPTED BY THE PLENARY SESSION OF THE SCCNFP OF 21 JANUARY 1998. (2) Amended Safety Assessment of Salicylic Acid and Salicylates as Used in Cosmetics Tentative Amended Report for Public Comment July 3, 2018 September 24-25, 2018 Cosmetic Ingredient Review. (3) Sánchez Saldaña L, Lanchipa P, Pancorbo J, Regis A, Sánchez E. Topical photoprotectors. Peruvian Dermatological Review. 2002;12(2). Ethylhexyl 5466-77-3 UV filter/ UV VI/ 1,12 < Based on the current scientific knowledge, the SCCNFP is of the none (1) OPINION ON THE EVALUATION OF POTENTIALLY ESTROGENIC EFFECTS Methoxycinna chemical 10% opinion that the organic UV-filters used in cosmetic sunscreen OF UV-FILTERS ADOPTED BY THE SCCNFP DURING THE 17TH PLENARY mate absorbing products, allowed in the EU market today, have no estrogenic effects MEETING OF 12 JUNE 2001. sccs 04831/01 (EHMC) that could potentially affect human health (1). OTHER STUDIES Octinoxate ( (2) Included in the UN list: United Nations Environment programme Overview Report II: OMC) An overview of current scientific knowledge on the life cycles, environmental exposures, and environmental effects of select endocrine disrupting chemicals (EDCs) and potential EDCs July 2017 Prepared by: The International Panel on Chemical Pollution (IPCP). (3) Stiefel C,Schwack W Photoprotection in changing times – UV filter efficacy and safety, sensitization processes and regulatory aspects. Int J cosmet Sci.2015;37(1):2–30. Available in: doi: 10.1111/ics.12165 Review Article . (4) Carvalhi UM.Official publication of the Brazilian Society of Dermatology. An Bras Dermatol.2014;89(6s1):01-74.. (5) Maerkel K1, Lichtensteiger W, Durrer S, Conscience M, Schlumpf M. Sex- and region- specific alterations of progesterone receptor mRNA levels and estrogen sensitivity in rat brain following developmental exposure to the estrogenic UV filter 4-methylbenzylidene camphor. Environ Toxicol Pharmacol. 2005 May;19(3):761-5. Available in: doi:10.1016/j.etap.2004.12.055. Ethylhexylglyc 70445-33-9 Deodorant. none none The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed (1) Safety Assessment of Alkane Diols erin ,1,2- Skin the safety of 10 alkane diol ingredients as used in as Used in Cosmetics Propanediol, conditioner cosmetics. The alkane diols are structurally related to each other as Status: Final Report 3-(2- small diols, and most are reported to function in cosmetics Release Date: June 13, 2018 ethylhexyloxy) as solvents. The Panel reviewed the relevant data for these Panel Meeting Date: March 5-6, 2018. IJT 32 (Suppl. 3): 5-21, 201. (2) American Contact ingredients, and concluded that seven alkane diols are safe in Dermatitis Society Core Allergen Series: 2017 Update. DERMATITIS, Vol cosmetics in the present practices of use and concentration described 28.No2.March/April, 2017. in this safety assessment, but that the available data are insufficient to make a determination of safety for three ingredients, namely 1,4-Butanediol, 2,3-Butanediol, and Octanediol . (1) Ethylparaben 120-47-8 Preservative. V/ 12 < 0,4 – 0,8% Based upon the above, the SCCS considers the use of butylparaben and The CIR Expert Panel concluded that the following 20 of 21 parabens (1) Opinion on Prabens SCCS/1348/10. 0,4% for propylparaben as preservatives in finished cosmetic products as safe to are safe in cosmetics in the present practices of use and concentration (2) Amended Safety Assessment of Parabensas Used in Cosmetics. Status: Tentative Methylparaben the consumer, as long as the sum of their individual concentrations described in the safety. Also concluded that the available data are Amended Report for Public Comment. Release Date: January 23, 2019. Panel Meeting or does not exceed 0.19%. This conclusion is based on the lack of insufficient to make a determination that Benzylparaben is safe under Date: April 8-9, 2019. Ethylparaben scientifically sound data on the pivotal link between dermal absorption the intended conditions of use in cosmetic formulations. This (3) Included in the UN list: United Nations Environment programme Overview Report II: (simple esters in rats and humans, in particular with regard to the metabolism of the ingredient is not reported to be in current use(2) An overview of current scientific knowledge on the life cycles, environmental exposures, or their salts), parent compound in the skin. and environmental effects of select endocrine disrupting chemicals (EDCs) and potential and 0,8% for The latter can only be addressed through additional human data. EDCs July 2017 Prepared by: The International Panel on Chemical Pollution (IPCP). the mixture of With regard to methylparaben and ethylparaben, the previous opinion, (4) Assessment of principal parabens used in cosmetics after their passage through human them stating that the use at the maximum authorized concentrations can be epidermis-dermis layer. S El Hussein, P Muret, M Berard… - Experimental …, 2007 - considered safe, remains unchanged. Wiley Online Library. Finally, the SCCS emphasizes that the studies submitted to the (5) Aquatic toxicity and ecological risk assessment of seven parabens: Individual and Committee primarily (1) additive approach HiroshiYamamotoaIkumiTamuraaYoshikoHirataaJunKatoaKeiichiroKagotaaShotaKatsukia AtsushiYamamotobYoshihiroKagamicNorihisaTatarazakod (6) Harvell, JByford JR, Shaw LE, Drew MG, Pope GS, Sauer MJ, Darbre PD. Oestrogenic activity of parabens in MCF7 human breast cancer cells. J Steroid Biochem Mol Biol. 2002 Jan;80(1):49-60. (7) Boberg J, Taxvig C, Christiansen S, Hass U. Possible endocrine disrupting effects of parabens and their metabolites. Reprod Toxicol. 2010 Sep;30(2):301-12. Epub 2010 Apr . (8) Andersen FA. Final amended report on the safety assessment of Methylparaben, Ethylparaben, Propylparaben, Isopropylparaben, Butylparaben, Isobutylparaben, and Benzylparaben as used in cosmetic products. Int J Toxicol. 2008;27 Suppl 4:1-82.

Eugenol 97-53-0 perfume, III/71 none none Included in List of 26 Fragances That Must be Included on Label of Cosmetic Products, denaturant , according to the Seventh Amendment of the European Cosmetics Directive. tonic Fragance deodorant, no data Contact allergy to fragrance ingredients may develop following skin no data (1) Scientific Committee on Consumer Safety SCCS masking, contact with a sufficient amount of these substances, often through the OPINIONon Fragrance allergens in cosmetic productsSCCS /1459/11. (2) Included Mix of perfuming use of cosmetic products (1) fragrances-II 14% pet in the Spanish standard series of the GEIDAC 2016 (Grupo Español de Investigación en Dermatitis de Contacto y Alergia Cutánea). (3) In chemical assessment of potential sensitizers: Stability and direct peptide reactivity of 24 fragrance ingredients Cristina Avonto Yan­Hong Wang Amar G. Chittiboyina StanislavVukmanovic Ikhlas A. Khan First published: 16 October 2018.https://doi.org/10.1002/jat.3732. (4) Anne Birgitte Simonsen, Mette Deleuran, Jeanne Duus Johansen & Mette Sommerlund. 2011. Contact allergy and allergic contact dermatitis in children - a review of current data. Contact dermatitis 65 (5), 254-65. (5) J Elberling, P. S. Skov, H. Mosbech, H. Holst, A. Dirksen & J. D. Johansen. 2007. Increased release of histamine in patients with respiratory symptoms related to perfume. Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology 37(11), 1676-80. (6) Kumar P, Caradonna-Graham VM, Gupta S, Cai X, Rao PN, Thompson J. Inhalation challenge effects of perfume scent strips in patients with asthma. Ann Allergy Asthma Immunol. 1995 Nov;75(5):429-33. (7) SC Rastogi, S Heydorn, JD Johansen & DA Basketter. 2001. Fragrance chemicals in domestic and occupational products. Contact dermatitis 45(4), 221-5. (8) Tatyana Hamilton & Gillian C. de Gannes. 2011. Allergic contact dermatitis to preservatives and fragrances in cosmetics. Skin therapy letter 16(4), 1-4. (9) The Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers. 2002. POSITION STATEMENT CONCERNING FRAGRANCE CHEMICALS IN DETERGENTS AND OTHER HOUSEHOLD PRODUCTS. SCCNFP/0588/02, finaL. (10) Reguiai Z1, Bachet JB, Bachmeyer C, Peuvrel L, Beylot-Barry M, et al. Supportive Care in Cancer Management of cutaneous adverse events induced by anti EGFR (Epidermal Growth Factor Receptor): a French interdisciplinary therapeutic algorithm. Support Care Cancer. 2012 Jul;20(7):1395-404. Ginkgo biloba 90045-36-6 Antioxidant GB leaf: skin none Are safe in the present practices of use and concentration described in (1) Safety Assessment of Ginkgo biloba-Derived Ingredients. as Used in Cosmetics. Status: conditioning. GB the safety assessment when formulated to be non-sensitizinxtract (1). Draft. Final Report for Panel Review. Release Date: August 29, 2018. Panel Meeting Date: leaf cellextract: September 24-25, 2018 (2) Kim SJ, Lim MH, Chun IK, Won YH. Effects of flavonoids of flavouring, skin Ginkgo biloba on proliferation of human skin fibroblast. Skin Pharmacol 1997; 10:200-5. protecting. GB leaf extract : skin conditioning, GB Leleaf power: skin consditioning. GB leaf water: masking, perfuming, skin conditioning, GB nut: extract: hair and skin coditioing; GB root extract: .skin consditioning. GB leaf terpenoide: Glycerin 56-81-5 denaturant none none Highly safe for cosmetic use (1) (1) Safety Assessment of Glycerin as Used in Cosmetics Status: Final Report Release Date: hair January 14, 2015 Panel Meeting Date: December 8-9, 2014 conditioning humectant oral care perfuming skin protecting viscosity controlling glycine soja 84776-91-0 Vegetable none none Safe as long as they are used in the appropriate concentration (1) (1) Safety Assessment of Plant – Derived Fatty Acid Oils. Cosmetic Ingridient Review (soybean) active (International Journal of Toxicology 2017 germ extract ingredient. Skin conditioner/ emollient Glycol, Name 107-21-1 fragrance, none none Ethylene glycol metabolites must not be in cosmetic formulas as they (1) IJT 18 (S2): 53-67, 1999 Ethane-1,2- huemctant, as toxic and endocrine disruptors (1) (2) Included in the EU list of endocrine disruption substances with concern diol, Ethylene solvent, (http://ec.europa.eu/environment/chemicals/endocrine/strategy/substances_en.htm) with glycol viscosity category 3C control Glycosaminogl 94945-04-7 Emollient, No restrictions none none (1) Metabolism in skin homeostasis and inflammatory disease.2017 Mar;101:128-138. doi: ycans skin 10.1016/j.fct.2017.01.012. Epub 2017 Jan 18. conditioner, Hamamelis 84696-19-5 Vegetable No restrictions none This ingredient and its derivatives are safe as long as they are used in (1) Safety Assessment of Hammamelis virginiana (Witch Hazel) Derived Ingredients as virginiana active the appropriate concentrations and manufacturerd to not be irritant Used in Cosmetics. Cosmetics Ingredients Review 2018. water (Agua ingredient. nor sensitising (1). de Astringent, hammamelis) hair conditioner, Helianthus 8001-21-6 emollient, none none They are safe as long as they are used in the appropriate (1) Safety Assessment of Plant – Derived Fatty Acid Oils. Cosmetic Ingridient Review annuus seed masking, concentration 0.000007 to 96% (1). (International Journal of Toxicology 2017. IJT 36(Suppl. 3):51-129, 201 oil conditioner Hexyl 101-86-0 perfuming III/87 none none (1) In chemical assessment of potential sensitizers: Stability and direct peptide reactivity of cinnamal 24 fragrance ingredients. Cristina Avonto Yan­Hong Wang Amar G. Chittiboyina Stanislav Vukmanovic Ikhlas A. Khan First published: 16 October 2018 https://doi.org/10.1002/jat.3732 , 118-56-9 skin 10% as a UV filter This favourable review doesn't contemplate its use in spray (1) none (1) Scientific Committee on Consumer Products SCCPOPINION ON HOMOSALATE Benzoic acid, conditioner, SCCP/1086/07 2-hydroxy- UV absorbent, (2) Environmental Health Perspectives • VOLUME 109 | NUMBER 3 | March 2001 3,3,5- UV filter Pont AR, Charron AR, Brand RM. 2004. Active ingredients in act as topical tromethylcycl penetration enhancers for the herbicide 2,4-dichlorophenoxyacetic acid. Toxicol Appl ohexyl ester / Pharmacol 195(3): 348-354. (3) In Vitro and in Vivo Estrogenicity of UV Screens Margret Schlumpf, Beata Cotton, Marianne Conscience, Vreni Haller, Beate Steinmann, and Walter Lichtensteiger Institute of Pharmacology and Toxicology, University of Zurich, Zurich, Switzerland (4) Sunscreens: are they beneficial for health? An overview of endocrine disrupting properties of UV-filters M. Krause,* A. Klit, M. Blomberg Jensen,* T. Søeborg,* H. Frederiksen,* M. Schlumpf,à W. Lichtensteiger,à N. E. Skakkebaek* and K. T. Drzewiecki Received 5 January 2012; revised 13 March 2012; accepted 13 March 2012 . (5) PubMed Central, Tabla 2: Salud Ambiental. 2017; 16: 94. Publicado en línea el 2 de septiembre de 2017. doi: 10.1186 / s12940-017-0287-4

Hydrolyzed 92113-31-0 / skin none none Safe in the present practices of use and concentration described in (1) Safety Assessment of Skin and Connective Tissue-Derived collagen 73049-73-7 conditioning, this safety assessment.. up to 6% (1). Proteins and Peptides as Used in Cosmetics.Final Report antistatic, The Panel expressed concern for the sensitisation. They wouldn't Release Date: October 5, 2017. emollient, film easily recognise cosmetic products that contain colagen derived from (2) Burnett CL, et al. Safety Assessment of Keratin and Keratin-Derived forming, hair fish based on the current denomination conventions used in the list of Ingredients as Used in Cosmetics. , Cosmetic conditioning, ingredients in product labels (for exeample, Colagen and hydrolised Ingredient Review. 2016 humectant Colagen can come from fish, although "fish" isn't in the named ingredients) (2). hypericum 84082-80-4 antioxidant none none Insufficient data to determine safety (1). (1) Becker.L,Amended ssafety assessment of - derived ingredients perforatum 68917-49-7 / hair asused in cosmetics .IJT 2014,vol.33(sup[lement 3) 2014. 84082-80-4 conditioning (2) .Franco P, Potenza I, Moretto F, Segantin 4, Grosso M, et al. Hypericum perforatum humectant and neem oil for the management of acute skin toxicity in head and neck cancer patients skin protecting undergoing radiation or chemo-radiation: a single-arm prospective observational study. emollient Radiat Oncol. 2014 Dec 29;9:297.

Isopropyl 67-63-0 antifoaming, none none Safe in the present practices of use and concentration. Irritante ocular (1) Final Report of Cosmetic Ingrediente Review Expert Panel on the Safety assessment of Alcohol perfuming, (1) Methyl acetate. Bart Heldreth . IJT 31(Suppl. 1):112-136, 2012. (2) J Drugs Dermatol. solvent, 2016 Jul 1;15(7):870-3.Differences in Cutaneous Irritation of Five Commonly Used viscosity Topical Products. Draelos ZD. controlling. Isostearyl 112-92-5 emollient, none none Based on the available data included in this report, it is concluded (1) International journal of Toxicology, JT 27(Suppl. 1):77-142, 2008 JACT 7(3):359- alcohol emulsifying, that Cete- aryl Alcohol, Cetyl Alcohol, lsostearyl Alcohol, Myristyl 413, 1988. (2) (1) IJT 25(Suppl. 2) :1-89,2006 Annual Review of Cosmetic Ingredient (stearyl stabilizing, Alcohol, and Behenyl Alcohol are safe as cosmetic ingredients in the Safety Assessment 2004/2005 alcohol ) surfactant, present practices of use (1). The CIR expert panel noted that the viscosity Hannuskela (1988) report reviewed the previous literature which control included a report of positive patch test reactions to Stearyl Alcohol as high as 44% (2). Lanolin 8027-33-6 emollient, none none Based on the available animal data and human experience, it is (1) FINAL REPORT OF THE SAFETY ASSESSEMENT FOR alcohol antistatic, skin concluded that lanolin and related lanolin materials described in the ACETYLATED LANOLIN ALCOHOL AND RELATED COMPOUNDS) JEPT 4(4):63- conditioning, report are safe for topical application to humans in the present 92, 1980 hair practice of use and concentration : Lanolin (2) JT 24 (Supl. 1): 1-102, 2005 Annual review of cosmetic ingredient safety assessment conditioning, Lanolin Oil 2002/2003 IJT 24 (Supl. 1): 1-102, 2005. (3) Drug Delivery and Translational Research emulsifyng, Lanol in Wax April 2018, Volume 8, Issue 2, pp 398–413. Lanolin-based organogel of salicylic acid: surfactant Lanolin Acid evidences of better dermatokinetic profile in imiquimod-induced keratolytic therapy in Lanolin Alcohol BALB/c mice model. (3) Amerian Contact Dermatitis Society Core. Dermatitis. Vol 24- Acetylated Lanolin No 1- JAnuary/February 2013. Acetylated Lanolin Alcohol Hydrogenated Lanolin Hydroxylated Lanolin (1) Not repoen (2) Lavandula 8000-28-0 masking, tonic none no data no data (1) Exposure to estrogenic substances, such as lavender, should be explored in children angustofila, presenting with prepubertal gynecomastia/thelarche (Prepubertal gynecomastia and chronic lavanda lavender exposure: report of three cases. Diaz A, Luque L, Badar Z, Kornic S, Danon M. J Pediatr Endocrinology Metabolism2016 Jan;29(1):103-7. doi: 10.1515/jpem-2015- 0248...... -Schempp CM, Schopf E, Simon JC. 2002. [Plant-induced toxic and allergic dermatitis (phytodermatitis)]. Der Hautarzt; Zeitschrift fur.... .Henley et al 2007. Prepubertal gynecomastia linked to lavender and tea tree oils. N Engl J Med. 2007 Feb 1;356(5):479-85. Dermatologie, Venerologie, und verwandte Gebiete 53(2): 93-7.

Macadamia 128497-20-1 / emollient, skin No restrictions none safe in the present practices of use and concentration described in this (1) Safety Assessment of Plant- Derived fatty Acid Oils. Christina L. Burnett. JT Ternifolia 129811-19-4 conditioning safety assessment(1). 36(Suppl. 3):51-129, 2017 seed oil (Aceite de macademia Melaleuca 68647-73-4 Antioxidant, No restrictions Tea Tree Oil is a skin sensitiser. Skin sensitisation may also be none (1) SCCP/1155/08Scientific Committee on Consumer Products SCCP OPINION ON Tea Alternifolia perfume enhanced by irritancy. (1) tree oil. (2) Thomson KF, Wilkinson SM. Allergic contact dermatitis to plant Leaf Oil (tea extracts in patients with cosmetic dermatitis. Br J Dermatol. tree oil, aceite 2000;142:84-8. de arbol de te) Melatoniona 73-31-4 Antioxidant none The SCCS is of the opinion that the use of melatonin in hair products none (1) SCCS/1315/10 24 March 2010. Scientific Committee on Consumer Safety in a concentration of SCCS OPINION ON Melatonin 0.0033% w/w (33 µg/g) does not pose a risk for the health of the (2) Tresguerres A. Prevention of radiodermitis with topicl melatonin. Masters in life quality consumer. The results of this LLNA indicate that Melatonin is not to and aesthetic medical care. I edition. Universidad de Alcala. (2017). 23. Butcher K, be considered as a skin sensitizer. (1) Willianson K. Management of erythema and skin preservation; advice for patients receiving radical radiotherapy to the breast: a systematic literature review. J Radiother Pract 11:44– 54. Methlylene 103597-45-1 UV filter 10% VI/23 As a UVfilter at a concentration up to 10% in dermally applied none (1) SCCS1546/15-nano. Scientific Committee on Consumer Safety bis- cosmetic products is considered to not SCCS OPINION ON benzotrizolyl pose a risk of adverse effects in humans after application on healthy, 2,2’-Methylene-bis-(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3- tetramethylbu intact skin. This Opinion therefore does not apply to such applications tetramethylbutyl)phenol)(nano form) tylpheol that might lead to Submission III . (2) Carrascosa JM. The future becomes the present in solar (biscotrizole) exposure of the consumer’s lungs to MBBT nanoparticles by inhalation photoprotection. Elsevier Piel. 2011;26(7):311–314. (3) Lim HW, et al. Current (1) challenges in photoprotection. J Am Acad Dermatol.2017;76(3S1):S91-9. (4) Simonsen AB et al. Photosensitivity in atopic dermatitis complicated by contact allergy to common sunscreen ingredients. Contact Dermatitis.2016. 74(1):56-8. Available in: doi:10.1111/cod.12477. Methylparabe 99-76-3 Preservative V/ 12 Based upon the above, the SCCS considers the use of butylparaben and The CIR Expert Panel concluded that the following 20 of 21 parabens (1) Opinion on Parabens SCCS/1348/10. n 0,4% (as acid) for propylparaben as preservatives in finished cosmetic products as safe to are safe in cosmetics in the present practices of use and concentration (2 ) Amended Safety Assessment of Parabensas Used in Cosmetics. Status: Tentative single ester the consumer, as long as the sum of their individual concentrations described in the safety. Also concluded that the available data are Amended Report for Public Comment. Release Date: January 23, 2019. Panel Meeting 0,8% (as acid) for does not exceed 0.19%. This conclusion is based on the lack of insufficient to make a determination that Benzylparaben is safe under Date: April 8-9, 2019. mixtures of esters scientifically sound data on the pivotal link between dermal absorption the intended conditions of use in cosmetic formulations. This (3) Included in the UN list: United Nations Environment programme Overview Report II: in rats and humans, in particular with regard to the metabolism of the ingredient is not reported to be in current use (2). An overview of current scientific knowledge on the life cycles, environmental exposures, parent compound in the skin. and environmental effects of select endocrine disrupting chemicals (EDCs) and potential The latter can only be addressed through additional human data. EDCs July 2017 Prepared by: The International Panel on Chemical Pollution (IPCP). With regard to methylparaben and ethylparaben, the previous opinion, stating that the use at the maximum authorized concentrations can be considered safe, remains unchanged. Finally, the SCCS emphasizes that the studies submitted to the Committee primarily (1). Mimosa 93685-96-2 Vegetable No restrictions none none (1) Contact Dermatitis. 2016 Dec;75(6):388-390. doi: 10.1111/cod.12665.Allergic contact Tenuiflora active dermatitis caused by argan oil, neem oil, and Mimosa tenuiflora. Bark Extract ingredient. Int J Biol Macromol. 2016 Dec;93(Pt A):1217-1225. doi: 10.1016/j.ijbiomac.2016.09.083. Skin protector/ Epub 2016 Sep 28. Sedative Chitosan/Mimosa tenuiflora films as potential cellular patch for skin regeneration. .

Niacinamide 98-92-0 smoothing none no data it is safe for cosmetic use.The panel noted that certain (1) Final report of safety assessments.of the niacinamide and niacin (Cosmetic Ingredient formulations,marginal to slight ocular irritants(1) Review). 2006. IJT24. Washington DC (2).Bolderston A, Lloyd NS, Wong RK, Holden L, Robb-Blenderman L; Supportive Care Guidelines Group of Cancer Care Ontario Program in Evidence-Based Care. The Prevention and Management of Acute Skin Reactions Related to Radiation Therapy: A Clinical Practice Guideline Support Care Cancer. 2006 Aug;14(8):802-17 . (2) Master en Calidad de Vida y Cuidados Médico Estéticos I edición (2017). Nitrophenol 100-02-7 hair dyeing none none none (1) Incluido en lista ONU: United Nations Environment programme Overview Report II: (4- An overview of current scientific knowledge on the life cycles, environmental exposures, nitrophenol) and environmental effects of select endocrine disrupting chemicals (EDCs) and potential EDCs July 2017 Prepared by: The International Panel on Chemical Pollution (IPCP).

Octocrylene, 6197-30-4 UV filter VI/ 10 <10% as an none none (1) Frequent allergies of facial contact dermatitis (Allergic contact dermatitis by 2-Cyano-3,3- acid anatomical regions .Diagnostic keys. E. Rozas-Muñoz, Actas Dermosifiliografica. diphenyl 2018;109(6):485-507). 829. acrylic acid, 2- (2) "Buser HR, Balmer ME, Schmid P, Kohler M. 2006. Occurrence of UV filters 4- ethylhexyl methylbenzylidene camphor and in fish from various swiss rivers with inputs ester from wastewater treatment plants. Environmental Science & Technology 40(5): 1427-1431. (3) Hanson KM, Gratton E, Bardeen CJ. 2006. Sunscreen enhancement of UV-induced reactive oxygen species in the skin. Free Radic Biol Med 41(8): 1205-1212. de Groot AC, Roberts DW. 2014. Contact and photocontact allergy to octocrylene: a review. Contact Dermatitis. 70(14):193-204.

Octyldodecyl 423772-95-6 emulsifying, none none (1) Octyldodecyl xyloside: a novel contact allergen xyloside surfactant Mark Wilkinson and Rachel Ann Powis Department of Dermatology, The General Infirmary Leeds, Leeds LS1 3EX, UK doi:10.1111/j.1600-0536.2011.01951.x COD Contact Dermatitis. (2) Allergic Contact Dermatitis Caused by Cosmetic Products P. González-Muñoz, L. Conde-Salazar, S. Vañó- Galván. Actas Dermosifiliogr. 2014;105(9):822-832 olea europaea 8001-25-0 masking, No restrictions none The panel concluded that the 244 plants derived fatty acid oils (1) IJT 36(Suppl. 3):51-129, 2017 ¨Safety Assessment of Plant – Derived Fatty Acid Oils. fruit oil (olive perfuming, included in this review are safe in the present practice of use and Cosmetic Ingridient Review (International Journal of Toxicology 2017¨ (2) Ferreira EB, oil) skin concentration discribed inthis safety assessment (1) Vasques CI, Gadia R, Chan RJ, Guerra EN, et al. Topical interventions to prevent acute conditioning radiation dermatitis in head and neck cancer patients: a systematic review. Support Care Cancer. 2017 Mar;25(3):1001-1011. (3) Cui Z, Xin M, Yin H, Zhang J, Han F. Topical use of olive oil preparation to prevent radiodermatitis: results of a prospective study in nasopharyngeal carcinoma patients. Int J Clin Exp Med. 2015 Jul 15;8(7):11000-6. eCollection 2015 (4) Talanta. 2012 Apr 15;92:1-14. doi: 10.1016/j.talanta.2012.01.016. Epub 2012 Jan 30. Analysis of olive allergens. Esteve C1, Montealegre C, Marina ML, García MC. panthenol 81-13-0 / antistatic none none Panthenol was non-to-mildly irritating and non-sensitizing in dermal (1) Safety Assessment of Panthenol, Pantothenic Acid, and Derivatives as Used in (dexpanthenol 16485-10-2 hair exposure studies (1)- Cosmetics.Final Report. ) conditioning (2) Ferreira EB, Vasques CI, Gadia R, Chan RJ, Guerra EN, et al. Topical interventions to skin prevent acute radiation dermatitis in head and neck cancer patients: a systematic review. conditioning Support Care Cancer. 2017 Mar;25 1001-1011Release Date: March 9, 2018

Parfum no tiene Deodorant/ none none none (1) Anne Birgitte Simonsen, Mette Deleuran, Jeanne Duus Johansen & Mette Sommerlund. masking, 2011. Contact allergy and allergic contact dermatitis in children - a review of current data. perfuming Contact dermatitis 65(5), 254-65. (2) J Elberling, P. S. Skov, H. Mosbech, H. Holst, A. Dirksen & J. D. Johansen. 2007. Increased release of histamine in patients with respiratory symptoms related to perfume. Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology 37(11), 1676-80. (3) Kumar P, Caradonna-Graham VM, Gupta S, Cai X, Rao PN, Thompson J. Inhalation challenge effects of perfume scent strips in patients with asthma. Ann Allergy Asthma Immunol. 1995 Nov;75(5):429-33. (4) SC Rastogi, S Heydorn, JD Johansen & DA Basketter. 2001. Fragrance chemicals in domestic and occupational products. Contact dermatitis 45(4), 221-5. (5) Tatyana Hamilton & Gillian C. de Gannes. 2011. Allergic contact dermatitis to preservatives and fragrances in cosmetics. Skin therapy letter 16(4), 1-4. (6) The Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers. 2002. POSITION STATEMENT CONCERNING FRAGRANCE CHEMICALS IN DETERGENTS AND OTHER HOUSEHOLD PRODUCTS. SCCNFP/0588/02, fina. (7) Reguiai Z1, Bachet JB, Bachmeyer C, Peuvrel L, Beylot-Barry M, et al. Supportive Care in Cancer Management of cutaneous adverse events induced by anti EGFR (Epidermal Growth Factor Receptor): a French interdisciplinary therapeutic algorithm. Support Care Cancer. 2012 Jul;20(7):1395-404. Phenoxyethan 122-99-6 Preservatives V/ 29 < 1,0% The toxicological effects of the substances tabulated will be the same Safe in the concentrations recommended. Annual Review of (1) OPINION OF CONCERNING RESTRICTIONS ON MATERIALS LISTED IN ol for all potential uses of them; a higher exposure as permitted by "other Cosmetic Ingridient Safety assessment 2007-2010 (International ANNEX VI OF DIRECTIVE 76/768/EEC ON COSMETIC PRODUCTS ADOPTED BY uses" could reasonably be expected to lead to increased toxicological Journal of Toxicology 2011) (2). THE PLENARY SESSION OF THE SCCNFP OF 17 FEBRUARY 1999. SCCNFP hazard. is safe as a cosmetic ingredient in the present practices of use and opinions 1997-2004. Therefore, it is the opinion of the SCCNFP that those substances concentration (3). (2) Annual Review of Cosmetic Ingridient Safety assessment 2007-2010 (International indicated by (+) in Annex VI, when incorporated into cosmetic Journal of Toxicology 2011.JACT 9(2):259-77, 1990. formulations for non-preservative functions, should be subjected to the (3) Final Report on the Safety Assessment of Phenoxyethanol JOURNAL OF THE same restrictions in usage levels and warnings as when used for AMERICAN COLLEGE OF TOXICOLOGY Volume 9, Number 2,199O preservative effect (1). Mary Ann Liebert, Inc., Publishers (4) 2-fenoxietanol 1% pet included in the Spanish standard series of the GEIDAC 2016 (Grupo Español de Investigación en Dermatitis de Contacto y Alergia Cutánea). (5) Frequent alergen in scalp contact dermatitis (Alergic contact dermatitis by anatomical regions. Key diagnosis. E. Rozas-Muñoz, Actas Dermosifiliografica. 2018;109(6):485- 507). (6) Fragrance material review on 2-phenoxyethanol. J.ScognamiglioaL.JonesbC.S.LetiziaaA.M.Apia https://doi.org/10.1016/j.fct.2011.10.030. (7) Amerian Contact Dermatitis Society Core. Dermatitis. Vol 24-No 1- JAnuary/February 2013. Polypodium no tiene skin protection none none none (1) Food Chem Toxicol. 2015 Dec;86:328-41. doi: 10.1016/j.fct.2015.11.008. Epub 2015 leucotomos Nov 14. 2)J Am Acad Dermatol. 2012 Jan;66(1):58-62. doi: 10.1016/j.jaad.2010.09.773. leaf extract Epub 2011 Jun 22. Oral administration of a hydrophilic extract of Polypodium leucotomos for the prevention of polymorphic light eruption. Tanew A1, Radakovic S, Gonzalez S, Venturini M, Calzavara-Pinton P. Author information1 Department of Dermatology, Medical University of Vienna, Vienna, Austria. adrian.tanew@meduniwien. (2) Food Chem Toxicol. 2015 Dec;86:328-41. doi: 10.1016/j.fct.2015.11.008. Epub 2015 Nov 14. A comprehensive toxicological safety assessment of an aqueous extract of Polypodiumleucotomos (Fernblock(®)). Murbach TS1, Béres E2, Vértesi A3, Glávits R4, Hirka G5, Endres JR6, Clewell AE7, Szakonyiné IP8. (3) Mrak S. Nelson, Brian Berman, Nicole Swenson. Safety and Efficacy of Oral Polypodium leucotomos Extract in Healthy Adult Subjects. J Clin Aesthet Dermatol. 2015 Feb; 8(2): 19–23. (4) Concepción Parrado, Marta Mascaraque, Yolanda Gilaberte, Angeles Juarranz, Salvador González. Fernblock (Polypodium leucotomos Extract): Molecular Mechanisms and Pleiotropic Effects in Light- Related Skin Conditions, Photoaging and Skin Cancers, a Review. nt J Mol Sci. 2016 Jul; 17(7): 1026.

Propylene 57-55-6 humectant/diso No restrictions none Safe as used in cosmetics when formulated to be non-irritant (1) (1) Safety Assessment of Propylene Glycol, Tripropylene Glycol, and PPGs as Used in glycol lvent/skin Csometicas. Monice M. Fiume. IJT 31 (supll2) 2455-2605.DOI: conditioner/vis 10.1177/1091581812461381. (2) Alergic contact dermatitis by anatomical regions. Key cosity diagnosis. E. Rozas-Muñoz, Actas Dermosifiliografica. 2018;109(6):485-507). controllers 32) Allergic Contact Dermatitis Caused by Cosmetic Products P. González-Muñoz, L. Conde-Salazar, S. Vaño-Galván Actas Dermosifiliogr. 2014;105(9):822-832. (4) Skin Res Technol. 2007 Aug;13(3):268-79.Evaluation of formulations on irritation using the modified orearm-controlled application test method. Farage MA(1), Ebrahimpour A, Steimle B, Englehart J, Smith D. Int J Pharm. 2009 Nov 3;381(2):220-30. doi: 10.1016/j.ijpharm.2009.07.007. Epub 2009 Jul 16. (5) Natural surfactant-based topical vehicles for two model drugs: Influence of different lipophilic excipients on in vitro/in vivo skin performance.Savić S(1), Weber C, Savić MM, Müller-Goymann C. (6) Mixture Toxicity of Methylisothiazolinone and Propylene Glycol at a Maximum Concentration for Personal Care Products. Juyoung Park, Handule Lee and Kwangsik Park. Toxicol. Res. Vol. 34, No. 4, pp. 355-361 (2018) https://doi.org/10.5487/TR.2018.34.4.355. (7) Masters in Life Quality and Aesthtical Medical Care II edition.(8) Moisturizer Allergy Diagnosis and Management. CLINICAL Aesthetic Dermatology. [November 2008 • Volume 1 • Number 4] (9) Propylene Glycol in Contact Dermatitis: A Systematic Review Maria A. McGowan, MD,* Andrew Scheman, MD,† and Sharon E. Jacob, .DOI: 10.1097/DER.0000000000000307. 2017 American Contact Dermatitis Society. Propylparabe 94-13-3 Preservative/ V/12 < 0,14% It reiterates the concerns of the previous reports, SCCS/1348/10 y The CIR Expert Panel concluded that the following 20 of 21 parabens (1) SCCS 1514/13 OPINION ON Parabens Updated request for a scientific opinion on n fragance SCCS/1446/11. (1) are safe in cosmetics in the present practices of use and concentration propyl- and butylparaben. described in the safety. Also concluded that the available data are (2) Amended Safety Assessment of Parabens as Used in Cosmetics Tentative Amended insufficient to make a determination that Benzylparaben is safe under Report for Public Comment January 23, 2019. April 8-9, 2019. Assessment of principal the intended conditions of use in cosmetic formulations. This parabens used in cosmetics after their passage through human epidermis-dermis layer. S El ingredient is not reported to be in current use (2) Hussein, P Muret, M Berard… - Experimental …, 2007 - Wiley Online Library. OTHER STUDIES (3) Aquatic toxicity and ecological risk assessment of seven parabens: Individual and additive approach. Author links open overlay panel. HiroshiYamamotoaIkumiTamuraaYoshikoHirataaJunKatoaKeiichiroKagotaaShotaKatsukia AtsushiYamamotobYoshihiroKagamicNorihisaTatarazakod. (4) Harvell, JByford JR, Shaw LE, Drew MG, Pope GS, Sauer MJ, Darbre PD. Oestrogenic activity of parabens in MCF7 human breast cancer cells. J Steroid Biochem Mol Biol. 2002 Jan;80(1):49-60. (5) Boberg J, Taxvig C, Christiansen S, Hass U. Possible endocrine disrupting effects of parabens and their metabolites. Reprod Toxicol. 2010 Sep;30(2):301-12. Epub 2010 Apr 8. (6) Included in the UN list: United Nations Environment programme Overview Report II: An overview of current scientific knowledge on the life cycles, environmental exposures, and environmental effects of select endocrine disrupting chemicals (EDCs) and potential EDCs July 2017 Prepared by: The International Panel on Chemical Pollution (IPCP).

Resorcinol 108-46-3 antioxidant, III/22, maximum The SCCS is of the opinion that the use of resorcinol as an ingredient On the basis of the available animal and clinical data presented in this (1) Scientific Committee on Consumer Safety denaturant, concentration 1,25% in oxidative hair dye formulations with a maximum on-head report, the CIR Expert Panel concludes that 2-Methylresorcinol and SCCS OPINION ON Resorcinol SCCS 1270/09. (2) Final Report on the Safety hair dyeing, for hair dye and concentration of 1.25% will not pose a risk to the health of the Resorcinol are safe as cosmetic ingredients in the present practices of Assessment of 2-Methylresorcinol and Resorcinol. Final Report on the Safety perfuming eyelash colour. consumer, apart from its sensitising potential. Studies on use and concentrations (2). Assessment of 2-Methylresorcinol and Resorcinol.(3) Included in the UN list: United Max.concentration genotoxicity/mutagenicity in finished hair dye formulations should be Nations Environment programme Overview Report II: An overview of current scientific 0,5% in hair undertaken following the relevant SCCNFP/SCCP opinions and in knowledge on the life cycles, environmental exposures, and environmental effects of select and shampoos. Can accordance with its Notes of Guidance. Resorcinol is also used as a endocrine disrupting chemicals (EDCs) and potential EDCs July 2017 Prepared by: The cause serious food additive and was recently evaluated by EFSA. The exposure from International Panel on Chemical Pollution (IPCP). allergic reactions. other sources has not been considered in this EFSA-opinion (1)

Retinyl 79-81-2 Active The SCCS has also estimated that exposure to Vitamin A (retinol, The Expert Panel confirmed that retinyl palmitate and retinol are safe (1) Scientific Committee on Consumer Safety SCCS palmitate ingredient. retinyl palmitate, and retinyl acetate) from all cosmetic products as cosmetics ingredientes in the present practices of use and OPINION ON Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate) Skin (including lip products) may lead to a daily systemic dose of 4855 IU concentration and recomemended monitoring the progress os a new SCCS/1576/16 Final version of 6 October 2016 Corrigendum on 23 December 2016 conditioner for an adult. This exposure could constitute up to 97% of the UL of ongoing National Toxicology Program (NTP) photocarcinogenesis NTP Technical Report on the study of Photocarninogenesis Retinoic acid and Retinyl 5000 IU/day of Vitamin A. Excluding lip products, the daily systemic satudy on retinyl palamitate and retinoic acid (2) Palmitate. National Toxicology Program .P.O.box 122233.research Triangle arrk,NC dose is estimated at 4256 IU for an adult, which constitutes up to 85% 27709. August 2012. (2) Retinol and Retinyl palmitate (Wilbur Johnson Jr) IJT-2017-vol of the UL of 5000 IU/day of Vitamin A. 36(suplem 42)535-585. DOI: 10001177/1091581817716657.(3) journal of the american It is of note that these estimates are based on a worst-case scenario college of toxicology, vol 6, numbre3,1987. Mary Ann Liebert, inc, publidhers. Final assuming that all the cosmetic products used (hand and face cream, report os Safety on retinyl palmitate an Retinol IJT 36 (Suppl 2): 14-58, 2017. IJT 27 (Supl. body lotion, rinse-off products, products for the lips) contain Vitamin 1): 77-142, 2008. ACT 6 (3): 279-320, 1987. (4) Photochem Photobiol. 2017 A at the maximum concentrations. Jul;93(4):1096-1114. doi: 10.1111/php.12730. Epub 2017 Apr 28. Photo-co-carcinogenesis (1). of Topically Applied Retinyl Palmitate in SKH-1 Hairless Mice. Boudreau MD1, Beland FA1, Felton RP2, Fu PP1, Howard PC3, Mellick PW4, Thorn BT2, Olson GR4. (11) Biomed Pharmacother. 2019 Jan;109:1394-1405. doi: 10.1016/j.biopha.2018.10.115. Epub 2018 Nov 13. (56 Retinol palmitate and ascorbic acid: Role in oncological prevention and therapy. de Carvalho Melo-Cavalcante AA1, da Rocha Sousa L1, Alencar MVOB1, de Oliveira Santos JV1, da Mata AMO1, Paz MFCJ1, de Carvalho RM1, Nunes NMF1, Islam MT2, Mendes AN3, Gonçalves JCR4, da Silva FCC5, Ferreira PMP6, de Castro E Sousaa JM7. (5)NTP Technical Report on the study of Photocarninogenesis Retinoic acid and Retinyl Palmitate. National Toxicology Program https://www.ncbi.nlm.nih.gov/pubmed/23001333 (7) Boehnlein J, Sakr A, Lichtin JL, Bronaugh RL. 1994. Characterization of esterase and alcohol dehydrogenase activity in skin. Metabolism of retinyl palmitate to retinol in ethanol by UVA light-formation of photodecomposition products, reactive oxygen species, and lipid peroxides. Chem Res Toxicol 18(2): 129-38 (8) .Duell EA, Kang S, Voorhees JJ. 1997. Unoccluded retinol penetrates human skin in vivo more effectively than unoccluded retinyl palmitate or retinoic acid. J Invest Dermatol 109(3): 301-5. Rosa canina 84603-93-0 emollient, skin none none The CIR Panel assessed the safety of 244 plant-derived fatty oils as (1) Safety Assessment of Plant-Derived Fatty Acids Oils. Christina L. Burkett. IJT Fruit oil (Hip conditioning used in cosmetics. Oils are used in a wide variety of cosmetics 36(Suppl. 3):51-129, 2017 (2) Tzu-Kai Lin, Lily Zhong, José Luis Santiago. Anti- Rose) (aceite products for their skin conditioning, occlusive, emollient, and Inflammatory and Skin Barrier Repair Effects of Topical Application of Some Plant Oils. rosa mosinturizing properties. Since many of theses oils are edible, and nt J Mol Sci. 2018 Jan; 19(1): 70. (3) * Int J Mol Sci. 2017 Jun; 18(6): 1137 mosqueta) their systemic toxicity potential is low, tjhe review focused on Therapeutic Applications of Rose Hips from Different Rosa Species. Inés Mármol,1 potential dermal effects. The Panel concluded that the 244 Cristina Sánchez-de-Diego,2 Nerea Jiménez-Moreno,3 Carmen Ancín-Azpilicueta,3,* and plant.derived fatty oils are safe as uses in cosmetics (1) María Jesús Rodríguez- Salicylic acid 69-72-7 antidandruff, (a) 3.0% The SCCS considers that Salicylic acid (CAS 69-72-7) issafe when it is Amended Safety Assessment of Salicylic Acid and Salicylates as (1) Preliminary Opinion hairr (b) 2.0% used as a preservative with leess than 0,5% concentration in cosmetic Used in Cosmetics Status: Release Date: Panel Date: Tentative Opinion on salicylic acid (CAS 69-72-7) - Submission I. Scientific Committee on conditioning,ke products, taking into account the current restrictions. This opinion does Amended Report for Public Comment July 3, 2018 September 24-25, Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7) Submission I ratolytic,maski not apply to oral products such as toothpaste or mouthwash. Spray- 2018 (2) SCCS/1601/18. ng, based products ar also excluded as they could lead to the lungs being (2) Amended Safety Assessment of preservative,ski exposed to inhalation of the product. (1) It is safe when used for Salicylic Acid and Salicylates as Used in Cosmetics n conditioning different purposes than a preservative at a concentration of upto 3.0% Status: Release Date: Panel Date: in mouth products with whitening cosmetics upto 2.0% for other Tentative Amended Report for Public Comment July 3, 2018 products, taking into account current restrictions. September 24-25, 2018. (3) 2018 May;45(5):609-612. doi: 10.1111/1346-8138.14255. Epub 2018 Mar 3. Case of punctate palmoplantar keratoderma type I treated with combination of low-dose oral acitretin and topical salicylic acid and steroid. Jo JW1, Jeong DS1, Kim CY1,2.. (4) Int J Pharm. 2018 Jul 30;546(1-2):31-38. doi: 10.1016/j.ijpharm.2018.05.021. Epub 2018 May 8. Characterization and cytotoxicity evaluation of biocompatible amino acid esters used to convert salicylic acid into ionic liquids. Moshikur RM1, Chowdhury MR1, Wakabayashi R2, Tahara Y1, Moniruzzaman M3, Goto M4. Simmondsia 90045-98-0s emollient none none The Expert Panel recognized that these ingredients can enhance (1) Final Report of the Cosmetic Ingredient Review. Expert Panel.Safety Assessment of chinensis seed hair the penetration of other ingredients through the skin (e.g. Simmondsia Chinensis (Jojoba) Seed.Oil, Simmondsia Chinensis (Jojoba) Seed Wax, oil( jojoba oil) conditioning fluconazole and aminophylline). The Panel cautioned that care Hydrogenated Jojoba Oil, Hydrolyzed Jojoba Esters, Isomerized Jojoba Oil, Jojoba skin should be taken in formulating cosmetic products that may contain Esters,Simmondsia Chinensis (Jojoba) Butter, Jojoba Alcohol, and Synthetic Jojoba Oil conditioning these ingredients in combination with any ingredients whose September 23, 2008. safety was based on their lack of dermal absorption data, or when (2) Masters in Life Quality and Aesthtical Medical Care I edition. (2017). dermal absorption was a concern (1). Sodium 9004-61-9 humectant, No restrictions none Hyaluronic acid and its sodium and potasium salts are considered (1) Final Report of the Safety Assessment hyaluronate skin safe for use in cosmetics as is described in the safety evaluation (1) of Hyaluronic Acid, Potassium Hyaluronate, and Sodium Hyaluronat.eInternational Journal (Ácido conditioner of Toxicology Volume 28 Number 4SJuly/August 2009 5-67 Lillian C. Becker, MS, Wilma hialuronico) F. Bergfeld, MD, Donald V. Belsito, MD, Curtis D. Klaassen, PhD, James G. Marks Jr, MD, Ronald C. Shank, PhD, Thomas J. Slaga, PhD, Paul W. Snyder, DVM, PhD, Cosmetic Ingredient Review Expert Panel, and F. Alan Andersen, PhD Topical no data none no data (1) 34. Ji-Won Kim1, Myeong Gyu Kim2, Hyun Jung Lee3, Youngil Koh4,5,6, Ji-Hyun epidermal Kwon7, Inho Kim4,5,6, Seonyang Park4,5,6, Byoung Kook Kim4,5,6, Jung Mi Oh2,8, growth factor Kyung Im Kim9,10*, Sung-Soo Yoon4,5,6*Topical Recombinant Human Epidermal Growth Factor for Oral Mucositis Induced by Intensive Chemotherapy with Hematopoietic Stem Cell Transplantation: Final Analysis of a Randomized, Double-Blind, PlaceboControlled, Phase 2 Trial PLOS ONE pp:10.1371January 3, 2017. (2) 35. Kang, H.C., Ahn, S.D., Choi, D.H., Min K., Chung W.K., Wu,H.G.( 2014) ” The safety and efficacy of EGF-based cream for the prevention of radiotherapy-induced skin injury: results from a multicenter observational study”, Radiat Oncol J, 32(3):156-162 . (3) Caussaa, J. E., Herrero Vila, Elisabeth.,(2015)” Epidermal growth factor, innovation and safety”, Med Clin ,145(7),pp305-12. (4) Parabens and ligands of the human epidermic growth receptors in breast cancer cells. Shawn Pan , 1, * Chaoshen Yuan , 1, * Abderrahmane Tagmount , 1 Ruthann A. Rudel , 2 Janet M. Ackerman , 2Paul Yaswen , 3 Chris D. Vulpe , 1 y Dale C. Leitman 1, †. Environmental health perspectives . 2016 May; 124 (5): 563–569.. Doi: 10.1289 / ehp.1409200 Triclosan 3380-34-5 Preservative, V/25 the toxicological evaluation made by SCCP in its opinion The Panel concluded that triclosan was safe as a cosmetic ingredient (1) Scientific Committee on Consumer Safety antibacterial, SCCP/1192/08 still as valid. Thus, the in the present practices of use and concentration of this safety SCCS OPINION ON TRICLOSAN COLIPA n° P32 ADDENDUM to the SCCP Opinion deodorant continued use of triclosan as a preservative at the current concentration assessment, even were all products types to contain triclosan and used on Triclosan (SCCP/1192/08) from January 2009. SCCS/1414/11 . (2) Final Reort of limit of maximum 0.3% in all cosmetic products is not safe for the concurrently, on a daily basis.(2) Triclosan. CIR. December 14, 2010 (3) (Included in the UN list: United Nations consumer because of the magnitude of the Environment programme Overview Report II: An overview of current scientific knowledge aggregate exposure. Based on the recent revision of the Notes of on the life cycles, environmental exposures, and environmental effects of select endocrine Guidance (7TH Revision) some adjustments for disrupting chemicals (EDCs) and potential EDCs July 2017 Prepared by: The International the amount of certain products applied and/or frequency of use were Panel on Chemical Pollution (IPCP) (4) Non-antibiotic antimicrobial triclosan induces indicated, and resulted multiple antibiotic resistance through genetic mutation in some changes in the consumer exposure assessment and the related Author links open overlay panelJiLuaMinJinaSon HoangNguyenbLikaiMaoaJieLiaLachlan safety evaluation. The use of triclosan at a maximum concentration of J.M.CoinbZhiguoYuanaJianhuaGuoa 0.3% in toothpastes, hand soaps, body Show more https://doi.org/10.1016/j.envint.2018.06.004Get rights and content. (5) soaps/shower gels and deodorant sticks ("common-use products" as Amerian Contact Dermatitis Society Core. Dermatitis. Vol 24-No 1- JAnuary/February defined by the applicant) is considered safe. Additional use of triclosan 2013. in face powders and blemish concealers at this concentration is also considered safe. The use of Triclosan in other leaveon products (e.g. body lotions) is not considered safe for the consumer due to the resulting high exposures.Inhalation exposure to triclosan from spray products (e.g. deodorants) was not assessed. (1) Triphenyl 115-86-6 plasticizer, none Safe in cosmetics in the present practices of use and concentration (1) Safety Assessment of Triphenyl Phosphate as Used in Cosmetics Status: Final Report phosphate manicure described in this safety assessment. estreogenicidad in vitro (1) Release Date: September 18, 2018 Panel Meeting Date: June 4-5, 2018. (2) Included in the UN list: United Nations Environment programme Overview Report II: An overview of current scientific knowledge on the life cycles, environmental exposures, and environmental effects of select endocrine disrupting chemicals (EDCs) and potential EDCs July 2017 Prepared by: The International Panel on Chemical Pollution (IPCP).

Ubiquinone 303-98-0 / antioxidant, No restrictions none none (1) Gaspar LR, Tharman J, Maia Campos PM, Liebsch M. Skin phototoxicity of cosmetic (coenzyma Q 1339-63-5 / skin formulations containing photounstable and photostable UV-filtersand vitamin A palmitate. 10) 60684-33-5 conditioning Toxicol In Vitro. 2013Feb;27(1):418-25. (2) Allergic Contact Dermatitis Caused by Cosmetic Products P. González-Muñoz, L. Conde-Salazar, S. Vañó-Galván. Actas Dermosifiliogr. 2014;105(9):822-832. (3) EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) .Coenzyme Q10 in breast cancer care,Coenzyme Q10 in breast cancer care.2017 EFSA Journal 2011;9(4):2067 Urea 57-13-6 antistatic, No restrictions none Safe used in cosmetics (1) (1) Final report in safety assessment of Urea. IJT 24(Suppl. 3):1-56, 2005 buffering, (2) Urea: A Clinically Oriented Overview from Bench to Bedside. humectant, Friedman AJ, von Grote EC, Meckfessel MH.J Drugs Dermatol. 2016 May 1;15(5):633-9. skin (3) Quantitative Analysis of Free Amino Acids and Urea Derived from Isolated conditioner Corneocytes of Healthy Young, Healthy Aged, and Diseased Skin. Hussain H1, Ziegler J2, Hause G3, Wohlrab J4,5, Neubert RHH6,7. (4) Eur J Pharm Sci. 2013 Dec 18;50(5):638-45. doi: 10.1016/j.ejps.2013.04.022. Epub 2013 May 3. Glycerol and urea can be used to increase skin permeability in reduced hydration conditions. Björklund S1, Engblom J, Thuresson K, Sparr E.

Zinc oxide 1314-13-2 UV filter VI/30 a. max 25%. . It poses no or limited risk for use on the skin as UV filter in sunscreen none (1) Scientific Committee on Consumer Safety SCCS ADDENDUM to the OPINION In case of combined formulation (1) There is no evidence for the absorption of ZnO SCCS/1489/12 on (nano form) SCCS/1518/13. (2) Scientific Committee on use of zinc oxide nanoparticles through skin and via the oral route. Nano ZnO- Consumer Safety SCCS OPINION ON Zinc oxide (nano form)SCCS/1489/12 and zinc oxide containing cosmetic formulations are likely to contain a small Revision of 11 December 2012 (nano), the sum proportion of solubilized zinc, a further small proportion of which may shall not exceed the be absorbed through skin and other routes.Although the current limit of 25%. No to evidence in relation to potenial genotoxicity of ZnO is not conclusive, be used in the use of nano ZnO in cosmetic products should not pose a risk to the applications by consumer in the absence of a significant systemic exposure. It is inhalation.IV/144 considered that ZnO is safe when used as colorant in cosmetics for (color white) dermal application. In view of the lung inflammation induced by ZnO particles after inhalation exposure, the use of ZnO in cosmetic products which may result in inhalation is of concern. Any cosmetic products containing ZnO particles (nano or non-nano) with coatings that can promote dermal penetration will also be of concern (2). zinc sulfate 7446-19-7 / antimicrobial III/24 none The Panel noted that zinc salts are rapidly absorbed both dermally (1) Safety Assessment of Zinc Salts as Used in Cosmetics.Final Report. 7733-02-0 / antiplaque and from the gastrointestinal tract, and that zinc ingredients in Release Date: September 12, 2018. 7746-20-0 astringent oral care products would have high bioavailability. However, concern (2).Feight D, Baney T, Bruce S, McQuestion M. Putting Evidence Into Practice. Clin J oral care about systemic effects is mitigated by low use Oncol Nurs. 2011 Oct;15(5):481-92 concentrations and by low toxicity of these ingredients in oral exposures (1).