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Preserving the Faith a Cosmetic Formulators Overview John Woodruff John Woodruff: the Personal Stuff

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Preserving the Faith a Cosmetic Formulators Overview John Woodruff John Woodruff: the Personal Stuff Preserving the faith A cosmetic formulators overview John Woodruff www.creative-developments.co.uk John Woodruff: the personal stuff 1960: joined Smith & Nephew Research 1976: Co-founded Pava, responsible for all technical aspects, from formulation and development to manufacture and filling and originated many well-known brands. October 1988: Established consulting laboratory for formulation of cosmetics and toiletry products. Developed Creativity a unique programme written for formula creation and cosmetic manufacture Two books and many articles published on cosmetic technology. Twice appeared as an expert witness, 3 times Chairman of the European UV & Sun Filters Conference, Twice chaired a technical session at In-Cosmetics 1990 – 1996: Cosmetics Consultant to Manufacturing Chemist 1996 – Present: Regular contributions to Soap, Perfumery and Cosmetics (SPC) Supports the Distance Leaning Course run by the SCS Lectures on product formulation at the Principles and Practice of Cosmetic Science When he is not working he is sailing. 2 The cosmetic product brief • Product type • Claims • Product format • Application • Texture • Colour • Perfume • Packaging • Cost 3 What about the preservative? Preservatives are one of the last things that most chemists think about when formulating a product and one of the first things that are suspected when a problem occurs. They are important ingredients, the value of which is never noticed when functioning properly and which are worthless when not. Preservatives are much maligned and misunderstood within the cosmetics industry. Because of this, they are often over-dosed, under-dosed or improperly formulated even by experienced chemists Cosmetic formulations require a delicate balance of a large number of raw materials. The preservative system should be among those materials considered when developing a new formula, not an afterthought Schϋlke • http://www.cosmetic-preservation.com/ 4 The legal stuff EU Cosmetics Regulation (EC) No. 1223/2009 Cosmetics must be resistant to microbial contamination Preservative efficacy must be assessed experimentally to ensure microbial stability and preservation during storage and use SCCS/1501/12 gives guidance for the testing of cosmetic substances and includes guidelines on microbiological quality of the finished cosmetic product For cosmetics sold in Europe (EC) No. 1223/2009 lists a table of permitted preservatives as Annex V This list was first compiled in 1982 and more than half are not in general use and there have only been two new ones added in the last decade The prohibitive cost of gaining acceptance for any new ones will severely restrict any future additions 5 The problem A presentation from Inolex, Cosmetic Preservation, Market Review, makes the very valid point that the internet gives voice to all, regardless of qualification and that …… “Real science” and “Junk science” are given the same credibility by an ill- informed public Consumer, environmental and political groups are capitalising on this to move their cause forward And so are cosmetic companies And ingredient suppliers 6 The result For various reasons consumers do not like preservatives in general and parabens in particular; this makes cosmetic preservation even more difficult “The limited number of available preservatives increases the risk of developing resistant strains of bacteria. It also increases the risk that consumers will develop allergic reactions to the preservative and a diverse palette is needed” Valérie Murset of the *EFfCI “The biggest issue confronting the preservative market is the potential for misinformation to impact a formulator’s choice in product preservation and imperil consumers” Mark Miller, McIntyre *EFfCI - European Federation for Cosmetic Ingredients 7 The formulators challenge Stay legal in all potential markets lack of harmonisation between EU, USA, Japan, Brazil, Australia etc. Please the marketing department who are trying to please consumers Provide adequate preservation throughout the life of the product shelf life period after opening Watch out for next consumer or legislative target • Isopropylparaben, isobutylparaben, phenylparaben, benzylparaben and pentylparaben now banned • Maximum concentration of propylparaben and butylparaben reduced from 0.4% when used individually and 0.8% when mixed with other esters, to 0.14% when used individually or together – early 2015 • MCI/MI mix banned from leave-on products such as body creams July 2015 • Will methylisothiazolinone be next? 8 The formulators frustrations Parabens work but consumer perception is that they are “bad” Organic acids do not work well but consumer perception is that they are “good” Consumer perception is that chemicals are “bad” and petrochemicals are even worse yet benzyl alcohol is good. Also if benzyl alcohol is part of a perfume it is a potential allergen at 0.001% yet can be used as a preservative at up to 1% Other materials that have this anomalous behaviour includes salicylic acid: listed in Annex V to be used at a maximum concentration of 0.5% as a preservative however it is permitted at 3% in rinse-off hair products and 2% in leave-on skin care with the provision that its primary purpose must not be the inhibition of micro-organisms and its purpose must be apparent from the presentation of the product! 9 The formulators frustrations What is good in Europe becomes bad in the USA or Japan etc. and visa –versa Example: o-cymen-5-ol is closely related to thymol, which occurs naturally in many plants including thyme, where it may represent 60% of its essential oil Annex V: permitted at up to 0.1% in leave-on and wash-off products The CIR Review shows it as safe at concentrations up to 0.5% No upper limit in Japan provided the product is not intended for use on mucous membranes. Perhaps we should add 1% thyme oil to our products. Many essential oils have antimicrobial activity and suppliers are creating interesting mixtures that circumvent Annex V 10 Some answers Convince the consumer that preservatives protect them from potential harm Make products anhydrous Formulate the product to provide an unfriendly environment to bacteria, yeasts and moulds Use permitted preservatives Look for synergy between preservatives Use materials that coincidently have an antimicrobial action 11 Convince the consumer • Present the facts Scientific opinions by the SCCS and CIR reports The CTPA simplifies reports and presents www.thefactsabout.co.uk/ The Personal Care Products Council www.cosmeticsinfo.org/ Cosmetics Europe www.cosmeticseurope.eu/ Chemical Watch https://chemicalwatch.com/ First convince the marketing department Then convince beauty editors Then educate the consumer 12 Make products anhydrous Lipsticks and pressed powders Seal from the environment – aerosols; collapsible tubes; certain pump dispensers Powdered shampoos Non-aqueous shower gels & bath additives Solvent-based products e.g. Mascara; After-shave; Toilet Waters 13 Unfriendly environments: a.k.a. Hurdle technology Reduce water availability Lowering the water activity of the final composition is a possible route to avoid the use of traditional preservatives however it is rarely practical with an oil-in- water composition or with other water-based products Materials used to achieve lower water activity include glycols such as glycerin and butylene and propylene glycols Higher diols like pentylene glycol, 1,2-hexanadiol and caprylyl glycol appear to have an antimicrobial effect beyond their water-binding capacity but they also become less water-soluble Unfriendly pH Preservative-free & self-preserving cosmetics & drugs; Jon J Kabara, Donald S Orth 14 Use permitted preservatives (EC) No. 1223/2009 Annex V- permitted preservatives Benzoic acid and its sodium salt Glutaral 2-Bromo-2-nitropropane-1,3- diol (Bronopol) Hexamidine & salts 5-Bromo-5-nitro-1,3-dioxane Hexetidine 7-Ethylbicyclooxazolidine Imidazolidinyl urea Benzalkonium chloride, bromide etc Iodopropynyl butylcarbamate Benzethonium Chloride Kathon CG Mix Benzyl alcohol Methenamine Benzylhemiformal Methylisothiazolinone Biphenyl-2-ol, and its salts o-Cymen-5-ol Bromochlorophene o-Phenylphenol, sodium o-phenylphenatae etc Cetrimonium Chloride etc Parabens Chlorhexidine, Chlorhexidine diacetate p-Chloro-m-Cresol Chloroacetamide Phenoxyethanol Chlorobutanol Phenoxyisopropanol Chlorophene Phenylmercuric salts Chlorophene Piroctone Olamine Chloroxylenol Polyaminopropyl biguanide Chlorphenesin Propionic acid + salts Climbazole Quaternium-15 Dehydroacetic acid, sodium dehydroacetate Silver chloride Diazolidine urea Sodium Hydroxymethylglycinate Dibromohexamidine Isethionate Sorbic acid and sorbates Dichlorobenzyl Alcohol Sulfites Dimethyl Oxazolidine Thimerosal DMDM Hydantoin Triclocarban Formaldehyde, Paraformaldehyde Triclosan Formic acid, sodium formate Undecylenic acid and its salts Zinc pyrithione 15 Annex V Simplified. 54 ingredients plus salts Useful permitted preservatives Benzoic acid and its sodium salt Iodopropynyl butylcarbamate 2-Bromo-2-nitropropane-1,3- diol MIC/MI mix Chlorhexidine, Chlorhexidine diacetate Methylisothiazolinone Chloroacetamide o-Cymen-5-ol Chlorophene Parabens Chloroxylenol p-Chloro-m-Cresol Chlorphenesin Phenoxyethanol Dehydroacetic acid, Na dehydroacetate Phenoxyisopropanol Diazolidine urea Polyaminopropyl biguanide Dichlorobenzyl alcohol Quaternium-15 DMDM Hydantoin Silver chloride Glutaral Sodium Hydroxymethylglycinate Sorbic acid and sorbates Undecylenic acid + salts Annex V Very Simplified. 26 ingredients plus salts 16 Useful permitted
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