New Preservative Guidelines

by Kolbjorn Borseth RevisedDecember2011

Aromantic 2011

Free for Customers and Subscribers

 2 December 2011

Formulation News
PRESERVATIVE 12
Important New Dosage Guidelines
NewinformationhasbeensenttomebytheGermanproducerof Preservative12.Theynowrecommendthatyouuseabove0.7%concentrationinproducts,andbetween0.8 1%tobeonthesafeside. InthepastIhavepersonallyrecommendedusingadosageof0.6%andthroughalloftheseyearsthisisthe dosageIhaveusedonallofourcourses(andasyouknow,itisnotalwayseasytomaintainlaboratoryhygienic standardsoncourseswhenanumberofpeopleareworkinginasmallareanotnormallyreservedforthistype ofwork)andinourownrangeofbaseandreadymadeproducts,allwithnoproblem.

On the safe side

Thisnewrecommendationcomesaftertheproducerchallengetestedmanycosmeticformulationsattheir factory.Theystillrecommendusingfrom0.51%asPreservative12stillworksat0.5%.AsPreservative12isa socalledsoftpreservative,theirnewrecommendationis0.81%inallcosmeticpreparationstobeonthesafe side.If,likeus,youhavehadnoproblemsusingPreservative12atadosageof0.6%,thenitisuptoyouto decidewhetheryouwanttoincreaseto0.81%concentrationtobeonthesafeside.

Preservative 12 Dosage for Products containing Herbal Infusions or Decoctions

Ihavealwaysrecommendedthatyouuse1%inpreparationscontainingherbalinfusionsordecoctions,and afterdiscussingthiswiththeproducers,theyagreethat1%shouldworkbutthatyoushouldtestyourown products.

Using the Right Kind Water

WhatweveseenfromfeedbackfromtwoofourcustomerswhosecreamswentoffusingPreservative12isthat theyusednormaltapwater,whichisanunnecessarychallengetotheproduct.Othercustomershaveused osmosiswater,andthattoocanbeachallenge. Ihavealwaysrecommendedusingreputablebottledspringwaterfromsupermarketsandnevertapwater, exceptforshampoos/liquidsoapsasthedetergenthelpstopreservetheproductsaswell.Hereitisalwaysa goodideatoboilthewaterforatleast10minutesbeforehandand,veryimportantly,tousefreshlyopened bottledwaterforeachbatch!

Other challenges
OtherchallengestothepreservativeeffectinproductstheGermanproducersofPreservative12havetoldus aboutiswhenyouusefoodproductsinyourcosmeticse.g.groundalmondsinanexfoliatingcream,etc.

Too many Ingredients can spoil the Preservative Effect

Themoreactiveingredientsonehasinaproduct,themorechallengingitistopreserveit.Havingsaidthat,the AntiWrinkleCreamwemakeonCourseshasamaximumamountofactivesinitandwehaveusedadosageof 0.6%Preservative12withoutanyproblems.
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PRESERVATIVE ECO
Abroadspectrumpreservationsystembasedonacombinationofingredientsthat haveglobalacceptanceourmostnaturalPreservative! INCIName:BenzylAlcohol,SalicylicAcid,Glycerine,SorbicAcid

What is it?
Wearedelightedtointroduceanewbroadspectrumpreservationsystembasedona combinationofingredientsthatisbothECOCERTandCOSMOSapproved.(Cosmosisa Europeanorganicstandardhasbeencreatedbyanallianceof5ofEurope'sleadingorganic certifiers:TheSoilAssociationUK;BDIHGermany;CosmebioFrance;EcocertFrance; ICEA.PreservativeEcomeetsECOCERTstandardsforuseinnaturalandorganicskinandhaircareproducts [pleasenote:itisoursupplierthatholdtheEcocertcertification,notAromantic].Itsfourcomponents,Benzyl Alcohol,SalicylicAcid,Glycerine,SorbicAcid,areallwellacceptedinawiderangeofpersonalcareproducts. Thisnovelcompositionofthisantimicrobialblendoffersbroadspectrumprotectioninadiverserangeof products,againstgrampositiveandgramnegativebacteria,yeastandmoulds.Itisclearliquidwithamild smell.NaturalOdourReducermaybeneededforfragrancefreeandfragrancesensitiveformulations.

Benefits:

Nonparaben,nonformaldehyde,nonisothiazolonebasedpreservativesystem. Haswideglobalregulatoryacceptance. Broadspectrumactivityonbacteria,yeastandmoulds. Suitableforuseinoilinwater,waterinoilandanhydrous(nonwatercontaining)formulassocompatible withawiderangerangeofskin,hairandsuncareformulations. SafetouseinproductswithawiderangeofpHvalues(38).

Recommended dosage for Preservative Eco:

Recommendednumberofdrops,gramsand%per100ml/gofproduct20dropsusingsmall0.7mmdropper/ OR1g/OR1%.Ifproductcontainsherbaldecoctionsorinfusionsadd22dropsusingsmall0.7mmdropper/OR 1.1g/OR1.1%per100ml/g.BecauseofthehighquantityofBenzylAlcoholinPreservativeEcoandtomeetthe EuropeanCosmeticDirectivestandards,themaximumamountuseinproductsshouldbe1.15%.

Usage:
ItisveryimportantthatPreservativeEcoisaddedtoyourrecipesforwhichheatingisnecessarywhenthe temperatureisbelow45degreesCelsius.Sothebestistoaddthepreservativeinthethirdstageofmaking creamsandlotions.However,everypersonalcareformulationrequiresspecialattention.Itisalwaysimportant toensurethateverynewlydevelopedoralteredformulationbechallengetestedtoguaranteeproper preservation. WhenaddingPreservativeEcotocoldproducts(i.e.whennoheatingisrequiredtomaketheproduct,make sureyoumixitinthoroughlyahandheldelectricstickblendermaybeusefulifyoufinditdoesn'tmixin correctly.
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Caution:
DuetotheSalicylicAcidcomponentinPreservativeEco,donotuseitinproductsforchildrenunder3yearsof age, except in rinseoff products such as shampoos, shower gels, etc. Some people with sensitive skin or allergiescanalsoreacttoPreservativeEcoandPreservative12maybemoreappropriateforthem.Whilstitis morenaturalthanPreservative12,Preservative12maybemoreappropriateforsomepeoplesskin.Doaskin allergytestbeforemakingbigbatchesorbuyinglargequantitiesofPreservative.

Further information about using Preservative Eco

Aromantic has challengetested 2 creams made using 1% Preservative Eco at Microbiological Consultancy Servicesandwenowhavetheresultsbackfromtheirlab.Thecreamswetestedare:AromanticsMatureSkin Cream;andAromanticsActiveCream1(whichcontainsherbalinfusions)andbothpassedthechallengetestto comply with the criteria of the European Pharmacopeia for topical products. Our tests were successful and PreservativeEcoalsocomesfromareputablecompanythatproducesotherECOCERTapprovedrawmaterials butasIvesaidinmyPreservativesarticle,thefinalresponsibilityfortheendresultofyourproductslieswith youaswearenotwithyouwhenyoumakeyourproducts. If you are happy with the preservative you are using I see no reason to change preservatives. If you want a natural preservative to use in products containing detergents (shampoos, foam baths, shower gels, etc) then thismaybethepreservativeforyou.

Some common sense or safety rules when changing to other preservatives:

Change12productsfirst,notalltheproductsinyourrange. Doyourownstabilitytest,seeNewsletter32.Ifstilluncertain,getourMicrcountCombitestkit. Ifstillnotconvinced,getyourproductchallengetested. Ideally, dont start selling your test products containing your new preservative until 6 months have passedfromproductiondate.

Taking responsibility and Microbiological Challenge Testing

Attheendoftheday,you,asaproducer,needtotakeresponsibilityforhowmuchpreservativeyouchooseto put into your products. The only categorical way to check is to submit the product to the full European Pharmacopoeia challenge test. This is carried out by a microbiological testing laboratory, e.g. Microbiological ConsultantServices;thetesttakesabout40daystoperform.Thisiswhatwerecommendeventhoughitsnot compulsory.

We now sell a simple test kit

Wenowsellasimpletestsetthatcostsafewpoundstotestbacteria,yeastsandfungusincosmeticproducts. ItiscalledMicrocountCombi.Forfulldescriptionortoorder,click:http://www.aromantic.co.uk/buy mikrocountcombiuk.htm

Ifyouwanttouseamicrobiologicaltestingcompany,youcancontactAngusMalcolmatMicrobiological ConsultancyServices,whoareofferingAromanticcustomersaspecialprice.Theirwebsiteishttp:// www.mcs.uk.netPleasecontactthemdirectly.

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Stability Testing
Stabilitytestingiscompletelydifferenttomicrobiologicalchallengetesting.Stabilitytestingcheckswhetherthe productshowsseparationorotherchangesinappearance,textureorsmellduetoe.g.oxidationofvegetable oils and perfumes or due to incorrect emulsifier selection. Large cosmetic companies will always check their productsbybothchallengetestingandstabilitytestinganda12monthshelflifecannotreallybeclaimedunless bothtestsaredone.

Edmund Fowles, one of the experienced industrial chemist and safety assessors we recommend for cosmetic safetyassessmentshasgivenyouhereasimplestabilitytestingmethod:

Stability Testing Method by Edmund Fowles

Iwouldrecommenddoingbasicstabilitytestingforanyonesellingproductstothegeneralpublicandsothat theygetanideaoftheirshelflife.Thebasicstandardindustrymethodistoputintoaglassjarat45Cinanoven for 2 or 3 months, check it every 2 weeks, note their observations (after cooling each time to room temperature) including colour, smell, texture and skin feel. If it survives this time with no changes then it is deemedtobeprobablystablefor12monthsatroomtemperature.Extraindustrymethodsinvolveputtingthe product in a fridge at 4 C for 3 months and submitting the product to temperature cycles of freezing and melting.

Theminimumthatyourcustomersshoulddoisputsamplesinclearglassjarsonsunnywindowsillsandtest themasabove.Thelongertheyhaveseenitbestablefor,thelongertheshelflifetheycanwriteonthelabel.At leastmakesureitisstablefor1monthinthiswaybeforestartsellingtothegeneralpublic.Ifpossible,people shouldalsostoreandobservesamplesintheairingcupboard.Butideally,itwouldbegoodtoinvestina45C oven.

Safety Assessment
At its simplest, the EU legislation requires that a product placed on the market is safe for human use and in ordertoensurethatitssafeitmustundergoasafetyassessmentbyaqualifiedsafetyassessor.Thisisabasic legalrequirement;donotconfuseasafetyassessmentwithchallengetesting. Thelegislationstipulateswhatingredientsareallowedincosmeticandskincareproductsandwhatingredients aresubjecttorestrictionsandthesafetyassessorwillcheckthis.Clickhereforsafetyassessorswerecommend: http://www.aromantic.co.uk/pdf/Useful_Contacts_Safety_Testing.pdf ClickherefordetailsofourComplyingwithLegalRequirementsCourse: http://www.aromantic.co.uk/coursecomplyingwithlegalrequirements.htm

Very Important Information

The best method for measuring the Preservatives when adding to your products is to weigh them on a very good scale that weighs down to 0.1 grams. If you still decide to continue using drops to measure our Preservatives,wenowrecommendusingdifferentquantitiesdependingonwhichofourPreservativesyouare usinginyourproducts.

InourrecipesthatyoumayhavefromoldNewsletters,ourbooksandrecipebrochures,youlloftenfindthat wedontsaywhichpreservativetouse,wesimplysayxnumberofdropsofPreservativeintherecipe.AsI mentioned before, you need to decide how much of a Preservative you will put into your own products, but thesearemynewrecommendations.Ifyouhaveoldrecipes,Isuggestinmostcases(unlessitagreesitwiththe dosages in this table, that you ignore the number of drops or volume recommended and use my recommendationsasaguideline.Seethenextpageforthetable.
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 6 December 2011

New Recommended number of drops Aromantics Preservatives to use

AromanticPreservative Newrecommendednumberof oldnumberofdropsper100ml/gof drops,gramsand%per100ml/g product ofproduct Newrecommended drops,mls,gramsand%ofdrops per100ml/gofproductcontaining herbalinfusionsordecoctions

Dropsn/aPreservativeEco 12dropsPreservative12

20dropsusingsmall0.7mmdrop 22dropsusingsmall0.7mmdrop per/1g/1% per/1.1g/1.1% 2025dropsusinglarge2mm/0.8 25drops/0.9ml/1g/1% 1g/0.81%dropper 1215dropsusinglarge2mm dropper/0.50.6g/0.50.6% Still12dropsusinglarge2mm dropper/0.5g/0.5% 25drops/0.9ml/1g/1%

12dropsPreservativeK

12dropsParabens (AromanticBlend)

20drops/0.72ml/0.8g/0.8%

*NBDropsreferstodropsfromthebottlesourPreservativesaresuppliedtoyouin.Thebestisalwaystoweighthe Preservatives!

Conversion Table for Aromantics Preservatives

1gramofAromanticPreservative PreservativeEco Preservative12 PreservativeK Parabens(AromanticBlend) Approximateno.ofdrops* =approx.20drops =approx.25drops =approx.25drops =approx.25drops Density/SpecificGravity(gramsper cubiccentimetre) 1.0181.118at21Celsius 1.09g/cm3at20Celsius 1.105g/cm3at20Celsius 1.125g/cm3at25Celsius

*NBDropsreferstodropsfromthebottlesourPreservativesaresuppliedtoyouin.Thebestisalwaystoweighthe Preservatives!

So,generally10gramsofthesePreservativeswillgiveyouasmallervolume(approximately10%less)i.e.10 grams=about9millilitresofPreservative,so1gramofpreservative=about0.9millilitres. AstemperatureaffectstheviscosityofthePreservatives,measuringbydropsormillilitres(volume)isnotas accurateasmeasuringbygrams(weight).ItisbestthereforetokeepyourPreservativesatroomtemperature (20Celsius)andrememberthatthedropsintheconversiontableonthepreviouspagerefertotheamount comingoutofAromantics30mlglassdropperbottleswithlargedropperlidsandnotsomeoneelsesdroppers asthesecanvarysomuch.Ihavealwaysadvisedthatmeasuringonaverygoodscaleisthemostaccurate.

Good luck! Kolbjorn Borseth

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