Consumer product preservation - BASF · pharmaceuticals, cosmetics, household products, surfactants...

Specialty Chemicals by BASF

Consumer product preservation

BASF Biocides

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BASF Biocides - protecting the worldThe biocide business for Specialty Chemicals, BASF AG

BASF is one of the world’s leading suppliers ofspecialty biocides. We create products that makelife safer, simpler and more comfortable formillions of people worldwide.

Our high performance biocides are used in everyaspect of life. From the toiletries that you useeveryday, to the air conditioners used in bothindustry and home, from Iceland to Equador ourtechnology spans the globe in preservation anddisinfection. We help to protect the lives of millionsof people across the world every day.

Through our product range, marketing expertise,technical and regulatory knowledge, BASF’sinnovative biocides approach positions thebusiness at the very forefront of antimicrobialtechnology. The marketing, technical and researchand development headquarters for BASF’sspecialty biocide business is located inNottingham.

Our products are made in ‘state of the art’manufacturing facilities at Cramlington, Englandand Ludwigshafen, Germany. In each of ourplants, the expert integration of process andenergy requirements leads to manufacturingefficiencies and quality production.

To demonstrate our commitment to our customers,we have made significant investment in long termdedicated biocide resources within Europe, AsiaPacific and the USA.

In 2000, we established a direct presence in theUSA with a new dedicated marketing andtechnical centre based at BASF Corporationheadquarters in Mount Olive, New Jersey. Productis supplied through an integrated BASFwarehousing facility in Charlotte, North Carolina.Our US operation is part of BASF Corporation’sChemical Division, situated in Mount Olive, NewJersey.

How we work for youBASF’s biocides are sold through BASF’sestablished network of sales offices worldwide. Inthis way, we aim to offer valuable local supportand the highest standards of customer excellence.

Working with BASF provides access to manyessential regulatory approvals. For example ourEPA registrations allow products and customerformulations to be sold in the USA and ourapprovals ensure supply to the paper industry inthe Nordic area. We are also well positioned tosupport our actives under the European BiocidalProducts Directive.

We believe in long-term commitment to ourproducts and customers and this is reflected inour substantial registrations and the data requiredto obtain them. To this end many of our productsare supported with extensive safety andenvironmental data packages.

In addition, BASF is committed to providing thehighest standard of health, safety andenvironmental protection as part of ourcommitment to Responsible Care. We continuallyresearch and innovate to produce the mostadvanced products on the market.

At BASF, we are also constantly reviewing ways inwhich we can improve our products and servicesto ensure that we keep pace with the rapidlychanging developments in information technology.BASF is harnessing these changes and ensuringthat we are aligned with our customer’srequirements, making it more efficient andconvenient for you to do business with us.

BASF’s specialty biocide products are marketedunder the Myacide® and Protectol® trade names.

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Introduction to consumer product preservation

Microbiological problems in theconsumer product industryThe consumer product industry encompasses awide range of product types which includetopical pharmaceuticals, cosmetics, toiletries,household products and also many of the rawmaterials which are used in them. Each sectorcomprises a variety of formulations designed todeliver a particular function or benefit to meetlabel claims or customer expectations. There isalso a requirement that these formulations shouldhave a stable shelf-life for at least 2 years andlonger if possible.

The majority of these products are formulated assolutions or emulsions, where water is the maincomponent. The use patterns of many of theproducts also involve storage and application inwarm, humid environments and also frequentopening and reclosure of the final container.

These conditions provide the ideal environmentfor the growth of microorganisms and that,coupled with the rich nutrient sources providedby many of the raw materials, means thatmicrobial contamination can be a seriousproblem. This can have consequences from theaspect of product stability but it may also have animpact on the safety to the consumer.

From the spoilage viewpoint, the main problemorganisms are the aerobic bacteria such asPseudomonas, Klebsiella, Enterobacter andBacillus spp. In certain systems yeasts such asCandida and Saccharomyces spp. and mouldssuch as Aspergillus spp. can be problematic.These microbial contaminants may cause foulodours, colour changes and can also destabilisesome systems by consuming viscosity modifiersor producing acidic by-products. Of equalconcern is the possibility for contamination withpotentially pathogenic organisms, particularly inproducts used around the eyes and mouth.

For these reasons there is a requirement,statutory for some products, to ensure aneffective level of preservation for stability andsafety reasons. BASF’s specialty chemicals rangeof products is ideally suited to meet these needsfor the manufacturer and consumer alike.

CONTENTS

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Myacide® Pharma BP Preservative 6

Protectol® DA / DA S Preservative 10

Protectol® PE Preservative 12

Protectol® PP Preservative 13

Protectol® GA 50 Preservative 14

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The efficacy of Myacide Pharma BP preservativeis well established in pharmaceutical, cosmetic,personal care and household products, where theability to preserve over an extended shelf life,coupled with an excellent safety and compatibilityprofile, have been key success factors.

QUALITYBronopol is an odourless, white or almost whitecrystalline material. Bronopol crystals remainstable for a minimum of 3 years when kept undergood storage conditions. The INCI name is 2-Bromo-2-nitropropane-1,3-diol.

Bronopol is available in a number of grades, asfollows:

Myacide® Pharma BP

Guaranteed minimum 99% purity conforming tothe British Pharmacopoeia. For use inpharmaceuticals, cosmetics, household products,surfactants and other specialised areas requiringan extensive package of safety and toxicity data.

Liquid Formulations

For manufacturing processes requiring liquidformulations, Myacide Pharma BP is also availableas a 30% (w/w) solution.

ANTIMICROBIAL ACTIVITYBronopol is a highly effective broad-spectrumantibacterial agent, with particular activity againstthe problematic Pseudomonas species.

The following table compares Minimum InhibitoryConcentrations (M.I.C.) of Bronopol against somekey microorganisms.

Where control of yeasts and moulds is alsorequired, Bronopol can be combined withantimicrobials which offer fungicidal activity.

The performance of Bronopol has been assessedin a range of formulation types. Using preservativeefficacy tests, it has been proven that Bronopolcan offer excellent long-term microbiologicalcontrol. Many formulation types showed stabilityfor up to 3 years.

Bronopol can also be used as an antibacterialactive ingredient in products which have arelatively long contact time. For applications whichrequire a rapid kill time, e.g. surface disinfection, itwould be more appropriate to use Bronopol incombination with other active ingredients.

USAGE RECOMMENDATIONS

Solubility, Stability and Compatibility

Bronopol has excellent water solubility (28% w/v).This, combined with equally good solubility inother polar solvents (e.g. 50% w/v in propyleneglycol) makes it very easy to use either as a liquidor a solid. In emulsion systems, Bronopolpartitions preferentially into the polar (usuallyaqueous) phase. Since microorganisms growprimarily in the aqueous phase Bronopol can exertmaximum effect at the site of contamination.

Bronopol’s stability makes it an excellent long termpreservative for most cosmetics, toiletries andhousehold products. It shows optimum pH stabilityin the acidic range with excellent efficacy. Atalkaline pH, Bronopol is less stable but efficacy ismaintained. In this case Bronopol reaches anequilibrium with its breakdown products which arealso microbiologically active. This self-stabilisationmeans that preservative efficacy can bemaintained over an extended shelf life even withinaggressive, more alkaline formulations.

Bronopol has excellent compatibility and stabilitywith a wide range of surfactants (cationic, non-ionic, anionic and amphoteric) and many otherraw materials including other preservatives,sunscreens and natural extracts. In addition,Bronopol’s antimicrobial activity is not affected bythe presence of proteins at levels of up to 10% informulation systems.

Test Organism M.I.C. (ppm)

Staphylococcus spp 7 species 49 strains 12.5 - 50

Pseudomonas spp 5 species 58 strains 12.5 - 50

Candida spp 1 species 4 strains 400

Aspergillus spp 2 species 2 strains 3200

Myacide® Pharma BPPreservative

Recommended Dose Rates

Experience gained over 30 years in more than 40countries has shown that Bronopol is an effectivepreservative in a wide range of product types frompharmaceuticals and skincare to bath and babyproducts. Typical dose rates vary from 100-500ppm with the most common use level being200ppm. Formulation chemists should optimisethe requirements for particular products based ontheir properties, intended uses and packaging.

In skincare emulsions and problematic wet wipeformulations, the low usage levels of Bronopolfavour its inclusion. However, often in theseformulations it is combined with a suitable

antifungal agent to broaden the spectrum ofactivity. In less sophisticated detergent-basedproducts such as shampoos, bath and dishwashing liquids, Bronopol alone is sufficient tooffer long term protection.

The low concentrations of Bronopol necessary toprovide effective preservation mean that the costper preserved tonne of finished product issignificantly lower than most other preservatives.

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CASE STUDYAlthough Bronopol is potent enough to perform atvery low levels in a diverse range of householdproducts, it is also stable enough to give longterm protection. A simple household formulation isshown below.

SAFETY CHARACTERISTICSBronopol is non-irritant to healthy human skin atrecommended use concentrations of 0.01-0.1%.Indeed, the skin compatibility of Bronopol is sogood that it is used to preserve hypoallergenicskin creams and baby products. Bronopol is oneof the least sensitising of all commonly usedpreservatives and sensitisation is unlikely to occurin people with normal, healthy skin.

Bronopol is officially classified in the EU CouncilDirective - 67/548/EEC as harmful, irritant and

dangerous for the environment.

Animal Testing

Since 1975 there have been no experiments onanimals designed to assess the safety of Bronopolin cosmetic and toiletry applications.

REGISTRATIONSPharmaceutical products containing Bronopol are registered in anumber of countries and Bronopol is the subject of a specificmonograph in the British Pharmacopoeia 1998.

NORTH AMERICA

USAThe Cosmetic Ingredient Review (CIR) Expert Panel approvesthe use of Bronopol at levels up to and including 0.1% as acosmetic preservative, except where there is a risk ofnitrosamine or nitrosamide formation.

JAPANRegistered for pharmaceutical use in a wound irrigant solution.

EUROPE (EU)Listed in Annex VI (Part I) of the EU Cosmetics Directive as anapproved preservative at levels up to and including 0.1% exceptwhere there is a risk of nitrosamine formation.

BASF is well positioned to support bronopol under the BiocidalProducts Directive, which will include all household productapplications.

SWITZERLANDBASF’s Bronopol is approved as a preservative at up to 0.05% inskin care formulations and up to 0.1% in rinse-off products.

FRANCEBASF’s Bronopol is approved as a preservative for food contactapplications under Répressions des Fraudes.

OTHER REGIONSBASF’s Bronopol is widely used in other territories around theWorld.

Myacide® Pharma BP

Passes BP Preservation Test

at Initial and 12 month stage.

Expected shelf life - 3 years

Time (months)

Bro

nopo

l (pp

m)

Bronopol in a Fabric Softener

Fabric Softener

Ingredient % by weight INCI name

Rewoquat W75 6.67 Quaternium-27

Bronopol 0.02 2-Bromo-2-nitropropane-1,3-diol

Perfume q.s.

Dye q.s.

Water to 100

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Protectol DA preservative (2,4-Dichlorobenzylalcohol) is a well recognised, safe and reliable,broad spectrum antifungal preservative for use ina range of products including cosmetic, suncare,toiletry and baby care products. Protectol DA isalso an effective antimicrobial active ingredient foruse in oral and topical pharmaceuticals.

QUALITYProtectol DA is a white to slightly yellow crystallinesolid of minimum 98% purity with a shelf life of atleast 3 years. The INCI name is 2,4-Dichlorobenzylalcohol.

Protectol DA S is a special grade currentlyavailable for use in pharmaceuticals and otherspecialist applications requiring access to a DrugMaster File.

ANTIMICROBIAL ACTIVITYProtectol DA is active against a broad range ofmicroorganisms, but is more effective againstfungi. Minimum Inhibitory Concentrations (M.I.C.)of Protectol DA against four key organisms are asfollows:

In formulations where broad spectrum control isrequired, Protectol DA can be used incombination with other antimicrobials with wellknown bactericidal activity.



Protectol DA is highly soluble in organic solventsand sparingly soluble in water. In emulsionsystems, it can be incorporated by dissolution intothe oil phase. In aqueous systems, the use of anorganic solvent carrier is helpful. For example, a20% w/v solution of Protectol DA can be preparedin propylene glycol to facilitate addition.

Protectol DA is extremely stable at hightemperature and over a wide pH range

and can offer effective control for productsformulated at high pH.

Protectol DA is compatible with all commonly usedsurfactant types - anionic, cationic, nonionic andamphoteric. It is also compatible with otherantimicrobials such as Bronopol (Myacide PharmaBP).

RECOMMENDED DOSE RATESEffective preservation can be achieved in a varietyof formulations where fungal contamination is aproblem. From cosmetics and toiletries to suncareand babycare products, Protectol DA may be ofparticular value to formulators looking for a safeand effective antifungal agent.

The majority of consumer product types can bepreserved within the dosage range of 500ppm to1500ppm but it is most commonly used at a levelof 1000ppm.

In certain topical and oral pharmaceuticals,Protectol DA S is used as an active ingredient.Use levels range from 0.06% for oraladministration to 0.5% for skin disinfection.

CASE STUDYThe formulation below was prepared andsubjected to BP Challenge testing at regularintervals over a period of 24 months at ambienttemperature. The results confirmed that therequirements of the BP test were satisfied for bothbacteria and fungi throughout this time. In thiscase, the unpreserved sample failed againstPseudomonas aeruginosa and Aspergillus niger.

Mild Shampoo Formulation Details

Ingredient (%w/v)

Sodium Laureth Sulphate 18.5

Lauryl Betaine 6.0

PEG-150 Distearate 1.0

2-Bromo-2-nitropropane-1,3 -diol 0.02

Dichlorobenzyl alcohol 0.1

Propylene Glycol 2.0

Acetic Acid q.s. to pH 6

Sodium Chloride q.s.

Water to 100


Candida albicans 250

Aspergillus niger 250

Staphylococcus aureus 500

Pseudomonas aeruginosa 2000

Protectol® DA / Protectol® DA SPreservative

SAFETY CHARACTERISTICS2,4-Dichlorobenzyl alcohol was first introduced byThe Boots Company in the late 1950’s as afungicidal preservative in cosmetics and as anactive ingredient in pharmaceuticals. This longperiod of practical in-use experience hasdemonstrated Protectol DA and DA S’s safety.

It is non-irritant to the skin and non-sensitising.

Protectol DA and Protectol DA S is officiallyclassified in the EU Council Directive - 67/548/EECas irritant.

REGISTRATIONSNORTH AMERICAAccepted for use in cosmetic and toiletry products.

EUROPE (EU)2,4-Dichlorobenzyl alcohol is listed as a preservative at up to0.15% in the EU Cosmetic Directive.

The Pharmaceutical use of 2,4-Dichlorobenzyl alcohol as anactive ingredient in Strepsils (a well known medicated throatlozenge) is registered in many countries including Belgium,Canada, Denmark, Germany, the Netherlands and the UK.

In the UK, the Medicines Control Agency has also approved theuse of 2,4-Dichlorobenzyl alcohol in an antimicrobial skin gel, anantibacterial peel-off facemask, an antiseptic cream and anathletes foot cream at 0.5%w/w and in a cold sore lotion at0.25% w/v. The product is also used at 0.2% w/v in anantibacterial skin cleansing lotion for oily skin.

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Protectol PE preservative (2-Phenoxyethanol) isdesigned for use as a preservative in cosmetic,toiletry and household product areas. Thisbiocidal alcohol has well known bactericidal andfungicidal properties as well as being a commonco-formulant due to its excellent solvent properties.

QUALITYProtectol PE is a clear, colourless liquid ofminimum 99% w/w purity.

Also available is Protectol PE S that meets therequirements of the EP II (EuropeanPharmacopoeia), DAB 1997 (DeutschesArzneibuch) and JSCI 1993 (Japanese SocietyCosmetics Ingredients) monographs. This highpurity special grade is particularly useful forpharmaceutical preparations.

The INCI name is 2-Phenoxyethanol.

ANTIMICROBIAL ACTIVITYProtectol PE is active against a broad range ofmicroorganisms, especially Gram negativebacteria. Minimum Inhibitory Concentrations(M.I.C.) of Protectol PE against four key organismsare as follows:

For formulations where broad spectrum control isrequired, Protectol PE is often used incombination with other actives. It is a well knownco-formulant and can often be used to boost theantimicrobial properties of other preservatives.



Protectol PE is soluble in all common glycols andalcohols and is moderately soluble in water. Dueto its own solvent properties it can be used todissolve other products with poor water solubility.

Protectol PE is extremely stable in the presence ofacids and alkalis and under conditions of hightemperature. Consequently it will tolerate hotmanufacturing processes and give effectivecontrol over a broad pH range.

Protectol PE is compatible with all commonly usedsurfactant types - anionic, cationic, nonionic andamphoteric. It is also compatible with most otherantimicrobials and active ingredients which makesit a very versatile addition to any fomulation.


Protectol PE is an effective preservative in a widerange of product types from skincare and haircareto bath and baby products. When used alone as apreservative, concentrations up to 1% arerecommended. However, Protectol PE findsoptimum benefit when used in combination withother antimicrobials when levels can be reduced.

SAFETY CHARACTERISTICSDuring many years of use it has been shown thatPhenoxyethanol is extremely safe and effective,having no adverse effects on health at in-useconcentrations. It is non-irritating and non-sensitising at normal in-use concentrations.

REGISTRATIONSProtectol PE is widely accepted around the world and allowed asa preservative in cosmetics and toiletries.

NORTH AMERICANo restrictions for use.

JAPANJSCI listed as an approved preservative for cosmetics.

MITI listed.

EUROPE (EU)Listed in Annex VI (Part I) of the EU Cosmetic Directive as anapproved preservative at levels up to 1.0%.






Protectol® PEPreservative

Protectol PP preservative is a mixture of 1-Phenoxy-2-propanol and 2-Phenoxy-1-propanol. Ithas very similar properties to Protectol PE beingan effective preservative and co-formulant.

QUALITYProtectol PP is a clear, colourless liquid ofminimum 99% w/w purity. The INCI name isPhenoxyisopropanol.

ANTIMICROBIAL ACTIVITYProtectol PP has broad spectrum activity against arange of organisms. Minimum InhibitoryConcentrations (M.I.C.) of Protectol PP are shownbelow:

Protectol PP is often used in combination withother actives to enhance their activity and also asa co-formulant due to its excellent solventproperties.



In common with Protectol PE, Protectol PP issoluble in all common glycols and alcohols butonly moderately soluble in water. It is often usedas a co-solvent to dissolve products with poorwater solubility. Similarly, it is extremelytemperature stable, is active over a broad pHrange and is not discoloured by light. Protectol PPis also compatible with all commonly usedsurfactants and other raw materials.


Protectol PP is an effective preservative in a widerange of rinse-off product types within thepersonal care and household markets. It is alsoused to preserve raw materials. When used aloneas a preservative, concentrations up to 1% arerecommended.

SAFETY CHARACTERISTICSProtectol PP is extremely safe and effective,having no adverse effects on health at in-useconcentrations. It is non-irritating and non-sensitising at normal in-use concentrations.

Protectol PP is officially classified in the EUCouncil Directive - 67/548/EEC as irritant.

REGISTRATIONSProtectol PP is widely accepted around the world and is allowedas a preservative in cosmetics, toiletries and householdproducts.

NORTH AMERICANo restrictions for use.

JAPANMITI listed.

EUROPE (EU)Listed in Annex VI (Part I) of the EU Cosmetic Directive as anapproved preservative at levels up to 1.0% (only for rinse-offproducts).





Protectol® PPPreservative

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Protectol® GA 50Preservative

Protectol GA 50 biocide is a broad spectrumpreservative that is particularly effective against awide range of bacteria and fungi commonly foundwithin detergent systems. This, combined with itsrapid action and cost effectiveness, makes it mostsuitable for use in rinse-off and household productapplication areas.

QUALITYProtectol GA 50 is a 50% w/w clear, colourlesssolution of 1,5-Pentanedial commonly known asGlutaraldehyde. It has a shelf life of six months.The INCI name is Glutaral.

ANTIMICROBIAL ACTIVITYProtectol GA 50 is extremely effective against abroad range of microorganisms but especially theproblematic bacteria commonly found indetergent based systems. Protectol GA 50 isactive against the key organisms as shown below.


Solubility, Stability and Compatibility.

Protectol GA 50 is soluble in water and a widerange of polar organic solvents. This facilitatesuse in the vast majority of water-based systemsand ensures that it can exert maximum effect atthe site of contamination. Protectol GA 50 showsoptimum stability under normal processing andformulating conditions. Stability is reduced abovepH 7 and at high temperatures (> 40˚C). It iscompatible with all raw materials commonly usedin the detergent industry, however, in commonwith other preservatives, it can be inactivated bystrong reducing and oxidising agents.


For rapid control of microbial contamination aswell as long term preservation, Protectol GA 50should be used at levels between 100-600ppm. Itis most suitable for the preservation of detergentbased systems such as dishwashing and cleaningproducts where cost effective preservation isrequired.

SAFETY CHARACTERISTICSProtectol GA 50 is supported by an extensivepackage of safety studies confirming that atnormal in-use concentrations it does not have anyharmful effects and it is neither irritant orsensitising to the skin.

REGISTRATIONSNORTH AMERICANo restrictions for use.

EUROPE (EU)Protectol GDA is permitted for use under the EU CosmeticsDirective Annex VI up to 0.2% but must not be used in aerosols.





Saccharomyces cerevisiae 1250


Pencillium funiculosum 250

The information submitted in this publication isbased on our current knowledge andexperience. In view of the many factors that mayaffect processing and application, this datadoes not relieve processors of the responsibilityof carrying out their own tests and experiments;neither do they imply any legally bindingassurance of certain properties or of suitabilityfor a specific purpose. It is the responsibility ofthose to whom we supply our products toensure that any proprietary rights and existinglaws and legislation are observed.

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BASF Belgium S.A.

Specialty Chemicals

B-1180 Bruxelles / Brussel

Fax: +32 (0) 2 373 7055

BASF AktiengesellschaftSpecialty Chemicals

D-67056 Ludwigshafen

Fax: +49 (0) 621 60 93 937

BASF MicroCheck LimitedRuddington Fields Business Park,

Mere Way, Ruddington, Nottingham,

NG11 6JS, England

Telephone: +44 (0)115 912 4586

Fax: +44 (0)115 912 4592

e-mail: [email protected]

www.basfbiocides.com

BASF Espanola S.A.

Specialty Chemicals

E-08080 Barcelona

Fax: +34 (0) 93 488 30 16

BASF AB

Specialty Chemicals Nordic

S-41314 Göteborg

Fax: +46 (0) 31 639 900

BASF South East Asia PTE Ltd

7 Temasek Boulevard

30-01 Suntec Tower One

Singapore 038987

Fax: +65 (0) 432 36 93

BASF plc

Specialty Chemicals

Cheadle, Cheshire, SK8 6QG

Fax: +44 (0)161 485 5487

BASF Italia Spa

Specialty Chemicals

I-20031 Cesano Maderno MI

Fax: +39 (0) 3 62 512 902

BASF S.A.

Specialty Chemicals

09851-550 S~ao Bernardo do Campo - SP

Brazil

Fax: +55 (0) 11 751 25 43

BASF Aktiengesellschaft

Specialty Chemicals

D-60551 Frankfurt

Fax: +49 (0) 69 633 08 121

BASF Corporation3000 Continental Drive-North

Mount Olive, NJ 07828-1234

www.basf.com

For technical service,

Call (800) 294 6750

Or fax (847) 244 9633

For customer service,

Call (800) 443 6460

Or fax (973) 426 4906

BASF Canada Inc.

345 Carlingview Drive, Toronto,

Ontario M9W 6N9

Fax: +1 416 764 2588

Specialty Chemicals by BASF

Consumer product preservation

BASF Biocides

Consumer product preservation - BASF · pharmaceuticals, cosmetics, household products, surfactants...

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