Consumer product preservation

Transcription

1 Specialty Chemicals by BASF BASF Biocides Consumer product preservation

2 PAGE 2

3 BASF Biocides - protecting the world The biocide business for Specialty Chemicals, BASF AG BASF is one of the world s leading suppliers of specialty biocides. We create products that make life safer, simpler and more comfortable for millions of people worldwide. Our high performance biocides are used in every aspect of life. From the toiletries that you use everyday, to the air conditioners used in both industry and home, from Iceland to Equador our technology spans the globe in preservation and disinfection. We help to protect the lives of millions of people across the world every day. Through our product range, marketing expertise, technical and regulatory knowledge, BASF s innovative biocides approach positions the business at the very forefront of antimicrobial technology. The marketing, technical and research and development headquarters for BASF s specialty biocide business is located in Nottingham. Our products are made in state of the art manufacturing facilities at Cramlington, England and Ludwigshafen, Germany. In each of our plants, the expert integration of process and energy requirements leads to manufacturing efficiencies and quality production. To demonstrate our commitment to our customers, we have made significant investment in long term dedicated biocide resources within Europe, Asia Pacific and the USA. In 2000, we established a direct presence in the USA with a new dedicated marketing and technical centre based at BASF Corporation headquarters in Mount Olive, New Jersey. Product is supplied through an integrated BASF warehousing facility in Charlotte, North Carolina. Our US operation is part of BASF Corporation s Chemical Division, situated in Mount Olive, New Jersey. How we work for you BASF s biocides are sold through BASF s established network of sales offices worldwide. In this way, we aim to offer valuable local support and the highest standards of customer excellence. Working with BASF provides access to many essential regulatory approvals. For example our EPA registrations allow products and customer formulations to be sold in the USA and our approvals ensure supply to the paper industry in the Nordic area. We are also well positioned to support our actives under the European Biocidal Products Directive. We believe in long-term commitment to our products and customers and this is reflected in our substantial registrations and the data required to obtain them. To this end many of our products are supported with extensive safety and environmental data packages. In addition, BASF is committed to providing the highest standard of health, safety and environmental protection as part of our commitment to Responsible Care. We continually research and innovate to produce the most advanced products on the market. At BASF, we are also constantly reviewing ways in which we can improve our products and services to ensure that we keep pace with the rapidly changing developments in information technology. BASF is harnessing these changes and ensuring that we are aligned with our customer s requirements, making it more efficient and convenient for you to do business with us. BASF s specialty biocide products are marketed under the Myacide and Protectol trade names. PAGE 3

4 PAGE 4

5 Introduction to consumer product preservation Microbiological problems in the consumer product industry The consumer product industry encompasses a wide range of product types which include topical pharmaceuticals, cosmetics, toiletries, household products and also many of the raw materials which are used in them. Each sector comprises a variety of formulations designed to deliver a particular function or benefit to meet label claims or customer expectations. There is also a requirement that these formulations should have a stable shelf-life for at least 2 years and longer if possible. The majority of these products are formulated as solutions or emulsions, where water is the main component. The use patterns of many of the products also involve storage and application in warm, humid environments and also frequent opening and reclosure of the final container. These conditions provide the ideal environment for the growth of microorganisms and that, coupled with the rich nutrient sources provided by many of the raw materials, means that microbial contamination can be a serious problem. This can have consequences from the aspect of product stability but it may also have an impact on the safety to the consumer. CONTENTS PAGE Myacide Pharma BP Preservative 6 Protectol DA / DA S Preservative 10 Protectol PE Preservative 12 Protectol PP Preservative 13 Protectol GA 50 Preservative 14 From the spoilage viewpoint, the main problem organisms are the aerobic bacteria such as Pseudomonas, Klebsiella, Enterobacter and Bacillus spp. In certain systems yeasts such as Candida and Saccharomyces spp. and moulds such as Aspergillus spp. can be problematic. These microbial contaminants may cause foul odours, colour changes and can also destabilise some systems by consuming viscosity modifiers or producing acidic by-products. Of equal concern is the possibility for contamination with potentially pathogenic organisms, particularly in products used around the eyes and mouth. For these reasons there is a requirement, statutory for some products, to ensure an effective level of preservation for stability and safety reasons. BASF s specialty chemicals range of products is ideally suited to meet these needs for the manufacturer and consumer alike. PAGE 5

6 Myacide Pharma BP Preservative The efficacy of Myacide Pharma BP preservative is well established in pharmaceutical, cosmetic, personal care and household products, where the ability to preserve over an extended shelf life, coupled with an excellent safety and compatibility profile, have been key success factors. QUALITY Bronopol is an odourless, white or almost white crystalline material. Bronopol crystals remain stable for a minimum of 3 years when kept under good storage conditions. The INCI name is 2- Bromo-2-nitropropane-1,3-diol. Bronopol is available in a number of grades, as follows: Myacide Pharma BP Guaranteed minimum 99% purity conforming to the British Pharmacopoeia. For use in pharmaceuticals, cosmetics, household products, surfactants and other specialised areas requiring an extensive package of safety and toxicity data. Liquid Formulations For manufacturing processes requiring liquid formulations, Myacide Pharma BP is also available as a 30% (w/w) solution. ANTIMICROBIAL ACTIVITY Bronopol is a highly effective broad-spectrum antibacterial agent, with particular activity against the problematic Pseudomonas species. The following table compares Minimum Inhibitory Concentrations (M.I.C.) of Bronopol against some key microorganisms. Test Organism M.I.C. (ppm) Staphylococcus spp 7 species 49 strains Pseudomonas spp 5 species 58 strains Candida spp 1 species 4 strains 400 Aspergillus spp 2 species 2 strains 3200 Where control of yeasts and moulds is also required, Bronopol can be combined with antimicrobials which offer fungicidal activity. The performance of Bronopol has been assessed in a range of formulation types. Using preservative efficacy tests, it has been proven that Bronopol can offer excellent long-term microbiological control. Many formulation types showed stability for up to 3 years. Bronopol can also be used as an antibacterial active ingredient in products which have a relatively long contact time. For applications which require a rapid kill time, e.g. surface disinfection, it would be more appropriate to use Bronopol in combination with other active ingredients. USAGE RECOMMENDATIONS Solubility, Stability and Compatibility Bronopol has excellent water solubility (28% w/v). This, combined with equally good solubility in other polar solvents (e.g. 50% w/v in propylene glycol) makes it very easy to use either as a liquid or a solid. In emulsion systems, Bronopol partitions preferentially into the polar (usually aqueous) phase. Since microorganisms grow primarily in the aqueous phase Bronopol can exert maximum effect at the site of contamination. Bronopol s stability makes it an excellent long term preservative for most cosmetics, toiletries and household products. It shows optimum ph stability in the acidic range with excellent efficacy. At alkaline ph, Bronopol is less stable but efficacy is maintained. In this case Bronopol reaches an equilibrium with its breakdown products which are also microbiologically active. This self-stabilisation means that preservative efficacy can be maintained over an extended shelf life even within aggressive, more alkaline formulations. Bronopol has excellent compatibility and stability with a wide range of surfactants (cationic, nonionic, anionic and amphoteric) and many other raw materials including other preservatives, sunscreens and natural extracts. In addition, Bronopol s antimicrobial activity is not affected by the presence of proteins at levels of up to 10% in formulation systems. PAGE 6

7 Recommended Dose Rates Experience gained over 30 years in more than 40 countries has shown that Bronopol is an effective preservative in a wide range of product types from pharmaceuticals and skincare to bath and baby products. Typical dose rates vary from ppm with the most common use level being 200ppm. Formulation chemists should optimise the requirements for particular products based on their properties, intended uses and packaging. antifungal agent to broaden the spectrum of activity. In less sophisticated detergent-based products such as shampoos, bath and dish washing liquids, Bronopol alone is sufficient to offer long term protection. The low concentrations of Bronopol necessary to provide effective preservation mean that the cost per preserved tonne of finished product is significantly lower than most other preservatives. In skincare emulsions and problematic wet wipe formulations, the low usage levels of Bronopol favour its inclusion. However, often in these formulations it is combined with a suitable PAGE 7

8 Myacide Pharma BP Bronopol (ppm) CASE STUDY Although Bronopol is potent enough to perform at very low levels in a diverse range of household products, it is also stable enough to give long term protection. A simple household formulation is shown below. Ingredient Time (months) Fabric Softener % by weight INCI name Rewoquat W Quaternium-27 Bronopol Bromo-2-nitropropane-1,3-diol Perfume q.s. Dye q.s. Water to 100 Bronopol in a Fabric Softener Passes BP Preservation Test at Initial and 12 month stage. Expected shelf life - 3 years SAFETY CHARACTERISTICS Bronopol is non-irritant to healthy human skin at recommended use concentrations of %. Indeed, the skin compatibility of Bronopol is so good that it is used to preserve hypoallergenic skin creams and baby products. Bronopol is one of the least sensitising of all commonly used preservatives and sensitisation is unlikely to occur in people with normal, healthy skin. Bronopol is officially classified in the EU Council Directive - 67/548/EEC as harmful, irritant and dangerous for the environment. Animal Testing Since 1975 there have been no experiments on animals designed to assess the safety of Bronopol in cosmetic and toiletry applications. REGISTRATIONS Pharmaceutical products containing Bronopol are registered in a number of countries and Bronopol is the subject of a specific monograph in the British Pharmacopoeia NORTH AMERICA USA The Cosmetic Ingredient Review (CIR) Expert Panel approves the use of Bronopol at levels up to and including 0.1% as a cosmetic preservative, except where there is a risk of nitrosamine or nitrosamide formation. JAPAN Registered for pharmaceutical use in a wound irrigant solution. EUROPE (EU) Listed in Annex VI (Part I) of the EU Cosmetics Directive as an approved preservative at levels up to and including 0.1% except where there is a risk of nitrosamine formation. BASF is well positioned to support bronopol under the Biocidal Products Directive, which will include all household product applications. SWITZERLAND BASF s Bronopol is approved as a preservative at up to 0.05% in skin care formulations and up to 0.1% in rinse-off products. FRANCE BASF s Bronopol is approved as a preservative for food contact applications under Répressions des Fraudes. OTHER REGIONS BASF s Bronopol is widely used in other territories around the World. PAGE 8

9 PAGE 9

10 Protectol DA / Protectol DA S Preservative Protectol DA preservative (2,4-Dichlorobenzyl alcohol) is a well recognised, safe and reliable, broad spectrum antifungal preservative for use in a range of products including cosmetic, suncare, toiletry and baby care products. Protectol DA is also an effective antimicrobial active ingredient for use in oral and topical pharmaceuticals. QUALITY Protectol DA is a white to slightly yellow crystalline solid of minimum 98% purity with a shelf life of at least 3 years. The INCI name is 2,4-Dichlorobenzyl alcohol. Protectol DA S is a special grade currently available for use in pharmaceuticals and other specialist applications requiring access to a Drug Master File. ANTIMICROBIAL ACTIVITY Protectol DA is active against a broad range of microorganisms, but is more effective against fungi. Minimum Inhibitory Concentrations (M.I.C.) of Protectol DA against four key organisms are as follows: Test Organism Candida albicans 250 Aspergillus niger 250 Staphylococcus aureus 500 Pseudomonas aeruginosa 2000 In formulations where broad spectrum control is required, Protectol DA can be used in combination with other antimicrobials with well known bactericidal activity. USAGE RECOMMENDATIONS Solubility, Stability and Compatibility Protectol DA is highly soluble in organic solvents and sparingly soluble in water. In emulsion systems, it can be incorporated by dissolution into the oil phase. In aqueous systems, the use of an organic solvent carrier is helpful. For example, a 20% w/v solution of Protectol DA can be prepared in propylene glycol to facilitate addition. Protectol DA is extremely stable at high temperature and over a wide ph range M.I.C. (ppm) and can offer effective control for products formulated at high ph. Protectol DA is compatible with all commonly used surfactant types - anionic, cationic, nonionic and amphoteric. It is also compatible with other antimicrobials such as Bronopol (Myacide Pharma BP). RECOMMENDED DOSE RATES Effective preservation can be achieved in a variety of formulations where fungal contamination is a problem. From cosmetics and toiletries to suncare and babycare products, Protectol DA may be of particular value to formulators looking for a safe and effective antifungal agent. The majority of consumer product types can be preserved within the dosage range of 500ppm to 1500ppm but it is most commonly used at a level of 1000ppm. In certain topical and oral pharmaceuticals, Protectol DA S is used as an active ingredient. Use levels range from 0.06% for oral administration to 0.5% for skin disinfection. CASE STUDY The formulation below was prepared and subjected to BP Challenge testing at regular intervals over a period of 24 months at ambient temperature. The results confirmed that the requirements of the BP test were satisfied for both bacteria and fungi throughout this time. In this case, the unpreserved sample failed against Pseudomonas aeruginosa and Aspergillus niger. Mild Shampoo Ingredient Formulation Details (%w/v) Sodium Laureth Sulphate 18.5 Lauryl Betaine 6.0 PEG-150 Distearate 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 PAGE 10

11 SAFETY CHARACTERISTICS 2,4-Dichlorobenzyl alcohol was first introduced by The Boots Company in the late 1950 s as a fungicidal preservative in cosmetics and as an active ingredient in pharmaceuticals. This long period of practical in-use experience has demonstrated Protectol DA and DA S s safety. It is non-irritant to the skin and non-sensitising. Protectol DA and Protectol DA S is officially classified in the EU Council Directive - 67/548/EEC as irritant. REGISTRATIONS NORTH AMERICA Accepted for use in cosmetic and toiletry products. EUROPE (EU) 2,4-Dichlorobenzyl alcohol is listed as a preservative at up to 0.15% in the EU Cosmetic Directive. The Pharmaceutical use of 2,4-Dichlorobenzyl alcohol as an active ingredient in Strepsils (a well known medicated throat lozenge) 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 the use of 2,4-Dichlorobenzyl alcohol in an antimicrobial skin gel, an antibacterial peel-off facemask, an antiseptic cream and an athletes foot cream at 0.5%w/w and in a cold sore lotion at 0.25% w/v. The product is also used at 0.2% w/v in an antibacterial skin cleansing lotion for oily skin. PAGE 11

12 Protectol PE Preservative Protectol PE preservative (2-Phenoxyethanol) is designed for use as a preservative in cosmetic, toiletry and household product areas. This biocidal alcohol has well known bactericidal and fungicidal properties as well as being a common co-formulant due to its excellent solvent properties. QUALITY Protectol PE is a clear, colourless liquid of minimum 99% w/w purity. Also available is Protectol PE S that meets the requirements of the EP II (European Pharmacopoeia), DAB 1997 (Deutsches Arzneibuch) and JSCI 1993 (Japanese Society Cosmetics Ingredients) monographs. This high purity special grade is particularly useful for pharmaceutical preparations. The INCI name is 2-Phenoxyethanol. ANTIMICROBIAL ACTIVITY Protectol PE is active against a broad range of microorganisms, especially Gram negative bacteria. Minimum Inhibitory Concentrations (M.I.C.) of Protectol PE against four key organisms are as follows: Test Organism M.I.C. (ppm) Staphylococcus aureus 6400 Pseudomonas aeruginosa 3200 Candida albicans 3200 Aspergillus niger 3200 For formulations where broad spectrum control is required, Protectol PE is often used in combination with other actives. It is a well known co-formulant and can often be used to boost the antimicrobial properties of other preservatives. Protectol PE is extremely stable in the presence of acids and alkalis and under conditions of high temperature. Consequently it will tolerate hot manufacturing processes and give effective control over a broad ph range. Protectol PE is compatible with all commonly used surfactant types - anionic, cationic, nonionic and amphoteric. It is also compatible with most other antimicrobials and active ingredients which makes it a very versatile addition to any fomulation. Recommended Dose Rates Protectol PE is an effective preservative in a wide range of product types from skincare and haircare to bath and baby products. When used alone as a preservative, concentrations up to 1% are recommended. However, Protectol PE finds optimum benefit when used in combination with other antimicrobials when levels can be reduced. SAFETY CHARACTERISTICS During many years of use it has been shown that Phenoxyethanol is extremely safe and effective, having no adverse effects on health at in-use concentrations. It is non-irritating and nonsensitising at normal in-use concentrations. REGISTRATIONS Protectol PE is widely accepted around the world and allowed as a preservative in cosmetics and toiletries. NORTH AMERICA No restrictions for use. JAPAN JSCI listed as an approved preservative for cosmetics. MITI listed. EUROPE (EU) Listed in Annex VI (Part I) of the EU Cosmetic Directive as an approved preservative at levels up to 1.0%. USAGE RECOMMENDATIONS Solubility, Stability and Compatibility Protectol PE is soluble in all common glycols and alcohols and is moderately soluble in water. Due to its own solvent properties it can be used to dissolve other products with poor water solubility. PAGE 12

13 Protectol PP Preservative Protectol PP preservative is a mixture of 1- Phenoxy-2-propanol and 2-Phenoxy-1-propanol. It has very similar properties to Protectol PE being an effective preservative and co-formulant. QUALITY Protectol PP is a clear, colourless liquid of minimum 99% w/w purity. The INCI name is Phenoxyisopropanol. ANTIMICROBIAL ACTIVITY Protectol PP has broad spectrum activity against a range of organisms. Minimum Inhibitory Concentrations (M.I.C.) of Protectol PP are shown below: Test Organism M.I.C. (ppm) Staphylococcus aureus 5000 Pseudomonas aeruginosa Candida albicans 7500 SAFETY CHARACTERISTICS Protectol PP is extremely safe and effective, having no adverse effects on health at in-use concentrations. It is non-irritating and nonsensitising at normal in-use concentrations. Protectol PP is officially classified in the EU Council Directive - 67/548/EEC as irritant. REGISTRATIONS Protectol PP is widely accepted around the world and is allowed as a preservative in cosmetics, toiletries and household products. NORTH AMERICA No restrictions for use. JAPAN MITI listed. EUROPE (EU) Listed in Annex VI (Part I) of the EU Cosmetic Directive as an approved preservative at levels up to 1.0% (only for rinse-off products). Protectol PP is often used in combination with other actives to enhance their activity and also as a co-formulant due to its excellent solvent properties. USAGE RECOMMENDATIONS Solubility, Stability and Compatibility In common with Protectol PE, Protectol PP is soluble in all common glycols and alcohols but only moderately soluble in water. It is often used as a co-solvent to dissolve products with poor water solubility. Similarly, it is extremely temperature stable, is active over a broad ph range and is not discoloured by light. Protectol PP is also compatible with all commonly used surfactants and other raw materials. Recommended Dose Rates Protectol PP is an effective preservative in a wide range of rinse-off product types within the personal care and household markets. It is also used to preserve raw materials. When used alone as a preservative, concentrations up to 1% are recommended. PAGE 13

14 Protectol GA 50 Preservative Protectol GA 50 biocide is a broad spectrum preservative that is particularly effective against a wide range of bacteria and fungi commonly found within detergent systems. This, combined with its rapid action and cost effectiveness, makes it most suitable for use in rinse-off and household product application areas. QUALITY Protectol GA 50 is a 50% w/w clear, colourless solution of 1,5-Pentanedial commonly known as Glutaraldehyde. It has a shelf life of six months. The INCI name is Glutaral. ANTIMICROBIAL ACTIVITY Protectol GA 50 is extremely effective against a broad range of microorganisms but especially the problematic bacteria commonly found in detergent based systems. Protectol GA 50 is active against the key organisms as shown below. Test Organism M.I.C. (ppm) Pseudomonas aeruginosa 150 Staphylococcus aureus 50 Candida albicans 1250 Saccharomyces cerevisiae 1250 Aspergillus niger 500 Pencillium funiculosum 250 USAGE RECOMMENDATIONS Solubility, Stability and Compatibility. Protectol GA 50 is soluble in water and a wide range of polar organic solvents. This facilitates use in the vast majority of water-based systems and ensures that it can exert maximum effect at the site of contamination. Protectol GA 50 shows optimum stability under normal processing and formulating conditions. Stability is reduced above ph 7 and at high temperatures (> 40 C). It is compatible with all raw materials commonly used in the detergent industry, however, in common with other preservatives, it can be inactivated by strong reducing and oxidising agents. Recommended Dose Rates For rapid control of microbial contamination as well as long term preservation, Protectol GA 50 should be used at levels between ppm. It is most suitable for the preservation of detergent based systems such as dishwashing and cleaning products where cost effective preservation is required. SAFETY CHARACTERISTICS Protectol GA 50 is supported by an extensive package of safety studies confirming that at normal in-use concentrations it does not have any harmful effects and it is neither irritant or sensitising to the skin. REGISTRATIONS NORTH AMERICA No restrictions for use. EUROPE (EU) Protectol GDA is permitted for use under the EU Cosmetics Directive Annex VI up to 0.2% but must not be used in aerosols. PAGE 14

15 The information submitted in this publication is based on our current knowledge and experience. In view of the many factors that may affect processing and application, this data does not relieve processors of the responsibility of carrying out their own tests and experiments; neither do they imply any legally binding assurance of certain properties or of suitability for a specific purpose. It is the responsibility of those to whom we supply our products to ensure that any proprietary rights and existing laws and legislation are observed. PAGE 15

16 BASF MicroCheck Limited BASF Aktiengesellschaft BASF AB Ruddington Fields Business Park, Mere Way, Ruddington, Nottingham, NG11 6JS, England Specialty Chemicals D Frankfurt Fax: +49 (0) Specialty Chemicals Nordic S Göteborg Fax: +46 (0) Telephone: +44 (0) Fax: +44 (0) BASF Belgium S.A. Specialty Chemicals B-1180 Bruxelles / Brussel Fax: +32 (0) BASF Italia Spa Specialty Chemicals I Cesano Maderno MI Fax: +39 (0) BASF Aktiengesellschaft Specialty Chemicals D Ludwigshafen Fax: +49 (0) BASF Espanola S.A. Specialty Chemicals E Barcelona Fax: +34 (0) BASF plc Specialty Chemicals Cheadle, Cheshire, SK8 6QG Fax: +44 (0) BASF Corporation 3000 Continental Drive-North Mount Olive, NJ BASF South East Asia PTE Ltd 7 Temasek Boulevard Suntec Tower One BASF S.A. Specialty Chemicals S ao ~ Bernardo do Campo - SP Singapore Brazil For technical service, Call (800) Or fax (847) For customer service, Call (800) Or fax (973) Fax: +65 (0) Fax: +55 (0) BASF Canada Inc. 345 Carlingview Drive, Toronto, Ontario M9W 6N9 Fax: Myacide and Protectol are registered trademarks. ES0013e (July 2000)

17 Specialty Chemicals by BASF BASF Biocides Consumer product preservation