VARA

personal care

02 At a glance 03 Products for the Cosmetic and Pharmaceuticals Industry

Sasol Wax products are supplied world-wide in many different markets.

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At a glance ...

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The specialist in paraffin wax At a glance ... Products for the Cosmetic and Pharmaceutical Industry MERKUR and VARA Pharmaceutical Petroleum jellies Pharmaceutical White Oils, paraffinic Sasolwax for the Cosmetic and Pharmaceutical Industry The Sasol Wax difference GMP, ISO & HACCP certification The latest technology safeguards quality Matrix

Sasol Wax is the leading specialist in innovative wax technology. Sasol Wax products are supplied worldwide into many different markets and are used in a diversity of applications. Paraffin wax is the major raw material for the production of candles and is also used in the manufacture of rubber and tires, chipboards, plastics, foodstuffs, food packaging, printing inks and paints, textiles, asphalt and many other products. Sasol Wax offers a comprehensive product range of pharmaceutical white oils, petroleum jellies and waxes. For decades, Sasol Wax has been concentrating on the development and optimization of paraffin and paraffin blends as well as petroleum jellies for a large number of different applications. The products are renowned for a broad spectrum of applications. Their use ranges from

relatively simple applications to process oriented tailor-made products for state of the art production equipment. Specialties are created for innovative solutions, e. g. as medium for latent heat storage. Both macrocrystalline and microcrystalline paraffin and petroleum jellies represent complex multicomponent blends consisting of saturated hydrocarbons. Extracted from fossil raw materials, our products are cleaned of any possible pollutants with the aid of environmentally friendly procedures (e.g. high-pressure hydrogenation). These highly refined products are subject to continuous quality control and from a toxicological point of view pose no risk to health. Their environmentally compatible properties are characterized by good biodegradability and an absence of ecotoxic and cumulative effects.

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Products for the Cosmetic and Pharmaceutical Industry
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The products are used in large areas of the cosmetic and pharmaceutical industry, where they are employed as processing aids, as plasticizers for adjusting hardness, in many lotions and creams (e.g. cleansing milk, lipid-replenishing cosmetics and sun protection agents) and act as the base for creams, lipsticks, rouge and eye cosmetics such as eye-shadow, eyebrow pencils and mascara. Solid and liquid paraffins and petroleum jellies are essential constituents in formulations as they have outstanding properties in terms of their protective action, color and also as a consistency regulator. They help

to enhance the health of the skin and reduce desiccation. Other applications range from shaving foam, hot and cold depilatory waxes to thermal therapy, which exploits the outstanding heat storing properties of paraffin waxes. An especially demanding application of paraffin waxes is histology. Highest purity products are composed with certain additives to give the desired flexibility. Screening through fine mesh screens guarantees the absence of any particulate matter. Only these high quality products are suitable for the embedding of tissue, which has to be cut in razor-thin sections.

Solid and liquid paraffins and petroleum jellies help to enhance the health of the skin and reduce desiccation.

04 MERKUR and VARA pharmaceutical petroleum jellies 05 Pharmaceutical White Oils

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MERKUR and VARA pharmaceutical petroleum jellies
MERKUR and VARA petroleum jellies are ointment-like, nearly odorless, homogeneous mixtures of high-purity, hydrogenated, predominantly saturated hydrocarbons. They are snow-white, off-white, pale yellow or yellow pharmaceutical qualities depending on the degree of refining. In the table below we have indicated the extent to which the degree of purity is covered by various pharmacopoeias. In each case, reference is made to the latest monographs. MERKUR 794, MERKUR 717, VARA 2600, MERKUR 793 T, MERKUR 791 and MERKUR 773 are
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ceutical industry. MERKUR 546 is particularly stable to heat and suitable for countries with tropical climates. We recommend MERKUR 110 as Melkfett (Milking Grease) quality. MERKUR and VARA pharmaceutical petroleum jellies are mainly used for the following applications: Base material for eye creams, ointments and hair care agents as well as the main constituent of skin care creams, baby care, hand-cleaning pastes, body lotions, hand and skin creams and eye make-up. Melkfett petroleum jellies and Melkfett ointments (Milking Grease). Particularly in the pharmaceutical field, not

only white, but also yellow pharmaceutical petroleum jellies are used as a base material and consistency regulator. They are a constituent of many dermatological preparations. Yellow vaselines are also used in cosmetic formulations such as milking grease/fatty ointments and other skin protection creams, and in veterinary products. Yellow pharmaceutical jellies can be obtained either by coloring white pharmaceutical petroleum jelly or by bleaching. The yellow petroleum jellies in the following table are produced by bleaching and are not stabilized. We will be glad to inform you about colored petroleum jelly types on request. INCI name: Petrolatum

very high-grade petroleum jellies with excellent oil-binding capacity, especially for the pharma-

Colour Lovibond/ ASTM Colour

Density 80 C kg/m3

Congealing Point C

Consistency 25 C mm/10

Viscosity 100 C mm2/s

Drop Point C

Melting Range C

Total Compliance with Pharmacopeias

Pharmaceutical petroleum jellies, white Ph. Eur. (BP), USP/JP typical data
VARA AB VARA 26001) VARA 4800 VARA 5422 MERKUR 110 MERKUR 500 MERKUR 500 USP MERKUR 546 MERKUR 717 MERKUR 773 MERKUR 774 MERKUR 791 MERKUR 794
1)

0.7 y max 0.7 y max 1.0 y max 0.7 y max 1.0 y max 0.5 y max 0.5 y max 1.0 y max 0.5 y max 0.5 y max 0.7 y max 0.5 y max 1.0 y max 0.5 y max

820 825 810 820 810 810 810 805 825 825 820 820 825 820

50 55 48 53 50 56 48 55 50 56 50 56 45 55 48 56 48 54 47 53 49 55 49 56 50 55 50 55

165 185 165 185 155 175 210 240 170 190 140 160 140 160 95 120 160 180 155 175 190 210 150 170 145 170 160 180

9.0 12.0 7.0 7.0 10.0 7.0 7.0 6.0 7.0 10.0 12.0 7.5 10.0 10.0 13.0 13.0

35 70 35 70 35 70 35 70 35 70 35 70 35 70 35 70 35 70 35 70 35 70 35 70 35 70 35 70 38 60 38 60 38 60 38 60

Ph. Eur. Ph. Eur. Ph. Eur. Ph. Eur. Ph. Eur. Ph. Eur. Ph. Eur./USP/JP Ph. Eur. Ph. Eur./USP/JP/CF Ph. Eur./USP/JP Ph. Eur. Ph. Eur. Ph. Eur./USP/JP Ph. Eur.

MERKUR 793 T

Pharmaceutical petroleum jellies, yellow Ph. Eur. (BP), USP/JP typical data
VARA CB VARA 4200 MERKUR 638 1.0 1.5 1.0 max 1.0 2.0 820 820 810 50 55 50 55 50 55 165 185 165 185 145 165 7.0 9.0 6.5 8.5 5.0 9.0 40 60 40 60 40 60 Ph. Eur. Ph. Eur. Ph. Eur.
1) Subsequently bleached, not stabilized.

All products comply with the purity requirements of USP, Ph. Eur. (BP), JP and FDA (21 CFR Section 172.880) Colipa Recommendation No. 14 (oral & lip care) on request. Total USP/JP compliant yellow type on request.

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Pharmaceutical White Oils, paraffinic

MERKUR and VARA White Oils Pharma are colorless, clear, odorless, tasteless, non-fluorescent liquids. They comply with the purity standards of the European pharmacopoeia, the United States pharmacopoeia, and the U.S. Food and Drug Administration, latest issue each, as indicated under Typical Data. White Oils Pharma feature constant high quality and exceptional color and oxidation stability. The different levels of viscosity permit a wide range of uses. INCI name: Paraffinum Liquidum

MERKUR and VARA White Oils Pharma are recommended for the following applications: Pharmaceuticals and cosmetics Base materials for ointments, skin creams, hair preparations, and suntan products, ingredients for baby and bath oils, lotions, lipsticks, massage oils, laxatives, etc. Lubricants Lubricants for medical instruments and apparatus, filling and packaging machines in the food industry, and compressor cylinders in the beverages industry. White Oils Pharma

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Sasol Wax products are supplied world-wide into many different markets.

are also recommended as rayon oils and defoaming and glossing agents. Pharma 40 PB and 240 PB have US Department of Agriculture (NSF) H1 approval (Category H1/H2).

Nonfood Compounds Program Listed

Pharma 40 PB Pharma 240 PB

NSF Product ID: Reg # 139484 NSF Product ID: Reg # 139485

06 Pharmaceutical White Oils 07 Sasolwax for the Cosmetic and Pharmaceuticals Industry

MERKUR und VARA WOP*, paraffinic typical data 40 PB VARA 200

Colour Saybolt Density 15 C Density 20 C Viscosity 20 C Viscosity 20 C 40 C 100 C Flash Point COC, typ. Pour Point, typ. Sulphur Neutralisation number Carbon Distribution, typ. CA CN CP Ph. Eur., last edition (DAB), BP US Pharmacopoeia (USP) NF FDA 172.878 BFR 155 Information Odor and Taste Acidity or alkalinity, polycyclic aromatic hydrocarbons, readily carbonisable substances
1) with exception of Viscosity/Density * WOP: White Oil Pharmaceutical

06 kg/m3 kg/m3 mPa*s mm2/s mm2/s mm2/s C C % % % %

240 PB VARA 600

+30 860 880 865 230 max. 190 250 62.0 75.0 8.5 min. 220 -9 < 0.001 0 0 31 69

At a room temperature below 20 C, cloudiness of the product may occur but disappears again as the temperature increases. This does not constitute a quality defect.

+30 830 856 848 30 30 60 14.0 18.5 3.5 170 -12 < 0.001 0 0 35 65

x x x x none

x x x x none

Meets the test of pharmacopoeia indicated

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Sasolwax for the Cosmetic and Pharmaceuticals Industry
Hard Paraffin Waxes are mainly used in the formulation of lipsticks, creams, lotions and make-up. INCI name: Paraffin Soft Paraffin Waxes are used in the formulation of lipsticks, creams and lotions. Sasolwax 6050 is preferably used as an emollient to obtain the desired consistencies. Sasolwax 5217 and 4608 are raw materials for hot and cold depilatory products. INCI name: Paraffin Microcrystalline Waxes are used for the formulations of creams and lipsticks to adjust hardness/softness as well as solidification point. All microcrystalline waxes in this brochure conform to the COLIPA requirements for lip care products. INCI name: Microcrystalline Wax Genuine ozokerite was found in association with petroleum deposits, from which it was extracted by mining. Purified ozokerite is known as ceresin. To this day, cosmetic and pharmaceutical applications use white, purified ceresin. Today, however, ozokerites/ceresins are mixtures of various waxes with high solidification points and specific properties with regard to hardness, viscosity and penetration. Ozokerites/ ceresins are highly valued in creams and many other formulations because of their special oil binding properties.They also help to stabilize emulsions and regulate viscosity, bind powders or preparations containing powders, and help to give hair cosmetics antistatic and conditioning properties. INCI name: Ceresin Synthetic Waxes produced by the FischerTropsch process show a high molecular linearity and therefore low penetration values with high congealing points. Due to these properties they are used in formulations for hardness regulation. Powdered synthetic waxes with a particle size of 90% finer than 10 m and a topcut of 20 m are used for abrasion regulation in abrasive pastes (e. g. tooth paste). INCI name: Synthetic Wax
Sasolwax 5005 Sasolwax 5006 Sasolwax 5105 Sasolwax 5603 Sasolwax 5803 Sasolwax 6203 Sasolwax 4444 Sasolwax 4586 Sasolwax 4608 Sasolwax 5217 Sasolwax 6050 Sasolwax 6063 Sasolwax 9106 Sasolwax 0907 Sasolwax 1800 Sasolwax 3971 Sasolwax 7835 Sasolwax 6090 Sasolwax 6403 Sasolwax 6660 Sasolwax C80 Sasolwax H1 Sasolwax H105 Sasolwax SP30 Sasolwax SP105

Congealing Point C Hard Paraffin Wax typical data

50 53 50 52 52 54 50 58 58 60 62 65 46 50 47 49 46 48 52 54 59 61 44 47 50 52 83 94 70 80 70 75 70 80 64 69 63 66 67 70 78 83 96 100 102 108 96 100 102 108

Oil Content %

Penetration 25 C mm/10

Viscosity 100 C mm2/s

0.0 0.8 0.0 1.0 0.0 0.5 0.0 0.8 0.0 0.5 0.0 0.5 0.0 5.0 0.0 4.0 0.0 1.5 0.0 2.5 0.0 6.0 0.0 1.0 0.0 2.0 0.0 2.0 0.0 2.0 0.0 2.5

19 22 28 32 21 25 15 19 15 19 16 20 40 65 40 65 50 70 35 45 55 65 60 80 28 32 4 10 18 22 25 33 25 30 40 60 8.6 8.9 14.0 18.0 13.0 17.0 12.0 16.0 13.0 16.0 9.0 12.0 5.5 6.5 8.0 10.0 2.0 4.0 3.0 4.0 5.8 6.5 07 3.0 5.0 3.0 5.0 3.0 5.0 4.0 5.0 5.0 6.0 3.0 5.0

Soft Paraffin Wax typical data

Microcrystalline Wax typical data

Ozokerite/Ceresin typical data

0.0 0.5 0.75 1.5 0.0 0.75 16 20 15 18 07 01 01 01 01

Synthetic Wax typical data

Powder Wax typical data

08 GMP, ISO & HACCP certification 09 The latest technology safeguards quality

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The Sasol Wax difference GMP, ISO & HACCP certification
Sasol Wax supply first-class products offering many benefits for the user. Our
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poeia monographs and many other details, we have in particular laid down the highest standards for filling of petroleum jelly and white oils. Both product lines are filled in new installations, with high hygiene requirements and to some extent under protective atmosphere with filtered air in closed systems. This, combined with production in closed tank and pipeline systems, ensures that we reach a standard which has been given unrestricted approval* by the German Association of Research-Based Pharmaceutical Companies (VFA) under the Joint Audit Programme for Excipients (JAVfH).

products are available all over the world. Whats more, our technical expertise extends from Hamburg to all destinations, either directly or via our contacts and sales partners. Our production facilities and processes benefit from our constant efforts to improve and innovate. Our research and development are state of the art. We will be able to offer customerspecific solutions for your products. We are thoroughly familiar with the special requirements of the cosmetic industry and the pharmaceutical and food industries. We have committed ourselves to production and documentation in accordance with the basic GMP rules, and we therefore follow the Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients. In addition to the basic requirements such as 100% traceability of batches, comprehensive quality control having regard to pharmaco-

It goes without saying that our company maintains an integrated management system. We are certified under DIN EN ISO 9001 (quality), DIN EN ISO 14001 (environment) and OHSAS 18001 (occupational safety and health). For products used in the food industry, work has started on introducing an HACCP system (Hazard Analysis and Critical Control Point) in accordance with the Codex Alimentarius. * for non-sterile preparations

Our production facilities and processes benefit from our constant efforts to improve and innovate.

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The latest technology safeguards quality
In Chapter 8 we demonstrated the importance we attach to GMP, ISO and HACCP. This page gives you examples of how these requirements are implemented in our technology. The picture at bottom right shows one The picture at top left shows the filling system for pharmaceutical white and yellow petroleum jellies: a hermetically sealed system that works with filtered air under over-pressure. The closed drums are fed to the filling chamber through a first airlock, opened, filled by weight, closed again, then fed out via a second airlock. The batch is marked on the body of the drum by an inkjet printer. And all this takes place continuously and automatically. This is how we ensure the quality, hundred perof our three high-pressure hydrogenation units. The reactor works with a fixed-bed catalyst. All substances that have no place in our products are removed at high temperature under hydrogen over-pressure. High-pressure hydrogenation is the most important step in manufacturing products for use in cosmetics, foods and pharmaceutical preparations. Storage and transport take place in closed systems.
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cent traceability, and the stringent hygiene requirements ruling out dirt, microorganisms etc. Bottom left: Filling nozzle and drum opening on completion of filling.

High-pressure hydrogenation, bleaching, storage and filling our production facilities are in line with the latest technology and conform to the highest standards.

10 Matrix

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Matrix
Pharmaceutical Base Creams Food Machinery Lubrication Milking Grease/Fatty Creams Ethnic Haircare/Hair Relaxer Gum Base/Food Coatings/ Confectionery Dividing Agents Food Additives in relation to 21 CFR FDA

Fango Applications/Hand Baths/Thermal Therapy

Pharmaceutical Creams, Lotions, Salves, Pastes

Body Care/Skin Creams

Bath Oils and Baby Oils

Decorative Cosmetics/ Beauty Products

Hair Care and Styling

Pain-relieving Balms

Portofolio white petroleum jellies MERKUR 115 MERKUR 110 VARA 2600 VARA 5422 MERKUR 793 T MERKUR 791 MERKUR MERKUR 7941) 7731) MERKUR 546

MERKUR 774 10 Portfolio yellow petroleum jellies VARA CB Portfolio Pharm. White Oil MERKUR WOP 40 PB MERUKR WOP1) 240 PB MERKUR WOP 100 PB Portfolio Paraffin Wax Sasolwax 5006 Sasolwax 4444 Sasolwax 6063 Sasolwax 9106 Sasolwax 4586 Sasolwax 4608 Sasolwax 5105 Sasolwax 6203 Portfolio1) Microcrystalline Wax FDA/BFR Sasolwax 7835 Sasolwax 0907 Portfolio Synthetic Wax Sasolwax C80 Sasolwax H11) Portfolio Ozokerite/Ceresin

1) The products comply with the COLIPA recommendations for use in lip care products. 2) FDA 21 CFR/172,878 for pharmaceutical white oil; 172,886 for paraffin wax and micro wax; 172,880 for pharmaceutical yellow and white petroleum jellies. Always observe national and EU regulations.

Veterinary Products

Depilation Products

Medical Oil Baths

Insect Repellents

Pharmaceutical Eye Preparations

Body Lotions

Baby Care

Exfoliants

Cold Rubs

Lip Sticks

Lip Care

Sasol Wax Personal Care We invest in your future!

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With personal care, petroleum jelly, microcrystalline wax, paraffin wax, FT hard wax and paraffin oil (pharmaceutical white oil) are used in many different products of daily living.

Sasol Wax GmbH Birkenhead

Sasol Wax GmbH Hamburg Sasol Wax GmbH Linz Sasol Wax S.A.S. (France) Sasol Chemicals Shanghai (China)

Sasol Wax North America Corp.

Alexandria Wax Products Co. (Egypt)

Sasol Wax Sdn. Bhd. (Malaysia)

Sasol Wax (South Africa)

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Sasol Wax GmbH

Worthdamm 13-27 20457 Hamburg Germany Phone: +49 40 78 115-481 Fax: +49 40 78 115-495 personalcare@de.sasol.com www.sasolwax.com

This publication/data sheet and the information within were assembled and checked with utmost care and are to be regarded as accurate as of the date of issue. Nevertheless, Sasol Wax GmbH takes no responsibility or warrant for its timeliness, completeness, quality or correctness. This publication/data sheet is for information only and does not warrant any particular product properties. It is the users obligation to check the products and use them safely as well as to comply with all applicable laws and regulations. Sasol Wax GmbH shall not be responsible for any damage or injury in particular resulting from use, other than the stated use of the material, from any failure to abide to recommendations, or from any dangers inherent in the nature of the material. It is recommended to contact the manufacturer for further information, especially if it is intended to use the product for applications other than the stated. In addition, the most recent version of our General Business Conditions will apply. March 2012