Support_manual_edited

Support Manual for Indigenous Body Products

EDITED VERSION 1

Copyright ©Darwin Regional Indigenous Advancement & CDEP Incorporated T/A Aboriginal Bush Traders To the extent permitted by law, all rights are reserved and no part of this publication covered by copyright may be produced or copied in any form or by any means, except with the written permission of Aboriginal Bush Traders. Important Disclaimer Aboriginal Bush Traders shall not be responsible in any way to any persons relying in whole or in part on the contents of this booklet. To the extent permitted by law, Aboriginal Bush Traders excludes all liability to any person for any consequences, including but not limited to all losses, damages, costs, expenses and any other compensation arising directly or indirectly from using this publication (in part or in whole) and any information or material contained in it . This booklet was prepared by: Belinda Pilmore Product Development & Regulatory Affairs Institute of Personal Care Science PO Box 551, Blackwood, SA 5051 Phone: +61 8 8463 0990 Fax: +61 8 8278 6360 Email: [email protected] Website: www.personalcarescience.com.au

The production of this booklet was sponsored by the Northern Territory Government Acknowledgements Aboriginal Bush Traders would like to thank all Indigenous organisations and individuals who participated and contributed to the development of this booklet. For Further information please contact: [email protected] www.aboriginalbushtraders.com

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Preface The Australian cosmetics and personal care industry has a call for high quality cosmetic and personal care products. The Institute of Personal Care Science has been developed to support and exceed these quality standards and ever growing needs. Our training and services cover all areas of cosmetic and personal care development, marketing, formulation and regulatory affairs; and are kept up to date with industry innovations reflective of quality and consumer demands. At the Institute of Personal Care Science, our goals are to: • enhance the success of current and emerging cosmetic and personal care brands • advance the quality of cosmetic and personal care products • lead the field in distance education in the cosmetic and personal care industry • encourage the ethical content of cosmetic and personal care product promotions and consumer information • provide training in cosmetic and personal care science not currently available within Australia

This support manual has been developed to meet the specific needs of Aboriginal Bush Traders (ABT) and the types of products that are advised to be made under their current organisational and capability structure. The information contained in this publication is intended for general use to assist ABT knowledge and discussion and to help improve the development of basic personal care and cosmetic products. While reasonable care has been taken in preparing this publication to ensure that information is true and correct at the time of printing, The Institute of Personal Care Science can provide no guarantees as to the accuracy of this information as regulations change. It also relies on the common sense of the person executing manufacturing functions, due diligence and an Occupational Health and Safety approach to all processing methods mentioned herein. The Institute of Personal Care Science expressly disclaim all responsibility and liability to any person, arising directly or indirectly from any act or omission, or for any consequences of any such act or omission, made in reliance on the contents of this publication, whether or not caused by the Institute of Personal Care Science. This support manual may be reproduced in part or in whole by ABT to its interested parties to support the research, development and manufacture of personal care products and the personal care industry associated with ABT products.

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Table of Contents Item

Page

Preface

3

Part 1: Market Considerations of Product Development 1.

Positioning products

7

1.1

The marketing mix

7

1.2

SWOT analysis

8

1.3

Differentiated marketing

8

1.4

How to position your product

8

2.

Developing products

9

2.1

Identify organisational requirements

9

2.2

Identify product requirements

10

2.3

Combining product and organisational requirements

11

2.4

Current market trends

13

2.5

Pricing your product

14

3.

Patents

15

4.

Promotional techniques

16

4.1

Methods of promoting a product

16

4.2

Writing a press release

17

4.3

Potential marketing networks

18

Part 2: Basic Formulation Development 1.

Role within the formulation

20

2.

Basic ingredient functions

20

3.

Basic formulation considerations

24

3.1

Lipids

24

3.2

Essential oils

24

4.

Preparing herbal extracts

29

5.

Recording and storing your formulations

29

4

Appendix A: Properties of natural lipids

31

Appendix B: Overview of common essential oils

35

Appendix C: Product specification, formulation and method of manufacture template

43

Part 3: Regulatory Considerations 1.

Overview of personal care promotion in Australia

45

1.1

Definitions and products

45

1.2

Regulatory authorities and their jurisdiction

51

1.3

What is considered a promotional activity?

54

2.

Regulations pertaining to labels

55

2.1

Ingredients

57

2.2

Weights and measures

57

2.3

Other information

59

2.4

Exemptions

61

2.5

Label checklist for cosmetics

61

3.

Adapting text to suit compliance requirements

62

4.

Keeping up to date with changes

65

Appendix A: NCCTG Cosmetic Claims Guidelines

67

Part 4: Quality Control Considerations 1.

Microbiology and personal care

73

1.1

Microbial limits

74

1.2

Finished product testing

75

1.3

Raw material and finished product quality control

77

2.

Raw material microbiological control

78

2.1

Water

79

3.

GMP to limit microbiological burden

79

3.1

Facility and equipment

79

3.2

Cleaning and sanitizing

80

3.3

Hygiene and training

81

5

4.

Sanitisation and sterilisation

81

4.1

Cleaning methods for your facility

81

References

82

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Part 1: Market Considerations of Product Development 1. Positioning products ‘Positioning’ your product means to project an image of your product relative to competitor offerings. It incorporates the perceptions and values a consumer has of your product compared with other brands.

1.1 The marketing mix The four major elements that make up a marketing campaign for a product are its features (the Product), its Pricing, its Place of availability and how it is Promoted. Each of the four P’s has an influence on the success of the marketing campaign. The emphasis placed on each of the four P’s should be suited to each product and its target market. 1. product – marketing the product based on its features. Consider the following: o what are the features of this product? Does it have several? Does it have none? o are the features of this product its most outstanding offering? Or is it one of the other P’s? o are the features of your product too similar to a competitor product? What will make your product different, and stand out in the market place? 2. pricing – marketing the product based on its price. Consider the following: o is the price of the product low, moderate or high? o is the price competitive for the type of product it is? o how does the price of this product compare with other brands on the market? o does it represent value for money? 3. place of availability (distribution) – selling the product through the right distribution stream. Consider the following: o will you be selling this product locally (ie within your store only), nationally, or internationally? o how accessible will this product be? Is it available over the internet? o is the product suited to warm, cold or all climates? o is the geographic area densely populated or limited by population? 4. promotion – marketing the product through suitable advertising mediums. Consider the following: o are you communicating the right message to the right people? o have you considered all possible promotional streams? o are you communicating your message too far or too narrow? o have you provided an offer of some sort to entice consumers (eg try the latest or buy one get one free)?

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1.2 SWOT analysis A SWOT analysis involves analysing competitor products against your own, and determining the strengths, weaknesses, opportunities and threats unique to each product. When performing your SWOT analysis, always keep your target market in mind, and how the strengths, weaknesses, opportunities and threats apply specifically to your product and it’s consumer profile. • strengths – this is what your product does well; and better than your competitors. For example, your product may compare similarly to another product on its price and place of availability; but yours may have a unique ingredient in it that your competitor doesn’t. This would be the strength of your product. • weaknesses – this is what your product does not do that well; or as well as your competitors. For example, your product may not be as readily available as a competitor product; or it may not smell as nice. • opportunities – these are the opportunities that your product has within the market place. For example, if your product is in demand and the first of its kind in the market palce, it will have a unique opportunity until competitors can follow suit. Consider also the opportunities of your competitor, and see how these could apply to your product and/or how you could focus on opportunities unique to your product. • threats – these are the threats that challenge your product in the market place. Consider economics and the environment, as well as other external influences that may affect the chances of a products success. Consider also the threats of your competitor, and how you can avoid such threats to your own product.

1.3 Differentiated marketing Identify and promote the key points of difference of your product. Whatever it is that makes it different to everything else on the shelf will make it stand out to your consumer. Make sure the differences are communicated effectively through clever advertising so your consumer actively wants to purchase your brand over another. Differentiated marketing can be applied to every product in your range. What makes your balm unique, and why would your consumer want to use it? What about your soap? Differentiated marketing can enable you to promote each product or group of products to a specific target market.

1.4 How to position your product You have by now recognised various features that differentiate your product and considered the product’s marketing mix. So how do you turn this information into a positive position for your product? 1. List the product’s competitive advantages 2. Determine which competitive advantages are going to suit your target market, product and company the best You don’t want to promote too many advantages or too broad a message for your product otherwise the message could be confusing and lost on the consumer. Be careful not to promote too few advantages, or too narrow a range of advantages, otherwise consumers may not realize how the product could benefit

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them. How many competitive advantages are just right? This does depend on the product, but as a general guide aim for three to five specific competitive advantages for your product. These advantages could be one primary competitive advantage and two or three secondary advantages. For example, a product could be promoted fore most as containing a unique anti-aging ingredient; but could also promote the natural extracts it contains, gentle-on-the-skin formula, competitive pricing and availability from various stores. While the four secondary advantages may not make the product that different on their own, the use of the unique anti-aging ingredient in combination with its natural image, gentleness, pricing strategy and ease of purchase together provide the product with a unique story and position. 3. Communicate these competitive advantages through the appropriate advertising media Now that you have decided which competitive advantages to promote, and the story of the product, you need to determine the appropriate way to communicate these advantages to your target market. Consider the marketing mix you want to use and also the funding you have to back up any promotional activities. The point here is to make sure your communication strategy matches the position of your product and other elements of the marketing mix.

2. Developing products The development of new products is crucial for the growth and ongoing success of a brand. With every new product, there must be substantial background research to determine what the product should look, smell, feel and perform like. It is also essential to work on the promotional claims, to provide a unique selling point of the product from competitor offerings; to ensure a successful launch into the market place. All of these aspects form part of the new product development process.

2.1 Identify organisational requirements A company has its position in the market place based on the types of products it offers. You will not find any products within the one brand that diversify too greatly – all products in the range will carry a similar theme or message. For example, a company may build its product philosophy, and therefore it’s entire product range, on being SLS, PEG and paraben free. For this company, any new product development would have to meet the criteria of avoiding these ingredients. Note, however, that there are several companies who have this same philosophy; so identifying organisational requirements can enable you to identify what other philosophies your company should adopt in order to be unique and successful in the market place. Organisation requirements can include not only the company’s current position, but also its future directions. Product development can be used to manipulate and change a company’s image. Consider the following elements of a company, which therefore affects how its products are defined: • profile: • what is the profile of your company? Who is its target market? What is the age group and socio-economic status of the majority of its consumers? Is this a profitable target market to capture, or is there a more profitable segment you could develop new and existing products to suit better? • determine the strengths, weaknesses, opportunities and threats of your company to recognise what elements of its profile are best promoted, and what elements should be strengthened. • who are the major competitors to your company? What is their profile and marketing

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message? How does your company, and product offerings, differ to theirs? • does your company profile currently cover too wide a scope to be effective? Should its profile be refined through future developments? • philosophy: • what is the philosophy of your company? Is its philosophy based around the use of, or avoidance of, certain ingredients? Is it technology based, natural based or a combination of both? • is your company leading its field by constantly coming up with revolutionary products, or following the leaders with similar products? • do your products have a unique difference to others in the market place? • is your company currently changing its philosophy and image to find its niche in the market place? Where does it hope to align itself within the market? • size and coverage: • how large is your company? Is it able to take on the challenge of competing against major brands? Or is it small and requires a really unique position to stand out in the market place? • does your company have the finance and staff to invest necessary funds into constant new developments? • is there a large scope for expanding the range and coverage of the company? What are its limitations in doing so? How can product development overcome these limitations?

2.2 Identify product requirements By identifying product requirements, you will be able to recognise what is going to make the product unique in the market place at the very early stages of product development, and how you can convey this information to your formulator. Careful consideration of the product requirements may also help you identify where a product needs a more unique message, which can be built upon when discussing the product with the formulator. The requirements of developing a new, or re-developing an existing product can include: • exact purpose of the product: • what is the exact purpose of the product? For example, is it a body lotion to moisturise the skin, or firm it? Is it a foaming gel to cleanse the skin, or exfoliate it? • how different does this purpose make the product from competitor brands in the market place? For instance, if it is a body wash, does it have a hydrating or other effect? Is it a creamy cleanser instead of a foaming cleanser? • if its purpose is the same as others on the market, have you considered what other aspects, such as performance characteristics, will make it unique? • use by a target market: • have you adequately captured the needs of your target market? Or do you need to develop

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products or make changes to existing products to better suit their needs? • are you developing products to fill gaps in the market place? • are you trying to capture a new target market by varying a product or developing a new product range? • have your methods in developing this product adequately considered the needs of your target market? Is it a product they are likely to want and use? Are you being too broad in your developmental approach? • what does your target market actually want right now? Will you be able to deliver the product to the market in a timely fashion, to beat a competitors response to market needs? • performance characteristics: • what are the specific performance characteristics of this product? Have you given specific parameters? How moisturising is ‘moisturising’? How clean is ‘clean’? • is the product specific to certain groups of people within your target market? For example, is the product a cleanser for oily, normal or dry skin? • how should the product feel and perform on the skin? Should it be light and easy to apply, or have a heavier feel for longer lasting hydration? • what aesthetic characteristics need to be considered? For example, should the fragrance be short or long lasting? Light or concentrated? How should it look in the container? Should the product be viscous or a mobile liquid? • should the consumer expect immediate results, or will they need to use the product repeatedly and look for results over days or weeks?

2.3 Combining product and organisational requirements After considering your company’s requirements for a product, and the needs of the product, combine these two requirements to clearly define the product you want to develop. Consider the following aspects: • how does the product relate to the company and it’s philosophies? • consider you have determined that a product should be a skin firming moisturiser with self tanning agent. Your company philosophy states that where possible, your products use natural or naturally derived ingredients. Combining these two aspects, you can now define your product as a skin firming moisturiser using plant extracts to achieve its skin firming effect; with the most natural self tanning agent possible. • product name: • how would a consumer instantly recognise the purpose of a product, and your company’s philosophy, if presented with just its name in the market place? • can you combine the philosophy of your company and the characteristics of the product into a simple name? For example, ‘Plantceuticals Firming Body Lotion’ informs the consumer the product contains plant-derived ingredients in a firming body lotion. • if the product name can’t achieve both philosophy and purpose in its name, aim for at least

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one or the other. • pricing strategy: • how does the size of your company, it’s profile and the target market of the product impact on the possible price of a product? • is your company able to place large orders to get the cost of the product down, or does its small ordering capacity mean products need to be more moderately, or higher priced? Does the target market for the product match this pricing strategy? Can the product be developed and delivered at the right price for the target market and company profile? • packaging design: • is the packaging suitable for the product, and does it match your company’s profile and philosophy? For example, glass jars may look very classy, but are they the best choice if your company is exporting? Is your company philosophy based on natural preservatives, in which case open mouth jars are not the best choice to maintain the integrity of your product? • does your company promote a natural image and then use non-recyclable packaging? The philosophy and the product in this case do not match! • is your company large enough to develop its own unique packaging or does it need to use packaging that is more generic? How will it make such packaging unique to the company profile and attractive to its target market? • opportunities and threats: • what opportunities does your company philosophy provide? For example, if your company philosophy is to lead via technology combined with plant science, there are multiple opportunities for your company to incorporate a variety of revolutionary ingredients into their products. • what threats or limitations does your company philosophy create? For example, if your company philosophy is certified organic products, it can limit the choice of ingredients that can be used in your products, as well as how those products can be formulated and packaged. It may mean your company can never launch a particularly popular product because in doing so, it would need to stray from its certified organic philosophy. • what role do socio-economic factors play in the possible development of new products? For example, how will the Australian water crisis impact on your company’s development of bath and spa products? • positioning compared to competitors: • what makes your company different to competitors? What makes your products different to competitors? How can the product encompass your company philosophy and tell this unique story to consumers? For example, if your company uses natural and organic ingredients where possible, but also incorporates technology based ingredients for the best possible results, how does this define the product you want to develop? • target market: • the target market for your company and your product should be the same. How does your

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company philosophy, and the product you want to develop, meet the needs of your target market? • are you looking to redefine your target market by redeveloping products to suit? If so, have you aligned your new company philosophy and target market to match? • distribution channels: • do the distribution channels you have selected for the product suit the product and your company requirements? Do they suit your target market and other aspects of the product and your company size and coverage? • do you need to rethink your distribution channels and/or develop products to specifically suit the needs of different distribution channels?

2.4 Current market trends The three big trends in personal care products that have emerged since the Global Financial Crisis (GFC) are:

1. Science + beauty: • products in this category have been able to maintain a higher price tag where their innovation is related to scientific claims and/or technology during development • to succeed in this category, products must have real points of difference from competitor offerings; utilise excipients with marketable stories and/or utilise delivery systems; and have clinical studies and data to support their use



2. Green and sustainable products: • products in this category must be environmentally aware and good for the planet • consumers tend to believe products in this category are safer simply because they are more natural • to succeed in this category, products must be natural with no synthetic chemicals added; fair trade; preserve nature and ecological systems; and have an ethical story to tell 3. Minimalist products: • products in this category are very low priced and suit the budget conscious consumer • covers mostly commodity items such as every day personal care and basic hygiene eg body wash, shampoo and conditioner (non-professional), deodorant etc • to succeed in this category, products must be cheap and readily accessible to the mainstream consumer; functional performance only expected

Before developing products, you should consider how these trends impact on your product offerings, source of promotion, distribution and product ‘story’ you intend to create. Never forget your competitors – they are in the same market space and if they are using the same trend category as you, you need to be able to compete through at least one of the following: product, price, place or promotion. If you cannot do this, your brand will not succeed.

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2.5 Pricing your product In order to determine the price your product should sell for, you need to conduct a market analysis for that product, compared to your key competitors, using that same method of distribution. For example, if you are selling product through pharmacies, you should identify who your key competitors are through the pharmacy chain, and determine how your pricing structure should sit compared to theirs. If selling through a market stall, you should identify your key competitors at the market or through more budget offerings, and determine how your pricing structure should sit compared to theirs. Once you have determined the recommended retail price for your product, you then need to work backwards to determine how much the product can cost you to manufacture (including labour and packaging); which will depend on how much profit you want to make (in the early stages of a business, most, if not all, of this profit would go back into developing the business), payments you need to make to distributors, and company overheads. For example, for a product to sell for $10.00: • ex GST this product would be (divide the RR by 11 and multiply by 10): $9.09 • less distributor mark up; this would be your wholesale price (allow 40%; divide the ex GST price by 1.4): $6.49 • less profit margin (allow 35%; divide the wholesale price by 1.35): $4.81 This means your product can cost you $4.81 – but this price must include: • overheads • labour/manufacture • packaging • promotions • raw materials For the purposes of this example, let’s allow: • 50% for overheads; • 50c for packaging; • 50c for promotions This would then leave you with $1.41 to cover the costs of labour and raw materials. This does assume that based on your sales, 50% of the cost price will be sufficient to cover your overheads, that you can get suitable packaging for 50c and that your overall promotional budget is covered within that 50c allowance. As you can imagine, these costs are extremely tight and limiting for brands with a small value of sales. To calculate your raw material costs: • calculate the cost of the raw material in kg – note that volume and kg do not equate in a 1:1 ratio; particularly for oils. You should factor in an allowance of 0.85 for the weight of oils (ie 1 litre of oil will weigh approximately 850g). This means that if 1 litre of oil costs you $10, then it actually costs $11.77/kg. You need to use this price in your calculations.

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• total the costs of the raw materials by % weight in the formulation to get a total product cost. • multiply this total raw material cost by 1.1 to allow for wastage and residual product left in containers that would be thrown away. • this will give you a workable raw material price. To calculate your labour costs: • multiply the number of people doing the job by the number of hours they took to do the job; this includes all aspects of the job including dispensing raw materials, manufacturing/ mixing (compounding), filling packaging, labeling, secondary and tertiary packaging ready for delivery. • multiply the total ‘human hours’ by $25/hr – even if this is not their full pay rate, it covers added extras like super, leave allowance etc; and allows a ‘buffer’ for labour costs where jobs run over time. • divide this total labour cost by the number of units created by the job – this will give you a per unit cost for the labour component. Then, add the raw material price per unit and the labour cost per unit to determine the product cost for labour and raw materials. Using the example above, this would need to come in at $1.41 to ensure your product is within budget. Where the product does not come within the required budget, you will need to consider the following ways to reduce price: • use cheaper raw materials • use less of the more expensive raw materials • improve your manufacturing methods to reduce staff time You could also consider less expensive packaging or promotions to enable you to spend more on the product. Getting the price right for your market is essential to have a successful product. If you pitch the wrong kind of product with the wrong promotion and/or price to the wrong group of consumers, the product simply won’t sell. Based on market trends, consumers are savvier than ever with their spending and will only pay what they believe a product to be worth, regardless of how much it cost you to produce.

3. Patents A patent is ‘a right granted for any device, substance, method or process which is new, inventive and useful.’ (IP Australia webitse). Basically a patent, in the context of personal care products, applies where ingredients have been put together in a new and innovative way to yield surprising results. A patent can be applied for where new technology has been invented that would lead to a product, composition or process with significant long term commercial gain. So you can not patent a standard moisturiser and combination of ingredients present in the emulsion; but if it is a new and inventive way of putting together the emulsion, then it may be patentable.

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In many cases, and for many ‘standard’ formulations, patents are not applicable; however cases where patents may apply and you may not be aware of them, include new uses for traditional extracts; but trying to patent a extract based on its traditional uses would not be successful. If you sell or discuss a product using the technology before you file a patent application, you may also not be able to patent it later. If you need to discuss the technology with anyone, ensure confidentiality agreements are in place before discussions commence. Without a confidentiality agreement in place, you will then be relying on the rules associated with grace periods to enable you to patent the concept later; and these may not be applicable in your circumstances. Where patents do apply, they provide protection and control over an invention in one of two ways: • standard patents apply for up to 20 years although annual maintenance fees apply from the 5th year onward. • standard patents can be a costly and lengthy process. The standard patent process can take up to 4 years from the date of filing to when full protection is in place. • innovation patents last a maximum of 8 years. • innovation patents cover innovations rather than inventions. • innovation patents can be applied for and put in place quite rapidly compared to standard patents – in some cases within a month. • innovation patents can help you be the first to the market place with an innovation. They are also especially suited to the rapid changes seen in the personal care industry; where innovations are rapidly changing in response to consumer demands. • you are not able to protect an innovation patent unless it has been examined and certified; after which time it will have the same protection as a standard patent. In essence, applying for an innovation patent does not instantly give you full patent protection. Further examination and certification is required to ensure full patent protection. IP Australia is the Federal Government organisation in charge of patents; you can find detailed information on their website: www.ipaustralia.gov.au under the patents section. If you are considering patenting a process or product; or need to check if patents currently apply to a process or product, it is strongly recommended that you seek the advice of a patent attorney (or similar) before proceeding with the process. Not consulting appropriate legal advice in the early stages of using or patenting a new process could affect the marketability of a product later on.

4. Promotional techniques A product cannot be known without promoting it. Promotional techniques encompass the methods used to promote a product, as well as the media used to increase awareness of the product, to a larger audience. Simply stated, the more people that know about your product and are influenced to purchase it using minimum effort and cost, the more successful your product will be in the market place.

4.1 Methods of promoting a product Promotional methods are used to influence the purchasing behaviour of consumers through various forms:

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personal selling – where a representative of the company presents and sells a product direct to a consumer. This is the most costly form of promotion because of the labour involvement. advertising – where the company promotes its products to the public at large; with the focus on trying to attract and influence as many consumers from the target market as possible. While usually an expensive exercise initially, the cost per product is usually much lower than personal selling because one advertisement can communicate effectively to thousands of people; while one representative can usually only effectively present to one or a few people at a time. sales promotion – used as an adjunct to advertising and personal selling, sales promotion includes activities used to support other promotional techniques. Sales promotion includes contests, trade shows, point-of-sale displays, product samples and discount offers. publicity – an unpaid form of advertising, publicity is most commonly seen in the form of editorials or write-ups. Companies provide the promotional material to be used in the publicity in the form of news releases, editorials and demonstrations. Publicity is one of the best forms of advertising because it does not cost the company anything; yet has the capacity to generate substantial interest in a product. It involves the use of special interest news stories, generated to inform consumers of interesting events or products that are entering the marketplace. This form of promotion can be very effective where you have a unique and interesting story to tell. It will require contacting media personalities and selling the story so they want to run it as a feature.

The methods best recommended to ABT include: • market stall/ABT direct sales: • publicity • personal selling • pharmacies/salons/specialty stores: • publicity • personal selling • advertising Make sure any form of promotion you use quickly and clearly identifies the key points of difference for your product – consumers have a very short attention span and must be lured to purchase before distractions or doubts prevent the sales process from occurring.

4.2 Writing a press release A press release is information provided to the media to entice them to interview you and run a longer story. The press release you send to the journalist should follow a set format, and include the information outlined below: 1. Your ‘hook’ – this should attract attention and could also be used in your email or fax cover letter to get noticed by the journalist. Remember they are bombarded with mediocre stories constantly, so your hook needs to get them interested in your story to read more.

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2. A strong, catchy headline – avoid the, a and an. 3. Two concise paragraphs outlining the subject matter – these should answer who, what, when, where, why and how type questions and be limited to two paragraphs. 4. A third paragraph which elaborates on the story a little but without waffle – be concise and use actual examples rather than generalizations. 5. One or two quotes from your spokesperson – these may be used in the article so make sure they are catchy but true. 6. A second quote from a 3rd party is best included next – this should support the basis of the article and serves as a testimonial. 7. Contact and interview details – these should be clear and provide the who and how to contact for more information. 8. Critical aspects of your organisation – this should be written in the form of a mini corporate profile at the end of every media release. This should cover your organisations core values, when and why it was founded, whom it represents and website address. The whole press release should be no longer than 1 page or 400 words. Make sure the message is simple but catchy, and is something the journalist wants to find out more about. Before sending your press release, make sure you contact the journalist first with the hook and 2-3 key points of your story. You will need to be extremely quick on the phone and be able to peak their interest. As soon as they take the hook, ask them if you can send them more information and let your press release tell the rest of the story. Be careful of approaching too many journalists with the same story at any one time – start with the one you would most like to pick up the story and if they don’t, you can then send it to others, but still contact only 1-2 at a time.

4.3 Potential marketing networks When selecting your marketing network, you will need to make sure you speak to the right journalists at each type of network/publication for them to be interested in your story. Speak first with those reporters who have already run stories on your organisation or review the different networks/publications for journalists who have featured articles on organisations similar to your own. Magazines and newspapers also have specific sections with different journalists writing for each section, which can also influence their decision whether to run with your story or not. Making sure you have a constant media presence is one of the best keys to successfully promoting your brand without having to advertise. However, you will need to make sure you keep the stories interesting and don’t hound the one journalist from the one source constantly. It is ideal if you can spread your different stories around different media sources, to ensure you appear in at least one network or publication every month. Before heading too far down the PR path, make sure you have distribution channels set up and ready to go – there is no point promoting your product if people can’t get it from anywhere! The following is a non-exhaustive list of potential marketing networks you could go to, to boost the profile of ABT products: • Darwin and Alice Springs news

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• Other state and National Newspapers (eg The Australian) – you should be selling in the local state of the paper or provide an 1800 number or website where they can place orders to make sure you don’t miss out on potential purchases • Current affairs programs – you should be selling in the local state of the paper or provide an 1800 number or website where they can place orders to make sure you don’t miss out on potential purchases • News programs • Qantas, Jetstar and Virgin Blue in-flight magazines; as well as International Flights to Darwin magazines • Tourist magazines and brochures that are located in hotel rooms

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Part 2: Basic Formulation Development 1. Role within the formulation Each ingredient has a specific role to play within a formulation. The four main categories are: functional ingredients – these ingredients are selected by the product type. For example, to make a shampoo, you need to use cleansing agents, classified as surfactants. The product may contain more than one functional ingredient, and may also include secondary functional ingredients to serve a secondary purpose. structural ingredients – provide the structure for the product. Continuing with the shampoo example, structural ingredients such as viscosity increasing agents may be added to increase the ‘thickness’ of the product and help create the impression it is more concentrated and effective. supportive ingredients – added to improve the stability and shelf life of the product. In order to maintain the integrity of your shampoo, you will need to add preservatives and may choose to add a chelating agent to improve suitability in hard water conditions. added extras – these ingredients, usually added in small amounts, have no functional, structural or supportive role in the product but add to consumer acceptance. For instance, the smell and colour of your shampoo.

2. Basic ingredient functions The International Cosmetic Ingredient Dictionary and Handbook lists over 70 different functions for ingredients found in personal care products today. We will consider the more commonly used ones here. abrasives – used to remove skin cells or plaque from teeth, these functional ingredients are commonly found in body scrub/exfoliating products and toothpastes. Common abrasives, by product types, include: • body exfoliants – Avena sativa (oat) kernel meal, Juglans regia (walnut) shell powder, hydrogenated jojoba wax. • toothpaste abrasives – silica, sodium bicarbonate. antioxidants – used in products to reduce oxidation or rancidity from occurring over time. These supportive ingredients not only help lengthen the shelf life of the product, but may also be marketed as nurturing for the skin. Common vitamin and plant extract antioxidants include: • vitamin –tocopherol (vitamin E). • plant extracts – Camellia sinensis leaf extract (green tea extract), Rosmarinus officinalis (rosemary) leaf extract, Vitis vinifera (grape) seed extract. cosmetic astringents – commonly used in skin toners, cosmetic astringents induce a tightening and toning effect on the skin. They are also used in aftershave lotions. Common examples of these functional ingredients include: • alcohol, Hamamelis virginiana (witch hazel) extract.

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emulsion stabilisers – emulsions are the white, creamy complexes formed when oil and water are mixed; such as body lotions and skin creams. Emulsion stabilisers do not form the emulsion, but help improve the stability of emulsions once formed, preventing it from separating out into separate oil and water phases. These supportive ingredients can be either derived from natural sources, or composed of synthetic materials; and may also be thickening agents. Common examples include: • derived from nature – cellulose gum, hydroxyethyl cellulose, xanthan gum. exfoliants – exfoliants help remove dead skin cell layers by dissolving the intracellular ‘cement’ holding surface skin cells together. Chemical exfoliants are functional ingredients and usually found in skin whitening or skin peel products, in the presence of a low pH. Common exfoliants include: • glycolic acid, lactic acid, salicylic acid. hair conditioning agents – used to condition the hair, these functional ingredients also improve the appearance, gloss and shine of hair while facilitating styling and reducing static of the hair. They can also be used to improve the texture of hair that has been dried through styling, chemical exposure or environmental drying. Hair conditioning agents can be synthetically made or derived from and/or complexed with natural ingredients. Common examples include: • derived from nature – guar hydroxypropyltrimonium chloride, hydrolysed silk. pH adjusters – used to adjust the pH of the finished product to a desired range, these supportive ingredients are also commonly referred to as acids (lower the pH) or bases (raise the pH). Common examples include: • acids – citric acid, lactic acid. • bases – potassium hydroxide, sodium hydroxide. preservatives – used to prevent or retard microbial growth, preservatives are supportive ingredients. A lot of misinformation exists about the natural status of some preservatives; so it is best to check any claims you wish to make with the raw material supplier by asking them for a statement of natural or synthetic origin for the preservative in question. Preservatives must be used in products containing water; and must be effective against bacteria, yeast and mould. The recommended preservatives for ABT include: • Mikrokill ECT (trade name): • INCI name: benzyl alcohol, salicylic acid, glycerin, sorbic acid • effective for pH range: 3.0 – 8.0 • temperature: stable in heat • incompatibilities: n/a • use: 1.0% • considered naturally derived and nature identical Euxyl K712 (trade name): • INCI name: aqua (water), sodium benzoate, potassium sorbate • effective for pH range: <5.5

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• temperature: <80°C (max 4 hrs) • incompatibilities: n/a • use: 0.5 – 1.5% • considered nature identical skin conditioning agents – one of the two biggest categories in cosmetic chemistry, skin conditioning agents are functional ingredients that can be broken into the following categories: • emollients – used to impart softness to the skin by remaining on or in the upper layers of the skin, reducing flaking and improving the appearance of smoothness. They include ingredients of: • derived from nature - cocoglycerides, esters, lipids humectants – retard moisture loss by holding water within the surface layers of the skin and drawing in moisture from the surrounding air. Humectants can also have a supportive role in helping retard moisture loss from the finished product. Common examples include: • glycerin and sodium hyaluronate. miscellaneous – with the many specialty ingredients available today, there is seemingly endless choices when it comes to skin conditioning agents. These are grouped together under the heading of ‘miscellaneous’ and include various plant extracts, algae extracts, dimethicone complexes and hydrolyzed proteins. occlusive – these agents block the evaporation of water from the surface of the skin, keeping it moist and increasing its water content. They include ingredients of: • natural - Butyrospermum parkii (shea butter), Simmondsia chinensis (jojoba) seed oil. • derived from nature - caprylic/capric triglyceride. solvents – liquids used to dissolve constituents or act as carriers in cosmetic and personal care products. Solvents are predominantly classified as structural ingredients but may serve a functional role as well. Common examples are: • water, alcohol, glycerin. surfactants – the biggest category in cosmetic chemistry, surfactants are functional ingredients also known as surface-active agents because of their ability to modify the surface of a substance. They can be broken into the following categories: cleansing agents – cleansing surfactants are able to produce a foam and clean the surface of the skin and hair. They can be synthetic in origin or derived from natural sources. Common cleansing agents include: • derived from nature - cocamidopropyl betaine, decyl glucoside, sodium lauryl sulfate, sodium methyl cocoyl taurate. emulsifying agents – used to mix the oil and water phases in an emulsion, these functional ingredients enable creams and lotions to be made. They are predominantly derived from natural sources. Common examples include:

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• cetearyl alcohol, stearic acid. solubilisers – used to solubilise a substance that is normally insoluble in a continuous medium. A common example of this is face toners or room fresheners, where a fragrance oil is solubilised in an aqueous (water) base. Solubilisers enable the oil phase to be homogenously dispersed in the aqueous base, and prevent an oil layer from forming at the top of the finished product. Common examples include: • natpuresol (glycerin, sucrose laurate, sucrose dilaurate, sucrose trilaurate, sorbitol); natisol (cocoyl proline).

viscosity increasing agents – aqueous – structural ingredients used to thicken the water soluble components of a personal care formulation. Common viscosity increasing agents – aqueous include: • natural – agar, xanthan gum, Zea mays (corn) starch. • derived from nature – guar hydroxypropyltrimonium chloride, hydroxyethylcellulose, potato starch modified. viscosity increasing agents – nonaqueous – structural ingredients used to thicken the oil soluble components of a personal care formulation, they can be natural. Common viscosity increasing agents – nonaqueous include: • natural – beeswax, Euphorbia cerifera (candelilla) wax. • derived from natural sources – corn starch modified, ethylcellulose.

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3. Basic formulation considerations 3.1 Lipids Most of the formulas you create will be oil based. In cosmetic chemistry, oils, fats and waxes are referred to as ‘lipids’. In formulas, lipids serve as functional ingredients with an emollient and/or occlusive action. They are used to: • increase the lipid content of the skin • provide spreadability and ‘feel’ of a formulation • provide an occlusive barrier to reduce transepidermal water loss through natural evaporation • increase or adjust the viscosity of a product • improve or adjust the consumer’s perception of a product • provide the lasting ‘moisturising’ benefits of serums and balms • provide a marketing tool for the product ‘story’ Different lipids will have different impacts on the performance of a formula and its marketing story, but must also be selected based on their cost. These form the three key considerations for lipid selection: sensory benefits, marketing benefits and price. Lighter feeling formulas need lighter oils; while heavier feeling formulas will benefit from heavier feeling oils. Body and lip balms need waxes to set hard; however a combination of liquid oils will be required to obtain the right substantive benefits and consistency. Jojoba oil is the only natural oil that will not oxidize – this is because it is actually a wax ester, and chemically not quite the same as an oil. Other oils have varying oxidative tendencies; their use should be limited and/or relative proportions of antioxidants should be used in the formulation to protect against rancidity. Oils that have relative stability, and show little rancidity over time, include coconut, castor oil and jojoba oil. Other oils, in decreasing order of stability, will show oxidation over time: safflower, apricot kernel, almond, avocado, wheat germ, canola, sunflower, grapeseed, borage, evening primrose oil. Any formulation that contains oils must contain antioxidants. If you are using oils with susceptibility to oxidize over time, you will need to use a greater quantity of antioxidant than when formulating with those that do not. You will need to use 0.5 – 2.0% of an antioxidant, like tocopherol (vitamin E) in formulas containing oils. Appendix A lists the properties of a variety of natural lipids.

3.2 Essential oils Essential oils are used for their tangible and intangible benefits. • tangible benefits: can add to the positive experience or enjoyment of using the product; covers body odours; leaves a lasting, desired aroma; leaves a subtle, fresh smell; provides some performance benefits to the product • intangible benefits: adds to the perception of the product; can evoke emotions or feeling within a person

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Essential oils can also be used to help brand a product range by grouping the products or having a signature smell or story associated with their use. Essential oil blends should contain: • Top notes: 20 – 30% • Middle notes: 40 – 80% • Base notes: 10 – 25% Below is a table showing which oils have particular notes for easy reference.

Top Notes

Middle Notes

Base Notes

Bergamot

Chamomile, German

Carrot seed

Clove

Cardamom

Cedarwood

Cinnamon

Eucalyptus

Cistus

Grapefruit

Geranium

Clary sage

Lemon

Ginger

Frankincense

Lemongrass

Lavender

Myrrh

Lemon myrtle

Marjoram, sweet

Patchouli

Lime

Palmarosa

Peru balsam

Mandarin

Pine

Sandalwood, Australian

Neroli

Rosemary

Sandalwood, East Indian

Petitgrain

Rosewood

Spikenard

Orange, sweet

Tea tree

Vetiver

Peppermint

Ylang ylang

Thyme Table 1: Top, middle and base notes of common essential oils Appendix B provides an overview of common essential oils.

3.2.1 Blending by aroma type Limit your blending to the use of 3-5 essential oils, to avoid notes becoming confused or incompatible. When blending by aroma, use the following guide: floral oils: • use extenders for more expensive oils. • suitable with woody, fruit, sweet and musty oils. • may not be suitable with some herbaceous oils.

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• not suitable with camphorous oils. fruity oils: • suitable with most oils except woody and camphorous oils. green oils: • suitable with most oils when used in small amounts. herbaceous oils: • suitable with camphorous and woody oils. • not suitable with most florals. camphorous oils: • suitable with herbaceous and woody oils. • not suitable with floral and fruity oils. spicy oils: • use only in small amounts with care; they may or may not be suitable with the blend in any amount. woody oils: • can be used in just about any blend. earthy oils: • suitable in most blends up to 10%.

Essential oils: • imported products will need to comply with NICNAS requirements • must be checked for compliance with the poisons schedule (SUSDP) • to check the SUSDP: • go to: http://www.frli.gov.au/ComLaw/Legislation/LegislativeInstrument1.nsf/0/2F53B6114CD64CE 5CA25778B007CC7B0/$file/PoisonsStandard2010SUSMP1FRLIforregistration.pdf • using the search bar at the top of your page, or by pressing CTRL and F, enter the botanical name for the plant you are investigating • if that search does not reveal anything, enter the common name • you may need to use shortened versions of the name (either botanical or common) to enable the most comprehensive search • if a search does not show the plant, there are no restrictions. You should still make sure the plant is safe for use, particularly if it is a new or novel extraction method

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• if a search does show the plant, review the restrictions and limits of use. You can only use plants scheduled by S5 or S6; and only where the correct warnings are used in relation to that plant. You can not use substances listed as S2, S3, S4 or S8 in cosmetic or personal care products • some citrus oils are phototoxic. This means their inclusion should be limited otherwise the warning “Application to the skin may increase sensitive to sunlight” is required. This includes: • bergamot oil (except those that are bergaptene free) – used in leave on products > 0.4% • bitter orange oil – used in leave on products > 1.4% • lemon oil – used in leave on products > 0.05% • lime oil – used in leave on products > 0.5% other oils with limits include: • eucalyptus – restrictions exist for products containing >25% eucalyptus oil • melaleuca oil – restrictions exist for products containing >25% melaleuca oil

In addition: • essential oils can not be used to make insecticide claims unless the product is registered with the Australian Pesticides and Veterinary Medicines Authority (APVMA). • even though essential oils can be used in high concentrations for therapeutic uses, it is important to remember that cosmetic products can not make therapeutic claims.

This list should not be considered exhaustive; and searches should be conducted to ensure safety of your product for all plant materials.

3.2.2 Usage rates In order to maintain safety, yet provide an aroma of intensity which consumers are used to, fragrances and essential oils should be used in products within set amounts. A typical guideline is: • face products – up to 0.5% essential oils. • body products – up to 1.5% essential oils. • wash off products – up to 1.8% essential oils. • around the eyes and mucous membranes – up to 0.3% essential oils. • baby products – up to 0.3% essential oils. • other products - deodorants and sunscreens may require dosing to cover undesirable smells, and hence a greater concentration of fragrance and essential oils may be used, (up to 2-3%). In combination with the irritancy profile of these products and exposure to sunlight, safety evaluation is essential.

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3.2.3 Essential oils and pregnancy In general, it is best to avoid the following classes of essential oils in a product intended for pregnant women:

Effect

Action

Oils

Oestrogenic agents

Enhances the action of oestrogen

Aniseed and fennel

Emmenagogue agents

Used to induce a period in a non-pregnant woman

Cedarwood, clary sage, cypress, peppermint, rosemary, rose and sweet marjoram

Teratogenic agents

May injure or cause malformation to the foetus

Wormwood and sage

Abortifacient agents

May cause spontaneous abortion

Mugwort, parsley seed, pennyroyal, rue, thuja, tansy and wormwood

Note: this table is not intended to be exhaustive and the use of any essential oils during pregnancy should be evaluated by referring to several essential oil specialty texts before use.

Guidelines for cosmetic products marketed specifically for pregnant women are: • all over body use - limited to 0.5% in total for non contra-indicated essential oils. • spot treatments – products marketed for specific areas of the body, such as creams to reduce the appearance of stretch marks, can be used at normal concentrations; so long as they do not contain contra-indicated essential oils. • frequent use products – products intended to be used several times a day, even when intended for use as spot treatments, should contain low concentrations of non-contraindicated essential oils (maximum 0.5% in total).

3.2.4 Incorporating essential oils into products Essential oils will almost always be supplied to you in a liquid form. If they are resinous, they will first need to be mixed in a suitable quantity of carrier oil to become more liquid. Essential oils can be oxidized or destabilized by unsuitable conditions. Before adding essential oils ensure: • the pH of the product is not going to adversely affect the essential oil. • temperature is even through out the product and is below 40°C – this can not be achieved with balm products, so the balm product should instead be cooled to as low as possible before setting (usually around 55 - 65°C) and the essential oil added at this point.

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• mixing of the product ensures there will not be any ‘hot spots’ or uneven distribution of acids or bases which may still be able to react with the essential oil.

Also make sure that on addition, the essential oil is evenly dispersed throughout the entire product. Antioxidants should always be used when essential oils are added to a product.

4. Preparing herbal extracts When making herbal extracts, the herb/plant part should first be crushed and weighed. It should then be placed in a suitable vessel and immersed in the desired solvent. Cover the herb/plant part and seal the jar. The extract preparation should be inverted at least weekly; the preparation should be mixed in this way for at least 4 – 8 weeks. Store in a cool dark place during this period. Suitable solvents include: • oils: • jojoba oil • safflower oil plus 2.0% tocopherol • extracts using oil as a solvent will extract the oil soluble components of the plant and form an oil soluble preparation • if oils are used, the product should be stability tested under accelerated and real time conditions to check against possible rancidity • glycerin: • ensure it is vegetable derived • extracts using glycerin as a solvent will extract the water soluble components of the plant as well as some alcohol soluble components • the extract formed will be water soluble At the end of the preparation period, the extract should be poured through a fine mesh stainless steel sieve to strain off the solvent from the bulk. Measure the strained liquid and determine the produced quantity. Make this liquid up to a 1:1, 1:3 or 1:5 extract as required. For example, if you originally used 1kg of plant material, and obtained 750g oil after extraction, you would add an additional 250g of oil to make the extract up to a 1:1 ratio.

5. Recording and storing your formulations Your formulations must be recorded properly and stored effectively to ensure that all future batches of product are the same (excluding small variations due to the use of natural ingredients, which can

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be subject to seasonal variations). Appendix C provides a template for a formulation and method of manufacture. Use the same types of descriptions, and present your quantities in % by weight, to ensure the same amounts will be used every batch. Your formula should also have a version number and an official name attached to it. Make sure the name on your formula is the same as that on your finished product, to avoid confusion. The first version of your formula would be version 1, or could be written like FOR001 – 0. Any changes you make to the formula over time should then be recorded with a new version number, so you can track any changes made. Any new formulas, and changes to existing formulas, will require extensive stability testing. Refer to section 4 on Quality Control for more information on stability testing. You would not normally change a formula every batch; but instead only every couple of years or as improvements develop. Consumers like to be able to buy products consistently and know what they are purchasing, so change is not always accepted well. Make sure to follow your formula and only change when necessary for consumer appeal, to reflect latest innovations or if necessary for stability reasons.

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Appendix A: Properties of natural lipids Natural fats and oils Below is a brief overview of the properties of the more commonly used oils and popular exotic oils: almond oil (sweet): • rich in oleic and linoleic fatty acids, it is suited to hand and body care preparations. • moderately low priced. apricot kernel oil: • rich in oleic and linoleic fatty acids, it has a light texture making it ideal for facial care products. • moderately low priced. avocado oil: • penetrates and spreads easily on the skin making it suitable for a variety of deeply hydrating products for the face and body. • naturally rich in vitamins A and D; it is soothing to dry skin making it particularly suitable in after sun or mature skin products. • moderately priced. • virgin avocado oil is quite green and can taint the finished colour of products to a pale green; a colour not always well accepted by consumers. babassu oil: • melting point is skin temperature imparting a highly substantive feel to products it is used in. • ideal to use in exotic body lotions, body butters, lipsticks or lip balms. • moderately priced. borage oil: • rich in gamma linolenic acid and especially suited to ‘skin repair’ products to nurture damaged skin. • very high priced. cocoa butter: • a relatively hard butter, it helps impart a lasting moisturising feel to skin care products. • particularly suited to lip and body balms.

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• can cause ‘balling’ (the presence of small, hard wax-like droplets) if not blended correctly or cooled slowly. • can impart a mild cocoa aroma and flavour to products. • moderately priced. evening primrose oil: • rich in linoleic and gamma linolenic acid, making it especially suited to ‘skin repair’ products. • ideal to improve the appearance and condition of damaged, irritated skin, hair and nails. • high priced. grape seed oil: • absorbs rapidly into the skin and spreads easily. • nurtures normal cell turnover making it suitable for oily skin types. • low price. macadamia oil: • rich in palmitoleic acid, which occurs in the skins sebum, making it particularly suited to mature skin, which has a naturally reduced sebum production. • has a good skin feel and good penetration into the skin. • moderately low priced. mango butter: • suitable for a variety of skin types, it melts at skin temperature making it ideal for a variety of lotions and body products. • has good skin feel. • high priced. olive oil: • a heavier type of oil, it is suited to body products, particularly for dry, mature skins. • soothing to dry skin. • moderately low priced. rosehip oil: • revitalizes the appearance of the skin and smoothes the appearance of wrinkles and scars. • rich in linoleic and linolenic fatty acids and naturally occurring retinoic acid to nurture skin

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cell regeneration. • suited for exclusive skin serums to restore texture and impart elasticity. • very high priced. shea butter: • melts at skin temperature giving it exceptional skin feel. • ideal for body butters, balms, lotions and skin creams. • high priced. soyabean oil: • rich in natural vitamin E. • ideal for body lotions and massage oils. • very low priced. sunflower oil: • suitable for a variety of personal care products and massage oils. • can go rancid over time even at low storage temperatures. • very low priced. wheatgerm oil: • very rich in natural vitamin E, it is relatively stable against heat and light. • nurtures skin cell regeneration so is ideal to use in skin repair and soothing creams. • moderately high priced.

Natural waxes Waxes are used in a variety of products for their ability to alter the viscosity and melting point of finished products. Below are details on the more commonly used natural waxes: beeswax: • obtained by melting the empty hives of honey bees, it is refined and often bleached before incorporation in personal care products. • used to increase the viscosity and consistency of creams and body butters; it is also ideal to use for lip and body balms and lipsticks. • moderately priced.

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candelilla wax: • obtained from the leaves of the Candelilla shrub in Mexico. The leaves are boiled until the wax melts and floats to the surface where it is skimmed off and refined. • often used with, or in place of, carnauba wax or beeswax to harden products and increase their melting point. It also provides a gloss to the finished product. • moderately high priced. carnauba wax: • obtained from the wax coating on Brazilian wax palm tree leaves. The wax is beaten off dried leaves, refined and bleached. • the hardest of all natural waxes, it is used mainly in lipsticks to achieve the right consistency and increase the melting point. It also provides a gloss to the finished product. • moderately priced. jojoba: • obtained from the crushed seeds of the jojoba plant. • naturally rich in tocopherols making it stable against light and heat. • due to its wax ester nature, it forms a moisture protective barrier on the skin to reduce transepidermal water loss. • intensive hydration and emollient properties improve elasticity and suppleness within the skin. • ideal for all skin types as well as the scalp and hair. lanolin: • obtained by heating wool to 90°C using steam. The steam causes fat on the wool to float to the surface of contained water where it is then skimmed off and purified. • composed of various high molecular weight lanolin alcohol esters. • suitable to use in heavier creams, balms and ointments. • moderately priced.

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Appendix B: Overview of common essential oils Listed below are aroma descriptions of the more common essential oils you may encounter throughout your time formulating. The descriptions below also include: • brief notes about the sensory effect of the oil: the mood or emotion they tend to evoke within the consumer. • reputed cosmetic benefits: uses where they may be of particular benefit for the hair or skin. • contra-indications: when they should be used with caution or not at all. Bear in mind that used at normal cosmetic amounts, contra-indications may not be a concern but you need to still be aware of them; particularly if combining several oils with the same contra-indication. Remember to check the latest SUSDP for any labeling or content requirements to exempt your product from being considered schedule 5 (or other). basil oil, sweet (flowering tops of Ocimum basilicum): • top: FRE, ANI; HER • body (3): SWE; HER; ANI; SPI • dry out: WRM; MIN; SPI (24 hours) • cosmetic: refreshing, tonic action for tired skin; controls the appearance of acne. • sensory: uplifting, clarifying and stimulating. • contra-indications: can be an irritant for sensitive skin; do not use during pregnancy. bergamot (rind of fruit of Citrus bergamia): • top: FRE; SHP; LEM • body (3): SWE; RIC; HER; PPR; FLO • dry out: NON; HER; DRY (18 hours) • cosmetic: recommended for oily skin or as a regenerative oil where there are existing skin conditions. Also has a deodorizing action. • sensory: relaxing, restoring and calming. • contra-indications: photosensitization; use in wash off products only or in leave-on products up to 0.4%. • notes: sensitive to oxidation; store in tightly closed containers away from light. cedarwood (bark of Cedrus atlantica): • top: LHT; CAM; CRE • body (3): SWE; WDY • dry out: no change

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• cosmetic: oily hair, skin and to cleanse dandruff. • sensory: uplifting and stimulating. • contra-indications: conflicting information regarding use during pregnancy; use with caution. chamomile, German (flowers of Chamomilla recutita): • top: SWE; FRU;HER • body (4): SWE; HAY; TOB • dry out: TOB; HER; DRY (48 hours) • cosmetic: sensitive skin; can reduce the appearance of redness. • sensory: calming. • contra-indications: none. chamomile, Roman (flowers of Anthemis nobilis): • top: SWE; FRU; HER • body (4): FRU; HER; WRM • dry out: DRY; HER (36 hours) • cosmetic: sensitive skin; can reduce the appearance of redness. • sensory: calming. • contra-indications: none. citronella (leaves of Andropogon nardus or Cymbopogon nardus): • top: FRE; GRN; WDY • body (4): WDY; CAM; FLO; ROS • dry out: WDY; ROS; HER (3 days) • cosmetic: insect repellent; it is also ideal for oily skin types and excessive perspiration. • sensory: invigorating. • contra-indications: may be irritating to sensitive skin. clary sage (aerial parts of Salvia sclarea): • top: SWE; LHT; HER; AMB • body (3): SOF; HER; AMB • dry out: DRY; WDY; CED (48 hours) • cosmetic: oily skin and hair. • sensory: uplifting and balancing. • contra-indications: pregnancy.

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cypress (leaves and twigs of Cupressus sempervirens): • top: FRE; CON; PIN • body (4): BAL; RES • dry out: SWE; AMB; LAB • cosmetic: oily skin and excessive perspiration; also used for foot care. • sensory: balancing and purifying. • contra-indications: none. • notes: may oxidize over time. eucalyptus (leaves of Eucalyptus globulus): • top: FRE; CNL • body (4): CNL • dry out: DRY; ALD; GRN (6 hours) • cosmetic: insect repellent and ideal to use for a variety of skin conditions. • sensory: stimulating, soothing and purifying. • contra-indications: none. frankincense (bark of Boswellia spp): • top: TER; LEM • body (4): BAL; WDY; SPI • dry out: BAL; AMB • cosmetic: dry and mature skin; reduces the appearance of scars and wrinkles. • sensory: uplifting, soothing, warming. • contra-indications: none. • notes: may oxidize over time. geranium (leaves and branches of Pelargonium graveolens): • top: SOF; SWE; ROS • body (2): SWE; ROS; WDY • dry out: NON (48 hours) • cosmetic: balancing for dry, oily or combination skin. • sensory: uplifting and balancing. • contra-indications: none.

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jasmine absolute (flowers of Jasminum officinalis): • top: FLO; JAS; GRN • body (3): FLO; JAS; FRU; HER; HVY; ANM • dry out: HVY; IND (5 days) • cosmetic: dry and sensitive skin. • sensory: balancing and warming. • contra-indications: none. • notes: may discolour products over time. lavender (aerial parts of Lavandula officinalis): • top: FRE, LHT, SWE, FRU • body: HER, LVD, FLO • dry out: HER, FLO, WDY (24 hours) • cosmetic: suitable for all skin types; insect repellent; soothing for dry skin. • sensory: balancing, soothing, purifying. • contra-indications: none. lemon (rind of the fruit of Citrus limonum): • top: LHT; SHP; CIT; LEM • body (3): SWE; FRE; LEM • dry out: WRM; NON (5 hours) • cosmetic: problem skin types. • sensory: uplifting, stimulating. • contra-indications: may cause sensitization in some skin types; phototoxic – should not be used over 0.05% in leave on products. lemongrass (fresh leaves of Cymbopogon citratus): • top: FRE; CIT; LEM • body (3): LEM; FRE; FTY; HER • dry out: FRE; LEM; FRU (48 hours) • cosmetic: cleansing, wash off products; insect repellent. • sensory: uplifting, stimulating. • contra-indications: may be irritation and sensitizing to some people. • notes: sensitive to oxidation; store tightly sealed in a cool place.

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lemon myrtle (leaves of Backhousia citriodora): • top: FRE; CIT; LEM • body (3): LEM; FRE; FTY; HER • dry out: FRE; LEM; FRU (48 hours) • cosmetic: cleansing, wash off products; anti-bacterial. • sensory: uplifting, stimulating. • contra-indications: may be irritation and sensitizing to some people. • notes: sensitive to oxidation; store tightly sealed in a cool place. myrrh (resin exuded from Commiphora spp): • top: BAL; SHP • body (4): SPI; WRM • dry out: SPI; WRM • cosmetic: soothing for dry or damaged skin types. • sensory: uplifting, stimulating. • contra-indications: pregnancy. neroli (flowers of Citrus aurantium var. amara): • top: LHT; FLO; BIT • body (4): FLO; HER; GRN • dry out: FLO; OFL (18 hours) • cosmetic: reduces the appearance of redness and irritation. Useful for dry sensitive skin; rejuvenates appearance. • sensory: uplifting, balancing, soothing, purifying. • contra-indications: none. • notes: sensitive to oxidation; store tightly sealed in a cool place. orange, sweet (rind of the fruit of Citrus aurantium var dulcis): • top: LHT; SWE; FRE; FRU • body (4): FRU; CIT; ALD • dry out: NON (6 hours) • cosmetic: soothes dry skin; rejuvenates the appearance. softening for rough skin and restores a youthful look to the skin. • sensory: uplifting, soothing.

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• contra-indications: none. palmarosa (leaves of Cymbopogon motia): • top: FRE; FLO; ROS • body (4): SWE; ROS; FRU • dry out: GER; OLY (48 hours) • cosmetic: hydrating and balancing for all skin types; rejuvenates the skins appearance. Useful for problem skin and dry, dull looking skin. • sensory: calming and uplifting. • contra-indications: none. patchouli (leaves of Pogostemon pactchouli): • top: SWE; RIC; HER; BAL • body (5): SWE; CAM; ERT; WDY; BAL; SPI • dry out: DRY; WDY; BAL; SPI (4 days) • cosmetic: regenerating, soothing and hydrating for all skin types. • sensory: uplifting, balancing, soothing. • contra-indications: none. peppermint (herb of Mentha piperita): • top: FRE; GRS; MIN • body (5): BAL; SWE • dry out: SWE; CLN (48 hours). • cosmetic: soothing for dry skin; cleansing for problem and congested skin. Often used for feet preparation because of its cooling and refreshing effect. • sensory: uplifting, warming, stimulating, purifying, soothing. • contra-indications: may be sensitizing for some skin types. Use at less than 1% in body products; do not use in face products. petitgrain (leaves and twigs of Citrus aurantium var amara): • top: BIT; FLO; SPI • body (4): SWE; HVY; FLO; WDY • dry out: WRM; CIT; ORB; HER (18 hours) • cosmetic: tonic for problem and oily skin types; deodorizing. • sensory: uplifting, refreshing. • contra-indications: none.

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rosemary (aerial parts of Rosmarinus officinalis): • top: FRE; HER; WDY • body (4): RES, CNL; WDY; BAL • dry out: DRY; RES (5 days) • cosmetic: tones the appearance of skin; stimulating for the hair. Used to cleanse dandruff. • sensory: uplifting, stimulating, soothing. • contra-indications: pregnancy, those with epilepsy or high blood pressure. rose otto (flowers of Rosa damascena): • top: WXY; ROS • body (5): RIC; WXY; ROS; SPI; CLO • dry out: ROS; ALD (5 days) • cosmetic: softens and hydrates the skin; suitable for all skin types but particularly suited to mature, dry and sensitive skin. Helps reduce the appearance of redness and soothing for inflamed skin. • sensory: uplifting, balancing, purifying, warming. • contra-indications: none. rosewood (wood of Aniba rosaeodora): • top: SPI; NMG; CAM • body (4): SPI WDY; FLO • dry out: WDY; SPI • cosmetic: rejuvenating for the skin; ideal for dry, sensitive or inflamed skin types. Reduces the appearance of ageing and wrinkles. Deodorising action. • sensory: uplifting, balancing, stimulating. • contra-indications: none. sandalwood, Australian (wood of Santalum spicatum): • top: none • dody (2): SOF; SWE; WDY; BAL; FTY • dry out: little change. • cosmetic: soothing, cooling and hydrating for dry skin. Suitable for damaged, irritated skin. • sensory: uplifting, warming, soothing, balancing. • contra-indications: none. tea tree (leaves of Melaleuca alternifolia):

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• top: WRM; SPI • body (4): CNL • dry out: DRY; ALD; GRN (6 hours) • cosmetic: problem skin; dandruff. • sensory: uplifting, purifying. • contra-indications: can be sensitizing in some people. • notes: can oxidize if exposed to light – store in dark areas. ylang ylang (flowers of Cananga odorata): • top: FLO; WDY; MED • body (4): SWE; FLO; MED • dry out: SWE; FLO (24 hours) • cosmetic: balancing for oily and dry skins; also stimulating for the scalp to promote thicker looking hair. • sensory: cooling. • contra-indications: none.

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Appendix C: Product formulation and method of manufacture template ABT PRODUCT FORMULATION & METHOD OF MANUFACTURE FORM001-0 Page: 1 of 2

Product Name: Customer: Item No.:

Supersedes:

Issue Date:

Sample code: Prepared by:

Authorised by:

Date:

Date:

1. FORMULATION AND METHOD OF MANUFACTURE

PHASE

ADDED

RAW MATERIALS

SUPPLIER

%w/w

Total

100%w/w

METHOD

43

ABT PRODUCT SPECIFICATION, FORMULATION & METHOD OF MANUFACTURE FORM001-0 Product Name: Customer: Item No.: Sample code: Prepared by:

Page: 2 of 2 Supersedes:

Issue Date: Authorised by:

Date:

Date:

2. REVISION HISTORY

Date

Rev. No.

Brief Description of changes New.

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Part 3: Regulatory Considerations 1. Overview of personal care promotion in Australia In Australia, there are two classifications for products that are applied topically: cosmetics and therapeutic goods. Between these two classifications, there are also a number of topical products that fall somewhere between the definition of cosmetic and therapeutic products. These products are considered to fall at the cosmetic/therapeutic goods interface. In Australia, the regulations pertaining to cosmetics, therapeutic goods and products at the cosmetic/ therapeutic goods interface, are governed by two regulatory agencies: Therapeutic Goods Administration (TGA) and National Industrial Chemicals Notification and Assessment Scheme (NICNAS). There is also a third regulatory agency, the Australian Competition and Consumer Commission (ACCC), which oversees the administration of the Trade Practices Act and associated acts to ensure fair trade in the market place.

1.1 Definitions and products In Australia, the following definitions apply:

1.1.1 Therapeutic goods Therapeutic goods (as defined in the Therapeutic Goods Act 1989) are goods: (a) resented or for any other reason, likely to be taken to be: (i)

for therapeutic use; or

(ii) for use as an ingredient or component in the manufacture of therapeutic goods; or (iii) for use as a container or part of a container for goods of the kind referred to in subparagraph (i) or (ii); or (b) included in a class of goods the sole or principal use of which his, or ordinarily is, a therapeutic use or a use of a kind referred to in subparagraph (a) (ii) or (iii) In other words, a therapeutic goods is any product or ingredient that appears to be, or is, for a therapeutic use. The Therapeutic Goods Act 1989 goes on to define therapeutic use as: Therapeutic use as meaning use in or in connection with: (a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons or animals; or (b) influencing, inhibiting or modifying a physiological process in persons or animals

To combine these two definitions into one simple guideline for you, a therapeutic good is one that would be perceived by the common person as having a therapeutic function. Consider the following examples:

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1. a product that is used to whiten the skin by deactivating the normal melanin process, and claims as such with before and after photos to show the difference in the skin after use 2. a product that is used to whiten the skin by exfoliating and removing upper layers of dead skin cells to reveal fresher looking skin beneath, and claims to whiten the appearance of the skin with before and after photos to show the difference in the skin after use Example 1 is an example of a therapeutic good because of its claims, its physiological action, and because it would be perceived by the common person as having a therapeutic effect. It would need to meet strict therapeutic guidelines, be manufactured in a facility with a license issued by the TGA to manufacture this type of goods, and carry specific directions, warning statements and other information as stipulated by the ingredients it contains, in accordance with therapeutic goods requirements. Example 2 is an example of a cosmetic product because its method of action does not inhibit or claim to modify a physiological process (as does example 1), but instead claims to change the appearance of the skin. The key here is change to ‘appearance’ of the skin, rather than a physiological change to the skin as per example 1. When packaged in a jar, within a box, with normal directions and promotional text, this product is likely to be perceived by the normal consumer as a cosmetic product. Consider also the following examples: 3. a cream, containing essential oils, that claims to relieve the redness and soreness associated with sunburn 4. a cream, containing essential oils, that claims to reduce the appearance of redness of sunburn, and hydrate the skin after sun exposure Example 3 is clearly a therapeutic good, because it claims to relieve an ailment, and would be perceived by a normal consumer as reducing pain and discomfort associated with sunburn, and healing the skin. Example 4, however, only claims to reduce the appearance of redness and hydrate the skin – both functions of cosmetics. It would be perceived by a normal consumer as effective to soothe the after effects of sunburn by hydrating and reducing the appearance of redness, rather than healing the burn itself.

Examples of therapeutic products can include the following items: hair: • agents to restore growth face: • sunscreens, lip balms and other products with sun protection claims and/or an SPF of 15 or more products for use in the eyes or ears oral: • desensitising gels and pastes

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skin care: • sunscreens with sun protection claims and/or an SPF of 15 or more • ointments, gels, creams, lotions and balms to relieve skin conditions (eg eczema, dermatitis, fungal conditions) • acne preparations containing therapeutic ingredients • ointments, gels, creams, lotions and balms claiming to relieve hormonal or other physiological disorders hygiene aids: • personal lubricants

1.1.2 Cosmetics Cosmetic (as defined by the Industrial Chemicals (Notification and Assessment) Act 1989) means: (a) a substance or preparation intended for placement in contact with any external part of the human body, including: (i) the mucous membranes of the oral cavity; and (ii) the teeth; with a view to: (iii) altering the odours of the body; or (iv) changing its appearance; or (v) cleansing it; or (vi) maintaining it in good condition; or (vii) perfuming it; or (viii) protecting it; or

(a) a substance or preparation prescribed by regulations made for the purposes of this paragraph; but does not include: (b) a therapeutic good within the meaning of the Therapeutic Goods Act 1989; or (c) a substance or preparation prescribed by regulations made for the purposes of this paragraph. AND The product must NOT be for preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons. However, this does not preclude use of the words prevent/preventing/prevention for general cosmetic purposes.

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AND The product must be marketed as a cosmetic taking into account the labeling, packaging, advertising and/ or the label statements: • the product must have full ingredient disclosure in accordance with the Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991; • the product may be presented as being explicitly for cosmetic purposes only; and • the product name would NOT of itself make the product a therapeutic good, unless that name makes a reference to a disease, ailment, defect or injury in persons. AND The product must meet any applicable conditions detailed in the new Cosmetics Standard (made under section 81 of the ICNA Act). The Cosmetics Standard sets out the standards (or conditions) that apply to certain product categories. [Note: these will be presented in a moment]. The SUSDP must also be consulted before use of essential oils to check for any usage restrictions. The definition of a cosmetic clearly separates these products from those that would be recognised as therapeutic goods. The definition starts by clarifying where cosmetics are applied; that they are only for external use or for contact with the mucous membranes of the mouth and teeth. It goes on to stipulate the only functions of cosmetic are to alter odours, appearance, cleanse, maintain, perfume and protect it. The words maintain and protect deserve a special mention here: maintain: • should only be used in the context of maintaining in good condition by cleansing, moisturising, exfoliating and/or drying. • must not be used in the context of maintaining good health, as this would be making a therapeutic claim. protect : • should only be used in the context of protecting the skin by cleansing and moisturising. • must not be used in the context of protecting the skin from UV light or other damage.

The definition also clearly stipulates what a cosmetic product should NOT be used for, such as preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons. The name of the product must also not make the product a therapeutic good. It is important to note that companies must ensure their representation of a product and its promotions, whether intentional, implied or accidental, must not mis-represent the product as being a therapeutic good or having a therapeutic use.

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Some examples to consider: 1. A product called Skin Repair that claims to protect skin exposed to the sun, treat and prevent stretch marks, and relieve skin conditions such as eczema. 2. A product called Skin Repair that claims to protect moisture levels of skin exposed to the sun, hydrate and prevent the appearance of stretch marks, and nurture dry skin conditions.

The first example claims the therapeutic actions of protecting skin exposed to the sun, treating and preventing stretch marks, and relieving a named disease. This is a product that is clearly represented as a therapeutic good. It would therefore need to comply with all relevant legislation of the Therapeutic Goods Act in regards to composition and scientific evidence, as well as be manufactured in a TGA licensed facility and carry specific directions and information on its product label.

The second example uses allowable cosmetic claims by qualifying certain terms through clever wording. This includes: • protecting moisture levels of the skin - note, the word protection has been qualified by the use of the word ‘moisture’ and is therefore suitable to use. • hydrating and preventing the appearance of stretch marks – note, the use of the word ‘appearance’ has qualified the use of the word prevent. • nurture dry skin conditions – note, the description of nurturing dry skin conditions is a cosmetic claim, as opposed to the first example, where the product claims to relieve eczema.

It is important that you understand the key differences, by definition, of what is considered a therapeutic good versus what is acceptable as a cosmetic product.

1.1.3 Products at the cosmetic/therapeutic goods interface As the personal care industry evolves, there are more and more products that fall at the interface between cosmetic and therapeutic goods. For example, is an anti-dandruff shampoo cleansing the hair or changing a physiological function of the scalp? Is a foundation that contains SPF colouring the skin or protecting it from UV damage? In September 2007, Cosmetic Guidelines were introduced that provided distinct definitions of when products at the cosmetic/therapeutic goods interface could be classified as cosmetic, and when their function deemed them therapeutic.

In practice, these regulations cover the interface of the following products: hair: • anti-dandruff products:

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• considered cosmetic when claims are made about the control and prevention of dandruff through cleansing, moisturising, exfoliating or drying the scalp • considered therapeutic when claims are made about physiological changes to the scalp matrix face: • tinted bases, foundations and lip preparations with sunscreen added: • considered cosmetic when claims are limited to statements such as ‘contains SPF 15’, or ‘protects the skin from the damaging effects of the sun’s rays’; so long as the products claims are primarily focused on its tinting and colouring action. Very specific evidence of testing the product to protect the skin from UV rays must also be held by the company promoting such a product. • considered therapeutic when claims are predominantly about the sun protection activity of the product rather than its colouring action, the SPF is claimed at more than 15, water resistant claims are made, and/or representations are made about protection from skin cancer or other physiological damage induced by the sun. • whether cosmetic or therapeutic, any product making a claim about sun protection must meet specific requirements regarding the evidence required to make such claims. This includes sending the product for SPF testing in accordance with an Australian standard known as AS/NZS 2604:1998. You are not required to know the elements of this standard, but you are required to know the product must comply with this standard and tests required to prove its SPF rating within this standard. • cosmetic products claiming SPF must also not contain ingredients listed in the poisons schedule as S2, S3, S4 or S8 (refer to your formulator for clarification). • anti-acne products including cleansers, toners, moisturisers, exfoliants and masks: • considered cosmetic when ingredients comply with cosmetic standards, and claims are limited to controlling or preventing acne through cleansing, moisturising, exfoliating or drying the skin. • considered therapeutic when ingredients are of a therapeutic nature, listed in the poisons schedule as S2, S3, S4 or S8 (your formulator should be able to confirm this), and make claims about the control or prevention of acne through physiological changes within the skin. oral: • toothpastes, mouth washes and breath fresheners: • considered cosmetic when claims are limited to improvements in oral hygiene such as fresher breath, clean/whiter looking teeth, removal of plaque by brushing, the prevention of tooth decay, and the use of fluoride for the prevention of tooth decay. • considered therapeutic when claims are made in relation to oral diseases such as gum or mouth diseases and periodontal conditions. skin care: • any skin care product containing SPF, including self-tanning agents, skin-whitening products and antiageing products:

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• considered cosmetic where the SPF claim is 15 or less, no water resistance claims are made, the product is marketed as being for a different primary purpose (ie SPF claims are not the major focus of the promotional campaign), claims are limited to ‘contains SPF 15’, or ‘protects the skin from the damaging effects of the sun’s rays’. A claim can also be made about protection from premature skin ageing resulting from sun exposure but only if the product meets specific criteria and has evidence to prove its protection against certain UVA rays with a minimum SPF of 4; but can not make any claims about the use of the product in relation to protection against skin cancer or similar. The product must also be in a pack that is 300g/mL or smaller, and have an expiry date on the label if it is not stable for at least 36 months. Very specific evidence of testing the product to protect the skin from UV rays must also be held by the company promoting such a product. • considered therapeutic when claims are predominantly about the sun protection activity of the product rather than its moisturising or other action, the SPF is claimed at more than 15, water resistant claims are made, and/or representations are made about protection from skin cancer or other physiological damage induced by the sun. • whether cosmetic or therapeutic, any product making a claim about sun protection must meet specific requirements regarding the evidence required to make such claims. This includes sending the product for SPF testing in accordance with an Australian standard known as AS/NZS 2604:1998. You are not required to know the elements of this standard, but you are required to know the product must comply with this standard and tests required to prove its SPF rating within this standard. • cosmetic products claiming SPF must also not contain ingredients listed in the poisons schedule as S2, S3, S4 or S8 (refer to your formulator for clarification). • antibacterial skin products: • considered cosmetic when claims are limited to the product being active against bacteria; but must not name bacteria associated with a disease or medical condition. It must also not claim to be suitable for use against viruses, fungi and other microbial organisms; or for use before skin piercings, medical procedures, or contact with another person in relation to a medical or health care service. • considered therapeutic when claims are made in relation to the product being active against a named bacteria associated with a disease or medical condition, viruses, fungi or other microbial organisms; when it is recommended for use before skin piercings, medical procedures, or contact with another person in relation to a medical or health care service. • cosmetic products claiming an antibacterial action must also not contain ingredients listed in the poisons schedule as S2, S3, S4 or S8 (refer to your formulator for clarification).

1.2 Regulatory authorities and their jurisdiction There are three regulatory agencies who oversee the personal care industry in Australia. While these agencies act independently from each other, their combined scope covers all aspects of personal care promotion and regulation. Whenever your company considers compliance issues, it should never think, ‘but company ABC does it, and they get away with it,’ because that attitude simply is not acceptable to regulatory agencies. If your company has been found to breach regulations, it will be held accountable for that breach no matter what other companies are saying or doing in the market place. However, your company can report the actions of others in the market place who are doing the incorrect thing.

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1.2.1 Australian Competition& Consumer Commission (ACCC) The ACCC oversees the administration of the Trade Practices Act and associated acts to ensure fair trade in the market place. There are two main sections of the Trade Practices Act that are relevant to the promotion of personal care products, and with which companies must comply: section 52 – misleading or deceptive conduct • the act states that a corporation shall not, in trade or commerce, engage in conduct that is misleading or deceptive or is likely to mislead or deceive. • this means that any and all promotional activities conducted by your company can not in any way, intentionally or by accident, mislead or deceive a consumer into purchasing your product. Section 53(c) – false or misleading representations • the act states that a corporation shall not, in trade or commerce, in connexion with the supply or possible supply of goods or services or in connexion with the promotion by any means of the supply or use of goods or services represent that goods or services have sponsorship, approval, performance characteristics, accessories, uses or benefits they do not have. • this means that you can not make claims about the use or benefits of a product that you can not support with appropriate evidence; and where that evidence has specific conditions under which it applies, those conditions must be stated too. For example, if your evidence shows a benefit to the skin of rodents, you can not claim that benefit applies to the product unless you also state words to the effect ‘as proven in animal tests’. The reason for this is, because it occurred in rodents, it does not mean it will perform that way in humans; and your company can not imply that it will.

Examples of breaches of section 52 and/or 53(c) of the Trade Practices Act include, but are not limited to: • packaging a product into a container with a false bottom to make it look like a bigger container than it actually is. • promoting a product as being clinically proven, scientifically tested, dermatologist approved etc where your company does not have evidence in humans or on human skin to sustain such claims. • using animal studies to declare the benefits of a product without specifically stating those benefits were observed in animal studies. • claiming an organic content by %, when that % content is not true. • misrepresenting statistical claims about the acceptability, use or performance characteristics of a product. If you want to make statistical claims about a product you must state how those statistics apply. For example, if you were to say, ‘9 out of 10 women preferred our product over leading Brand X’, you would also need to state how you arrived at those figures; for example: ‘as tested in 100 women.’ Next time you see a statistical claim, check on the promotion for a small disclaimer stating the tests conditions under which that statistic was obtained. Providing this disclaimer allows the consumer to make an educated decision as to how likely they are to feel the same way about the product too.

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• presenting a product as having benefits pertaining to a particular ingredient based on research that used a greater concentration than that which is used in your final product. For example, if you want to use graphs in your promotional material showing results when a certain active was used on human skin tissue at 2%, but you only use this active ingredient in your product at 1%, you can not use those graphs or make claims about the results of the study because your product does not contain the same amount of active that was used to obtain results in the clinical setting. • implying a competitors brand is harmful or ineffectual because they use, or don’t use, certain ingredients. For example, you can not claim that competitor products, or the chemicals they contain, are harmful or induce certain health effects in individuals unless you clearly state the conditions under which those products, or the ingredients it contains, cause those conditions. Examples of such misinformation in breach of these acts abounds in the personal care industry. The most common examples of such breaches are: • companies who promote that parabens are linked to breast cancer. The truth is, the use of parabens in under arm deodorants was at one point questioned as to whether it may be associated with an increase in breast cancer. It has since been proven that using parabens does not have any association with an increased risk of breast cancer, and that they are considered safe to use as part of normal personal care regimes. If your company chooses not to use parabens that is their choice; but any statements about why they choose not to use parabens should not breach the Trade Practices Act. • companies who promote that using sodium laureth sulfate or sodium lauryl sulfate (SLS) can cause a myriad of health problems including cancer, corneal damage and skin conditions such as eczema or dermatitis. The truth is, in animal studies where concentrated solutions of SLS were scratched into the eyes or skin of rabbits and not washed off, irritation and damage did occur. There has been no evidence to suggest its link to cancer. If companies want to state that SLS can cause skin or corneal damage, then in order to comply with the Trade Practices Act, they would also need to state when SLS had that effect, the conditions under which that damage occurred and that those concentrations are not present in personal care products. There have been in depth studies to prove the safety of SLS for use in personal care products at the concentration and wash off methods of use involved. If your company chooses not to use SLS that is their choice; but any statements about why they choose not to use SLS must comply with the Trade Practices Act.

If the ACCC finds your company in breach of the Trade Practices Act, they will require that you remove the offending promotional material from the market place immediately. If this promotional activity extends to your labels, you will need to remove your product from the market place immediately and return it only when new labels have been applied that comply with the Trade Practices Act. Repeat offences (or first time offences, if the breach is serious enough) will incur substantial penalties and fines.

1.2.2 Therapeutic Goods Administration (TGA) If the TGA contacts your company because of a therapeutic representation of a non-therapeutic good, they will present you with specific details of why the claim is considered a therapeutic representation; and ask that it be removed from the market place. For a company, this means removing the promotional campaign containing that claim or representation, including the product, if the label contains that statement.

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Having to remove a product from the market place and replace its label; or having to withdraw a promotional activity because of its claims is obviously a very costly and undesirable situation for a company to be faced with. It is for this reason you should ensure your product and promotions fully comply with the definitions of a cosmetic product. Repeat offences (or first time offences, if the breach is serious enough) will incur substantial penalties and fines. The TGA will also be likely to monitor future promotional campaigns issued by your company.

1.2.3 National Industrial Chemicals Notification and Assessment Scheme (NICNAS) NICNAS regulates cosmetic products and those at the cosmetic/therapeutic interface. While a therapeutic claim will be acted upon by the TGA, NICNAS is the first point of contact for cosmetic product queries. If you are producing soap or an extract, you will need to be registered with NICNAS. Note, it is the individual company name that must register; a group cannot register if they are then selling products under different company names. The registration year runs from September 1st to August 31st. Registration involves payment of an annual registration fee, along with a registration charge, which varies according to the value of the chemicals that are manufactured. Where you are manufacturing and using only local Australian ingredients (ie not importing ingredients directly), the value of the chemicals you manufacture are calculated by adding the cost of labour, materials (all ingredients) and manufacturing overhead expenses. The 2010-11 registration costs, for companies manufacturing chemicals up to and including the value of $499,999, is $395. Make sure you refer to the NICNAS website for the most up-to-date charges as they will vary annually.

To register: 1. Go to: http://www.nicnas.gov.au/Forms/Registration.asp 2. Download the correct form; ie new registration or registration renewal 3. Complete all necessary sections of the relevant form 4. Send to NICNAS For more information, refer to: http://www.nicnas.gov.au/Industry/Registration/NICNAS_Registration_ Brochure_PDF.pdf

1.3 What is considered a promotional activity? So exactly what is a claim, and what is a promotional activity? a claim: • is any statement, pictorial representation or design, however made, in respect of a product. an advertisement: • is any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of a product.

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a promotional activity • includes, but is not limited to, any of the following items used to promote the use or supply of a product: • websites, electronic media and emails • brochures, pamphlets, flyers, leaflets, swing tags, business cards where product is mentioned/pictured, or point of sale material • labels, information in product kits or on bags • advertisements in magazines, newspapers, brochures, on or in buses, trains, taxis, in shopping centres, on the back of toilet doors, in the mail and any form of communication • advertisements on television, radio, product parties and information and training sessions • testimonials in any form of promotion In short, an advertisement or promotion is any activity your company or its reprentatives take part in or use to promote the use or supply of a product, whether that activity results in a sale or not. A claim is any statement they make in relation to a product. Ensuring regulatory compliance therefore means monitoring everything your company says, in every form of media, about all of its products.

2. Regulations pertaining to labels Labels can be an effective way to promote your product to a consumer every time they use it. Labels may also contribute to the selection of your product from a retailer’s shelves. They can pose a regulatory problem if they do not contain the correct information. Your company is responsible for ensuring that its products meet labeling requirements.

2.1 Ingredients The Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991, pertains to the information required in regards to ingredients on cosmetic product labels. Ingredients must be listed: • on the container of the product, or where the product is not in a container, on the product itself. It must be available for a consumer to read at the point of sale, without having to open a box or purchase the product and open it first. • in descending order by volume or mass: • ingredients (except colour additives) present in concentrations of 1 per cent or more must be listed in descending order. • ingredients (except colour additives) present in concentrations of less than 1 per cent may be listed in any order. • colour additives may be listed in any order, regardless of their % input.

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• if the container or product can not meet these requirements because of its size, shape or nature, then the ingredients list must be provided in another way so as to inform a consumer of the ingredients in that product. For example, swing tags could be connected to a product; brochures could be provided with the product; the product could be attached to a display card; or an information card could be placed next to the product with the ingredients list. • an ingredients list may include a reference to a colour additive that is not present so long as that additive is: • added for the purposes of colour matching to some batches and not others (for example, lipsticks or nail polishes) • used in one or more (but not all) of a range of cosmetic products (for example, eye shadows) • listed in the ingredients panel using the words ‘may contain (name of the additive)’ OR the symbol ‘+/- (name of the additive)’ • flavour/s must be shown using the word ‘flavour’, ‘flavours’, ‘aroma’, ‘aromas’ or the ingredients in the flavour/s. • fragrance/s must be shown using the words ‘fragrance’, ‘fragrances’, ‘parfum’, ‘parfums’, or the ingredients in the fragrance/s. • an incidental ingredient does not need to be included in the ingredients list. • an incidental ingredient is one that has no technical or functional effect in the product and is present at insignificant levels in the product. • this can often be found by checking the International Nomenclature Cosmetic Ingredient (INCI) name on the raw material specification sheet: for example, if an ingredient lists the INCIs as: ‘horsetail extract, glycerin’; then the two ingredient names are horsetail extract and glycerin. In such a case, you would need to contact the supplier of that raw material and ask them for information on the concentration of each ingredient. While they will not likely give you a specific percentage input, they can at least give you a range which should enable you to list the ingredients of this raw material correctly in the overall ingredients list. If, for example, this same raw material only listed ‘horsetail extract’ as the INCI name, even though you know it contains glycerin, you do not need to declare glycerin on the label because the INCI listing only states horsetail extract. • if in doubt, check with your formulator whether an ingredient is an incidental ingredient. They should be able to provide you with information as to the correct INCI names of all ingredients used in the product; and approximate amounts, so you can prepare your own ingredients panel. • note: any ingredient, even if present in very minute amounts, that has a technical or functional effect in the product must be listed as an ingredient. • the ingredients list must be prominently shown and clearly legible. • the name of the ingredient in the ingredients list must be either its English name or its International Nomenclature Cosmetic Ingredient (INCI) name. • there may also be a list of ingredients present in another language. Any information present in another language should not contradict that information that is present in English.

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How to search for correct INCI names: 1. Go to: http://ec.europa.eu/consumers/cosmetics/cosing/ 2. Enter the supposed INCI name or CAS number of the ingredient 3. Review the results for the most suitable description and/or to double check the information provided on the MSDS and/or CofA by the supplier of the material 4. If the INCI and CAS do not match on the MSDS, go back to the supplier for clarification on the correct INCI name and CAS number Once you have a match by INCI and CAS, including plant part description and form of product (eg oil, extract etc), this is the correct name to use on the label. You can choose to put the common name in brackets after the botanical name if you want. If an INCI name does not exist for your ingredient, you should use the correct and full botanical name for that ingredient. You can choose to put the common name in brackets after the botanical name if you want.

2.2 Weights and measures The Trade Measurement (Pre-Packed Articles) Regulations 2000 covers all aspects of compliance regarding weights and measures of packaged and cosmetic products. It requires that all inner and outer packages carry the following information unless: • the product is ordinarily sold only in the outer package that is marked in accordance with the requirement OR • the outer package is only used for the purposes of transportation OR • the inner package is always sold with the outer package and the outer package is transparent such that the inner package showing the weight of the package is clearly visible Information that is specifically required under this legislation includes: name and address of company: • a pre-packed product must be marked with the name and address of the company for whom it was packed. This information must be: • readily visible and legible • such as to enable the company to be identified and located • with an Australian address that enables legal process to be served (ie a street address) a statement of contents must be made: • on the main display part of the package unless otherwise not required by the appropriate regulatory authority • be close to and marked to be read in the same direction as any name or brand of the product • at least 2mm from the limits of the package and separate by at least 2mm in all directions from other

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graphic matter of copy • use metric measurements in the English language • if the package is cylindrical, spheroidal, conical or of oval cross-section, the measurement marking must comply with the above as well as be positioned so that no part of the marking is further than onesixth of the circumference of the package from the line that vertically bisects that part of the package on which the marking is required to be made • stamped or printed in a colour that provides a distinct contrast with the colour of the background and be of at least the minimum height required below • in the following sizes:

Maximum dimension of package

Minimum character height

120mm or under

2.0mm

Over 120mm but not over 230mm

2.5mm

Over 230mm but not over 360mm

3.3mm

Over 360mm

4.8mm

• where the maximum dimension of a package: • if rectangular = whichever is the greatest of the breadth, height or length • if cylindrical, spheroidal, conical or of oval cross-section = whichever is the greatest of the height, length or maximum dimension of the package • using the following units of measurement: • liquids – reference to volume • skin cream in jars – reference to volume or mass • toothpaste – reference to mass • semi-solids or solids – reference to mass • measurements are to be expressed to not more than 3 significant figures statements of contents must be such that: • the permissible actual deficiency is 5% AND • the permissible average deficiency is nil • where the average is calculated by averaging the contents of at least 12 packages exemptions to the weights and measures legislation includes: • articles packed in a quantity of less than 15g or 15mL

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2.3 Other information It is expected that a cosmetic product should be considered safe when used for the conditions it is recommended, and in the manner in which it is intended. So while it is not essential that the following information be added to a label, it is strongly recommended that it is, to ensure safe and effective use of the product by the consumer: claims/statement of use: • a brief statement of what the product is and what it should be used for. • the claims must comply with cosmetic claims requirements. directions for use: • directions on how the consumer is to use the product, including any safety or performance aspects that may be required. directions for storage: • directions on how best to store the product for maximum shelf life. For example, ‘Store below 30°C’, or ‘Store in a cool dark place.’ batch number: • the manufacturer should apply a batch number to your product. • this batch number will help you track which batch is delivered and sold over what dates. • the batch number is also used if product recalls need to be issued or if there is a problem with the product, so you can go back to the manufacturer and they can trace their batch to determine why that problem has occurred. • without a batch number it is almost impossible to trace a product to its batch and know how many products may be affected.

Expiry or best before dates are not required on cosmetic products, and where the shelf life is at least 2 years, not normally recommended. The only exception to this, however, is products that make a secondary claim of SPF, as per the cosmetic/therapeutic interface. These products MUST have an expiry date or useby date on the label if they are not stable or able to maintain that SPF rating for at least 36 months. The expiry date for such products must be the date at which the claimed SPF is no longer provided by that product, or its stability is otherwise affected so as to render the product ineffective or no longer safe to use.

Activity 2.1 Prepare a label for the following product, to be sold by XYZ Cosmetics, 1 Jones Street, Smithville, QLD 4000:

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Formulation: Kakadu Plum & Mango Body Butter To 100

Purified water

3.0

Glycerin

3.0

Mango butter

1.5

Shea butter

1.6

Beeswax

6.4

Cosmowax D (65% cetearyl alcohol, 35% ceteareth-20

1.8

Stearic acid

7.4

Coconut oil

2.5

Grapeseed oil

0.3

Kakadu plum extract

0.2

Xanthan gum

0.5

Vitamin E

0.4

Fragrance

0.2

Germall plus (diazolidinyl urea, iodopropynyl butylcarbamate)

Pack size: 250mL Marketing message: Naturally hydrating using the essence of the Australian bush. Free from SLS, PEGs, parabens, propylene glycol and silicone derivatives. Not tested on animals Nourishing Australian botanicals to nurture Australian skin. Your answer should include: On the front: Kakadu Plum & Mango Body Butter Company logo 250mL (min. 3.3mm) On the back/side: Marketing spiel incorporating the marketing message; such as: Indulge your skin in the essence of the Australian bush. Containing extract of Kakadu plum, this

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enticingly sweet body butter infuses your skin with nourishing Australian botanicals and deeply hydrates with vitamin E, mango and shea butters. Free from SLS, PEGs, parabens, propylene glycol and silicon derivatives. Not tested on animals. Directions: Apply to the skin and massage in well. Use daily or more often as desired. Ingredients: Purified water, coconut oil, cetearyl alcohol, mango butter, glycerin, grapeseed oil, ceteareth-20, stearic acid, beeswax, shea butter, vitamin E, Kakadu plum extract, xanthan gum, fragrance, diazolidinyl urea, iodopropynyl butylcarbamate. Barcode (optional) XYZ Cosmetics, 1 Jones Street, Smithville, QLD 4000 Batch No: (to be added by manufacturer) Note: your ingredients list could also have used the INCI names for the ingredients, eg: Ingredients: Aqua (water), Cocos nucifera (coconut) oil, cetearyl alcohol, Mangifera indica (mango) seed oil, glycerin, Vitis vinifera (grape) seed oil, ceteareth-20, stearic acid, Cera alba (beeswax), Butyrospermum parkii (shea) butter, tocopherol (vitamin E), Terminalia ferdinandiana (Kakadu plum) fruit extract, xanthan gum, parfum (fragrance), diazolidinyl urea, iodopropynyl butylcarbamate.

2.4 Exemptions These labeling requirements do not apply to cosmetic products that are: • free samples – for example, samples received in the mail or in magazines, hotelier in-room free products or samples given out in a shop or similar environment. • testers – for example, testers supplied at a retail outlet for consumers to trial the product before purchasing a correctly labeled item.

2.5 Label checklist for cosmetics When first presented with a label, it can be very daunting to try and remember to include all information that is necessary. Even after you have written and checked many labels, it is always a good idea to refer to a checklist to ensure you have included and checked every item that is required on a label. Use the following checklist to ensure regulatory compliance:

2.5.1 Label compliance checklist • is the product name clear?

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• are the contents of the product in compliance with weights and measures? • is there a marketing message on the pack? • are there clear directions for use? • are all ingredients listed: • at 1 per cent or higher, in descending order? • below 1 per cent in any order? • colour additives – in any order? • ingredients the product may contain as ‘may contain’ OR ‘+/-‘ • flavours • fragrances • in English or INCI names? • are there contact details for the company (Australian street address)? • is there a batch number (optional)? • is there an expiry date (where claims of SPF only)? Note: if you are looking to export, additional labeling and regulatory compliance is required. Refer to a Regulatory Affairs Consultant for more information and assistance.

3. Adapting text to suit compliance requirements Appendix A contains the NCCTG Cosmetic Claims Guidelines. The NCCTG is the National coordinating Committee on Therapeutic Goods. These guidelines are now quite old in a regulatory sense – from 1997. They have been superseded somewhat by the recently established NICNAS Cosmetic Guidelines (located at: http://www.nicnas.gov.au/Current_Issues/Cosmetics/Cosmetic_Guidelines_PDF.pdf); however the NCCTG Cosmetic Claims Guidelines is a very useful document to help guide you in what constitutes an acceptable versus an unacceptable cosmetic claim. If there is ever a conflict in information presented between the NCCTG Cosmetic Claims Guidelines and the NICNAS Cosmetic Guidelines, then the NICNAS Cosmetic Guidelines should be given precedence. The NCCTG Cosmetic Claims Guidelines are set out in the following way: the left hand column: • lists the subject and type of product to which the remaining columns and claims refer to column A: • lists acceptable wording for a cosmetic, and alternative wording that can be used as part of acceptable

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wording. • for example, the claim ‘helps prevent (reduce, slow) the signs (appearance) of ageing (age lines, premature ageing)’ means it can be written as: • helps prevent the signs of ageing • helps prevent the appearance of premature ageing • helps slow the signs of ageing • and so on, using the various combinations of words in the claim column B: • lists words that may be used to promote a cosmetic so long as they are appropriately qualified by other terms to modify their implication to cosmetic products only. • for example, in skin cleansers, it lists the word purify. This means you can’t just say ‘purify’ in relation to a skin cleanser, but if you use other words to put ‘purify’ into a cosmetic context, you can use it. Such as: ‘gently purifies the skin by cleansing deep into the pores’. • as another example, in skin moisturisers, it lists the word soothing agent. So you can’t say a moisturiser is a ‘soothing agent’ on its own; however you could qualify this claim by stating, ‘soothes as it moisturises dry skin’. column C: • provides examples of claims that are distinctly unacceptable; those which you should not make.

Refer now to Appendix A and familiarise yourself with the NCCTG Cosmetic Claims Guidelines. When you have read through these claims and thought about how they can apply to various products, consider the final points to note below: claims regarding anti-ageing: • acceptable cosmetic claims involve the use of the word ‘appearance’, ‘look of’ or similar wording. • unacceptable cosmetic claims make statements about diminishing wrinkles without using a qualifying word about appearance. • for example, ‘slows the formation of wrinkles’ is unacceptable; while ‘slows the appearance of wrinkles’ is acceptable. claims regarding nourish: • you can describe a vitamin, mineral or oil as nourishing, but you can not describe a product as nourishing; nor can you describe its action on the skin as nourishing. • for example, ‘contains nourishing shea butter’ is acceptable; while ‘contains shea butter to nourish your skin’ is not.

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• any implication of an ingredient as nourishing to the skin should instead be changed to the word ‘nurture’ or ‘nurturing’. For example, ‘contains shea butter to nourish your skin’ should not be used, but instead changed to ‘contains shea butter to nurture your skin’. claims regarding vitamins and antioxidants: • you can say a product contains a vitamin, mineral or antioxidant, but you can not say the vitamin, mineral or antioxidant is going to do anything. • for example, ‘contains antioxidants from green tea and vitamin E’ is acceptable, however, ‘contains antioxidants from green tea and vitamin E to fight free radicals’, is not acceptable. • another example: ‘contains vitamin A’ is acceptable; while ‘contains vitamin A to repair the skin’ is not. claims regarding herbal extracts and essential oils: • you can not promote therapeutic benefits of herbal extracts and essential oils in relation to a product, even if used in a different sentence. • for example, ‘contains witch hazel extract to remove toxins and rosemary extract to stimulate ciculation,’ is unacceptable; even if used in a separate sentence or paragraph to the product. However, changing this to ‘contains witch hazel to tone and rosemary to invigorate the appearance of the skin’, is acceptable. Without the final words ‘appearance of the skin’ this last sentence would not be acceptable either. Alternatively, you could keep it simple and just write, ‘contains extracts of witch hazel and rosemary’. This would also be acceptable. use of the word treatment: • you can use the word treatment in the sense of moisturising, nurturing or caring for the skin. You can not use the word treatment in any other way. • for example, you could call a deep conditioning hair product a hair treatment so long as your product description states its purpose is to deeply moisturise the hair. • you could not call a skin product a treatment where its purpose is not clearly stated, or where the purpose implies it is suitable to use for a specific skin condition.

Consider also other changes that may be required, such as: • claims that are likely to mislead, deceive or make false representations. • text following words such as ‘cosmeceuticals’ or ‘nutraceuticals’. These words are specific to the cosmetic and personal care industry and are relatively recent. They are meant to imply cosmetics with a quasi-physiological effect; and are only acceptable to use as an adjective to describe a type of product. For example, it is acceptable to claim, ‘this cosmeceutical cream fights the appearance of ageing’. • claims that need supporting evidence – make sure you have evidence to support such claims on file before you approve the use of the text. For example, claims about clinical evidence or dermatologist

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approval – have this information in the product file in case you ever get asked to provide it. When making claims, you must ALWAYS have the information on file BEFORE the claim is made; not scramble to find the evidence after you have been challenged. Ensure the supporting evidence uses the same concentration of raw material as you have used in your product; and that any trials have been conducted on humans or using human tissue (not animals). To edit your advertising copy: • identify all claims that need to be considered • consider those claims you need to get evidence for: • does the evidence support the claim, or does the evidence carry a different claim/message? • does the evidence only support a therapeutic action? • does the evidence relate to humans or human tissue? • is the same concentration used in the product as was used in the evidence? • consider those claims that are not acceptable for cosmetics: • make changes as required to adapt the claim to be suitable for cosmetics. • refer to the NCCTG Cosmetic Claims Guidelines and the NICNAS Cosmetic Guidelines for assistance. • refer to promotions by large companies for inspiration. • check the copy is easy to read and understand. • check the overall message to ensure it is not misleading, deceptive or makes false representations. • does the message still carry impact? If not, make changes to create impact, and review from the beginning again. • communicate the copy and changes to internal staff for their comments. • review comments for cosmetic claims acceptability and suitability in the overall promotional context. • make changes and communicate the copy for approval.

4. Keeping up to date with changes You may not necessarily get notified of changes to compliance requirements. It is the company’s responsibility to ensure their products and promotional activities are always compliant, therefore the onus is on you to ensure you regularly check compliance requirements, and your company’s products, to ensure ongoing compliance.

There are several documents you will need to review on an ongoing basis: NICNAS Cosmetic Guidelines:

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• review this every 6 months by going to the NICNAS website: www.nicnas.gov.au and checking the ‘current issues’ section. • every 12 months, also review the cosmetic guidelines put out by NICNAS: http://www.nicnas.gov.au/ Current_Issues/Cosmetics/Cosmetic_Guidelines_PDF.pdf NCCTG Cosmetic Claims Guidelines: • this is a historical document so will not change. • you can find this by going to the TGA website: www.tga.gov.au and clicking on the link to cosmetics. label checklist: • go to the Trade Measurement (Prepacked Articles) Regulation 1991: http://www.legislation.act.gov. au/sl/1991-29/current/pdf/1991-29.pdf and check for any changes. • check the ACCC’s guide to cosmetic ingredient labeling by visiting: http://www.accc.gov.au/content/ index.phtml/itemId/525955 and clicking on the link to the Product safety guide. • incorporate any changes from the NICNAS Cosmetic Guidelines, Trade Measurement (Prepacked Articles) Regulation and ACCC Product safety guide into your label checklist. • update your label checklist by checking and noting any changes every 12 months. promotional material: • review these at every reprint for compliance; the responsibility is on the company to make sure all literature they print is up to date with regulatory compliance issues. • by ensuring your label checklist is updated every 12 months, and you are familiar with any other changes to the cosmetic regulations by checking all sites listed above, you will be able to keep up to date of any changes that may need to be made to products and promotional material. • where promotional material does not regularly get reprinted, mark required changes in product/ promotional files at least once a year. Then, when the item becomes due for print or action, you will have at least noted changes required so you should only need to perform a quick review for compliance before sending away for printing.

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Appendix A: NCCTG Cosmetic Claims Guidelines Subject

Column A Acceptable wording for a cosmetic

Column B Unacceptable wording for a cosmetic claim unless sufficiently modified to provide a cosmetic implication

Column C Unacceptable wording for a cosmetic (but not necessarily acceptable for a drug)

Active ingredient

cosmetic active ingredient

 

medicinal (therapeutic) ingredient

Ageing, anti-wrinkle

cover up (hide) age spots (blemishes, dark pigmented areas)

temporarily reduces depth of wrinkles by moisturisation

feel (look) younger (youthful)

anti-ageing (antiwrinkle)

any references to fading age spots (depigmentation, bleaching of the skin)

helps prevent (reduce, slow) the signs (appearance) of ageing (age lines, premature ageing)

eliminates (prevents, stops, reduces, slows, reverses) ageing (wrinkles, premature ageing, ageing process)

moisturise ageing skin smooths wrinkles Astringent

refreshes1 (warms, cools, tightens, tones) skin Usually contains alcohol or equivalent

Cosmetic sense of astringent by means of physical surface effect (eg. aftershave lotion).

 

bio (biological)

1

Bio, biological

energizes (stimulates, invigorates) skin2 2

decongests skin removes toxins stimulates circulation

action (mechanism) due to biological/ physiological activity bio-active (-cellular) biological performance (function) growth (repair) (metabolism) (structural change)

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Comedomes, acne, pimples, blackheads

cleaner for acne-prone skin

 

prevent (stop) (heal) comedones (pimples) (acne) (blemishes)

 

any reference to treatment (reduction) of cellulite (orange peel skin)

cover (hide) comedones (acne, blemishes) removes oil Contour creams3

 

See also - Astringent, Skin 3

enhances (smoothes) (contours) your silhouette lose inches, removes fat reduces (controls) puffiness (swelling) (oedema) restructures skin slimming tighten (firm) sagging skin (eyelids) (chin) (muscles) Dentifrice NB: In terms of Section 7 of the Therapeutic Goods Act 1989, toothpastes are declared to be ‘not therapeutic goods’ providing: 1. the product is not subject to poisons schedules; 2. it contains 1000mg/ kg or less or nil of fluoride ion; and 3. claims are restricted to oral hygiene or the use of fluoride to help prevent tooth decay.

cleans (whitens, brightens polishes) teeth removes stains prevent (reduce) plaque (tartar) build-up (deposit) by brushing (other mechanical means) helps maintain healthy teeth and gums

 

any implication of effect below the gumline references to abscess, antiseptic action, gumboil, gingivitis, inflammation of gums, mouth ulcers, periodontitis, pyorrhoea, periodontal disease, sensitivity, stomatitis, thrush

tooth decay - fluoride protects against, reduces cavities

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Deodorant

absorbent that helps keep you dry

helps keep you dry

controls moisture (sweat) (perspiration)

anti-odorant (deodorant)

Antiperspirants are regulated as therapeutic goods 4

fights bad odour kills odour-causing bacteria Hair

removes (washes) (cleans) loose dandruff (flakes) from the hair

makes your hair stronger

alopecia

help make hair look thicker (fuller)

prevent (stop) (cure) hair loss, hair thinning (baldness)

revitalise appearance (look) of hair, restore beauty (lustre) (sheen) to the hair

replace thinning hair restore hair cells

promote lustre healthy5 looking (healthy glowing) appearance

control (eliminate) dandruff dandruff (anti-dandruff) shampoo (formula)

add body to (colour) (alter shape of) hair

Healthy

antiperspirant4

stimulate hair follicles (growth)  

healthy (healthy tan) promotes (restores) health

feels healthy5 “Healthy” in the sense of “clean.” 5

Mouthwash

fight (reduce) (end) bad breath (mouth odours) helps eliminate (kill) odour -causing bacteria (bacteria that cause bad breath)

Nails

repair fingernails

references to plaque or tartar (see under Dentrifrice)

antiseptic (antiviral) germicide kills pathogens (germs) (odour-causing germs) antibacterial (antimicrobial)

reference to growth resulting from protection of fingernails (eg. by a nail hardener)

reference to growth resulting from nourishing fingernails

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Nourish

 

nurture (take care of)

nourish (in the sense of promoting growth) (skin) (hair) (fingernails) (tissue)

Perfumes (fragrances, colognes, toilet water)

 

 

any implication of hormonal attraction reference to relieving stress or improving physical well-being (ie. health)

Relax

relax (moisturise) skin (taut skin)

reference to relaxing the body (unless this is in the sense of bath oil in a warm bath)

relax muscles

Repair

repair beauty (appearance)

 

 

Respiration

reference to nonclogging, letting skin breathe

 

cellular respiratory factor

moisturise the skin so that complexion looks radiant

revitalise (skin) (scalp) (hair)

rejuvenate, revitalise living tissue (eg. hair follicles), living cells

purify

antibacterial (antimicrobial)

Revitalise

reference to stress

promotes skin respiration

revitalise the appearance (the look) of skin, hair, scalp, face Skin - (Cleansers, Soap) helps eliminate odour caused by bacteria cleanse oily skin · removes top layer of dead skin

antiseptic / disinfectant (fungicide) (germicide) (virucide)

cleans all types of skin (not just oily)

reference to diseasecausing organisms, kills pathogens

cleans skin clarify, purity

anti-blemish cream cleans cuts (wounds) helps control (treat) infection (jock itch)

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Skin - (Facial Peels)

facial scrub

keratolytic

remove (reduce) scars (permanent markings)

moisten (hydrate) (lubricate) (soften) skin dried (chapped) by the elements

chapped skin

reference to numbing (pain) (analgesic effect)

long lasting protection

desensitize (makes less sensitive)

smooths (retextures) skin removes top layer of dead skin Skin - (Moisturisers)

promotes elasticity (suppleness) cools skin desensitize razorburned skin (eg. aftershave lotion) prevent (protect) skin (dry skin) (lips) chapped (dried) against the abuse of the elements (solvents)6

feel (look) young (youthful)

reduce (prevent) irritation

relieves (soothes) abrasions (bites) (insect bites) (cuts) (nicks) (irritated skin) (inflamed skin) (rashes)

prevent (protect) damage (drying) relieves (soothes) itching (due to dry skin) soothing agent7 Soothes wind-burned skin, for example 7

relieves (soothes) (softens) skin (dry skin) (lips) chapped (dried) by wind (cold) (elements) soothes skin, makes skin feel fresher, smoother firms top layer of skin (temporary effect only) Barrier creams, for example 6

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Sun, suntan products, aftersun treatments, sun protection, tanning accelerators

gives skin a bronze reference to achieving (suntanned) colour your darkest tan with (appearance) (i.e. dyes)8 less time in the sun

prevents (protects) tan enhancer NB: Primary sunscreens against drying effects of (magnifier) and secondary the sun sunscreens which moisturiser-type state an SPF number, claims for aftercategory description sun moisturising or other therapeutic creams (e.g. soothes use are regulated as [moisturises] skin after therapeutic goods. tanning) Secondary sunscreens with no claimed SPF “...with sunscreen” number, category - only acceptable for description or other a cosmetic if there is therapeutic use may be no statement of SPF marketed as cosmetics.9 number, sunscreen ‘category description’ (Aust Std) or other therapeutic use.9 Therapy, treatment

care

bath (beauty) (dry skin) treatment (therapy) treatment on surface of skin

helps protect (prevent) the skin against burning (harmful effects of UVrays) (sunburn) (photoageing) SPF number or sunscreen category description (Aust Std)9 accelerates (speeds up) (activates) suntan pre-tan (tanning) accelerator reference to allowing you to stay out in the sun x times longer screens (blocks) (filters) out some of the sun’s UV (UVA/UVB/UVC) (harmful) rays reference to disease control (treatment) (healing) medicated (therapeutic) treatment for infections (burns)

Vitamins [NB: Oral vitamin supplements are regulated as therapeutic goods, as are topical products containing vitamins (eg. creams) if intended for a therapeutic effect]

 

 

any reference to the nutrient (therapeutic) effects of vitamins

Dyes, some barrier creams, self tanners, sunless tanners for example. (This type of product should include a warning that it does not provide sun protection.) 8

The two exceptions to this are tinted facial make-up products (other than moisturisers) and preparations for application to the lips which are tinted and unmedicated ie. these products may state the actual sun protection factor & equivalent category description. 9

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Part 4: Quality Control Considerations 1. Microbiology and personal care Micro-organisms are organisms that are too small to be seen with the naked eye. They become a problem when they cause spoilage. For personal care products, microbiological contamination can render entire batches un-saleable and potentially dangerous, costing companies thousands or millions of dollars in product waste and bad public image. Micro-organisms need water to grow; therefore any product containing water, or which has water introduced to it during consumer use (this includes a humid environment), is at risk of microbial contamination. Micro-organisms require specific conditions to grow. They require water; an energy source (commonly carbon based molecules such as those found in oil); nutrients such as proteins, extracts, vitamins; optimal temperatures (around room temperature); pH and the presence or absence of oxygen. Table 1 summarises the ideal growth conditions of the types of micro-organisms that can contaminate personal care products. Table 1: Characteristics and growth conditions for bacteria, yeast and mould Microbe

Average Size

Bacteria

2μm long; 0.5μm diameter

Growth (reproduction) Binary fission (exponential)

Temperature

Aerobic/

pH

anaerobic Thermophiles >40°C; Mesophiles 20-40°C; Psychrophiles <20°C.

Water requirement

Aerobic, facultative anaerobes, anaerobes

6-8

High requirements

Mould

1 – 30μm Hyphae (aerial – Best at 25°C light weight and easily spread)

Aerobic

5-6

Low requirements

Yeast

5 – 8μm

Anaerobic

5-6

Low requirements

Budding

Best at 25°C

When conditions become adverse, some bacteria can form endospores: protective coatings which protect the nucleoid when the bacteria would otherwise die. These endospores can resist heat, radiation and other chemicals that would otherwise be lethal. When conditions become favourable again, a vegetative cell can germinate from the spore and begin reproducing. Endospores take around 10 to 15 hours to form, so rapid introduction of heat, radiation or chemicals can effectively kill bacteria that has not managed to form protective spores. Germination, on the other hand, can occur rapidly, in as little as 15 minutes. Consider now your jar of moisturising cream. It is a water rich source of various hydrocarbons, with added and naturally occurring vitamins, minerals and amino acids; pH regulated to around 5.5, stored at room temperature (25°C), readily exposed to oxygen. No wonder personal care products are an ideal medium for prolific growth!

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1.1 Microbial limits Microbes can be potentially dangerous and disease causing. In order to ensure the safety of personal care products, there are limits which you should ensure the finished product can maintain throughout its shelf life, including allowances for the introduction of many various types of microbes added as a person dips their finger in the cream or exposes it to air. Ensuring finished product is within these limits not only ensures consumer safety, but also the shelf life of the product without the appearance of unsightly colonies forming. The growth of microbes also results in the release of toxic by products; these by products can alter the pH of the product, cause undesirable odours and also be dangerous to humans; another reason to ensure growth can not occur. There are no microbial ‘limits’ for Australian personal care products other than ensuring the safety of a product for consumer use. There are, however, limits set for therapeutic goods in Australia (set by the Therapeutic Goods Administration [TGA]); and cosmetics in the United Kingdom as set by the CTFA. Both of these limits can serve as a good guide as to what would be considered ‘safe’. These limits assume that microbial growth will not occur after the product is filled into its final package, and are outlined below.

Org. TGA

Product Type General

Microbial Limits Total microbial count not more than 200 per mL or per gram, amongst which there should be: • no pseudomonads • no Staphylococcus aureus

TGA

Oral care (no natural components)

Total microbial count not more than 2000 per mL or per gram, amongst which there should be: • not more than 200 yeast and mould • not more than 200 enterobacteria • no E Coli in 1mL or 1g • no salmonellae in 10mL or 10g

TGA

Oral care (with natural components)

Total microbial count not more than 20,000 per mL or per gram amongst which there should be: • not more than 200 yeast and mould • not more than 200 enterobacteria • no E coli in 1mL or 1g • no salmonellae in 10mL or 10g

UK CTPA General

Total microbial count not more than 1000 per gram or per mL, amongst which there should be: • no gram negative bacteria, particularly Pseudomonas aeruginsa

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UK CTPA Eye area and babies

Total microbial count not more than 100 per gram or per mL, amongst which there should be: • no gram negative bacteria, particularly Pseudomonas aeruginosa

1.2 Finished product testing The following testing requirements apply only to products containing water, or those that will have water introduced to them during use. Finished product should be moved as soon as possible from the processing vat after completion to reduce the risk of bulk contamination through condensation. Once processing is complete, move the bulk to suitable storage containers while awaiting microbial results in preparation for filling. Always wait for bulk test results to pass testing before filling into final packaging – it is too late when it is packed to take it back for further processing or dumping.

Finished product should be sampled: • at the completion of the bulk product before release for filling AND • at the beginning, middle and end of the filling process OR • if filling is going to take longer than one day, at the beginning, middle and end of each day of filling. Figure 1 shows when to release, retest or reject product.

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Figure 1: When to release, retest or reject product samples:

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1.3 Raw material and finished product quality control In order for your products to sell successfully, they must look professional and be suitably presented to make a consumer want to purchase the product and trust that they have been manufactured in a way that ensures they are safe to use. In particular, there are two key elements you should be checking during and on completion of manufacture: the raw materials, and the finished products. Since you are selling natural products from Indigenous groups, it is even more important to ensure the products are of a consistent, professional level and do not look homemade or backyard produced.

1.3.1 Raw materials Make sure your raw materials are of consistent quality. This means consistent appearance, smell, colour etc. Since you are using natural materials, there will be some batch-to-batch variation; this is to be expected. However, raw materials that are significantly different in colour, aroma, texture and so on, are not acceptable and will cause too much variation in your finished product. Consumers want to be able to consistently purchase the same product knowing it will look, smell and perform the same each time. Where you allow too much variation in raw materials, it will adversely affect repeat sales and limit the success of your brand. Before releasing raw materials to be used in manufacture, they should be checked to ensure they are of the required quality. Where they are not suitable, send back to your supplier and ask for replacement products plus the postage costs.

1.3.2 Finished product Consumers will not purchase a product where it looks damaged, an odd shape, colour or smell, or where labels are peeling off, are crooked or where the product looks, smells or feels otherwise unprofessionally made. It is important to ensure that every product manufactured is of a consistent colour, shape, smell, performance and presentation. This also applies to your finished product packaging. Before releasing product for sale, make sure they are professionally presented and consistent with previous batches. For example, soaps should be of a consistent size and shape; and should be smooth and even without lumps; and cut square if appropriate. Labels should be applied firmly and squarely to the product without peeling or loose edges. Boxes, if used, should not look tattered or damaged. It is a legislative requirement that all products contain the minimum volume or weight that is printed on the front of the packaging. It is your responsibility as the manufacturer/producer of these products to ensure they meet this requirement. Where weights may vary, the minimum weight must be presented on the packaging to ensure compliance with this requirement. Where product is not suitable, it should not be released for sale. The damage to a brand goes far beyond replacement costs – it could lead to no purchases of product, both now and in the future!

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2. Raw material microbiological control Raw materials form the basis of your finished product; so it is imperative they are not a ready source of microbial contamination. Each raw material must be assessed as to its ability to impose excessive bioburden on the finished product, by considering their microbial risk classification: microbial risk classification – some raw materials are more susceptible to carrying micro-organisms while others are inherently anti-microbial. Obviously a raw material that is unable to support the growth of a micro-organism requires little if any testing; while others may be potent sources of micro-organisms. This classification system is composed of: • MRC 1 – inherently antimicrobial non-aqueous materials. You would only test these if packaging is damaged or the product looks or smells suspect. This category includes: • preservatives in powder or flake form. • materials whose composition or processing methods provides a broad spectrum antimicrobial function; for example, glycerin; glycerin, or ethanol based extracts; and essential oils. • MRC 2 – preserved raw materials with an aqueous content. You would test these items for a minimum of three batches (from the one supplier) and ensure they pass, before then testing occasionally, for example, every third or fifth batch. This category includes: • naturally derived raw materials that have been synthetically processed, with a free water content and added preservatives (for example, plant derived surfactants provided as 30 or 70% dilutions). • synthetic raw materials dispersed or processed with water with added preservatives. • MRC 3 – materials that pose significant microbial risk. You would test these items every batch. This category includes: • mineral and terrestrial materials such as talcs, clays, kaolin, bentonite and some coloured pigments. Talc, kaolin and bentonite can contain deadly Clostridium species, so should be purchased already decontaminated, and still tested on arrival. • botanical materials such as natural gums, thickeners, starches and powdered extracts. • animal materials where applicable.

Natural, water friendly raw materials pose a microbial risk under most circumstances. In order to reduce the risk of contamination from these raw materials: • source your raw materials only from reputable suppliers who are able to provide you with documentation of testing and quality control details of the batch. • check batches and do not order from suppliers where there is frequent contamination or unsatisfactory documentation. • store raw materials in a clean, dry area of the warehouse free from external sources of contamination. Monitor stored raw materials and retest if suspect. • introduce the raw material in to bulk manufacture at a stage where it can be exposed to high temperature processing.

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• ensure adequate preservative is used in the raw material.

General microbial limits for raw materials should be set at: • total microbial count 100 per mL or per gram, amongst which there should be: • no pseudomonads • no Staphylococcus aureus • no E coli • no salmonellae

2.1 Water Water often makes up the majority of a product, so its purity is essential. Water is also used in the cleaning process, and the dilution of cleaning agents; and must therefore be tested regularly to ensure quality. Only treated mains water should be used for washing equipment. It can also be used to dilute cleaning solutions and sanitising preparations, and should not be used in the final rinse of equipment or surfaces. The mains/rain water used by your premises should be tested routinely to ensure it is free from E. coli. These conditions only apply to products being manufactured without the use of water. If products are being manufactured with the inclusion of water, then rinse water must be the same as process water, which must meet a high standard of cleanliness. For this reason, no water based products should be manufactured by ABT.

3. GMP to limit microbiological burden GMP stands for Good Manufacturing Practice. It means following a set of principles designed so as to reduce the introduction and risk of microbial contamination from the raw materials used in a product; through production, filling and packing to ensure a finished product that always falls below microbial limits.

3.1 Facility and equipment Within the facility: • all walls, floors and ceilings should be smooth, non-absorbent, easily cleaned surfaces. • the production area should not be used as a thoroughfare. • floors should be cleaned daily using a hot detergent solution followed by a disinfectant; walls and ceilings will also need regular cleaning. • raw materials should be stored in clean, dry areas, off the floor and separate to manufacturing areas.

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• air should be filtered and provide positive pressure from manufacturing rooms out into the warehouse to expel dust and reduce the possibility of any dust entering from the warehouse. • written procedures detailing how and when to clean each part of the facility should be prepared and used for training. • record sheets should be used to record compliance with procedures and detection of any shortcomings of the cleaning process. • toilets and washroom areas should not directly communicate with the production area. Equipment: • all equipment that comes into contact with product should be 316 stainless steel. • design of equipment should be such that there are no ‘dead legs’ where product can stagnate; extra care should be taken with pipes, joints, pumps and valves. • pipes should be kept short as possible and right angled joints avoided so as to ensure easy cleaning. • pipes should always have a slope so they can drain. • vats should be fitted with removable lids where possible. • written procedures detailing how and when to clean each part of the equipment should be prepared and used for training; along with clean stickers to mark when equipment has been cleaned and to avoid the possible misuse of un-cleaned equipment.

3.2 Cleaning and sanitising Where possible, cleaning should occur at different times to manufacturing and filling; and in different parts of the facility. Cleaning and sanitisation procedures should encompass: • written procedures for every piece of equipment and part of the facility as outlined above. • training should be conducted regularly on cleaning to ensure staff understand its importance and are cleaning in accordance with the procedures. • equipment that comes into contact with product must be completely stripped down, cleaned and sanitised after every use. • equipment should be first thoroughly washed using a hot detergent solution, followed by thorough rinsing with water, then wiping over with disinfectant, and finally rinsed using water and allowed to air dry. Once it has air dried, it should be stored with all open ends covered. • equipment should never be left with product in it for prolonged periods; and definitely never overnight. • during short breaks product should be covered to minimise air contact or replacement staff scheduled over breaks so as to continue production/filling. • if equipment has not been used for some time, it should be re-sanitised before using again. • regular swabs should be taken to ensure cleaning has been effective.

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3.3 Hygiene and training Staff should: • wear appropriate, clean clothing, shoe covers and hair nets in the production areas. • wear powder free gloves and face masks around open product. • wash their hands before starting work and after using the toilet. • report skin infections or respiratory conditions, and be placed away from direct contact with product. • not smoke, drink or eat within production areas. • observe hygiene rules at all times. Training should: • include microbiological training for all staff at induction; emphasizing how contamination can occur and its impact on the business and company image. • be regular and recorded on various aspects of GMP.

4. Sanitisation and sterilisation Microbicidal agents kill micro-organisms causing their numbers to decrease. Bacterial spores may remain however, if the agent is not strong enough to kill these too. Microbicidal agents can perform various levels of decontamination: sterilisation – destroys all micro-organisms including spores. disinfection – removes most microbes but does not remove bacterial spores. sanitisation – cleaning methods that remove dirt and microbes, generally enough for food establishments.

4.1 Cleaning methods for your facility At a minimum, the following procedures should be incorporated: • cleaning of equipment and premises using hot detergent to remove residues of product/debris, then rinsed using sterile water, followed by disinfection with a 200ppm chlorine solution (from properly prepared hypochlorite solution). Floors and surfaces that do not come into contact with product do not need further rinsing; however equipment that does come into contact with product will then require a further rinse with water. Equipment cleaned this way should be allowed to air dry and then be stored in clean, dry conditions until required. • positive air flow incorporating air filtration suitable for room and facility size.

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References and Additional Reading: Australian Competition & Consumer Commission: www.accc.gov.au

CosIng website (for INCIs): http://ec.europa.eu/consumers/cosmetics/cosing/

Cosmetics and Toiletries Ingredient Labelling: http://www.accc.gov.au/content/item.phtml?i temId=323594&nodeId=38610870513459eafa806ca2b89133a4&fn=Product%20safety%20 guide%E2%80%94cosmetics%20and%20toiletries.pdf

NCCTG Cosmetic Claims Guidelines: http://www.tga.gov.au/docs/pdf/cosclaim.pdf

NICNAS: www.nicnas.gov.au

NICNAS Cosmetic Claims Guidelines, 2007: http://www.nicnas.gov.au/Current_Issues/Cosmetics/ Cosmetic_Guidelines_PDF.pdf

TGA: www.tga.gov.au

Trade Measurement (Prepacked Articles) Regulation 1991: http://www.legislation.act.gov.au/sl/1991-29/ current/pdf/1991-29.pdf

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