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FREQUENTLY ASKED QUESTIONS

We know the development and formulation process can be overwhelming. There are so many moving parts and timelines can end up longer than anticipated.  One of the best ways to ensure your project runs smoothly is to understand the entire product development and formulation process as best you can. 

Below are some of our most frequently asked questions to help get the ball rolling. Do you still have a question or require more information? No problem, simply contact us with your query.

PRODUCT DEVELOPMENT AND FORMULATION

What is the process to create a new product?

The skinterest process to create a new product is as follows:

1. The client completes a briefing form (which we provide) that outlines the requirements and anticipated claims for the product

2. The skinterest team review the brief

3. A project scope call is held where the skinterest team will highlight any concerns or raise any questions from the brief to ensure all parties are aligned on the product specifications

4. A project quote is submitted for review, once the client approves the quote an invoice is generated

5. Once the invoice is paid, the skinterest team begin drafting a formulation and experimenting. Subject to no delays on obtaining any ingredients that skinterest might not already have in stock, generally the first sample is mailed in 2-4 weeks after starting the process

6. Once the sample is received  client feedback is provided and if required, formulation tweaks are made up to and including v3, which is included in the formulation price

7. Once the formula is approved, product documentation is issued (including full formulation, proposed manufacturing process and product specifications which becomes the intellectual property of the client), you can then take this to the manufacturer of your choice and get quotations

8. If you’d like to have the product shelf-life substantiated, we can perform accelerated stability and compatibility testing, and also recommend preservative efficacy testing. Whilst these tests are not required by law for cosmetic products in Australia they are highly recommended. 

This blog also covers product development steps and timeline and may be helpful.

How long does it take to create a product?

The time from idea to launch varies with so many factors. The first is if you are looking to create a cosmetic or a therapeutic product. Therapeutic products (such as a primary SPF) have testing and substantiation processes mandated by the TGA that must be completed prior to launch and even within the realm of SPF additional claims (such as ‘water resistance’) may take additional time.  You can view our recent blog that outlines the product development steps, estimates their timing and provides hints to speed up the process. 

What is a benchmark product? Do I need one?

Benchmarks refer to existing reference products in the market that illustrate the various attributes that you wish to exist in your final formulated product. This may relate to the colour, texture, smell or performance of your product, and are strongly encouraged. 

Using benchmark product/s is helpful to clearly articulate the desired outcomes for your product without the challenge of interpretation. For example, one persons ‘runny’ might be another persons ‘sticky’ – where as a physical and tactile item for comparison leaves little room for interpretation. 

How do I know if my product is a cosmetic or a therapeutic?

This article outlines the difference between cosmetic and therapeutic goods in Australia and here is a decision tool that can be completed to confirm where your product falls.

If you are still unsure please contact us we are happy to recommend a regulatory expert that can assist.

Will my SPF formulation be a therapeutic or cosmetic product?

Unfortunately, this is not as straightforward as simply if your product contains an SPF it is therapeutic or not.

Whether a sunscreen is considered cosmetic or therapeutic varies with an array of factors but largely relates to whether the ‘primary’ function is to protect the skin from the sun or the ‘secondary’ function is to protect the skin, with the primary function being something else, such as moisturise or colour the skin for example. A product can switch between being primary or secondary SPF depending on the claim, but also with the changing of a single word.

A summary of items below that affect if a product is cosmetic or therapeutic for guidance, however we always recommend engaging a regulatory consultant as early as possible.

  • The labelled SPF – a sunscreen with an SPF of 15 or below is usually classed as cosmetic 
  • Tinted or untinted – a sunscreen with an SPF over 15 is a therapeutic, unless it is tinted
  • Broadspectrum – this is compulsory for all products, with the exception of colour/lip products with an SPF of less than 30 (this also must be substantiated with testing)
  • Claims – Any claim in relation to skin cancer makes a sunscreen therapeutic (anti-aging claims are allowed)
  • Lip balms and sticks can claim up to SPF50+ and remain as a cosmetic product

Colour cosmetics (including tinted moisturisers, foundations) can be labelled up to SPF50+  and be considered a cosmetic with consideration of the above.

You can learn more via the TGA here

What testing do I need to do on my product before I go to market?

This depends on the type of product you are creating, and what claims you would like to make about how it performs. We suggest you review the TGA’s definitions of either a cosmetic or a therapeutic product and you can use this TGA tool to confirm where your product sits.

For cosmetic products, based on the assumption that they are formulated using approved ingredients (Industrial Chemicals Act 2019) then no testing is legally required prior to launch the product. The exception here would be to back up any label or product claims, such as ‘dermatologically tested’.

Despite this, we highly recommend undertaking both Preservative Efficacy Testing (PET) and Stability/Compatibility testing. These tests help ensure your product is safe, the preservatives are working well and also help substantiate your shelf life and PAO (period after opening)claims.

In addition, you should always engage a regulatory consultant to ensure you are meeting your compliance and labelling requirements.

What are the benefits of using a chemist to formulate my product?

Essentially there are 5 options for formulating a product, each with their own pros and cons. 
1. Formulate the product yourself
2. Recruit an in-house formulator for your brand
3. Use a contract manufacturer, often referred to as ‘private labelling’
4. ‘Rent’ an ‘off the shelf’ formula from a manufacturer, often referred to as ‘white labelling’
5. Hire an individual formulator or chemist or an independent professional organisation such as skinterest

Using a professional formulator or organisation is the best way to acquire a custom formulation while ensuring that the IP is owned by the brand. It allows you to have direct communication with the chemist that is formulating for you, with less chance for confusion and communication errors. The commercial value of owning your own IP/formula should also be considered. 

The short term costs will likely be higher than formulating via a manufacturer, however being able to shop your formula to various manufacturers will deliver longer term savings and flexibility. In addition, the skinterest team have an intense focus on controlling formulation costs. We do this through reverse costing client targets to understand material costs necessary to achieve the target. We also add other manufacturer costs including packaging, labour, overheads plus the manufacturers margin to ensure your formula cost is within your desired target. 

SKINTEREST SERVICES

What kinds of products do you have experience with?

skinterest primarily focuses on cosmetics, personal care, topical therapeutics, and related products. The team have experience with cleansers, moisturisers, serums, sunscreens, face and hair masques, shampoo and conditioner and colour cosmetics. The team can formulate products that are powders, creams, washes, mousse, aerated and airless pumps, hard gel capsules, sticks and foaming items.

Do you have your own brand?

No – we enjoy working on other peoples brands so much that we have no desire to create our own! We believe that this is the best way to ensure we are not competing with our clients, and that there is no conflict of interest.

Do you sell samples?

No. As all our formulations are bespoke and created based on a unique brief so we do not have ‘ready made’ samples available to sell.

Can I buy a formula that already exists?

No. skinterest develops products to a brief so that our clients ultimately own their unique formulas. We don’t create formulations and then sell them to multiple people (this is typically the domain of contract manufacturers). We also don’t have code stock/white label products that we adjust for clients. We feel that doing this is counter intuitive to being able to create unique formulations our clients own.

Do you own the IP/rights for my product?

No, once a project is complete our clients receive the transfer of IP with their formulation documentation.

The terms of skinterest outline that following payment and completion of the project we irrevocably and unconditionally assigns all current and future rights to the client.

Do you test the products you develop on animals?

Absolutely not, cosmetic testing on animals is banned in Australia.

Where dermatological studies have been undertaken; these are performed on human subjects using standard test procedures such as Repeat Insult Patch Testing (RIPT) or Cumulative Irritancy Testing (CIT) on willing test subjects under the guidance of ethics committees.

However, it should be noted that many ingredients used in cosmetics have been tested on animals prior to the ban on 1 July 2020 where new ingredients used exclusively in cosmetics cannot use information from animal testing to prove safety.

What testing services do you offer?

We offer a variety of testing services which you can see here.

Most testing is done in house at the skinterest laboratory, however some tests are completed at a partner laboratory, with the testing coordinated and overseen by skinterest. We will also review and consolidate any results on your behalf.

The most common testing we perform is accelerated and real time stability testing and preservative efficacy testing (PET) which are reccomended for all cosmetic products.

What is shelf life or stability testing and how does it work?

We undertake stability and compatibility testing to help estimate the shelf life and period after opening (PAO) of a product. In Australia, there is no requirement to outline the shelf life of a cosmetic on packaging, however it is required for therapeutic products and is required in some areas outside of Australia.

Stability testing refers to physicochemical testing performed periodically on the formulation to assess how stable it is over time, the aim being to have a product that has comparable properties at the completion of testing as was found at the start of testing.

Tests include the assessment of appearance, odour, pH (acidity/alkalinity), viscosity/rheology in addition to freeze-thaw cycling and in some cases active ingredients. The duration of testing varies with the type of stability testing and conditions, for example, ‘real-time’ testing is performed at room temperature for the duration of the proposed shelf life, ie 24 months for a 2 year shelf life, whereas ‘accelerated testing’ is performed at elevated temperatures for 6 months for the same shelf life. The testing is performed at intervals or time points, throughout the test period.

Accelerated testing can cause reactions and degradations that won’t necessarily occur at ambient conditions so the results are more interpretive as a result. Real time testing is more reliable, however, time rarely allows us to wait that long!

Compatibility testing is interlinked with stability testing, extending further to include assessment of the packaging itself and how it performs with the formulation. Tests can include leak tests, weight loss, pumps to prime and dispensation rate where relevant. At skinterst we undertake compatability testing alongside stability testing as no additional cost.

What is preservative testing and how does it work?

Preservative Efficacy Testing (PET) is an evaluation of how effective a products preservative system is and how resilient it is to possible contamination. Contamindation can occur during both manufacture, filling and consumer use. Effective preservatives helps to avoid occurrences of spoilage, unsightly mould, foul odours or possibly causing irritation or infection.

The test requires a sample of the product be intentionally contaminated with a known concentration of microbes, stored at controlled temperatures and periodically tested to ensure the microbes are being ‘killed off’. The test has prescribed limits that determine whether it passes or fails, although some interpretation of results is possible with consideration for packaging format and expected consumer use practices.

How long does shelf life, stability and preservative testing take?

Real-time stability testing is the slower stability testing method as it takes the time of the anticipated shelf life. For example, a 24 month test time for a 2 year shelf life.

Accelerated Stability testing and shelf life verification for a therapeutic product is a 6-9 month process to substantiate 3 years (or 4-6 months for 2 years), for a cosmetic product, it is a 4 month process to substantiate 2-3 year shelf life.

Usually we review at the 2-3 month time point and assess any change, and communicate findings so that clients can decide whether the product is sufficiently low risk to proceed to production. Stability testing is typically done in parallel with PET, but doesn’t need to be and will depend on individual circumstances (time constraints, uncertain preservative system etc).

Preservative Efficacy Testing (PET) is a 6-7 week process, with the actual testing process lasting 4 weeks.

Can you help me with an existing product I have?

Absolutely! We offer troubleshooting services to help with problemtic products or formulas that are not performing as intended.

We also offer formulation robustness analysis (FRA) unique to skintererst, which you can learn more about here.

Can you help with packaging selection?

Whilst we don’t sell packaging we have a list of suppliers that we recommend. We can also make suggestions on the most appropriate packaging for your product requirements.

Can you manufacture my product for me?

No, we intentionally operate independently of, and separate to the manufacturing environment. We are able to make very small scale batches (up to roughly 5kg) for market research or other sampling requirements.

We can also offer our consulting services and support with the scale up process for your product, and are available to attend manufacturing productions across Australia and New Zealand.

Can you help me work with my manufacturer?

Sure! Many of the skinterest team actually have previously worked for manufacturers across Australia, so we know how they operate. The team are available at hourly rates to consult on manufacturing issues, as well as to attend scale up or other batch supervision services.  Get in touch to see how we can help with any manufacturing challenges you might be experiencing. 

How long does it take to formulate a cosmetic product?

How long the product development process takes (for both cosmetics and therapeutic/SPF products) is extremely varied and depends on a handful of factors. You can read our blog here to learn more.

Can you help with an organic/vegan/natural product?

Absolutely! However, we always caution against greenwashing, or using vague, unsubstantiated or unaccredited claims. We can formulate within established guidelines with parameters, for example COSMOS. The skinterest formulation process includes working with our clients unique brief and formulating in line with a brand ethos and positioning, get in touch to discuss your needs.

We also highly recommend engaging a regulatory consultant, (even if your product is not therapeutic) to ensure that any claims being made are not misleading or illegal. Contact us if you would like an introduction to a regulatory consultant who can assist you in this area.    

 

How much is it to make a new product?

Due to the bespoke nature of our work and not offering ‘off the shelf’ or white label formulations we need an understanding of your product before we can accurately quote. Contact us, book a free consultation and we can discuss your requirements.

We would never share your great ideas outside the skimterest team, however if you would like an NDA in place before we speak we have a template you can use here

What is your payment process and terms?

We require full upfront pre payment before we begin formulating your product however testing costs will not need to be paid before the formulation begins. Prepayment is required before testing begins, however we are happy to invoice this only once the formulation is approved and finalised, helping you better distribute development expenses.

We accept both credit card (third party fees apply) and bank transfer.

What is the process to work with you?

The process to work with skinterest to formulate your product is generally as follows:

  1. Complete our brief document (or you can supply your own)
  2. The technical team will review your brief, ensure we think the project is achievable and flag any items for discussion
  3. We have a phone or video call to discuss the reviewed brief, this ensures that we are aligned on the project expectations
  4. You make any tweaks to the brief before it is finalised
  5. We will provide a quote, once approved an invoice is sent
  6. Once payment is received we begin to draft a formulation, source suppliers for materials we may need and experiment with concepts
  7. We then then issue you a sample for evaluation. This typically happens within 2-4 weeks (pending receipt of any ingredients we don’t have in our inventory)
  8. You’ll evaluate the samples and provide feedback, we’ll then modify and optimise the formulation (if required)
  9. Once the formula is approved we provide you with a full formulation, proposed manufacturing process and product specifications, which becomes your intellectual property, you can then take this to a contract manufacturer of your choice and get quotations, (we can also help with manufacturing recommendations if desired)
  10. If you’d like to have the shelf life substantiated, we can perform accelerated stability and compatibility testing, we also recommend preservative efficacy testing (PET)

Read an overview of the process, and hints to stop delays here

MORE QUESTIONS?

Please get in touch and see how we can help

ADDRESS

3/505 Balmain Road
Lilyfield NSW 2040

 

EMAIL US

info@skinterest.com.au