10 Food Labelling Mistakes That Can Delay Your Product Launch
Launching a new exciting food product in Australia involves much more than developing a great recipe, attractive packaging and a strong marketing strategy. Before your product reaches supermarket shelves, online stores or consumers, its label needs to meet Australia's food regulatory requirements.
Getting that label wrong can be expensive.
A seemingly minor mistake—such as an incorrectly formatted allergen declaration, an incomplete Nutrition Information Panel or an unsupported health claim—can lead to artwork revisions, additional testing, reprinting and delays to your planned launch.
Understanding food labelling regulations Australia businesses must comply with is therefore an important part of product development.
Food Standards Australia New Zealand (FSANZ) develops the Australia New Zealand Food Standards Code, which contains general labelling requirements as well as requirements applying to particular types of foods. In Australia, these standards are enforced by state and territory authorities.
Here are 10 common food labelling mistakes that can cause problems during the final stages of bringing a product to market.
1. Missing Mandatory Information
One of the most fundamental mistakes is designing packaging before determining exactly what information must appear on it.
The Food Standards Code contains numerous labelling and information requirements. Depending on the product, these may cover areas such as food identification, ingredient statements, date marking, directions for use and storage, warning and advisory statements, nutrition information and characterising ingredients.
Additional requirements can also apply to specific categories of food.
Leaving mandatory information until late in the packaging design process can create significant problems. There may simply not be enough space to add everything while maintaining an attractive and legible design.
How to avoid it: Create a regulatory labelling checklist for the specific product before finalising the packaging layout.
2. Incorrect Allergen Declarations
Allergen labelling is one area where mistakes can have particularly serious consequences because consumers rely on this information to make safe purchasing decisions.
Australia's Plain English Allergen Labelling requirements specify how prescribed allergens must be declared.
Allergens generally need to appear using their required names in the ingredient statement, in bold type with a font size no smaller than other listed ingredients. A separate bold allergen summary statement beginning with “Contains” must also appear directly next to the ingredient statement and in the same field of view.
Prescribed allergens include substances such as wheat, milk, egg, peanut, soy, sesame, fish, crustaceans, molluscs, lupin and specified individual tree nuts. Certain cereals containing gluten must also be identified appropriately, while added sulphites require declaration at specified concentrations.
Using outdated allergen terminology or formatting can therefore result in a label requiring correction.
How to avoid it: Review every ingredient, compound ingredient, additive and processing aid for potential allergen declarations and check the final artwork against current FSANZ requirements.
3. Using an Inaccurate Ingredient List
An ingredient statement cannot simply be copied from an early product development specification.
Recipes frequently change during commercialisation. Suppliers may change, ingredients can be reformulated, and compound ingredients can introduce components or allergens that were not obvious in the original formulation.
If the final production formulation and the ingredient statement do not match, the packaging may no longer be compliant.
Ingredient declarations are governed by Standard 1.2.4 of the Food Standards Code.
How to avoid it: Conduct the final regulatory review using the actual commercial formulation and current supplier specifications—not an outdated prototype recipe.
4. Getting the Nutrition Information Panel Wrong
Most packaged foods requiring a Nutrition Information Panel (NIP) must provide specific nutrition information in a prescribed format.
Under Standard 1.2.8, a standard NIP generally includes average quantities for:
- energy
- protein
- fat
- saturated fat
- carbohydrate
- sugars
- sodium.
The information is generally presented per serving and per 100 g or 100 mL.
Errors can occur when businesses calculate nutrition information using an outdated formulation, apply incorrect serving sizes, use inappropriate data or fail to include additional nutrients triggered by claims.
For example, if a product makes a “good source of fibre” claim, dietary fibre information needs to be included in the NIP.
How to avoid it: Make sure the NIP is based on the final formulation and review whether any claims on the packaging trigger additional nutrition declarations.
5. Making Nutrition Content Claims Without Checking the Criteria
Marketing teams naturally want to highlight a product's strongest nutritional attributes.
Terms such as “low fat” or “good source of calcium”, however, aren't simply creative advertising language. Nutrition content claims are regulated.
Standard 1.2.7 establishes requirements for nutrition content and health claims. A nutrition content claim must satisfy the applicable conditions before it can be used. FSANZ notes, for example, that a product carrying a “good source of calcium” claim must contain at least the amount required by the Standard.
Problems can arise when marketing copy is approved before regulatory assessment.
How to avoid it: Treat every nutritional statement on the label as a potential regulated claim and verify the relevant conditions before artwork approval.
6. Making Unsupported Health Claims
Health claims require even greater care.
A health claim connects a food, nutrient or substance with a health effect. Under Australia's framework, health claims must be supported by scientific evidence and comply with Standard 1.2.7.
There are two main categories: general level health claims and high level health claims.
General level health claims may rely on pre-approved food-health relationships or, subject to the Code's requirements, a relationship self-substantiated by the food business. High level health claims must be based on pre-approved food-health relationships. Foods carrying health claims must also satisfy applicable requirements, including the Nutrient Profiling Scoring Criterion (NPSC).
A marketing phrase that sounds harmless can therefore create significant regulatory implications.
How to avoid it: Have proposed health-related marketing language reviewed before incorporating it into packaging, advertising or launch materials.
7. Forgetting That Claims Can Change the Rest of the Label
Another common mistake is reviewing each part of a label independently.
Food labelling requirements are interconnected.
Adding a claim to the front of the package can trigger additional requirements elsewhere. For example, certain nutrition claims require the relevant nutrient or substance to be declared in the Nutrition Information Panel.
This means a last-minute marketing change may require more than simply adding a badge or sentence to the front panel.
It could affect the NIP, supporting documentation and potentially whether the claim can legally be made at all.
How to avoid it: Whenever marketing copy changes, conduct another regulatory review of the entire label rather than reviewing only the amended wording.
8. Overlooking Warning and Advisory Statement Requirements
Allergens aren't the only substances that may trigger mandatory declarations.
Standard 1.2.3 deals with warning statements, advisory statements and declarations. Depending on a product's ingredients and composition, additional statements may be required.
The exact requirements vary considerably according to the food and its ingredients, which makes generic label templates risky.
A label used successfully for one product should not automatically be copied across an entire range without checking whether the formulation introduces different regulatory obligations.
How to avoid it: Assess each SKU individually against the relevant requirements of the Food Standards Code.
9. Treating Label Design as Only a Graphic Design Exercise
A beautiful label isn't necessarily a compliant label.
Branding agencies and graphic designers are experts at creating visually appealing packaging, but regulatory information has its own requirements regarding wording, placement, format and presentation.
Allergen declarations demonstrate this clearly: prescribed allergens must be presented using particular terminology and formatting, including bold declarations and a separate “Contains” summary statement in the required location.
Changing the layout for aesthetic reasons can unintentionally create a compliance problem.
How to avoid it: Build regulatory review into the artwork process. Ideally, review the text before design begins and then conduct a final artwork review before files are released for printing.
10. Waiting Until the Final Week to Check FSANZ Compliance
Perhaps the most expensive food labelling mistake is simply leaving compliance too late.
Imagine that packaging has been designed, thousands of labels are ready for printing, retailers have been given a launch date and a marketing campaign is scheduled.
Then someone discovers that the allergen statement is incorrect or a front-of-pack claim doesn't meet the necessary criteria.
Suddenly the business may need revised artwork, additional calculations, new approvals and potentially reprinted packaging.
The better approach is to incorporate food labelling regulations Australia compliance into the product development process from the beginning.
FSANZ's Code covers general requirements applying broadly across foods as well as specific requirements for certain food categories.
Early regulatory review allows potential issues to be identified while they are still relatively easy—and inexpensive—to fix.
Why Pre-Launch Food Label Reviews Matter
Food labels sit at the intersection of product development, regulatory compliance and marketing.
The formulation determines the ingredient and allergen information. Nutrition data affects the Nutrition Information Panel. Marketing statements can trigger additional nutrition requirements. Health claims can introduce further substantiation and eligibility criteria.
That interconnectedness is why reviewing only the finished artwork can be risky.
A thorough pre-launch assessment should consider the final formulation, supplier specifications, ingredient declarations, allergens, mandatory statements, nutrition information, marketing claims and any category-specific FSANZ requirements.
It should also consider whether the final presentation accurately represents the product. FSANZ notes that food representations are also subject to applicable food and fair-trading laws prohibiting false, misleading or deceptive representations.
Get Your Food Label Right Before You Launch
Launching a food product requires substantial investment in formulation, manufacturing, packaging, marketing and distribution. A preventable labelling problem should not be the reason all that work is delayed.
Understanding food labelling regulations Australia requirements early can help businesses identify compliance issues before packaging goes to print and before launch deadlines become difficult to change.
Regulatory Matters can assist food businesses with regulatory and labelling considerations during product development and commercialisation.
Whether you're developing a new food product, reformulating an existing range or preparing new packaging, obtaining regulatory advice before artwork approval can help reduce costly last-minute changes.
The Complete Product Compliance Checklist for Australian Manufacturers
Australian manufacturers operate in a tight regulatory environment where product safety, accurate labelling, compliant ingredients and defensible marketing claims are essential. Whether your business manufactures cosmetics, personal care products or other consumer goods, compliance needs to be considered throughout the entire product lifecycle—not simply in the final days before launch.
For cosmetic manufacturers in particular, effective cosmetic check procedures can help identify potential regulatory problems before a product reaches consumers. A systematic compliance process can reduce the likelihood of costly reformulation, packaging changes, delayed launches, recalls and regulatory action.
The challenge is that Australian product compliance can involve several regulatory frameworks and authorities. The requirements that apply depend on the type of product, its ingredients, intended purpose and the claims made about it.
This complete checklist outlines the key areas Australian manufacturers should consider when developing, reviewing and launching compliant products.
1. Confirm Your Product Classification
Product classification should be one of the first steps in any compliance assessment.
For cosmetics, classification is particularly important because a product that appears to be cosmetic may actually fall within Australia's therapeutic goods framework depending on factors such as its composition, intended use and claims.
A cosmetic generally has purposes such as cleansing the body, changing its appearance or odour, perfuming it, protecting it or maintaining it in good condition.
Therapeutic products, however, are subject to a different regulatory framework.
For example, seemingly minor changes to advertising language may affect a product's regulatory status. A moisturiser promoted simply as hydrating dry skin may be treated differently from a product claiming to treat a particular medical condition.
Your cosmetic check procedures should therefore begin with questions such as:
- What is the product's intended purpose?
- Where and how will consumers use it?
- What ingredients does it contain?
- What claims will appear on the label, website and advertising?
- Could any claim imply a therapeutic purpose?
Classification should be resolved before investing heavily in packaging, marketing or production.
2. Conduct a Complete Ingredient Review
Ingredient assessment is a fundamental part of cosmetic compliance.
In Australia, cosmetic ingredients are generally regulated as industrial chemicals by the Australian Industrial Chemicals Introduction Scheme (AICIS).
Businesses manufacturing or importing cosmetic ingredients need to determine their applicable obligations. This can involve checking chemicals against the Australian Inventory of Industrial Chemicals and determining the appropriate introduction category and any applicable restrictions.
A thorough ingredient review should consider:
- The regulatory status of every ingredient
- Ingredient concentrations
- Applicable restrictions or conditions
- Australian Inventory requirements
- Poisons Standard implications
- Correct ingredient nomenclature
- Documentation supporting the formulation
Do not assume that an ingredient permitted overseas will automatically satisfy Australian requirements.
Australian manufacturers using formulations developed internationally should conduct a dedicated Australian regulatory review before production begins.
3. Check AICIS Obligations
Businesses introducing industrial chemicals into Australia through manufacture or importation may have obligations under AICIS.
Depending on the circumstances, manufacturers should determine whether business registration is required and correctly categorise their chemical introductions.
Each ingredient may have different requirements.
Manufacturers should also understand applicable declaration, reporting and record-keeping obligations. AICIS requires certain records relating to chemical introductions to be retained for five years.
Building these checks directly into your cosmetic check procedures makes compliance easier to maintain than attempting to reconstruct documentation after a regulatory query arises.
4. Review Product Safety
A legally compliant ingredient list does not eliminate the need to consider the safety of the finished product.
Manufacturers should establish appropriate quality and safety controls based on the product's formulation, intended use, packaging and foreseeable consumer behaviour.
Depending on the product, checks may include:
- Stability testing
- pH testing
- Viscosity and texture assessment
- Packaging compatibility
- Preservative Efficacy Testing (PET)
- Microbiological testing
- Colour and fragrance stability
- Product separation monitoring
- Contamination controls
Appropriate specifications should be established so batches can be assessed consistently.
Stability testing can also provide important information about how a cosmetic behaves throughout its expected shelf life.
5. Check Applicable Mandatory Standards
Australian businesses must determine whether mandatory product safety or information standards apply to their products.
Mandatory standards can prescribe requirements relating to matters such as composition, performance, construction, packaging, labelling and safety information.
Cosmetics have specific mandatory ingredient-labelling requirements under the Consumer Goods (Cosmetics) Information Standard 2020.
Manufacturers should identify all applicable standards before commercial production rather than assuming general quality-control processes are sufficient.
6. Complete a Cosmetic Label Compliance Check
Labels are a frequent source of avoidable compliance problems.
For cosmetics sold in Australia, consumers must have access to ingredient information in accordance with the mandatory cosmetics information standard.
Ingredient information generally needs to appear on the product or its container. Where the nature, size or shape makes this impractical, provisions exist for the information to be prominently displayed alongside the product.
Ingredients generally need to be presented in descending order by mass or volume, although the standard also provides an alternative approach for ingredients at concentrations below 1% and colour additives.
Your label review should check:
- Product identity and description
- Complete ingredient information
- Ingredient ordering
- Legibility
- Required warnings
- Directions for safe use where relevant
- Consistency between formulation and label
- Packaging and accompanying information
The final artwork should undergo a regulatory check before being approved for printing.
7. Review Every Product Claim
Claims can significantly change a product's regulatory risk.
Cosmetic manufacturers should review statements appearing across all consumer touchpoints, including:
- Product labels
- Packaging
- Websites
- Online stores
- Social media
- Digital advertisements
- Retail displays
- Brochures
- Influencer campaigns
Claims must not be false, misleading or deceptive under Australian Consumer Law.
Manufacturers should also be cautious about claims that suggest a product treats, prevents, diagnoses or manages a medical condition. Depending on the circumstances, therapeutic claims can affect how the product is regulated.
This is why marketing review should form part of cosmetic check procedures, rather than being treated as an entirely separate activity.
8. Establish Manufacturing Quality Controls
Compliance needs to continue after the formula and label have been approved.
Manufacturers should establish documented procedures that help ensure products are consistently manufactured according to their specifications.
Quality-control systems may include:
- Approved raw-material specifications
- Supplier qualification
- Incoming material checks
- Batch manufacturing records
- In-process controls
- Finished-product specifications
- Cleaning procedures
- Equipment maintenance
- Batch-release processes
- Deviation management
- Complaint handling
Traceability is particularly valuable if a problem is identified after distribution.
9. Maintain a Product Information File
Every product should have a central compliance record containing the documentation used to support its legal supply.
Depending on the product, this could include formulation details, ingredient specifications, supplier documentation, regulatory assessments, safety data, test reports, stability information, packaging specifications, approved artwork and claims substantiation.
Maintaining an organised compliance file makes regulatory reviews and internal audits significantly easier.
It also creates continuity when staff, suppliers or manufacturing arrangements change.
10. Establish Post-Market Monitoring
Compliance does not finish when a product launches.
Manufacturers should monitor consumer complaints, product defects, adverse reactions and emerging safety issues.
A documented process should establish how complaints are received, investigated, escalated and resolved.
Businesses should also have procedures for responding to serious product problems, including circumstances where corrective action or a recall may be necessary.
A Practical Cosmetic Compliance Checklist
Before releasing a cosmetic product in Australia, manufacturers should be able to answer yes to the following:
Classification: Has the product been correctly classified as a cosmetic rather than a therapeutic good?
Ingredients: Has every ingredient undergone an Australian regulatory assessment?
AICIS: Have applicable registration, categorisation, reporting and record-keeping obligations been identified?
Restrictions: Have applicable Inventory conditions and Poisons Standard requirements been considered?
Safety: Is appropriate evidence available to support finished-product safety and quality?
Testing: Have suitable stability, PET, microbiological and packaging compatibility assessments been conducted where appropriate?
Labelling: Does the ingredient information comply with Australian requirements?
Claims: Have product and marketing claims been reviewed for regulatory risk?
Quality: Are manufacturing and batch-release procedures documented?
Records: Is there a complete compliance file supporting the product?
Post-market controls: Are complaint, incident and corrective-action procedures established?
If any answer is uncertain, further assessment should occur before the product is supplied.
Frequently Asked Questions About Cosmetic Check Procedures
What are cosmetic check procedures?
Cosmetic check procedures are systematic reviews used to assess whether a cosmetic product satisfies applicable regulatory, ingredient, safety, labelling, quality and marketing requirements before and after entering the Australian market.
Who regulates cosmetics in Australia?
Cosmetic regulation involves several authorities and regulatory frameworks. AICIS regulates the introduction of industrial chemicals used as cosmetic ingredients, while the ACCC has responsibilities relating to consumer product safety and cosmetic ingredient labelling. The TGA becomes particularly relevant when determining whether a product is actually a therapeutic good rather than a cosmetic.
Do cosmetics need TGA approval in Australia?
Most products that are genuinely cosmetics are not regulated by the TGA as therapeutic goods. However, a product's ingredients, intended use and particularly its claims can affect classification. Products determined to be therapeutic goods are subject to different requirements.
Do cosmetic ingredients need to comply with AICIS?
Almost all ingredients used in personal care, skincare, make-up and cosmetic products are treated as industrial chemicals for these uses. Businesses introducing these chemicals through manufacture or importation should determine their AICIS obligations for each ingredient.
What should be checked on an Australian cosmetic label?
Checks should include ingredient information, ordering and presentation, legibility and any additional information or warnings applicable to the particular product. The finished label should also be checked against the approved formulation to prevent discrepancies.
How often should cosmetic compliance be reviewed?
There is no set frequency. Compliance should be reviewed before launch and whenever there is a material change to the formulation, supplier, manufacturing process, packaging, label or marketing claims. It should also be reviewed before entering a new market. As regulatory requirements can change at any time they should be monitored on an ongoing basis so products can be reviewed as soon as a change affects them.
Why Work With Regulatory Matters?
Product compliance involves much more than completing a checklist immediately before launch. Decisions made during formulation development, ingredient selection, product classification, testing, packaging and marketing can all affect regulatory compliance.
Professional regulatory support can help manufacturers identify potential issues earlier, develop effective cosmetic check procedures, review ingredients and labels, assess product claims and establish a stronger compliance pathway before products reach the Australian market.
A proactive approach can save considerable time and expense compared with addressing compliance problems after manufacturing, packaging or distribution has already begun.
For Australian manufacturers, the objective should therefore be straightforward: build compliance into the product from the beginning rather than checking for it at the end.
Cosmetic Microbiological Testing: What Australian Cosmetic Brands Need to Know
You have spent months & months getting a cosmetic formulation right. The texture feels good, the fragrance works, the packaging looks exactly as you imagined and the product appears stable.
But there is another question that needs to be considered before that product reaches a customer's bathroom cabinet:What happens if microorganisms get into it?
Cosmetics can provide surprisingly favourable conditions for microorganisms. Products containing water, botanical materials and other ingredients capable of supporting microbial growth can be particularly vulnerable if the formulation, preservation system, manufacturing process or packaging does not provide adequate protection.
That is where cosmetic microbiological testing comes in.
Microbiological testing helps cosmetic manufacturers and brands assess the microbiological quality of their products and identify potential problems before they become much more expensive problems in the marketplace.
For Australian businesses, it should form part of a broader product safety, quality and regulatory strategy rather than being treated as a last-minute box to tick before launch.
What is cosmetic microbiological testing?
Cosmetic microbiological testing is used to determine whether a cosmetic product contains unacceptable levels or types of microorganisms and, where appropriate, whether its preservation system can control microbial contamination.
Depending on the product and the purpose of the testing, this may involve measuring the overall microbial population and testing for particular microorganisms of concern.
International standards provide established approaches for assessing cosmetic microbiological quality. ISO 17516, for example, deals with microbiological limits for cosmetics.
Importantly, testing requirements are not necessarily identical for every cosmetic. The microbiological risk associated with a water-based face cream is very different from the risk associated with some low-water-activity or otherwise microbiologically low-risk products.
The testing strategy therefore needs to make sense for the actual formulation, packaging, manufacturing process and intended use.
Why can microorganisms be a problem in cosmetics?
Cosmetics are not necessarily sterile products, nor are they generally expected to be. The issue is whether microorganisms are present at unacceptable levels or whether objectionable organisms are present.
Microbial contamination can occur through a number of routes, including:
-
raw materials
-
water used during manufacture
-
processing equipment
-
manufacturing environments
-
filling and packaging operations
-
employees handling the product
-
packaging components
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consumer use after opening.
A product may look and smell perfectly normal while still having a microbiological problem.
In other cases, contamination makes itself obvious. A product may develop an unusual smell, separate, discolour, change viscosity or show visible microbial growth.
By the time a consumer notices something is wrong, however, the manufacturer or brand owner may already have a serious quality issue to manage.
Which microorganisms are tested for?
The exact testing program depends on the product, its risk profile and the applicable market or standard.
Microbiological quality testing commonly considers the overall number of viable microorganisms and the absence of specified microorganisms where relevant.
ISO has developed a series of cosmetic microbiology standards covering areas such as enumeration and detection of particular microorganisms.
Rather than simply requesting a laboratory to “test for bacteria”, it is better to establish what testing is appropriate for the particular cosmetic and why.
That distinction matters, especially when products will be sold in several countries.
What is a preservative efficacy or challenge test?
This is an area that often causes confusion.
Routine microbiological testing and preservative efficacy testing, often called challenge testing, are related but they do not answer the same question.
A routine microbiological test essentially asks:
What is the microbiological quality of this product sample?
A challenge test asks something different:
Can this formulation adequately control microorganisms if contamination occurs?
During a preservation efficacy test, the product is challenged with specified microorganisms under controlled conditions. Their survival or reduction is then assessed over defined periods.
ISO 11930 provides an internationally recognised approach for evaluating the antimicrobial protection of cosmetic products.
This can be particularly important for water-containing products that may be repeatedly exposed to contamination during normal use. Think of a moisturiser in a jar: a consumer may open it every day and put their fingers into the product. Compare that with a product in a well-designed airless dispensing system. The potential exposure is quite different.
A good microbiological assessment considers those real-world differences.
Does every cosmetic need challenge testing?
Not necessarily.
Some cosmetic products can be considered microbiologically low risk based on characteristics of the formulation and product. International cosmetic microbiology standards recognise risk-based approaches rather than assuming that identical testing is appropriate for every cosmetic.
However, deciding that a product is “low risk” should be technically justified.
Simply saying that a product contains preservatives, is “natural”, has been sold before or has never generated a customer complaint is not, by itself, a sound microbiological risk assessment.
Factors that may need to be considered include the formulation, available water, pH, alcohol content where relevant, manufacturing process, packaging, intended use and expected consumer handling.
What about preservative-free and natural cosmetics?
“Preservative-free” does not mean “microbiology-free”.
In fact, formulations marketed as natural, organic or preservative-free can require particularly careful microbiological consideration.
Plant extracts, hydrosols and other naturally derived ingredients may introduce their own microbiological considerations, while reducing or removing a conventional preservative system can change the way a formulation responds to contamination.
That does not mean a preservative-free product is automatically unsafe.
It means the manufacturer needs a technically defensible strategy for controlling microbiological risk.
The formulation itself, manufacturing controls, packaging design and product characteristics can all contribute to antimicrobial protection.
When should microbiological testing be performed?
One of the most common mistakes is leaving microbiological testing until the product is effectively ready to launch.
Discovering a preservation problem at that point can mean reformulation, repeat stability work, new samples, packaging delays and a postponed launch.
Microbiological considerations are better incorporated into product development.
Testing may be appropriate during formulation development, before commercial manufacture, as part of stability programs, during production validation or verification, and when significant changes are made to a product.
Changes that appear minor can sometimes matter. A different raw-material supplier, packaging system, preservative concentration or manufacturing process may affect the microbiological profile of the finished product.
Microbiology and stability testing are not the same thing
Another common misconception is that a successful stability study automatically proves microbiological safety.
It does not.
Stability testing looks at how a product changes over time under defined conditions. Depending on the program, this might include appearance, odour, colour, pH, viscosity, packaging compatibility and other relevant characteristics.
Microbiological testing addresses a different set of questions.
The two programs often complement one another, but one should not automatically be treated as a substitute for the other.
For many cosmetic products, considering stability, packaging compatibility and microbiological quality together gives a much more useful picture of whether a product is ready for market.
What are the Australian regulatory considerations?
Cosmetic regulation in Australia involves more than one regulatory framework.
The Australian Industrial Chemicals Introduction Scheme (AICIS) regulates the introduction — importation or manufacture — of industrial chemicals, including most chemicals introduced for cosmetic use.
AICIS does not generally test or approve finished cosmetic products. Businesses introducing cosmetic ingredients need to understand the obligations applying to those chemical introductions.
Cosmetics supplied to consumers can also be subject to Australian consumer product requirements. For example, cosmetic ingredient information is subject to the Consumer Goods (Cosmetics) Information Standard 2020.
Businesses also need to consider whether a product really is a cosmetic.
A product's intended use, ingredients and particularly the claims made for it can affect whether it falls within the cosmetic or therapeutic goods framework. Products presented with therapeutic purposes may fall within the Therapeutic Goods Administration (TGA) framework instead.
This is why microbiological testing should not be considered in isolation from the product's overall regulatory position.
What standards are relevant to cosmetic microbiology?
A number of ISO standards are commonly associated with cosmetic microbiology.
One important example is ISO 17516:2014 — Cosmetics — Microbiology — Microbiological limits.
As at September 2026, ISO 17516:2014 remains the published edition, although ISO is developing a second edition to replace it. Businesses working to ISO requirements should therefore make sure they are referring to the applicable current version rather than relying indefinitely on an old specification or test plan.
Another important standard is ISO 11930:2019, which addresses evaluation of the antimicrobial protection of cosmetic products and includes preservation efficacy testing.
There are also ISO methods covering microbiological enumeration and detection of specified microorganisms.
Which standards should be applied depends on the product, purpose of the assessment and markets in which it will be supplied.
What happens if a cosmetic fails microbiological testing?
A failed result should be investigated rather than simply sending another sample to the laboratory and hoping for a better number.
The real question is: Why did it fail?
Possible causes might include raw-material contamination, inadequate water quality, insufficient cleaning or sanitation, problems during filling, unsuitable packaging or an inadequate preservation system.
The appropriate corrective action depends on the root cause.
In some cases, reformulation may be necessary. In others, the problem may lie with manufacturing controls rather than the formulation itself.
This is one reason good records are so valuable. Batch information, raw-material documentation, manufacturing records, stability data and laboratory reports can make investigations considerably more effective.
Frequently Asked Questions
Is microbiological testing compulsory for every cosmetic sold in Australia?
There is no simple rule that every cosmetic must undergo an identical microbiological test program. The appropriate approach depends on the product, its regulatory classification and its microbiological risk. Businesses should be able to support the safety and quality of the products they place on the market.
What is the difference between microbial limits testing and challenge testing?
Microbial limits testing assesses the microbiological quality of the sample being tested. Challenge or preservative efficacy testing evaluates how effectively the product's antimicrobial protection controls deliberately introduced microorganisms over time. They answer different questions and may both be relevant.
Can a product pass microbial testing and fail challenge testing?
Yes. A sample can have acceptable microbiological quality when tested but still have an inadequate preservation system. That is why a single satisfactory microbial result does not necessarily demonstrate that a formulation will remain adequately protected during its useful life.
Do anhydrous cosmetics need microbiological testing?
Some products with very low microbiological risk may not require the same testing approach as conventional water-based formulations. However, low-risk status should be established through an appropriate risk assessment rather than assumed simply because a product is described as anhydrous.
Does natural mean lower microbiological risk?
No. “Natural” is not a microbiological safety category. Natural ingredients and extracts can introduce different microbiological considerations, and the complete formulation needs to be assessed.
Should microbiological testing be repeated after reformulation?
Potentially, yes. Changes to ingredients, preservative systems, concentrations, manufacturing processes or packaging can alter microbiological risk. The significance of the change should be assessed to determine what additional testing is appropriate.
Can Regulatory Matters help with cosmetic microbiological requirements?
Yes. Regulatory Matters can help businesses understand how microbiological testing fits within a broader cosmetic regulatory and product-development strategy, including product classification, ingredient considerations, stability programs, labelling, claims and requirements for Australian and export markets.
Getting the testing strategy right before launch
Cosmetic microbiological testing is easy to see as another laboratory expense. In practice, it is better viewed as part of protecting the product, the consumer and the brand.
The important question is not simply, “Have we done a microbiology test?”
It is:
“Do we have appropriate evidence that this product's microbiological quality and protection are suitable for its formulation, packaging, intended use and target market?”
Answering that question early can help prevent costly reformulation, launch delays, complaints and other problems later.
If you are developing, importing or exporting cosmetics and are unsure what microbiological, stability or regulatory work may be appropriate, Regulatory Matters can help you identify the requirements relevant to your product and target markets.
Contact Regulatory Matters to discuss your cosmetic product and regulatory requirements.
