Ever feel excited to launch your own product range… until someone mentions “regulatory approvals”? Suddenly, those dreams can hit a wall. The maze of TGA rules, labelling standards, and compliance codes can make even the most passionate founder freeze, second-guess their plans, and wonder where on earth to start.

The truth is, requirements aren’t one-size-fits-all. Depending on your ingredients and how your product is positioned, the rules can shift. Some formulas may need a full TGA listing, while others simply require correct labelling and transparent ingredient disclosure, and it’s not always obvious which applies to you.

Whether you run a wellness clinic, spa, or emerging retail brand, understanding this early isn’t just red tape; it protects your business, builds trust, and keeps your growth on track.

That’s where Miakara steps in – helping you navigate these approvals with confidence, clarity, and the right support from day one.

Understanding Government Authority Over White Label Cosmetics

Main regulatory bodies and their roles

If you’re working with white-label cosmetics, understanding who sets the rules is half the battle. In Australia, the Therapeutic Goods Administration (TGA) regulates products that make therapeutic or medicinal claims, ensuring they meet strict safety and efficacy standards.

The ACCC steps in to protect consumers from misleading statements and false advertising  so your marketing claims must stack up. And then there’s AICIS (formerly NICNAS), which oversees the use of chemicals in cosmetics, making sure every ingredient is approved and properly managed.

Together, these bodies safeguard product safety, accuracy, and compliance — so your brand can launch with confidence and stay on the right side of the law.

Legal framework governing cosmetic sales

Selling cosmetic products isn’t just about a good smell and pretty labels – it comes with legal strings. In the US, the Federal Food, Drug and Cosmetic Act outlines what’s allowed. Europe applies EU Regulation EC 1223/2009 to make sure products don’t pose health risks.

Australia’s rules fall under the Industrial Chemicals Act, managed by AICIS. It’s our toolkit for ingredient approval and safe chemical usage. Skipping this can lead to serious penalties.

Differences between therapeutic goods and cosmetics

What seems like a lotion to you might actually be a therapeutic good under Australian law. It all depends on the claims you make. If one suggests a healing benefit, like treating eczema or infections, it jumps into the therapeutic basket.

These need TGA listing and must comply with the advertising code to prevent false hope. It’s easy to drift into medical territory, so the messaging must stay sharp and legit.

Licences and Approvals Required to Sell White Label Cosmetics

Registering your cosmetic brand and products

Before launching any product, you’ll need to register with AICIS under your ABN. This step links your brand to your business legally. If your ingredients already have existing assessments, you might only need to notify AICIS rather than submit for chemical assessment.

This lowers costs and speeds your go-to-market window. At Miakara, we help simplify this process so brands can hit the shelves confidently.

Regional and international licensing pathways

If you’re planning to take your cosmetic brand beyond Australian shores, get ready — global compliance is a whole new playing field. In Europe, you’ll need to appoint a Responsible Person to manage product safety files and ensure everything meets EU cosmetic regulations. In the United States, FDA compliance under MoCRA is key, covering safety substantiation, labelling, and reporting obligations.

Each market brings its own regulatory hurdles, but with accurate records, compliant ingredients, and properly structured labelling, you can expand without costly rewinds or delays. We support our clients through every major compliance step to help make international growth as seamless as possible.

Documentation and regulatory filings essentials

You’ll want to have solid documentation from day one. That means keeping ingredient transparency files, safety data, and Good Manufacturing Practice (GMP) compliance ready. Safety assessments for high-risk ingredients are also a non-negotiable.

We ensure every Miakara product meets these standards, grounded in clean manufacturing and formula clarity. It’s part of building trust with buyers – and legal protection too.

Labelling and Packaging Regulations in White Label Cosmetics

Product label content requirements

A label is more than a name and a logo, it’s your product’s legal identity. Every ingredient must be listed using INCI terminology, along with clear usage directions, batch details, and country of origin. These requirements ensure consumers know exactly what they’re applying to their skin and allow your brand to demonstrate transparency and trust.

We support our partners in meeting all Australian-mandated labelling standards across both custom-formulated and white-label products, so every launch is compliant and consumer-ready.

Special claims and mandatory warnings

Saying a product is “natural”, “SPF-protective”, or “hypoallergenic” might sound appealing – but it invites scrutiny. Regulatory bodies don’t take kindly to unverified statements. Claims must be backed by testing, and certain phrases trigger warning requirements.

For example, SPF items must state protection limits, and certain oils need advisory notes. We guide all our Miakara partners around these common traps from design to shelf.

Packaging compliance and environmental expectations

What your product comes in matters too. Material choice needs to meet toxin safety standards, including avoiding leakage or chemical transfer. But increasingly, buyers want eco-aware packaging.

That’s why we offer biodegradable, plastic-free, and sustainable packaging options that match compliance with consumer demand. Our small-batch production method keeps waste low too.

Safety Testing and Standards in Cosmetic Compliance

Toxicology and allergen assessments

Even gentle formulas need toxicology checks. Testing helps screen for skin sensitisers and irritation potential, especially vital if your product goes near eyes or babies. Claims like “dermatologically tested” only work if you’ve got the data.

At Miakara, we work closely with dermatologists and chemists to assess reactions. It’s our way of keeping both your customers and your label safe.

Regulatory safety certifications and evidence

Showing your product is safe isn’t just about saying it – it’s about proving it. Cosmetic Product Safety Reports, also known as PIFs, contain formula data, test outcomes and safety findings.

We also provide certifications like cruelty-free and vegan status. These aren’t just stamps – they resonate with buyers who care. Every certification we provide reflects the standards we live by in our Epping facility.

Ingredient Restrictions and Compliance Considerations

Prohibited and restricted substances lists

Some ingredients can make a product unsafe or illegal. The TGA and EU guidelines list hundreds of restricted or banned cosmetic ingredients. Nano-materials, while allowed, require clear declaration and specific evaluation.

We screen every formula for compliance before it hits production. That way, our clients avoid costly reformulations or forced withdrawals.

Natural and organic ingredient compliance

Going natural isn’t enough – it must meet protocol. If your product claims “100% organic”, it must pass through certified organic standards. Labelling anything “natural” must sit within COSMOS or similar criteria.

We’ve developed recipes at Miakara with these certifications in mind, staying honest with labels and upholding integrity in every mixture.

Ingredient sourcing and ethical expectations

Today’s sellers care about where ingredients come from. Using cruelty-free, fair trade, and sustainable sources is key to building customer trust.

Our raw materials come from ethical suppliers, with transparent declarations of origin. Supporting the environment and fair trade doesn’t just meet regulations – it keeps your brand respected.

International Market Approvals and Export Compliance

Key import/export documentation

Taking your product global involves more than shipping. You’ll need customs documents, ingredient disclosures, and translated labels that match import country laws.

We make this part of our white label service, helping brands compile every required form so your goods won’t get stuck at international borders.

Specific country compliance: US, EU, China

Europe’s EC 1223/2009 requires a Responsible Person and locally reviewed safety files. In the US, MoCRA means mandatory registration and usage reporting. China has its own rules around animal testing unless criteria are met.

We help you meet these standards based on your target markets. Selling abroad shouldn’t come with surprises or delays.

Exporting from Australia: Local steps

If you’re based here, AICIS and NICNAS approvals apply before you even think of shipping overseas. These guarantee your product fits local standards, making it easier to comply globally.

At Miakara, we support outbound regulatory filings so our clients grow stress-free – from Melbourne shelves to overseas boutiques.

Compliance Maintenance and Post-Market Monitoring

Ongoing compliance audits and inspections

Once you’re in business, it’s not “set and forget”. Staying compliant involves routine audits. Regulatory bodies might inspect your manufacturing, especially for GMP or ISO 22716 adherence.

We keep thorough internal records to make sure documentation is ready if regulators come knocking.

Responding to product recalls or safety issues

Things can go wrong – and fast action matters. All cosmetic businesses must know how to initiate a recall, notify authorities, and inform customers precisely.

With Miakara’s risk procedures in place, your brand’s reputation stays protected even if challenges arise.

Post-market surveillance requirements

Monitoring your products after launch includes tracking customer reactions and adverse responses. Any of these must be documented and reported to maintain compliance.

We support all our brands in refining their product lines whenever safety data suggests updates are needed.

FAQ

Do I need a licence to sell skincare in Australia?

You don’t need a specific skincare licence, but your product must be registered with AICIS, and your business must meet ingredient and labelling compliance.

What insurance do I need for a cosmetic brand?

You’ll need public and product liability insurance. It covers incidents like allergic reactions and ensures your brand is protected.

Can I sell homemade or DIY cosmetics legally?

Yes, but they must still meet the same registration and safety standards as commercial products, and be labelled correctly.

Are regulations different for kids’ or baby cosmetics?

Yes. Products for children or babies have stricter testing and ingredient scrutiny. Claims like “gentle” or “safe for babies” must be supported by data.

What happens if I don’t comply with cosmetic regulations?

You risk penalties, product recalls, or business shutdowns. Compliance keeps your business protected, trusted, and profitable.

You’ve Got the Dream – Now Let’s Make It Legal

Bringing your product idea to life is exciting until the regulations show up. It’s that point where creativity meets compliance, and clarity suddenly becomes just as important as vision.

The good news? You don’t need to become a legal expert to launch a cosmetic brand. You simply need to know the key steps, follow the right labelling rules, and ensure your products meet safety standards. Once that foundation is in place, the rest of the journey feels far more achievable and a lot more enjoyable.

We at Miakara help simplify the manufacturing journey by guiding you through every compliance step with ease. Let us handle the approvals while you focus on creating products your customers will love.