Compliance for private label cosmetics
Selling cosmetics in the US and the EU is straightforward once you know who does what. Here is the split between your brand and the factory, and the documents we supply with every order.
What we supply with every order
Full ingredient list
INCI names in descending order, ready for your label, plus the percentage breakdown for your safety assessor under NDA.
Batch certificate of analysis
Appearance, odour, pH, viscosity and microbial results for your production batch.
Raw material data
Specifications and safety data sheets for the raw materials, and the fragrance allergen breakdown for scented products.
Label template
Filled in for your formula in US and EU format: identity, net quantity, ingredient list, required warnings.
Stability and preservative-efficacy (challenge) test data is available for stock formulas on request, and quoted for custom formulas.
Who does what
| Market | Rule | Factory (us) | Brand (you) |
|---|---|---|---|
| United States | MoCRA (Modernization of Cosmetics Regulation Act) | Facility registration, good manufacturing practice, batch records | Product listing, safety substantiation, adverse event reporting, US contact on the label |
| United States | Labelling (FD&C Act, FPLA) | Ingredient list and label template | Final label, claims you choose to make |
| European Union | Regulation (EC) 1223/2009 | Formula, raw material and test data for the safety assessment | EU Responsible Person, safety assessment (CPSR), Product Information File, CPNP notification |
| European Union | Claims (Regulation 655/2013) | Guidance on wording | Evidence for any performance claim |
| United Kingdom | UK Cosmetics Regulation | Same data package as the EU | UK Responsible Person, SCPN notification |
Cosmetic or drug? The line that matters most
In the US, what a product claims decides how it is regulated. A cosmetic changes how you look; a drug changes how your body works. These product types are drugs in the US and are outside what we make:
| Product type | Why it is a drug in the US | Cosmetic alternative we make |
|---|---|---|
| Sunscreen / SPF | Protects skin from UV damage | Moisturisers and lip balms without SPF claims |
| Anti-dandruff shampoo | Treats a scalp condition | Scalp-refreshing shampoo |
| Antiperspirant | Reduces sweating | Aluminium-free deodorant (controls odour) |
| Acne treatment | Benzoyl peroxide or salicylic acid acne claims | Cleansers and serums for oily-looking skin |
| Hair regrowth | Changes hair growth | Hair oils and serums for shine and softness |
Frequently asked questions
Who is responsible under MoCRA — the brand or the factory?
Both, for different things. The manufacturing facility registers with the FDA. The brand (the “responsible person” whose name is on the label) lists each product, keeps safety substantiation on file and reports serious adverse events. We supply the formula data and batch documents that support the brand’s part.
Can I sell your products in the EU?
Yes, once an EU Responsible Person has a safety assessment (CPSR) for each formula and notifies it on the CPNP portal. The Responsible Person is usually the brand itself or a service provider in the EU. We supply the ingredient list, raw material data and test data the safety assessor needs.
Do I need a separate UK notification?
Yes. After Brexit the UK has its own portal (SCPN) and needs a UK Responsible Person. The data package is the same as for the EU.
What is on a compliant US cosmetics label?
Product identity, net quantity, the ingredient list in descending order by INCI name, the name and address of the brand (with a US contact for adverse event reports under MoCRA), and any required warnings. We supply a label template filled in for your formula.
Why can’t my shampoo say “anti-dandruff”?
Because in the US that is an over-the-counter drug claim with its own active ingredients, testing and labelling. The same goes for SPF, antiperspirant, acne treatment and hair regrowth. We make cosmetics and keep your claims cosmetic.
Ask for the document pack with your quote
Ingredient list, label template and sample COA come with every quote.