Safety · Intermediate ·
Can I sell what I make? The basics of cosmetic regulation
Making products for yourself and selling them are very different things. Here is what changes.
Key takeaways
- Selling cosmetics usually requires a documented safety assessment. Home recipes alone are not enough.
- Rules differ by country and change over time, so check your regulator before you sell anything.
- Good records, correct labels and avoiding medical claims are universal expectations.
Home use versus selling
A product made for yourself carries only your own risk. As soon as you give it to others or sell it, you take on legal responsibility for its safety, and in most countries that means documentation, testing and labelling.
In the EU and UK
- A Responsible Person based in the EU (or UK) must be named for each product.
- A Cosmetic Product Safety Report (CPSR) must be written by a qualified safety assessor.
- A Product Information File (PIF) must be kept, and available to authorities, for ten years after the last batch is placed on the market.
- Products must be notified to the official portal before being sold.
- Manufacturing should follow GMP (ISO 22716).
In the United States
The FDA does not pre-approve cosmetics, but you are responsible for the safety and correct labelling of what you sell. Recent legislation (MoCRA) added requirements such as safety substantiation, adverse event reporting and, for many businesses, facility registration and product listing. Some small businesses are partly exempt, so check the current rules.
Elsewhere
Most other regions have their own versions of these rules. Look up your national cosmetics regulator before you start.
Labels
- Product name and function.
- Full INCI ingredient list, in the correct order.
- Batch number and period-after-opening or expiry information.
- Name and address of the responsible person or manufacturer.
- Warnings and usage directions where needed.
Claims
Cosmetics may improve appearance or cleanse, but they must not claim to treat, cure or prevent disease. "Heals eczema" or "kills acne bacteria" are medical claims. Marketing terms such as "natural", "vegan" or "COSMOS" also need evidence from suppliers.
Documents to prepare
| Document | What it contains | Where Formularium helps |
|---|---|---|
| INCI list | Ingredients in label order | Generated in the Product Information File export |
| Formula and batch records | Weights, phases, process and results | Printed batch ticket and quality record |
| Supplier documents | SDS, CoA, allergen and IFRA declarations | Ask each supplier; track them with your stash |
| Stability and challenge tests | Evidence the product stays safe and preserved | Done by you or a lab; record the results |
| Safety assessment (CPSR) | Toxicological evaluation of every ingredient | Needs a qualified assessor |