To get into the EU cosmetics market, you need more than just a pretty formula and packaging that stands out. There is a lot of paperwork that goes into every cosmetic product that is legally sold in the EU. Two of the most important parts are the Cosmetic Product Safety Report (CPSR) and the Product Information File (PIF).
These two documents are not just formalities; they are legal requirements under EU Regulation 1223/2009. This guide will tell you what each document contains, how they work together, and why cosmetics must have both CPSR and PIF in order to be legal in the European Union.
What Is CPSR in Cosmetics?
The Cosmetic Product Safety Report (CPSR) is a scientific paper that shows that your cosmetic product is safe for people to use in normal or reasonably expected ways.
Every cosmetic product sold in the EU must go through a safety check that ends in a CPSR, according to EU law.
The Two-Part Structure of CPSR
There are two main parts to the CPSR:
Part A: Cosmetic Product Safety Information:
This part has technical information like
- Full INCI list and concentrations of the product’s ingredients
- Specifications for physical, chemical, and microbiological properties
- How things are made
- Results of the stability test
- Information about how and where the product is used
- Toxicological profiles for each ingredient
- Looking at possible interactions
Part B: Cosmetic Product Safety Assessment:
This is the written opinion of a qualified safety assessor who evaluates the data in Part A. It includes:
- Final thoughts on the safety of the product
- Instructions for use and warnings
- Qualifications of the assessor
- Reason for the conclusion
Who Can Prepare a CPSR?
Only a qualified professional with a degree in toxicology, medicine, pharmacy, or a related field can write and sign the CPSR. This person is called the safety assessor.
The CPSR is one of the most technical and closely watched parts of your product’s documentation. If you make a mistake here, your product could be taken off the market.
What Is a Product Information File (PIF)?
The Product Information File (PIF) is the full technical file that contains all the paperwork that shows your product is safe, high-quality, and meets all the rules. The CPSR is only one part of the PIF.
EU authorities must be able to easily get to the PIF at the Responsible Person’s address, and it must be kept for ten years after the last batch is sold.
Components of the PIF
- CPSR (A + B)
- Description of the product
- Evidence of GMP and the way things are made
- Proof of Effect Claimed (for example, keeps skin moist for 24 hours)
- Statement about testing on animals
- Artwork and labels for products (including claims and translations)
Storage and Access Requirements
The PIF must be:
- The Responsible Person must keep it electronically or physically and make it available to EU authorities upon request.
- Correct and up-to-date, any changes to the formula, packaging, or claims need a PIF update.
CPSR and PIF: What’s the Difference?
The CPSR and PIF are very similar, but they are not the same.
| Feature | CPSR | PIF |
| Required by EU Regulation? | Yes | Yes |
| Prepared by Safety Assessor? | Yes | No |
| Includes safety assessment? | Yes | As part of CPSR |
| Must include label artwork? | No | Yes |
| Must include GMP evidence? | No | Yes |
The CPSR is the scientific proof that your product is safe, and the PIF is the complete technical file for it.
Why Are CPSR and PIF Mandatory in the EU?
Legal Basis and Enforcement
EU Regulation 1223/2009 says that both documents are required. Your product can’t be sold in the EU without them.
DGCCRF (France), BfR (Germany), and MHRA (UK for NI) can ask for your PIF at any time. If you can’t give it, your products can be:
- Removed from the shelves
- Fined
- Not allowed to be sold
Compliance Benefits
Having a compliant CPSR and PIF not only protects you legally but also helps you:
- Make your brand more trustworthy
- Get in touch with retailers and distributors
- Follow the rules for paperwork that Amazon, Etsy, and Notino set.
- Show that you did your homework in case of complaints.
How to Get a CPSR and PIF for Your Cosmetic Products
What You’ll Need
You need to collect the following before you can ask for a CPSR and PIF:
- Complete INCI list with % concentrations
- Safety data sheets (SDS) for raw materials
- Results of stability and microbiological tests
- Label for the final product, Packaging art, and claims
- GMP certificate (not required but a good idea)
Where to Get Help
Most small brands or people who are new to this can’t make these documents on their own. This is where Certified Cosmetics can help.
We have:
- EU-certified toxicologists prepare for CPSR like pros
- Full PIF paperwork
- Review of labels and claims
- Individual help throughout the whole compliance process
Common Mistakes to Avoid
Even brands that have been around for a while can mess up. Here are some things to stay away from:
- Using old safety data for ingredients
- Not updating the PIF when the packaging or claims change
- Putting your trust in an unqualified safety assessor
- Not doing microbiological or stability tests
- Not remembering to translate labels into the right languages for the EU
So, double-check everything because each of these could have legal or business effects.
CPSR and PIF Checklist
Use this easy list to make sure you’re on the right track:
- INCI list with % and functions
- SDS for every raw material
- Data on stability and microbial tests
- Art with legal claims and translations
- GMP is the best way to do the manufacturing process.
- An expert signed Parts A and B of the CPSR
- The final PIF is kept safe and updated regularly
FAQ: CPSR and PIF for Cosmetics
Q1. Is CPSR enough on its own?
No. The PIF has more than just the CPSR. You need to have the whole file.
Q2. Do these papers need to be with handmade or small-batch goods?
Yes. All cosmetics, no matter how big or small, must follow these rules.
Q3. Is it possible for me to write my own CPSR?
No. Under EU law, a qualified safety assessor must write and sign it.
Q4. When do I need to update my PIF?
Whenever you change the formula, packaging, manufacturer, or claims.
Q5. Can I use the same CPSR and PIF for more than one product?
No. Each item needs its own set of documents.
Final Thoughts
The Cosmetic Product Safety Report (CPSR) and Product Information File (PIF) are two things you can’t get out of if you want to be compliant with the EU. Together, they make up the legal basis for your product’s presence in the European market.
You can’t legally sell, list, or give out your cosmetics to retail partners without them. But if you prepare them correctly and have them professionally checked, you can confidently and credibly access the whole EU market.
Need CPSR and PIF Support?
We at Certified Cosmetics are experts at making CPSR and PIF documents that meet all the rules for brands of all sizes. Our team of experts makes sure that your paperwork is 100% EU-ready, whether you’re just starting out or adding to your product line. Explore our CSPR and PIF services.
