Description and formula
Art. 11 §2 a- Full qualitative and quantitative formula
- Compliant INCI nomenclature
- Raw material specifications
- Physicochemical characteristics
- Safety data sheets
Cosmetic PIF: your regulatory file built from A to Z
Safety assessment, testing, ISO 22716 manufacturing and labeling: we compile every document required by Regulation (EC) No 1223/2009.
The PIF in 30 seconds
The Product Information File (PIF) is the mandatory regulatory file for every cosmetic sold in the European Union. Required by Article 11 of Regulation (EC) No 1223/2009, it proves your product is safe, properly manufactured and correctly labeled.
- Art. 11
- A PIF is mandatory for every product placed on the market
- 10 years
- Retention after the last batch is placed on the market
- Annex I
- The safety report (CPSR) in two parts, A and B
- Art. 4
- A designated Responsible Person in the EU
Safety report (CPSR)
Art. 10 · Annex I- Part A: product safety information
- Part B: assessment by a qualified safety assessor
- Toxicological profile of the ingredients
- Margin of safety (MoS) calculation
- Conclusions and precautions for use
Tests and analyses
Annex I · Part A- Accelerated aging stability
- Container and contents compatibility
- Challenge test (preservative efficacy)
- Microbiological analyses
- PAO determination
ISO 22716 manufacturing
Art. 8 · GMP- Description of the manufacturing method
- Compliance with good manufacturing practice (ISO 22716)
- Batch traceability
- In-process quality control
- Storage and transport conditions
Claims and labeling
Art. 19 · Reg. 655/2013- Claim substantiation
- Mandatory information on the packaging
- INCI list and PAO
- Labeling in the languages of the countries of sale
- Review of visuals and marketing messages
Notification and Responsible Person
Art. 4 · Art. 13- Support in appointing the Responsible Person
- Support with CPNP notification
- ONSSA and AMMPS registration in Morocco
- Batch numbering and identification
- File kept for 10 years
Why your manufacturer
The lab that makes your product already holds the documents for your file
Formula, test results, manufacturing records, batch traceability: with us, everything originates on the same site. Your PIF is consistent from page one.
- No data to chaseOur formulators, quality control and regulatory team work side by side.
- A file that stands up to scrutinyEvery statement is backed by a test, a data sheet or a production record.
- A certified factoryISO 22716 and ISO 9001, certified by Bureau Veritas.
A file tailored to your target market
European Union
Regulation (EC) No 1223/2009
Full PIF, safety report, Responsible Person and CPNP notification before the product goes on the market.
Exporting to EuropeMorocco
Law 25-08 and Circular 771
Registration file for your product with AMMPS and ONSSA so it can be sold in Morocco.
The registration stepsUnited States
MoCRA (FDA)
Our facility is registered with the FDA (MoCRA) for export to the United States.
Gulf countries
GSO 1943 standard
A file adapted to the cosmetic product safety requirements of the Gulf countries.
Another market? Tell us where you want to sell: we state the applicable framework in your quote.
From your formula to a file ready for notification
- 01
Formula audit
Formula, ingredients, target markets and desired claims: we identify the regulatory points to watch.
- 02
Tests and safety report
Raw material data, stability, compatibility, challenge test, then the CPSR written by the qualified assessor.
- 03
Final file and notification
PIF assembly, approval of claims and labeling, support with notification.
Brands that sell with full compliance
4.984 verified Google reviewsHaving worked with many cosmetics subcontractors in the past, I must say I have rarely had partners this professional, passionate and attentive to the client.
What I particularly appreciate is that they handle everything, from creating my brand to designing the packaging and delivering the products.
I received my order exactly on the agreed date, and the products arrived in excellent condition.
FAQ on the PIF and cosmetic regulations
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What is a cosmetic PIF?
The PIF, or Product Information File, is the mandatory regulatory file for every cosmetic product placed on the European Union market. Required by Article 11 of Regulation (EC) No 1223/2009, it brings together the product description and formula, the cosmetic product safety report (CPSR), the manufacturing method in line with good manufacturing practice (ISO 22716), claim substantiation and test data.
Is a PIF mandatory?
Yes. No cosmetic can be sold in the European Union without a PIF kept available to the authorities and a designated Responsible Person. Without one, a product faces withdrawal from the market and penalties.
What do cosmetic regulations cover?
Cosmetic regulations are the rules governing the manufacture, safety and marketing of cosmetic products. In the European Union, they are based on Regulation (EC) No 1223/2009, which notably requires the PIF, the safety assessment, the Responsible Person, CPNP notification and labeling rules. In Morocco, they are based on Law 25-08 and Circular 771.
Who carries out the safety assessment (CPSR)?
The cosmetic product safety report (CPSR) is written by a qualified safety assessor holding the qualifications required by Article 10 of Regulation (EC) No 1223/2009. It includes Part A (safety information) and Part B (assessment and conclusion).
How much does a cosmetic PIF cost?
The price depends on the number of products, the complexity of the formulas, the tests required and the target markets. When we manufacture your product, much of the data already exists, which simplifies the file. Send your formula to receive a free, detailed quote.
How long does it take to compile a PIF?
The timeline depends on the tests required, especially stability and the challenge test, and on the availability of raw material data. It is defined with you in the quote.
How long must the PIF be kept?
The PIF must be kept and made available to the authorities for 10 years after the last batch of the product is placed on the market, at the address of the Responsible Person shown on the label.
Can my product be sold outside the European Union?
Yes. We adapt the file to the target market: European Union (Regulation (EC) No 1223/2009), Morocco (Law 25-08, Circular 771, ONSSA and AMMPS registration), Gulf countries (GSO 1943 standard) and the United States, where our facility is registered with the FDA (MoCRA). For any other market, we state the applicable framework in your quote.
Sell your product with full compliance
Send us your formula and target markets: you receive an audit of the points to watch and a detailed quote, with no commitment.