Product information file (PIF) for cosmetic products
Following cosmetic regulations in the European Union and United Kingdom requires attention for businesses at every level – from brand owners to distributors.
This Product Information File guide and the PIF checklist Tool will help you collect all necessary information for your Product Information File to meet requirements of Regulation (EC) 1223/2009 and UK Cosmetic Regulation.
What is a Product Information File (PIF)?
The Product Information File (PIF) is a mandatory document required before launching any cosmetic product in the EU or UK. It proves your product follows all relevant regulations before reaching consumers.
According to EC Regulation 1223/2009, the PIF enables market surveillance and consumer protection. It must be accessible to authorities at one address within the Community or UK – typically the Responsible Person’s address, which must appear on the product label.
Think of the PIF as your product’s complete technical identity card. Without it, your products cannot legally enter the market.
Key components of a compliant PIF
Creating a PIF requires regulatory knowledge and toxicology expertise. A complete PIF works like a passport for your cosmetic product to enter EU and UK markets.
Description of the cosmetic product
This includes details that identify the specific product. Your formula must comply with EU and UK regulations by checking against prohibited substances in Annex II of Regulation 1223/2009. Non-compliant formulas need reformulation.
The composition section lists the exact percentage of each ingredient, including chemical identity (INCI name, CAS number, EINECS/ELINCS number where possible) and function. Raw material names must be complete – for plant extracts, include extraction concentration and agent.
Raw material specifications
For each ingredient, you’ll need:
- Supplier information
- Grade and purity details
- Analytical controls
- Safety Data Sheets (SDS)
- Certificates of Analysis (CoA/TDS)
- Various declarations regarding regulatory compliance
Fragrances require additional documentation like IFRA certificates and allergen reports.
Manufacturing process documentation
Non-EU suppliers should get external GMP audits to meet European ISO 22716 standards.
Cosmetic Product Safety Report (CPSR)
A key PIF component with two parts:
Part A collects all safety information:
- Physical/chemical traits
- Stability data
- Microbiological specifications
- Impurities information
- Usage instructions
- Exposure calculations
- Toxicological profiles for each ingredient
- Documented side effects
Part B is the Safety Assessment completed by a qualified Safety Assessor. It includes safety conclusions, label warnings, scientific reasoning, and the assessor’s credentials.
“The safety assessment is not just paperwork – it’s the scientific foundation that proves your product is safe for consumers under normal use conditions.”
Evidence for product claims
Products with specific claims need supporting data. Claims must be truthful, evidence-based, and fit the definition of a cosmetic product (not claiming to treat diseases).
For example, if you claim “reduces wrinkles by 27%,” you need clinical testing to back this up. If you state “contains vitamin C,” you need analytical proof of its presence.
Animal testing documentation
Since September 11, 2004, the EU banned animal testing on finished cosmetic products. In 2009, this ban extended to cosmetic ingredients.
You must provide official declarations stating no animal testing was done on the product or ingredients. Document any animal testing by manufacturers, agents, or suppliers, including tests for non-EU/UK countries.
Labeling and packaging information
Include all label details for primary packaging, secondary packaging, and leaflets. Products contacting packaging may need a food-grade certificate or leach test results.
Maintaining your PIF over time
The PIF needs regular updates to stay current with regulations. When product information changes (like reformulation), update or replace the PIF. As Responsible Person, you must keep your PIF current and accessible for ten years after the last batch enters the market.
Some common reasons to update your PIF include:
- Formula changes
- New safety data
- Regulatory updates
- Packaging modifications
- Manufacturing process changes
PIF management tools
My PIF checklist Tool kit guides you through gathering all information for a compliant PIF. By collecting and organizing documents systematically, you save time in the registration process.
Remember, this tool doesn’t replace an official PIF that needs a Safety Assessor’s signature.
For sensitive formula data, consider storing it in an encrypted system where suppliers and R&D teams can share information securely. Check https://my-proof.com/en/ and use code “coslabs15” for 15% off your first year.
Conclusion
A properly prepared PIF is not just about regulatory compliance – it’s about consumer safety and brand protection. Taking the time to develop a thorough PIF demonstrates your commitment to quality and safety in the cosmetics market.
The process may seem complex, but with the right tools and approach, you can navigate cosmetic regulations successfully and bring your products to market with confidence.
Frequently asked questions
We’re here to help with all your questions and answers in one place. Can’t find what you’re looking for? Reach out to our support team directly.
Can I use the same PIF for identical products sold under different brand names?
Yes, you can use the same core PIF for identical products sold under different brand names, but with important modifications. While the safety assessment, formula documentation, and manufacturing information can remain the same, you must create separate PIF sections for each product variant covering: specific product identification, unique labeling information, brand-specific claims and their substantiation, market-specific requirements, and separate CPNP (Cosmetic Products Notification Portal) registrations. Each product requires its own notification number despite sharing the same formula. This approach saves resources while ensuring compliance for each branded product.
How often should stability testing be performed for cosmetic products?
Stability testing should be performed before market launch and whenever significant changes occur to the formula, manufacturing process, or packaging. For standard cosmetics, accelerated stability testing (typically 3 months) and real-time testing (minimum 12 months) are recommended. Products with a shelf life exceeding 30 months require more extensive testing. Testing protocols should evaluate physical stability (appearance, color, odor), chemical stability (pH, viscosity), microbiological stability, and packaging compatibility under various conditions (temperature cycles, light exposure). Annual verification testing is advised for continuous production.
What happens if authorities inspect my PIF and find it incomplete?
If authorities find your PIF incomplete during an inspection, consequences vary by severity. Minor issues might result in a compliance notice with a deadline for corrections. Major deficiencies can trigger product recalls, market withdrawal orders, financial penalties (ranging from €5,000 to €100,000 depending on the member state), and potential legal action. Additionally, non-compliance damages brand reputation and may affect retailer relationships. Authorities typically publish non-compliance findings, which can impact consumer trust.
What specific qualifications must a Safety Assessor have to sign off on the CPSR?
A Safety Assessor must hold a formal qualification in pharmacy, toxicology, medicine, or a similar discipline as specified in Article 10(2) of Regulation (EC) No 1223/2009. This typically means a university degree (minimum bachelor’s level) in these fields, plus demonstrated expertise in safety assessment methodology. The assessor must understand cosmetic ingredient toxicology, exposure calculations, and risk assessment principles. They should stay current with regulatory developments through continuous professional education. Many companies verify credentials by requesting CV, degree certificates, and professional memberships. The assessor takes personal professional responsibility for the safety evaluation, so their qualifications must be documented within the PIF itself.
Who is legally responsible for maintaining the Product Information File?
The Responsible Person (RP) is legally accountable for PIF maintenance. This is typically the manufacturer for EU-made products or the importer for products manufactured outside the EU. The RP must be a legal entity established within the EU or UK and must ensure the PIF remains complete, up-to-date, and accessible to authorities for 10 years after the last batch is marketed. Their name and address must appear on product packaging, and they bear legal liability if compliance issues arise.
