A Compliant PIF is Essential for EU Cosmetics Market Access
Legal background
Entering the EU cosmetics market without a compliant product information file compilation (PIF) is not just risky, it is illegal. The European regulations are among the strictest in the world, especially concerning banned or restricted ingredients. A formula that is perfectly legal in one country may be rejected in the EU. Non-compliant PIFs can delay your launch, lead to product recalls, or even result in market bans.
A strong and compliant PIF:
- Prepares your product for the Safety Assessment Report (SAR), a mandatory report for cosmetics.
- Demonstrates your product complies with GMP and EU regulations.
- Protects your brand from costly regulatory consequences.
- Keeps you prepared for inspections and regulatory updates.
Our services
Expert Support from Obelis: Product Information File Compilation
Obelis offers a full-service solution to help you build, review, and maintain a compliant Product Information File. Our services include:
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- Ingredient-by-ingredient verification against EU restrictions and bans.
- Detailed formula checks, including INCI names, CAS numbers, concentrations, and functions.
- Support compiling the formula overview and all necessary documentation.
- Review of labels and claims
- Lab testing
- Preparation and submission of your Safety Assessment Report (SAR) or coordination with a certified Safety Assessor.
- Collection and review of raw material documents, with proactive outreach to producers if needed.
- Confidentiality assurance via a Non-Disclosure Agreement (NDA) when necessary.
By choosing Obelis, you gain a reliable partner for managing your cosmetic product information file PIF, ensuring a smooth, compliant, and delay-free market entry.
FAQ
Frequently Asked Questions
A Product Information File (PIF) is a mandatory regulatory document required under the EU Cosmetics Regulation (EC) No. 1223/2009. It contains detailed information about a cosmetic product, including its safety assessment, product description, manufacturing method, proof of claimed effects, and data on animal testing. The PIF must be readily accessible to authorities at the Responsible Person’s address for 10 years after the last batch is placed on the market.
If a cosmetic product does not have a compliant PIF, it cannot legally be sold in the EU market. Authorities may issue warnings, impose fines, or enforce product recalls. Non-compliance can also damage your brand’s reputation and delay market entry. A complete and accurate PIF is crucial for demonstrating product safety and regulatory compliance.
No, each cosmetic product must have its own dedicated PIF, even if the formulations are similar. Slight variations in ingredients, concentrations, or intended use can impact safety assessments and regulatory requirements. However, data can be reused or referenced across files where applicable, to streamline the process.
Obelis Group offers end-to-end support in creating and maintaining fully compliant PIFs. Our team of regulatory experts ensures that all required elements—such as the Cosmetic Product Safety Report (CPSR), labeling review, and supporting documentation—are accurate and up to date. We act as your EU Responsible Person, helping you achieve a seamless and compliant market entry.
