What is Product Information File (PIF)?
What is Product Information File (PIF)?
If you want to sell cosmetic products in the EU, there are certain compliance requirements you must achieve. While PIF information requirements can seem extensive, these documents are designed to protect the safety of consumers who use personal care products every day.
The information requirements can seem exhaustive to the un-initiated and many companies lose sight of the core information required because they get lost in the different terminology used in the EU compared to other regions around the world.
The information EU regulators are asking for is not prohibitive, it is simply more involved than what is required to sell cosmetic and personal care products in most other regions.
Here are the common industry terminology and ‘laypersons’ descriptions of the essential paperwork needed to comply with PIF requirements. This will help you make sense of what they are asking for – forming an ‘essential guide’ to the information you will need to provide if you want to sell your cosmetic product in the EU.
The figure below shows the essential constituents of framing EU PIF:
STEP 1: Finished Product Information
STEP 1: Finished Product Information
A PIF needs to start with the product name, its description and intended uses. It also needs to contain company information including the street address of all distributors and the details of the ‘Responsible Person’. This is the person in the EU responsible for ensuring all required information is provided and registered in the Cosmetics Products Notification Portal (CPNP).
This information serves to identify the product, its uses, and who the regulatory authorities should contact regarding product safety and distribution if required.
STEP 2: Compliance Statements
STEP 2: Compliance Statements
Accompanying the PIF must be several statements which declare your product’s compliance with EU regulations relative to the presence and purity of certain materials, manufacturer requirements and details of animal testing. To comply with these information requirements, you will need to provide details of:
- Any animal testing conducted – remember this is largely banned in the EU and you must show you have not conducted any testing that is prohibited
- Presence of nanomaterials with particle distribution curves – if used
- Purity and compliance of all colorants, including FD&Cs, D&Cs and iron oxides
- GMP license of the manufacturer (covered in more detail in the next item)
Statements which declare your products compliance with EU regulations
This will require documentation checks to ensure all evidence requirements are met for each specific type of product you are looking to sell, and any additional information provided must not conflict with the information provided as part of the PIF, particularly when it comes to:
- CAS number
- INCI name, and
- Compositional information
STEP 3: Formulation Information
STEP 4: Proof of Efficacy, Quality & Stability
STEP 4: Proof of Efficacy, Quality & Stability
Before you can place a product into the EU marketplace, you need to make sure you have the required efficacy, quality, and stability information. This includes:
- Proof of effect – Having suitable evidence to support all claims made in relation to the product. This means not only complying with labeling requirements and claims but having suitable evidence to support all claims made in your labeling and marketing. This is especially relevant for cosmeceutical products and products with claims of SPF.
- Quality – Ensuring you have suitable quality information especially relative to microbiological content and Preservative Efficacy Testing to confirm that your product is suitably preserved over its declared shelf life and will not pose a risk to consumer safety.
- Stability – Ensuring you have suitable stability data to support shelf-life claims and expiration dating. In the EU, your product needs to carry an expiry date OR a Period After Opening (PAO) symbol. Whether your product has the expiry date or PAO can only be determined and supported by the results of stability testing, and it is the results of stability testing that must be provided as part of the PIF to support expiry or PAO statements. Without stability data or appropriate stability justifications by a suitably qualified person, your product will not be able to support the stated shelf life or PAO.
STEP 5: Safety Assessment
STEP 5: Safety Assessment
A Cosmetic Product Safety Report (CPSR) must be provided for each product that you wish to sell in the EU. The CPSR must be provided by a suitably qualified person who has been trained in Pharmacy, Toxicology or Chemistry and has the appropriate experience to undertake the safety assessment. The CPSR takes into consideration:
- MSDS of the finished product
- Safety calculations – extensive calculations performed based on the No Observed Adverse Effect Level (NO(A)EL), Low Observed Adverse Effect Level (LO(A)EL) or LD50 of individual raw materials based on the amount of exposure, daily application levels and method of use
- Required warnings and directions for use provided on the product label and limits/restrictions imposed as part of the EU Cosmetic Regulations
Once a CPSR has been finalized, all required warnings and directions for use are then cross-checked against provided label information and again, all information MUST match.
Giving Europe What it Wants!
It really is not that hard to give Europe what it wants, but it takes a careful eye, a complete compilation of documentary requirements, necessary cross-checks and results of relevant product quality, stability and efficacy tests to ensure your product is compliant.
The European market represents a fantastic opportunity to grow your brand but achieving regulatory compliance is essential – don’t let the paperwork scare you off on what can be a fantastic business opportunity, by handing the paperwork to someone who understands and can give Europe what it wants!
The Institute of Personal Care Science runs training on how to compile your PIFs, with templates to guide you and help you manage the process, all online to study anytime. This will help you be compliant with all steps and collate all documentation, ready to hand the PIF to a Safety Assessor to complete their Assessment and Evaluation. This saves a lot of time and money in having intermediaries involved up to this stage, and then your PIF is ready to hand to your Responsible Person in the EU.
Visit this site for more information or to be able to take care of your PIFs:
https://personalcarescience.com.au/