Preparing your EU 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

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

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

This part sounds simple, but it is usually where the problems start. First, let’s start with what information is required:

Full formulation showing % of each ingredient used
Fragrances, essential oils and/or flavors with allergens present listed
Method of manufacture
Compliance with GMP – this needs to be in the form of a GMP license, statement of compliance, or ISO 22716 accreditation

The formulation provided must match the ingredient list provided on the label. This means that all raw material Material Safety Data Sheets (MSDSs) and Product Data Sheets (PDSs) need to be submitted with the PIF, and; the information provided in the MSDS and PDS MUST match what is in the PIF formula AND what is listed on the finished product label. In effect then, as part of this section, additional paperwork requirements include:

MSDS for each raw material, listing the number of allergens present
PDS for each raw material, showing full composition information, CAS numbers, and INCI designations
Label, which must contain all required labeling information and comply with EU labeling requirements

Rigorous searches of the CosIng database and checking all paperwork matches and provides a consistent ‘picture’ of what is in the product is essential and is where companies struggle to ensure compliance. this is because, at least one of these pieces of information contains a wrong CAS number or wrong INCI name, wrong position in the ingredient list or omissions of ingredients otherwise listed in the MSDS or PDS.

When preparing your documentation for EU, you MUST make sure to search the CosIng database carefully and double-check all MSDS and PDS information against your formula and ingredient list to make sure that ALL CAS numbers and INCI names on ALL documents match exactly. If they don’t, they need to be corrected until they do!

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

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/

Preparing your EU Product Information File (PIF) – Detailed Guide