Cosmetic PIF: Definition and Best Practices

The Product Information File (PIF) is an essential document to ensure the safety and compliance of a cosmetic product. It centralizes a wealth of essential information and fulfills a legal requirement for the marketing of the product (European Regulation 1223/2009).

However, compiling this file can be a complex business! It requires meticulous preparation and numerous exchanges with a variety of contacts. This article provides the best practices to follow when preparing your cosmetic PIF.

What is a cosmetic PIF?

The Product Information File (PIF) ensures that a cosmetic product is safe for those who use it and meets all the current standards. It's a must-have document for any product introduced to the European market. It's presented in paper or electronic format and serves as a kind of ID for the product, bringing together all the info about it.

The cosmetic PIF follows the product throughout its life cycle and beyond. The file must be kept for 10 years after the last batch of the product has been placed on the market. During this period, it must be available to respond to any request from the authorities. This is the responsibility of the Responsible Person.

What's the role of the Responsible Person?

Article 4 of the Regulation says you must appoint a Responsible Person to market a cosmetic product. This person can be a natural or legal entity, such as a manufacturer, importer, or distributor.

The Responsible Person is key to making sure products are safe for consumers. They make sure the Product Information File meets the regulations.

As we said earlier, the Responsible Person must also ensure the PIF is available. It should be easy for the supervisory authorities to access it if needed. So, the product label must show where the file can be found. If multiple addresses exist, the one corresponding to the PIF location should be underlined. On top of that, the PIF must be written in a language that the control authorities in the country where it's being used can easily understand.

The Responsible Person also makes sure the file is updated when needed throughout the product's life cycle.

How important is the PIF?

The PIF is a legal requirement. The file is needed by regulation n°1223/2009.
Ensuring its completeness and the relevance of the information is crucial to guarantee product safety, regulatory compliance, and to allow its commercialization. Failure to comply with PIF obligations can result in significant penalties, such as fines, product recalls, or legal action.

Structure and content of the PIF

Each Responsible Person can organize the file and customize its structure as they see fit. However, certain mandatory elements must be included.

Mandatory elements of the Product Information File

The Regulations specify the information required. They are as follows:

1. Description of the cosmetic product: this description links the product and the Product Information File. It includes information such as name, reference and brand, product category, description, etc.
2. Cosmetic Product Safety Report (also known as CPSR or safety assessment): this report is a significant component of the PIF. It comprises two main parts and several sub-categories, which will be detailed later in this article.
3. Description of manufacturing method and declaration of conformity to Good Manufacturing Practice (GMP): This part of the PIF demonstrates that established quality standards are used to manufacture the product. GMP refers to the practical and organizational requirements to be met during product manufacture, such as ISO 22716.
4. Proof of claimed effect: results of studies and data confirming that the product fulfills its promises.
5. Animal testing data: this section contains information on animal testing. These tests may be required for export to certain third countries.

Focus on the cosmetic safety report

The cosmetic product safety report is the most important part of the cosmetic PIF. In accordance with the European Regulation, the assessment must be carried out by a qualified expert.

Contents of the Cosmetic Product Safety Report

The safety assessment is divided into two main parts: Part A and Part B, each containing specific information.

Part A: Cosmetic product safety information

This first part of the report provides an overview for assessing product safety. It is dedicated to describing the product and its various ingredients.

• Qualitative and quantitative formula: this section includes an exhaustive list of ingredients, together with their identification, precise concentration, and intended function. Raw materials are detailed where necessary, and allergens subject to mandatory declaration are specified.
• The physical and chemical specifications of raw materials and finished products: these properties enable the physico-chemical control of the product after its introduction on the market.
• Stability data: results of tests carried out and method used.
• Microbiological quality: microbiological specifications are detailed, along with challenge test results where applicable. Particular attention is paid to products used around the eyes, mucous membranes, or damaged skin areas. Also, when used on children under three, the elderly, or those with weakened immune systems.
• Impurities and traces in raw materials: the levels of impurities in the substances and mixtures used in the cosmetic product. If traces of prohibited substances are present, proving their presence is technically unavoidable is necessary.
• Information on the packaging material: this data must make it possible to assess possible interactions between the product and its packaging material.
• The normal and reasonably foreseeable use of the product: the description of the product's expected use under normal conditions by users. Possible uses are considered considering the warnings and explanations given on the label.
• Exposure to cosmetic products: This information concerns, for example, the type of product, the duration and frequency of application, the amount of product to be used, and the areas of application. The possibility of secondary exposure, such as involuntary inhalation, must also be mentioned.
• Exposure to substances contained in the cosmetic product: data on users' exposure to substances, including traces and impurities present in the product.
• The toxicological profile of substances: particular attention is paid to assessing local toxicity, skin sensitization, and photo-induced toxicity.
• Undesirable effects: especially when the formula is already on the market, as may be confirmed with a white-label product.
• Tolerance tests and any other test results that may be relevant.
• Any other necessary product information.

Part B: Safety assessment

While the information in Part A can, for example, be written by the Responsible Person, Part B is the work of the safety assessor. They analyze the information gathered in the first part and concludes the product's safety. They may express reservations, leading to further instructions for use.

Here is a more detailed of the contents of Part B of the report on the safety of the cosmetic product by Annex 1 of the Cosmetic Products Regulation:

1. Safety assessment conclusion: the evaluator's statement concerning the product's safety for its intended use.
2. Warnings and instructions for use: recommendations on precautions to be taken during use and warnings to be included on the label to ensure safe use of the product.
3. Scientific reasoning: a detailed explanation justifying the safety conclusion (point 1), integrating all the data and analyses presented.
4. The safety assessor's references and approval: contact details, qualifications, and professional experience of the person in charge of the assessment, as well as the date and signature of the document.

 

Who is the safety assessor? The safety assessment must be carried out independently by a qualified safety assessor with a diploma or title justifying their expertise in pharmacy, toxicology, medicine, or a similar discipline.

Cosmetic PIF: best practices and mistakes to avoid

Keeping your Product Information File (PIF) up to date is essential to ensure the safety and conformity of your cosmetic product. Here are a few best practices to adopt to ensure that your PID is complete and accurate.

Don't wait until the last minute

Since creating the PIF involves a wide range of stakeholders and the exchange of numerous documents, it's best not to leave it to the very last minute! Be proactive and involve all stakeholders as early as possible to obtain the correct information as quickly as possible.

This way, the document can be completed gradually as the project progresses.

Organize the document clearly and legibly

The PIF can be inspected at any time by the relevant authorities, so it's essential to make it as organized and straightforward as possible. Structure the document logically, with distinct, well-defined sections, and ensure that information is presented accurately. Make sure that all the required information is present in the document and that it is adequately documented. A well-structured document makes it easier for the supervisory authorities to understand and access the information.

And don't forget to always make sure it's available and written in the correct language!

Keep your PIF regularly updated

The Product Information File isn't a static document. It changes and needs to be updated regularly to keep up with new products and regulations. There are many reasons why it might change, for example, if there are new rules to follow, if the way the product is made changes, if the packaging is different, or if the person responsible for it changes their details.

If the changes made to the product are significant and are likely to affect its safety, it might be necessary to do a new safety  evaluation. Then, you'll need to check with the evaluator to see if the report needs to be updated with the latest info.

At the same time, keeping track of cosmetic product-related incidents in the Product Information File is essential. This also includes the ratio between the number of reported adverse reactions and products sold yearly. This ongoing monitoring helps us monitor product safety in the market.

Use the right solutions

The use of formulation and regulatory compliance software can significantly facilitate the creation of a cosmetic PIF. These tools, for example, enable you to centralize and secure your data, collaborate efficiently, ensure traceability and transparency, automate alerts to track regulatory developments, generate reports with a single click, and more.

• Read also: How do you know if you need PLM for your cosmetic development projects?

How Coptis can help

Coptis Lab is an integrated software package for cosmetic formulation and regulatory compliance. It helps the cosmetics industry manage development projects more efficiently, reduces time-to-market, and improves the quality and reliability of information. How can we help?

• Being proactive at every stage of development.
• By centralizing all data and documents in a single solution.
• By boosting collaboration between teams through an intuitive, ergonomic interface.
• Save time by automating tedious tasks such as one-click PIF generation.
• By ensuring global compliance of your formulas through the centralization of regulations and real-time regulatory alerts to avoid backtracking.

As the leading benchmark in cosmetics R&D, Coptis Lab enables you to ensure your digital transformation and stay ahead of your competitors! Want to know more about our solution?