How to create your cosmetic Product Information File?

The Product Information File: a strategic and vital document

What is the Product Information File?

Regulation (EC) No. 1223/2009, known as the "Cosmetics Regulation" and governing the obligations concerning cosmetic products, which came into force on 11th July 2013, requires responsible persons and manufacturers in the cosmetics sector to compile a Product Information File (PIF) for each product placed on the market.

This file, described in Article 11 of the Regulation, aims at gathering relevant information on the cosmetic product. It therefore includes elements relating to the identity, quality and safety of the product.

The PIF must be kept by the Responsible Person for a period of ten years from the date on which the last batch of cosmetic product was placed on the market.

The challenges of the cosmetic PIF

PIF checks are frequent. According to Article 22 of Regulation 1223/2009, Member States monitor compliance with the Cosmetics Regulation through controls on cosmetic products placed on the European market. If during an inspection the authorities note that the cosmetic product is non-compliant, sanctions may be applied.

It is therefore important to properly build and follow the evolution of the Product Information File, a fundamental stake for industrialists of the cosmetics sector!

The PIF must be kept available for inspection by health authorities at all times. In France, for example, the health authorities can be broken down into:

• The ANSM (National Agency for the Safety of Medicines and Health Products).
• The DGCCRF (General Directorate for Competition, Consumer Affairs and Fraud Control).

What does the Cosmetic Product Information File contain?

Regulation 1223/2009 requires that the Cosmetic PIF consists of the five parts:

Product Information File for Cosmetic Product

1. Description of the cosmetic product
2. Safety report of the cosmetic product
3. Manufacturing method and declaration of conformity to Good Manufacturing Practices
4. Proof of claimed effect
5. Data related to animal testing

1) Description of the cosmetic product

Above all, a clear link must be established between the cosmetic product and the Product Information File. In the descriptive part of the cosmetic product, you can for example include:

• The exact name of the product
• The code, identification or formula names allowing the product to be identified (without ambiguity) and above all to establish a clear link between the cosmetic product and its PIF.
• All names in the local language if the product is marketed in other countries, and a description of the function of the product (if not obvious).

2) Product safety report

The product safety report is drawn up in accordance with Schedule 1 of the Cosmetic Regulations. This is the part of the PIF that assesses the safety of your cosmetic product and is divided into two parts:

• Part A: Information on the safety of the cosmetic product

Part A is intended to collect the numerous data necessary for the safety assessment of the product. It contains:

1. The quantitative and qualitative composition of the cosmetic product
2. Physical/chemicalcharacteristics and product stability data
3. Microbiological quality
4. Impurities, traces, and information about the packaging material
5. Normal and reasonably foreseeable use
6. Exposure to the cosmetic product
7. Exposure to substances
8. The toxicological profile of the substances
9. Adverse reactions (ARs) and serious adverse reactions (SARs)
10. Information on the cosmetic product

• Part B: Cosmetic product safety assessment

Part B is a safety assessment leading to a conclusion on the safety of your products. The person in charge of the safety assessment takes into account all the information, checks its completeness and relevance, assesses the risk and finally concludes on the safety of the product. It contains:

• The conclusion of the safety assessment
• Warnings and instructions for use on the label
• Scientific reasoning
• The reference of the person in charge of the evaluation and approval of Part B

3) Manufacturing method according to Good Manufacturing Practices

The 3rd part of your PIF must contain the method of manufacture of the cosmetic product as well as a declaration of compliance to Good Manufacturing Practices (GMP).

GMPs for cosmetic products are a set of practical and organisational requirements in which the product must be manufactured. This involves in particular the control of human, technical and administrative factors.

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These guidelines are aimed in particular at compliance with product hygiene and safety criteria. This declaration of compliance must be found in each PIF of each cosmetic product.

To comply with Good Manufacturing Practices, the product must be manufactured in accordance with ISO 22716. In order to prove this compliance, it is necessary to carry out an audit.

4) Evidence of the claimed effect

The PIF must also contain supporting information, or a short summary with the technical data necessary to substantiate the effect(s) claimed by the cosmetic product. This concerns any claim for a cosmetic product, whatever the means of communication or type of marketing tool used and whatever the target audience (consumers, professionals, etc.).

The choice of the adequate and appropriate way to substantiate a claim rests with the Responsible Person (RP) and depends on the type of product, the claims and their context, etc.

5) Data relating to animal experiments

The Product Information File must contain data relating to animal testing carried out by the manufacturer, its agents or suppliers and relating to the safety assessment or development of the cosmetic product and its ingredients and raw materials.

If no animal testing has been conducted, a statement to this effect may be included in the PIF. Therefore, if an animal test has been carried out, it is necessary to include in the Product Information File information describing it such as:

• The identification of the animal experimentation carried out,
• Identification of the ingredients used,
• The date of the animal test,
• The place of the event,
• Information on the entities that performed the test,
• The legislative objective of animal testing and justification of the declared objective.

As a reminder, here are the dates since which animal experiments in cosmetics have been banned.

‍September 2004
Ban on animal testing for finished cosmetic products.

March 2009
Ban on ingredients or combinations, with exceptions
(repeated dose toxicity, reproductive toxicity, and toxicokinetics).

March 2013
Definitive ban, even in the absence of alternative methods.

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The PIF is likely to change often

Regulation 1223/2009 is updated every 6 months on average. It is possible that some of the information contained in the PIF may become outdated. Thus, the Product Information File must be continuously updated if new scientific data or new regulatory requirements become available.

COSMETIC Factory: a tool to manage the entire lifecycle of your cosmetics

A software to manage the entire lifecycle of your cosmetics

Incorporating artificial intelligence algorithms, COSMETIC Factory is a software suite that enables you to manage the compliance of your cosmetic product, from formulation to marketing. COSMETIC Factory integrates in particular:

• formulating and checking the compliance of formulas,
• document and test management,
• automatic calculation of MoS and impurities,
• the creation of your SDS,
• editing and compliance of your labels,
• cosmetovigilance,
• etc.

With the help of customisable workflows and dashboards, employees can now digitalise all processes and monitor the progress of projects. You also have the option of outsourcing some of the work to our regulatory and toxicological experts.

Simplify the creation of your PIF

COSMETIC Factory, allows you to create your Cosmetic Product Information File, very simply and quickly. Thanks to its algorithms, automatic calculations and EcoMundo's team of experts, creating your PIF has never been this easy.