Product Information File Cosmetics

Creating your PIF in Compliance with the EU Cosmetics Regulation: A Quick Guide

The product information file cosmetics PIF is a document required when placing a cosmetic product on the market in the European Union, and this requirement has also been adopted for example in ASEAN countries. All information related to the product’s identity, quality, safety, and several other significant aspects must be included in the PIF.

The following guide explains what you need to know when creating your EU-compliant PIF.

PIF Cosmetic Regulation (EC) No. 1223/2009

Since July 11th 2013, the Cosmetic Regulation (EC) No 1223/2009 specifies a new regulatory framework covering cosmetics and personal care products placed on the European Union market, including requirements for the maintenance of an up to date Product Information File (PIF). This requires a more extensive set of data in a move to promote better consumer safety and must be kept for 10 years and in at least two separate locations.

Responsible Person

Regulation No (EC) 1223/2009 requires the Responsible Person (RP) to keep and have access to a PIF for each product. They have the duty to maintain the PIF as described in the Regulation’s Article 11 and to make it available to the pertinent authorities of the member state wherein the file is kept at the address specified on the product label. The RP may keep the file in electronic or paper format.

Cosmetic Product Information File Contents

As per the Regulation, the Product Information File should contain the following groups of information:

1. A description of the cosmetic product
2. A cosmetic product safety report (CPSR), parts A and B.
3. A manufacturing method description and declaration of compliance with the Good Manufacturing Practices specified in the regulation’s Article 8
4. Proof of the product’s claimed effect(s)
5. Information on any animal testing done in connection to the development or safety assessment of the product or its ingredients

Here is a more detailed description of each of these five PIF sections.

1. Cosmetic Product Information

The regulation mandates that the PIF must contain a description of the product, in a manner that makes the file “clearly attributed to the cosmetic product.” According to the guidelines, the PIF must include the exact product name, an internal reference identifying it and its formulation, along with the product’s function, if this is not obvious from the product name.

The declared product name must be consistent with the name to be used in the product notification on the CPNP. The product description section must also contain the product notification reference number. Furthermore, it must include the details of the Responsible Person.

In summary, this PIF section serves to answer the following questions:

• What is the product?
• What are its uses?
• Who should the regulatory authority contact regarding the product?

2. Cosmetic Product Safety Report (CPSR)

This section must contain a safety report known as the Cosmetic Product Safety Report (CPSR), provided by a qualified safety assessor, consistent with the guidelines set by the Regulation. Other than the conclusion of the safety assessment, it must also indicate warnings and instructions that should be displayed on the product label and references of the assessor.

This part of the PIF aims to provide statements declaring the compliance with the EU regulations in terms of the presence and purity of the materials used.

3. Method of Manufacture and GMP

Based on the Colipa guidelines, the method of manufacture must include a brief overview of the process, including storage and filling in the manufacturing sites. You must also add references to the manufacturing documentation used in the production of the cosmetic product.

Compliance with the Good Manufacturing Practice (GMP) is another major requirement in this section. This is to ensure that the product is safe to use. There must be compliance with the pertinent harmonized standards such as the EN ISO 22716:2007. While the regulation does not require third-party certificate or proof of a third-party audit, declaration of adherence to GMP is intended to demonstrate that you observe good practices in manufacturing your product.

4. Proof of Effect and Claims

Claims made for the product should be substantiated. The information gathered when substantiating the claim should be indicated in the PIF. Claims for cosmetic products must meet a set of criteria including truthfulness, fairness, honesty, legal compliance, evidential support, and informed decision-making.

The Responsible Person is required to substantiate the claims and to ensure that the means used are sufficient and appropriate for the cosmetic product.

To sum up, this PIF section focuses on whether the product has the necessary:

• Efficacy
• Quality
• Stability

5. Animal Testing - Cosmetics PIF

The product information file cosmetics PIF must also include details on any animal testing, whether performed by the manufacturer, suppliers of raw materials used in your product or their individual ingredients. This information should make it clear whether or not the product meets the existing regulatory and legal requirements concerning the EU’s ban on animal testing for cosmetics and personal care products. The data specified in this section of the document must be open to inspection by the concerned authorities. Article 18 of the Regulation details the prohibitions.

This PIF section underlines the important requirement for companies to communicate with their suppliers to obtain complete and accurate information on any animal testing.

Cosmetics PIF Structure

The regulation requires no specific format in terms of the cosmetics PIF’s structure. The most important thing to remember is that it must contain and reference all data required. Remember that through the cosmetics PIF you must:

• provide product information and specifications;
• present the product safety report;
• specify manufacturing processes and GMP compliance;
• substantiate the product’s efficacy, quality, and stability; and
• declare compliance with the EU animal testing regulations.

In terms of language, the PIF must be written in a language that is easily understood by the relevant authorities. Ideally, it must be in the national language of the country where your PIF is to be held. Another language can be accepted only if the authority permits, though English is accepted throughout the EU. Supporting documents can be retained in the language they were written, provided it is an official EU language.

While the PIF is deemed to be the intellectual property of the Responsible Person, the regulation requires that the public must be given access to certain product information as specified in Article 21. This includes information about the product’s composition (qualitative and quantitative); the supplier’s name; information on undesirable effects (mild and serious); etc.

Contact details must be printed on your product’s label or package so that consumers can contact the Responsible Person should they wish to access such information.

In Summary

Remember that you need to fulfil all of these requirements to meet regulatory requirements. The EU region market is a great avenue to introduce and grow your cosmetic brand. And your first step to achieving success in this market is to achieve regulatory compliance.