Product Information File for Cosmetics

Originally posted March 31, 2021 Ready to market your cosmetics in the European Union? One of the key requirements you'll need to meet is generation of a product information file (PIF). A PIF is documentation that contains all information related to the product’s identity, quality, safety, and several other significant elements. It must be kept by the designated Responsible Person (RP) for each cosmetic product sold on the European market. PIFs are also required when selling cosmetics in ASEAN countries. This guide explains what you need to know when creating your EU-compliant PIF, including:

• Duties of the Responsible Person
• Contents required in a PIF
• PIF structure tips
• Public access guidelines

PIF Cosmetic Regulations

On July 11th 2013, the Cosmetic Regulation (EC) No 1223/2009 specified a regulatory framework covering cosmetics and personal care products placed on the EU market. These include requirements for maintenance of an up-to-date PIF which requires a more extensive set of data, promoting better consumer safety. RPs must keep PIFs for 10 years from the date the last batch of the product was sold on the EU market and in at least two separate locations.

Responsible Person

Regulation No (EC) 1223/2009 requires cosmetics brands’ Responsible Person (RP) to keep and have access to a PIF for each product. RPs must maintain the product information file as described in the regulation’s Article 11. They must also make them available to authorities of the member state where the files are kept and store them at the address on the product label. RPs may keep PIFs in electronic or paper format, but they must be accessible to the authorities and in a language they can understand. Another language may be accepted 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.

Cosmetic Product Information File Contents

Product information files 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

The regulation requires no specific format in terms of the cosmetics PIF’s structure. Here's a more detailed overview of each of the five PIF sections.

Cosmetic Product Information

The regulation mandates that the PIF contain a description of the product that makes the file “clearly attributed to the cosmetic product.” The description should answer the following:

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

According to the guidelines, the PIF must include the exact product name, an internal reference identifying it, and its formulation. It must also include the product’s function if not obvious from the product name. The declared product name must be consistent with the name used in the product notification on the European Commission’s cosmetic products notification portal (CPNP). The product description section must also contain the product notification reference number and details of the RP.

Cosmetic Product Safety Report (CPSR)

A CPSR is provided by a qualified safety assessor and created based on regulation guidelines. It’s made up of two parts: cosmetic product safety information and cosmetic product safety assessment. Part A must contain safety information such as:

• Cosmetic product formula (quantitative and qualitative)
• Product physicochemical characteristics and stability
• Microbiological quality
• Packing material impurities, traces, and information
• Normal and reasonably foreseeable use

Part B, the safety assessment should contain:

• Assessment conclusion
• Warnings and instructions to be displayed on the product label
• Assessor’s references

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

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. It should also include references to the manufacturing documentation used in the cosmetic product’s production. Compliance with GMPs is another major requirement in this section. GMPs ensure the product is safe to use and compliant with recognized international standards such as ISO 22716. While the regulation does not require third-party certificate or proof of a third-party audit, declaration of adherence to GMP demonstrates that you observe good practices in manufacturing your product.

Proof of Effect and Claims

This PIF section focuses on whether the product contains the necessary efficacy, quality, and stability to substantiate product claims. To demonstrate substantiation, 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 RP is required to substantiate the claims and to ensure that the means used are sufficient and appropriate for the cosmetic product.

Product Animal Testing

Finally, PIFs must include details on any animal testing of the product whether performed by the manufacturer, their agents, raw material suppliers, or in individual ingredients. Any animal testing done to meet legal or regulatory requirements of other countries must be disclosed as well. The data specified in this section should be open to inspection by concerned authorities. This information clarifies whether the product meets existing EU regulatory and legal requirements for animal testing. EU’s ban on animal testing for cosmetics and personal care products is detailed in Article 18 of the regulation. This PIF section underlines the importance of communicating with suppliers to obtain complete and accurate information on any animal testing.

Public Access Requirements

While PIFs are considered 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), and more. 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.

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• Generate and export PIFs or product dossier in EU or ASEAN formats
• Fully integrate CSPRs into PIFs and product dossiers within the platform
• Maintain GMP requirements for batch traceability
• And more

Maintain cosmetics EU compliance with Cosmetri PM. Get in touch to request your software demo today.