Bite-size guide to Product Information File

Product Information File is one of the requirements of EU/UK Cosmetic Regulation, but what is it and why do you need one? Continue reading to find out!

Product Information File - Requirements and Content

The EU Regulation states: 'When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it. The product information file shall be kept for a period of then years following the date on which the last batch of the cosmetic product was placed on the market'.

This requirement applies to all manufacturers big or small, all cosmetic products and free samples. You need to have PIF in order to sell cosmetics legally in the EU or UK. Read on to find out what to include in the PIF and practical considerations for compiling one.

The Product Information File should contain the following:

• Description of the cosmetic product: the description must be specific enough to link it clearly to the product PIF refers to. This can be accomplished by introducing formulation codes, reference numbers, CPNP reference number, and specific product descriptions. Also, the final product formulation can be included here.

• The Cosmetic Product Safety Report. CPSR is an integral part of PIF. Please check our previous blog posts for further details.

• A description of the manufacturing method: how the product is made and a statement confirming compliance with Good Manufacturing Practice (GMP).

• Proof of the effect claimed. In practical terms, it means substantiation for all claims made on the cosmetic product and promotional materials.

• Data on any animal testing: this includes tests performed by the cosmetic product manufacturer, supplier of ingredients, or Responsible Person in order to meet the requirements of other regulatory frameworks. Animal testing of cosmetics is banned in the European Union; therefore in practical terms statement from the supplies will be needed confirming that no animal tests have been done on the ingredients.

Product Information File - Practicalities

There are a few points to consider when compiling the Product Information File:

• All cosmetic products placed on the EU/UK market must have PIF in place, this includes not only new products entering the market but also products already being sold. So if you already market your products, but don't have PIF it's time to compile one as soon as possible.

• All the information contained in PIF is the intellectual property of the Responsible Person. The Product Information File is not to be made public but must be readily available to inspectors from competent authorities responsible for cosmetic products.

• The Product Information File must be kept for 10 years after the last batch of the product described in the file was placed on the market.

• The PIF must be kept up to date. When new information regarding the product or its ingredients becomes available, the PIF must be updated. Also when the product is reformulated, this needs to be reflected in the Product Information File.

• The PIF language must be easily understood by the competent authority inspectors, so typically local language should be used, but raw data e.g. lab reports can be kept in the original langue.

• The PIF doesn't have to be a single file or document. References can be made to the location of data included, but PIF has to be located at the address specified on the packaging of the marketed product.

• Comprehensive information on ingredients used should be included, e.g. manufacturers' addresses, properties of the ingredients, safety data sheets. Also, stability data on the finished product and final product specification are required.

• Cosmetic Product manufacturers are required to have a system established for monitoring of any undesirable effects caused by their products, PIF is a good place to describe this system.

In summary, PIF is not only a regulatory requirement but also a very useful file to keep all your cosmetic product information in. It is important to establish it right at the beginning of the cosmetic product lifecycle and keep it up to date with new information becoming available. Don't leave it until the last minute!

PIF is only one of many obligations under the current EU/UK cosmetic legislation. Please get in touch via info@moleculeregulatoryservices.co.uk for further information.

Watch this space for upcoming blog posts exploring further aspects of cosmetic regulations and how to make and sell your cosmetics in a safe and compliant way. We will make it simple!

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