Cosmetics product information file (PIF)

About the cosmetics product information file (PIF)

The product information file is a cosmetic product dossier containing all the most important information about the finished product, ingredients which the product is made from, packaging in which the product is sold, manufacturing process and product labelling, which shows the product characteristics, its safety and efficacy. Each product placed on the EU/UK market needs to have a product information file prepared.

According to the EU Cosmetics Regulation 1223/2009 (and the same in the UK cosmetics regulation), the responsible person must keep a product information file for each cosmetic product placed on the EU/UK market, at the address specified on the product label, readily accessible for the competent authority of the EU member state (or UK) where the responsible person is established. The product information file has to be available in a language easily understood by the local competent authority of the country where the responsible person is keeping the cosmetics product information file.

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 ten years following the date on which the last batch of the cosmetic product was placed on the market (EU Regulation 1223/2009, Article 11.1).

The responsible person shall make the product information file readily accessible in electronic or other format at his address indicated on the label to the competent authority of the Member State in which the file is kept. The information contained in the product information file shall be available in a language which can be easily understood by the competent authorities of the Member State (EU Regulation 1223/2009, Article 11.3).

The product information file must be kept at one single address within the EU/UK, even if the cosmetic product is sold in various EU countries. This also means that there can only be one responsible person per product for the whole of the EU - there cannot, for example, be one responsible person in Germany and one in France for the same product.

Product information file (PIF) content

The product information file content is described in article 11 of EU Cosmetics Regulation 1223/2009 and UK Schedule 34 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019. The content of the cosmetics product information file is standardized and does not change, irrespective of the type of cosmetic product in question.

According to article 11, the product information file must contain the following information and data:

A description of the cosmetic product

A description of the method of manufacturing and either a good manufacturing practice certificate or a statement on compliance with good manufacturing practice (the GMP standard which must be followed in the EU is standard ISO 22716)

Where justified, a proof of the effect claimed for the cosmetic product

Any data on animal testing

The product information file should also contain product labelling

CPSR* (See text box)

A complete cosmetics product information file (PIF) is the basis for the notification to the EU CPNP portal or the UK SCPN portal, which must be performed before the cosmetic products can be placed on the EU/UK market.

*Cosmetic product safety report (CPSR)

The most important and most extensive part of the cosmetics product information file is the cosmetic product safety report (CPSR), which contains all the information, specifications and tests relating to the raw materials, finished product, packaging, etc. Based on these, the safety and the compliance of the cosmetic product with the EU/UK cosmetics regulation can be proven.

Cosmetic product safety report (CPSR), the contents of which are described in annex I, consisting of the following:

Part A: Cosmetic product safety information

Quantitative and qualitative composition of the cosmetic product

Physical/chemical characteristics and stability of the cosmetic product

Microbiological quality

Impurities, traces, information about the packaging material

Normal and reasonably foreseeable use

Exposure to the cosmetic product

Toxicological profile of the substances

Undesirable effects and serious undesirable effects

Information on the cosmetic product

Part B: Cosmetic product safety assessment

Assessment conclusion

Labelled warnings and instructions for use

Reasoning

Assessor's credentials and approval

Cosmetics regulatory services

CE.way services related to the product information file

CE.way can offer various services related to the preparation of the product information file. We can offer:

Start selling in the EU and UK!

And what do they say about us?

Pharmaplast began to work with CE.way almost one year ago. CE.way is our cosmetics consultant who look after compilation of PIF, safety assessments and CPNP notifications. In addition to this, CE.way is our European representative as our company is not located in Europe. Working with CE.way has been a joy so far. Their replies are very swift and Mr Tadej is very cooperative, helpful and with a deep knowledge about the cosmetics regulations. In addition to this, CE.way is very cost effective company in comparison with their European counterparts. For all the above reasons, I really recommend CE.way to other cosmetic product manufacturers.

Mena, Egypt

Pharmaplast

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