"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. 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."
EU & UK regulatory
Cosmetics product information file (PIF)
Most cosmetic regulations require manufacturers or the responsible persons to maintain technical documentation demonstrating that a cosmetic product complies with the applicable legal requirements. This documentation is commonly referred to as the Product Information File (PIF), although its name and specific contents may vary between jurisdictions.
In the following sections, we describe the Product Information File (PIF) as required under the European Union and United Kingdom regulations. Most other regulatory frameworks requiring a PIF follow a similar structure and set of documentation requirements. Information on market-specific requirements is available on the respective country and regional pages.
About the PIF
About the cosmetics product information file (PIF)
About the PIF
About the cosmetics product information file (PIF)
According to the EU Cosmetics Regulation 1223/2009 (and the same in the UK cosmetics regulation), the EU responsible person or UK 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.
Legal basis
Regulatory requirements
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.
PIF contents
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:
- Product description
- Good Manufacturing Practice (GMP) and method of manufacturing description
- Claims substantiation, where justified
- Animal testing information
- Product labels
- Cosmetic Product Safety Report (CPSR)*
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, consists 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
Our 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:
Getting started
What's the process?
01
Documentation Review
We review your formulation and documentation.
02
Gap Assessment
Identify any missing information.
03
Additional Testing
Request additional testing if required.
04
PIF Preparation
Compile the complete Product Information File.
05
Notification Support
Support the CPNP/SCPN notification if needed.
Client reviews
Trusted by 1000+ cosmetic brands worldwide.
Pulled from verified Google reviews — independent, unedited, and updated continuously.
"We were looking for a stand-alone service, not too sure what to expect... The professionalism, the assistance and the responsiveness were very much appreciated, amongst the best we have ever experienced."
"We are a small manufacturing company located in the US. We recently used CE.way Regulatory Consultants to help guide us through the Cosmetic regulatory changes that have taken place in the EU. They were instrumental in helping us understand the new laws and streamline the entire process. I would highly recommend their services."
1 / 5
Get started
Need a Product Information File for your cosmetic products?
Speak with our regulatory experts about your product information file and safety assessment requirements.
