Creating your PIF in Compliance with the EU Cosmetics Regulation: A Quick Guide
Ready to market your cosmetic 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.
Along with being a prerequisite to marketing cosmetics in the EU, PIFs are also required when selling cosmetics in ASEAN countries.
The following 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 Regulation (EC) No. 1223/2009
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, including requirements for maintenance of an up to date Product Information File (PIF).This requires a more extensive set of data, promoting better consumer safety.
PIFs must be kept for 10 years and in at least two separate locations.
Regulation No (EC) 1223/2009 requires the Responsible Person (RP) to keep and have access to a PIF for each product.
RPs must maintain the PIF as described in the Regulation’s Article 11 and make it available to authorities of the member state where the file is kept, according to the address on the product label.
RPs may keep files in electronic or paper format.
Cosmetic Product Information File Contents
The Product Information File should contain the following groups of information:
- A description of the cosmetic product
- A cosmetic product safety report (CPSR), parts A and B.
- A manufacturing method description and declaration of compliance with the Good Manufacturing Practices specified in the regulation’s Article 8
- Proof of the product’s claimed effect(s)
- Information on any animal testing done in connection to the development or safety assessment of the product or its ingredients
Here's a detailed description of each of these 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 CPNP. The product description section must also contain the product notification reference number and details of the RP.
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 the assessor's references.
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.
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 Good Manufacturing Practice (GMP) is another major requirement in this section. GMPs ensure the product is safe to use and must be compliant with 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 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.
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 CPSR
- Specify manufacturing processes and GMP compliance
- Substantiate the product’s efficacy, quality, and stability
- 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 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.
Public Access Requirements
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.
Remember that you need to fulfill all of these requirements to meet regulatory requirements. The EU region market is an exceptional avenue to introduce and grow your cosmetic brand. And your first step to achieving success in this market is to achieve regulatory compliance.
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