Last Updated on May 10, 2022 by Ithos Global Regulatory Team
Directive 76/768/EEC has been governing the composition, labeling, and packaging of finished cosmetic products in the European Union (EU) since 1976 and required that manufacturers keep a record of all pertinent product information. In 2003, the Directive was revised to include new requirements for a more detailed product information file (PIF) and a cosmetic safety assessment.
In 2009, Regulation (EC) N° 1223/2009 was adopted, becoming the primary regulatory standard for cosmetic products created and proposed for sale on the EU market. This regulation greatly reinforced product safety by ensuring that manufacturers create and maintain proper records for the cosmetics they develop. 1223/2009 provides clearer direction for the content and format of the PIF file and requires a full cosmetic safety report in place of the previously accepted assessment. The new standard also introduces a requirement for a responsible person to be named as the owner and primary contact for the file.
What is the Meaning of the Product Information File?
The product information file is a detailed account of the manufacture, testing, and composition of a cosmetic product. The PIF formally documents the complete safety profile and efficacious properties for a cosmetic product within a standardized file format. This mandatory file – which may include electronic records as well as hard copy – is a compilation of technical documents that must be kept on record for 10 years following the release of the last batch of product placed on the market for sale.
The file contains specific information about the product that would be of interest to the consumer, including the identity and description of the product, the list of ingredients, and any use precautions or possible side effects that may occur. The information in the file is comprised of documents from several stakeholders such as suppliers, testing laboratories, and safety assessors.
The PIF must be available for review by the regional competent authorities at any time, but manufacturers are under no obligation to provide the public access to the files. Competent authorities from other countries or member states do not have the right to access to the PIF and can only request verification of compliance from the regional competent authorities.
Documents Included in the PIF File
Detailed description of the cosmetic product: This allows the file to be clearly linked to the product and should include the exact product name and a description of the product’s function.
Complete Cosmetic Product Safety Report (CPSR): The requirements for the product safety assessment are outlined in the next section.
Description of the production process: This should include an overview of the manufacturing process, including bulk storage and filling and references to all manufacturing documentation. This description must be applicable to all manufacturing sites.
Evidence of compliance with good manufacturing practices (GMP): A statement of compliance with GMP must be included in the file. Compliance is presumed if the product is manufactured in accordance with a relevant standard such as EN ISO 22716:2007.
Proof of the effects claimed for the cosmetic product: Where justified by the nature or the effect of the product, proof of effects claimed for the cosmetic product must be supported with evidence and all technical data kept within the file, or clearly referenced.
Statement on testing cosmetic products on animals: Any animal testing performed by the manufacturer, their agents or suppliers must be documented in the file. This applies to both ingredients and the finished product. Details of any animal testing performed in compliance with legislative or regulatory requirements of countries outside the EU should also be included if the product is to be sold in those countries.
Product labelling, which includes primary and secondary packaging: The name and address of the responsible person must be posted on all packaging in indelible and clearly legible lettering.
Cosmetic Product Safety Report
While Directive 76/768/EEC required a cosmetic safety assessment, Regulation (EC) N° 1223/2009 expanded the requirement to a complete cosmetic product safety report as part of the product information file. The safety report is intended to collect the necessary data to justify the safety of the cosmetic product.
Part A – Cosmetic Safety Information
The cosmetic product safety report is formatted similarly to a chemical Safety Data Sheet (SDS) and must contain the following information at a minimum:
- Qualitative and quantitative composition of the cosmetic product
- Physical and chemical characteristics and stability
- Microbiological quality
- Impurities, traces, and information about packaging
- Normal and reasonably foreseeable use
Additional data that may be collected as part of the safety report includes:
- Data on exposure to the cosmetic product
- Data on exposure to the substances
- Toxicological profile of all substances
- Undesirable effects and serious undesirable effects
Part B – Cosmetic Safety Assessment
The assessment must be performed by a qualified assessor with a diploma in theoretical and practical study in pharmacy, toxicology, medicine, or a similar discipline, and is required to contain a review of products intended for use on children under the age of three and for those products intended exclusively for use in external intimate hygiene.
The safety assessment includes:
- Assessment Conclusions
- Instructions for Use and labelled warning
- Reasoning
- Safety Assessor’s credentials and approval
Role of the Responsible Person
Regulation (EC) N° 1223/2009 mandates that a responsible person be named in the PIF as a primary contact for the competent authorities. The responsible person should have access to a file for every product placed onto the market and be able to produce that file at any time upon request, in a language easily understood by the regional competent authority. The responsible person must be available to answer inquiries and be able to demonstrate that the product complies with the regulations.
The responsible person is tasked with maintaining the file in accordance with the regulations, as well as ultimately ensuring that the product is safe for human health under normal or reasonably foreseeable use. This means that the responsible person of record must ensure that the safety assessment has been performed by an appropriately qualified and credentialed assessor and that all product performance claims can be substantiated by the data on file.
Next Steps
The regulations that govern the creation of cosmetic products are designed to ensure that manufacturers create products that are safe for consumers to use. The product information file is a manufacturer’s best option for documenting development in accordance with EU cosmetic safety standards and industry best practices. Investing in the development of a complete PIF file streamlines a product’s path to approval by the competent authorities and the ability to bring a product to market.
Contact us to discuss your products, formulas, and ingredients for compliance – and for improved agility bringing new products to market: Contact Ithos Global Today.
