How to Create a PIF for Cosmetics: Compliance Tips for Small Businesses
You may have heard about Product Information Files when researching the steps involved in launching a cosmetic product in the UK or EU. In short, the PIF is a key document, or a foundation document needed by the EU Regulation 1223/2009 to evidence that the products you intend to bring to market (or have brought to market) are safe and meet strict standards before they reach consumers. This blog post explains what a PIF includes, how to organise it and how small businesses can simplify the PIF making process. Please note that I have given a general description of what is expected of a PIF, this is not an exhaustive list; what is required is largely dependent on the product and intended market.
What is the purpose of a PIF
The main purpose of a PIF is to ensure that a product is safe under normal conditions of use. It is a collection of files that has data on each marketed product including ingredients, manufacturing processes and procedures, safety tests, claims proof, operational data, up to date batch records. This ‘file’ allows for authorities to quickly access product details in order to perform compliance checks and for marketing surveillance purposes.
What is inside a PIF?
1. Product Description
General information – this would be the name, assigned product code (if applicable), type of product i.e. facial toner, moisturiser, shampoo etc), general characteristics i.e. it is a white, opaque oil in water emulsion or it is a clear low viscosity microemulsion.
Intended Use – how is the customer supposed to use it? This will include statements on areas of the body it is intended for, frequency of use and the intended age and sex of the consumer i.e. a chemical hair removal cream meant for women’s facial hair. It would also include method of application, usage instructions, warnings and restrictions.
Physical and Chemical Characteristics – This includes the chemical composition of the product in percentages. It may also include information that your development chemist may be able to share with you such as pH, odour, appearance, viscosity, stability data, storage conditions, antioxidant system, and possibly water activity and density (though this may not be available and is not usually necessary).
2. Cosmetic Product Safety Report
This is a key component of the PIF and has two main sections:
· Part A: Safety information about the product (compiled by the safety assessor)
This will include the toxicological profile of the ingredients that are used in the formulation, the full composition of the formulation – each ingredient (common/trade name) and international nomenclature of cosmetic ingredients (INCI), the function of each ingredient, the CAS number, EC number and toxicological profile, as well as the general characteristics of the product (as above in general information), stability test and microbiological test.
· Part B: A safety assessment by a qualified expert – this will contain the qualifications of the safety assessor and their contact details. Safety assessors will usually have some kind of scientific background and would likely have taken a specialised safety assessor course.
3. Manufacturing Process
· What is the method of manufacture? This will include the step by step procedure, critical steps in manufacturing, ambient humidity (if this is important for manufacturing), equipment used, temperatures used in each step, and any other parameters critical to the manufacturing process.
· A statement of good manufacturing practice (GMP), whether that is inhouse or outsourced manufacturer. If using an external contractor you must ensure they have GMP certification.
· Keep all records of batches either inhouse or by the contractor – include a standard operational procedure.
4. Proof of product Claims or ‘efficacy effects’
If you are making claims that your product has certain benefits then you need to show the evidence for this. This can be any research from scientific studies, consumer tests or lab results. Research labs have various studies and models that you can use to make your claims. As part of the marketing materials for certain active ingredients, the manufacturer will have scientific studies to support their ingredients used at a certain levels. These can be used to support your claims.
5. Animal Testing Information
This section confirms that the product and its ingredients haven’t been tested on animals, as required by EU/UK law.
How should a PIF be organised?
The EU/UK doesn’t specify a particular format, however structuring your PIF will make it easier for you to navigate. You may even want to create an excel sheet for each product. You could organise it as follows:
Table of contents
Product information – product name, general description, properties
CPSR – this can be attached or linked to the excel sheet
Proof of claims – attach any external studies, lab reports etc
Compliance Documents – GMP declaration, animal testing statement, CofA, SDA
Packaging and Labelling – keep records of artwork, labels and packaging in general
Post-Marketing Surveillance – detailed records of adverse effects, records of correspondence with any regulatory bodies or customers in the event of adverse events.
Who is Responsible for the PIF?
The Responsible Person (usually the manufacturer, importer, or a designated EU/UK representative) must:
Keep the PIF up to date and accessible for up to 10 years after last batch is manufactured
Share the PIF with authorities if requested.
Update the PIF when formulas change or new safety data is available as well as update CofA with every new purchase.
Select a safety assessor who is suitably qualified to do the CPSR
Report any serious safety issues with the relevant authorities.
Maintain up to date records of batches, new supplier details and documentation of new, current and used ingredients.
Conclusion
The PIF is probably the most crucial part of the cosmetic regulations as it ensures products meet the required safety standards necessary for launching and monitoring products placed on the market. This has been a quick and general guide to cosmetic product information files. For more information it is always good to look directly at the legislation and guidance in your region.