Cosmetic Product Safety Report - documents you need to have on file

Cosmetic product compliance can be complicated at times. One of the main issues is the documentation. Do you need to have Certificates of Analysis for the ingredients used? Do you need stability data reports to support your product shelf-life?

Read on to find out!

Product Information File

As you may already be aware, a Product Information File or PIF for short is your place to store all the required information on your cosmetic product. You can read more about the Product Information File in this blog post. The important point to note is that the Product Information File must be kept for 10 years after the last batch of the product described in the file was placed on the market.

Cosmetic Product Safety Report (CPSR) is an integral part of the Product Information File (PIF); therefore the documents and paperwork you need for CPSR are also required for the compilation of the PIF. Read the following blog post to learn more about CPSR basics.

Cosmetic Product Safety Report

Now we know that CPSR is an integral part of PIF, but what documents do you need to have and provide to the assessor to be able to get the Cosmetic Product Safety Report in the first place?

The below list is just a baseline, as some products may require additional paperwork. Use the list below as a starting point and seek advice from your cosmetic safety assessor if in doubt.

Once you've formulated your product and want to get it safety assessed and compliant with the current regulations, get the following documents ready:

• Certificates of Analysis for all the ingredients used in the formulation. These should also be kept on file (in the PIF). Certificates of Analysis (CofAs) should be freely available from your ingredient suppliers. In case your supplier cannot provide these, it is a good idea to look for a different supplier. Having a CofA for each ingredient is vital to ensure the quality of the ingredient and in turn, the quality of the finished product.

• Safety Data Sheets (SDS) or Material Safety Data Sheets (MSDS) for all the ingredients used in the formulation. As above, these should be available from your supplier and are essential to the assessment of the safety of the ingredient and final formula.

• Allergen certificates and IFRA certificates are required for all essential oils, flavours or fragrances used in the cosmetic product. Again, these should be available from your supplier. Allergen certificates and IFRA certificates are essential to establishing the allergen levels of the final cosmetic product formula. This in turn is required for the correct labelling of the product.

• Information on the packaging. Is it food grade, and what type of material is it made from? This will help establish if the chosen container is suitable for the product.

• Stability data. The stability data requirements can vary depending on the type of formulation, e.g. is it water-based or water-free? Stability data is essential to establishing the shelf life of the product and whether the Period After Opening instead of the expiry date can be used. Stability studies can be conducted under a variety of conditions and in a variety of containers, but it is essential to have stability data generated from the product stored in the type of container designated for the commercialisation.

• Product properties need to be documented and presented to the assessor. These include the following (this is not a full list): pH for water-based cosmetic products, viscosity, appearance, colour, scent, etc.

• Preservative Efficacy Test (PET) results for water-containing products. As you may be aware, water-based formulations have to be properly preserved, and PET results provide information on whether the chosen preservative system is appropriate for the formula and is able to keep the product safe from contamination during the intended use.

In summary, the above-mentioned documents and information are necessary for your assessor to be able to compile a Cosmetic Product Safety Report. The list is just a baseline and certain formulations may require additional documentation and data to be properly assessed. Don't leave collecting the above until the last minute, as a lack of the required documentation may delay the assessment or may prevent your products from being certified.

Please get in touch via info@moleculeregulatoryservices.co.uk for further information or any questions you may have regarding PIFs, CPSRs or cosmetic product safety in general.