The EU and UK Regulations on cosmetic products aim at ensuring the safety of cosmetic products in the European Union and the United Kingdom, independently from where they are manufactured. The law requires each cosmetic product to have a Product Information File (PIF) collecting safety information. The results of specific laboratory testing and the safety assessment report are part of the PIF.
Below is a summary of the mandatory laboratory testing your cosmetic products must undergo before selling it in the EU and UK.
What are the mandatory laboratory tests for cosmetic products in the EU and UK?
Each cosmetic product should have a:
1. Stability test to determine the shelf life of a product, i.e., how long the product keeps its function and can be used safely.
2. Test on the compatibility between the product and its container
3. Preservative efficacy (challenge) test to ensure there is no risk of microbial growth during storage and use of the product.
Additional tests might be required depending on the product type or the claims on the labels. For example, if you want to state that a product is “dermatologically tested”, you should perform a patch test.
On top of the 3 above mandatory tests, all cosmetic products must pass a safety assessment, which is a toxicological evaluation of the product considering its exposure to target users. The safety assessment (SA) must be performed by a qualified safety assessor who concludes whether the product is safe for use.
How to obtain the safety tests for the EU and UK markets
Mandatory laboratory testing can be performed everywhere globally, not just in the EU or UK. However, they must follow recognized protocols and methodologies. For this reason, we suggest you consult with your Responsible Person who can advise you on the best laboratories to approach. This will save you time and unnecessary expenses.
The results of laboratory tests must be stored in the Product Information File (PIF) kept by the Responsible Person and available to competent authorities in case of inspection. Moreover, those results are among the documents that the Safety Assessor considers in the assessment of the safety of the product.
In light of the above, it is clear that laboratory testing and safety assessment are an essential part of the EU & UK compliance process for cosmetic products. Hence, you need to pay close attention to those requirements and rely on trustworthy partners to carry out the operations.
How we can support you
Check Obelis one-stop solution for regulatory compliance: from laboratory tests and safety assessment to pre-market notification. With 35 years of experience in the business, we will be at your side along the process and help you enter the EU and UK markets.