Difficulties of the EU/UK Cosmetic Regulations and BIORIUS’ expertise

A lot of people are not always aware of it, but the EU/UK Cosmetic Regulations are the most complicated in the world. The EU/UK Cosmetic Regulations are more or less the same but there are indeed some minor changes (due to Brexit).

Biorius is specialized in cosmetic regulations in Europe, the United Kingdom, the United States and internationally (in more than 60 countries). If you wish to develop the sales of your cosmetic products in Europe or other countries, this is clearly something we can help you with. We can even act as a Responsible Person in Europe and/or the UK (due to the Brexit). Biorius is indeed mainly composed of regulatory experts, specialists, toxicologists, and scientists (chemists and biologists), we have more than 1,000 international clients, we have already evaluated more than 50.000 products and we never had any compliance issues (fines, withdrawals of the market, etc.) in 12 years of existence. Working with Biorius simply is reassuring and comfortable.

The first Step: The Formulation and the Laboratory Test

Firstly, and more importantly, before you sell any cosmetic product in Europe, you must formulate it! It doesn’t matter if your product is 100% organic, bio, natural, or if it’s only a mix of 2 products… another way to say it is… no formula = no Europe! Therefore, to start selling your cosmetic products in Europe, you will first have to contact a formulator. Biorius is not a formulator, but Biorius will check that everything is compliant and regulatory when the formula has been established.

A Formula Review is indeed completely necessary to check if everything is compliant and regulatory (because some ingredients are prohibited) and to check which lab tests are mandatory.

Examples of a formula for a cosmetic product:

Some cosmetic products indeed also require additional laboratory tests (it mainly depends on the cosmetic product and the cosmetic formula), example:

• Stability and compatibility – 3 months at 40°C
• Challenge test (PET) – USP 51 (no Challenge test if no water)
• Microbiological Test – USP 61 + 62

How Biorius can help you with the Laboratory Test

For your information:

• The mandatory tests are evaluated by our toxicologists during the examination of the formula.
• Some cosmetic products do not require any laboratory tests, and some cosmetic products may require 1, 2 or all laboratory tests.
• We are not a laboratory, but we can also organize these tests for you (with very serious laboratories).
• Tests made by other serious laboratories are usually also totally compliant and sufficient
• The time of these tests depend on the tests to be performed (a few weeks or months).

What About the Others Steps?

We then continue with the rest of the process, meaning:

• Cosmetic Product Safety Report (CPSR A&B) signed by a Toxicologist
• Label and claims review
• PIF (Product Information File) preparation

Biorius can indeed support the entire regulatory process and constitute the entire PIF (Product Information File). In short, you don’t have to worry about anything, and we will take care of everything. Thanks to our very sophisticated tools (completely developed by Biorius), we are very fast, highly reliable and extremely reactive (and proactive)! We always try our best to answer messages in a timely fashion!

A lot of well-known brands trusted in us and keep on trusting, here are some references.

For more information, please contact us via the Request Form or by email: info@biorius.com