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Cosmetic Regulation

Cosmetic regulation is crucial to ensure that the everyday skincare products we use are safe, effective, and manufactured in compliance with health standards. It covers all aspects, from ingredient formulation to labeling, including safety testing. Manufacturers must adhere to stringent laws that vary across different regions of the world, such as the European Regulation (EC) 1223/2009 in Europe or the FDA in the United States.

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FAQ about cosmetic regulation

What are the labeling requirements for skincare products?
Cosmetics are required to include a comprehensive list of ingredients (INCI list), information on shelf life, usage precautions, and the name and address of the individual responsible for market distribution.
Is the regulation for cosmetics the same as the regulation for medications?
No, cosmetics are not medications, thus the regulations governing their respective uses differ.
Are animal tests permitted?
This varies by region worldwide. In the European Union, animal testing for cosmetics has been banned since 2004, while the FDA, which governs the American market, does not prohibit this practice. In China and Japan, animal testing for cosmetics is still widely practiced.
What does cosmetic regulation say about CMR substances?
The European Union prohibits the use of substances classified as CMR, with the exception of some deemed safe by the SCCS, which believes that a substance's hazardous property does not necessarily pose a risk in its use.
What is the regulation on sunscreens in Europe?
In the European Union, sunscreens are regarded as active ingredients that must be validated for their effectiveness and safety. They are listed in Annex VI of Regulation (EC) No 1223/2009.
What is the difference between a Best Before Date (BBD) and a Period After Opening (PAO)?
The minimum durability date MDD (for example: "Use before end 12/2025") applies to products with a limited lifespan (< 30 months), while the period after opening (for example: "6M") applies to those whose stability is guaranteed for more than 30 months but must be used within a defined period after opening.
What is a cosmetic claim and how is it regulated?
A claim (for example: "24-hour hydration") must be substantiated by tests or scientific evidence, in accordance with Regulation (EU) No 655/2013.
What are the responsibilities of a skincare product manufacturer in Europe?
A manufacturer is obligated to ensure the safety of the skincare product, compile a product information file (PIF), adhere to good manufacturing practices (GMP), and register their product on the Cosmetic Products Notification Portal (CPNP).