Regulatory Framework For Cosmetics Products in The European Union

Regulatory Framework For Cosmetics Products

Regulatory Framework For Cosmetics Products in The European Union

A cosmetic product placed on the European Union market must demonstrate that it is safe for consumers. Aside from the statutory testing, extra tests may be required depending on the claims to be utilized or the type of cosmetic product introduced into the market.

EU Legal Framework

When used under normal or reasonably anticipated usage conditions, a cosmetic product placed on the market must be safe for human health.

To show that a cosmetic product adheres to this statement, the Responsible Person (RP) should, before placing a cosmetic on the market, verify that the product has undergone a safety assessment and that a Cosmetic Product Safety Report (CPSR) is prepared in line with the Regulation.

A CPSR must include cosmetic product safety information (part A) in the Product Information File (PIF), which involves:

  • Cosmetic product composition, both qualitative and quantitative;
  • Microbiological purity; 
  • Physical/chemical properties and longevity of the cosmetic product;
  • Harmful byproducts, traces, and packaging material information;
  • Usage that is normal and relatively predictable;
  • Sensitivity to the cosmetic product; 
  • Substance exposure;
  • Toxicity profile of the drugs; 
  • Unfavorable and seriously unfavorable consequences;
  • Details about the cosmetic product.

To meet some of these standards, the product/substance must undergo specific testing, which must be done by recognized laboratories following Good Laboratory Practices (GLP). The bulk of the tests are done on the finished cosmetic product and must be repeated if the recipe, packaging, or manufacturing method changes.

The Cosmetic Product Safety Assessment (part B of the CPSR) is created based on the information supplied in part A and must contain:

  • The assessment conclusion;
  • Labeled warnings and directions for use;
  • Reasons;
  • The assessor’s qualifications;
  • Part B approval.

Cosmetic Product Testing

Product testing can be different depending on the product category, claims, and whether it is considered a drug. Below is a list of the most common test ensuring your cosmetic product is safe for consumer use.

  • Stability Testing – For items supplied in the EU, the Stability test is necessary to fulfill the PIF. Product samples undergo rigorous testing to ensure their stability and physical integrity – no color, odor, or material feature changes. It also enables producers to assess storage conditions and product shelf life.
  • Safety and Toxicological Testing – Manufacturers must-do safety testing, including a toxicology test. It enables them to assess whether any product’s constituents or mixes pose a risk. Several tests show that the substance causes skin irritation, corrosion, penetration, and sensitization when it comes into contact with the skin and eyes.
  • Performance Testing – Product claims are demonstrated and verified through performance testing. It evaluates the functionality, usefulness, durability, and performance of the product.
  • Compatibility Testing – In addition to product testing, packaging should be evaluated, especially when it comes into touch with the completed product. The Compatibility test will determine whether or not there are any corrosive effects between the product composition and the packaging.

Launching a cosmetic product on the shelf is a complex job. Nonetheless, we at Cosmetics Works are here to help you every stage of the way. We have vast expertise in evaluating and ensuring the quality of cosmetic items. 

We can provide complete cosmetics test kits for analyzing items for perceptual attributes and performance parameters and identifying and quantifying the presence of active constituents.

Please reach us at +353 1 535 3507 or email us at if you have any questions.


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