What Process Is Involved In The Safety Assessment Of Cosmetic Products?

Currently, about 1,328 chemicals have been banned by the EU due to their potentially harmful compounds which can cause damage to the human skin. Cosmetic products must be put through rigorous testing to ensure that it is safe for users and would not cause short or long-term adverse effects. The EU has put in place several rigid regulations which check the production and distribution of cosmetic products all over Europe.

To effectively carry out this assessment, a manufacturer must follow this process;

  • Characterization of ingredients through the relevant physiochemical data, the chemical structure of constituent elements, and purity and profile of impurities.
  • Assessment of toxicological hazard and data on related structural analogues.
  • Considerations concerning stability of ingredients and microbiological status as well as product formulation.
  • Exposure assessment which should include information on how the product may be used, frequency, amount, target users, duration of the intended use.
  • Exposure margins or calculation of safety using the relevant dose metric.
  • Post-market surveillance to monitor the product for side effects of use after a short or long term.


What is the role of the individual responsible for this assessment?

The individual responsible for the assessment of a cosmetic product plays an integral role in that process of safety assessment and must possess the all necessary qualifications to fulfill this role in an ethical and responsible way.

The individual must possess;

  • Competence and training in evaluation, analysis, and interpretation of toxicological information.
  • The safety assessor must have access to the analytical and toxicological data which is relevant to safety. The assessor must also be impartial and objective when considering the safety of the product.
  • The safety assessor must also carry out the assessments which are based on an exhaustive analysis of all the available data, appropriate consideration of the data and conditions of exposure.

When an assessment is concluded, the conclusion of the assessor may be that the product is safe to be used with any restrictions or that the product is safe with restrictions and that the product is not safe for use. The assessor may also state his/her recommendations and the limitations or restrictions of the cosmetic product in question.

What is the role of challenge tests in cosmetic safety?

It is crucial to undertake a routine microbiological challenge test to guarantee that a cosmetic product is safe and of good quality, and each batch of the end product should be tested before it is approved to enter the market.

Microbiological contamination can originate from production and filling of the product or after the seal is broken and the consumer is using it. For microbiological challenge tests, the cosmetic product must be inoculated with some germs and the germ reduction must regularly be investigated over a specified period. Microbiological challenge tests involve the determination of the bacterial count in a cosmetic product and testing the product for sufficient levels of preservation.

The stringent EU rules and legislation provide regulations which must be followed by all manufacturers of cosmetics in the EU region and safety assessment such as challenge test must be carried out for the overall safety of the consumers of the products.

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