AEMPS: Quarterly report of the Spanish Authorities about cosmetic products – July to September 2019

The Spanish Authorities have published their quarterly report about cosmetic products vigilance and control and some points are to be highlighted.

The Spanish Medicines and Health products Agency has been lately reviewing the studies concerning specific sunscreen cosmetic products. From its report, an appreciable variability, with regards to the followed methodology of assessment, stands out. The Agency (AEMPS) verified that all the clinical tests were performed in accordance with the reference methods, but contends that the different results may be a consequence of such a disparity.

In this light, the Agency informed the group of experts in charge of drafting the methods of reference of the possible influence that new cosmetics’ presentation – like transparent sprays or hazes – shall have upon the results of future clinical trials.

In addition, legal breaches have been noticed and published through RAPEX[1], which is publicly accessible. From July to September 2019, 22 alerts were registered in the cosmetic field, while two being commercialized in Spain. Those products have already been recalled from the market and the Spanish Autonomous Communities were notified to check them effectively.

The most frequent causes of RAPEX alert generally include:

  • Microbial contamination,
  • Presence of forbidden substances by Annex II,
  • Presence of substances outside the set limits by Annex III,
  • Presence of colorants excluded from Annex IV
  • Labeling errors,
  • Deceptive appearance, which misleads the customer into confusing cosmetics with food.

If interested, you can check the guidance issued by the European Union competent authorities concerning the application of the Cosmetic Regulation in the Spanish State of Autonomies in the following link.


Carlos Francisco Marín Barrios

Regulatory Affairs and Quality Assurance

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[1] the fast information exchange system of the EU

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