Regulation and Safety of Cosmetics: Pre- and Post-Market Considerations for Adverse Events and Environmental Impacts

Abstract

Cosmetic products have been increasingly regulated, particularly in Europe. With the introduction of the cosmetic regulation in 2013, stricter quality standards were implemented, surpassing those set by the 1976 legislation. The primary objective of these regulations is to safeguard consumer safety during the use of cosmetic products. Despite these advancements, certain regulatory gaps remain, indicating the need for more effective measures to enhance human and environmental health protection. Considering the aforementioned, this work aims to provide an overview of the current Cosmetics Regulation, highlighting the weakest cornerstones that represent the missing link keeping the core objective from being achieved. While there is ongoing reliance on historical data from animal studies, efforts are actively underway to replace these methods with new new approach methodologies for risk assessment. Additionally, regulatory authorities continue to improve environmental considerations in the assessment process. These measures, along with enhanced surveillance systems, are gradually addressing existing gaps and contributing to a more robust regulatory framework that balances market access with consumer safety. Legally non-compliant—or perhaps compliant but unknowingly dangerous—products may be used by people who relativize them as inherently safe, leading to adverse events. Whether caused by an underlying disease or purely by the chemical’s toxicity, these may never come to the attention of the authorities as they are generally under-reported, making it unfeasible to implement corrective or preventive measures to address their root cause. To illustrate, non-compliant products that have been detected by the Portuguese authority, INFARMED, I. P., from January 2018 to September 2023 are discussed, which were found to be potentially dangerous to human health and, therefore, withdrawn from the market.