Presence of Prohibited & Restricted Substances in Cosmetics

In the study by ​Pratiwi et al. (2022)​, the authors explored several common substances which are prohibited or restricted for use in cosmetics. They found that despite their regulation, they may still be present in cosmetic products. The study largely focused on analytical methods such as micellar electrokinetic chromatography (MEKC), gas chromatography (GC), and spectrophotometry. These analytical methods, amongst others, were used to identify prohibited and restricted substances in cosmetic products. 

A point of discussion in the larger legislative scope is the difference between theoretical regulation and real-world application/implementation. The work of ​Pratiwi et al.​ is a good example of the real-world implications of this idea. The study provides tools for the industry to better understand the analytical methods for detection of substances, something important in the cosmetovigilance process. This is especially important for competent authorities (CAs) and in the post-market surveillance process of cosmetic companies. Many studies speak of the importance of post-market surveillance ​(Ferreira et al., 2022)​, ​(G. et al., 2025)​, ​(Vieira et al., 2024)​, although the guidance on how to perform post-market surveillance is limited to Chapter VII – Market Surveillance in the European Union’s Cosmetic Products Regulation (EU CPR) (EU 1223/2009). The regulation states: ”Member States shall monitor compliance with this Regulation via in-market controls of the cosmetic products made available on the market. They shall perform appropriate checks of cosmetic products and checks on the economic operators on an adequate scale, through the product information file and, where appropriate, physical and laboratory checks on the basis of adequate samples.” The legislation, however, does not provide guidance on when to carry out ’laboratory checks’ and doesn’t stipulate what ’adequate samples’ are. The article by ​Pratiwi et al. (2022)​ provided some ideas on what tests could be performed on finish cosmetic products to test for the presence of prohibited and restricted substances such as cadmium, bithionol and formaldehyde. Recently, formaldehyde releasers have been a topic of conversation with in the European Commission (EC), with a recent publication of Commission Regulation (EU) 2022/1181 of 8 July 2022 in which it is stated that; ”All finished products containing substances which are listed in this Annex and which release formaldehyde shall be labelled with the warning “releases formaldehyde” where the total concentration of formaldehyde released in the finished product exceeds 0,001 % (10 ppm), irrespective of whether the finished product contains one or more” (2022/1181). Formaldehyde-releasing preservatives will be phased out in the European Union. Therefore, understanding analytical tests which identify this substance, and other highly regulated substances, is an important step in meeting compliance within the community. 

The best source of data for incompliance in the market is the Safety Gate ​(Safety Gate: The EU Rapid Alert System for Dangerous Non-Food Products, n.d.)​, where authorities post the results of inspections on specific non-food products, including cosmetics. A face paint set picked up in Cyprus was found to contain 0.22mg/kg of mercury ​(Safety Gate: The EU Rapid Alert System for Dangerous Non-Food Products, n.d.)​. Mercury is a prohibited substance according to the EU CPR, and therefore, the product is not compliant and has been withdrawn from the market. According to ​Pratiwi et al. (2022)​, there are many methods of detecting mercury in cosmetics. The method used for the largest variety of products was atomic absorption spectrometry (AAS), including the testing of body lotions. In order to meet the requirements of Article 22 ’In-market Control’ of the EU CPR, the brand should have tested the product if there were any suspicions that the product could contain mercury, and as part of the quality management system in place. 

The topic of theoretical legislation and in-industry practice is common in all sectors and is discussed internationally. Legislators often state that regulations are only as strong as their enforcement, and if the enforcement (largely from CAs) is insufficient, the addition of additional legislation may only be a legislative burden. This topic has been explored by scholars ​(Zakaria, 2012)​​(Ferreira et al., 2022) but​ deserves some attention in the discussion of potential harmonisation of future legislation.