Legislative Comparison of Cosmetics and Medicines in the European Union

Comparing cosmetic legislative systems is the key aspect of my research, however, an understanding of how cosmetic law relates to other forms of legislation helps to broaden the scope and awareness of my work. Drug and cosmetic legislation is related in many regions I am investigating in my research, including – but not limited to, the U.S. Food, Drug and Cosmetic Act (FD&C Act, 1938), the Canadian Food and Drugs Act (F&D Act, 1985) which enacts the Cosmetic Regulations (CR, 1977) and the Japanese Pharmaceutical and Medical Devices Law (PMDL, 2014). In the review article by G. et al. (2025), the main differences between drugs and cosmetics were discussed in the European Union (EU). Most notably, the differences between an EU responsible person (RP) and EU qualified person (QP) are a significant difference – yet a familiar concept to regulators. The main differences between an RP and QP are the years of expertise, qualification and position within a company. For cosmetic products, these requirements are not stipulated (EU CPR, 2013). This means that anyone within the company could be a responsible person provided that they ensure compliance with the listed articles in the regulation (namely article 3 (safety), article 13 (notification) and article 19 (labelling)). This is a stark difference compared to the requirements for medicinal products. Under article 49, the QP must fulfil the conditions and qualifications laid out in paragraphs 2 and 3 which include a diploma or certificate of formal qualification from a university extending over a period of at least 4 years in a field related to medicines. The directive also lists the theoretical and practical study material required in the course to be deemed satisfactory. The qualified person must have at least two years of practical experience in the field (EU MPD, 2001). This increases the barrier to entry for medicinal products compared to cosmetic products as firms are required to hire a QP with the above listed requirements. This barrier is justified due to the higher risk nature of medicines compared to cosmetics. One might argue that cosmetic products should also require a QP instead of an RP to provide a higher level of consumer safety, but in practice, many medium to large firms already hire regulatory specialists to fulfil the requirements of an RP (ref?), and requiring a QP for cosmetics may hinder international trade as foreign universities may not provide suitable courses for this subject area. The idea of an RP is featured in many regions across the globe, including Canada (CR, 1977), the ASEAN region (AHCRS, 2003), Andean Community (HLCP, 2018) and MERCOSUR region (ref?). The RP requirement ensure a high level of consumer safety by instilling the idea of responsibility over the products manufactured and sold in these regions. A named RP must be listed on pack in all the above listed regions, making the RP easily identifiable (EU CPR, 2013).