# Spreading of Dangerous Skin-Lightening Products as a Result of Colourism: A Review
## 6 Regulations  
The Minamata Convention on Mercury, adopted in 2013 [62], is a global treaty that aims to protect human health and the environment from the adverse effects of mercury; one of its goals is to phase out mercury in a large number of popular products. By the end of 2020, parties to the Convention will have banned the production, import and export of soaps and skin-lightening creams containing more than 1 ppm (1 mg/kg) of mercury, while no limit value has been set for eye cosmetics in which mercury derivatives are used as preservatives and for which there are currently no effective and safe alternatives available.  
To protect European citizens, EU Regulation 1223/2009 [63] banned the use of hydroquinone, mercury and topical steroids in skin-whitening cosmetics; in particular, corticosteroids and mercury and its compounds (except phenylmercury salts, listed in Anne V of Regulation 1223/2009 and which are allowed as antimicrobial preservatives in eye products) are present in Anne II, the list of substances prohibited in cosmetic products. Concerning hydroquinone, it was initially listed in Anne III of EU Cosmetic Regulation 1223/2009 (the list of substances that cosmetic products must not contain except in specific cases) and was only allowed as an oxidising dye for professional hair dyes (maximum concentration 0.3%). Subsequently, with Regulation 344/2013 [64], the use of hydroquinone was further restricted, and it was included in Anne II (substances whose use is prohibited in cosmetics), except for entry 14 of Anne III, where hydroquinone is no longer allowed in hair dyes but only in artificial nail systems for professional use (maximum concentration 0.02%). The intention of the community legislator therefore seems to be the progressive exclusion of hydroquinone from cosmetic products, thus narrowing its use to professional use products that do not involve direct contact with the epidermis.  
In the United States, the 1974 FDA regulation [65] states that any cosmetic product that contains more than unavoidable trace amounts of mercury (defined as no more than 1 part per million [1 ppm = 0.0001 per cent] calculated as a metal) is in violation of the Federal Food, Drug and Cosmetic (FD&C) Act and is subject to legal action. The only exceptions are cosmetics intended for use only in the eye area, which may not contain more than 65 ppm (0.0065%) of mercury, calculated as a metal, as a preservative, when no effective and safe alternatives are available. As for hydroquinone, in 2014 the U.S. Cosmetic Ingredients Review (CIR) Expert Panel [66] stated that this ingredient was safe for use in nail adhesives, but should not be allowed in other leave-on cosmetic products. Recently, based on the CARES Act (2020; [67]), all OTC products containing hydroquinone have been withdrawn from the US market, and products containing this ingredient must be approved by the FDA via the new drug that process.  
\begin{table}
\begin{tabular}{c c c} \hline \hline
**Skin-Lightening Agent** & **Mechanism of Action** & **Toxic Effects** \\ \hline Mercury derivatives & \begin{tabular}{c} Inhibition of melanin synthesis (competition \\ with copper in tyrosinase’s activity site) \\ \end{tabular} & \begin{tabular}{c} Dermatological, gastrointestinal, neurological \\ and renal effects \\ \end{tabular} \\ \hline Hydroquinone & Inhibition of tyrosinase activity & \
\begin{tabular}{c} Irritant contact dermatitis, ochronosis; \\ suspected of causing cancer \\ \end{tabular} \\ \hline Corticosteroids & Interference with the production of \(\alpha\)-MSH &
\begin{tabular}{c} Dermatological (acne, contact dermatitis, skin \\ atrophy) and systemic (Cushing’s syndrome, \\ immunosuppression, hypertension, diabetes \\ mellitus, hypothalamic-pituitary-adrenal axis \\ suppression) effects \\ \end{tabular} \\ \hline \hline \end{tabular}
\end{table}
Table 2: Mechanisms of action and toxic effects of the banned depigmenting agents examined.