# Plaaben Compounds--Part I: An Overview of Their Characteristics, Detection, and Impacts
## 4 Legislation
### Paraben Legislation for Industrial Use in European Union  
The European Union is updating the regulations for the use of parabens is some industries.  
Regarding the food industry, the use of additives is contemplated in regulation (EC) N\({}^{\circ}\) 1333/2008 [116] but was already updated by regulation (EU) n\({}^{\circ}\) 1129/2011 [117] and regulation (EU) n\({}^{\circ}\) 1130/2011 [118]. The updates were related to the authorized food additives and the conditions of their use, depending on the type of food, and the creation of a list of substances allowed to be used in food additives, food enzymes, food flavors and nutrients, and their guidelines of use. Regulation (EU) n\({}^{\circ}\) 1130/2011 [118] authorizes the use of MP and EP but with restrictions, such as a maximum amount in preparation of enzymes that cannot exceed 2000 mg/kg, restricted to 2 mg/kg for use in food and limited to 1 mg/L for use in drinks. Regulation (EU) N\({}^{\circ}\) 231/2012 [119] establishes the necessary characteristics for the use of food additives.  
Regarding the cosmetic industry, regulation (EC) N\({}^{\circ}\) 1223/2009 [120] establishes the standards for these products on European markets, which were already amended by regulation (EU) N\({}^{\circ}\) 358/2014 [121] and regulation (EU) N\({}^{\circ}\) 1004/2014 [122]. These changes banned the use of some substances in cosmetic products, such as iso-propylarben and its salts, as well as iso-butylparaben and its salts--phenylparaben, benzylparaben and pentylparaben. On the other hand, methylparaben and ethylparaben, their salts and derivatives, and propylparaben, butylparaben and their derivatives are authorized substances.  
These updates also brought new restrictions. The uses of MP and EP are restricted to maximum concentrations of 0.4% and 0.8% for a single ester or a mixture of ester, respectively. Additionally, PP and BuP can only be used up to a maximum concentration of 0.14% for the sum of individual concentrations and 0.8% for mixtures of MP, EP, PP and BuP, where the sum of PP and BuP and their salts does not exceed 0.14%. The other huge restriction is the ban of use of PP and BuP and their salts in products for children under 3 years old, such as unrinsed products designed for application to covered areas by diapers.  
In the pharmaceutical industry, the maximum concentration of parabens in pharmaceuticals is usually around 1% [22]. For oral formulations, MP and PP are used within a concentration ranges of 0.015-0.2% and 0.01-0.02%, respectively. Regarding the labeling and package leaflet of human's pharmaceutical products procedures, if a product contains in its composition parabens, that information must be provided, and, also, the use of antimicrobial preservatives in a medical product needs justification. The guidelines also say that these types of compounds must be avoided, especially in products aimed at children, and, when they are used, their quantities should be as low as possible.  
In pharmaceutical formulations, EMAs do not restrict the use of MP since they have not been associated to adverse effects, but, on the other hand, the use of PP is restricted to a No Observable Effect Level (NOEL) of 100 mg/kg/day, due to its associated estrogenic effects.  
In general, the regulations already consider restrictions and prohibitions for the use of some parabens. In the food industry, the most common parabens are MP, EP and PP, but PP is not allowed in Europe; for the cosmetic industry the most used ones are MP and PP [22], but EP and BuP are also allowed; regarding the pharmaceutical industry, the most common are MP and PP, but the use of PP is restricted by EMA to a NOEL of 100 mg/kg/day.