Regulatory uses European Union

Similar to the US requirements, there are two regulatory steps to go through before a drug is approved to be marketed in the European Union. These two steps are clinical trial application and marketing authorization application. There are 27 member states in the European Union (as of August 2007) clinical trial applications are approved at the member state level, whereas marketing authorization applications are approved at both the member state or centralized levels. 

Internationally, the BMD approach is used by the US-EPA to derive health-based limit values (US-EPA 2007a). Within the OECD (OECD 2000) and the European Union (EC 2003), the BMD approach is also mentioned as an alternative to the traditional NOAEL approach in health risk assessment but is not implemented in regulatory toxicology within the European Union. 

It must be noted that the international regulatory organizations (World Health Organization (WHO), European Union (EU)/EFSA, the US EPA, etc.) have not established safety limits yet for PFC in drinking water. However, recently, Schriks et al. [106] derived provisional drinking water guideline values for PFOS and PFOA of 0.5 and 5.3 p.g/1, respectively, on the basis of the tolerable daily intake (TDI) values proposed by EFSA (2008). 

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