EU Regulation No. 1223/2009, Part III: The Responsible Person

This column is the last in a three- part series on the European Union’s (EU) Regulation No. 1223/2009,¹ which was published on Dec. 22, 2009. This series began in the August 2010 issue of Cosmetics & Toiletries magazine with a focus on the regulation’s cosmetic safety reports,² followed by a January 2011 column reviewing its additional changes,³ save for the Responsible Person’s (RP) obligations. The RP’s role is so complex that it warrants its own column, which is presented here.

The concept of the RP is not new, as Japan established this concept in 2002 (effective 2005) for cosmetics, drugs, quasi-drugs and medical devices. Based on Japanese regulations, the RP must be located in Japan and is responsible for ensuring that all cosmetics comply with regulations; the EU has taken a similar approach to ensure total compliance with its new regulation.

When lecturing about the RP, this author often addresses the same unanswered question: Is the RP a single human being or a corporate entity? The present column will first review text within the regulation to answer this and many other questions specific to the RP. Following citations from the regulation, the author provides a recap of what duties are outlined for the RP in the text presented, as well as a discusses the implications.