Subhead

(as of June 2017)

Introduction

A product applied on external parts of the human body, which is claimed as antibacterial or antimicrobial, can, from the legal point of view, be classified as either biocidal or as a cosmetic product. If, however, the claim or advertising explicitly refers to the treatment or the relief of an illness caused by bacteria/microorganisms the product has to be classified as a drug.

It is of critical significance to differentiate between a cosmetic product and a biocidal product that claims for the antimicrobial efficacy can be judged as secondary compared to the main cosmetic purposes in the sense of Art. 2, 1(a) of the Regulation (EC) No 1223/2009 [1]. If the product is classified as cosmetic product, adequate and verifiable proof of the claimed antimicrobial efficacy has to be provided with regard to the provisions made in Annex I, 3 of the VO (EC) 655/2013 [2]. Detailed legal requirements or binding normative standards regarding the kind and extent of such proof is, however, missing for cosmetic products. This position paper shall give proposals and assistance for choosing appropriate proof.