HELENA EIXARCH, DAVID ANDREW
TSGE Consulting Ltd., Concordia House, St. James Business Park, Grimbald Crag Court, Knaresborough, United Kingdom

Abstract

The correct classification of a product which could be both a cosmetic or a biocide (a borderline product) is essential as this will determine the applicable legal framework. A wrong product classification can lead to product withdrawal from the market and increased costs. Among other factors, product presentation can be key in the classification of borderline products

INTRODUCTION

Products such as antibacterial hand soap or antiseptic mouthwash are very commonly used in everyday life. But whereas hand soap and mouthwash are clearly cosmetic products, the fact that they have antibacterial or antiseptic properties might also lead to their classification as biocidal products. These can be then considered as “borderline” products between cosmetics and biocides. This article reviews the often subtle considerations required to push the classification of these products toward one side or the other of the borderline.

GENERAL OVERVIEW

Regulation (EU) No 528/2012 (1) defines a biocidal product as a product consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.

According to the Cosmetics Regulation (1223/2009) (2), a cosmetic product is any substance or mixture intended to be placed in contact with the external parts of the human body (epi ...